Senate Bill S3840

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

                                  3840

                       2009-2010 Regular Sessions

                            I N  S E N A T E

                              April 2, 2009
                               ___________

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

AN ACT to amend the public health law and the insurance law, in relation
  to protocol for treatment of rare disease

  THE PEOPLE OF THE STATE OF NEW YORK, REPRESENTED IN SENATE AND  ASSEM-
BLY, DO ENACT AS FOLLOWS:

  Section  1. Section 4900 of the public health law is amended by adding
a new subdivision 11 to read as follows:
  11. "RARE DISEASE TREATMENT" MEANS A TREATMENT OR SERVICE ADMINISTERED
TO AN ENROLLEE WITH A RARE DISABLING OR  LIFE-THREATENING  CONDITION  OR
DISEASE  WHICH IS LISTED AS A RARE DISEASE BY THE NATIONAL INSTITUTES OF
HEALTH OFFICE OF RARE DISEASES OR IS ELIGIBLE FOR SUCH LISTING UNDER THE
FEDERAL RARE DISEASES ACT OF 2002.
  S 2. Section 4905 of the public health law is amended by adding a  new
subdivision 16 to read as follows:
  16.  WHEN MAKING DETERMINATIONS IN RELATION TO RARE DISEASE TREATMENT,
THE  UTILIZATION  REVIEW  AGENT  SHALL  REVIEW  MEDICAL  AND  SCIENTIFIC
EVIDENCE  RELATING TO CONDITIONS OR DISEASES OF HIGHER PREVALENCE IN THE
SAME CLASS OR CATEGORY, DETERMINED BY THE REVIEW AGENT TO BE  COMPARABLE
TO THE RARE DISEASE, AS WELL AS MEDICAL AND SCIENTIFIC EVIDENCE RELATING
TO  THE  RARE  DISEASE,  IN  ORDER TO DETERMINE WHETHER THE TREATMENT IS
LIKELY TO BENEFIT THE PATIENT,  IF  THE  SPECIFIC  HEALTH  TREATMENT  OR
SERVICE  RECOMMENDED BY THE HEALTH CARE PROFESSIONAL WOULD NOT OTHERWISE
BE EXCLUDED FROM COVERAGE UNDER THE POLICY ON GROUNDS OTHER THAN MEDICAL
NECESSITY OR EXPERIMENTAL TREATMENT.
  S 3. Subparagraphs (ii) and (iii) of paragraph (b) of subdivision 2 of
section 4910 of the public health law, as added by chapter  586  of  the
laws of 1998, are amended to read as follows:
  (ii)  the enrollee's attending physician has certified that the enrol-
lee has a life-threatening or disabling condition  or  disease  (a)  for
which  standard  health  services or procedures have been ineffective or

 EXPLANATION--Matter in ITALICS (underscored) is new; matter in brackets
                      [ ] is old law to be omitted.
                                                           LBD01759-01-9
              

