Assembly Bill A469

                             
                     S T A T E   O F   N E W   Y O R K
 ________________________________________________________________________
 
                                    469
 
                        2023-2024 Regular Sessions
 
                           I N  A S S E M B L Y
 
                              January 9, 2023
                                ___________
 
 Introduced by M. of A. PEOPLES-STOKES, THIELE, SANTABARBARA -- read once
   and referred to the Committee on Health
 
 AN ACT to amend the public health law, in relation to creating the lupus
   research  enhancement  program; and to amend the state finance law, in
   relation to creating the lupus research enhancement fund

   THE PEOPLE OF THE STATE OF NEW YORK, REPRESENTED IN SENATE AND  ASSEM-
 BLY, DO ENACT AS FOLLOWS:
 
   Section  1.  Article 2 of the public health law is amended by adding a
 new title 4-A to read as follows:
                                TITLE IV-A
                      LUPUS RESEARCH ENHANCEMENT ACT
 SECTION 256.   SHORT TITLE.
         256-A. LEGISLATIVE INTENT.
         256-B. DEFINITION.
         256-C. LUPUS RESEARCH ENHANCEMENT PROGRAM.
         256-D. LUPUS RESEARCH ADVISORY COUNCIL.
         256-E. LUPUS RESEARCH ENHANCEMENT FUND.
   § 256. SHORT TITLE.  THIS TITLE SHALL BE KNOWN AND MAY BE CITED AS THE
 "LUPUS RESEARCH ENHANCEMENT ACT".
   § 256-A. LEGISLATIVE INTENT. 1.   THE  LEGISLATURE  HEREBY  FINDS  THE
 FOLLOWING:
   (A)  LUPUS IS A SERIOUS, COMPLEX, DEBILITATING AUTOIMMUNE DISEASE THAT
 CAN CAUSE INFLAMMATION AND TISSUE DAMAGE TO VIRTUALLY ANY  ORGAN  SYSTEM
 IN  THE BODY, INCLUDING THE SKIN, JOINTS, OTHER CONNECTIVE TISSUE, BLOOD
 AND BLOOD VESSELS, HEART, LUNGS, KIDNEY, AND BRAIN.
   (B) THE LUPUS FOUNDATION OF AMERICA, INC. ESTIMATES THAT APPROXIMATELY
 1.5 TO TWO MILLION AMERICANS LIVE WITH SOME FORM OF LUPUS; LUPUS AFFECTS
 WOMEN NINE TIMES MORE OFTEN THAN MEN AND EIGHTY PERCENT OF  NEWLY  DIAG-
 NOSED CASES OF LUPUS DEVELOP AMONG WOMEN OF CHILDBEARING AGE.
   (C)  LUPUS  DISPROPORTIONATELY  AFFECTS  WOMEN OF COLOR - IT IS TWO TO
 THREE TIMES MORE COMMON AMONG AFRICAN-AMERICANS, HISPANICS,  ASIANS  AND
 
  EXPLANATION--Matter in ITALICS (underscored) is new; matter in brackets
                       [ ] is old law to be omitted.
                                                            LBD00052-01-3
              

