WHAT THIS BILL REGULATES · 2 REQUIREMENT TYPES
How Is This Bill Enforced
Verbatim statutory text on the left; plain-language analysis and a per-section checklist on the right. Numbered markers cross-link to the matching checklist row.
(a)(1)–(7) As used in this section, the following terms shall have the following meanings: (1) "Adverse determinationAdverse determination"Adverse determination" shall have the same meaning as such term is defined by section forty-nine hundred of this chapter.Ins. Law § 338(a)(1)" shall have the same meaning as such term is defined by section forty-nine hundred of this chapter. (2) "Artificial intelligence-based algorithmArtificial intelligence-based algorithm"Artificial intelligence-based algorithm" means any algorithm-based system that can, for a given set of human-defined objectives, make predictions, recommendations and/or decisions influencing real or virtual environments. An artificial intelligence-based algorithm uses machine and human-based inputs to: (A) perceive real and virtual environments; (B) abstract such perceptions into models through analysis in an automated manner; and (C) use model inference to formulate options for information or action.Ins. Law § 338(a)(2)" means any algorithm-based system that can, for a given set of human-defined objectives, make predictions, recommendations and/or decisions influencing real or virtual environments. An artificial intelligence-based algorithmArtificial intelligence-based algorithm"Artificial intelligence-based algorithm" means any algorithm-based system that can, for a given set of human-defined objectives, make predictions, recommendations and/or decisions influencing real or virtual environments. An artificial intelligence-based algorithm uses machine and human-based inputs to: (A) perceive real and virtual environments; (B) abstract such perceptions into models through analysis in an automated manner; and (C) use model inference to formulate options for information or action.Ins. Law § 338(a)(2) uses machine and human-based inputs to: (A) perceive real and virtual environments; (B) abstract such perceptions into models through analysis in an automated manner; and (C) use model inference to formulate options for information or action. (3) "Clinical peer reviewerClinical peer reviewer"Clinical peer reviewer" shall have the same meaning as such term is defined by section forty-nine hundred of this chapter.Ins. Law § 338(a)(3)" shall have the same meaning as such term is defined by section forty-nine hundred of this chapter. (4) "Emergency conditionEmergency condition"Emergency condition" shall have the same meaning as such term is defined by section forty-nine hundred of this chapter.Ins. Law § 338(a)(4)" shall have the same meaning as such term is defined by section forty-nine hundred of this chapter. (5) "Health care providerHealth care provider"Health care provider" shall have the same meaning as such term is defined by section thirty-two hundred twenty-four-a of this chapter.Ins. Law § 338(a)(5)" shall have the same meaning as such term is defined by section thirty-two hundred twenty-four-a of this chapter. (6) "InsurerInsurer"Insurer" means an insurer authorized to write accident and health insurance in this state, a corporation organized pursuant to article forty-three of this chapter, and a health maintenance organization certified pursuant to article forty-four of the public health law.Ins. Law § 338(a)(6)" means an insurerInsurer"Insurer" means an insurer authorized to write accident and health insurance in this state, a corporation organized pursuant to article forty-three of this chapter, and a health maintenance organization certified pursuant to article forty-four of the public health law.Ins. Law § 338(a)(6) authorized to write accident and health insurance in this state, a corporation organized pursuant to article forty-three of this chapter, and a health maintenance organization certified pursuant to article forty-four of the public health law. (7) "Utilization reviewUtilization review"Utilization review" shall have the same meaning as such term is defined by section forty-nine hundred of this chapter.Ins. Law § 338(a)(7)" shall have the same meaning as such term is defined by section forty-nine hundred of this chapter.
This subsection establishes the definitions governing the bill's new requirements for AI use in utilization review. Key terms include artificial intelligence-based algorithm, which is defined broadly to cover any algorithm-based system that makes predictions, recommendations, or decisions using machine and human inputs, and insurer, which encompasses accident and health insurers, Article 43 corporations, and HMOs. Other terms — adverse determination, clinical peer reviewer, emergency condition, health care provider, and utilization review — are cross-referenced to existing Insurance Law § 4900 and § 3224-a definitions.
