RULES AND REGULATIONS
Title 49--PROFESSIONAL AND VOCATIONAL STANDARDS
STATE BOARD OF MEDICINE
[49 PA. CODE CHS. 16 AND 18]
Physician Assistants
[36 Pa.B. 7009]
[Saturday, November 18, 2006]The State Board of Medicine (Board) amends §§ 16.11 and 16.13 (relating to licenses, certificates, and registrations; and licensure, certification, examination and registration fees) and §§ 18.121, 18.122, 18.131, 18.141--18.145, 18.151--18.159, 18.161, 18.162, 18.171, 18.172 and 18.181 regarding physician assistants and their supervising physicians to read as set forth in Annex A.
A. Effective Date
The amendments will be effective upon final-form publication in the Pennsylvania Bulletin.
B. Statutory Authority
Section 8 of the Medical Practice Act of 1985 (act) (63 P. S. § 422.8) authorizes the Board to promulgate standards for licensing of physician assistants consistent with the requirements of sections 13 and 36 of the act (63 P. S. §§ 422.13 and 422.36). Section 13 of the act authorizes the Board to promulgate regulations which define the services and circumstances under which a physician assistant may perform a medical service.
C. Background and Purpose
The Board has determined that its regulations regarding the services and circumstances under which a physician assistant may perform a medical service, which define the supervision and personal direction required by the standards of acceptable medical practice embraced by the medical doctor community in this Commonwealth, are unduly restrictive. Since the physician assistant regulations were last amended in 1993, experience in the application of the regulations has demonstrated the need for amendments that reflect the current state-of-the-art of medical practice as can also be observed in the American Medical Association (AMA) guidelines for physician assistants. The existing regulations prevented the effective use of physician assistants to the full extent of their training. Over 1,000 medical doctors, physician assistants and physician organizations wrote to support the proposed rulemaking, noting that the previous regulations were in many ways overly and unnecessarily restrictive.
D. Summary of Comments and Responses to Proposed Rulemaking
Proposed rulemaking was published at 35 Pa.B. 6127 (November 5, 2005). The Board entertained public comment for a period of 30 days during which time the Board received comments from well over 1,000 medical doctors, physician assistants, health care facilities, medical practices, the Philadelphia College of Osteopathic Medicine, professional societies and physician assistant training programs. These individuals and entities were overwhelmingly supportive of the proposed rulemaking. The Pennsylvania Medical Society and the Pennsylvania Society of Physician Assistants were not only involved in the proposed rulemaking, they were positively disposed to the amendments and urged the rulemaking's expeditious completion.
Specific comments were made by the Pennsylvania Rural Health Association (PRHA), the Pennsylvania Association of Nurse Anesthetists, the Pennsylvania Association for the Treatment of Opioid Dependence, the Pennsylvania State Coroner's Association, The Hospital and Health Association of Pennsylvania (HAP) and Highmark.
Following the close of the public comment period, the Board received comments from the House Professional Licensure Committee (HPLC) and the Independent Regulatory Review Commission (IRRC). The Senate Consumer Protection and Professional Licensure Committee (SCP/PLC) did not comment. The following is a summary of the comments and the Board's response.
The Pennsylvania Association of Nurse Anesthetists expressed concern that § 18.145 (relating to biennial registration requirements; renewal of physician assistant license) could be interpreted to allow delegation of authority to physician assistants to administer general anesthetic agents. The Board believes that the Pennsylvania Association of Nurse Anesthetists is actually concerned about the amendment to § 18.151(a) (relating to role of physician assistant), which includes language that permits physician assistants to administer drugs. The physician assistant training program and recertification each 6 years by the National Commission on the Certification of Physician Assistant ensures that physician assistants are constantly kept up to date with the state of technology on general anesthesia and conscious sedation. In addition, oversight by the supervising physician acts as a control on, and verifies the ability of, the physician assistant to competently perform appropriately delegated anesthesia services. Further, administration of general anesthetic agents is generally performed in hospital settings and is subject to additional oversight in that setting.
The Pennsylvania Coroner's Association recommended that language in the amendment to § 18.151(c) be clarified to ensure that the supervising physician or the county coroner, in the event the supervising physician is not available, certify the cause and manner of death. The Board agrees with this recommendation and has included clarifying language.
The PRHA and HAP both commented on § 18.153(b) (relating to executing and relaying medical regimens) in diametrically opposed directions. The PRHA suggested that the amendment which increased the time for reporting of changes to medical regimens from 12 hours to 36 hours was insufficient and too restrictive. It was suggested that 72 hours was a more reasonable time frame. HAP suggested that 24 hours was more than sufficient to communicate the execution or relaying of a medical regimen. In light of numerous favorable comments, the Board has decided not to alter the amendment.