 A. 469                              2
 
 NATIVE AMERICANS AND IS GENERALLY MORE PREVALENT IN MINORITY POPULATIONS
 -  A HEALTH DISPARITY THAT REMAINS UNEXPLAINED. ACCORDING TO THE CENTERS
 FOR DISEASE CONTROL AND PREVENTION  THE  RATE  OF  LUPUS  MORTALITY  HAS
 INCREASED  SINCE  THE  LATE NINETEEN SEVENTIES AND IS HIGHER AMONG OLDER
 AFRICAN-AMERICAN WOMEN.
   (D) NO NEW DRUGS HAVE BEEN APPROVED BY THE U.S. FOOD AND DRUG ADMINIS-
 TRATION SPECIFICALLY FOR LUPUS IN NEARLY FORTY YEARS, AND WHILE  CURRENT
 TREATMENTS  FOR  THE DISEASE CAN BE EFFECTIVE, THEY CAN LEAD TO DAMAGING
 SIDE EFFECTS.
   (E) THE PAIN AND FATIGUE ASSOCIATED WITH LUPUS CAN  THREATEN  PEOPLE'S
 ABILITY  TO LIVE INDEPENDENTLY, MAKE IT DIFFICULT TO MAINTAIN EMPLOYMENT
 AND LEAD NORMAL LIVES, AND ONE IN FIVE  PEOPLE WITH LUPUS IS DISABLED BY
 THE DISEASE, AND CONSEQUENTLY RECEIVES SUPPORT FROM GOVERNMENT PROGRAMS,
 INCLUDING MEDICARE, MEDICAID, SOCIAL  SECURITY  DISABILITY,  AND  SOCIAL
 SECURITY SUPPLEMENTAL INCOME.
   (F)  THE  ESTIMATED  AVERAGE  ANNUAL  COST OF MEDICAL TREATMENT FOR AN
 INDIVIDUAL WITH LUPUS CAN RANGE BETWEEN TEN THOUSAND DOLLARS AND  THIRTY
 THOUSAND  DOLLARS;  FOR  PEOPLE WHO HAVE THE MOST SERIOUS FORM OF LUPUS,
 MEDICAL COSTS CAN GREATLY EXCEED  THIS  AMOUNT,  CAUSING  A  SIGNIFICANT
 ECONOMIC, EMOTIONAL AND SOCIAL BURDEN TO THE ENTIRE FAMILY AND SOCIETY.
   (G)  MORE THAN HALF OF THE PEOPLE WITH LUPUS SUFFER FOUR OR MORE YEARS
 AND VISIT THREE OR MORE  PHYSICIANS  BEFORE  OBTAINING  A  DIAGNOSIS  OF
 LUPUS;  EARLY  DIAGNOSIS  OF AND COMMENCEMENT OF TREATMENT FOR LUPUS CAN
 PREVENT OR REDUCE SERIOUS ORGAN DAMAGE, DISABILITY, AND DEATH.
   (H) DESPITE THE MAGNITUDE OF LUPUS AND ITS IMPACT ON  INDIVIDUALS  AND
 FAMILIES,  HEALTH PROFESSIONAL AND PUBLIC UNDERSTANDING OF LUPUS REMAINS
 LOW; ONLY ONE OF FIVE AMERICANS CAN PROVIDE EVEN BASIC INFORMATION ABOUT
