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A11048 Summary:

BILL NOA11048
 
SAME ASNo Same As
 
SPONSORWeprin
 
COSPNSR
 
MLTSPNSR
 
Add §338, amd §§3216, 3221, 4303 & 4900, Ins L
 
Relates to the use of artificial intelligence by insurers and clinical peer reviewers for utilization review; establishes additional notice requirements for adverse determinations.
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A11048 Text:



 
                STATE OF NEW YORK
        ________________________________________________________________________
 
                                          11048
 
                   IN ASSEMBLY
 
                                     April 24, 2026
                                       ___________
 
        Introduced by M. of A. WEPRIN -- read once and referred to the Committee
          on Insurance
 
        AN ACT to amend the insurance law and the public health law, in relation
          to the use of artificial intelligence for utilization review
 
          The  People of the State of New York, represented in Senate and Assem-
        bly, do enact as follows:

     1    Section 1. The insurance law is amended by adding a new section 338 to
     2  read as follows:
     3    § 338. Notification regarding the use of artificial  intelligence  for
     4  utilization  review.  (a)  As  used in this section, the following terms
     5  shall have the following meanings:
     6    (1) "Adverse determination" shall have the same meaning as  such  term
     7  is defined by section forty-nine hundred of this chapter.
     8    (2)  "Artificial  intelligence-based  algorithm"  means any algorithm-
     9  based system that can, for a given set of human-defined objectives, make
    10  predictions, recommendations and/or decisions influencing real or virtu-
    11  al environments. An artificial intelligence-based algorithm uses machine
    12  and human-based inputs to:
    13    (A) perceive real and virtual environments;
    14    (B) abstract such perceptions into models through analysis in an auto-
    15  mated manner; and
    16    (C) use model  inference  to  formulate  options  for  information  or
    17  action.
    18    (3)  "Clinical peer reviewer" shall have the same meaning as such term
    19  is defined by section forty-nine hundred of this chapter.
    20    (4) "Emergency condition" shall have the same meaning as such term  is
    21  defined by section forty-nine hundred of this chapter.
    22    (5) "Health care provider" shall have the same meaning as such term is
    23  defined by section thirty-two hundred twenty-four-a of this chapter.
    24    (6) "Insurer" means an insurer authorized to write accident and health
    25  insurance  in  this  state,  a corporation organized pursuant to article
    26  forty-three of this  chapter,  and  a  health  maintenance  organization
    27  certified pursuant to article forty-four of the public health law.
 
         EXPLANATION--Matter in italics (underscored) is new; matter in brackets
                              [ ] is old law to be omitted.
                                                                   LBD15313-01-6

