Add Art 29-H §2999-ff, Pub Health L; add §6801-b, Ed L; amd §5, Chap 21 of 2011
Authorizes physicians and pharmacists to enter into collaborative practice medication adherence protocols for their patients; makes permanent certain provisions relating to authorizing pharmacists to perform with physicians in certain settings.
NEW YORK STATE ASSEMBLY MEMORANDUM IN SUPPORT OF LEGISLATION submitted in accordance with Assembly Rule III, Sec 1(f)
BILL NUMBER: A6564
SPONSOR: McDonald (MS) TITLE OF BILL:
An act to amend the public health law and the education law, in relation
to collaborative practice medication adherence; and to amend chapter 21
of the laws of 2011 amending the education law relating to authorizing
pharmacists to perform collaborative drug therapy management with
physicians in certain settings, in relation to making the provisions of
such chapter permanent
PURPOSE OR GENERAL IDEA OF BILL:
Authorizes physicians to refer selected patients to qualified pharma-
cists for collaborative practice medication adherence (CPMA) services
specified in a written protocol issued by the treating physician with
consent of the patient.
SUMMARY OF PROVISIONS:
Section 1 adds Article 29-H to Public Health Law entitled Collaborative
Practice Medication Adherence, includes definitions and authorizes a
treating physician to refer one or more patients to a qualified pharma-
cist for collaborative practice medication adherence services specified
in the written protocol. Section 1 defines patients eligible for refer-
ral by their treating physician as those with a chronic disease or
diseases, who have not met the clinical goals of therapy, are at risk
for hospitalization, or who are otherwise in need of extra medication-
related services as determined by their physician. Section 1 of the bill
lists medication-related services. The written protocol applies to an
individual named pharmacist and a named physician and is voluntary for
all parties including the patient. This section requires sharing of
patient data in real-time through a bi-directional interoperable medical
records system.
Section 2 amends Section 6801 of the Education Law to create a new para-
graph Section 6801-b. This section recognizes collaborative practice
meditation adherence as a service that can be provided by a qualified
pharmacist pursuant to a protocol with a licensed physician, and
conforms to changes being made in Public Health Law.
Section 3 amend s Section 5 of chapter 2.1 of the laws of 2011, amending
the education law relating to authorizing pharmacists to perform colla-
borative, drug therapy management with physicians in hospital facilities
to remove the sunset and make the law permanent.
Section 4 establishes the effective date.
JUSTIFICATION:
Collaborative Practice Medication Adherence (CPMA) has been accepted by
the NYS Health Department as a policy recommendation from a Value-Based
Payment stakeholder workgroup. CPMA is a professional service provided
by qualified pharmacists to patients who are referred by their treating
physicians for extra medication support services. The service represents
a targeted strategy developed to reduce avoidable hospitalizations and
healthcare costs resulting from the exacerbation of chronic diseases due
to sub-optimal medication use. With expertise in pharmacotherapy and
pharmacokinetics, pharmacists are uniquely positioned healthcare provid-
ers to address medication-related problems. One key aspect of profes-
sional practice is patient counseling which includes an assessment of a
patient's understanding of how to use the medication, what side-effects
to expect, how to manage them, what side-effects are dangerous and
should be reported, etc. Patients are not compliant for many reasons,
and pharmacists are well equipped for effective one-to-one discussions
that produce positive results. Peer-reviewed studies in published liter-
ature consistently document the effectiveness of increasing direct
interactions between pharmacists and patients. I n fact, the evidence
was so compelling that the Centers for Medicaid and Medicare included
Medication Therapy Management as a mandatory element in Medicare Part
1-) Prescription Drug Plans. CPMA represents a logical progression.
Under CPMA, only at-risk patients receive the additional service.