 LUPUS, AND AWARENESS OF LUPUS IS LOWEST AMONG ADULTS  AGES  EIGHTEEN  TO
 THIRTY-FOUR - THE AGE GROUP MOST LIKELY TO DEVELOP SYMPTOMS OF LUPUS.
   (I)  LUPUS  IS  A  SIGNIFICANT  NATIONAL  HEALTH ISSUE THAT DESERVES A
 COMPREHENSIVE AND COORDINATED RESPONSE BY STATE AND FEDERAL  GOVERNMENTS
 WITH INVOLVEMENT OF THE HEALTH CARE PROVIDER, PATIENT, AND PUBLIC HEALTH
 COMMUNITIES.
   2. THE PURPOSES OF THIS TITLE ARE:
   (A) TO PROMOTE BASIC AND CLINICAL RESEARCH PROGRAMS DESIGNED TO REDUCE
 OR  PREVENT  SUFFERING  FROM  LUPUS,  BY PROVIDING ADDITIONAL FUNDING TO
 STATE ACADEMIC MEDICAL INSTITUTIONS WITHIN THE STATE CURRENTLY  CONDUCT-
 ING  OR  HAVING  AN  INTEREST  IN CONDUCTING BASIC AND CLINICAL, SOCIAL,
 TRANSLATIONAL, TECHNOLOGICAL, EPIDEMIOLOGICAL, AND  BEHAVIORAL  RESEARCH
 ON LUPUS. SUCH ACTIVITIES MAY INCLUDE:
   (I) INVESTIGATING THE PATHOGENESIS AND PHYSIOLOGY OF LUPUS;
   (II) IDENTIFYING AND VALIDATING LUPUS BIOMARKERS;
   (III)  ENHANCING  THE  STATEWIDE  INFRASTRUCTURE  TO  CONDUCT CLINICAL
 TRIALS OF POTENTIAL NEW LUPUS THERAPIES;
   (IV) DEVELOPING OR IMPROVING DIAGNOSTIC TESTS FOR EARLY  DETECTION  OF
 LUPUS; AND
   (V) DEVELOPING NOVEL THERAPIES TO TREAT LUPUS.
   (B)  TO  ESTABLISH A MULTIDISCIPLINARY LUPUS RESEARCH ADVISORY COUNCIL
 TO MONITOR PROGRESS AND MAKE GRANTING RECOMMENDATIONS TO THE DEPARTMENT.
   § 256-B. DEFINITION. AS USED IN THIS TITLE, "PROGRAM" SHALL  MEAN  THE
 LUPUS  RESEARCH  ENHANCEMENT  PROGRAM  CREATED  PURSUANT  TO SECTION TWO
 HUNDRED FIFTY-SIX-C OF THIS TITLE.
   § 256-C. LUPUS RESEARCH ENHANCEMENT PROGRAM. 1. THE COMMISSIONER SHALL
 ESTABLISH WITHIN THE DEPARTMENT A  LUPUS  RESEARCH  ENHANCEMENT  PROGRAM
 THROUGH WHICH THE DEPARTMENT SHALL MAKE GRANTS TO STATE ACADEMIC MEDICAL
 INSTITUTIONS WITHIN THE STATE CURRENTLY CONDUCTING OR HAVING AN INTEREST
 A. 469                              3
 