        A. 11048                            2
 
     1    (7)  "Utilization  review" shall have the same meaning as such term is
     2  defined by section forty-nine hundred of this chapter.
     3    (b)(1)  The superintendent shall require all insurers to provide writ-
     4  ten notice to insureds, enrollees, and health care providers  about  the
     5  use  of  artificial  intelligence-based  algorithms in their utilization
     6  review process. Such written notice shall be sent  when  the  artificial
     7  intelligence-based  algorithm  is  first adopted by the insurer and once
     8  during each subsequent policy period. In addition, such  insurers  shall
     9  provide a clear and conspicuous notice on their websites about their use
    10  of  artificial  intelligence-based  algorithms in the utilization review
    11  process.
    12    (2) If artificial intelligence-based algorithms are used in the utili-
    13  zation review process, each insurer shall disclose to the  insured's  or
    14  enrollee's  health  care  provider, and, upon request, to the insured or
    15  enrollee, the following information: the criteria governing such artifi-
    16  cial intelligence-based algorithm, the data  sets  used  to  train  such
    17  artificial  intelligence-based  algorithm,  the artificial intelligence-
    18  based algorithm itself, and the outcomes produced by software that  uses
    19  the artificial intelligence-based algorithm.
    20    (3)  An  insurer's  use of artificial intelligence-based algorithms in
    21  the utilization review process shall be  disclosed  to  the  insured  or
    22  enrollee  and to the insured's or enrollee's health care provider in the
    23  notice of an adverse  determination  made  by  clinical  peer  reviewers
    24  pursuant  to  subsection (e) of section forty-nine hundred three of this
    25  chapter and subdivision five of section forty-nine hundred three of  the
    26  public health law.
    27    (4)  Any artificial intelligence-based algorithms used in the utiliza-
    28  tion review process by an insurer shall not  base  an  adverse  determi-
    29  nation solely on a group data set.
    30    (5)  Any artificial intelligence-based algorithms used in the utiliza-
    31  tion review process by an insurer shall not directly or indirectly cause
    32  harm to the insured or enrollee.
    33    (6) Any artificial intelligence-based algorithms used in the  utiliza-
    34  tion  review process by an insurer shall be open to inspection for audit
    35  or compliance reviews by the superintendent in accordance with  applica-
    36  ble state and federal laws.
    37    (7)  Insured  and  enrollee data shall not be used beyond its intended
    38  and stated purpose, consistent with the federal Health Insurance  Porta-
    39  bility and Accountability Act of 1996, as applicable.
    40    (c) Every insurer shall submit the artificial intelligence-based algo-
    41  rithms and training data sets that are being used or will be used in the
    42  utilization  review  process  to  the superintendent.   Such submissions
    43  shall include, at a minimum, a certification that such artificial intel-
    44  ligence-based algorithms and training data sets:
    45    (1) have minimized the risk of bias  based  on  the  covered  person's
    46  race,  color,  religious  creed,  ancestry,  age,  sex, gender, national
    47  origin, handicap or disability, and are consistent with state and feder-
    48  al antidiscrimination laws;
    49    (2) adhere to evidence-based clinical guidelines;
    50    (3) do not rely on information that is  not  in  compliance  with  the
    51  requirements  for  utilization  review  pursuant  to  section forty-nine
    52  hundred three of this chapter and section forty-nine  hundred  three  of
    53  the public health law; and
    54    (4)  do not independently create or change clinical standards or other
    55  coverage criteria.