(b)(1) 1 The superintendent shall require all insurersInsurer"Insurer" means an insurer authorized to write accident and health insurance in this state, a corporation organized pursuant to article forty-three of this chapter, and a health maintenance organization certified pursuant to article forty-four of the public health law.Ins. Law § 338(a)(6) to provide written notice to insureds, enrollees, and health care providersHealth care provider"Health care provider" shall have the same meaning as such term is defined by section thirty-two hundred twenty-four-a of this chapter.Ins. Law § 338(a)(5) about the use of artificial intelligence-based algorithmsArtificial intelligence-based algorithm"Artificial intelligence-based algorithm" means any algorithm-based system that can, for a given set of human-defined objectives, make predictions, recommendations and/or decisions influencing real or virtual environments. An artificial intelligence-based algorithm uses machine and human-based inputs to: (A) perceive real and virtual environments; (B) abstract such perceptions into models through analysis in an automated manner; and (C) use model inference to formulate options for information or action.Ins. Law § 338(a)(2) in their utilization reviewUtilization review"Utilization review" shall have the same meaning as such term is defined by section forty-nine hundred of this chapter.Ins. Law § 338(a)(7) process. Such written notice shall be sent when the artificial intelligence-based algorithmArtificial intelligence-based algorithm"Artificial intelligence-based algorithm" means any algorithm-based system that can, for a given set of human-defined objectives, make predictions, recommendations and/or decisions influencing real or virtual environments. An artificial intelligence-based algorithm uses machine and human-based inputs to: (A) perceive real and virtual environments; (B) abstract such perceptions into models through analysis in an automated manner; and (C) use model inference to formulate options for information or action.Ins. Law § 338(a)(2) is first adopted by the insurerInsurer"Insurer" means an insurer authorized to write accident and health insurance in this state, a corporation organized pursuant to article forty-three of this chapter, and a health maintenance organization certified pursuant to article forty-four of the public health law.Ins. Law § 338(a)(6) and once during each subsequent policy period. In addition, such insurersInsurer"Insurer" means an insurer authorized to write accident and health insurance in this state, a corporation organized pursuant to article forty-three of this chapter, and a health maintenance organization certified pursuant to article forty-four of the public health law.Ins. Law § 338(a)(6) shall provide a clear and conspicuous notice on their websites about their use of artificial intelligence-based algorithmsArtificial intelligence-based algorithm"Artificial intelligence-based algorithm" means any algorithm-based system that can, for a given set of human-defined objectives, make predictions, recommendations and/or decisions influencing real or virtual environments. An artificial intelligence-based algorithm uses machine and human-based inputs to: (A) perceive real and virtual environments; (B) abstract such perceptions into models through analysis in an automated manner; and (C) use model inference to formulate options for information or action.Ins. Law § 338(a)(2) in the utilization reviewUtilization review"Utilization review" shall have the same meaning as such term is defined by section forty-nine hundred of this chapter.Ins. Law § 338(a)(7) process.
(b)(2) 2 If artificial intelligence-based algorithmsArtificial intelligence-based algorithm"Artificial intelligence-based algorithm" means any algorithm-based system that can, for a given set of human-defined objectives, make predictions, recommendations and/or decisions influencing real or virtual environments. An artificial intelligence-based algorithm uses machine and human-based inputs to: (A) perceive real and virtual environments; (B) abstract such perceptions into models through analysis in an automated manner; and (C) use model inference to formulate options for information or action.Ins. Law § 338(a)(2) are used in the utilization reviewUtilization review"Utilization review" shall have the same meaning as such term is defined by section forty-nine hundred of this chapter.Ins. Law § 338(a)(7) process, each insurerInsurer"Insurer" means an insurer authorized to write accident and health insurance in this state, a corporation organized pursuant to article forty-three of this chapter, and a health maintenance organization certified pursuant to article forty-four of the public health law.Ins. Law § 338(a)(6) shall disclose to the insured's or enrollee's health care providerHealth care provider"Health care provider" shall have the same meaning as such term is defined by section thirty-two hundred twenty-four-a of this chapter.Ins. Law § 338(a)(5), and, upon request, to the insured or enrollee, the following information: the criteria governing such artificial intelligence-based algorithmArtificial intelligence-based algorithm"Artificial intelligence-based algorithm" means any algorithm-based system that can, for a given set of human-defined objectives, make predictions, recommendations and/or decisions influencing real or virtual environments. An artificial intelligence-based algorithm uses machine and