[This Transcript is Unedited]
Doubletree Hilton Hotel
8727 Colesville Road
Silver Spring, MD 20910
DR. SUAREZ: Good morning, everyone. Welcome to the early edition of NCVHS. This is an early start for our committee. We work hard and try to make sure that we use in the best way we can all the time that we have during the day. Thank you for your indulgence in coming this early to our meeting.
My name is Walter Suarez. I am the director of health IT strategy and policy for Kaiser Permanente and one of the co-chairs of the NCVHS Subcommittee on Standards. We're going to go around and do introductions. Then we're going to start our hearing and say a few introductory words. Then we will go to our panels.
MR. SOONTHORNSIMA: Good morning. My name is Ob Soonthornsima, chief information officer, Blue Cross blue Shield of Louisiana, and member of the committee.
MS. KLOSS: Linda Kloss, health information management consultant, a member of the full committee and a corresponding member of the Standards Subcommittee, co-chair of the Privacy, Security, and Confidentiality Subcommittee.
MS. PICKETT: Donna Pickett, National Center for Health Statistics, CDC, and staff to the subcommittee.
MS. DOO: Lorraine Doo, with the Office of E-Health Standards and Services at CMS and lead staff to the Standards Subcommittee.
DR. WARREN: Judy Warren, University of Kansas School of Nursing, member of the subcommittee.
DR. SCANLON: Bill Scanlon, National Health Policy Forum, member of the subcommittee.
MR. TAGALICOD: Robert Tagalicod, director of Office of E-Health Standards and Services and the CMS liaison.
DR. CARR: Justine Carr, Steward Health Care, member of the subcommittee, chair of the committee.
MS. GREENBERG: Good morning. Marjorie Greenberg, National Center for Health Statistics, CDC, and executive secretary to the committee.
MS. SQUIRE: Marietta Squire, staff to the subcommittee.
MS. WEIKER: Margaret Weiker, Hewlett-Packard, representing ASC X12.
MR. DALEY: Jim Daley, Blue Cross blue Shield South Carolina, representing WEDI.
DR. JOPP: Devin Jopp, WEDI.
MS. BUENNING: Denise Buenning, acting deputy director, Office of E-Health Standards and Services, CMS.
MS. JACKSON: Janet Jackson, Blue Cross blue Shield of North Carolina.
MS. STRICKLAND: Debra Strickland, with TIBCO, representing WEDI.
MS. SPECTOR: Nancy Spector, from the American Medical Association.
MR. ALFANO: Bill Alfano, Blue Cross and Blue Shield Association.
MS. BANKS: Tammy Banks, American Medical Association.
MS. REIMERS: Mona Reimers. I work in Fort Wayne, Indiana, for Orthopedics Northeast, and I'm with MGMA.
MR. HATCH: Keith Hatch, with Florida Blue.
MR. BURLEIGH: Bob Burleigh, representing HBMA, Healthcare Billing and Management Association.
MR. FINERBROCK: Bill Finerbrock, here on behalf of HBMA.
MS. RIVERA: Sara Rivera, California Department of Health Care Services, here to talk about the UDI.
MS. BURGESS: Marchel Burgess, California Department of Health Care Services.
MS. HAVENS: Deb Havens, with AAPC.
MS. BUCKHOLTZ: Rhonda Buckholtz, AAPC.
MR. WINKLER: Dennis Winkler, Blue Cross blue Shield of Michigan.
MR. HEBERT: Sid Hebert, Humana, representing America's Health Insurance Plans.
MS. SLAKER: Lauren Slacker (phonetic), Department of Veterans Affairs.
DR. PREBBLE: Dave Preble, American Dental Association.
MR. BROWN: Tim Brown, National Association of Dental Plans.
MS. JACKSON: Debbie Jackson, National Center for Health Statistics, committee staff.
MS. GABEL: Annette Gabel, Express Scripts, representing NCPDP.
MR. MCMULLEN: Tim McMullen, with Cooperative Exchange.
MS. MEISNER: Debbi Meisner, Emdeon.
MS. LOUIE: Holly Louie, HBMA.
MR. TENNANT: Rob Tennant, Medical Group Management Association.
MS. DARST: Laurie Darst, Mayo Clinic, representing WEDI.
MR. FIRFIR: Jordan Firfir, representing Florida Blue.
MS. CARTER: Cathy Carter, director of the Business Applications Management Group in CMS.
MS. HOLLAND: Priscilla Holland, NACHA.
MR. LAZARUS: Steve Lazarus, Boundary Information Group, representing CAQH CORE.
MS. FOESTER: Rachel Foerster, Boundary Information Group, representing CAQH CORE.
DR. SUAREZ: Thank you very much. Again, welcome.
We have a very rich and very important set of topics that we want to cover. We're going to jump into the hearing right away.
A couple of logistics. Given the time that we have in each of the sessions, we really want to make sure that we have enough time for the committee to have Q&A, so we have asked testifiers to limit their time to about ten minutes. I know Lorraine has some instructions in terms of color-coded warnings.
I think this is an exciting time for the committee and this subcommittee, because we are going to be addressing and getting into some ongoing regular activities that we do by virtue of listening to the industry and understanding the status of implementation of current transaction standards and code sets and identifiers and operating rules, in preparation for the first round of operating rules coming up later on, at the meeting next year. We are going to hear also, of course, some comments and remarks and testimony regarding ICD-10, a very significant element in the administration standardization of health care.
Then we're going to talk about three additional important topics, as you saw on the agenda:
• Dental code set updates and considerations. We're going to look at some important points about dental code sets.
• We're also going to hear about the unique device identifier and some of the developments that have occurred over the last few years regarding the identification and recommendations towards standardization of unique device identifiers. Specifically, the idea is how it relates to the administration transactions that we use in health care.
• We're going to conclude the day with testimony regarding an Affordable Care Act provision that calls for the submission by health plans of certification of compliance with all the standards and operating rules that are being adopted and that are in place. We're going to hear about what the perspectives are from the industry with respect to that compliance certification process.
Lorraine?
MS. DOO: You all are very far away this time, and so I made it simple. The last time we had several images which were very difficult to see, so I made it very easy. It's pink and green, because I like colors. The green will be when you have five minutes left and the pink will be when you have one minute left. For those of you who are speaking, your neighbors will help you. When they see the pink, they will give you a little nudge. When it comes to the zero, then I'll probably put my hand up. I do have a utility that will help me help you stay on time. That will give the committee an opportunity to ask questions.
Thanks very much. I think the order is okay with everyone. I think Debbi and Tim are going to share their presentation. We're going to start with Laurie.
DR. SUAREZ: Before we start, one last comment. I think we are utilizing for those participants who are listening in on the Web a new WebEx phone system. We're hoping that everything is working well. We have staff monitoring the process here. We're very excited that all of you are joining us out there in cyberspace. Thank you very much.
Laurie?
Agenda Item: Panel 1: 5010/D.0 and 3.0 -- Issues, Approaches To solutions and Lessons Learned
Overall Industry Update
MS. DARST: Members of the subcommittee, I am Laurie Darst, vice chair of program and services of the Workgroup at WEDI and also revenue cycle regulatory advisor at Mayo Clinic. I would like to thank you for the opportunity to present testimony today on behalf of WEDI concerning the matter of 5010 implementation and lessons learned.
Just briefly, WEDI represents a broad industry perspective of providers, clearinghouses, payers, vendors, and other public and private organizations that partner together to collaborate on industry issues. WEDI is a named advisor to HHS under the HIPAA regulation and we take an objective approach to resolving issues.
I would like to start by talking a little bit about a partnership on 5010 implementation issues.
Throughout the implementation of 5010, WEDI has been working with the industry to facilitate implementation and to identify and address implementation issues. This spring, WEDI, CMS, and private industry partners joined together to launch an online reporting tool and to hold a series of webinars to address industry-wide issues. I first want to talk a little bit about the webinars.
There were three webinars that were planned to provide a communication vehicle to the health-care industry. These included live online presentations that analyzed and discussed submitted 5010 implementation and interpretation issues and worked to identify appropriate solutions. The goal of the collaboration was to bring all stakeholders together to help bring the healthcare industry into full compliance in the implementation of 5010.
Topics discussed on the first two webinars, which were April 19th and May 23rd, included ongoing implementation challenges associated with the following:
• First, inconsistent editing of not otherwise classified codes. A few payers misapplied edits requiring descriptions for procedures codes that were truly not otherwise classified. Therefore, claims were rejecting back to the providers were for missing descriptions when descriptions were not really needed.
• The second issue we tackled was the billing provider address change impact. The billing provider address required changes to support the NPI subpart rules. A physical address is now required in the billing provider address field. The post office box and, most importantly to the providers, the lockbox address is only allowed in the pay-to address field. What happened in these situations -- in one case vendors were not supplying the right fields. In others, it was really a fear factor on the provider side, concerns that if they did not have the lockbox and the physical address, their checks would be misrouted.
• A third topic that we addressed on the webinars was acknowledgements. Many payers included acknowledgements as part of their 5010 implementation. However, a standard approach for use of these acknowledgements is needed.
• A fourth issue is interpretation and implementation of the 835 ERA. Readiness issues and lack of standardized use of the data content within the 835 caused numerous issues with the implementation.
• Extra data and redundant data sent in the claim was the fifth topic. New rules were written to reduce and eliminate interpretation differences regarding when and where data should be sent in the claim.
• Finally, we talked about how to resolve other interpretation differences o Outlined steps to resolve interpretation issues, including researching the issue with the appropriate parties, such as ASC X12, CMS. Make sure to collaborate with your trading partners, and finally, how to file a complaint with CMS.
It's important to note that each of these categories of issues was either an interpretation or an implementation issue based on stakeholder decisions. None of these were actually related to problems with the actual ASC X12 implementation specification.
The third and final webinar is scheduled for June 25th and will include the complaint filing process and addressing barriers to submitting complaints and next steps on administrative simplification mandates on the horizon.
Just a couple of comments on the online reporting tool. The online issues reporting tool allows users to submit issues associated with 5010 implementation and be able to search through a database of current documented problems. WEDI and CMS triaged issues to the appropriate parties for resolution.
Based on feedback from these webinars and the database entries, WEDI feels there needs to be a central location to log implementation issues, not only for transaction implementations, but also for other future industry implementations, such as identifiers and operating rules. Looking back, it would have been ideal to offer these webinars and database tools early in the implementation process to help facilitate the implementation of 5010.
Participation on the webinars was very successful for a number of reasons. The webinar was a free service and cosponsored by CMS. Industry stakeholders continue to seek guidance and a place to go with their implementation questions. In the future, we recommend free-of-charge and early implementation education. We also recommend there is a forum for discussion and a place to have questions addressed. Strong collaboration with CMS, ASC X12, CORE, HL7, and other entities is essential to ensure the questions are vetted through the appropriate entities on future implementations.
Now I want to talk a little bit about other WEDI efforts and our lessons learned.
In addition to the collaborative webinars and databases, WEDI has held a number of forums and conference breakout sessions over the past couple of years on 5010, and we identified a number of lessons learned:
• Many providers rely on their practice management systems vendors to educate them on transaction business requirements and the delivery of the necessary system upgrades. Not all practice management systems are providing this education or delivering the necessary system upgrades in a timely manner.
• Greater communication is needed for all stakeholders.
• There was a general misconception that 5010 only included minor technical changes. There were a number of data content business rule changes that needed business review and had significant impact on the industry. Going back to the example of the billing provider address was one of those.
• There were some health plans that took the opportunity to implement major system changes as part of their 5010 project, of which these included changes to the front-end editing systems. In some instances, health plans decided to revamp their provider enrollment process in conjunction with their 5010 rollout. These additional initiatives, while beneficial long-term, added complexity in isolating the problems when issues occurred during the 5010 testing process.
• In addition to the system enhancements, many payers implemented standard acknowledgments. Previous reports were proprietary and human-readable. In some cases the acknowledgments were not in the standard format or providers were not educated in how to read the new reports.
• There were a number of reports of call centers being overwhelmed with incoming calls and difficulty getting through to report issues.
• Errata impacted the rollout of the 5010 implementation. Many stakeholders decided to hold off on moving forward with the implementation until the errata were finalized instead of assuming the changes in the errata would be approved. Consequently, many stakeholders did not follow the CMS recommended timeline for level 1 and level 2 testing
• Finally, stakeholders cited competing priorities as an issue. Many providers and vendors focused on meaningful use, and this was a distraction to 5010.
In conclusion, we feel there are valuable lessons learned from the 5010 implementation process that should be applied to all future implementations. Early and ongoing broad education is essential, in addition to a central location to log implementation issues that are then vetted to the appropriate entity for comment and resolution. WEDI's strength is bringing all types of stakeholders together to discuss opportunities and challenges in an open and collaborative environment on issues that truly need to be addressed. We look forward to the opportunity to do this with future implementations. We also seek greater industry research on standards and operating rule implementations and would ask NCVHS to recommend to Health and Human Services that they invest funding into the industry surveys on all administrative simplification provisions. WEDI, in its advisory role, offers our support to NCVHS and Health and Human Services in achieving these goals and stands ready to assist as needed.
Members of the subcommittee, thank you for the opportunity to testify.
DR. SUAREZ: Thank you very much.
MS. DOO: Rob Tennant, MGMA.
Agenda Item: Provider Perspective
MR. TENNANT: Thanks so much. I'm Rob Tennant, senior policy advisor with the Medical Group Management Association. It's a pleasure to speak with you today on a very important issue.
What I want to do today in the short time that Lorraine has given me is talk about lessons learned from the 5010 implementation process, take a glimpse into what's happening currently. We did a survey, and I want to talk about some of the results there and offer some short-term and longer-term recommendations.
A lot of what I'm going to say is going to mirror what Laurie talked about, because I think there is a lot of commonality that the industry saw throughout the process:
• Needless to say, practices rely heavily on their vendors to make things happen. We saw a lot of issues with practice system and billing system upgrades not happening in a timely manner.
• A lot of issues about claims that were successful in the test period, but once they went into production, they were rejected.
• Certainly, problems with secondary payers and inconsistent claim edits. We heard from many health plans they would accept the 5010, push it out to a secondary, only to find it rejected.
• Certainly, a lot of issues that Laurie talked about -- the pay-to address obviously is a critical one for us.
• Crosswalk NPI numbers not recognized.
• Lost claims. We heard that a lot. Practices would call and they would find out the claims were lost, and please resubmit. That slowed down the payment process.
• Old submitter validation information not being transferred.
• Sporadic payment of resubmitted claims with no explanation.
• Protracted hold times. We heard from practices that would literally get on in the morning and have the phone on all day trying to get through to clearinghouses, vendors, and health plans.
• A lot of what I would call 5010 fog, meaning the practice wouldn't know what the problem was. They would call the vendor, they would call the clearinghouse, they would call the health plan, and everybody was pointing the finger at someone else.
I can't tell you how many calls we had to our office from practices that weren't paid for months -- in some cases more than $1 million in outstanding claims. In some practices, for the first time in 20-plus years, they weren't able to pay their rent, pay their salaries. We had, of course, advised them long before January 1st of this year to establish a line of credit. Many of them did that and ran out of that line of credit.
Practices did take action, of course. Many of them switched clearinghouses, trying to get paid. Some went back to 4010 and some even dropped back to paper.
There are a lot of challenges faced with 5010 and other types of implementations:
• In talking to health plans, of course, a lot of health plan legal teams are telling them to take a very conservative approach to avoid enforcement action.
• The insistence on perfection to be compliant, and that's certainly an issue with coordination of benefits.
• Other than Medicare, no delineated testing period.
• Certainly problems with Medicaid. We're all aware of that.
• Delays in vendor deliveries.
• And we can't forget the costs. Our surveys show that the average cost per FTE physician to move to 5010 was in the neighborhood of $16,000.
We did perform some research over the last couple of weeks, understanding that it's not a scientific poll, but rather a self-selected survey.
We asked, first of all, had you experienced any cash-flow disruptions related to 5010? You can see that an overwhelming number said yes.
We asked, are you currently experiencing any cash-flow disruptions due to 5010? Surprisingly, 40 percent said yes.
We asked, of course, what was the problem? They identified -- my apologies to the clearinghouses -- they were singled out by the majority as still causing some problems, certainly commercial health plans, a lesser number for Medicare and Medicaid and practice management systems.
The average amount in outstanding claims according to the survey: $172,000 -- pretty substantial.
Then we asked them, how confident are you that the claims you are submitting are fully 5010-compliant? Forty-one percent, very confident. But you can see here, 35 percent moderately confident, and it moved on from there.
So what can we do in the short term? Our argument is that CMS should extend the discretionary enforcement delay period through the end of the year. This would mirror what the industry went through for 4010. We had extensions throughout the year. At a minimum, CMS should permit health plans to continue to accept noncompliant 5010 transactions. As long as the health plan is willing to adjudicate the claim, there's really no reason to reject it because it isn't, quote, fully compliant.
I think one of the things that Laurie talked about was the feedback loop. We really need for health plans and clearinghouses to let practices know what the problems are with the claims as early in the process as possible. Obviously, we're coming up to the June 30 deadline. We need to know what the problems are so we can fix them on the front end, so the claims will be adjudicated.
Longer-term, obviously we need to be looking at the overlapping nature of the initiatives that many of us are going to be talking about here today. We need to have a cost/benefit analysis of each administrative simplification provision prior to its implementation. We need to pilot-test. I know there's some interest in the industry and CMS in piloting 6020, the next version. We think that's critical, and we're certainly willing to work with the industry to identify practices that would be willing to test these.
We also need staggered implementation dates. I think the fact that we're all vectored towards a single date creates a problem for the industry. For us, it makes a lot of sense to have the health plans and clearinghouses be compliant 12 months before providers. Therefore, we can have dual use. We can test. We can know what the problems are, identify solutions before the compliance data.
Again, Laurie talked about this -- improving the feedback loop. We need standardized acknowledgments. We need to have that feedback loop working in an automated fashion so that practices know exactly what the problems are.
We are very strongly supportive of certification of each trading partner. That means something akin to what Section 1104 calls for for health plans. We need certification for health plans in all areas of administrative simplification -- 6020, ICD-10 if we go forward, and operating rules.
Clearinghouses as well should be subject to certification. Therefore, we would know exactly which clearinghouses are ready and which need more help.
We also strongly recommend that the government start to work with private industry to start to certify practice management and billing system software. We have seen the success of meaningful use in their certification process. We think the same process can be applied to the billing systems. The only way practices can take advantage of these standards is if they have the software and the capability, and they need to have the confidence to purchase those that certification brings -- and, obviously, creation of a national certification registry, one-stop shopping, where practices can go to find out the certification level of health plans, clearinghouses, and practice management systems.
We need to improve the problem identification and resolution process. We need to have surveys. MGMA is happy to do surveys, but we need robust national surveys every quarter at least prior to an implementation so that we know as an industry where everybody is.
We recommend moving towards advanced payment policies so practices have cash as they move into the implementation period and don't experience the kinds of cash-flow issues that we saw with 5010.
We recommend naming a HIPAA ombudsman, where you could have a centralized point for problems and, potentially, an office of a national coordinator for administrative simplification. We have that for HIT. Admin simplification is just as important. It has the opportunity of saving the industry billions of dollars. We need to be a little bit more aggressive.
Of course, a more proactive enforcement approach that is not driven strictly by complaints -- we need to have the types of audits that providers experience with RACs and others.
In summary, the industry faced significant problems migrating to 5010 -- not a surprise. Protracted and expensive software, as I mentioned, the fog -- we experienced that. We continue to experience 5010-related problems, mostly due to clearinghouses and health plans.
Short-term, extend the enforcement delay or at least allow health plans to accept noncompliant transactions, and longer-term, revise the process.
Thank you so much.
MS. DOO: Perfect.
Jordan?
Agenda Item: Health Plan Perspective
MR. FIRFER: Hello. My name is Jordan Firfer. I am the director of provider connectivity services for Florida Blue, with primary responsibility for managing and monitoring the effective and efficient processing of HIPAA transactions and, of course, ensuring continuity for all the tools, services, internal or external, that rely on those transactions.
To give you a flavor of where Florida Blue sits against other payers that may provide you with their experience, Florida Blue is the largest health plan in Florida, with approximately 102 million members, with 24 million included in national accounts.
Rather than focus on a majority of the primary issues that many payers -- in fact, all of the constituents across all of the layers of submission -- instead of focusing mainly on the issues we faced, I'm going to focus a little more on lessons learned and what worked for us. Relatively speaking, Florida Blue had a pretty good experience with the migration.
Like all of us, we had the same challenges as everyone else. In addition to the ones eloquently stated by Laurie and Robert, our goal was to:
• Ensure operational efficiency and effectiveness.
• Make sure that we continue to have quality reporting accuracy.
• Of course, maintain compliance with industry regulations, corporate policies, and procedures, which was a challenge.
• Strategic alignment with the industry. I'm going to go into that. It falls under collaboration.
• Ensuring confidence at the provider, trading partner, and member level.
Florida Blue took -- I wouldn't call it unique, but an approach that we didn't see very common in the industry, and that is a production validation process, which is really a controlled migration. What this allowed us to do was to identify that a certain percentage of our overall providers actually accounted for a majority of our submitted claims. So we took that group and allowed them to submit in chunks, if you will, 5010 claims, sometimes mixed with 4010, sometimes independently. We were able to allow these to flow in what we called flash cuts and evaluate any issues that might have occurred and then report back to them through a very strong collaboration effort -- again, a controlled migration, which, of course, required a dual-mode production environment, that allowed submitters to submit 4010 claims ahead of when they believed they were ready to get a feel for us.
Why did we do this? We did this because one of the primary complexities was that Florida Blue, along with a lot of other payers, did not have a true end-to-end testing environment. We hadn't been put through a circumstance where we actually had to account for the time it leaves the health-care provider until it returns back to them. The only way to really accomplish this effectively was to actually push it through our production environment and through effective monitoring and evaluation, business continuity efforts, to ensure that that didn't affect our actual product flow. Of course, we limited the initial claims that they would submit to a very small number -- it could even be six to a dozen -- and then slowly ramped those up through additional flash cuts with specific providers.
We did have criteria for participating in this flash cut testing:
• Number one, the top submitters came first. When we say top, we don't mean VIP, we mean by volume.
• Secondly, they had to have some sort of ability to submit 5010 to us, either in a mixed mode or be able to flip back and forth as necessary.
• Have their agreement that, once the turned on 5010, if we found any issues at all, they would be able to effectively flip back to 4010 while we resolved the issue with them and then turn it back on for another flash test, until we knew we had it right.
Although we focused on our top-volume submitters first, we did actually go back to smaller submitters upon request and/or provide confidence to smaller submitters that we had gone through this testing with some of the larger volumes to increase their confidence.
We did engage a reusable process that we called business continuity monitoring. The primary purpose of this process was to proactively keep an eye on our claims flow -- I should say, transactional flow, because it's more than just claims. What does this mean? This means engaging in trending. As these claims would flow through our system, whether it's the 5010 claims that were flash-cut or the 4010s and 5010s that were already going through our system in live production -- to actually look at the submission stats, look at the error ratings and error volumes every day. We created a specific criteria evaluation system that allowed us to rate them in a numerical system and determine how critical they were to our continued production. So the ability to use data and analytics to predict issues before they occur was absolutely critical to making this flash-cut in production succeed.
We talked a little bit about the remediation management of business disruption. One of the things we did through this business continuity process was that we actually, every day, produced a list of the top errors we were seeing across specific providers. We were able to single out, for example, the PO box issue, ones that were industry-wide and were affecting every provider that tried to submit through us and ones that related to specific providers that we could hand-hold with them, their clearinghouse, their vendor, and walk them through resolving some of the issues that they were facing.
We also had -- which was very, very successful -- open-line Fridays. These open-line Fridays were open calls with all of our providers, vendors, submitters, other health plans if they felt like they would find value in joining the call -- all of the layers between the provider and the payer and back. They were heavily attended. We used that for troubleshooting sessions across multiple folks. The calls were more complex at first, but after a few calls, when people began to realize that everybody was facing the same problems, including their vendors and clearinghouses, the calls became very, very productive.
In addition to that, we had internal-line Thursdays. These calls were for all of our internal stakeholders to get together, understand all of the issues that our providers were facing, what topics we were going to talk about on the upcoming call, and also talk about the remediation efforts we were going through to ensure that errors and issues were kept to a minimum and provider were being given the most information possible.
Of course, we also engaged something called the dynamic edit management process. We determined a methodology for being able to flip specific edits on and off, sometimes for a short period of time, sometimes a longer period of time. We would go through this analysis, this business continuity management analysis. We would work with compliance to determine a plan to eventually flip the edits back. This allowed us to get claims into the system at a high rate, with a high success rate, while working the longer-term solution at a better pace.
If there was one term that I would use for both past and successful implementations of this type, it is "collaboration." Collaboration was absolutely key across the entire company. This included everything from finance and clinical review, project management, to clearinghouses, provider third-party billers, vendors, practice management systems, other payers. We engaged in very serious, continuous collaboration and created a special HIPAA 5010 team that was doing the business continuing management and focusing on this very, very high level of collaboration.
Additionally, we had a very strong governance process in place. It is absolutely critical that you have buy-in from the top down and from the bottom up. From the very beginning, we had an executive sponsor that was a high-level executive within the company. We had a steering committee, where the majority of folks were vice presidents and directors, governance committees, which had the leaders from all the various stakeholders in the company. We had a special HIPAA 5010 team under provider connectivity solutions that focused on this every day. Then we had an IT project team. All of these levels of governance that as we had issues in those flash-cuts, we were able to shoot up those issues right away. If there was funding or dollars that were necessary to get them fixed, there was nothing standing in our way, as long as we could represent the issue clearly.
What were the benefits? We have a plethora of reusable processes, from the PDP process, this controlled migration, to a criterion for rating issues, our collaboration components, which will absolutely be in place for ICD-10, new levels of trust and collaboration. We have already heard from providers saying, when are we going to start up those calls again? We can't wait. We learned so much. All of these things really played well into what is to come, whether it's 5010, ICD-10, et cetera, with the exception of how applicable a controlled migration may or may not be, depending on the mandate.
Some of our results: At the beginning of the year, we saw results as high as 84 percent for claims, but now we're seeing pretty much 100 percent across the board. Unlike some of our payer peers, whether or not we have an extension may or may not be as valuable, because we are also working with our clearinghouse and having a lot of success with the up-coding process for those providers that aren't ready.
If I could state a few key components, the few key components for success are -- there are four of them. One and two would both be collaboration. Focus on it once and then focus on it again, using data and analytics to monitor the process, and make sure that you start early. We started in April of 2011. If we could do it over, we would have started even sooner.
Thank you very much for the opportunity to speak about the lessons learned from Florida Blue around the 5010 implementation.
MS. DOO: Very good. Thank you so much.
Cathy Carter.
Agenda Item: Medicare Fee-for-Service
MS. CARTER: Thank you very much. My name is Cathy Carter. I'm the director of the Business and Applications Management Group in the Office of Information Services at CMS.
My general responsibilities, aside from the implementation of 5010 for fee-for-service Medicare, relate to managing to all the systems that relate to fee-for-service -- the claims-processing systems, the eligibility query systems, cost-report data collection systems, Medicare appeal systems, and things like that.
Today's agenda: I was asked to cover these points. Our agenda goes basically in this order.
How well did the implementation go from a Medicare fee-for-service perspective? I have heard lots of things here I could probably echo. I'll go through this really quickly. Like many payers, we leveraged this implementation to expand all of our systems and databases and space for ICD-10. That was really the most difficult initial piece, but that was not really so much the public part of it. That was something that we took a couple of years -- actually, we started in 2008 trying to get ready, I believe, 2008 or 2009, for this implementation.
Based on the timing, we had another challenge. The Medicare administrative contractors, I'm sure you know, are being implemented. We are nearly at the end of that journey, at least for the first implementation. So we decided, based on the plan timing, that we would not upgrade the legacy FIs and carriers to do 5010. That was a good decision at the time, but it turned out to be a challenge later, because we had some delays and we had to put in place contingency plans more or less late in the process.
Medicare fee-for-service was one of those. We did eliminate the use of proprietary acknowledgments for claims submission. We shifted to the national transaction for that. That, in fact, was a challenge, but it was a benefit as well.
Medicare did also adopt a new front end for our claims-processing environment. I'm sure many of you actually are aware of that. I think in the long term, it certainly is going to be a good thing and, in fact, is a good thing now. It did present some additional challenges. The goal was to actually edit the claims as much as possible before putting them into the internal part of our system, so that they could be rejected up front.
Medicare also adopted standardized companion guide formats across all of our different systems, and we created quite an extensive testing process -- 17,000 test and use cases -- in order to do our internal certification process. We did this mostly because we were trying to standardize our front end and we needed to do those test cases to make sure that everybody was coming out with the same result across all of the Medicare administrative contractors.
We would, actually, for Medicare, prefer that only one translator be used for all of the Medicare administrative contractors. We didn't get that far. We did reduce it to three. That was a help, because we only had to deal with three translator companies when we had issues to resolve as part of the implementation.
We also post our edit spreadsheets. We are being very transparent. That new front end that I was talking about -- we post those edit spreadsheets every quarter, the changes to those, the updates to those, on our website.
The concerns: I think submitters generally, whether they were providers or vendors or whoever, waited longer than they should have, in spite of all the outreach efforts. We didn't receive our first test files until May of what was supposed to have been the testing year. The errata, of course, delayed things. It delayed Medicare as well, not just everyone else. So we made a decision not to actually be in production and ready until then, so that we could have a consistent across-the-board readiness.
Industry interpretation -- you have heard this already from others -- varied across the industry. People really do need, in fact, to agree on definitions and usage of those definitions.
This was one of the benefits, but it's also a concern. We were very ambitious in our implementation of 5010 by changing a lot of business processes. Again, I think it's a good long-term result. It was definitely a challenge while we were doing it.
Medicare did, in fact, use the same time period for re-verifying the enrollment of clearinghouses and providers in our EDI enrollment systems. This did cause some confusion. The communication on that was either misinterpreted or not done correctly or whatever -- a combination of those things. So that was a challenge.
We received, of course, some congressional inquiries, as we always do, as well as other kinds of inquiries. But overall I think it was really a very small volume, considering the 1.2 billion claims that we process every year. Many times -- and again I hate to pound on the vendors and the clearinghouses, but what we found was -- we kept directing providers to their agents because many times it was actually something we couldn't deal with. It was something the clearinghouse or the vendor had to help resolve. We would like to recommend that more testing be done prior to adoption of new standards.
We were asked specifically to opine on the value of an enforcement discretion period. There's just one bullet there, which says, double-edged sword. It's always nice to have extra time. Every time there is a delay announced, we would lose momentum, and it's very difficult to get it back.
Important technical issues: You have seen these before. These were challenges where we had to really do education over and over:
• Post office box issue for the billing provider. That was a huge issue.
• The nine-digit zip was a big issue.
• The modification which allowed the new diagnosis codes.
• Present on admission. Medicare had an additional issue here, I think, because we implemented that even prior to 5010, and so there was a change to that process.
• The errata adoption process and the education around that.
• Claims payment advice, the remittance advice we had. There was a lot of education that we did on interest and payment discounts through our national provider calls.
• The advance payment and reconciliation process.
• We had to provide a lot of guidance about the claim adjustment reason codes and remittance advice remark codes in order to standardize usage.
We had sort of a concurrent project that has actually been going on for some years now. Those were also education al points that we covered.
Our lessons learned:
• Communicate early and often. We had lots and lots of calls. We counted up a quarter of a million members of the health-care industry present on those calls over that year-and-a-half-or-so period. We had internal weekly status calls with over 100 participants in the program, all the vendors and all of our contractors.
• We did obtain support at the highest levels of our agency in order to implement the changes for 5010.
For lessons learned, one of the issues on D.0 -- I just would like to say that we have very little claim activity with this transaction, about 40,000 claims, compared t our 1.2 billion. We're looking at that to see if we really have to continue that. We spent a lot of money and effort upgrading everything for that transaction, and we barely use it.
I think that's it. Thank you very much for the opportunity to speak with you today.
MS. DOO: Thank you, Cathy.
Next, Debbi Meisner and Tim McMullen are going to do a joint presentation from the clearinghouse perspective -- I guess clearinghouse and vendors.
Agenda Item: Clearinghouses/Vendors
MS. MEISNER: Good morning, members of the subcommittee. My name is Debbi Meisner. I'm the vice president of regulatory strategy for Emdeon, along with Tim McMullen, who is the executive director of the Cooperative Exchange.
We would like to take this opportunity to thank the subcommittee for allowing us to present the clearinghouse perspective in the 5010 implementation, approaches to solutions and lessons learned.
I'm not going to go through our bios. You can read those in our package.
What we're going to try to cover today is our perspective on the need for a transition period, the one-thing-at-a-time syndrome that we felt contributed to the problems, policy changes that took place between one version and the next that caused some issues, acknowledgments, some issues we faced with the MACs, and then talk about the industry calls.
On the need for a transition, the main challenge that the health-care industry faces is the number of regulations that must be adopted in a very tight timeframe. However, another challenge is the asynchronous way that the industry implements new versions. Typically, the large providers and health plans are ready to begin testing long before their smaller counterparts are ready. This creates problems when trying to account for new, deleted, and modified elements, as well as code values. Much of the industry is dependent on clearinghouses and vendors to help them manage the transition from one version to another.
It is also important to note that in order to complete testing and implementation with the vast numbers of health-care entities, trading partners may choose to be early adopters, going into production prior to the compliance date. This poses some challenges in the upward and downward compatibility of the transactions.
There are two common flows used by trading partners. Certainly there are other variations, but these are the two most common. The first is a direct approach or pass through, while the second provides up-and-down mapping from current versions to new versions. Each presents challenges during the transition period from one version to the next. The current approach to developing and implementing the new or modified business requirements assumes that the changes will be implemented all at the same time without any consideration for the asynchronous way the industry handles these changes.
This just depicts the direct approach, where both the receiver and the submitter need to keep track of what version the other is on and make sure that they submit the correct version. Each trading partner needs to keep both versions going at the same time. The burden of knowing which version a receiver is able to accept is placed on the submitter. In this case the receiver also has to keep both versions up allowing submitters to send transactions on either one.
In the second version, there's an intermediary or a clearinghouse in the middle. The submitter and/or receiver of the transaction only support the current version or the future version, but not both. In the case of a submitter, a file is transmitted to an intermediary, or clearinghouse, containing transactions going to multiple receivers. The transactions are up-converted when received in the older version going to the receiver on a newer version or down-converted when received in the newer version going to a receiver on the older version. In the case of a receiver, a file is transmitted from an intermediary containing transactions from multiple providers. Again, the transactions are up-converted or down-converted depending on how they were received and what the health plan expects. This approach allows for implementers to go into production with the newer versions regardless of where the submitter/receiver is in their implementation, thus supporting an asynchronous implementation over a longer period of time.
