PURPOSE: In accordance with sections 334.104 and 335.175, RSMo, this rule defines collaborative practice arrangement terms and delimits methods of treatment; review of services; and drug/device dispensing or distribution pursuant to prescription.

PUBLISHER’S NOTE: The secretary of state has determined that publication of the entire text of the material that 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) For the purpose of these rules, the following definitions shall apply:

1. (A) Advanced practice nurse—A registered professional nurse

1. (RN) who is also an advanced practice registered nurse (APRN) as defined in section 335.016(2), RSMo;

   1. (B) Controlled substance prescriptive authority—The eligibility and certificate granted by the Missouri State Board of Nursing (MSBN) to an APRN who has been delegated the authority to prescribe controlled substances from Schedules III, IV, and/or V in a written collaborative practice arrangement by the collaborating physician as defined in section 335.019, RSMo;
   2. (C) Collaborative practice arrangements—Refers to written agreements, jointly agreed upon protocols, or standing orders, all of which shall be in writing, for the delivery of health care services;
   3. (D) Population-based public health services—Health services provided to well patients or to those with narrowly circumscribed conditions in public health clinics or community health settings that are limited to immunizations, well child care, human immunodeficiency virus (HIV) and sexually transmitted disease care, family planning, tuberculosis control, cancer and other chronic disease, wellness screenings, services related to epidemiologic investigations, and prenatal care; and
   4. (E) Registered professional nurse—An RN as defined in section 335.016(16), RSMo, who is not an APRN.

2. (2) Methods of Treatment.

   1. (A) The methods of treatment and the authority to administer, dispense, or prescribe drugs delegated in a collaborative practice arrangement between a collaborating physician and collaborating APRN shall be within the scope of practice of each professional and shall be consistent with each professional’s skill, training, education, competence, licensure, 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.
   2. (B) The methods of treatment and authority to administer and dispense drugs delegated in a collaborative practice arrangement between a collaborating physician and a collaborating RN shall be within the scope of practice of each professional and shall be consistent with each professional’s skill, training, education, and competence and shall not be delegated to any other person except the individuals identified in sections 338.095 and 338.198, RSMo, may communicate prescription drug orders to a pharmacist.
   3. (C) The collaborating physician shall consider the level of skill, education, training, and competence of the collaborating RN or APRN and ensure that the delegated responsibilities contained in the collaborative practice arrangement are consistent with that level of skill, education, training, and competence.
   4. (D) Guidelines for consultation and referral to the collaborating physician or designated health care facility for services or emergency care that is beyond the education, training, competence, or scope of practice of the collaborating RN or APRN shall be established in the collaborative practice arrangement.
   5. (E) The methods of treatment, including any authority to administer or dispense drugs, delegated in a collaborative practice arrangement between a collaborating physician and a collaborating RN shall be delivered only pursuant to a written agreement, jointly agreed-upon protocols, or standing orders that shall describe a specific sequence of orders, steps, or procedures to be followed in providing patient care in specified clinical situations.
   6. (F) The methods of treatment, including any authority to administer, dispense, or prescribe drugs, delegated in a collaborative practice arrangement between a collaborating physician and a collaborating APRN shall be delivered only pursuant to a written agreement, jointly agreed-upon protocols, or standing orders that are specific to the clinical conditions treated by the collaborating physician and collaborating APRN.

   7. (G) Methods of treatment delegated and authority to administer, dispense, or prescribe drugs shall be subject to the following:

      1. 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;

1. 2. All labeling requirements outlined in section 338.059,

RSMo, shall be followed;

1. 3. Consumer product safety laws and Class B container

standards shall be followed when packaging drugs for distribution;

1. 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/recommendedconditions, which is incorporated by reference. This does not include any later amendments or additions;

1. 5. Outdated drugs shall be separated from the active

inventory;

1. 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;

1. 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 APRN;

1. 8. An RN shall not, under any circumstances, prescribe

drugs. The administering or dispensing of a controlled substance by an RN or APRN who has not been delegated authority to prescribe in a collaborative practice arrangement, pursuant to 19 CSR 30-1.066, shall be accomplished only under the direction and supervision of the collaborating physician, or other physician designated in the collaborative practice arrangement, and shall only occur on a case-bycase determination of the patient’s needs following verbal consultation between the collaborating physician and collaborating RN or APRN. The required consultation and the physician’s directions for the administering or dispensing of controlled substances shall be recorded in the patient’s chart and in the appropriate dispensing log. These recordings shall be made by the collaborating RN or APRN and shall be cosigned by the collaborating physician following a review of the records;

1. 9. In addition to administering and dispensing controlled

substances, an APRN, as defined in section 335.016, RSMo, may be delegated the authority to prescribe controlled substances listed in Schedule II-hydrocodone and Schedules III, IV, and V of section 195.017, RSMo, in a written collaborative practice arrangement, except that the collaborative practice arrangement shall not delegate the authority to administer any controlled substances listed in Schedule II-hydrocodone and Schedules III, IV, and V of section 195.017, RSMo, for the purpose of inducing sedation or general anesthesia for therapeutic, diagnostic, or surgical procedures. When issuing the initial prescription for an opioid controlled substance in treating a patient for acute pain, the APRN 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 one hundred twenty- (120-) hour supply without refill. An APRN may prescribe buprenorphine, a Schedule III controlled substance, for up to a thirty- (30-) day supply without refill for patients receiving medication-assisted treatment for substance abuse disorders under the direction of the collaborating physician as described in sections 334.104 and 630.875, RSMo;

1. 10. An APRN may not prescribe controlled substances 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-inlaw, sisters-in-law, daughters-in-law, and sons-in-law. Adopted and step members are also included in family;

1. 11. An APRN or RN in a collaborative practice arrangement

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;

1. 12. The collaborative practice arrangement shall clearly

identify the controlled substances the collaborating physician authorizes the collaborating APRN to prescribe and document that it is consistent with each professional’s education, knowledge, skill, and competence; and

1. 13. The medications to be administered, dispensed, or

prescribed by a collaborating RN or APRN in a collaborative practice arrangement shall be consistent with the education, training, competence, and scopes of practice of the collaborating physician and collaborating RN or APRN.

