The recommendations call for greater standardization in oversight and performance monitoring at all 23 Maryland hospitals that perform PCI and/or cardiac surgery.  The new system of oversight would:

 

 

 

·         Establish PCI as a category of regulated health care service in state law and formulate a streamlined Certificate of Need process for hospitals that seek to perform PCI without on-site cardiac surgical back-up. The application review process will replace a waiver system that has been used to authorize hospitals that do not offer cardiac surgery to perform PCI in limited situations such as participation in research studies.  

 

 

 

·         Authorize the creation of new standards for the ongoing review of the performance of PCI and cardiac surgery that will uniformly apply to all hospitals at which these services are provided. Larger hospitals that perform both cardiac surgery and PCI are not currently subject to ongoing oversight. Any hospital could lose authority to offer PCI or cardiac services, if it did not meet performance thresholds.  

 

 

 

·         Add MHCC to the list of State agencies that can share data to investigate the quality or utilization of care in regulated health care facilities.   Enhanced data sharing will facilitate better coordination among MHCC and other state agencies with authority over hospitals and physicians that offer cardiac and PCI services.

 

 

 

The report is the result of legislation passed in 2011 that directed MHCC to provide recommendations on how oversight of PCI could be strengthened.  The report now goes to the Governor and the General Assembly for consideration in the upcoming legislative session.  These changes, along with the Commission’s current requirement that each Maryland hospital report data on all of its PCI services to national registries, would make oversight of PCI some of the most stringent in the country. 

 

Should these changes be incorporated into Maryland law, MHCC would be assigned responsibility for specifying oversight standards.  To assure that hospitals with PCI programs operate at the highest level of competence and quality, MHCC will define standards for hospital and physician performance and specify ongoing quality assurance programs that will include internal and external peer review.

 

Marilyn Moon, Ph.D., Chair of the MHCC, stated, "These recommendations will substantially strengthen oversight and accountability for these important and lifesaving services.” 

 

 

 

About PCI

 

PCI is the most frequently used invasive method of treating the narrowing, or stenosis, of  coronary arteries and is performed in cardiac catheterization facilities at acute care hospitals.  Primary PCI, also known as emergency angioplasty, is a life-saving intervention performed during a heart attack (acute ST-segment elevation myocardial infarction, or STEMI).  Non-primary PCI, or elective angioplasty, is a scheduled intervention to relieve the narrowing of the artery with the goal of preventing a heart attack from occurring in the future. Since 1996, emergency angioplasty has been performed in thirteen community hospitals that do not offer cardiac surgery services, first during a research study approved by the Commission and, since 2006, as a service regulated by the Commission. A hospital without on-site cardiac surgery that provides emergency angioplasty is required by the Commission to meet certain quality standards, including: minimum qualifications of staff and the physicians who perform PCI procedures; minimum number of PCI procedures that must be performed annually by the hospital and its physicians; and 24/7 staff coverage to provide emergency angioplasty within a specific time frame.  Eight of these thirteen hospitals have also participated in a national research study that is investigating the safety of non-primary PCI performed in hospitals without cardiac surgery programs.  

 

 

 

About the Maryland Health Care Commission

 

 

 

The Maryland Health Care Commission is a 15-member independent regulatory agency whose mission is to plan for health system needs, promote informed decision-making, increase accountability, and improve access in a rapidly changing health care environment by providing timely and accurate information on availability, cost, and quality of services to policy makers, purchasers, providers and the public. The 15 Commissioners are appointed by the Governor with the advice and consent of the Maryland Senate. The Commission's vision for Maryland is to ensure that informed consumers hold the health care system accountable and have access to affordable and appropriate health care services through programs that serve as models for the nation.

 

 

 

For Additional Information, contact: Paul Parker, Acting Director of the Center of Hospital Services, MHCC, at 410-764-3261