Our recommendation is to allow for this staggered approach. To provide a smooth transition and allow the industry to implement in a staggered way, there should be a grace period to transition the change to span over two versions of the transaction. When adding or modifying an element, the use must take into account that the older versions cannot accommodate the new information until the software is updated and the data entry staff is properly trained. Deleting elements must consider the early adopters who will not have a place to put the information if it is removed. Translator products should build the edits and logic to take the transition period into account, making the requirements date-driven.
Emdeon has presented this concept to the ASC X12 management team and it is under consideration as guidelines for future versions of the implementations.
I have included the full recommendation in my written testimony in the appendix, if you are interested in the devil in the details.
Our next issue is this one-thing-at-a-time. During the implementation of the first set of transactions named under HIPAA, the industry was faced with a new way to format the transactions, moving from flat files to the variable-length formats, using qualifiers and syntax rules to govern the way the files are created. Many stakeholders recognized the need to implement the transactions in a phased approach, making it easier to test and determine the root causes of the problems.
The formatting is to ensure that the files are syntactically correct and that the content is placed in the right place within the transaction, where the content is based on the business needs to ensure that the new content and codes are supported in the application systems and placed according to the implementation guides. Then adding on the next layer of enforcing the logic as the industry moved closer to the compliance date.
Focusing on each aspect independently allowed for the continued growth of EDI and reduced the risk to provider cash flow. With the implementation of 5010 the industry was faced with multiple changes being implemented simultaneously. I think we heard some from Cathy in her testimony. Not only were there changes to formats, there were also new policy changes introduced along with additional data requirements. To add to the complexity, the industry embraced the use of acknowledgments at the same time.
Our recommendation on this is that regulations should establish milestones for new initiatives that allow the industry to stagger the implementation over a transition period focusing on one piece of the project at time. Focus on the syntax: Did you get it right? Next, focus on rules for existing content. Experience shows that not all products are equal. Finally, focus on the new content when business use is applicable.
The next issue is the introduction of policy changes. The major problems we encountered were the result of the 5010 transactions aligning with policy changes that occurred between the publications of the two versions. We have already talked about the billing provider issue that was really just aligning with the NPI regulations that had come out years before. Unlike other changes, this change was not one that could be fixed by the software vendor and required the provider to become actively involved in the resolution. State regulations occur on a different schedule, requiring workarounds in some cases, and health plans' policies changes over time to support their customers' needs. All of these changes that occur between versions can create the perfect storm.
Our recommendation is that when policy changes go into effect, the transactions should be updated to align with the policy. For example, the 4010 guides did not fully support the regulations set forth under the NPI rule and the industry did not make all of the necessary changes. We encourage HHS to work with the standards development organizations to ensure that any changes to the transaction guides are implemented at the same time as the new policy. Although this will require errata, it will help the industry adopt the policy changes in the expected timeframe and make the next migration easier.
What our experience showed was if the information is in the implementation guide, the perception is the industry must abide by what is published. We will be facing this with the HPID and should learn from this experience.
Finally, what I would like to talk about are the acknowledgments and how they contributed to what Rob has named "the fog."
We absolutely support the use of acknowledgments and encourage our trading partners to return the acknowledgments for all transactions. We agree with the need for standard acknowledgments and encourage CMS to adopt standards moving forward. However, the industry must recognize that acknowledgments must be part of the analysis, development, and testing cycles.
Our experience showed that many of our trading partners used the pre-packaged 999 in their translator software without testing and had no idea what the results were going to be. This added confusion to the issue resolution in trying to determine whether the transaction had errors or the 999 was at fault. During the 5010 testing phase, we found that errors in the 999 where mandatory data content was missing prevented us from parsing and distributing the acknowledgments to the providers, causing the fog. This issue was a negative impact to cash flow while we worked with the health plans to solve the problems.
We also experienced inconsistent use of the 999 versus the 277, and we found that the 999 was used to reject files that contained claims where there were no errors. Our implementation of the 999 for claims limited the rejection of files only to catastrophic errors in the file, and we would encourage the industry to do the same.
The inconsistent use of the acknowledgments required a lot of manual processing of many of the acknowledgments until coding could be implemented to account for the variety of uses, slowing down the move to production in many cases.
Our recommendation: We encourage CMS to adopt a standard approach to acknowledgments. When deliberating on certification, we encourage you to consider certification for translator products to ensure consistent use of the transactions. The industry guidance must stress the need for testing of the acknowledgements as part of the implementation cycle. This testing should be done internally prior to external testing with trading partners to avoid delays.
Now I'll turn it over to Tim for a few more issues.
MR. MCMULLEN: Thank you, Debbi, and thank you, committee, for having us here today.
My name again is Tim McMullen. I'm the executive director of Cooperative Exchange, which is the recognized resource and representative of the clearinghouse industry for the media, governmental bodies, and other outside interested parties.
Today I am going to focus on issues our clearinghouse members had with -- one of the bullet points at the beginning was testing Medicare administrative contractors, or MACs, and industry calls.
This is not a complete list. I do have in my written testimony an appendix that will have a lengthy list of lessons learned.
Also at this time, I want to commend Lorraine Doo and her staff for bringing Cooperative Exchange, WEDI, MGMA, SSI, Emdeon, and a lot of other stakeholders together to conduct those collaborative webinars which Laurie was talking about earlier. We really believe that this is a good model, and it should be implemented in the future.
I'm going to talk, first of all, about testing in and of itself because of the issues that happened during just regular clearinghouse testing with partners.
In some respects, testing prior to the implementation date was a mirage. Varying scenarios that payers accepted made testing inconsistent, and other lingering 4010 issues complicated testing. Trading partners were unaware that some payers tested 5010 transactions in the then-current 4010 platforms, and provided approval for production. This resulted in high rejection rates once the payers went live with their 5010 software updates.
All trading partners should have coordinated activities to allow implementation and testing of internal software changes prior to the initiation of external trading partners testing at least one year prior to the mandated effective date. All trading partners should have tested systems in place with the capability of conducting software/hardware tests, but also the capabilities of simulating testing of the new requirements with trading partners. Some of the payers utilized a ramp manager testing system which was not identical to the production environment. Clearinghouses need the payers to be forthright and confirm the actual platforms being tested.
Lack of communication from payers regarding edits and requirements impacted successful 5010 transaction submission and compliance. Some payers don't even have testing systems at all, which further impacts prevention of issues prior to production.
We also believe that the industry needs to include revenue management systems in the testing process. As mentioned by Jordan, true end-to-end testing through actual claim adjudication will be necessary for any regulatory implementations, such as ICD-10, to be successful.
Let me talk a little bit about the testing days, which actually provided important feedback. The data from testing days was used to refine implementation approaches and reduce production issues.
However, there was a lot of ramp-up to getting ready for those testing days. Reenrolling every Medicaid provider's NPI and Tax ID with their state prior to the test date for electronic submission stressed already stretched resources. NHIC, Palmetto, and Trailblazer had an extra PTAN requirement, which is a data field that clearinghouses don't regularly utilize, and which caused delays and added unnecessary work. The process of reenrolling took two weeks and added additional workload to the personnel already managing the regular testing duties.
We agree that testing days are necessary and bring value. We suggest a collaborative effort with government and industry to begin monthly industry test dates starting a year in advance until the compliance date. This is similar to what Debbi was talking about.
It was nice to see that Cathy recognized that there were some inconsistencies with the MACs. Some of the MACs accepted dual versions 4010/5010. Some did not. There were different acceptance days, and some are still not accepting as of 1/1. Some may not be accepting at all still. There were different enrollment requirements and different rejection codes. Medicare fee-for-service, we believe, should do a better job managing the MACs by more quickly addressing issues that were identified -- i.e., phones not being answered or providers not being paid. Also we believe that CMS/OESS and the central Medicaid office should do more to manage the state Medicaid agencies, and more quickly address issues that were identified with the states and hold them accountable for noncompliance.
Just quickly, there were a number of Medicare fee-for-service teleconferences regarding the status of 5010 implementation compliance. The one thing that, of course, is very important during any of these calls, even the calls that WEDI has, the industry calls that Laurie was talking about earlier, is that the question-and-answer portion, which is very important, was never transcribed or put up on the website, and so we never had a chance to really follow up on those issues. We just would recommend for those to be done a little more quickly.
Thank you again for giving us the opportunity to share our lessons learned and present our recommendations.
MS. DOO: Thank you very much.
Next on the agenda is Holly Louie, with HBMA
MS. LOUIE: Thank you. Good morning, members of the subcommittee.
There's one advantage about going last. I could just say, what they said. But I do have some points I would like to make.
As Lorraine said, I'm with the Healthcare Billing and Management Association. Our members process, as a conservative estimate, 350 million claims per year. We think that makes us somewhat qualified to speak to these issues.
Our organization would also like to extend a special thank-you to Lorraine and Denise Buenning. They have really made themselves available, accessible, and really worked hard to help our organization when problems arose. We do thank you very much for that.
I suppose one could flaunt the "I told you so" mantra for all the hiccoughs and hurdles that we have just heard discussed and that we experienced, although I don't know that that's particularly helpful. I think the more important message is that those of us around this table who live and work in the operational implementation trenches foretold, knew, understood, and were proven correct on virtually every concern we have expressed in testimony, articles, publications, and also to this workgroup and subcommittee over the last three years.
As you know, while some claims processing by some payers was very smooth, there were also disruptions so significant, the provider or entity had their very survival threatened. We have heard that some practices or entities simply had to close because they could not survive for lack of cash flow. Even when claims were eventually paid correctly, a delay of weeks or months created untenable and unnecessary hardship.
So what could we have done better? It is our belief that the need for contingency plans and delayed enforcement could have been avoided completely if some solid business premises had been developed and required of the industry at large.
First, "5010-ready" was a completely meaningless term. It meant any number of things that were idiosyncratically determined by whoever was talking, and none of them, hardly, with few exceptions, meant through, as Jordan described, full, real adjudication of a live claim, as it was going to be processed in the real environment. As a result, the health-care industry had no idea who was able to correctly process claims and issue payment using the 5010 standards until we were in that live claims environment. Unfortunately, that was way too late to correct the problems and/or avoid the payment disruptions.
We believe that anytime a complex, multistep process involving a series of events this complex and numerous participants -- the terminology has to be clearly defined, clearly understood, and used accurately and consistently.
HBMA recommended then and will continue to provide a definition of "ready" that we would like the industry to adopt so that we all are speaking the same language and know what it means. That definition has been provided for this group.
Next, successful testing was a misnomer. Testing was quantitative, not qualitative. We heard over and over terms like 60 percent are testing successfully, 10 percent aren't going to make it. It sounded pretty good, until claims processing started in the live environment -- or didn't. Because testing was at such a high level and the test environment did not accurately represent what would happen with real claims, many had a false sense of security. In many cases, testing was, quote/unquote, successful, but ongoing payer programming changes were not shared. Suddenly claims that had been successfully were denied or rejected. Like "ready," successful testing must be at the live, claims adjudication level.
To compound the testing problems, most payers tested the 837, not the 835.
The final straw was the profound lack of transparency. What we have learned is that multiple vendors, clearinghouses, payer hand-offs, et cetera, handed off to another entity that was not disclosed or not known in the chain. It was a hide-the-pea shell game. You though you tested successfully. Suddenly you had a problem and subsequently learned there was another clearinghouse or another vendor in the story that had not been disclosed.
All of those parties must be openly and honestly transparent, because each of them could be the source of the problem.
While we recognize that progress will not always be simultaneous and reasonable latitude must exist, allowing any schedule for testing, by default, creates no schedule for testing. If real testing of live claims had been required on a standardized schedule, these problems would have been known in adequate time to remediate them and avoid the disruptions.
For all future updates and changes of this significance, we strongly recommend allowing enough time to test adequately, correct problems, retest and revalidate as many times as it takes before implementation. The process that Jordan shared would be very effective, I believe.
The go-live date also was whatever any given payer decided they wanted it to be. Although January 1, 2012 was the implementation date, we experienced actual go-live dates that varied from significantly earlier to significantly later. Obviously, this created myriad additional problems for the industry.
Mandatory changes should have one implementation date for everybody involved, not whatever somebody decides.
5010 wasn't a technical problem with a technical solution. We talked about that at this committee several years ago. As predicted, many of our physician clients did believe this was a technical problem their vendor or their clearinghouse or their practice management system would just solve for them. After all, what we heard was, how hard can a few programming changes be?
While we applaud the education CMS and others prepared in the diligent efforts of virtually all of these professional organizations, the fact is that most physicians did not really understand how 5010 or 835 or 837 or any of the other technical lingo meant anything in their actual practice.
Major problems were not anticipated. We have heard about the post office box as the practice address over and over. That was very common for physicians who did not have an office or certain specialties, like psychiatry, who did not want to use their home address on a claim. So the cry of "how could this have been allowed to happen" came way too late.
We believe that too few stakeholders that really understood that environment got to participate in the standards setting and resulted in these issues.
Specific to one of the questions Lorraine spent about eligibility, claim status, our members are experiencing very few payers supporting these additional standards at this time. Typically, it is just the minimum requirement.
Lastly, in addition, of the current standard remittance remarks and explanations, many of our payers only use a tiny subset of the codes available in the standards, so a denial for medical necessity could really be a preauthorization issue, an exceeds-benefits issue, or any other number of real reasons. While insurers are technically compliant by using standard codes, they are tendering useless information that may have been more clear in their legacy codes.
We strongly encourage mandatory of use of all of the standard codes and accurate reporting in the adjudication determinations.
Thank you very much for your time and attention.
MS. DOO: Thank you very much, Holly.
Now we have Annette Gabel, who will talk about D.0 and 3.0, I'm assuming.
MS. GABEL: D.0, 5010, and 3.0, right.
Good morning. My name is Annette Gable. I'm with Express Scripts. I'm here today representing NCPDP.
We submitted two documents to the subcommittee. One went into a little bit more detail. I'm going to be going through today the presentation, which pulled some of the items from the detailed documentation.
For those of you that are not aware of who NDPDP is, we are an ANSI-accredited standards-development organization. We're particularly focused on health care as it relates to pharmacy business solutions.
We have a committee at NCPDP. We still maintain our SNIP committee, which is the Strategic National Implementation Process Committee. We got together to go through the information that NCVHS was asking for so that we could provide the information to the subcommittee.
As we looked through how the implementation was actually going forward, the 5010, the D.0, and the 3.0, unfortunately we did not have a survey that was sent out to the industry, so what we are providing here are our best estimates. So far what we know -- and this is a little out of date, so I think the numbers are a little better -- is that the industry information indicates that greater than 96 percent of pharmacy claims are being submitted in the D.0 standard. I think that number has increased in the past few weeks, and we are probably closer to 99 percent. What is interesting to note is that what we have heard from some of the pharmacies is that they will be submitted on July 1, and they are not submitting sooner. Even though the percentages look like, we have indications that they will be compliant by the first of July.
As far as the 5010, we have found that the majority of trading partners have completed installation of 5010. For my organization, we actually stopped processing 4010 back in December, which I think helped push the industry into where they needed to be for the January 1 compliance date. I think by us forcing that, a lot of the entities then started to get on the ball and move more quickly to implementing the 5010 standards.
As far as the Medicaid subrogation standard, which is the version 3.0, we have indications that everyone is processing and using that standard.
We were looking at one of the questions. It was related to what we thought was the most important business or technical issues that might still be remaining for the transactions. The only one that has been brought to our attention is related to multi-ingredient compound submission. Basically what the change was from -- and it's not really a change, because it was available in the 5.1 version -- it was available in a method where there were two other methods, and the method that was being used in the 5.1 standard was actually to pull the most expensive legend ingredient and submit that on the claim. With the D.0 transaction standard, that opportunity went away, and the pharmacies were required to submit all of the components, all of the individual ingredients that went into the compound.
That provided some interesting situations, not so much from the standard, because the standard accommodated what needed to be submitted, but it was more around the business practices. There are still to this day a lot of different business practices which occur between the pharmacy and the processor-payer. The pharmacies are having some issues related to what the rules are for the submission of compound billing.
NCDPD has been providing guidance to the industry, basically related to what the correct use of the transaction standard is. We put together some questions that have come into us from our Frequently Asked Question Task Group. We have been discussing compounds, providing recommendations back to the industry as those questions are coming in. As a result of that, the NCDPD version D.0 editorial document has been updated to reflect those questions and answers that have been approved by NCDPD, so it gives an opportunity for those individuals who are still struggling with the transaction to go and look at that information. Hopefully it will help them with processing.
We're also going to be working on a white paper to assist the industry with additional guidance. That's one of the things that they have asked us to do. We formed a new task group which is specifically concentrated on specialty and compound pharmacy work items. Later on, after we get all this information together, the NCPDP SNIP committee will be holding another webinar to see if we can get that information out to the industry.
Then we were asked to discuss the two or three lessons learned from the transition. Obviously, we went a little bit beyond the two or three lessons learned. I'll quickly go through this.
One of the things that was observed by NCPDP was that the entities that actually participated in the meetings, those that attended the webinars that we held, and those that participated in the workgroup and task group meetings had a higher level of success in installing the revisions that were required for the new standards. Those that participated in the development had a better understanding, broader knowledge of why the changes were being made, what was required for implementation. Where there was lack of participation, it resulted in a lesser degree of success and a higher incidence of complications while implementing the standard.
Basically, what we're recommending is, from a CMS communication effort standpoint, we need to engage all entities, and specifically those that were identified this round as outliers, to get them involved earlier in the process.
Although the regulations included different stages of compliance, some entities within the industry did not adhere to the stages. This resulted in those entities not working through the transition period and subsequently were not ready prior to or as of the compliance date.
NCDPD had created a payer sheet template, which is similar to the companion guide on the X12 side of the world. We updated it and spent a lot of time on it. We thought that would help the processors communicate the requirements in a standard format to the providers, but what we found was that we could potentially provide more instructions than we had actually provided when we created these payer sheets.
You asked, is there anything we would like to bring up as it was related to the implementation of the new standards? What we have, as a group, determined is that -- and I don't think this is anything that anyone else probably isn't aware of -- due to the other industry required implementations that were occurring at the first of the year, some of the entities were not ready to comply, because they had other existing priorities. It was recommended, if possible, that we stay off of a compliance date that's associated with a January 1 date.
NCDPD's education and outreach for the new standards did begin in 2007. We started very early. It consisted of surveys, webinars, presentations at industry events. We did create white papers.
The NCPCP telecommunication FAQ and coordination of benefit task groups has responded to a significant number of questions, and we continue to respond to questions that are now related to implementation issues.
As a result of industry education and communication efforts, as well as the defined stages of the HIPAA transaction standard regulation, the industry achieved a better rate of compliance. I believe at this time we are in much better shape than we were for the last round of HIPAA. I think that's pretty obvious.
As I mentioned earlier, we created a payer sheet template, which we thought would help to communicate the information that the payers were looking for the providers to supply on the claim. As I said, we believe that a lesson learned for the industry was that, although we tried really hard to make this an easier process, we made it a little bit more confusing than it needed to be. We will be updating the implementation guide and providing additional guidance about how to complete those payer sheets.
The other recommendation we came up with through the SNIP Committee was that maybe -- because we know that everyone has to purchase the implementation -- maybe we should add some language to the front of the implementation guide that encourages the individuals to stay involved in the industry discussions, to be aware of the implementation issues and resolutions as it regards the industry implementations. The editorial document, we believe, will provide guidance on industry and implementation issues.
NCPDP, with their next version -- whatever version we determine we will be moving forward with for the next recommended standards -- we will update the implementation guide to include this information.
That's all I have today. Thank you very much for allowing me to present.
MS. DOO: Thank you, Annette.
That is the end for this panel.
DR. SUAREZ: Thank you again very much for preparing this very comprehensive review of perspectives of where we are with 5010 and D.0 and 3.0.
I'm going to open it up for questions from the committee members. Go ahead, Judy.
DR. WARREN: This is for Rob Tennant. In your presentation -- and other people mentioned it as well, so after you respond, if anybody else wants to chime in, that would be good -- you mentioned that you had completed successful testing and that, after the testing, when you went to go live, you still had problems. Could you talk more about what wasn't covered in the testing that led to those problems? I'm trying to get a handle on -- we thought we tested, and it sounds like we did, but it still didn't work.
MR. TENNANT: That's a good question. I think it had a lot to do with the edits in terms of what the clearinghouse and the health plans were accepting. Things may have changed. Plans may have changed their policies. Again, it get backs to the point that it's very confusing to the provider to try to understand what's happening with their claim. I think we heard from a number of folks that the acknowledgment issue is going to be critical, because that's the feedback loop that we need from the clearinghouse and the plans.
But the critical point is, a lot of practices can't even accept the acknowledgment transactions, especially the smaller ones. Their software just simply can't handle them. So I think, A, we need to mandate them, we need to standardize them, but again we need to allow the practices to have the capability of actually leveraging transactions, meaning that we have to certify the software, so the buyer has some confidence that when they purchase that software, they can accept the acknowledgments and then fix the problems long before they become a problem.
MS. DARST: One of the things that I testified with WEDI was the NOC codes. If we were testing 5010 and everything looked good, the transaction looked sound, but once we actually go into production, if a payer changed their edits -- in this case, very large payers changed their edits to include needing descriptions on codes that really didn't need them. They maybe misinterpreted what they read in the implementation guide. We didn't see this coming, as a provider community. It really went to the point that once we went live with the claims, live with the transactions, that's where we saw the problems.
DR. WARREN: So, really, what happened was that you had good test plans and then when you went live, you found out people had changed policies, had changed requirements that you didn't know about during testing.
MS. DARST: Right. They implemented additional changes in conjunction with their 5010 rollout. At least that was our experience.
MR. FIRFER: I think, though, that as we think about why those changes might have been made, part of the issue was that there certainly were no mandated levels of communication. In the flow between the provider and the payer and back, you have folks that work together cooperatively and you have entities that may even be in competition with each other that would not communicate. In fact, Florida Blue probably spent most of its time in the communication process being a moderator between all these different layers, trying to get them to talk to each other so we could understand an edit that was either changed at our level or at the clearinghouse level. It could be at a PMS vendor level. Some of the ways that they change the processing of the claim to make it more successful may hinder other efforts that had already complied with the first wave if they were doing it.
I think there's a lot to be learned in identifying the best way to ensure that communication occurs, and it may be useful for CMS to become involved in helping to push that that process is both warranted and required.
MS. GABEL: I just want to add that we actually did software testing. We did software testing during the certification period, which was in our test environment. One of the things that we found was really important was to do the transition testing -- actually, doing production testing with the vendors -- so when we went live, we had that year to do transition testing before we were required to move over to the new standard. It gave you the opportunity to test completely the transactions in a real-time production environment. Because you had that transition period, if you ran into issues, you could back out and go to the prior version. So I think it was very important and helpful that we had that transition period.
MS. MEISNER: Judy, to your question, the biggest issue we found -- and we have talked about it a little bit -- we tested heavily, and we used production environment data to test -- the reenrollment in association with the clearinghouse did not show up in the test environment. As a matter of fact, we went into production for several weeks and the claim cleared production, and then all of a sudden we started getting rejections.
To add to that, several of the translator products had issue with the 997, so we were unable to read them, unable to parse them, and unable to deliver them. So the providers weren't even aware of the fact that the claims were rejecting for the provider linkage problem.
So it was a compound problem that didn't show up in the testing, but showed up as soon as we went into production.
The other thing, I think, that's important for people to understand is that software vendors, big software vendors, typically will test with their clearinghouse trading partners and make sure that their software works properly. Then they go out and they deploy it. The Mayo Clinics will do their own testing. The large providers will. The small provider doesn't test. They get their software delivered. They go into production. They don't understand the new rules. They start getting rejections. It causes phone calls to come in. Then you have to troubleshoot to say why it is rejecting, what the message was, who rejected it. You have to follow the bouncing ball.
But a lot of times the small docs aren't doing the testing. That, to me, is problematic, and I think it's going to be very problematic moving forward with ICD-10, because that is not something the software vendors can test. I think this is a big challenge that we're going to be facing with our next big initiative.
MS. DARST: Can I just make one other comment? When we talk about end-to-end testing -- and we did test with Blue Cross blue Shield of Florida in that state -- one of the things, too, that we find is that there is a difference in definition between payers and providers in end-to-end testing. The reality is that providers' nirvana would be, I want to send you in a test environment, I want you to process back a remit in a test environment, and I don't have any kind of risk associated. The reality is that payers can't do that.
I think there's an assumption on the payer's perspective that providers -- just send us a day's worth of claims in 5010, switch it back to 4010. It's not that easy to do that. Even as a large provider that has control of what environment we're in, this is no small process. For the smaller provider, this becomes even more difficult.
So I think we fundamentally have a problem when we talk about end-to-end testing. We need to come to an understanding as a community of what that means and what's really doable by both parties. I think we're at a crossroads right now.
MS. MEISNER: To that point, too, I understand that a lot of payers don't have end-to-end testing. We don't get acknowledgments back. We don't get 835s back. But on the same token, many of the small providers have no test environment at all. It's going to be very interesting to see how they can test their ICD-10. They are given a software upgrade. It's a production system. They have no way of testing. They rely on their vendor to do the testing for them. We need more conversation.
MR. FIRFER: In addition to collaboration, to Rob's point, if we could at least be saying to providers, look for this specific certification from your vendor, obviously they will know whether or not they are at that right version, at least to alleviate a lot of the issues.
DR. SUAREZ: Thank you very much for that.
Any other questions from the committee?
I do have one. We heard a lot about the situation with transactions, but a lot of them really related to claims and claim payment. We heard a lot, actually, about acknowledgments, which was very good. But I want to explore the status of the other, not so well known or used transactions, particularly two that I'm interested in, eligibility and prior authorization. Could you say a couple of words about what your perspectives are on how those transactions are going in terms of 5010?
MR. FIRFER: At least at Florida Blue, once we had gotten through the primary claims transaction, although we did experience issues with other transactions -- probably more so for E&B -- they were not anywhere near in the realm of claims.
However, I would also say that some of the issues in testing those other transactions were that other people in the chain, other entities in the chain, were so focused on claims -- and rightfully so -- that there was very little time from the time they finally got their claims issues sorted out to test other transactions.
Another point I would make regarding off-referrals is that we have 278-C, which is covered, but we have a 278-I, inquiry, which is not covered. So we have a lot of entities that are saying, we're going to continue to send 4010 for the 278 inquiry, and you had better not reject it because it's not a covered transaction.
DR. SUAREZ: Any other comments? Laurie?
MS. DARST: Just going back to my testimony for WEDI, there were a number of reported 835 issues. It really came down to just interpretation issues, that type of thing. I think that was definitely another spot that especially the provider community struggled with as far as getting what I guess I would say probably are noncompliant 835s, and that continues to be an issue.
DR. SUAREZ: Other comments about eligibility or prior authorization?
(No response)
MR. SOONTHORNSIMA: A real quick question. I heard some comment themes around testing and nuances around testing with various trading partners, vendors, payers, and so forth. Another thing I heard consistently is the test period. I'm not sure whether there is some consistency around what you think, in an ideal world, that timeframe is to do this testing, and otherwise.
MS. LOUIE: I don't know what my colleagues are going to say, but our organization thinks there should be at least a year of full testing, to have time to identify problems, remediate problems, retest -- similar to what you described. It's not just throwing a switch and six weeks later you can go live. We really think a full year is needed.
MR. TENNANT: We would agree with that, with the caveat that there has to be a start point. That start point would be when health plans and clearinghouses have proven their readiness level. I think the theme that I have heard here is that there were problems during the test process. Medicare didn't even get started until May. We need to get a full year where everyone is ready on the front end and then do the end-to-end testing throughout the next 12 months, then go live with production. That's what I would say.
MR. MCMULLEN: Really, the errata changes threw a wrench into it. When you asked partners if they were going to test before that, they all said, no, they were just going to wait until after that. So you really had a May to December testing period.
MR. FIRFER: I would also highlight that as we move into some of the other mandates, in particular ICD-10, and we're talking about a flash-cut, a single point of time before which you do one, after which you do the other -- as we talk about the complexities of end-to-end testing, and even the ability to use a production environment to do small chunks -- because we want to test all the way through if we don't have an end-to-end testing environment -- for ICD-10, we exclude that possibility by enforcing a flat flash-cut that will not allow us to do any kind of parallel production.
MS. CARTER: I would just like to echo the need to define end-to-end testing. Medicare doesn't do end-to-end testing. We actually never have, with one exception, back in, I think, the year 2000, when we implemented the outpatient prospective payment system -- or maybe it was home health prospective payments, one of those two -- right after Y2K. It was quite an ordeal to do. Not that it can't be done, but that is not the way we're set up. So I think that getting a common definition of what we mean by end-to-end or what is done -- we went so far into the system to be able to process through the front end and give back an acknowledgment. That piece we did, but end-to-end all the way through -- that's just not the way it's set up. I think that people really just do need to understand that. I'm not saying we can't do it any differently, but it would be quite a reach to go beyond that. We just need to all be clear on that.
DR. SUAREZ: Thank you again. Thank you so much for these very rich presentations and for your graciousness with the time that we gave you. We are exactly at 9:45. I thank you again.
We're going to move to our next item, which is a break. We'll be back at 10:00.
(Brief recess)
DR. SUAREZ: Panel number 2 is going to focus on the preparatory work that the industry is undergoing for the implementation of the operating rules for eligibility and claim status. As you all know, the deadline for the first set of operating rules is approaching. We have about six months before the start of that compliance. What we want to hear about is how things are going. Now that we just heard about the importance of preparatory work in testing and transitioning and all the significance of starting early and doing it sooner, it's important to, of course, hear from the industry about how things are going in terms of preparing for these operating rules.
I'm going to turn it over to Lorraine for the start of this new panel.
MS. DOO: Thank very much.
We're going to be starting with Tim Kaja, from United Health. You will look at me once in a while and look for the green when you have five minutes left and the red when you have one minute left.
I heard you are very passionate about this subject, from someone who works with you. So we're going to enjoy listening to your passion.
Agenda Item: Health Plan Perspective
MR. KAJA: Thank you, everybody, and thanks to the committee for allowing us to present.
My name is Tim Kaja. I'm senior vice president with UnitedHealth Group and president of Network Service Operations for the UnitedHealthcare.
I think you are all familiar with UnitedHealth Group. We service more than 75 million Americans in the health-care space and are highly focused on creating solutions that modernize our health-care system. I'm going to talk a little bit about that today.
Let me begin by focusing on the transition relative to operating rules.
UnitedHealth Group made the decision to voluntarily more to CORE Phase I and Phase II certification influenced, based in part -- actually, in most -- on the benefits that EDI would bring to both payers and providers. We were able to do that during our implementation of 5010. The combined two-year project also included the transition to the operating rules.
As part of this process, we did develop a business case around the process. I'll talk a little bit more about this in a few minutes. But the business case revolves heavily around adoption in the industry, by the provider community, of both eligibility and claim status transactions. The driving force behind that business case sits around the conversion of phone calls to EDI. I think that's really important for us to recognize.
A couple of concerns out of the gate:
• It's recognized that there are some entities that submit 4010 transactions today and their clearinghouses upgrade those 4010 transactions. We are not in favor of that. If the data is not there in the beginning, we can't return the data.
• Secondly, we are concerned about the non-covered entities' practice management systems and their ability to perform to the connectivity and the performance rules associated with system availability, publishing regularly scheduled downtimes, and providing a week's notice for non-routine downtimes.
• Thirdly, and probably the most important item here, is adoption. Can the industry really align around this, all the way up and down the chain, to take advantage of the significant opportunity that sits in front of us with eligibility and claim status?
What's our experience on the internal side relative to preparations? This is all pretty textbook stuff. You review your requirements. You put the resources together. But I think that one of the keys here is associated with the ability to leverage the broad experience of CAQH and their resources and tools, their lessons learned, and their staff, to help us identify -- we didn't know a whole heck of a lot going into this -- what we actually have to do in order to get the operating rules to a point where they can be deployed and, beyond the business case, to be sure that we don't interrupt cash flow for physicians.
Our biggest challenge at UnitedHealthcare was the complexity and number of systems. We have 22 systems and over 150 applications that we had to put in place. That was from the technical side of things. From the business side of things, it was really around how you ensure that you are going to get something out of this.
I think it's important to note that from a 5010 perspective, the combination of 5010 and the operating rules is really important. Without the operating rules, there is very little value in 5010 from a payer perspective. The operating rules bring all the value to 5010, because they are focused on what happens inside of the physician office and the hospital back office.
So from a business perspective, implementing 5010 alone would have been a significant loss of valuable healthcare dollars, but combining it with the operating rules -- that's where the value is.
A couple of recommendations: We do highly recommend that as we get into the next version, 6020, the payers, the providers, X12, and the operating rules entity, CAQH, work closely together to ensure that there is value there from a physician/hospital perspective.
Some of the business and technical issues that we identified and advice for other entities -- I'm going to jump right to the advice. UnitedHealth Group continues its commitment to CORE CAQH and the processes that revolve around it. We do encourage both covered and non-covered entities to go through the CORE certification process that is voluntary today.
We have participated in a whole bunch of industry presentations to share our lessons learned. It's important, at least from our perspective -- we are unable to find another entity that can get us into the same place with the same set of standards so that when we all say we comply, we all know what that means. Today the CAQH process gets us there. In absence of that, I think the consequence is going to be years of calibration that will happen with HHS as we go through the enforcement period. We don't have years of calibration in front of us in order to take advantage of the opportunities that are there.
Relatively to eligibility, let me just give you a couple of facts here. The combined operating rules and 5010 activity get us to a 70 percent solution to why providers call UnitedHealth Group today. That's really important. I'm going to talk about that in a couple of minutes. Getting to 70 percent is one point, but getting that last 30 percent, from a lessons-learned perspective, and focusing in on the physician practice and the hospital acknowledge office to get rid of all of the transactions is important. When you go to buy something at your merchant, they don't do the electronic transaction part of the time and then call the Visa company and say, can I make this transaction happen for the other 30 percent? It's a full solution. We need to figure out how to get there, meeting the needs of the physicians and hospitals' back office.
From an operating rules and 5010 perspective on claim status, it's important to note that only 27 percent of the calls that we get into UnitedHealth Group today will be remediated by the current rules that are in place.