        A. 11048                            3
 
     1    (d)(1) An insurer with a utilization  review  process  that  initially
     2  uses artificial intelligence-based algorithms, shall ensure that adverse
     3  determinations are made only by clinical peer reviewers. A clinical peer
     4  reviewer who participates in a utilization review process for an insurer
     5  that  initially  uses  artificial  intelligence-based  algorithms  for a
     6  utilization review shall, prior to  issuing  an  adverse  determination:
     7  consider  the requesting health provider's recommendation, the insured's
     8  or enrollee's medical or other  clinical  history,  as  applicable,  and
     9  individual  clinical  circumstances;  open  and document the utilization
    10  review of the individual clinical records and data; and comply with  all
    11  requirements  of  article  forty-nine of this chapter and article forty-
    12  nine of the public health law regarding utilization review. In addition,
    13  a utilization review determination with respect to an  emergency  condi-
    14  tion  shall  require  application of a prudent layperson standard to the
    15  patient's presenting symptoms, without regard to final diagnosis.
    16    (2) Every insurer shall submit to the superintendent, in such form and
    17  manner as the superintendent may require, data on the amount of  time  a
    18  clinical  peer  reviewer spends examining an adverse determination prior
    19  to signing off on each adverse determination.
    20    (3) An artificial intelligence-based algorithm shall not be  the  sole
    21  basis  of  an  insurer's  decision to deny, delay, or modify health care
    22  services based, in whole or in part, on medical necessity.
    23    (4) Every clinical peer reviewer that participates  in  a  utilization
    24  review process for an insurer issuing adverse determinations shall issue
    25  a signed statement in accordance with paragraph one of subsection (e) of
    26  section  forty-nine  hundred  three  of this chapter or paragraph (a) of
    27  subdivision five of section  forty-nine  hundred  three  of  the  public
    28  health law.
    29    (e) Every insurer shall establish an ongoing quality assurance testing
    30  process  that meets any requirements that the superintendent may specify
    31  with defined parameters on safety and efficacy of all artificial  intel-
    32  ligence-based  algorithms,  and shall submit the results of such quality
    33  assurance testing process to the superintendent at such time and in such
    34  form and  manner  as  the  superintendent  may  specify,  but  not  less
    35  frequently  than  semiannually.  The  results  of such quality assurance
    36  testing process shall be published on a  public  website  within  thirty
    37  days of the submission of such results to the superintendent.
    38    (f) (1) A violation of the provisions of this section shall be subject
    39  to  one  or  more  of  the  following penalties at the discretion of the
    40  superintendent, in consultation with the commissioner of health and  the
    41  commissioner of education as applicable:
    42    (A) Where a violation is made by an insurer:
    43    (i) suspension or revocation of license;
    44    (ii)  refusal,  for  a  period  not to exceed one year, to issue a new
    45  license;
    46    (iii) a fine of not more than five thousand dollars for each violation
    47  of this section; or
    48    (iv) a fine of not more than ten thousand  dollars  for  each  willful
    49  violation of this section.
    50    Fines  imposed  pursuant  to  the provisions of this subparagraph on a
    51  single insurer shall not exceed five hundred thousand dollars in  aggre-
    52  gate during a calendar year.
    53    (B) Where a violation is made by a clinical peer reviewer:
    54    (i) suspension or revocation of license;
    55    (ii)  refusal,  for  a  period  not to exceed one year, to issue a new
    56  license;

        A. 11048                            4
 
     1    (iii) a fine of not more than five thousand dollars for each violation
     2  of this section; or
     3    (iv)  a  fine  of  not more than ten thousand dollars for each willful
     4  violation of this section.
     5    Fines imposed pursuant to the provisions of  this  subparagraph  on  a
     6  single  clinical  peer  reviewer  shall  not exceed one hundred thousand
     7  dollars in aggregate during a calendar year.
     8    (2) Penalties pursuant to the provisions of this subsection  shall  be
     9  in addition to any other remedies or penalties that may be imposed under
    10  any other applicable law.
    11    (g)  The  superintendent  shall  promulgate  all rules and regulations
    12  necessary for the implementation of this section.
    13    § 2. Subparagraph (C) of paragraph 9 of subsection (i) of section 3216
    14  of the insurance law, as amended by chapter 219 of the laws of 2011,  is
    15  amended to read as follows:
    16    (C)  For  purposes of this paragraph, an "emergency condition" means a
    17  medical or behavioral condition that, regardless of the final diagnosis,
    18  manifests itself by acute symptoms  of  sufficient  severity,  including
    19  severe  pain, such that a prudent layperson, possessing an average know-
    20  ledge of medicine and health, could reasonably  expect  the  absence  of
    21  immediate  medical  attention to result in (i) placing the health of the
    22  person afflicted with such condition in serious jeopardy, or in the case
    23  of a behavioral condition placing the health of such person or others in
    24  serious jeopardy; (ii) serious impairment to such person's bodily  func-
    25  tions;  (iii)  serious  dysfunction  of any bodily organ or part of such
    26  person; (iv) serious disfigurement of such person; or  (v)  a  condition
    27  described  in  clause (i), (ii) or (iii) of section 1867(e)(1)(A) of the
    28  Social Security Act.
    29    § 3. Item (ii) of subparagraph (E) of paragraph 24 of  subsection  (i)
    30  of  section  3216 of the insurance law, as amended by chapter 219 of the
    31  laws of 2011, is amended to read as follows:
    32    (ii) "Emergency condition" means a  medical  or  behavioral  condition
    33  that,  regardless of final diagnosis, manifests itself by acute symptoms
    34  of sufficient severity, including  severe  pain,  such  that  a  prudent
    35  layperson, possessing an average knowledge of medicine and health, could
    36  reasonably  expect  the absence of immediate medical attention to result
    37  in (I) placing the health of the person afflicted with such condition in
    38  serious jeopardy, or in the case of a behavioral condition  placing  the
    39  health  of  such  person  or  others  in  serious jeopardy; (II) serious
    40  impairment to such person's bodily functions; (III) serious  dysfunction
    41  of  any  bodily organ or part of such person; (IV) serious disfigurement
    42  of such person; or (V) a condition described in  clause  (i),  (ii),  or
    43  (iii) of section 1867(e)(1)(A) of the Social Security Act.
    44    § 4. Subparagraph (C) of paragraph 4 of subsection (k) of section 3221
    45  of  the insurance law, as amended by chapter 219 of the laws of 2011, is
    46  amended to read as follows:
    47    (C) In this paragraph, an "emergency condition"  means  a  medical  or
    48  behavioral  condition that, regardless of the final diagnosis, manifests
    49  itself by acute symptoms of sufficient severity, including severe  pain,
    50  such  that a prudent layperson, possessing an average knowledge of medi-
    51  cine and health,  could  reasonably  expect  the  absence  of  immediate
    52  medical  attention  to  result  in  (i) placing the health of the person
    53  afflicted with such condition in serious jeopardy, or in the case  of  a
    54  behavioral  condition  placing  the  health  of such person or others in
    55  serious jeopardy; (ii) serious impairment to such person's bodily  func-
    56  tions;  (iii)  serious  dysfunction  of any bodily organ or part of such

