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September 12, 2013

SCAI Opposes Rules Proposed by CMS Regarding PCI Outpatient Payments and the Physician Fee Schedule for Out-of-Hospital Peripheral Procedures

September 13, 2013—The Society for Cardiovascular Angiography and Interventions advised in its weekly bulletin that the society has submitted comments to the Centers for Medicare & Medicaid Services (CMS) regarding concerns with the 2014 Hospital Outpatient Prospective Payment System (HOPPS) proposed rule. In a separate communication to CMS, SCAI voiced its opposition to the 2014 Medicare Physician Fee Schedule (MPFS) proposed rule.

As summarized in the society's bulletin, SCAI told CMS that it opposes the HOPPS proposed establishment of comprehensive, “super” bundled ambulatory payment classifications (APCs) for device-dependent procedures, specifically for APCs involving the new percutaneous coronary intervention codes that went into effect on January 1, 2013.

In comments submitted to CMS, SCAI noted that CMS does not have the necessary data to accurately set comprehensive APC payment rates for these procedures, that the APC payment rates and patient coinsurance amounts for coronary bare-metal and drug-eluting stent procedures would increase by 44% and 34%, respectively, and that SCAI is concerned that not all the costs for items that are currently billed separately were included in the new bundled rates, according to the summary in the SCAI bulletin on September 13.

Regarding the MPFS, the society voiced strong opposition to the proposed rule and what is characterized as CMS's attack on reimbursement rates for some peripheral procedures performed outside of a hospital. According to SCAI, CMS is proposing to lower Medicare payments for some peripheral procedures performed in physicians' offices to no more than the rates in hospital outpatient or ambulatory surgical centers (ASCs).

In comments submitted to CMS on September 6, SCAI President Ted A. Bass, MD, stated that the ASC payment rates were not valid comparisons for the cardiovascular community because cardiologists rarely— if ever—perform procedures in ASCs; one reason is that the ASC payment system does not provide adequate reimbursement for device-intensive procedures that are also equipment intensive.

SCAI also responded to CMS's ongoing projects aimed at validating relative value units (RVUs), expressing concern over the potential bias toward primary care by one of the lead investigators. SCAI recommended criteria that should be applied to any activities surrounding the validation of RVUs, ensuring that any alternative valuation methodologies proposed are at least as fair/equitable as the existing process.

In the MPFS rule, CMS also proposed significant changes to the existing National Coverage Determination process for clinical trials. SCAI stated that CMS sets new scientific and ethical standards for clinical trials differing from that of the US Food and Drug Administration, Institutional Review Boards, and other agencies currently tasked with the oversight of clinical trials. However, SCAI notes that CMS asserted their motivation was to propose a “transparent, centralized review process that would be more efficient by reducing the burden for stakeholders interested in conducting nationwide trials.”

However, SCAI expressed grave concern that CMS's vision would create an administrative bottleneck, thwarting Medicare beneficiaries' access to and participation in clinical trials. SCAI urged CMS to issue a public notice coupled with town hall meetings to address the development of relevant standards for clinical trials.

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September 13, 2013

Enrollment Concluded for EVOLVE II Trial of Boston Scientific's Synergy Stent System

September 13, 2013

Enrollment Concluded for EVOLVE II Trial of Boston Scientific's Synergy Stent System


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