[This Transcript is Unedited]

NATIONAL COMMITTEE ON VITAL AND HEALTH STATISTICS

Subcommittee on Standards and Security

March 3, 2004

Washington Terrace Hotel
1515 Rhode Island Avenue, N.W.
Washington, DC 20005

Proceedings by:
CASET Associates, Ltd.
10201 Lee Highway, suite 160
Fairfax, Virginia 22030
(703) 352-0091

TABLE OF CONTENTS


P R O C E E D I N G S [9:25 a.m.]

Agenda Item: Call to Order, Welcome and Introductions - Dr Cohn

DR. COHN: Good morning, everyone, would everyone please be seated? I want to call this meeting to order, this is a single day hearing of the Subcommittee on Standards and Security of the National Committee on Vital and Health Statistics. I think as you all know the full committee will be meeting tomorrow and on Friday at the HHS building and I actually want to thank all of you for coming to a different site. For those on the internet we are actually at the Washington Terrace Hotel.

I want to start by apologizing to those in attendance as well as on the internet that we're starting a little late, a combination of traffic in the metropolitan area plus I think the fact that everyone is sort of used to going to the HHS building for meetings I think contributed some to a delay in having everyone here for the meeting.

Anyway, I am Simon Cohn, chairman of the Subcommittee on Standards and Security and I'm the national director for health information policy for Kaiser Permanente. Obviously I want to welcome everyone here, all of our subcommittee members, staff, others here in attendance and welcome those listening in on the internet. This is being broadcast on the internet and I do want to remind everyone to speak clearly and into the microphone as I'm trying to do this early morning.

Now we have a fair amount to cover today. This morning we begin with a HIPAA update and I want to thank Stan Nachimson for coming to provide that update. This is being followed by a discussion of claims attachments. As many of you will remember the subcommittee in December was updated on the work of a number of the standards development organizations related to the claims attachment standard and we received some input from the health care industry on this work. Now based on that hearing we decided that we needed to hear additional testimony from others in the industry and other standards development organizations. Obviously we want to thank our testifiers who will be testifying to us today for coming forward with some additional insights and thoughts on this proposed standards. Obviously we all recognize the importance of computerized claims attachments to administrative simplification and decreasing administrative costs in health care and obviously we look forward to the comments and the discussion today.

This afternoon after the testimony is completed the subcommittee will further discuss the issue and may decide to develop a letter of recommendations to the Secretary. Now following that discussion will be a discussion of a letter we received from the designated standards maintenance organizations concerning standards for billing for supplies and I think subcommittee members have received background documentation on all of that but we'll be discussing that and sort of seeing what we want to do and whether a letter is appropriate at that time.

Finally we complete the afternoon with sort of an introduction to version seven of our e-prescribing work plan. I really want to thank Jeff Blair, our vice chair, for very hard work on this, albeit version seven, as well as all the staff support to help bring us to this point. Obviously the point of the discussion, and we'll I think be starting it this afternoon, probably continuing it during our breakout tomorrow, we'll be making sure that we're all comfortable with the focus of the work as well as the overall plan for the hearings recognizing that it's a very aggressive plan, there's going to be a lot of sessions between now and November, at least in the current work plan so we want everyone to reflect on it, sort of the view is at this point either improve or approve. And at that point comes the issue of having us all begin to look at our calendars and see if we can by the time we leave on Friday have people's availability so we can put together the actual hearing dates. Remember how difficult that is sometimes to handle over the internet it might be useful if we could actually be able to announce by Friday morning that hearing schedule, at least for the next six month.

Now I want to emphasize that this is an open session. Those in attendance are welcome to make brief remarks if you have information pertinent to the subject being discussed. We will also have time at the end of the morning session for basically an open mic and we invite anyone who has comments to make to make them at that point regarding the claims attachment standards. Finally, for those on the internet we welcome email and letter comments on issues coming before the subcommittee.

Now with that let's have introductions around the table and then around the room. For those on the national committee I would ask if you have any conflicts of interest related to any of the issues coming before us today that in your introduction we would like you to so indicate those conflicts of interest. And obviously let's start with the introductions. Jeff?

MR. BLAIR: Thank you, Simon. Jeff Blair, Medical Records Institute, member of AIMA, ASTM, HL7, HIMSS, not aware of anything which would be a conflict of interest.

DR. STEINDEL: Steve Steindel, Centers for Disease Control and Prevention, staff to the subcommittee and liaison to the full committee.

DR. HUFF: Stan Huff with Intermountain Health Care in Salt Lake City and University of Utah. I have potential conflict if we discuss HL7 or ICD-10-PCS or LOINC.

DR. WARREN: Judy Warren, University of Kansas, I also have potential conflict if we discuss anything with HL7 or SNOMED.

MS. GRAHAM: Gail Graham, staff to the subcommittee from the Department of Veterans Affairs.

DR. FITZMAURICE: Michael Fitzmaurice, senior science advisor for information technology to the director of the Agency for Healthcare Research and Quality, liaison to the national committee and staff to the subcommittee.

MS. AULD: Vivian Auld, National Library of Medicine, staff to the subcommittee.

MS. PICKETT: Donna Pickett, National Center for Health Statistics, CDC, staff to the subcommittee.

MS. GREENBERG: Marjorie Greenberg, National Center for Health Statistics, CDC, and executive secretary to the committee.

MR. REYNOLDS: Harry Reynolds, vice president, Blue Cross and Blue Shield in North Carolina, member of the committee.

MR. NACHIMSON: Stanley Nachimson from the Office of HIPAA Standards in the Centers for Medicare and Medicaid Services.

MS. FRIEDMAN: Maria Friedman, CMS, staff to the subcommittee.

[Introductions around the room.]

DR. COHN: I think Jeff you wanted to make an additional disclaimer?

MR. BLAIR: Yes. My employer is personally involved with the development of the CCR and if discussion comes up related to the Continuity of Care Record then I would recuse myself.

DR. COHN: Before we move on to our first presentation I should comment that even though I am generally conflicted I don't think I actually have anything that I am in conflict of interest on today, so this is the chair.

Now with this, Stan Nachimson we're obviously pleased to have you come and join us and brief us on sort of current HIPAA updates and issues, so thank you.

Agenda Item: HIPAA Update - Mr. Nachimson

MR. NACHIMSON: Good morning, thank you very much, I appreciate the opportunity to bring the subcommittee up to date on what we're doing in terms of HIPAA, both implementation and policy, and enforcement. The October 16th 2003 compliance date for transactions and code sets was of course a momentous date, at least for CMS and the Office of HIPAA Standards, but I'm hear today to talk about some other compliance dates, regulatory dates, and enforcement actions that we continue to be involved in.

Starting this year we begin a series of compliance dates with additional standards regulations that have already been published. July 30, 2004 is the compliance date for the National Employer Identifier, for all entities except for small health plans who had an additional year. The next year, April 21, 2005, is the compliance date for security, plans with a security regulation. I mention that particularly because in our discussions with entities there's a realization that security does take some advanced planning and work and covered entities should be looking at least beginning their risk analysis and other efforts so that they do meet the compliance date of April 21, 2005.

Recently we had the pleasure of publishing on January 23rd of this year the National Provider Identifier, the second identifier standard to be published under HIPAA. Compliance date is May 23rd, 2007, a fairly lengthy period of time, longer then the two years that are generally given for compliance. The reason for that is the time that CMS needs to take to build the system to assign that provider identifier. Some of the work on that system could not be started until the reg was actually published so we're taking the time to build the system and make sure that the two year period starts when we will be able to assign National Provider Identifiers to those providers that request it, so there will be two years from the date that the first National Provider Identifier can be assigned to the compliance date. The covered entities should have enough time to prepare for the use of that.

We have plans for some upcoming regulations during the rest of 2004. A proposed rule on the National Plan Identifier is expected towards the latter part of the summer and the rest of the year we should expect to see a regulation on, proposed regulation on claims attachments, obviously it's a subject for discussion later today. And also later this year what we're affectionately calling the Modifications Two Notice of Proposed Rulemaking, another regulation that deals with some changes to transactions and code sets primarily in regards to some of the policy issues that have been particularly problematic for the industry during the initial implementation of the transactions and code sets.

Regarding our outreach activities, CMS, the Office of HIPAA Standards, continues activities to work with industry and inform all necessary parties of the requirements for all the HIPAA regulations, especially through our 866 number, it's a toll free number, and our Ask HIPAA email box, and reminding people that's at HIPPA@CMS.HHS.gov where we will respond to individual questions about all of the HIPAA standards and policy.

We continue to work on additional guidance papers for critical issues to the industry, both in the transactions and code set areas and this year you should expect to see a series of papers on security implementation, especially for the smaller provider audience, there the feeling that the more sophisticated entities have the opportunity for the review of documents from the National Institute for Standards and Technology and other areas to really understand what's necessary to implement the security standards, however there seems to be some concern that especially smaller providers are not as technologically oriented as other entities, will be able to I think explain what they need to do in order to comply with the security standards.

We also continue to monitor industry readiness in the implementation of the transactions and code sets, there was last year of course the issuance in July of contingency plan option for all covered entities where although the October 16th, 2003 date remained in effect covered entities were entitled to implement contingency plans so that payments especially could continue to flow in the health care industry in case one side or the other in a transaction was not yet ready to handle the standard transactions.

We continue to monitor the readiness of the industry to move towards full compliance with transaction and code set standards, participating in surveys and hearings, a recent hearing by the Workgroup for Electronic Data Interchange for example that basically had testimony, various segments of the industry as to their readiness and certain problems that are getting in the way of full compliance, we continue to work with those organizations to make sure that we can resolve and remove some of the obstacles.

We believe that although most covered entities can exchange some of the standard transactions I don't believe that there are a large number that are already exchanging all of the standard transactions. Medicare seems to be leading the way in the claims, especially in, the claims transactions latest figures show roughly 66, 67 percent of Medicare claims are coming in in the HIPAA standard formats. Last Friday the Medicare program announced a slight change to their contingency efforts where they are now saying that as of July 1st claims that come in the HIPAA standard format will continue to be considered electronic claims if you paid using the 14 day floor, but those claims that come in in non-HIPAA formats as well as the paper claims will be paid with the 27 day floor, so in essence that's sort of a slow down in payment for non-HIPAA compliant claims in an attempt by the Medicare program to encourage providers to submit claims in the compliant format. And I believe also it shows their willingness to at least give the industry reasonable notice that a change is coming. They announced this at the end of February, July 1st is when this policy goes into effect so there's several months providers have to move towards compliance.

Talk a little bit about the status of enforcement actions and complaints for transactions and code sets. As folks might know our enforcement process for transactions and code sets similar to that for privacy is a complaint based effort where we're not taking any action to go out and review covered entities but are only responding to complaints of non-compliance from others. As of February 25th CMS received 66 total complaints, 53 of those were valid transaction and code set complaints, 13 of those were not transaction and code set complaints, they were either privacy complaints that were forwarded to the Office for Civil Rights or non-HIPAA complaints, was explained to the complainer that this is not the place to send in those complaints.

But of the 53 total transactions and code sets complaints 16 were against the Medicaid program, eight Medicare, 29 against the private sector. Of those 36 were because the complainant, or the complainer, felt that a compliant transaction was rejected, one had to do with companion guides, 15 had to do with code sets, and one had to do with a complaint about an NCPDP transaction.

CMS is currently investigating those complaints, 13 of the complaints have been closed at the request of the complainant, 40 still remain open. So we haven't had a huge influx of complaints but of the ones that we've had we are actively investigating those and hoping to resolve those. The idea is to resolve those between the two covered entities, the entities that are involved in the complaint rather then attempting to do any harsher enforcement, that's the tack that we're trying to take.

So that's pretty much where we are in CMS on the HIPAA standards, I'll be happy to answer any questions if there are any.

DR. COHN: Questions from the subcommittee? Any questions from the floor? Okay, well, Stan thank you, I'm sure we'll be having additional conversations on this as we go through the day and into Thursday and Friday. I'm sorry, Stan?

DR. HUFF: What was the percent of compliant transactions that you're receiving now?

MR. NACHIMSON: The Medicare program looks like approximately two thirds of the claims that are being submitted electronically are coming in as HIPAA compliant claims.

MR. REYNOLDS: Stanley, could you define what Medicare finds a compliant claim to be?

MR. NACHIMSON: No, I can't. In terms of Medicare they have set up, what the Medicare program considers a HIPAA claim they have set up a series of edits to measure compliance with the standard and the implementation guide, they have specific edits and should a claim pass those edits that's considered a HIPAA compliant claim. But CMS at this moment, the department at this moment has not defined with a HIPAA compliant claim is.

DR. COHN: Michael?

DR. FITZMAURICE: Stan, is there any anticipation of changes in HIPAA policy regarding electronic submission through email or through the web on a secure basis?

MR. NACHIMSON: I think you're asking for the Medicare program, and just for the general audience let me explain a little bit of separation in CMS in my hesitancy in answering certain questions. CMS has responsibility for operation of the Medicare program, oversight of the Medicaid program, and HIPAA policy regulations and enforcement, plus the fact that Medicare is a covered entity the agency has erected what we might call a virtual fire wall between the Office of HIPAA Standards and the folks in Medicare and Medicaid that operate the program where we tend to keep some distance because we have some enforcement authority over them. Their policies and a number of their policy discussions are sort of their own and we don't get involved in all of the details nor do they necessarily get involved in all of the HIPAA policy discussions, we keep some distance. So when I answer questions I have to be careful that I'm answering either from the HIPAA policy, the OHS perspective, or this is a Medicare or a Medicaid question.

So your question has to do I believe with the Medicare policy that several years ago they issued directives out to the industry that they would not allow individually identifiable Medicare information to flow to the Medicare program to the Medicare contractors over the internet. My general understanding is there is, there either are plans or there is something already in the words to allow for some limited access over the internet but I'm not intimately familiar with those, I can't give you any details on that.

From a HIPAA policy perspective, put on the HIPAA hat, there's nothing in HIPAA that prevents claims or other information from being sent over the internet via email, again assuming that it meets the appropriate standards.

DR. COHN: Any other questions or comments? I mean certainly I would sort of comment that that issue around the internet and use by CMS and all of this is I think a topic that we have on our issues list for a more thorough briefing from CMS from somebody who actually wears the right hat there. I do appreciate your comments, you're clearly not responsible for that policy or the implementation of it.

Yes, Harry.

MR. REYNOLDS: Locally many of us are seeing a consolidation of the industry, the number of people that used to directly submit is going down quite dramatically and appears to be consolidating into third party submitters, it's been dramatic at least in our environment. Are you seeing that nationally?

MR. NACHIMSON: I'll just speak from some conversations that I've had with different folks and I've heard a mix of plans saying that they're getting more and more of their claims from third party submitters, clearinghouses, or both, and others that are saying that they're actually seeing a lot more direct submission from providers, I think that differs depending on the area of the country and a particular plan that you're in. I haven't seen in some of the Medicare statistics where they report the number of submitters, it seems to be staying relatively stable. Then again that's only the experience of the Medicare program.

DR. COHN: Other questions or comments? Okay, well Stan thank you, we'll be asking additional questions as we go forward I'm sure.

With that why don't we move t our first panel, I think we have Kepa Zubeldia, Don Bechtel, and Gary Beatty, if you'd like to come and sit in the front. I obviously want to take this occasion to welcome back one of our former subcommittee member who has been I think absent from the subcommittee, it's been a month now? Kepa, we want to thank you for coming back and joining us.

DR. ZUBELDIA: Simon, I'm having withdrawals.

Agenda Item: Industry Perspective on Claims Attachment - Dr. Zubeldia

DR. ZUBELDIA: Good morning, my name is Kepa Zubeldia and like Dr. Cohn said I was a member of the subcommittee a month and a week ago. I'm bringing today a summary of issues concerning the transaction known as the claims attachment.

It's an overview and before I start I'd like to make it clear that I have no stake in the game although I'm a member of X12 and HL7, but Claredi is not a transactions processor such as a clearinghouse or provider or payer, so we will not see these transactions flowing through our system other then in a test environment.

I'm going to be talking about the need for attachments, the approaches for attachments today, a little bit of historical background of where we are and why we're here, and then I'll be talking about five different issues, and a little bit of a summary of what we learned from the HIPAA experience.

The attachments are additional information that must be provided to the payer in order to adjudicate a claim, that's a claim attachment. There's not only a need for additional information to adjudicate a claim but sometimes there's a need for additional information for preauthorization or even for a referral sometimes.

The needs for attachments vary among the different payers, they're very dependent on their specific claim reimbursement practices, on state law requirements for certain attachments, and other kinds of requirements, specifically for reimbursement and their fiduciary duty.

Attachments are the ugly duckling of the HIPAA transactions. Providers don't like attachments, they're time consuming, they're expensive to produce, they're difficult to understand what the payer really wants, you really don't know what to send sometimes, you just send everything, and they're perceived by providers as a payment delay tactic.

Payers don't like attachments either because they're time consuming, they're expensive to handle, they're sometimes difficult to understand, especially they're just photocopies of the medical record, and increases the cost of administration of the claims. Most payers will ask for attachments not to be sent by the provider unless the payer request them, but there's not a good mechanism to request the attachment. The payer sends a letter and because the providers receive this letter requesting the attachment maybe weeks after the claim was filed and just delays the reimbursement cycle there is a tendency by some providers to just send the attachment proactively to avoid delays. And the send the attachment when in their past experience there's a high probability for the payer to request the attachment.

There is three types of approaches for the attachment, one is this predictability factor, when it's required by law or regulation or a business practice of the payer then you send it immediately with the claim, there's no reason to wait. Certificates of medical necessity, prescriptions, consent forms, remittance advice from the primary payer when you're filing a secondary claim.

Then there's the other kind that is frequently required and these are proactively sent with some of the claims. A provider will send what in his or her past experience has proven to be useful for reimbursement. For instance there are certain dental procedures that practically always need an x-ray, bite wings or plenarex(?) or whatever, and they'll send it automatically with the dental claim. Anecdotally, somebody was telling me the other day about a dentist that was sending x-rays to the insurance company and one day the insurance company called him and said this x-ray doesn't quite match the teeth of this patient, and this is fraud. And the doctor said no, I've been sending x-rays for ten years and this is the first time I have a problem, in fact I've been sending the same x-ray for ten years. So they don't always look at the attachments.

And there are some attachments infrequently required, as a response to the payers request for additional information then the provider will send the attachment and typically this is a copy of part or all of the medical record. If a provider cannot make sense of what the request is they'll send the entire medical record, if they can make sense they'll only send part of it.

Let's talk for a second about the transmission mechanism, because there are two different topics here, one is the attachment content and the other is how it's sent. The most frequent transmission mechanism is paper. There's some attachment information that's now part of the 837 implementation under HIPAA, for instance adjudication information from the previous payer on secondary claims, certificate of medical necessity for Medicare claims, ambulance, oxygen, other certificates, they're part of the standard 837, it doesn't need to be sent as a separate attachment. But of course most of the time this is sent on paper.

There's also electronic dental attachments that are increasing and these are being sent today in a substantial number, I believe they'll be another testifier discussing this, and they're being sent as x-rays, pictures, periodontal chart, models, actually pictures of the models, reports, etc. But also most of the time these are sent on paper.

There is no implementations currently of the proposed HIPAA standard attachment using X12 and CDA as of yet and that kind of information is being sent on paper. There's no standard attachment in use today, there is no standard content, no standard format, no standard method of transmission, and the most frequent method of sending attachments is paper. The message here is the attachments today are sent as paper.

Let me give you a little bit of the history of how we got where we are. About ten years ago X12 was seeking ANSI accreditation as an SDO in the United States. ANSI asked for X12, I'm sorry, HL7 was seeking an ANSI accreditation. ANSI asked for X12 support of HL7's accreditation request and ANSI essentially wanted to have a memorandum of understanding between HL7 and X12 as part of the HL7 accreditation. This was a time to draw some lines in the sand. The memorandum of understanding says that the two SDOs would work together to avoid overlaps and make things easier for the implementation of electronic connectivity in health care. At last the way this was presented in X12 was that X12 was for administrative transactions and HL7 was for clinical messages. X12 was for inter organization data transfers and HL7 was for intra organization data transfers.

Now after the lines were drawn in the sand the sand has shift and HL7 is now an international standard, not just a U.S. national standard. I remember in that memorandum of understanding, at that time they were talking about HL7 meetings having somewhere between 150 and 200 attendees, that's probably just one of the war groups today. So as an international standard HL7 is responding to the needs of all of its members, not just the U.S. members. For instance, Australia is using some HL7 messages for administrative transactions. HL7 messages are being sent between institutions, that's normal practice today. And the international affiliates are really not all that concerned about ANSI, that A in ANSI is American and they really don't care much about that, HL7 responds to international needs.

So that 275 ORU HL7 message was a shotgun wedding, it satisfied the HL7 X12 agreement because the clinical information was sent in an HL7 message, there are no X12 standards for clinical information, clinical information standards are the domain of HL7. And the message routing and administrative information is sent in an X12 transaction. The 275 X12 transaction was created specifically to send HL7 messages and other forwarding objects within the X12 transaction.

So the result of that was an HL7 message encapsulated inside a binary object in the 275 X12 transaction. The syntax is inefficient, it's difficult to handle, it's unproven, it's not very clear that all the translator companies out there can handle this, that's one of the objectives of the pilot project. But it's politically correct according to the agreement between HL7 and X12.

So what are the issues of attachments as I understand them today? There are several parts, the attachment needs a standard request for additional information, the provider needs to know exactly what the payer is asking for. The attachments use a standard attachment request, which is a 277 proposed transaction, 277, and the content of the request would be as LOINC codes inside a 277, so it would be clear and codified what is it that the payer is asking for. In theory if the request is a standard the provider that receives the request could build a system to automatically respond to the request, so if the payer is requesting a specific lab test the provider's system could automatically without human intervention respond with the results of that lab test. That's a theory, we'll see later that it's not quite like that.

But there's a little bit of an issue with this automated codified request, must all attachment requests be codified, if they're all codified the list will probably never be complete, somebody is going to need something that is not on the list, that's going to happen. If they're not codified and the requester is free to request just about everything, whether it's codified or not, then what's the value of a standard, what's the value of a standard request, if there is the freedom to use an un-standard request who will use the standard. What did we learn from HIPAA in this area?

One a provider gets the request the provider is supposed to respond with a standard response to a request for that additional information. Now some attachments are easy to standardize, electronic remittance advice, certificates of medical necessity, certifications and so on, they're easy to codify. Other standards are more, other attachments are more difficult to define and codify. The HL7 and LOINC booklets for the proposed HIPAA attachments have done an outstanding job in codifying those things that are difficult to codify, it's amazing the work they've done. Some of the attachments are practically impossible to standardize as a response, free from text, well, you can tag the text but it's difficult to standardize free from text. Graphic lab reports, you can include the graphic but it's very difficult, pictures and so on.

So when the payer gets a non-standard response to a request, and the non-standard attachment gets to the payer, what are the choices? Can the payer ask again for that same attachment to be delivered in a different form, to be delivered as a standard? Can the payer ask a different question to satisfy the payers needs? What's the value of a standard in this case if there is difficulty or impossibility to codify some of the standard attachments? Again the 80/20 rule applies, 80 percent of the cases may be possible to standardize, 20 percent not, there has to be a balance between the two.

The third issue is the issue of unsolicited attachments, unsolicited attachments are sent along the 837 claim. There is an electronic staple mechanism between the claim and the attachment, the 837 claim refers to the attachment control number that is included in the 837, and the 275 attachment is labeled with an attachment control number that links the two. These unsolicited attachments are sent when the payer's standard operating procedures or the provider experience indicates that they should be sent. Like I said before most payers discourage these unsolicited attachments.

One of the biggest questions in this area is what's the impact of HIPAA privacy in sending unsolicited attachments, does the minimum necessary apply to unsolicited attachments or are they exempt from the minimum necessary and just as the other X12 transactions are exempt from the minimum necessary. So that's something that I'd have done before I bring a lot of questions, I don't bring the answers.

Another issue is work flow automation, there's multiple systems involved. I explained earlier how the theory is that if the provider receives the standard request for an attachment the provider could build a work flow to automatically create a response to the standard request, in fact to create a standard response to the standard request. This would involve multiple systems. The claims are administrative transactions, most attachments are clinical, and typically administrative and clinical systems don't talk to each other. Now there's a possibility of an administrative and clinical system talking to each other to create this automatic response to a standard attachment but I think that possibility at least at this point is very remote.

There's also the issue of multiple attachments per claim, there has to be a strong linkage between the attachment request and the attachment response because if there are multiple attachments to one claim it needs to be very clearly understood what attachment belongs to each request.

How is the attachment handled by the payer once the payer gets the attachment? Today they handle mountains of paper, there's absolutely, there's no question about human intervention handling that paper. The ideal situation would be that the standard attachment is electronically automatically processed by the payer without human intervention. Is that attainable? Is that the goal for the first round of HIPAA attachments? Are the payers willing and ready to take the attachment automation step? Keep in mind that large payers are very different from small payers. Are the vendors and clearinghouses ready to provide these automation tools?

Finally, the fifth issue is telecommunication and formatting issues. There's multiple parts to an attachment standard. Putting aside the historical reference to the MOU between HL7 and X12, we'll talk about that, the data content could be sent as LOINC codes and that's very, in my opinion a very good approach. But there's different possibilities of saying data content using different vocabularies, terminologies, images, plain text, there's all kinds of data content that could be sent in the attachment. I don't think that everything will fit into one standard form of data content.

The data format could be sent in multiple different ways, it could be sent as an HL7 message without any X12 wrapper, either as a 2.X syntax or an XML syntax. It could be sent as an HL7 message encapsulated inside X12. It could be sent as free form text, free form text inside an HL7 message, free form text inside X12, free from text inside HL7 encapsulated inside X12. it could be sent as a scanned document as TIF or JPEG, that TIF or JPEG could be codified as a DICOM image that could be then sent inside an HL7 message, it could then be sent inside an X12 transaction. So there's all kinds of options for sending the attachment and the data format for the attachment.

Transmission mechanism, could be over the internet. Stanley just talked a minute about CMS's internet policy that doesn't allow the Medicare contractors to use the internet, that could be a problem for Medicare, they may want to reconsider the policy. The would be some encryption and authentication issues in sending attachments over the internet. And there could be a combination of standard and non-standard components in the attachment that could be standard format, standard codes, standard transmission mechanism, or a combination of all of the above. And perhaps as moving one step at a time towards the automation of the attachments, it may be wise for the subcommittee to recommend certain standards or a variety of standards for different purposes. I don't know if they'll be one attachment that suits everybody.

So HL7 is also recommending this incremental implementation and in their CDA attachment documents they're talking about how providers that don't have a lot of automation could be sending a scanned image of a document and they could also send if they have the automation the ORU message that has everything codified, so it's kind of a step wise approach.

I bring a little bit of lessons learned from HIPAA, I don't know if they will be 100 percent applicable to this but it may be. Even with detailed standards such as the X12 standards under HIPAA implementation vary greatly. Each payer today has a different set of companion documents specifying their particular requirements and making generic interpretability very difficult or impossible. Rather then trying to fight it we probably ought to learn to live with the differences. Interpretability is the biggest problem in implementing the standards.

Process reengineering is also very, very difficult. Is the industry going to automate the current attachment process, which is done on paper, or is it going to switch to a more efficient process of automated request and responses to the attachments? There's a lot of value in taking one step at a time. Without a clearly understood return on investment most implementations will focus just on the minimum necessary for compliance, whatever that is, whatever I have to do that's what I'm going to do. Even the best designed standards will run into problems during the implementation phase.

We've also learned that the big bang approach does not work, there has to be an implementation plan. The implementers wait until the deadline, in the X12 case was the final rule or beyond, to implement. The NPRM for the transaction and code sets didn't have much impact on implementation. I would not expect an NPRM on attachments to have a very significant impact on implementations and attachments.

Early adopters are very few, I think at this point they're pretty much a myth, maybe two or three early adopters around the country but I haven't found any yet. Well, there are some, okay. The government must lead by example and incentives. CMS is now applying an incentive to the implementation of X12 HIPAA transactions. Smaller payers and smaller providers will feel left out of the process no matter what, and no matter how much inclusion(?) you do smaller payers and providers will always feel left out, so that's something to keep in mind.

And I think that's the end, if you have some questions now or later I'll be available here the rest of the morning.

DR. COHN: Kepa, thank you very much. Are you passing out Prozac with your presentation? Thank you for reminding us of the complexity, seriously. I think our next presenter is Don Bechtel and today you're representing AFECHT. Thank you for joining us.

Agenda Item: Industry Perspective on Claims Attachment - Mr. Bechtel

MR. BECHTEL: Mr. Chairman and members of this committee I am Don Bechtel, I am the current chair of AFECHT. I'd like to make the opening comment that AFECHT is in its mission dedicated to the implementation of standards and transactions and their efficient use in an secure and open network. Some of the testimony I'm about to make may not sound that way, but we truly are and the reason we bring up the issues we bring up today is to make sure that we do have a smooth transition to their implementation and avoid some of the pitfalls that we've experienced in the past.