In § 18.155(b)(4) (relating to satellite locations), the PRHA commented that the time frame requirement for physicians to visit satellite facilities ought to be increased from ''at least weekly'' to every 2 weeks or 10 working days. The PRHA advised that the reason for establishment of satellite facilities would be compromised if weekly visits are required. The Board agrees with the PRHA's recommendation and has reduced the requirement for physician visits to 10 days.
The PRHA requested the deletion of the phrase ''originally prescribed by the supervising physician'' from § 18.158(a)(3) (related to prescribing and dispensing drugs, pharmaceutical aids and devices), as this requirement would be overly restrictive in rural clinics. IRRC also requested clarification from the Board on the necessity for this language. The Board agrees with the PRHA and has deleted this phrase in this final-form rulemaking.
The Pennsylvania Association for the Treatment of Opioid Dependence expressed concern that § 18.158 would give too much latitude to physician assistants in prescribing methadone and that the ''typical PA'' would not be in a position to properly prescribe using their own judgment. The Board acknowledges that although methadone is a Schedule II drug with special societal concerns as it relates to addicts, physician assistants who may prescribe this drug are not only specially trained to recognize the signs of addiction, they also work with supervising physicians who are also specially trained in addictions and choose those categories of drugs that physician assistants are permitted to prescribe or dispense.
HAP was generally supportive of the proposed rulemaking. The primary areas of concern for HAP were § 18.142 (relating to written agreements) and § 18.153. Regarding § 18.142, HAP indicated that the written agreement would have limited applicability in the hospital setting, and that it would not be the authoritative document that would dictate physician assistant practice in a licensed acute or specialty hospital. HAP commented that a hospital could decide to limit the practice of a physician assistant in that setting to be more restrictive than in the written agreement. The Board is fully cognizant of how physician assistants operate within health care facilities and notes that their functioning in these environments will not change under the final-form rulemaking. However, to clarify to its licensees that health care facilities may restrict the practice of physician assistants, the Board has added language to that effect in § 18.161 (relating to physician assistant employed by medical care facilities).
The concerns of HAP regarding § 18.153 centered on the issuing of written and oral orders given by physician assistants in the setting of health care facilities. HAP recommended that specific language be drafted to address the issuing of orders by physician assistants within health care facilities. The Board agrees with HAP's recommendation and has included language in § 18.153(c) which addresses HAP's concerns. The remainder of comments by HAP generally address credentialing and licensure matters and not how physician assistants practice in health care facilities or a change in that practice. The Board has decided that further revision to the amendment is not warranted at this time. The Board will continue to monitor the role and utilization of physician assistants as is already established in § 18.156 (relating to monitoring and review of physician assistant utilization).
Highmark was generally supportive of the proposed rulemaking and noted that it reflects the current standards for medical practice and allows for the effective use of physician assistants to the full extent of their training. Highmark specifically commented on § 18.158, requesting that the Board retain language on prohibiting prescribing of Schedule II drugs, prohibiting off-label prescribing and preventing the prescribing and dispensing of drugs until 90 days have elapsed after Food and Drug Administration (FDA) approval. Highmark also suggested that the Board specify which medications could be ordered by a physician assistant to be refilled annually. As more fully described as follows, this final-form rulemaking brings into line how the medical doctor community utilizes physician assistants. The physician assistant is still subject to the regulations of the Board and the Department of Health regarding dispensing standards, prescribing and labeling. In specialties that deal with chronic pain management and specialties such as oncology, surgery, anesthesiology or in the family practice setting, physician assistants are an integral part of patient care. Managing the patients' pain in these settings often requires the ability to write prescriptions for Schedule II narcotics on both a short-term and long-term basis. Also, there are many physician assistants that work in settings such as emergency rooms, walk-in clinics and industrial clinics. The inability to write a prescription for a Schedule II narcotic impedes the care of the patient in these settings.
Highmark commented that a requirement be added to § 18.142 requiring specific protocols be laid out for communication between physicians and physician assistants when a patient's condition changes suddenly. The Board sees this as contrary to the purpose of this final-form rulemaking, which provides for the supervising physician to develop protocols based upon the specific nature and setting of the physician's practice. Highmark recommended that language be added to § 18.144 (relating to responsibility of primary supervising physician) that the supervising physician assess the physician assistant's knowledge, abilities and skills on an ongoing basis. Highmark acknowledged that supervising physicians have the ultimate responsibility for the physician assistant's work. Experience has shown that when physicians work with physician assistants or other practitioners on an ongoing basis, there is naturally an ongoing assessment of that individual's skill, abilities and knowledge. The Board notes that physician assistants must maintain National certification which requires, among other things, periodic reexamination.