human-based inputs to: (A) perceive real and virtual environments; (B) abstract such perceptions into models through analysis in an automated manner; and (C) use model inference to formulate options for information or action.Ins. Law § 338(a)(2), the data sets used to train such artificial intelligence-based algorithmArtificial intelligence-based algorithm"Artificial intelligence-based algorithm" means any algorithm-based system that can, for a given set of human-defined objectives, make predictions, recommendations and/or decisions influencing real or virtual environments. An artificial intelligence-based algorithm uses machine and human-based inputs to: (A) perceive real and virtual environments; (B) abstract such perceptions into models through analysis in an automated manner; and (C) use model inference to formulate options for information or action.Ins. Law § 338(a)(2), the artificial intelligence-based algorithmArtificial intelligence-based algorithm"Artificial intelligence-based algorithm" means any algorithm-based system that can, for a given set of human-defined objectives, make predictions, recommendations and/or decisions influencing real or virtual environments. An artificial intelligence-based algorithm uses machine and human-based inputs to: (A) perceive real and virtual environments; (B) abstract such perceptions into models through analysis in an automated manner; and (C) use model inference to formulate options for information or action.Ins. Law § 338(a)(2) itself, and the outcomes produced by software that uses the artificial intelligence-based algorithmArtificial intelligence-based algorithm"Artificial intelligence-based algorithm" means any algorithm-based system that can, for a given set of human-defined objectives, make predictions, recommendations and/or decisions influencing real or virtual environments. An artificial intelligence-based algorithm uses machine and human-based inputs to: (A) perceive real and virtual environments; (B) abstract such perceptions into models through analysis in an automated manner; and (C) use model inference to formulate options for information or action.Ins. Law § 338(a)(2).
(b)(3) 3 An insurerInsurer"Insurer" means an insurer authorized to write accident and health insurance in this state, a corporation organized pursuant to article forty-three of this chapter, and a health maintenance organization certified pursuant to article forty-four of the public health law.Ins. Law § 338(a)(6)'s use of artificial intelligence-based algorithmsArtificial intelligence-based algorithm"Artificial intelligence-based algorithm" means any algorithm-based system that can, for a given set of human-defined objectives, make predictions, recommendations and/or decisions influencing real or virtual environments. An artificial intelligence-based algorithm uses machine and human-based inputs to: (A) perceive real and virtual environments; (B) abstract such perceptions into models through analysis in an automated manner; and (C) use model inference to formulate options for information or action.Ins. Law § 338(a)(2) in the utilization reviewUtilization review"Utilization review" shall have the same meaning as such term is defined by section forty-nine hundred of this chapter.Ins. Law § 338(a)(7) process shall be disclosed to the insured or enrollee and to the insured's or enrollee's health care providerHealth care provider"Health care provider" shall have the same meaning as such term is defined by section thirty-two hundred twenty-four-a of this chapter.Ins. Law § 338(a)(5) in the notice of an adverse determinationAdverse determination"Adverse determination" shall have the same meaning as such term is defined by section forty-nine hundred of this chapter.Ins. Law § 338(a)(1) made by clinical peer reviewersClinical peer reviewer"Clinical peer reviewer" shall have the same meaning as such term is defined by section forty-nine hundred of this chapter.Ins. Law § 338(a)(3) pursuant to subsection (e) of section forty-nine hundred three of this chapter and subdivision five of section forty-nine hundred three of the public health law.
(b)(4) 4 Any artificial intelligence-based algorithmsArtificial intelligence-based algorithm"Artificial intelligence-based algorithm" means any algorithm-based system that can, for a given set of human-defined objectives, make predictions, recommendations and/or decisions influencing real or virtual environments. An artificial intelligence-based algorithm uses machine and human-based inputs to: (A) perceive real and virtual environments; (B) abstract such perceptions into models through analysis in an automated manner; and (C) use model inference to formulate options for information or action.Ins. Law § 338(a)(2) used in the utilization reviewUtilization review"Utilization review" shall have the same meaning as such term is defined by section forty-nine hundred of this chapter.Ins. Law § 338(a)(7) process by an insurerInsurer"Insurer" means an insurer authorized to write accident and health insurance in this state, a corporation organized pursuant to article forty-three of this chapter, and a health maintenance organization certified pursuant to article forty-four of the public health law.Ins. Law § 338(a)(6) shall not base an adverse determinationAdverse determination"Adverse determination" shall have the same meaning as such term is defined by section forty-nine hundred of this chapter.Ins. Law § 338(a)(1) solely on a group data set.