        A. 11048                            5
 
     1  person; (iv) serious disfigurement of such person; or  (v)  a  condition
     2  described  in  clause (i), (ii) or (iii) of section 1867(e)(1)(A) of the
     3  Social Security Act.
     4    § 5. Subparagraph (C) of paragraph 2 of subsection (a) of section 4303
     5  of  the insurance law, as amended by chapter 219 of the laws of 2011, is
     6  amended to read as follows:
     7    (C) For the purpose of this provision, "emergency condition"  means  a
     8  medical or behavioral condition that, regardless of the final diagnosis,
     9  manifests  itself  by  acute  symptoms of sufficient severity, including
    10  severe pain, such that a prudent layperson, possessing an average  know-
    11  ledge  of  medicine  and  health, could reasonably expect the absence of
    12  immediate medical attention to result in (i) placing the health  of  the
    13  person afflicted with such condition in serious jeopardy, or in the case
    14  of a behavioral condition placing the health of such person or others in
    15  serious  jeopardy; (ii) serious impairment to such person's bodily func-
    16  tions; (iii) serious dysfunction of any bodily organ  or  part  of  such
    17  person;  (iv)  serious  disfigurement of such person; or (v) a condition
    18  described in clause (i), (ii) or (iii) of section 1867(e)(1)(A)  of  the
    19  Social Security Act.
    20    §  6.  Subsection (c) of section 4900 of the insurance law, as amended
    21  by chapter 219 of the laws of 2011, is amended to read as follows:
    22    (c) "Emergency condition" means a medical or  behavioral  condition[,]
    23  that, regardless of the final diagnosis, manifests itself by acute symp-
    24  toms  of sufficient severity, including severe pain, such that a prudent
    25  layperson, possessing an average knowledge of medicine and health, could
    26  reasonably expect the absence of immediate medical attention  to  result
    27  in (1) placing the health of the person afflicted with such condition in
    28  serious  jeopardy,  or in the case of a behavioral condition placing the
    29  health of such person or others in serious jeopardy; (2) serious impair-
    30  ment to such person's bodily functions; (3) serious dysfunction  of  any
    31  bodily  organ  or part of such person; (4) serious disfigurement of such
    32  person; or (5) a condition described in clause (i),  (ii)  or  (iii)  of
    33  section 1867(e)(1)(A) of the Social Security Act.
    34    §  7.  Subdivision  3  of  section  4900  of the public health law, as
    35  amended by  chapter 219 of the laws of  2011,  is  amended  to  read  as
    36  follows:
    37    3.  "Emergency  condition"  means a medical or behavioral condition[,]
    38  that, regardless of the final diagnosis, manifests itself by acute symp-
    39  toms of sufficient severity, including severe pain, such that a  prudent
    40  layperson, possessing an average knowledge of medicine and health, could
    41  reasonably  expect  the absence of immediate medical attention to result
    42  in (a) placing the health of the person afflicted with such condition in
    43  serious jeopardy, or in the case of a behavioral condition, placing  the
    44  health of such person or others in serious jeopardy; (b) serious impair-
    45  ment  to  such person's bodily functions; (c) serious dysfunction of any
    46  bodily organ or part of such person; (d) serious disfigurement  of  such
    47  person;  or  (e)  a  condition described in clause (i), (ii) or (iii) of
    48  section 1867(e)(1)(A) of the Social Security Act.
    49    § 8. Paragraph 1 of subsection (e) of section 4903  of  the  insurance
    50  law, as amended by chapter 28 of the laws of 2024, is amended to read as
    51  follows:
    52    (1)  Notice  of  an adverse determination made by a utilization review
    53  agent shall be in writing and must include:
    54    (i) the reasons for the determination including the  clinical  ration-
    55  ale,  if  any,  and the specific coverage or clinical criteria that were
    56  not  satisfied,  including  explicit  identification  of  the   relevant