A key point for both eligibility and claim status transactions is that their value around non-covered entities is such that the non-covered entities may not necessarily be incented -- we don't believe they are incented -- to actually make this whole system work. The practice management system vendors and clearinghouses need to make it easier and less expensive for the provider practice to submit EDI transactions. We need to have EDI transactions submitted out of the practice management systems in order to drive efficiency. If we don't get to that point and those EDI transactions aren't transacted across clearinghouses, payers, and back to providers, we're going to have a hard time getting there.
Even with the 70 percent solution that we have in place today, our experience so far is that 40 percent of that 70 percent is only being taken advantage of today, even though it's available, and the usability of that 40 percent is only a fraction that sits inside of the physician's practice today and how they are using the transaction. We have a long way to go.
A couple of opportunities: Relative to industry-wide implementation, we would recommend a mandatory registration process of readiness by covered entities. We would also recommend that covered entities go through the voluntary CORE Certification process. It would be our preference that the testing process be mandatory for both covered and non-covered entities to ensure that the significant investment made by those complying entities can be realized and that cash flow is protected at the physician office level.
The considerable fines outlined in the Affordable Care Act should be based upon fines for not registering or passing certification. We also believe that entities who hold CORE Phase I and II certification should be grandfathered into the voluntary CORE certification process.
Practice management sand clearinghouses should be required to create, pass, receive, and post standard X12 transactions with the regulatory mandated operating Rules. Without this, we believe it is hopeless that adoption in the industry will get to adoption.
Relative to milestones, if you chart out all the milestones around putting business rules in place, system design, system code change, testing, trading partner testing and certification, et cetera, we believe at this point in time all entities should be at the system code change and be at the point where they are testing internally. If we're not there now and if all the entities aren't there now, we're going to have a hard time meeting the 1/1/2013 date.
Just a couple of other pieces of feedback. I have three of them.
UnitedHealthcare fully supports CAQH CORE as the authoring entity for operating rules. We also support work that CAQH CORE is doing relative to a multi-stakeholder conversion. The work completed by X12 and CORE can really create a meaningful environment to drive change in how health care is transacted in this industry.
UnitedHealthcare does not endorse or recommend layering other parties into the already collaborative operating rules process, either in the role of decision makers or with special authority. The established working relationship with that exist between payers and providers and CAQH CORE is really important that we protect.
Secondly, UnitedHealthcare recommends that we put a beta testing group in place relative to how we realize the benefits of pulling through these transactions so the industry to more broadly utilize them all the way up and down the chain. We volunteer to participate in that process, and we would like to see the entire industry participate in this process and ask the committee to put together a white paper around what it's going to take for us to get there.
Thirdly, we have learned that the pure implementation of just the technology doesn't make things work. In order for a physician practice to change to what we are looking for her, the physician practice has to be able to utilize these transactions across their entire space. That means the commercial space, that means the government space, Medicare, and state Medicaid agencies. Without all these entities participating for enabled transactions in the operating rules, it's going to be a far fetch in order for the physician offices to convert their business of calling today, which is an expensive transaction, to one that should be implemented.
In conclusion, UnitedHealth Group is highly supportive of the operating rules created for eligibility and claim status. We remain complimentary of the CORE operating rule process for their discipline around industry collaboration and sensitivity to the needs of physicians and hospital back offices. We recommend that future iterations of operating rules for all HIPAA transactions be authored by CAQH CORE. From a business perspective, it is the operating rules that create value. Our activity really proves that out.
We encourage HHS to apply the same standards of compliance to all entities that exchange HIPAA-based transactions, not just health plans. It's unclear why only health plans are being held accountable to this. While UnitedHealth Group will be ready on 1/1/13, we are concerned that the industry will not be ready.
We also encourage the NCVHS Subcommittee to recommend a registration and certification process that recognizes the investment that entities are making operating rules, while protecting provider cash flow.
By this time, all covered entities should be in the programming phase, with internal testing completed at the end of July. Sufficient time is needed to ensure that trading partners can exchange transactions in a 5010 CORE environment prior to the January 1, 2013 date. We don't see any testing process today in the regulation.
We request that the NCVHS Subcommittee support joint surveying of covered entities to gauge where the industry is at a number of points between now and the end of the year for the continued viability of a January 1, 2013 date.
Lastly, it would be advisable for the NCVHS subcommittee to recommend a white paper study that would review the rules around claim status and eligibility transactions to ensure that the industry can adopt those transactions and we can make this thing work.
Thanks for the opportunity to present today.
MS. DOO: Thank you.
Next we have Janet Jackson, from Blue Cross blue Shield North Carolina.
MS. JACKSON: Good morning. My name is Janet Jackson. I am the director of document operations and Electronic solutions at Blue Cross and Blue Shield of North Carolina, where my responsibility includes implementing, enhancing, and supporting our HIPAA solution for providers.
I am speaking on behalf of our plan, an independent licensee of the Blue Cross and Blue Shield Association. We are a leader in delivering innovative health-care products, services, and information to more than 3.7 million members, including approximately 900,000 members served on behalf of other Blues. We appreciate the opportunity to offer our comments on the operating rules.
Blue Cross and Blue Shield of North Carolina has a history of participating with CAQH and CORE. Members of our management teams actively collaborated with the other health plans, providers, vendors, clearinghouses, and standard-setting bodies in the creation of the voluntary CORE Phases I and II operating rules, which are now the mandated operating rules for eligibility and claim status. We also actively participated on the proposed rules for HIPAA 835 remittances and electronic funds.
We believe the existing CAQH CORE process meets industry needs and should serve as an effective framework for the remaining sets of operating rules.
Blue Cross voluntarily adopted the CORE Phase I operating rules and some of the then-draft CORE Phase operating rules in 2007. We became CORE Phase I-certified at the end of that project to demonstrate our compliance.
Our project costs then exceeded $2 million, but the results were great. At the time of our implementation, we were only receiving approximately 100,000 eligibility inquiries a month. Today we're receiving 2.8 million eligibility transactions a month, which represents about a 300 percent increase in just the last two years. We realized a growth of 15 to 20 percent per month for a while. Providers are realizing the benefit of the enhanced content of the eligibility transactions, and many are also executing the transaction as a demographic check prior to submitting a claim and have built this into their claims work stream. This helps to reduce the number of invalid member ID and member ID and member ID/name/date of birth claim error rejections, which streamlines the claims submission process and helps to reduce accounts-receivable days.
Additionally, the system we constructed for this effort is now leveraged throughout our enterprise for almost all applications performing member validation checks or returning member benefits. As a result, we have realized significant cost savings, and the value has been and continues to be spread across our enterprise.
Our experience with CORE Phase I has been extremely beneficial in the transition to the new operating rules. There are enough of us still around with the scars from our 2007 project.
Somebody in my organization said I needed to say "experience" instead of "scars."
We knew we needed to begin work early on the operating Rules project, which we did, in July of 2011. Our project budget is $2.8 million. For ease of implementation, we broke the project down into three manageable work streams, one each for our two adjudication systems for eligibility and then a work stream for claim status. We implemented one of the work streams this month and are in application development for the other two work streams. Both are on track for a November implementation.
From an enterprise perspective, timely completion of this project is critical because our plates are very full, including implementing two new adjudication systems, additional operating rules, product enhancements for the health benefit exchange, ICD-10, and health plan ID, just to name a few.
We currently have two EDI front ends, as a result of a merger several years ago. To eliminate this redundancy, we have taken the opportunity in our project design to streamline the support of the HIPAA eligibility and claim status transactions and to receive and respond through a single front end. This will simplify the EDI interaction for our trading partners, as well as reduce our administrative costs for these transactions.
We also took the opportunity to start the transition to new EDI translation software, so that when our current one goes unsupported in 2017, we'll be ready. This allows us to maximize our cost-savings opportunities through architecture simplification.
We currently do not offer real-time claim status capability to our local trading partners. Therefore, the claim status operating rule changes represent new functionality and will enhance our ability to meet our providers' business need. We have wanted to do this for a number of years, but getting it put on the project books has been a challenge, so we are glad that the mandate is forcing us to do it.
Clearinghouse and practice management vendor interfaces will be able to automate our on-demand claim status inquiries and reduce customer service phone calls.
From a technical perspective, for the real-time claim status, we will leverage the connectivity channels that we built for our eligibility real-time services and then also the web services that were used for our batch claim status, to streamline support and maintenance costs for this capability.
One of our lessons that we learned when we implemented the real-time eligibility, and especially with the subsequent growth of our real-time transactions, is that we needed to utilize a governing device for the real-time transactions to ensure that the systems are available for all trading partners and does not allow one trading partner to consume all available system resources. Our internal goal is to have highly available systems that can be leveraged in our service-oriented architecture to reduce the implementation costs for these capabilities in other applications, including provider and member portals, VRU, customer service, et cetera.
The biggest challenge that we have found so far is the 86 percent system availability operating rule. Our claims adjudication systems are the source systems for the eligibility and claim status data. These systems are designed for batch processing with more loosely defined availability service levels and have traditionally operated in an online mode during the day and a batch processing at night. To address the needs of the operating rules, we needed to build surrounding systems and services that enable 86 percent availability compliance, which has been both challenging and resource-intensive. We have worked closely with our technical teams on the system design and in developing more robust support processes to ensure our solutions support both the operating rule availability requirements and continue to support our enterprise needs for batch processing.
As we begin this transition to operating rules, it is important that we, as an industry, adhere to published compliance dates for eligibility and claim status operating rules. Any change of compliance dates only creates a domino effect, increases the cost of each project along the way, and also damages our internal credibility when we are negotiating for already over-allocated resources. Think of the little boy who cried wolf. Internally, people think that we just say, oh, it has to be on this date, and then when it's extended, they just think we don't need to comply.
We have already begun our project initiation process for the HIPAA 835 and EFT operating rules, so if HHS is going to make a change to future operating rule compliance dates, we recommend that they make them at least year to 18 months in advance of the already published date.
We support the current CAQH CORE process for authoring operating rules. CAQH CORE conducts outreach to all industry stakeholders to encourage participation and collaboration in establishing the rules that will further functional use of the transactions. If more than one entity is responsible for authoring the operating rules, we are concerned about the additional requirement of stakeholder resources that will be needed to ensure that we are actively participating in driving change.
While we are implementing our solution for eligibility and claim status operating rules in 2012, we do not yet know what will be required for certification by December 31 of 2013. We participated in the development of the multi-stakeholder approach to CAQH CORE certification and believe that it is valuable. We have encouraged our trading partners to get CORE-certified over the last five years and have been exchanging CORE Phase I compliant transactions during this period. We encourage CMS to recognize CORE certification as being sufficient for certifying operating rule compliance for the administrative simplification certification.
As an industry, we need to continue our education and outreach efforts to include all stakeholders. Blue Cross of North Carolina actively works with CAQH CORE and other industry groups to share our experience with implementing CORE Phase I. We will continue outreach with our trading partners and providers to ensure they understand our plans for meeting the mandated operating rules, what tools we have available, and, as importantly, that we understand their growth patterns to ensure that our systems will support the additional transaction volume.
We see demonstrated value and firm ROI from the current sets of operating rules. We recommend continued thoughtful evaluation of future operating rule opportunities. Our commitment to partner with all stakeholders in this process remains firm. We encourage all providers to expand their use of electronic transactions beyond claims and for clearinghouses/practice management vendors to expand the interfaces between their applications and the transactions to allow for seamless integration and use of the information. Otherwise, we will simply add costs and complexity to an already overburdened system and those costs are ultimately passed onto the consumers of healthcare.
I thank you for the opportunity to testify, and I am happy to answer any questions.
MS. DOO: Thank you.
Next we have Tammy Banks, with the AMA.
Agenda Item: Provider Perspective
MS. BANKS: Thank you, Lorraine.
Good morning. I'm Tammy Banks, director of Practice Management Center with the American Medical Association. The AMA would like to thank the NCVHS Subcommittee on Standards for inviting our input on the implementation of operating rules to increase the value of the HIPAA standard transactions.
The AMA strongly supports the administrative simplification provisions in the ACA, which are designed to fix the problems associated with the transmission of health-care information. The AMA supports the work that X12, WEDI, and CORE have undertaken to identify and remedy the hurdles which have been encountered to date, and urges NCVHS to implement the ACA administrative simplification provisions in a fashion that leverages and enhances those efforts.
The AMA is gratified by the increasing industry-wide commitment to addressing the problems associated with the transmission of health-care information, and particularly by the increasing sensitivity of the national commercial health insurers to the automation needs of the physician community.
Administrative simplification is a team sport. It simply cannot be achieved without the coordinated efforts of all the trading partners and all the standard, operating rule, and code-setting bodies. Health care is often compared to the banking industry. However, we need to realize one of the main differences between the automation efforts of the banking and health-care industries is that the work of creating electronic transactions is distributed among a number of separate entities in health care, while in the banking industry it is consolidated in a single entity, the Electronic Payments Association, commonly known as NACHA. This undoubtedly reflects, in part, the greater complexity of the health care system, but it also makes the standard setting and operating rule process more complex. Indeed, as between X12 and CORE, the process is iterative, with the potential for each organization to build on the work of the other as operating rules are incorporated in the implementation guide for the subsequent X12 standard, which then creates the opportunity for further refinement in the subsequent operating rule. The work of X12 and CORE must also be harmonized with the pharmacy standards created by the NCPDP and the work of the various code set developers.
The physician practice experience with the implementation of new versions of standards and operating rules should be seamless and incorporated within their daily workflow, using their practice management, or PM, system. Physician practices look to their PM system and clearinghouses to implement and be compliant with the mandated standard transactions and operating rules. Without PM systems, trading partner, and payer compliance with the transactions and operating rules, we as an industry will not realize the cost savings being touted today. Physicians simply cannot establish separate workflows for each of the many payers they typically work with, not to mention the different product lines. When the electronic standards do not work industry-wide, physician practices must drop to paper.
I must reemphasize the importance of enforcement if we are ever to get to the fully automated health-care system envisioned by HIPAA and now mandated by the ACA. Lack of compliance by health plans is slowing the adoption of electronic transactions by the provider community, as the value of these transactions is dramatically reduced to the extent that they cannot be implemented within a physician's practice management system consistently to provide an integrated and automatic single practice workflow across all payers with which a physician or other health-care provider does business. It is extremely difficult for organizations, particularly smaller practices, to implement multiple workflows. They will almost certainly not adopt new versions of standards or operating rules if the industry-wide functionality will not be forthcoming. Unless all of a practice's trading partners use electronic transactions which meet the practice's needs, the practice will likely find it more efficient to continue to use manual processes which cannot be used consistently and effectively.
This is the same issue we messaged out in 2008 and remains equally relevant today. We must increase enforcement, accuracy, and functionality of existing transactions, and this should also apply to the upcoming eligibility operating rules and future operating rules. Fully compliant implementation of all the standard transactions has not been completed by many HIPAA-covered entities, let alone third-party administrators, PM systems, and other agents of those covered entities. Moreover, some covered entities using standard transactions have implemented them with variations of interpretation. Thus, true standardization has not yet been attained, despite the transaction rules.
Even though the industry has experience with the transactions through both the 4010 and 5010 versions of the standards, realizing the full potential of administrative savings, as we all know, has yet to become a reality. The primary barrier to maximizing savings is the gap between syntactical compliance and functional compliance. Functional compliance, for purposes of this document, is defined as meeting the business requirement that the transaction supports. It is all too common for a transaction to be syntactically correct, but fail to meet the business requirements. For instance, the payer has a critical business need to know if a physician who has submitted a claim is in the patient's network or out of the patient's network. The payer may be syntactically correct in selecting a status code of in-network relating to the patient's in-network benefit plan, but the physician may in fact be out-of-the patient's network. The resulting error and rework for one or both parties cancels the expected efficiency of the transaction standard.
The AMA strongly recommends that mandated functionality testing of the HIPAA transactions and operating rules be conducted by all payers and trading partners, including PM system vendors. PM system vendor certification should also be considered to encourage the increased functionality that will benefit all stakeholders.
In addition to our advocacy efforts to improve the value of the electronic transactions for physicians, for the past five years, the AMA has rolled out the national "Heal the Claims Process" campaign, focused on encouraging physician practices to use the HIPAA transactions, and will include this year preparing for the upcoming eligibility operating rules. The AMA and MGMA have partnered to create the practice management system software vendor directory that complements the online resource, Selecting a Practice Management System toolkit. Thirty-three vendors currently comprise this vendor database, and the majority of the self-reported information was compiled in 2011. However, of these PM system vendors, 23 percent provide the functionality as contained in the CORE Phase 1 and 2 operating rules, 7 percent made the functionality optional, 33 percent were under development, and, more concerning, 37 percent did not provide this functionality at all.
The AMA and MGMA will continue to raise vendor awareness of the functionality needs of physician practices and will also continue to educate physician practices on the functionality that they will need to succeed in the 21st century. They have also partnered with WEDI to host two vendor and practice engagement conferences.
The AMA is committed to the administrative simplification objective within the physician practice and is pressing for point-of-service pricing through automated real-time health plan transactions, single integrated workflow for all lines of businesses, and increased transparency and reduced ambiguity during the health insurer claim payment process. The upcoming operating rules that cover eligibility, health claim status, electronic funds transfers, and others, as well as future mandated standards -- specifically, attachments, acknowledgements, and identifying of those entities who perform in the claims process -- are critical to achieving these goals, but only if they are implemented industry-wide.
We look forward to continuing to work collaboratively with NCHVS and respective stakeholders to bring about administrative simplification for physicians and others in the industry.
Thank you, Lorraine.
MS. DOO: Outstanding. Thank you.
Next we have Deb Strickland. You are representing WEDI today, right?
Agenda Item: Industry Engagement/Education
MS. STRICKLAND: Yes, I am representing WEDI.
Members of the subcommittee, I am Debra Strickland. I'm co-chair of the 835 and EFT workgroups for the Workgroup for Electronic Data Interchange, and I'm also a solutions architect for TIBCO Software. I would like to thank you for the opportunity to testify on behalf of WEDI concerning the matter of operating rules for eligibility and claim status.
WEDI represents a broad industry perspective of providers, clearinghouses, payers, vendors, and other public and private organizations that partner together to collaborate on industry issues. WEDI is a named advisor to HHS under the HIPAA regulation, and we take an objective approach to resolving issues.
On May 29th, WEDI released a brief poll that sought to gain insights into the industry's readiness for eligibility and claim status rules. The goal in this effort was to assess how prepared organizations are for eligibility and claim status operating rules. The methodology was to collect responses. We collected 71 responses as of June 12. Entities were able to select that they were more than one of these entities. They could be a payer and a provider. The method was a Web-based poll using SurveyMonkey. It was sent to general media, WEDI, member companies, health IT, SmartBrief subscribers, and also WEDI partners.
The limitation was that the poll was meant to just be a snapshot of the readiness of the industry, and not really generalizable.
A summary of the poll, what we found:
• As far as awareness of the operating rules effective 1/1/13, there is awareness.
• Not all of the operating rules, however, were understood by the respondents at the same level.
• The level of effort in order to meet these needs was medium-sized, for most organizations surveyed.
• Two-thirds of the respondents had started assessments.
• Half of the respondents knew where to go for questions regarding the operating rules.
Looking at the participant response, the results show that 60 percent of the respondents are payers, as we would expect, as they are the most impacted by the operating rule implementation effort. The majority of the respondents who completed the poll were not CAQH participating organizations. This is pertinent because CAQH members would likely have already been well aware of the requirements, may also be certified, and have worked with CAQH on these requirement efforts. So they would have potentially been having to be compliant before the implementation date.
The poll showed that the large majority of the responders were aware they had to comply with the operating Rules. This is positive news. The rules have existed for a long time. They do align with the HIPAA 5010 transaction in many ways. We do need to make sure that we consider that success and relative base knowledge when we consider the next round of operating rules. The next set will be less circulated, so more education and outreach may be necessary.
As far as readiness, the majority of the responders did say that they had been in the assessment stage of the operating rules. That might not be good news.
Of the 71 responders, we wanted to get a general idea where they had heard about the operating rules and which communication vehicle was getting the word out to the broader audience. This will help us to leverage these communication avenues for the next set of operating rules. What we found was that CAQH, WEDI, and government communications were the highest and most impactful communication vehicles. This should be considered as the next circuit of rules comes you, and these vehicles should be used in a similar fashion, or even greater fashion.
As mentioned before, two-thirds of the respondents said that they were in assessment. It is somewhat concerning that there is less than six months left before the mandate, and even those in assessment will have to get through that assessment into development and into testing in six months.
So the good news is that that are some folks who are in development and there are some that are in testing.
A little over half of the respondents reflected that the rules were clear and easy to understand.
In light of this result, WEDI attempted to determine which, if any, of the operating rules were more difficult to understand than others. The responses received reflect that for five out of the 11 rules, 30 percent or more of the respondents indicated that they had some degree of difficulty. This highlights areas that would benefit from additional industry education and clarity around the documents and requirements. We need to increase education around the rules for future versions and documentation.
On the plus side, two-thirds of the responders felt that the requirements were clear enough to complete assessment of the impact of these operating rules. So they could get to the assessment completion.
One area that was identified to be a gap is the area of locating guidance, as well as where to go to ask questions. WEDI is prepared to facilitate this process with an evolving question online form service, which will facilitate getting the industry the answers they need during these times.
Overall, the majority of the responders felt that the implementation of operating rules effort was a medium-sized effort. WEDI believes that there was significant awareness of the operating rules ahead of the Federal Register date of 7/8/2011. Additionally, a compliance date of 1/1/2013 has allowed industry adequate time to prepare their efforts. We need to understand, for future operating rules, that they will likely have less socialization time than the eligibility and claim status rules. Thus, there will be a need to adjust the implementation dates accordingly.
On to the NCVHS questions:
As far as the transition to the new required operating rules for eligibility, how is that status going?
It appears that there are some who are ready for the operating rules and clearly on track for the 1/1/2013 date. However, it will be key for us to supplement education and push the rest of the industry to be on track and continue to monitor this as the date nears. Additional surveys, educational tracks, and forums will help the industry to meet this date. Based upon the results from this poll, it appears that additional, earlier education and clarity around operating rules requirements is a good idea for the next set of operating rules.
The perspective: The survey group felt, again, that it was a medium effort. Comments that were obtained from some of the survey results indicated that it was actually greater than they had originally expected.
Gaps include a central location for operating rules questions and answers, separate documentation of just the what those requirements were for the operating rules that can be clearly interpreted by different audiences., and to start education earlier in the operating rules process.
In the process of implementing this first set of operating rules, what are the businesses or technical issues you've identified? There is a subset of the industry that had issues with the documentation of the rules. Communications rules were found to be the most difficult for some to interpret.
As the approach to handling these issues and advice for other entities, WEDI has the following tools and sessions planned:
Anything else? WEDI feels that there is a need to continue to educate the industry on the new operating rules and to continue to engage the industry to learn what methods are most helpful as we near the implementation date.
In closing WEDI would like to thank the committee for allowing us to comment on this important topic.
MS. DOO: Thank you.
Now we'll have Gwen Lohse with CORE.
MS. LOHSE: I'm Gwendolyn Lohse, from CAQH CORE. Thank you for allowing us to testify today. It's nice to see many of you.
It's an exciting time. The earlier panel was very informative.
For the outline of the testimony that I'm going to try to keep to, there is a written submission that we gave you that has a lot of detail. I'm going to try to keep it at a very high level and let you know what we have been doing today:
That's just a quick flow of the outline.
On the background, I think most of you are familiar, but just as a reminder CAQH is a nonprofit catalyst for administration simplification. It was formed in 2000. CORE was formed in 2005 solely to work on operating rules, to develop operating rules and then promote their adoption and maintenance, and also track their ROI, which I'll talk about in a minute.
Operating rules support other efforts. I think we have heard a lot today -- for instance, supporting 5010, supporting aspects of the NHIN, which is out from ONC. How do we make sure that we're integrating and coordinating?
The integrated model is how we have presented CAQH CORE to date. CORE participants have really held us to this. This particular presentation is about implementation of the operating rules, and that starts from the very beginning through each of these steps. Whether we're developing the rules and making sure they align with other industry efforts -- again, the underlying standards, ONC efforts, policies, doing straw polls to make sure there is support -- it starts from the beginning, designing and testing a certification process -- I think you heard from some of the CORE participants that started from the beginning -- all the way through building awareness and creating an implementation base. Without an implementation base, there's no one to lead. With any people that have said they have done it, it seems almost insurmountable -- then promoting the alignment, tracking the ROI, maintaining, making adjustments, and then reporting out status.
So across the board, this is really a layered process. It's integrated and obviously fits into a bigger picture. The implementation -- from the perspective of CAQH CORE, without these steps, we're not going to have strong implementation.
What have the activities that CAQH CORE has done to date? We have thrown ourselves in to say, what can we do to help with this implementation, considering all those steps that need to happen in the process?
One of the things to think about, too, is that operating rules are new to the health-care environment. Even though we have an implementation base, they are new to many people. So how do we educate both on awareness and then also on the drill-down to the individual rules? We have been doing quite a lot of education programming in a variety of venues, different modalities, and evolving in-depth tools. They have to change constantly because what the industry needs is changing constantly, and how people learn varies.
We're collaborating with other organizations -- WEDI obviously, the Medicaid organizations, and the also NeHC. NeHC has a whole new audience. We need to get to those people that aren't at the usual venues.
Low or no-cost -- a lot of people out there just do not have the dollars to attend sessions that cost money. How do we get to a critical mass?
We have been putting out interactive tools based on lessons learned. For instance, there is an analysis and planning guide. For those of you on the diagram 2 in the detail shows what's in that analysis and planning guide. That is solely based on the 60 entities that are already CORE-certified. What did they feel the challenges were to identify what systems were going to be impacted? I think you heard from Tim Kaja, 60 systems, so making sure you are looking at that first, then drilling down to the next level what vendors you need to work with, how many, what the timing is going to be, who is going to do what, and then drilling down to each of the rules.
We have held open public calls on that guide. We have a request process that's open. There have been about 300 requests to date. We refer a lot of people to ASC X122 and CMS. Conference calls, FAQs that are constantly being added to, and then polling evaluations -- and I'll give you an example of one of those -- on content, knowledge base, challenges, the voluntary CORE certification, and then also ROI tracking and business case awareness. Then there are other things, such as publications by other organizations that we are distributing, repackaging the rules for usefulness, and then updating CMS OESS office on a monthly basis.
As we think about all of these activities -- and we're talking about three to four activities a month, plus all the interactive tools -- pricing, quality, and evolving depth -- again, just to emphasize, CAQH CORE and other organizations are bearing much of the cost of the education, because there are just not the resources out in the market. If we want it to be a critical mass, someone has to bear the cost. As we move forward, we just need to think through that.
Also collaboration -- there's more than the capability to have 300-plus people on every single call that are varied and new and different types of entities. That's going to take collaboration to do that.
Also then assessing what we do -- we constantly look at every opportunity to say, are we going to get to the right number of people? Are they going to be diverse? Are there going to be those people that aren't at the table yet? How do we get experts? People volunteer their time, without entities that have already gone through it. We can't learn and then we pass along information that may not be accurate. How do we get the experts to the table that have been through it? They are a key resource.
Our statistics also show that you have to dig down into the depths of the rules and show that. I'll talk about that again in a minute.
Statuses and key challenges: Just before I go into the key challenges, a quick overview on the status. There is awareness of operating rules. It appears that it's strong.
There are a few things to note. Many entities are moving from planning and analysis into implementation. The Medicaid agencies are very engaged. NCVHS asked CAQH CORE to reach out to the Medicaids. We have placed a lot of time on that. They seem to be engaged.
Health plans are especially interested because of the certification requirements in the ACA. We have shared questions with the OESS staff so they can understand exactly what is being asked.
Specific operating rules are more challenging for specific audiences that may be lacking knowledge of things like SOAP, and others may have major system upgrades to make, like response time.
The early adopters are key. We have 60 percent of the commercially insured that have adopted. We need to take advantage of that and get their business cases out there.
Programming and venues must speak to where they are. Some people don't want to be in a public setting. Other people do. How do we keep that variance moving?
Then there's a growing appreciation, now that we're moving to implementation, about operating rules and standards working together, which is great news.
There are two levels of challenges. We have system-level challenges and then implementation challenges. On the system-level challenges, these have been spoken about by others, so I don't want to spend a lot of time here. The providers are not required to use the electronic transactions. The practice management systems aren't HIPAA-covered entities. There is a gap in the end-to-end transactions.
There is also a lack of a coordinated network. I'm not talking about a hard network, a system IT network, but a network that connects us to all of those people that are out there that actually need to get the job done. We all need to work on that. We need an ability to really educate those -- where are the loci for specific tools, education, business cases, for each of these types of requirements? And there is a lot of expertise. Like clinical, if you think about the rec centers, you think about other efforts, how do we continue to do that into administrative simplification?
On the next slide are implementation-level challenges. Reaching a critical mass -- this is again through collaboration and building out awareness in all the areas. Then we really have the challenges of new venues, the impact on the revenue cycle, getting those business cases out there so they are clear and consistent, making sure there are costs that are good -- if the costs are the barrier to educating, we're not going to get the implementation we need -- and then quality and evolving, and then testing.
Then an underlying of the standards -- certain rules are more difficult than others.
As we move forward, I think you all had issued The Tenth Report to Congress, and developing meaningful metrics, identifying incentives, and harmonizing -- these all ring through. There's no doubt -- the testing, everything.
We gave an update on CORE, where we are. I'm going to skip over that and move to the next slide.
Where are we? We're going to expand our venues, promote information and tools from others, utilizing more feedback mechanisms, and document strategic drivers to change things, and update OESS.
This is an example of the type of metrics we're looking for. Where exactly in the rule do people not understand? How do we drill down our education to focus there? We're doing a lot of this polling. We have a lot of good data on all efforts. It's in your appendix of the written document. We have a lot more for those of you if you did want more.
Recommendations:
Thank you for having us give this update. We're excited to move to the next stage. This gives us -- and I think you said in your Tenth Annual Report -- a chance to get it right. We're looking forward to figure out how we do more innovation to get it right.
MS. DOO: That was great. Thank you.
DR. SUAREZ: I think we are ready for some questions from the committee. Let's open it up for any questions.
MS. KLOSS: I guess I just have one observation. Tim, your comment was that we should be here, in that very compelling diagram, but it doesn't sound like we are. If the group could discuss the short term, other than the awareness building -- what can the committee do to underscore the urgency?
MS. STRICKLAND: I agree. I think that, besides those entities that are very involved in the CAQH CORE efforts, we have a critical mass of people who, at least on a first blush, from a poll perspective, don't appear to be ready to do this. That's a little scary. But I don't think that means that it's critical stuff. I think we need to do some additional surveying, some detailed qualitative and quantitative analysis to make sure that we really, really understand where everybody is within the industry, and then provide them with the tools that will help to get there, and make sure that we do that incrementally so that we can make that we can have a 1/1/13 implementation date, or at least set ourselves up for understanding where we need to go next with this.
MR. KAJA: If I can comment, I think the point of where I think we all should be at -- it might be advisable for HHS or whatever vehicle or mechanism of communication happens -- there is so much on everybody's plate right now, with just reacting to 5010, with the development of ICD-10, with the other activity that's out there -- it might be advisable to put a communication out to the CIOs or the COOs of the health plans that clearly states, are you aware that 1/1/13 is an important date, and are you also aware that there's an enforcement period and an enforcement action that is very expensive for health plans if you are unable to comply?
I think there is some communication that we could do, just in light of everything that's going on in the industry right now.
MS. JACKSON: One of the battles that we have fought internally is, the date is 1/1/13, the fines don't take effect until 1/1/14, and so one of the messages I have had to repeat over and over and over again is 1/1/13. It doesn't matter that the dollar per day doesn't truly start until April 1 of 2014. 1/1/13 is the compliance date. I think as an industry, that's what we have to continue to emphasize, and we have to stick with it. If we blink again, every compliance date -- everybody is going to think we'll continue to blink.
MS. LOHSE: I'm just going to add one other thing. I think the testing piece is an excellent tool. We could educate people to use that. It is free. They don't need to get certified. They could use the testing tool without getting certified. Obviously the certification is great because it lets you know -- your trading partners -- that you are actually done.
With regard to what Janet said with the education, there is a penalty for January, as we all know, the 1.5 million due to high tech. We are getting a lot of questions on it and have information to educate people that there are two penalties. We need to educate more on that and get the word out.
With regard to distribution of information that already exists, on drill-down on the individual rules and experiences, how do we get out two different audiences? I think new entities like NeHC will be very important to that. They are bringing in people that aren't typically in this fold.
MR. KAJA: If I can add just one more comment, the overarching objective here is -- and Rob stated this well during his testimony -- we have between now and 1/1/13. Being sensitive to Janet's comments here, if we get to 1/1/13 and we're not tested and we're not fully understanding the nature of how these transactions are going to flow, the overarching objective is interruption in cash flow in the physician's office. We cannot let that happen. We saw the consequences of that with 5010. We don't want to see that happen here with operating rules. While we're not talking about an 837 in this case, we are talking about eligibility, which has the potential to interrupt whether or not I'm sending the claim to the right place, whether or not benefits are covered, and claim status, whether or not I'm getting paid on time.
MR. SOONTHORNSIMA: Going back to Tim's comment and maybe some others will chime in on this as well -- the dependency on the non-covered entity -- you gave some number, 40 percent something to that effect. Can you just speak broadly about how big that is in terms of adoption and getting to the goal?
MR. KAJA: The nature of the transactions is such that a transaction has to first flow in, and it has to be easy enough to flow in, from the practice management system. So the transaction, ideally, is created right out of the practice management system, whether it's the appointment book or it's the accounts reconciliation activity that sits in the practice management system. If we were to survey the practice management systems today and look at where those capabilities exist for the installed base, I think we might be surprised to see how many practice management systems can actually support a 270 transaction directly out of their appointment scheduling system, much less the ability to promote a 276 transaction out of their accounts reconciliation activity.
That's point one.
Other than that, they are relying on anything that sits outside of their practice management to submit those transactions. When we look at what the capabilities are -- I talked about a 70 percent capability with a 5010 CORE-enabled I and II transaction base. The 30 percent that sits outside of that is really based upon benefits that are not covered in the operating rules today, which physician offices would find helpful. It's different by specialty. Take a look at PT, OT, ST. You might find differences in what the actual uptake can be. But 70 percent is the optimal today, given what's out there. Forty percent today of those transactions, even though they are out there, are only being utilized, in our experience. Even though those 40 percent of transactions that are coming in from an EDI perspective, when you go back and look in the physician's practice at whether or not they are using just the EDI transaction to update their activity and use their activity, we're finding that only a very small percentage of those actually are using those transactions to update their practice management system about eligibility and claim status. We are getting the calls, even though the EDI transaction is still coming in.
