In this subtitle the following words have the meanings indicated. “Authorized prescriber” means a licensed physician, licensed podiatrist, certified midwife licensed under Title 8, Subtitle 6D of this article, or certified advanced practice nurse with prescriptive authority under § 8–508 of this article. “Group model health maintenance organization” has the meaning stated in § 19–713.6 of the Health – General Article. “Health maintenance organization” has the meaning stated in § 19–701(g) of the Health – General Article. “Institutional facility” means a facility other than a nursing home whose primary purpose is to provide a physical environment for patients to obtain inpatient or emergency care. “Institutional facility” does not include an urgent care facility that is not part of a facility. “Prescriber–pharmacist agreement” means an agreement between an authorized prescriber and a licensed pharmacist that is disease–state specific and specifies the protocols that may be used. “Protocol” means a course of treatment predetermined by the authorized prescriber and licensed pharmacist according to generally accepted medical practice for the proper completion of a particular therapeutic or diagnostic intervention. “Therapy management contract” means a voluntary arrangement that is: Disease–state specific; Agreed on by: One licensed pharmacist and the licensed pharmacist’s designated alternate licensed pharmacists; One authorized prescriber and alternate designated authorized prescribers involved directly in patient care; and One patient receiving care from an authorized prescriber and a licensed pharmacist pursuant to a prescriber–pharmacist agreement and protocol under this subtitle; and Related to treatment using drug therapy, laboratory tests, or medical devices, under defined conditions or limitations for the purpose of improving patient outcomes.

A therapy management contract is not required for the management of patients in an institutional facility or in a group model health maintenance organization.

An authorized prescriber and a licensed pharmacist who wish to enter into therapy management contracts shall have a prescriber–pharmacist agreement. A licensed pharmacist who has entered into a prescriber–pharmacist agreement shall submit to the Board of Pharmacy a copy of the prescriber–pharmacist agreement and any subsequent modifications made to the prescriber–pharmacist agreement or the protocols specified in the prescriber–pharmacist agreement.

Subject to subsection (b) of this section, a pharmacist is authorized to enter into a prescriber–pharmacist agreement if the pharmacist: Is a licensed pharmacist; Has a Doctor of Pharmacy Degree or equivalent training as established in regulations adopted under this subtitle; Is approved by the Board to enter into a prescriber–pharmacist agreement with an authorized prescriber in accordance with this subtitle; and Meets the requirements that are established by regulations adopted under this subtitle. A pharmacist may enter into a prescriber–pharmacist agreement that authorizes a pharmacist to treat an opioid use disorder using controlled dangerous substances drug therapy if the pharmacist: Individually registers with the federal Drug Enforcement Agency; Individually registers with the Office of Controlled Substances Administration; Completes any applicable training required by federal or State laws; and Follows a protocol that meets the requirements of § 12–6A–06 of this subtitle.

Subject to the regulations adopted under this subtitle, a licensed pharmacist may enter into a therapy management contract initiated by an authorized prescriber. A licensed pharmacist may not employ or provide economic incentives to an authorized prescriber for the purpose of entering into a prescriber–pharmacist agreement or a therapy management contract.

A protocol under this subtitle: May authorize: For protocols by a licensed physician and licensed pharmacist, the initiation of drug therapy under written, disease–state specific protocols; The modification, continuation, and discontinuation of drug therapy under written, disease–state specific protocols; The ordering of laboratory tests; and Other patient care management measures related to monitoring or improving the outcomes of drug or device therapy; and May not authorize acts that exceed the scope of practice of the parties to the therapy management contract. A protocol shall prohibit the substitution of a chemically dissimilar drug product by the pharmacist for the product prescribed by the authorized prescriber, unless permitted in the therapy management contract. A protocol that authorizes controlled dangerous substances drug therapy shall require the pharmacist to request relevant data from the Prescription Drug Monitoring Program before initiating or modifying a controlled dangerous substances drug therapy.

A therapy management contract shall apply only to conditions for which protocols have been agreed to by an authorized prescriber and a licensed pharmacist in accordance with the regulations adopted under this subtitle. A therapy management contract shall include: A statement that none of the parties involved in the therapy management contract have been coerced, given economic incentives, excluding normal reimbursement for services rendered, or involuntarily required to participate; Notice to the patient indicating: That the patient may terminate the therapy management contract at any time; and The procedure by which the patient may terminate the therapy management contract; A procedure for periodic review by the authorized prescriber, of the drugs modified pursuant to the agreement or changed with the consent of the authorized prescriber; and Reference to a protocol, which will be provided to the patient on request. A therapy management contract may be entered into in writing or orally. If a therapy management contract is entered into orally, the parties to the therapy management contract shall reduce the agreement to writing within 30 days after entering into the therapy management contract. A therapy management contract may be in electronic form. Any party to the therapy management contract may terminate the contract at any time. The Board may assess a fee, as established in regulation, for approval of a pharmacist to enter into a prescriber–pharmacist agreement.

The authorized prescriber shall maintain complete patient records with respect to the therapy management contract. The authorized prescriber’s patient record shall be fully updated in writing by the licensed pharmacist in a timely manner, as provided in the prescriber–pharmacist agreement.

Nothing in this subtitle supersedes the provisions of § 5–902 of the Criminal Law Article.

Subject to subsection (b) of this section, the Board, together with the Board of Physicians and in consultation with the Board of Podiatric Medical Examiners and the Board of Nursing, shall jointly develop and adopt regulations to implement the provisions of this subtitle. The regulations adopted under subsection (a) of this section: Shall include provisions that: Define the criteria for prescriber–pharmacist agreements; and Establish guidelines concerning the use of protocols, including communication, documentation, and other relevant factors; and May not require a health occupations board to approve a prescriber–pharmacist agreement or the protocols specified in a prescriber–pharmacist agreement.