        A. 11048                            6
 
     1  language  contained  in  any  clinical  criteria relied upon to make the
     2  adverse determination and a clear explanation of the rationale  support-
     3  ing the determination that such clinical criteria were deemed not satis-
     4  fied;
     5    (ii)  instructions  on  how to initiate standard appeals and expedited
     6  appeals pursuant to section four  thousand  nine  hundred  four  and  an
     7  external  appeal pursuant to section four thousand nine hundred fourteen
     8  of this article;
     9    (iii) notice of the availability, upon request of the insured, or  the
    10  insured's  designee, of the clinical review criteria relied upon to make
    11  such determination. Such notice shall also specify what, if  any,  addi-
    12  tional  necessary  information  must be provided to, or obtained by, the
    13  utilization review agent in order to render a decision  on  the  appeal;
    14  [and]
    15    (iv)  for  an adverse determination related to a step therapy protocol
    16  override request, information that includes the clinical review criteria
    17  relied upon to make such determination and  any  applicable  alternative
    18  prescription  drugs subject to the step therapy protocol of the utiliza-
    19  tion review agent[.];
    20    (v) a statement signed by the clinical peer  reviewer  that  made  the
    21  adverse determination containing the following information:
    22    (a) the full printed name of such clinical peer reviewer;
    23    (b)  such  clinical  peer  reviewer's national provider identification
    24  number;
    25    (c) such clinical peer reviewer's  credentials,  including  any  board
    26  certifications  and areas of specialty expertise and training, as appli-
    27  cable;
    28    (d) the taxonomy code of such clinical peer reviewer;
    29    (e) an attestation by such clinical peer reviewer that they  have  the
    30  appropriate  training  and  expertise  in  the field of medicine that is
    31  sufficient to make an informed decision regarding the medical  necessity
    32  of  the  health  care service or supply being requested on behalf of the
    33  insured and that they have no conflicts of interest that would interfere
    34  with their ability to make  an  impartial  determination  based  on  the
    35  merits of the specific patient case;
    36    (f)  documentation  of  the amount of time such clinical peer reviewer
    37  spent evaluating the medical record or other information related to  the
    38  review before confirming the adverse determination;
    39    (g)  an  indication  of whether such clinical peer reviewer reviewed a
    40  prepared summary of the patient's medical records or the patient's actu-
    41  al medical records in making their adverse determination; and
    42    (vi) a statement as to whether an artificial intelligence-based  algo-
    43  rithm,  as such term is defined by section three hundred thirty-eight of
    44  this chapter, was used in the utilization review process,  and  a  plain
    45  language  explanation as to how such artificial intelligence-based algo-
    46  rithm was employed and where the insured and health  care  provider  can
    47  find more information about the specific usage of such artificial intel-
    48  ligence-based algorithm.
    49    §  9.  Paragraph  (a)  of  subdivision 5 of section 4903 of the public
    50  health law, as amended by chapter 28 of the laws of 2024, is amended  to
    51  read as follows:
    52    (a)  Notice  of  an adverse determination made by a utilization review
    53  agent shall be in writing and must include:
    54    (i) the reasons for the determination including the  clinical  ration-
    55  ale,  if  any,  and the specific coverage or clinical criteria that were
    56  not  satisfied,  including  explicit  identification  of  the   relevant

