S T A T E   O F   N E W   Y O R K
 ________________________________________________________________________
 
                                  3591--A
 
                        2023-2024 Regular Sessions
 
                             I N  S E N A T E
 
                             February 1, 2023
                                ___________
 
 Introduced  by Sens. BRESLIN, ADDABBO -- read twice and ordered printed,
   and when printed to be committed to the Committee on Health -- commit-
   tee discharged, bill amended, ordered reprinted as amended and  recom-
   mitted to said committee
 
 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:
 
   Section 1. This act shall be known and may be cited as the "Collabora-
 tive Practice Medication Adherence Act".
   §  2. The public health law is amended by adding a new article 29-H to
 read as follows:
                               ARTICLE 29-H
              COLLABORATIVE PRACTICE MEDICATION ADHERENCE ACT
 SECTION 2999-FF. COLLABORATIVE PRACTICE MEDICATION ADHERENCE.
   § 2999-FF.  COLLABORATIVE  PRACTICE  MEDICATION  ADHERENCE.  1.  DEFI-
 NITIONS.  AS  USED  IN  THIS ARTICLE, THE FOLLOWING TERMS SHALL HAVE THE
 FOLLOWING MEANINGS:
   (A) QUALIFIED PHARMACIST. THE TERM "QUALIFIED PHARMACIST" SHALL MEAN A
 PHARMACIST WHO MAINTAINS A  CURRENT  UNRESTRICTED  LICENSE  PURSUANT  TO
 ARTICLE ONE HUNDRED THIRTY-SEVEN OF THE EDUCATION LAW, WHO HAS A MINIMUM
 OF  TWO  YEARS  OF EXPERIENCE IN PATIENT CARE AS A PRACTICING PHARMACIST
 WITHIN THE LAST FIVE YEARS, AND WHO HAS DEMONSTRATED COMPETENCY IN MEDI-
 CATION ADHERENCE OF PATIENTS WITH A CHRONIC DISEASE OR DISEASES, INCLUD-
 ING, BUT NOT LIMITED TO, THE COMPLETION OF ONE OR  MORE  PROGRAMS  WHICH
 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.
                                                            LBD08609-04-3
 S. 3591--A                          2
              

