Bill Text: NY S04043 | 2023-2024 | General Assembly | Introduced


Bill Title: Includes nurse practitioners as a provider of services for purposes of collaborative drug therapy management; makes the authorization for pharmacists to perform such management permanent.

Spectrum: Partisan Bill (Democrat 4-0)

Status: (Introduced) 2024-01-03 - REFERRED TO HIGHER EDUCATION [S04043 Detail]

Download: New_York-2023-S04043-Introduced.html



                STATE OF NEW YORK
        ________________________________________________________________________

                                          4043

                               2023-2024 Regular Sessions

                    IN SENATE

                                    February 2, 2023
                                       ___________

        Introduced  by  Sens.  RIVERA, GOUNARDES, KRUEGER, SALAZAR -- read twice
          and ordered printed, and when printed to be committed 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.

         EXPLANATION--Matter in italics (underscored) is new; matter in brackets
                              [ ] is old law to be omitted.
                                                                   LBD00382-01-3

        S. 4043                             2

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

        S. 4043                             3

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

        S. 4043                             4

     1  record.  If  the  patient or the patient's authorized representative who
     2  consented to collaborative drug therapy management chooses to no  longer
     3  participate  in  such  management, at any time, it shall be noted on the
     4  patient's  medical  record.  In  addition,  the existence of the written
     5  agreement or protocol and the patient's consent to such management shall
     6  be disclosed to the patient's primary physician  or  nurse  practitioner
     7  and  any  other  treating  physician or nurse practitioner or healthcare
     8  provider.
     9    5. Participation in a written agreement or protocol authorizing colla-
    10  borative drug therapy management shall be  voluntary,  and  no  patient,
    11  physician  or  nurse  practitioner,  pharmacist,  or  facility  shall be
    12  required to participate.
    13    6. Nothing in this section shall be deemed to limit the scope of prac-
    14  tice of pharmacy nor be deemed to limit the authority of pharmacists and
    15  physicians or nurse practitioners to  engage  in  medication  management
    16  prior to the effective date of this section and to the extent authorized
    17  by law.
    18    §  2.  Section 5 of chapter 21 of the laws of 2011 amending the educa-
    19  tion law relating to authorizing pharmacists  to  perform  collaborative
    20  drug  therapy management with physicians in certain settings, as amended
    21  by section 5 of part CC of chapter 57 of the laws of 2022, is amended to
    22  read as follows:
    23    § 5. This act shall take effect on the one hundred twentieth day after
    24  it shall have become a law[, provided, however, that the  provisions  of
    25  sections  two,  three,  and  four of this act shall expire and be deemed
    26  repealed July 1, 2024]; provided, however, that the amendments to subdi-
    27  vision 1 of section 6801 of the education law made  by  section  one  of
    28  this act shall be subject to the expiration and reversion of such subdi-
    29  vision  pursuant  to  section 8 of chapter 563 of the laws of 2008, when
    30  upon such date the provisions of section one-a of this  act  shall  take
    31  effect;  provided,  further,  that  effective immediately, the addition,
    32  amendment and/or repeal of any rule  or  regulation  necessary  for  the
    33  implementation  of  this  act  on  its effective date are authorized and
    34  directed to be made and completed on or before such effective date.
    35    § 3. This act shall take effect on the one hundred twentieth day after
    36  it shall have become a law. Effective immediately, the addition,  amend-
    37  ment and/or repeal of any rule or regulation necessary for the implemen-
    38  tation  of  this act on its effective date are authorized to be made and
    39  completed on or before such effective date.
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