Patients are identified by their treating physicians and referred to an
individual pharmacist with whom the treating physician has developed a
written Protocol for a particular patient related to a particular
disease or diseases. As Value-Based payment methodologies evolve and
quality is increasingly measured by therapeutic outcomes in defined
patient populations, the need for CPMA services by pharmacists will
become more and more apparent. In fact, QARR and HEDIS measures current-
ly include many directly concerned with medication adherence, for exam-
ple: medication management for people with asthma, statin therapy for
patients with diabetes, persistence of beta-blocker treatment after a
heart attack, antidepressant medication management, and adherence to
antipsychotic. medications for people with schizophrenia. CPMA as
described in the bill applies to pharmacists in community settings as
well as patients with chronic medical conditions and th eir treating
physicians who have relationships with local pharmacists. The protocols
envisioned in this proposal will deal with common conditions such as
asthma, diabetes, hypertension and hypercholesterolemia. This legis-
lation represents a modest and logical extension to the services that
pharmacists in community practice settings can provide if they meet the
additional qualifications included in the bill. Finally, under current
Education Law pharmacists employed in hospitals who meet additional
qualification requirements receive a credential from the Education
Department authorizing them to enter into collaborative agreements with
physicians in hospitals. This bill removes the sunset on this section of
law which has been in place since 2011, making it permanent.
PRIOR LEGISLATIVE HISTORY:
2017-2018 A.8664-A/S.7682
2019-2020 A.3849/S.5296
2021-2022 A.6699/S.6110
2023: S.3591
FISCAL IMPLICATIONS FOR STATE AND LOCAL GOVERNMENTS:
This legislation is expected to result in a savings for the State under
Medicaid and other public programs.
EFFECTIVE DATE:
This act shall take effect immediately, provided that sections one and
two of this act shall take effect on the one hundred eightieth day after
it shall have become a law provided, that, effective immediately, the
addition, amendment and/or repeal of any rule or regulation necessary
for the implementation of this act on its effective date is authorized
and directed to be made and completed on or before such effective date.
STATE OF NEW YORK
________________________________________________________________________
6564
2023-2024 Regular Sessions
IN ASSEMBLY
April 19, 2023
___________
Introduced by M. of A. McDONALD, BENEDETTO, SEAWRIGHT, JOYNER,
J. M. GIGLIO, STECK, LUPARDO, JONES, COLTON, DICKENS, FAHY, RA,
SAYEGH, MORINELLO, BYRNES, WALLACE, BUTTENSCHON -- Multi-Sponsored by
-- M. of A. 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 collaborative practice medication adherence; and to amend chapter
21 of the laws of 2011 amending the education law relating to author-
izing pharmacists to perform collaborative drug therapy management
with physicians 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. This act shall be known and may be cited as the "Collabora-
2 tive Practice Medication Adherence Act".
3 § 2. The public health law is amended by adding a new article 29-H to
4 read as follows:
5 ARTICLE 29-H
6 COLLABORATIVE PRACTICE MEDICATION ADHERENCE ACT
7 Section 2999-ff. Collaborative practice medication adherence.
8 § 2999-ff. Collaborative practice medication adherence. 1. Defi-
9 nitions. As used in this article, the following terms shall have the
10 following meanings:
11 (a) Qualified pharmacist. The term "qualified pharmacist" shall mean a
12 pharmacist who maintains a current unrestricted license pursuant to
13 article one hundred thirty-seven of the education law, who has a minimum
14 of two years of experience in patient care as a practicing pharmacist
15 within the last five years, and who has demonstrated competency in medi-
16 cation adherence of patients with a chronic disease or diseases, includ-
17 ing, but not limited to, the completion of one or more programs which
18 are accredited by the accreditation council for pharmacy education,
EXPLANATION--Matter in italics (underscored) is new; matter in brackets
[] is old law to be omitted.
LBD08609-05-3
A. 6564 2
1 recognized by the education department and acceptable to the patient's
2 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) Collaborative practice medication adherence. The term "collabora-
11 tive practice medication adherence" shall mean a program conducted by a
12 qualified pharmacist that ensures a patient's medications, whether
13 prescription or nonprescription, are individually assessed to determine
14 that each medication is appropriate for the patient, effective for the
15 medical condition, safe given the comorbidities and other medications
16 being taken, and able to be taken by the patient as intended. Collabora-
17 tive practice medication adherence protocols conducted by a qualified
18 pharmacist shall include sharing of applicable patient clinical informa-
19 tion with the treating physician as specified in a collaborative prac-
20 tice medication adherence protocol.
