Pennsylvania state laws and regulations that affect your medical practice
I. UNLICENSED PHYSICIAN AIDES
1. What tasks may a physician direct his or her unlicensed employee to administer?
A physician may delegate to an unlicensed technician1 the performance of a medical service if the following conditions are met:
B. The delegation is not prohibited by the statutes or regulations.2
C. The physician has knowledge that the technician has education, training, experience and continued competency to safely perform the medical service being delegated.
D. The physician has determined that the delegation to a technician does not create an undue risk to the particular patient being treated.
E. The nature of the service and the delegation of the service has been explained to the patient and the patient does not object to the performance by the technician. Unless otherwise required by law, the explanation may be oral and may be given by the physician or the physician's designee.
F. The physician assumes the responsibility for the delegated medical service, including the performance of the service, and is available to the technician as appropriate to the difficulty of the procedure, the skill of the technician and risk level to the particular patient.
G. A physician may not delegate the performance of a medical service if performance of the medical service or if recognition of the complications or risks associated with the delegated medical service requires knowledge and skill not ordinarily possessed by nonphysicians.
H. A physician may not delegate a medical service which the physician is not trained, qualified and competent to perform.
I. A physician maintains responsibility for the medical services delegated to the technician.
63 P.S. § 422.17
2. May a physician bill for the services rendered by an unlicensed assistant?
While there is no specific State law addressing this issue, physicians are encouraged to contact third party payors and get written confirmation prior to billing for such services. For self-pay patients, physicians should establish written financial policies which address billing for services rendered by unlicensed personnel in accordance with State law.
II. LICENSED PHYSICIAN ASSISTANTS
1. What qualifications must an assistant have to be licensed as a physician assistant?
The State Board of Medicine (Board) will issue a physician assistant license to an applicant if the following requirements are met. The applicant must:
A. Be at least 18 years of age;
B. Be of good moral character and reputation;
C. Be a graduate of an approved program;
D. Have passed a proficiency exam approved by the Board;
E. Have submitted a completed application detailing his education and work experience, together with the required fee; and
F. Present evidence that any continuing education requirements have been completed as are required under the law.
63 P.S. § 422.13
2. Who may employ a physician assistant?
A physician assistant may be employed by a physician, a health care facility or institution.
63 P.S. § 422.13
3. What regulations must the employer of a physician assistant follow?
A. A physician may act as a supervising physician only if he or she registers as supervising physician. The Board will allow an applicant to serve as a supervising physician if he or she:
1. Possesses a current license without restriction to practice medicine and surgery in Pennsylvania
2. Has filed a completed registration form accompanied by the written agreement (see Section B immediately below) and the required fee(relating to licensure, certification, examination and registration fees). The registration requires detailed information regarding the physician's professional background and specialties, medical education, internship, residency, continuing education, membership in American Boards of medical specialty, hospital or staff privileges and other information the Board may require.
3. Includes with the registration, a list, identifying by name and license number, the other physicians who are serving as supervising physicians of the designated physician assistant under other written agreements.
49 PA ADC § 18.143
B. A physician may delegate certain medical tasks to a qualified physician assistant consistent only with a written agreement. The agreement must:
1. identify and be signed by each physician the physician assistant will be assisting;
2. describe the manner in which the physician assistant will be assisting each named physician. The description must list functions to be delegated to the physician assistant;
3. describe the nature and degree of supervision and direction each named physician will provide the physician assistant;
4. designate one of the named physicians as having the primary responsibility for supervising and directing the physician assistant;
5. require that the supervising physician must countersign the patient record completed by the physician assistant within a reasonable amount of time. This time period may not exceed 10 days;
6. identify the locations and practice settings where the physician assistant will serve;
7. identify the parameters for prescribing or dispensing drugs;
8. have been approved by the Board as satisfying the foregoing and as consistent with the restrictions contained in or authorized by this section; and
9. a physician assistant must not assist a physician in a manner not described in the agreement or without the nature and degree of supervision and direction described in the agreement.
49 PA ADC § 25.161
C. The physician designated as having primary responsibility for the physician assistant must not have primary responsibility for more than two (2) physician assistants.
49 PA ADC § 18.152
D. A supervising physician may not allow a physician assistant to measure the range or powers of human vision or determine the refractive status of the human eye.
63 P.S. § 422.13
E. If the primary supervising physician is unavailable to supervise the physician assistant, the primary supervising physician may not delegate patient care to the physician assistant unless appropriate arrangements for substitute supervision are in the written agreement and the substitute physician is registered as a supervising physician with the Board.