S. 3840                             2

would be medically inappropriate, or (b) for which there does not  exist
a  more  beneficial  standard health service or procedure covered by the
health care plan, or (c) for which there exists a clinical trial OR RARE
DISEASE TREATMENT, and
  (iii)  the  enrollee's  attending  physician,  who must be a licensed,
board-certified or board-eligible physician qualified to practice in the
area of practice appropriate to treat the enrollee's life threatening or
disabling condition or disease,  must  have  recommended  either  (a)  a
health  service  or procedure (including a pharmaceutical product within
the meaning of subparagraph (B) of paragraph [b] (B) of subdivision five
of section forty-nine hundred of this article) that, based on two  docu-
ments  from  the available medical and scientific evidence, is likely to
be more beneficial to the enrollee  than  any  covered  standard  health
service  or procedure; or (b) a clinical trial OR RARE DISEASE TREATMENT
for which  the  enrollee  is  eligible.    Any  physician  certification
provided  under  this  section shall include a statement of the evidence
relied upon by the physician in certifying his  or  her  recommendation,
and
  S  4.  Item  1  of clause (ii) of subparagraph (B) of paragraph (d) of
subdivision 2 of section 4914 of the public  health  law,  as  added  by
chapter 586 of the laws of 1998, is amended and a new subdivision 2-a is
added to read as follows:
  (1) that the patient costs of the proposed health service or procedure
shall  be covered by the health care plan either: when a majority of the
panel of reviewers determines, upon review of the applicable medical and
scientific evidence (or upon confirmation that the recommended treatment
is a clinical trial OR RARE DISEASE TREATMENT), the  enrollee's  medical
record,  and  any  other pertinent information, that the proposed health
service or treatment (including  a  pharmaceutical  product  within  the
meaning  of  subparagraph  (B)  of  paragraph (b) of subdivision five of
section forty-nine hundred of this article) is likely to be more benefi-
cial than any standard treatment or treatments for the enrollee's  life-
threatening  or  disabling  condition  or  disease (or, in the case of a
clinical trial OR RARE DISEASE  TREATMENT,  is  likely  to  benefit  the
enrollee  in  the  treatment of the enrollee's condition or disease); or
when a reviewing panel is evenly divided as to a determination  concern-
ing coverage of the health service or procedure, or
  2-A. FOR EXTERNAL APPEALS REQUESTED IN RELATION TO RARE DISEASE TREAT-
MENT  UNDER ITEM ONE OF CLAUSE (II) OF SUBPARAGRAPH (B) OF PARAGRAPH (D)
OF SUBDIVISION TWO OF THIS SECTION, THE  EXTERNAL  APPEALS  AGENT  SHALL
REVIEW  MEDICAL  AND  SCIENTIFIC  EVIDENCE  RELATING  TO  CONDITIONS  OR
DISEASES OF HIGHER PREVALENCE IN THE SAME CLASS OR CATEGORY,  DETERMINED
BY  THE  EXTERNAL APPEALS AGENT TO BE COMPARABLE TO THE RARE DISEASE, AS
WELL AS MEDICAL AND SCIENTIFIC EVIDENCE RELATING TO THE RARE DISEASE, IN
ORDER TO DETERMINE WHETHER  THE  TREATMENT  IS  LIKELY  TO  BENEFIT  THE
PATIENT,  IF THE SPECIFIC HEALTH TREATMENT OR SERVICE RECOMMENDED BY THE
HEALTH CARE PROFESSIONAL WOULD NOT OTHERWISE BE EXCLUDED  FROM  COVERAGE
UNDER THE POLICY ON GROUNDS OTHER THAN MEDICAL NECESSITY OR EXPERIMENTAL
TREATMENT.
  S  5.  Section  4900  of  the insurance law is amended by adding a new
subsection (k) to read as follows:
  (K) "RARE DISEASE TREATMENT" MEANS A TREATMENT OR SERVICE ADMINISTERED
TO AN INSURED WITH A RARE DISABLING  OR  LIFE-THREATENING  CONDITION  OR
DISEASE  WHICH IS LISTED AS A RARE DISEASE BY THE NATIONAL INSTITUTES OF
HEALTH OFFICE OF RARE DISEASES OR IS ELIGIBLE FOR SUCH LISTING UNDER THE
FEDERAL RARE DISEASES ACT OF 2002.