 
 RECOGNIZED BY THE EDUCATION DEPARTMENT AND ACCEPTABLE TO  THE  PATIENT'S
 TREATING PHYSICIAN.
   (B)  PATIENT  CARE.  THE  TERM "PATIENT CARE" SHALL MEAN ASSESSING THE
 APPROPRIATENESS OF PRESCRIPTION AND NON-PRESCRIPTION DRUGS FOR  INDIVID-
 UAL PATIENTS BASED ON AN ASSESSMENT OF THE PATIENT'S MEDICATION HISTORY,
 MEDICATION  EXPERIENCE  INCLUDING  BELIEFS,  CONCERNS, UNDERSTANDING AND
 EXPECTATIONS, THE CLINICAL  GOALS  OF  THERAPY,  POTENTIAL  DRUG-TO-DRUG
 INTERACTIONS  OR  OTHER  MEDICATION SAFETY CONCERNS, RECOMMENDATIONS FOR
 ADHERENCE AND CONSULTING WITH A PATIENT OR CAREGIVER.
   (C) COLLABORATIVE PRACTICE MEDICATION ADHERENCE. THE TERM  "COLLABORA-
 TIVE  PRACTICE MEDICATION ADHERENCE" SHALL MEAN A PROGRAM CONDUCTED BY A
 QUALIFIED PHARMACIST  THAT  ENSURES  A  PATIENT'S  MEDICATIONS,  WHETHER
 PRESCRIPTION  OR NONPRESCRIPTION, ARE INDIVIDUALLY ASSESSED TO DETERMINE
 THAT EACH MEDICATION IS APPROPRIATE FOR THE PATIENT, EFFECTIVE  FOR  THE
 MEDICAL  CONDITION,  SAFE  GIVEN THE COMORBIDITIES AND OTHER MEDICATIONS
 BEING TAKEN, AND ABLE TO BE TAKEN BY THE PATIENT AS INTENDED. COLLABORA-
 TIVE PRACTICE MEDICATION ADHERENCE PROTOCOLS CONDUCTED  BY  A  QUALIFIED
 PHARMACIST SHALL INCLUDE SHARING OF APPLICABLE PATIENT CLINICAL INFORMA-
 TION  WITH  THE TREATING PHYSICIAN AS SPECIFIED IN A COLLABORATIVE PRAC-
 TICE MEDICATION ADHERENCE PROTOCOL.
   (D) COLLABORATIVE PRACTICE MEDICATION  ADHERENCE  PROTOCOL.  THE  TERM
 "COLLABORATIVE  PRACTICE  MEDICATION  ADHERENCE  PROTOCOL"  SHALL MEAN A
 WRITTEN DOCUMENT PURSUANT TO AND CONSISTENT WITH  ANY  APPLICABLE  STATE
 AND  FEDERAL  REQUIREMENTS, THAT IS ENTERED INTO VOLUNTARILY BY A PHYSI-
 CIAN LICENSED PURSUANT TO ARTICLE ONE HUNDRED THIRTY-ONE OF  THE  EDUCA-
 TION LAW AND A QUALIFIED PHARMACIST WHICH ADDRESSES A CHRONIC DISEASE OR
 DISEASES  AS DETERMINED BY THE TREATING PHYSICIAN AND THAT DESCRIBES THE
 NATURE AND SCOPE OF  THE  COLLABORATIVE  PRACTICE  MEDICATION  ADHERENCE
 SERVICES TO BE PERFORMED BY THE QUALIFIED PHARMACIST, IN ACCORDANCE WITH
 THE PROVISIONS OF THIS ARTICLE. COLLABORATIVE PRACTICE MEDICATION ADHER-
 ENCE  PROTOCOLS  BETWEEN  LICENSED  PHYSICIANS AND QUALIFIED PHARMACISTS
 SHALL BE MADE AVAILABLE TO THE  DEPARTMENT  FOR  REVIEW  AND  TO  ENSURE
 COMPLIANCE WITH THIS ARTICLE, UPON REQUEST.
   2. AUTHORIZATION TO ESTABLISH COLLABORATIVE PRACTICE MEDICATION ADHER-
 ENCE  PROTOCOLS.  A  PHYSICIAN  LICENSED PURSUANT TO ARTICLE ONE HUNDRED
 THIRTY-ONE OF THE EDUCATION  LAW  SHALL  BE  AUTHORIZED  TO  VOLUNTARILY
 ESTABLISH  A COLLABORATIVE PRACTICE MEDICATION ADHERENCE PROTOCOL WITH A
 QUALIFIED PHARMACIST TO PROVIDE COLLABORATIVE PRACTICE MEDICATION ADHER-
 ENCE SERVICES FOR A PATIENT WHO HAS NOT MET CLINICAL GOALS  OF  THERAPY,
 IS  AT  RISK  FOR  HOSPITALIZATION OR FOR WHOM THE PHYSICIAN DEEMS IT IS
 NECESSARY  TO  RECEIVE  COLLABORATIVE  PRACTICE   MEDICATION   ADHERENCE
 SERVICES.   PARTICIPATION BY THE PATIENT IN COLLABORATIVE PRACTICE MEDI-
 CATION ADHERENCE SERVICES SHALL BE VOLUNTARY.
   3. SCOPE OF COLLABORATIVE  PRACTICE  MEDICATION  ADHERENCE  PROTOCOLS.
 UNDER  A  COLLABORATIVE PRACTICE MEDICATION ADHERENCE PROTOCOL, A QUALI-
 FIED PHARMACIST SHALL BE PERMITTED TO:
   (A) ADJUST OR MANAGE A DRUG REGIMEN OF  A  PATIENT,  PURSUANT  TO  THE
 PATIENT SPECIFIC ORDER OR PROTOCOL ESTABLISHED BY THE PATIENT'S TREATING
 PHYSICIAN,  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 TREATING  PHYSI-
 CIAN  UNLESS  SUCH  SUBSTITUTION  IS EXPRESSLY AUTHORIZED IN THE WRITTEN
 ORDER OR PROTOCOL. THE QUALIFIED PHARMACIST SHALL BE REQUIRED  TO  IMME-
 DIATELY  DOCUMENT  IN  THE  PATIENT'S MEDICAL RECORD CHANGES MADE TO THE
 PATIENT'S DRUG THERAPY. THE PATIENT'S TREATING PHYSICIAN  MAY  PROHIBIT,
 S. 3591--A                          3
 