1. It is the responsibility of the substitute supervising physician to ensure that supervision is maintained in the absence of the primary supervising physician.
2. During the period of supervision by the substitute supervising physician, the substitute supervising physician retains full professional and legal responsibility for the performance of the physician assistant and the care and treatment of the patients treated by the physician assistant.
3. Failure to properly supervise may provide grounds for disciplinary action against the substitute supervising physician.
49 PA ADC § 18.154
4. What are the requirements for issuing prescriptions and orders; dispensing medications and devices?
A. The supervising physician may delegate to the physician assistant the prescribing, dispensing and administering of drugs and therapeutic devices.
B. A physician assistant may not prescribe or dispense Schedule I controlled substances as defined by section 4 of The Controlled Substances, Drug, Device, and Cosmetic Act (35 P. S. § 780-104).
C. A physician assistant may prescribe a Schedule II controlled substance for initial therapy, up to a 72-hour dose. The physician assistant must notify the supervising physician of the prescription as soon as possible, but in no event longer than 24 hours from the issuance of the prescription. A physician assistant may write a prescription for a Schedule II controlled substance for up to a 30-day supply if it was approved by the supervising physician for ongoing therapy. The prescription must clearly state on its face that it is for initial or ongoing therapy.
D. A physician assistant may only prescribe or dispense a drug for a patient who is under the care of the physician responsible for the supervision of the physician assistant and only in accordance with the supervising physician's instructions and written agreement.
E. A physician assistant may request, receive and sign for professional samples and may distribute professional samples to patients.
F. A physician assistant authorized to prescribe or dispense, or both, controlled substances must first register with the Drug Enforcement Administration (DEA).
G. The requirements for prescription blanks are as follows:
1. Prescription blanks must bear the license number of the physician assistant and the name of the physician assistant in a printed format at the heading of the blank. The supervising physician must also be identified.
2. The signature of a physician assistant must be followed by the initials 'PA-C' or similar designation to identify the signer as a physician assistant. When appropriate, the physician assistant's DEA registration number must appear on the prescription.
3. The supervising physician is prohibited from presigning prescription blanks.
4. The physician assistant may use a prescription blank generated by a hospital provided the information in paragraph (1) appears on the blank.
H. The supervising physician must immediately advise the patient, notify the physician assistant and, in the case of a written prescription, advise the pharmacy if the physician assistant is prescribing or dispensing a drug inappropriately. The supervising physician must advise the patient and notify the physician assistant to discontinue using the drug and, in the case of a written prescription, notify the pharmacy to discontinue the prescription. The order to discontinue use of the drug or prescription must be noted in the patient's medical record by the supervising physician.
I. Recordkeeping requirements are as follows:
1. When prescribing a drug, the physician assistant must keep a copy of the prescription, including the number of refills, in a ready reference file, or record the name, amount and doses of the drug prescribed, the number of refills, the date of the prescription and the physician assistant's name in the patient's medical records.
2. When dispensing a drug, the physician assistant must record the physician assistant's name, the name of the medication dispensed, the amount of medication dispensed, the dose of the medication dispensed and the date dispensed in the patient's medical records.
3. The physician assistant must report, orally or in writing, to the supervising physician within 36 hours, a drug prescribed or medication dispensed by the physician assistant while the supervising physician was not physically present, and the basis for each decision to prescribe or dispense in accordance with the written agreement.
49 PA ADC § 18.158
III. NURSE PRACTITIONER
1. What qualifications must an individual have to be a certified registered nurse practitioner ("CRNP")?
(a) The board may certify a licensed registered nurse as a CRNP in a particular clinical specialty area if the nurse satisfies the requirements established by this act and regulations promulgated by the board. Certification of a nurse by the board shall expire on the same date as the license of that nurse expires.
(b) A nurse shall not qualify for initial certification as a CRNP unless the nurse:
(1) Is a graduate of an accredited, board-approved master's or post-master's nurse practitioner program; and
(2) Holds certification as a CRNP from a board-recognized national certification organization which required passing of a national certifying examination in the particular clinical specialty area in which the nurse is seeking certification by the board.
( c ) A nurse who does not otherwise meet the qualifications of this section may nevertheless qualify for initial certification as a CRNP if he or she completed a course of study considered by the Board to be equivalent to that required in this State at the time such course was completed or who is licensed or certified by another state, territory or possession of the United States or a foreign country as deemed equivalent to Pennsylvania's certification requirements in accordance with the joint rules and regulations of the Boards of Nursing and Medicine.