The HPLC directed that the Board consider the comments made by other commentators. The Board has done so. The HPLC requested that Board obtain comments and recommendations from the State Board of Pharmacy (Pharmacy Board) on physician assistants prescribing or dispensing pharmaceuticals. The Board requested comments from the Pharmacy Board. The Pharmacy Board was generally supportive of the amendments. The Pharmacy Board's main concerns were that using a negative formulary would place a delay on dispensing of medications to a patient while waiting for receipt of a copy of the written agreement from the physician assistant in confirming the physician assistant's prescriptive authority. The Pharmacy Board also commented that some pharmacists report resistance from physician assistants in providing a copy of the written agreement. The Board takes note of this concern. However, the Board is cognizant of the fact that a positive formulary would also have required the pharmacist to obtain a copy of the written agreement. Therefore, delay in dispensing of prescribed medications to patients would not change with this final-form rulemaking. The Pharmacy Board encouraged the Board to remind physician assistants of the requirement to provide a copy of the written agreement when requested, as well as reminding physician assistants to ensure that the supervising physician's name and license number appear on the prescription blank. The Pharmacy Board expressed concern that prescriptions for Schedule II controlled substances might not conform to time limitations of the regulations. The Federal Drug Enforcement Administration (DEA) makes it incumbent upon the pharmacist who fills the prescription to ensure that the physician assistant is prescribing within the parameters established by the state in which that individual practices. The Board has clarified the language in § 18.158(a)(3) and requires physician assistants to state on the prescription blank when the prescription is for initial therapy (for up to 72 hours) and ongoing therapy (up to a 30-day supply) if it was approved by the supervising physician for ongoing therapy. The Board places the onus of complying with these regulations on the physician assistant and the supervising physician, as the physician assistant must notify the supervising physician within 24 hours of the initial therapy prescription. The Board intends to place an article in its next newsletter reminding physician assistants and supervising physicians of their obligation to comply with requests for production of their written agreement upon implementation of this final-form rulemaking.
The HPLC requested that the Board define ''supervising physician'' in § 18.122 (relating to definitions). That term was already defined in the proposed rulemaking and continues to be defined. The HPLC requested clarification that all physicians assisted by physician assistants be called supervising physicians. The Board has modified the definition of ''supervising physician'' in § 18.122 to reflect the HPLC's concern.
The HPLC recommended that, to be consistent with the act, § 18.142 should contain language requiring each physician who supervises a physician assistant to sign the written agreement. The Board notes that requirement is already in the regulations as they were originally promulgated. The HPLC further recommended that language which the Board deleted in the proposed rulemaking concerning the approval of written agreements be restored. The Board has complied with this recommendation. The HPLC recommended that ''works with'' in § 18.142 be deleted and ''assists'' be restored for consistency with the act. The Board has complied with that recommendation.
In § 18.151(b), the HPLC recommended that the phrase ''training and experience'' be added. The Board has no objection to including this language since it does not alter the intent of the subsection and the regulated community believes the language will be understood by practitioners.
The HPLC believes there is a drafting error in § 18.158(a)(3) and recommends that the second sentence be its own paragraph. The Board believes that it is critical that the sentence stay where it is, as it reinforces the mandate for the physician assistant to notify the supervising physician immediately, and no longer than within 24 hours, that a Schedule II drug has been prescribed.
The HPLC requested clarification regarding the duty of confidentiality between a physician assistant and a patient, and how the amendments would impact upon this duty. The Board is not cognizant of any changes in the amendment which would alter the current requirements of patient confidentiality, and how physician assistants interact with patients. There is no change in access to medical records or other patient information from the regulations as they currently exist. The HPLC also requested assurance that the medical regimen changes and countersignature requirement changes, as well as notification and countersignature changes of prescribing of drugs by a physician assistant in § 18.158 are consistent with medical standards of the medical doctor community. The Board notified the regulated community that it intended to propose updating its physician assistant regulations and sought predraft input. Numerous medical doctors and physician organizations wrote to support the proposed rulemaking, noting that the regulations were, in many ways, overly and unnecessarily restrictive. It was due to the ground swell of demand for increasing the flexibility of physician assistant regulations, and the recognition that physician assistants are a valuable and indispensable asset to physicians, that the changes have been made.
In § 18.161(b), the HPLC recommended that the language that addresses the number of physician assistant supervisors a physician assistant may have, which was deleted in proposed rulemaking, be restored to be consistent with the act. The Board has complied with that recommendation.
The HPLC recommended that the language in § 18.171 (relating to physician assistant identification), which is amended to state that the typeface be easily readable, be modified to state that it be at least a specified font size. The Board believes this recommendation for additional language is unnecessary. The regulations prohibit a physician assistant from providing medical service to a patient until that individual or their guardian has been notified that the physician assistant is not a physician, and that the patient has the right to be treated by the physician if the patient desires. Therefore, the Board believes the requirement that the identification tag be easily readable is sufficient.