 BY  WRITTEN  INSTRUCTION, ANY ADJUSTMENT OR CHANGE IN THE PATIENT'S DRUG
 REGIMEN BY THE QUALIFIED PHARMACIST;
   (B)  EVALUATE AND, ONLY IF SPECIFICALLY AUTHORIZED BY THE PROTOCOL AND
 ONLY TO THE EXTENT NECESSARY TO DISCHARGE THE RESPONSIBILITIES SET FORTH
 IN THIS ARTICLE, ORDER DISEASE STATE LABORATORY  TESTS  RELATED  TO  THE
 DRUG  THERAPY  MANAGEMENT  FOR  THE SPECIFIC CHRONIC DISEASE OR DISEASES
 SPECIFIED WITHIN THE WRITTEN AGREEMENT OR PROTOCOL;
   (C) ONLY IF SPECIFICALLY AUTHORIZED BY THE WRITTEN ORDER  OR  PROTOCOL
 AND  ONLY  TO THE EXTENT NECESSARY TO DISCHARGE THE RESPONSIBILITIES SET
 FORTH IN THIS ARTICLE, ORDER OR PERFORM ROUTINE PATIENT MONITORING FUNC-
 TIONS AS MAY BE NECESSARY IN THE DRUG THERAPY MANAGEMENT, INCLUDING  THE
 COLLECTING  AND REVIEWING OF PATIENT HISTORIES, AND ORDERING OR CHECKING
 PATIENT VITAL  SIGNS,  INCLUDING  PULSE,  TEMPERATURE,  BLOOD  PRESSURE,
 WEIGHT AND RESPIRATION; AND
   (D)  ACCESS  THE  COMPLETE  PATIENT  MEDICAL  RECORD MAINTAINED BY THE
 TREATING PHYSICIAN WITH WHOM THE QUALIFIED PHARMACIST HAS THE COLLABORA-
 TIVE PRACTICE MEDICATION ADHERENCE PROTOCOL AND DOCUMENT ANY ADJUSTMENTS
 MADE PURSUANT TO THE PROTOCOL IN THE PATIENT'S MEDICAL RECORD AND  SHALL
 NOTIFY  THE  PATIENT'S TREATING PHYSICIAN OF ANY ADJUSTMENTS IN A TIMELY
 MANNER ELECTRONICALLY OR BY OTHER MEANS.
   (E) UNDER NO CIRCUMSTANCES, SHALL THE QUALIFIED PHARMACIST BE  PERMIT-
 TED  TO DELEGATE COLLABORATIVE PRACTICE MEDICATION ADHERENCE SERVICES TO
 ANY OTHER LICENSED PHARMACIST OR OTHER PHARMACY PERSONNEL.
   4. MEDICATION ADJUSTMENTS. ANY  MEDICATION  ADJUSTMENTS  MADE  BY  THE
 QUALIFIED  PHARMACIST  PURSUANT TO THE COLLABORATIVE PRACTICE MEDICATION
 ADHERENCE PROTOCOL INCLUDING ADJUSTMENTS IN DRUG STRENGTH, FREQUENCY  OR
 ROUTE OF ADMINISTRATION, OR INITIATION OF A DRUG WHICH DIFFERS FROM THAT
 INITIALLY  PRESCRIBED  AND AS DOCUMENTED IN THE PATIENT'S MEDICAL RECORD
 SHALL BE DEEMED AN ORAL PRESCRIPTION  AUTHORIZED  BY  AN  AGENT  OF  THE
 PATIENT'S  TREATING  PHYSICIAN  AND  SHALL  BE DISPENSED CONSISTENT WITH
 SECTION SIXTY-EIGHT HUNDRED TEN OF THE EDUCATION LAW. FOR  THE  PURPOSES
 OF  THIS  ARTICLE,  A PHARMACIST WHO IS NOT AN EMPLOYEE OF THE PHYSICIAN
 MAY BE AUTHORIZED TO SERVE AS AN AGENT OF THE PHYSICIAN.
   5. REFERRALS. A PHYSICIAN LICENSED PURSUANT  TO  ARTICLE  ONE  HUNDRED
 THIRTY-ONE OF THE EDUCATION LAW WHO HAS RESPONSIBILITY FOR THE TREATMENT
 AND CARE OF A PATIENT FOR A CHRONIC DISEASE OR DISEASES AS DETERMINED BY
 THE PHYSICIAN MAY REFER THE PATIENT TO A QUALIFIED PHARMACIST FOR COLLA-
 BORATIVE  PRACTICE MEDICATION ADHERENCE SERVICES, PURSUANT TO THE COLLA-
 BORATIVE PRACTICE MEDICATION ADHERENCE PROTOCOL THAT THE  PHYSICIAN  HAS
 ESTABLISHED  WITH THE QUALIFIED PHARMACIST. THE PROTOCOL AGREEMENT SHALL
 AUTHORIZE THE PHARMACIST TO SERVE  AS  AN  AGENT  OF  THE  PHYSICIAN  AS
 DEFINED  BY  THE  PROTOCOL.  SUCH  REFERRAL  SHALL  BE DOCUMENTED IN THE
 PATIENT'S MEDICAL RECORD.
   6. PATIENT  PARTICIPATION.  PARTICIPATION  IN  COLLABORATIVE  PRACTICE
 MEDICATION ADHERENCE SERVICES SHALL BE VOLUNTARY, AND NO PATIENT, PHYSI-
 CIAN  OR  PHARMACIST SHALL BE REQUIRED TO PARTICIPATE. THE REFERRAL OF A
 PATIENT FOR COLLABORATIVE PRACTICE MEDICATION ADHERENCE SERVICES AND THE
 PATIENT'S RIGHT TO CHOOSE TO NOT PARTICIPATE SHALL BE DISCLOSED  TO  THE
 PATIENT.  COLLABORATIVE PRACTICE MEDICATION ADHERENCE SERVICES SHALL NOT
 BE  UTILIZED  UNLESS  THE  PATIENT OR THE PATIENT'S AUTHORIZED REPRESEN-
 TATIVE CONSENTS, IN WRITING, TO SUCH SERVICES.  SUCH  CONSENT  SHALL  BE
 NOTED  IN  THE PATIENT'S MEDICAL RECORD. IF THE PATIENT OR THE PATIENT'S
 AUTHORIZED REPRESENTATIVE WHO CONSENTED CHOOSES TO NO LONGER PARTICIPATE
 IN SUCH SERVICES, AT ANY TIME, THE SERVICES SHALL BE DISCONTINUED AND IT
 SHALL BE NOTED IN THE PATIENT'S MEDICAL RECORD.
 S. 3591--A                          4
 
