RULES AND REGULATIONS
Title 49--PROFESSIONAL AND VOCATIONAL STANDARDS
STATE BOARD OF MEDICINE
STATE BOARD OF NURSING
[49 PA. CODE CHS. 18 AND 21]
CRNP Prescriptive Authority
[30 Pa.B. 5943] The State Boards of Medicine and Nursing (Boards) amend their regulations governing certified registered nurse practitioners (CRNPs) in Chapters 18 and 21 (relating to State Board of Medicine; and State Board of Nursing) to read as set forth in Annex A.
A. Effective Date
The amendments will be effective upon publication of final-form regulations in the Pennsylvania Bulletin.
B. Statutory Authority
Section 15(b) of the Medical Practice Act of 1985 (63 P. S. § 422.15(b)) authorizes the Boards to jointly promulgate regulations authorizing CRNPs to perform acts of medical diagnoses and prescription of medical, therapeutic, diagnostic or corrective measures. Section 2(1) of the Professional Nursing Law (63 P. S. § 212(1)) similarly indicates that a professional nurse may perform acts of medical diagnosis or prescription of medical therapeutic or corrective measures if the Boards promulgate regulations authorizing the acts.
C. Purpose
Under their statutory authority, the Boards have negotiated rulemaking which authorizes CRNPs to prescribe and dispense drugs within specified parameters. CRNPs are advanced practice nurses who are certified by the Boards in a particular clinical specialty area. This rulemaking will enable Pennsylvania CRNPs to make full use of their advanced education and skills and is consistent with the regulations of 41 other states which authorize CRNPs to prescribe or dispense, or both, with varying degrees of regulation or limitation. A detailed explanation of the purpose and background of the rulemaking may be found in the publication of proposed rulemaking at 29 Pa.B. 5101 (October 2, 1999).
D. Compliance with Executive Order 1996-1
In accordance with Executive Order 1996-1 (February 6, 1996), in drafting and promulgating the regulations the Boards solicited input and suggestions from the regulated community. The Boards mailed a draft on June 26, 1998, to 54 organizations, entities and individuals who had an interest in CRNP prescribing. The Boards received 373 responses to the solicitation. The Boards revised the draft as a result of the responses and submitted that revised draft as proposed rulemaking.
E. Summary of Comments and Responses to Proposed Rulemaking
Proposed rulemaking was published at 29 Pa.B. 5101 (October 2, 1999) followed by a 30-day public comment period. The Boards received reports from the House Professional Licensure Committee (HPLC) and the Independent Regulatory Review Commission (IRRC) and public comments from more than 600 associations, entities and individuals. As a result of these reports and comments, a number of changes were made to the proposed rulemaking. These changes include specifications regarding the course work in advanced pharmacology that will be a prerequisite to prescribing and dispensing; a requirement of continuing education in pharmacology for a CRNP who prescribes or dispenses; a requirement that every category of drugs from which a CRNP might prescribe be identified in the collaborative agreement; greater precision in the listing of the categories of drugs from which a CRNP might prescribe, prescribe with limitations or not prescribe; a definition of ''collaborative agreement''; identification of the contents of a collaborative agreement necessary for a CRNP who prescribes or dispenses; identification of the CRNP by nametag; and limiting a physician to collaborating with not more than four CRNPs who prescribe and dispense drugs at any one time unless the physician requests and obtains a waiver of this ratio. The Boards also combined subsections (b) and (c) of §§ 18.54 and 21.284.
The HPLC in its report of November 16, 1999, made recommendations regarding education in pharmacology, continuing education, the collaborative agreement, substitute collaborating physicians, and notice to patients when a patient is treated by a CRNP who prescribes drugs. IRRC in its report of December 2, 1999, made recommendations regarding the collaborative agreement, education in pharmacology, the categories of drugs, action to be taken if a drug is prescribed inappropriately and the clarity of draftmanship.