We talked about this white paper analysis around what it's really going to take to move this industry to full electronic adoption in these first two transactions. I don't know that we understand that. We certainly don't understand it well enough at UnitedHealth Group. We're trying to. But it's clear that the industry doesn't, or we would have better uptake on what's available today.
MS. LOHSE: I would like to add to what he said. We have been retaining IBM to do retrospective studies and look at markets where there is a percentage of CORE-certified entities -- 60 percent at least, because then the providers offices have a certain payer mix that we can look at. There is no doubt that they have walked into offices where the version of the practice management system is not updated to show the information that the health plan may be providing. You need end-to-end, and the practice management systems are a major gap. IBM probably found several offices -- and we do have the data or you could talk to them directly -- where there was that gap. We weren't actually able to study the impact because the impact didn't get to them. That's a pretty clear finding, I think.
MS. STRICKLAND: I'll just make one quick comment. Based on some experience that we have had with the payment systems, especially around the remittance advice, as well as the other response transactions, the PMS vendors do not update even to the current HIPAA standard transaction in content. As much as we push forward these standard transactions, anything that has a response that has to go back to the provider -- if we not mandated for those entities, those PMS vendors, those vendors in general to be content-compliant, we're missing that entire loop. That is our response loop. We can assume that the providers are not getting the complete content coming back to them, because they are not required to do so, and they do so upon request of their customers, who don't know to ask for it.
MS. LOHSE: One thing to just add. You have heard a lot about registries and certification. It's not just the product. It's the version also. Keep that in mind. We track the version, as well as the product on the CORE certification. It's very time-consuming to get down to the right version.
MS. BANKS: Just one last comment. I don't think we can just look at this from an operating rule perspective. We have to look at it from an end-to-end moving of information across the cycle. So it also needs to be for several of the standard transactions, as well as operating rules, because many, unfortunately, do not offer all the HIPAA-mandated standard transactions. That should be at the back end of the seamless workflow so that the provider doesn't have to send and receive these transactions. It should be integrated within the user experience.
DR. SUAREZ: Thank very much. That was really terrific testimony. We very much appreciate the time that you took to come today and comment.
By the way, I want to acknowledge that we received some written testimony that will be incorporated into the record. I just want to acknowledge that there is some written testimony that we will not hear in person, but that certainly, as always, will be incorporated and considered in the preparations of our observations and recommendations.
MS. LOHSE: And if there is any data in the written testimony that you want more detail on, we're happy to share that with you, as well as with the OESS staff, on the findings from the education sessions or other polling.
DR. SUAREZ: Thank you very much.
We're going to move to our next panel, which is not much of a panel. It's an update from the DSMO. As a brief background, every year we try to receive at least one report from the DSMO, the Designated Standards Maintenance Organization, to learn and to understand the process and the activity that has gone on at the DMSO in terms of input that they have received about the standards questions and other areas that they are addressing.
I think we have Stacy Barber on the phone.
Agenda Item: Panel 3: DSMO Update
MS. BARBER: Good morning. I'm Stacy Barber. I am the ASC X12 primary representative to and the immediate past chair of the Designated Standard Maintenance Organizations.
On behalf of the DSMO, we would like to thank the NCVHS for the opportunity to present our 2011 annual report on the changes, challenges, and opportunities affecting the HIPAA Transaction Standards. This reporting period covers the period of January 2011 through December of 2011.
As you know, the DSMO includes three ANSI-accredited standards-development organizations -- ASC X12, HL7 International, and NCPDP -- as well as three non-ANSI-accredited data-content organizations, the ADA's Digital Content Committee, the NUBC, and the NUCC. Collectively, the DSMO reviews change requests to the HIPAA-designated standards and for new standards and code sets to be adopted.
A change request can be made by anyone in the industry by completing a change-request form that is found on the HIPAA-DSMO website. Once change requests are entered, each DSMO organization can opt in and review the change request and discuss its merits within their own organization. Normally, each organization has 90 days to review change requests. However, there is the opportunity to request a 45-day extension if additional time is needed for review.
Once the organizations complete their review, we collectively meet to discuss the actions that each organization has made toward the change request. As the DSMO reviews each of the responses, a final DSMO recommendation and response is made and published on the DSMO website.
For the period of the 2011 reporting timeframe, there was a total of 40 change requests that were entered. Seven of those change requests were withdrawn by the submitter and one was withdrawn by the Web administrator because it was not a valid DSMO request. Thirty-two were subsequently approved and reviewed by the DSMO. Of the 32 change requests that were reviewed by the DSMO, ten were approved for adoption. Two of the approved change requests pertain to one or more of the HIPAA transactions, one pertains to the health-care professional claim, six pertain to the payment of a health-care claim, and one pertains to the health-care eligibility request and response. A detailed report was provided with the annual report that gives detailed information regarding the outcome of each of those change requests.
There were other activities and challenges that we faced during this reporting period. During the past year, the DSMO continued to discuss provisions of the health reform legislation, particularly the provisions in the administrative simplification sections calling for the creation of operating rules for the HIPAA transaction standards. At the April 27, 2011 NCVHS Subcommittee on Standards meeting, the DSMO reviewed the current process for industry-requested changes. At the November 18, 2011 NCVHS Subcommittee on Standards meeting, the DSMO provided ideas on improvements that could be made to the current process to make it more efficient. As a result, we were presented with four problem statements to which the DSMO provided recommendations and other observations and recommendations to the NCVHS.
One of the problems noted was that the industry was unclear about how to request changes. The DSMO developed an educational presentation which is now available on the DSMO website that provides the industry with valuable information on the DSMO process and the HIPAA regulation process. The DSMO also began discussion on how to implement some of the recommendations of streamlining the change request process. We plan to continue this work during the upcoming year.
In addition, in February 2010, the DSMO made a recommendation to adopt standards for acknowledgement transactions. During the April 2011 hearing, virtually all testifiers were supportive of a mandate for acknowledgment standards because of the time and cost-saving benefits associated with their use. In the September 2011 letter to the Secretary, NCVHS recommended the adoption of the ASC X12 TA1, 999, and 277CA acknowledgment transactions as standard transactions. To date, no activity has occurred, nor has it appeared on the HHS regulation schedule. The DSMO recommends that NCVHS submit another letter to the Secretary calling for immediate action for the adoption of the acknowledgement transactions.
Thank you for allowing me to present the DSMO annual report for 2011.
DR. SUAREZ: Thank you very much, Stacy, for that very short and succinct report.
Let me open it up for questions. Are there any questions from subcommittee members about the DSMO report?
DR. CARR: I think at one of our hearings we heard that there were additional changes that were talked about that were not going through the DSMO. Am I remembering that correctly? Is 40 the right number, or 32? Do we feel like that's the appropriate, expected number of requests that would come in in a certain time?
MS. BARBER: Forty is the number that were officially submitted through the DSMO process. It is possible that people within the industry could go directly to the standards-development organizations and request additional changes. Those would have been made outside of the DMSO process.
DR. SUAREZ: That's a good point. I think we heard that, progressively over the last five years or so, or since the start to the DMSO, there has been sort of a progressive shift from entering and processing change requests through the DSMO and, instead, going directly to the SDO -- for example, X12. Is that your sense as well, Stacy?
MS. BARBER: Well, I think what we saw in this past year, the 2011 reporting period, is that the DSMO change requests were much greater than they have been in the past several years. I think that's a direct result of ASC X12 6020 development and a press release made by ASC X12 in the fall of 2010 giving a deadline cutoff date for when change requests could be made for the 6020 development cycle. I think that did help the increase of the number of change requests that we received during this reporting period.
I can tell you that ASC X12 is working on a change request system where, if the change requests are made directly to ASC X12, we will evaluate those changes to determine if they need to be moved into a DMSO change request as well.
DR. CARR: I think that was my question. What determines which requests go where? Is there any guidance as to where they should go?
DR. SUAREZ: The organization that is making the request can go --
MS. BARBER: Either place.
DR. SUAREZ: Either way, can go directly to the DSMO to file the request or they can go directly to the SDO to file the request. Those are two open ways. The person really decides in all the cases. There's that possibility. Is that correct, Stacy?
MS. BARBER: That is correct. It really is up to the individual who is making the request for change and where they go. We do try to encourage that if the change is in relation to one of the HIPAA-covered transactions, it should be made through the DSMO change-request system.
DR. SUAREZ: And the other, related point is that when one thinks of the change requests that come to the DSMO, pretty much all of them -- for example, in the 2011 year, the 40 changes were all related to the X12 transactions, even though, in reality, change requests can come to the DSMO for any aspect of the standards, including, of course, NCDPD, for example. A code-set change request could come as well to the DSMO. They can come to the DSMO. It's a matter of whether there is a -- probably except medical codes. The medical codes would have to go to the -- ICD-9, ICD-10 changes or CPT changes.
Remember, in the codes that were under HIPAA, there are external medical code sets, which are ICD-10 and CPT, and then there are non-medical external code sets, which are code sets like the taxonomy codes and things like that.
But it is my understanding that the non-medical code sets -- the DSMO could also receive requests for changes, but in most cases people go directly to the maintainer of that code set. Is that your sense, too, Stacy?
MS. BARBER: Yes, that is true.
I think we did a good job of putting together the educational presentation that explains a lot of that. That is available on the DSMO website now. I encourage everyone to go out there and review that.
DR. SUAREZ: Thank you. Just for the record, could you remind us of the DMSO website? Is that dsmo.org?
MS. BARBER: It is hipaa-dsmo.org.
DR. SUAREZ: Thank you.
Any other questions from any of the committee members?
(No response)
All right, thank you very much, Stacy, for the report.
MS. BARBER: You're welcome.
DR. SUAREZ: We're almost on time, about three or four minutes late, which is unusual for our committee. So I don't know what to do.
(Laughter)
No, we're very fortunate, actually, because that will give us more time to spend with our next panels. Panel number 4 is our panel on ICD-10. We invite all the testifiers to come to the table.
What we want to focus on with the ICD-10 discussion is primarily considering the fact that there is a very likely possibility of having an extension, as the proposed regulations have stated, of a year. Rather than debating about this extension and all sorts of other things, more important is, what are the key strategies and milestones that we really need to focus on to achieve compliance by the date? That's the real important part. That is one of the things we wanted to focus on.
Of course, your insights and your comments about all sorts of other aspects related to ICD-10 will be very much welcome and appreciated.
To start us off, we are very fortunate to have a former member of the National Committee, and chair of the National Committee for several years, Dr. Simon Cohn, from Kaiser Permanente. We're going to invite him to open up our panel with some overview remarks.
Overview Remarks
DR. COHN: Thank you. Hello down there.
I want to thank you for inviting me to be here today. I'm not going to use PowerPoints, which is actually very unlike me, but I thought that probably by this time in the hearing, you would have seen enough PowerPoints to enjoy the reprieve here.
As Walter described, I am Dr. Simon Cohn. I'm the associate executive director with The Permanente Federation of Kaiser Permanente. I also serve, among other things, as our national medical group leader on the transition to ICD-10.
As Walter commented, I was fortunate to be a member of the committee from 1996 to 2008 and gained a firsthand understanding of the important work this public advisory committee. I would just observe that during my tenure, we talked about this being one of the hardest-working public advisory bodies, though I do have to say, Walter, that starting at 8:00 in the morning with your hearings does set a new bar.
I am testifying today on behalf of the Kaiser Permanente Medical Care Program. We are the nation's largest health maintenance organization and integrated health-care delivery system. We provide comprehensive health-care services to nearly 9 million members in nine states and the District of Columbia.
You asked us to share our experiences and challenges in the transition to ICD-10 and offer recommendations on how the federal government can facilitate a successful transition to ICD-10, in view of at least the proposed one-year delay. A more comprehensive overview of our experiences and our recommendations is included in our written testimony. Obviously, because of time constraints, these comments are going to be necessarily abbreviated, so hopefully we'll have time to talk.
In a sense, Kaiser Permanente is a microcosm of the entire health-care system. We are a health plan. We have hospitals and we also have physician groups. Our experience with the ICD-10 impacts, as you know, in all three areas.
ICD-10 impacts us in another unique way. That was really the reason that I decided to come out today for the testimony and discussion. We have successfully implemented our electronic health record, which we call KP HealthConnect, throughout our organization. We have also developed a SNOMED-based terminology solution for use within our electronic health record, which we call convergent medical terminology, or CMT. It is mapped, of course, to industry standard codes, and both CMT and our electronic health record must be updated for ICD-10.
It is important to recognize that using an electronic health record in the ambulatory setting changes the process of coding. It is no longer just a manual function performed retrospectively by coders. With the electronic health record, clinicians have a significant role, through the process of documentation and diagnosis selection, in, actually, determination of the final code. Because of this expanded role in the clinical process, it is important for a broad group of clinical stakeholders to review proposed changes to codes. It is an issue that I will come back to at the end.
I would like now to talk briefly about our experience preparing for ICD-10. First, of course, is technology readiness. We talked about that a lot with the 5010 earlier today. For us, it has represented a really major undertaking that started in 2008. From a technology point of view, we have actually compared the ICD-10 readiness activities to those of Y2K. We think the costs are also relatively similar.
We have nearly 200 IT applications that are in the process of being remediated and are being impacted. They include clinical, administrative, and ancillary systems. KP, of course, like the rest of the industry, has a combination of internally developed systems that we are having to remediate, but, like everyone else, we depend a lot on external vendors to actually upgrade their systems. Really, we can't begin to do end-to-end testing until we have received ICD-10-compliant updates -- again, an issue and a dependency.
Readiness also, of course, involves updating our convergent medical terminology. This process involves hundreds of clinicians across Kaiser Permanente systematically reviewing ICD-10 codes and our CMT terms and determining the changes and the many additions that are needed.
To address the increased detail in ICD-10 codes, we had also had vendor-developed electronic health record workflow tools that can assist physicians. However, determining when and where to use these tools, then configuring them, does involve significant work. Of course, in all of this, we actually have the migration by all of our regions to install, test, and upgrade our electronic health record system to make it ICD-10-compliant.
The transition to ICD-10, of course, also impacts people and processes. I know you know that well. This has required targeted communication, and we're in the process of working on job-specific education and training. For coders, one of the groups most impacted by the ICD-10 transition, preparations include refresher courses, courses on medical terminology and anatomy and physiology, as well as a course preparing for the ICD-10 training. We are also considering piloting dual-coding functionality and the use of computer-assisted coding to facilitate the transition and mitigate any possible reduced productivity.
Among clinicians, who are also another impacted group, those most significantly impacted treat injuries, manage pregnancies, and care for behavioral health conditions. This includes, like myself, emergency medicine, urgent care for clinic physicians, but also providers who cover OB/GYN, orthopedics, podiatry, mental health, and primary care, among others.
We obviously have established workgroups to guide and support clinician-readiness efforts.
We will, of course, to be compliant, complete the education and training processes before the date of ICD-10 compliance.
KP submitted comments to HHS in support of the proposed one-year delay of the ICD-10 compliance date. We also support the extension of the ICD-10 partial code freeze to October 1, 2015. The additional year, from our perspective, will give us more time for testing with trading partners and also more time to prepare the people at Kaiser Permanente for the change, plus it will also give us more time to explore automated solutions in our electronic health record to support some of the more recently introduced code details.
I will close by summarizing our recommendations on how NCVHS and HHS can facilitate a successful transition to ICD-10.
First and foremost, we recommend that HHS announce a final ICD-10 compliance date as soon as possible. Uncertainty about timing impacts planning and resourcing efforts. I think it's an issue that the entire industry has been having.
Second, we recommend that HHS establish and fund trading partner testing pilots. We recommend that these pilots begin about ten months prior to the actual implementation -- in other words, January 1 of the year prior to implementation.
Third, health plans and providers are facing multiple HHS initiatives and deadlines that may compete for time and resources with preparation for ICD-10. We recommend that HHS comprehensively review other upcoming and proposed deadlines, many of which you heard earlier today, determine critical priorities, and consider extensions or delayed implementation for lower-priority initiatives.
Fourth, we recommend that HHS modify the medical loss ratio final rule to allow ICD-10 conversion costs in 2014 to be included in the MLR calculation.
Fifth, we recommend that HHS assure appropriate funding for developing and testing ICD-11. This code set is designed to integrate the SNOMED and has the potential over the longer term to be a more functional and powerful code set. It's something we need to begin to look forward to even as we talk about implementing ICD-10.
Finally, HHS should use the opportunity presented by the extended code freeze to reevaluate the current ICD-9 coordination and maintenance committee process, in particular to provide more advance notice and to engage a broader group of clinical stakeholders in the review of the proposed changes. This is important because of ICD-10's greater granularity, the increased adoption of electronic health records, as I discussed, and the expanded role of clinicians in the coding process. We actually believe that NCVHS has an important role in assisting HHS in this review.
As I mentioned, there is a more complete overview that we have submitted, with much more detail on all of this stuff.
I would like to thank the Subcommittee on Standards for the opportunity to provide this testimony.
DR. SUAREZ: Thank you very much, Simon.
MS. DOO: Thank you.
Next we have Dan Rode, with AHIMA.
MR. RODE: Thank you very much. On behalf of our over 64,000 members, I would like to thank you for the opportunity to testify this morning and talk about ICD-10.
AHIMA is an 84-year-old not-for-profit professional association, and our members are working in over 40 different employer groups and in 120 different functions. Think of us as a group working with health information and data, and do not pigeonhole us into any one particular function, like coding, because we're trying to look at this in a much broader fashion.
To explain that a little further, we are part of the Cooperating Parties associated with setting up the rules and regulations and guidance for ICD-9-CM, ICD-10-CM, and ICD-10-PCS. I'm going to listen to Simon's one recommendation after I'm done here.
We also serve on the editorial boards for the guidance of not only the ICD classifications, but also CPT and HCPCS. We're a part of the World Health Family of International Classifications and working on both ICD-10 and ICD-11, and we are part of the IHTSDO, the International Health Terminology Standards Development Organization, which is working on SNOMED CT. Of course, if you have been following this, we're looking at the convergence of SNOMED and ICD-11. In our work with ICD-10, recognizing it as the first foot in the door toward that process, we have been very active in seeing where this goes. Obviously, this committee will be talking about this for some time to come.
Finally, I will just mention that we are the designated secretariat for the ISO 215, which is also looking at the integration of terminologies and classifications into the international standards.
We're making the assumption in our testimony today that the one-year extension that CMS is proposing will be the final rule. I say that because if it is not, then a number of the things that Simon said and that several, I suspect, will say will have to change, because there will be considerably more change necessary and a much greater amount of cost to the process. It has been estimated by some of the folks we have talked to that the one-year delay will cost about a third of what they have already put into implementation and a two-year delay will almost double the cost of the current implementation activity that has gone on. So we not only have the loss of not having the ICD-10 data available, but we then have the cost of implementation increasing.
Today is one of those milestones that you asked us to talk about. We have a significant portion of providers that have moved ahead, have gone on with the implementation of ICD-10 since 2009, when the rule came out. We have groups that have failed to move forward because there has been confusion on a variety of different activities that they need to follow and what the due date is. There are groups that have been told, don't worry, there will be an extension. You have time. Just stay the course.
I think it's very important for this committee, in its letter to the Secretary -- we do need a definitive, final date. The idea that dates can continue to be changed, we have already heard this morning, causes confusion, causes a belief that when you're dealing with HIPAA, you can always get a delay. If we keep that up, then we don't have a date. We have to have a date that moves on.
We have milestones for a variety of covered entities because we're engaged in so many different things associated with electronic health records, health information exchange, other health systems that have to be integrated -- laboratories, pharmacies, and the like -- and, of course, systems that organizations need to put in their own place to stay up with the industry.
We also have the meaningful-use incentive milestones. I can get money for this, but do I get money for ICD-10? Maybe I have to go for the incentive payment right now.
Our concern is that in all of this process -- and Simon alluded to it a bit, too -- if we're not also thinking ICD-10 and the need to implement this as we are looking at implementing electronic health records and the rest, then we have lost something. We have increased our cost. We think it's very important that HHS consider putting ICD-10-CM and PCS, appropriately for different users, in the criteria for the 2014 meaningful-regulations associated with criteria. If we can get the ICD-10 requirements in the software associated with EHRs, whether or not someone is going in that direction, that's one thing less they have to worry about. We think it's extremely important that they look at this and put it into that certification criterion for meaningful use. We hope that this committee will recommend that as well.
We have to look at the final rule, which becomes the next milestone. As Simon has already indicated, it's that final rule that's going to give us the dates that we know we have to work within. The longer CMS delays in putting that date out, the longer the delay. We already have a delay. We're not talking about whether we are going to have a delay. The notice in February created the delay. Now the question is, how much longer are we going to be delayed one year or beyond, because people are waiting? The momentum has ceased. There needs to be a movement to keep going. AHIMA has called since 2009 that entities keep moving. Do not consider the delay. Do not consider the implementation date something you should stop and wait, but keep moving through that process.
I think we have heard this morning in previous testimony -- and I like the way you had that all set up -- of the need of organizations to keep looking forward and to work together. That certainly becomes part of the implementation process that we have to look at.
They are not the only things coming into place right now. We have got to integrate our privacy and security information. We have to look at the programs that are causing the confusion and clarify the confusion. We have to try to get a coordination and a strategy roadmap, as Simon mentioned, across the HHS programs, not just in silos that cause problems for our providers.
One of the concerns we have -- and hope that this committee will agree -- we have asked in our comments on the delay that HHS put out a strategic roadmap on the implementation of all the programs that are associated with the HHS's providers and certainly with the MACs and other groups that integrate across the board. That would then bring along, of course, all our health plans that are not associated with Medicare and Medicaid, and bring the industry to a point where we can move together on these different pieces -- and Simon added one more piece -- and establish some priorities. The priorities are not there today.
We should ask, and hope that you will ask, for a single strategic plan from HHS to assist the industry in doing this. After the rule, we have to put that map in place and move forward. That's something that I think every provider and certainly health plans need to consider as well.
We can devise our guidance. We have lots of tools out there for implementation. But the question is, how do I use the tools? What's the education? How does this all work together? We're looking for a coordinated process, not only a roadmap, but then how we educate. We heard this loud and clear this morning.
We also heard this morning about testing and the serious need for coordinated testing. I had to think, as I was listening to Florida -- one of the things they mentioned was, hey, we were the big guy in Florida. If I look at Pennsylvania, I can think of a couple of health plans, plus Medicare and Medicaid, that, if they took the coordination responsibilities on in that state to work with all the providers and other health plans, could be doing some of the same things that were done in Florida with the process that we're looking at for ICD-10. We have to have that cooperation.
We need that timing. The timing and the lessons we have learned from 5010, from our early-on HIPAA implementations -- we ought to be taking those lessons right now and putting them into place.
If we continue to move in our implementation now and not wait for a date to be given, one of the things we can also do in our various locations is begin to build a testing map, a means for the organization to do very similar -- and Florida could give us their plans -- to move along and put that testing piece into place. I think we now know how important that is, but it still takes a lot of effort. You have heard in the last two panels, especially with physician offices, small entities, getting them involved, getting them involved with their vendors, becomes a very significant part of this process.
So in looking at the lessons we have learned from implementations under HIPAA, hopefully we can take the delay that we have had put forward by HHS and begin to move that forward as well to a coordinated testing process. Taking the education efforts of CMS, which have been very good, and expanding them across the industry so people actually see them and get involved with them becomes a significant problem.
The last thing -- and it kind of bounces off of Simon's comment -- we need to come up with a data-governance process. We need to look at how we are going to coordinate our terminologies and classifications, and move forward in this process. We cannot continue to segregate these so that we're dealing with some issues over in ONC, other issues at CMS, other issues at CDC, but a coordinated effort that says how we are going to bring the terminologies and classifications we need in this country forward. How do we have a public-private partnership to make that happen?
This is the beginning. ICD-10 is the beginning. We're going to be talking about SNOMED implementations. We're going to be talking about link with the laboratory reporting process. We have other classifications and terminologies that we are going to have to face. I think that's a role that this committee can very well play to move that issue of governance forward.
A lot of recommendations, certainly more in our written testimony. I want to thank you for the time, and especially for the lessons learned that we have built across this morning.
MS. DOO: Thank you so much.
Now we have Stanley Nachimonson.
Agenda Item: Provider Perspective
MR. NACHIMONSON: Thank you. Good morning.
It has been several years since I had the opportunity to the committee. Looking at all the people here, I feel like I'm at a high school reunion. Frankly, you all have gotten a few years older.
(Laughter)
I want to thank you for the opportunity to testify. I'm here today on behalf of HIMSS, as a HIMSS member, as a participant in a recent HIMSS G7 meeting, which I'll speak about, and as the incoming ICD-10 task force co-chair for HIMSS, starting in just a month or so.
Just a few minutes about what HIMSS is, for folks that may not know about the organization. It's a cause-based, not-for-profit organization focused on leadership for the optimal use of IT and management systems for better health care. We frame and lead practices and public policy through content expertise, professional development, research initiatives, and media vehicles designed to promote information and management systems' contributions to improving the quality, safety, access, and cost-effectiveness of patient care. I want to underline "patient care," because that's really the bottom line here.
The HIMSS G7 is actually a World Bank-endorsed thought leadership council. We don't quite get the same level of demonstrations outside the HIMSS G7 meetings that the World Bank gets outside their meetings. They meet three times a year to discuss critical health-care industry topics and work in a collaborative effort on potential projects to address some of those issues. The idea is really to design the health-care financial network of the future, combining thought leadership and action around key projects that have the potential to transform critical path areas in health-care -- i.e., the implementation of ICD-10. Each meeting is captured in an advisory report that comprises a thoughtful discourse of issues and a series of industry recommendations. That's what I will be discussing today.
In April we had a HIMSS G7 meeting to discuss creating a smooth glide path to ICD-10 implementation. At the meeting were representatives of providers, payers, financial institutions, government, consumers, employers, and technology firms -- a wide variety of folks in the industry. We feel that we got all the different perspectives in discussing this particular issue, focusing on smoothing the ICD-10 implementation.
We came up with a series of recommendations that I'll discuss today. When the final report is approved by the HIMSS Board of Directors, we will submit it to the committee for the record. But I want to talk particularly bout the several recommendations to smooth the ICD-10 implementation. Actually, we feel that these are things that could occur no matter what the particular date that's finally chosen by CMS is.
The first of the recommendations had to do with vendor readiness and self-reporting. What we did in the meeting was discuss the key risks to the industry and then come up with ways to address and mitigate those risks. There's no real, true definition of vendor readiness. We have heard a little bit about that already today. No provider necessarily knows if their vendor is ready. It's very difficult for organizations to determine if their vendors are ready, so that they can go ahead and move in their ICD-10 transition.
Our recommendation is to accelerate and encourage vendor self-reporting, the key to supporting payers, providers, and other vendors in the ICD-10 implementation. HIMSS already had some efforts using a company named VitalVendors as a tool on the HIMSS website which allows self-reporting of vendors to tell their status of where they are in developing their ICD-10 products. A similar tool is on the MGMA website in terms of vendor readiness. We really feel that we want to promote those existing efforts.
Secondly, a pilot program, including end-to-end testing. One of the key risks for ICD-10 implementation -- again, we have heard it today -- is that there is not a true ICD-10 testing process that's agreed upon in the industry. There's a lack of test data. There's a lack of test partners. Plans are uncertain of how to set up end-to-end testing, especially if an organization has not even developed their electronic remittance advice transaction. We have heard of a number of health plans that, as of today, still do not support electronic remittance advice.
Our recommendation is that HHS provide financial and staffing resources as a participant in the creation of a national pilot program that will include end-to-end standardized testing and monitor the actual processing environment. Program participants will include associations, payers, providers, vendors, financial institutions, government, and clearinghouses. We actually convened a multi-stakeholder meeting just two days ago -- nice timing -- in Chicago. The slide says we will share results with NCVHS during our testimony. I'm going to do that right now.
At the meeting, where we had over 40 people attending, representing a variety of organizations, a mix nationally of plans, providers, vendors, and organizations, the group clearly is interested in moving forward to develop a pilot program, with possibly four regional solution centers, representing different mixes of plans, providers, clearinghouses, and vendors, and different approaches to implementation and testing for ICD-10. We see these as groups of early-adopter participants so that we can find out the obstacles to ICD-10 implementation and the solutions for others to learn from.
There clearly will be a need to publicize the results of these pilot tests to a large audience, the nation as a whole, and the group would like to ask CMS for help in disseminating that information.
There is a recognized need for CMS to participate through a variety of ways -- funding, the endorsement of these, in-kind resources, and certainly both Medicare and Medicaid entities joining the solution centers. This is really for the purpose of perception, in that it's a supported effort, and to give providers some sense of trust that, yes, CMS does view this as a worthwhile effort. The contributions from CMS may not necessarily be tangible things, but it's clear that CMS backing builds credibility for the initiatives rather than this being a solely privately funded entity.
Seed funding is necessary. The group will be developing budgeting and participation options. There is a fervent wish for government funding for these efforts -- at least some participation.
So that's the pilot program.
The next recommendation, as we have heard today, is the enhancement of ICD-10 education, with the risk being that messaging for ICD-10 has to shift from what we have put out so far in information -- that it costs, there are very complicated implementation tactics, and what the exact timelines are -- to some very pragmatic pieces of information -- the impact on providers, why the changes are critical, and why, especially, they are beneficial to not only providers and health plans, but to the industry as a whole. Small provider groups, small hospitals, and, frankly, small health plans are still largely unaware of the ICD-10 impact on their revenue cycles.
Our recommendation would be to increase and improve ICD-10 education targeted especially at small provider groups and small hospitals, talking about the benefits of the new code set and financial risk assessments. Our idea is to leverage a number of existing organizations, like state and national specialty societies, regional extension centers, practice management system vendors, clearinghouses -- those folks that already have direct connections to providers and that providers, at times, rely on for critical information.
Our last recommendation is the CCDI awareness campaign. Like any good group, we wanted to come up with our own new acronym, so we developed CCDI, the Campaign for Coding and Clinical Documentation Improvement. The risk here is that -- in fact, Dan just mentioned it -- health-care organizations have differing methodologies around coding and mapping that will clearly result in delayed payments.
Our recommendation is that we have a campaign to broaden awareness and leverage the existing Cooperating Parties who maintain ICD-10. Those are the AHA, AHIMA, CMS, and CDC's National Center for Health Statistics. We want to make sure that we are providing education on coding resources, the roles and responsibilities of the Cooperating Parties, and credentials for HIM professionals. We think it's critical that this group provide timely answers. We can't wait for weeks or months for an answer on a coding question. It has to be days. We want to prepare for a large volume of inquiries, certainly before go-live date and right afterwards.
Moving forward, we certainly recommend that implementation continue, that folks move full steam ahead and not worry about what the final date is going to be. HIMSS's current engagements include hosting a comprehensive, credible, and timely website, the ICD-10 playbook. We convene ongoing education nationally and at the regional level. We will be hopefully initiating the multi-stakeholder visioning of the ICD-10 national pilot program. We will continue to work with many organizations to create more robust educational tools and programs. And we will be encouraging vendors to use the VitalVendors self-reporting readiness tools.
Voila.
MS. DOO: Excellent. Thank you very much.
We have next Rhonda Buckholttz.
MS. BUCKHOLTTZ: First of all, on behalf of AACP, I want to say thank you for allowing us to provide testimony and to speak today.
Our focus on this was to point out, since the announcement of the intent to delay, what it has done to existing providers that have already begun the implementation process.
AAPC is a membership organization. Currently we have about 114,000 members. Of those 114,000 members, we represent not only coding, but compliance, auditing, and practice managers as well within our organizations.
Our focus so far in working with ICD-10 is getting the word out about implementation and working on that piece of it, not just on the code set piece, but all of the implications of what ICD-10 really is going to be in a provider practice. To that end, we do a lot of implementation training. To date, we have trained over 7,000 individuals on ICD-10 implementation for the business aspects of ICD-10.
We sent a survey out to all of those that had received training from us on the implementation. The people who represent our implementation training largely represent physician offices. However, we also do have vendors that receive the training and health plans, as well as some educators and consultants and those types of things. The positions from the people who responded to the survey that they hold include CEOs, administrators, IT, billing, coding and claims, compliance and auditing professionals. We had about 948 people respond to our survey at the time that we had to get it ready.
The first question that we asked of those people was, when the notice came out with the intent to delay, how many of you had already begun implementing ICD-10? Actually, 818, or 86 percent said that they had already begun working on ICD-10 implementation in their practice when the announcement came out.
We asked them what their efforts were, where they were in the industry, so that we would have a good feeling of, when they say implementation and what was started, what exactly they had been doing. Two hundred thirty were performing impact assessments, 78 had gone past that and were working on budgets, and 314, or 37 percent, had begun actual training of internal staff, and about 26 percent were "other" responses. From those responses, we gathered that they were working with their vendors or else they were working on curriculum, consulting, working with clients, and those types of things, so they just didn't fit into those caveats.
Then we asked them how the announcement of the delay had impacted their ICD-10 implementation. Surprisingly enough, only 5 percent said their budget money was reallocated and that they had to stop implementation efforts. Twenty-four percent indicated that they lost physician attention, which is interesting because when we get into the comment section and we go through the comments, most of the comments were how they had lost the attention. Forty-seven percent, though, said that even though there was an intent to delay, they were going to continue moving forward with implementation efforts and they haven't stopped. We found that number a little bit surprising. About 24 percent said they lost momentum and credibility. Their committees were put on hold, and they had to stop where they were.
Many additional comments that were received but didn't quite fit into some of the survey questions were that they feel that the physicians believe now that ICD-10 would never happen and that there is actually on reason to prepare. Many believe that delays will continue, and they can't allocate funds that are needed elsewhere when they are not sure that the ICD-10 is really going to happen. They want to make sure that everybody knows they don't want to prepare for something that may never happen. A lot of our respondents felt that they were making progress, but now they have lost all momentum.
I did find it interesting that we actually had several people say they consider the ICD-10 the code that cried wolf: We have talked about it a lot, but when it comes down to it, it just keeps getting postponed over and over again.
We really are facing some tough times here in trying to get the attention of the physicians. We have heard a lot of people testify about collaboration and those types of things, but I don't think anyone realizes the ramifications when it comes to the small providers. They only hear certain things. When we talk about testing and those types of things -- I personally live in a rural part of Pennsylvania, and I have worked with a lot of providers that just don't even understand the need to keep up the maintenance on their practice management, because they don't understand the initiatives that are coming down. When people say they don't think the providers are listening, it's true, because they are not hearing the messages. They are not up to date and they don't understand.
