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

                                  6889

                       2015-2016 Regular Sessions

                          I N  A S S E M B L Y

                              April 8, 2015
                               ___________

Introduced  by M. of A. ROSENTHAL, GUNTHER, GALEF, ZEBROWSKI, BENEDETTO,
  BROOK-KRASNY, ARROYO, DUPREY, COLTON, MILLER, COOK --  Multi-Sponsored
  by -- M. of A. BLAKE, SIMON -- read once and referred to the Committee
  on Health

AN  ACT  to amend the public health law, in relation to establishing 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.  This act shall be known and may be cited as the "right to
try act".
  S 2. The public health law is amended by adding a new article  29-CCCC
to read as follows:
                             ARTICLE 29-CCCC
                            RIGHT TO TRY ACT
SECTION 2994-AAA. DEFINITIONS.
        2994-BBB. MANUFACTURERS' OBLIGATIONS.
        2994-CCC. COVERAGE.
        2994-DDD. LIABILITY FOR PATIENT DEBT.
        2994-EEE. ACTIONS AGAINST LICENSE OR CERTIFICATION.
        2994-FFF. IMMUNITY.
        2994-GGG. ACCESS TO TREATMENT.
        2994-HHH. CAUSE OF ACTION.
  S  2994-AAA.  DEFINITIONS.  THE  FOLLOWING WORDS AND TERMS WITHIN THIS
ARTICLE SHALL HAVE THE FOLLOWING MEANINGS, UNLESS  THE  CONTEXT  CLEARLY
INDICATES OTHERWISE.
  1.  "TERMINAL  ILLNESS",  FOR  PURPOSES  OF THIS ARTICLE ONLY, MEANS A
PROGRESSIVE DISEASE  OR  MEDICAL  OR  SURGICAL  CONDITION  THAT  ENTAILS
SIGNIFICANT  FUNCTIONAL IMPAIRMENT, THAT IS NOT CONSIDERED BY A TREATING
HEALTH CARE PROVIDER  TO  BE  REVERSIBLE  EVEN  WITH  ADMINISTRATION  OF
CURRENT  UNITED  STATES FOOD AND DRUG ADMINISTRATION APPROVED AND AVAIL-

 EXPLANATION--Matter in ITALICS (underscored) is new; matter in brackets
                      [ ] is old law to be omitted.
                                                           LBD09973-03-5

              