The Pennsylvania Coalition of Nurse Practitioners endorsed the proposed rulemaking but made recommendations for changes. The Nurse Practitioner Association of Southwestern Pennsylvania, individual physicians and nurses, and health care practices and entities supported the proposed rulemaking. The Hospital & Healthsystem Association of Pennsylvania (HAP), the Pennsylvania Academy of Pediatrics, the Pennsylvania Society of Anesthesiologists, the Pennsylvania State Nurses Association (PSNA) and Pennsylvania Academy of Family Physicians (PAFP) generally supported the proposed rulemaking, but made recommendations for changes. The Pennsylvania Medical Society (PMS) did not object to the proposed rulemaking, but also recommended changes. The American College of Emergency Physicians endorsed the recommendations of PMS and made several suggestions of their own.
Several associations and individuals generally opposed the proposed rulemaking. These associations included the Pennsylvania Podiatric Medical Association, the Pennsylvania Association of Chain Drug Stores and one chain drug store, and the Pennsylvania Osteopathic Medical Association.
The Boards received comments from consumers (individuals who did not identify themselves as physicians or nurses), physicians, and nurses. Of approximately 41 consumer comments, 40 favored the proposed rulemaking, one opposed. Consumers who favored the rulemaking stressed the quality of care received from CRNPs and said that the rulemaking would facilitate access to quality health care. Nurses almost uniformly favored the rulemaking and offered several suggestions which will be addressed in this Preamble. While a number of physicians opposed prescriptive authority for CRNPs, most physician commentators indicated that they were not opposed to the proposed rulemaking but made recommendations for changes. A large number of physician commentators supported the comments of PMS. The recommendations of physicians and their associations will also be addressed.
Equivalency of Programs in Other States--§§ 18.53(1) and 21.283(1).
The proposed rulemaking began by indicating that a CRNP might prescribe if the CRNP, among other things, completed a CRNP program approved by the Board or, if the nurse completed a CRNP education program in another state, the program was equivalent to programs approved by the Boards. IRRC asked how the Boards would determine equivalency. Section 7(b) of the Professional Nursing Law (63 P. S. § 217(b)), authorizes the State Board of Nursing to issue a certification to registered nurse practitioners who have completed a course of study in another state if the Board considers the program to be equivalent to that required in this Commonwealth. Under §§ 18.42 and 21.272 of the Boards' regulations the Boards may grant certification by endorsement to a CRNP who had been certified in another state if the credentials are equivalent to those required by the Boards. In implementing the statute and regulations, the Boards compare the courses of the non-Pennsylvania program with that of Pennsylvania program. If a comparison reveals that the programs are equivalent in course work and hours, the State Board of Nursing certifies the applicant.
Course in Advance Pharmacology--§§ 18.53(2) and 21.283(2).
The proposed rulemaking would have authorized a CRNP to prescribe and dispense if the ''CRNP program include[d] a core course in advanced pharmacology.'' The HPLC recommended that a minimum number of hours of core education in advanced pharmacology be required for a CRNP to be permitted to prescribe and dispense drugs. IRRC, the Pennsylvania Society of Health-System Pharmacists (PSHSP), and others also suggested greater clarity in describing what would qualify as an advanced pharmacology course. PMS, which recommended that the Boards clarify the proposed rulemaking in regard to the responsibility and accountability of both the CRNP and collaborating physician, requested that the course should be at least 30 hours. The PAFP recommended a 50-hour course. Individual physicians recommended specific courses of from 30 to 50 hours.
IRRC and others noted that some programs did not have a specific course but integrated pharmacology into the overall curriculum. Some commentators suggested that boards devise a way to ''grandfather'' those whose education in pharmacology was not contained in a specific course. Pennsylvania Association of Nurse Anesthetists, PSNA, and numerous individual nurse commentators supported this view. The PSNA recommended that the Boards consider ''grandfathering'' and requiring continuing education in advanced pharmacology or requiring the CRNP to provide documentation of cumulative advanced pharmacology.
In response to these comments, the Boards have adopted a 45-hour course work requirement and further refined the education acceptable to the Boards. A course in advanced pharmacology of 45 hours has been standard in Board approved CRNP programs since 1992. A course is at a level above the pharmacology courses taught in registered nursing programs. A course in pharmacology/pharmacotherapeutics of 45 contact hours is recommended in ''Curriculum Guidelines & Regulatory Criteria for Family Nurse Practitioners Seeking Prescriptive Authority to Manage Pharmacotherapeutics in Primary Care: Summary Report 1998'' (Curriculum Guidelines), prepared by the Health Resources & Services Administration of the United States Department of Health and Human Services recommends.1 Forty-five hours of course work in advanced pharmacology provides a level of education necessary for a CRNP to safely prescribe and dispense drugs. This is the standard adopted by the Boards in this rulemaking. The rulemaking has been drafted so that a CRNP who has not taken 45 hours of course work as part of the CRNP education program will be able to take additional course work from a program or programs approved by the Boards. Advanced pharmacology which has been ''integrated'' into other courses will be acceptable, if it can be verified through means such as a course syllabus or catalog which identifies the hours devoted to advanced pharmacology.
