Bill Text: NY A06564 | 2023-2024 | General Assembly | Introduced


Bill Title: 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.

Spectrum: Slight Partisan Bill (Democrat 17-6)

Status: (Introduced) 2024-01-03 - referred to higher education [A06564 Detail]

Download: New_York-2023-A06564-Introduced.html



                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.
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