S T A T E   O F   N E W   Y O R K
 ________________________________________________________________________
 
                                   1036
 
                        2021-2022 Regular Sessions
 
                           I N  A S S E M B L Y
 
                              January 7, 2021
                                ___________
 
 Introduced  by  M. of A. SEAWRIGHT, STIRPE, LUPARDO, BUTTENSCHON -- 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:
 
   Section  1. Section 6801-a of the education law, as amended by chapter
 238 of the laws of 2015, is amended to read as follows:
   §  6801-a.  Collaborative  drug  therapy   management   [demonstration
 program].    1.  As used in this section, the following terms shall have
 the following meanings:
   a. "Board" shall mean the state board of pharmacy  as  established  by
 section sixty-eight hundred four of this article.
   b. "Clinical services" shall mean the collection and interpretation of
 patient  data  for  the  purpose of initiating, modifying and monitoring
 drug therapy  with  associated  accountability  and  responsibility  for
 outcomes in a direct patient care setting.
   c.  "Collaborative drug therapy management" shall mean the performance
 of clinical services by a pharmacist relating to the review,  evaluation
 and  management  of drug therapy to a patient, who is being treated by a
 physician OR NURSE PRACTITIONER for a  specific  disease  or  associated
 disease  states, in accordance with a written agreement or protocol with
 a voluntarily participating  physician  OR  NURSE  PRACTITIONER  and  in
 accordance with the policies, procedures, and protocols of the facility.
 Such  agreement  or  protocol  as entered into by the physician OR NURSE
 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.
              

                                                            LBD05638-01-1

 A. 1036                             2
 
   (i) adjusting or managing a drug regimen of a patient, pursuant  to  a
 patient  specific  order  or protocol made by the patient's physician OR
 NURSE PRACTITIONER, which may include adjusting drug strength, frequency
 of administration or route of administration. Adjusting the drug regimen
 shall  not  include  substituting  or  selecting  a different drug which
 differs from that initially prescribed by  the  patient's  physician  OR
 NURSE  PRACTITIONER  unless such substitution is expressly authorized in
 the written order or protocol. The pharmacist shall be required to imme-
 diately document in the patient record changes  made  to  the  patient's
 drug therapy and shall use any reasonable means or method established by
 the  facility to notify the patient's other treating physicians OR NURSE
 PRACTITIONERS with whom he or she does not have a written  agreement  or
 protocol  regarding such changes. The patient's physician OR NURSE PRAC-
 TITIONER may prohibit, by written instruction, any adjustment or  change
 in the patient's drug regimen by the pharmacist;
   (ii)  evaluating  and, only if specifically authorized by the protocol
 and only to the extent necessary to discharge the  responsibilities  set
 forth  in  this section, ordering disease state laboratory tests related
 to the drug therapy management for the specific disease or disease state
 specified within the written agreement or protocol; and
   (iii) only if specifically authorized  by  the  written  agreement  or
 protocol  and only to the extent necessary to discharge the responsibil-
 ities set forth in this section, ordering or performing routine  patient
 monitoring functions as may be necessary in the drug therapy management,
 including  the collecting and reviewing of patient histories, and order-
 ing or checking patient vital signs, including pulse, temperature, blood
 pressure and respiration.
   d. "Facility" shall mean: (i) a [teaching hospital or general]  hospi-
 tal,  [including  any  diagnostic center, treatment center, or hospital-
 based outpatient department] as defined in SUBDIVISION  ONE  OF  section
 twenty-eight  hundred  one  of  the public health law; or (ii) a nursing
 home  with  an  on-site  pharmacy  staffed  by  a  licensed  pharmacist;
 provided,  however, for the purposes of this section the term "facility"
 shall not  include  dental  clinics,  dental  dispensaries,  residential
 health care facilities and rehabilitation centers.
   [For  the purposes of this section, a "teaching hospital" shall mean a
 hospital licensed pursuant to article twenty-eight of the public  health
 law  that  is  eligible  to  receive direct or indirect graduate medical
 education payments pursuant to article twenty-eight of the public health
 law.] IN ADDITION, A FACILITY MAY ALSO INCLUDE UP TO FIFTEEN  COMMUNITY-
 PRACTICE  SITES,  SELECTED  BY  THE  DEPARTMENT IN CONSULTATION WITH THE
 DEPARTMENT OF HEALTH, WHERE PHARMACISTS AND PHYSICIANS OR NURSE  PRACTI-
 TIONERS  MAY  PROPOSE TO ENTER INTO COLLABORATIVE ARRANGEMENTS, PURSUANT
 TO THE PROVISIONS OF THIS SECTION. SUCH SITES SHALL  BE  SELECTED  BASED
 UPON  A REVIEW OF APPLICATIONS SUBMITTED TO THE DEPARTMENT BY SUCH PHAR-
 MACISTS AND PHYSICIANS OR NURSE PRACTITIONERS,  WHICH  DEMONSTRATE  THAT
 THE APPLICANTS CAN SATISFY THE REQUIREMENTS OF THIS SECTION.
   e.  "Physician"  OR  "NURSE  PRACTITIONER" shall mean the physician OR
 NURSE PRACTITIONER selected by or assigned to a patient, who has primary
 responsibility for the treatment and care of the patient for the disease
 and associated disease states that are the subject of the  collaborative
 drug therapy management.
   f.  "Written  agreement  or  protocol"  shall mean a written document,
 pursuant to and consistent with any applicable state or federal require-
 ments, that addresses a specific disease or  associated  disease  states
 and  that  describes  the nature and scope of collaborative drug therapy