The Pennsylvania Association of Physician Assistants expressed the view in regard to § 18.53 that it would be a great undertaking for the Board to approve CRNP programs in this Commonwealth and elsewhere. The Boards, however, have a history and duty and the necessary staff to approve CRNP programs. See, §§ 18.41--18.42 and 21.271--21.272.
Continuing Education--§§ 18.53(3) and 21.283(3).
The HPLC recommended that a minimum number of hours of continuing education in advanced pharmacology be required per biennium for a CRNP to maintain prescriptive authority. PMS, PAFP, PSHSP, the Pennsylvania Psychiatric Society (PPS), and numerous physician commentators also recommended continuing education for a CRNP who prescribes drugs. The Boards believe this is a sound recommendation that would help the CRNP to stay current in pharmacological knowledge, would help insure public safety, and would be consistent with the current regulations of the Boards which require a CRNP to provide evidence of continuing competency in the area of medical diagnosis and therapeutics at the time the CRNP renews certification. See §§ 18.41(c) and 21.271(d). The Boards determined that 16 hours of continuing education biennially in pharmacology approved by the State Board of Nursing would be appropriate.
The Collaborative Agreement--§§ 18.55 and 21.285.
The HPLC, IRRC and others made recommendations concerning the collaborative agreement. The proposed rulemaking referred to, but did not define, the collaborative agreement. The HPLC recommended that the collaborative agreement be in writing, contain a list of the classes of medications that the CRNP would be authorized to prescribe, identify the collaborating physician, and provide for an identified substitute collaborating physician for up to 30 days when the collaborating physician is not available. IRRC recommended that the collaborative agreement be defined, that the collaborative agreement be signed by both the physician and CRNP before the CRNP could prescribe drugs, and that the rulemaking specify the contents of the collaborative agreement.
A number of commentators, both individual physicians and associations, recommended that the collaborative agreement be a written document that clarifies the collaborating physician/CRNP relationship. HAP recommended that the collaborative agreement be defined. The PAFP, the Pennsylvania Society of Anesthesiologists, PSHP and the Pennsylvania Association of Physician Assistants expressed the view that the proposed rulemaking did not define the collaborative agreement and that the parameters of collaborative practice should be memorialized in writing so that the parties to the agreement will have a clear understanding of their responsibilities to their patients. The PAFP recommended that the collaborative agreement be in writing, identify the parties, describe the direction each physician will provide the CRNP, the frequency with which the collaborating physician will provide chart review and consultation, identify the drugs which the CRNP may prescribe, be available to anyone seeking to confirm the scope of the CRNP's prescriptive authority, and be filed with the Board. The American Academy of Pediatrics (AAP) recommended that the collaborative agreements be spelled out publicly and in writing and kept on file with the State. The PMS recommended that the final rulemaking include a section on the collaborative agreement; that when a CRNP prescribes or dispenses drugs, the agreement should be in writing; that it be available at the practice site; that it identify the collaborating physician and any substitute collaborating physician by name; that the agreement contain the list of drugs for which the CRNP might prescribe; that it outline when a physician should see the patient and what occurrences would necessitate physician intervention; and that the collaborative agreement be filed with the State Board of Medicine if it authorized the CRNP to prescribe or dispense Schedule II controlled substances. The PMS and PPS recommended that the Boards be notified of the existence of every collaborative agreement and who is party to the agreement. PMS and PPS recommended that a physician not be permitted to include any drug in a collaborative agreement unless the physician has the expertise required to prescribe that drug so that she would be able to recognize any inappropriate prescribing or adverse reaction.