When we put mixed messages out in the marketplace, it really sets us back, I think, further than people anticipate.
Then we asked them the question, what was the cost of the delay if they had begun implementing? Thirteen percent said it was more than $100,000. We would expect that number to be lower because most of the people that attend our implementation boot camps aren't from the larger organizations, although we do have some of that representation. Thirteen percent said that it was between $50,000 and $100,000, and then 74 percent said that it was less than $50,000, what the impact of the delay would be.
The one question that I didn't ask that we probably should have was, was it less than $50,000 or was it zero? We did get those. I did get several emails from people that said that as of right now, their costs were just in the thousands, moving forward.
Other concerns that were mentioned included that they believed that sufficient documentation would still need to be the largest focus for the implementation strategy. We at the AAPC believe that as well. We do what we call documentation-readiness assessments, ongoing, and overall we find that with the clinical documentation, only about 40 percent will actually make the transition to ICD-10. So I think that's a real concern that's out there.
Many said that they were still struggling to try to understand the EHR initiatives and make them work in their practices. Others said they were still reeling from 5010 and the lack of vendor coordination, as well as the costs to now have to complete retraining because of the delay. Many were frustrated that they have already paid for training, and now they may have to get retraining because of the intent to delay.
We asked, not only with our poll, but through our local chapters -- we have close to 500 local chapters across the United States, and we routinely go out and make visits to them, through our executive team and speakers and those types of things. They kind of mirror what the survey results were as well. Of course, our coders -- if that's all they are involved in, if they are not involved in implementation -- don't have much to contribute to that. But with everyone else, they said the same across the board: We need clear, concise messaging. They feel that a lot of the messaging that's out in the industry right now is giving them conflicting information. They are not sure where to turn, and so they are going to sit and wait.
They would like to see some accurate cost estimates for what it's really going to cost to implement in a smaller provider's office. They feel that that would help their practice and help them to be able to make the decisions and determinations.
Of course, comprehensive education on how the data that we collect is actually going to be used and how it really is going to impact a physician -- how are the codes going to benefit a physician? They want that type of information. This is what they are indicating to us. Moving forward, here's what is going to get them moving. They want clear, concise information. They want everybody to agree on what's going to happen and how it really is going to impact a physician moving forward or what benefits it's going to be to them moving forward.
That's all I have.
MS. DOO: Thank you, Rhonda.
Next we have Mona Reimers.
MS. REIMERS: Thank you for inviting me to give input today to this very challenging initiative. I hope that I'm able to make clearer what's going on in the struggles of the average physician practice and what we might have going on with ICD-10, trying to implement it.
I know this section is supposed to giving the high-level physician -- what physicians want for milestones to make a successful transition. But I feel a little bit more like Joe the Plumber, because in my practice I actually do the work -- I come from an orthopedic practice in Fort Wayne, Indiana. We have 37 physicians, a variety of midlevel providers, therapists, one ASC, and one MRI. My practice, I feel, represents a middle-sized practice, but it could also be within an integrated delivery system.
We have a variety of the software that you would expect to find in a medical practice. All of these are nationally recognized vendors.
To understand what's going on in the medical practice, I think it is important to understand where we are right now, except for ICD-10. We have to understand that we have had an economic downturn. It has required patients to have more personal expense. Some of that turns into bad debt. We have had increased billing costs. We have multiple competing federal mandates, incentive programs, such as ICD-10, ACA administration simplification, et cetera. These all bear down on us with a lot of competing, for our time and energy, initiatives. We are at the mercy of the software developers to redesign and update our software to meet these mandatory specifications.
Just from a personal perspective, we received an update for our billing software with probably less than a week in advance for 5010. We had gotten other upgrades along the way, but our first actual 5010 go-live that we could have really practiced was delivered to us at the last minute. Had we had the software delivered earlier, it's important for you to know that we would have not been able to really test it, because of our trading partners would not have been able to test with us, at least not end-to-end, as we have been hearing.
There is also tremendous uncertainty with ACA and the flawed SGR. I think where this is important to the relevance of ICD-10 is that every year it's nearly impossible to create a budget. If you don't know your revenue, how can you budget? In the CMS documentation on the ICD-10 implementation guide for physician practices, on page 18 and 19, it tells us that we should be prepared to not have our claims processed directly and we should be prepared for cash-flow interruptions. It's very difficult to want to budget that. I don't mean to be flip, but that's just true.
With all of this stage setting, MGMA would like to present to you the strategies to help you get to ICD-10.
One of them is to conduct a cost/benefit analysis so that the community at large can see the benefits and the costs of what's going on with ICD-10. They include several of these bullet points here that I won't read to you, as you all have them. Our first recommendation obviously is to conduct this cost/benefit analysis.
On the cost/benefit analysis, there is the second page of these, which will get you through the entire strategy in that regard.
Getting on to strategy 2, we would need to:
Leverage the experience of other nations and consider any one of these options or any combination of them:
Strategy 4: We also are recommending pilot testing. Pilot testing, we think, should be conducted prior to national implementation.
Strategy 5 asks that certification in ICD-10 be required of the major IT stakeholders -- again, this was spoken of several times today -- including the health plans, the clearinghouses, EHRs, practice management, and other billing software. HHS could partner with the existing meaningful-use certification entities. As we have seen with the meaningful-use certification, certification can drive implementation, standardize software, and leverage market forces to ensure that practices can meet the federal requirements.
With strategy 6, we are recommending that health plans continue on the path of transparency for all parties. This will necessitate the need for much granular information before the go-live date with ICD-10. For example, what level of granularity will the federal health plans require? What if a physician treats a patient in the emergency room and never learns enough details to give the granularity required of the payer? Since every health insurer and self-funded health plan can determine their own requirements, those requirements need to be made available to the necessary parties in advance.
Approximately half of the patients in my practice are covered under the Department of Labor self-funded health plans. This means every employer can create their own rules. These rules need to be available to the patients in their plan descriptions and to their third-party administrators quite some time before go-live with ICD-10.
How will the many different public and private quality rating systems be maintained? How will unspecified be viewed? Will there be true payment neutrality?
To continue on the topic of health plan transparency, the industry will need to know how predetermination, pre-authorizations, and pre-certifications will be affected, and whether the providers will have access to payment policies prior to the time of the service.
Finally, it is essential that the industry determine whether each health plan will adopt its own proprietary crosswalk or if differing crosswalks will impact payment policies, and CMS should lead the way.
In strategy 7, we are suggesting staggered implementation by business type. We recommend that the clearinghouses and health plans be required to comply a full 12 months before providers are required to comply and to allow dual use of ICD-9 and ICD-10 during testing year, minimizing the disruption of health-care delivery and claims payment. During this staggered implementation timeline, CMS could also implement a problem-resolution and cash-advance process to minimize the impact on practice cash flow -- again, spoken about several times today.
There are additional considerations, which I won't read due to time. They are part of the record. We would like to point out one important aspect, and that is that clearinghouses cannot serve as a conduit to fixing a problem between ICD-9 and ICD-10, because it requires data from the health record that they don't have. Although clearinghouses have been a part of the problem and a part of the solution, this is one problem they really can't solve, other than to help pass along the information. In the past, they have been able to help us bridge into 4010 and 5010.
To review, there are ten critical milestones that we think are essential to ICD-10 implementation:
In summary, unprecedented change and potential for disruption exits. Significant pushback from physicians and outpatient providers on ICD-10 necessitates a new approach. The impact/cost/pathway must be established prior to moving forward with ICD-10.
The traditional single-date implementation approach where providers rely on clearinghouses will not work. HHS should explore code set and timing alternatives. Too many unknowns at this point are out there to set a firm compliance date.
On behalf of MGMA, thank you for inviting me to speak.
MS. DOO: Thank you.
Dennis Winkler.
Agenda Item: Health Plan Perspective
MR. WINKLER: Good morning. My name is Dennis Winkler. I am the director of technical program, including ICD-10, of Blue Cross Blue Shield of Michigan. On behalf of Michigan, I would like to thank the committee for inviting us to present a payer's view of what it takes for ICD-10 to be successful.
Up until Mona's discussion, I would say, I couldn't ask to be in a better position relative to the agenda. But even then, I think it will really elaborate or confirm some of the recommendations we would be making.
Starting with 5010, the lessons learned, the discussion on testing, what do we have to do for end-to-end testing to be successful, including on the operating rules, Kaiser's discussion that it really affects what's going on in the doctor's office and the facilities' billing back office activities. All those things really come together, I think, in ICD-10.
With that, we were asked to respond from a payer's perspective to four questions. I think, even though what we'll talk about here differs as far as what the answers are, there is a common overriding theme, and that is the need for collaboration between the payers and the providers. Again, that message is very, very consistent with, I think, everything we have heard this morning.
The first question asked, what needs to occur for a successful transition? From our perspective, the most critical milestones have to do with the implementation date. It must be solid. It must be firm. As we heard earlier, we need to have a definitive date defined. It has to be adequately enforced, and really needs to be all or nothing. Three, four years ago, five years ago, had we talked about a split implementation of maybe the procedure codes, diagnostic codes separate, small physician offices one conversion date, large physician groups second -- we probably could have had that discussion, but a lot of time has gone and I think a lot of efforts have been geared towards building this on a single data service conversion date, with an all-or-nothing mentality and mindset. To change that now would cause significant impacts in the entire industry to recalibrate everyone's architectures and approaches.
Is it doable? Yes. Is it costly? Yes. Is it going to be done in the timeframe that we're all talking about? No.
So I think it's something that we really need to get our arms around. But once that decision is made -- and I think there's a consistent theme -- we need to anchor on it and we need to enforce it. Once that date is made, we really can't go back and start talking about other issues for it.
The penalties of noncompliance need to be firmly understood, communicated, and enforced. What I really would love to say is, is there a way that we can get a carrot in there? At some point in time, you can only pound and pound and pound on the penalties. That's the stick aspect of it. But is there a way that we really can deal with carrots in this process? I don't have an answer to that, but I just know it's an opportunity for us to consider.
If we don't address all those components, there will be groups of people -- payers and providers alike -- that say, it's going to be delayed again. So long as you have that mindset or that thought, there will be a group that will not be as committed to moving forward and hitting the date as others.
That closely ties with the next question, which centers around how it is that you can maintain the momentum and avoid slowdowns. One of the views that we think is associated with a slowdown is noise in the pipeline. We understand that you will never ever stop noise in the pipeline. Whether it's the multiple opinions of the industry, both payers and providers alike, special interest groups, the political aspect of it, it really doesn't matter. There's noise in the pipeline. But if that noise in the pipeline is heard and people believe that there is a possibility that that noise will result in a slowdown, you are going to get more and more people listening to it. You can't eliminate it, but the question is, how can you create an environment in which that noise, everyone understands, is discounted, it's just noise in the pipeline?
Really, from our standpoint, we are asking, is there a way to basically get consensus and get a collaborative working environment between all the major constituents. This is where we believe that HHS, CMS can come into play to endorse at a broad level a consortium or a summit of the major constituents to sit down and start talking about the hurdles that each of the groups faces relative to pulling this off. The reason for the summit, or the collaborative nature of that, is that when you can get everybody at the table listening to the other areas' concerns, then you are in a much better position to propose solutions that satisfy the whole. I know that when the payers get together and they talk about it, they can come up with one concept. I'm sure that on the provider side, they can come up with another concept. But it's when you bring the two groups together that we think, holistically, you can actually come up with alternatives that start getting the entire industry moving in lockstep at the same time.
Other thoughts related to the transition: This really gets back into the more local nature. This is one of the things that we have found at Michigan. From a payer's perspective, we really don't understand what the provider pain points are in ICD-10. Just listening to Mona's summary of the ten steps, it gives us a fresh perspective. I can talk to payers and understand our pain points. I don't necessarily have the same view on the providers.
But we have also seen that the providers and the facilities have their perspective and don't necessarily understand the perspective and the pain points of a payer.
At Michigan, we have set up partners relative to a small group of medical practices and facilities that we work with up front to define how we go about defining our neutrality or the environment. Part of that learning process is sitting down and just getting to a common definition and nomenclature and an understanding of what everyone is working on. It's not something that's going to happen fast. If it's difficult at the micro level, at the regional level, just imagine, going back to this summit, the opportunity that we would have nationally to be able to bring those two groups together.
Another thing -- and it was mentioned earlier -- on the ICD-10 is to come up with a roadmap that really lists all the initiatives, from regulation and statutory requirements, not just on the dates that they are going live, but from a duration standpoint -- when does the initiative start the activities for the most part and when does it end? -- literally to line those up, both on the payer side, as well as the provider/facility side, to see the interrelationships, so that when we do start talking about any movement of any date, it's very, very easy to see how it impacts the other activities. Does it solve the problems? No. But does it help build line of sight and awareness overall relative to what it is, in fact, everybody is working on? We think it would be yes. Again, that sharing of information, having a common baseline, that collaborative process, we feel is key to being successful long-term.
But the fun one that we want to talk about is testing. Like I said, you could not have possibly choreographed this better than what occurred today.
First, I want to say that the end-to-end testing concept, or what we call external testing, in our environment is very, very much tied to our provider-readiness initiative. Basically, in this case we believe traditional testing methodologies will not work. We know that the providers in today's environment, based on all the good work of 5010 -- the 5010 environment is up and operating. That's the core foundation for ICD-10. The only thing that changes in ICD-10 is the data content for procedure and diagnostic codes. The infrastructure is there.
So our argument would be, then why test -- no, excuse me, definitely have to test, I'm sorry. That's a Freudian slip.
Why concentrate on sending claims to do the ICD-10 testing?
Basically, we're taking a different approach at Michigan, and we're concentrating on building an environment that is medical scenario-based. If we can get the complete scenario in front of the providers, the providers would take that scenario and say, given all this, here are the diagnostic and procedure codes we would use. They would send just those codes over to us from a payer's standpoint. Because it's a controlled environment, we would have our claims test environment set up in the background. We would plot those codes in, actually run claims, kick out the results, and then communicate the output to the providers.
We're not testing the ability to send HIPAA-compliant transactions to and from. That has already been done. What we are doing in that approach is basically saying, here's what you are able to send us. We process it and send the results.
We think there are fourfold benefits to this approach:
• One is that the providers define codes that they would send for defined medical scenarios, which demonstrates their ability to use and determine ICD-10 codes.
• Secondly, now payers will understand what actual information providers will be sending us.
• The third is that when we process the claims and send the information back, the payers will understand that the results are actually being processed by the payer.
• The providers understand how the payer is going to actually process and reimburse the claim.
We just believe it's a different model, and it's a model that really concentrates on the ability to get the content understood and communicated back and forth, not the technology, because that infrastructure has already been established.
From our standpoint, this is a radically different approach. We understand that. However, we believe it also provides a baseline for a different type of testing that could be used on future health-care reform initiatives, including the migration to ICD-10, 11, et cetera.
In summary, we believe that the success to ICD-10 is predicated on strong collaboration between providers and payers, at the national, regional, and local level. We really believe that we are all in this together. If we can send that message and create a collaborative environment where we all believe that, we believe we can come up with solutions that will collectively work in the totality of everything.
We also feel that testing, to be successful here, really needs to be done differently. We hope to concentrate on medical scenarios that really provide the baseline for testing.
Again, we would like to thank you for the opportunity to give Blue Cross Blue Shield of Michigan's perspective on ICD-10.
MS. DOO: Thank you.
Mr. Hebert.
MR. HEBERT: Thank you. I would like to thank the committee for having me here to testify on behalf of AHIP. My name is Sid Hebert. I'm the ICD-10 program manager for Humana. My primary responsibilities are implementation of the revised HIPAA electronic transaction standards, the ICD-10 code sets, and administrative simplification mandated by the Affordable Care Act.
You can see that my plate is pretty full.
What you are going to hear is sort of a uniting thread. Most of my comments here, and if you catch me at any other venue, are that we can't even validate our intentions without testing. The core of what we have ahead of us is testing. It is an unprecedented requirement for health care, considering the broad spectrum of stakeholders. Quite frankly, if we do not get it correct, we're probably just not going to produce a very good result.
I work for Humana, but I am representing AHIP. Humana is one of the nation's largest publicly traded health and supplemental benefits companies. We offer a wide array of health and supplemental benefit plans for employer groups, government programs, and individuals.
The testimony today is based on a number of meetings with AHIP's HIPAA Standards Transactions and ICD-10 Task Force. To say that we have labored over this delayed decision is an understatement. This is important to the health-care community. It has not only great implications to out-of-pocket costs for implementation, but it has great implications to our ability to deliver quality health outcomes for patients.
As we all know, the migration to the upgraded HIPAA electronic transaction standards, as we heard this morning, and ICD-10 code sets have and will continue to have major impacts on the business and administrative operations for health plans and will require significant resources for successful implementation. At Humana, we began planning and execution for ICD-10 in 2009, and we have worked consistently and diligently since then. We recognize that the complexity of this coding system would require careful and systematic management for successful implementation.
Humana will expend 58 percent of our projected ICD-10 implementation budget by year-end 2012, so we have a lot of spend ahead of us, and we're anticipating a minimum of 11 to 15 percent increased costs for delay just for this first year. Our anticipation is that our costs would escalate well beyond that for a second-year delay.
On behalf of AHIP, I want to let the subcommittee know that the health insurance industry is committed to the implementation of ICD-10, which will allow practitioners to identify and report conditions and condition management in more specific ways that will lead to more effective measurements of quality and outcomes. The recent delay puts implementation momentum at serious risk and, as acknowledged by CMS in the proposed rule, increases implementation costs.
I have spent an entire career on large-scale integration projections, and I can tell you, delays never produce positive outcomes. They delay the outcome and they dilute the outcome. Although in this particular case we may be able to come up with some positive attributes for this delay, because I do not believe this industry was ready, overall if we can continue this behavior, we're going to see dilution in the quality of the outcome.
We have a number of recommendations. I have diluted my verbal comments to just the recommendations.
The first one: NCVHS should work with HHS to develop a detailed ICD-10 testing and implementation plan. You have heard it echoed from early this morning. Testing gave us a false sense of security in the 5010 implementation. Effective testing in ICD-10, as we are approaching it now, will produce the same false sense of security.
Quality has to be built in before testing begins, and testing can only validate the usability of the product delivered. To believe that testing is going to give us 100 percent assurance that we are going to be successful I think is a little shortsighted. What it will do is give us an opportunity to validate how well our planning and executive work was for building out our ICD-10 solution, and it will tell us whether or not people who choose to use a testing methodology -- and, by the way, I do very much like what Dennis Winkler had to say for Michigan about taking a medical approach to it -- but it will only validate our ability to use it. It will not validate the outcome we should expect in the real world. ICD-10 is all about the content. 5010 was all about the envelope. If we get bad content, we're going to get bad results.
Payers will build their systems for sensible, science-based coding of medical records. If you give us something that's not one of those, something that is an aberration, you are not going to get a good result. So not only are we testing for good, effective outcomes consistent with best medical practice, but we're also testing for the aberration that's going to occur as people try to learn how to use this new coding system.
I propose that testing that is also the opportunity to calibrate our test bed, which will include the provider all the way through to the payer, and everyone in between. We're really calibrating our ability to produce quality encoding of true medical conditions in a consistent manner -- a much broader requirement for testing.
The second thing I will tell you about testing is that end-to-end testing, just the definition of it, is an arduous task. I have worked with a group at WEDI. Stanley Nachimonson and I are co-chairs. We have just completed quite an extensive effort just to define what end-to-end testing is in the English language that a business person can understand at a very high level. It is a frighteningly scary document, just because of the breadth of everyone who is involved.
So as we approach testing, it has to be multi-stakeholder. It has to be all-in. If you are not part of the testing process, you're not part of the ability to calibrate your own ability to perform your element of the chain of events, the cycle management. So testing has become a very broad topic, and I expect that we'll continue to have avid discussions about it.
But this plan that we're recommending that NCVHS recommend to the Secretary would allow for all covered entities to begin testing around October 1 of next year, 2013. I believe that should be a hard requirement, as opposed to the soft requirement that we have from 5010, which basically said everyone ready to test by October 1, 2011. There were a lot of people who were ready to test who actually weren't. There were a lot of people who weren't ready to test until well into 2011, almost the compliance date. We need hard testing dates, and everyone should be prepared to begin no later than October 1, 2013.
The program should include milestones and metrics that would be monitored to better understand the state of the industry. A failing of the 5010 engagement was that it did not put actionable, usable information about the process. People were self-attesting that they were ready to test, but there was no information beyond that.
In tandem, we recommend that the subcommittee consider recommending the use of other incentives to ensure that all stakeholders can meet the new deadline. Once again, let's introduce a carrot. One approach would be to leverage the momentum towards achieving meaningful use by ensuring that certified EHR vendors are required to comply with ICD-10, as well as SNOMED CT.
Our second recommendation is that NCVHS should recommend that HHS stand firm and not move the date again. I can't reinforce enough that in my entire career I haven't seen a benefit to delay. The continued uncertainty regarding the enforcement deadline for 5010 over the first six months of 2012 have demonstrated the high costs with delayed enforcement dates that are often extended at the last minute. The implementation of 5010 was extended when it became clear at the very last moment that certain entities were not prepared. I would contend that delaying enforcement to support people who actually do the heavy work and lifting is probably not an effective strategy, as demonstrated by experience.
Further changes to the ICD-10 compliance date or similar enforcement delays throughout 2013 and 2014 prior to the October 1, 2014 deadline would cause significant costs for health plans when the industry will be preparing for the implementation of health insurance exchanges and other ACA-mandated changes. Health plans naturally evolve over time, and extended delay will require an extension of testing activities and prolonged maintenance of the testing environment.
We stand ready to ensure that member plans will be able to meet the deadline, and thus strongly encourage HHS to not make any further changes to the implementation date.
To achieve this and to avoid last-minute delays, HHS needs a mechanism to assess the readiness -- not a survey, by the way -- of the provider community to hit a certain date. I will acknowledge that I'm saying the payers are going to be there. So now I'm focusing on the providers. You can also use the same mechanism for us. If implementation is highly likely, then set that date and do not change it. Health plans view October 1, 2014 as achievable, but if other stakeholders will not be ready we are setting ourselves up for some serious challenges.
We strongly recommend against any dual implementation periods for ICD-10, as some have suggested. We have heard recommendations for different implementation dates for health plans and providers -- to which we have to ask, what really is the point? The point is to get ICD-10 implemented, not to drag it out over a number of years. Others have also suggested phasing in the implementation of ICD-10 procedure codes and diagnostic codes. To Dennis Winkler's earlier point, we have it planned, our design for that. It would be a major restart if we did.
Among other costly impacts, this option would require a new set of hybrid DRG definitions and would cause a two-phase approach to changing impacted hospital contracts. Both approaches would be nearly impossible to implement from an operational perspective and would cause great challenges both in the development of health plan and provider contracts and implementation of quality-improvement strategy reporting.
Our third recommendation: We recommend that a comprehensive review of upcoming administrative simplification and other regulatory and statutory deadlines take place. The implementation of administration simplification reforms included in the Affordable Care Act, along with ICD-10, requires significant changes to health plan infrastructure and impacts almost every facet of a health plan's operations. We believe it is prudent for the NCVHS to conduct such a review to determine if the forthcoming compliance dates for operating rules, such as ERA, EFT, and future operating rules related to enrollment, authorizations, referrals, and claims, can be adjusted.
Our fourth and final recommendation: The Department should provide allowances in the medical loss ratio final rule to account for impact of ICD-10 delay. HHS has recognized that ICD-10 conversion implementation costs are quality improvement activities. However, the MLR final rule proposed to limit the amount of ICD-10 conversion costs to those costs incurred in 2012 and 2013, which are capped at .3 percent of earned premium in a relevant market.
We have asked HHS, one, to adjust the .3 percent cap and, two, to allow health plans to include 2014 implementation costs because of this proposed delay.
In closing, I do want to reiterate that the health insurance industry fully supports the implementation of ICD-10, which has numerous benefits, including greater precision in the identification of diagnoses and procedures, improved reporting for public health and biosurveillance, and support for quality-improvement programs. Health plans have expended significant resources to date in implementation, and it is critical that this momentum be sustained through October 1, 2014. There is considerable change coming with the implementation of the Affordable Care Act, which will stress health plan systems and resources. It is critical that the industry come together to make this happen.
I thank you for the opportunity and your attention.
MS. DOO: Thank you.
Now we have Holly Louie, from HBMA
MS. LOUIE: I thank the members of the subcommittee for allowing me to speak again.
I chair the ICD-10/5010 committee for HBMA.
HBMA does support the proposed delay of a year to allow those portions of the industry that just plain were not going to be ready to meet that deadline. However, we believe that there need to be very specific issues effectively addressed to make this delay mean anything for the health-care industry. We don't want to be in the same place again as we move ahead when there are big portions of the industry saying, we're not ready, and, as my colleagues have spoken about, more delays to follow.
The first thing that we think is important -- and you guys have probably heard this ad nauseum today -- just as there was no definition of what 5010-ready meant, there is no definition of what ICD-10-ready means either right now. I think that's a huge thing.
Several years ago, before the final regs were even published, we had a vendor with a monstrous sign that said, "We are HIPPA-ready," spelled H-I-P-P-A. That's kind of where we are right now with ICD-10.
As a result, ICD-10 means anything that anybody wants it to mean. I think if this shortsightedness is not corrected promptly, there will be far-reaching negative impacts, and it will be much greater than 5010, which really was just a technical change.
You have our proposed definition of ready for the industry.
As we have talked about, testing does need to be at a claim line adjudication level -- the medical that we have heard talked about -- so that we actually know what happens with that claim when it goes through, what the payer does with it, and how it comes back. We think one of the oversights truly in the standards right now is the that diagnosis code is not returned in the 5010 format when it comes back. It's not on the remit. You don't know what diagnosis code the payer used to make a determination. We think that's a critical oversight. We think it ought to be part of the standards. We think it ought to be part of 5010 and incorporated as part of this transition.
We think that's really important, as we have heard various payers and entities throughout the industry say they are going to use a wide variety of mapping or crosswalk programs that can be proprietary. We could potentially be looking at a different map or crosswalk for every plan out there. We just don't know what that is going to be.
Equally important, we think testing must begin and be successfully completed well before October of whatever the year ends up being. We need time to correct and remediate problems. That should be mandatory. While we do understand the need for latitude in testing dates, it cannot be such that testing is so superficial, the parameters so hidden, and the dates so late that it will be impossible to address the issues that are certain to arise. We strongly recommend one full year for testing, including time for remediation.
We believe that CMS and the commercial payers must publish their coverage policies and LCDs and NCDs far in advance of the implementation. We recommend at least a year. When the reality of payment policies can be so specific that shortness of breath is a covered indication for a test, but difficulty breathing is not a covered indication for a test, we need full disclosure and full understanding of what implementation of ICD-10 will mean from the payer's perspective as they look at these clinical scenarios.
We have pleaded for three years for payers and CMS to fully disclose if they will continue to reimburse nonspecific codes. Yes, we know they exist in ICD-10, but that's an answer that has no meaning. We also know that the vast majority of current physician documentation can't be coded to the most specific ICD-9 level.
There must be time to work with our physicians, educate them, help them learn and understand how and what they need to document to allow correct coding and appropriate payment for services that they are providing. Physicians have to clearly understand how what they document is not currently representative of the details needed to measure quality, and we believe their coding is typically not really representative of what they are actually doing in diagnosing and treating. They just don't document very well.
If there will be no requirement for specificity with ICD-10, then I have to say, why are we doing this? Is it all pain and no gain? If we end up with every code still unspecified, how does that help anybody measure quality as we move ahead?
Next, we believe there needs to be a clear understanding of the false implications of crosswalks, maps, and electronic health records as some type of magic bullet. We are aware of numerous vendors and others marketing these products as the conversion-to-ICD-10 solution, and physicians are looking to these products as a one-stop fix. Even worse, we have already had physicians asking vendors and clearinghouses to just change the code to the right one so it will get paid.
The missing piece of critical information is that these are simply tools. They are not coding, and they can't replace accurate coding based on documentation in a medical record. A recent article from a major payer stressed that attempting to use maps and/or crosswalks as a coding reimbursement solution will result in catastrophic failure of the system. They are not a viable solution, and CMS, as well as the other industry educators, must be explicit in their outreach and education on this issue.
The need for in-depth physician involvement, understanding of documentation and coding, and that they will need to invest time and effort, is the one area where we believe CMS has done the physician community a disservice. They have made it sound really simple and really easy and they don't have to change anything.
EHRs and automated coding assist products identify keywords that could be used to assign codes. It doesn't mean the codes are correct. For example, a radiology report may state that if the patient smokes or has a history or smoking, clinical follow-up is recommended. Imagine if that's you. You have never smoked, but you are suddenly diagnosed as a smoker. The ramifications for coverage, insurance costs, preexisting risk, et cetera, are now significant, but incorrect. That doesn't mean that EHRs and automated products should not be chosen and implemented -- they are going to become more and more necessary -- merely that they are not a magic answer to accurately coding.
The ability for HIPAA-exempt plans to require the use of codes long outdated or invalid must stop, in HBMA's opinion. While we fully understand the unique needs for documentation and other information required for auto, tort, work comp, et cetera, utilization of codes from the 1990s or 2005, as California has asked for this year, is just frankly ludicrous. It greatly compounds the challenges of ICD-10 implementation to also have to meet requirements for codes that haven't been valid for years and aren't and won't be maintained. It increases cost, increases system programming complexity, and adds undue burden throughout the entire system. There is latitude for reasonable and unique requirements, but we do not believe that coding should be one of those.
As we all should be aware, there are numerous other requirements on concurrent timelines with ICD-10, as we have discussed. Unfortunately, these all require system updates or changes, programming modifications, cost, and people. More importantly, CMS requirements have a significant impact on claims for commercial payers that is often not recognized. For many, if not most, in the industry, this means the same resources have to be allocated to the same project. We have heard some commercial plans say that they expect that there will be two to five years of claims disruptions and payment disruptions post-go-live. I don't know what to say to that, other than, "Yikes." I just don't think there's a word.
We have heard the stories about entities stopping their work upon the Secretary's announcement. It's foolhardy, but it is a fact. Our members who have made substantial gains in preparation for ICD-10 have all stated it was at the cost of other things they needed to accomplish for successful business. There are just simply not enough resources. We would recommend a consecutive versus a concurrent schedule for anything that's not statutorily required so that we have time to do ICD-10 right and then build from there on other initiatives.
Lastly, as I think we have heard from everybody, this is going to require a lot of collaboration from all of the stakeholders and vested parties. We're going to need standard definitions, we're going to need real testing, and we're going to need timely publication of policies and extensive education.
Thank you.
MS. DOO: Thank you.
Denise, did you want to say anything about the regulation from a CMS perspective?
MS. BUENNING: Sure. Good afternoon. For the record, I'm Denise Buenning. I'm the acting deputy director of the Office of E-Health Standards and Services at CMS.
I have been listening with great interest to all of the discussion and discourse today on all of the topics, but especially ICD-10, my very favorite. No, it truly is.
I just want to give you all an update as to where we are in terms of working towards an announcement of a revised date for ICD-10. I think you all know that the Department published a notice of proposed rulemaking on April 17 of this year proposing a one-year delay in ICD-10, until October 1 of 2014. There was a 30-day public comment period associated with that proposed rule, which closed on May 17. As a result of that public comment period, we received 565 comments, and variations thereof, on ICD-10 and on the proposal to delay for a year.
Those of you who were with us all when we did the initial ICD-10 proposed rule in 2008 will remember that as a result of that comment period, when we received over 3,000 comments -- if there were a dozen people in the room, we had 13 different opinions. It's the same on this go-round. The public comments are literally all over the place. Some ask us to stick to the 2013 date. Others say they agree with the one-year delay. Others advocate for a two-year, three-year, five-year delay. Don't go to ten, but go directly to 11. Split the implementation. Stay with ICD-9, et cetera, et cetera.
Where we stand on this is that we have actually read each and every one of the comments. We have categorized it. We have come up -- when I say "we," I and our staff -- with a recommendation that we will be taking forward to the administrator for her consideration. Since this is an HHS initiative, it will also go up to the Secretary's level as well.
We are preparing to do that. Right now, in terms of a final rule, all I can tell you, because of all the clearances and all the discussion that this topic has elicited and is going to elicit at the Department, we are going to work to get out a final rule just as quickly as we possibly can. And I'm also from CMS and I'm here to help you.
The other thing that I would like to mention as well -- that proposed rule also had two other areas of interest, one of which was a change in the national provider identifier and also, most notably, the health plan identifier. Believe it or not, we got some comments on that, too.
So that's where it stands right now.
MS. DOO: Thank you very much.
We are finished with that. This is now the lunch break. We were supposed to reconvene at 1:15, but I'm assuming you want a little more time than that. We'll reconvene at 1:30.
Thank you very much to our panelists. That was wonderful.
(Recess for lunch)
DR. SUAREZ: All right we are going to go ahead and get started. I know people in the audience will be probably coming back during the next 10-15 minutes, but we have our panelists here, and we have the members of our subcommittee here, so we are going to jump in and start. The next panel is going to focus on dental codes and updates and considerations. I'll turn to Lorraine.
Agenda Item: Panel 5: Dental Code Set Updates and Considerations
MS. DOO: Thank you very much, and we do – everybody's back, right? So first up we have Dave Preble from the ADA, and you were watching this morning so you know my color codes, right? Five minutes and one minute.
Agenda Item: ADA
MR. PREBLE: On behalf of the American Dental Association, I want to thank the sub-committee for the opportunity to testify and bring you up to speed on what have been some major changes in the code maintenance process for the CDT code.
First, just to give the ADA's position on why do we have code, I mean, obviously you'd know more than anybody why we have codes in general, but the CDT code is there to provide a mechanism for specifically and accurately recording dental procedures. That's the basic idea. Is a very a major use of the code claims adjudication? Absolutely. But it is also used for other things, for within – however robust electronic health records are in, dental maintenance systems in offices, to record the procedural part of that and the subsequent data collection, which is going to become increasingly important as we move into more measuring quality. You need a standardized code set to specify what the procedures are. An electronic health record will need much more than that, so we do not expect that the code on dental procedures and nomenclature, or the CDT Code, will grow to populate everything that's needed for an electronic health record. That's not its purpose. It's specifically the procedural part of it, not the parts that would be diagnostic or anything else that the record might need.
The feature of the code maintenance process, as it has developed – we, this past year, developed a process that at first looked okay, but we received a lot of comments and concerns from a variety of stakeholders.
