Carotid Artery Stenting Facility Recertification Process

Overview

The Centers for Medicare & Medicaid Services (CMS) has developed this plan to serve as the facility recertification process for facilities that have been approved by CMS to perform carotid artery stenting (CAS). Recertification is required every two years and must be achieved by following this two part process.

First, facilities must submit an affidavit to CMS stating that they continue to meet all of the CMS facility standards. Second, facilities must submit specific data elements to CMS. The affidavit will serve as an interim certification while facilities gather and submit data to CMS and CMS reviews submitted data for completeness.

Upon review of submitted data elements, each facility will either maintain certification or no longer be certified by CMS to perform CAS procedures. Facilities that do not maintain certification will no longer be eligible for Medicare reimbursement for these services.

Background

The national coverage determination (NCD) for carotid artery stenting (Pub. 100-3, 20.7) requires, as a condition of coverage, that all facilities must be certified by CMS to perform CAS procedures. To become initially certified, facilities submit a written affidavit attesting that they meet the minimum standards outlined in the NCD. These include physician training standards, facility device inventory and support standards, and data collection to evaluate outcomes during a required reevaluation period. The NCD also states that facilities will be expected to submit data to CMS upon request, and internal analysis of these data should occur no less than every 6 months.

Recertification

In accordance with the NCD, CMS is initiating this recertification plan for facilities already approved by CMS to perform CAS. Facilities must submit a written affidavit in order to be recertified stating that the facility continues to meet each of the standards specified in the NCD. CMS must receive this affidavit no later than 24 months after each facility's initial effective date and failure to submit an affidavit will result in nonpayment for future CAS procedures.

Data from all procedures performed within 24 months of each facility's effective date must be submitted to CMS no later than 27 months after the effective date. The NCD allows for data to be collected through either a mechanism established by facilities or contractors to facilities. Therefore the requested data, in the format discussed below, may be submitted directly to CMS by each facility or by facility contractors. Continuation of an additional two year facility certification is contingent upon the submission of the requested data elements.

Facilities must submit all requested data for CAS procedures performed during their initial two year CMS certification. This data must be submitted after the initial two year certification expires all at one time. For example, Facility X has an effective date of 5/1/05. It must submit all requested data elements for all CAS procedures performed between 5/1/05 and 5/1/07 after 5/1/07. Facility X must submit this data all at one time.

UPDATE – April 1 and October 1 Submissions

Following each facility's initial data submission, data is required to be submitted twice a year on April 1 and October 1. The April 1, 2008 submission is for data from procedures performed from the day after a facility's two year certification expired thru December 31, 2007.

For example, a facility with an initial effective date of July 15, 2005 that has submitted its initial two years of data is required to submit data from procedures performed on July 16, 2007 thru December 31, 2007 no later than April 1, 2008. The next submission deadline would then be October 1, 2008 and must include data from procedures performed on January 1, 2008 thru June 30, 2008. The next April 1, 2009 submission must include data from July 1, 2008 thru December 31, 2008. This schedule provides facilities with three months to assemble and format data for submission from the last procedure date until the submission due date.

Facilities that performed no CAS procedures during a six month reporting period (January 1 thru June 30 or July 1 thru December 31) should not submit any information to Fu Associates or CMS (i.e. please do not submit a blank CD or any type of notification if no CAS procedures were performed). Facilities should only submit data when CAS procedures are performed during the six month reporting period.

Submissions will continue to follow this schedule unless new instructions are posted to this website. The current process for data submission will continue and any changes to the process will be posted to this website.

Interim Data Submission Instructions

The online tool CMS expected to have available for CAS facility data submission is not currently available so we have developed an alternate means for data submission until the tool becomes available. Until further notice, all facilities due to submit data must use the data submission mechanism described below to submit the requested data elements for all patients who received CAS during each facility's initial two year certification.

Please download the Excel file via the link in the downloads section below and enter the requested data elements for each CAS procedure on a separate row. Below are instructions and an example of how to fill out the spreadsheet.