It would be fair also to say that AFECHT does not represent all the vendors or the providers in the health care arena for plans or providers, but we do represent a large number of more prominent organizations in the industry.

Over the last two weeks, we had short notice of this meeting, but over the last two weeks or so we've been trying to assemble among our members some answers to some questions that were posed to us. Those questions were what is the readiness of the vendor community to implement the standard, what are the issues we anticipate may impede the successful implementation, and what recommendations could we offer to ensure successful roll out of the next wave of transaction standards, in particular claim attachment.

Again, as a general remark AFECHT does support the standards under HIPAA and we believe the claim attachment will significantly improve the efficiency and the processing of our systems for claims adjudication and payment. We believe that when the standard is integrated into the provider and health plan systems it will increase the efficiency and improve the overall quality of health information being exchanged. However, having learned from the previous HIPAA transactions we realize that there may be many unknown and untried processes and system enhancements to implement before we can realize this objective. We believe the claim attachment was originally put in second phase because quite simply it's harder and it's going to take a lot of work.

The implementation planning we perform now should follow or allow enough time for both, for all organizations to understand and resolve the issues that are certain to be found prior to imposing deadlines for completion. And due to the complexity of the problems we've experienced during the first round of HIPAA AFECHT strongly recommends that the industry establish a project plan to coordinate the validation and implementation schedule of all covered entities and the key players, namely vendors. AFECHT and many of its members and other organization associations that we worked with over the years stand ready to help the industry discover and document what these issues are that lie ahead. We are committed to assist in the identification and the resolution of these problems and to conduct trial implementation with other interested members in the industry from each effected health care segment to complete this work.

Speaking to the question of readiness, some of the clearinghouses and vendors within our organization have begun to make the necessary enhancements to implement the claim attachment for certain attachments, namely the DMEs and home health forms. Some of have participated in small pilots with earlier versions of the standards and some have developed prototypes which were recently demonstrated at the February HIMSS. But most of this work has been preliminary and very basic, and to our knowledge now of it has attempted to implement all the various functions that will need to be supported to fully support claim attachments.

In general most vendors, payers, providers have been fully occupied trying to implement the first round of HIPAA, this has where most of our attention has been and we still have a long way to go. There's still some transactions that have seen very little progress at all. And it is fair to say that the vendor community is apprehensive about the implementation of claims attachment standard, there is uncertainty about the potential problems that will be encountered and a desire to have some level of industry study and education on the transaction before we begin to develop our solutions.

Some of the issues and concerns that our members have shared with us, and we'll share with you, begin with a very simple statement that this is going to be a very complex transaction to implement and that there will be a number of issues and problems to deal with and we've kind of outlines in the next few pages what we believe some of the major issues are going to be. We've ordered this list by the way in what we believe are kind of the priority or the major issues, the major issues to the less major issues, they're all major but some are more important then others.

Work flows are probably the most serious concern for us. When a request for additional information is received what will happen? And Kepa shared with us a number of scenarios and I think he outlined that very nicely. But the point being when a transaction comes into a provider's application it's most likely going to hit a billing application, not the clinical applications. And so some sort of decision mechanism is going to be required to determine where the transaction needs to be directed, what kind of system interface exists if any, some sort of routing table for where to direct various requests of various types. This work can be quite complicated in more sophisticated environments and I believe there's going to be a lot of work necessary to make that happen.

Of course both the request and the response transactions must be captured and the provider must maintain these together with the claims in some sort of status indicator to indicate what work has been completed or what work is still pending, so that they can properly manage their claims and billing process. These requests will not only require application logic but also databases to store these requests and the information together with the statuses for audit purposes and for the billing departments to use in terms of managing their process. Policies and procedures within the institutions will need to be modified to account for these new work flows.

The work flows just described would imply that there are interfaces between financials and clinical systems but generally these don't exist today. We have lots of interfaces in an enterprise system that are between the financials and the clinicals but these interfaces are not request response in nature, they're mostly communicating among the clinical systems the clinical data that they need or among the financial systems that the financial systems need. Clinical systems are generally pushing charges and information for the financial world but they're not normally pushing the clinical data that's needed for an attachment. This is all new work for us. So these are mostly push transactions, not such much request and pull, and this is what we will be experiencing with claims attachments.

Developing these work flows and the associated interfaces will be complicated which may require additional standards. As noted above each vendor will have to agree on some sort of protocol as to how to handle these and the point that I failed to make above is although these systems may be contained in one institution sometimes they're on different systems, sometimes using different technologies, different protocols, different methods of storing data, different coding systems, different data structures, all these make for complications to be dealt with in some sort of normalizing standard to be able to interface between the two. Additionally some of these systems aren't even located in the same enterprise, and we'll talk about that under data flows.

Locating the data within the health enterprise has potential problems, in some cases where the data will be contained in one system while in other cases it's located in multiple systems, especially with clinical and financial applications operating usually on different machines and potentially different technology platforms, both the clinical and the financial systems could potentially even be outsourced in certain enterprises. So laboratories and billing systems could be operated on totally different systems from the organization that's using that data.

Beyond the challenge of knowing where to find the data and how to use it there could be other problems, and an example of this would be establishing user or system access controls for security and privacy reasons, and once you're in the data store knowing exactly how to acquire it because of the technology issues that I just described.

We believe that for these interfaces between the various systems to actually work you're going to need to have, develop as vendors, some sort of application interface program, some sort of remote procedure calls that will allow data to be requested and retrieved, to be able to work in a truly ubiquitous environment among disparate systems such as we have.

We believe health care setting issues are a potential problem as indicated above, billing systems, labs, could be in separate enterprises --

MR. BLAIR: I'm sorry, what did you say was a potential problem?

MR. BECHTEL: Health care settings, organizations, large hospital environments versus maybe larger systems that are all self contained or smaller practice management systems, small laboratory systems, home health organizations and so on. The settings themselves have issues that may make the exchange of this data more complicated.

Interoperability as Kepa has mentioned we also believe is going to be a key issue between the financial and clinical systems, to establish the connectivity in the exchange of data that's needed to conduct these business transactions that have traditionally not been automated. Most interfaces between billing and clinical systems today are just done manually, establishing the standard protocols for these interfaces within the health enterprise will require in our opinion additional collaboration among the vendor community.

We also think coordination with EHR would be beneficial to the implementation of claim attachments and we suggest that this be considered as well.

The standards point is really to the point of interoperability within the enterprise that I've already described.

There's also a concern about LOINC codes, outside of clinical systems these are not widely implemented as a code set today and interfaces between this and other code sets such as SNOMED will need to be further defined in ways that include documentation for the consistent use and interpretation for mapping purposes to be used by all providers and all health plans consistently.

Identifiers is another concern we have, as a new standard we're all trying to get this implemented, it becomes a distracter from the work that needs to be done with claim attachments.

At minimum necessary we have a number of issues surrounding minimum necessary considerations and I think Kepa did a nice job of describing that, I'm not going to outline what he's pretty much already said.

Infrastructure changes may be required as many of the systems that we have today are not fully utilizing XML or using XML at all, and to handle the CDA standard this will become a requirement.

Competing standards is also an issue that confronts us, as we saw with other standards in the first round when we implement portal solutions, this begins to distract from the quality of the standard that could be implemented. It also creates more confusion on how to implement these standards if we're trying to do portals and trying to do the standards too. And although we appreciate the portal being used in some setting, we see the value of it, we're just saying it's a distracter.

We have some number of recommendations based on the issues described above. AFECHT does recommend that the NPRM for claim attachments be issued soon but we say that with some caution. We would request that consideration be given to the work that's already in progress and that we time the release of the NPRM in such a way that the work that we're trying to get done for round one gets closer to get completion so that we can focus on this new NPRM. We also recognize that without the NPRM the industry is not going to move forward very fast so this is an issue that we need to begin to try to find the right answer for.

AFECHT recommends that the industry develop a project plan as I've noted before with realistic timetables being established for the claim attachment, which should consider a number of aspects to allow, to have time allowed for. A without going through any detail there's on the next page, we've outline what a plan should consider. In quick summary there needs to be time for analysis, time for the development of the application codes, time to validate that development. We believe there needs to be time included in any project plan for the trial implementation to be conducted, and for that trial implementation to be able to create documentation on the issues and underlying problems that may need resolution before we try to implement this nationally with a mandated timeframe.

We recommend that those findings be considered by the SDOs and CMS for correction prior to a final rule being issued, and that the national implementation plan that might be developed for the pilot work with some modification after finding out what the real issues are could be adjusted to be a better timetable for full implementation by the industry.

Obviously this plan needs more vetting and needs more input but we believe it contains most of the important elements that should be considered and we feel it is extremely important to industry to have such a plan. And AFECHT and a number of other organizations, HL7, HIMSS, WEDI-SNIP, are currently working together now to try to start an implementation trial process with some interested vendors, providers and payers and we think if that work can actually get executed we would hope NCVHS would look to that effort for some input.

AFECHT recommends that the final rule should not be issued before the input from the beta trial is done. AFECHT recommends that NCVHS consider recommended a phased deployment of the claim attachment. And AFECHT also recommends that NCVHS consider finding a means to help fund a pilot or trial implementation, especially for some of the provider settings that probably won't be able to participate unless there's some funding available and without their participation the trial really can't be successful.

This would conclude my prepared remarks, I welcome any questions, and I again thank the committee for the opportunity to speak with you today.

DR. COHN: Don, thank you very much. A final presenter is Gary Beatty, welcome, and thank you for joining us, and I believe you're representing X12 today.

Agenda Item: Industry Perspective on Claims Attachment - Mr. Beatty

MR. BEATTY: I will be representing X12, thank you and good morning. I apologize for not getting copies of the testimony prior to the session today as we were working on it yet this morning and ran into logistical problems with copy centers this morning, so I don't even have a paper copy, so I'm running in a virtual world this morning if you will.

On behalf of X12 I'd like to thank you for the opportunity to testify today regarding health care claim attachments requirements for HIPAA, the Health Insurance Portability Accountability Act. X12, just a little background, consists of approximately 370 member organizations, we are represented by organizations not individuals. Within X12 develop standards that are both based upon X12 as well as XML formats for cross industry standards, so we're not focused solely on just the health care industry, we develop standards for doing business electronically across a broad spectrum of industries within North America.

Within X12N the insurance subcommittee, which I currently chair, there are approximately 140 member organizations as well as over 95 non-members of X12 organizations that represent payers, providers, software vendors, clearinghouses, value added networks, sponsor organizations, and consulting organizations. Unfortunately you can't see it but I do have a model that highlights the transactions that are mandated under HIPAA and I believe you've seen several very similar models to this one at your prior December hearing dealing with attachments.

X12 as you've heard from Kepa has been working on health care claims attachments actually since the early 1990's when we developed the 837 health care claim transaction. As Kepa mentioned contained within the 837 transaction set we have data content to support different types of attachments such as durable medical certification, ambulance certification, chiropractic certification, home health care information, home oxygen therapy, the ability to link to external documents as Kepa related, I think he referred to it as the electronic stapling which has been a term we've used and batted around within the standards community a long time, that can refer to either paper or electronic transactions. This attachment information is still contained with the 837 transaction and is currently part of the mandated 837 that is required of the industry under HIPAA today.

Since 1997 X12 has been working with HL7 and we have been working together to develop a national standard for health care claim attachments to meet the attachment requirements under HIPAA. By working together we're better able to meet the needs of the health care industry as we can incorporate both financial administrative data content along with the clinical data content into a single standard. This combined standard can take advantage of the same routing that the health care industry is establishing as it goes through the current implementation of the other administrative transactions.

As a result of X12 and HL7's attachment special group coordination X12 has developed several attachments supporting health care claim attachments including the 275, additional information to support a health care claim or encounter. In the X12 world we have an implementation guide for it which has reference of 004050X151 so it's based upon what we refer to as our 4050 version release of the standard with a guide ID of 151, which can be used as either unsolicited attachment to the 837 health care claims submission, which Kepa referred to as the early front end submission of attachments unsolicited with the claim, as well as the response to the 277 health care claim request for additional information, again based upon version 4050 with a guide ID of 150. Both of these transactions had their respected implemented guides approved for publication at the recent X12 trimester meeting this past February and will be publicly available the second quarter of 2004, so even though it is approved for publication it's still not publicly available today but will be soon.

Within the 275 transaction is a binary segment as Kepa had referred to, which will contain the HL7 CDA document representing the clinical data needed for health care claim adjudication. The HL7 CDA document can be structured, codified, or it can be unstructured, imaged, and it may be a complete document or a portion of a document. Originally HL7 developed six attachments based upon their version 2.4, which has a similar syntactical structure as the X12 standards. In 1998 the 277 transaction requesting attachments was pilot tested in coordination with HCFA, then HCFA, which did involve both payers and providers. The pilot however did not include the 275 HL7 version 2.4. Another pilot test was conducted in 2000 by Empire Blue Cross and Blue Shield and HGSA administrators along with CMS which did provide limited proof of concept of these transactions, and I'd also like to refer you to your December testimony as well where you did receive comments relative to the year 2000 pilot.

Given the capabilities of the health care industry and varied success, the length of time since the pilot, and the emergency of internet technologies HL7 has evolved its standards to the clinical document architecture which is based upon extensible markup language XML. HL7 has already provided testimony to this committee on their CDA approach on December 10th, 2003. X12 is also looking to use a similar process for moving clinical data content to support the 278 transaction for pretreatment authorizations and referrals, and that's in its initial stages and evaluation.

In April 2003 X12 and HL7 jointly sent a letter to the Secretary of Health and Human Services expressing concern over the length of time that has elapsed since the original recommendations for attachments based upon HL7 version 2.4 and the need to provide HL7 enough time to complete the CDA and pilot test the 277, the 275 with CDA, CDA, prior to the issuance of the NPRM for these transactions to ensure completeness, accuracy, and business proof of concept. To date the CDA development has been completed however the industry still needs to conduct pilot testing to verify the industry business needs will be met through the usage of the CDA and the flexibility it affords the health care industry for both structured and unstructured content for the health care claim attachments. This pilot testing must be completed prior to the issuance of the health care claim attachments NPRM.

Some recommendations, obviously we need pilot testing, we've learned that from our experience with the other transactions that are mandated under HIPAA. X12, HL7, CMS, again have gained valuable insights relative to these transactions as part of the first two pilot tests. The need for pilot testing was emphasized again recently at the WEDI hearing on implementation of transactions and code sets January 27th down in Tampa. They stated that if testing early business and data content uses can be addressed prior to the actual mandate under HIPAA. X12 supports the need for pilot testing the attachment transactions however this requires broad volunteer participation from representatives of the health care industry user community including the payers at varying levels including commercial, governmental, governmental can be broken down all the way from the federal government all the way down to state and county governments, ERISA(?) health plans, including the representative organizations and TPAs, TPOs, ASOs, and the rest of the alphabet soup in the ERISA world. HMOs, PPOs need to be able to participate in this project.

Health care providers, and again from varying levels, hospitals, clinics of different sizes, individual physicians and practices, clearinghouses, value added network software vendors for both payers and providers. In addition these pilot tests will require time, funding, to be successful. We and AFECHT are in the early stages to facilitate pilot testing and X12 workgroup members have participated in these early discussions.

Transition from the X12 837, as we mentioned the 837 currently does support some of the attachments even today currently mandated under HIPAA. X12 and HL7 need to develop a joint recommendation for the transition process and timeline to move the data content from the health care claim that will be contained within the attachments. In 1999 across workgroup team within X12 identified specific data elements that need to be migrated from the 837 health care claim to an attachment standard. Discussions are underway between X12 and HL7 on how we should move forward with the decisions from 1999 ensuring a current day plan is defined and agreed to and the appropriate communications and education is made available to the health care industry relative to these decisions and plans.

Usage of health care claim attachments, we also recommend that the NCVHS work with the Office of HIPAA Standards and the health care industry representatives to ensure the attachments provide policy guidance to the health care industry on the appropriate usage of health care claim attachments. This includes but not limited to appropriate business situations where attachments should or should not be required, frequency of usage, and amount of clinical data required to satisfy health care adjudication.

Education, X12 and HL7 is currently developed an education program for our June 2004 X12 trimester meeting in Chicago, which will cover business process and usage of the health care claim attachment, including the 277, the 275, and the CDA documents, and perhaps time permitting the prospective work flow and best practices. This education program will be evaluated and presented in subsequent X12 trimester meetings depending upon industry needs. X12 believes that such education is crucial to the industry's success of implementation of claims attachment standards.

Electronic claims attachments and specifically the combination of X12 and HL7 standards are new to the health care industry, as such awe believe there needs to be a concerted effort to educate the health care industry on the issue as quickly as possible. At this stage only education will provide an adequate preparation for the publication of the claim attachment NPRM and ensuring implementation of the proposed standards. X12 will support such education efforts where possible. X12 welcomes the information sharing during this hearing as well as ongoing input to make the best EDI standards we can for the health care industry.

Thank you.

DR. COHN: Thank you very much, and I presume we'll be getting a paper copy of your testimony. And actually Kepa I presume we'll get a copy of your overheads --

DR. ZUBELDIA: yes.

DR. COHN: Okay, great. Well, questions from the subcommittee, I guess maybe I'll start out with just a question and I'm sort of listening to all of you and am once again reminded of the complexity of successful implementation of almost any of the standards and I think in many ways we need to congratulate ourselves on how far we've gotten with the transaction and code set standards at this point, but obviously we're learning more. Now I think I'm hearing as I listen to everyone, I think I've heard sort of the need for pilots and I think everybody is sort of nodding their heads, I want to make sure I did hear that right. As we look at models for this going forward I find myself sort of looking at the recent Medicare Modernization Act and the description of how they framed sort of the comments around pilot testing, in this case for e-prescribing as an idea of coming up with provisional standards, piloting, and then having the results of those pilots feed into a final standard. Is that the model that you're all thinking about or is it a different model for pilot testing? Kepa?

DR. ZUBELDIA: It's important that the result of the pilot be fed back to the government before there is a final rule. I'm a little bit concerned about the flexibility of the government process to do that. Ideally what I would like to see is have some sort of NPRM or Notice of Intent that triggers some pilots and that then can be fed as, perhaps a Notice of Intent that triggers some pilots that that can be fed as an NPRM so there can be feedback once the industry knows what is it that the government is going to propose because if you start with an NPRM and then the pilot there is no way for the industry to feed back into the government the recommendations or the intention of the government after the pilot.

Let me explain this. When we went through the NPRM and final rule for the HIPAA transactions as a result of the NPRM there were a number of comments that were adopted by new implementation guides and part of those was the expression of the type of service code. When the final rule came out a lot of people were surprised by the type of service code had been suppressed and if there had been something from the government saying this is what is going to come out there would have been less of a shock. I guess a lot of people did not watch the implementation guides and the standards setting process close enough to know what was going to happen and they only look at what the government says in the Federal Register. So if there is an NPRM and then a pilot and the result of the pilot is fed back into the final rule they don't get the time or the opportunity to comment until the final rule hits and it's too late. And perhaps there would be, another cycle may be helpful to have that feedback and say this is the intent, let's get the pilot started, then the feedback of the pilot will appear as an NPRM and people will have the opportunity comment on the NPRM before the final rule. I know it's a lengthy process but it may give a lot more opportunity for feedback and less people would feel disenfranchised.

MR. BECHTEL: I would agree with what Kepa just said, I think though from my own way of thinking, I was not anticipating creating a step before the NPRM, I was looking more for a step between the NPRM and the final rule to occur, accomplishes the same thing. But I think Kepa's absolutely right in what he says, we need to be sure that what we put into the process from a trial is actually what we expected to get out. So I think that's important.

DR. COHN: Gary, and then Jeff has a question.

MR. BEATTY: I guess two things. I came up through the e-business world from outside the health care industry many, many years ago and when I first got involved with doing business electronically it was through the strong armed tactics, do it or else, or it just simply made good business sense in the early days working with companies like Sears and Wal-Mart, some of those folks. As I got into the health care industry I learned this industry doesn't do anything unless it absolutely positively has to, doesn't matter how much good business sense it makes.

I think a Notice of Intent is good but I think if we, without some muscle behind it people just simply won't do it within this industry. I think things that will encourage the pilot to happen will again be we need education, we need volunteerism, we need to some extent funding to make this happen because it is going to take a concentrated effort to do a pilot and people won't do the pilot unless they have to, or unless there's significant motivation and as we heard from Kepa, I mean attachments are kind of the ugly duckling of the industry, it's sort of the thing we have to do.

But we have to get through this, I think we need to get through this before or during, as closely to the time of the comment period as we possibly can so that the industry can make informed comments through the proposed rule process before we get to a final rule, because otherwise we're going to get a point where we're mandating some of the industry and they don't know what they're being mandated to do and that's going to cause a lot of frustrations and we need to limit, those are the problems that we're running into now, that the industry did not pay attention as much as they should have during the initial development of the phase one parts of HIPAA and now they're running into the wall of we should have paid attention earlier. And we need to make sure we do that the right way this time.

DR. COHN: Okay, Jeff?

MR. BLAIR: First of all let me just indicate that I found the testimony this morning very helpful to me, it really clarified a lot of issues, and it does appear as if both Kepa and Don are agreeing on advice to the subcommittee in that we would wind up posing a Notice of Intent followed by pilot tests followed by the NPRM --

DR. COHN: I don't know that I heard, I think we need to stay away from, I think what we heard from them is they want to an opportunity to have evidence of government direction, pilots, input from those pilots, and a final rule, is that --

DR. ZUBELDIA: Let me clarify, what I think needs to happen is the input from the pilot, the feedback from the pilot needs to be fed into a process that provides the opportunity for public review and comment before a final rule. I don't know if Notice of Intent is the process, two NPRMs is the process, I don't know what the process is but there has to be opportunity for public feedback and comment on the proposed rule from the government after the pilot.

MR. BLAIR: This was sort of a set up for my question in a sense that sometimes I hear folks say we need a demonstration, and then I hear people say we need demonstration projects plural, and it appears to me, and maybe you could give me some guidance on this, that it doesn't sound like one demonstration project would be appropriate even for the six different claim attachments that were being looked at by X12 and HL7 even some years back, including ambulance, durable medical equipment, home health. Could you give us some guidance, not only on which particular claim attachments would be appropriate for the first set of demonstration projects but also the stakeholders and players that need to be part of that? Because it sounds like we're looking at a series of parallel demonstration projects.

MR. BEATTY: I would agree and when you see the handwritten testimony that I have, I mean we broke it down into various type of organizations that are going to be exchanging the information and it won't be one big type of project, we need to be able to gain experience from varying levels and varying parties within the industry. Certainly the dental industry will have its own unique requirements, the institutional venues, hospitals, inpatient/outpatient types of situations, hospice, home health care and so forth, home oxygen therapies, it needs to be a concerted effort of many efforts to test the various business scenarios within the industry. Because when you look at the current transaction we have now, I mean some of the transactions are having limited amount of success because some segments of the industry did not participate in the process, behavioral health care, to some extent the anesthesia parts of the industry and some other verticals within industry did not participate in the early development and review process and are stuck now. We want to make sure that we can get as broad of input as these pilots go forward so that when it does come time to have a final rule everybody is represented at the table.

DR. COHN: Let me ask a question and then Michael and Stan. This has to do with the business case for all of this and I think it had something to do with pilots and sort of general industry adoption. Now I'm actually reminded of actually one of, a couple of years ago one of our now members of the subcommittee testified before us, and you probably have to recuse yourself from any knowledge of this, but he at that point sort of indicated well, they were already pretty much doing the basic HIPAA style transactions, obviously in the old format, but they were doing most of them, and that they saw the real value of the whole thing to be around claims attachments, that there was really going to be industry savings and all of this.

Now I guess my question is is as you've all talked about the complexity and the issues and all of this I'm left sort of wondering, I mean is there a strong business case that if people are given sort of the benefit of some federal direction of we're going to go, likely going to go this way, that there would likely be spontaneous people beginning to implement and driving business value in advance of a mandate on this one? Or is there some other, is there something I'm missing here, and Gary it sounds like you wanted to comment.

MR. BEATTY: Are you asking is there a value proposition to doing attachments?

DR. COHN: Yes.

MR. BEATTY: And I would suggest there is, it gets to the whole revenue cycle, we live with attachments and it's part of why I had the one statement that we have to evaluate when do we really require attachments. When I was on the payer side the payer I was involved with required attachments all the time whether they used them or not, and it was kind of one of those situations I think Kepa had alluded to. And as we evaluated that process very quickly we learned, once I started getting involved with it that you really didn't need them all the time. But we have to look at the requirements to figure out what are the values and when you look at revenue cycles and so forth, because I also have experience from the provider side implementing a lot of these transactions, a lot of providers measure everything by how long revenue is outstanding or days revenue outstanding, however you'd like to refer to it. When I look at the attachments process today when a payer has a nice letter writing system, they create a letter, they send it to the provider, provider goes out, does the research, collects the information, sends the attachments usually on paper back to the payer and they start processing it, that process delays the remittance by usually an average of about four to six weeks is what usually I'm finding. And what we're trying to do is reduce that and eliminate much of that four to six week delay timeframe. At the same time we're trying to standardize the information that we're exchanging, which is also going to provide some benefit.

In the past when payers would ask for information generally providers would send sometimes the entire medical record even though the payer was only really looking for one isolated piece of information, instead they get a stack of paper two inches thick. And this afford us the opportunity to ask very specific focused questions from a payer to provider on what exactly are they looking for to be able to move the process forward. So there's a lot of value propositions to that. But at the same time as Don and as Kepa pointed out there's a lot of complexities to make that all work together.

MR. BECHTEL: I guess I'd like to also add to this a little bit, I would agree with what Gary just shared with you. I think the other element of is it required is there are a lot of state requirements today to provide certain information that can only be obtained through an attachment, so I think there is current need to be able to do attachments aside from just payers saying they want it. There is also infrastructure issues, which I described to you and I think the infrastructure being built is a positive thing, it's just going to take time and it's complicated but it's positive in many ways as it will improve other functions that we're trying to do in our information systems in the clinical side as well as exchanging data between health plans and entities that are looking to understand outcomes and other kinds of things of this sort.

Clearly having those capabilities will be a benefit, and maybe not just from the claim attachment perspective but maybe from broader perspectives as well. And there's also when you look at managed care the claim attachment is not just associated to the claim, it's also associated to the authorizations and referrals, and in that environment where we see a growth of need to know why certain things are being prescribed or ordered, therapies, etc., with some medical being provided through an attachment, so I think even if we took away the claim we'd still see a growing need on the managed care side telling us that we would need to do this.

DR. ZUBELDIA: There's different ROI to the different components of this puzzle. The standard request for additional information sent electronically has a very high ROI, instead of the provider getting a letter in the mail which takes time that is hard to interpret the provider will be getting a standardized code that says this is what I want and would get it electronically, which is immediately, very high ROI. The ability to send the attachment electronically, whatever the attachment is, the ability to send it electronically rather then paper as ROI for both ends, for payer and provider, because the payer doesn't have to handle the paper and can get it right away.

Now the ability to codify the attachment as a particular RU message inside a 275, I would say that has a more long term ROI and perhaps in the long term very high ROI because it allows for the whole process to be automated, it is not a short term ROI, so I don't think you can look at the whole attachment puzzle and try to identify the ROI for the whole puzzle because it depends on how you look at the different pieces. For instance the dental industry is using very effectively very simple mechanism that I think you're going to hear about today of sending x-rays and images electronically, very simple, it doesn't have all of these information that we have in the attachment proposed with a 275, and I don't think it would work for all attachments but for some attachments that very high ROI is causing the dental industry to use it today. So you need to look at the different pieces, different components.

Let me also comment on the pilot project. There's a risk with the pilot project, the pilot projects need to be very focused on what is it that they're going to do, the risk is that if the pilot projects start exploring things just for the sake of exploring them they may diffuse their value and they need to be focused on what is it they're looking for. There is all kinds of things that could be done and as an industry we need to know what needs to be done and how, and there's an opportunity there to just do pilots on the umbrella of attachments to do pilots on EKI(?), pilots on security, pilots on sending x-rays, pilots on this and that and at the end perhaps not have a good conclusion.

So it's important to do the pilots, get different parties involved, large payers, small payers, direct submitters, clearinghouse submitters, with a vendor, with more then one vendor, with small provider, with large provider, different specialties, but they need to be focused on the task at hand and that's going to be a challenge.

DR. COHN: Mike and then Stan.

