(a) (1) In this section the following words have the meanings indicated.
(2) “Documented informed consent” means:
(i) A written consent form signed by a patient; or
(ii) Verbal or otherwise communicated consent signified by a notation in a patient’s electronic medical record maintained by a group model health maintenance organization.
(3) “Drug therapy management” means treatment of a patient using drug therapy, laboratory tests, or medical devices under conditions or limitations set forth in a protocol specified in a physician–pharmacist agreement for the purpose of improving patient outcome.
(4) “Group model health maintenance organization” means a health maintenance organization that:
(i) Contracts with one multispecialty group of physicians who are employed by and shareholders of the multispecialty group; and
(ii) Provides and arranges for the provision of physician services to patients at medical facilities operated by the health maintenance organization.
(5) “Licensed pharmacist” means an individual who is licensed to practice pharmacy under Title 12 of the Health Occupations Article.
(6) “Licensed physician” means an individual who is licensed to practice medicine under Title 14 of the Health Occupations Article.
(7) “Patient” means:
(i) A patient who is a member of a group model health maintenance organization; or
(ii) An individual to whom the group model health maintenance organization is contractually or legally obligated to provide, or arrange to provide, health care services.
(8) “Physician–pharmacist agreement” means an agreement between a licensed physician and a licensed pharmacist that is disease–state specific and specifies the protocols that may be used.
(9) “Protocol” means a course of treatment predetermined by the licensed physician and licensed pharmacist according to generally accepted medical practice for the proper completion of a particular therapeutic or diagnostic intervention.
(b) (1) In a group model health maintenance organization, a licensed physician and a licensed pharmacist who wish to provide drug therapy management to patients shall have a physician–pharmacist agreement.
(2) Drug therapy management shall be provided under this section only:
(i) In accordance with a physician–pharmacist agreement; and
(ii) Through the internal pharmacy operations of the group model health maintenance organization.
(3) A licensed physician who has entered into a physician–pharmacist agreement shall submit to the State Board of Physicians a copy of the physician–pharmacist agreement and any subsequent modifications made to the physician–pharmacist agreement or the protocols specified in the physician–pharmacist agreement.
(4) A licensed pharmacist who has entered into a physician–pharmacist agreement shall submit to the State Board of Pharmacy a copy of the physician–pharmacist agreement and any subsequent modifications made to the physician–pharmacist agreement or the protocols specified in the physician–pharmacist agreement.
(c) A licensed pharmacist is authorized to enter into a physician–pharmacist agreement if the licensed pharmacist:
(1) Has a Doctor of Pharmacy degree or equivalent training as established in regulations adopted by the State Board of Pharmacy;
(2) Is approved by the State Board of Pharmacy to enter into a physician–pharmacist agreement with a licensed physician; and
(3) Meets any other requirements established by regulation by the State Board of Pharmacy.
(d) A physician–pharmacist agreement shall prohibit the substitution of a chemically dissimilar drug product by the pharmacist for the product prescribed by the physician, unless permitted in the protocol specified in the physician–pharmacist agreement.
(e) A patient may decline to participate or withdraw from participating in drug therapy management in a group model health maintenance organization at any time.
(f) A licensed physician or licensed pharmacist or both shall inform a patient:
(1) Regarding the procedures that will be utilized for drug therapy management under the associated protocols;
(2) That the patient may decline to participate or withdraw from participating in the drug therapy management at any time; and
(3) That neither the physician nor the pharmacist has been coerced, given economic incentives, excluding normal reimbursement for services rendered, or involuntarily required to participate.
(g) A licensed physician or a licensed pharmacist or both shall obtain documented informed consent from a patient after disclosing the information required to be disclosed under subsection (f) of this section.