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Centers for Medicare & Medicaid Services

National Coverage Analysis (NCA) Tracking Sheet for Cardiac Catheterization Performed In Other Than A Hospital Setting (CAG-00166N)

The Centers for Medicare and Medicaid Services (CMS) has discovered a discrepancy in section 35-45 of the Coverage Issues Manual (CIM). The policy states that cardiac catheterization may be covered in a freestanding clinic when the carrier, in consultation with the appropriate Peer Review Organization, determines that the procedure can be performed safely in all respects in the particular facility. The Peer Review Organizations (recently renamed Quality Improvement Organizations) ceased doing reviews of core freestanding, cardiac catheterization facilities in the early 1990s. Since the implementation of CIM 35-45, we are unaware of any emerging evidence that there is a greater risk of adverse events at these freestanding clinics. Therefore, CMS is opening this policy to review the evidence and correct the discrepancy.

Diagnostic Tests (other)
Requestor Name(s)Internally generated
Formal Request Accepted and Review Initiated10/08/2002
Expected NCA Completion Date01/18/2006
Public Comment Period10/08/2002 - 11/08/2002
Proposed Decision Memo Released10/21/2005
Proposed Decision Memo Public Comment Period: 10/18/2005 - 11/21/2005 
Decision Memo Released01/12/2006
Comments for this NCA:View Public Comments
Lead Analyst(s)
  • JoAnna Baldwin
Lead Medical Officer(s)
  • Joe Chin, MD

October 8, 2002

CMS is requesting public comment before any corrections are made to §35-45

January 16, 2003

CMS is extending the due date to February 7, 2003, to allow time for internal review and clearance.

February 10, 2003

Additional time is necessary for clearance, due date extended to March 7, 2003.

September 14, 2005

CMS commissioned a technology assessment by the Agency for Healthcare Research and Quality regarding catheterization procedures in freestanding facilities. The technology assessment is now available on our web site. In addition, CMS is preparing a proposed decision memorandum regarding the current policy. When completed, the proposal will be posted on this web site for 30 days of public comment.

October 18, 2005

CMS posts a proposed decision memorandum indicating its intent to repeal the National Coverage Determination (NCD) Manual §20.25. CMS is requesting public comment on its proposal. After considering public comment, we will release a final decision memorandum.

Instructions for submitting public comments can be found here.

October 21, 2005

The proposed decision memorandum has been corrected by including previously omitted quotes from the technology assessment. The comment period will end 30 days from today.

January 12, 2006

The final decision memorandum  is now posted.