Pennsylvania Physician Assistant Regulations Key Revisions by HAP regarding hospital based PAs

The Pennsylvania State Board of Medicine’s physician assistant regulations were recently published as final in the Pennsylvania Bulletin.
Some key items addressed in the revised rules that are of importance to hospitals include:

Supervision
The final regulations do not require constant physical presence of the supervising physician with the physician assistant as long as they have the means to remain in communication and contact with each other. The final regulations specifically delete the definition of direct supervision, which required the physical presence of the supervising physician on the premises so that the supervising physician was immediately available to the physician assistant. This only applied to physician assistants practicing in emergency medicine.

This change effectively allows physician assistants to practice in a hospital emergency department without the physician assistant’s supervising physician being physically onsite. However, the requirements about maintaining a means to effectively communicate with his/her supervising physician remain in effect.

Medical Regimens
The final rule updates the definition of a medical regimen. The new definition clarifies that a physician can carry out or order medical regimens. Specifically, the new definition reads that a medical regimen is “a therapeutic, corrective, or diagnostic measure performed or ordered by a physician, or performed or ordered by a physician assistant acting within the physician assistant’s scope of practice and in accordance with the written agreement between the supervising physician and the physician assistant.”

This change more clearly allows for physician assistants to order medical regimens.

Orders and Prescriptions
The final rule retains the original definition for prescription but adds a definition for the term order. An order is an oral or written directive for therapeutic, corrective or diagnostic measures, including a drug to be dispensed for onsite administration in a hospital, medical care facility, or office setting.
The new definition clarifies that a physician assistant may give oral or written orders in hospitals and other medical care facilities.

Responsibility of the Primary Supervising Physician
The final rule requires at a minimum that the primary supervising physician see each patient hospitalized at least once. Hospitals need to determine what its expectations are for supervising physicians who employ or utilize physician assistants to see their patients in the hospital as well as what the requirements will be for the physician assistant and supervising physician with respect to recording, reviewing and countersigning information included in the patient’s medical record.

Role of the Physician Assistant
In the old regulations, there was a list of defined functions that could be performed by the physician assistant, but the list was not meant to be all-inclusive. The new regulations eliminate the list of tasks and describe the role of the physician assistant much broadly. The regulations state, “The physician assistant shall be considered the agent of the supervising physician in the performance of all practice-related activities including the ordering of diagnostic, therapeutic and other medical services.”

The new language clearly identifies that the physician assistant’s practice is tied to the physician assistant’s education and training, but that physician assistants can provide other services when the service is part of the physician’s scope of practice, is included in the written agreement, provided with an acceptable level of supervision, and is within standards accepted in the medical community.

Additionally, new language allows for physician assistants to pronounce death and to authenticate with the physician assistant’s signature any form that may otherwise be authenticated by a physician’s signature as permitted by the supervising physician, State or Federal law and facility protocol, if applicable.

Hospitals may have utilized the list of tasks contained in the old regulations in physician assistant credentialing and privileging processes. Hospitals should consider meeting with physician assistants and supervising physicians to determine how best to revise credentialing and privileging forms for physician assistants and to determine what forms, if any, could be authenticated with the physician assistant’s signature, including forms that might be used in outpatient settings.

Executing and Relaying Medical Regimens
The previous language in this section primarily reflected physician assistant practice in outpatient settings. The new language responds to some of the concerns expressed about the clarity of the old language by hospitals and other medical care facilities. In particular, the old language did not adequately capture how a physician assistant who was not physically present in the hospital related to other licensed health care professionals when an order needed be issued and executed by someone other than the physician assistant.

In the final regulations,

• A physician assistant may execute a written or oral order for a medical regimen or may relay a written or oral order for a medical regimen to be executed by a health care practitioner.
• As provided for in the written agreement, the physician assistant shall report orally or in writing to the supervising physician, within 36 hours, those medical regimens executed or relayed by the physician assistant while the supervising physician was not physically present, and the basis for each decision.
• The physician assistant shall record, date, and authenticate the medical regimen on the patient’s chart at the time it is executed or relayed. When working in a medical facility, a physician assistant may comply with the recordation requirement by directing the recipient of the order to record, data, and authenticate that the recipient received the order, if this practice is consistent with the medical care facility’s written policies. The supervising physician shall countersign the patient record within a reasonable time not to exceed 10 days, unless countersignature is required sooner by regulation, policy within the medical care facility or requirements of a third-party payor.