Most vehement, I would say, of those concerns were that the body that we had created, the Advisory Committee, the Code Advisory Committee, was not a voting body, and the question was, if you're looking to build consensus and measure consensus without a vote, how can you really show that you had even a majority, much less a consensus?
As it played out this year, I don't think there were any actions on the Code that were not supported in the discussions of the CAC, but listening to those stakeholders, we have changed for the future, for the next year, the code advisory to be a voting body, and part of the reason for the change at all is – I have with me, by the way, so I can introduce – he wasn't introduced earlier. I have Mr. Mike Kendall here, who's Senior Associate General Counsel for the ADA, and at some point, I'm going to turn one part of this over to Mike, because there were some questions in some of the written testimony that came out yesterday, concerning the settlement agreement, and he's better equipped to answer any questions you might have, and give some information about that.
But that will be a very small part. But just, as the settlement agreement, which was not a government thing, this was a private settlement agreement, moved into its next phase, the provisions for the Code Revision Committee were no longer there, so we tried to devise a better process, a process that included more stakeholders, had an annual update which, along with the idea of a process that was more responsive to the evolving needs of the profession, which came from CMS two years ago in a letter, we also requested to do it on a yearly basis rather than an every two year basis, so we've added it into it as well.
There is provision for input from all stakeholders, public, private, anyone either by the website or in the hearings themselves, the way that this Committee works now or will work next year, is that there will be one day of meetings where there be open mike for anyone to give comment, as well as for the Committee to discuss things. It will then move into two days of talking about the code change requests and actually voting on them. There will be no requirement for ratification of those votes by any ADA entity. There will be a final voting process by the Code Advisory Committee. And it's 21 members; the same as it was this past year.
We go to the composition of the Committee. There are five ADA members, five payer members. All the nine recognized dental specialties have a seat at the table, as well as general dentistry and the world of dental academia, through ADEA, the American Dental Education Association. All of these stakeholders have been, over a number of years, clamoring for a voice at the table, because they felt that they had a distinct voice from either the payers or the ADA, and if you're going to create a viable consensus process, we felt that we needed to have all the stakeholders at the table.
The idea in some of the written testimony, that just because the specialty organizations are either members of the ADA or practicing dentists, means that they only would be voting or allied with the ADA's position, has not been shown to be true in the past. They've had major differences. We have a diverse population of dentists that are ADA members, they have proven to be independent thinkers. They wanted a vote at the table, and we've given it to them, to create a process that takes stakeholders into account for a consensus process.
The ADA's role is just, at this point, administrative. It does mean that we put time, effort and money into maintaining the code. As any of you know, it does take money to maintain a code set, and we're willing to do that, but as far as any control over the process is concerned, we've taken, listened to the concerns of the stakeholders and taken that out of it. The Code Advisory Committee will be the voting body that will do those things.
I'm not even going to go into this slide. This is – I don't even know if you can see it, but it's basically just a flow chart of the process. It's not as complicated as it looks on here. It's basically that the code change requests come in, we've tried to address the timing of those requests so that we get the information out to the Code Advisory Committee in a timely manner, so they have more time to look at them.
We've tried to address, obviously have addressed the voting and the ratification angle of it. Actually, I think that we've developed a process that completely satisfies and may be better than a lot of other code maintenance processes, the regulatory requirements for openness that we're governed by.
We kind of were coming to this hoping that everyone would say wow, you came a long way and did a good job. I know that there are still some lingering concerns, because I've read the written testimony, but we remain open to looking at, talking to all stakeholders, although I can say that I think that right now, we do indeed have a process in place that satisfies any regulatory or legislative requirements.
I want to turn it over to Mike, since we've only got a couple of minutes, just to briefly give us some clarification about the settlement.
MR. KENDALL: Thank you. I also appreciate and add my thanks to Dr. Preble's for the opportunity to talk here.
One of the things I wanted to just cover really quickly that came in David's remarks, is the notion of the yearly update, because the yearly update really was in response to a CMS request, as he said. One of the things that the testimony said was that this gives increased opportunities for the ADA to make money. The fact is, the way this process works and the way this will go forward, the ADA will not make any additional revenue through this yearly update, even though it is taking on some additional responsibilities and costs in connection with a more frequent update.
The reason I'm here to talk is just to make a couple points clear. It appears, from the written testimony, that the settlement agreement between Delta and the ADA, that is now about eleven years old, has sort of colored, or is being used to inform, or perhaps it's better to say inadvertently misinforming, the conversation that's going on about the new code maintenance process that's been adopted. It's important to remember that the settlement agreement between Delta and the ADA was a settlement between two private parties of a civil action that involved copyright and other matters.
Contrary to what it said in some of the written testimony, the settlement agreement has not expired. The settlement agreement will continue for another 19 years, with provisions of interest to both parties to that agreement. No government agency was a party to the original settlement negotiations over a decade ago, when the Code was already being used universally.
We've read the testimony, and from what we've been able to find, there is no support for the contention that the use of the code, as it is being used, was contingent upon any composition of the code maintenance process.
Rather than look to the settlement agreement for guidance there, one should look to the statutes and the regulations that set the procedures up for a code maintenance type body.
In fact, the specific contention was that there was a requirement for parity between the payer representatives on the CRC and the ADA representatives on the CRC. While the settlement agreement in general is confidential, the CRC rules really aren't. The actual makeup of the original CRC was five representatives from the ADA, four payer representatives, and then there was supposed to be a representative from a major buyer of insurance, as the other representatives, kind of a swing vote, who was going to be appointed, or selected by, nominated, in effect, by the payer representatives, and then affirmed by the ADA representatives.
Early on, the CRC talked about this, the payer representatives said they couldn't find a buyer of major insurance that wanted to volunteer for this job, and so the ADA members agreed that instead, the payer representatives could nominate a consultant to the insurance industry to take that place. So there was never any kind of parity requirement for the CRC being the code maintenance body.
The reason I'm bringing all this up is because I think the settlement agreement, which is, again, a private agreement; most of its terms are confidential, between two parties, should just be put aside, and not used as you discuss and evaluate the pros and cons of the proposal that the ADA has now made for the code maintenance body that's going to go forward.
And again, while it is a private agreement, I will just really quickly say that because some statements have been made about it, I think the ADA is constrained to say, and I think it's justified in saying -
Number one, the agreement has not expired, as I said,
Two, because of that, there are provisions affecting both sides, both sides have things still hanging in this agreement. In other words, one side gets something in exchange for something else. Not relevant, though, to the general discussion of how a code maintenance body should move forward.
And finally, the settlement agreement is being carried out in accordance with its terms, and it simply no longer includes provisions concerning how the code maintenance body looks. That's why there's a new procedure involved.
So thank you for listening to that, and as I said, the reason I'm going into this detail, which I know can sometimes seem like little bugs buzzing around peoples' heads when they're thinking about so many different things, is simply to make the point that the settlement agreement should not be part of the consideration here, concerning what we are proposing. Thank you.
MS. DOO: Thank you. Next we have Tim Brown.
MR. BROWN: Yes, and since we're after lunch, I think I'm going to give up my time so we can do the hokey pokey and wake everybody up.
Good afternoon. My name is Tim Brown. I'm the Deputy Executive Director of the National Association of Dental Plans, or NADP. We've all said thanks; I want to add our thanks also to your excellent staff; you have a great group of people that we've been working with, you really should appreciate and value them.
The CDT is the core communication tool between the payers and the providers, which makes NADP a really essential contributor in this whole process. So, a little bit of our background. For the past 20 years, and I've been with NADP for 14 of those, we've been representing the industry in code sets development, electronic transactions, UDI standards, state and Federal regulations; in fact, we testified to this body back in 2002 and 2004. We are the largest nonprofit trade association, focused exclusively on the dental benefits industry, and our members provide benefits to over 90 percent of the 176 million Americans with dental benefits.
You have our written testimony; I'm certainly not going to read that and go through that. I do want to talk about – highlight a few issues and talk about one issue that's still unresolved.
Again, as we said, we've been an active participant in the CDT process. We were an observer and then a voting member, and it was disbanded rather summarily in September of 2011, and again, that came from a negotiation of which we are not a part. After the CRC was dismantled, they came with a new Code Advisory Committee, or CAC, process, and we agreed to serve on that, but we still had a lot of issues; pretty numerous issues with the new procedures.
One, that they were developed without a lot of input from the dental benefits industry and other folks that had been engaged in the process. The other was it would be an advisory body, and it appeared to be fully controlled by the Council on Dental Benefit Programs. Dave has answered both of those issues, that is now a voting body. It also will not have the votes ratified by the Council. So those two issues have been sort of dealt with.
So out of the five things that we identified in both our letters, where we contacted CMS in December of 2011, and since the two new sets of changes that have come out, those two are off the table.
The third one really probably relates to the timeline, and we think that one's been resolved as well. Dave didn't go; he put the flow chart but didn't show the timeline. The initial timeline only allowed members of the Committee thirty days to review those submissions, and because so many of our representatives on that group are representatives of large national organizations, there just wasn't enough time to really get a lot of input from our membership. They have actually now re-released that. They've expanded that time period, and are also putting the code out about a month earlier, so those three changes, we think, are absolutely steps in the right direction. I think part of that came from ADA's willingness to be open and listen, and make some changes, that they heard not just from the payers, but from many aspects of the industry, including the specialty organizations.
I need to mention one thing that we didn't talk about in our written testimony a little bit. One of that is the change from a two-year to a one-year process. It's my understanding that in the past, again, as Dave mentioned, that is something that CMS was very interested in seeing it move from a two-year to a one-year process. We still have to share our concerns that this is a significant cost; it basically doubles our cost. What we used to do over a two-year process we now have to do in one. You're very, very aware that health care is a much regulated industry.
Every time the code set changes, we have to file new plan documents, we have to update websites, we have to update disclosure documents, contracts – it goes on and on. So again, we're now doing that on an annual basis, so it's doubling those costs, and many of those changes may or may not have any impact on the care that's given to consumers.
An example of that would be, we made pretty significant changes to the section on x-rays and radiographs. We still were using the word "films". I think we all agree that updating those codes is beneficial, but again, those costs really won't impact the care that we give to consumers. It will just be administrative cost to the plans and to the providers, as they have to update their systems. So that's our concern with a two-year to a one-year system.
So back to our written testimony, the issue where I think we still need clarification; in the original May memo where the ADA updated the CAC process, there was a concept of any rejected proposals would just be rolled forward to the next cycle, and we just think that's an administrative nightmare. If you just keep moving what we might call bad ideas forward, you're just going to consume more resources. I think we understand that that concept is off the table, and we're very pleased with that. We would just like to see the ADA make a statement to that effect from the memo they sent out in May.
I think the big unresolved issue relates to guidelines for submissions, as well as for the people on, the representatives on the CAC. Under the old process, there were some very clear guidelines, and just to kind of name a few, a new code couldn't unbundle widely-accepted code groups of procedures, it couldn't just be a different technique, a laser versus another technique, you couldn't add a level of difficulty so you have a difficult prophy. While the new revised CAC process includes a few guidelines, about six, we don't think that goes far enough.
In their most recent update, the ADA did ask for CAC members to submit recommendations to be reviewed and decided on by the council, and that's a little concerning for us. I think the ADA has moved in the right direction over the last couple of months, to make this a bit more transparent, more open, and so what we would like to ask, as opposed to just sending something in and having the council decide, is ask the ADA to actually hold a full open meeting, let everyone bring their proposals to the table, everything from scientific to clinical to administrative kind of guidelines, that would assist the submitters, as well as the members of the Committee, in making those deliberations and those decisions.
I think the ADA, in very recent conversation, said they were open to this and the possibility of having this kind of meeting, and we just would encourage that moving forward.
So finally, with the requests that we've made, or have either been resolved by the ADA, NADP actually has a request for this Committee. Many of these revisions to the CAC process were just announced. We have the potential, as I mentioned, for a meeting in August to review and develop guidelines. The next meeting of the CAC is scheduled in early February of next year, and I think that's before this committee meets again. So what we would ask is that the subcommittee request of us a progress report in six months from this hearing. It would give you feedback on how things are moving forward, it would continue to move forward, and it also makes sure that everyone here stays engaged in this process and keeps it moving forward.
So again, greatly appreciate your generosity of your time. We appreciate the ADA's willingness to listen and respond. One of the things that we have to remember is while the CDT is the language that we use between providers and payers, it really is what drives the ability for us to provide excellent care to consumers. So it is something between us, but it has a much larger role in the overall.
I'd be happy to take any questions now or can certainly wait until after the rest of the panel. Again, thank you for your time.
MS. DOO: Thank you. Next we have Bill Kohn.
MR. KOHN: Hi I am Bill Kohn; I'm Vice President for Dental Science and Policy for Delta Dental Plans Association, and we do appreciate this opportunity to present before this sub-committee.
My testimony is in regards to our concerns with the changes to the process that the ADA recently implemented. We believe these recent changes were made without an appropriate open process, as required under HIPAA regulations.
We're going to ask the Committee to recommend to the Secretary that these changes to the Code Revision Process and the changes proposed to the code set itself, since these new processes were implemented, not be allowed. We would also ask for a recommendation that the ADA be required to hold a true open process that includes key stakeholders, and is sensitive to the business needs of the industry for changes that will be made to a new code revision process.
That said, let me just tell you a little bit about DDPA. Of those 176 million people that Tim mentioned are covered by dental benefits in the US, we cover 59 million of those lives. There are approximately 142 thousand dentists in the Delta Dental Provider Networks and we process over 90 million claims per year. So the CDC code set is our principal means of communications between dentists and dental benefit payers. It's central to our core business and it's of great importance to our member companies, employer groups, enrollees and dental providers. Mr. Kendall talked about the settlement agreement between DDPA and ADA, and for the past ten years, DDPA and other major dental benefit payers, including CMS, and a national dental benefit purchase rep, or industry rep, have been equal voting members on the ADA.
The purpose for putting us in there was not to confuse or suggest anything other than the portion of that settlement agreement that dealt with the code revision committee is no longer in place.
The part that goes on, as he mentioned, for another 19 years, has nothing to do with the code revision process at all. So our point being – the point to be made here is that as soon as they were freed of a requirement under an agreement to have this equal voting in place, they dissolved it and made major revisions, then, to the whole process. Equal voting has been in place not just in the last ten years; it was prior to that, with another agreement, I believe with AHIM. So at the time the ADA was given this code set, they remained the standard maintenance organization for this, equal voting was in place, and that's been the case.
So now there's these drastic changes were basically made to the process, without literally any consultation at all, with what we consider ourselves, to be a key stakeholder in this entire process.
So the ADA continues to modify the initial process that they, we think, hurried into place, but still there has been no meaningful consultation with the payer community on these changes. This highlights some of the very concerns that payers had back in 2000, when they awarded code sets to these proprietary code sets, such as CDT.
Just to give you an example, the first meeting in CAC, the new body, the Code Advisory Committee, was held in February of 2012. This was the third meeting of a two-year cycle, the final decision-making meeting of this cycle. There is now no voting, and the ADA really seized upon this opportunity to revisit codes that had already been voted down in the first two meetings of this cycle.
They introduced a number of new submissions that sought to eliminate many of the existing code descriptors, with really no rationale or explanation given. For many of the existing CDT codes, the descriptor language had been previously crafted from really hours of deliberation between the payers and the ADA, and now, with no voting in place, they were being summarily asked to be dismissed.
In addition, the ADA determined kind of unilaterally, that the code would now be updated annually rather than on a more manageable and cost-effective two-year cycle. This change, we believe, imposes undue cost and burden on payers, providers, practice management communities and ultimately the consumer in the form of higher costs with little benefit.
The need for DDPA and other dental benefit payers to address NCVHS over a problem with the ADA's management of this important process isn't new. We were here in February of 2002 and again in January of 2004, to seek redress with NCVHS over actions of the ADA in regards to management of this process. On both occasions, subsequent changes were made to the process and yet, discouragingly, here we are again and some of the same issues still exist.
One major problem we see is a lack of rigorous scientific and other objective criteria for the evaluation and acceptance of new code submissions. Indeed, in connection with prior code revisions, this lack of objective criteria has been the source of most of the disagreement between the ADA and payers. DDPA, and I'm certain many other payers, attempt to base their dental benefit plan coverage, including covered procedures and frequency, on the best available science, and employers and consumers are increasingly requesting, often demanding, to know the scientific evidence base utilized to determine health care, including dental benefits.
Since the implementation of the ADA, the new CAC, the ADA has stated the previously CRC was not an optimal process to promote dialogue. A deadlock was created over minor differences. We disagree with that statement. I was on the code revision committee, I am on the code revision committee, we had some very healthy discussion, and agreement on most code submissions. Where we disagreed, it usually was on new codes representing unbundling of existing procedures where there was lack of scientific criteria, how was a code performed at some significant level of frequency around the country? Was there FDA clearance for whatever was being put forward technology-wise, but most importantly, whether the procedure had a sufficient established scientific criteria.
These are areas where if we had consistent application of rigorous objective criteria for the submission and evaluation of these revisions, there wouldn't be much disagreement, or any non-collegial dialogue at these meetings.
Full representation and input from appropriate payer organizations in the decisions to adapt or reject proposed revisions to the code is crucial to proper code updating and maintenance. In defining an open process, we believe the Secretary must look beyond merely a permitted presence and input at the meeting. Because these code sets are core to our business, an open process must in practice take into account the concerns of the payers on more or less an equal basis. For this to occur, they must have a greater role in the development of the decision-making process, not just this granted permission to participate in the process, as only five votes out of twenty-one, it nominally represents our interests.
In other payer organizations, having played an integral role in the development and maintenance of the CDT for the past 10 years, we believe that even in the absence of these rigorous criteria, that this equal voting process has helped maintain – limiting unnecessary codes from being implemented, and assuring that clear descriptors were written to help providers properly file claims. Until objective scientific criteria are adopted, it's even more crucial that we have an equal role in this process.
We believe there's a basic philosophical difference in how the use of the code is interpreted. We believe the primary role is to promote the accurate and efficient submission and adjudication of claims, a more or less complete listing of what dentists do, but in a scientifically rational format. HIPAA regulations largely support this view. Given this, we also believe more emphasis should be given to the payer perspective and needs, and the ADA has stated belief, and you heard briefly Dr. Preble give that, but they believe the primary role is to include all procedures that a dentist currently performs, in order that they may prepare a comprehensive, accurate and detailed patient record.
He also states it's important for electronic health records, and it's been stated for medical and legal reasons.
Procedural codes without corresponding diagnostic codes, however, add little or no value to an electronic dental health record. They simply record a service without documenting a corresponding purpose or outcome. In addition, procedure codes should not be, and never were intended, as a replacement for a narrative description in a medical or a dental chart. So we see no evidence that quality of care, access to care, medical or legal process is harmed or impeded by the payer's efforts to limit unnecessary codes or by our insistence by clear procedure descriptors.
We can provide you numerous instances, however, where consumer and health system costs are negatively impacted by inappropriate codes or unclear and ambiguous descriptors.
Updates and improvements to the process are definitely needed. In addition to the rigorous criteria for code submission and evaluation, a code set needs different types of codes that better reflect current practice and health care system realities. We need emerging technology codes, codes that measure performance and quality, those that reflect diagnosis, similar to what you already see on the medical side.
The best interest of the consumer is ignored by including codes that do not have scientific validity behind them or by excluding these other kinds of codes that measure performance or quality. The Affordable Care Act calls for NCVHS to assist in the achievement of administrative simplification in order to reduce the burden on patients, providers and health plans.
As per the HIPAA regulations, we believe that also, the Secretary's responsibility, through her delegated representatives, to continue to review the process of code modification to ensure the code sets continue to meet the business needs of the industry, and that specific shortcomings are brought to the attention of the code set maintainers. We don't believe the ADA's reconstituted CRC meets requisite standards.
We respectfully request that the NCVHS advise the ADA to take several actions, including develop a new code revision process, with rigorous submission and evaluation criteria, in close open collaboration with key stakeholders, particularly the payer community. This process should meet the standard of an open updating process.
We also ask that changes made to the CDT code set after this new CAC process was instituted be set aside or denied until such time as the Secretary or representatives can evaluate the propriety of the recent changes made to the updating process. Code set changes scheduled to be implemented for the 2013-2014 CDT, the two-year cycle that we just ended, be limited to those approved by all parties prior to the dissolution of the CRC by the ADA.
We recommend, and also would appreciate, any oversight by the NCVHS to this process, and finally, if the ADA cannot, and we hope this wouldn't occur, but if they cannot in a timely manner resolve their differences with payers regarding primary use of the HIPAA-designated code set, that the NCVHS advise the Secretary to create a committee to explore the establishment of an alternative HIPAA-designated code set for the purpose of electronic claims transaction.
My previously submitted written comments contain more information and background, and I will be pleased to provide any more, but I thank you for this opportunity to present in person.
MS. DOO: Thank you. Lynn Mouden, please, from CMS.
MR. MOUDEN: Good afternoon. I am Lynn Mouden. I am the new Chief Dental Officer at CMS and the Center for Medicaid and CHIP Services. Obviously I want to add my thanks to the Committee for the opportunity to address these issues.
Medicaid and CHIP programs in the states rely on accurate and complete data for payment of claims, and obviously, in turn, to assure accurate reporting of those services to CMS. As the new Chief Dental Officer and yes, I'm coming up on about four months anniversary, I don't have the long history of working with the CDT revision process that some others may have. On the other hand, I've been an enthusiastic member of the ADA for almost 38 years, and as a private practicing dentist for 16 of those years. I obviously have a strong connection both to the Association and the use of the code in the private practice of dentistry. So I'm going to limit my comments to the process in place for code revisions and how that process has changed.
For ten years, the CRC considered changes to the Code. The process was collegial and provided opportunity for open and frank discussion of requested changes. As has been alluded to, sometimes a decision was thought to be deadlocked because of unequal voting process. That's not necessarily a bad thing. In fact, if learned colleagues on both sides of the discussion can't come to an agreement and a compromise, maybe having a code revision laying on the table is an advantage to the process and the outcome.
When I was in practice in the 70s and 80s, I used the code exclusively for billing insurance companies and Medicaid. I thought I was a pretty typical dentist in a small town practice. My concern was insuring that what I considered to be the best treatment for my patients would be appropriately reimbursed by whichever payer was involved. A claim that was not paid or a claim that was denied because the specific code procedure was not covered was a problem for me as the dentist, a problem for the patient, who now may bear unexpected responsibility for payment and also for the doctor/patient relationship that's so important in maintaining that patient's health.
Codes are vitally important in that setting to ensure that the patient receives not only the appropriate dental treatment but also that they receive the benefits to which they are entitled, through whichever insurer is involved. Concerns about the lack of a scientific basis for a code change, I believe are indeed valid. Without a true scientific basis for adding a code, the CDT itself becomes a reflection of someone's wanting to bill for a service whether or not the service itself is evidence-based. This, again, can lead to problems for the patient now having to bear the cost because the service is not covered.
At least equally important, if not more important, is that the service might not be covered because there is insufficient clinical evidence to support that practice, so the patients are not only stuck with a bill, but they've had a procedure with possibly irreversible changes when the clinical efficacy of the procedure may not yet be proven.
While the ADA's position is that these procedures are not illegal, frankly, being legal is not sufficient quality. In addition, the patient has no way of knowing what science is behind the procedure, as they determine whether or not to undergo the treatment and to pay for it. The ADA's Clinical Evidence Review Board is not conducting objective scientific review, and may frankly have a conflict of interest. Changes to the code are problematic for state Medicaid and CHIP programs that must process claims. Any change, addition or modification of a billing code requires a change in computer programming that processes claims. While this might seem like a small thing to somebody practicing dentistry, it in fact could mean huge investments in computer changes needed to address that change at the payer level.
However, it is the position of CMS, as addressed in the letter from Cindy Mann, Director of the Center for Medicaid and CHIP Services, Deputy Administrator of CMS, to the ADA, that we did in fact stand behind the annual possibility for changes to the Code that would help us address issues such as new mid-level providers that are allowed in some state practice acts, that would allow for these changes to be incorporated in a timely fashion.
Following the agreement with the ADA that expired in 2011, the ADA unilaterally instituted the new process for code revision under what you now know as the Code Advisory Committee. As it functioned starting in early 2012, the CAC was truly only an advisory body, with final decisions and changes left to the ADA's counsel.
Following concerns by several of the members of the CAC, including CMS, the ADA again modified the process so the council could only accept or reject recommendations from the CAC. Further modification announced in just the past few weeks eliminated the council approval as part of the protocol. We see these modifications as positive steps in the code revision. However, the makeup of the Code Advisory Committee is still problematic. Instead of the longstanding committee composition of equal numbers of dentists and payer representatives, the current CAC, as designed by the ADA, has five members representing payers and the 16 members representing the practice of dentistry.
Having been in the dental community for 38 years, I don't expect any group of dentists to all vote the same way, it just doesn't happen that way. I would certainly not expect the members of this committee to vote in lockstep, either. But we also understand that most committee members, even if they're nominally representing a dental specialty organization, are in fact members of the organization that represents practicing dentists. It's important to note that the ADA was given authority to maintain the CDT codes only when, and only because, it did agree to give insurers not just a vote, but an equal number of votes. Whether that decision might have been different had there not been that agreement in place, frankly I have no way of knowing.
We ask that the Committee do several things.
We ask the NCVHS to consider exactly who gains and who loses when the ADA unilaterally refuses to consider clinical evidence for unproven procedures. We ask that the committee recommend to the Secretary of Health and Human Services to further consider the code revision group's membership, to address how it is constituted, and how revisions to the code are approved for inclusion. We ask the Committee to immediately put a process in place whereby the code set maintenance authority cannot be changed for any of the six HIPAA adopted standard national code sets without review by the Secretary or by NCVHS.
Finally, we ask the NCVHS to consider requesting that the Secretary temporarily place revisions of the CDT on hold and any change to the Code Committee or process and to restore the Coode Revision Committee membership and process until such time as the NCVHS has completed its review.
I certainly thank you for your time and for your efforts as we all are working to provide optimum oral health for all our Americans. Thank you.
MS. DOO: Thank you very much. Now I'll turn it over to Ob and Walter for questions.
DR. SUAREZ: Yes, thank you indeed. I think as a little bit of background, I guess the Committee started to hear about some of these challenges a couple months ago, relatively, -- so this is a very helpful, more detailed description and explanation of this series of issues that exist with the maintenance of the dental code set, and the process itself. I think I'm going to open it to the Committee members for any questions they might have, and I know there is certainly going to be questions about what is ultimately the role and the responsibilities of NCVHS with respect to code set activity. I know we have done, and certainly as part of our overall HIPAA responsibility, we certainly look at the code sets, but I don't know that we have engaged ourselves in the process of actually reviewing and approving code changes of code sets like ICD or CPT or others.
So anyway, I'll just open it for questions – Bill, do you have -
DR. SCANLON: This actually could be for the panel as well as maybe other committee members – you understand some of this more than I do. What I was thinking as you were talking is sort the issue is, what's the parallel with the CPT, sort of process, because it seems to me that there were more criteria decisions that were embedded in what you were talking about than what I'm familiar with for CPT. CPT, as I understand it, a procedure code is created for something that's done, but then CMS, and particularly Medicare, can decide is this appropriate for us to cover and not all CPT codes end up sort of being covered for various reasons. We also have, besides CMS, we used to have the carriers, and now I guess the Medicare administrative contractors still may play a role in local coverage policies, and those are based upon their reviews of evidence, and so here it seemed like multiple decisions were being wrapped up into this one process of producing a code, which was very, very different, and it doesn't seem that that's necessarily inevitable that it needs to be that way, because I would think the payers could play the same role as CMS does and Medicare does, is that after a code is created, we decide whether or not it's appropriate for coverage.
There is always that issue and this applies to physicians as well as dentists, that yes, things can be legal, but whose job is it to stop things that are legal but not necessarily beneficial? I was just having trouble kind of following the parallels.
DR. SUAREZ: Any comments or reactions?
MR. KOHN: There are some major differences between CPT, or the medical side, and CDT. CDT is purely procedure codes. We're talking about hundreds of codes versus thousands of codes, and because Medicare has no impact on dental coding or dental payment because dentistry is not included in Medicare, that whole role was eliminated, that very important role that comes into play for CPT codes. So it's really a rather simplistic process, and I think this whole idea, though, of having rational criteria, and particularly good science, it's just – it's a basic professional standard, I would think, that needs to be in place if you're going to have a code for the consumer or something that should be paid.
So that's – it's definitely not the same as CPT, but there are some basic principles that are –
DR. SCANLON: I didn't want to have us sidetracked by the issue of Medicare. I brought up Medicare because I was familiar with sort of what CMS does. But it seems to me that there is the issue that a Blue Cross plan and Humana United can also make the same kinds of decisions that Medicare does, saying that this is what our coverage policy is going to be with respect to that procedure code.
So it's the issue of what seemingly are independent decisions about here's a code, here's our coverage policy, versus what you seem to be talking about, is we're not going to have a code unless it meets certain criteria of sort of benefit, and that would imply something about coverage.
MR. KENDALL: That articulates very well the ADAs position. We don't think these things should be wrapped up together. The adoption of a code does not determine payment because that's a determination made by the individual payers, and the adoption of a code does not represent an endorsement necessarily of a particular procedure. It's a code to describe what dental procedures are being used, and as David said in his remarks, will be extremely important in helping us collect data to determine efficacy of procedures in the future.
MR. KOHN: We hear that all the time, that you can deny payments on whatever code is in place, and that's true, and we do. There is a large number of codes that aren't paid. But we don't think it's appropriate for the consumer to then have to pay for things that aren't found – we're talking about a small number of codes. Most codes we all agree on. But in a small number where there's not adequate scientific basis for it, where it's performed with such little frequency and it's not really accepted yet as an accepted clinical procedure other than it may be used in a small number of dental schools, or where a technology has not been cleared by the FDA.
We don't think it's appropriate that consumers should then have to pay for those things, either, even though we can deny them, it's really not a problem for us. We think this is a very consumer unfriendly and nonprofessional thing to do.
DR. SUAREZ: You have another comment on this question?
MR. PREBLE: A couple of things. I don't think any code set is looked at as an arbiter of what any profession does or does not do. That's putting too much on a code set to do. The code set is there just to reflect what is being done. Even if there is no code for a particular procedure, there are block codes that unspecified procedure by report, that could be used to do that, so you can't put something on a code set that it's not its purpose to do. If just really briefly, if I may, and get indulgence, there were two issues for NADP that they said were unresolved.
I just want to let the committee know that they really are resolved, that the issue of rolling over codes that were denied automatically is not part of the process, and we're happy to send that out as a written communication so all the stakeholders know that. So that one, we did actually resolve.
The guidelines part, since we did see that in the written testimony before I came; I even asked for permission to be able – can I get a decision on that?
We are going to have a meeting in August to address guidelines. We are going to invite the stakeholders to that meeting. It will not be just a meeting of the ADA taking in the testimony, which we had already said we would do – we're actually going to invite the stakeholders to that.
So I think except for the final result of those guidelines, we've addressed all of the five issues that NADP put forward, and as far as the makeup of the Committee, as far as the makeup of the Committee, as far as the numbers of that.
I think if you look at the other code maintenance processes, which is where, as was discussed, NCVHS's role is to assess the process, not necessarily in the complete weeds of it, from an open standpoint, as a process that is geared towards developing consensus of all the stakeholders.
I think it looks like on its face, that it would satisfy that.
DR. WARREN: So my question is, there was a comment made that there are different categories in CPT. Some of the new cutting edge procedures will have those codes, they may not necessarily have the science all established yet. And there's certainly a lot of examples with CPT codes, of cutting procedure codes that are out there that don't have – they're in the process of building the science, and building the expectation that at some point in future, they will be reimbursed But they don't guide reimbursement. And so I think that's one thing that you might want to think of, is maybe there's a separate category of codes that fall into that area.
The other thing, what I'm hearing, is this whole issue of communication, communication, communication, and oh by the way, transparency. So I'm hearing some dialogues; I've been on the SNOMED editorial board when it was owned by CAP and made the transition to IHDSDO and sit now on their quality assurance committee. We had a lot of changes to go from a code set that was owned by a professional organization to an international standards development organization that now has, I think the last count, we had 20-some odd international countries that belonged.
One of the things that we've struggled with is what do we have to have in place to accept a new concept and add a code to it? And so I think maybe if you work on some of that, that might help some of this. When you look at what our role might be, I agree with Walter; our role, if you go back and look at the HIPAA legislation, is to make sure that there is a legitimate process in place that is transparent, that is meeting the expectations of that group, and if there's a group that comes in that isn't' transparent, that doesn't allow for input and stuff, then we have the opportunity to say well, this code set doesn't meet these criteria of openness and everything that was laid out in HIPAA, but this new one coming up does. And I don't want to see dentistry get into that kind of battle; you've got a good code set going with what you're doing, so I think maybe if you take a look at what do you need to do to be more transparent and more in line, might be helpful here. It would certainly make our job a lot easier in trying to figure out how we work with you in order to keep the code set designations that we're responsible for ensuring.
MR. KOHN: You will see in my written comments, I talk about CPT emerging technology codes, CPT 3 codes, and I can tell you as a member of the CRC, I brought this up and there was discussion on it; two meetings at least, and there was no response from the ADA on establishing those type of codes. We believe that that is a good thing for emerging technology to be tracked and followed and develop before you get FDA clearance, more information, also performance and quality measures. We have a very simple code set right now. We think it could be improved with some very small changes like emerging technology.
DR. WARREN: So I guess my response to that is code sets do not enforce practice. Nor do they enforce what's paid for. If we did that, we would ratchet down immediately what happens in our health care system, and there would only be a few chosen few that could practice and bill through that practice, and so we wouldn't have new models emerging; we wouldn't have new innovation. So I would hate to see code sets viewed in that light.
What they are is support for helping us harness all the other infrastructure that we currently have, and that's evolving, and some of the infrastructure will disappear, some will evolve into new kinds of things. As new technology comes out, we're going to have new ways of doing or of delivering health care in this country, and so I'd like to see it open, that we don't use code sets to shut down. Because I've heard the comments before, well if we allow those codes to come out, all we're going to do is increase health care costs, so we need not to share billing and money with people. We'll keep it down with code sets.
And I don't want us to go back to that kind of dialogue. I think we're in a better place now. But that's my opinion, so -
DR. CARR: I was sort of following on what Judy said, because I think today, there are codes that may be covered for a pediatric or Medicare population, but not another population, and similarly, benefit design may exclude codes. So I think when trying to take it to add further value judgments, for one thing, because the knowledge evolves, I think it becomes a difficult task, and then on top of that, a payer can choose to pay for some things and not others. I think the point about the patients, I mean, this happens all the time on the medical side, whether it's medications that may or may not be covered or procedures, and I think it speaks more to the transparency of informing the individual, who may decide they still want the procedure, or maybe they don't. But that's the model I think they're accustomed to in medicine.
