LCO No. 1677 1 of 7 General Assembly Raised Bill No. 186 February Session, 2022 LCO No. 1677 Referred to Committee on GENERAL LAW Introduced by: (GL) AN ACT CONCERNING COLLABORATIVE DRUG THERAPY MANAGEMENT AGREEMENTS AND POLICIES. Be it enacted by the Senate and House of Representatives in General Assembly convened: Section 1. Section 20-631 of the 2022 supplement to the general 1 statutes is repealed and the following is substituted in lieu thereof 2 (Effective from passage): 3 (a) For the purposes of this section: 4 (1) "Care-giving institution" has the same meaning as provided in 5 section 20-571; 6 (2) "Commissioner" means the Commissioner of Consumer 7 Protection; 8 (3) "Collaborative drug therapy care plan" means a written document 9 memorializing the outcome of the process through which a patient and 10 one or more health care providers discuss, review and agree on an 11 approach to achieve the patient's desired health outcome; 12 Raised Bill No. 186 LCO No. 1677 2 of 7 (4) "Collaborative drug therapy management agreement" means an 13 agreement between one or more qualified pharmacists and one or more 14 prescribing practitioners to manage the drug therapy of individual 15 patients, or a patient population, based on a written protocol or a 16 collaborative drug therapy care plan; 17 (5) "Collaborative drug therapy management policy" means a written 18 policy adopted by a care-giving institution under which one or more 19 qualified pharmacists manage the drug therapy of individual patients, 20 or a patient population, based on a written protocol or a collaborative 21 drug therapy care plan; 22 (6) "Pharmacist" has the same meaning as provided in section 20-571; 23 (7) "Prescribing practitioner" has the same meaning as provided in 24 section 20-571; 25 (8) "Provider-patient relationship" means a relationship between a 26 prescribing practitioner and a patient in which (A) the patient has made 27 a medical complaint, (B) the patient has provided such patient's medical 28 history, (C) the patient has received a physical examination, and (D) 29 there exists a logical connection between such medical complaint, 30 medical history and physical examination and any drug prescribed for 31 such patient; and 32 (9) "Qualified pharmacist" means a pharmacist who (A) is deemed 33 competent under regulations adopted by the commissioner pursuant to 34 subsection (e) of this section, and (B) has reviewed the latest edition of 35 the "Pharmacists' Patient Care Process" published by the Joint 36 Commission of Pharmacy Practitioners. 37 [(a)] (b) Except as provided in section 20-631b, one or more qualified 38 pharmacists [licensed under this chapter who are determined 39 competent in accordance with regulations adopted pursuant to 40 subsection (d) of this section] may enter into a [written protocol-based] 41 collaborative drug therapy management agreement [with one or more 42 physicians licensed under chapter 370 or advanced practice registered 43 Raised Bill No. 186 LCO No. 1677 3 of 7 nurses licensed under chapter 378 to] or manage the drug therapy of 44 individual patients or a patient population under a collaborative drug 45 therapy management policy. In order to enter into a [written protocol-46 based] collaborative drug therapy management agreement [, such 47 physician or advanced practice registered nurse shall have established] 48 or collaborative drug therapy care plan, or operate under a collaborative 49 drug therapy management policy, a prescribing practitioner must first 50 establish a provider-patient relationship with the patient or patients 51 who will receive collaborative drug therapy. Each patient's collaborative 52 drug therapy management shall be [governed by a written protocol 53 which may include guideline-directed management established by the 54 treating physician or advanced practice registered nurse in consultation 55 with the pharmacist. For purposes of this subsection, a "provider-patient 56 relationship" is a relationship based on (1) the patient making a medical 57 complaint, (2) the patient providing a medical history, (3) the patient 58 receiving a physical examination, and (4) a logical connection existing 59 between the medical complaint, the medical history, the physical 60 examination and any drug prescribed for the patient] based on a 61 diagnosis made by such patient's prescribing practitioner or a specific 62 test set forth in a collaborative drug therapy management agreement or 63 collaborative drug therapy management policy. 