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A01321 Text:



 
                STATE OF NEW YORK
        ________________________________________________________________________
 
                                          1321
 
                               2025-2026 Regular Sessions
 
                   IN ASSEMBLY
 
                                     January 9, 2025
                                       ___________
 
        Introduced  by M. of A. SEAWRIGHT, STIRPE, LUPARDO, BUTTENSCHON, FORREST
          -- read once and referred to the Committee on Higher Education
 
        AN ACT to amend the education law, in relation to including nurse  prac-
          titioners as a provider of services for purposes of collaborative drug
          therapy management; and to amend chapter 21 of the laws of 2011 amend-
          ing  the  education law relating to authorizing pharmacists to perform
          collaborative drug  therapy  management  with  physicians  in  certain
          settings,  in  relation to making the authorization for pharmacists to
          perform collaborative drug therapy management permanent
 
          The People of the State of New York, represented in Senate and  Assem-
        bly, do enact as follows:
 
     1    Section  1. Section 6801-a of the education law, as amended by chapter
     2  238 of the laws of 2015, is amended to read as follows:
     3    §  6801-a.  Collaborative  drug  therapy   management   [demonstration
     4  program].    1.  As used in this section, the following terms shall have
     5  the following meanings:
     6    a. "Board" shall mean the state board of pharmacy  as  established  by
     7  section sixty-eight hundred four of this article.
     8    b. "Clinical services" shall mean the collection and interpretation of
     9  patient  data  for  the  purpose of initiating, modifying and monitoring
    10  drug therapy  with  associated  accountability  and  responsibility  for
    11  outcomes in a direct patient care setting.
    12    c.  "Collaborative drug therapy management" shall mean the performance
    13  of clinical services by a pharmacist relating to the review,  evaluation
    14  and  management  of drug therapy to a patient, who is being treated by a
    15  physician or nurse practitioner for a  specific  disease  or  associated
    16  disease  states, in accordance with a written agreement or protocol with
    17  a voluntarily participating  physician  or  nurse  practitioner  and  in
    18  accordance with the policies, procedures, and protocols of the facility.
    19  Such  agreement  or  protocol  as entered into by the physician or nurse
    20  practitioner and a pharmacist, may include, and shall be limited to:
 
         EXPLANATION--Matter in italics (underscored) is new; matter in brackets
                              [ ] is old law to be omitted.
                                                                   LBD02944-01-5