DR. FITZMAURICE: In response to Jeff's question Gary raised the idea of different scenarios and that certainly I think that NCVHS can supply a forum for determining, or for getting suggestions for individual scenarios and communicate that to the Secretary. But in mentioning pilots I wonder, you want to develop standards, you want to make them work in a laboratory, then put them out into pilot testing, I suppose you want industry input to different scenarios tested in a pilot, who funds the pilot, should this be an entirely government funded pilot, should it be a cooperative venture with the industry for somebody volunteers and says I'll do it in my health plan for these claims, let's give it a try, how would that work, what would you recommend that it work?

MR. BECHTEL: My feeling on this subject is it's a combination of all those things. I think the vendors will want to participate because these are products they're going to have to build and roll out, they're going to want the opportunity to do it right. I think there are some forward thinking organizations that would want to be involved in that.

I think the same would be true of payers, there are some who won't have the resources to do it but there are others who will and I'm sure you will be able to find payers that want to participate, in fact there are payers who have participated in prior beta runs. So I think from those organizations they may do this because it's the right thing to do.

From the provider perspective I think you're going to have more issues because the resources aren't available for this kind of work and they are going to need funding to be able to pay for it. So I think there is going to be a need for some funding for some segments of the industry to participate in a pilot.

MR. BEATTY: I would agree, and it's not restricted just to the provider side, I think there's also certain segments of the payer side that also need, will need some funding to make it really work, especially you start getting smaller risk based worlds where you have small TPAs, TPOs and so forth that really don't have the funding to be able to do a pilot project as well.

DR. ZUBELDIA: The government normally doesn't give money away that easy. I think that a realistic approach to the funding could be, if I want to explore being realistic myself, it's difficult, but it could be perhaps allowing or funding some Medicare contractors or Medicaid contractors to participate in the pilot, perhaps reimbursing some of the small physicians that send electronic attachments and passing at least during the pilot project some of the savings along to those physicians that send the attachments, because there are substantial savings for the payer when the payer gets an electronic attachment rather then paper. So perhaps that's a mechanism of semi direct funding or indirect funding or whatever you want that can get to the small physicians that participate in the pilot, and if then Medicare/Medicaid contractors, if two or three in the country participate in the pilot because in the end Medicare and Medicaid are the largest payers in the country they can essentially pull the rest of the industry behind them.

DR. FITZMAURICE: I think one of the lessons that we're learning a little bit from what Kepa said is that many times in the health care system somebody does something that improves the working of the system but doesn't get paid for it, and so Kepa suggested that if the health plan is a major beneficiary of something is there a mechanism that a pilot under the Medicare program or the Medicaid program could do to maybe estimate the savings and pass some of the savings back to those who do attachment in some fashion. I gather that was your suggestion

DR. ZUBELDIA: And I think there is some precedent to that, some of the quality improvement organizations in a different state have demonstration project where hospitals that improve the quality through perhaps electronic medical records, perhaps some quality measures, get additional funding or reimbursement from Medicare. So this could be part of the same kind of project.

DR. COHN: Stan?

DR. HUFF: Again, I would like to thank the presenters for a nice, I think bringing to the forefront the important issues that are surrounding this. A couple of thoughts that came to mind, some of these are just comments and maybe you could reflect on them. A lot of the issues that I think you brought up Don reflect the complexity of doing business regardless of whether you're doing it electronically or not, that is the separation of the billing department from the clinical systems, I mean even if you think of this as a manual system somebody in the billing office has to walk over and find the medical chart or ask a physician or a nurse about this information and so part of it is just a complexity of how we have silos within institutions relative to these things.

But the other thing that came to mind is it seems to me that we want to if we can allow a spectrum of automation that could slowly build, that is at the one end sort of building from what Kepa said, everything is paper and so at one end somebody sends a paper request and somebody does a bunch of manual work and they send a paper response, and then you could build to a situation where your electronically at least making the request and maybe in the middle ground you've got an electronic request and you end up with an image that's sent electronically and then ultimately you have this end to end where you send it electronically this system can ask another system in an automated way for that information, bundle it up and you fully automate it.

But it seems like to the extent that we can we ought to try and support sort of increasing sophistication through the pilots and then through implementation so that in fact the flexibility for instance that's offered by the CDA to either contain an image or to contain structured data is actually an important characteristic because it allows that kind of phasing along with it.

MR. BEATTY: Just like with other transactions, the staging is extremely important and I think the model you presented is a very viable model, but at the same time having the mandates but also having the volunteer implementation of the others as you progress forward. So if somebody does have the ability to move forward with CDA in a codified fashion they can do it even though it hasn't been yet mandated upon the industry. So we can have early adopters if you will of the requirements.

DR. ZUBELDIA: The risk of that is that people may stop after the first step and say I've done it, I'm sending scanned images of my medical records back, I don't need to do anymore. And most of the ROI, long term ROI is in the automated process with real codified attachments that can be automated, that's the long term ROI. And sometimes, we've learned from the PCS implementation that people are very concerned about compliance and they'll do whatever it takes to be compliant without really benefiting from the real ROI, so there has to be a clear indication in this area.

DR. HUFF: I would see that danger and I guess the oppose danger is then instead of making a stairway you make a high jump that nobody can get over the bar.

MR. BECHTEL: I would agree, I think we could build a plan that takes us in steps to where we're trying to get to that would take into account the kinds of things you described, and would have some mandate to get to the end point so that we don't have the issue that Kepa's describing, because I agree, that could happen if we don't force an end point.

MR. BEATTY: In some ways CMS is doing that stepping point now and we've gotten the contingency plans, we now have incentive to move forward by setting the dates for adjudication of payment, so in some ways we're stepping transactions forward in a similar fashion.

DR. HUFF: One last quick comment.

DR. COHN: And then I have one final question and then we will take a break.

DR. HUFF: I just wanted to challenge a little bit the, I can't get the image out of my mind of the shotgun marriage, and I guess my characterization would have been that actually it was a marriage that was built on strengths of two, that is X12 has an established pipeline between the business partners that have the most interest in this and HL7 really has the knowledge and appropriate formatting for clinical data and is the most used clinical format. And so I actually saw it as a thoughtful careful union of two strengths rather then a forced political solution, but that's just a comment.

DR. COHN: You have to recuse yourself from that whole comment since you're with HL7.

MR. BEATTY: That's right, I have to retract --

DR. COHN: Now I have a final question and I want to give everybody at least a ten minute break, but I think we've been talking about around it but I just wanted to get you on record. Obviously there was a proposal made in December related to the HL7 X12 claims attachment and obviously it's not, I don't think it's fully formed, I think we've all been talking about it needs to be piloted and all of this stuff. But are you all generally comfortable with that approach, I mean we've talked about the idea of flexibility, low technology, high technology, all things that this seems to have, but fundamentally are you supportive of that approach and that particular standard at this point? And Gary I think I heard you in your testimony saying yes since you co-developed it, is that right?

MR. BEATTY: Right.

DR. COHN: Don, representing AFECHT?

MR. BECHTEL: Yes, I believe we support that as well.

DR. COHN: Kepa?

DR. ZUBELDIA: Sure.

DR. COHN: I wanted to ask.

DR. ZUBELDIA: I see some benefits and some problems with it, I'll explain what I see. The scanned image which is probably going to be the first step in deployment of the attachments, the thing that a lot of people are willing to implement first. The scanned image included inside an XML structured, included an X12 bin segment, it's a triple layering of a document that is potentially problematic to manipulate today with the existing tools. There are some, most of the translators around that can translate X12 can also translate HL7 and can also translate XML, but not necessary when they're imbedded inside each other. So the fact that a translator can process XML, HL7, and X12 doesn't necessarily mean that that same translator can process HL7 inside an X12 bin segment and an image inside the HL7 message. So that's something that needs to be explored so that's my hesitancy. Other then that I think it's an excellent approach because it gets the structures in place for the migration to the end goal, so once people understand the structures the migration to the end goal, which is the completely automated codified attachment, will be much easier. So if we can resolve the technical issue of the nested syntax I think it's an excellent approach.

MR. BECHTEL: I would also just add one additional thought to that. Kepa mentioned scanned documents as sort of the starting point and that is a logical place to begin, but I think we also want to consider the EHR and the impact that that will have to allow us to really do the segmented discreet data elements that we're looking for ultimately. And when we get to EHR I think we can do attachments better and it may be part of the stepping process as we do the things we can easily and then we get EHR in place and then we go and do the things that are maybe more complicated.

DR. COHN: Well, great. Thank you all, it's been a great beginning panel on this discussion today. We'll take a ten minute break and come back at 11:25.

[Brief break.]

DR. COHN: Okay, we have two presenters for this which is further discussion industry perspectives on claims attachments. I want to thank David Schinderle for joining us as well as Michael Icenhower, okay, Mitch, apologies. David, I think you you're to start off the testimony please.

Agenda Item: Industry Perspective on Claims Attachment- Mr. Schinderle

MR. SCHINDERLE: Thank you, Mr. Chairman. I'd like to thank you for the opportunity to be here today and to explain what started out originally as an advocacy effort in Southern California, it has now led into a business enterprise owned and operated by the Hospital Association of Southern California in concert with its technology partner, Health Logic Systems Corporation in Atlanta, Georgia.

One of the things that I'd like to give you a little background on myself as well, I come out of the provider community over 30 some years, the last 18 or so I was the vice president of finance and treasurer of the St. Joseph Health System, about a 4,400 bed 14 hospital system headquartered in Southern California. And at that facility I was responsible for revenue cycle which included managed care during much of my tenure there, as well as responsibility for accounts receivable and cash flow. And as such I participated actively in the X12 process since 1989 and used to co-chair the 835 workgroup for remittance advices and I'm now actively working on the attachment standard workgroup as well. So I also sit on the Electronic Health Care Network Accreditation Commission so I'm very familiar with the clearinghouse side of the business from an accreditation perspective, so I appreciate again the opportunity to be here and to share with you some of our experiences in a working environment.

Four years ago we came together as a hospital association with some of our largest payers in Southern California to begin to address back office issues. We had a lot of outstanding issues and when we got folks in a room and we started prioritizing all the places that we could potentially put our energies the number one issue that sort of came out of those discussions was the need to address claims attachments. At that time we were four years ago thinking that we were going to have an attachment NPRM come out within a few months and so this was fairly high on folks' radar screen at the time and right about, actually within a couple months of our committee being formed to work on this the HCFA at that time had issued a white paper actually outlining what their approach and goals were to the approach of electronic attachments. So we were pretty well focused with a footprint of what we were expecting both from an X12 standard perspective as well as the outline that had been provided to us by the Health Care Financing Administration, now CMS, to focus on this particular issue.

And we ran into as we began our research all of the problems and then some that you have heard today from the other speakers, I won't elaborate on those but to say that there are many and they are an extremely costly proposition for the industry, both on the payer and provider side and I'll talk more about that here in a second.

Hospitals are currently spending between $20 and $30 dollars, one of our major medical centers in California just completed a study last summer where they discovered that they are spending on average $33 dollars per request to respond to attachments, and they have 35 million electronic records sitting in their electronic medical records system, so this is a very costly business proposition on the hospital side. And as Gary Beatty mentioned earlier the processing cycle time is 30 to 40 plus days as this moves through the cycle, it's a very disjointed process. Generally speaking the requests from the payers go to a lock box because the only address the payers can support in their system today generally is the address where they send the remittance money. And so it goes to the lock box and then the lock box vendor doesn't know what to do with it because it's not a check or remittance advice and so it gets lost and it gets routed, it becomes a difficult process as it goes through this cycle. The cost to the payers as we have worked with the payer group appears to exceed and is approaching $20 plus dollars per transaction for them, fully loaded cost. So it is costly on both sides of the equation and it takes up considerable amount of time.

The other thing that we found is that one of the major limitation on the payer's goal of 100 percent electronic submission of claims is claims attachments. In California we are stuck at around 60 percent electronic submission. That last 40 percent is very much tied up with the attachment problem and is one that the payers are very focused on trying to fix at least in our market because they are attempting to see if they can't get more claims to auto adjudicate, eliminate all the key punch costs of all these paper claims that are coming in with attachments.

Coordination of benefit claims is another major portion of that problem because the 837 COB transaction today is not working very well and it's very early in its adoption phase, we're probably a few years away before that becomes heavily utilized by the industry, and we just got some consolidation regulations that were published here in the last week or two indicating that the Medicare program is going to consolidate some of its coordination of benefit activities which is probably going to further delay adoption as people sort out these new regulations and how those guidelines are going to work.

Payers are also incurring significant interest and other costs that are not in the cost numbers I previously gave you. Because of all the delays that are going on here under prompt pay laws a significant portion of the problem is related to interest cost and also we have the problem of misdirected claims in California where we have heavy delegation to provider organizations who have taken managed care risk and our actually paying claims on behalf of the payers. And so providers have difficulty sorting out who should get the claim and because of what they call division of financial responsibility issues and that leads to further attachment problems and shotgunning of claims that adds up to delays and higher interest cost.

So our objectives as a community of users was to try to find a new way to do business. How could we expand this and create at least a starting place for a single way to do business that would work, lower the cost of doing business with fewer touches per claim, improve the business process, and finally deal with the IT platform that was in place today, which was primarily Microsoft based products on desktops so users both at the payers and at the providers and to not bring new software in that had to be installed or had to be integrated, that it was basically IT light, it had to be so simple the business manager in a medical group could implement this without IT support, that a business office in a hospital could implement this without IT support. Because if we had to involve the IT department this wasn't going to happen. And the health plans wanted it that simple as well because they had 500 other projects that were in front of this one. And so getting IT resources to pay attention to this was a mission that drove our goal, it just became very important to us.

So we developed what we call the Claims Attachment Document Exchange, that was primarily an ASP type web based service where the provider, I'm sorry, where the payer could request and then scan and upload those documents in response to that request. We found that many of the provider's documents were already in some electronic repository, like transcribed dictation, the statement of charges or itemization of charges, the ER face sheets for example, and these documents tend to be the core of a very high percentage of what people are asking for routinely. And that research that we did suggested that those documents if they could be uploaded easily like an email attachment would be very attractive to the providers and so we built it around that and we also built around the concept of scanning for those other documents that were generally handwritten, where were not available in electronic form so that those could be uploaded as well.

We supported thinking that it would work, at the time we decided to support the 837 claims transaction set relative to the attachment piece but as we've since learned that is not a fully, is not been fully adopted by many people in the communication chain from the provider all the way through to the health plans. In many cases the health plan is receiving the information but they have not updated their claims adjudication system such that their claims examiners can see that there isn't an attachment control number that's been sent to them so that they can go look for the attachment, whether it's been mailed into them, faxed in, or electronically transmitted.

The providers wanted fax capability because we had payers that couldn't support electronic but yet very much wanted to receive those attachments, and we found that many payers, their preferred way of receiving attachments today is fax, which is challenging at best. The payer reviews the submitted documents and then completes the adjudication process so that's basically what we did. We set up a simple attachment document request form which basically follows the 275 and 277 transaction sets as they're currently being composed in terms of data content. We set up a relatively simple check off list, at least we thought it was relatively simple at first. One of the things we discovered very early on was a nomenclature problem in that the definition of simple things like a complete chart, we have seven, eight people around the table and we have seven or eight different definitions of what is a complete chart and what hospitals were sending in in response to the payer's request. And so we have worked very diligently to try to define among our user community what is meant by all of these different document types that we have come up with that our frequently requested.

We also provided work lists then for the provider to receive those requests, to sort and filter them in order to respond to the business need, and then set up a way for them to go into a detailed request and have a scan or an upload capability to send the records back to the payers. When we first started this we thought the easiest way to do this is just send an entire document and put everything into one envelope and that doesn't work very well for the payers because we found that the payers would then print everything out in order to review it because it wasn't indexed for them, so we found out that it was very necessary to index the documents by document type so that they weren't looking at a 300 page medical record to try and find a history and physical, all they had to do was click on the history and physical or the discharge summary or the statement of charges and then go directly to that document.

We have built this to try to be HIPAA compatible for all known requirements that we know of today. We've been active as I mentioned earlier in the standards process and we're committed to supporting the HIPAA standard as it moves through the approval process. We currently are installed in two early adopter health plans, PacifiCare who's been installed the longest with us now across their entire product line. I guess we've been installed there 20 some months. Health Net came up last fall, Aetna is planning to implement a pilot with us in the spring for their California operations, and we are moving forward with the California Medicaid program with EDS to begin an operational pilot there. We also have been selected by the Utah Health Information Network to begin a process of rolling this out across their various provider types this summer of '04 and we are currently faxing attachments to a number of other payer partners.

We also did participate in a very limited pilot with the approval of the Kansas City Regional Office with Mutual of Omaha to explore at a nursing level could the nurses deal with images and could they reach the same clinical conclusion on a very small sample of records. And that study only involved about 20 patient records that had previously been adjudicated, the team at Mutual of Omaha sort of pre looked at those, then they had us, they requested the attachments through our system, we responded through the system, they re-reviewed them to see if they could reach the same results, and in fact they did and as we understand it it was fairly well received, but a very small study of the viability of that as a proof of concept. Additional Medicare pilots have been under discussion for some time with the CMS Office of Program Integrity, but that is moving very slowly. And we would obviously encourage pilots as folks had discussed earlier.

We do have 76 hospitals that are either live or committed to go live with us so far in California, we are planning to expand to other provider types like large medical groups, medical management companies, who are managing like emergency room physician claims and things like that as we tend to move out and across. And we are beginning to work in some other states and explore relationships with those hospital associations, try to get more experience and to better understand what's happening.

So what have been our results that we've seen out of this project so far? We've seen a decrease in the days in accounts receivable for the providers, that's been primarily driven by a substantial reduction in cycle time ranging from six to 18 days depending on how fast some of our providers have been responding to the cycle time process in general. Most requests that are made by a payer across our system are responded to within three or four days and some are processed on the day they're requested and are closed out by the health plan in the same day, so it's amazing to see those kinds of things occur. And we've seen at least at a theoretical level a cost reduction of about $21 dollars per transaction so far. I say theoretical because until you have a much larger number of payers participating you're not really going to realize those dollars, so in a limited number of payers you're not laying staff off and taking Social Security numbers off the payroll, so as a result of that today that's a theoretical opportunity of savings that we believe is achievable if we had broader participation across a larger number of payers.

What we've basically learned is that this is a lot less about technology and it's a lot more about standardized process and nomenclature. The technology that we built is all off the shelf, we went with cheap and inexpensive scanners, although some institutions have installed multi thousand dollar scanners, most people have under $500 dollars scanners in place, and some have under $100 dollar scanners in place. It is about developing trust, if a provider changes his process will they get paid timely and efficiently by the payer, it's all about the work flow and making sure that if they bet the farm and change their business process that the payer is going to support that change in business process and pay them in a timely and efficient manner.

The providers need simple clear guidelines on when and what type of attachments are needed. We've been working with our community of payers to do that and they have graciously come forward and are providing that kind of information and the additional guidelines that are sort of needed as to when they're going to need certain types of documents, what are those thresholds so that we avoid this process of providers trying to second guess when documents are going to be needed or getting the trust factor high enough that they're willing to wait after submitting an electronic claim for the payer to ask for those attachments, knowing that they'll be processed and turned around quickly.

LOINC codes seem to have little appeal out there right now, it's not how folks do their work today and it will require significant training and at some point it becomes a work force issue. The folks that do this type of work do not have the skill set necessarily to deal with the coding complexities if this is done manually. If it can be fully automated, and we support that long term, we believe that that's a good thing. But we have to move as many of the other folks have spoken to in baby steps and we're not sure that folks are ready for this yet. Payers and providers generally work at the document level related to attachments today, they're not dealing with the data elements within documents typically. Payers typically based off the information they see on a UB92 or HCFA 1500 do not have sufficient information to really drill down and ask data element type questions typically, unless it was a missing data element on the UB. They're typically looking for a document to determine a pattern of care, a preexisting condition, things that they need to have answered under the type of insurance contract that was sold to that beneficiary or member. And we do believe the clinical documentation architecture using XML is a step in the right direction, but it will still be very challenging for smaller providers and payers we think for many years.

Providers still prefer to submit attachments at the time of billing today if they know what's needed. They think it's just faster and more efficient and they're reluctant to separate that claim from those attachments because they're still fearful of reassociation problems. I mean one of our health plans that we've been working with for some time has 100 people in a dead letter office where they try to match this stuff up, this is not an insignificant problem, we have had situations that we've uncovered where the mailroom receives the attachments and they separate the claim from the attachments and they scan it, they index it, they do all those wonderful things, then somebody checks to see if anybody had asked for the attachments and if they said no they trashed it and through the file away. And then two weeks later when the claim finally got around to be examiner they discovered oh, we need the attachments, and then they request it. And then of course the provider is sitting there with a FedEx receipt signed for that they sent the attachments and can't understand where their attachments went. So you have these kind of provider and payer type stories that come out.

We had one very large institution in California we went into and we were working with them and just to give you another little horror story, but they made two copies of every request for attachments and they kept a bank of file cabinets in the business office and because 90 percent of the time the payer lost the first one, and of course when the second request came in they made another copy and then put it in the file cabinet. And once the claim was paid they would always wait six months after the claim was paid and then they would finally destroy and shred the document. Because it was cheaper then annoying the medical records department that many times asking for the attachments and incurring the copy service costs or the scanning service costs or whatever to go get their documents another time. So there's lots of industry stories out there that I won't bore the committee with but just to give you a couple of those example as a baseline.

The paperwork segment as I mentioned earlier, there's many communications problems, right now the biggest one being that the vendors who supply the adjudication software or the in-house teams that wrote that software and maintain it have not updated their software in many cases to allow for that information to be seen, so that's problematic at the moment. The 837 COB transaction set, again tends to be very problematic at the moment. We are optimistic that that problem will get solved but in the short term we think it may make some sense to look at some exceptions for moving that data possibly through the attachment transaction.

Providers and payers need simple tools that work with what they have today as we mentioned, and electronic medical record systems generally don't easily support electronic claims today. We have many situations where it works wonderfully in-house in the medical center but when you try to export one document from the medical record set, you can print it, yes, you can attach it, no, you can send the entire file but you frequently can't send just the one document and so there are workarounds and some of the vendors are now starting to move forward to modify their software to permit those kinds of things but in the past for security reasons in many cases the EMR vendors didn't permit those kinds of activities because they were afraid someone would go in and steal record and do things that way and so they put barriers to some of the things that we're trying to do today with the attachment standard and hopefully they'll address those in the near term.

So what's our recommendations based on our sort of experiences in California and other places? In order to achieve the fiscal goals of the transaction and code set we believe the attachment rule should be published soon. We need to get the industry on notice, get this process moving. We do believe that payers should provide clear guidelines on when and what attachments and why the documents are needed so that the providers have a better understanding of what they're doing and why they're doing it.

The proposed rule should support multiple approaches, we believe the changes recently at the HL7 level is a very good step in the right direction and we think the final rule should, and proposed rule should support those approaches.

LOINC codes should be used I think initially at the document level for claims attachments to support the claims adjudication and be broad enough to do that and allow for folks to phase in to the deeper adoption for greater clinical integration of systems as we develop that sophistication and as we get through enough pilots to be able to understand how all that plugs together. Because work flow and process flow as Don Bechtel indicated and Kepa indicated are not going to be easy and it's going to take a lot of effort to work all those things out.

We think the attachment rule should permit alternate submission modes for the coordination of benefit transaction in order to allow for more of this to move electronically and to address some of the concerns we're hearing from the payers in trying to get to their goal.

And finally we support and endorse the comments that the American Hospital Association has submitted previously to the subcommittee, we think they made some very good points in their letter to you and we would support those as well.

I think the committee and would welcome any comments you have at the appropriate time.

DR. COHN: Okay, David, thank you very much. And Mitch Icenhower, thank you also for joining us.

Agenda Item: Industry Perspective on Claims Attachment - Mr. Icenhower

MR. ICENHOWER: Mr. Chairman and members of the committee I'm pleased to have this opportunity to talk to you. I am the product line manager for Health Care Data Exchange, it's the EDI's subsidiary of Siemens Health Services. We've been very involved in the HIPAA efforts up to date, migration to the existing TCS transactions, and Siemens provides the revenue cycle solution for approximately 1,000 of the acute or institutional customers that we have in the United States. That's roughly about 25 percent of the acute care facilities out there. So my comments today will reflect a little bit on what we think the background is here, what our status is, some of the issues that we see, a couple things that we think are positive trends that we can hit, and then just some specific recommendations.

As I said, represent about 25 percent of acute care provider market, really some of the slant that I'm going to talk about today is really about those acute or institutional customers. Some of the solutions that are, David, you got some great stuff that's going on, will work at certain levels better then others. One of the biggest challenges that we see is that the institutional customers have an internal challenge of corralling their information and using that correctly, and a lot of the comments and suggestions that we'll make will kind of try to reflect that that's some of the complications that we're going to face.

As far as where we are in the scope of claims attachments, we've worked with all the TCS transaction, that really wasn't that big of a stretch for us, like a lot of vendors we've been doing electronic filings and claims type transactions since 1980. It seems to funny to say that now but compared to the effort that we're going to have with the claims attachments, the other HIPAA transactions are actually the low hanging fruit and I know that Stanley will laugh when I say that because we haven't actually really implemented of his industry yet, but the ROI, the focus on the administrative simplification, that was sweet spot stuff that we really did know what we wanted to do it was just a question of how we were going to implement it. With claims attachments we think we have more of a situation where there's still a lot of debate as to the what and as to the how and we think that it's going to really require industry collaboration such as these kind of forums and a collaborative plan to really be successful.

As far as where Siemens is and its status with claims attachments, we have been heavily involved in the analysis pieces, working with different SDOs, HL7, and have gotten to that point, but like a lot of other software vendors the actual development work isn't going to happen until an NPRM is published. We obviously have laid some of the groundwork, we've started incorporating things like the LOINC codes into our common vocabulary engine, but we really need to have that opportunity to get the feedback, get the final rule before we would start having development in one area or another and it's really because our lessons learned from the previous HIPAA implementation, it really gets down to you can actually destroy the momentum for our customers if we take them in the wrong direction. That's why I think the suggestions that I've heard today about this trial period, a pilot period with feedback that has input to the NPRM, really it could take more time to do but in the long run it's going to increase the quality and the communication of the expectation of what that final rule is with the providers.

We've talked a lot about how health care, and especially the providers, will not do something until they have to do it, well part of that is that there was a lot of conversation and noise before the final rule got in place, and they screamed that out until they know what they really have to work on. And a process that's iterative, that takes a pilot and gives that feedback and really winnows it down so that we have a shorter gap between that NPRM and the rule and what we really want to implement is going to get their attention a lot more. And the credibility of having that feedback is going to make a big difference to the adoption rate.

Industry organizations such as WEDI, AFECHT, the AMA, all the organizations that are represented here today can work with the vendors in a more effective way then we did on the first round of the HIPAA implementation to help spread that message of credibility and how we're doing, get the feedback and to reach out to the provider. I think more collaboration between those organizations to get that provider education piece is going to be critical.

As far as our participation in a test pilot, Siemens would be happy to participate in an initiative like that, I'm sure that other major vendors would express the same type interest. We have to represent the industry in the plans and the pilots we do here and it's a challenge as we said, even the six types of attachments we've identified really does bring a variety of scenarios that we could be doing, so the pilot as you said could be multiple pilots at multiple sites, but again, a structured test system that we get the results back on a structured pilot and bring that into the NPRM, it's going to just cover so many scenarios where we got caught up after the final rule this last time.

As far as the challenges that we see, really one of the ones that's going to effect institutional customers the most and I'll probably expand a little more then my previous presenters is the data collection, storage, and access. In a typical acute care provider today the billing system, the clinical system, the departmental systems, are all separate, they don't contain information, there's usually a patient type index that pulls these things in an index way so that you can pull the information together. But as far as when that request comes in from a payer to get those things, it's not only a question of it might be different data and it might be different formats, but it's going to be different systems, different vendors, and different access control. The billing people are not going to have the access control that they need to get to to get to all these different systems. And while some of the things that we've looked at like quartile solutions do a great job of dealing with the request and response workflow, and the UI and presentation of those things, there's still a problem we need to address which is that provider, how they turn around and how they handle the data internally, and that really puts vendors like Siemens right in the middle of that solution because we're the ones who can help them pull this together. We think that the way to pull it together is in sync with the industry and in complement with the movement towards an electronic health record.

The other key areas for problems, standards deployment, of course we're big supports of HL7 and been involved in HL7 for some time, and again we're particularly supportive of the recent initiative that support the vocabulary and definitions that are going to be used in electronic health record. But some of the other things that have happened like LOINC, we think LOINC has great value. As you said it's not a great adoption rate and the vendors have not done a great job or just haven't fully supported the LOINC codes yet. Again, we have them loaded in our common vocabulary engine, we're ready to go, but we don't have widespread implementation of them in our customers. Using it in a manual UI type approach, it's cumbersome and there's an education issue. But if you're going to try to automate some of this to go out to an electronic health record and to be able to get to this data, the LOINC codes are key and they do provide the mechanism to be able to do that mapping and be able to have those requests relate to the individual systems that are out there. So I agree that LOINC as implemented for the manual interface can be burden, I think that where it really gets its value is when we go to those automated solutions and we're tapping into an electronic health record instead of a million disparate systems in each provider.