A. 6889                             2

ABLE TREATMENTS AND THAT, WITHOUT LIFE-SUSTAINING PROCEDURES, WILL  SOON
RESULT IN DEATH.
  2. "ELIGIBLE PATIENT" MEANS AN INDIVIDUAL WHO MEETS ALL OF THE FOLLOW-
ING CONDITIONS:
  (A)  HAS  A  TERMINAL  ILLNESS,  ATTESTED TO BY THE PATIENT'S TREATING
HEALTH CARE PROVIDER.
  (B) HAS CONSIDERED ALL OTHER TREATMENT OPTIONS CURRENTLY  APPROVED  BY
THE UNITED STATES FOOD AND DRUG ADMINISTRATION.
  (C) HAS RECEIVED A RECOMMENDATION FROM HIS OR HER TREATING HEALTH CARE
PROVIDER FOR AN INVESTIGATIONAL DRUG, BIOLOGICAL PRODUCT OR DEVICE.
  (D)  HAS GIVEN WRITTEN, INFORMED CONSENT FOR THE USE OF THE INVESTIGA-
TIONAL DRUG, BIOLOGICAL PRODUCT OR DEVICE.
  (E) HAS DOCUMENTATION FROM HIS OR HER TREATING  HEALTH  CARE  PROVIDER
THAT HE OR SHE MEETS THE REQUIREMENTS OF THIS SUBDIVISION.
  3.  "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.
  4. "WRITTEN, INFORMED CONSENT" MEANS A WRITTEN DOCUMENT THAT IS SIGNED
BY THE PATIENT; PARENT, IF THE PATIENT IS A MINOR;  LEGAL  GUARDIAN;  OR
HEALTH  CARE AGENT DESIGNATED BY THE PATIENT UNDER ARTICLE TWENTY-NINE-C
OF THIS CHAPTER AND ATTESTED TO BY THE PATIENT'S  TREATING  HEALTH  CARE
PROVIDER  AND  A  WITNESS  AND  THAT,  AT A MINIMUM, INCLUDES ALL OF THE
FOLLOWING:
  (A) AN EXPLANATION OF THE CURRENTLY APPROVED PRODUCTS  AND  TREATMENTS
FOR THE DISEASE OR CONDITION FROM WHICH THE PATIENT SUFFERS.
  (B)  AN  ATTESTATION THAT THE PATIENT CONCURS WITH HIS OR HER TREATING
HEALTH CARE PROVIDER  IN  BELIEVING  THAT  ALL  CURRENTLY  APPROVED  AND
CONVENTIONALLY   RECOGNIZED  TREATMENTS  ARE  UNLIKELY  TO  PROLONG  THE
PATIENT'S LIFE.
  (C) CLEAR IDENTIFICATION  OF  THE  SPECIFIC  PROPOSED  INVESTIGATIONAL
DRUG, BIOLOGICAL PRODUCT OR DEVICE THAT THE PATIENT IS SEEKING TO USE.
  (D)  A DESCRIPTION OF THE POTENTIALLY BEST AND WORST OUTCOMES OF USING
THE INVESTIGATIONAL DRUG, BIOLOGICAL PRODUCT OR DEVICE AND  A  REALISTIC
DESCRIPTION  OF  THE  MOST LIKELY OUTCOME. THE DESCRIPTION SHALL INCLUDE
THE POSSIBILITY THAT NEW, UNANTICIPATED,  DIFFERENT  OR  WORSE  SYMPTOMS
MIGHT RESULT AND THAT DEATH COULD BE HASTENED BY THE PROPOSED TREATMENT.
THE  DESCRIPTION  SHALL BE BASED ON THE HEALTH CARE PROVIDER'S KNOWLEDGE
OF THE PROPOSED TREATMENT  IN  CONJUNCTION  WITH  AN  AWARENESS  OF  THE
PATIENT'S CONDITION.
  (E) A STATEMENT THAT THE PATIENT'S HEALTH PLAN OR THIRD PARTY ADMINIS-
TRATOR  AND PROVIDER ARE NOT OBLIGATED TO PAY FOR ANY CARE OR TREATMENTS
CONSEQUENT TO THE USE OF THE INVESTIGATIONAL DRUG, BIOLOGICAL PRODUCT OR
DEVICE, UNLESS THEY ARE  SPECIFICALLY  REQUIRED  TO  DO  SO  BY  LAW  OR
CONTRACT.
  (F) A STATEMENT THAT THE PATIENT'S ELIGIBILITY FOR HOSPICE CARE MAY BE
WITHDRAWN  IF  THE PATIENT BEGINS CURATIVE TREATMENT WITH THE INVESTIGA-
TIONAL DRUG, BIOLOGICAL PRODUCT OR DEVICE AND THAT  CARE  MAY  BE  REIN-
STATED  IF THIS TREATMENT ENDS AND THE PATIENT MEETS HOSPICE ELIGIBILITY
REQUIREMENTS.
  (G) A STATEMENT THAT THE PATIENT UNDERSTANDS THAT HE OR SHE IS  LIABLE
FOR  ALL  EXPENSES  CONSEQUENT  TO  THE USE OF THE INVESTIGATIONAL DRUG,
BIOLOGICAL PRODUCT OR DEVICE AND THAT  THIS  LIABILITY  EXTENDS  TO  THE