1. (H) 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 APRN or RN. If the APRN is providing services pursuant to section 335.175, RSMo, the collaborating physician, or other physician designated in the collaborative practice arrangement, may conduct the examination and evaluation required by this section via live, interactive 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 and all other applicable state and federal laws and regulations.
2. (I) Nothing in these rules shall be construed to permit medical diagnosis of any condition by an RN pursuant to a collaborative practice arrangement.

1. (3) Review of Services.

   1. (A) In order to assure true collaborative practice and to foster effective communication and review of services, the collaborating physician, or other physician designated in the collaborative practice arrangement, shall be immediately available for consultation to the collaborating RN or APRN at all times, either personally or via telecommunications.
   2. (B) The collaborative practice arrangement between a collaborating physician and a collaborating RN or APRN shall be signed and dated by the collaborating physician and collaborating RN or APRN 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 maintained 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 collaborating physician and collaborating RN or APRN. Documentation of the annual review shall be maintained as part of the collaborative practice arrangement.
   3. (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/she is engaged in any collaborative practice arrangement, including collaborative practice arrangements delegating the authority to prescribe controlled substances and also report to the board the name of each licensed RN or APRN with whom he/she has entered into such arrangement. A change shall include but not be limited to resignation or termination of the RN or APRN, change in practice locations, and addition of new collaborating professionals.
   4. (D) An RN or an APRN practicing pursuant to a collaborative practice arrangement shall maintain adequate and complete patient records in compliance with section 334.097, RSMo.
   5. (E) The collaborating physician shall complete a review of a minimum of ten percent (10%) of the total health care services delivered by the collaborating APRN. If the APRN’s practice includes the prescribing of controlled substances, the physician shall review a minimum of twenty percent (20%) of the cases in which the APRN 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 collaborating APRN’s documentation shall be submitted for review to the collaborating physician at least every fourteen

2. (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 produce evidence of the chart review upon request of the Missouri State Board of Registration for the Healing Arts.

   1. (F) If a collaborative practice arrangement is used in clinical situations where a collaborating APRN provides health care services that include the diagnosis and initiation of treatment for acutely or chronically ill or injured persons, then the collaborating 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. In such settings, the use of a collaborative practice arrangement shall be limited to only an APRN. If the APRN is providing services pursuant to section 335.175, RSMo, 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 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 and all other applicable state and federal laws and regulations.
   2. (G) The collaborating physician and collaborating RN or APRN shall determine an appropriate process of review and management of abnormal test results which shall be documented in the collaborative practice arrangement.
   3. (H) The Missouri State Board of Registration for the Healing Arts and the Missouri State Board of Nursing separately retain the right and duty to discipline their respective licensees for violations of any state or federal statutes, rules, or regulations regardless of the licensee’s participation in a collaborative practice arrangement.

3. (4) Population-Based Public Health Services.

   1. (A) In the case of the collaborating physicians and collaborating registered professional nurses or APRN practicing in association with public health clinics that provide population-based health services as defined in section (1) of this rule, 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 initiation of treatment of disease or injury not related to population-based health services, then the provisions of sections (2) and (3) above shall apply.

AUTHORITY: section 334.125, RSMo 2016, and sections 334.104.3, 335.036, and 335.175, RSMo Supp. 2023.* This rule originally filed as 4 CSR 200-4.200. Original rule filed Jan. 29, 1996, effective Sept. 30, 1996. Amended: Filed April 1, 1998, effective Oct. 30, 1998. Amended: Filed Oct. 30, 2002, effective June 30, 2003. Moved to 20 CSR 2200-4.200, effective Aug. 28, 2006. Amended: Filed June 27, 2008, effective Dec. 30, 2008. Rescinded and readopted: Filed April 30, 2010, effective Nov. 30, 2010. Amended: Filed Nov. 14, 2014, effective June 30, 2015. Emergency amendment filed April 16, 2018, effective April 26, 2018, expired Feb. 5, 2019. Amended: Filed April 16, 2018, effective Oct. 30, 2018. Emergency amendment filed Feb. 22, 2019, effective March 4, 2019, expired Aug. 30, 2019. Amended: Filed Feb. 22, 2019, effective Aug. 30, 2019. ** Emergency amendment filed March 28, 2022, effective April 11, 2022, expired Oct. 7, 2022. Amended: Filed Feb. 1, 2024, effective July 30, 2024.

*Original authority: 334.104, RSMo 1993, amended 2002, 2003, 2006, 2008, 2009, 2012, 2013, 2015, 2018, 2019, 2023; 334.125, RSMo 1959, amended 1993, 1995, 2014; 335.036, RSMo 1975, amended 1981, 1985, 1993, 1995, 1999, 2007, 2008, 2011, 2018, 2023; and 335.175, RSMo 2013, amended 2016, 2019, 2023. **Pursuant to Executive Order 21-09, 20 CSR 2200-4.200, paragraph (2)(B)2. was suspended from March 26, 2020 through December 31, 2021 and subsections (2)(C) and (4)(E) was suspended from April 2, 2020 through December 31, 2021.