The HPLC further requested detailed information on the following: a list of states which permit physician assistants to prescribe Schedule II drugs and their limitations; the scope of practice of physician assistants in other states; the supervision requirements of physicians in other states; in-depth information on the training, certification, clinical study and continuing education of physician assistants; and a list of the types of documents which may be authenticated by a physician assistant. The Board is providing this information to the HPLC as a supplement to the rulemaking because it is too voluminous to be incorporated into this preamble.
IRRC concurred with, and incorporated, the HPLC's comments as part of its comments. IRRC recommended that in § 18.122 the phrase ''personal direction'' be restored in the definition of ''supervision.'' The Board is agreeable to inserting the word ''personal'' in the revised definition of ''supervision.'' IRRC requested clarification that the definition of ''supervising physician'' includes all physicians who are assisted by physician assistants and that there may be more than one supervising physician. The Board has no objection and has clarified the definition.
IRRC requested clarification on how the Board would interpret personal contact in § 18.142(a)(3) as the definition of ''direct supervision'' is being deleted. The Board believes that the definition of ''supervision,'' which includes personal direction, in conjunction with the language in § 18.142(a)(3), which states that the written agreement must specify the frequency of personal contact, addresses this concern. Further, the Board is of the opinion that the degree and nature of personal contact is best determined between the supervising physician and the physician assistant. Ultimately, it is the belief of the Board that a form of communication which allows for interactive discussion in some form, be it in person, by telephone, radio, video-conferencing or other means, would accomplish personal contact.
In § 18.158(a)(3), IRRC requested clarification from the Board on the necessity for the phrase ''originally prescribed by the supervising physician.'' The PRHA, as previously noted, requested that this wording be removed. The Board agrees with IRRC and the PRHA and has deleted this wording in the final-form rulemaking. Therefore, clarification is no longer needed.
IRRC commented that ''at least weekly'' or other specific time period be added to the record review requirement in § 18.159 (relating to medical records). The Board has no objection and has added language that record review be done within 10 days.
E. Description of Amendments
In § 18.121 (relating to purpose), the term ''physician assistant supervisor'' is replaced with ''supervising physician'' and at all other places that it appears in Chapters 16 and 18. The change emphasizes that the physician assistant's supervisor must be a physician and eliminates the confusion that sometimes surrounded the term ''physician assistant supervisor.''
The amendments to § 18.122, in addition to being primarily editorial in nature, clarify and emphasize that all supervising physicians still maintain personal direction over physician assistants. The definition of ''supervising physician'' reflects that a physician who is so designated in a written agreement is a supervising physician over that particular physician assistant. This is also compatible with the deletion of the definition of ''direct supervision,'' a term which was only found in § 18.162 (relating to emergency medical services). The Board amended that section by deleting the requirement that physician assistants provide emergency services only under the ''direct'' supervision of a supervising physician.
The definition of ''supervision'' is also amended to more accurately reflect how physician assistants are actually supervised and more clearly reflect the important responsibility that the physician assistant assumes when serving in this role. The changes primarily ease the need for the physical presence and intervention of the physician in oversight of the physician assistant, although maintaining the requirement for personal direction. The amended definition reiterates that the constant physical presence of the supervising physician is not required so long as the supervising physician and physician assistant are, or can easily be, in contact with one another by radio, telephone or other telecommunication device.
In the definition of ''supervision,'' examples of the ''appropriate degree of supervision'' are amended to eliminate the requirement for weekly review of patient charts. This amendment more closely aligns with the practicality of a physician's practice. Current requirements of chart review and counter-signature of physician assistant charts are cumbersome and ineffective. A review of selected charts which have specific diagnoses or complex medical management will support a more effective use of physician time and promote quality assurance.
The definition of ''medical regimen'' is changed to ''a therapeutic, corrective or diagnostic measure undertaken or ordered by a physician or physician assistant acting within the physician assistant's scope of practice and in accordance with the written practice agreement between the supervising physician and the physician assistant.''
In this final-form rulemaking, the definition of ''order'' is ''an oral or written directive for a therapeutic, corrective or diagnostic measure, including a drug or device to be dispensed for onsite administration in a hospital, medical care facility or office setting.'' This new language provides clarity as to the parameters of an order and provides a comprehensive foundation which lends itself to the expanded definition of ''medical regimen.'' This is further delineated as it pertains to medical facilities by language in § 18.161(d). The new language in this section is responsive to the concerns of medical facilities in their utilization of physician assistants and the integration of individuals in the fabric of facility operations.
Section 18.131 (relating to recognized educational programs/standards) amends ''approval'' of physician assistant training programs to ''recognition'' of those programs to more accurately reflect that the Board does not approve programs, but rather recognizes those that are accredited as mandated by section 36(b) of the act.