 IN  CONDUCTING BASIC AND CLINICAL, SOCIAL, TRANSLATIONAL, TECHNOLOGICAL,
 EPIDEMIOLOGICAL, AND BEHAVIORAL RESEARCH ON LUPUS.
   2.  ALL  RESEARCH  FUNDS SHALL BE AWARDED ON THE BASIS OF THE RESEARCH
 PRIORITIES ESTABLISHED FOR THE PROGRAM AND THE SCIENTIFIC MERIT  OF  THE
 PROPOSED  RESEARCH,  AS  DETERMINED  BY AN OPEN, COMPETITIVE PEER REVIEW
 PROCESS THAT ENSURES OBJECTIVITY, CONSISTENCY,  AND  HIGH  QUALITY.  ALL
 INVESTIGATORS,  REGARDLESS  OF  AFFILIATION, SHALL HAVE EQUAL ACCESS AND
 OPPORTUNITY TO COMPETE FOR PROGRAM FUNDS.
   3. THE PEER REVIEW  PROCESS  FOR  THE  SELECTION  OF  RESEARCH  GRANTS
 AWARDED  UNDER  THIS  PROGRAM SHALL BE MODELED GENERALLY ON THAT USED BY
 THE NATIONAL INSTITUTES OF HEALTH IN ITS GRANT MAKING PROCESS.
   4. AN AWARDEE SHALL BE AWARDED GRANTS FOR THE FULL COST,  BOTH  DIRECT
 AND INDIRECT, OF CONDUCTING THE SPONSORED RESEARCH CONSISTENT WITH THOSE
 FEDERAL  GUIDELINES GOVERNING ALL FEDERAL RESEARCH GRANTS AND CONTRACTS.
 ALL INTELLECTUAL PROPERTY ASSETS DEVELOPED UNDER THIS PROGRAM  SHALL  BE
 TREATED IN ACCORDANCE WITH STATE AND FEDERAL LAW.
   5.  IN  ESTABLISHING  ITS RESEARCH PRIORITIES, THE STATE SHALL CONSULT
 WITH THE LUPUS RESEARCH ADVISORY COUNCIL AND CONSIDER A BROAD  RANGE  OF
 CROSS-DISCIPLINARY  LUPUS  RESEARCH,  INCLUDING,  BUT  NOT  LIMITED  TO,
 RESEARCH INTO THE CAUSE, CURE, AND DIAGNOSIS OF LUPUS; TRANSLATIONAL AND
 TECHNOLOGICAL RESEARCH, INCLUDING RESEARCH TO DEVELOP IMPROVED  DIAGNOS-
 TIC TESTS; RESEARCH REGARDING THE CULTURAL, ECONOMIC, AND LEGAL BARRIERS
 TO ACCESSING THE HEALTH CARE SYSTEM FOR EARLY DETECTION AND TREATMENT OF
 LUPUS;  AND  RESEARCH EXAMINING THE HEALTH DISPARITIES SEEN IN THE INCI-
 DENCE AND PREVALENCE OF LUPUS.
   § 256-D. LUPUS RESEARCH ADVISORY COUNCIL. 1. OPERATIONS. (A) THE COUN-
 CIL SHALL BE COMPRISED OF FIFTEEN MEMBERS REPRESENTING A BROAD RANGE  OF
 EXPERTISE AND EXPERIENCE.
   (B)  INDIVIDUALS  AND  ORGANIZATIONS  MAY  SUBMIT  NOMINATIONS  TO THE
 COMMISSIONER THROUGH THE COUNCIL.
   (C) EACH APPOINTED COUNCIL MEMBER SHOULD HAVE FAMILIARITY  WITH  LUPUS
 AND  ISSUES  THAT SURROUND LUPUS AND BE ONE OF THE FOLLOWING: HEALTH AND
 MEDICAL PROFESSIONAL WITH EXPERTISE IN LUPUS; AN INDIVIDUAL WITH  LUPUS;
 A  REPRESENTATIVE  FROM A LOCAL OR COUNTY HEALTH DEPARTMENT; OR A RECOG-
 NIZED EXPERT IN  THE  PROVISION  OF  HEALTH  SERVICES  TO  WOMEN,  LUPUS
 RESEARCH OR HEALTH DISPARITIES.
   (D) THE COUNCIL SHALL BE COMPRISED AS FOLLOWS:
   (I) AT LEAST THREE INDIVIDUALS WITH LUPUS;
   (II) NO MORE THAN TWO REPRESENTATIVES FROM THE DEPARTMENT;
   (III)  AT LEAST FIVE INDIVIDUALS FROM LUPUS NONPROFIT HEALTH ORGANIZA-
 TIONS; AND
   (IV) AT LEAST FIVE SCIENTISTS OR CLINICIANS WITH EXPERIENCE  IN  LUPUS
 AND WHO PARTICIPATE IN VARIOUS FIELDS OF SCIENTIFIC ENDEAVOR, INCLUDING,
 BUT  NOT LIMITED TO, THE FIELDS OF BIOMEDICAL RESEARCH, SOCIAL, TRANSLA-
 TIONAL, BEHAVIORAL AND EPIDEMIOLOGICAL RESEARCH, AND PUBLIC HEALTH.
   (E) ALL MEMBERS OF THE COUNCIL SHALL BE APPOINTED BY THE  COMMISSIONER
 AND THE COMMISSIONER SHALL CHOOSE FROM AMONG THE FIFTEEN COUNCIL MEMBERS
 ONE MEMBER TO SERVE AS CHAIR.
   (F)  ALL  MEMBERS  OF THE COUNCIL SHALL SERVE TERMS OF TWO YEARS EACH.
 MEMBERS CAN BE NAMED TO SERVE A TOTAL OF TWO  TERMS  AND  TERMS  CAN  BE
 CONSECUTIVE.
   (G) MEMBERS SHALL SERVE WITHOUT COMPENSATION, BUT SHALL BE ENTITLED TO
 ACTUAL, NECESSARY EXPENSES INCURRED IN THE PERFORMANCE OF THEIR BUSINESS
 AS MEMBERS OF THE COUNCIL.
 A. 469                              4
 