There has been, just a quick moment on the clinical document architecture, again, we think that is a worthwhile initiative but in the U.S. implementation just the adoption isn't there yet. We think it's got great potential, we'd like to see it addressed as part of the pilot transition in the pilot periods that we do, but at this point we're not seeing the widespread adoption and we think that it's critical that we pull it into the pilot process if it's going to be successful.

Finally, just a quick comment that there have been a lot of suggestions that ICD-10 would eliminate the need for some of the stuff that we're talking about here because their ability to define down to a greater and more granular level, haven't heard much of those comments here today, I think that's because the people here understand that ICD-10 can help to be a filter to reduce the amount of claims attachments requests that you see by giving that more granular definition, but it's not going to eliminate the need to do it. And I think it's just one of those clarification things, there's some folks who feel strongly the other way but we feel it's just, adoption of ICD-10 gives us better opportunity to reduce the amount of requests that go but we're still going to have requests, it's still going to be the ugly duckling that we're going to have to deal with.

The last challenge we see is really that workflow that Mr. Bechtel and Kepa have referred to. There really is a workflow issue that vendors like ourselves can help resolve and it really is those two major workflows that you talked about. One is the proactive, they're sending it out with it every time because that's what their experience tells them to do, and the other one is the ad hoc request that comes back from the payer for those things. That's where we really see the opportunity that if an EHR was in place that really, you look at those workflows and you define them, today they're very difficult to automate because of where we are but if we have a transaction standard, if we have the LOINC codes, if we have those pieces, and an EHR where we can pull that data together instead of having it be in disparate systems, that is really where the automation opportunity is and that's where we can really tackle the workflow problem.

We feel pretty strongly that the initiatives that are going on right now with the electronic health record, AHIMA's recommendation to have something implemented by 2010 for the provider base, those things have a lot of value. I know we need to do interim steps and we need to do things that will provide interim value and the test pilots, the rules, all those things. But alignment with the EHR initiatives really gives the providers more incentive to get into an adoption mode, gives their organizations more incentive to fund these things, and helps us bring all things forces, whether it's HIMSS, AMA, the MPMA, all these organizations together in a common goal. So I think that when you look at the long term range goals of what we're trying to do alignment of that E HR initiative and the claims attachment initiative is really where you're going to deliver a true ROI savings and a true workflow savings to the providers. And when they see that vision they will be more likely to adopt the claims attachment steps that they need to do.

The final thing that we think could be helpful is a national implementation plan. It goes under what Kepa said, lessons learned from HIPAA. In HIPAA we did a lot of things right, we did a lot of things that we could learn from, I think one of the things that was right but we could still learn from is a Strategic National Implementation Process, SNIP, we probably got into that game too late and because of the tight timeframes for implementation did not have the opportunity to effect provider implementation the way we have. We know big bang is not a good way to go at it after the first time around, we know that universal feedback coming back through organizations like WEDI and AFECHT is that a staged implementation, and one that is not dictated by the government but really helped developed by the industry itself, is what's going to be successful in walking us through to get to that end goal. And that end goal still can be that EHR claims attachment alignment but the important thing is to involve the industry in developing a stage plan that we can work through together.

I'd just like to end with a couple of specific recommendations that we had talked about and I think they'll flow right into the general tone of what we're talking about today. We definitely recommend a required trial implementation and the opportunity to get that feedback before the final rule is developed. Absolutely have, look at the in time of the final rule implementation and have a realistic implementation of what the industry is going to take to implement it.

We need to permit adequate time for each market segment to adopt it and I think we've done an okay job with HIPAA, certain segments were able to react faster, sooner, better then others.

The deployment plan really should be developed amongst the industry players and maximized in the organizations that are involved and represented here today. The individual providers will not get the message unless those organizations not only bring their needs forward here but help us on the out push of the information back to them.

If I could summarize everything in a general philosophy of claims attachments and what we think is for a plan here be aggressive but also focus on being achievable, we want to have something that mandates their behavior but if we don't have the buy in in the creation of the timeframes we get to the point where we are. The last thing we want to do is have contingency plan after contingency plan, we want to get a realistic approach the first time, have a step wise improvement that may have interim phases, and ends up with us in the timeframes of having achieved both goals, a claims attachments process that saves the industry money and an electronic health record initiative that has decreased costs and increased quality in health care.

DR. COHN: Thank you both for some very interesting testimony. Are there questions from the subcommittee? Harry?

MR. REYNOLDS: I would also like to thank the excellent information. Talking about CADX for a minute again, you have a comment in here that it was built to meet on the HIPAA requirement. We have a continuing argument going on in the HIPAA world, which is direct data entry versus actual records and what's in the records, that they're the same. Can you help me understand if you in the CADX, you're actually capturing, entering and transmitting all the same data that would be in an attachment?

MR. SCHINDERLE: That's a good question. The way we're doing it today is we're trying to follow the data content, we have not incorporated fully like LOINC codes for example behind the scenes, or are we translating it in note to an X12 envelope today because we're doing predominantly HTML type based transactions. What we are finding is that some of our health plan partners are treating us as a clearinghouse, which we admittedly say we are, and that we as their business associate they are looking to us to basically put these documents into their format such that it's ready to go into their document workflow. If they have like a file net system for document management and workflow they want us to flow our documents right into their workflow as if those documents had come into their mailroom, had been scanned, indexed, key punched, whatever, we're just feeding right into that workflow so that they're not having to change their workflow.

Other smaller organizations very much want to have a web based interface for their staff, they don't have a place to store the images, they want to have sort of that interactive web based experience with the product. What we're trying to focus on is staying as close as possible to the data content, to the definitions that are in the X12 standard.

MR. REYNOLDS: A follow up question. If you stayed with the HTML and as you have it now how does that play when we actually go to a standard? You made an earlier comment which also lay in an IS world, you don't want to include IS. But as soon as you step into that actually X12 and the other things you're entering the IS world again aren't you?

MR. SCHINDERLE: To some extent, I mean we can code things behind the scene, we can deliver that information and if someone requires the transaction, for example if someone out bounds a 277 request for attachments to us we can convert that and render it HTML to a provider who can't deal with the complexity of a 277 request. We can then turn that around and feed it back to the health plan when they submit the attachments and put it back into the X12 standard and batch it into them. So we can act as that sort of clearinghouse if you will to move the transaction both ways. So yeah, we're going to have to deal with it but we'd rather do the heavy lifting then have to force the provider to do it or potentially the payer if it's a small self funded health plan or some other organization that doesn't have the expertise to deal with that. If they have the expertise, fine, we can just deliver in the X12 standard. Right now we don't have any takers, nobody seems to want to deal with it at the standard level although we've offered it several times.

MR. ICENHOWER: I'm taking off my clearinghouse hat and putting on my vendor hat, obviously what I would look as a vendor if I'm going to develop the workflow automation that the providers need to pull this together and interface, that's where the standard transaction delivers a lot of value. As accommodating as any HTML feed to me could be I need the standard to be able to code something that's going to be used across the industry.

DR. COHN: I have a question and then Jeff and then Gail. I think you both have in one way or another sort of referenced I believe LOINC, and this may be a piece of ignorance on my own part but I was, I think we all I think have appreciated the value added that LOINC provides in the more robust claims attachment scenarios as we described. I guess I'm having, I'm sitting here my own self sort of trying to figure out A, whether even in the most basic implementation, the scanned document, etc., etc., both whether LOINC is required or is being suggested and the value added and the complexity, and I guess I'm, once again I know in the end stage it has great value but can you comment about that, somebody just trying to scan and get images up through whatever standard may be approached.

MR. ICENHOWER: Basically, and I do not claim to be an expert on LOINC, I defer to Mr. Bechtel as more, but the idea, where we see it is that if there's a manual intervention just like you talked about here then requiring the using to understand the codes and its in their heads to be able to utilize those things, I really don't even think that's why if I'm one of the folks who primarily design it, they wanted vendors like me to be able to take that and map so that the code values as well as the format could be mapped and could be a pass between those so that I can, basically the reason that's there is so that I can automate these solutions for providers and if you're not, if that link from the request is a UI to a human then that really isn't adding that much value at that point. We think that long term the LOINC codes are going to be a critical part in allowing us to really interface back and understand the request and pull the right data from what might be a myriad of vendor systems that we're fronting into an EHR.

DR. COHN: So I think you're saying that in the very basic scenario you question the value added of LOINC in that one.

MR. ICENHOWER: It would seem to have reduced value in that scenario, yes.

MR. SCHINDERLE: In a human interface environment it probably has limited value today, assuming we have standardized nomenclature for what people are requesting. Now LOINC is a way to get to that standardized nomenclature if there are good definitions behind that and the industry is working pretty hard to try to do that. But in the absence of having all that pulled together what we've attempted to do when we started this thing, we continued and we keep watching what's going on with the development of the LOINCs is to attempt to have our own sort of glossary of definitions that our user base has sort of agreed on at the payer and the provider level that this is what we mean by pertinent chart information, this is what we mean by an emergency room record, whether it includes the physicians notes or not, those kinds of things so that there's some commonality because we found there was no commonality among the medical directors and the nurse reviewers and the hospital business office and HIM people, and it varied from different parts of the country. As we've moved around different terminology means the same thing and so nomenclature tends to be a problem in the industry and one that is going to continue to plagues us for a while.

DR. COHN: Well said. Jeff.

MR. BLAIR: Thank you, Mitch and David. Could you help me understand a little bit better the environment we're dealing with, and let me tell you the intent of where I'm trying to go with this question before I ask it. I'm hearing everyone indicate that there's really a business case once we're able to automate health claim attachments with the standards, the HL7, the X12, LOINC and all, that that's where we want to go. On the other hand I'm also hearing that there's a lot of workflow issues, a lot of environmental issues, and lack of infrastructure, so that there's a lot of problems to be worked out. So now that I've indicated those two different things I'm wondering whether it would be helpful if we didn't look at this as one entire issue but if we could understand the pieces a little bit better because maybe there's certain pieces that could move forward faster and others that we need to be more sensitive to and more accepting to. So I'm going to ask this in two ways because I'm not sure the best way to answer it or analyze it, so one of the ways would be when you're dealing with health claim attachments are you getting the majority from the ambulatory sector, from home health, from hospitals, maybe that's one way to look at it, from the source that it's coming from. The other is that we have the six different health claim attachments that have been defined, the ambulance, the durable medical equipment, the home health areas, maybe if you could kind of give us a picture that way as to which ones have the great volume or which ones have the greatest opportunity to be moved forward more quickly then others and which ones we need to maybe not impose a sophisticated technical solution on very quickly. So help me understand the health claim attachment environment by pieces and which pieces could be moved forward faster and which ones may need to take more time.

MR. SCHINDERLE: I have two responses I guess to that question. I guess my accounting training is coming into the forefront here but if you follow the dollars and use that as a barometer the initial sweet spot here that we've uncovered in our projects in California has been in the automating of the request and the automating of the delivery of the response, and those two areas slice a huge component of the cost that we have uncovered out of the equation. If you did that first you're dropping $20 some dollars off the cost. If the next slide of that, now you're down to a cost of $6, $7 dollars, how do you get that next slice cost. Well that's going to be harder to get to because it's going to require a lot more automation inside the health care organization and inside the health plan and this is where Siemens and other vendors like that are going to come into play because they're going to have to develop all of that infrastructure to get that next slide of cost. But that big first layer is the transport layer in my opinion and that could be a win first phase if you will.

MR. JEFF: Which portions of the environment that we're looking at, okay you're saying all portions on the first phase.

MR. SCHINDERLE: Well, no, if you're talking about, that's the second part of my sort of response. You were saying if we looked at just the six document types or if you looked a the 18 or 19 different provider types where's sort of the sweet spot, that's a very difficult question. We've asked like the state Medicaid program who had pretty good analytical data on their data to sort of answer that question for us, they're very rules based. The largest single group of attachments that they receive from providers in California tends to come from hospital institutional providers, the next layer is like DME, and then it drops down into all the other provider types as they go down the list. But their organizational list is a little different then the next payer we talked to, who is a different sort of volume mix depending on how their rules are driven. So I don't have a global industry standard that I could really respond to this to because as we go out to payers and to providers and we ask for metrics we find they don't have any. And part of the reason why this hasn't been managed is because you can't manage something you can't measure and so one of the things we've been attempting to do with our product is build in reporting, tracking, and metrics because you can't figure out where you're going to go or where you need to go if you don't have solid metrics and statistical counts of what's being asked for and how often and how when, and how long is it taking people to respond and so on and so forth. So we're trying to build all that in in an effort to try to get to the answer to the question you've raised, but I would say it's too early for us with our limited data that we've collected so far to have a solid answer for you.

MR. ICENHOWER: And I would say the same thing for a slightly different reason. As I noted our customer base is slanted toward the institutional customers, which actually are some of the prime candidates for the improvement here, and the long story short is it depends on who you ask. When I talk to our customer base it really depends on the provider, the payer, and the rules that are implementation in those regions as to where they think the biggest savings are. From our surveys and the things in our research we've done with our customers there's been a great variance on it. That's why we think the pilot programs should be looking at it, not just a usability but the cost savings that are associated and really try to gage that back into the plan that we have for roll out. Anecdotally I've heard things that they feel the savings might not be exactly as David has allocated the amount of $20 on the transport, but closer to the half and half savings that you might expect. So it really has been a pretty varied answer and we've done sampling on our customer base but I think you need to do it across the different provider segments to really get an accurate representation. I'm sorry I can't give you a more direct answer then that.

DR. COHN: Okay, great. We have I think one or two more questions, one more question, we are running seriously behind and I'm going to try to --

MS. GRAHAM: This will be fairly brief, this is for David. In your estimated initial cost of $33 dollars versus the $21 dollars, is that taking into consideration all three, what sounds like three parts of it, the payer, the provider, and the clearinghouse?

MR. SCHINDERLE: The provider cost numbers that we gave you there that were between $20 and $30 dollars with sort of a high end being the $33 at this one medical center is sort of a range, they sort of fall in the middle, that would be sort of a bell shaped curve if you will if you sort of took the middle of that and said it was around $25 dollars, if we're getting a savings of $21 you're sort of falling into that, you see what the delta is, about $4 to $5 dollars is the net cost. So there is a sweet spot in there that we're finding but in order to achieve that as I mentioned earlier you need broad adoption. This isn't something that, at least in California it would take the top ten or 15 payers in order to achieve those kind of economics, to get full adoption. Where we are today with three, four payers coming in, we need much broader adoption in order to drive that number and to have that opportunity for savings to be realized because otherwise people aren't going to take people off the payroll then you're not really achieving that, it's really just paper savings.

DR. COHN: Well, I want to thank our panelists, it's been a very interesting conversation and it will obviously be continuing with yet another panel after lunch. Now we do have on the agenda an opportunity for brief comments, really an open microphone from the floor, would anybody like to make any statements or otherwise? Would you like to go to a microphone and introduce yourself.

Agenda Item: Open Microphone - Ms. Doyle

MS. DOYLE: Teresa Doyle. We forwarded to everyone a copy of a letter and we would just like it to be considered as part of your deliberations, and I'd like to just highlight a couple of the points. One is is that we think that the pilot program really should be done before the NPRM, we think that it will actually create better information and that that information will be very helpful for the comment period and also understanding what the implementation process. I think we found HIPAA transactions and code sets many people even after the final rule came out really didn't understand what it required in terms of systems changes and business processes and so we think it's very helpful before the NPRM to know that not only it's workable but what it takes to be compliant and then we would have a comment period and then ultimately a final rule.

Secondly we think that in terms of process, right now many of our plans are still between 25 and 50 percent receiving HIPAA compliant transactions, 25 and 50 percent, and so we still have a long way to go. And I guess we're somewhat concerned that if we don't have full compliance with what's currently on our agenda and then to add yet another standard could be detrimental ultimately to achieving a successful implementation.

And the final point really is that as we look at any of these issues going forward we want to keep in mind what our ultimate goal is and again, trying to create some coordination and a national strategy in moving forward and when you look at the claim attachment standard that's before us does that fit with where we want to go ultimately with the electronic health record and I know that some of our presenters this morning certainly did address that issues, they believe that it was compatible and timely. I can tell you that sometimes I hear other comments that they believe maybe it's not the only way to go, that there are alternatives. And I'm not saying that one way is right and one way is wrong but I think it's important as NCVHS moves forward that it constantly sort of reconciles that, the standard that you're talking about today to the ultimate goal. And yes, if we're going to invest our resources it is still in line with ultimately perhaps an electronic health record and more importantly one in which there's a shared electronic health record.

Thank you.

Agenda Item: Open Microphone - Ms. Ward

MS. WARD: My name is Maria Ward, I am one of the co-chairs of the Attachment Special Interest Group in Health Level Seven, I have been working on this project for nine years now. As I've been listening to discussion this morning I've just sort of been making a list of things that I think will be relevant to your discussions and your consideration and I know we're pushing the lunch hour so I'm not going to go through that right now, hopefully I'll have an opportunity to do that before I leave.

But to one of the very last question I think you asked Jeff I think it's important for you all to know, for years we have tried to figure out what is the low hanging fruit and that's how we came up with what we came up with, six or seven or eight years ago. You should know that several activities are underway which I can talk about the others later but one of them is a survey that HL7 approached WEDI, probably two months or so ago, maybe in December, and WEDI is actually leading and working with us and with X12 on conducting a national survey through WEDI that's going to ask those very questions, Jeff and Simon, what are your attachment needs, who are you, when do you need them, why do you need them, what happens if you don't do them. We haven't come up with a complete list of questions yet and we have to define our scope and so forth but we hope that we would actually have some substantive information that comes out of that that could be useful to you, it probably won't be for at least several months but we recognize the need --

MR. BLAIR: Will that include more then the hospital community, will that include ambulatory and home health?

MS. WARD: That will hopefully include everybody, it will go out and be advertised through HL7, through X12, through WEDI, through this committee if you choose to, through CMS, through whoever will broadcast it, and people will have an opportunity just to log on to the WEDI-SNIP website and use the tool to respond right there and then we'll be able to analyze and kind of come up with some trends and get some really hopefully some good ideas, broad based diverse ideas about that.

Agenda Item: Open Microphone - Mr. Tennent

MR. TENNENT: Two really quick notes, I'm Robert Tennent with the Medical Group Management Association. One, I support the idea of pilots and it will be wonderful to have some of those pilots conducted before the NPRM to identify obviously data content issues but also to built momentum going forward and if I can add a new term for the claim attachment standards it's the Rolls Royce of the transactions, it's only going to effect the highest level of providers right away and I think what we need to do is build ROI throughout the industry and if we've learned anything from transactions and code sets it's that providers have to rely on their software vendors and so we have to build ROI with the vendors. They have to start developing these systems before the short 16 month window.

The last thing is there's also an ROI for the vast majority of providers that are paper based that has not been discussed and that is when a payer sends an electronic request for attachments that speeds up the process. Maybe the provider has to send on paper through the mail the response to that but if they can get it quickly it will lower their AR and that's going to be a huge improvement for providers.

Agenda Item: Open Microphone - Mr. Kay

MR. KAY: Good afternoon, thank you, my name is Brett Kay, I'm the director of government affairs with the National Health Council, which is a private non-profit umbrella organization, more then 110 national health related organizations are our members and what we really work to do is bring quality health care to people and give a patient voice and patient perspective to this issue which is the comments I want to present today.

We do represent, our core membership is more then 50 of the nation's leading patient based organization groups such as the American Heart Association, American Cancer Society, Epilepsy Foundation, Easter Seals, and others with chronic diseases and disabilities. But our members do cover the major stakeholders sort of that run the gambit from providers to patients, and really want to voice our strong support for protecting patient privacy and the confidentiality of medical records.

We've heard a lot here about technical standards and things but I think we want to take a step back and really take a look at it from what is the ultimate impact and goal on patients and as you all know the medical records really contain information that patients would prefer not to share in some cases, with insurers and others out there who have access to them, patients pay out of pocket in order to keep information off of medical records and do other things as well so that they don't want to assume that their insurers will have access to that. And many times people pay out of pocket they assume that this cost will not go there.

What we are concerned about is if XML or any other type of standard that allow really, that is adopted that permits an entire document or the entire medical record containing all the patient's information to go to, to transfer across when that is not necessary really made an issue of concern involving the patient provider information.

The approach we think really does undermine protections afforded in the minimum necessary standard for the privacy rule by giving health plans the access to information which they may or may not really need as necessary for the current payment. And it does easily expose information related to treatment for which patients have paid out of pocket with an expectation that it would not be shared with their health plans and so what in sum we really urge is that you strongly consider the consequences of allowing such a standard to be adopted.

When HIPAA was put into place it was put into place precisely to protect patient confidentiality and shield sensitive medical records from insurers and others who were in a position to use it in a discriminatory manner and so we really hope that allowing the providers to send the patients entire medical record under this protection of the minimum necessary standard, it's in direct conflict really with the spirit of the rule and so we urge you to consider that. Thank you for this opportunity.

DR. COHN: Thank you.

DR. HUFF: Will you accept a question? Aren't there times when sending the entire record is required?

MR. KAY: If it's required yes, but I think that this where it would be a wholesale --

DR. HUFF: Well, I want to make the distinction I guess between, technically we should be able to send the whole record, if you want to have policies and procedures to prevent that that's a separate issue of how you want to protect privacy and confidentiality. But you're not saying we should make it impossible technically to send the whole record --

MR. KAY: No, where it is necessary, where it is required by law, certainly we want that to happen. What we're saying is there should be policies and procedures in place so that it's not just every single time a whole record is going through for no reason rather then just to send it.

DR. COHN: Thank you for the testimony, and thank you all, our testifiers during the open mic. Any final comments before we break for lunch? Well, I do want to apologize to everyone, we are running late. However I would remind everyone that we weren't scheduled for lunch until 12:15 anyway and we did start about a half an hour late because of late arrivals, so on our new timeframe we are now at 12:50, we will adjourn until 1:50 and we will do our best to make up time as we can during the afternoon, so thank you all.

[Whereupon at 12:50 p.m. the meeting was recessed, to reconvene at 2:05 p.m. the same afternoon, March 3, 2004.]


A F T E R N O O N S E S S I O N [2:04 p.m.]

DR. COHN: Well, welcome everyone back, I realize we are running even a little later then expected. This afternoon we're continuing our testimony with other stakeholder perspectives on claims attachments. I want to thank our panel for joining us, I think our first speaker replacing Dr. Guay is Frank Kile, and then we have Penny Sanchez and Tom Hughes, so please lead off.

Agenda Item: Other Stakeholder Perspectives - Dr. Kile

DR. KILE: Thank you, Dr. Cohn, members of the subcommittee. As you mentioned I'm not Dr. Al Guay, I'm Dr. Frank Kile, I work for the ADA here in Washington, D.C. Dr. Guay was unable to make it to Washington for testimony today so sort of at the last minute I agreed to step in and try to provide the information that he would have if he'd been here. This also allows the association all plausible deniability about anything I say.

On behalf of the association I would like to express are appreciation to the NCVHS for their interest in dental attachments. I'd like to discuss the ADA's policy on attachment, the current methods for providing attachments, and finally how attachments could promote administrative simplification.

The ADA's policy on attachment is that they're not necessary in the vast majority of cases, and in those cases all the information necessary for claims adjudication could be included in the dental claim form itself. The ADA has worked with the payers, the dental providers, and vendors to develop claim forms, both electronic and paper, which meet the needs of all interested parties. This has been quite successful as many payers have reduced the requirements for attachment when dental claims are submitted electronically. Unfortunately there is no agreement on situations for which attachments are required. Consequently most dental offices submit far more attachments then are required in an effort to avoid payment delays, and I think this was echoed earlier today with other testimony that you heard about over doing the attachment process in order to expedite the possible payment.

Most dental attachments are already graphs but increasingly periodontal chartings or operative reports are being requested for specialized treatment. Most dental attachments are submitted in the same envelope with the paper claim, however when a dentist submits an electronic claim and the attachments are mailed separately there has been significant difficulty in matching the claim to the attachment and again, I think this was echoed this morning in some of the earlier testimony. This often requires a duplication of the attachment and delays the payment. Scanned attachments may be submitted to a repository for reviewing by dental consultant but the current technology is proprietary and image quality lacks clinical quality. This may also require resubmission of the attachment and again delays payment.

The ADA does not currently support this approach because it is not standards based. The ADA has supported the use of DICOM images for image transfer but the dental plans apparently currently do not accept those images.

In the interest of administrative simplification the ADA proposes that the data content of a dental claim be reduced from a maximum data set to a minimum data set. This data set would be consistent with the information on the ADA paper claim that is sufficient for adjudication of most claims by most third party payers. Additional information may be required in certain specific situations by payers under contract would be provided in a supplemental attachment. This would prevent about 90 percent of the claims to be processed expeditiously with only the essential information. The remaining ten percent of dental claims would be subject to be exception processes with the dentist providing the additional information upon request and as required for payment.

This approach has been successfully used in the pharmacy industry where the median pharmacy claim amount is comparable to the median dental claim amount. Further simplification would result if all payers were to agree on the criteria for attachments. The dentist would know in advance what additional information might be required for prompt adjudication. Clear and unambiguous criteria for submission of attachments can be support successful implementation of a national standard. The ADA is proposing to work with the National Association of Dental Plans and the Delta Dental Plans Association on this effort.

I want to thank you for this opportunity to share the association's ideas with you, I'd be pleased to answer any questions if I'm able and if not I will certainly bring them back to Dr. Guay and he will provide further information. Thank you very much.

DR. COHN: Thank you. Penny?

Agenda Item: Other Stakeholder Perspectives - Ms. Sanchez

MS. SANCHEZ: Hi, thank you, my name is Penny Sanchez with Electronic Data Systems, who is currently the fiscal intermediary for California Medicaid where I've been working for I hate to admit about the last 20 years. I'm also as some of you may know a co-chair of HL7's Attachment Special Interest Group, however today I'm here representing the National Medicaid EDI HIPAA Workgroup, which I think many of you have heard of at this point, we're more commonly known as the NMEH, and that's NMEH, not NEMH, which most people want to say.

The NMEH is subdivided up into many separate sub-workgroups and we focus on specific issues within those workgroups, one of which of course is claims attachments. And I'm one of two co-chairs within that workgroup, the other one is Linda Louise Bush of Pennsylvania Medicaid. We also have two other sub-workgroups that actually are focusing on claims attachment development content for Medicaid, and that is the Dental Sub-Workgroup, is working on periodontal charting and then the Prior Authorization Sub-Workgroup is working on attachments specific to prior authorization. We would like to thank you for the opportunity to share our perceptions of the impending proposal for electronic claims attachment.

I'd like to first give you a little bit of background on NMEH so you understand where we're coming from. The NMEH was formed under the sponsorship of the Systems Technical Advisory Group of the National Association of State Medicaid Directors back in November of 1999, which was about when most of the Medicaids were really starting to focus in on HIPAA, before then there were wasn't a lot of attention from the Medicaid agencies on HIPAA. So in 1999 we formed, we started out with only ten states, and most people believed we would never get all 50 states to play in the same sandbox, and within six months we had representatives from all 50 states, the District of Columbia, and some of the other U.S. territories. So it's been a very successful group in accomplishing some wonderful tasks that we've done.

NMEH members are very active participants in all of the standards development organizations related to HIPAA, X12, HL7 and NCPDP, they've had very long standing relationships with NCPDP and have really focused a lot of effort in the last four years on X12 and on HL7. We are also members and actively participate in WEDI-SNIP committees and AFECHT whenever we can. We also have seats on the National Uniform Claim Committee and the National Uniform Billing Committee as representatives of NASMED(?), so we try to stay very focused and make sure that we represent the needs of the Medicaid organizations.

Our main goal is to identify HIPAA related issues that are common to Medicaid agencies to find resolutions to those issues, represent Medicaid on a national and state level, and one of the things that I think is more important is to share ideas and common processes. We seek to find processes and develop processes that meet the needs of our provider community who serve an at risk beneficiary population, at the same time we have to make sure we maintain the integrity and the policies of the Medicaid program which is not always an easy balance to create.

How does Medicaid use attachments? Obviously we use it for claims adjudication and to meet some specific state and federal requirements that require us to get attachments. However we see the potential for uses of electronic attachments and other ways and other business purposes and I think Kepa mentioned one of them which is prior authorization and I think somebody else mentioned managed care as well. Those are some of the uses that we see as well to adequately assess prior authorization requests, to assess the effectiveness of some of our state programs and some of the special programs that we have so that we can validate that the program standards are met. To support case management clinical data collection, which is pretty important in many states. To perform post payment review and to probably most importantly is to mitigate fraud and abuse within the Medicaid program.

