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A00301 Summary:

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A00301 Floor Votes:

A00301 Text:

 
                STATE OF NEW YORK
        ________________________________________________________________________
 
                                           301
 
                               2009-2010 Regular Sessions
 
                   IN ASSEMBLY
 
                                       (Prefiled)
 
                                     January 7, 2009
                                       ___________
 
        Introduced  by M. of A. MILLMAN, GOTTFRIED, ROSENTHAL, KELLNER -- Multi-
          Sponsored by -- M.  of  A.  BRENNAN,  BRODSKY,  BROOK-KRASNY,  CAMARA,
          CLARK,  COOK,  DINOWITZ,  ESPAILLAT,  FIELDS,  GLICK, GORDON, GUNTHER,
          HOOPER, HYER-SPENCER, JACOBS, JAFFEE, JOHN,  KOON,  V. LOPEZ,  MAISEL,

          MARKEY,  MAYERSOHN,  ORTIZ,  PEOPLES-STOKES,  PHEFFER,  REILLY, SPANO,
          STIRPE, WEISENBERG, ZEBROWSKI -- read once and referred to the Commit-
          tee 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:
 
     1    Section  1. Section 4900 of the public health law is amended by adding
     2  a new subdivision 11 to read as follows:
     3    11. "Rare disease treatment" means a treatment or service administered
     4  to an enrollee with a rare disabling or  life-threatening  condition  or
     5  disease  which is listed as a rare disease by the National Institutes of
     6  Health Office of Rare Diseases or is eligible for such listing under the

     7  federal Rare Diseases Act of 2002.
     8    § 2. Section 4905 of the public health law is amended by adding a  new
     9  subdivision 16 to read as follows:
    10    16.  When making determinations in relation to rare disease treatment,
    11  the  utilization  review  agent  shall  review  medical  and  scientific
    12  evidence  relating to conditions or diseases of higher prevalence in the
    13  same class or category, determined by the review agent to be  comparable
    14  to the rare disease, as well as medical and scientific evidence relating
    15  to  the  rare  disease,  in  order to determine whether the treatment is
    16  likely to benefit the patient,  if  the  specific  health  treatment  or
    17  service  recommended by the health care professional would not otherwise

    18  be excluded from coverage under the policy on grounds other than medical
    19  necessity or experimental treatment.
 
         EXPLANATION--Matter in italics (underscored) is new; matter in brackets
                              [ ] is old law to be omitted.
        A                                                          LBD01759-01-9
        A. 301                              2
 
     1    § 3. Subparagraphs (ii) and (iii) of paragraph (b) of subdivision 2 of
     2  section 4910 of the public health law, as added by chapter  586  of  the
     3  laws of 1998, are amended to read as follows:
     4    (ii)  the enrollee's attending physician has certified that the enrol-
     5  lee has a life-threatening or disabling condition  or  disease  (a)  for
     6  which  standard  health  services or procedures have been ineffective or

     7  would be medically inappropriate, or (b) for which there does not  exist
     8  a  more  beneficial  standard health service or procedure covered by the
     9  health care plan, or (c) for which there exists a clinical trial or rare
    10  disease treatment, and
    11    (iii) the enrollee's attending physician,  who  must  be  a  licensed,
    12  board-certified or board-eligible physician qualified to practice in the
    13  area of practice appropriate to treat the enrollee's life threatening or
    14  disabling  condition  or  disease,  must  have  recommended either (a) a
    15  health service or procedure (including a pharmaceutical  product  within
    16  the meaning of subparagraph (B) of paragraph [b] (b) of subdivision five
    17  of  section forty-nine hundred of this article) that, based on two docu-
    18  ments from the available medical and scientific evidence, is  likely  to

    19  be  more  beneficial  to  the  enrollee than any covered standard health
    20  service or procedure; or (b) a clinical trial or rare disease  treatment
    21  for  which  the  enrollee  is  eligible.    Any  physician certification
    22  provided under this section shall include a statement  of  the  evidence
    23  relied  upon  by  the physician in certifying his or her recommendation,
    24  and
    25    § 4. Item 1 of clause (ii) of subparagraph (B)  of  paragraph  (d)  of
    26  subdivision  2  of  section  4914  of the public health law, as added by
    27  chapter 586 of the laws of 1998, is amended and a new subdivision 2-a is
    28  added to read as follows:
    29    (1) that the patient costs of the proposed health service or procedure
    30  shall be covered by the health care plan either: when a majority of  the
    31  panel of reviewers determines, upon review of the applicable medical and

    32  scientific evidence (or upon confirmation that the recommended treatment
    33  is  a  clinical trial or rare disease treatment), the enrollee's medical
    34  record, and any other pertinent information, that  the  proposed  health
    35  service  or  treatment  (including  a  pharmaceutical product within the
    36  meaning of subparagraph (B) of paragraph  (b)  of  subdivision  five  of
    37  section forty-nine hundred of this article) is likely to be more benefi-
    38  cial  than any standard treatment or treatments for the enrollee's life-
    39  threatening or disabling condition or disease (or,  in  the  case  of  a
    40  clinical  trial  or  rare  disease  treatment,  is likely to benefit the
    41  enrollee in the treatment of the enrollee's condition  or  disease);  or
    42  when  a reviewing panel is evenly divided as to a determination concern-
    43  ing coverage of the health service or procedure, or