The final-form rulemaking updates the reference to the training program approvals for physician assistants by the AMA's Committee on Allied Health Education and Accreditation (CAHEA), Commission for Accreditation of Allied Health Educational Programs (CAAHEP), Accreditation Review Commission (ARC-PA) or a successor organization. In 1994, the AMA made CAHEA its accreditation body, independent and changed its name to CAAHEP. In 2000, ARC-PA was created due to the overwhelming growth of physician assistant programs and the difficulties that developed in trying to evaluate them appropriately. The AMA and other physician groups remain active in the accreditation process and occupy seats on the committee.
Section 18.142(a)(2) is amended so that the written agreement will no longer be specific as to the requirement for describing how the physician assistant will assist each physician. The section is amended to state that the agreement must list functions that will be delegated to the physician assistant, deleting the requirements that it also describe how the physician assistant will assist each named physician and the details of how the supervising physician will be assisted. Prior to this final-form rulemaking, the regulations specified that the agreement contain procedures selected from the list in § 18.151, all other delegated tasks, instructions for use of the physician assistant in the performance of delegated tasks and medical regimens to be administered or relayed by the physician assistant. This requirement inhibits the effective utilization of physician assistants. In addition, it forces the Board to become more directly involved in the approval of practice guidelines for physicians and physician assistants rather than credentialing health care professionals. The final-form rulemaking also requires the agreement to be signed only by each physician acting as a supervising physician or a substitute supervising physician instead of by each physician in the practice group, as well as the physician assistant.
Sections 18.144 and 18.155 are amended to eliminate the requirement for the supervising physician to see each patient on every third visit or at least once a year. The Board now requires in § 18.144(4) that the physician determine the need to see each patient based upon the patient's individual needs or at the patient's request. The amendment recognizes that the involvement of the supervising physician should be predicated on factors such as the practice type, site and the condition of the patient. This also applies to satellite facilities. Because the previous requirement applied to patients who are treated by a physician assistant, it included within its application situations in which it is virtually impossible for a physician to meet. For example, if a patient is seen by a physician assistant for a minor problem and does not return within 1 year to be seen by the physician, the physician could not comply with the requirement. Attempts to meet the requirements of the prior regulation resulted in inefficient use of resources. The physician assistant can easily manage a patient with a well-controlled chronic problem who is checked periodically to see if all is well. However, if the patient is checked only once annually, a physician had to be involved due to the requirements of the prior regulation. Experience has demonstrated that the prior regulation was counter-productive. The option remains, as always, for the patient to request to be seen by the supervising physician.
Section 18.151 includes a list of tasks that the physician assistant could perform (subject to the proviso that the list is not all-inclusive). The Board determined that the list of tasks physician assistants could perform was somewhat limiting. Although the regulation stated that the list was not intended to be all-inclusive, the Board is prohibited by court rulings from rendering advisory opinions. Therefore, one is left to speculate as to whether or not a given task not on the list, but critical to a particular practice, would be permitted. This final-form rulemaking replaces the list with statements that the physician assistant may practice medicine with physician supervision and perform duties as delegated by the physician. This section now establishes as a baseline standard that the physician assistant should be authorized to perform any medical service delegated by the physician, and which comports with the skills, training and experience of the physician assistant.
Section 18.152 (relating to prohibitions) currently prohibits a physician assistant from pronouncing death. The amendments to §§ 18.151 and 18.152 allow a physician assistant to pronounce a patient dead and also allow a physician assistant to authenticate with his signature any form related to pronouncing death. Physician assistants who practice in long-term care facilities, hospital wards, hospice care or in hematology/oncology, among other specialties, encounter circumstances when they may be the only medical care provider available at the time of a patient's death. Allowing delegation of the pronouncement of death simplifies procedures for the patient's family at a difficult time. The final-form rulemaking allows only pronouncement of death. Certification as to the cause of death continues to be reserved for the supervising physician or a coroner as set forth in section 502 of the Vital Statistics Law of 1953 (35 P. S. § 450.502). Further, the amendment provides clarity that in situations where the attending physician is not available the county coroner be advised.
Final-form § 18.151 allows the physician assistant to sign any form that otherwise requires a physician's signature as permitted by the supervising physician, State or Federal law and facility protocol, if applicable. This will relieve the physician of much routine paperwork, such as signing forms for school physicals.
Among the list of things in § 18.152 that a physician assistant may not do is the performance of a medical service without physician supervision as set forth in the written agreement.
Amendments to § 18.153 change the 12-hour requirement for the physician assistant to relate all medical regimens executed or relayed while the physician was not present to the supervising physician to 36 hours. This is also reflected in § 18.158 for medications prescribed or dispensed and is applicable to prescribing or dispensing ''in accordance with the written agreement.'' The 12-hour time frame in both aspects of the regulations had proven to be overly restrictive. It is not uncommon that a treatment for a minor illness done late in the day goes unreported until the start of the next business day, more than 12 hours later. For physician assistants taking weekend calls, the reporting for minor problems would not occur until the following Monday.
