S T A T E   O F   N E W   Y O R K
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                                  4716

                       2015-2016 Regular Sessions

                            I N  S E N A T E

                             April 10, 2015
                               ___________

Introduced  by  Sen.  HANNON -- read twice and ordered printed, and when
  printed to be committed to the Committee on Health

AN ACT to amend the public health  law,  in  relation  to  enacting  the
  "right to try act"

  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
40-A to read as follows:
                               ARTICLE 40-A
                        ACCESS TO TREATMENTS FOR
                         TERMINALLY ILL PATIENTS
SECTION 4050. SHORT TITLE.
        4051. LEGISLATIVE INTENT.
        4052. DEFINITIONS.
        4053. AVAILABILITY OF INVESTIGATIONAL DRUGS, BIOLOGICAL PRODUCTS
                AND DEVICES.
        4054. ACTION AGAINST HEALTH CARE PROVIDER.
        4055. ACCESS  TO  INVESTIGATIONAL DRUGS, BIOLOGICAL PRODUCTS AND
                DEVICES.
        4056. NO CAUSE OF ACTION CREATED.
  S 4050. SHORT TITLE. THIS ARTICLE SHALL BE KNOWN AND MAY BE  CITED  AS
THE "RIGHT TO TRY ACT".
  S  4051.  LEGISLATIVE INTENT.   IT IS THE INTENT OF THE LEGISLATURE TO
ALLOW FOR TERMINALLY ILL PATIENTS TO USE POTENTIALLY LIFE-SAVING  INVES-
TIGATIONAL DRUGS, BIOLOGICAL PRODUCTS AND DEVICES.
  S  4052. DEFINITIONS. AS USED IN THIS ARTICLE, THE FOLLOWING WORDS AND
PHRASES SHALL HAVE THE FOLLOWING MEANINGS:
  1. (A) "ELIGIBLE PATIENT" MEANS A PERSON WHO HAS:
  (I) A TERMINAL ILLNESS, ATTESTED TO BY THE PATIENT'S  TREATING  PHYSI-
CIAN;

 EXPLANATION--Matter in ITALICS (underscored) is new; matter in brackets
                      [ ] is old law to be omitted.
                                                           LBD09968-02-5

              

