Provider Types Affected
Hospitals, physicians, and suppliers billing Medicare carriers or fiscal intermediaries (FIs) for Percutaneous Transluminal Angioplasty (PTA) services provided to Medicare beneficiaries

Provider Action Needed
Impact to You
MM 3811 and related CR 3811 announce the expansion of Medicare coverage for PTA of the carotid artery.

What You Need to Know
Effective March 17, 2005, Medicare revised its coverage of PTA of the carotid artery as detailed in this article and CR 3811.

What You Need to Do
If you are a provider of PTA services, be aware of the coverage changes and make certain that your billing staff is aware of the expanded national coverage allowed to Medicare beneficiaries receiving PTA services.

Background
Medicare covers PTA of the carotid artery concurrent with carotid stent placement when all the requirements stipulated by the Food and Drug Administration (FDA)-approved policies for Category B Investigational Device Exemption (IDE) clinical trials are met, effective for dates of service on or after July 1, 2001.

PTA of the carotid artery concurrent with the placement of an FDA-approved carotid stent for an FDA-approved indication is covered, when all the requirements stipulated by the FDA-approved policies for post-approval studies are met, for dates of service on or after October 12, 2004.

Expanded Coverage
Effective March 17, 2005, the Centers for Medicare & Medicaid Services (CMS) expanded the coverage of PTA of the carotid artery concurrent with placement of an FDA-approved carotid stent with embolic protection for the following:

• Patients who are at high risk for carotid endarterectomy (CEA) and who also have symptomatic carotid artery stenosis ≥ 70 percent. Coverage is limited to procedures performed using FDA-approved carotid artery stenting systems and embolic protection devices;
• Patients who are at high risk for CEA and have symptomatic carotid artery stenosis between 50 percent and 70 percent in accordance to the Category B IDE clinical trials regulation (42 CFR 405.201), as a routine cost under the clinical trials policy (Medicare National Coverage Determination (NCD) Manual, Section 310.1), or according to the NCD on carotid artery stenting (CAS) post-approval studies (Medicare NCD Manual ,Section 20.7); and
• Patients who are at high risk for CEA and have asymptomatic carotid artery stenosis ≥ 80 percent (according to the Category B IDE clinical trials regulation (42 CFR 405.201)), as a routine cost under the clinical trials policy (Medicare NCD Manual 310.1), or according to the NCD on CAS post-approval studies (Medicare NCD Manual, Section 20.7 ).

CMS defines high risk patients as those having significant comorbidities and/or anatomic risk factors and are considered by a surgeon to be poor candidates for CEA. The significant comorbidities, include, but are not limited to, those listed in Section 20.7 of the Medicare NCD Manual as follows:

• Congestive heart failure (CHF) class III/IV;
• Left ventricular ejection fraction (LVEF) < 30 percent;
• Unstable angina;
• Contra lateral carotid occlusion;
• Recent myocardial infarction (MI);
• Previous CEA with recurrent stenosis;
• Prior radiation treatment to the neck; and
• Other conditions that were used to determine patients at high risk for CEA in the prior CAS trials and studies, such as ARCHER, CABERNET, SAPPHIRE, BEACH, and MAVERIC II.

Symptoms of carotid artery stenosis include carotid transient ischemic attack (distinct focal neurologic dysfunction persisting less than 24 hours), focal cerebral ischemia producing a nondisabling stroke (modified Rankin scale < 3 with symptoms for 24 hours or more), and transient molecular blindness (amaurosis fugax). Patients who have had a disabling stroke (modified Rankin > 3) would be excluded from coverage.

The appropriate documentation confirming that a patient is at high risk for CEA and records of the patient’s symptoms of carotid artery stenosis should be available in the patient medical records prior to performing any procedure.

The degree of carotid artery stenosis should be measured by duplex Doppler ultrasound or carotid artery angiography and recorded in the patient medical records. If the stenosis is measured by ultrasound prior to the procedure, then the degree of stenosis must be confirmed by angiography at the start of the procedure.

If the stenosis is determined to be less than 70 percent by angiography, the CAS should not proceed.

• Carotid artery stenting with embolic protection is reasonable and necessary only if performed in facilities that have been determined to be competent in performing the evaluation, procedure, and follow-up necessary to ensure optimal patient outcomes.
• All facilities must at least meet the minimum standards outlined in Pub 100-03, Section 20.7 of the NCD Manual in order to receive coverage for CAS for high-risk patients. Briefly, facilities must have high quality X-ray imaging equipment, device inventory, staffing, and infrastructure to support a dedicated CAS program.
• Advanced physiologic monitoring, including real time and archived physiologic, hemodynamic, and cardiac rhythm monitoring equipment, and associated support staff capable of interpreting findings and responding appropriately.
• Readily available emergency management equipment and systems, such as resuscitation equipment, a defibrillator, vasocative and antiarrhythmic drugs, endotracheal intubation capability, and anesthesia support.
• A clearly delineated program for granting CAS privileges and for monitoring the quality of the individual interventionists and the program as a whole. The oversight committee for this program is encouraged to apply published standards from national specialty societies recognized by the American Board of Medical Specialties to determine appropriate physician qualifications.