(b)(5) 5 Any artificial intelligence-based algorithmsArtificial intelligence-based algorithm"Artificial intelligence-based algorithm" means any algorithm-based system that can, for a given set of human-defined objectives, make predictions, recommendations and/or decisions influencing real or virtual environments. An artificial intelligence-based algorithm uses machine and human-based inputs to: (A) perceive real and virtual environments; (B) abstract such perceptions into models through analysis in an automated manner; and (C) use model inference to formulate options for information or action.Ins. Law § 338(a)(2) used in the utilization reviewUtilization review"Utilization review" shall have the same meaning as such term is defined by section forty-nine hundred of this chapter.Ins. Law § 338(a)(7) process by an insurerInsurer"Insurer" means an insurer authorized to write accident and health insurance in this state, a corporation organized pursuant to article forty-three of this chapter, and a health maintenance organization certified pursuant to article forty-four of the public health law.Ins. Law § 338(a)(6) shall not directly or indirectly cause harm to the insured or enrollee.
(b)(6) 6 Any artificial intelligence-based algorithmsArtificial intelligence-based algorithm"Artificial intelligence-based algorithm" means any algorithm-based system that can, for a given set of human-defined objectives, make predictions, recommendations and/or decisions influencing real or virtual environments. An artificial intelligence-based algorithm uses machine and human-based inputs to: (A) perceive real and virtual environments; (B) abstract such perceptions into models through analysis in an automated manner; and (C) use model inference to formulate options for information or action.Ins. Law § 338(a)(2) used in the utilization reviewUtilization review"Utilization review" shall have the same meaning as such term is defined by section forty-nine hundred of this chapter.Ins. Law § 338(a)(7) process by an insurerInsurer"Insurer" means an insurer authorized to write accident and health insurance in this state, a corporation organized pursuant to article forty-three of this chapter, and a health maintenance organization certified pursuant to article forty-four of the public health law.Ins. Law § 338(a)(6) shall be open to inspection for audit or compliance reviews by the superintendent in accordance with applicable state and federal laws.
(b)(7) 7 Insured and enrollee data shall not be used beyond its intended and stated purpose, consistent with the federal Health Insurance Portability and Accountability Act of 1996, as applicable.
This subsection imposes a suite of disclosure, data governance, and regulatory transparency obligations on insurers that use AI-based algorithms in utilization review. Insurers must provide written notice to insureds, enrollees, and providers when AI algorithms are first adopted and once per policy period thereafter, and must maintain a conspicuous website disclosure. They must also disclose upon request the criteria, training data sets, the algorithm itself, and the outcomes produced. AI use must also be disclosed in adverse determination notices.
The subsection further restricts AI in utilization review: algorithms may not base adverse determinations solely on group data sets, may not directly or indirectly cause harm, and must be open to regulatory inspection. Insured and enrollee data may not be used beyond its intended purpose, consistent with HIPAA.
(c) 8 Every insurerInsurer"Insurer" means an insurer authorized to write accident and health insurance in this state, a corporation organized pursuant to article forty-three of this chapter, and a health maintenance organization certified pursuant to article forty-four of the public health law.Ins. Law § 338(a)(6) shall submit the artificial intelligence-based algorithmsArtificial intelligence-based algorithm"Artificial intelligence-based algorithm" means any algorithm-based system that can, for a given set of human-defined objectives, make predictions, recommendations and/or decisions influencing real or virtual environments. An artificial intelligence-based algorithm uses machine and human-based inputs to: (A) perceive real and virtual environments; (B) abstract such perceptions into models through analysis in an automated manner; and (C) use model inference to formulate options for information or action.Ins. Law § 338(a)(2) and training data sets that are being used or will be used in the utilization reviewUtilization review"Utilization review" shall have the same meaning as such term is defined by section forty-nine hundred of this chapter.Ins. Law § 338(a)(7) process to the superintendent. Such submissions shall include, at a minimum, a certification that such artificial intelligence-based algorithmsArtificial intelligence-based algorithm"Artificial intelligence-based algorithm" means any algorithm-based system that can, for a given set of human-defined objectives, make predictions, recommendations and/or decisions influencing real or virtual environments. An artificial intelligence-based algorithm uses machine and human-based inputs to: (A) perceive real and virtual environments; (B) abstract such perceptions into models through analysis in an automated manner; and (C) use model inference to formulate options for information or action.Ins. Law § 338(a)(2) and training data sets: (1) have minimized the risk of bias based on the covered person's race, color, religious creed, ancestry, age, sex, gender, national origin, handicap or disability, and are consistent with state and federal antidiscrimination laws; (2) adhere to evidence-based clinical guidelines; (3) do not rely on information that is not in compliance with the requirements for utilization reviewUtilization review"Utilization review" shall have the same meaning as such term is defined by section forty-nine hundred of this chapter.Ins. Law § 338(a)(7) pursuant to section forty-nine hundred three of this chapter and section forty-nine hundred three of the public health law; and (4) do not independently create or change clinical standards or other coverage criteria.