Final rulemaking contains a definition of the term ''collaborative agreement'' and requires that it be in writing.2 See §§ 18.55(a) and 21.285(a). Sections 18.55(b) and 21.285(b) specify the contents of a collaborative agreement between a physician and a CRNP who prescribes and dispenses drugs. These subsections adopt the recommendations of the HPLC and IRRC. Additionally, under the final rulemaking the collaborative agreement of a CRNP who prescribes and dispenses drugs is required to identify the area of practice in which the CRNP is certified, contain attestation that the collaborating physician has knowledge and experience with any drug that the CRNP prescribes, specify the circumstances and how often the collaborating physician will personally see the patient, specify the conditions under which a CRNP may prescribe a Schedule II controlled substance for up to 72 hours, be kept at the primary practice location of the CRNP and a copy filed with the Bureau of Professional and Occupation Affairs, be made available for inspection to anyone seeking to confirm the scope of practice of the CRNP, be updated when it is changed substantively, and specify the amount of professional liability insurance carried by the CRNP.
Professional Liability Insurance--§§ 18.55(b)(10) and 21.285(b)(10).
The PMS, PPS, AAP, the Pennsylvania Academy of Emergency Physicians, the Pennsylvania Podiatric Medical Association, and both nurse and physician commentators recommended that a CRNP with prescriptive authority should be required to carry malpractice insurance. The PMS recommended that the Boards require a CRNP who prescribes and dispenses medications to carry $400,000 in professional liability insurance, the current level of coverage mandated for certain health care practitioners under the Health Care Services Malpractice Act (40 P. S. §§ 1301.101--1301.1004). The Boards support the principle that a CRNP should carry professional liability insurance, but lack the statutory authority to require it by regulation. The Boards, however, can require that the collaborative agreement of a CRNP with prescriptive authority identify the level of insurance that the CRNP carries. This does not require a CRNP to carry any insurance, but will assure that the collaborating physician and anyone with an interest in reviewing the agreement will be aware of the amount of professional liability insurance, if any, carried by the CRNP.
Prescribing and Dispensing Parameters--§§ 18.54 and 21.284.
IRRC and physician and nurse commentators had several recommendations regarding these sections. IRRC requested that the Boards explain the basis for restrictions and prohibitions of certain drugs in the proposed section. These sections authorize, restrict or prohibit prescribing categories or classes of drugs rather than specific drugs. Sections 18.54(a) and 21.284(a) adopt the American Hospital Formulary Service Pharmacologic-Therapeutic Classification (AHFS) and either: (1) authorize a CRNP to prescribe and dispense from the formulary if the authorization is documented in the collaborative agreement (§§ 18.54(b) and 21.284(b)); or (2) authorize a CRNP to prescribe and dispense if the collaborating physician originally prescribed the drug and approved it for ongoing therapy (§§ 18.54(b)(3) and 21.284(b)(3)); or (3) authorize a CRNP to prescribe or dispense from a category while prohibiting certain subcategories (See §§ 18.54(b)(7)(i)--(ii) and 21.284(b)(7)(i)--(ii)); or (4) prohibit categories of drugs (§§ 18.54(c) and 21.284(c)); or (5) establish parameters for prescribing and dispensing controlled substances (§§ 18.54(e) and (f) and 21.284(e) and (f)). The bases for the restrictions and prohibitions include potential for harm and side effects, need for physician intervention, complexity of prescribing, categories of exceptional breadth, and potential for addiction or abuse.
IRRC suggested that the Boards delete the words ''which the CRNP may prescribe and dispense subject to the parameters identified in this section'' from §§ 18.54(a) and 21.284(a). The Boards have not done so to avoid suggesting that if a classification of drug were in the AHSF a CRNP would automatically be able to prescribe or dispense from it.
Under subsection (b) of the proposed rulemaking, a CRNP would have been able to prescribe and dispense any drug within the categories of the subsection ''without limitation,'' that is, without the need to list the category of drug in the collaborative agreement. Moreover, it would have been at best implicit that a CRNP, a practitioner who is certified in a specialty area, would prescribe only in the CRNP's area of practice. Under subsection (c) of the proposed rulemaking, a CRNP would have been able to prescribe any drug if the authorization was documented in the collaborative agreement.