This new language makes it clear that physician assistants may execute or relay oral or written orders and should comply with the medical record policies when writing orders and relaying orders, including that the supervising physician countersign oral orders issued by the physician assistants and that it be in accordance with regulatory requirements.

Administration of Controlled Substances and Blood / Blood Components
The final regulations allow a physician assistant practicing in a hospital, medical facility or physician’s office to order or administer, or both, controlled substances and whole blood and blood components if the authority to order and administer these medications and fluids is expressly set forth in the written agreement.

This provision was changed because of the different kinds of physician practices in which physician assistants worked, such as pain management settings and oncology practices.

A hospital could credential and privilege a physician assistant to perform or order these services.

Prescribing and Dispensing Drugs, Pharmaceutical Aids and Devices
The final rule eliminates the different categories of medications. Instead, “The supervising physician may delegate to the physician assistant the prescribing, dispensing and administering of drugs and therapeutic devices.” In this same section in the final rules, it states, “The written agreement must list the categories of drugs, which the physician assistant is not permitted to prescribe.”

The revisions were made because the formulary was out of date and hard to maintain in regulations. Additionally, the formulary restricted the use of medications that were commonly being used to manage patients, such as warfarin for atrial fibrillation or deep vein thrombosis by physicians in private practice. The new rule retains the requirements about notifications when the supervising physician becomes aware of inappropriate prescribing. The supervising physician must notify the patient, physician assistant or pharmacy when he/she becomes aware if the physician assistant is prescribing a drug inappropriately.

The final rule eliminates the following restrictions:

• There is no longer a waiting period that a physician assistant must adhere to after the FDA approves a new drug or a new use for a drug before the physician can prescribe or dispense the drug.
• Eliminates prohibition on prescribing or dispensing a pure form or combination of drugs.
• No longer prohibits off-label prescribing by noting that the FDA approves uses of medications for the purpose of marketing by the manufacturer. Off-label use may represent the best standard of care and eliminating this provision will allow the physician assistant to prescribe or dispense drugs in accordance with his/her supervising physician’s preferences and practices. Cites use of aspirin after myocardial infarction as an off-label use.
• Eliminates statement that a physician assistant may not prescribe or dispense drugs not approved by the FDA since existing law prevents anyone from doing so.
• Eliminates restrictions on preparation or dispensing of parenteral drugs.
• Eliminates restrictions on refills or duration of prescription, indicating that it is common to prescribe contraceptives for up to one year for healthy individuals.
• Deletes prohibition against a physician assistant compounding ingredients when dispensing drugs except for adding water. Cites several medication mixtures commonly used in practice, such as Benadryl, viscous Lidocaine and Maalox in treatment of stomatitis secondary to chemotherapy

Also allows for:

• A physician assistant may prescribe a Schedule II controlled substance for initial therapy, up to a 72-hour dose. The physician assistant must also notify his/her supervising physician within 24 hours after issuing that prescription. Final rule recognizes the need to write for pain medications depending on the setting in which the physician assistant practices and when the supervising physician is not present, such as in walk-in clinics.
• The physician assistant can write a prescription for a Schedule II controlled substance for up to a 30-day supply if the supervising physician approved it for ongoing therapy. The prescription must indicate initial or ongoing therapy.
• Authorizes physician assistant to request, receive and sign for professional samples and to distribute samples to patients.

And retains the following restrictions:

• A physician assistant cannot prescribe or dispense a Schedule I controlled substance.

As with the administration and ordering of blood and blood products, hospitals need to determine what medications, including controlled substances, they will allow physician assistants to administer or order in their organizations.

Physician Assistant Employed by Medical Care Facilities
The new rule continues to state that a physician assistant may be employed by a medical care facility; that the physician assistant cannot be responsible to more than three physician assistant supervisors; and that there is no requirement for medical care facilities to employ physician assistants or permit their utilization on their premises. However, they can provide medical services in a facility to hospitalized patients if permitted by the supervising physician and facility. The final rule adds that “physician assistants granted privileges by, or practicing in, a medical care facility shall conform to policies and requirements delineated by the facility.”

Physician Assistant Identification
The final rule deletes a requirement that the physician assistant wear an identification tags using 16 point or larger type. Instead, the final rule requires the physician assistant to wear an identification tag in easily readable type.