(d) As a condition for biennial renewal of certification by the board, a CRNP must, in the two (2) years prior to renewal, complete at least thirty (30) hours of continuing education approved by the board. In the case of a CRNP who is prescribing medical therapeutic or corrective measures, that continuing education must include at least sixteen (16) hours in pharmacology in that two-year period.
63 P.S. § 218.1
2. What is the scope of practice for a CRNP?
(a) A CRNP while functioning in the expanded role as a professional nurse shall practice within the scope of practice of the particular clinical specialty area in which the nurse is certified by the board.
(b) A CRNP may perform acts of medical diagnosis in collaboration with a physician and in accordance with regulations promulgated by the board.
( c ) A CRNP may prescribe medical therapeutic or corrective measures in accordance with his or her prescriptive authority.
(d) A CRNP is not limited or prohibited from engaging in those activities which normally constitute the practice of nursing.
63 P.S. § 218.2
3. What is the prescriptive authority for a CRNP?
A CRNP may prescribe and dispense drugs if the following requirements are met:
(1) The CRNP has completed a CRNP program which is approved by the Boards, or if completed in another state, is equivalent to programs approved by the Boards.
(2) The CNRP has successfully completed at least 45 hours of course work specific to advanced pharmacology in accordance with the following:
(i) The course work in advanced pharmacology may be either part of the CRNP education program or, if completed outside of the CRNP education program, an additional course or courses taken from an educational program or programs approved by the Boards.
(ii) The course work in advanced pharmacology must be at an advanced level above a pharmacology course required by a professional nursing (RN) education program.
(3) A CRNP who has prescriptive authority shall complete at least 16 hours of State Board of Nursing approved continuing education in pharmacology in the 2 years prior to the biennial renewal date of his or her CRNP certification. The CRNP shall show proof that she completed the continuing education when submitting a biennial review.
(4) In prescribing and dispensing drugs, a CRNP shall comply with standards of the State Board of Medicine (relating to prescribing, administering and dispensing controlled substances; packaging; and labeling of dispensed drugs) and the Department of Health.
49 PA ADC § 18.53
4. Which specific drugs may be prescribed and dispensed by CRNP's?
(a) The Board of Medicine has adopted the American Hospital Formulary Service Pharmacologic-Therapeutic Classification to identify drugs which the CRNP may prescribe and dispense subject to the parameters identified below.
(b) A CRNP may prescribe and dispense a drug relevant to the area of practice of the CRNP from the following categories if that authorization is documented in the collaborative agreement (unless the drug is limited or excluded under this or another subsection):
(2) Anti-infective agents;
(3) Antineoplastic agents, unclassified therapeutic agents, devices and pharmaceutical aids if originally prescribed by the collaborating physician and approved by the the collaborating physician for ongoing therapy;
(4) Autonomic drugs;
(5) Blood formation, coagulation and anticoagulation drugs, and thrombolytic and antithrombolytic agents;
(6) Cardiovascular drugs;
(7) Central nervous system agents, except that the following drugs are excluded from this category:
(i) General anesthetics;
(ii) Monoamine oxidase inhibitors;
(8) Contraceptives including foams and devices;
(9) Diagnostic agents;
(10) Disinfectants for agents used on objects other than skin;
(11) Electrolytic, caloric and water balance;
(13) Antitussive, expectorants and mucolytic agents;
(14) Gastrointestinal drugs;
(15) Local anesthetics;
(16) Eye, ear, nose and throat preparations;
(17) Serums, toxoids and vaccines;
(18) Skin and mucous membrane agents;
(19) Smooth muscle relaxants;
(21) Hormones and synthetic substitutes.
(c) A CRNP may not prescribe or dispense a drug from the following categories:
(1) Gold compounds;
(2) Heavy metal antagonists;
(3) Radioactive agents;
(d) If a collaborating physician determines that the CRNP is prescribing or dispensing a drug inappropriately, the collaborating physician shall immediately take corrective action on behalf of the patient and notify the patient of the reason for the action and advise the CRNP as soon as possible. This action shall be noted by the CRNP or the collaborating physician, or both, in the patient's medical record.