This subsection requires every insurer to submit its AI-based algorithms and training data sets to the Superintendent of Financial Services, with certifications that the algorithms have minimized the risk of bias across enumerated protected characteristics, adhere to evidence-based clinical guidelines, comply with existing utilization review requirements, and do not independently create or change clinical standards or coverage criteria. This is a proactive regulatory submission obligation — insurers must file before or upon deploying AI algorithms in utilization review, not merely respond to a regulatory request.
(d)(1) 9 An insurerInsurer"Insurer" means an insurer authorized to write accident and health insurance in this state, a corporation organized pursuant to article forty-three of this chapter, and a health maintenance organization certified pursuant to article forty-four of the public health law.Ins. Law § 338(a)(6) with a utilization reviewUtilization review"Utilization review" shall have the same meaning as such term is defined by section forty-nine hundred of this chapter.Ins. Law § 338(a)(7) process that initially uses artificial intelligence-based algorithmsArtificial intelligence-based algorithm"Artificial intelligence-based algorithm" means any algorithm-based system that can, for a given set of human-defined objectives, make predictions, recommendations and/or decisions influencing real or virtual environments. An artificial intelligence-based algorithm uses machine and human-based inputs to: (A) perceive real and virtual environments; (B) abstract such perceptions into models through analysis in an automated manner; and (C) use model inference to formulate options for information or action.Ins. Law § 338(a)(2), shall ensure that adverse determinationsAdverse determination"Adverse determination" shall have the same meaning as such term is defined by section forty-nine hundred of this chapter.Ins. Law § 338(a)(1) are made only by clinical peer reviewersClinical peer reviewer"Clinical peer reviewer" shall have the same meaning as such term is defined by section forty-nine hundred of this chapter.Ins. Law § 338(a)(3). A clinical peer reviewerClinical peer reviewer"Clinical peer reviewer" shall have the same meaning as such term is defined by section forty-nine hundred of this chapter.Ins. Law § 338(a)(3) who participates in a utilization reviewUtilization review"Utilization review" shall have the same meaning as such term is defined by section forty-nine hundred of this chapter.Ins. Law § 338(a)(7) process for an insurerInsurer"Insurer" means an insurer authorized to write accident and health insurance in this state, a corporation organized pursuant to article forty-three of this chapter, and a health maintenance organization certified pursuant to article forty-four of the public health law.Ins. Law § 338(a)(6) that initially uses artificial intelligence-based algorithmsArtificial intelligence-based algorithm"Artificial intelligence-based algorithm" means any algorithm-based system that can, for a given set of human-defined objectives, make predictions, recommendations and/or decisions influencing real or virtual environments. An artificial intelligence-based algorithm uses machine and human-based inputs to: (A) perceive real and virtual environments; (B) abstract such perceptions into models through analysis in an automated manner; and (C) use model inference to formulate options for information or action.Ins. Law § 338(a)(2) for a utilization reviewUtilization review"Utilization review" shall have the same meaning as such term is defined by section forty-nine hundred of this chapter.Ins. Law § 338(a)(7) shall, prior to issuing an adverse determinationAdverse determination"Adverse determination" shall have the same meaning as such term is defined by section forty-nine hundred of this chapter.Ins. Law § 338(a)(1): consider the requesting health provider's recommendation, the insured's or enrollee's medical or other clinical history, as applicable, and individual clinical circumstances; open and document the utilization review of the individual clinical records and data; and comply with all requirements of article forty-nine of this chapter and article forty-nine of the public health law regarding utilization reviewUtilization review"Utilization review" shall have the same meaning as such term is defined by section forty-nine hundred of this chapter.Ins. Law § 338(a)(7). In addition, a utilization reviewUtilization review"Utilization review" shall have the same meaning as such term is defined by section forty-nine hundred of this chapter.Ins. Law § 338(a)(7) determination with respect to an emergency conditionEmergency condition"Emergency condition" shall have the same meaning as such term is defined by section forty-nine hundred of this chapter.Ins. Law § 338(a)(4) shall require application of a prudent layperson standard to the patient's presenting symptoms, without regard to final diagnosis.