One of the major gaps for Medicaid agencies in implementing the initial transactions and code sets rule was the absence of a standard way to electronically receive the required supporting documentation needed for claims and prior authorization. The current process to receive additional information is I think as you probably know very manual and labor intensive since we still continue to get them on mostly paper and fax. This is obviously very inefficient for both providers and the Medicaid agencies. We see the move towards electronic standard attachments as a definite improvement on efficiency in processing both claims and prior authorization requests.

Although prior authorization requests don't fall under the HIPAA regulation we mention it here because Medicaid agencies such as California and Minnesota, North Carolina to name a few may voluntarily implement electronic attachments in support of that business function, so we're hoping that happens. In addition the Medicaid, the National Medicaid Information Technology Architecture Framework, MITA(?), which is currently under development by CMS, will strongly encourage states to adopt common national IT standards to facilitate interoperability, improve data exchanges between trading partners and make better use of the internet and emerging technology. MITA's mission is to establish a national framework of enabling technologies and processes that are specifically designed to support improved program performance for today's patient centered Medicaid enterprise. A critically important piece of that strategy is the development of standard claims attachments and prior approval attachments that can be uniformly utilized and understood by everyone.

We eagerly anticipate the release of a claims attachment NPRM and eventual final rule and urge the department to release this as soon as possible so that gap between the electronic claim and the remaining supporting documentation can be closed.

Members of the NMEH actively participate in the workgroup at X12 and HL7 that have been developing a solution for claims and prior approval attachments. The NMEH fully supports definition of a standard to electronically transmit claims attachment data and what we mean by a standard is a definitive data set, minimum and maximum, defined by a standard organization. By defining standard content for attachments both providers and payers know what data content is required at the time of the encounter allowing providers to capture the appropriate data.

The NMEH supports the current claims attachment approach defined by HL7 and X12, we are really pleased with HL7's recent decision to move away from the fully codified HL7 traditional messaging structure to the more flexible XML based HL7 clinical document architecture, the CDA. Since the CDA offers different levels of implementation we see it as a definitive benefit for both providers and health plans including Medicaid agencies. Many Medicaid agencies felt that the initial approach using only structured codified data would have posed challenges for both providers and Medicaid agencies. The fully codified model poses several operational and business challenges, some of those are cost to implement this model is expensive, an analysis needs to be performed to ensure that the appropriate return on investment can be achieved. And then some provider organizations maintain their clinical and attachment data in imaged medical record systems and discreet codified data is not easily available to their administrative systems, and we've heard this in several cases.

The CDA's capability to capture either image documents, text data, or fully structured codified data allows both the provider and the Medicaid agency the flexibility to determine which business model best meets their needs. We see this flexibility in the CDA as a means to greater participation in electronic attachments. Most Medicaid agencies anticipate that the initial implementation phase for claims attachment will be limited to image documents and/or text data due to state budget limitations and systems staff resource availability. As states are able to complete cost/benefit analysis on various attachment types they may choose to integrate into their processing systems fully codified capabilities in order to realize the full benefit of the structured content and that is auto adjudication of claims.

I think many state Medicaid agencies would like to get to that point but I see that they would actually do a cost benefit analysis first on various attachment types to determine which of those types would be best suited for fully codified data. I don't envision they would actually do it for all attachment types. As with the transactions and code set standards Medicaid agencies need to work through the issues and operationalizing the claims attachment solution and integrating it into their current infrastructure.

The models defined by X12 and HL7 allow providers to send attachments in an unsolicited manner if the health plan or Medicaid agency has instructed the provider that the additional information will always be needed at the time the claim is transmitted. Health plans or Medicaid agencies can also request the additional information in a solicited manner using the X12 277 request with the appropriate LOINC value. We agree that both of these models should be available but are concerned that the unsolicited model may result in the receipt of attachments not necessary for processing the claim. This will likely result in the need for both the Medicaid agencies and the providers to be mindful of the minimum necessary provision under the HIPAA privacy legislation. Medicaid agencies and health plans need to be cognizant of this provision when requesting additional information under the solicited model and providers need to ensure that the data provided under both the solicited and unsolicited model adheres to the minimum necessary principle.

Some of the issues and concerns that we had I'd like to address now. First off, are we ready for XML? Some Medicaid agencies have already begun development of web portals and applications using XML while others have expressed concern about the ability to forge into a new application language and technology where they have no familiarity. Most of these concerns seem to be centered around whether Medicaid agencies will have the knowledge base, system staff, and funding necessary to support XML based applications and to make the appropriate business changes.

Issue number two is can we constrain file sizes? It is our expectation that many of the attachments we receive will be image documents. Image files can be quite large even when captured in a compressed format. In order to maximize our efficiency in receiving batch transmissions we believe that health plans, including Medicaid agencies, should be able to define file size limitations for each transmission. This allows these covered entities the ability to better handle capacity planning within their own network.

The adoption of new attachment types. The NMEH sees a great deal of value in the six attachment types that have already been developed and published by HL7's Attachment Special Interest Group and we do expect that these attachment types will cover many of the attachment needs under Medicaid. However in addition NMEH has been working very hard over the past several years to define data content to the attachment types that meet specific Medicaid needs beyond those of the six attachments already published by HL7.

We have been actively participating with the HL7 Attachment Special Interest Group to perform the requisite industry outreach and draft the data requirements into HL7's additional information specifications booklets. These attachment types include children's preventative health services, periodontal charting, durable medical equipment, and consent forms which cover the federally required abortion, hysterectomy and sterilization consents. HL7 has also defined data content for home health attachments which several Medicaid agencies plan to use. Medicaid has identified several other types of important attachments that still require content definition, a few of these are non-emergency transportation, proof of timeliness, third party liability, eligibility, vision and x-rays.

The changing face of Medicaid medicine requires that we adopt quickly and efficiently. In the past many Medicaid agencies have used quickly adopted local codes to accommodate changes in policy or to accommodate new medical technologies. Under HIPAA use of local codes is not an option and one alternative to capture this additional information may be through the use of attachments. The NMEH recognizes that the legislative rulemaking process takes a considerable amount of time. We encourage the department to develop a process to adopt future attachment types for use under HIPAA in a more timely manner or to look at alternatives other then the time intensive NPRM process to adopt additional attachment types while still allowing for the appropriate level of scrutiny and public comment on the attachment content. In the interim Medicaid agencies may choose to use the published attachment specifications voluntarily, however until there is a rule mandating the use of those attachments it may not be possible that we will get trading partners to actually work with us.

Consent attachments. One of the more onerous attachment types for both providers and payers and Medicaid agencies is the federal requirement for physical consent documents for abortion, hysterectomy and sterilization, and in the testimony I've provided the exact code of regulation. Medicaid agencies must obtain a physical paper copy of the consent form in order to receive federal matching funds. This documentation can contain several signatures validating that specific federal requirements are met.

The NMEH has worked hard to define these exact requirements in an electronic attachment format so that an HL7 additional information specification standard can be published. This attachment type would allow Medicaid agencies to capture the federally mandated validation requirements electronically, however we continue to find barriers to completing this attachment definition. According to the Medicaid division at CMS the wet signature of the entities defined on the consent form must be obtained in their appropriate context before the claim can be processed and federal matching funds receives. In the past this has required Medicaid agencies to obtain paper copies of these forms.

In 2001 we submitted a white paper which is attached to the testimony to CMS proposing several options to improve efficiency of this process. The preferred options are allow the providers to retain the documentation in the office. Allow a scanned image of the paper documentation to be submitted with the electronic attachment. And allow structured codified data with an indicator for signature on file at the physician's office. We also explored several other alternatives, such as digital signatures, using public key infrastructure, point of service swipe cards, smart card technology and biometrics. None of these methods were recommended due to cost and implementation difficulty.

Unofficially CMS has stated that they will allow an image of the entire consent form showing the wet signatures with the electronic attachment, however we are still waiting for a formal response on this issue. We need to send in this data in paper format, the need to send in this data in a paper format is both a burden to the provider and the Medicaid payer. The NMEH continues to develop this electronic attachment and hopes that it may be able to use it voluntarily or as a HIPAA standard in the future.

Medicaid involvement in attachment pilots. Medicaid payers are an integral part of the health care industry, we believe that pilots should be conducted as new transaction types are adopted under HIPAA. However, the release of an NPRM or a final rule should not be contingent of completion of pilot. The reason we say that is we, there are many states eagerly anticipating the use of attachments in their process and they believe waiting for an NPRM or a final rule until after pilots are completed would delay that process even further, something they actually see a return in investment on. Most states are not in the position to participate in pilots at this time, however a couple of states have expressed some level of interest in participating. While one state has expressed they would be willing to participate with or without funding others are concerned with the level of effort and costs associated with such an endeavor. Some questions they have are is enhanced funding available, what technical support is available during the pilot project, and who would coordinate trading partners and vending support.

In closing the NMEH believes that the implementation of a standard electronic claim attachment would improve efficiency for the provider process as well as efficiency for the Medicaid agencies claims adjudication process. It is our hope that as the industry moves towards more technical sophistication the ability to use the CDA to its fullest potential will be realized so that claims can be auto adjudicated providing lower processing costs for providers and payers and allowing faster payment for providers.

I want to thank you for this opportunity to share our views of the National Medicaid EDI HIPAA Workgroup and we look forward to seeing a future NPRM for attachments. Thank you.

DR. COHN: Sandy, thank you. Tom Hughes, welcome.

Agenda Item: Other Stakeholder Perspectives - Mr. Hughes

MR. HUGHES: Thank you. My name is Tom Hughes and I'm with a company called National Electronic Attachment. Let me thank this body for giving me the opportunity to speak to you today. First let me say a word about my background and my company. I've been in the insurance transaction business for 14 years and previously owned what is now today the dental division of WebMD, so that you know that we have experience in that area of the business.

When I sold this company in 1995 I took back a contract to run it, had a three year contract and at the end of that contract was when we started National Electronic Attachment. And we built it, until today it has contracts with 93 commercial payers, including the Delta's, and 25 Medicaid payers to process electronic attachments over the web. While we process millions of attachments or images each year we generally store the most recent six million images on line at any given moment in time. I tell you this not to brag about our company but to give credence to the fact that this is just not a good idea, that this is a business, but rather a live active business solely in electronic attachments.

Let me speak for a moment about what I mean by electronic attachments. I look at attachments as anything that's needed to send in support of an electronic claim is an electronic attachment. This could be an x-ray, a narrative, a perio chart, and EOB, a student verification, a lab test, a certificate of medical necessity, an EKG, or anything else that the payer might request. These are non-coded, non-imbedded, not in another transaction such as an X12, but in most cases are scanned images of paper documents with the exception of x-rays which are scanned images of film.

Now my prepared remarks are broken down into several areas, number one the internet and electronic attachments, the attachment regulations, the cost benefits, the provider to provider services, what I call the magic and the potential attachment specifications.

In the internet and electronic attachments first and foremost the prevailing rule, law, prohibitions from the federal government that does not allow attachments or claims to be transmitted over the internet is in itself ridiculous. Medicare has this prohibition. The FDIC insures banks that allow transfer in and out of bank accounts to pass information. If a patient is insured on the commercial side with Blue Cross and Blue Shield of Georgia for example, Well Point, which is one of our clients, the attachments for a claim can be transmitted to that organization over the internet. If that same patient changes coverage to Medicare federal requirements state that the claim must be sent electronically whereas the attachments must be sent on paper through the mail. This is not logical.

In areas where there is Medicare fraud or Medicaid fraud investigation is dramatically enhanced when given the ability to service attachments by doctor ID number, and any time a list of attachments will show what the doctor is doing and a total structure of that doctor's work. On the provider side the ability to transmit information by the internet means millions of dollars in administrative savings. It does now appear that the CMS Medicare may be getting closer to using the internet. We have recently received an enterprise architecture approach and a request for comments on this. Our initial request for a CMS pilot, and I'll just share that with you, in regards to doing durable medical equipment claims, was well received and two of the four durable medical equipment payers instantly gave their desire to participate. Just to be safe and to share with this group, this is being done working with the program integrity group and not with the HIPAA people, so I just need to clarify that. I'm certainly not here to beat up on CMS but to share with this group that we simply concur with statements that this body has already received relative to using the internet, I'm just adding my weight to it.

Under the attachment regulations, a central question is do attachments as transmitted today now meet federal guidelines. Attachments through the attachment's network now in use in the country meet the contemplated regs approach that support an imbedded scanned image into the X12 XML document. Thus providers and payers that have begun using scanned attachment products will be on a migration pat and not on a dead end.

I also am aware that there is much discussion within CMS, NCVHS, and other agencies regarding HIPAA standards and contemplated HIPAA claims attachment regulations. I have communicated along with my contemporaries directly to CMS, OHS, about my concerns relating to the complexity, the cost, and the ability of providers, let along payers, to technically implement and deploy the systems essential to comply with the approach that may be proposed using X12.

My biggest concerns relative to this is cost, the impact to the way business is being conducted today and major changes to the work flow. I'm aware that these concerns have reached the chair of this committee and at this point I would not be placing any bets on the viability of the contemplated NPRM should it be promulgated late summer as predicted. Also as we know even after the NPRM comes out there's 60 days of comments followed by months of preparing the responses followed by the final rule. Finally, which means it will be possibly another year before the final reg is published. In my opinion we are years away from final regulations for HIPAA claims attachments.

Additionally it's highly unlikely that major clearinghouses such as WebMD, PayerPath(?), ProxyMed(?), Infotech Global, Global HealthNet(?) or others will spend the millions of dollars necessary and invest two to four yeas of development time to support the contemplated X12 277 275 HL7 approach. These vendors will not invest as the ROI on change is necessary to be able to process these attachments are measured in light years while these companies are looking for the ROI to be measured in months. Also as far as I understand WebMD, PayerPath and Global HealthNet have already made a conscious decision to recommend the systems they already have in place to their providers who want to send attachments, meaning images and texts electronically now.

In the meantime providers and payers simply must take advantage of already in place robust scalable and functioning secure services for sending electronic attachments to get out of the fax, snail mail attachment business. If providers could leverage the capability today to make attachments quickly, reliably and securely available to payers the positive impact to cash flow and productivity would be huge. Most payers currently provide for us today the attachments that are necessary to match up to specific procedure codes.

I'll digress a moment from my remarks here to say that in the dental arena with only one exception the payer must tell the provider for this procedure code this is what's required. In our case in our company we've got 112, 113 different payers, I have 112, 113 different schedules. But a provider in their office knows that when they do a procedure code number something this is what's required or nothing is required. If nothing is required they send the claim electronically and the claim gets paid, there's no further attachment necessary.

In some cases the attachment comes back, if you send the claim electronically the attachment request comes back electronically. If you send the claim in the mail, needless to say the attachment request comes back in the mail.

Let me share if you would some comments in regards to dental electronic claims. First, it's been interesting in the last few years in signing up payers to accept these electronic attachments. Electronic attachment companies, which would be my competitors, my other companies, provider payer software and the ability through job aminoapolation(?) to see an x-ray, to lighten it, to darken it, to contrast it, to zoom in, to zoom out, and to get the best x-ray possible without changing it. Then the provider can see on their own system what it was that they send to the payer before it actually leaves. Currently some of the major dental payers in the country run attachment entry stations in their mailrooms so that their people who adjudicate claims never see anything in the way of a piece of paper, every claim and every attachment is put in in the mail room prior to it going to the floor.

For other payers who don't already do imaging most of the electronic attachment companies recommend to those payers that they scan in every claim and every attachment where they're either doing the work, to a change to the work or where they're denying the work to be done. This way if you go to peer review the payer is not put in the position of requiring the provider to send back to the payer the attachments and more importantly receiving back different attachments then they originally received.

We are very pleased to have the American Association of Dental Consultants, these would be the people who review electronic claims and attachments at the various insurance companies in the country, decide to use the electronic attachment systems on a national basis for their members to use in the area of education. Also the American Academy of Periodontology(?), the AAP, the Association of Oral Surgeons, the AAOMS, two of the eight groups of specialty dentists recognized by the ADA and some of the largest senders of attachments in the country have now both endorsed electronic attachments for their members to use when sending electronic claims.

In the cost benefit, in order for a provider to send attachments electronically they need a simple $100 dollar scanner. In the case of x-rays they probably need a $200 dollar scanner because it must have a transparency adapter, and they need a monthly fee of either $20 to $25 dollars to be connected to the network to send all the attachments that they want electronically from their office. Included is all the training, the technical support, and the customer service. Programs are available in some office where the registration fee and the scanners are paid for by the payers who recognize the savings to them in having the claims come electronically, and the attachments coming electronically.

Dental attachments are sent from providers in every state in the country today. Our research through other attachment companies who are members of NDEDIC, the National Dental EDI Council, found that for each attachment that is sent electronically in the area of dental, which is scanned in attachments over the internet the saving to the provider is about $1.27 an attachment, quite a bit different from the numbers I saw up here for medical. And the savings to the payer is approximately $1.46.

The question can always be asked as to why wouldn't a provider desire to spend the bucks to go to the contemplated X12 277 275 HL7 approach. Simple answer, the cost. You must remember that the use of any electronic capability is not going to happen at the provider end without the input of the practice management companies and the software vendors. In the dental arena you're looking at roughly six major players, although there are more then 100 different dental softwares in the field. My thought is that only these six could afford to make the changes necessary.

I'll stop one second and say that HIPAA alone ran probably 100 people out of the market who were dental practice management vendors who have systems in the field and can't support them in terms of doing things.

Today Renaissance Clearinghouse, which services dental claims and is owned by Delta Dental Plan of Michigan will process all dental claims for providers in the United States at no charge, and yet we struggle to get more then 50 percent of the dental claims to go electronically.

After the 16th of October last year everyone thought that any payer who accepts and pays claims would be required to accept the claims electronically, yet thousands of claims will be almost 100,000 at the end of this month, will be printed and mailed daily to payers by clearinghouses where the payer cannot or will not accept the claim electronically.

While I may appear to be rambling, dentists in America whose job it is to make teeth healthy, white, and provide painless treatment are not programmers and are not going to get rid of their current computer systems and buy another one to send a set of X12 based attachments to a payer when they already have a simple inexpensive off the shelf approach and products from the companies approaching electronic attachments now.

When we first started at NEA, talk about myself for a moment, I presumed the payers would do attachments in the same way they do claims, claims basically go from the provider to the clearinghouse to the payer and it's gone. In the case of attachments it goes from the provider to the clearinghouse repository, and that attachment sits. And the main reason is because in the area of medical claims payers have humungous amounts of money to throw at programming and in the area of dental they have basically none.

I am happy to report to you today after talking with some of the electronic attachment companies that the first group of worker's compensation payers are coming on this week, which means the acceptance of electronically scanned images. Every new claim in the worker's comp area requires an attachment for adjudication.

In provider to provider services, which we see as one of the major focuses of attachments, providers can also use the provider to provider electronic medical record exchange capability, which means scanned images sent scanner to computer, even if they don't initially plan to use the provider to payer service for claims attachment. The benefits here for the providers are enormous, no more faxing medical records by referring physicians to specialists or consulting physicians. No more handing medical records to the patient to take with them. No more special courier costs to deliver medical records. No more will a patient show up for an appointment with a specialist only to find that the medical records from the primary physician have not arrived.

DR. COHN: Tom, I don't mean to break in, are you getting close to finishing?

MR. HUGHES: Yes.

DR. COHN: Okay, thank you.

MR. HUGHES: Let's talk about the specific attachment specs that might be put in the proposed rule for HIPAA, the ambulance, the emergency department, rehabilitation services, clinical reports, laboratory reports, and medical records. We are absolutely not critical of those people who spent hundreds of hours working on this to make this happen. The electronic attachment industry could have built these specs for probably less then $10,000 bucks a spec. Complete implementation of these we certainly hope will happen. But having read the previous testimony from people who have spoken before this group my consensus is is that the payers aren't going to spend the money to build in-house attachment receiving software until they can see the utilization will be there to justify the cost.

Again, I want to thank this body for asking me to come.

DR. COHN: Questions from the subcommittee? Michael.

DR. FITZMAURICE: A quick one, I wasn't sure, this is for Frank Kile, that you were for or against claims attachment.

DR. KILE: Again, I think the basic policy of the ADA is that we would prefer not to have attachments if at all possible --

DR. FITZMAURICE: You prefer the health plans not ask you --

DR. KILE: Right, exactly. But I think we also recognize that there is going to be a requirement in a selected percentage of all claims, dental claims, so we'd rather not have to do them but we understand we have to.

DR. FITZMAURICE: And if you have them you'd rather have them structured --

DR. KILE: We'd rather have them structured, simplified so that we don't have to try to figure out which exact format, which exact plan goes with which exact kind of procedure.

DR. FITZMAURICE: And is that the same for you Penny Sanchez?

MS. SANCHEZ? Yeah, the NMEH supports standardized claims attachments, I mean we've been focusing, definitely been focusing our efforts over the last three years on developing content for those specific state Medicaid attachments we still need, so we definitely are on board with getting standards electronically.

DR. FITZMAURICE: You would like to see even additional attachments --

MS. SANCHEZ: We want additional attachments that are very specific to Medicaid needs and we're trying to get them out there for the requisite industry outreach so they can be used by the whole industry. It's important because Medicaid is unique in many ways, I think most people realize and we have some very unique needs.

DR. FITZMAURICE: And Tom, I didn't sense the overall enthusiasm from your microphone that you wanted attachments and you wanted them structured, but maybe I'm wrong, maybe I wasn't listening correctly.

MR. HUGHES: The ones that they have recommended, I don't have any problem with those being structured certainly because we don't do those but we could very easily do those. I think that attachments need to go, in the meantime I think attachments should go electronically whether structured or not structured while this group works on the structure.

DR. FITZMAURICE: Very good, thank you.

DR. COHN: Penny, I actually have a question for you and obviously I'm always concerned about the state Medicaid agencies just because you typically have not real flexible IT infrastructures at least historically and I know at least there was a period of time when you were having trouble actually implementing the basic HIPAA standards that were coming forward.

It sounds like in contradistinction that claims attachments there seems to be sort of a ground swell from state Medicaid and they are going, are they already doing things out there --

MS. SANCHEZ: There aren't any states, there's one state that I know of that's exchanging electronic attachments at this point but not in obviously the standard way. You're right, in the past Medicaid have had funding difficulties within their own states in getting the basic and transactions and code sets rule up and running. What I see though is the attachment, the people that have been coming to the table at our conference calls which is not every state, I'm going to have to admit that, there's about, we average about 23 states represented in our calls so we really we have stakeholders of about 23 different states who see a definite return on investment by implementing attachments, and specifically even though they see the six that are already developed as important, some of the bigger ones for them are the ones that are not developed, DME is another one that's a very big deal to them, we've had a lot of interest from the Medicaid and the children's preventative health services one because it helps them gather information they need for assessment of their EPSDT programs. So there are still attachments out there that are probably very critical to Medicaid agencies that are not developed fully yet. So we're working as quickly as we can to get those developed.

DR. COHN: Actually Penny one final question, this actually relates to some of the things Tom was saying. Obviously I think one of the things that we've been trying to explore knowing that the X12 HL7 standard has sort of very basic functionality to very sophisticated functionality, which I think Tom was alluding to. From your view is the basic functionality basic enough that it would be able to be easily implemented by the Medicaid groups?

MS. SANCHEZ: I haven't seen any resistance from specifically the imaged version with the human decision variament that uses images. I think most of the Medicaid agencies that I've spoken to that have attended the calls see that as a definite way that they can implement claims attachments. There are those also that want to do the fully codified for only specific attachments and some of those that come to mind, clinical reports I'm not sure ever, we will ever implement the fully codified, it doesn't make a whole lot of sense. But ambulance probably yes, rehabilitation probably yes, because there's some return on investment, and DME definitely once it finally comes down. So, yeah.

MR. HUGHES: We work totally with 28 different Medicaid states, some of the problems are really, the latest one we brought on which was Denatel(?), which is this from California, there was no money in the budget from the state level to be able to do that. Medicaid a lot of time get the short shrift of what takes place which is totally different then payers and other people.

DR. COHN: I think that's been all of our observations about that. Other questions or comments? Okay, well I want to thank everyone, I think we're going to take like a ten minute break and then come, actually, I'm sorry, before we do that, open mic, Maria did you want to make a comment? This would be a good time for you to make a comment and then we will take a ten minute break.

MS. WARD: I've got my list. My name is Maria Ward, I'm a co-chair of the HL7 Attachment Special Interest Group and I've been listening very carefully to a lot of the discussion this morning and I shared some thoughts with you earlier. But I also have a number of things that I think are important so therefore they are of course for you all to consider as you go forward and talk through your position on this whole claim attachment standards stuff.

The first thing, there was a mention this morning, I think it was in Gary's testimony, about the motivation of HL7 for moving from what we had previously developed really in 1998 to last year when we kind of took a turn and we went forward with developing a CDA approach to attachments. Yes, that was about technology and that was about timing and that was about it had been a really long time and we knew it would be yet several years before a final rule came out. But most importantly it was about feedback that we got as a standards developer from the industry. We were being responsive, we were listening, and we were trying in our new approach to accommodate as we've all, Simon, you just talked about, the lower end and the higher end in terms of trading partners and sophistication. So we think it's important for you all to know that it wasn't just because it had taken so long, it was because we were trying to be responsive to in fact things that we heard through WEDI presentations, through HIPAA summit presentations, through national presentations on our proposed, prior proposed approach.

And then to that point about presentations, one of my soap boxes right now is about education. Education on what this recommendation really is and what it really does and what it really doesn't do and there aren't a whole lot of folks who know that and that's because you can't reach the whole world when you're just talking about it within a committee or two committees or three committees. So we in HL7 have reached out to WEDI-SNIP in conjunction with X12 and I think that you all should know that there's a couple of things going on, concurrent efforts right now, many of them through SNIP, some through AFECHT, we talked a lot about the vendor, the sort of joint collaborative vendor, traction that we're trying to get with pilots, that's one of them.

In an education front we have within HL7 we now do several times a year what they call educational summits and we are on the agenda as teaching about half a day, even a full day in November, teaching about HIPAA, teaching about claims attachments, I'll be doing that at the end of this month in Chicago, three hours to whoever wants to come and listen about what this is all about. So through HL7 we're starting to try and get some outreach going with education, through WEDI-SNIP we have a series of web casts planned, national web casts where we're going to have panel kind of presentations.

The first one is going to be I think April 19th, Wes Rischel and I from HL7 are going to spend an hour or whatever doing a talk at the most fundamental level about this and then allowing for Q&A and then the next one will take it down a layer and get a little more detailed and then we'll get into business issues and the business processes in terms of the payer side and in terms of the provider side, so through WEDI-SNIP we're trying to do education there, through AFECHT, with HIMSS, and WEDI and HL7 and X12, we're trying to get some traction on the vendor side in terms of pilots and also in terms of education on the vendor side, focused vendor education sometime probably in May I think we've been speculating via web casts and then a focused full day of bringing vendors in and having just the long day of education with the vendors, letting them take it all in, digest it a little bit, and get their thoughts and their feedback once they're better informed versus just kind of trying to figure out from stuff they've been reading and not having had the opportunity to get that more formal education.

Just a couple of comments on the pilot. It's funny, I fall on both sides of this argument. I think, I believe, that we have to do this, I believe that we have to get some people going on this and we have to flesh it out and we have to figure out what works and what doesn't work. We're kind of forging new ground here, we all know that but at the same time my experience has shown me without a regulation there's not a lot of motivation for anybody to do anything so I don't know what the answer is. I don't think a Notice of Intent, which was some of the discussion this morning, is going to motivate anybody to do a pilot.

I've had an interesting last couple of weeks as part of a project I'm working on reaching out to payers, talking to payers about their current status of the HIPAA implementation of transactions and one of the transactions we put, my client put on that survey was for attachments because they just wanted to see, do people even know, do people even know it's in HIPAA, is it on anyone's radar, and unilaterally every response from every payer has been the same response I would give if somebody asked me, which is well, yeah, we know it's there but we're not going to do anything with that until we see a proposed rule, why would they really invest in that until they had some reason both on the payer and the provider side to believe that it was actually real and actually really going to happen. So I don't have the answer to that, I think it's important to test, I think it's important to try and get folks motivated to do that, I'm not sure how to do that short of regulation.

I talked to you earlier about the WEDI survey which I think the results of which will prove to be very informative for yourselves and for us as a standards developer as well in terms of where the industry seems to be falling right now on some of the more important questions around claims attachments.