The Board is amending § 18.153(b) by extending the period for reporting to the supervising physician from 12 to 36 hours in § 18.155(b)(4), as in § 18.153(c). For satellite facilities, the amendments also lengthen the time for counter-signature to 10 days. During predraft input and proposed rulemaking, the medical doctor community advised the Board that the current 3-day counter-signature requirement is too restrictive and causes compliance problems. The regulation does not take into consideration weekends or a supervising physician's vacation schedules. This is particularly troublesome for satellite facilities. By expanding to a 10-day signature, compliance becomes more practical. This amendment is also incorporated into §§ 18.142 and 18.158. In §§ 18.153(c) and 18.161(d), the Board clarifies further that relaying, execution and recordation requirements or medical regimens and orders comply with written policies of medical facilities. The Board clarifies by these amendments that the written policies of medical care facilities may be more restrictive than the regulations of the Board.
Section 18.157 (relating to administration of controlled substances and whole blood and blood components) provides that a physician assistant may administer controlled substances as well as whole blood and blood components if that authority is addressed in the written agreement and is separately ordered by the supervising physician specifying a named drug for a named patient. The Board is eliminating the requirement for the separate order of the supervising physician specifying the drug and patient, and allowing it to be addressed only in the written agreement and be administered by the physician assistant on that authority. The Board believes that the prior language created an unnecessary barrier to utilization of physician assistants in surgical, hematology/oncology, pain management and hospice care.
Section 18.158 includes a formulary of categories of drugs that a physician assistant may prescribe if permission is granted in the written agreement. The supervising physician would review this formulary and choose the categories of drugs that he would allow the physician assistant to prescribe or dispense. The list would become a part of the written agreement that must be submitted to the Board. The final-form rulemaking eliminates the formulary. Instead, new subsections (a) and (b) state that the physician can delegate prescribing, dispensing and administration of drugs and therapeutic devices to the physician assistant if the drug or device is permitted under the written agreement. The physician assistant is subject to the regulations of the Board and the Department of Health regarding dispensing standards, prescribing and labeling. The amendment has the written agreement only containing a list of the categories of drugs that the physician assistant may not prescribe. The formulary suffers from the same limitations noted with the list of tasks a physician assistant can perform. The formulary is out-of-date and places restrictions on common drugs used to treat patient problems routinely managed by physician assistants. For example, the management of warfarin sodium therapy for atrial fibrillation, deep venous thrombosis and mechanical heart valves has become commonplace in the family practice setting. Physician assistants are routinely called upon to adjust medication levels. The final-form rulemaking deletes current restrictions on prescribing of blood formation or coagulation drugs.
Section 18.158(a)(4) creates a 90-day waiting period after approval by the FDA for a new drug or new uses for a drug before a physician assistant can prescribe it. The final-form rulemaking eliminates that waiting period. The original purpose has been overcome by practice in recent years. Because physicians provide ongoing input and oversight in the treatment of patients by the physician assistants, delaying the prescribing for 90 days is overly restrictive.
The final-form rulemaking also deletes a statement in § 18.158(b)(4) specifying that the supervising physician assumes responsibility for all prescriptions and dispensing of drugs by the physician assistant. However, § 18.144 requires the supervising physician to assume responsibility for the performance of the physician assistant, so this change is editorial in that it simply eliminates redundancy.
The amendments further delete subsection (g), which states that the physician assistant may only prescribe or dispense drugs for a patient under the care of the supervising physician. Physician assistants often provide care to patients in a practice that are new patients or regularly see one of the primary supervisor's partners. This section is also redundant and limiting because the supervising physician assumes ultimate responsibility for every patient seen by the physician assistant as set forth in § 18.402(a)(6) (relating to delegation) and section 17(c) of the act (63 P. S. § 422.17(a)).
The Board is eliminating a prohibition in § 18.158(c)(4)(i)which prevents a physician assistant from prescribing or dispensing a pure form or combination of drugs. The Board finds the prohibition is vague and unnecessary due to the current state of training received by physician assistants. Predraft input suggested that experience has demonstrated that physician assistants have the knowledge and skill to properly perform this function.
Section 18.158(c)(4)(iii) does not allow physician assistants to prescribe medications for uses not approved by the FDA. The final-form rulemaking no longer prohibits this ''off-label'' prescribing, but instead mandates that the physician assistant follow the supervising physician's instructions and the written agreement. The FDA approves uses of medications for the purpose of marketing by the manufacturer, not for use by physicians. Off-label use may represent the best standard of care. Physicians often prescribe drugs for uses other than those approved by the FDA. This allows physician assistants to use the same drugs that the supervising physician uses for the same purposes. The decision to use a medication for a purpose such as this should be left to the physician. The best example of an off-label use of a drug is the millions of prescriptions for aspirin after myocardial infarction. Off-label use of drugs is common in areas such as AIDS-related treatment, oncology and pediatrics. In pediatrics, as many as 80% of drugs are administered off-label because manufacturers are understandably reluctant to enroll young children in clinical trials of many drugs.
