S T A T E   O F   N E W   Y O R K
 ________________________________________________________________________
 
                                   1296
 
                        2025-2026 Regular Sessions
 
                           I N  A S S E M B L Y
 
                              January 9, 2025
                                ___________
 
 Introduced  by  M. of A. PAULIN, SAYEGH, LUCAS -- read once and referred
   to the Committee on Health
 
 AN ACT to amend the public health law, in relation to  establishing  the
   rare disease advisory council
 
   THE  PEOPLE OF THE STATE OF NEW YORK, REPRESENTED IN SENATE AND ASSEM-
 BLY, DO ENACT AS FOLLOWS:

   Section 1. Title 2-F of the public health law is amended by  adding  a
 new section 245 to read as follows:
   §  245.  RARE  DISEASE  ADVISORY  COUNCIL. 1. FOR THE PURPOSES OF THIS
 SECTION, "RARE DISEASE" MEANS ANY DISEASE  OR  CONDITION  WHICH  AFFECTS
 LESS THAN TWO HUNDRED THOUSAND PERSONS IN THE UNITED STATES.
   2.  A. THERE SHALL BE ESTABLISHED WITHIN THE DEPARTMENT A RARE DISEASE
 ADVISORY COUNCIL TO IDENTIFY BEST PRACTICES, RAISE  AWARENESS  REGARDING
 RARE  DISEASES,  EVALUATE BARRIERS TO ACCESS TO CARE, AND TO MAKE RECOM-
 MENDATIONS TO THE LEGISLATURE AND THE GOVERNOR.
   B. AN EXISTING BODY OR PREVIOUSLY CONVENED BODY, WHETHER DISSOLVED  OR
 NOT, MAY BE REPURPOSED TO MEET THE REQUIREMENTS OF THIS SECTION.
   3. A. THE COUNCIL SHALL CONSIST OF AT LEAST FIFTEEN MEMBERS, INCLUDING
 THE  COMMISSIONER OR SUCH COMMISSIONER'S DESIGNEE, THE SUPERINTENDENT OF
 FINANCIAL SERVICES OR SUCH SUPERINTENDENT'S DESIGNEE, AND  NINE  MEMBERS
 TO  BE  APPOINTED BY THE GOVERNOR. TWO MEMBERS SHALL BE APPOINTED BY THE
 SPEAKER OF THE ASSEMBLY, TWO MEMBERS SHALL BE APPOINTED BY THE TEMPORARY
 PRESIDENT OF THE SENATE.  MEMBERSHIP OF SUCH COUNCIL  SHALL  CONSIST  OF
 RESIDENTS  OF  THE STATE OF NEW YORK AND INCLUDE, BUT NOT BE LIMITED TO,
 INDIVIDUALS WITH EXPERTISE IN RARE DISEASES, INCLUDING PHYSICIANS, NURS-
 ES AND OTHER HEALTH  CARE  PROFESSIONALS  WITH  EXPERIENCE  RESEARCHING,
 DIAGNOSING OR TREATING RARE DISEASES; MEMBERS OF THE SCIENTIFIC COMMUNI-
 TY  ENGAGED  IN  RARE  DISEASE RESEARCH; REPRESENTATIVES FROM THE HEALTH
 INSURANCE INDUSTRY; A REPRESENTATIVE OF THE BIOPHARMA INDUSTRY; INDIVID-
 UALS WHO HAVE A RARE DISEASE AND CAREGIVERS OF  A  PERSON  WITH  A  RARE
 DISEASE; AND REPRESENTATIVES OF RARE DISEASE PATIENT ORGANIZATIONS.
 
  EXPLANATION--Matter in ITALICS (underscored) is new; matter in brackets
                       [ ] is old law to be omitted.
                                                            LBD02189-02-5
              