The PPS requested that subsections (b) and (c) be combined to clarify that all categories of drugs from which a CRNP would be authorized to prescribe shall be identified in the collaborative agreement. The PAFP also recommended that the collaborative agreement identify every category of drug from which a CRNP might prescribe. Similarly, the HAP recommended that subsection (c) be modified to authorize a CRNP to prescribe a drug in the subsection if the collaborating agreement specifically included the category. Some commentators, including the Pennsylvania Association of Nurse Anesthetists, the PSNA, and a number of nurses, requested that the Boards employ a ''negative formulary,'' and not require the collaborative agreements to list every category of drug from which a CRNP might prescribe. The Boards have not adopted this suggestion.
On final-form rulemaking, the Boards have determined that the collaborative agreement of a CRNP who prescribes should contain a ''positive formulary'' which specifies every category of drug from which a CRNP might prescribe and dispense. A ''positive formulary'' assures that the parties to a collaborative agreement have made a conscious determination that the identified categories are appropriate for the CRNP to prescribe. Subsections (b) and (c) have been combined. Subsection (b) makes explicit that the CRNP will be permitted to prescribe and dispense drugs relevant to the CRNP's area of practice.
IRRC, PPS and several other commentators questioned the phrase ''without limitation'' in §§ 18.54(b) and 21.284(b). IRRC suggested that the phrase could be interpreted in a way that was inconsistent with the current regulations. The Boards have concluded that the phrase was confusing and susceptible to varying interpretations. The Boards have deleted the phrase on final rulemaking.
Several commentators pointed out that several categories of drugs in the AHFS Pharmacologic-Therapeutic Classification were omitted from the proposed rulemaking: eye, ear, nose and throat preparations, hormones and synthetic substitutes, devices, pharmaceutical aids, and unclassified therapeutic agents. These have been included in final rulemaking. Hypoglycemic agents and endocrine replacement agents, not identified as categories in the AHFS Pharmacologic-Therapeutic Classification, have been removed and are replaced with hormones and synthetic substitutes (into which categories these drugs do fall).
In regard §§ 18.54(c) and 21.284(c) of the proposed rulemaking (now subsection (b) in the final rulemaking) IRRC asked how documentation of categories of drugs would be authorized in the collaborative agreement. The parties to the collaborative agreement would simply identify the categories of drugs in the collaborative agreement.
Inappropriate Prescribing--§§ 18.54(d) and 21.284(d).
In regard to §§ 18.54(e) and 21.284(e) (now subsection (d) in final-form rulemaking), IRRC questioned the use of the word ''learn'' in regard to a physician's method of determining that a CRNP had prescribed incorrectly and recommended a more general course of corrective action than had been proposed. The Boards have adopted both of IRRC's suggestions. The PAFP recommended that if a physician learns that a drug has been wrongly prescribed, the physician should be required to resume direct care of the patient and make the appropriate notifications. Several nurse commentators suggested that the physician should tell the CRNP how to proceed if the physician determines that there has been incorrect prescribing. In final rulemaking, the Boards require the physician to 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. Further, the action is required to be noted in the patient's medical record.
Controlled Substances--§§ 18.54(e) and (f) and 21.284(e) and (f).
The Boards made two editorial changes recommended by IRRC to clarify CRNP prescribing of controlled substances. In regard to §§ 18.54(f) and 21.284(f) of the proposed rulemaking (now subsection (e) in the final-form rulemaking), IRRC questioned the clarity of the phrase ''immediately (within 24 hours).'' The Boards agreed with IRRC's concern that the wording was unclear and replaced the phrase in question with ''as soon as possible but in no event longer than 24 hours.''
''Off-label'' Uses--§§ 18.54(f)(2) and 21.284(f)(2). In regard to §§ 18.54(g)(2) and 21.284(g)(2) of the proposed rulemaking (now subsection (f)(2) in the final rulemaking), IRRC, PSHP and others questioned the use of the word ''permitted,'' pointing out that the Food and Drug Administration approves drugs for clinical use for a single indication and that after a drug has been approved for a single indication a prescriber is free to use that drug for any indication that the prescriber chooses. These alternative uses are generally referred to as ''unlabeled uses'' or ''off-label uses.'' The Boards replaced the word ''permitted'' with ''approved,'' and will authorize a CRNP to prescribe or dispense a drug for a use not approved by the FDA if the collaborating physician approves the use.