I have a cryptic note here that I'm not sure what the relevance was, there was a discussion about business case this morning and it's actually funny, those of you who know me, know me well enough, I've spent the last seven or eight years doing this and I spent the last two years in physical therapy following two shoulder surgeries and after every clear last year, I have a national plan, a national payer, every claim was denied for five months, it's started totally about $6,000 dollars before I got angry enough to be aggressive about it when I got billed, balance billed because they weren't paying it and the wind up was it wasn't because they weren't, I truly believe it wasn't because they were trying to delay payment, it was because they're such a big organization they had paper in medical review for me, they had paper in appeals from me, they had paper in the claims adjudication part of the department from me, and so to take a step towards eliminating all of those pockets and all of that paper and being able to centralize this a little bit and automate this a little bit would have made me the patient a whole lot happier because I ended up having to take that on actually with my insurance company instead of my provider because it ended up becoming my bill that had to get resolved, so I think just the sheer volume and the sheer manual process involved in the paper world today is motivation enough to really try and get this moving forward.

A comment about pilots and limiting, nobody I don't think wants to limit it because we've heard Kepa and we heard all the folks this morning talk about the need for a really diverse broad based industry input into these pilots. There was some discussion about if we could get supplemental funding from Medicare/Medicaid sector which might be easier from CMS.

I would make the observation and caution that just a Medicare or just a Medicaid pilot probably isn't going to give us a really good idea of the world of attachments, especially when you have a single payer Medicare kind of situation. Their policy on physical therapy for example, $1500 dollars a year and that's it. My policy with a private insurance company is I have no cap but I have to prove justification every six weeks. So to do a pilot that just sort of has similar generic across a Medicare contractor kinds of rule versus the diverse payer where you have negotiated contracts based on employer groups and so forth, I think you really need to test that and I think you really need to shake that out because that's where you're going to see a lot of variability from private payers, so I think that's important that private payers participate in that.

A comment about the X12 HL7 XML, and I'm not going to try and step too far out of my area of knowledge here but this morning we were talking about the ability, I think Kepa had made a comment about the ability to have an XML document, a CDA inside a binary segment of an X12 transaction so that you know there has been limited work already done toward that, it's not completely gee we wonder if it's going to work. In April of last year Microsoft and a vendor called Gorilla Logic pulled something together in less then a month to do demonstrations at HL7 for us that demonstrated putting the CDA inside a bin inside an X12 segment. And just recently at HIMSS Epic and I'm at a loss for the other vendor that participated in this but there was a CDA claims attachment part of the HL7 IHE interoperability demo at HIMSS, so they did demonstrate creating a CDA, putting it where it belongs and sending it along.

So we've had a little, yeah, it's all demonstration kind of stuff, it's not real provider/payer exchange, but we have had vendors do it. I couldn't even tell you about the success of it but it has started at least to be looked at.

I have to say this because I think you all have to know this, I know Stan knows this, about LOINC, there's a lot of concern and I think that's because it's new and it's different and there are some expectation not knowing any different that all of a sudden implementers of claims attachments are going to have to support this 35,000 or 40,000 code set for attachments. Not the case, not even close to being the case.

What we're doing with the majority of attachments with LOINC is literally tagging a question, identifying a question, what is the patient's weight, that's the LOINC code, that's the question. The answer is the value, 120 pounds, 180 pounds, it's not a LOINC code value that existed in LOINC for its truest sense of use in the clinical and laboratory environment, it's sort of LOINC for attachments. And so back to the education, no, why would anybody know that unless they learned about it but it's important to understand that we all think at least in the HL7 side that some of the fear about LOINC is the fear of the unknown not necessarily consistent with what folks are thinking in terms of LOINC.

Let's see, there was a comment, and I'm wrapping up, there was a comment right before lunch about concern expressed that with the development and perhaps the promulgation of this rule and development of this standard that the entire medical record, the entire chart would be required to be sent by a provider in every situation. I just want to be on record with HL7 saying that isn't even close to the case, there's no requirement for anything. The transmission vehicle, the standard allows, if the payer were to request from the provider, as my payer did for my PT provider, came one year they said give me her entire, I want to see her entire chart, all of her progress notes. They asked for it, could they send it in this solution? Yes. Is there a requirement for a provider to do that each and every time they submit a bill? Never the intent, not even close, why would the payer want that, why would the provider want to do that, and furthermore one would think that again, references made earlier as well, the minimum necessary provisions of privacy would prohibit that. The provider would be inappropriate in doing that, so can it support it, sure, but don't anybody be misunderstood to say that this thing will now start requiring that because that couldn't be farther from the truth.

I think I'm done, those were my points. Thank you.

DR. COHN: Maria, you've been very patient all day with us, so thank you. Other comments from the open mic before we --

DR. BICKFORD: Carol Bickford, American Nurses Association. Throughout today's sessions I've been bothered by the thought that we are just automating a mess and getting it worse and worse and worse. I'm inquiring about what we're doing to evaluate exactly what it is we're trying to move or talk about the data components, can some of that be resolved by doing it right at the front end so we don't have to deal with attachments? What is the purpose of the attachments?

There's a second thought and that is we've been focusing on the financial components, how are we looking at it from the further use of the data that are being transmitted in the attachments and those reporting structures to help us to dour evidence based practice and understanding of outcomes in the diagnosis and interventions pieces. Are we setting up the structure so that we're able to do the research that needs to be accomplished?

So I guess my biggest concern is we're automating a mess so we're doing it faster.

DR. COHN: Thank you. Sheila?

MS. FRANK: Sheila Frank from Delta Dental Plans Association. A little bit on the same vein but not quite, DDPA understands that the whole industry would like to simplify the claims process to the point where attachments are not required, but at what cost? HIPAA doesn't mandate the standardization of health insurance plan design, payment models, or payer operations.

Some plans are dependent on the data in the attachments to operate their plans according to contractual obligations, government reporting requirements such as Medicaid expressed today, and sound business practices. And also the concern for the health of our beneficiaries, this data is used for evidence based practice research and improvement of payment models. This is the state of the art of our business today. The type of data found in attachment is now collected almost exclusively in hard copy.

To resist finding a solution for today's immediate dilemma eliminating the transfer of paper and x-ray films in my industry will not move us rapidly toward anybody's broader goal, or the ADA's goal of simpler dental care models, or dental care payments models. DDPA is not willing to say that the solution proposed by HL7 is the best one for conveying attachment information but it's the only one being given serious consideration as a HIPAA sanctioned national standard right this minute.

For that reason we're supporting it like the Medicaid agencies, and are looking forward to the balloting of a periodontal attachment standard that can be adopted uniformly across the dental industry as a maximum dataset when and if such information is needed in support of claims. We think that building the standards absent any HIPAA regulations will at least get us in the right direction of defining our maximum datasets for these attachments. And I'm sure that view is shared by the NMEH, being a member of the NMEH also myself.

DR. COHN: Thank you. Any final comments? Okay, well I want to thank everyone, I want to thank our panelists as well as those on the open mic and we'll take a ten minute break.

[Brief break.]

Agenda Item: Subcommittee Discussion and Development of a Draft Recommendation Letter to the Secretary - Dr. Cohn

DR. COHN: Now before we start sort of discussing a letter and what we ought to do, etc., I think Stan Nachimson wanted to just reflect a little bit on what he'd been hearing as well as I think some thoughts that CMS has had about all of this as they draft various documents, is that a nice way to describe that?

MR. NACHIMSON: Thank you, Simon. In some ways I feel actually very good about the testimony, so I really appreciate the time the testifiers took to think about these issues around claims attachments and present them to the subcommittee. What I feel good about is that we've been able to address a number of them in the development of the NPRM and in some of the things that we're doing and I just wanted to bring those to the subcommittee's attention.

I think the NPRM will address some of the critical issues that were raised today, certainly will make some proposals and ask for further public comment on things like unsolicited attachments and the concern that the payers have expressed to us that if we allow unsolicited attachments then providers are just going to send lots and lots of not paper, but they'll be electronic attachments and what are payers supposed to do with all that information.

We will look at the incremental approach, staged approach that several people have mentioned and ask for public comments on things like that. I think it's critical, it was mentioned in the WEDI testimony, that the rest of the transactions appears to be a major industry concern about implementation. They'll be a discussion about minimum necessary concerns as people have already addressed.

There was a lot of mention about the role of vendors and clearinghouses and whether they will or they won't be ready, whether they will or they won't be willing to adopt this particular standard. We're working through AFECHT and a number of other committees to sit down and really had mentioned this in our testimony to work with the vendor community, both expose them to the standard and actually get input even before we come out with the NPRM as to the appropriate, how they feel about the standard, what the timing is, what the cost involved and the effort involved in building these systems and whether these kind of a standard makes sense for their systems.

The concern about whether or not plans will implement this, the simple answer is that if we were to publish a regulation adopting these standards there's a requirement that plans have to be able to support the standard, I think that's why it's critical to get their input as to what, as to the cost and timing involved in that.

We do continue to look for pilot tests, not a whole lot of government funding available at this point, we are researching different possible places to get some funding for pilots. Anyone, any groups that have already expressed interest we'd be happy to work with them in setting up a pilot test and trying to define what some of the parameters are.

The mention of the NPRM and the Notice of Intent, I just want to make sure that people understand that should we publish an NPRM and there be a pilot test and should the pilot test say that you were completely wrong in the proposed approach in the NPRM we actually would go out then and publish another NPRM, we would not move immediately to a final rule and say oh, made a mistake, we're going to go this way.

DR. COHN: Say again what you just said.

MR. NACHIMSON: Should we publish an NPRM that proposes an approach and through pilot tests and other public comments the response is their approach is not correct we would not say oh, we'll change the approach and then publish that in a final rule without giving the industry enough opportunity to comment, we would in all probability publish another Notice of Proposed Rule Making and allow the industry to comment on the major change of approach. I think that's an important consideration, under the APA if there's a major change from what you're proposing to what you'd like to have as a final you do need to publish a Notice of Proposed Rule Making.

DR. COHN: We were trying to figure out how all that would work in the world of the regulatory environments, actually it's reassuring to hear that there's provisions for that sort of flexibility. Other questions for Stan before we --

MR. REYNOLDS: Has that ever been done before?

MR. NACHIMSON: Published additional NPRMs? I'm certain it has, I'm not aware of particular items but that discussion takes place all the time so I would guess very much that --

MR. REYNOLDS: Just a question on theory versus practicality.

DR. COHN: I guess the other piece would be this issue --

DR. STEINDEL: Simon, I can directly answer that question. In the area of HIPAA probably not but in the area of CLEA(?) that has happened.

DR. COHN: Well good. And I was going to say another option obviously would be an extended public comment period that would include the actual pilot period themselves. I think we need to somehow reflect support of that idea because I think that was one of the things we were hearing that if you're going to do pilots you want to make sure the pilots, results of the pilots get put into a final reg and probably it isn't just the pilots but it's everybody's comments about the pilots.

MR. NACHIMSON: And for HIPAA regs there is no deadline by which we have to publish a final rule after the Notice of Proposed Rule Making is published so some of the comments, should we publish a Notice of Proposed Rule Making comments could come in that say do not publish a final rule until the results of pilots tests are known and we could take that into account.

DR. COHN: Yes, Jeff, I'm sorry.

MR. BLAIR: Stan, is there a mechanism to accommodate the request that we heard from a few folks that we're saying that there should be an opportunity for industry comment on the success, limitations, or failures of the pilot test that would be reflected in the NPRM, not saying that the NPRM wouldn't begin until after that's all done but what I was, I'm thinking that if there would be a mechanism, this is what some folks were saying, they wanted there to be public comment on the output of the pilot tests and that that would be reflected in the NPRM and I thought maybe if there was an extended comment period for the NPRM that they would have an opportunity to somehow get that reflected in, or if there's some mechanism, maybe some, whether it is a publication of the results of the pilot test so people could respond and react to them. Is there anything like that that could be done?

MR. NACHIMSON: I don't know the answer to that question, I can think of several possibilities and it would depend on perhaps who's sponsoring the pilot test given that the department has to rely on the advice of several outside organizations under HIPAA, the NUBC, the NUCC, ADA, and WEDI for example, before publishing and finally adopting standards. I would think it might be possible that should one of those organizations sponsor the pilot test and gather comments we could rely on that. I don't know how far we could actually extend the public comment process.

DR. COHN: It sounds like rather then trying to decide the exact mechanism here we need to stay at a high enough level where we're sort of, I mean whatever we come forward with needs to sort of reflect that view that, assuming we decide we want to start with an NPRM we also want pilots, we also want sort of the results of the pilots, and I think Jeff you're commenting about comments about the pilots as well as the results of the pilots to be reflected in whatever process leads to a final rule. And I think that that's sort of what we're saying and I think we've heard a couple of different methods to do that. I guess I would suggest that we might, rather then trying to micromanage this particular process, that we leave to the Secretary and the department how to ensure that's actually worked out and we try to focus to make sure that the sort of the process pieces are in place where the input is as we sort of would like to see it. Does that make sense?

Any other questions for Stan before we take a look at this letter? Okay.

Well, now there's a letter, for those on the internet there's a letter on the screen that we're going to start reading through, this was a draft letter that we began to prepare after the December 10th hearings and then realized as we were writing it that we really didn't feel that we had enough input perspective from the industry for us to really go forward with it, which is of course the reason for the session today.

As I've reflected on it as I'm listening and of course we all know that we hear through sort of a filtering process, but I think that a lot of the letter actually still stands even after the hearings today though I think we all need to reflect on them and certainly I think it remains a good starting point for us to either begin to wordsmith or accept or otherwise. I think in the interest, recognizing that others around the room probably don't have copies of it, I'm sure those on the internet haven't seen it, how about if I just start reading through it from paragraph to paragraph and we'll see if we sort of agree with it, and then we'll move to the next paragraph, after we're sort of done with whatever changes to a paragraph we can reflect on are there more things that need to be in here that we've somehow missed. Is that an acceptable process for everyone?

Let me start with the first paragraph. Dear Secretary Thompson, as part of its responsibilities under HIPAA the NCVHS is responsible for studying, selecting, and recommending standards for health care claim attachments. To fulfill these responsibilities NCVHS's Subcommittee on Standards and Security recently held hearings on standards for electronic claims attachments, and probably I would at this point say held a set of hearings on electronic claims attachments, this is wordsmithing, or we could say held hearings on standards for electronic claim attachments on X and Y date, dates, okay, why don't we do dates.

MS. GRAHAM: Does it matter if the language, I mean in one part we refer to them as health claim attachment and then we refer to them as electronic claims attachments, does that need to be consistent?

MR. BLAIR: I think it's health claims attachments --

DR. COHN: I guess it's electronic health claims attachments, right? And probably the same changes needs to be like electronic health claims attachments two lines above. Okay, are we comfortable with those changes? Should we move on? Did you have a comment? Okay. And obviously we can do minor word tweaking and wordsmithing even post this session if great additional words or we somehow mis-described some of the concepts here.

Next paragraph. The subcommittee heard testimony about the need for both basic and advanced functionality in a claims attachment standard. For example, such a standard should be flexible so that physician offices and others with minimal infrastructure can electronic transfer claims attachment information to health plans and clearinghouses. At the same time the standards should possess the flexibility to permit users with more sophisticated infrastructures, such as hospitals and payers using electronic health records, to fully leverage their investments in electronic technology. HL7, X12, and it says and others, I don't know that we've heard about any others, I think it's just HL7 and X12 have been working to develop a claims attachment standard that can meet these requirements. And I guess I would just ask you to correct me if I'm wrong, somebody in an edit had put others, I don't think despite our investigation we've heard of any others working on the claims attachment standard. I'm sorry, what?

PARTICIPANT: [Comment off microphone.]

MR. BLAIR: Were you thinking like DICOM as an image or XML or what were you thinking of when you said other standards?

PARTICIPANT: [Comment off microphone.]

DR. HUFF: But it's not an attachment standard, it's an image transmission standard. I agree with you but I don't, I would strike and others.

DR. COHN: I think we heard testimony today about other approaches to electronic claims attachments but I didn't hear anybody coming forward with a standard in this area.

DR. FITZMAURICE: You could qualify this by saying the HIPAA claim attachment, I think X12 and HL7 are the only ones working on the HIPAA claims attachment standard.

DR. COHN: Okay, that sounds good.

PARTICIPANT: [Comment off microphone.]

DR. COHN: We're only going to advise on the HIPAA piece. Now a minor change up here which is an earlier sentence, talked about permit users with more sophisticated infrastructures, such as hospitals and payers using electronic health records, I don't know about payers using electronic health records, I mean it seems like that really relates to hospitals.

MR. REYNOLDS: Interfacing might be a word.

DR. COHN: I guess the question, what should we do with that sentence to make it sound reasonable, I'm open, we're talking about the idea of a more sophisticated infrastructures, maybe such as some hospitals and payers?

PARTICIPANT: [Comment off microphone.]

DR. COHN: Okay, we're comfortable Harry?

MR. REYNOLDS: I have a question before we move on. The second sentence in that paragraph, are we saying that the minimal infrastructure is base compliance philosophically and then you can go from there? We're setting that, once we decide what that minimum requirement would be that is the minimum requirement, people go up from there as they choose.

DR. COHN: That was my understanding, I mean if it says something different we need to --

MR. REYNOLDS: Well, that's what I'm trying to understand, it can sound like two standards the way it reads right now.

DR. FITZMAURICE: Is there one standard and it has many component, or are there many standards?

MR. REYNOLDS: Well, if it has multiple levels, again, you can, it's the idea of minimum infrastructure is one way of looking at it, might be a lower cost way of doing it also, versus going the other way possibly in some kind of a transition period, so just making sure that are we saying for the small it's this and the larger it's this or is this --

DR. COHN: Well, no, actually we aren't saying that, we were saying that people have minimal infrastructures regardless of whether you're small or large.

MR. REYNOLDS: I just want to make sure.

DR. COHN: Can start with the basics and be in compliance, and I guess the belief is is that there's business value in moving to greater functionality. And I guess the other question is in this last paragraph, is this HIPAA claims attachment standards, or is, I think it's a standard --

DR. FITZMAURICE: It's a standard with many components I would guess.

DR. COHN: Yeah, that what's I, okay, good. We sort of talk about standards and standard, Maria, it looks like you have --

MS. WARD: [Comment off microphone.]

DR. FITZMAURICE: But when you combine them you have a HIPAA standard right? You don't combine them you don't have a HIPAA standard.

MS. WARD: [Comment off microphone.]

DR. FITZMAURICE: The HIPAA standard has several ANSI components, several ANSI accredited standard --

DR. COHN: I think leaving it singular makes more sense because I think it's, I think we're just talking about our two components of a complete package that would likely be, if it were going to go forward would have to be specified by the Secretary or else it wouldn't work. Okay, Michael. I'm sorry, I apologize, I've been having back problems and I'm not turning real well. Carol, would you like to comment and then Michael and then Stan.

DR. BICKFORD: In the second sentence you have physician offices, that needs to be provider or practitioner to allow those of us who are not physicians to be included.

PARTICIPANT: Just make it practitioners or providers?

DR. COHN: Why don't we say physician and other practitioners offices? The problem we get provider is in the outside world, at least in CMS provider also relates to institutions which provides no end to confusion here. Michael.

DR. FITZMAURICE: We've gotten down now to the third paragraph and we haven't told the Secretary from whom we heard testimony. I would offer a suggestion of moving the testimony from payers and providers up to the top of the second paragraph.

MS. FRIEDMAN: Should I move all that?

DR. COHN: We haven't gotten to the third paragraph yet, heard testimony from vendors, payers, associations, and providers further emphasizing --

MS. FRIEDMAN: Move all that up, heard testimony from --

DR. COHN: Okay, sure. Okay, other comments on this? I'm sorry, Judy?

DR. WARREN: Back on the change we made, physician and other practitioner offices, we got rid of the others, I thought the others was important, I mean that could be small community hospitals, rural hospitals, or other kinds of places, not necessarily practitioner offices.

DR. COHN: And other providers.

MS. FRIEDMAN: So physicians, other practitioner --

MR. BLAIR: No, physicians, practitioners, and other providers.

DR. COHN: This needs to have some wordsmithing, no, it still doesn't make any sense here.

DR. WARREN: Or it could be physician and other practitioners, to me the problem wordsmithing providers because we never know what providers means, whether it's somebody can do a bill or whether it's someone who gives care.

DR. COHN: No, I agree with you --

DR. WARREN: It's the organization that I'm trying to get at, small organizations, back to where we have a continuum of standards.

DR. COHN: So we might say physicians, other practitioners, and small hospitals?

DR. STEINDEL: I was going to suggest then a diversity of providers, so we get rid of the two others.

DR. WARREN: Or maybe it's provider organizations.

DR. COHN: Well, I think we're getting into terms that no one even understands, and this is an example, so let's see, how exhaustive do we want this example.

MS. FRIEDMAN: How about provider, provider something such as small physician practices and rural hospitals?

DR. FITZMAURICE: Or just say providers.

MR. BLAIR: Just health care providers.

DR. COHN: That sounds fine. We've really taken this down to the basics, okay, sounds good. Michael?

DR. FITZMAURICE: We said a whole paragraph about making it useful for everybody but we haven't mentioned the payers and we did have such as hospitals and payers using electronic health records, and we got hung up on records, we could say hospitals and payers using electronic health information.

MR. REYNOLDS: That's not a key word, I agree with you, that's not a key phrase. Electronic health records has its own world right now.

DR. FITZMAURICE: And I would take out the large provider practices and replace that with and payers so we have something for everybody, there's something for providers, there's something for payers.

MS. GRAHAM: You're saying the payers that the ability to receive electronic --

DR. FITZMAURICE: Not only receive but they use electronic health information for myriad purposes.

DR. COHN: Okay, at the same time the standard should possess the flexibility to permit users with more sophisticated infrastructures, such as hospitals and payers using electronic health information to fully --

MR. NACHIMSON: I was going to say just to stock to the HIPAA vocabulary we use health plans rather then payers.

DR. COHN: Okay, let's change it to health plans, to fully leverage their investment in electronic technology. It's probably information technology rather then electronic technology at the end there, but I guess I'm trying to think of how we're differentiating the provider with minimal infrastructure from the fact that we're saying hospitals here with, you see what I'm sort of saying here, what sort of hospital, using electronic health --

MR. NACHIMSON: Is there a need for you to give that example or can you take that entire phrase out and just have it read standards should possess the flexibility to permit users with more sophisticated infrastructure to fully leverage investment.

DR. COHN: Is that better? Okay. Sounds good. Now are we leaving the hospitals and health plans or are we getting rid of those?

PARTICIPANT: The software's not taking that.

DR. COHN: Oh, interesting. Okay.

DR. WARREN: So on the first line do we need to change payers up there to health plans?

DR. COHN: Yes. Now associations is important in this, okay everybody I think we're almost done with this, I'm just sort of looking at the first sentence where it says the subcommittee heard testimony from health plans, vendors, associations, and providers, it seems like sort of an odd group and I'm trying to think of how better --

PARTICIPANT: [Comment off microphone.]

DR. COHN: And standards, thank you. I don't know that we should, this is one maybe we want to look at previous letters that we've written because we usually, I think we've used these terms before somehow and maybe it's the vendors and associations, I mean usually providers are number two and, something about the wording here seems a little, Maria, is that something I could have you take a look at off line?

MS. FRIEDMAN: Yes.

DR. COHN: Okay, great. Okay, should we go on to the next paragraph? Yes.

PARTICIPANT: [Comment off microphone.]

DR. COHN: Okay. I guess we should call this Accredited Standards Committee X12 --

MR. BLAIR: Accredited Standards Committee X12N.

DR. HUFF: That first number seven should be spelled out.

DR. COHN: Okay, should we go on to the next paragraph and let some of this cleaned up, we'll put parenthesis after Accredited Standards Committee X12N, we'll call it ASC X12N. Okay, move on to the next paragraph? Everybody okay?

The next paragraph is said the committee heard testimony further emphasizing the need for demonstration projects and pilot studies to identify problems and quantify benefits and costs associated with the implementation of the new HL7 and ANSI X12 claims attachment study. Should be standards, stop there and fix that.

DR. FITZMAURICE: I would strike out the new HL7 because the Secretary, it says old from new, and we haven't explained that difference to him.

MR. BLAIR: I don't even think you need the last part of that sentence because we just wound up saying what the standards are so I think you could just say we need the demonstration projects to identify the issues and problems.

MR. REYNOLDS: I would also add in there by identifying problems also process impacts, one of the things I don't think we heard enough about today possibly Simon was what's it actually going to do to people's processes to have to get ready for this, I think that's one of the big deliveries that the pilot studies will give.

MR. BLAIR: Is this the sentence where, I don't want to stick a whole lot of stuff in but maybe we could just add just a few things and then this lists our concerns, like for example we've got the workflow issues, the business case issues, and the privacy issues, and if that's in this sentence then maybe we've taken care of it and don't have to have a separate list of concerns.

PARTICIPANT: How long do you want the laundry list to be?

MR. REYNOLDS: You could replace my word process with impacts with workflow, I think workflow impacts is probably a better way to say it.

DR. COHN: I'm just trying to think of where it should be and whether it should be here or --

PARTICIPANT: Workflow impacts, privacy concerns and --

DR. COHN: I guess that part of the issue is as I'm looking at identify workflow impacts, I'm not necessarily expecting a pilot study necessarily to identify workflow impacts as opposed to --

MR. BLAIR: What if we listed as issues --

DR. WARREN: Workflow impacts is in the wrong place, it should be after the other one, let the pilots identify them.

MR. BLAIR: Right.

MR. WATCHKINS(?): I'm Larry Watchkins, co-chair of WEDI-SNIP, as we've been working through these same types of issues, obviously not in a pilot which would have been nice for the regular HIPAA transactions or the ten, the three I would list it as workflow impacts, implementation obstacles, and probably privacy concerns fits in there as well but I think implementation obstacles is another item that's not necessarily about workflow, it's just what are the realities that the industry is dealing with both cost wise and implementation wise that might cause issues, and that we need to identify through a pilot.

MR. BLAIR: I can't see how far along you are because I don't want to interrupt what you're doing but I have a different word there that I'd like to suggest when you're ready, Maria.

MS. FRIEDMAN: Okay, let me read this as it is, and I have a suggestion to take off the back end of this. The subcommittee heard testimony further emphasizing the need for demonstration projects and pilot studies to identify issues and problems as well as quantify benefits, costs, workflow impacts, implementation obstacles and privacy concerns associated with implementation of the claim attachment standards. And I just think we should end it at privacy concerns.

DR. COHN: I agree, I think the first part of the sentence needs some clean up too.

DR. STEINDEL: Take out say heard the need, we don't usually say --

MS. FRIEDMAN: Heard some testimony --

DR. STEINDEL: Heard the need, take out the clause testimony for, we don't usually, when we introduce that we've heard testimony in the first paragraph we usually don't repeat that we heard testimony again, we just say we heard the need or something like that.

DR. COHN: Jeff, you were going to make a suggestion and then I'll make a suggestion.

MR. BLAIR: After workflow the word impacts has a negative connotation, I think we need a more neutral word, either workflow changes, accommodations, or issues, whatever everyone feels comfortable with, workflow changes.

MS. GRAHAM: Is that meant to encompass the issues brought up by numerous people about the process being a little broken, as far as even the carriers, so that's meant to encompass that?

DR. COHN: I hope so, it's obviously a high level, beyond obviously, hopefully it will include that. Judy?

DR. WARREN: Yeah, I was just responding to Jeff's thing for a neutral term, implementation obstacles bothers me, could we say implementation challenges?

DR. COHN: Sounds good.

PARTICIPANT: You like that better then barriers?

DR. WARREN: Yes.

DR. COHN: Let's take a look at the beginning, we started talking about to identify issues and problems as well as quantify benefits, costs, workflow changes, implementation challenges, and privacy concerns. I don't know what the issues and problems, those seems like we're already specifying issues and problems that we, I think basically to, I think we want to have studies to quantify benefits, costs, needed workflow changes, identify implementation challenges, I think we can sort of get rid of that first part.

DR. HUFF: Standard should just be singular at the very end of the sentence, right, the claim attachment.

DR. COHN: I think we're going to get rid of the, do you want me to read this as it is right now? The subcommittee heard the need for demonstration projects and pilot studies to quantify benefits, costs, workflow changes, implementation challenges, and privacy concerns associated with the implementation of the claims attachment standards. Probably there's too may implementations but we talked about maybe removing that last part. It sounds like we need an end to all of that. Jack, it sounds like you have a wordsmithing --

PARTICIPANT: No, actually this makes the sentence a little bit longer. You had heard testimony and I thought there was some committee interest in the idea of multiple pilots across a variety of public and private payers rather then just -- if that's in fact the committee or subcommittee feels worthwhile putting in the fact that it ought to be public and private, not just Medicare --

PARTICIPANT: I think that's down a couple of sentences, maybe address that when we get to there.

DR. FITZMAURICE: Should standards be singular?

PARTICIPANT: They should be singular but the question is do we even want to keep that part.

DR. COHN: Why don't we get rid of the s there, why don't we get rid of implementation in the sentence above --

PARTICIPANT: And just end it at privacy concerns.

