Sec. 10.24.05.02. Purpose and Scope

A. In 2007, the Commission established a one-time process by which certain licensed acute general hospitals without on-site cardiac surgery services were awarded time-limited research waivers from the requirements of COMAR 10.24.17.04E, Policy 5.0, and were permitted to provide non-primary PCI services as part of the C-PORT E study to assess the safety and efficacy of providing non-primary PCI services for certain patient groups without on-site cardiac surgery, as provided in COMAR 10.24.17.04E, Policy 5.3.

B. In 2007, the Commission determined that the C-PORT E study offered a means of acquiring information to support future evidence-based State health care policy and planning with regard to cardiovascular services.

C. In 2011, after the C-PORT E research study concluded active enrollment, the Commission continued the research waiver of each hospital that was in good standing, thereby permitting each such hospital to continue to offer nonprimary PCI services while the required follow-up data on C-PORT E patients was collected and analyzed, provided that the hospital continued to perform non-primary PCI under the limitations and for the Registry term provided in prior regulations until such time as the Commission has the information from the research study that is needed to guide State policy about the regulation of non-primary PCI.

D. Health-General Article, §19-120.1(d), Annotated Code of Maryland, effective July 1, 2012, provides that a certificate of conformance to establish a nonprimary PCI service is not required for a Registry hospital that the Commission determines, on or before December 31, 2012, continues to be in compliance with:

(1) Commission regulations, including COMAR 10.24.17, Table A-1; and

(2) The requirements of the Registry.

E. The Commission has convened a clinical advisory group, in accordance with Health-General Article, §19-120.1(g)(3), Annotated Code of Maryland, that will offer advice to the Commission on the update of COMAR 10.24.17, the Cardiac Surgery and PCI Services Chapter of the State Health Plan. The analysis conducted as part of this update will review the C-PORT E study results, which were published in a peer-reviewed journal in March 2012 and will consider the system impact, including access, cost-effectiveness, and quality implications, of non-primary PCI being performed in hospitals without on-site cardiac surgery.

F. Until the updated COMAR 10.24.17 is effective, each Registry hospital shall continue to meet each requirement in these regulations, including each requirement in the Registry’s manual of operations, in order to continue to provide nonprimary PCI.