STATE OF NEW YORK
________________________________________________________________________
6699
2021-2022 Regular Sessions
IN ASSEMBLY
March 25, 2021
___________
Introduced by M. of A. McDONALD, BENEDETTO, SEAWRIGHT, JOYNER,
J. M. GIGLIO, NIOU, CAHILL, STECK, LUPARDO, JONES, COLTON, DICKENS,
FAHY, RA, SAYEGH, ASHBY, MORINELLO, BYRNES, GOTTFRIED, GRIFFIN, GALEF,
WALCZYK, WALLACE -- Multi-Sponsored by -- M. of A. ENGLEBRIGHT,
HAWLEY, TAGUE -- read once and referred to the Committee on Higher
Education
AN ACT to amend the public health law and the education law, in relation
to comprehensive medication management; and to amend chapter 21 of the
laws of 2011 amending the education law relating to authorizing phar-
macists to perform collaborative drug therapy management with physi-
cians in certain settings, in relation to making the provisions of
such chapter permanent
The People of the State of New York, represented in Senate and Assem-bly, do enact as follows:
1 Section 1. The public health law is amended by adding a new article
2 29-H to read as follows:
3 ARTICLE 29-H
4 COMPREHENSIVE MEDICATION MANAGEMENT
5 Section 2999-ff. Comprehensive medication management.
6 § 2999-ff. Comprehensive medication management. 1. Definitions. As
7 used in this article, the following terms shall have the following mean-
8 ings:
9 (a) Qualified pharmacist. The term "qualified pharmacist" shall mean a
10 pharmacist who maintains a current unrestricted license pursuant to
11 article one hundred thirty-seven of the education law, who has a minimum
12 of two years of experience in patient care as a practicing pharmacist
13 within the last five years, and who has demonstrated competency in the
14 medication management of patients with a chronic disease or diseases,
15 including, but not limited to, the completion of one or more programs
16 which are accredited by the accreditation council for pharmacy educa-
EXPLANATION--Matter in italics (underscored) is new; matter in brackets
[] is old law to be omitted.
LBD10613-01-1
A. 6699 2
1 tion, recognized by the education department and acceptable to the
2 patient's treating physician.
3 (b) Patient care. The term "patient care" shall mean assessing the
4 appropriateness of prescription and non-prescription drugs for individ-
5 ual patients based on an assessment of the patient's medication history,
6 medication experience including beliefs, concerns, understanding and
7 expectations, the clinical goals of therapy, potential drug-to-drug
8 interactions or other medication safety concerns, recommendations for
9 adherence and consulting with a patient or caregiver.
10 (c) Comprehensive medication management. The term "comprehensive medi-
11 cation management" shall mean a program conducted by a qualified pharma-
12 cist that ensures a patient's medications, whether prescription or
13 nonprescription, are individually assessed to determine that each medi-
14 cation is appropriate for the patient, effective for the medical condi-
15 tion, safe given the comorbidities and other medications being taken,
16 and able to be taken by the patient as intended. Comprehensive medica-
17 tion management conducted by a qualified pharmacist shall include shar-
18 ing of applicable patient clinical information with the treating physi-
19 cian as specified in a comprehensive medication management protocol.
20 (d) Comprehensive medication management protocol. The term "comprehen-
21 sive medication management protocol" shall mean a written document
22 pursuant to and consistent with any applicable state and federal
23 requirements, that is entered into voluntarily by a physician licensed
24 pursuant to article one hundred thirty-one of the education law and a
25 qualified pharmacist which addresses a chronic disease or diseases as
26 determined by the treating physician and that describes the nature and
27 scope of the comprehensive medication management services to be
28 performed by the qualified pharmacist, in accordance with the provisions
29 of this article. Comprehensive medication management protocols between
30 licensed physicians and qualified pharmacists shall be made available to
31 the department for review and to ensure compliance with this article,
32 upon request.
33 2. Authorization to establish comprehensive medication management
34 protocols. A physician licensed pursuant to article one hundred thirty-
35 one of the education law shall be authorized to voluntarily establish a
36 comprehensive medication management protocol with a qualified pharmacist
37 to provide comprehensive medication management services for a patient
38 who has not met clinical goals of therapy, is at risk for hospitaliza-
39 tion or for whom the physician deems it is necessary to receive compre-
40 hensive medication management services. Participation by the patient in
41 comprehensive medication management services shall be voluntary.
42 3. Scope of comprehensive medication management protocols. Under a
43 comprehensive medication management protocol, a qualified pharmacist
44 shall be permitted to:
45 (a) adjust or manage a drug regimen of a patient, pursuant to the
46 patient specific order or protocol established by the patient's treating
47 physician, which may include adjusting drug strength, frequency of
48 administration or route of administration. Adjusting the drug regimen
49 shall not include substituting or selecting a different drug which
50 differs from that initially prescribed by the patient's treating physi-
51 cian unless such substitution is expressly authorized in the written
52 order or protocol. The qualified pharmacist shall be required to imme-
53 diately document in the patient's medical record changes made to the
54 patient's drug therapy. The patient's treating physician may prohibit,
55 by written instruction, any adjustment or change in the patient's drug
56 regimen by the qualified pharmacist;
A. 6699 3
1 (b) evaluate and, only if specifically authorized by the protocol and
2 only to the extent necessary to discharge the responsibilities set forth
3 in this article, order disease state laboratory tests related to the
4 drug therapy management for the specific chronic disease or diseases
5 specified within the written agreement or protocol;
6 (c) only if specifically authorized by the written order or protocol
7 and only to the extent necessary to discharge the responsibilities set
8 forth in this article, order or perform routine patient monitoring func-
9 tions as may be necessary in the drug therapy management, including the
10 collecting and reviewing of patient histories, and ordering or checking
11 patient vital signs, including pulse, temperature, blood pressure,
12 weight and respiration; and
13 (d) access the complete patient medical record maintained by the
14 treating physician with whom the qualified pharmacist has the comprehen-
15 sive medication management protocol and document any adjustments made
16 pursuant to the protocol in the patient's medical record and shall noti-
17 fy the patient's treating physician of any adjustments in a timely
18 manner electronically or by other means.