Please note that the spreadsheet utilizes macros to help ensure data is entered correctly. Macros must be enabled in order to enter data into the spreadsheet.

To enable macros for Excel 2000:
Open Carotid Template.xls.
When prompted, click Enable Macros.

To enable macros for Excel 2003:
Open Excel.
Go to Tools\Macro\Security
Select Medium and click OK.
Close Excel.
Open Carotid Template.xls.
When prompted, click Enable Macros.
To enable macros for Excel 2007:
Open Carotid Template.xls
Click Options.
Select Enable this content.
Click Ok.

Data Entry
Carefully following the instructions below will help ensure that you have an error free submission.

Do not alter the structure of the spreadsheet in any way. For example:
Do not add or remove columns or rows.
Do not change any formatting.
Do not hide or delete any rows.
Do not modify any of the shaded areas.

Do not include any explanatory or other additional information other than the items listed in the spreadsheet. If additional explanatory information is provided your submission will be rejected.

Beware that the spreadsheet will auto-save itself when Excel is closed.

Pasting data into the spreadsheet from other spreadsheets has proven to be problematic. For instance, the validation macros designed to help ensure your submission is error free are bypassed and formatting from the source spreadsheet will override formatting in the destination spreadsheet.

Provider Number
Enter your facility's 6-digit Medicare provider number in the space provided.

Email Address
Enter a contact email address in this field. It will be used to notify you of the status of your submission.

Patient's Medicare ID number
The only 2 acceptable values for this field are a valid Health Insurance Claim (HIC) ID number or NA. Any other values will cause your submission to be rejected.

For Medicare patients, please be sure to enter the correct HIC for each patient. For example: 123456789A. Valid HICs are between 6 and 12 digits and contain at least one letter. If you enter a HIC without a letter, your submission will be rejected. For additional information on HICs, please see the section below "What is the Health Insurance Claim (HIC) Number?"

For non-Medicare patients and Medicare Advantage plans (Medicare HMO, Medicare Replacement Insurance, etc.), please enter NA in this field.

Patient's date of birth
Must be in MM/DD/YYYY format. Any other format including a 2-digit year will cause your submission to be rejected. Valid DOB's are from 1/1/1900 to the current date (not in the future). DOB's outside of this range will cause your submission to be rejected.

Date of Procedure
Must be in MM/DD/YYYY format. Any other format including a 2-digit year will cause your submission to be rejected. Valid procedure dates must be between 3/1/2005 and the current date (not in the future). Procedure dates outside of this range will cause your submission to be rejected.

Is the patient symptomatic?
The only valid values for this field are Y or N. Any other values will cause your submission to be rejected.

Conditions qualifying patients as symptomatic:

• Carotid Transient Ischemic Attack (TIA): distinct focal neurologic dysfunction persisting less than 24 hours.
• Non-disabling stroke: Modified Rankin Scale < 3 with symptoms for 24 hours or more.
• Transient monocular blindness: amaurosis fugax.

Does the patient meet high surgical risk criteria?
The only valid values for this field are Y or N. Any other values will cause your submission to be rejected

Conditions qualifying patients as at high surgical risk:

• Age >80.
• Myocardial Infarction (MI).
• Left Ventricle Ejection Fraction (LVEF) < 30%.
• Contralateral carotid occlusion.
• New York Heart Association (NYHA) Class III or IV.
• Unstable angina: Canadian Cardiovascular Society (CCS) Class III/IV.
• Renal failure: end stage renal disease on dialysis.
• Common Carotid Artery (CCA) lesion(s) below clavicle.
• Severe pulmonary disease.
• Clinically significant cardiac disease (congestive heart failure (CHF), abnormal stress test, or need for open-heart surgery).
• Previous neck radiation.
• High cervical Internal Carotid Artery (ICA) lesion(s).
• Restenosis of prior carotid endarterectomy (CEA).
• Tracheostomy.
• Contralateral larnyngeal nerve palsy.