   (H)  A  MAJORITY  OF  THE  MEMBERS  OF  THE COUNCIL SHALL CONSTITUTE A
 QUORUM.  A MAJORITY VOTE OF A QUORUM SHALL BE REQUIRED FOR ANY  OFFICIAL
 ACTION OF THE COUNCIL.
   (I) THE COUNCIL SHALL MEET AT THE CALL OF THE CHAIR, BUT NOT LESS THAN
 FOUR TIMES PER YEAR.
   2. FUNCTIONS. THE LUPUS RESEARCH ADVISORY COUNCIL SHALL:
   (A)  REVIEW  SUBMITTED  GRANT APPLICATIONS AND MAKE RECOMMENDATIONS TO
 THE COMMISSIONER, AND THE COMMISSIONER SHALL, AT HIS OR HER  DISCRETION,
 GRANT APPROVAL OF APPLICATIONS FOR GRANTS FROM THOSE APPLICATIONS RECOM-
 MENDED  BY THE COUNCIL (IF A COUNCIL MEMBER SUBMITS AN APPLICATION FOR A
 GRANT FROM THE LUPUS RESEARCH AND EDUCATION FUND,  HE  OR  SHE  WILL  BE
 PROHIBITED  FROM  REVIEWING  AND MAKING A RECOMMENDATION ON THE APPLICA-
 TION);
   (B) CONSULT WITH  THE  NATIONAL  INSTITUTES  OF  HEALTH,  CENTERS  FOR
 DISEASE  CONTROL  AND PREVENTION, THE AGENCY FOR HEALTHCARE RESEARCH AND
 QUALITY, THE NATIONAL ACADEMY OF SCIENCES (INSTITUTE OF MEDICINE), LUPUS
 ADVOCACY GROUPS, AND  OTHER  ORGANIZATIONS  OR  ENTITIES  WHICH  MAY  BE
 INVOLVED  IN  LUPUS RESEARCH TO SOLICIT BOTH INFORMATION REGARDING LUPUS
 RESEARCH PROJECTS THAT ARE CURRENTLY BEING CONDUCTED AND RECOMMENDATIONS
 FOR FUTURE RESEARCH PROJECTS; AND
   (C) SHALL TRANSMIT ANNUALLY ON  OR  BEFORE  DECEMBER  THIRTY-FIRST,  A
 REPORT  TO  THE  LEGISLATURE ON GRANTS MADE, GRANTS IN PROGRESS, PROGRAM
 ACCOMPLISHMENTS,  AND  FUTURE  PROGRAM  DIRECTIONS.  EACH  REPORT  SHALL
 INCLUDE, BUT NOT BE LIMITED TO, THE FOLLOWING INFORMATION:
   (I)  THE  NUMBER  AND DOLLAR AMOUNTS OF RESEARCH GRANTS, INCLUDING THE
 AMOUNT ALLOCATED TO INDIRECT COSTS;
   (II) THE SUBJECT OF RESEARCH GRANTS;
   (III) THE RELATIONSHIP BETWEEN FEDERAL AND  STATE  FUNDING  FOR  LUPUS
 RESEARCH;
   (IV) THE RELATIONSHIP BETWEEN EACH PROJECT AND THE OVERALL STRATEGY OF
 THE RESEARCH PROGRAM;
   (V)  A  SUMMARY OF RESEARCH FINDINGS INCLUDING DISCUSSION OF PROMISING
 NEW AREAS;
   (VI) THE INSTITUTIONS AND CAMPUSES RECEIVING GRANT AWARDS; AND
   (VII) THE FIRST ANNUAL REPORT SHALL INCLUDE AN EVALUATION  AND  RECOM-
 MENDATIONS  CONCERNING  THE  DESIRABILITY  AND  FEASIBILITY OF REQUIRING
 FOR-PROFIT GRANTEES TO COMPENSATE THE STATE IN THE EVENT  THAT  A  GRANT
 RESULTS  IN  THE DEVELOPMENT OF A PROFIT-MAKING PRODUCT. THIS EVALUATION
 SHALL INCLUDE, BUT NOT BE LIMITED TO, THE COSTS AND BENEFITS OF  REQUIR-
 ING  A  FOR-PROFIT GRANTEE TO REPAY THE GRANT, TO PROVIDE THE PRODUCT AT
 COST TO STATE PROGRAMS SERVING LOW-INCOME LUPUS PATIENTS, AND TO PAY THE
 STATE A PERCENTAGE OF THE ROYALTIES DERIVED FROM THE PRODUCT.
   3. CONTRIBUTIONS. THE SECRETARY OF THE LUPUS RESEARCH ADVISORY COUNCIL
 MAY ACCEPT GRANTS, SERVICES, AND PROPERTY FROM THE  FEDERAL  GOVERNMENT,
 FOUNDATIONS,  ORGANIZATIONS,  MEDICAL SCHOOLS, AND OTHER ENTITIES AS MAY
 BE AVAILABLE FOR THE PURPOSES OF  FULFILLING  THE  OBLIGATIONS  OF  THIS
 PROGRAM. ANY SUCH FUNDS SHALL SUPPLEMENT AND NOT SUPPLANT APPROPRIATIONS
 PROVIDED FOR THE IMPLEMENTATION OF THIS ARTICLE.
   4. WAIVERS. THE SECRETARY OF THE LUPUS RESEARCH ADVISORY COUNCIL SHALL
 SEEK  ANY  FEDERAL  WAIVER  OR WAIVERS THAT MAY BE NECESSARY TO MAXIMIZE
 FUNDS FROM THE FEDERAL GOVERNMENT TO IMPLEMENT THIS PROGRAM.
   § 256-E. LUPUS RESEARCH ENHANCEMENT FUND. ALL MONEYS RECEIVED PURSUANT
 TO SECTION TWO HUNDRED FIFTY-SIX-C OF THIS TITLE SHALL  BE  CREDITED  TO
 THE  FUND,  AS ESTABLISHED BY SECTION NINETY-FIVE-L OF THE STATE FINANCE
 LAW. THE COMMISSIONER  SHALL  USE  THE  FUND  TO  ADMINISTER  THE  LUPUS
 A. 469                              5
 