DR. WARREN: There's also a problem with the word quantify, are we quantifying costs or quantifying workflow changes and quantifying implementation challenges and quantifying privacy, to identify?

DR. COHN: To investigate?

DR. FITZMAURICE: In case we don't do it we can say that we investigated it.

DR. HUFF: You could put the quantify right ahead of cost because I think --

DR. WARREN: Isn't investigate meant to apply to that whole string?

MR. BLAIR: I think she was replacing quantify because we don't know that we could quantify all of that but we could investigate it?

DR. HUFF: No, I was just trying to put quantify right ahead of, inside a comma, benefits, quantify costs --

DR. WARREN: You still have investigate all the rest.

DR. COHN: Well, I think it's really a question here about whether or not we're putting verbs in front of each of those that relate to them because I guess the point to my view of a project and pilot study is not just to investigate something but it's also to come up with strategies to overcome obstacles is what I tend to think of the point of these things, or recommend best practices around so I don't know that we, if all we want to do is investigate implementation challenges --

MS. GRAHAM: -- do want to just add and recommend options or solutions or strategies, I though all part we don't know, we know what some the privacy concerns are but there might be more then what we've heard, roll out --

MS. FRIEDMAN: [Comment off microphone.]

DR. COHN: Maybe it's potential privacy concerns, okay --

DR. WARREN: We've taken the negative out of everything else but that.

DR. COHN: My question is is that I think I was just sort of making a comment here, basically we have investigate the benefits, cots, workflow changes, I think it may be challenges, implementation challenges, and potential privacy concerns as well as best practices --

DR. STEINDEL: I don't like the word potential in front of privacy concerns, just privacy concerns, there may be none that were identified.

DR. COHN: Yeah, you're probably right.

MS. GRAHAM: With really privacy requirements, can this solution address privacy requirements --

MS. FRIEDMAN: [Comment off microphone.]

MR. BLAIR: I don't think it hurts anything for us to list it as privacy concerns. There's many people that have concerns about privacy and will investigate that as it applies to these standards, what will come out in terms of, what comes out comes out, but those concerns already exist.

MR. REYNOLDS: I think a key thing is not to confuse, we want the pilots to truly do what they need to do and then we need to decide whether it's a concern or not a concern afterwards in each of those categories.

PARTICIPANT: [Comment off microphone.]

MR. REYNOLDS: Simon, I'm with you, I think investigate, I'd like a stronger word, document, whatever but investigate says I can look at it and I don't have to, if I was doing a pilot I could investigate it, it's not a problem, I wouldn't have to document it coming forward to say this is what the impact is.

DR. COHN: Probably it messes up the first, middle part, we almost want to demonstrate the benefits, costs, and all of that which is what a pilot study typically does but it sort of falls apart as you go through all the comments here.

DR. WARREN: Maybe the last comment after privacy concerns, as you were saying demonstrate best practices, kind of changes the members of the list a little bit.

DR. COHN: Jeff, what were you thinking?

MR. BLAIR: I'm not sure this is right but the purpose of the demonstration projects is to try to provide additional information on all of these issues, and then Health and Human Services and the general public will wind up either, the general public I'm assuming is going to make comments on those and Health and Human Services will try to put that forth into an appropriate guidance for regulations, so I don't necessarily see that the demonstration projects are going to solve what they surface as issues in all cases. So I think that if we just indicate that the purpose of the demonstration projects is to, I'm not sure what I'm saying is entirely correct because hopefully we're going to wind up showing that the demonstration projects will also prove the feasibility and appropriateness of the standard, so I guess I'm going to withdraw my comment.

DR. COHN: And maybe it isn't demonstrate, maybe it's identify best practices, let me read this because it still doesn't quite hang together, we actually need to sort of somehow come to enough agreement that we can do some more wordsmithing on the side. But basically we have the subcommittee heard the need for demonstration projects and pilot studies to, right now we have investigate the benefits, costs, workflow changes, implementation challenges and privacy concerns as well as identify best practices associated with the claims attachment standard. Yes, Jeff, well it's bad now but you can certainly add more.

MR. BLAIR: Finish what you're working on because I have a different part related to this and I don't want to interrupt.

DR. COHN: Well, it's not together but maybe --

MR. BLAIR: A thousand years ago when we were dealing with the HIPAA transaction standards one of the major issues was the readiness of the standards and we don't have that in here, and I think that since we're in such an early stage here that that's an important issue that shouldn't be left out, is the demonstration projects should also be demonstrating the readiness of the standards.

PARTICIPANT: Readiness for adoption --

MR. BLAIR: Readiness for implementation, implementation, adoption, either word.

DR. STEINDEL: Could that be covered under implementation challenges, Jeff?

MR. BLAIR: Well, the implementation challenge, maybe it should replace implementation challenge, maybe it should be readiness for adoption or readiness for implementation instead of the challenges.

DR. STEINDEL: No, I don't think so, I think implementation challenges includes the ability to express the standard as well as other technical issues associated within the organization.

MR. REYNOLDS: I want to go back to investigate one more time, the reason I say that is if people are going to consider stepping up to help fund this it's much harder to fund an investigation then it is to fund something that is going to be documented and can be used in further deliberations. And when you're starting to talk about this kind of money and this kind of effort and everything that clean documentation of what the findings are out of that puts it in a context that people might be more willing up front to put money in because they know there's going to be a documented occurrence coming up.

DR. COHN: So what are we talking about, to identify --

MR. REYNOLDS: Instead of investigate --

DR. STEINDEL: Can I suggest enumerate?

MR. REYNOLDS: Put document. Funding is much, when you're looking in the funding world I think it's much more palatable of a word.

DR. COHN: Sounds fine, okay, document the benefits, costs, workflow changes, implementation challenges and privacy concerns as well as identify best practices, as well as the best practices.

PARTICIPANT: Want me to get rid of that whole clause?

MR. BLAIR: Or just and best practices.

DR. COHN: Okay, so and best practices associated with claims attachment standard. Yes?

PARTICIPANT: [Comment off microphone.]

DR. COHN: I'd be fine with that, further requirements, what do you think? Everybody comfortable with that? I think it all sort of means the same thing. Okay, are we okay with that sentence? We'll go on to the next one and we'll come back and reread the paragraph since it's gone through some changes. Okay.

A pilot proposed by the Empire Blue Cross and Blue Shield, and then in parenthesis which is under consideration by CMS, is an example of the kind of projects that should be encouraged, supported and encouraged. Actually I think getting rid of which is under consideration by CMS, let's get rid of that. For example the kind of project --

PARTICIPANT: [Comment off microphone.]

MS. FRIEDMAN: What's the best way to describe it, just the way it is?

PARTICIPANT: Yeah, that's fine.

DR. COHN: Are we okay there then? NCVHS urges the department to support several different claims attachments, excuse me, it's claims attachment demonstration projects and pilots that would include institutional providers, physicians, dentists, pharmacies, multiple payers, clearinghouses, and software vendors. I'm not sure what multiple payers means, I think it's maybe payers.

MS. FRIEDMAN: Multiple payers at multiple sites. It's the whole cast of characters in different combinations.

DR. STEINDEL: Well first it could be health plans, I would just say health plans.

DR. COHN: I think we just change that to health plans, get rid of multiple.

PARTICIPANT: [Comment off microphone.]

DR. COHN: Exactly, you want multiple pharmacies, you'd want multiple dentists, we'd want multiple physicians.

DR. STEINDEL: Now getting back to the issue of the first paragraph when we had physicians and other providers, do we want to repeat that?

MS. FRIEDMAN: You're trying to cover home health --

MR. BLAIR: Home health is not in there, we need to add that don't you think?

DR. COHN: I don't know.

MR. BLAIR: Isn't it one of the very first high priorities of Medicaid and it was one of the first six --

PARTICIPANT: [Comment off microphone.]

MR. BLAIR: It's not? Durable medical equipment --

PARTICIPANT: [Comment off microphone.]

DR. COHN: Does it even make sense with those six to include pharmacies?

PARTICIPANT: [Comment off microphone.]

MR. BLAIR: Could you reread the six for us again?

PARTICIPANT: [Comment off microphone.]

DR. STEINDEL: Would dentists come in that group?

PARTICIPANT: [Comment off microphone.]

MS. FRIEDMAN: I think the idea of putting dentists in there is because the dental world as we've heard is fairly proactive in doing some of this already.

DR. STEINDEL: Yeah, but they may not be part of the first set of six claims attachments that are out there.

MS. FRIEDMAN: I understand that, the question is do you want to limit this, do you want to prescribe the set of studies to only stuff that's on the list but exclude people who are out there doing it already? That's the question.

DR. STEINDEL: That's a good question to raise because my personal feeling is that we probably should extend this list, in which case home health would be appropriate. I don't think we're going to be able to do another set of pilots, we'll be lucky if we can do this set of pilots.

MR. BLAIR: Maybe if we had an other at the end then it leaves it open because yes, dental is doing it now but they're not necessarily doing it with the HIPAA, HL7, X12N standard and we're thinking about --

MS. FRIEDMAN: That might be one of the things that a pilot would look at.

MR. BLAIR: Yeah, exactly, is there an ability to accommodate the standard we're talking about or the degree to which they're doing it now could be accepted.

DR. COHN: So help me with where we're going here, we've obviously got the claims attachment standard that has six attachments right now and so do we identify people for the pilots that have no relationship to those demonstration, I mean to those claims attachments and if so how would we involve them in this pilot, exactly what are we doing here?

MR. BLAIR: If we list it as e.g., such as, and then we're giving examples, then it leaves it to HHS to make it as broad or as narrow as, as broad as they can but it doesn't constrain them, we're not being descriptive we're giving examples.

MS. FRIEDMAN: You could say have a different claim attachment demonstration project and pilots that would include a wide range of stakeholders or some other word such as institutional providers, etc.

DR. COHN: Okay, maybe a wide variety --

MS. FRIEDMAN: Or a variety?

MR. BLAIR: Let's use the words our testifiers gave us, they said it should be broad, a broad set --

DR. FITZMAURICE: Broad representation of.

MS. FRIEDMAN: Representation of stakeholders.

MR. BLAIR: Yes, such as and then you could list them and end it with others.

MS. FREIDMAN: You really want and others at the end?

MR. BLAIR: You don't have it, we have such as.

MS. FRIEDMAN: Okay, the way the sentence now reads is NCVHS urges the department towards several different claims attachment demonstration projects and pilots that would include a broad representation of stakeholders, such as institutional providers, physicians, dentists, pharmacies, health plans, clearinghouses, and software vendors. Or that would broadly, we could say that would broadly represent.

DR. COHN: I guess the question is whether, I mean an alternative way to describe this would be a broad representation of providers, health plans, clearinghouses, and software vendors, and leave it at that and use the wider concept of provider.

MS. FRIEDMAN: So you take out dentists and pharmacies?

DR. COHN: Well, I would take out institutional providers, I'd take out physicians, I'd take out dentists, pharmacists, I guess it still begs the question of how are dentists and pharmacists going to participate in this particular pilot.

DR. HUFF: Well, the dentists, the one thing that occurred to me is that they did mention that there could be applicability for oral surgeons, the op reports from oral surgeons.

DR. COHN: That's true, but that's not coming forward as one of the claims attachments.

DR. HUFF: If I submit a claim for payment for oral surgery they may want the op report from oral surgery.

MR. REYNOLDS: You could shorten it even more just by saying a broad representation of effected stakeholders, period. In other words, I agree with what somebody said a minute ago, home health is not up there, there's all kind of players that aren't up there. We either have to list 25 or almost nobody.

DR. COHN: I think it's one I'd be willing to get rid of because we're having trouble identifying appropriately, everybody okay with that? Going. Okay, let me bring up another issue here as we have, we basically have a sentence where it says a pilot proposed should be Empire Blue Cross/Blue Shield is an example of the kind, kinds of projects, I mean it's actually the example of the kind of project, which should be supported and encouraged. NCVHS urges the department to support several different claims attachment demonstration projects and pilots that would include a broad representation of effected stakeholders. Now my question is are we supporting or are we having them support and encourage, is our recommendation here is that HHS fund these, are we using support in the broad --

PARTICIPANT: To encourage, I mean there's different kinds of support beyond funding.

DR. COHN: Well, maybe encourages the department to encourage and support, I mean clearly we've got support and encourage, I don't know, I'm not sure I have a strong feeling on this one, do we want to leave it support for the moment?

Okay, last sentence is NCVHS recommends that these demonstration projects, I'm sorry?

DR. STEINDEL: Simon, do you think considering how we reworded the sentence, do you think we should put the Empire Blue Cross/Blue Shield example after?

DR. COHN: That's probably better. Okay, that looks good. Should I read the last sentence now? NCVHS recommends that these demonstration projects and pilots occur expeditiously so that the results and findings may feed directly into the development of the claims attachment rule.

PARTICIPANT: The final rule?

DR. FITZMAURICE: If you leave it like that then they can do it however they want, unless you feel strongly that it should come before the NPRM.

MR. BLAIR: This is I think where the testimony we were hearing today, I think people wanted the opportunity to comment on the results of these demonstration projects before there was a final rule, so maybe if we left it open ended without being too prescriptive that the results just simply would be reflected in the final rule or the rulemaking process, one of the two. But if it goes directly then people don't have a chance to comment.

DR. COHN: So are you agreeing with this sentence or not, Jeff, I'm sorry.

MR. BLAIR: No, I'm not agreeing with it because it says it goes directly into the final rule and people were saying that they wanted a chance to make comments as a results of the findings from the pilot tests before it went into a final rule.

DR. FITZMAURICE: Do you want to read it again so that Jeff can see what the sentence says? Because it doesn't say final rule --

DR. STEINDEL: It doesn't say final rule, the claims attachment rule.

PARTICIPANT: I think you need to take may out of there.

DR. COHN: Jeff, do you want to me to read this back to you? NCVHS recommends that these demonstration projects and pilots occur expeditiously so that the results and findings will feed into the development of the claims attachments rule. Okay? Okay everybody? Next paragraph?

PARTICIPANT: [Comment off microphone.]

MS. FRIEDMAN: You could put it here and say pilots proposed by Empire Blue Cross/Blue Shield and our examples --

DR. COHN: I guess I'm confused because I didn't hear that as a pilot, I thought that was a survey.

PARTICIPANT: That is both a survey and a pilot.

DR. COHN: Okay, because I only heard about the survey.

PARTICIPANT: It might be pilots, not just one pilot --

DR. COHN: Okay, having heard testimony on this one I guess I feel uncomfortable --

PARTICIPANT: I did mention this --

DR. COHN: No, what we heard from you was the survey.

PARTICIPANT: No, I said education survey and AFECHT [off microphone] --

DR. COHN: Well, that isn't a pilot though.

PARTICIPANT: [Comment off microphone.]

MS. FRIEDMAN: But you don't have a pilot yet, you don't have one in hand yet, well this one is in hand. This is in hand.

DR. COHN: We're obviously fully supportive but I'm just trying to think, we've obviously encouraged them to support and encourage a broad, several different claims attachment demonstration projects and pilots, I think that at this point that has to sort of reflect what you are all trying to do.

PARTICIPANT: [Comment off microphone.]

DR. COHN: No, no, once you guys get it together maybe we need to hear about it and we can just send a follow-up. Okay, are we okay there? Obviously we'll reflect on this tonight, I'm sure we'll have a chance tomorrow to also further wordsmith.

Finally NCVHS recommends that the rulemaking process begin without delay. We understand that an NPRM concerning electronic claims attachments currently is under development and we urge the department to issue this NPRM as soon as possible.

The NCVHS wishes to thank you for the opportunity to submit these recommendations.

MR. NACHIMSON: Simon, the first sentence of that paragraph, the rulemaking process has already begun, we've already begun to develop the proposed rules, I'm not sure what your first sentence --

MS. FRIEDMAN: How about continue without delay?

DR. COHN: How about finally we understand that a Notice of Proposed Rule Making concerning electronic claims attachments currently is under development and we urge the department to issue this NPRM as soon as possible.

PARTICIPANT: [Comment off microphone.]

DR. COHN: Is that okay? Now the question is are we missing anything here? This is not one of our greatest letters ever --

PARTICIPANT: [Comment off microphone.]

DR. COHN: You mean about the actual contents of the NPRM, or are you referring to about whether it should come out?

PARTICIPANT: [Comment off microphone.]

DR. FITZMAURICE: We heard a testimony that without an NPRM people won't even take anything seriously, they probably won't even volunteer for a pilot, so I think we do want to go ahead advocating an NPRM as soon as possible.

MR. BLAIR: The thought that I would have on this, and this is where I tend to feel a little awkward and uncomfortable, is we heard testimony on the one hand that people are not going to make investments in a demonstration project or implementing the standards into their vendor systems until they see some indication that an NPRM is underway and the federal government is serious about going down this track, so that's the reason that we're saying move forward and do this as fast as possible. On the other hand I think all of us, well, I can't say all of us but I certainly would feel very uncomfortable issuing a HIPAA rule when we haven't had demonstration projects to check all the issues that we've talked about above, so I think it's a balance between the two, we want to move forward, we want to encourage things, but I think those demonstration projects are critical.

DR. COHN: Vivian, do you have a comment?

MS. AULD: The second to the last paragraph, why don't you end it by saying we urge the department to issue this NPRM as soon as possible so pilot studies can be initiated or something to that effect, so you're implying at that point specifically that the pilot studies are waiting for the NPRM.

DR. FITZMAURICE: That's a good point because the NPRM would inform the pilot studies.

MR. BLAIR: There were a lot of testifiers that didn't want the NPRM to be released before the pilot studies concluded, so that's why we were kind of leaving that ambiguous so that HHS could --

DR. FITZMAURICE: I don't think they minded so much, Jeff, except that they wanted to be able to have comments in there before the final rule came out and if there were changes they would like to see another NPRM following the first NPRM, they just wanted to have a chance to see what the results of the pilots are and then to comment before they get hit with a final rule.

DR. STEINDEL: Mike, in regard to that do you think we, since Stanley has briefed us that actually under the Administrative Procedures Act they're required to do that, either in response to the comment or response to drastic changes in the NPRM that they originally released. Do you think we should explicitly state that to make people who are reading this letter feel more comfortable? Because the people won't know it --

DR. FITZMAURICE: But that's an administrative judgment.

PARTICIPANT: [Comment off microphone.]

DR. STEINDEL: No, that's exactly right.

MS. FRIEDMAN: Why would you want to even bring that up?

DR. STEINDEL: I was just reacting to Mike's comment, I personally do not see the need for it, I was --

DR. FITZMAURICE: I agree with you.

PARTICIPANT: [Comment off microphone.]

MS. FRIEDMAN: Why don't you reverse the order? Just move this last paragraph up and say we understand that an NPRM is underway, we urge that the department issues the NPRM as soon as possible, and then say we heard the need for all this and those results will feed into the development of the claims attachment --

DR. COHN: Come to the microphone please.

PARTICIPANT: Based on what you were all saying about people saying that they didn't really, that it's a double edged sword, people want to see pilots before they want the NPRM but they want the NPRM so that people will believe that there is going to be a reason to do the pilots, so why not consider with that sentence you just moved saying in order to encourage the development of these pilots so that people do believe that there will be a value add to this investment, come out with the rule so that people will take it seriously.

DR. COHN: Putting it back at the end here.

PARTICIPANT: Either that or say in order to ensure that people understand the government is committed to this rule NCVHS encourages the promulgation of this NPRM because it will help people feel that we are serious. And then the committee heard the need for the demonstration projects, so you can still leave it there but put in what one of the members was talking about in terms of that need for understanding that there is an investment or a commitment.

DR. COHN: I guess I first of all say that I sort of agree with the idea that we need to link it but I think it needs to be the last part back where it was because it makes absolutely no sense with the information we have above because we're just talking about well they're all working together and they're doing something, and there's sort of, I think we do and I think Jeff made probably the right comment, that we need to link, part of the value of getting the NPRM out was to really give the industry something to be able to do demonstrations and pilots around --

MR. BLAIR: And maybe we could use the words in order to be willing to invest in demonstration projects and software development.

MS. FRIEDMAN: So that the pilot projects --

MR. BLAIR: So that the industry is willing to invest in pilot projects and software development.

MS. FRIEDMAN: Willing to participate and, wait a minute, participate in pilot projects and invest in the needed infrastructure.

DR. COHN: Stan?

PARTICIPANT: I'm a little uncomfortable with the fact that from the previous conversation that we don't mention the fact that there's a desire to comment on this post the pilot, if we have a letter that says put out a Notice of Proposed Rule Making, do the pilots, and there's no reflection of the concern to then be able to comment on those pilots, we can essentially have something still go through that does not allow the public to comment on it.

DR. COHN: I actually agree with you, how about, up above, NCVHS understands that an NPRM concerning electronic claims attachments currently is under development. We urge the department to issue this NPRM as soon as possible so that the industry is willing to participate in the pilot projects and invest in the needed, willing to participate in pilot projects and invest in the needed infrastructure. We also encourage the department to provide for public comment on the results of the demonstrations and pilot before a final rule is promulgated.

The second sentence here is a little weird, I think the final sentence has gotten the view that we've all been trying to deal with, it says we urge the department to issue this NPRM as soon as possible so that the industry is willing to participate in pilot projects and invest in the needed infrastructure, maybe willing is, there's a couple wrong words there.

MS. FRIEDMAN: Be motivated.

DR. COHN: Motivated, okay.

PARTICIPANT: We urge them to do it as soon as possible, period, and then something like this will motivate the industry, but I think it's two thoughts, I don't think the only reason that you want it to move forward is so people will participate in a pilot, which is what you're saying.

DR. COHN: Thank you. Are we comfortable? Have we missed anything?

PARTICIPANT: The last sentence, you're thanking them for the opportunity to make a recommendation, actually they didn't give you that opportunity, that was given to you by legislation, so I would say you thank them for considering these recommendations or taking these recommendations, doing it, so that's just a comment from Larry.

DR. COHN: Okay. Now I'm actually expecting that there will be a couple more wordsmithing because I think that probably as we look at this, as Maria reviews it a little further there probably will be slightly, this will be slightly changed tomorrow, but barring wordsmithing changes are people comfortable with the contents and all this? I do apologize to everybody for the pain of this, that's why we keep our letters short usually because otherwise we'd never get through them. But is everyone comfortable with this? Do we have a motion to bring to the full committee tomorrow morning?

DR. HUFF: I move that we bring it to the full committee --

DR. COHN: With possible wordsmithing changes between now and then.

MR. BLAIR: I'll second that.

DR. COHN: Discussion? All in favor? Opposed? Abstentions? Okay, this letter is passed. Okay, Maria I'll let you do wordsmithing on it as you think about it and all of that. Should we move to the next issue?

Agenda Item: Subcommittee Discussion of Letter from DSMOs Concerning Standards for Billing for Supplies - Dr. Cohn

DR. COHN: I do want you to know that I had my yearly review in my regular job, the one I actually get paid for generally, and people thought that I was wonderful except that they just wished I would end meetings on time, they actually weren't even, they didn't even ask you to comment. So I do want to apologize that this is unfortunately running a little beyond where we thought it was going to end.

Now I did want to bring up this next issue and ask for your input and otherwise, there's a letter that we received recently from the DSMOs related to the billing of supplies for the pharmaceutical world basically and at issue is a request or ERISA recommendations brought to us back in I think it was 2002 related to a request from the DSMOs that the NCPDP standard could be utilized by pharmacies for supplies, for billable supplies. Now we hadn't actually given them a formal response and I was actually, one of the great things about taking long plane flights is I get to review all of the issues related to all of this stuff and so looked back to 2001, 2002 and see what was going on. Now there are a couple of things going on here and I actually need help from the subcommittee to see what sort of response, as well as what additional investigation we might need to do around all of this.

There are sort of two issues, one is should supplies be able to be billed using an NCPDP transaction, and that's one particular issue. There's also the issue which was really part of the original request from NCPDP, which is really what made the whole thing so problematic, at least as I remember looking at it from a couple of years ago, that they were describing the use of a couple of different code sets for the actual billing of those supplies, and these were code sets that we were not familiar with, did not do additional hearings on because of the press of events otherwise, and really have no knowledge of the quality of those code sets, I mean by our acceptance of the original recommendation we're obviously not only just approving the transaction and its use but also what at least appear to me to be effectively accepting two other medical code sets under HIPAA.

And so I guess the question number one is what sort of letter might we want to respond to them about, and then the other question is is do we need a briefing or dig in a little deeper around this issue of these code sets that NCPDP was recommending for supplies. Now that's the question, should we take a look at this letter and then we can reflect on that issue.

Maria, you're looking pained, is that, this is the advantage of having long plane flights on the way to NCVHS.

So our letter that we have sort of put together is thank you for your February 16th letter concerning the recommended use of NCPDP 5.1 for billing for supplies as a standard under the provisions of HIPAA. The NCVHS did not act on the recommendation, however we understand that the Department of Health and Human Services is aware of your request and the issues underlying it. We further understand that the department is taking these consideration into account in its rulemaking deliberations. We look forward to continuing collaboration with the DSMOs as HIPAA implementation moves ahead.

A relatively vanilla response but then bringing up these other issues about whether or not we need to pursue a little more around all of this. Maria? Tom?

MR. LOUDER: Thank you, my name is Tom Louder and I'm with AAHP/HIAA and I'm here today not only on behalf of our member companies but also on behalf of a coalition that includes the Academy of Managed Care Pharmacy, the American Pharmacists Association, the Pharmaceutical Care and Management Association, the National Association of Chain Drug Stores, and the National Council for Prescription Drug Programs, and we very strongly urge that you give favorable consideration to the NCPDP request and if not that you put this issue on your agenda for discussion and resolution at the earliest possible moment.

Just to give you a little bit of background, and we did send a letter and a white paper to this subcommittee supporting our request, currently most retail pharmacies use the NCPDP standard to bill both prescription drugs and supplies, it's a real time standard and it permits the retail pharmacy to get an almost instantaneous response back from the payer whether or not this is a covered benefit and whether or not there is any kind of a co-payment or co-insurance requirement involved. As it came time for the final HIPAA addendum to be issued I think people took another look at this and had one of those kind of oh my experiences where if you looked at the way the standard came out it appeared as if you would continue billing the prescription drug using the NCPDP standard but you would have to use the 837 to bill the supply, and the problem with that is the 837 professional claims standard is not real time, it's a batch transaction, and so you would have a situation, just as an example where someone would go into the pharmacy and they would have this prescription for, let's say they're a diabetic and so they've got a scrip for insulin and four syringes and the pharmacist would say to them okay, that's fine, I can go ahead and clear the prescription for the insulin but because I've got to use the 837 for the supply I've got to wait to clear that to give you the supply or in the alternative I'm going to go ahead and give it to you but I'm kind of on the hook here for the supply.

Just to give you an example, one of our member companies bills over a million dollars a month in supply claims right now using the NCPDP standards, so last August on behalf of this coalition we wrote to CMS and we went and talked to them, I know Stanley was there at that meeting, and kind of laid out the issue and at the time we were saying to CMS that we thought that the standard was actually somewhat unclear, that as long as the payer and the pharmacy worked out what standard they wanted to use it was okay for them to continue using the NCPDP because that's what they're using now, most of them, and CMS response to us was no, that they felt like it was pretty clear and that you had to use the 837. But they also pointed out to us there is of course this kind of interim period where you can use a contingency plan, which is what most of the members of the coalition are continuing to use as under this contingency idea there continuing to use the NCPDP standard for both supplies and for prescription drug claims. But I can tell you for the members of this coalition it's a huge issue and it needs to get resolved sooner rather then later.

DR. COHN: Tom, can I ask you a question because I actually reviewed, and I think many of you, I will apologize if not everybody received your letter, but I think I sent it out to everybody, you sent it to a number of us, okay, I did, there are obviously a couple of new members that didn't receive it. The letter that I received from you obviously spoke very strongly in support of the NCPDP 5.1, and I think the reasons you've given are good reasons, real time response and all of this. I didn't see anything in that letter that in any way dealt with the other issue that I was reflecting on, which was the use of the UPC or HRI for the billing of supplies within the NCPDP standard. Was there a position that your coalition was taking on that? Is that something that you've all investigated and have an opinion about?

MR. LOUDER: I don't know that we've investigated and have an opinion, I will just say, because this is actually the first time it's kind of presented itself in that context, I'll just say right now that our members are very successfully using the NCPDP standard, whatever that may mean in terms of these codes.

DR. HUFF: Are they using consistent codes, or are they all using, do they have bilateral agreements about what codes they'll put in this?

MR. LOUDER: That's a good question and that's something we can dig down into.

DR. COHN: I guess, Harry?

MR. REYNOLDS: NCPDP I think is a good thing, the two code sets when we're dealing with a regulation that's already got a lot of code sets, understanding that, I would like to know more about it, personally I would like to know a lot more about that before I'd vote it yes or no.