MR. PREBLE: Speaking to the idea of openness and willingness to listen to comments, not just words, but I think in the actions of the ADA over the past six months, I think that we've shown to be extremely willing to listen to stakeholder comments and actually act on them. We've completely changed from what many members from my council thought was not a good idea at first, moving to a completely independent voting situation, but they came to the conclusion that even though you have these specialty groups in the academic world, and the ADD and the payers, all at the table voting, the basic idea is with that level of diversity of stakeholders, if a compelling argument comes to the table for or against a particular code, whether it's based on science or any other thing, then you're going to get the right decision from that diverse stakeholder group, and so they said okay, we're going to give up control of this and let those stakeholders make the decisions, because the compelling arguments will rise to the top.
DR. SUAREZ: Thank you so much again for the testimony.
MS. DOO: Thank you so much, everybody.
Agenda Item: Panel 6: A Unique Device Identifier and its Relationship to Administrative Transactions
DR. SUAREZ: We are going to be moving on to the next panel, which is focusing on unique device identifiers, and we will try to focus on the relationship to the administrative transactions. So we invite our testifiers to join us here today. I think we're going to go ahead and get started with this next panel. We appreciate, again, your taking the time to come and participate in this discussion about the unique device identifiers. As you know, there's been a lot of work over the last several years in defining and establishing a national device identifier, with many, many perspectives, and implications for many areas, from patient safety to administrative issues, so we wanted to bring this panel together to try to focus on that administrative transaction side, and see how the development of this unique device identifier relates to and fits into the standards that are being used for transactions in the industry. So I'll turn you to Lorraine.
MS. DOO: Thank you. And you all have been here for part of the day, I think I've recognized your faces. Wonderful. Welcome. And thank you all for coming. It's really great. So we're starting with Terrie.
Agenda Item: FDA representative
MS. REED: I am Terrie Reed, Associate Director of Informatics at the Food and Drug Administration Center for Devices and Radiological Health. I run a team that focuses on data management within the Center, and as part of that foundational to that is this unique device identification system and development of a unique device identification database.
So I was asked to come here today to give you an overview of what unique device identification means to us, the FDA; what work we've accomplished so far in a broad brush, because it has been many years of work, some of the benefits that we see, what our current status is, and time lengths, as we can get them out today.
So we'll start with what we see as the qualities – I'm going to start out broad overview and then get a little bit deeper as we go along. The main qualities that we have been charged with developing in the UDI system is to develop one that identifies devices in a consistent, unambiguous, standardized way, that provides an identifier that's unique at all levels of packaging – very important that it's harmonized internationally, and I will talk about that a little bit, and that it facilitates the storage, exchange and integration of data and systems.
We see what are called post-market, so after a device gets on the market there are a lot of challenges for us to identify the safety of those devices and how they're performing in the marketplace. One of the challenges is because we don't have an identifier right now as compared to the National Drug Code that's for our drug counterparts.
So we are in a place where submitters send us text. They literally write text for what the device is, who the manufacturer is of the device, and we have to sort through that in our databases, so the UDI will help with that.
We also have a similar situation in the supply chain, because there is no unique identifier; at all levels along the supply chain, the supplier to the hospital distributer; they all add a different number. I have a slide that shows for one catheter, made by Becton, Dickinson, there were 32 different identifiers for that particular device. And so trying to track that down once it got into a hospital, and we send out a recall or the manufacturer sends out a recall, identifying that device without a unique identifier is a real problem for all along the supply chain.
Similarly, registries that are trying to perform outcomes research or compare device effectiveness are hampered by the fact that people are still using text or their own numbering systems. There's no unique identification that can be used to exchange data from those registries or to build comprehensive registries about a particular type of device.
Electronic health records do not have a place for unique identification, and we are working – I'll talk a little bit about some other efforts that we have to have UDI represented in electronic health records. We even have some demonstration projects in that regard, where we're trying to test that out.
The benefits – we will have a better way to document product performance. As I said, understanding adverse event reports, developing that risk profile on devices to allow – another aspect of this is because we don't have that identifier, it can't be on claims data, we can't put it in insurance claims, we can't mine the data. If you've heard of the sentinel system for our Center for Drugs, they're able to look at claims data, mine data for device effectiveness, for drug effectiveness. We can't do that. So this will allow FDA to quickly address those concerns, and one of the big aspects of our post-market side is, of course, to feed better decision-making for approval of devices as they are changed, updated and approved.
So we see UDI as an enabler, literally, to unlock these data sets that are already out there, these databases.
Claims data, of course, as your focus is – registry data, EHRs and meaningful use. We're working in all of those areas to try to integrate UDI throughout the health care system. It will facilitate linking across these various data sources and amplify the usefulness of each one of them.
So those are the methods. I thought I would start out with that and then just give you how we got here. This is the paragraph, in 2007, that was put in the FDA Amendments Act, and it says that the Secretary should promulgate regulations to require placement of a unique identifier to the point of use. I'm not going to read the whole thing. But it was a paragraph, and since then we have worked on a proposed rule, which I'll tell you a little bit about.
One of the important aspects I mentioned earlier was this international harmonization. The National Drug Code is administered by FDA, and so when a drug crosses borders, just like our catheter example, that drug can get another unique identifier for whatever country it was made in, and so it's difficult for track. So we didn't want to repeat that.
We've worked very hard with what used to be a global immunization task force for devices, that has been renamed now to be the International Medical Device - actually it's Regulators' Forum. And so the attributes that we are using, we're actually harmonized internationally and I have the link to those and the link to the new UDI roadmap on their website.
The benefits of that are that the device manufacturers can use that single UDI across a wide array of regulators and countries. It provides the foundation for eventually global security supply chain, global disability, automated import review; it supports the Department of Defense and WHO efforts requiring global device identification.
So this has been our road. We developed internally to FDA Center for Devices, the regulatory tests, the language, based on that small paragraph. That is complete, and also it contains a preamble, and an economic impact analysis, that was all approved by CDRH, FDA, NHHS, and was sent to the Office of Management and Budget in July of 2011, and we are waiting. One of the things we say at every presentation is that we expect it to be out in two weeks, and some day that will be true. So that's our speculation – and then once that is approved by the Office of Management and Budget, there will be publication of proposed rules and the final rule. We are working now but then the fun will begin.
We'll have a 90-day comment period, public meetings, analysis of the comments – you know all this drill – response and final publication of the rule.
So going a little deeper, we had four distinct steps and many stakeholders that we are trying to work with to achieve development of this system. The first one is to develop a standardized way to identify and issue those identifiers. We are working to place that UDI in a human readable or auto ID on a device. As I said, I'm in charge of the staff that's creating that UDI database, and working on data management, so that data is very high quality.
And then, probably one of our hardest efforts, because we can't control it as much, is this adoption and implementation by those that we don't regulate. We can regulate the manufacturers to submit the unique device identifier and the attributes associates, but we don't have control over whether hospitals or the health care systems will adopt.
UDI characteristics. This UDI code will be according to ISO 15459, which allows it to have anyone who meets that standard to be what's called an "issuing agency"; currently GS1 and HIBCC, but that doesn't limit it to those two entities. Anyone who would meet the requirements for an issuing agency would develop UDIs.
The UDI itself would be created and maintained by the manufacturer. What it actually contains is something called the device identifier piece and production identifier. So the device identifier is made by the manufacturer in make and model, and the production identifier has those things like serial number, expiration data. I'll show you an example of this, what it means for device identifier, production identifier, in a later slide.
So the UDI would be applied at all levels of packaging, and have a human readable and encoded auto-ID format. We are not going to specify the technology to be used, and they're not going to specify the standards to be used. That's not FDA's job. And the direct part marking for some devices, where that would be important.
We're going to use a risk-based approach, so we are not going to require someone who doesn't have a serial number now to apply a serial number, or who doesn't have expiration dates on their product's labels now to do that. It's based on really what's on the label now. The granularity that would be used for marking that is also based on this. Not all devices would require production, and we'd take into account the realities; the retail environment, UPC codes that already exist on products, and we are going to have a lot of robust alternative placement and guidance for industry on how to do this effectively.
So here is an example.
The numbering on the UDI, so that bar code right there, would be the auto-ID portion of the UDI, and then the numbers, sorry, they're so small, underneath would be the production identifiers.
This is a Medtronic product; they already had this on their labels. This is an ENDOPATH product, also has it on the label of the device. In this case, the bar code is in two segments, so we're not requiring it to be in one concatenated or not. If you see the 01, the numbers that follow after that 01 are what I had called the device identifier, and then 17, and this is a GS1 standard in this particular case, the numbers following the 17 are the expiration date, and the numbers following the 10 are the lot number, so parsers would be able to detect that and use that in databases.
Yet another example – in this case is the HIBCC code system with the bar, and that's also on the label of the device.
The development of the UDI database, as I said, is based on the attributes that were internationally harmonized. Because that is a public document and those attributes are available publicly, we can display them on the slide. If they weren't, and if we hadn't internationally harmonized and they were in that proposed rule, of course, we could not. This allows us to have folks have some understanding of where we're headed. It's not exactly the same, but it's very, very close.
Implementation will be based on premarket risk, so our plan right now is for the highest risk, which is our Class III, to have the labeling requirements twelve months after the final rule. Class II would then be 36 months after the final rule, Class I five years final rule. So it would be a phased-in approach, where we would expect to learn iteratively lessons learned as we go along and as we get further on into the process.
And during that, we would intend to phase out some numbering systems that are used on some devices now, so that all devices would have UDIs. Currently some have indices, which is confusing to people. And like I said, robust alternate placement.
I just wanted to list a couple of the efforts on this slide of what we're doing with other groups. We have a project, a large public private partnership, with some universities, to look at white papers on implementation of UDI and electronic health records, claims, registries, those things that I talked about earlier, where the gaps are, how we can integrate into those systems. We have some UDI-based surveillance activity in a multihospital system. We're working on a pilot in Mercy Health System, it's the St. Louis area, to integrate UDI into a particular device type and have that go as a pilot and see how that works out. We also have, as part of that, to integrate that with our adverse event reporting system. So we're really testing out some of these benefits that we expect to get from UDI. That's what ASTER-D is, to incorporate UDI into electronic adverse event reporting.
I don't have on here – a very important role. A couple of us are on a technical evaluation panel, a national quality forum, which is also looking at what are the current gaps and how could UDI fit into the health information systems.
This is a timeline. There is one error – I put 2012 right here, this should have been July 2011, when that preamble economics and approval was done and sent to OMB. Otherwise, there's a lot of TBDs but we have the timeline ready. Then I had listed, on the right side, some of those activities that I talked about, where we're more in the claims world and more in pilots and integration. These things. We have to rely on other groups like yourselves to help us implement, because we have no regulatory authority in these areas.
And this is our website.
MS. DOO: Thank you. Margaret, you're up next.
Agenda Item: Standards Organization
MS. WEIKER: I am Margaret Weiker, I'm an Offering Manager with Hewlett Packard, and today I'm representing ASC X12. I am the Chair of the Insurance Subcommittee. I was asked to speak on the EBI panel and talk about its relationship to the administrative transactions. So I'm going to focus on the X12 administrative transactions, and then once I complete, I'll put a plug in for NCPDP. I also am a standardization co-Chair at NCPDP, so I'm very actively involved in standards development in that area as well. That's just the typical disclaimer.
From a background point of view, and when you look at a lot of the standards, you will see that we reference it as a UPN, and many will even say "Oh, the UPN" or "the UPC". Well it may not be a UPN or a UPC. It could be a GTN. It could be an NHRIC number. So generically, a lot of the standards organizations generically say UPN or UPC, but we support multiple different numbers for multiple different entities. So as you can see, manufacturers typically use multiple different groups to enumerate these products, so there are just four of those that are listed and these are what are typically listed in the actual standards per se.
As Terrie mentioned, there was the FDA 2007 Act that actually established the UDI, or the development of a UDI. Also in 2007, the Department of Defense initiated a pilot task with the GPN and the GS1 global trade network, and of course, after I finish, the California Medicaid Pilot has also done some work in this area.
So from a standards transaction point of view, the X12 4010 Version, which hopefully everyone is off of right now or will be by the end of this month, does support it in the 837 Professional Claim. It accommodates it as a line level situation build reported item supply. So it's a situational data element, it's at the line level, and it can be used for billing or reporting, so that's – out of all of that, that's what – to get out of there. Because it's a situational data element, its only allowed use at this point in time is for the Medicare or Medicaid program, and the numbers that are actually supported are the HIBCC and the UPC numbers.
As we move to 5010, it's important to note that this was added as part of the errata. Initially we thought the pilot was complete, and had removed it because when discussing it with some people from California Medicaid, they're like oh, we don't think we'll go for it, blah, blah. Then after additional discussions, it was determined that they might want to continue to do that, so as part of the errata process, we put it back in and we worked with Medi-Cal and had other payers, et cetera, involved in developing the actual situational rule, because it is a situational data element, and it's used to report the item, so no longer is it used for billing per se, it's just to be used for reporting.
So the only allowed situations are for an HHS-approved pilot project, if it's government regulated, for medical and surgical supplies and then supports a plethora of identifiers. As you can see, hopefully, it supports a custom order number, the HIBCC number, the UCC-12 number, the EAN/UCC-8 number, the EAN/UCC-13 number, the GTIN number, so as I go through that, you can see why we need one number in the industry to do this.
So it was added back into the errata, so again, we support this.
Then in December of 2009, the DSMO received a change request, change request number 1093, that requested that the existing code qualifiers in both the X12 and the NCPDP standards be brought forward in the next version. Whatever the next version was, it was to bring the qualifiers that currently existed, hence my previous slide, into the next version, and then to add any other product qualifiers to support the UDI that was currently being developed and regulated by the FDA.
The DSMO disapproved of the change request. Basically we thought it was premature. We assumed that there would be a code set, the UDI code set would become the national code set for identifiers, and at the time that code set was brought forward to be mandated for use under HIPAA, then the transactions would be updated at the same time so they could kind of go in lockstep, in other words. I'm going to mandate the code set, I'm going to make the changes to the standard at the same time; they all go together.
So we thought, the DSMO thought, it was premature to go ahead and accept the recommendation, because one; the UDI database was not completed, there wasn't abstracts, et cetera, available for it. So the DSMO disapproved it.
So, going forward, as we have a UDI database, one database, one of the things that both SDOs, even HO7, so all of us, would need to know is, where do I get this code set? I have a code set, UDI, where do I get it? So we call that an external code source addition, or a reference, so where's the source, how do I get it, and then an abstract, which is basically a paragraph of exactly what it is. So first we need to know where to get the code set.
Then we need to know, what are the impacted standards that are involved? In 4010 and in 5010, we just had it in the 837 Professional, and the NCPDP claims transactions supported it as well. So what are the standards that it's going to be needed in? Could there be a need to do a prior authorization on a particular device? If so, that would need to be added to the appropriate transactions, and supported as such. So as we think about moving this forward and actually rolling it out for payer use in reporting, what transactions do we need to have it in? What are the usage rules? Is this only something to be used to report versus I'm going to bill for a service but the service was to insert a catheter, so I then am going to report the UDI. And then is it reporting, is it used for billing? Because if it's used for billing, that's a different location in a transaction versus if it's just being used for reporting purposes.
So what's – how's the usage of the code going to be used, which of course then will precipitate, how the situational rule would be written. So we would need to add qualifiers to the appropriate standards going forward.
Now most of the standards organizations, in their process, have built into the standards the fact that there may be a need for a qualifier that is not currently in the base existing standard. So in the X12 standard, there is something called a ZZ qualifier, and basically what that does is it allows the SDOX12 to say, in this data element, in this location, for this situation, you use a ZZ qualifier, and that represents the UDI. So initially we would probably use, depending on time frame and where we were in the development cycle, use a ZZ qualifier to say this would be used for the UDI, and at the same time, we would be adding a specific qualifier for UDI into the base underlying standard. Then, as the next version rolled out, ZZ would no longer be used for the UDI; you would use the actual qualifier that said, "This is for UDI".
So both X12 and NCPDP, they use a code of 99 for other, have built this into their standards that allows this flexibility for modifications that can be incorporated while the base underlying standard is going through the process and being modified.
And again, new qualifier code source, those types of things.
Also, some other items to consider are editing of Med data. What's the structure of the number? Am I going to edit to say, does it start with 01, does it start with 10, does it start with 7, are there dates, so I need to look at dates? So those type of things need to be thought out as well, and that's more from a system point of view versus a standard point of view. And as I mentioned before, NCPDP does have a qualifier, the 99; X12 uses 77, and they do support the UPC, the HRI, the HIBCC, the GTN and the UPN today.
So it would be a matter of adding another code to our qualifier into an external code list and then any situational rules, et cetera, around that from an NCPDP point of view.
So, as Stanley would say, Ta da! I'm done. Thank you.
MS. DOO: Wow, thanks very much, Margaret. All right, and now we have – so is it who all actually ended up coming, because I know you came a long way. So it is Pansy, Sara and Marchel. Great.
MS. BURGESS: I'm just going to give a brief introduction of who we are, and who's going to do what. My name is Marchel Burgess, and I'm currently a consultant with the Department of Health Care Services in the Office of HIPAA Compliance. While I have worked on several initiatives, including 5010, a little bit of don't shoot me for 5010, it's not my fault – ICD 10 a little bit and some other medical code set transitions, I was not actually involved in the pilot process and the project for UPN UDI, but I'm going to be involved going forward because Sara is moving on to more challenging, by far – somewhat challenging activities within the Department, and I will be involved working with Pansy, moving forward with California's ongoing use of the UDI, and very hopefully, its adoption as a HIPAA coding standard at some point in the future.
With me today is Sara Rivera, who was the project manager for the UDI pilot project. Sara has worked for many years with the department to bring this project to where it is today. On the phone we have Pansy Watson, who is the Chief of California's Medi-Cal Medical Supply and Enteral Nutrition Branch. This branch oversees the policies and processes for hundreds of millions of dollars in reimbursements to health care providers for medical supply expenditures.
Pansy also worked on this project for multiple years and brings extensive knowledge about how California is currently using the UDI to support the payment, tracking and reporting of medical supplies, and with that little introduction, I will turn it over to Sara and Pansy. Thank you.
MS. RIVERA: Thank you Marchel, and thank you Walter and NCVHS Standards Committee, for allowing us to speak about the California experience. We think this is a very important initiative, and we look forward to sharing our experiences and lessons learned.
I also want to thank Terrie Reid and Margaret – Terrie's been very supportive of our pilot over the years, and Margaret, you helped us with the X12 standard. So we'll spend the next few minutes of this presentation – Pansy and I, we're going to go back and forth talking, giving you a little bit of background on how we got here, a brief overview of the UDI pilot, our main findings and experiences, lessons learned and our recommendation to the Secretary on how to move forward.
So briefly, on our background – the background of this project; I'm sure everybody knows that the HIPAA standard, currently the HIPAA standard for reporting medical supplies and devices and equipment is HCPCS. HCPCS is a five digit alpha numeric coding system which is designed to aggregate products based on common characteristics, into a single code, that HCPCS is not intended to uniquely identify medical products.
From a reporting and a claims processing perspective, essentially information is lost when you're using just the HCPCS for paying claims, and for establishing quality and utilization controls, so for California and other health plans to overcome this gap, this reporting gap, many times payers will require providers to submit a claim attachment with the claim, and this is a very inefficient way to process a claim. Much of the information on a claim attachment isn't codified, and so you essentially lose what it is that you're paying for. We're kind of getting, in my mind, to that point where many of these health plans need to know what they're paying for and to be able to track those products in a codified process.
This occurred really back in probably about 2002, but California passed a law to mandate that the Medi-Cal program, which is the name for California's Medicaid program, to contract with medical supply manufacturers for the purpose of establishing rebates and other cost-saving mechanisms. But early on, California determined that HCPCS would not support its laws to comply with this law, because the claim itself, we needed some mechanism to uniquely track the product, to identify the product that was contracted within the Department.
So the UDI, which formerly, I think people might be more familiar with the term "Universal Product Number", this is the term that was used even way before I got onto the project, that was considered as a viable option for placing on the claim what is it that California is actually paying for and tracking as part of this contracting process?
So California pursued a request to test the standards, the UPN standards, which at the time were kind of defined as – it's not in statute anyway, but the universal Product Number was defined as either the GS1/G10 standards or HCPCS, so California pursued an exception to the standards through the 162.940 to test the UDI as a standard. And that was approved back around the 2004 time frame.
So it took a couple of years to get the pilot up and running, but eventually we did, and we presented a report to the Secretary and we are here now.
Just quickly, Terrie talked about what the UDI is, so I'm not going to go back and explain it, but from a very simplistic purpose view, a lot of people will think of the UDI as the bar code itself, but it's really more than that. The bar code and the numbers you see on the bar code are much broader. Where you see on the bar code are much broader. Where you see, on the bar code, on the slide, where it says "UDI", that really is the device – It should say "DI", Device Identifier. So within the UDI coding scheme itself, you actually have a number that uniquely identifies the product itself.
So from a claims processing perspective, that's the data that we want to use; not necessarily the serial code and the expiration dates and all that.
And as Terry mentioned, the two primary coding councils are HIBCC and GS1. But the overall concept is to allow providers, pharmacies, to be able to take the UDI that's currently on the package, scan it, place it on its electronic health records and then promulgate it through the claims processing system.
So I'm going to turn over the next few slides, starting on slide six, to Pansy to talk about the pilot itself, and the lessons learned. Pansy?
MS. WATSON: Thank you Sara, and thank you Marchel, and greetings to everyone. Thank you on behalf of the California Medi-Cal program for this opportunity to present the California UDI pilot project findings. Hopefully you can hear me okay?
I'll mention it as the UDI, but we refer to it as the UPN pilot project, was authorized by the HHS Secretary to test the cost effectiveness and the feasibility of UDI as a HIPAA coding standard. The pilot objectives were to lower costs, provide better reporting data, reduce fraud and abuse and improve patient safety. These were actually many of the benefits of the Medi-Cal contracting program. The pilot testing was authorized for a three-year period, with over five thousand Medical providers participating. The scope of the project included over sixty seven hundred products in the diabetic testing supplies, enteral nutrition, incontinence, ostomy, tracheostomy, urologicals and wound care product categories. Most of the manufacturers participating used the GS1 and the HIBCC standards for product identification.
Slide eight – Over the three year test period, California Medicaid Management Information System processed over seven million claims with UDIs that resulted in over six hundred million dollars in provider reimbursement. The UDIs were allowed on the ASC X12 837 Professional claims that Margaret talked about. They were reported in the 2400 product identifications – Sara has a presentation on that as well. But the diabetic supplies and the enteral nutrition products were only allowed on the NCPDP pharmacy claims transactions, reported in the product identification segment.
On slide nine, we talk about the lower program costs. For the success of our Medical contracting program, a mechanism which requires to identify and validate that the product dispensed and billed by the provider match the Medical contracted product. Allowing the product UDI on the claims provided specific product identification and eliminated the need to request additional product information on claims attachments. This resulted in lowering operational cost and much faster and more accurate claim adjudicating.
Slide ten. The UDI improved our quality of reporting data by allowing Medi-Cal to identify the specific products reimbursed. This product specificity allowed better control when establishing rates and policy. It also enhanced fiscal reporting and monitoring of health care outcomes. The product specificity reporting is not possible using only the HCPCS on claims. The next slide demonstrates that.
Slide eleven. This is an example of HCPCS description versus a product specificity using the UDI. The products in the list all meet the description and are coding on the HCPCS 87520; I use this as an example because under the HCPCS codes there were hundreds of different products with cost variants, as you see, from 20 bucks to over 200 dollars.
All of these products meet the HCPCS, but the specific product list using the UDI allows for pricing specific to the product type, size and materials, and all these are within one HCPCS code.
Slide twelve. Sara, do you have anything to add to that one? It shows the difference between the HCPCS and using the specific UDI.
MS. RIVERA: And this was just one example. We had many HCPCS where there just represented multiple different types of classifications, assumptions and price ranges, where even trying to set – a lot of people will think okay, we'll just set an average price – well this is a classic example, if you set an average price between 20 and nearly 300 dollars, it means nothing, and that's where you need that supplemental information. SO using the UDI really makes sense.
MS. WATSON: The UDI also helped in the reduction of the fraud and abuse, because the product dispensed must match the product billed on the claim using UDI. This also added a level of provider accountability and improved fraud investigators' ability to identify and analyze claims.
Slide thirteen. Medi-Cal contracted programs performed quality reviews of contracted products to ensure how products meet industry standards. The providers use the UDI to ensure they are purchasing and dispensing only products that meet Medi-Cal's quality standards. The UDI also helps us identify specific product recalls as well, so the UDI helped Medi-Cal in improving our patient safety.
Slide fourteen. This kind of ends the portion of my presentation, and Terrie – thank you Terrie – addressed a lot of these challenges that we had with using the UDI, and they included the lack of that central repository which the FDA is working on. One of the things that we found is that our medical supply contracting team used sample packaging to help validate some of the UDIs, but the complex packaging labeling formats made it very difficult to visually identify and decipher the UDI. So we felt that it would really be helpful if we had a very exact and neat number on there that clearly identifies the UDI.
And lastly, a lack of a mandate for all manufacturers of labels to use a specific coding standard such as GS1 or HIBCC, for their products, we found that a very few, not many, manufacturers, are still using their proprietary coding and it made it a little difficult to validate and identify a product identification.
So thank you again. This concludes my portion of the presentation, and Sara will continue with the next slide.
MS. RIVERA: So what this next slide shows is within the HIPAA exception evaluation criteria for evaluating HIPAA standard, there were ten conditions, and as we went through the pilot and we were trying to objectively analyze is this a useful coding standard or not, we felt pretty confident that eight out of the ten areas of evaluation, that we could say yes, UDI is a good thing, it can help improve the efficiency and the effectiveness of the health care system, it meets the needs of the health data standards user committee, both the GS1 and the HIBCC standards are ANSI accredited. They have timely updating procedures, they're technologically independent, and ultimately they'll result in minimum data collection and paperwork burdens on users, and they adapt – HCPCS are a little less flexible in terms of adapting to changes. We believe that once the UDI standards are up and running, they'll adapt to advances and technological changes much faster than HCPCS.
The two areas that we scored partially matched were number three, be uniform and consistent with other HIPAA standards. We compared UDI, obviously, to the National Drug Code standard, which ultimately we envision the UDI becoming kind of like the NDC, the National Drug Code standard, where it's maintained by the FDA, there's a place where you can actually go and view the UDI codes, there's a process for updating them, but we're just not there yet. Originally, when this pilot started, we thought that there already was a national database out there with UDIs and we realized that there really wasn't.
Number eight, be precise, unambiguous and as simple as possible. Once we worked really close with the manufacturers and we identified what the UDI code was on their package, it was relatively simple, but getting to that point, asking them give us your UDI, just that process of what is the UDI, where is it on the claim or on the package – that was a challenging process, but as I said, once our database was billed and we saw them, it's a usable process, but it takes a while to get to that point.
This slide just kind of reiterates what I said, of the two areas that we identified as "partially" met, I won't repeat those.
Lessons learned. Alright, so we talked about all the great benefits that California observed using the UDI, so we do believe that the benefits that California achieved as a Medicaid program could be realized by other health plans; Medicare, commercial payers, once the system is up and running. We do believe that the benefits of using the UDI on claim and general health care transactions will outweigh the costs to implement once we get to that point.
The FDA, what Terrie is working on to actually promulgate regulations to name the UDI as a standard and to actually have a definition for the UDI and have a database to store UDIs, will play a critical role, and as I mentioned, we do kind of envision this leading to a system similar to the National Drug Code.
The FDA regulations, when implemented, will help overcome the challenges that we already identified as problems with the current system.
So in our report, as part of the testing a new HIPAA standard, we had to write a report and submit it to the HHS Secretary, which we did, and we had a recommendation, and our recommendation was to align the naming of the UDI as a HIPAA coding standard, using the same timelines that the FDA promulgates their regulations; at that same time, name the UDI as a HIPAA coding standard. We didn't mandate it as a HIPAA coding standard, but just name it as a HIPAA coding standard. And this would be similar to how the NDC, the National Drug Code, was allowed for physician-administered drug products, where right now they can use it, or they can use HCPCS. We think it's too early to mandate it, but once the FDA UDI regulations are out, we don't see any reason why it couldn't be named as a standard, where a payer could use it as an alternative.
Bullet number two – obviously, modify the applicable HIPAA transaction standards, which include the NCPDP and X12, to allow UDI reporting as a situational data element. So again, there would be language in there to say okay, if it meets the reporting needs of the health plan and the provider, allow for the reporting of this coding system.
And the final bullet is really to allow that process for HIPAA-covered entities to start using it to meet their business needs. Again, we think it's premature to mandate the standard, but California had a very specific business need to start using it, or to use something other than a claim attachment. We think that other payers, Medicare, will also, at some point, would see this database up and ready, and the UDI regulations are promulgated, they'll start saying well wow, this is a great alternative to what we're currently doing. So allow that process.
Other components of our recommendation were to collaborate with the FDA. When we say collaborate, the FDA is doing their work to make sure manufacturers use it, but we think that Medicare's, Medicaid's, commercial health payers, should work very close together to make sure that this rolls out in a way that makes sense, a very clear, concise transition plan to go from HCPCS to the UDI standards, and that could be a multi-year process.
But also to ensure that the UDIs are clearly identified on the packaging label, that the manufacturer is clearly labeling, because even if you recall the slides that Terrie showed, UDI on a bar code is complex. On a claim transaction, you don't really need all those numbers; you just need one component of it, so we want to make sure that's very easy to read. So one of our recommendations is on the package, actually have the manufacturers say UDI, and then colon and then the number, so that anyone looking at it truly knows what the number is to put on the claim.
And then establish a committee, which I kind of mentioned, to start developing a transaction plan, and that committee should include representatives from the FDA, X12, NCPDP, GS1, HCPCS and the medical community.
On this slide, it's just an example of how we envision, on the X12 standard, the placement of the UDI. The X12 standards themselves have a loop, and it's actually called Product Identification, but when the implementation guides are created for HIPAA, that loop is named "Drug Identification". But we believe that same loop should be used for identifying UDIs and drugs. It's just a matter of adding the appropriate qualifiers to differentiate between an NDC versus a UDI, and that's where Margaret and her team will be very helpful in terms of developing those qualifiers. And again, it should be a situational element.
So UDI should be on the institutional and professional claim. Dental we're not really too sure; we weren't sure if that was a need, that that would probably come out of the industry. And of course the NCPDP, which there's already a data element for it, the de-identification of the co-payers.
And Margaret had mentioned other X12 transactions and NCPDP transactions that might be impacted. This is the list from our perspective of all the different HIPAA-covered transactions that would be impacted, so obviously, get claims, but it would be the claims status, response requests, the eligibility benefit inquiry, the claim payment, the 837, service authorizations, coordination of benefit and Medicaid pharmacy subrogation. So it would be more than just the claim transaction itself.
And the final slide is just kind of a picture of how the UDI can kind of bring all the HIPAA-covered entities together; manufacturers, health plans and providers.
And we do believe that UDI ultimately can improve patient safety, reduce fraud and abuse, enhance the quality of reporting data and promote cost savings and efficiencies. And that is it.
DR. SUAREZ: Thank you very much for this, this is very, very informative. I think we're going to open it to the committee for questions?
DR. SCANLON: Actually I have a question and comment. I think this is an incredibly important thing for all you have done, and hopefully, that your optimism about its adoption will become a reality, because actually, I was at JO about 13-14 years ago, we were focused on the same topic. We were looking at sort of Medicare and HCPCS codes. Our example were catheters; at that point the range in price was $1 to $17; Medicare was paying $11 for every one of them and had no idea what kind they were getting, so at that point we were saying we don't care if you change the price, just know what you bought. And I think that's what we need to do. We really need to move forward on this, because it's unacceptable to be using something as crude as the HCPCS code for this.
MS. KLOSS: Assuming it gets adopted, what thought have you given to how it will be maintained? Because I can imagine that this is very dynamic, with a lot of change in devices. Would that become an ongoing function of FDA?
MS. REED: The development of the UDI database, just like any other database that FDA regulates, that our product codes or anything, our adverse event reporting, we have business rules, we'll have, as part of the regulations that I can't share with you – it does. How to exactly do this, when to update -
MS. KLOSS: But that process has been all laid out as well –
DR. SUAREZ: I have a question about the regulations – it's hard to imagine why or what is holding the regulations for a year; is there any sense of that you can refer to or mention? I don't know if you have any -
MS. REED: I really can't comment – we continue to have conversations with the Office of Management and Budget. We supply them with information, they have questions.
DR. SUAREZ: So it is, on OMB, and OMB has – normally they have 90 days, that's how I understand it, to clear this – okay. A quick other question I have is about the timing. So this was also interesting that this is an MPIN, it's a proposed rule, so if one were to project how soon this can be done if they were, let's say, released some time later this year, what's the time line from that point on with all the comments and all the processing comments and then the final action – are we looking at two years from now before the actual –
MS. REED: So it's a phased approach; I had shown it's risk-based, Class III, so we're anticipating a 90-day comment period, respond to those comments. We are going forward with that UDI database as if - we are having user acceptance testing that we're planning in July, so we are moving forward, as if that's going to all go through.
Our plan is to have it available for final – for submissions to be coming in Spring 2013.
DR. SUAREZ: Spring of 2013? Okay.
MS. REED: So the database to be up and running.
DR. SUAREZ: Thank you. Judy.
DR. WARREN: So if the FDA is going to build and maintain the database, I assume that's also the generation of any more codes that are needed. How does that relate to the work that you talked about at the beginning, that's international, where Australia owns the Secretariat -
MS. REED: So we're not going to assign – we will not be assigning the codes. Those are through those – they're called issuing agencies, as part of that ISO standard that I referred to, and they have to meet certain criteria to be an issuing agency and how they assign those codes. So GS1 and HIBCC has been mentioned here already in that business, and they're already working internationally, GS1 to B10.
So rather than an FDA taking on that, we wanted to play the marketplace and be part of the environment landscape instead of proposing some kind of FDA. And also get the benefit of having it be global, working internationally, as opposed to one country, since right now, as I said, in the NDC world, each country has their own national drug code, not international. So we wouldn't assign the codes, but we would require the submission of the codes to us and along with that UDI, I didn't spend a whole lot of time on this, but there would be a specified set of attributes that have also been harmonized internationally; things like brand, model, which really trip us up now, because people are typing in, you know, in those adverse event reports, the brand name, which we have an example of Medtronic being spelled hundreds of ways in our databases because we don't have those assigned to a standard.