A. 6889                             3

PATIENT'S ESTATE, UNLESS A CONTRACT BETWEEN THE PATIENT AND THE MANUFAC-
TURER OF THE DRUG, BIOLOGICAL PRODUCT OR DEVICE STATES OTHERWISE.
  S 2994-BBB. MANUFACTURERS' OBLIGATIONS. 1. A MANUFACTURER OF AN INVES-
TIGATIONAL  DRUG, BIOLOGICAL PRODUCT OR DEVICE MAY MAKE AVAILABLE AND AN
ELIGIBLE PATIENT MAY REQUEST THE  MANUFACTURER'S  INVESTIGATIONAL  DRUG,
BIOLOGICAL  PRODUCT  OR DEVICE UNDER THIS SECTION. THIS SECTION DOES NOT
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
ASSOCIATED WITH, THE MANUFACTURE OF THE INVESTIGATIONAL DRUG, BIOLOGICAL
PRODUCT OR DEVICE.
  S  2994-CCC.  COVERAGE.  1.  THIS ARTICLE DOES NOT EXPAND THE COVERAGE
REQUIRED OF AN INSURER UNDER THE INSURANCE LAW OR ANY  OTHER  APPLICABLE
LAWS.
  2.  A  HEALTH  PLAN, THIRD PARTY ADMINISTRATOR, OR GOVERNMENTAL AGENCY
MAY, BUT IS NOT REQUIRED TO, PROVIDE COVERAGE FOR THE COST OF AN  INVES-
TIGATIONAL  DRUG,  BIOLOGICAL  PRODUCT OR DEVICE OR THE COST OF SERVICES
RELATED TO THE USE OF AN INVESTIGATIONAL  DRUG,  BIOLOGICAL  PRODUCT  OR
DEVICE UNDER THIS ARTICLE.
  3.  THIS ARTICLE DOES NOT REQUIRE ANY GOVERNMENTAL AGENCY TO PAY COSTS
ASSOCIATED WITH THE USE, CARE OR TREATMENT OF A PATIENT WITH AN INVESTI-
GATIONAL DRUG, BIOLOGICAL PRODUCT OR DEVICE.
  4. THIS ARTICLE DOES NOT REQUIRE A HOSPITAL  OR  FACILITY  ESTABLISHED
UNDER  ARTICLE TWENTY-EIGHT OF THIS CHAPTER TO PROVIDE NEW OR ADDITIONAL
SERVICES, UNLESS APPROVED BY THE HOSPITAL OR FACILITY.
  5. THIS ARTICLE DOES NOT AFFECT ANY MANDATORY HEALTH CARE COVERAGE FOR
PARTICIPATION IN CLINICAL TRIALS UNDER THE INSURANCE LAW OR OTHER APPLI-
CABLE LAWS.
  S 2994-DDD. LIABILITY FOR PATIENT DEBT. IF A PATIENT DIES WHILE  BEING
TREATED  BY  AN  INVESTIGATIONAL DRUG, BIOLOGICAL PRODUCT OR DEVICE, THE
PATIENT'S HEIRS ARE NOT LIABLE FOR ANY OUTSTANDING DEBT RELATED  TO  THE
TREATMENT OR LACK OF INSURANCE DUE TO THE TREATMENT.
  S  2994-EEE.  ACTIONS  AGAINST  LICENSE  OR CERTIFICATION. A LICENSING
BOARD OR DISCIPLINARY SUBCOMMITTEE SHALL  NOT  REVOKE,  FAIL  TO  RENEW,
SUSPEND  OR  TAKE  ANY  ACTION  AGAINST A HEALTH CARE PROVIDER'S LICENSE
BASED SOLELY ON THE PROVIDER'S RECOMMENDATIONS TO  AN  ELIGIBLE  PATIENT
REGARDING  ACCESS  TO OR TREATMENT WITH AN INVESTIGATIONAL DRUG, BIOLOG-
ICAL PRODUCT OR DEVICE. AN ENTITY RESPONSIBLE FOR MEDICARE CERTIFICATION
SHALL NOT TAKE ACTION AGAINST A HEALTH CARE PROVIDER'S MEDICARE  CERTIF-
ICATION  BASED  SOLELY ON THE HEALTH CARE PROVIDER'S RECOMMENDATION THAT
AN ELIGIBLE PATIENT HAVE ACCESS TO AN INVESTIGATIONAL  DRUG,  BIOLOGICAL
PRODUCT OR DEVICE.
  S  2994-FFF.  IMMUNITY.  IF  AS  A RESULT OF THE INVESTIGATIONAL DRUG,
BIOLOGICAL PRODUCT OR DEVICE, A PATIENT'S SYMPTOMS WORSEN OR CHANGE OR A
PATIENT DIES, NO HEALTH CARE PROVIDER SHALL BE SUBJECT TO CIVIL  LIABIL-
ITY  PROVIDED  THAT SUCH HEALTH CARE PROVIDER PARTICIPATED IN GOOD FAITH
COMPLIANCE WITH THE PROVISIONS OF THIS  ARTICLE  AND  OBTAINED  WRITTEN,
INFORMED CONSENT FROM THE PATIENT.
  S  2994-GGG.  ACCESS  TO  TREATMENT. 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. COUN-
SELING, ADVICE OR A RECOMMENDATION CONSISTENT WITH MEDICAL STANDARDS  OF

A. 6889                             4

CARE  FROM  A  LICENSED  HEALTH CARE PROVIDER IS NOT A VIOLATION OF THIS
SECTION.
  S  2994-HHH.  CAUSE  OF ACTION. THIS SECTION DOES NOT CREATE A PRIVATE
CAUSE OF ACTION AGAINST  A  MANUFACTURER  OF  AN  INVESTIGATIONAL  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 THE ELIGIBLE
PATIENT RESULTING FROM THE INVESTIGATIONAL DRUG, BIOLOGICAL  PRODUCT  OR
DEVICE,  IF  THE  MANUFACTURER OR OTHER PERSON OR ENTITY IS COMPLYING IN
GOOD FAITH WITH THE TERMS OF THIS ARTICLE AND HAS  EXERCISED  REASONABLE
CARE.
  S  3.  This  act shall take effect on the ninetieth day after it shall
have become a law.