19 (e) Under no circumstances, shall the qualified pharmacist be permit-
20 ted to delegate comprehensive medication management services to any
21 other licensed pharmacist or other pharmacy personnel.
22 4. Medication adjustments. Any medication adjustments made by the
23 qualified pharmacist pursuant to the comprehensive medication management
24 protocol including adjustments in drug strength, frequency or route of
25 administration, or initiation of a drug which differs from that initial-
26 ly prescribed and as documented in the patient's medical record shall be
27 deemed an oral prescription authorized by an agent of the patient's
28 treating physician and shall be dispensed consistent with section
29 sixty-eight hundred ten of the education law. For the purposes of this
30 article, a pharmacist who is not an employee of the physician may be
31 authorized to serve as an agent of the physician.
32 5. Referrals. A physician licensed pursuant to article one hundred
33 thirty-one of the education law who has responsibility for the treatment
34 and care of a patient for a chronic disease or diseases as determined by
35 the physician may refer the patient to a qualified pharmacist for
36 comprehensive medication management services, pursuant to the comprehen-
37 sive medication management protocol that the physician has established
38 with the qualified pharmacist. The protocol agreement shall authorize
39 the pharmacist to serve as an agent of the physician as defined by the
40 protocol. Such referral shall be documented in the patient's medical
41 record.
42 6. Patient participation. Participation in comprehensive medication
43 management services shall be voluntary, and no patient, physician or
44 pharmacist shall be required to participate. The referral of a patient
45 for comprehensive medication management services and the patient's right
46 to choose to not participate shall be disclosed to the patient. Compre-
47 hensive medication management services shall not be utilized unless the
48 patient or the patient's authorized representative consents, in writing,
49 to such services. Such consent shall be noted in the patient's medical
50 record. If the patient or the patient's authorized representative who
51 consented chooses to no longer participate in such services, at any
52 time, the services shall be discontinued and it shall be noted in the
53 patient's medical record.
54 § 2. The education law is amended by adding a new section 6801-c to
55 read as follows:
A. 6699 4
1 § 6801-c. Comprehensive medication management. 1. As used in this
2 section:
3 (a) "comprehensive medication management" shall mean a program for the
4 management of chronic disease or diseases that ensures a patient's medi-
5 cations, whether prescription or nonprescription, are individually
6 assessed to determine that each medication is appropriate for the
7 patient, effective for the medical condition, safe given the comorbidi-
8 ties and other medications being taken, and able to be taken by the
9 patient as intended; and
10 (b) "comprehensive medication management protocol" shall mean a writ-
11 ten document, pursuant to and consistent with any applicable state or
12 federal requirements, that is entered into voluntarily by a physician
13 licensed pursuant to article one hundred thirty-one of this title and a
14 licensed pharmacist who meets the qualification requirements specified
15 in article twenty-nine-H of the public health law which addresses a
16 chronic disease or diseases as determined by the physician and that
17 describes the nature and scope of the comprehensive medication manage-
18 ment service to be performed by the qualified pharmacist. Comprehensive
19 medication management protocols between licensed physicians and quali-
20 fied pharmacists shall be made available to the department for review
21 and to ensure compliance with this article, upon request.
22 2. A licensed pharmacist qualified pursuant to article twenty-nine-H
23 of the public health law is authorized to serve as an agent of the
24 physician when executing the terms of the written comprehensive medica-
25 tion management protocol as established by the licensed physician for
26 the management of patients with a chronic disease or diseases.
27 § 3. Section 5 of chapter 21 of the laws of 2011, amending the educa-
28 tion law relating to authorizing pharmacists to perform collaborative
29 drug therapy management with physicians in certain settings, as amended
30 by section 20 of part BB of chapter 56 of the laws of 2020, is amended
31 to read as follows:
32 § 5. This act shall take effect on the one hundred twentieth day after
33 it shall have become a law[, provided, however, that the provisions of
34 sections two, three, and four of this act shall expire and be deemed
35 repealed July 1, 2022]; provided, however, that the amendments to subdi-
36 vision 1 of section 6801 of the education law made by section one of
37 this act shall be subject to the expiration and reversion of such subdi-
38 vision pursuant to section 8 of chapter 563 of the laws of 2008, when
39 upon such date the provisions of section one-a of this act shall take
40 effect; provided, further, that effective immediately, the addition,
41 amendment and/or repeal of any rule or regulation necessary for the
42 implementation of this act on its effective date are authorized and
43 directed to be made and completed on or before such effective date.
44 § 4. This act shall take effect immediately, provided that sections
45 one and two of this act shall take effect on the one hundred eightieth
46 day after it shall have become a law. Effective immediately, the addi-
47 tion, amendment and/or repeal of any rule or regulation necessary for
48 the implementation of this act on its effective date are authorized to
49 be made and completed on or before such effective date.