 RESEARCH  ENHANCEMENT PROGRAM AND TO MAKE GRANTS TO AWARDEES PURSUANT TO
 SECTION TWO HUNDRED FIFTY-SIX-C OF THIS TITLE.
   §  2. The state finance law is amended by adding a new section 95-l to
 read as follows:
   § 95-L. LUPUS RESEARCH ENHANCEMENT FUND. 1.  THERE  IS  HEREBY  ESTAB-
 LISHED  IN THE JOINT CUSTODY OF THE COMMISSIONER OF TAXATION AND FINANCE
 AND THE COMPTROLLER, A SPECIAL FUND TO BE KNOWN AS THE  "LUPUS  RESEARCH
 ENHANCEMENT FUND".
   2.  SUCH FUND SHALL CONSIST OF ALL MONIES APPROPRIATED FOR THE PURPOSE
 OF SUCH FUND AND ANY GRANT, GIFT OR BEQUEST MADE TO THE  LUPUS  RESEARCH
 ENHANCEMENT PROGRAM AS ESTABLISHED BY TITLE FOUR-A OF ARTICLE TWO OF THE
 PUBLIC HEALTH LAW.
   3.  MONEYS OF THE FUND SHALL BE AVAILABLE FOR GRANTS THROUGH THE LUPUS
 RESEARCH ENHANCEMENT PROGRAM ADVISORY COUNCIL AND FOR  THE  EXPENSES  OF
 THE  LUPUS  RESEARCH  ENHANCEMENT PROGRAM ADVISORY COUNCIL, AND SHALL BE
 EXPENDED ONLY FOR THE PURPOSES  SPELLED  OUT  IN  SECTIONS  TWO  HUNDRED
 FIFTY-SIX-C AND TWO HUNDRED FIFTY-SIX-D OF THE PUBLIC HEALTH LAW.
   4.  MONEYS  IN THE LUPUS RESEARCH ENHANCEMENT FUND SHALL BE KEPT SEPA-
 RATE AND SHALL NOT BE COMMINGLED WITH ANY OTHER MONEYS IN THE CUSTODY OF
 THE COMMISSIONER OF TAXATION AND FINANCE AND THE COMPTROLLER.
   5. THE MONEYS OF THE FUND SHALL BE PAID OUT ON THE AUDIT  AND  WARRANT
 OF THE COMPTROLLER ON VOUCHERS CERTIFIED OR APPROVED BY THE COMMISSIONER
 OF  HEALTH,  OR  BY  AN  OFFICER OR EMPLOYEE OF THE DEPARTMENT OF HEALTH
 DESIGNATED BY SUCH COMMISSIONER.
   § 3. This act shall take effect immediately.