21 (d) Collaborative practice medication adherence protocol. The term
22 "collaborative practice medication adherence protocol" shall mean a
23 written document pursuant to and consistent with any applicable state
24 and federal requirements, that is entered into voluntarily by a physi-
25 cian licensed pursuant to article one hundred thirty-one of the educa-
26 tion law and a qualified pharmacist which addresses a chronic disease or
27 diseases as determined by the treating physician and that describes the
28 nature and scope of the collaborative practice medication adherence
29 services to be performed by the qualified pharmacist, in accordance with
30 the provisions of this article. Collaborative practice medication adher-
31 ence protocols between licensed physicians and qualified pharmacists
32 shall be made available to the department for review and to ensure
33 compliance with this article, upon request.
34 2. Authorization to establish collaborative practice medication adher-
35 ence protocols. A physician licensed pursuant to article one hundred
36 thirty-one of the education law shall be authorized to voluntarily
37 establish a collaborative practice medication adherence protocol with a
38 qualified pharmacist to provide collaborative practice medication adher-
39 ence services for a patient who has not met clinical goals of therapy,
40 is at risk for hospitalization or for whom the physician deems it is
41 necessary to receive collaborative practice medication adherence
42 services. Participation by the patient in collaborative practice medi-
43 cation adherence services shall be voluntary.
44 3. Scope of collaborative practice medication adherence protocols.
45 Under a collaborative practice medication adherence protocol, a quali-
46 fied pharmacist shall be permitted to:
47 (a) adjust or manage a drug regimen of a patient, pursuant to the
48 patient specific order or protocol established by the patient's treating
49 physician, which may include adjusting drug strength, frequency of
50 administration or route of administration. Adjusting the drug regimen
51 shall not include substituting or selecting a different drug which
52 differs from that initially prescribed by the patient's treating physi-
53 cian unless such substitution is expressly authorized in the written
54 order or protocol. The qualified pharmacist shall be required to imme-
55 diately document in the patient's medical record changes made to the
56 patient's drug therapy. The patient's treating physician may prohibit,
A. 6564 3
1 by written instruction, any adjustment or change in the patient's drug
2 regimen by the qualified pharmacist;
3 (b) evaluate and, only if specifically authorized by the protocol and
4 only to the extent necessary to discharge the responsibilities set forth
5 in this article, order disease state laboratory tests related to the
6 drug therapy management for the specific chronic disease or diseases
7 specified within the written agreement or protocol;
8 (c) only if specifically authorized by the written order or protocol
9 and only to the extent necessary to discharge the responsibilities set
10 forth in this article, order or perform routine patient monitoring func-
11 tions as may be necessary in the drug therapy management, including the
12 collecting and reviewing of patient histories, and ordering or checking
13 patient vital signs, including pulse, temperature, blood pressure,
14 weight and respiration; and
15 (d) access the complete patient medical record maintained by the
16 treating physician with whom the qualified pharmacist has the collabora-
17 tive practice medication adherence protocol and document any adjustments
18 made pursuant to the protocol in the patient's medical record and shall
19 notify the patient's treating physician of any adjustments in a timely
20 manner electronically or by other means.
21 (e) Under no circumstances, shall the qualified pharmacist be permit-
22 ted to delegate collaborative practice medication adherence services to
23 any other licensed pharmacist or other pharmacy personnel.
24 4. Medication adjustments. Any medication adjustments made by the
25 qualified pharmacist pursuant to the collaborative practice medication
26 adherence protocol including adjustments in drug strength, frequency or
27 route of administration, or initiation of a drug which differs from that
28 initially prescribed and as documented in the patient's medical record
29 shall be deemed an oral prescription authorized by an agent of the
30 patient's treating physician and shall be dispensed consistent with
31 section sixty-eight hundred ten of the education law. For the purposes
32 of this article, a pharmacist who is not an employee of the physician
33 may be authorized to serve as an agent of the physician.