Schedule II Controlled Substances. The PSS and PAFP recommended that CRNPs not be given the authority to prescribe Schedule II controlled substances at all. PAFP alternatively expressed the view that if CRNPs are permitted to prescribe Schedule II controlled substances, the prescription be limited to 72 hours and the types of drugs be identified in the collaborative agreement. The American Academy of Pediatrics (AAP) recommended that a CRNP be required to notify the collaborating physician promptly and obtain approval prior to dispensing or prescribing ''certain'' Schedule II drugs, but did not specify which drugs. PMS recommended that a CRNP be permitted to prescribe a Schedule II controlled substance for up to a 72-hour dose only if the CRNP obtains approval from the collaborating physician prior to dispensing or prescribing the medication. The Boards did not adopt these recommendations. Under the final rulemaking the CRNP will be authorized to prescribe a Schedule II controlled substance for up to 72 hours but shall inform the collaborating physician as soon as possible, but in no event longer than 24 hours. The rulemaking will, however, require the collaborative agreement to specify the conditions under which a CRNP may prescribe a Schedule II controlled substance. If a physician does not think it appropriate for a CRNP to prescribe Schedule II controlled substances, that limitation could be included in the collaborative agreement.
Identification of the CRNP--§§ 18.56 and 21.286.
The HPLC, IRRC and others recommended that a CRNP who prescribes medications provide clear and conspicuous notice to patients that he is a CRNP. Similar recommendations were made by the PMS, AAP and individual physicians. The PMS and others also recommended that a CRNP not use abbreviations that are not recognizable to the public and that a CRNP who possesses a doctorate not use only the title, ''Doctor'' in a clinical setting.
The final-form rulemaking requires that a patient be informed at the time of making an appointment that he or she will be seen by a CRNP, that the CRNP wear a nametag that clearly identifies himself with the title ''Certified Registered Nurse Practitioner,'' and that a CRNP with a doctorate should take appropriate steps to inform patients that he is not a doctor of medicine or doctor of osteopathic medicine.
Physician Supervision--§§ 18.57 and 21.287.
The PMS and PPS recommended that a physician not be permitted to supervise more than four CRNPs who prescribe because it would be, in the view of the PMS, very difficult for a physician to carefully monitor more than that number. Other physician commentators noted that the regulations should require strict physician supervision and oversight. Some nurse commentators maintaind that CRNPs in ''solo practice'' should not need a collaborating physician. The legislative scheme, however, requires CRNPs to act in accordance with regulations authorized by section 15(a) of the Medical Practice Act (63 P. S. § 422.15(a)). Current regulations define a CRNP as a registered nurse certified in a particular clinical specialty area who performs acts of medical diagnosis or prescription of medical therapeutic or corrective measures ''in collaboration with and under the direction of a physician. . . .'' (See §§ 18.21 and 21.251) Final rulemaking emphasizes that a collaborating physician is required to provide meaningful direction to a CRNP who prescribes by generally limiting the number of prescribing CRNPs with whom a physican might collaborate. Sections 18.57 and 21.287 would permit a physician to collaborate with four CRNPs who prescribe and dispense drugs at any one time. Under these sections a physician could supervise a total of more than four prescribing and dispensing CRNPs, but not at the same time. Moreover, the regulation would not prohibit the physician from further collaborating with other CRNPs who do not prescribe and dispense and would permit the physician to request a waiver of the limit of four prescribing CRNPs for good cause.
Further Comments.
The Pennsylvania College of Emergency Physicians recommended that the Boards include specific regulatory requirements pertaining to CRNPs prescribing in emergency departments. The Boards decline to do this but point out that the contents of a collaborative agreement could reflect the particular needs of any type of practice, including emergency departments.
The PAFP and several commentators, most of whom were physicians, recommended that CRNPs be required to pass a standard examination for certification. While a board examination is not required for certification under the Medical Practice Act of 1985 (63 P. S. §§ 422.1--422.45) and the Professional Nursing Law (63 P. S. §§ 211--225.5), §§ 18.41 and 21.271 of the regulations of the State Board of Medicine and Nursing establish educational criteria for certification of nurse practitioners. Moreover the Boards carefully review CRNP education programs and approve only those which offer rigorous course work and assessment of the nurse practitioner students.