        A. 11048                            7
 
     1  language  contained  in  any  clinical  criteria relied upon to make the
     2  adverse determination and a clear explanation of the rationale  support-
     3  ing the determination that such clinical criteria were deemed not satis-
     4  fied;
     5    (ii)  instructions  on  how to initiate standard and expedited appeals
     6  pursuant to section forty-nine  hundred  four  and  an  external  appeal
     7  pursuant to section forty-nine hundred fourteen of this article;
     8    (iii) notice of the availability, upon request of the enrollee, or the
     9  enrollee's designee, of the clinical review criteria relied upon to make
    10  such  determination.  Such notice shall also specify what, if any, addi-
    11  tional necessary information must be provided to, or  obtained  by,  the
    12  utilization  review  agent  in order to render a decision on the appeal;
    13  [and]
    14    (iv) for an adverse determination related to a step  therapy  protocol
    15  override request, information that includes the clinical review criteria
    16  relied  upon  to  make such determination and any applicable alternative
    17  prescription drugs subject to the step therapy protocol of the  utiliza-
    18  tion review agent[.];
    19    (v)  a statement signed by the physician who made the adverse determi-
    20  nation containing the following information:
    21    (A) the full printed name of such physician;
    22    (B) such physician's national provider identification number;
    23    (C) such physician's credentials, including any  board  certifications
    24  and areas of specialty expertise and training, as applicable;
    25    (D) the taxonomy code of such physician;
    26    (E)  an  attestation  by such physician that they have the appropriate
    27  training and expertise in the field of medicine that  is  sufficient  to
    28  make  an informed decision regarding the medical necessity of the health
    29  care service or supply being requested on behalf of the insured and that
    30  they have no conflicts of interest that would interfere with their abil-
    31  ity to make an impartial  determination  based  on  the  merits  of  the
    32  specific patient case;
    33    (F)  documentation of the amount of time such physician spent evaluat-
    34  ing the medical record or other information related to the review before
    35  confirming the adverse determination;
    36    (G) an indication of whether such physician reviewed a prepared summa-
    37  ry of the patient's medical records  or  the  patient's  actual  medical
    38  records in making their adverse determination; and
    39    (vi)  a statement as to whether an artificial intelligence-based algo-
    40  rithm, as such term is defined by section three hundred thirty-eight  of
    41  this  chapter,  was  used in the utilization review process, and a plain
    42  language explanation as to how such artificial intelligence-based  algo-
    43  rithm  was  employed  and where the insured and health care provider can
    44  find more information about the specific usage of such artificial intel-
    45  ligence-based algorithm.
    46    § 10. This act shall take effect on the sixtieth day  after  it  shall
    47  have become a law. Effective immediately, the addition, amendment and/or
    48  repeal  of  any  rule  or regulation necessary for the implementation of
    49  this act on its effective date are authorized to be made  and  completed
    50  on or before such effective date.
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