 A. 1296                             2
 
   B.  THE  COUNCIL  SHALL  PRIORITIZE  THE REPRESENTATION OF PATIENT AND
 CAREGIVER VOICES WHILE ENSURING NO SINGLE DISEASE  STATE  IS  DISPROPOR-
 TIONATELY REPRESENTED.
   C.  THE  MEMBERS OF THE RARE DISEASE ADVISORY COUNCIL SHALL RECEIVE NO
 COMPENSATION FOR THEIR ROLE ON THE COUNCIL, BUT SHALL BE  ALLOWED  THEIR
 ACTUAL  AND  NECESSARY  EXPENSES  INCURRED  IN  THE PERFORMANCE OF THEIR
 DUTIES AS COUNCIL MEMBERS.
   D. TIME SERVED ON A PREVIOUSLY CONVENED BODY SHALL NOT  COUNT  TOWARDS
 THE TERM OF OFFICE FOR MEMBERSHIP ON THE RARE DISEASE ADVISORY COUNCIL.
   4. A. COUNCIL MEMBERS SHALL SERVE UP TO TWO FOUR YEAR TERMS COMMENCING
 FROM  THE DATE OF THEIR APPOINTMENT. MEMBERS MAY SERVE BEYOND THEIR TERM
 EXPIRATION AT THE PLEASURE OF THE APPOINTING AUTHORITY.
   B. IF A VACANCY OCCURS FOR AN UNEXPIRED TERM, THE COUNCIL, BY A MAJOR-
 ITY VOTE, SHALL FILL SUCH VACANCY IN A TIMELY MANNER AND  IN  COMPLIANCE
 WITH  THE  REQUIREMENTS  SET FORTH IN SUBDIVISIONS TWO AND THREE OF THIS
 SECTION.
   C. THE COUNCIL SHALL ANNUALLY ELECT A CHAIR FROM AMONGST ITS  MEMBERS.
 A CHAIR IS ELIGIBLE FOR REELECTION.
   5.  A. THE INITIAL MEETING OF THE COUNCIL SHALL OCCUR WITHIN THE FIRST
 ONE HUNDRED EIGHTY DAYS AFTER THE EFFECTIVE DATE OF  THIS  SECTION.  THE
 COUNCIL  SHALL MEET AT LEAST ONCE PER QUARTER IN PERSON OR VIA AN ONLINE
 MEETING PLATFORM AS DETERMINED BY THE CHAIR. SUCH MEETINGS SHALL  COMPLY
 WITH ARTICLE SEVEN OF THE PUBLIC OFFICERS LAW.
   B.  THE  COUNCIL  SHALL  PROVIDE  OPPORTUNITIES FOR THE PUBLIC TO HEAR
 UPDATES AND PROVIDE PUBLIC COMMENT AND  CREATE  AND  MAINTAIN  A  PUBLIC
 WEBSITE OR UTILIZE AN EXISTING WEBSITE WHERE MEETING MINUTES, NOTICES OF
 UPCOMING MEETINGS, AND PUBLIC COMMENTS CAN BE SUBMITTED.
   6. THE COUNCIL'S FOCUS SHALL INCLUDE, BUT NOT BE LIMITED TO:
   A. IDENTIFYING BEST PRACTICES THAT COULD IMPROVE THE AWARENESS OF RARE
 DISEASES AND REFERRAL OF PEOPLE WITH POTENTIAL RARE DISEASES TO SPECIAL-
 ISTS;
   B.  EVALUATING  BARRIERS TO TREATMENT, INCLUDING FINANCIAL BARRIERS ON
 ACCESS TO CARE;
   C. ESTABLISHING BEST PRACTICES AND PROTOCOLS TO INCLUDE IN STATE PLAN-
 NING RELATED TO NATURAL DISASTERS, PUBLIC HEALTH  EMERGENCIES  OR  OTHER
 EMERGENCY DECLARATIONS TO ENABLE THE CONTINUITY OF CARE FOR RARE DISEASE
 PATIENTS  AND  ENSURE SAFEGUARDS AGAINST DISCRIMINATION FOR RARE DISEASE
 PATIENTS ARE IN PLACE;
   D.  CONVENING  PUBLIC  HEARINGS,  MAKING  INQUIRIES,  AND   SOLICITING
 COMMENTS FROM THE GENERAL PUBLIC IN THE STATE TO ASSIST THE COUNCIL WITH
 A  FIRST-YEAR LANDSCAPE OR SURVEY OF THE NEEDS OF RARE DISEASE PATIENTS,
 CAREGIVERS, AND PROVIDERS IN THE STATE;
   E. PROVIDING TESTIMONY AND COMMENTS ON PENDING LEGISLATION  AND  REGU-
 LATIONS  BEFORE THE LEGISLATURE AND OTHER STATE AGENCIES THAT IMPACT NEW
 YORK'S RARE DISEASE COMMUNITY;
   F. CONSULTING WITH EXPERTS ON RARE DISEASES TO DEVELOP  POLICY  RECOM-
 MENDATIONS  TO  IMPROVE  PATIENT ACCESS TO, AND QUALITY OF, RARE DISEASE
 SPECIALISTS, AFFORDABLE AND COMPREHENSIVE HEALTH CARE COVERAGE, RELEVANT
 DIAGNOSTICS, TIMELY TREATMENT, AND OTHER NEEDED SERVICES;
   G. ADVISING THE MEDICAID DRUG UTILIZATION REVIEW BOARD IN THEIR REVIEW
 OF PRODUCTS  OR  MEDICATIONS  FOR  THE  TREATMENT  OF  RARE  AND  ORPHAN
 DISEASES, AND DRUGS OR BIOLOGICAL PRODUCTS WITHIN THE EMERGING FIELDS OF
 PERSONALIZED  MEDICINE  AND  NON-INHERITABLE  GENE EDITING THERAPEUTICS.
 ALL ADVISORY COUNCIL RECOMMENDATIONS SHALL BE PRESENTED  IN  WRITING  TO
 MEMBERS  OF  SUCH BOARD AND EXPLAINED TO MEMBERS OF SUCH BOARD BY REPRE-
 SENTATIVES OF THE ADVISORY COUNCIL DURING THEIR PUBLIC  MEETINGS.    THE
 A. 1296                             3
 
