Assistant Physician Collaborative Practice Agreements

PURPOSE: In accordance with section 334.036, RSMo, this rule defines collaborative practice arrangement terms and implements section 630.875, RSMo related to “Improved Access to Treatment for Opioid Addictions Act” (IATOA). PUBLISHER’S NOTE: The secretary of state has determined that the publication of the entire text of the material which is incorporated by reference as a portion of this rule would be unduly cumbersome or expensive. This material as incorporated by reference in this rule shall be maintained by the agency at its headquarters and shall be made available to the public for inspection and copying at no more than the actual cost of reproduction. This note applies only to the reference material. The entire text of the rule is printed here. (1) Geographic areas. (A) The collaborating physician in a collaborative practice arrangement with an assistant physician shall not be so geo graphically distanced from the collaborating assistant physi cian as to create an impediment to effective collaboration in the delivery of health care services or the adequate review of those services. (B) The following shall apply in the use of a collaborative practice arrangement by an assistant physician who provides health care services that include the diagnosis and initiation of treatment for acutely or chronically ill or injured persons: 1. If the collaborating physician and assistant physician are utilizing telehealth in providing services in a medically under served area no mileage limitation shall apply; or 2. If the assistant physician is not utilizing telehealth in providing services the collaborating physician, or other phy sician designated in the collaborative practice arrangement, shall be no further than seventy five (75) miles by road, using the most direct route available, from the collaborating assis tant physician; or 3. Pursuant to section 630.875, RSMo, an assistant physi cian collaborating with a physician who is waiver-certified for the use of buprenorphine, may participate in the “Improved Access to Treatment for Opioid Addictions Program” (IATOAP) in any area of the state and provide all services and functions of an assistant physician. A remote collaborating physician work ing with an on-site APRN shall be considered to be on-site for the purposes of IATOAP. (C) An assistant physician who desires to enter into a collab orative practice arrangement at a location where the collab orating physician is not continuously present shall practice together at the same location with the collaborating physician continuously present for a period of at least one (1) month before the collaborating assistant physician practices at a loca tion where the collaborating physician is not present. During this one (1) month period, the collaborating physician must review ten percent (10%) of the assistant physicians’ patient’s records. It is the responsibility of the collaborating physician to determine and document the completion of the same location practice and records review as described above. (D) For purposes of this rule, the following shall apply: 1. The term “continuously present” shall mean the super vising physician is physically present and seeing each and every patient with the assistant physician when said assistant physician is seeing and/or treating a patient; and 2. The term “one (1) month period” shall mean a minimum of one hundred twenty (120) hours of clinic time, where the supervising physician and assistant physician are seeing and treating patients. (E) A collaborating physician shall not enter into a collabo rative practice arrangement with more than six (6) full-time equivalent assistant physicians, full-time equivalent physician assistants, full-time equivalent assistant physicians, or any combination thereof. This limitation shall not apply to collabo rative arrangements of hospital employees providing inpatient care service in hospitals as defined in Chapter 197, RSMo, or population-based public health services or to a certified regis tered nurse anesthetist providing anesthesia services under the supervision of an anesthesiologist or other physician, dentist, or podiatrist who is immediately available if needed as set out in section 334.104(7), RSMo. (2) Methods of treatment. (A) The methods of treatment and the authority to adminis ter, dispense, or prescribe drugs delegated in a collaborative practice arrangement between a collaborating physician and collaborating assistant physician shall be within the scope of practice of each professional and shall be consistent with each professional’s skill, training, education, competence, licen sure, and/or certification and shall not be further delegated to any person except that the individuals identified in sections 338.095 and 338.198, RSMo, may communicate prescription drug orders to a pharmacist. (B) The collaborating physician shall consider the level of AND INSURANCE skill, education, training, and competence of the collaborating assistant physician and ensure that the delegated responsi bilities contained in the collaborative practice arrangement are consistent with that level of skill, education, training, and competence. (C) Guidelines for consultation and referral to the collaborat ing physician or designated health care facility for services or emergency care that is beyond the education, training, com petence, or scope of practice of the assistant physician shall be established in the collaborative practice arrangement. (D) The methods of treatment, including any authority to ad minister, dispense, or prescribe drugs, delegated in a collabo rative practice arrangement between a collaborating physician and a collaborating assistant physician, shall be delivered only pursuant to a written agreement, jointly agreed-upon proto cols, or standing orders that are specific to the clinical condi tions treated by the collaborating physician and collaborating assistant physician. (E) Methods of treatment delegated and authority to ad minister, dispense, or prescribe drugs shall be