        A. 1321                             2
 
     1    (i) adjusting or managing a drug regimen of a patient, pursuant  to  a
     2  patient  specific  order  or protocol made by the patient's physician or
     3  nurse practitioner, which may include adjusting drug strength, frequency
     4  of administration or route of administration. Adjusting the drug regimen
     5  shall  not  include  substituting  or  selecting  a different drug which
     6  differs from that initially prescribed by  the  patient's  physician  or
     7  nurse  practitioner  unless such substitution is expressly authorized in
     8  the written order or protocol. The pharmacist shall be required to imme-
     9  diately document in the patient record changes  made  to  the  patient's
    10  drug therapy and shall use any reasonable means or method established by
    11  the  facility to notify the patient's other treating physicians or nurse
    12  practitioners with whom [he or she] such  pharmacist  does  not  have  a
    13  written  agreement  or  protocol  regarding  such changes. The patient's
    14  physician or nurse practitioner may prohibit,  by  written  instruction,
    15  any  adjustment  or  change in the patient's drug regimen by the pharma-
    16  cist;
    17    (ii) evaluating and, only if specifically authorized by  the  protocol
    18  and  only  to the extent necessary to discharge the responsibilities set
    19  forth in this section, ordering disease state laboratory  tests  related
    20  to the drug therapy management for the specific disease or disease state
    21  specified within the written agreement or protocol; and
    22    (iii)  only  if  specifically  authorized  by the written agreement or
    23  protocol and only to the extent necessary to discharge the  responsibil-
    24  ities  set forth in this section, ordering or performing routine patient
    25  monitoring functions as may be necessary in the drug therapy management,
    26  including the collecting and reviewing of patient histories, and  order-
    27  ing or checking patient vital signs, including pulse, temperature, blood
    28  pressure and respiration.
    29    d.  "Facility" shall mean: (i) a [teaching hospital or general] hospi-
    30  tal, [including any diagnostic center, treatment  center,  or  hospital-
    31  based  outpatient  department]  as defined in subdivision one of section
    32  twenty-eight hundred one of the public health law;  or  (ii)  a  nursing
    33  home  with  an  on-site  pharmacy  staffed  by  a  licensed  pharmacist;
    34  provided, however, for the purposes of this section the term  "facility"
    35  shall  not  include  dental  clinics,  dental  dispensaries, residential
    36  health care facilities and rehabilitation centers.
    37    [For the purposes of this section, a "teaching hospital" shall mean  a
    38  hospital  licensed pursuant to article twenty-eight of the public health
    39  law that is eligible to receive  direct  or  indirect  graduate  medical
    40  education payments pursuant to article twenty-eight of the public health
    41  law.]  In addition, a facility may also include up to fifteen community-
    42  practice sites, selected by the  department  in  consultation  with  the
    43  department  of health, where pharmacists and physicians or nurse practi-
    44  tioners may propose to enter into collaborative  arrangements,  pursuant
    45  to  the  provisions  of this section. Such sites shall be selected based
    46  upon a review of applications submitted to the department by such  phar-
    47  macists  and  physicians  or nurse practitioners, which demonstrate that
    48  the applicants can satisfy the requirements of this section.
    49    e. "Physician" or "nurse practitioner" shall  mean  the  physician  or
    50  nurse practitioner selected by or assigned to a patient, who has primary
    51  responsibility for the treatment and care of the patient for the disease
    52  and  associated disease states that are the subject of the collaborative
    53  drug therapy management.
    54    f. "Written agreement or protocol"  shall  mean  a  written  document,
    55  pursuant to and consistent with any applicable state or federal require-
    56  ments,  that  addresses  a specific disease or associated disease states

        A. 1321                             3
 
     1  and that describes the nature and scope of  collaborative  drug  therapy
     2  management  to  be  undertaken by the pharmacists, in collaboration with
     3  the participating physician or nurse practitioner in accordance with the
     4  provisions of this section.
     5    2.  a. A pharmacist who meets the experience requirements of paragraph
     6  b of this subdivision and who is either employed by or otherwise  affil-
     7  iated with a facility or is participating with a community-practice site
     8  selected  pursuant  to  paragraph  d  of subdivision one of this section
     9  shall be permitted to enter into a written agreement or protocol with  a
    10  physician  or  nurse practitioner authorizing collaborative drug therapy
    11  management, subject to the limitations set forth in this section, within
    12  the scope of such employment [or], affiliation or participation.
    13    b. A participating pharmacist must:
    14    (i)(A) have been awarded either a master of science in clinical  phar-
    15  macy or a doctor of pharmacy degree;
    16    (B) maintain a current unrestricted license; and
    17    (C) have a minimum of two years experience, of which at least one year
    18  of such experience shall include clinical experience in a health facili-
    19  ty,  which  involves consultation with physicians or nurse practitioners
    20  with respect to drug therapy and may include a residency at  a  facility
    21  involving such consultation; or
    22    (ii)(A) have been awarded a bachelor of science in pharmacy;
    23    (B) maintain a current unrestricted license; and
    24    (C) within the last seven years, have a minimum of three years experi-
    25  ence,  of which at least one year of such experience shall include clin-
    26  ical experience in a health facility, which involves  consultation  with
    27  physicians  or  nurse practitioners with respect to drug therapy and may
    28  include a residency at a facility involving such consultation; and
    29    (iii) meet any additional education, experience, or other requirements
    30  set forth by the department in consultation with the board.
    31    c. Notwithstanding any provision of law, nothing in this section shall
    32  prohibit a licensed pharmacist from engaging in clinical services  asso-
    33  ciated  with  collaborative  drug  therapy  management, in order to gain
    34  experience necessary to qualify under clause (C) of subparagraph (i)  or
    35  (ii)  of paragraph b of this subdivision, provided that such practice is
    36  under the supervision of a pharmacist that currently  meets  the  refer-
    37  enced  requirement, and that such practice is authorized under the writ-
    38  ten agreement or protocol with the physician or nurse practitioner.
    39    d. Notwithstanding any provision of this section, nothing herein shall
    40  authorize the pharmacist to diagnose disease. In the event that a treat-
    41  ing physician or nurse practitioner may disagree with  the  exercise  of
    42  professional  judgment  by  a  pharmacist,  the judgment of the treating
    43  physician or nurse practitioner shall prevail.
    44    3. The physician or nurse practitioner who is a  party  to  a  written
    45  agreement  or protocol authorizing collaborative drug therapy management
    46  shall be employed by or otherwise affiliated with the same facility with
    47  which the pharmacist is also employed or affiliated.
    48    4. The existence of a written agreement or protocol  on  collaborative
    49  drug therapy management and the patient's right to choose to not partic-
    50  ipate in collaborative drug therapy management shall be disclosed to any
    51  patient  who  is  eligible to receive collaborative drug therapy manage-
    52  ment. Collaborative drug therapy management shall not be utilized unless
    53  the patient or the  patient's  authorized  representative  consents,  in
    54  writing,  to such management. If the patient or the patient's authorized
    55  representative consents, it shall be  noted  on  the  patient's  medical
    56  record.  If  the  patient or the patient's authorized representative who

