S T A T E   O F   N E W   Y O R K
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                                  8950

                       2009-2010 Regular Sessions

                          I N  A S S E M B L Y

                              June 16, 2009
                               ___________

Introduced by M. of A. GIBSON -- 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;  to  amend  the  state finance law, in
  relation to creating the lupus research enhancement fund;  and  making
  an appropriation therefor

  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.
  S 256. SHORT TITLE.  THIS TITLE SHALL BE KNOWN AND MAY BE CITED AS THE
"LUPUS RESEARCH ENHANCEMENT ACT".
  S  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

 EXPLANATION--Matter in ITALICS (underscored) is new; matter in brackets
                      [ ] is old law to be omitted.
                                                           LBD02148-01-9

              

A. 8950                             2

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
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.
  S 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.

A. 8950                             3

  S 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
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.
  S 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.

A. 8950                             4

  (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.
  (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.
  S 256-E. LUPUS RESEARCH ENHANCEMENT FUND. ALL MONEYS RECEIVED PURSUANT
TO SECTION TWO HUNDRED FIFTY-SIX-C OF THIS TITLE SHALL  BE  CREDITED  TO

A. 8950                             5

THE  FUND,  AS ESTABLISHED BY SECTION NINETY-FIVE-H OF THE STATE FINANCE
LAW. THE COMMISSIONER  SHALL  USE  THE  FUND  TO  ADMINISTER  THE  LUPUS
RESEARCH  ENHANCEMENT PROGRAM AND TO MAKE GRANTS TO AWARDEES PURSUANT TO
SECTION TWO HUNDRED FIFTY-SIX-C OF THIS TITLE.
  S  2. The state finance law is amended by adding a new section 95-h to
read as follows:
  S 95-H. 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.
  S 3. The sum of two hundred fifty thousand dollars  ($250,000.00),  or
so  much  thereof  as  may  be  necessary, is hereby appropriated to the
department of health out of any moneys in  the  state  treasury  in  the
general  fund to the credit of the state purposes account, not otherwise
appropriated, and made immediately available, for the purpose of  carry-
ing out the provisions of this act.  Such moneys shall be payable on the
audit  and  warrant of the comptroller on vouchers certified or approved
by the commissioner of health in the manner prescribed by law.
  S 4. This act shall take effect immediately.