Examples of standards and clinical competence guidelines include those published in the December 2004 edition of the American Journal of Neuroradiology and those published in the August 18, 2004, Journal of the American College of Cardiology.

A data collection system maintained by the facility or its contractor on all CAS procedures done at that facility. The data must be analyzed routinely to ensure patient safety (to be determined by the facility but should not be less frequent than 6-month intervals), will be used in recredentialing the facility, and must be made available to CMS upon request.

For evaluation purposes, all facilities must provide written documentation to CMS indicating it meets one of the following criteria:

• Was an FDA-approved site that enrolled patients in prior CAS IDE trials, such as SAPPHIRE, and ARCHER;
• Is an FDA-approved site that is participating and enrolling patients in ongoing CAS IDE trials, such as CREST;
• Is an FDA-approved site for one or more FDA post-approval studies; or
• Has provided a written affidavit to CMS affirming that the facility meets the minimum facility standards.

The affidavit must include the facility’s name and complete address, Medicare provider number, point-of-contact name and telephone number, CAS procedure data collection mechanism, and a senior facility administrative official’s signature. (Note that a new affidavit is required every two years.)

The affidavit should be sent to:

Director, Coverage and Analysis Group
7500 Security Boulevard , Mail-stop C1-09-06
Baltimore , MD 21244

Additional Information
All providers should note that the following relate to services on or after March 17, 2005:

• FIs and carriers will only pay CAS claims from providers who are listed on the approved facility list which is at: http://www.cms.hhs.gov/MedicareApprovedFacilitie/CASF/list.asp .
• Carriers will pay claims containing ICD-9-CM 433.10 and any of the following procedure codes: 37215, 37216, 0075T, or 0076T, for beneficiaries meeting the high risk criteria previously specified.
• FIs will pay claims containing ICD-9-CM 433.10 and both procedure codes 00.61 and 00.63.
• FIs will reject claims that do not have both procedure codes 00.61 and 00.63
• FIs and carriers will deny CAS services for patients at high risk if the appropriate diagnosis code is not on the claim and use the appropriate Medicare Summary Notice (MSN) message and claim adjustment reason code in doing so.
• FIs and carriers will deny claims where the service was performed in an unapproved facility and use the appropriate MSN message and claim adjustment reason code in doing so.

You may also want to review the following Medlearn Matters article MM 3489 and CR 3489 for additional information relating to Medicare coverage of PTA. They are available at http://www.cms.hhs.gov/MedlearnMattersArticles/downloads/MM3489.pdf and http://www.cms.hhs.gov/Transmittals/downloads/R314CP.pdf on the CMS Web site.

The official instruction issued to your carrier/FI regarding this change may be found at http://www.cms.hhs.gov/Transmittals/ on the CMS Web site. From that Web page, look for CR 3811 in the CR NUM column on the right, and then click on the files for that CR. You will see two versions of CR 3811. One version identified by Transmittal# 33 contains the NCD Manual revision, and Transmittal# 531 contains the revisions to the Medicare Claims Processing Manual.

If you have questions regarding this issue, contact your carrier/intermediary on their toll-free number, which is available at http://www.cms.hhs.gov/MedlearnProducts/downloads/CallCenterTollNumDirectory.pdf on the CMS Web site.

Disclaimer
This article was prepared as a service to the public and is not intended to grant rights or impose obligations. This article may contain references or links to statutes, regulations, or other policy materials. The information provided is only intended to be a general summary. It is not intended to take the place of either the written law or regulations. We encourage readers to review the specific statutes, regulations and other interpretive materials for a full and accurate statement of their contents.

For more information, visit the Medlearn Matters Web page at: http://www.cms.hhs.gov/MedlearnMattersArticles/ .

Pub. 100-4, Transmittal# 531, CR# 3811
Pub. 100-3, Transmittal# 33, CR# 3811
Medlearn Matters Number: MM 3811 Revised
Related CR Release Date: April 22, 2005
Effective Date: March 17, 2005
Implementation Date: July 5, 2005

Posted: 12/08/2005

CPT codes, descriptions, and other data only are copyright 2005 American Medical Association (or such other date of publication of CPT). All Rights Reserved. Applicable FARS/DFARS Apply.