The PAFP observed that the Boards did not specify that a CRNP must comply with § 16.95 of the regulations of the State Board of Medicine (relating to medical records). While these regulations are not specifically cited, every professional nurse is required to document and maintain accurate records under § 21.18(a)(5) of the regulations of the State Board of Nursing. Further, § 18.111 of the regulations of the State Board of Medicine and § 21.351 of the regulations of the State Board of Nursing authorize the Boards to suspend or revoke the certification of a CRNP who violates any provision of the Medical Practice Act of 1985, the Professional Nursing Law, or the regulations adopted under those acts.
The Pennsylvania Podiatric Medical Association and a number of physician commentators in their opposition to the proposed rulemaking stated that the proposal did not require a collaborative agreement, that a CRNP lacked the knowledge to medically treat a patient, that the State Board of Nursing could amend future regulations without input from the State Board of Medicine, and that the CRNP was wrongly permitted to practice independently and was now the ''captain of the ship.'' While the proposed rulemaking did not adequately address the collaborative agreement, final rulemaking both requires a written agreement and outlines the contents of the agreement. The General Assembly has given the Boards the power to jointly promulgate regulations authorizing CRNPs to perform acts of medical diagnoses and prescription of medical, therapeutic, diagnostic or corrective measures. See Part B of this Preamble, Statutory Authority. The current regulations of both Boards provide that a CRNP while functioning in the expanded role as a professional nurse, performs acts of medical diagnosis or corrective measures ''in collaboration with and under the direction of a physician. . . .'' §§ 18.21 and 21.251. Section 15(b) of the Medical Practice Act of 1985 requires the joint action of both Boards to promulgate regulations regarding medical acts that might be performed by a CRNP.
The Pennsylvania Association of Chain Drug Stores, Inc. and one chain drug store opposed the proposed rulemaking. PACDS and the chain suggested that while the Boards have the statutory authority to implement regulations authorizing a CRNP to prescribe drugs, statutory authority to authorize a CRNP to dispense a drug is lacking. The Boards have the authority to jointly promulgate regulations authorizing CRNPs to perform acts of medical diagnoses and prescription of medical, therapeutic, diagnostic or corrective measures. See Part B of this Preamble, Statutory Authority. Prescribing drugs is the prescription of a medical measure. Section 8(2) of the Pharmacy Act (63 P. S. § 390-8(2)) makes clear that while it is unlawful for someone who is not licensed as a pharmacist to dispense drugs, that prohibition does not extend to ''a duly licensed medical practitioner.'' Section 2(9) of the Pharmacy Act (63 P. S. § 390-2(9)) defines the phrase medical practitioner as ''a physician, dentist, veterinarian or other individual duly authorized and licensed by law to prescribe drugs.'' Authorization to prescribe drugs includes authorization to dispense drugs.
Finally, the Pennsylvania Osteopathic Medical Association expressed the view that CRNPs should be ''under the jurisdiction of a physician'' and was concerned that ''CRNPs are not adequately trained to practice independently with prescriptive authority.'' A CRNP performs in an expanded role as a professional nurse and performs acts of medical diagnosis or prescription of medical therapeutic or corrective measures in collaboration with and under the direction of a physician licensed to practice medicine in this Commonwealth. See §§ 18.51 and 21.251. This rulemaking does not curtail the responsibility of the collaborating physician to provide collaboration and direction.