DR. COHN: Okay, I guess the question is, I mean this letter obviously doesn't address that piece but we can obviously go forward with this letter and we can also just tell, since we're expecting to see the DSMOs and I expect that Lynn Gilbertson would be there actually at the meeting where we have this sort of yearly discussion, we could at that point have a session where we sort of get some briefing and I know that Stan had offered to tell us more about these code sets and we might get others to tell us whether or not this is good or the right way to go or not. But once again, I guess in my own view it doesn't take a lot of brain power to figure that geez, if you're a pharmacy and you're billing supplies you probably want to use a real time transaction and so to me that's not an issue and I was once again reflecting that that was not what caused us to not address this issue a couple years ago, it was really the code set issue and I know as little now as I did two years ago about that so it sounds like we need to dig into that further and I'd obviously love it if you would talk to your coalition because we may ask you to come and give us your thoughts at that point.

DR. HUFF: I guess depending on how long we think that might take to investigate, because it seems like we're unanimously saying that we support NCPDP as the format standard, and could we make that statement with another sentence that said we need to investigate further what code sets should be used in that transaction.

MR. NACHIMSON: When this issue came up a couple of years ago during sort of the addenda process it came out after the proposed rule was published, which was one reason why we couldn't put it in the final rule, but there was also I'd call it dissention within the industry, there was not, after the final rule came out that said you use X12 for supplies, NCPDP for retail drugs if you're a pharmacy, there was not unanimous consent or even consensus in the industry about which to go to make the change and in fact some of the letters that we got even to this day say that some health plans ask for supplies to be billed on NCPDP, some health plans ask for supplies to be billed on X12, some health plans ask for prescriptions to be billed on X12 if it's considered a medical benefit. Some health plans call for drugs to be billed on NCPDP. Realizing that there's not consensus in the industry was one reason why we didn't make a change at that time but also why this is one of the issues that will be considered in the upcoming NPRM and allow for public comment. Although your coalition may have a different interpretation of the current reg then we do we at least recognize that it is clearly an issue that should be reopened and we intend that issue be reopened in this upcoming regulation, whether the subcommittee wants to discuss the details now or when we get closer or after the proposed rule is published is certainly a decision that is up to you but the department is clearly aware of this issue and willing to deal with it.

DR. COHN: Okay, well I guess we have some options about what we do with this letter, I mean we could say based on this conversation that we add a sentence, maybe we don't try to do the NCPDP sentence like we support this but we want to know more about code sets, we could just say to them expect to be discussing aspects of this further at our March 31st hearing assuming people are willing. We've got like a really full plate coming up next year so I'm afraid to sort of start overwhelming everybody.

MR. BLAIR: Simon if that's the case and we're going to hear more about this on March 31st why do we even need to actually send a letter?

PARTICIPANT: This is really just because there wasn't a full resolution to it so the DSMO is just coming back to the committee and saying where do you stand on this. There is a sense of urgency from NCPDP and that was expressed to us. There is a white paper, a great white paper that NCPDP put together on the billing for supplies and that may answer your questions if you don't want to wait until March 31st or whatever, it may answer your questions about current practices and using those code sets. I don't know, others may know better then I if that's available on their website, if not you certainly can get it, I could get it to you tomorrow if you want to distribute that, so that's the first thing, I really think you might find answers in that. And the second thing is Lynn Gilbertson at least at this point is not planning on coming here to talk about this unless you've expressly not in the context of DSMO, so if you think you want to add an agenda item you need to reach out and let them know that because the plan the right now was for Gary to come, Lynn doesn't typically come, for Gary to come and just talk about the DSMO annual report but Lynn wouldn't necessarily be here unless you invite her for this.

DR. COHN: I guess since she has been the one writing the letter I'd presumed we'd be seeing her. Maria?

MS. FRIEDMAN: Do we really even want to have an agenda item knowing that this issue is under consideration and will be addressed in the modifications reg? Wait and have those conversations after, or will they even be needed depended on how it's written?

MR. BLAIR: When does the modifications reg come out?

MR. NACHIMSON: Later this year, it is planned for 2004.

MR. REYNOLDS: Devoid of any recommendation from this committee, there is no other hearing, is that correct Stanley? Where the industry could give further testimony?

MR. NACHIMSON: Not a public hearing but certainly the public comment process, NPRM is the opportunity for an open --

DR. COHN: And if we're going to talk about this we need to talk about it soon because once an NPRM comes out, I mean we can comment on the NPRM but we don't hold hearings on topics that are being brought up in an NPRM during a comment period, it's way too confusing for everybody.

DR. FITZMAURICE: Stan, when this comes out will it come out as an NPRM or will it come out as a final rule, these changes?

MR. NACHIMSON: It's NPRM.

DR. COHN: As I said I personally think that the code issue is still an outstanding, it will likely be something we'd want to look at --

DR. FITZMAURICE: That does give us some time, if it's going to be an NPRM, even if we don't address it comments can come back saying please address this. If we act sooner they'll address it in the NPRM.

MR. BLAIR: For whatever it's worth Lynn is planning on being here to testify to us on e-prescribing on the 30th, which is the day before the 31st, so if there's any convenience in the fact that her trip would be here.

DR. COHN: Let's do this, what I think I'm hearing A, is that we ought to for example look at this letter, what I'd like to be able to do is to read it to the full committee tomorrow and it's pretty non-offensive, it shouldn't hurt anybody's feelings. I guess what I'm thinking is is that we should, I mean assuming that you're all willing we could A, approve this letter so that it could be read tomorrow as a hey, we'd like you to act on it. B, I'm hearing that Maria will be handing us a white paper that I sort of dimly remember from the old days but I've seen a number of white papers but this is a different white paper that NCPDP produced. My memory is that it still didn't address the code set issue but I'd be happy to be wrong, I mean this is getting to the limits of my space between my ears. So I mean we may, if we could have some copies of it we could all review it and then make a decision at our breakout tomorrow about whether we want to spend one session sort of getting briefed on these code sets, seeing how we feel about them, hearing a little about it and seeing if we feel comfortable going forward with anything around that or whether we still come away feeling it's too confusing and don't want to deal with it.

DR. FITZMAURICE: I agree with that plan, it sounds like a good plan. I wanted to draw attention that earlier we said that NCVHS understands about the claims attachment but I think the claims attachment rule is in a public notice that says this is on our standards plate for the coming year. Here we're talking about the we understand the department is aware of your request and we further understand, we don't say how we understand, it's not public knowledge --

DR. COHN: So?

DR. FITZMAURICE: So do we say rumor has it --

DR. COHN: Michael, I'm a special government employee.

MR. BLAIR: Could I ask a question? The letter isn't a problem, it's kind of non-committal and so I wonder if the letter has value to NCPDP and the representatives that use NCPDP that testified then I'd say okay, let's go ahead with the letter. But does it even have value because if it doesn't then we could use our time on other things until the 31st.

MS. FRIEDMAN: They had asked basically for closure on this and so this is the closure --

MR. BLAIR: But the letter doesn't give closure from what I could see, it basically --

MS. FRIEDMAN: It said we didn't act on this recommendation and that was the request, did you act on it or didn't you and we never heard back.

DR. FITZMAURICE: Let me address the other point, Simon, and that is as a special government employee we can't make comments about pre-decisional material, if we don't know this publicly then it's pre-decisional material that the department is aware of that request.

MS. FRIEDMAN: Didn't Stanley just say --

DR. FITZMAURICE: Oh, if he said it then let's say CMS. But otherwise it looks like rumor has it --

MS. FRIEDMAN: -- so does it really matter?

DR. FITZMAURICE: Well, if I'm reading the letter and it's a public letter well, how do they understand this, how do they understand it, the rumor mills say that, how do we act on the basis of a rumor.

DR. COHN: Should we say the department, how about this, how about if we say rather then we understand we say, get rid of that first part of the sentence and we say the Department of Health and Human Services is aware of your request and the issues underlying it.

PARTICIPANT: That makes it worse because that's even more --

DR. STEINDEL: I think we should just say Stanley is aware of your request --

PARTICIPANT: And he's on it.

DR. FITZMAURICE: Stanley while you were out we raised the issue of can we say that since there are special employees around here saying something about that maybe pre-decisional, that there's no public knowledge of --

MS. FRIEDMAN: He just said it and he's a real employee.

DR. FITZMAURICE: I don't think we want to pin Stanley to --

PARTICIPANT: I say put his name in there, and his phone number, for additional questions --

DR. FITZMAURICE: But does it say we're taking into account what Lynn Gilbertson wrote? I don't think the agenda is that specific.

DR. STEINDEL: I was actually rereading the letter because I did have a suggestion in that Stanley did say they were working on a modification rule for 2004 but this is very specific concerning something that might be in the modification rule.

MS. FRIEDMAN: And unfortunately we can't discuss content, it's about as far as we can go to say that we're aware of the request and issues underlying it and we're taking it into account.

MR. REYNOLDS: Simon one way of thinking about it since this has come in front of us again and there are new code sets involved wouldn't it be prudent for us to understand what that might effect? So that if we have a recommendation at this point to make it, so that the next letter back to the DSMOs --

DR. COHN: Well, we could have the next letter back to the DSMOs being a physician or we could say something like we expect to further discuss this issue on March 31st.

DR. FITZMAURICE: I like that better.

DR. STEINDEL: If the whole purpose of this letter is to just close the issue with the DSMOs then we should say that the national committee did not act on this recommendation however we do plan to discuss it on --

PARTICIPANT: [Comment off microphone.]

DR. COHN: So what I hear that I'm getting buy-in from the rest of the committee, subcommittee, to add this to our list of items, okay. As I said at this point don't want to make any further commitments of the subcommittee time until we've had, I mean we want to get buy-in as we go forward here as you begin to look at the agenda for the year you'll appreciate my comments.

MS. FRIEDMAN: Do you want me to then take out all the stuff about DHHS?

DR. COHN: Yeah. So is this letter okay?

MS. FRIEDMAN: I don't want to put a date on the hearing because we don't know about people's availability and the agenda.

DR. COHN: Are people comfortable with this letter?

MR. BLAIR: I move that we approve the letter.

DR. HUFF: Second.

DR. COHN: Comments and discussion? All in favor?

SUBCOMMITTEE: Aye.

DR. COHN: Against? Abstentions? Okay, got this one passed. Boy, for a vanilla letter this took a lot of discussion. Basically I think the conversations around the code sets were actually very helpful.

Agenda Item: Subcommittee Discussion of E-prescribing Work Plan - Dr. Cohn and Mr. Blair

DR. COHN: Now I think our last issue for the day and I'm sure we'll continue discussing this tomorrow is our e-prescribing. I should ask everybody you okay with another half an hour, discuss more work, you may regret having already agreed to work on this other standards issue.

This is actually, I mean this probably is a good introduction to it all because this is going to be our light for the next eight to ten months where we're going to be sort of juggling priorities and we're going to be dealing with this issues of e-prescribing as well as all the rest of our HIPAA agenda, so just keep that in mind as we talk about all this. Now Jeff I think you wanted to start talking a little bit about the e-prescribing work plan and all of this. I guess I'm hoping that we'll, I mean we'll talk about the work plan today and if we're sort of comfortable with the timelines we're talking about we'll get down to the actual physical acts assuming we're comfortable with that of trying to figure out how to schedule the time tomorrow that we need. Jeff, please go forward.

MR. BLAIR: Do you all have copies of the work plan in front of you? Okay, then we're dismissed.

Alright, you probably have noticed that this is version seven and there will be more, this is ongoing work. Now we have some new members here who may not have heard our discussions about this in December so let me go through this as quickly as I can and what we're driving towards to be honest with you is for you to understand the scope of the commitment we'll have to be making as Simon said.

Okay, the Medicare Prescription Drug Improvement and Modernization Act had a section in there asking the NCVHS to come up with recommendations for e-prescribing standards. It was a little bit unusual in that it was especially directive to us, outlining not only the stakeholders we should listen to but also a number of the issues related to e-prescribing that we should consider for standardization. In the work plan if you can flip to the stakeholders that are there, I don't remember the section number so I can't tell you by number, but there's a list of stakeholders. Well, the law wound up indicating quite a long list of folks, everything from pharmacists, pharmacies, physicians, hospitals, PBMs, state boards of pharmacy, state boards of medicine, federal agencies, they listed all these things and that was plenty, but when we took a look at it we realized that it didn't include the current demonstration projects for e-prescribing, it didn't include the existing implementations of e-prescribing, the networks that are being developed, and it didn't include the vendors and it didn't include the SDOs, so we added those and that wound up being a very healthy list, and there may be more as we go through this process so this may not be entirely completely but at least I think we're maybe starting to get close to all of those folks that we need to listen to either by law or what we deem to be really pretty important stakeholders that we should be considering their testimony.

Now the other piece that was interesting in the law was that it wound up indicating a pretty interesting list of areas that we should consider. It included not only eligibility issues like patient eligibility for a prescription but also whether or not the formulary would, whether they're eligible based on the formulary for that particular prescription. Obviously the message format or transaction standard for communicating the prescription, the code sets and terminologies that might be part of that. But it went on to list a number of other considerations including drug to drug checking, drug to allergy, drug to history, and it does turn out that they're referring to the history of medications that the patient is taking, and did I say drug to lab, and dosage forms I believe was also in there. So it had a pretty interesting list but it also included electronic signatures as well.

Now as Maria and Karen Trudel and Simon and Steve and I wound up trying to make some of the first cuts at this work plan it became apparent that there's quite a bit of sense of urgency to try to produce interim recommendations as soon as possible. Before I go into the interim recommendations let me just put in perspective that our recommendations to the Secretary are part of a series of major events that would be leading to e-prescribing standards in some form nationwide.

The Secretary is supposed to report to Congress by September of 2005 the initial standards recommendations. We feel like in order to give the Secretary and Health and Human Services enough time to take a look at our recommendations and turn them into whatever that recommendation would be we feel like we really need to have our recommendations, our final recommendations by June of 2005, and the interim recommendations, which I'll get to in the work plan, by the November full committee meeting of 2004. Following the Secretary's report to Congress in September 2005 e-prescribing demonstration projects are scheduled for 2006. The results of those would then be reported by I think it's April 2007 and the Secretary is to propose, or rather I think the word is promulgate, final e-prescribing standards by April on or before April 2008, and I think that there's many people who would like to see that happen prior to April 2008. You may notice that there is about, there's quite a bit of time after the demonstration projects are done so there is a possibility there that an NPRM might be done but it's not determined at this time whether it will be or not.

Well I think that that gives you an overall perspective. Maria, correct me if I've misstated anything.

MS. FRIEDMAN: No, it all sounds --

MR. BLAIR: I didn't lie? Not so far. Okay, now lets get back to trying to see what it would take for us to get interim recommendations to Health and Human Services by November of 2004 and that's what Simon was saying when he said the next eight to ten months looked pretty heavy.

What we did was we try to see how could we carve this up, how could we divide this up, what would be appropriate for the interim recommendations. And it was very hard to divide a lot of this out so there's a list of priorities there which you probably notice, which is the terminology, excuse me, the transaction standards, the terminology standards, the things that I listed as decision support which is drug to drug, drug to allergy, drug to lab, all of those pieces, and also the requirements of state and federal agencies as well. We had a hard time dividing those out either into near term or long term, we had a pretty much group those together. The only thing that we felt we could really carve off as a separate piece was the electronic signatures area. So if we are to go forward with that mindset, I just came back from four days at NCPDP and there's a lot to e-prescribing that I think many of us really need to learn in terms of a foundation, some of my preconceptions were not quite right, there's a lot of interesting differences from the world of electronic health records and acute care.

So Maria is taking the lead in pulling together for us a day of education on March the 30th --

MS. FRIEDMAN: That's tentatively outlined there just to give you a feel for what our current thinking is, it may change a little bit but it will give you a flavor of what we thought the day would look like.

MR. BLAIR: Yes. And please observe that, and I don't know what this particular one says, if it does say NCPDP on the item list there, we're looking for more then just NCPDP representing the scrip standard, we're looking for them to represent the industry with respect to the different models of how prescriptions are conveyed, the different information requirements, the different constraints, the market overall as well as how the scrip standard addresses and deals with these different models. And similarly with the e-health initiative and Simon had pointed out in one of our discussions that it is our hope that we could wind up having some overlap where we could get somewhat different perspectives from each of the folks that testified to us. Maria, did you have anything else that you wanted to indicate about?

MS. FRIEDMAN: No, we were talking about maybe a list of structured questions that we could get everybody to address or at least topics that we would like them to touch on as well as you'll notice that there's a group of feds there as well, federal perspective, VA, us, FDA, kind of an overview of where those agencies are again try to get them to touch on similar kinds of --

MS. GRAHAM: We're not listed here but you've asked me, the other thing I'd like to ask that DOD be added because we are Congressionally mandated to be able to do many of these things by 2005.

DR. BICKFORD: You also need to consider DEA don't you?

MS. FRIEDMAN: DEA will be handled later because the e-prescribing piece, if you look through the agenda it's going to be handled separately much later.

MR. BLAIR: Please understand this is just an introduction day.

MS. FRIEDMAN: So that's why DEA is not on the list but I will certainly add --

MR. BLAIR: Now if you look down to the schedule section in the work plan what we did was we tried to lay out the first four priorities after the introduction day, the first four of our five priorities would be part of the interim recommendations. And when we looked at all the stakeholders and started laying them out on a calendar, and this one is incomplete, I think Maria has an update that we will probably develop after today and tomorrow with additional discussions on schedule, but we were looking at between five and six days of testimony laid out probably a couple days in May, and although it shows I think here, if this is the right one, three days somewhere in July or August, that will probably become four days with maybe two days in July, maybe two days in August, that's something we can discuss. Maria, did you have any other --

MS. FRIEDMAN: No, I think the idea was not to overload people and there's availability issues, but on the other hand we really need to make sure that all the effected stakeholders have sufficient time and opportunity to come in and tell us what they need to tell us. And so we're looking, I would consider two days in July, two days in August.

MR. BLAIR: No the mindset on this, this May, July and August timeframe, this is where we would be hearing from all of the different users of the information, either users that are prescribing or filling or providing formulary information or DUR information, drug utilization review information, into the system or regulating it or accrediting it. So in a sense after that overview, which will be March 30th where we'll get a feeling for what's there, all of these will be the folks that will wind up indicating how they use the standards, what standards they need that are not there, what are the gaps, what are the other considerations, what are their recommendations, and then at the end of the August session we would take all of these issues, needs, gaps, and pull them together into a questionnaire, not a big questionnaire but a list of issues and questions, go back to NCPDP and other major terminology developers, and they would come back in September and indicate either that they have plans in place to address those additional requirements or how they would be addressing the gaps, or what other recommendations they have for us at that time. So that's when they return to us to indicate how they can meet all the requirements and needs that have been identified in May, July, and August.

And then following that September session we would then wind up going through our traditional three drafts, in this case of an interim recommendation letter, which we hope and trust would be approved by acclamation by the whole NCVHS committee in November. Simon and Maria do you have any comments on this portion of the schedule that I've left out?

DR. COHN: Well, you already know my comments, every time I look at this schedule I turn almost green just because of the number of days and yet I'm not sure I see much of an option. I mean we can look at everybody's schedule and I'm sure there's the ability to do some wiggling around of schedules one way or another, one option might, we are sort of stuck with full committee meetings the very beginning of September and then at the very beginning of November. This would be one year where I had wished they had decided to leave the November schedule late in November and give us a little bit of additional time. But there may be some ways, if we can't do four days in summer that we do some days in summer, some days in early September, and then in October. But I'm not sure that I see that there's ways to curtail the number of days that we're going to hold hearings, in fact as I've looked at some of the, for presentations, for example on day, one day you have physicians for an hour and a half, hospitals for an hour --

MR. BLAIR: We'll probably need more time.

DR. COHN: Well, I'm not terribly certainly that we're going to be able to hold it to that level nor should we --

MR. BLAIR: Can we ask people to speak fast?

DR. COHN: It leads me to believe for example when Jeff talks about a half day in October, he said one of the reasons in an email, I sent it to everybody, we probably ought to try to schedule two days in October because my belief is that all this could shift back and be a lot closer to November, so I do think we need to try to get the interims out in November but it may require, as I said I think that's a little bit optimistic.

Having said that you all may have a better idea then I do, as you know I'm not happy about this one but I've also sort of resigned myself that we're going to have to do something like this. Judy?

MR. BLAIR: Would you mind if I just sort of stepped through the rest of the schedule and then we can --

DR. WARREN: The five priorities that were here, were those specified in the law or were these priorities that the subcommittee came up with?

MR. BLAIR: We derived those priorities right out of the things that were indicated in the law, they wanted eligibility, they wanted electronic signature, they wanted all of --

DR. WARREN: My next question is in priority number one can we change physician to provider?

DR. COHN: Sure.

MR. BLAIR: Good. The other piece that I would add is we put e-prescribing, which will probably take more then one day, not e-prescribing, electronic signatures, probably in that January, February, March timeframe, we probably have at least two days I imagine, but at the same time it gives us a little bit of room if we decide that there's an ambiguous issue that we couldn't get resolved for the interim recommendations then we could follow-up with maybe additional clarifications during that first quarter of 2005 and then the second quarter of 2005 we would go into the phase of first, second, and third drafts of our final recommendations with the expectation that that would be approved by the full NCVHS committee in the June 2005 full committee meeting.

So that was our take at laying this thing out, any ideas, questions?

MR. REYNOLDS: In trying to think through how to think about this e-prescribing, I try to go down to the basis, and the basis to me is the physician in the office, the pharmacy that they send it to, and the PBM that answers it.

MR. BLAIR: And the vendors --

MR. REYNOLDS: Yeah, but I'm saying initially. But I would like to see if we couldn't move those three entities up earlier in the testimony so that as you listen to vendors, as you listen to people talking about codes, as you listen to everything else we're keeping in mind that the only way this can be ultimately successful in my opinion is if the general practitioner or the one doctor in an office can make it work and we at least take them into consideration. And listening that way, because a lot of times if you listen to vendors first or you listen to anybody else first you get molded in your thinking as to what they're delivering, that may not be what the end constituency is looking for.

MR. BLAIR: So let me try to capture this. You're saying that the first groups we should hear from are --

MR. REYNOLDS: After the education.

MR. BLAIR: After the education would be physician, PBMs, and pharmacists, that group.

MR. REYNOLDS: That's just a recommendation, I think it sets the stage for who are we dealing with.

DR. COHN: Do you think health plans are part of that universe or you think --

MR. REYNOLDS: Not initially, no, because most of them use PBMs.

DR. COHN: Well, no, the reason I'm asking is because the health plans typically do the formulary management.

MR. REYNOLDS: But the PBM has to have that, okay, you're going to get the eligibility, you're going to get the formulary, and you're going to get all that from the PBMs, so that's why, it was a direct track right to the end, who did it, who do I go to as a patient to get if filled, and did the PBM, yes, there's plenty other ways around that but that gives you a basic very clear track as to what the issues are.

MR. BLAIR: Could I ask you one --

DR. COHN: I think Harry is using the physician as described under Medicare, Judy.

MR. BLAIR: One of the thoughts was is that there's a number of networks that are moving very rapidly forward with implementations now in demonstration projects. And as you probably notice you put those up early because we figured we get real world feedback in terms of what they are doing, what they are not doing, and they're in Massachusetts and Ohio and Rhode Island, other areas, do you want them to wait until after you've heard from the other three?

MR. REYNOLDS: I would put them right afterwards because again, we hear from the constituency, then we hear what people are doing, and see if that's actually matching what we heard from the constituency. Again, a lot of people do pilots and they do pilots based on the local environment, they do pilots based on lots of other things, that's the only reason I said it, Jeff, I personally don't want to be tainted by what's already going on --

MR. BLAIR: Does the rest of the subcommittee agree with those priorities?

DR. COHN: I think Mike had his hand up, were you agreeing or further commenting?

DR. FITZMAURICE: I'm agreeing because I can hear what Harry is saying, let's find out what functions the three major users want, what are the principles that a system has to meet for them and then as we hear from the others we can see is it possible to meet what they want. It gives us something to shoot at, how close can we come to that target of things that they said they need. And maybe you have a list of here are the absolutes that won't work unless you have this and we'd like to have these from the physicians, the PBMs, and the pharmacists.

MR. BLAIR: Now I only have one thought because I'm willing to accept that, but the only thought that I had was that I was a little concerned that in terms of the physicians and hospitals that we're mandated to listen to and that we want to listen to, I'm a little concerned that many of them may not have that much experience yet so I was trying to go for the experience first. Do you feel like that's --

DR. COHN: I don't think we're talking about hospitals.

MR. BLAIR: They listed hospitals as well.

DR. COHN: Well no, talking to them, but I don't know they're a prescriber of Part D medications I don't think.

MR. BLAIR: They're not but they were there.

DR. COHN: No, a lot of stakeholders.

MR. REYNOLDS: I wasn't eliminating any stakeholders, Jeff, I was taking those three and putting them up at the top.

DR. STEINDEL: Actually I have a concern about shifting the order and it's because of what our charge specifically is. The charge to the NCVHS is to make recommendations to the Secretary concerning standards for e-prescribing, not necessarily to make recommendations to the Secretary for the e-prescribing system. Now if we were going to do that I would agree with your order, I'd want to hear from the people who were using it first to see what we need to recommend. But what the Secretary has asked us to do is take an inventory of standards that are out there and then report back to him what areas are covered and what areas do we need coverage. So I think we need to first find out what is really being covered by standards, what standards people are really using, which is the way Jeff's plan is laid out, and then look at the groups and ask them, well, we heard there are standards for this, do you really use it, probably we're going to hear no, what other types of standards might you need, well, we might need this. So we're actually hearing it from the necessary background when we talk to the actual users. That's the way I viewed the work plan.

DR. COHN: Harry, I'm actually looking at session two, day one, May 27th, and I'm wondering, I'm sort of seeing there we have people doing things, I also see PBMs and physicians, and obviously I don't see pharmacies there which I think is maybe the issue. I'm just sort of wondering does this begin to --

MR. REYNOLDS: That's fine, I just was recommending an order because a lot of times we forget, in many of these things we do we forget the people who actually do it. But we're going to include them, I understand, if you don't change it it doesn't bother me at all, just threw it out as an example.

DR. COHN: I'm just sort of wondering if there's some way to insinuate it around only because otherwise, I mean the way we have them is sort of moved around here, we have pharmacies off on during the summer for two hours, you're absolutely right what you're saying. I guess I'm wondering if maybe we need to hold your thought and sort of think about, and maybe the answer here is we have a whole day orientation and maybe at the end of that day we'll say geez, we really have a better sense of physicians, PBMs, and whatever, and we can sort of reconsider --

DR. STEINDEL: I think Simon capturing that thought, I think after the first day and after the second day we'll probably going to be making changes in this work plan --

DR. COHN: Other thoughts or comments about all of this stuff? I mean does anybody have any ideas about how we can do this so efficiently that we can get down to two days during the summer for example?

DR. STEINDEL: I have put a request into the department for an NCVHS house for this project in Georgetown, with tennis course and swimming pool.

MR. BLAIR: Did we accomplish Simon what you had hoped today and then --

DR. COHN: I think this is sort of an orientation to sort of what the work plan does. Tomorrow obviously we'll expect people to bring sort of calendars, we're not going to sit, I don't think we're going to start negotiate out dates but we might. I'm hoping that if I can find a couple spare moments that were sort of ranges of dates that we had been looking at moving out into the year and we'll be asking is having people sort of put X's on dates that they're available and we'll take that and if there's some clear dates we'll sort of say on Friday hey, these are the dates you should hold.

MS. GRAHAM: I have a question about the questions, especially for the March 30th, the committee is actually writing questions or is it going to be more like we'll hire a pharmacy consultant like we did for the terminologies?

DR. COHN: Well, we are going to get a consultant but I think we have to agree on the work plan first so that we know what we're hiring a consultant to help us with. They do typically sort of charge on the basis of all of that stuff. And I think that once we agree to the work plan then I think Maria begins to write up a work order, or Mike or somebody around the table here begins to follow that. In terms of actually questions for the 30th I think we need to be, I mean realistically I don't think we're going to have a consultant on tomorrow so if you have questions that you think need to be addressed --

MS. GRAHAM: We've got our pharmacy people looking at it, certainly if they have things that they would say this is the kind of thing you should ask we'll just send those to the committee --

MR. FRIEDMAN: Send them to me.

MS. GRAHAM: Okay.

MS. FRIEDMAN: And if anybody has burning issues that you think need to be covered we can put them on the list and we may have to winnow them down because obviously it's going to be a very packed agenda as it is but still we would like to get everybody to try and cover the same territory.

DR. COHN: Now it's 5:49 now. Are they any other issues coming before us today? Okay, once again my apologies. Okay, we will adjourn, we have a one hour breakout tomorrow, full committee is meeting at 9:00 a.m. at HHS, Hubert Humphrey Building, I look forward to seeing you then.

[Whereupon at 5:52 p.m. the meeting was adjourned.]