Section 2.08 - Physician Assistants(1)Definition of a Supervising Physician. Supervising physician means a full licensee who supervises a physician assistant. A physician assistant's supervising physician may use a physician assistant to assist in the process of gathering data necessary to make decisions and institute patient care plans. A physician assistant may not supplant a licensee as the principal medical decision maker.(2)Physician Supervision of a Physician Assistant. A full licensee must supervise the activities of a physician assistant. A supervising physician shall afford supervision adequate to assure that: (a) The physician assistant provides medical services in accordance with accepted medical standards. 243 CMR 2.08 does not require the physical presence of the supervising physician whenever a physician assistant renders medical services.(b) The physician assistant informs each patient that he or she is a physician assistant. A physician assistant renders medical services only under the supervision of a full licensee, except in life-threatening emergencies when no licensee is available.(c) The physician assistant wears a name tag which identifies him or her as a physician assistant.(d) The supervising physician reviews diagnostic and treatment information, as agreed upon by the supervising physician and the physician assistant, in a timely manner consistent with the patient's medical condition.(e) On follow up care, hospital visits, nursing home visits, attending the chronically ill at home, and in similar circumstances in which the supervising physician has established a therapeutic regimen or other written protocol, the physician assistant checks and records a patient's progress and reports the patient's progress to the supervising physician. Supervision is adequate under 243 CMR 2.08(2) if it permits a physician assistant who encounters a new problem not covered by a written protocol or which exceeds established parameters to initiate a new patient care plan and consult with the supervising physician.(f) In an emergency, the physician assistant renders emergency medical services necessary to avoid disability or death of an injured person until a licensee arrives.(g) When a supervising physician is unable or unavailable to be the principal medical decision maker, another licensed physician must be designated to assume temporary supervisory responsibilities of a physician assistant. The name and scope of responsibility for the physician providing the temporary supervision must be readily ascertainable from the records kept in the ordinary course of business which are available to patients. The supervising physician(s) of record is ultimately responsible for insuring that each task performed by a physician assistant is properly supervised.(3)Delegation of Medical Services to a Physician Assistant. (a) A supervising physician may permit physician assistants to perform those services which are under the authority of the supervising physician including, but not limited to, prescribing by a physician assistant licensed to prescribe pursuant to M.G.L. c. 94C, and as determined by the supervising physician's assessment of his or her training or experience, and within the scope of services for which the supervising physician can provide adequate supervision to ensure that accepted medical standards are followed.(b) Physician assistants may approach patients of all ages and with all types of conditions, elicit histories, perform examinations, perform and interpret diagnostic studies, perform therapeutic procedures, instruct and counsel patients regarding physical and mental health issues, respond to life threatening situations, and facilitate the appropriate referral of patients, consistent with his or her supervising physician's scope of expertise and responsibility and delegated to him or her by the supervising physician. Nothing contained in 243 CMR 2.08 shall be construed to allow a physician assistant to:1. give general anesthesia;2. perform procedures involving ionizing radiation; except where authorized to operate fluoroscopic X-ray systems pursuant to radiation control program regulations at 105 CMR 120.405(K): Operator Qualifications, and in compliance with 243 CMR 2.08(6) and the Board of Registration of Physician Assistants at 263 CMR 5.07: Physician Assistants Authorized to Operate Fluoroscopic X-ray Systems and to Perform Fluoroscopic Procedures; or3. render a formal medical opinion on procedures involving ionizing radiation.(c)Supervision of Major Invasive Procedures. Where major invasive procedures are allowed, such procedures shall be identified and shall be undertaken under specific written protocols, available to the Board upon request, developed between the supervising physician and the physician assistant, that must specify the level of supervision the service requires, e.g., personal (physician in room), direct (physician in building), or general (physician available by telephone).(4)Billing for Services of a Physician Assistant. A physician assistant may not bill separately for services rendered.(5)Prescriptive Practices of a Physician Assistant.(a)Definition of a Supervising Physician. Supervising physician means a licensee holding an unrestricted full license in the Commonwealth who:1. has completed ACGME-accredited, AOA accredited or accredited Canadian postgraduate medical training in a specialty area appropriately related to the physician assistant's area of practice, is board-certified in a specialty area appropriately related to the physician assistant's area of practice, or has hospital admitting privileges in a specialty area appropriately related to the physician assistant's area of practice;2. holds valid registration(s) from the Massachusetts Department of Public Health and the U.S. Drug Enforcement Administration to issue written or oral prescriptions or medication orders for controlled substances;3. signs mutually developed and agreed upon guidelines with the physician assistant engaged in prescriptive practice; and4. reviews the physician assistant's prescriptive practice at least every three months and provides ongoing direction to the physician assistant regarding prescriptive practice, or, pursuant to 263 CMR 5.04(3)(g), temporarily delegates such review and direction to another licensee holding an unrestricted full license in the Commonwealth who meets the requirements of 243 CMR 2.08(5)(a)1. and 2..