§ 6801-A — Collaborative drug therapy management demonstration program

* § 6801-a. Collaborative drug therapy management demonstration\nprogram. 1. As used in this section, the following terms shall have the\nfollowing meanings:\n a. "Board" shall mean the state board of pharmacy as established by\nsection sixty-eight hundred four of this article.\n b. "Clinical services" shall mean the collection and interpretation of\npatient data for the purpose of initiating, modifying and monitoring\ndrug therapy with associated accountability and responsibility for\noutcomes in a direct patient care setting.\n c. "Collaborative drug therapy management" shall mean the performance\nof clinical services by a pharmacist relating to the review, evaluation\nand management of drug therapy to a patient, who is being treated by a\nphysician for a specific disease or associated disease states, in\naccordance with a written agreement or protocol with a voluntarily\nparticipating physician and in accordance with the policies, procedures,\nand protocols of the facility. Such agreement or protocol as entered\ninto by the physician and a pharmacist, may include, and shall be\nlimited to:\n (i) adjusting or managing a drug regimen of a patient, pursuant to a\npatient specific order or protocol made by the patient's physician,\nwhich may include adjusting drug strength, frequency of administration\nor route of administration. Adjusting the drug regimen shall not include\nsubstituting or selecting a different drug which differs from that\ninitially prescribed by the patient's physician unless such substitution\nis expressly authorized in the written order or protocol. The pharmacist\nshall be required to immediately document in the patient record changes\nmade to the patient's drug therapy and shall use any reasonable means or\nmethod established by the facility to notify the patient's other\ntreating physicians with whom he or she does not have a written\nagreement or protocol regarding such changes. The patient's physician\nmay prohibit, by written instruction, any adjustment or change in the\npatient's drug regimen by the pharmacist;\n (ii) evaluating and, only if specifically authorized by the protocol\nand only to the extent necessary to discharge the responsibilities set\nforth in this section, ordering disease state laboratory tests related\nto the drug therapy management for the specific disease or disease state\nspecified within the written agreement or protocol; and\n (iii) only if specifically authorized by the written agreement or\nprotocol and only to the extent necessary to discharge the\nresponsibilities set forth in this section, ordering or performing\nroutine patient monitoring functions as may be necessary in the drug\ntherapy management, including the collecting and reviewing of patient\nhistories, and ordering or checking patient vital signs, including\npulse, temperature, blood pressure and respiration.\n d. "Facility" shall mean: (i) a teaching hospital or general hospital,\nincluding any diagnostic center, treatment center, or hospital-based\noutpatient department as defined in section twenty-eight hundred one of\nthe public health law; or (ii) a nursing home with an on-site pharmacy\nstaffed by a licensed pharmacist; provided, however, for the purposes of\nthis section the term "facility" shall not include dental clinics,\ndental dispensaries, residential health care facilities and\nrehabilitation centers.\n For the purposes of this section, a "teaching hospital" shall mean a\nhospital licensed pursuant to article twenty-eight of the public health\nlaw that is eligible to receive direct or indirect graduate medical\neducation payments pursuant to article twenty-eight of the public health\nlaw.\n e. "Physician" shall mean the physician selected by or assigned to a\npatient, who has primary responsibility for the treatment and care of\nthe patient for the disease and associated disease states that are the\nsubject of the collaborative drug therapy management.\n f. "Written agreement or protocol" shall mean a written document,\npursuant to and consistent with any applicable state or federal\nrequirements, that addresses a specific disease or associated disease\nstates and that describes the nature and scope of collaborative drug\ntherapy management to be undertaken by the pharmacists, in collaboration\nwith the participating physician in accordance with the provisions of\nthis section.\n 2. a. A pharmacist who meets the experience requirements of paragraph\nb of this subdivision and who is employed by or otherwise affiliated\nwith a facility shall be permitted to enter into a written agreement or\nprotocol with a physician authorizing collaborative drug therapy\nmanagement, subject to the limitations set forth in this section, within\nthe scope of such employment or affiliation.\n b. A participating pharmacist must:\n (i)(A) have been awarded either a master of science in clinical\npharmacy or a doctor of pharmacy degree;\n (B) maintain a current unrestricted license; and\n (C) have a minimum of two years experience, of which at least one year\nof such experience shall include clinical experience in a health\nfacility, which involves consultation with physicians with respect to\ndrug therapy and may include a residency at a facility involving such\nconsultation; or\n (ii)(A) have been awarded a bachelor of science in pharmacy;\n (B) maintain a current unrestricted license; and\n (C) within the last seven years, have a minimum of three years\nexperience, of which at least one year of such experience shall include\nclinical experience in a health facility, which involves consultation\nwith physicians with respect to drug therapy and may include a residency\nat a facility involving such consultation; and\n (iii) meet any additional education, experience, or other requirements\nset forth by the department in consultation with the board.\n c. Notwithstanding any provision of law, nothing in this section shall\nprohibit a licensed pharmacist from engaging in clinical services\nassociated with collaborative drug therapy management, in order to gain\nexperience necessary to qualify under clause (C) of subparagraph (i) or\n(ii) of paragraph b of this subdivision, provided that such practice is\nunder the supervision of a pharmacist that currently meets the\nreferenced requirement, and that such practice is authorized under the\nwritten agreement or protocol with the physician.\n d. Notwithstanding any provision of this section, nothing herein shall\nauthorize the pharmacist to diagnose disease. In the event that a\ntreating physician may disagree with the exercise of professional\njudgment by a pharmacist, the judgment of the treating physician shall\nprevail.\n 3. The physician who is a party to a written agreement or protocol\nauthorizing collaborative drug therapy management shall be employed by\nor otherwise affiliated with the same facility with which the pharmacist\nis also employed or affiliated.\n 4. The existence of a written agreement or protocol on collaborative\ndrug therapy management and the patient's right to choose to not\nparticipate in collaborative drug therapy management shall be disclosed\nto any patient who is eligible to receive collaborative drug therapy\nmanagement. Collaborative drug therapy management shall not be utilized\nunless the patient or the patient's authorized representative consents,\nin writing, to such management. If the patient or the patient's\nauthorized representative consents, it shall be noted on the patient's\nmedical record. If the patient or the patient's authorized\nrepresentative who consented to collaborative drug therapy management\nchooses to no longer participate in such management, at any time, it\nshall be noted on the patient's medical record. In addition, the\nexistence of the written agreement or protocol and the patient's consent\nto such management shall be disclosed to the patient's primary physician\nand any other treating physician or healthcare provider.\n 5. Participation in a written agreement or protocol authorizing\ncollaborative drug therapy management shall be voluntary, and no\npatient, physician, pharmacist, or facility shall be required to\nparticipate.\n 6. Nothing in this section shall be deemed to limit the scope of\npractice of pharmacy nor be deemed to limit the authority of pharmacists\nand physicians to engage in medication management prior to the effective\ndate of this section and to the extent authorized by law.\n * NB Repealed July 1, 2026\n