The Board amends § 18.158(c)(4)(iii) and (iv) to eliminate the statement that a physician assistant may not prescribe or dispense drugs not approved by the FDA. Existing law already prevents anyone, including physicians, from prescribing or dispensing drugs not approved by the FDA.
The final-form rulemaking removes from § 18.158(c)(4)(v)the prohibition on a physician assistant prescribing or dispensing parenteral drugs other than insulin or emergency allergy kits or other approved drugs. Comments provided in predraft input advised that this regulation is overly restrictive.
Section 18.158(c)(4)(viii) stated that a physician assistant may not issue a prescription for more than a 30-day supply of medication except in cases of chronic illness when the physician assistant could write for a 90-day supply. It also stated that the physician assistant can authorize refills up to 6 months from the original prescription. This final-form rulemaking eliminates these limitations. These limitations proved too restrictive. For example, it is not unusual to prescribe contraceptives for 1 year for healthy individuals or to prescribe medications for the management of stable chronic conditions. These limitations could cause patients to incur additional costs for unnecessary office visits to continue receiving the medication.
Section 18.158(a)(5) is amended to add a provision authorizing the physician assistant to receive, sign for and distribute drug samples. This provision will allow the physician assistant to relieve the supervising physician of this duty and allow the physician assistant to dispense samples of medications the physician assistant is already authorized to dispense.
In addition, the amendment to § 18.158(a)(6) specifically requires that the physician assistant who will prescribe controlled substances must register with the DEA. The amendment to § 18.158(b)(2) also specifies that space on prescription blanks must be provided for the physician assistant to record the DEA number. This amendment underscores the requirement to register and serves to bring the physician assistant's practice into conformance with Federal law.
Existing regulations do not allow physician assistants to prescribe or dispense Schedule I or II controlled drugs. The amendment to § 18.158(a)(3) calls for allowing them to prescribe or dispense Schedule II controlled drugs for initial therapy up to a 72-hour dose and requires that they notify the supervising physician within 24 hours. It also allows the physician assistant to write a prescription for a Schedule II controlled drug for up to a 30-day supply if approved for ongoing therapy by the supervising physician. There are many physician and physician assistant specialties that deal with chronic pain management. In specialties such as oncology, surgery, anesthesiology or in the family practice setting, physician assistants are an integral part of patient care. Managing the patients' pain in these settings often requires the ability to write prescriptions for Schedule II narcotics on both a short- and long-term basis. At times, patients may require therapy or need to renew prescriptions when the physician is not immediately available but the physician assistant is available. Also, there are many physician assistants that work in settings such as emergency rooms, walk-in clinics and industrial clinics. The inability to write a prescription for a Schedule II narcotic impedes the care of the patient in these settings. Allowing for a 72-hour supply of medicine until a physician sees that patient enhances the care rendered by the physician assistant.
The Board amends § 18.158 to delete the prohibition against a physician assistant compounding ingredients when dispensing drugs except for adding water. There are several medication mixtures that are commonly used in practice. One is the mixture of Benadryl, viscous Lidocaine and Maalox in the treatment of stomatitis secondary to chemotherapy. Pediatric groups will typically combine decongestants and cough suppressants in other doses than commercially available.
Section 18.159 calls for timely review of medical records. The Board clarifies this to state that the review may not exceed 10 days.
Section 18.161(b) is amended to clarify that health care facilities may have more restrictive requirements for the utilization of physician assistants.
The Board amends § 18.162 by adding subsection (b) to address the practice of physician assistants in emergency situations. The emergency situations addressed are those in a disaster situation and not in the normal course of a medical practice. The additions allow for the use of those licensed in other states to function without the usual requirements for themselves and the physicians working with them.
The amendments to § 18.171 maintain the requirement that a physician assistant wear an identification tag bearing the term ''physician assistant,'' but modify the requirement for it to be in 16 point or larger type to being in an easily readable type. The typeface for 16 point can be excessively large, particularly for individuals with lengthy or hyphenated names. Further, physician assistants are already currently prohibited from rendering medical service to a patient until the patient or legal guardian has been informed that they are not a physician, that they are performing the medical service as an agent of the physician and as directed by the supervising physician and that the patient has a right to be treated by the physician. Finally, the final-form rulemaking renders the regulations gender neutral.
F. Fiscal Impact and Paperwork Requirements
The final-form rulemaking has no adverse fiscal impact or additional paperwork requirements imposed on the Commonwealth, its political subdivisions or the private sector.
G. Sunset Date
The Board continuously monitors its regulations. Therefore, no sunset date has been assigned.
H. Regulatory Review
Under section 5(a) of the Regulatory Review Act (71 P. S. § 745.5(a)), on October 26, 2005, the Board submitted a copy of the notice of proposed rulemaking, published at 35 Pa.B. 6127, to IRRC and the Chairpersons of the HPLC and the SCP/PLC for review and comment.