64 [(b)] (c) A collaborative drug therapy management agreement or 65 collaborative drug therapy management policy may authorize a 66 [pharmacist to implement] qualified pharmacist or qualified 67 pharmacists to initiate, modify, continue, discontinue or deprescribe a 68 drug therapy that has been prescribed for a patient, order associated 69 laboratory tests and administer drugs, all in accordance with a patient-70 specific or patient population-specific written protocol [. Such 71 agreement] or collaborative drug therapy care plan, but may not 72 authorize a qualified pharmacist or qualified pharmacists to establish a 73 port to administer parenteral drugs. A collaborative drug therapy 74 management agreement or collaborative drug therapy management 75 policy may specifically address issues that may arise during a 76 medication reconciliation and concerns related to polypharmacy that 77 Raised Bill No. 186 LCO No. 1677 4 of 7 enable an authorized qualified pharmacist or qualified pharmacists to 78 [implement] initiate, modify, continue, discontinue or deprescribe drug 79 therapy. In instances where drug therapy is discontinued or 80 deprescribed, the qualified pharmacist or qualified pharmacists shall 81 notify the [treating physician or advanced practice registered nurse] 82 prescribing practitioner of such discontinuance or deprescribing [no] 83 not later than twenty-four hours [from the time of such discontinuance 84 or deprescribing] after such drug therapy is discontinued or 85 deprescribed. Each written protocol or collaborative drug therapy care 86 plan developed, pursuant to [the] a collaborative drug therapy 87 management agreement or collaborative drug therapy management 88 policy, shall contain detailed direction concerning the actions that the 89 qualified pharmacist or qualified pharmacists may perform for that 90 patient [. The] or patient population. Such written protocol or 91 collaborative drug therapy care plan shall include, but need not be 92 limited to, (1) the specific drug or drugs, therapeutic class of drug or 93 classes of drugs, or medical devices to be managed by the qualified 94 pharmacist or qualified pharmacists, (2) the terms and conditions under 95 which drug therapy may be [implemented] initiated, modified, 96 continued, discontinued or deprescribed, (3) the conditions and events 97 upon which the qualified pharmacist is, or qualified pharmacists are, 98 required to notify the [physician or advanced practice registered nurse, 99 and] prescribing practitioner, (4) the laboratory tests that may be 100 ordered, and (5) a definition of the patient population included in such 101 written protocol or collaborative drug therapy care plan. All activities 102 performed by the qualified pharmacist or qualified pharmacists in 103 conjunction with the protocol shall be documented in the patient's 104 medical record [. The pharmacist shall report any encounters within the 105 scope of the collaborative drug therapy management agreement within 106 thirty days to the physician or advanced practice registered nurse 107 regarding the patient's drug therapy management or document such 108 information within a shared medical record. The] in accordance with all 109 applicable caregiving institution policies. Each collaborative drug 110 therapy management agreement, [and protocols] collaborative drug 111 therapy management policy, written protocol and collaborative drug 112 Raised Bill No. 186 LCO No. 1677 5 of 7 therapy care plan shall be available for inspection by the [Departments] 113 Department of Consumer Protection and the Department of Public 114 Health. [and Consumer Protection.] A copy of the protocol shall be filed 115 in the patient's medical record. 116 [(c)] (d) A pharmacist shall be responsible for demonstrating, in 117 accordance with regulations adopted pursuant to subsection [(d)] (e) of 118 this section, the competence necessary for [participation] the pharmacist 119 to participate in each collaborative drug therapy management 120 agreement, [into which such pharmacist enters] collaborative drug 121 therapy management policy and collaborative drug therapy care plan in 122 which such pharmacist seeks to participate by, among other things, 123 demonstrating that such pharmacist has reviewed the latest edition of 124 the "Pharmacists' Patient Care Process" published by the Joint 125 Commission of Pharmacy Practitioners. 