National Medicare Coverage Updates


Radioimmunotherapy for Non-Hodgkin's Lymphoma
(ie, Ibritumomab Tiuxetan/Zevalin®/BEXXAR®)
CMS performed a national coverage analysis for the treatment of Non-Hodgkin's Lymphoma and determined that the evidence is insufficient to change current policy on the off-label use of Zevalin® or BEXXAR®, as set forth in section 50.4.5 of Chapter 15 of the Medicare Benefit Policy Manual.

The ACR was pleased to see that CMS specifically noted that Medicare carriers should continue to cover medically accepted off-label indications, as per the existing local policies. For more details, please refer to the CMS decision that can be accessed at http://www.cms.hhs.gov/mcd/viewdecisionmemo.asp?id=38.

Carotid Artery Stent Coverage
As a result of collective efforts between ACR and a multi-disciplinary coalition, coverage was expanded nationally for carotid artery stenting March 17, 2005. CMS has expanded its National Coverage Decision (NCD) for "Carotid Artery Stenting" that allows coverage for carotid stenting apart from the clinical trial setting for certain high-risk patients. For more details on the covered high-risk patients, please refer to the CMS NCD at http://www.cms.hhs.gov/coverage/id157.pdf. CMS noted one caveat for coverage where they "determined that CAS 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. Standards to determine competency will include specific physician training standards, facility support requirements, and data collection to evaluate outcomes during a required reevaluation."

CMS established a mechanism for evaluating facilities where the individual facility must provide written documentation to CMS stating that they meet 1 of the following criteria:

  1. The facility was an FDA-approved site that enrolled patients in prior CAS IDE trials, such as SAPPHIRE, and ARCHER.
  2. The facility is an FDA-approved site that is participating and enrolling patients in ongoing CAS IDE trials, such as CREST.
  3. The facility is an FDA-approved site for 1 or more FDA post-approval studies.
  4. The facility has provided a written affidavit to CMS attesting that the facility has met the minimum facility standards.

The letter must include the following information:

  • Facility's name and complete address
  • Facility's Medicare provider number
  • Point-of-contact for questions with telephone number
  • Mechanism of data collection of CAS procedures
  • Signature of a senior facility administrative official.

A list of certified facilities approved to provide this service is available at http://www.cms.hhs.gov/coverage/carotid-stent-facilities.asp.