    44    2-a. For external appeals requested in relation to rare disease treat-
    45  ment under item one of clause (ii) of subparagraph (B) of paragraph  (d)
    46  of  subdivision  two  of  this section, the external appeals agent shall
    47  review  medical  and  scientific  evidence  relating  to  conditions  or
    48  diseases  of higher prevalence in the same class or category, determined
    49  by the external appeals agent to be comparable to the rare  disease,  as
    50  well as medical and scientific evidence relating to the rare disease, in
    51  order  to  determine  whether  the  treatment  is  likely to benefit the
    52  patient, if the specific health treatment or service recommended by  the
    53  health  care  professional would not otherwise be excluded from coverage

    54  under the policy on grounds other than medical necessity or experimental
    55  treatment.
        A. 301                              3
 
     1    § 5. Section 4900 of the insurance law is  amended  by  adding  a  new
     2  subsection (k) to read as follows:
     3    (k) "Rare disease treatment" means a treatment or service administered
     4  to  an  insured  with  a rare disabling or life-threatening condition or
     5  disease which is listed as a rare disease by the National Institutes  of
     6  Health Office of Rare Diseases or is eligible for such listing under the
     7  federal Rare Diseases Act of 2002.
     8    §  6.  Section  4905  of  the insurance law is amended by adding a new
     9  subsection (p) to read as follows:

    10    (p) When making determinations in relation to rare disease  treatment,
    11  the  utilization  review  agent  shall  review  medical  and  scientific
    12  evidence relating to conditions or diseases of higher prevalence in  the
    13  same  class or category, determined by the review agent to be comparable
    14  to the rare disease, as well as medical and scientific evidence relating
    15  to the rare disease, in order to  determine  whether  the  treatment  is
    16  likely  to  benefit  the  patient,  if  the specific health treatment or
    17  service recommended by the health care professional would not  otherwise
    18  be excluded from coverage under the policy on grounds other than medical
    19  necessity or experimental treatment.
    20    §  7.  Subparagraphs  (B)  and (C) of paragraph 2 of subsection (b) of

    21  section 4910 of the insurance law, as added by chapter 586 of  the  laws
    22  of 1998, are amended to read as follows:
    23    (B)  the  insured's attending physician has certified that the insured
    24  has a life-threatening or disabling condition or disease (a)  for  which
    25  standard health services or procedures have been ineffective or would be
    26  medically  inappropriate,  or  (b) for which there does not exist a more
    27  beneficial standard health service or procedure covered  by  the  health
    28  care  plan,  or  (c)  for  which  there  exists a clinical trial or rare
    29  disease treatment, and
    30    (C) the insured's attending physician, who must be a licensed,  board-
    31  certified  or board-eligible physician qualified to practice in the area
    32  of practice appropriate to treat the insured's life-threatening or disa-
    33  bling condition or disease, must have recommended either  (a)  a  health

    34  service  or  procedure  (including  a  pharmaceutical product within the
    35  meaning of subparagraph (B)  of  paragraph  two  of  subsection  (e)  of
    36  section  four  thousand nine hundred of this article) that, based on two
    37  documents from the available medical and scientific evidence, is  likely
    38  to  be  more  beneficial to the insured than any covered standard health
    39  service or procedure; or (b) a clinical trial or rare disease  treatment
    40  for  which the insured is eligible. Any physician certification provided
    41  under this section shall include a statement of the evidence relied upon
    42  by the physician in certifying his or her recommendation, and
    43    § 8. Item (a) of clause (ii) of subparagraph (B)  of  paragraph  4  of
    44  subsection (b) of section 4914 of the insurance law, as added by chapter
    45  586  of the laws of 1998, is amended and a new subsection (b-1) is added

    46  to read as follows:
    47    (a) that the patient costs of the proposed health service or procedure
    48  shall be covered by the health care plan either: when a majority of  the
    49  panel of reviewers determines, upon review of the applicable medical and
    50  scientific evidence (or upon confirmation that the recommended treatment
    51  is  a  clinical  trial or rare disease treatment), the insured's medical
    52  record, and any other pertinent information, that  the  proposed  health
    53  service  or  treatment  (including  a  pharmaceutical product within the
    54  meaning of subparagraph (B)  of  paragraph  two  of  subsection  (e)  of
    55  section four thousand nine hundred of this article) is likely to be more
    56  beneficial  than  any standard treatment or treatments for the insured's
        A. 301                              4
 

     1  life-threatening or disabling condition or disease (or, in the case of a
     2  clinical trial or rare disease  treatment,  is  likely  to  benefit  the
     3  insured in the treatment of the insured's condition or disease); or when
     4  a  reviewing  panel  is  evenly divided as to a determination concerning
     5  coverage of the health service or procedure, or
     6    (b-1) For external appeals  requested  in  relation  to  rare  disease
     7  treatment under item (a) of clause (ii) of subparagraph (B) of paragraph
     8  four  of subsection (b) of this section, the external appeal agent shall
     9  review  medical  and  scientific  evidence  relating  to  conditions  or
    10  diseases  of higher prevalence in the same class or category, determined
    11  by the external appeal agent to be comparable to the  rare  disease,  as

    12  well as medical and scientific evidence relating to the rare disease, in
    13  order  to  determine  whether  the  treatment  is  likely to benefit the
    14  patient, if the specific health treatment or service recommended by  the
    15  health  care  professional would not otherwise be excluded from coverage
    16  under the policy on grounds other than medical necessity or experimental
    17  treatment.
    18    § 9. This act shall take effect immediately and  shall  apply  to  any
    19  utilization  review,  external  appeal, or action or proceeding relating
    20  thereto, pending on and after such effective date.