S T A T E O F N E W Y O R K
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3932
2017-2018 Regular Sessions
I N A S S E M B L Y
January 30, 2017
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Introduced by M. of A. ROSENTHAL, GUNTHER, GALEF, ZEBROWSKI, BENEDETTO,
ARROYO, COLTON, M. G. 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".
§ 2. The public health law is amended by adding a new article 29-CCCCC
to read as follows:
ARTICLE 29-CCCCC
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.
§ 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-
ABLE TREATMENTS AND THAT, WITHOUT LIFE-SUSTAINING PROCEDURES, WILL SOON
RESULT IN DEATH.
EXPLANATION--Matter in ITALICS (underscored) is new; matter in brackets
[ ] is old law to be omitted.
LBD05460-01-7
A. 3932 2
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
PATIENT'S ESTATE, UNLESS A CONTRACT BETWEEN THE PATIENT AND THE MANUFAC-
TURER OF THE DRUG, BIOLOGICAL PRODUCT OR DEVICE STATES OTHERWISE.
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§ 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.
§ 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.
§ 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.
§ 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.
§ 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.
§ 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
CARE FROM A LICENSED HEALTH CARE PROVIDER IS NOT A VIOLATION OF THIS
SECTION.
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§ 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.
§ 3. This act shall take effect on the ninetieth day after it shall
have become a law.