S. 4716                             2

  (II)  CONSIDERED ALL OTHER TREATMENT OPTIONS CURRENTLY APPROVED BY THE
UNITED STATES FOOD AND DRUG ADMINISTRATION;
  (III)  BEEN UNABLE TO PARTICIPATE IN A CLINICAL TRIAL FOR THE TERMINAL
ILLNESS WITHIN ONE HUNDRED MILES OF THE PATIENT'S HOME ADDRESS  FOR  THE
TERMINAL  ILLNESS, OR NOT BEEN ACCEPTED TO THE CLINICAL TRIAL WITHIN ONE
WEEK OF COMPLETION OF THE CLINICAL TRIAL APPLICATION PROCESS;
  (IV) RECEIVED A RECOMMENDATION FROM HIS OR HER PHYSICIAN FOR AN INVES-
TIGATIONAL DRUG, BIOLOGICAL PRODUCT OR DEVICE;
  (V) GIVEN WRITTEN, INFORMED CONSENT FOR THE USE OF THE INVESTIGATIONAL
DRUG, BIOLOGICAL PRODUCT OR DEVICE OR, IF THE  PATIENT  IS  A  MINOR  OR
LACKS THE MENTAL CAPACITY TO PROVIDE INFORMED CONSENT, A PARENT OR LEGAL
GUARDIAN  HAS  GIVEN  WRITTEN, INFORMED CONSENT ON THE PATIENT'S BEHALF;
AND
  (VI) DOCUMENTATION FROM HIS OR HER PHYSICIAN THAT HE OR SHE MEETS  THE
REQUIREMENTS OF THIS PARAGRAPH.
  (B)  "ELIGIBLE PATIENT" SHALL NOT INCLUDE A PERSON BEING TREATED AS AN
INPATIENT IN A HOSPITAL OPERATED PURSUANT  TO  ARTICLE  TWENTY-EIGHT  OF
THIS CHAPTER.
  2.  "INVESTIGATIONAL DRUG, BIOLOGICAL PRODUCT OR DEVICE" MEANS A DRUG,
BIOLOGICAL PRODUCT OR DEVICE THAT HAS SUCCESSFULLY COMPLETED  PHASE  ONE
OF A CLINICAL TRIAL BUT HAS NOT YET BEEN APPROVED FOR GENERAL USE BY THE
UNITED  STATES  FOOD  AND DRUG ADMINISTRATION AND REMAINS UNDER INVESTI-
GATION IN A UNITED STATES FOOD AND DRUG ADMINISTRATION-APPROVED CLINICAL
TRIAL.
  3. "TERMINAL ILLNESS" MEANS A CONDITION, ILLNESS OR INJURY FROM  WHICH
THERE IS NO RECOVERY AND WHICH REASONABLY CAN BE EXPECTED TO CAUSE DEATH
WITHIN ONE YEAR.
  4.  "WRITTEN, INFORMED CONSENT" MEANS A WRITTEN DOCUMENT SIGNED BY THE
PATIENT, AND ATTESTED TO BY THE PATIENT'S PHYSICIAN AND A WITNESS  THAT,
AT A MINIMUM:
  (A)  EXPLAINS  THE  CURRENTLY APPROVED PRODUCTS AND TREATMENTS FOR THE
DISEASE OR CONDITION FROM WHICH THE PATIENT SUFFERS;
  (B) ATTESTS TO THE FACT THAT THE  PATIENT  CONCURS  WITH  HIS  OR  HER
PHYSICIAN  IN  BELIEVING  THAT ALL CURRENTLY APPROVED AND CONVENTIONALLY
RECOGNIZED TREATMENTS ARE UNLIKELY TO PROLONG THE PATIENT'S LIFE;
  (C) CLEARLY IDENTIFIES THE  SPECIFIC  PROPOSED  INVESTIGATIONAL  DRUG,
BIOLOGICAL PRODUCT OR DEVICE THAT THE PATIENT IS SEEKING TO USE;
  (D)  DESCRIBES  THE  POTENTIALLY  BEST AND WORST OUTCOMES OF USING THE
INVESTIGATIONAL DRUG, BIOLOGICAL PRODUCT  OR  DEVICE  WITH  A  REALISTIC
DESCRIPTION  OF  THE MOST LIKELY OUTCOME, INCLUDING THE POSSIBILITY THAT
NEW, UNANTICIPATED, DIFFERENT OR WORSE SYMPTOMS MIGHT RESULT,  AND  THAT
DEATH  COULD  BE HASTENED BY THE PROPOSED TREATMENT, BASED ON THE PHYSI-
CIAN'S KNOWLEDGE OF THE PROPOSED TREATMENT IN CONJUNCTION WITH AN AWARE-
NESS OF THE PATIENT'S CONDITION;
  (E) MAKES CLEAR THAT THE PATIENT'S HEALTH INSURER AND PROVIDER ARE NOT
OBLIGATED TO PAY FOR ANY CARE OR TREATMENTS CONSEQUENT TO THE USE OF THE
INVESTIGATIONAL DRUG, BIOLOGICAL PRODUCT OR DEVICE;
  (F) MAKES CLEAR THAT THE PATIENT'S ELIGIBILITY FOR HOSPICE CARE MAY BE
WITHDRAWN IF THE PATIENT BEGINS CURATIVE TREATMENT AND CARE MAY BE REIN-
STATED IF THE CURATIVE TREATMENT ENDS  AND  THE  PATIENT  MEETS  HOSPICE
ELIGIBILITY REQUIREMENTS;
  (G)  MAKES  CLEAR  THAT IN-HOME HEALTH CARE MAY BE DENIED IF TREATMENT
BEGINS; AND
  (H) STATES THAT THE PATIENT UNDERSTANDS THAT HE OR SHE IS  LIABLE  FOR
ALL  EXPENSES CONSEQUENT TO THE USE OF THE INVESTIGATIONAL DRUG, BIOLOG-
ICAL PRODUCT OR DEVICE, AND THAT THIS LIABILITY EXTENDS TO THE PATIENT'S

