S T A T E   O F   N E W   Y O R K
 ________________________________________________________________________
 
                                   6699
 
                        2021-2022 Regular Sessions
 
                           I N  A S S E M B L Y
 
                              March 25, 2021
                                ___________
 
 Introduced   by   M.  of  A.  McDONALD,  BENEDETTO,  SEAWRIGHT,  JOYNER,
   J. M. GIGLIO, NIOU, CAHILL, STECK, LUPARDO,  JONES,  COLTON,  DICKENS,
   FAHY, RA, SAYEGH, ASHBY, MORINELLO, BYRNES, GOTTFRIED, GRIFFIN, GALEF,
   WALCZYK,  WALLACE  --  Multi-Sponsored  by  --  M.  of A. ENGLEBRIGHT,
   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 comprehensive medication management; and to amend chapter 21 of the
   laws  of 2011 amending the education law relating to authorizing phar-
   macists to perform collaborative drug therapy management  with  physi-
   cians  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.  The  public health law is amended by adding a new article
 29-H to read as follows:
                               ARTICLE 29-H
                    COMPREHENSIVE MEDICATION MANAGEMENT
 SECTION 2999-FF. COMPREHENSIVE MEDICATION MANAGEMENT.
   § 2999-FF. COMPREHENSIVE MEDICATION  MANAGEMENT.  1.  DEFINITIONS.  AS
 USED IN THIS ARTICLE, THE FOLLOWING TERMS SHALL HAVE THE FOLLOWING MEAN-
 INGS:
   (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 THE
 MEDICATION MANAGEMENT OF PATIENTS WITH A CHRONIC  DISEASE  OR  DISEASES,
 INCLUDING,  BUT  NOT  LIMITED TO, THE COMPLETION OF ONE OR MORE PROGRAMS
 WHICH ARE ACCREDITED BY THE ACCREDITATION COUNCIL  FOR  PHARMACY  EDUCA-

  EXPLANATION--Matter in ITALICS (underscored) is new; matter in brackets
                       [ ] is old law to be omitted.
                                                            LBD10613-01-1
              

 A. 6699                             2
 
 TION,  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) COMPREHENSIVE MEDICATION MANAGEMENT. THE TERM "COMPREHENSIVE MEDI-
 CATION MANAGEMENT" SHALL MEAN A PROGRAM CONDUCTED BY A QUALIFIED PHARMA-
 CIST THAT ENSURES  A  PATIENT'S  MEDICATIONS,  WHETHER  PRESCRIPTION  OR
 NONPRESCRIPTION,  ARE INDIVIDUALLY ASSESSED TO DETERMINE THAT EACH MEDI-
 CATION IS APPROPRIATE FOR THE PATIENT, EFFECTIVE FOR THE MEDICAL  CONDI-
 TION,  SAFE  GIVEN  THE COMORBIDITIES AND OTHER MEDICATIONS BEING TAKEN,
 AND ABLE TO BE TAKEN BY THE PATIENT AS INTENDED.  COMPREHENSIVE  MEDICA-
 TION  MANAGEMENT CONDUCTED BY A QUALIFIED PHARMACIST SHALL INCLUDE SHAR-
 ING OF APPLICABLE PATIENT CLINICAL INFORMATION WITH THE TREATING  PHYSI-
 CIAN AS SPECIFIED IN A COMPREHENSIVE MEDICATION MANAGEMENT PROTOCOL.
   (D) COMPREHENSIVE MEDICATION MANAGEMENT PROTOCOL. THE TERM "COMPREHEN-
 SIVE  MEDICATION  MANAGEMENT  PROTOCOL"  SHALL  MEAN  A WRITTEN DOCUMENT
 PURSUANT TO  AND  CONSISTENT  WITH  ANY  APPLICABLE  STATE  AND  FEDERAL
 REQUIREMENTS,  THAT  IS ENTERED INTO VOLUNTARILY BY A PHYSICIAN LICENSED
 PURSUANT TO ARTICLE ONE HUNDRED THIRTY-ONE OF THE EDUCATION  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  COMPREHENSIVE  MEDICATION  MANAGEMENT  SERVICES  TO  BE
 PERFORMED BY THE QUALIFIED PHARMACIST, IN ACCORDANCE WITH THE PROVISIONS
 OF THIS ARTICLE.  COMPREHENSIVE MEDICATION MANAGEMENT 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  COMPREHENSIVE  MEDICATION  MANAGEMENT
 PROTOCOLS.  A PHYSICIAN LICENSED PURSUANT TO ARTICLE ONE HUNDRED THIRTY-
 ONE OF THE EDUCATION LAW SHALL BE AUTHORIZED TO VOLUNTARILY ESTABLISH  A
 COMPREHENSIVE MEDICATION MANAGEMENT PROTOCOL WITH A QUALIFIED PHARMACIST
 TO  PROVIDE  COMPREHENSIVE  MEDICATION MANAGEMENT SERVICES FOR A PATIENT
 WHO HAS NOT MET CLINICAL GOALS OF THERAPY, IS AT RISK  FOR  HOSPITALIZA-
 TION  OR FOR WHOM THE PHYSICIAN DEEMS IT IS NECESSARY TO RECEIVE COMPRE-
 HENSIVE MEDICATION MANAGEMENT SERVICES.  PARTICIPATION BY THE PATIENT IN
 COMPREHENSIVE MEDICATION MANAGEMENT SERVICES SHALL BE VOLUNTARY.
   3. SCOPE OF COMPREHENSIVE MEDICATION  MANAGEMENT  PROTOCOLS.  UNDER  A
 COMPREHENSIVE  MEDICATION  MANAGEMENT  PROTOCOL,  A QUALIFIED 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,
 BY  WRITTEN  INSTRUCTION, ANY ADJUSTMENT OR CHANGE IN THE PATIENT'S DRUG
 REGIMEN BY THE QUALIFIED PHARMACIST;