        A. 1321                             4
 
     1  consented to collaborative drug therapy management chooses to no  longer
     2  participate  in  such  management, at any time, it shall be noted on the
     3  patient's medical record. In addition,  the  existence  of  the  written
     4  agreement or protocol and the patient's consent to such management shall
     5  be  disclosed  to  the patient's primary physician or nurse practitioner
     6  and any other treating physician or  nurse  practitioner  or  healthcare
     7  provider.
     8    5. Participation in a written agreement or protocol authorizing colla-
     9  borative  drug  therapy  management  shall be voluntary, and no patient,
    10  physician or  nurse  practitioner,  pharmacist,  or  facility  shall  be
    11  required to participate.
    12    6. Nothing in this section shall be deemed to limit the scope of prac-
    13  tice of pharmacy nor be deemed to limit the authority of pharmacists and
    14  physicians  or  nurse  practitioners  to engage in medication management
    15  prior to the effective date of this section and to the extent authorized
    16  by law.
    17    § 2. Section 5 of chapter 21 of the laws of 2011 amending  the  educa-
    18  tion  law  relating  to authorizing pharmacists to perform collaborative
    19  drug therapy management with physicians in certain settings, as  amended
    20  by  section 2 of part P of chapter 57 of the laws of 2024, is amended to
    21  read as follows:
    22    § 5. This act shall take effect on the one hundred twentieth day after
    23  it shall have become a law[, provided, however, that the  provisions  of
    24  sections  two,  three,  and  four of this act shall expire and be deemed
    25  repealed July 1, 2026]; provided, however, that the amendments to subdi-
    26  vision 1 of section 6801 of the education law made  by  section  one  of
    27  this act shall be subject to the expiration and reversion of such subdi-
    28  vision  pursuant  to  section 8 of chapter 563 of the laws of 2008, when
    29  upon such date the provisions of section one-a of this  act  shall  take
    30  effect;  provided,  further,  that  effective immediately, the addition,
    31  amendment and/or repeal of any rule  or  regulation  necessary  for  the
    32  implementation  of  this  act  on  its effective date are authorized and
    33  directed to be made and completed on or before such effective date.
    34    § 3. This act shall take effect on the one hundred twentieth day after
    35  it shall have become a law. Effective immediately, the addition,  amend-
    36  ment and/or repeal of any rule or regulation necessary for the implemen-
    37  tation  of  this act on its effective date are authorized to be made and
    38  completed on or before such effective date.
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