NOTICES
Moratorium on Demonstration Projects
[35 Pa.B. 2964] The Department of Health (Department) has adopted regulations regarding general and acute care hospitals in 28 Pa. Code Chapters 101--158 (relating to general and special hospitals). Included in these regulations are provisions regarding the performance of cardiac catheterization procedures in 28 Pa. Code Chapter 138 (relating to cardiac catheterization services). Cardiac catheterizations are categorized as either low risk or high risk. High risk cardiac catheterizations are those that present a high risk of significant cardiac complication. Included in this category are all percutaneous transluminal coronary angioplasties, also known as percutaneous coronary intervention procedures (PCI). These PCI procedures involve the use of a balloon catheter, plaque removing device, laser device or mechanical stent to reopen collapsed, blocked or partially blocked arteries. Section 138.15 of 28 Pa. Code (relating to high-risk cardiac catheterizations) provides that a hospital may perform high risk cardiac catheterizations only if it has an open heart surgical program onsite.
Over the past 4 years, the Department has received numerous requests for an exception to the requirements of 28 Pa. Code § 138.15. The Department reviewed these requests in accordance with the standards in 28 Pa. Code §§ 51.31--51.34 (relating to exceptions). These regulations state that the Department may grant exceptions to regulatory requirements for several reasons, including when compliance would create an unreasonable hardship and an exception would not endanger the health, safety or welfare of a patient.
Several of the requests that the Department received for an exception to 28 Pa. Code § 138.15 indicated that residents of the hospital's service area had difficulty obtaining emergent and elective PCI procedures due to the travel distances involved to tertiary facilities with open heart surgical services. After discussing this matter with numerous entities, including hospital representatives, cardiac surgeons and cardiologists, as well as reviewing the current medical literature on this subject, the Department determined that it would balance the potential risk of providing PCI in a hospital without open heart surgical services with the benefits of making this service available to more citizens of this Commonwealth. Accordingly, the Department established a demonstration project and granted exceptions to the requirements of 28 Pa. Code § 138.15 to those hospitals that could show that they would be providing PCI services to individuals who would otherwise have to travel substantial distances or faced other barriers that hindered access to this service.
Under the terms of the demonstration project, these hospitals were permitted to provide emergent and elective PCI procedures upon entering into an agreement with the Department under which the hospital agreed to: follow guidelines issued by the American College of Cardiology for the performance of PCI procedures, seek training and monitoring by a tertiary hospital that currently provides open heart surgical services, report all transfers of PCI patients to the Department, provide notification to its liability insurance carrier that it is providing primary and elective PCI services without the availability of onsite open heart surgical services, disclose information regarding the demonstration project to prospective PCI patients in a consent form and enroll in the American College of Cardiology--National Cardiovascular Data Registry and provide all required data to that organization regarding performance of the PCI procedures.
The Department currently has 11 hospitals enrolled in the demonstration project. These hospitals are located in several geographic regions around this Commonwealth and in rural, urban and suburban settings.
In a report issued on April 13, 2005, by the Legislative Budget and Finance Committee (Committee) entitled ''Quality Assurance for Specialized Clinical Services,'' the Committee reviewed these PCI demonstration projects. Due to various reasons, including the fact that the guidelines of the American College of Cardiology do not recommend the provision of elective PCI at hospitals without onsite open heart surgical services, the Committee recommended that the Department institute a moratorium on approval of additional exceptions to the requirements of 28 Pa. Code § 138.15 and admission of additional hospitals into the demonstration project.
The Department has agreed to adopt the Committee's recommendation. As detailed in the Department's response to the Committee's report, there is an ongoing discussion in the medical community concerning the issue of providing elective PCI at hospitals without onsite open heart surgical services. The Committee's report and the Department's response can be found at lbfc.legis. state.pa.us. While the Department believes that the exceptions granted were appropriate, there are a sufficient number of hospitals in the demonstration project to provide relevant and useful data on this matter.
Until further notice, the Department will not consider any further applications for an exception request to the provisions of the hospital regulations that require that high risk cardiac catheterization procedures shall be performed in hospitals with onsite open heart surgical services. Any further requests received by the Department will be returned to the applicant with a copy of this notice. If the Department decides to lift this moratorium, a notice will be published in the Pennsylvania Bulletin and only applications received after that publication will be considered by the Department.
Persons with a disability who require an alternative format of this notice (for example, large print, audiotape or Braille) should contact Sandra Knoble, Department of Health, Division of Acute and Ambulatory Care, P. O. Box 90, Room 532, Health and Welfare Building, Harrisburg, PA 17108, (717) 783-8980, for speech and/or hearing impaired persons, V/TT (717) 783-6514 or the Pennsylvania AT&T Relay Services at (800) 654-5984.
CALVIN B. JOHNSON, M.D., M.P.H.,
Secretary
[Pa.B. Doc. No. 05-957. Filed for public inspection May 13, 2005, 9:00 a.m.]
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