   § 3. The education law is amended by adding a new  section  6801-b  to
 read as follows:
   §  6801-B.  COLLABORATIVE PRACTICE MEDICATION ADHERENCE. 1. AS USED IN
 THIS SECTION:
   (A) "COLLABORATIVE PRACTICE MEDICATION ADHERENCE" SHALL MEAN A PROGRAM
 FOR THE MANAGEMENT  OF  CHRONIC  DISEASE  OR  DISEASES  THAT  ENSURES  A
 PATIENT'S  MEDICATIONS,  WHETHER  PRESCRIPTION  OR  NONPRESCRIPTION, ARE
 INDIVIDUALLY ASSESSED TO DETERMINE THAT EACH MEDICATION  IS  APPROPRIATE
 FOR  THE  PATIENT,  EFFECTIVE  FOR THE MEDICAL CONDITION, SAFE GIVEN THE
 COMORBIDITIES AND OTHER MEDICATIONS BEING TAKEN, AND ABLE TO BE TAKEN BY
 THE PATIENT AS INTENDED; AND
   (B) "COLLABORATIVE PRACTICE MEDICATION ADHERENCE PROTOCOL" SHALL  MEAN
 A WRITTEN DOCUMENT, PURSUANT TO AND CONSISTENT WITH ANY APPLICABLE STATE
 OR FEDERAL REQUIREMENTS, THAT IS ENTERED INTO VOLUNTARILY BY A PHYSICIAN
 LICENSED  PURSUANT TO ARTICLE ONE HUNDRED THIRTY-ONE OF THIS TITLE AND A
 LICENSED PHARMACIST WHO MEETS THE QUALIFICATION  REQUIREMENTS  SPECIFIED
 IN  ARTICLE  TWENTY-NINE-H  OF  THE  PUBLIC HEALTH LAW WHICH ADDRESSES A
 CHRONIC DISEASE OR DISEASES AS DETERMINED  BY  THE  PHYSICIAN  AND  THAT
 DESCRIBES  THE NATURE AND SCOPE OF THE COLLABORATIVE PRACTICE MEDICATION
 ADHERENCE SERVICE TO BE PERFORMED BY THE QUALIFIED PHARMACIST.  COLLABO-
 RATIVE  PRACTICE  MEDICATION ADHERENCE PROTOCOLS BETWEEN LICENSED PHYSI-
 CIANS AND QUALIFIED PHARMACISTS SHALL BE MADE AVAILABLE TO  THE  DEPART-
 MENT  FOR  REVIEW  AND  TO  ENSURE  COMPLIANCE  WITH  THIS ARTICLE, UPON
 REQUEST.
   2. A LICENSED PHARMACIST QUALIFIED PURSUANT TO  ARTICLE  TWENTY-NINE-H
 OF  THE  PUBLIC  HEALTH  LAW  IS  AUTHORIZED TO SERVE AS AN AGENT OF THE
 PHYSICIAN WHEN EXECUTING THE TERMS OF THE WRITTEN COLLABORATIVE PRACTICE
 MEDICATION ADHERENCE PROTOCOL AS ESTABLISHED BY THE  LICENSED  PHYSICIAN
 FOR THE MANAGEMENT OF PATIENTS WITH A CHRONIC DISEASE OR DISEASES.
   §  4.  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 5 of part CC of chapter 57 of the laws of 2022, 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, 2024]; 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.
   § 5. 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.  Effective immediately, the  addi-
 tion,  amendment  and/or  repeal of any rule or regulation necessary for
 the implementation of this act on its effective date are  authorized  to
 be made and completed on or before such effective date.