34 5. Referrals. A physician licensed pursuant to article one hundred
35 thirty-one of the education law who has responsibility for the treatment
36 and care of a patient for a chronic disease or diseases as determined by
37 the physician may refer the patient to a qualified pharmacist for colla-
38 borative practice medication adherence services, pursuant to the colla-
39 borative practice medication adherence protocol that the physician has
40 established with the qualified pharmacist. The protocol agreement shall
41 authorize the pharmacist to serve as an agent of the physician as
42 defined by the protocol. Such referral shall be documented in the
43 patient's medical record.
44 6. Patient participation. Participation in collaborative practice
45 medication adherence services shall be voluntary, and no patient, physi-
46 cian or pharmacist shall be required to participate. The referral of a
47 patient for collaborative practice medication adherence services and the
48 patient's right to choose to not participate shall be disclosed to the
49 patient. Collaborative practice medication adherence services shall not
50 be utilized unless the patient or the patient's authorized represen-
51 tative consents, in writing, to such services. Such consent shall be
52 noted in the patient's medical record. If the patient or the patient's
53 authorized representative who consented chooses to no longer participate
54 in such services, at any time, the services shall be discontinued and it
55 shall be noted in the patient's medical record.
A. 6564 4
1 § 3. The education law is amended by adding a new section 6801-b to
2 read as follows:
3 § 6801-b. Collaborative practice medication adherence. 1. As used in
4 this section:
5 (a) "collaborative practice medication adherence" shall mean a program
6 for the management of chronic disease or diseases that ensures a
7 patient's medications, whether prescription or nonprescription, are
8 individually assessed to determine that each medication is appropriate
9 for the patient, effective for the medical condition, safe given the
10 comorbidities and other medications being taken, and able to be taken by
11 the patient as intended; and
12 (b) "collaborative practice medication adherence protocol" shall mean
13 a written document, pursuant to and consistent with any applicable state
14 or federal requirements, that is entered into voluntarily by a physician
15 licensed pursuant to article one hundred thirty-one of this title and a
16 licensed pharmacist who meets the qualification requirements specified
17 in article twenty-nine-H of the public health law which addresses a
18 chronic disease or diseases as determined by the physician and that
19 describes the nature and scope of the collaborative practice medication
20 adherence service to be performed by the qualified pharmacist. Collabo-
21 rative practice medication adherence protocols between licensed physi-
22 cians and qualified pharmacists shall be made available to the depart-
23 ment for review and to ensure compliance with this article, upon
24 request.
25 2. A licensed pharmacist qualified pursuant to article twenty-nine-H
26 of the public health law is authorized to serve as an agent of the
27 physician when executing the terms of the written collaborative practice
28 medication adherence protocol as established by the licensed physician
29 for the management of patients with a chronic disease or diseases.
30 § 4. Section 5 of chapter 21 of the laws of 2011 amending the educa-
31 tion law relating to authorizing pharmacists to perform collaborative
32 drug therapy management with physicians in certain settings, as amended
33 by section 5 of part CC of chapter 57 of the laws of 2022, is amended to
34 read as follows:
35 § 5. This act shall take effect on the one hundred twentieth day after
36 it shall have become a law[, provided, however, that the provisions of
37 sections two, three, and four of this act shall expire and be deemed
38 repealed July 1, 2024]; provided, however, that the amendments to subdi-
39 vision 1 of section 6801 of the education law made by section one of
40 this act shall be subject to the expiration and reversion of such subdi-
41 vision pursuant to section 8 of chapter 563 of the laws of 2008, when
42 upon such date the provisions of section one-a of this act shall take
43 effect; provided, further, that effective immediately, the addition,
44 amendment and/or repeal of any rule or regulation necessary for the
45 implementation of this act on its effective date are authorized and
46 directed to be made and completed on or before such effective date.
47 § 5. This act shall take effect immediately, provided that sections
48 one and two of this act shall take effect on the one hundred eightieth
49 day after it shall have become a law. Effective immediately, the addi-
50 tion, amendment and/or repeal of any rule or regulation necessary for
51 the implementation of this act on its effective date are authorized to
52 be made and completed on or before such effective date.
