Cardiac Catheterization Regulation

Issue: Scientific advances and new technology development have improved patient outcomes and spurred significant growth in the number of cardiac catheterization procedures performed and an upsurge in the establishment of new cardiac catheterization laboratories. This expansion of service, combined with escalating health care costs, has led to increased efforts by some states to regulate cardiac catheterization laboratories.
Background: State certificate-of-need (CON) laws first emerged 30 years ago to prevent overprovision and utilization of services and to control health care costs. These laws require health care providers to receive state approval for major capital expenditures, the purchase of high-technology equipment, or expansion of services. Proponents of CON laws also believe that such regulation is necessary to ensure quality. Opponents of CON laws argue that market forces produce more effective controls. In the case of cardiac catheterization laboratories, it appears that some states are using CON laws to place strict and rigid controls on the practice of medicine through regulatory enforcement of volume criteria incorporated into clinical practice guidelines published by professional organizations.
Why Is It Important to Cardiologists? Public demand for high quality health care has never been higher. Public scrutiny is forcing hospitals and other health care providers to implement quality control systems to enhance quality and accountability. In addition, some health policy leaders are advocating that outcomes should be measured and tied to physician reimbursement rates.
ACC and SCAI Position: The American College of Cardiology and the Society for Cardiovascular Angiography and Interventions (SCAI) are leaders in setting standards for quality cardiovascular care. The College and SCAI are committed to working with ACC chapters, legislators and state regulatory boards to assist officials in leveraging ACC/SCAI expertise and quality evaluation and improvement strategies. The ACC and SCAI encourage the use of continuous quality improvement initiatives and outcomes data monitoring as mechanisms by which states may measure cardiac catheterization laboratory performance.
ACC Guidelines: The ACC, in conjunction with the American Heart Association (AHA), and with the involvement of SCAI, has developed practice guidelines and expert consensus documents to guide and measure clinical performance. The ACC has also established Guidelines Applied in Practice (GAP) which deploys customizable tools to improve adherence to evidence-based guidelines.
Data Collection: The ACC has developed the National Cardiovascular Data Registry (NCDR). The ACC-NCDR® enhances local quality improvement initiatives by providing participants with standardized data elements and definitions and provides quarterly comparative reports on the performance and outcomes of cardiac catheterization procedures. The ACC also has launched the ACC-CathKIT™ for use in improving the performance of cardiac catheterization laboratories through self assessment. Available since spring 2004, the ACC-CathKIT™ guides cardiac catheterization laboratories through a quality improvement methodology to effectively and efficiently improve quality of care.
State Action:

A number of states have faced regulation of cardiac catheterization laboratories. Most state action has centered on:

  • Establishing minimum volume standards for individual practitioners and cardiac catheterization laboratories
  • Requiring participation by cardiac catheterization laboratories in data collection and monitoring through the NCDR or Society of Thoracic Surgery databases, or some other means.

States that have developed regulatory schemes based on outcomes data monitoring include Massachusetts, Ohio, New York, West Virginia and California.

ACC and SCAI Contacts: Adam Nelson, CAE, senior specialist, State Legislative Affairs, 301-897-2612
SCAI regional governors – call 1-800-992-7224

For more information about State Advocacy, please contact stateadvocacy@acc.org, or call 301-897-2612.

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