(d)(2) 10 Every insurerInsurer"Insurer" means an insurer authorized to write accident and health insurance in this state, a corporation organized pursuant to article forty-three of this chapter, and a health maintenance organization certified pursuant to article forty-four of the public health law.Ins. Law § 338(a)(6) shall submit to the superintendent, in such form and manner as the superintendent may require, data on the amount of time a clinical peer reviewerClinical peer reviewer"Clinical peer reviewer" shall have the same meaning as such term is defined by section forty-nine hundred of this chapter.Ins. Law § 338(a)(3) spends examining an adverse determinationAdverse determination"Adverse determination" shall have the same meaning as such term is defined by section forty-nine hundred of this chapter.Ins. Law § 338(a)(1) prior to signing off on each adverse determinationAdverse determination"Adverse determination" shall have the same meaning as such term is defined by section forty-nine hundred of this chapter.Ins. Law § 338(a)(1).
(d)(3) 11 An artificial intelligence-based algorithmArtificial intelligence-based algorithm"Artificial intelligence-based algorithm" means any algorithm-based system that can, for a given set of human-defined objectives, make predictions, recommendations and/or decisions influencing real or virtual environments. An artificial intelligence-based algorithm uses machine and human-based inputs to: (A) perceive real and virtual environments; (B) abstract such perceptions into models through analysis in an automated manner; and (C) use model inference to formulate options for information or action.Ins. Law § 338(a)(2) shall not be the sole basis of an insurerInsurer"Insurer" means an insurer authorized to write accident and health insurance in this state, a corporation organized pursuant to article forty-three of this chapter, and a health maintenance organization certified pursuant to article forty-four of the public health law.Ins. Law § 338(a)(6)'s decision to deny, delay, or modify health care services based, in whole or in part, on medical necessity.
(d)(4) 12 Every clinical peer reviewerClinical peer reviewer"Clinical peer reviewer" shall have the same meaning as such term is defined by section forty-nine hundred of this chapter.Ins. Law § 338(a)(3) that participates in a utilization reviewUtilization review"Utilization review" shall have the same meaning as such term is defined by section forty-nine hundred of this chapter.Ins. Law § 338(a)(7) process for an insurerInsurer"Insurer" means an insurer authorized to write accident and health insurance in this state, a corporation organized pursuant to article forty-three of this chapter, and a health maintenance organization certified pursuant to article forty-four of the public health law.Ins. Law § 338(a)(6) issuing adverse determinationsAdverse determination"Adverse determination" shall have the same meaning as such term is defined by section forty-nine hundred of this chapter.Ins. Law § 338(a)(1) shall issue a signed statement in accordance with paragraph one of subsection (e) of section forty-nine hundred three of this chapter or paragraph (a) of subdivision five of section forty-nine hundred three of the public health law.
This subsection establishes the bill's human-oversight requirements when AI-based algorithms are used in utilization review. It mandates that adverse determinations be made only by clinical peer reviewers — not AI alone — and that those reviewers must consider the treating provider's recommendation and the individual patient's medical history and clinical circumstances before issuing an adverse determination. Emergency conditions must be evaluated under the prudent layperson standard without regard to final diagnosis. Insurers must also submit data to the Superintendent on the time clinical peer reviewers spend reviewing each adverse determination, and every clinical peer reviewer must issue a signed statement for each adverse determination.
(e) 13 Every insurerInsurer"Insurer" means an insurer authorized to write accident and health insurance in this state, a corporation organized pursuant to article forty-three of this chapter, and a health maintenance organization certified pursuant to article forty-four of the public health law.Ins. Law § 338(a)(6) shall establish an ongoing quality assurance testing process that meets any requirements that the superintendent may specify with defined parameters on safety and efficacy of all artificial intelligence-based algorithmsArtificial intelligence-based algorithm"Artificial intelligence-based algorithm" means any algorithm-based system that can, for a given set of human-defined objectives, make predictions, recommendations and/or decisions influencing real or virtual environments. An artificial intelligence-based algorithm uses machine and human-based inputs to: (A) perceive real and virtual environments; (B) abstract such perceptions into models through analysis in an automated manner; and (C) use model inference to formulate options for information or action.Ins. Law § 338(a)(2), and shall submit the results of such quality assurance testing process to the superintendent at such time and in such form and manner as the superintendent may specify, but not less frequently than semiannually. The results of such quality assurance testing process shall be published on a public website within thirty days of the submission of such results to the superintendent.