(e) Restrictions on CRNP prescribing and dispensing practices are as follows:
(1) A CRNP may write a prescription for a Schedule II controlled substance for up to a 72 hour dose. The CRNP shall notify the collaborating physician as soon as possible but in no event longer than 24 hours.
(2) A CRNP may prescribe a Schedule III or IV controlled substance for up to 30 days. The prescription is not subject to refills unless the collaborating physician authorizes refills for that prescription.
(f) A CRNP may not:
(1) Prescribe or dispense a Schedule I controlled substance as defined in section 4 of the Controlled Substance, Drug, Device and Cosmetic Act;
(2) Prescribe or dispense a drug for use not approved by the United States Food and Drug Administration without approval of the collaborating physician; or
(3) Delegate prescriptive authority specifically assigned to the CRNP by the collaborating physician to another health care provider.
(g) A prescription blank shall bear the certification number of the CRNP, name of the CRNP in printed format at the top of the blank and a space for the entry of the DEA registration number, if appropriate. The collaborating physician shall also be identified.
(h) The CRNP shall document in the patient's medical record the name, amount and dose of the drug prescribed, the number of refills, the date of the prescription and the CRNP's name.
49 PA ADC § 18.54
5. What are the standards for joint protocols between the CRNP and collaborating physicians?
(a) A collaborative agreement is the signed written agreement between a CRNP and a collaborating physician in which they agree to the details of the collaborative agreement between them with respect to the care of CRNP patients.
(b) The collaborative agreement between a physician and a CRNP who will prescribe drugs shall satisfy the following requirements. The agreement shall:
(1) Identify the parties, including the collaborating physician, the CRNP and a substitute physician who will provide collaboration and direction for up to 30 days if the collaborating physician is unavailable;
(2) Identify the area of practice in which the CRNP is certified;
(3) Identify the categories of drugs from which the CRNP may prescribe or dispense;
(4) Contain attestation by the collaborating physician that the physician has knowledge and experience with any drug that the CRNP will prescribe;
(5) Specify the circumstances and how often the collaborating physician will personally see the patient, based on the type of practice, sites of service and condition of the patient, whether the treatment is for an ongoing or new condition, and whether the patient is new or continuing;
(6) Specify the conditions under which the CRNP may prescribe a Schedule II controlled substance for up to 72 hours;
(7) Be kept at the primary practice location of the CRNP and a copy filed with the Bureau of Professional and Occupational Affairs.
(8) Be made available for inspection to anyone seeking to confirm the scope of practice of the CRNP;
(9) Be updated by the collaborating physician and the CRNP whenever it is changed substantively; and
(10) Specify the amount of professional liability insurance carried by the CRNP.
(c) The CRNP must notify the Bureau of Professional and Occupational Affairs whenever a collaborative agreement of a CRNP who prescribes and dispenses drugs is updated or terminated.
49 Pa. Code § 18.55
6. How should a CRNP be identified to a patient?
(a) A patient shall be informed at the time of making an appointment that the patient will be seen by a CRNP.
(b) A CRNP shall wear a name tag that clearly identifies the CRNP with the title "Certified Registered Nurse Practitioner."
(c) A CRNP who holds a doctorate should take appropriate steps to inform patients that the CRNP is not a doctor of medicine or doctor of osteopathic medicine.
49 PA ADC § 18.56
7. What are the supervision requirements for physicians with respect to CRNP's?
(a) At any time a physician may not supervise more than four CRNP's who prescribe and dispense drugs. This subsection does not limit the number of collaborative agreements that a physician may have with prescribing CRNP's. By way of example, a physician may supervise four prescribing CRNP's who work in the morning and four other prescribing CRNP's who work in the afternoon as long as the physician has a collaborative agreement with each CRNP.
(b) A physician may apply for a waiver of the supervision requirements expressed in subsection (a) for good cause, as determined by the Boards.
(c) The limit of the general rule of not more than four prescribing CRNP's to one physician does not apply to CRNP's who do not prescribe or dispense drugs. By way of example, a physician may supervise at the same time four CRNP's who prescribe and dispense drugs and one or more CRNP's who do not prescribe and dispense drugs.
49 PA ADC § 18.57
1A technician is defined as a person other than a health care practitioner or physician assistant, who, while unlicensed, through training, education or experience has achieved expertise in the technical details of a subject or occupation which is a compontent of the healing arts. (Pa Code 18.401)
2At the time of publication, regulations on the scope of unlicensed personnel have not yet been published.
Copyright Kern Augustine Conroy and Schoppmann, P.C. Used with permission.