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The Department of Health and Mental Hygiene

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DHMH Press Releases : Commission to Adopt Regulations for PCI



Baltimore, MD (April 23, 2012) -The Maryland Health Care Commission (MHCC or Commission) has been tasked with implementing HB 1141, MHCC- Cardiac Surgery and PCI Services, legislation agreed upon in the final days of the 2012 legislative session.

The legislation establishes a new legal framework for the oversight of percutaneous coronary intervention (PCI) services. The General Assembly took action shortly after the results of a clinical research trial, led by Dr. Thomas Aversano of Johns Hopkins University, were announced showing that elective (non-emergency) PCI could be performed safely on appropriate patients in a hospital without on-site cardiac surgery. An earlier study of emergency PCI in such hospitals, also led by Dr. Aversano, concluded in 1999 that emergency PCI for certain heart attack patients performed in community hospitals was superior to traditional drug therapy. The legislation will establish a consistent framework of oversight across all hospitals delivering emergency or elective PCI. HB 1141 requires MHCC to:

  • develop new mechanisms for oversight of services through certificates of conformance and certificates of ongoing performance;
  • develop requirements for peer or independent review of randomly selected and difficult or complicated PCI cases ; and
  • create a clinical advisory group to provide guidance to the Commission on appropriate standards for PCI and cardiac surgery oversight.

PCI is currently offered at 23 general hospitals, half of the general hospitals in Maryland. These hospitals will be subject to ongoing performance review of their PCI programs in order to maintain their authority to offer this service. Any hospital proposing to initiate PCI services for the first time or to provide elective PCI for the first time will need to obtain a certificate of conformance with the standards adopted by the Commission and, thereafter, will be subject to review of their ongoing performance to maintain their authorization. This process of continuing quality and performance oversight is a departure from the traditional approach historically used in certificate of need regulation of hospital and other health care facility projects. The details of these approval processes will be developed by MHCC with input from a clinical advisory group, which will be composed of experts from inside and outside of Maryland. For cardiac surgery hospitals, the advisory group will consider new specific standards for both surgery and PCI performance.

MHCC worked with individual hospitals, the Maryland Hospital Association, and the Maryland Chapter of the American College of Cardiology to ensure the legislation provides the foundation for consistent oversight of PCI services, while promoting the best feasible level of access to emergency PCI for all Maryland residents.