Ref: Request for Public Comments on Elimination of Quality Monitoring Requirements as a Condition for Coverage of Cardiac Catheterization Procedures in Freestanding Clinics (#CAG-00166N)

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Friday, November 22nd 2002

Thomas A. Scully
The Centers for Medicare & Medicaid Services
200 Independence Avenue, S.W.
Room 445-G, Hubert H. Humphrey Building
Washington, DC 20201

Dear Mr. Scully:

On behalf of our nearly 5,000 member hospitals, health care systems, networks and other providers of ambulatory care, the American Hospital Association (AHA) appreciates the opportunity to comment on the proposed elimination of quality monitoring requirements as a condition for coverage of cardiac catheterization procedures in freestanding clinics.

The AHA believes this course of action is ill advised and would establish a much lower quality standard for the procedure in freestanding clinics (where there is no emergency or cardiac surgical backup) than that applied to hospital outpatient departments (where there is emergency and surgical backup).  As the number and variety of specialized procedures provided outside the hospital setting increase, Medicare beneficiaries should be assured that those procedures, wherever performed, are subject to comparable levels of quality protection. Furthermore, we are concerned that this important policy change is being addressed through such an informal process. 

This proposed change in coverage policy was posted in the coverage section of the CMS Web site.  The notice is just one paragraph, in which CMS indicates that current Medicare rules in Section 35-45 of the Coverage Issues Manual state that cardiac catheterization may be covered in a freestanding clinic only when the carrier, in consultation with the appropriate Peer Review Organization (PRO), has determined that the procedure can be performed safely in all respects in the particular facility.  The notice goes on to explain that PROs (recently renamed Quality Improvement Organizations, or QIOs) ceased reviewing cardiac catheterization facilities in the early 1990s.  Apparently, the Medicare program has continued to pay for cardiac catheterization procedures in these facilities even though the conditions for coverage have not been met.

The notice then concludes that, since CMS is unaware of any emerging evidence of a greater risk of adverse events at these freestanding clinics, the agency is considering eliminating the quality review to in turn eliminate the “discrepancy” between the conditions for coverage and the agency's actual practice of paying for the service in the absence of any quality oversight.  The fact that there is no evidence of a quality problem may be attributable to the fact that CMS is not monitoring quality.  There simply is no basis for any assumption.  It is safe to say that there is an inherently greater risk in performing the procedure in an outpatient setting where there are no emergency or cardiac surgery services on site.

The notice suggests the same low priority for monitoring cardiac catheterization labs as was identified in the 2002 report from the Department of Health and Human Services’ Office of Inspector General (OIG), titled Quality Oversight of Ambulatory Surgical Centers.  That report highlighted several concerns with the lack of federal oversight in the ambulatory surgical center (ASC) care setting. Despite rapid growth in the complexity and volume of procedures performed in ASCs, the OIG noted that the standards governing ASCs have not changed since 1982.  OIG investigators also found ASCs to be  “near the bottom” of CMS’ survey and inspection priority list, with nearly one-third operating without any oversight survey in five or more years, and many without any inspections in the last 10 years. 

Clearly, quality standards and monitoring is an area where regulatory requirements have not kept up with the increased provision of specialized services in a variety of outpatient settings.  These settings include ASCs, cardiac catheterization laboratories, physician offices, and radiology and imaging centers.  While federal law requires hospitals and their outpatient departments to comply with specific regulations aimed at ensuring patient rights, providing a safe physical environment, and assessing and improving the quality of delivered health care, many non-hospital settings are subject to little or no federal oversight.  Implementation of the proposed change in policy would encourage the performance of critical health care procedures in environments of higher risk.

AHA recommends that:

  • Freestanding cardiac catheterization facilities be subject to quality standards and monitoring/enforcement requirements that are comparable to those applied to hospital outpatient departments for similar procedures.
  • Only routine diagnostic cardiac catheterization procedures performed on non-acute patients be covered in freestanding cardiac catheterization facilities that do not have onsite emergency and cardiac surgery capacity.
  • Freestanding cardiac catheterization facilities be required to establish written transfer arrangements with nearby hospitals that they intend to rely on for emergency services.
  • Because this is such an important policy change, with financial and care access implications for many stakeholders, it should be adopted only after solicitation of public comment in the Federal Register so that it is more likely to reach the public and be subject to broader input.

The AHA appreciates the opportunity to submit these comments.  If you have any questions, please feel free to contact me or Ellen Pryga, AHA director, policy development, by telephone at (202) 626-2267 or by email at


Rick Pollack
Executive Vice President


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