S. 4716                             3

ESTATE, UNLESS A CONTRACT BETWEEN THE PATIENT AND  THE  MANUFACTURER  OF
THE DRUG, BIOLOGICAL PRODUCT OR DEVICE STATES OTHERWISE.
  S 4053. AVAILABILITY OF INVESTIGATIONAL DRUGS, BIOLOGICAL PRODUCTS AND
DEVICES.  1. A MANUFACTURER OF AN INVESTIGATIONAL DRUG, BIOLOGICAL PROD-
UCT OR DEVICE MAY  MAKE  AVAILABLE  THE  MANUFACTURER'S  INVESTIGATIONAL
DRUG, BIOLOGICAL PRODUCT OR DEVICE TO ELIGIBLE PATIENTS PURSUANT TO THIS
ARTICLE. THIS ARTICLE SHALL NOT BE DEEMED TO REQUIRE THAT A MANUFACTURER
MAKE  AVAILABLE AN INVESTIGATIONAL DRUG, BIOLOGICAL PRODUCT OR DEVICE TO
AN ELIGIBLE PATIENT.
  2. A MANUFACTURER MAY:
  (A) PROVIDE AN INVESTIGATIONAL DRUG, BIOLOGICAL PRODUCT OR  DEVICE  TO
AN ELIGIBLE PATIENT WITHOUT RECEIVING COMPENSATION; OR
  (B) REQUIRE AN ELIGIBLE PATIENT TO PAY THE COSTS OF OR THE COSTS ASSO-
CIATED  WITH  THE  MANUFACTURE  OF  THE INVESTIGATIONAL DRUG, BIOLOGICAL
PRODUCT OR DEVICE.
  3. (A) NOTHING IN THIS ARTICLE SHALL BE DEEMED TO EXPAND THE  COVERAGE
PROVIDED  IN ARTICLE FORTY-FOUR OF THIS CHAPTER, ARTICLES THIRTY-TWO AND
FORTY-THREE OF THE INSURANCE LAW, AND TITLE ELEVEN OF  ARTICLE  FIVE  OF
THE SOCIAL SERVICES LAW.
  (B)  A  HEALTH  INSURANCE CARRIER MAY, BUT IS NOT REQUIRED TO, PROVIDE
COVERAGE FOR THE COST OF AN INVESTIGATIONAL DRUG, BIOLOGICAL PRODUCT  OR
DEVICE.
  (C)  AN INSURER MAY DENY COVERAGE TO AN ELIGIBLE PATIENT FROM THE TIME
THE ELIGIBLE PATIENT BEGINS USE OF AN INVESTIGATIONAL  DRUG,  BIOLOGICAL
PRODUCT  OR  DEVICE  THROUGH  A PERIOD NOT TO EXCEED SIX MONTHS FROM THE
TIME THE INVESTIGATIONAL DRUG, BIOLOGICAL PRODUCT OR DEVICE IS NO LONGER
USED BY THE ELIGIBLE PATIENT; EXCEPT THAT COVERAGE SHALL NOT  BE  DENIED
FOR  A  PREEXISTING  CONDITION  AND  FOR  COVERAGE  FOR  BENEFITS  WHICH
COMMENCED PRIOR TO THE TIME THE ELIGIBLE  PATIENT  BEGINS  USE  OF  SUCH
DRUG, BIOLOGICAL PRODUCT OR DEVICE.
  4.  IF  AN  ELIGIBLE PATIENT DIES WHILE BEING TREATED BY AN INVESTIGA-
TIONAL DRUG, BIOLOGICAL PRODUCT OR DEVICE, THE PATIENT'S HEIRS SHALL NOT
BE LIABLE FOR ANY OUTSTANDING DEBT RELATED TO THE TREATMENT OR  LACK  OF
INSURANCE DUE TO THE TREATMENT.
  S  4054.  ACTION  AGAINST  HEALTH  CARE  PROVIDER. NOTWITHSTANDING ANY
PROVISION OF LAW TO THE CONTRARY, NEITHER THE EDUCATION  DEPARTMENT  NOR
THE  STATE  BOARD FOR PROFESSIONAL MEDICAL CONDUCT SHALL REVOKE, FAIL TO
RENEW, SUSPEND OR TAKE ANY  ACTION  AGAINST  A  HEALTH  CARE  PROVIDER'S
LICENSE,  BASED  SOLELY ON THE HEALTH CARE PROVIDER'S RECOMMENDATIONS TO
AN ELIGIBLE PATIENT REGARDING ACCESS TO OR TREATMENT WITH AN  INVESTIGA-
TIONAL  DRUG,  BIOLOGICAL  PRODUCT OR DEVICE, SO LONG AS THE RECOMMENDA-
TIONS ARE CONSISTENT WITH MEDICAL STANDARDS OF CARE.  ACTING  AGAINST  A
HEALTH CARE PROVIDER'S MEDICARE CERTIFICATION BASED SOLELY ON THE HEALTH
CARE PROVIDER'S RECOMMENDATION THAT A PATIENT HAVE ACCESS TO AN INVESTI-
GATIONAL DRUG, BIOLOGICAL PRODUCT OR DEVICE IS PROHIBITED.
  S  4055.  ACCESS  TO  INVESTIGATIONAL  DRUGS,  BIOLOGICAL PRODUCTS AND
DEVICES. AN OFFICIAL, EMPLOYEE OR AGENT OF THIS STATE SHALL NOT BLOCK OR
ATTEMPT TO BLOCK AN ELIGIBLE  PATIENT'S  ACCESS  TO  AN  INVESTIGATIONAL
DRUG,  BIOLOGICAL PRODUCT OR DEVICE. COUNSELING, ADVICE OR A RECOMMENDA-
TION CONSISTENT WITH MEDICAL STANDARDS OF CARE FROM  A  LICENSED  HEALTH
CARE PROVIDER IS NOT A VIOLATION OF THIS SECTION.
  S  4056.  NO CAUSE OF ACTION CREATED. THIS ARTICLE SHALL NOT BE DEEMED
TO CREATE A PRIVATE CAUSE OF ACTION AGAINST A MANUFACTURER OF AN  INVES-
TIGATIONAL  DRUG,  BIOLOGICAL  PRODUCT  OR  DEVICE  OR AGAINST ANY OTHER
PERSON OR ENTITY INVOLVED IN THE CARE OF AN ELIGIBLE PATIENT  USING  THE
INVESTIGATIONAL DRUG, BIOLOGICAL PRODUCT OR DEVICE, FOR ANY HARM DONE TO

S. 4716                             4

THE ELIGIBLE PATIENT RESULTING FROM THE INVESTIGATIONAL DRUG, BIOLOGICAL
PRODUCT, OR DEVICE SO LONG AS THE MANUFACTURER OR OTHER PERSON OR ENTITY
IS  COMPLYING IN GOOD FAITH WITH THE TERMS OF THIS ARTICLE; UNLESS THERE
WAS A FAILURE TO EXERCISE REASONABLE CARE.
  S 2. This act shall take effect immediately.