S. 3840                             3

  S 6. Section 4905 of the insurance law is  amended  by  adding  a  new
subsection (p) to read as follows:
  (P)  WHEN MAKING DETERMINATIONS IN RELATION TO RARE DISEASE TREATMENT,
THE  UTILIZATION  REVIEW  AGENT  SHALL  REVIEW  MEDICAL  AND  SCIENTIFIC
EVIDENCE  RELATING TO CONDITIONS OR DISEASES OF HIGHER PREVALENCE IN THE
SAME CLASS OR CATEGORY, DETERMINED BY THE REVIEW AGENT TO BE  COMPARABLE
TO THE RARE DISEASE, AS WELL AS MEDICAL AND SCIENTIFIC EVIDENCE RELATING
TO  THE  RARE  DISEASE,  IN  ORDER TO DETERMINE WHETHER THE TREATMENT IS
LIKELY TO BENEFIT THE PATIENT,  IF  THE  SPECIFIC  HEALTH  TREATMENT  OR
SERVICE  RECOMMENDED BY THE HEALTH CARE PROFESSIONAL WOULD NOT OTHERWISE
BE EXCLUDED FROM COVERAGE UNDER THE POLICY ON GROUNDS OTHER THAN MEDICAL
NECESSITY OR EXPERIMENTAL TREATMENT.
  S 7. Subparagraphs (B) and (C) of paragraph 2  of  subsection  (b)  of
section  4910  of the insurance law, as added by chapter 586 of the laws
of 1998, are amended to read as follows:
  (B) the insured's attending physician has certified that  the  insured
has  a  life-threatening or disabling condition or disease (a) for which
standard health services or procedures have been ineffective or would be
medically inappropriate, or (b) for which there does not  exist  a  more
beneficial  standard  health  service or procedure covered by the health
care plan, or (c) for which  there  exists  a  clinical  trial  OR  RARE
DISEASE TREATMENT, and
  (C)  the insured's attending physician, who must be a licensed, board-
certified or board-eligible physician qualified to practice in the  area
of practice appropriate to treat the insured's life-threatening or disa-
bling  condition  or  disease, must have recommended either (a) a health
service or procedure (including  a  pharmaceutical  product  within  the
meaning  of  subparagraph  (B)  of  paragraph  two  of subsection (e) of
section four thousand nine hundred of this article) that, based  on  two
documents  from the available medical and scientific evidence, is likely
to be more beneficial to the insured than any  covered  standard  health
service  or procedure; or (b) a clinical trial OR RARE DISEASE TREATMENT
for which the insured is eligible. Any physician certification  provided
under this section shall include a statement of the evidence relied upon
by the physician in certifying his or her recommendation, and
  S  8.  Item  (a)  of clause (ii) of subparagraph (B) of paragraph 4 of
subsection (b) of section 4914 of the insurance law, as added by chapter
586 of the laws of 1998, is amended and a new subsection (b-1) is  added
to read as follows:
  (a) that the patient costs of the proposed health service or procedure
shall  be covered by the health care plan either: when a majority of the
panel of reviewers determines, upon review of the applicable medical and
scientific evidence (or upon confirmation that the recommended treatment
is a clinical trial OR RARE DISEASE TREATMENT),  the  insured's  medical
record,  and  any  other pertinent information, that the proposed health
service or treatment (including  a  pharmaceutical  product  within  the
meaning  of  subparagraph  (B)  of  paragraph  two  of subsection (e) of
section four thousand nine hundred of this article) is likely to be more
beneficial than any standard treatment or treatments for  the  insured's
life-threatening or disabling condition or disease (or, in the case of a
clinical  trial  OR  RARE  DISEASE  TREATMENT,  is likely to benefit the
insured in the treatment of the insured's condition or disease); or when
a reviewing panel is evenly divided as  to  a  determination  concerning
coverage of the health service or procedure, or
  (B-1)  FOR  EXTERNAL  APPEALS  REQUESTED  IN  RELATION TO RARE DISEASE
TREATMENT UNDER ITEM (A) OF CLAUSE (II) OF SUBPARAGRAPH (B) OF PARAGRAPH

S. 3840                             4

FOUR OF SUBSECTION (B) OF THIS SECTION, THE EXTERNAL APPEAL AGENT  SHALL
REVIEW  MEDICAL  AND  SCIENTIFIC  EVIDENCE  RELATING  TO  CONDITIONS  OR
DISEASES OF HIGHER PREVALENCE IN THE SAME CLASS OR CATEGORY,  DETERMINED
BY  THE  EXTERNAL  APPEAL AGENT TO BE COMPARABLE TO THE RARE DISEASE, AS
WELL AS MEDICAL AND SCIENTIFIC EVIDENCE RELATING TO THE RARE DISEASE, IN
ORDER TO DETERMINE WHETHER  THE  TREATMENT  IS  LIKELY  TO  BENEFIT  THE
PATIENT,  IF THE SPECIFIC HEALTH TREATMENT OR SERVICE RECOMMENDED BY THE
HEALTH CARE PROFESSIONAL WOULD NOT OTHERWISE BE EXCLUDED  FROM  COVERAGE
UNDER THE POLICY ON GROUNDS OTHER THAN MEDICAL NECESSITY OR EXPERIMENTAL
TREATMENT.
  S  9.  This  act  shall take effect immediately and shall apply to any
utilization review, external appeal, or action  or  proceeding  relating
thereto, pending on and after such effective date.