(b)Physician Supervision of a Physician Assistant Engaged in Prescriptive Practice.1. A supervising physician shall review and provide ongoing direction for the physician assistant's prescriptive practice in accordance with written guidelines mutually developed and agreed upon with the physician assistant pursuant to M.G.L. c. 112, § 9E, 263 CMR 5.00: Scope of Practice and Employment of Physician Assistants and 243 CMR 2.08, and signed by both parties. This supervision shall be provided as necessary, taking into account the education, the prescriptive authority under M.G.L. c. 94C, the training and experience of the physician assistant, the nature of the physician assistant's practice, and the availability to the physician assistant of clinical back-up by physicians, to ensure that the physician assistant is providing patient care services in accordance with accepted standards of practice.2. A supervising physician shall sign prescriptive practice guidelines only with those physician assistants for whom he is able to provide supervision consistent with 243 CMR 2.08(5)(a) and (b), taking into account factors including, but not limited to, geographical proximity, practice setting, volume and complexity of the patient population, and the experience, training and availability of the supervising physician and the physician assistant(s).(c)Development, Approval and Review of Guidelines for a Physician Assistant Engaged in Prescriptive Practice. A physician who supervises a physician assistant engaged in prescriptive practice shall do so in accordance with written guidelines mutually developed and agreed upon with the physician assistant, and signed by both parties. Such guidelines shall be reviewed annually, and dated and initialed by both the supervising physician and the physician assistant at the time of each review. The guidelines may be altered at any time upon agreement by the supervising physician and physician assistant; any such changes shall be initialed and dated by both parties. In all cases, the written guidelines shall: 1. identify the supervising physician;2. include a defined mechanism for the delegation of supervision to another physician including, but not limited to, duration and scope of the delegation;3. specifically describe the nature and scope of the physician assistant's practice;4. identify the types and classes of medication(s) to be prescribed, specify any limitations on medications to be prescribed, indicate the quantity of any medications, including initial dosage limits and refills, and describe the circumstances in which physician consultation or referral is required;5. include a defined mechanism to monitor prescribing practices, including documentation of review by the supervising physician at least every three months;6. include protocols for the initiation of intravenous therapies and Schedule II drugs;7. specify the frequency of review of initial prescriptions or changes in medication of controlled substances; any prescription or medication order issued by a physician assistant for a Schedule II controlled substance, as defined in 105 CMR 700.002: Schedules of Controlled Substances, shall be reviewed by his or her supervising physician, or by a temporary supervising physician designated pursuant to 263 CMR 5.04(3)(g), within 96 hours after its issuance;8. specify the types and quantities of Schedule VI medications which may be ordered by the physician assistant from a drug wholesaler, manufacturer, laboratory or distributor for use in the practice setting in question;9. identify and specify any limitations on the initiation or renewal of prescriptions which are not within the ordinary scope of practice for the specific work setting in question, but which may be needed to provide appropriate medical care; and10. conform to M.G.L. c. 94C, 105 CMR 700.000: Implementation of M.G.L. c. 94C, M.G.L. c. 112, § 9E, 263 CMR 5.00: Scope of Practice and Employment of Physician Assistants and 243 CMR 2.08.(d) The use of pre-signed prescription blanks or forms is prohibited.(e) The Board may request at any time an opportunity to review the guidelines under which a physician is supervising a physician assistant or physician assistants engaged in prescriptive practice. Failure to provide guidelines to the Board is a basis for and may result in disciplinary action. The Board may require changes in such prescriptive practice guidelines if it determines that they do not comply with 243 CMR 2.08 and accepted standards of medical practice. The Board may also disapprove guidelines in their entirety if it determines that the supervising physician is incapable of providing adequate supervision to the physician assistant(s) engaged in prescriptive practice.(f) The Board may request at any time documentation of review by the supervising physician of the physician assistant engaged in prescriptive practice. Failure to provide documentation to the Board may be the basis for disciplinary action against the physician.(6)Physician Assistants Authorized to Operate Fluoroscopic X-ray Systems.(a) Definitions Applicable to 243 CMR 2.08(6)1.Fluoroscopic Procedure means the production and display of serial X-ray images for the purpose of observing real-time motion of anatomical structures.2.Supervising Physician for the purpose of 243 CMR 2.08(6), means a physician holding an unrestricted full license in the Commonwealth who: a. Is board-certified in radiology, or has been trained in the subjects identified in the radiation control program regulations at 105 CMR 120.405(K): Operator Qualifications;b. Signs mutually developed and agreed upon guidelines, described in 243 CMR 2.08(6), with each physician assistant authorized to operate fluoroscopic X-ray systems whom such physician supervises; andc. Reviews the physician assistant's performance of fluoroscopic procedures at least once every three months and provides ongoing direction to the physician assistant regarding such procedures or, pursuant to the regulations of the Board of Registration of Physician Assistants (263 CMR), temporarily delegates such review and direction to another physician holding an unrestricted full license in the Commonwealth who meets the requirements of 243 CMR 2.08(6)(a)2.3.Physician Assistant Authorized to Operate Fluoroscopic X-ray Systems means a physician assistant who has submitted documentation to the facility where he or she works demonstrating that he or she meets the requirements set out in the radiation control program regulations at 105 CMR 120.405(K): Operator Qualifications.4.Fluoroscopy means a technique for generating X-ray images and presenting them simultaneously and continuously as visible images. This term has the same meaning as the term radioscopy in the standards of the International Electrotechnical Commission.