 A. 1036                             3
 
 management to be undertaken by the pharmacists,  in  collaboration  with
 the participating physician OR NURSE PRACTITIONER in accordance with the
 provisions of this section.
   2.  a. A pharmacist who meets the experience requirements of paragraph
 b of this subdivision and who is EITHER employed by or otherwise  affil-
 iated with a facility OR IS PARTICIPATING WITH A COMMUNITY-PRACTICE SITE
 SELECTED  PURSUANT  TO  PARAGRAPH  D  OF SUBDIVISION ONE OF THIS SECTION
 shall be permitted to enter into a written agreement or protocol with  a
 physician  OR  NURSE PRACTITIONER authorizing collaborative drug therapy
 management, subject to the limitations set forth in this section, within
 the scope of such employment [or], affiliation OR PARTICIPATION.
   b. A participating pharmacist must:
   (i)(A) have been awarded either a master of science in clinical  phar-
 macy or a doctor of pharmacy degree;
   (B) maintain a current unrestricted license; and
   (C) have a minimum of two years experience, of which at least one year
 of such experience shall include clinical experience in a health facili-
 ty,  which  involves consultation with physicians OR NURSE PRACTITIONERS
 with respect to drug therapy and may include a residency at  a  facility
 involving such consultation; or
   (ii)(A) have been awarded a bachelor of science in pharmacy;
   (B) maintain a current unrestricted license; and
   (C) within the last seven years, have a minimum of three years experi-
 ence,  of which at least one year of such experience shall include clin-
 ical experience in a health facility, which involves  consultation  with
 physicians  OR  NURSE PRACTITIONERS with respect to drug therapy and may
 include a residency at a facility involving such consultation; and
   (iii) meet any additional education, experience, or other requirements
 set forth by the department in consultation with the board.
   c. Notwithstanding any provision of law, nothing in this section shall
 prohibit a licensed pharmacist from engaging in clinical services  asso-
 ciated  with  collaborative  drug  therapy  management, in order to gain
 experience necessary to qualify under clause (C) of subparagraph (i)  or
 (ii)  of paragraph b of this subdivision, provided that such practice is
 under the supervision of a pharmacist that currently  meets  the  refer-
 enced  requirement, and that such practice is authorized under the writ-
 ten agreement or protocol with the physician OR NURSE PRACTITIONER.
   d. Notwithstanding any provision of this section, nothing herein shall
 authorize the pharmacist to diagnose disease. In the event that a treat-
 ing physician OR NURSE PRACTITIONER may disagree with  the  exercise  of
 professional  judgment  by  a  pharmacist,  the judgment of the treating
 physician OR NURSE PRACTITIONER shall prevail.
   3. The physician OR NURSE PRACTITIONER who is a  party  to  a  written
 agreement  or protocol authorizing collaborative drug therapy management
 shall be employed by or otherwise affiliated with the same facility with
 which the pharmacist is also employed or affiliated.
   4. The existence of a written agreement or protocol  on  collaborative
 drug therapy management and the patient's right to choose to not partic-
 ipate in collaborative drug therapy management shall be disclosed to any
 patient  who  is  eligible to receive collaborative drug therapy manage-
 ment. Collaborative drug therapy management shall not be utilized unless
 the patient or the  patient's  authorized  representative  consents,  in
 writing,  to such management. If the patient or the patient's authorized
 representative consents, it shall be  noted  on  the  patient's  medical
 record.  If  the  patient or the patient's authorized representative who
 consented to collaborative drug therapy management chooses to no  longer

 A. 1036                             4
 
 participate  in  such  management, at any time, it shall be noted on the
 patient's medical record. In addition,  the  existence  of  the  written
 agreement or protocol and the patient's consent to such management shall
 be  disclosed  to  the patient's primary physician OR NURSE PRACTITIONER
 and any other treating physician OR  NURSE  PRACTITIONER  or  healthcare
 provider.
   5. Participation in a written agreement or protocol authorizing colla-
 borative  drug  therapy  management  shall be voluntary, and no patient,
 physician OR  NURSE  PRACTITIONER,  pharmacist,  or  facility  shall  be
 required to participate.
   6. Nothing in this section shall be deemed to limit the scope of prac-
 tice of pharmacy nor be deemed to limit the authority of pharmacists and
 physicians  OR  NURSE  PRACTITIONERS  to engage in medication management
 prior to the effective date of this section and to the extent authorized
 by law.
   § 2. Section 5 of chapter 21 of the laws of 2011 amending  the  educa-
 tion  law  relating  to authorizing pharmacists to perform collaborative
 drug therapy management with physicians in certain settings, as  amended
 by  section  20 of part BB of chapter 56 of the laws of 2020, is amended
 to read as follows:
   § 5. This act shall take effect on the one hundred twentieth day after
 it shall have become a law[, provided, however, that the  provisions  of
 sections  two,  three,  and  four of this act shall expire and be deemed
 repealed July 1, 2022]; provided, however, that the amendments to subdi-
 vision 1 of section 6801 of the education law made  by  section  one  of
 this act shall be subject to the expiration and reversion of such subdi-
 vision  pursuant  to  section 8 of chapter 563 of the laws of 2008, when
 upon such date the provisions of section one-a of this  act  shall  take
 effect;  provided,  further,  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 are authorized and
 directed to be made and completed on or before such effective date.
   § 3. This act shall take effect on the one hundred twentieth day after
 it shall have become a law. Effective immediately, the addition,  amend-
 ment and/or repeal of any rule or regulation necessary for the implemen-
 tation  of  this act on its effective date are authorized to be made and
 completed on or before such effective date.