F. Fiscal Impact and Paperwork Requirements
There will be an increase in costs to the Commonwealth. Board staff will have to receive and file copies of the collaborative agreements of those CRNPs who prescribe and dispense drugs. Board staff will also have to slightly modify the CRNP renewal application to include a provision which will enable a CRNP with prescriptive authority to certify that the CRNP has completed the 16 hours of required continuing education courses. Board staff will have to review renewal applications to ascertain that prescribing CRNPs have fulfilled continuing education requirements. The Nurse Board and its staff will have to review programs wishing to offer either courses in advanced pharmacology or continuing education, or both. The amount of these costs have not been ascertained because there is no history of these costs. Costs to the regulated community will be increased in that collaborating physicians and CRNPs who wish to prescribe will have to modify their collaborative agreements to include the required content of §§ 18.55 and 21.285 (relating to the collaborative agreement). A CRNP who wishes to prescribe but who has not already taken 45 hours of advanced pharmacology will have to bear the costs of taking a course or courses in advanced pharmacology. Prescribing CRNPs will also have to bear the costs of continuing education courses. CRNPs who prescribe and their collaborating physicians will bear the costs of forwarding a copy of the collaborative agreement to the Bureau of Professional and Occupational Affairs. The costs of this rulemaking may be passed on to consumers of CRNP services. It is unlikely that these costs will result in significantly increased prices. The costs may be offset by the greater availability of medical services and the increased efficiency engendered by having CRNPs who can prescribe without the prior intervention of a physician. Citizens of this Commonwealth will benefit from having more ready access to cost-effective, quality health care. Revising collaborative agreements and forwarding a copy to the Bureau represent the largest increase in paperwork in regard to this rulemaking.
G. Regulatory Review
Under section 5(a) of the Regulatory Review Act (71 P. S. § 745.5(a)), the Boards submitted a copy of the notice of proposed rulemaking, published at 29 Pa.B. 5101, to IRRC and to the Chairpersons of the House Professional Licensure Committee and the Senate Consumer Protection and Professional Licensure Committee for review and comment. In compliance with section 5(c) of the Regulatory Review Act, the Boards also provided IRRC and the Committees with copies of the comments received as well as other documentation.
In preparing these final-form regulations, the Boards have considered the comments received from IRRC and the public.
These final-form regulations were disapproved by IRRC at its meeting of July 13, 2000. IRRC's order of disapproval was received by the Boards on September 11, 2000. On that date the Boards, under section 7(a) of the Regulatory Review Act (71 P. S. § 745.7(a)), submitted written notice of their intention to modify the final-form rulemaking in accordance with section 7(c) of the Regulatory Review Act, to the Governor, IRRC and the House and Senate Committees.
On October 2, 2000, the Boards delivered final revised rulemaking and the section 7(c) report to the Governor, IRRC and the House and Senate Committees.
The final-form regulations were approved by the House Committee on October 3, 2000, deemed approved by the Senate Committee on October 12, 2000, and approved by IRRC on October 19, 2000.
H. Sunset Date
The Board continuously monitors its final-form regulations. Therefore, no sunset date has been assigned.
I. Contact Person
Further information may be obtained by contacting Ann Steffanic, Board Administrator, State Board of Nursing or Cindy Warner, Board Administrator, State Board of Medicine, P. O. Box 2649, Harrisburg, PA 17105-2649, (717) 783-7142 and 783-1400, respectively.
J. Findings
The Boards find that:
(1) Public notice of proposed rulemaking was given under sections 201 and 202 of the act of July 31, 1968 (P. L. 769, No. 240) (45 P. S. §§ 1201 and 1202) and the regulations promulgated thereunder in 1 Pa. Code §§ 7.1 and 7.2.
(2) A public comment period was provided as required by law and all comments were considered.
(3) These amendments do not enlarge the purpose of proposed rulemaking published at 29 Pa.B. 5101.
(4) These amendments are necessary and appropriate for administration and enforcement of the authorizing acts identified in Part B of this preamble.
K. Order
The Boards, acting under their authorizing statutes, order that:
(a) The regulations of the Boards, 49 Pa. Code Chapters 18 and 21, are amended by adding §§ 18.53--18.57 and 21.283--21.287 to read as set forth in Annex A.
(b) The Boards shall submit this order and Annex A to the Office of General Counsel and to the Office of Attorney General as required by law.
(c) The Boards shall certify this order and Annex A and deposit them with the Legislative Reference Bureau as required by law.
(d) This order shall take effect on publication in the Pennsylvania Bulletin.
CHARLES D. HUMMER, Jr., MD,
STEPHEN K. ANDERSON, RN, CRNA,
ChairpersonsFiscal Note: Fiscal Note 16A-499 remains valid for the final adoption of the subject regulations.
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1 Of the 42 states which permit CRNPs to prescribe, 21 require that the CRNP have completed a separate pharmacology course. ''Curriculum Guidelines,'' Table 2, page 16.
2 The definition is based on the definition of the collaborative agreement between a physician and nurse midwife found at 49 Pa. Code § 18.1.
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