As you may be aware, the Pennsylvania Department of Health has recently brought enforcement actions against dozens of Pennsylvania hospitals under its hospital facility regulations at 28 Pa. Code §§107.61(Written Orders) and 107.62 (Oral Orders) for permitting Certified Registered Nurse Practitioners ("CRNPs") and Physician Assistants ("PAs") to write orders and/or issue verbal orders to other practitioners for medications and other diagnostic and therapeutic treatment. Hospitals have been cited for permitting any mid-level practitioner, such as CRNPs, PAs, and nurse midwives, to write or issue orders even if they are later countersigned by the attending or supervising physician. The department's inflexible stance has caused significant hardship for many hospitals, and, if the department's position does not change, it may affect patient access to care.

The department's position is that the hospital facility regulations require orders to be written or issued by a practitioner, defined in the hospital facility regulations as a licensed physician, dentist, or podiatrist, and that hospitals must comply with these regulations until such time as they are amended through Pennsylvania's regulatory review process, or request an exception from the department under the current regulations. The department has not relented from its strict interpretation despite the promulgation by the Pennsylvania State Board of Medicine and State Board of Nursing in 2002 of final regulations that permit CRNPs to prescribe medications, and the recent enactment of Act 2002-160, which places CRNPs under the sole authority of the State Board of Nursing. In contrast, the department's regulations governing long-term-care facilities and ambulatory surgery facilities expressly permit CRNPs and PAs to write orders in those facilities. Applying a higher standard to hospitals, where much greater control over the actions of CRNPs and PAs exists, does not seem reasonable.

We have advised several hospital clients in connection with issues surrounding the writing or issuing of orders by CRNPs and PAs. In addition, the firm is currently advising hospital clients who desire to undergo the process for requesting an exception from the department on the basis that compliance with the requirements of the regulations presents an unreasonable hardship, but an exception would not impair the health, safety, or welfare of any patient.

Efforts are under way to obtain department review and analysis of this matter. It is possible that new administration may take a more lenient stance with respect to the regulations, but Buchanan Ingersoll & Rooney cannot predict how new administration will proceed and whether the regulations will continue to be strictly enforced.

This memorandum provides only a short overview of the current status of the way in which the department is enforcing its hospital facility regulations. If you have any specific questions regarding the provisions of the regulations, or if you require any assistance in connection with correspondence with the department, especially with the filing of a request for an exception, please contact any member of Buchanan Ingersoll & Rooney's Health Care Section.