Modified Rankin Scale Score if Patient Experienced Stroke pre-procedure
The only valid values for this field are an integer from 0-6 or NA. Any other values will cause your submission to be rejected. For patients who did not experience a stroke before undergoing CAS, please enter NA.

% stenosis by angiography
The only valid values for this field are an integer from 0-99. Any other values will cause your submission to be rejected.

% stenosis of second lesion (if applicable)
The only valid values for this field are an integer from 0-99 or NA. Any other values will cause your submission to be rejected. For patients who did not have stenosis of a second carotid lesion, please enter NA.

Was embolic protection used?
The only valid values for this field are Y or N. Any other values will cause your submission to be rejected.

Were there any complications during hospitalization?
The only valid values for this field are Y or N. Any other values will cause your submission to be rejected.

Events qualifying as complications:

• All stroke: an ischemic neurologic deficit that persisted more than 24 hours.
• MI.
• All death.

Leaving any of the fields above blank will cause your submission to be rejected.

Example spreadsheet:

Facility Medicare Provider Number: 123456
Email Address:

first.last@mycompany.com

Each facility must name their data spreadsheets in the following format:

Facility Name_State_Medicare Provider # (i.e. Hospital X_MD_123456.xls)

Each facility must save their completed file (with the requested data elements for all CAS procedures performed during your facility's initial two year certification) using the spreadsheet and instructions provided on the cms.gov website to a CD-Rom. Facilities have two options for submitting these CDs.

1. Send an unencrypted CD through the mail using a carrier that requires the signature of the recipient upon delivery (i.e. US Postal Service Signature Confirmation, Fed/Ex, DHL, etc.); or

2. Create and send a CD through the mail, using either PointSec encryption, or AES encrypted .ZIP file. ZIP AES encryption must be done with an application that supports ZIP 5.2 standard or later. ZIP 5.2 is supported by third party applications such as Winzip 9.0 or later, any version of 7-Zip, Winrar 3.7 or later, etc. Other compression formats, such as .7Z, .LZMA, .ZIPX, .RAR, .ACE, etc. are not supported.

   When using PointSec please create an encrypted package with a built in extractor. All PointSec files that do not have a built in extractor will be rejected.

   Facilities that choose to encrypt their CDs must send their encryption key to Fu Associates, Ltd. at cas@nerdvana.fu.com to enable them to open and read the encrypted files. The subject of the email should be the same as the file name on the CD submitted by the facility. The body of the email should include the Facility Name, the Facility Medicare Provider Number, and the Encryption Key.

Each facility must send their CDs to:

Fu Associates, Ltd.
2300 Clarendon Boulevard
Suite 1400
Arlington, VA 22201
Attention : Michele Gore

In order to respond to each facility to let you know if your data has been accepted or rejected, you will need to provide an email address for your submissions. Please provide your email address in the space provided within the spreadsheet.

Within three months of receiving your facility's data, CMS will determine if your facility will maintain certification to perform CAS based on the completeness of data submitted. When a determination has been made, CMS will notify each facility.

Please note: if you submit incomplete data, a damaged file or data in a format other than that specified on this website and the spreadsheet, you will have one additional chance to resubmit a complete, useable and properly formatted data file via CD to the address specified above.

Failure to submit data as specified may result in a withdrawal of your CMS facility approval for performing CAS and thus prevent future Medicare reimbursement for CAS claims.

What is the Health Insurance Claim (HIC) Number?

The Health Insurance Claim (HIC) Number is the unique identifier issued to all Medicare eligible beneficiaries by either the Social Security Administration (SSA) for the Centers for Medicare and Medicaid Services (CMS) or for the Railroad Retirement Board (RRB). The HIC is used by CMS to determine an individual's eligibility for benefits under the hospital insurance (HI) and supplemental medical insurance (SMI) Medicare programs. The RRB program predates the Medicare program and there are a far smaller number of beneficiaries who receive benefits under this program.