 ADVISORY  COUNCIL  HAS  NO AUTHORITY ON ANY MATTER RELATING TO MEDICAID,
 NOR MAY IT REQUIRE SUCH BOARD TO FOLLOW ITS RECOMMENDATIONS; AND
   H.  ANY OTHER PRIORITIES AS IDENTIFIED BY THE DEPARTMENT OR A MAJORITY
 OF THE COUNCIL.
   7. A. THE COUNCIL, IN CONSULTATION WITH THE DEPARTMENT SHALL PREPARE A
 WRITTEN REPORT SUMMARIZING ITS FINDINGS  AND  RECOMMENDATIONS  FROM  THE
 COUNCIL  WHICH  SHALL  INCLUDE  A  LIST OF EXISTING, PUBLICLY ACCESSIBLE
 RESOURCES ON RESEARCH, DIAGNOSIS, TREATMENT, COVERAGE OPTIONS AND EDUCA-
 TION RELATING TO RARE DISEASES.
   B. THIS REPORT SHALL BE SUBMITTED TO THE GOVERNOR, THE SPEAKER OF  THE
 ASSEMBLY,  THE  MINORITY LEADER OF THE ASSEMBLY, THE TEMPORARY PRESIDENT
 OF THE SENATE, THE MINORITY LEADER OF THE SENATE, THE  SENATE  CHAIR  OF
 THE  COMMITTEE  ON  HEALTH,  AND  THE CHAIR OF THE ASSEMBLY COMMITTEE ON
 HEALTH, ONE YEAR FOLLOWING THE EFFECTIVE DATE OF  THIS  SECTION  AND  BY
 EACH  JANUARY  THIRTIETH  THEREAFTER  AND SHALL BE POSTED ON THE DEPART-
 MENT'S WEBSITE.
   C. ANY RECOMMENDATIONS OF THE COUNCIL SHALL BE POSTED ON  THE  DEPART-
 MENT'S  WEBSITE AND INCORPORATED INTO ANY FUTURE "PREVENTION AGENDA: NEW
 YORK STATE'S HEALTH IMPROVEMENT PLAN". THE RECOMMENDATION SHALL ALSO  BE
 SHARED  AT  A PUBLIC MEETING OF THE NEW YORK STATE HEALTH EQUITY COUNCIL
 FOR THEIR CONSIDERATION.
   8. THE COUNCIL MAY IDENTIFY PUBLIC, PRIVATE, AND OTHER AVAILABLE FUND-
 ING SOURCES AND MAY ACCEPT AND UTILIZE FUNDS FROM SUCH SOURCES TO IMPLE-
 MENT THE PROVISIONS OF THIS SECTION,  INCLUDING,  BUT  NOT  LIMITED  TO,
 STATE  FUNDS  APPROPRIATED  FOR RARE DISEASE RESEARCH, TREATMENT, EDUCA-
 TION, PROGRAMMING, AND RELATED ACTIVITIES.
   § 2. Of the monies appropriated in chapter 53 of  the  laws  of  2024,
 enacting the aid to localities budget, for services and expenses related
 to  rare  disease  of  which a portion may be transferred to state oper-
 ations, $100,000 shall be allocated by the department of health and  for
 use  by  administration  and support to implement this act. To implement
 this act, the department may use this allocation for personal services.
   § 3. This act shall take effect on the thirtieth day  after  it  shall
 have become a law. 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 to be made  and  completed
 on or before such effective date.