126 [(d)] (e) The Commissioner of Consumer Protection, in consultation 127 with the Commissioner of Public Health, shall (1) adopt regulations, in 128 accordance with chapter 54, concerning competency requirements for 129 participation in a [written protocol-based] collaborative drug therapy 130 management agreement, [described in subsection (a) of this section,] the 131 minimum content of the collaborative drug therapy management 132 agreement [and the written protocol] and such other matters said 133 commissioners deem necessary to carry out the purpose of this section, 134 and (2) on or after the effective date of this section, amend such 135 regulations to include competency requirements for participation in a 136 collaborative drug therapy management policy or collaborative drug 137 therapy care plan, the minimum content of collaborative drug therapy 138 management policies, collaborative drug therapy care plans and written 139 protocols governing collaborative drug therapy management. 140 Sec. 2. Section 19a-521d of the general statutes is repealed and the 141 following is substituted in lieu thereof (Effective from passage): 142 A medical director of a nursing home facility, as defined in section 143 19a-521, may establish protocols for a prescription drug formulary 144 Raised Bill No. 186 LCO No. 1677 6 of 7 system in accordance with guidelines established by the American 145 Society of Health-System Pharmacists and any applicable collaborative 146 drug therapy management agreement or collaborative drug therapy 147 management policy, as [described] defined in section 20-631, as 148 amended by this act. The medical director of a nursing home facility that 149 implements a prescription drug formulary system may make a 150 substitution for a drug prescribed to a patient of the facility in 151 accordance with the provisions of this section. Prior to making any 152 substitution for a drug prescribed to a patient of the facility in 153 accordance with the facility's protocols, the medical director, or the 154 medical director's designee, shall notify the prescribing practitioner of 155 the medical director's intention to make such substitution. If the 156 prescribing practitioner does not authorize the medical director or the 157 medical director's designee to make such substitution or objects to such 158 substitution, the medical director, or the medical director's designee, 159 shall not make the substitution. Notwithstanding the provisions of this 160 section, a facility, when administering prescription drugs to a patient 161 who receives benefits under a medical assistance program administered 162 by the Department of Social Services, shall consider and administer 163 prescription drugs to such patient in accordance with (1) the 164 department's preferred drug list, developed in accordance with section 165 17b-274d, (2) prescription drug formularies under Medicare Part D, or 166 (3) the patient's health insurance policy, as the medical director of the 167 nursing home facility deems appropriate. 168 This act shall take effect as follows and shall amend the following sections: Section 1 from passage 20-631 Sec. 2 from passage 19a-521d Statement of Purpose: To: (1) Enable care-giving institutions to institute, and certain pharmacists to operate under, collaborative drug therapy management policies; (2) provide that prescribing practitioners and pharmacists may enter into collaborative drug therapy management agreements and Raised Bill No. 186 LCO No. 1677 7 of 7 operate under collaborative drug therapy management policies; (3) provide that collaborative drug therapy management agreements and policies may apply to patient populations; (4) require that written protocols and collaborative drug therapy care plans (A) be specific to the patient, patients or patient populations involved, (B) contain detailed direction concerning the actions pharmacists may perform for the patient population involved, (C) include the therapeutic class of drug or classes of drugs, or medical devices, to be managed by pharmacists, and (D) contain a definition of the patient population involved; (5) eliminate a reporting requirement concerning encounters within the scope of collaborative drug therapy man agement agreements; (6) impose a reporting requirement concerning changes made to drug therapies within the scope of collaborative drug therapy management agreements and policies; and (7) require the Commissioner of Consumer Protection to adopt regulations concerning collaborative drug therapy management policies. [Proposed deletions are enclosed in brackets. Proposed additions are indicated by underline, except that when the entire text of a bill or resolution or a section of a bill or resolution is new, it is not underlined.]