(b)Physician Supervision of a Physician Assistant Authorized to Operate Fluoroscopic X-ray Systems. A supervising physician shall review and provide ongoing direction for a physician assistant authorized to operate fluoroscopic X-ray systems in accordance with written guidelines mutually developed and agreed upon with the physician assistant pursuant to M.G.L. c. 112, § 9E, 263 CMR 5.07: Physician Assistants Authorized to Operate Fluoroscopic X-ray Systems and to Perform Fluoroscopic Procedures and 243 CMR 2.08(6)(c). Such guidelines shall be developed, signed and dated by both parties prior to any fluoroscopic practice by the physician assistant pursuant to such guidelines. In addition, a physician who is board-certified in radiology or who meets the requirements set out in 105 CMR 120.405(K): Operator Qualifications, shall supervise the physician assistant each time the physician assistant operates a fluoroscopic X-ray system. The level of supervision necessary for each procedure shall be identified in the written guidelines.1. The supervising physician shall provide supervision of the physician assistant authorized to operate fluoroscopic X-ray systems as necessary, taking into account the education, training and experience of the physician assistant, the nature of the physician assistant's practice, and the availability to the physician assistant of clinical backup support by physicians, to ensure that the physician assistant is operating the fluoroscopic X-ray systems in accordance with accepted standards of medical practice.2. A supervising physician shall sign fluoroscopic X-ray system practice guidelines only with those physician assistants for whom such physician is able to provide the supervision required by 243 CMR 2.08(6)(b), taking into account factors including, but not limited to, geographical proximity, practice setting, volume and complexity of the patient population, and the experience, training and availability of the supervising physician and the physician assistant(s).(c)Development, Approval and Review of Practice Guidelines for a Physician Assistant Authorized to Operate Fluoroscopic X-ray Systems. A physician who supervises a physician assistant authorized to operate fluoroscopic X-ray systems shall do so in accordance with written practice guidelines mutually developed and agreed upon with the physician assistant, and signed by both parties. The supervising physician and the physician assistant shall review, initial and date such guidelines annually. The guidelines may be revised at any time upon written agreement by the supervising physician and physician assistant; any such changes shall be initialed and dated by both parties at the time of the revision. In all cases, the written guidelines shall:1. Identify the supervising physician by name;2. Identify by name each physician who will provide supervision over the physician assistant's operation of a fluoroscopic X-ray system, and describe each physician's qualifications to provide such supervision, as set out in 243 CMR 2.08(6)(a)(2);3. Provide that supervision shall be required whenever a physician assistant operates a fluoroscopic X-ray system and that a supervising physician shall be readily available, which means a supervising physician must be present in the facility at the time of the operation of the fluoroscopic system;4. Include a defined mechanism for the delegation of supervision to another physician who is qualified to operate fluoroscopic X-ray systems pursuant to 105 CMR 120.405(K): Operator Qualifications including, but not limited to, duration and scope of the delegation;5. Describe the nature of the supervising physician's practice and practice location;6. Specifically describe the nature and scope of the physician assistant's practice;7. Identify the types of procedures in which the physician assistant will operate fluoroscopic X-ray systems, including any limitations on the physician assistant's operation of fluoroscopic X-ray systems;8. Include a defined mechanism to monitor the physician assistant's operation of fluoroscopic X-ray systems, including documentation of review by the supervising physician at least once every three months;9. Describe the procedure for providing clinical backup support to the physician assistant in an emergency situation; and10. Conform to 105 CMR 120.405(K): Operator Qualifications; 263 CMR 5.07: Physician Assistants Authorized to Operate Fluoroscopic X-ray Systems and to Perform Fluoroscopic Procedures; and 243 CMR 2.08(6).(d) The Board may request at any time an opportunity to review the fluoroscopic X-ray system practice guidelines under which a physician is supervising a physician assistant authorized to operate fluoroscopic X-ray systems. A supervising physician's failure to have developed fluoroscopic X-ray system practice guidelines consistent with 243 CMR 2.08(6), or failure to provide such guidelines to the Board upon request may be a basis for disciplinary action against the physician. The Board may require changes in such fluoroscopic X-ray system practice guidelines if it determines that the guidelines do not comply with 243 CMR 2.08 and accepted standards of medical practice. The Board may disapprove guidelines in their entirety if it determines that the supervising physician is not able to provide adequate supervision to the physician assistant authorized to operate fluoroscopic X-ray systems.(e) The Board may request at any time documentation of review by the supervising physician of the physician assistant authorized to operate fluoroscopic X-ray systems. Failure to provide such documentation to the Board upon request may be a basis for disciplinary action against the physician.Amended by Mass Register Issue 1265, eff. 7/18/2014.Amended by Mass Register Issue 1397, eff. 8/9/2019.