 A. 6699                             3
 
   (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 COMPREHEN-
 SIVE  MEDICATION  MANAGEMENT  PROTOCOL AND DOCUMENT ANY ADJUSTMENTS MADE
 PURSUANT TO THE PROTOCOL IN THE PATIENT'S MEDICAL RECORD AND SHALL NOTI-
 FY 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 COMPREHENSIVE  MEDICATION  MANAGEMENT  SERVICES  TO  ANY
 OTHER LICENSED PHARMACIST OR OTHER PHARMACY PERSONNEL.
   4.  MEDICATION  ADJUSTMENTS.  ANY  MEDICATION  ADJUSTMENTS MADE BY THE
 QUALIFIED PHARMACIST PURSUANT TO THE COMPREHENSIVE MEDICATION MANAGEMENT
 PROTOCOL INCLUDING ADJUSTMENTS IN DRUG STRENGTH, FREQUENCY OR  ROUTE  OF
 ADMINISTRATION, OR INITIATION OF A DRUG WHICH DIFFERS FROM THAT INITIAL-
 LY 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
 COMPREHENSIVE MEDICATION MANAGEMENT SERVICES, PURSUANT TO THE COMPREHEN-
 SIVE  MEDICATION  MANAGEMENT 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 COMPREHENSIVE MEDICATION
 MANAGEMENT SERVICES SHALL BE VOLUNTARY, AND  NO  PATIENT,  PHYSICIAN  OR
 PHARMACIST  SHALL  BE REQUIRED TO PARTICIPATE. THE REFERRAL OF A PATIENT
 FOR COMPREHENSIVE MEDICATION MANAGEMENT SERVICES AND THE PATIENT'S RIGHT
 TO CHOOSE TO NOT PARTICIPATE SHALL BE DISCLOSED TO THE PATIENT.  COMPRE-
 HENSIVE MEDICATION MANAGEMENT SERVICES SHALL NOT BE UTILIZED UNLESS  THE
 PATIENT OR THE PATIENT'S AUTHORIZED REPRESENTATIVE 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.
   §  2.  The  education law is amended by adding a new section 6801-c to
 read as follows:

 A. 6699                             4
 
   § 6801-C. COMPREHENSIVE MEDICATION MANAGEMENT.  1.  AS  USED  IN  THIS
 SECTION:
   (A) "COMPREHENSIVE MEDICATION MANAGEMENT" SHALL MEAN A PROGRAM FOR THE
 MANAGEMENT OF CHRONIC DISEASE OR DISEASES THAT ENSURES A PATIENT'S MEDI-
 CATIONS,  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 COMORBIDI-
 TIES AND OTHER MEDICATIONS BEING TAKEN, AND ABLE  TO  BE  TAKEN  BY  THE
 PATIENT AS INTENDED; AND
   (B)  "COMPREHENSIVE MEDICATION MANAGEMENT PROTOCOL" SHALL MEAN A WRIT-
 TEN 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 COMPREHENSIVE  MEDICATION  MANAGE-
 MENT  SERVICE TO BE PERFORMED BY THE QUALIFIED PHARMACIST. COMPREHENSIVE
 MEDICATION MANAGEMENT PROTOCOLS BETWEEN LICENSED PHYSICIANS  AND  QUALI-
 FIED  PHARMACISTS  SHALL  BE MADE AVAILABLE TO THE DEPARTMENT 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 COMPREHENSIVE  MEDICA-
 TION  MANAGEMENT  PROTOCOL  AS ESTABLISHED BY THE LICENSED PHYSICIAN FOR
 THE MANAGEMENT OF PATIENTS WITH A CHRONIC DISEASE OR DISEASES.
   § 3. 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.
   § 4. 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.