DR. SUAREZ: Any other questions? All right, well thank you so much again, thank you for taking the time to come and present. I think we're going to take a break now and if we can take maybe a ten-minute break and come back at 5 minutes before the top of the hour so we can get the final panel.
(Break)
Agenda Item: Panel 7: ACA Health Plan Compliance Certification – Initial Ideas
DR. SUAREZ: So this last panel is going to focus on a very, very important topic, and that is Affordable Care Act provision related to compliance certification. As you'll know, the Secretary is going to be issuing regulations related to the establishment of a compliance certification process in accordance with the provisions of the Affordable Care Act, and there was certainly an interest in receiving feedback from the national committee, and so that's why we convened this panel, to listen to the perspective of the industry regarding this compliance certification process, and so we're very excited to have the various representatives that are going to testify today, so thank you again for joining us, and I'll turn it to Lorraine.
MS. DOO: Thanks everybody, and we will start the afternoon with Jim Daley, please.
MR. DALEY: Good afternoon. Again, I would like to thank you for the opportunity to testify today. I'm Jim Daley, from Blue Cross/Blue Shield South Carolina. I'm also the Chair-Elect of WEDI; I'm here today to testify on behalf of WEDI.
I'm not going to go over what WEDI does; you've heard that a couple of times today already. In a nutshell, we're trying to take manual paper-based processes and try and do them electronically, encouraging the industry to move that way. What I do want to say on this slide, though, is in anticipation of the certification requirements, we did hold a forum back in February of this year, well-attended. It was not an official PAG; we didn't take votes on any particular topics, or recommendations, but we just threw out a bunch of aspects of certification and got feedback from the attendees as to what they thought, some of their concerns, some of their considerations. Based on the notes taken during that session, that's what you'll see today in this presentation.
First concern was what are you trying to do with certification? What is the real goal of this? There needs to be some definition; are we trying to say is the industry ready? Everybody ready? Just one segment ready? Or are we trying to say not only do people appear to be ready, but they've resolved all the interpretation issues? Are we trying to say that in addition to getting the transactions flowing, we've actually resolved the internal processing and we agree that actual usage of the data on the transactions is appropriate, and of course there's another question of those are just trading partner issues, it has nothing to do with being ready or not ready, it's one specific relationship of one submitter to one receiver not working quite right.
Various aspects that have to be done to make the whole thing flow properly, so what is a certification going to accomplish? What's it trying to do? And that will have bearing on how best to do it.
Certainly it's got to provide some ROI. You don't want to go through an effort if there's no real return on what you're doing. It should look at the critical root issues; look at what real pain points we went through, not just the year but 4010, 5010 and maybe other implementations, and saying what are those real pain points and how do we work on those, not work on the trivial issues, the big ones.
And certainly avoid retesting; we've just gone through a tremendous amount of testing and implementation, the things are up and running, admitted operating rules are not there yet. But the 5010 is in place. We want to try and retest that to certify we've retested, so we need to try and avoid duplication of effort as well.
Another consideration is the health plan identifier, and it would be nice if we actually had that rule in front of us right now to look at, but based on some of the things in the proposal, what is a health plan? There's a HIPAA definition, certainly we know what that is, but we recognize in health plans, the HIPAA definition is not always everything you need. There are other entities involved in moving transactions back and forth – the OEID and the proposed rule; how does that enter into it? There are health plans, as defined by HIPAA, that don't do any of this. They just say here's my premium, just cover me, you handle all the transactions. Should they be involved in certification or should the people who are handling the transactions be involved in that process? So we really need to look at the interplay of what ACA said in terms of health plans should do certain things, or HIPAA says is a health plan and what's the HPID regulation going to do, and try and reconcile those.
Enumeration – things such as sub-plans were proposed, so does a health plan say I'm okay – for example CMS – Medicare is a health plan, but it's really administered through the MAC, so who certifies? How do we do that?
Fully insured plans, as I mentioned, they may not do anything in terms of transacting. They are technically a health plan, as defined by HIPAA, but they're not doing any of the transactions, somebody else is doing it on their behalf. So certainly, HIPD is an interesting thing to play into.
In terms of depth and format, health plans are supposed to provide evidence that they've done this kind of testing, et cetera, so the effort of doing that depends on what this really means; what documentation is going to be required. The simplest form is attestation – we did it, and there's a document certifying that they've done the transaction testing, they're in compliance. Very straightforward. There's another level you could go to –let's take a look at some EDI reports, see if they look like compliant transactions in there, look at number of rejections, things of that nature. You could use a validation tool. Back in the 4010 implementation, there were several agencies, or several vendors, that provided tools that said, your transactions are compliant, look good, or here's some compliant ones, see if you can process them. That's another way of going at it. And of course then there's the full-blown let's run things back and forth right through your systems and start to finish right through and all the way back out, and look at those results. There are a lot of different levels that could go about in terms of what the attestation really implies.
Certainly the sheer number of providers means you can't test – a payer cannot test with every single provider, and they don't transact with every single provider directly. They go through clearinghouses mostly. If you look at the hundreds of thousands of providers out there, the numbers are staggering.
And on the flip side, of course, if a payer tests with some submitter or a provider, that means a provider is also testing back with all the payers. So we need to look at both the aspects of that equation.
So here is a reiteration of some of that. You can look at end to end testing, and the rule was a little bit unclear in that, or the law, rather, was a little unclear. It said from end to end, such as from the providers – is it from the provider source to the health plan; in other words, out from the door of the provider to the door of the health plan, including all stops between? Is it from the time a health plan receives a transaction, to the time it sends some kind of an output back? But that's a claims status result, the eligibility response, remittance, what is that end to end? Or is it actually a testing of the full round trip from maybe somewhere within the provider organization to finally out the door there, through all the hops, through the payer, process through the payer, all the way back out through all the hops, back to the provider. What is this testing attestation that we have tested with these providers, and it works.
Synchronization – if you do try and do an actual full testing effort in here, the data synchronization is going to be something to be reckoned with. This is a simple picture, extremely simple picture, of what's involved in typical transaction flows. I guess I can't really point to my screen, but you'll see on the left side you've got providers, and I just put a couple of sample functions that occur within those organizations. On the right hand side, in the green, there's three simple functions that occur with the payers, and the provider could go directly to a payer, many do, and then the payer would respond directly to the provider.
However, a provider may also go through a clearinghouse, or billing service, to get their transactions out. A payer may also use some kind of a business partner, a clearinghouse, to receive the transactions. In between those clearinghouses/EDI gateway/billing services, there could be many more hops, so in terms of certification that this testing has occurred, all those different scenarios need to be looked at to determine what are we trying to do here, how do we do that, and if the health plan certifies they've tested, how do they know the testing went all the way back to the source, through those other hops?
Some of the challenges – I touched on this a little earlier. Federal health plans – does Medicare certify or does each MAC certify? For Tricare, for several Tricare contractors, does the Department of Defense certify I am good to go, or does each contractor do that, or would they actually partner with someone else who actually processes part of this? Does the partner certify that they're compliant? A lot of questions to be asked there. There's certainly a major part in handling these transactions. So should they be required to certify back to the other entity identifier and the HPID rules for what enters into certification?
Resources/dollars including trading partner and provider impacts. If a payer has to test with the providers, that means a provider has to test with the payer. If there's resource requirements, dollars, et cetera, on the other end; it doesn't happen just on one end. And also have to look at what happens within HHS. Somebody's going to have to review these attestations to say they make sense, I agree, you're good to go. If no one looks at them, then I'm not sure what the purpose would be. We have to look at the administrative overhead on the Federal side as well as amongst providers, payers, clearinghouses, or whoever needs to be involved in this process.
Control over who agrees to test. If health plans have to test with someone or other, how do they guarantee that other partner is willing to test with the health plan? So that's going to be another issue, and if you need to certify you've tested with everybody, what happens if only 90 percent say we'll test with you? Another consideration.
Multiple lines of business. Health plans are not just – most of them aren't one little entity that only does one kind of insurance. They do many things. Does each one of those lines of business have to certify, or as soon as one does, we consider that they're all certified?
Testing is not production. They may certify it works in testing – when the rubber hits the road you move to production. That doesn't guarantee it's going to work perfectly. Hopefully it does if you've tested well enough. No guarantee. And it's point in time only. Our systems aren't static. Even as we're implementing 5010, health plans are making changes nightly, weekly, monthly, whatever it is, for new initiatives to solve production problems, whatever they may be. It's a constantly changing environment so certification may look good, but it looks good at that point in time.
Some of the issues with health plan only certification – applying the requirement only to health plans – they look good to go, but to really make sure the industry is functioning as it should, there's all those players involved that also need to be functioning properly. That picture I just showed a couple of slides ago, if they're not all working, there's one weak link in the chain – then the health plan saying we're ready doesn't really make it work. So you could exclude critical parties by doing that.
The complication of attestation – once again, if the health plan says we've certified that we tested with everybody, how do they really certify that? That all those other parties have participated and they are also working well? I don't have the answer, I wish I did, but that's something we need to consider.
Another thing that could happen – this happened back in the 4010, I'm sure 5010 as well. I won't mention the legal groups, but there are many that say if we have to put our name on a paper to say this is it and we are absolutely perfectly in compliance, somebody's going to say well, you better be really strict about this and start rejecting items; none of this soft compliance. And we faced that in the past and I know we try to do our best to keep it flowing, but if we get to a very strict interpretation, that could cause some ripples.
And I should mention, there may be dependent entities outside of the health plan.
ROI – The certification process itself is an extra cost. So it needs to be offset by a benefit somewhere along the line. Hopefully everyone benefits by this, by having a smoother working environment and not a lot of issues to deal with, but we need to consider the impact to not just health plans, but all the trading partners, providers and HHS, as I indicated earlier. The documentation to say this proves that we've done this testing and we're in compliance, it's got to be minimal volume and maximum readability.
What is that minimum we can show that really proves this works? Must avoid replication – if you've already done this, do you have to redo it just to get the results in a form that can be sent somewhere else. Again, if that's a dump of transactions in hex format or binary format, I'm not sure how many people could read that and say it looks compliant to me, so it's got to be something really easy to read, easy to consume, easy to know and say this works. And it should focus, again, on the most critical issues. Let's not look at the little nits, one trading partner issue here and there – the global things of yes, this entity is ready to process, it seems like it's working, maybe you have trouble with one person, one group out there, but they're essentially ready when they should be.
Other considerations – certification is one tool, but pilot testing would certainly help. If we look at some of the recent issues with 5010, and we had the WEDI CMS collaboration statement, these are some of the other common issues across the industry; interpretation issues or just not understanding what was required out there. If we tested, some of these internal consumption issues may be resolved ahead of time so people know what those other impacts are; it's not just a sending from point A to point B, it's how you use the data once it's in there. How do we resolve those up front so we're not faced with an "Oh my goodness" once we start actually using these things.
Acknowledgements would help. A lot of the issues that we faced were – well it's not working – well the reason it's not working is because your transaction never got to the health plan – so how do we resolve that? Acknowledgments will help – not just that they got there, but in fact, these are the issues we saw with them.
There's the use of the 999 or whatever transaction was used for acknowledgments back there, and can the submitter then look at that and say a ha, I see what's wrong and I agree, I can fix it or that's not wrong, you have an interpretation issue. So the acknowledgments will help, not just in production but in the testing process as well.
And of course, market pressures are going to force compliance. We can say we need to get people moving along – sooner or later, if you want to stay in business, you're going to fix it. Once you're in production, if something goes wrong that night with somebody or other, people will be hopping all over trying to fix that, and I know many times, I've heard across the industry well they're the only ones that are having this problem, everybody else it works fine. That pressure is put to bear on that particular organization, saying why does yours not work and everybody else does? So there's a lot of other ways to get that compliance going.
And of course, web is – not required to create the web, so compliance should not really be a web aspect in there.
One more thing on the audits, that was also mentioned in the rule. Audits, they're an extra expense. In my life at Blue Cross, I was head of a unit which dealt with many, many, many audits; every single week, pretty much, and just dedicated staff, just to support the audits. So the question is, what is the overhead involved? Should that audit process be an on-site process? Couldn't evidence just be sent to a third party to review and say it looks like you are compliant? Certainly any audits that are involved should not introduce new requirements above and beyond operating rules and the standard itself. And it should focus on remediation; it shouldn't be out there to penalize; it should be there to say let's get us working smoothly together and focus on a positive way of resolving the issues.
And in conclusion, WEDI supports the need to assure timely and effective implementation of the standards and operating rules. We feel we need to clarify the objective; what we're trying to do here, consider the costs versus the benefit, the process must add value, be easy to understand, not just understand but easy to follow as well. We need to consider the impact to all parties, not just the health plan but others that would be involved in that process, and look at the future. This is not the first time, the only time we'll be implementing something else and making sure that we're doing it right. We're going to have new operating rules, new versions of standards, and other requirements as well.
Which fits into the topic of how on earth does the industry actually test itself and make sure it's functioning? Something to consider not today, but down the road; we really need to look at that process.
So with that in mind, I'd like to thank the committee for the opportunity to testify, and turn the mike over to Lee Barrett.
MS. DOO: Thank you very much. Yes, Lee?
MR. BARRETT: Good afternoon. Thank you again to the committee for inviting EINAC, the Electronic Healthcare Network Accreditation Commission, to testify before the committee.
What I want to try to do is to go through, really provide an overview of, who EINAC is. We're going to talk about the process. This is, I think, our overall presentation, which I didn't want to do. I had another one. That's got too many slides; we sent another one.
MR. BARRETT: Okay, in any event, I'm going to talk about who is EHNAC, I'm going to talk about our accreditation process. I want to talk about, as well, and how the EHNAC model, which has been in existence since 1995, how that really applies for the Affordable Care Act, and as Jim was talking about some of what WEDI is recommending here, I think it's going to hopefully become clear; we've got a model that has been working and is in existence, and gets national recognition out there.
So who is EHNAC? We were founded in 1995, and we are an independent 501(c)6 organization, not for profit. When started in 1995, we had over 30 organizations that participated in developing these industry standards, or what we call criteria. Criteria is the same word; basically it's synonymous with standards, although at least what we're doing is we're using it as criteria, and we looked at it, those people who were part of the initial set of criteria were developed, looked at it in relation to data transmission, data security, advertising and resources, so we'll go through that in a little more detail in a few minutes.
So the governance process of EHNAC really is; we're voluntary, we're Federally recognized as a standards development organization, we have nine commissioners that are broad-based and represent both public and private sector organizations across the health care industry, and it's guided by a peer evaluation which really focuses on quality, the innovation, cooperation as well as open competition amongst industry participants.
If you look at the purpose of EINAC and we even are in existence, really is we look to develop these various sets of criteria, and what you're going to find, hopefully, in a couple of minutes, hopefully people will be pleasingly surprised. We're more than just a clearinghouse accreditation. Initially that was our initial focus, but I think people get pleasingly surprised when they see that we're much more than that, and when I go through this.
We primarily are focused on health care data exchange, and if you look at health care data exchange today, it's far more than just what the clearinghouses or electronic health care networks are doing. We've got the health information exchanges, we have accountable care organizations, we have all the various stakeholders that are, in fact, exchanging both clinical and administrative data. So we're looking at this very holistically across all those stakeholders.
Therefore, our accreditation programs are focusing on the following areas. We're looking at electronic health networks, we look at financial services organizations; many of the banks, as many of you are aware, are into health care as well, big exchanges as well regarding electronic funds transfer and other transactions.
E-prescribing networks; medical billers, health information exchanges, managed in-service organizations. Jim talked about TPAs; payers, as well as other health care industry organizations and I'll talk about a couple of other areas that we're also focusing on this year, but it's a very broad-based set of stakeholders that we have focused on in developing accreditation programs for.
So what we are really focused on as far as an overall philosophy is really, as a voluntary accreditation organization for the industry, we've incorporated, and we have committees, that spend time looking at regulatory compliance, not only HIPAA, Hitech, ARRA, Affordable Health Care Act, all of the various regulatory legislation at the Federal, as well as we incorporate some state specific regs as well, into our criteria. So it's very broad-based.
We focus as well on really improving the efficiency and the quality of health care delivery, and that's an overall set of philosophy that we've been focused on as far as our accreditation programs.
So what's the value proposition that EINAC brings to the table here? Well there are four major pieces that we focus on. One is, on the framework side of the metric here, we're looking at providing usable policies and procedures; we're looking at promotion of best practices, in relation to electronic data exchange, we're looking at improving overall business practices, as well as providing a discipline for organization and planning.
On the metrics side, we want to raise the bar, and so on the metrics side, we're looking at enhancing overall performance through a whole set of requirements for quality metrics, as well as customer satisfaction, we think, is extremely important as part of some of the criteria that we're evaluating. On the quality side, we're looking at quality improvements in the products and services that organizations, vendors and others offer, we're looking at training, we're looking at, as well, cost reductions and efficiencies, as well as providing really an overall comprehensive evaluation and objective evaluation of all this criteria that organizations need to provide.
On the compliance side, as I mentioned, at the Federal level, we're looking at Federal regulation as well as we're looking at some state regulation as well. All of those are factored into the criteria that we go through, and I'll spend a couple of minutes to go through what our criteria and development process looks like.
On the development side, we have four areas that EINAC really focuses on. One is privacy, confidentiality and security. We're also looking at technical performance, best practices, as well as the resources that an organization has; they say that they have, to support and provide services to the industry.
We are also looking at several other accreditation programs this year. We're focusing on operating rules; we've already started a program and a committee in which what we're doing is this year we will be incorporating all of the operating rules into our existing criteria for all of our programs. So by end of year we will have all these operating rules incorporated.
Second, we're looking at development of an accreditation program for the health care information service providers, the HISPs. We're coordinating with a number of organizations in the industry that are focusing here on direct project, to develop an accreditation program here, and we're also looking at telemedicine. We have, for example, in Maryland, Maryland has a specific initiative, just passed legislation, in which they are looking at focusing on an accreditation for telemedicine vendors in the state of Maryland, and EHNAC is very involved with the advisory committee that they've put together to look at development of criteria for telemedicine accreditation as well.
So these are some of the additional initiatives that we're focused on as far as EHNAC.
Our development process is fairly rigid; again, we try to follow that of standards development organizations by having, through our Criteria Committee, developing of all of the various criteria and for each of the programs that we have, about 70 percent of the programs use what I would call core criteria that we have across all the programs. About 30 percent are therefore specific to that entity.
So we go through, then, a 45-day process of public review as well. It then goes to our executive committee and gets approved on an annual basis.
The programs that we have range all the way from E-prescribing, as I mentioned before, to outsourced programs, and you can see here on the next slide, for all the outsource or outsource accreditation programs, we have everything from that of data centers, as well as call centers, disaster recovery sites, we go through all of that, and then under our health care network accreditation program, it runs everything from TPAs to medical billers, electronic health care networks. So it's a very broad-based suite of accreditation programs across all the stakeholders.
The process is very electronic. We use the Web for everything from an organization goes through, applies for accreditation, the application and it goes all the way through from self-assessment is submitted; it goes back to the self-attestation aspect that Jim talked about. In the accreditation process we also have site reviews, so in every single one, we have auditors that actually go out and review each of these sites as well. And then an award of accreditation at the end of that process.
So an organization must go through – this is not just a one-shot deal, organizations have to re-accredit every two years. So if we're looking at this thing on how do we leverage the EINAC model that's already been in place since 1995 for ACA certification, we've got the framework; we've had that framework in place, and we have a payer accreditation program already in place.
We also have an accreditation program for TPAs that Jim was talking about. A lot of payers already mandate EHNAC as part of their RFI and RFP processes, as they're going out to look for electronic health care networks, clearinghouses and others. So it's already – we're also well known to a lot of the payers and a lot of the industry already.
And I would say if we needed to enhance or incorporate any enhancements, we certainly can do that through our criteria process, and our methodology, as I indicated, is already fairly well entrenched in the industry.
We would want to convene an industry action group, as far as recommendation of various stakeholders to look and see what would be needed for the criteria. We would identify some betas, as Jim was also talking about – we think that's extremely important, and others have talked about, to get that feedback and enhance the program, hold webinars and other feedback mechanisms to gain basically more support throughout the industry, and put together an overall accreditation model of criteria, basically as a release one, going through and leveraging our criteria, standards development organization process.
So those would be recommendations that we would make from an EHNAC perspective to leverage our existing framework that's already there.
Thank you to the committee, again, for the opportunity to present.
MS. DOO: Thank you. Next we have Jeanette Thornton, from AHIP.
MS. THORNTON: I know the day is getting short, so let's get right into it. I think you all are more than familiar with what the Affordable Care Act did in terms of this whole new category of operating rules. You all have been working on this for the past two years. So we have new categories of rules that apply to health plans, that apply to clearinghouses, and apply to providers. What's really interesting about the structure that was created in the Affordable Care Act was it created this whole new process whereby one of those entities, health plans, has to complete certification, and ACA includes very detailed requirements about what that certification has to include in terms of what a health plan actually has to demonstrate to the Secretary. That includes things like actually being compliant with standards and operating rules, which makes a lot of sense, also has completed end to end testing, and then a third thing which hasn't been mentioned, but really ensured that entities that health plans work with, their service partners, have insured that they are all compliant with these operating rules.
So we like to call this building half a bridge; these transactions are requests and responses between entities in the health care system, and we need to have someone to be sure to receive it at the other end of the request, so it really is an iterative process. We don't want to build half a bridge, so my recommendations are going to be focused on today, how do we develop a certification process that works for health plans but also ensures that this bridge goes somewhere? We don't have a bridge to nowhere, which many of you, I'm sure, are familiar with.
So looking at the Affordable Care Act and things that the Secretary has done using her authority in the past, we really believe that the Secretary has the broad-based authority to set up a certification process that can really define a certification process that's workable for the industry. So a couple of things.
In terms of actually demonstrating compliance with the standards and operating rules, we really feel that at this point it needs to be primarily an attestation-based process, and I think we heard this morning, a lot of the challenges with some of the different testing and standards implementation that we've all been going through over the past couple of years, more recently with 5010.
Next, the key thing in the Affordable Care Act is a requirement that health plans provide a documentation that they have completed end-to-end testing with partners; it says in the law; e.g., such as hospitals and physicians. Partners really needs to be narrowly defined as trading patterns, so those entities that we're actually conducting those transactions with, so in many cases this may be a practice management system or vendor, that's being used by the physician.
We also think that it would be important for the NCVHS to recommend that there is a high level testing schedule, that's put in place, and that health plans would work with their trading partners to implement this testing schedule.
Given all the challenges that were discussed this morning with 5010, I really feel that it's important for health plans to have this flexibility to define their own approach, to end-to-end testing. There are several different methods to be used to achieve that. Jim mentioned a couple in his testimony, which I thought were great – testing with a sample of providers, the use of testing modules, et cetera.
And also, under the Affordable Care Act, the Secretary does have the authority to designate an independent body to also do certification, and we recommend that entities that are already certified by CAQH CORE should be able to leverage that existing certification in meeting these requirements.
Regarding the requirement about service partners and then health plans having to ensure that they're in compliance with these transactions, you know, service partners is a very broad term; it could mean those that take out the garbage at a company. We really want to make sure that this is really narrowly focused on those covered entities that are actually conducting business transactions with health plans.
We also think that CMS could really promote that use of outside certification entities like CAQH CORE in helping health plans meet the service provider requirement so that all health plans, a lot of us use the same vendors, the same IT companies, so if those IT companies are certified, that would help us demonstrate that we are in compliance.
A key note, and I think this was mentioned earlier, this morning, health plans are in the process of setting up their testing plans for the first set of eligibility and claims status operating rules that are implemented as of January 1, 2013, but the requirement to certify doesn't come until the end of the year, December 31, 2013. So we're very concerned that any rules regarding certification may disrupt testing that's already underway right now in terms of getting ready for January 1.
So I mentioned my half a bridge, and let me go back to that point, with a couple of ideas that we've been noodling on, to think about how do we insure providers and most important, the vendors or practice management systems, are also brought on board and are in compliance with the standards and operating rules?
One of the things that we thought about is the role of the HHS OIG. In the past, CMS has used the OIG to help them demonstrate that through their compliance guidance, how to get these other entities on board. They have recognized, in some past reports, the missing link in terms of practice management system vendors and putting in place mechanisms to ensure that those vendors are in compliance. So one of the things the OIG could come out with as a recommendation that says "We recommend that provider work only with practice managers and vendors that are certified as being in compliance, as a way to ensure that that gap is filled."
Another option is always through the 800 pound gorilla in the room, and that's Medicare. We've been thinking a lot about this. I don't know if many of you are familiar with, there's something called the Administrative Simplification Compliance Act in 2003. We've come a long way, maybe, maybe not, but this was the requirement that first, as part of participation in Medicare, a provider actually had to submit an electronic claim for the first time in 2003, and this subsequent Act was used again in the Affordable Care Act, which requires, by January 1, 2014, providers that are participating in Medicare to actually, I think the exact language here – Medicare payments would be prohibited in a method other than the EFT or ERA.
Well, if under Medicare, provider are being required to comply with the EFT and ERA, wouldn't the corresponding operating rules go along with that, and so we think that's one idea to leverage.
A second idea that we've put forth in our comments is regarding the meaningful use, and I know that this was discounted as part of Stage Two, but I want to beat that dead horse again. We think that the meaningful use has to include some basic administrative transactions as part of meaningful use. At least the eligibility transaction and the claims status transaction, the ones that we have the most experience with over the – we think it's a missed opportunity to actually complete that bridge.
So those are some of the ideas that we had regarding certification, and I appreciate your time today.
MS. DOO: Now we have Marri-Lee Stine, with Aetna.
Agenda Item: Certification Strategies
MS. STINE: I am Marri-Lee Stine. I'm a manager for provisory solutions at Aetna, and I'd like to thank the committee for having me today.
I know there are some advantages and disadvantages to being the last person to testify. One of them is I could just sit here and say yes, what they said. But we won't do that. We are firmly committed to the successful implementation of the Affordable Care Act, and we do support all of the efforts to simplify the electronic processes between the providers and the plans, and as Jeanette was speaking about the half a bridge concept, we're at one end of the bridge and we really would like to connect that bridge together. We think that a key element to the successful implementation and completion of het bridge, I like that analogy, is the careful adoption and implementation of the requirements that were set forth, especially regarding this trading partner testing and compliance concept. I added trading partner in there.
It's my opinion that the concept of limiting that requirement to only health plans really doesn't ensure the consistency and compliance across an industry that historically has seen a wide variance in the adoption of these transactions, depending on the type of implementer.
We heard this morning in some of the 5010 Lessons Learned about the wide variations depending on which step in the process you look at. We heard about practice management systems that had not implemented some of those changes, and some of the difficulties that cause for providers and some of the other missteps along the way.
The fact is, it's my opinion, that we're only going to get to true administrative simplification if we really do seek consistent implementation.
What I would like to talk about today is some of our testing experiences, and this is testing experiences specific to transaction testing. As a large national payer, and we are, we've had a lot of experience with testing transactions with multiple types of individual partners; that individual testing that Jim talked about in his presentation, and we have partners that are both directly connected and that come to us through different types of clearinghouses. That individual testing is resource-draining, it is very closely, and because of just the nature of individual testing, it results in inconsistent results of testing. There's different data set up at different times, that each of those different partners have different scenarios they would like to see, a different times, so the testing efforts wind up being just inconsistent across the board.
The individual testing, the steps that you will take involve determining how you're going to connect, what environment will be available, drafting appropriate test scenarios, finding the test data. If the test data is not available you have to create it, refresh it, make sure that nobody's touched it in the meantime, Once you have it in place, than you get to schedule it. Sometimes you need to schedule it during off hours because you're using the same resources, either be they system or people resources, as you need for production. So once the tests begin to be performed, the results must be reviewed, checked, double checked, questions regarding results go back and forth between the payer and the partner.
After all that is satisfied, you might be able to get to sign off. That has to happen for each individual trading partner that you're working with, be it a directly connected provider or clearinghouse or whoever, that can be hundreds and hundreds. It's a lot of work.
Now that's one way to test. We also have experience with the CORE process; we certified for both CORE Phase I and Phase II. We did them incrementally. We did CORE Phase I as an early adopter. We did CORE Phase II once those rules were available and ready.
The testing scenarios outlined by CORE were developed by a multistate team. They're consistently applied across different types of i8mplementers and there are different test scenarios that are consistent across stakeholders, but there are sets of scenarios for each stakeholder type.
The process begins, that process. It is a different process. It begins with a pledge. You agree to abide by the operating rules. That's signed by a senior company executive. As anyone knows, this is a challenge. But once you get that signature, you can get started.
Each scenario requires a specific set of test data to be set up in our test environment, but we're all working with the same setoff test data. Still a lot of work, but at least we're all looking at the same setoff test data.
The test data did allow for some flexibility. We found that to be a benefit. We could use our own format for member IDs. We could use our own format for plan information, things like that, but the scenarios were consistent.
Once everything was set up, we were able to begin the testing. Some rules were tested in different ways. Some things required upload of a document, transactions themselves were actually initiated through a third party website. The third party website evaluated the transaction response for compliance and provided a determination of whether or not we were compliant with those operating rules.
During the testing process and during the data set-up process, we did find that we had questions. We heard during the operating rules section this morning, there was feedback where people did find that they had questions on the rules.
When we had questions on the rules, some of it was the rules, some of it was the testing process itself. We did raise the questions; the questions were answered. We didn't find that to be a barrier too much. We were an early adopter, so some of that took a little bit longer than it probably would today. But we didn't find it to be too much of a barrier to the testing process.
One of the things that we did in addition to our own testing was we implemented a requirement for our directly connected submitters that they also accomplish CORE certification to be a direct connected submitter to us.
We announced that in February 2008, so if you're going to submit to us you have to be CORE certified. That was something that we found to be quite beneficial.
To summarize, we believe that testing and compliance is key to the successful adoption and implementation of the standards and Affordable Care Act operating rules. We believe that the prior experiences of stakeholders must be a consideration when developing the rules around the testing and demonstration of compliance.
There is value to including all stakeholders. We heard that earlier. It doesn't make sense to only test with one stakeholder. Right now we're talking health plans. We're at the end of the road in many of these transactions, or at the beginning of the process. We strongly encourage testing of the entire process.
We believe in reuse of existing processes, be it the CORE process or whatever we have in place today, that may mitigate some of the costs involved in this effort. It is a costly effort, both in time and money.
And experience tells us that any effort requiring attestation of a senior executive must be clear in its requirements. It was mentioned earlier that if you're going to have somebody sign their name, we'd better be clear about what we're asking them to sign and why.
And that is what I have, and I'd like to thank you again for having me today.
MS. DOO: Thank you. We did, on this topic, we did receive a very comprehensive written testimony from Edifecs that could also be found from a link on the Agendas, and Edifecs does provide free software and certification testing for the transactions themselves, as well as for the operating rules, and there's a very nicely documented explanation of how that certification is done for the transactions, so I think the committee will certainly look at it, but those that are listening on the phone and other members of the group may wish to look at it as well.
DR. SUAREZ: Thank you very much for this last panel, and I think the very last testimony is a great way to summarize one of the most important themes of the day, which is testing, so I thank you very much for that. I really appreciate it. Let's see if there are any questions from the committee? Any questions on the certification, compliance certification process?
Okay, well, I think the concept here of this particular panel was to really begin to frame and understand what are some of the options and certainly, we heard, I think Jim did a nice job laying out some of the various options of compliance certification from simple attestation to external certification processes, and vendor offer type of certification.
Certainly these are some of the issues that we would need to look into and evaluate as we frame some of the observations that we had out of this hearing and this panel, and discuss any recommendations.
Just to conclude, I think, I'll just say a few words; but first let me mention the process, as with all our hearings that we have had, we are going to be putting together some letters, or a letter, depending on how we approach it, with a summary of the observations from the various subjects that we covered today, and any possible recommendations that the committee feels would be appropriate.
I think the intent, at least, is to process this in time for – and again, it depends on the discussions that we will have as a subcommittee, at least a report back to the full committee in September at the next meeting, at which point we might have something concrete about one or more of these topics, and we would be able to present those then.
I think we had some time allocated for some discussion, but I think it's getting close to our end of the day, and we want to give certainly a few minutes to the public input, so I just want to conclude by thanking all our testifiers; we had 34 testifiers today, and we really want to express our utmost appreciation for the time that you took in preparing this testimony and answering the questions that we provided for you to address, so thank you so much for taking the time for that.
I also wanted to thank our very, very able staff support – Lorraine, who did another amazing job in pulling together this one-day hearing, so thank you, Lorraine, for the time, for all the work contacting everybody and discussing all this with everyone, so thank you. Thank you to the committee members for joining us today and to the public as well, for participating and listening in.
Before we open it for public input, Ob, do you want to -
MR. SOONTHORNSIMA: Very briefly, again, I don't want to echo everything that you said, and our appreciation for the testifiers. One of the things I observed today is how nicely all these topics kind of came together; very nicely; it was grueling and we apologize for the tightness of time, especially that we are trying to listen on very, very important topics, but one of the observations I have is there's a lot of common themes going across all panels, around collaboration, around complexity and reliance on key stakeholders, and obviously, lots of obstacles.
Another running theme also is there's so many different ways of doing this, and take away from me is there's no panacea, it's not a silver bullet, but lots and lots of good ideas, and I think that an answer is somewhere in that, and it's going to require for us to spend lots and lots of time deliberating on all these different options and ideas, but most important thing, I think, it's the collaboration that is required, and all of you have stated that. SO thank you again.
DR. SUAREZ: Any comment from the committee members before we turn it for public input?
MS. KLOSS: I would just add to what your summary has been and just a sense of some urgency in bringing together that cohesive picture. I think the issue of a roadmap or a playbook or something like that was also one of the recurring themes.
DR. SUAREZ: We are going to open it up for any public input, any person here in the room, if you would like to make any public statement before we close, you're invited to do so now, if anyone cares to do that.
So we don't have anyone here in the room, so I wonder if anyone on the phone that has joined us through the WebEx is interested in making any public statement?
Do we need to provide instructions on how to do that, is there a way to – it's not possible, so those that are joining us via the web, they're not able to provide us with input? Okay.
If anybody on the phone has any comments, they can send it to us via e-mail, that certainly is something that we would appreciate and take into account. So thank you.
Our emails are on the NCVHS website.
Again, thank you so much for joining us, and look forward to continuing to work with everyone and we'll declare the meeting adjourned. Thank you.
(Whereupon, the meeting adjourned at 4:52 p.m.)