The HIC is an alpha-numeric identifier which consists of two parts, the Claim Account Number (CAN) and the Beneficiary Identification Code (BIC). The "wage earner's" nine-digit social security number (SSN) is assigned by the SSA/CMS and the SSA/RRB as the CAN. The CAN identifies the "wage earner" who earned the Medicare benefits and under whose account the individual receiving Medicare benefits is claiming the benefits. The BIC identifies the current relationship between the beneficiary and the "wage earner." RRB BICs are different from SSA/CMS BICs.

SSA/CMS HICs follow a standard format: a nine (9) digit CAN followed by a one or two position BIC (e.g., A or B and/or B1 or CA or DA). The one or two position SSA/CMS BIC can be a one position character (e.g., A, B, D, E, or W ), a two position character (e.g., BA, CA, DA, EB, WF, etc.), or a two position alpha-numeric (e.g., B1, B2, C1, C2, D1, D2, E1, E2, F1, F2, W1, W6, etc.). Examples of the SSA/CMS HIC format are: 123456789A, 123456789BA, or 123456789W6.

SSA/RRB HICs follow a standard format as well: a one, two, or three character BIC (e.g., A or H, MA or WA, or WCD or WCA) followed by a six (6) or nine (9) digit CAN. The RRB CAN is always a six or nine digit number. The RRB BIC is always a one, two, or three character letter. Examples of the RRB HIC format are: A123456 or A123456789, MA123456 or MA123456789, or WCD123456 or WCD123456789.

For CMS data processing purposes, RRB HICs are converted to SSA/CMS HICs so that the formats of the two types of HICs correspond (i.e., for data processing purposes, the goal is to convert the 7-12 character RRB HICS to the standard 11 character SSA/CMS HIC format).

RRB-converted HICs also follow a standard format: the RRB BIC (e.g., A, CA, JA, MA, WCD, etc.) which precedes the RRB CAN is mapped into a two-digit number and the new number is appended to the end of the CAN and considered to be the BIC (e.g., A is mapped to 10, CA is mapped to 17, JA is mapped to 11, MA is mapped to 14, WCD is mapped to 43, etc.).

The six digit RRB CAN is zero-filled to nine digits (e.g., 000123456) and the leading zero is converted to a '{' (for 0) which indicates that the HIC was assigned by the SSA/RRB. For example, an RRB HIC of WCD123456, where the RRB BIC of WCD was replaced by "43," would be converted to the SSA format as follows: {0012345643.

For nine digit RRB CANs, where the CAN does not need to be zero-filled, an RRB HIC of MA123456789 would be converted to A2345678914. In this case, the BIC (or MA) is converted to "14" and moved the follow the CAN. The first digit of the CAN (or 1) is replaced by an "A" to indicated that the HIC was assigned by the RRB (i.e., 0 is converted to {, 1 is converted to A, 2 is converted to B, 3 is converted to C, 4 is converted to D, 5 is converted to E, 6 is converted to F, and 7 is converted to G).

All Medicare eligible beneficiaries are entitled to Part A Medicare and can enroll in Part B Medicare. They can also elect to replace their original Medicare benefits with those provided by a Medicare Advantage (MA) organization (i.e., they are still getting their Medicare benefits just under a different delivery system). Regardless of how their Medicare benefits are delivered, all Medicare eligible beneficiaries are issued a HIC by either the SSA/RRB or SSA/CMS.

MA organizations may decide to issue the Medicare beneficiaries that are covered under their programs with a separate Plan Identifier which is unique to their organization. This separate Plan Identifier does NOT replace the HIC, it is an additional identifier used only by MA organizations for the beneficiaries that they cover. These beneficiaries will always have a separate HIC issued to them by either SSA/RRB or SSA/CMS. For purposes of the CAS recertification submission process, CMS has decided that CAS facilities can designate beneficiaries whose CAS procedure is covered by MA organizations with the designation "NA" in column 1 of their CAS spreadsheet, rather than their HIC.