Under section 5(c) of the Regulatory Review Act, IRRC, the HPLC and the SCP/PLC were provided with copies of the comments received during the public comment period, as well as other documents when requested. In preparing the final-form rulemaking, the Department has considered all comments from IRRC, the HPLC, the SCP/PLC and the public.
Under section 5.1(j.2) of the Regulatory Review Act (71 P. S. § 745.5a(j.2)), on October 3, 2006, this final-form rulemaking was approved by the HPLC. On October 18, 2006, the final-form rulemaking was deemed approved by the SCP/PLC. Under section 5.1(e) of the Regulatory Review Act, IRRC met on October 19, 2006, and approved the final-form rulemaking.
I. Contact Person
Further information may be obtained by contacting Sabina I. Howell, Counsel, State Board of Medicine, P. O. Box 2649, Harrisburg, PA 17105-2649, showell@state.pa.us.
J. Findings
The Board finds 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, 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) This final-form rulemaking does not enlarge the purpose of proposed rulemaking published at 35 Pa.B. 6127.
(4) This final-form rulemaking is necessary and appropriate for administering and enforcing the authorizing acts identified in Part B of this preamble.
K. Order
The Board, acting under its authorizing statutes, orders that:
(a) The regulations of the Board, 49 Pa. Code Chapters 16 and 18, are amended by amending §§ 16.11, 16.13, 18.121, 18.122, 18.131, 18.141--18.145, 18.151--18.159, 18.161, 18.162, 18.171, 18.172 and 18.181 to read as set forth in Annex A.
(b) The Board shall submit this order and Annex A to the Office of General Counsel and the Office of Attorney General as required by law.
(c) The Board 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., M. D.
Chairperson(Editor's Note: For the text of the order of the Independent Regulatory Review Commission, relating to this document, see 36 Pa.B. 6742 (November 4, 2006).)
Fiscal Note: Fiscal Note 16A-4916 remains valid for the final adoption of the subject regulations.
Annex A
TITLE 49. PROFESSIONAL AND VOCATIONAL STANDARDS
PART I. DEPARTMENT OF STATE
Subpart A. PROFESSIONAL AND OCCUPATIONAL AFFAIRS
CHAPTER 16. STATE BOARD OF MEDICINE--GENERAL PROVISIONS
Subchapter B. GENERAL LICENSE, CERTIFICATION AND REGISTRATION PROVISIONS § 16.11. Licenses, certificates and registrations.
(a) The following medical doctor licenses are issued by the Board:
(1) License without restriction.
(2) Institutional license.
(3) Extraterritorial license.
(4) Graduate license.
(5) Temporary license.
(6) Interim limited license.
(b) The following nonmedical doctor licenses are issued by the Board:
(1) Midwife license.
(2) Physician assistant license.
(c) The following registrations are issued by the Board:
(1) Registration as a supervising physician of a physician assistant.
(2) Registration as an acupuncturist.
(3) Registration as an acupuncturist supervisor.
(4) Biennial registration of a license without restriction.
(5) Biennial registration of an extraterritorial license.
(6) Biennial registration of a midwife license.
(7) Biennial registration of a physician assistant certificate.
(8) Biennial registration of a drugless therapist license.
(9) Biennial registration of a limited license-permanent.
(10) Biennial registration of an acupuncturist registration.
§ 16.13. Licensure, certification, examination and registration fees.
(a) Medical Doctor License:
License Without Restriction:
Application, graduate of accredited medical college $35 Application, graduate of unaccredited medical college $85 Biennial renewal $360 Extraterritorial License:
Application $30 Biennial renewal $80 Graduate License:
Application, graduate of accredited medical college $30 Application, graduate of unaccredited medical college $85 Annual renewal $15 Interim Limited License:
Application $30 Biennial renewal $10 Miscellaneous:
Application, institutional license $35 Application, temporary license $45 Biennial renewal, limited license (permanent) $25 (b) Midwife License:
Application $30 Biennial renewal $40 (c) Physician Assistant License:
Application $30 Biennial renewal $40 Registration, supervising physician $35 Registration of additional supervising physicians $5 Satellite location approval $25 (d) Acupuncturist Registration:
Application $30 Biennial renewal $40 Registration, acupuncture supervisor $30 (e) Drugless Therapist License:
Biennial renewal $35 (f) Radiology Technician: Application for examination $25 (g) Respiratory Care Practitioner Certificate:
Application, temporary permit $30 Application, initial certification $30 Biennial renewal $25 (h) Verification or Certification:
Verification of status $15 Certification of records $25 (i) Examination Fees:
The State Board of Medicine has adopted Nationally recognized examinations in each licensing class. Fees are established by the National owners/providers of the examinations and are indicated in the examination applications.
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