subject to the following: 1. The physician retains the responsibility for ensuring the appropriate administering, dispensing, prescribing, and control of drugs utilized pursuant to a collaborative practice arrangement in accordance with all state and federal statutes, rules, or regulations; 2. All labeling requirements outlined in section 338.059, RSMo, shall be followed; 3. Consumer product safety laws and Class B container standards shall be followed when packaging drugs for distri bution; 4. All drugs shall be stored according to the United States Pharmacopeia (USP), (2010), published by the United States Pharmacopeial Convention, 12601 Twinbrook Parkway, Rockville, Maryland 20852-1790, 800-227-8772; http://www.usp. org/ recommended conditions, which is incorporated by refer ence. This does not include any later amendments or additions; 5. Outdated drugs shall be separated from the active in ventory; 6. Retrievable dispensing logs shall be maintained for all prescription drugs dispensed and shall include all information required by state and federal statutes, rules, or regulations; 7. All prescriptions shall conform to all applicable state and federal statutes, rules, or regulations and shall include the name, address, and telephone number of the collaborating physician and collaborating assistant physician; 8. In addition to administering and dispensing controlled substances, an assistant physician, who meets the require ments of 20 CSR 2150-2.260, may be delegated the authority to prescribe controlled substances listed in Schedules II (hy drocodone), III, IV, and V of section 195.017, RSMo, in a written collaborative practice arrangement, except that, the collabo rative practice arrangement shall not delegate the authority to administer any controlled substances listed in Schedules II (hydrocodone), III, IV, and V of section 195.017, RSMo, for the purpose of inducing sedation or general anesthesia for ther apeutic, diagnostic, or surgical procedures. When issuing the initial prescription for opioid controlled substance in treating a patient for acute pain, the assistant physician shall comply with requirements set forth in section 195.080, RSMo. Schedule II (hydrocodone) and Schedule III narcotic controlled substance prescriptions shall be limited to a five- (5-) day supply without refill. Pursuant to section 334.037, RSMo an assistant physician may prescribe Schedule III - buprenorphine for up to a thirty- (30-) day supply without refill for patients receiving medica tion-assisted treatment for substance abuse disorders under the direction of the collaborating physician as described in sec tions 334.037 and 630.875, RSMo; 9. An assistant physician may not prescribe controlled sub stances for his or her own self or family. Family is defined as spouse, parents, grandparents, great-grandparents, children, grandchildren, great-grandchildren, brothers and sisters, aunts and uncles, nephews and nieces, mother-in-law, father-in-law, brothers-in-law, sisters-in-law, daughters-in-law, and sons-inlaw. Adopted and step family members are also included in family; 10. An assistant physician in a collaborative practice ar rangement may only dispense starter doses of medication to cover a period of time for seventy-two (72) hours or less with the exception of Title X family planning providers or publicly funded clinics in community health settings that dispense medications free of charge. The dispensing of drug samples, as defined in 21 U.S.C. section 353(c)(1), is permitted as appropriate to complete drug therapy; 11. The collaborative practice arrangement shall clearly identify the controlled substances the collaborating physician authorizes the assistant physician to prescribe and document that it is consistent with each professional’s education, knowl edge, skill, and competence; and 12. The medications to be administered, dispensed, or pre scribed by a collaborating assistant physician in a collaborative practice arrangement shall be consistent with the education, training, competence, and scopes of practice of the collaborat ing physician and collaborating assistant physician. (F) When a collaborative practice arrangement is utilized to provide health care services for conditions other than acute self-limited or well-defined problems, the collaborating physician, or other physician designated in the collaborative practice arrangement, shall examine and evaluate the patient and approve or formulate the plan of treatment for new or significantly changed conditions as soon as is practical, but in no case more than two (2) weeks after the patient has been seen by the collaborating assistant physician. If the assistant physician is utilizing telehealth in providing services, the collaborating physician, or other physician designated in the collaborative practice arrangement may conduct the exam ination and evaluation required by this section via live, inter active video or in person. Telehealth providers shall obtain the patient’s or the patient’s guardian’s consent before telehealth services are initiated and shall document the patient’s or the patient’s guardian’s consent in the patient’s file or chart. All telehealth activities must comply with the requirements of the Health Insurance Portability and Accountability Act of 1996, as amended, and all other applicable state and federal laws and regulations. (3) Review of Services. (A) In order to assure true collaborative practice and to foster effective communication and review of services, the collabo rating physician, or other physician designated in the collab orative practice arrangement, shall be immediately available for consultation to the assistant physician at all times, either personally or via telecommunications. (B) The collaborative practice arrangement between a col laborating physician and an assistant physician shall be signed and dated by the collaborating physician and assistant physi cian before it is implemented, signifying that both are aware of its content and agree to follow the terms of the collaborative practice arrangement. The collaborative practice arrangement and any subsequent notice of termination of the collaborative practice arrangement shall be in writing and shall be main tained by the collaborating professionals for a minimum of eight (8) years after termination of the collaborative practice arrangement. The collaborative practice arrangement shall be reviewed at least annually and revised as needed by the collab orating physician and assistant physician. Documentation of the annual review shall be maintained as part of the collabora tive practice arrangement. (C) Within thirty (30) days of any change and with each physician’s license renewal, the collaborating physician shall advise the Missouri State Board of Registration for the Healing Arts whether he or she is engaged in any collaborative practice agreement, including collaborative practice agreements del egating the authority to prescribe controlled substances and also report to the board the name of each licensed assistant physician with whom he or she has entered into such agree ment. A change shall include, but not be limited to, resignation or termination of the assistant physician; change in practice locations; and addition of new collaborating professionals. (D) An assistant physician practicing pursuant to a collabo rative practice arrangement shall maintain adequate and com plete patient records in compliance with section 334.097, RSMo. (E) The collaborating physician shall complete a review of ten percent (10%) of the total health care services delivered by the assistant physician. If the assistant physician practice in cludes the prescribing of controlled substances, the physician shall review a minimum of twenty percent (20%) of the cases in which the assistant physician wrote a prescription for a controlled substance. If the controlled substance chart review meets the minimum total ten percent (10%) as described above, then the minimum review requirements have been met. The assistant physician’s documentation shall be submitted for re view to the collaborating physician at least every fourteen (14) days. This documentation submission may be accomplished in person or by other electronic means and reviewed by the collaborating physician. The collaborating physician must pro duce evidence of the chart review upon request of the Missouri State Board of Registration for the Healing Arts. This subsection shall not apply during the time the collaborating physician and assistant physician are practicing together as required in subsection (2)(C) above or 20 CSR 2150-2.240. (F) If a collaborative practice arrangement is used in clinical situations where an assistant physician provides health care services that include the diagnosis and initiation of treatment for acutely or chronically ill or injured persons, then the col laborating physician shall be present for sufficient periods of time, at least once every two (2) weeks, except in extraordinary circumstances that shall be documented, to participate in such review and to provide necessary medical direction, medical services, consultations, and supervision of the health care staff. If the assistant physician is utilizing telehealth in providing ser vices the collaborating physician may be present in person or the collaboration may occur via telehealth in order to meet the requirements of this section. Telehealth providers shall obtain patient’s or the patient’s guardian’s consent before telehealth services are initiated and shall document the patient’s or the patient’s guardian’s consent in the patient’s file or chart. All telehealth activities must comply with the requirements of the Health Insurance Portability and Accountability Act of 1996, as amended and all other applicable state and federal laws and regulations. (G) The collaborating physician and assistant physician shall determine an appropriate process of review and management of abnormal test results which shall be documented in the col laborative practice arrangement. (4) Population-Based Public Health Services. (A) In the case of the collaborating physician and assistant physician practicing in association with public health clinics that provide population-based health services, the geographic areas, methods of treatment, and review of services shall occur as set forth in the collaborative practice arrangement. If the services provided in such settings include diagnosis and ini tiation of treatment of disease or injury not related to popula tion-based health services, then the provisions of sections (1), (2), and (3) above shall apply. AUTHORITY: sections 334.036, 334.037, and 630.875, RSMo Supp. 2018, and section 334.125, RSMo 2016.* Original rule filed June 29, 2016, effective Jan. 30, 2017. Emergency amendment filed Feb. 22, 2019, effective March 4, 2019, expired Aug. 30, 2019. Amended: Filed Feb. 22, 2019, effective Aug. 30, 2019. ** *Original authority: 334.036, RSMo 2014, amended 2017, 2018; 334.037, RSMo 2014, amended 2015, 2018; 334.125, RSMo 1959, amended 1993, 1995, 2014; and 630.875, RSMo 1980. **Pursuant to Executive Order 21-07, 20 CSR 2150-2.240, subsections (1)(A) and (1)(B) was suspended from April 3, 2020 through April 23, 2021. 20 CSR 2150-2.250 Assistant Physician—Collaborative Practice Change Requirements PURPOSE: This rule provides the requirements and time frames licensees must follow in reporting a change in collaborative prac tice arrangement. (1) Licensed assistant physicians who enter a collaborative prac tice arrangement with a physician or who terminate a collab orative practice arrangement with a physician, for any reason, must submit written notification and the required form to the board within thirty (30) days of such occurrence. AUTHORITY: section 334.036, RSMo Supp. 2018, and section 334.125, RSMo 2016.* Original rule filed June 29, 2016, effective Jan. 30, 2017. Emergency amendment filed Feb. 22, 2019, effective March 4, 2019, expired Aug. 30, 2019. Amended: Filed Feb. 22, 2019, effective Aug. 30, 2019. *Original authority: 334.036, RSMo 2014, amended 2017, 2018 and 334.125, RSMo 1959, amended 1993, 1995, 2014.