This subsection requires every insurer to establish an ongoing quality assurance testing process for all AI-based algorithms used in utilization review, with parameters on safety and efficacy as specified by the Superintendent. Test results must be submitted to the Superintendent at least semiannually and published on a public website within thirty days of each submission. This creates a dual obligation: periodic regulatory submission and mandatory public disclosure of testing outcomes.
(f)(1)–(2) A violation of the provisions of this section shall be subject to one or more of the following penalties at the discretion of the superintendent, in consultation with the commissioner of health and the commissioner of education as applicable: (A) Where a violation is made by an insurerInsurer"Insurer" means an insurer authorized to write accident and health insurance in this state, a corporation organized pursuant to article forty-three of this chapter, and a health maintenance organization certified pursuant to article forty-four of the public health law.Ins. Law § 338(a)(6): (i) suspension or revocation of license; (ii) refusal, for a period not to exceed one year, to issue a new license; (iii) a fine of not more than five thousand dollars for each violation of this section; or (iv) a fine of not more than ten thousand dollars for each willful violation of this section. Fines imposed pursuant to the provisions of this subparagraph on a single insurerInsurer"Insurer" means an insurer authorized to write accident and health insurance in this state, a corporation organized pursuant to article forty-three of this chapter, and a health maintenance organization certified pursuant to article forty-four of the public health law.Ins. Law § 338(a)(6) shall not exceed five hundred thousand dollars in aggregate during a calendar year. (B) Where a violation is made by a clinical peer reviewerClinical peer reviewer"Clinical peer reviewer" shall have the same meaning as such term is defined by section forty-nine hundred of this chapter.Ins. Law § 338(a)(3): (i) suspension or revocation of license; (ii) refusal, for a period not to exceed one year, to issue a new license; (iii) a fine of not more than five thousand dollars for each violation of this section; or (iv) a fine of not more than ten thousand dollars for each willful violation of this section. Fines imposed pursuant to the provisions of this subparagraph on a single clinical peer reviewerClinical peer reviewer"Clinical peer reviewer" shall have the same meaning as such term is defined by section forty-nine hundred of this chapter.Ins. Law § 338(a)(3) shall not exceed one hundred thousand dollars in aggregate during a calendar year. (2) Penalties pursuant to the provisions of this subsection shall be in addition to any other remedies or penalties that may be imposed under any other applicable law.
This subsection establishes a tiered penalty scheme for violations. For insurers, penalties range up to $5,000 per violation or $10,000 per willful violation, with a $500,000 annual aggregate cap. For clinical peer reviewers, the same per-violation amounts apply, with a $100,000 annual aggregate cap. Both parties face possible license suspension, revocation, or refusal to issue a new license. Penalties are in addition to any other remedies under other applicable law.
(g) The superintendent shall promulgate all rules and regulations necessary for the implementation of this section.
This subsection grants the Superintendent of Financial Services authority to promulgate all rules and regulations necessary for implementing section 338. This is a standard rulemaking delegation that creates no independent compliance obligation on regulated entities.
For purposes of this paragraph, an "emergency conditionEmergency condition"Emergency condition" shall have the same meaning as such term is defined by section forty-nine hundred of this chapter.Ins. Law § 338(a)(4)" means a medical or behavioral condition that, regardless of the final diagnosis, manifests itself by acute symptoms of sufficient severity, including severe pain, such that a prudent layperson, possessing an average knowledge of medicine and health, could reasonably expect the absence of immediate medical attention to result in (i) placing the health of the person afflicted with such condition in serious jeopardy, or in the case of a behavioral condition placing the health of such person or others in serious jeopardy; (ii) serious impairment to such person's bodily functions; (iii) serious dysfunction of any bodily organ or part of such person; (iv) serious disfigurement of such person; or (v) a condition described in clause (i), (ii) or (iii) of section 1867(e)(1)(A) of the Social Security Act.
This section amends the definition of emergency condition for individual accident and health insurance policies to add the clause "regardless of the final diagnosis" to the prudent layperson standard. This ensures that emergency coverage determinations are based on presenting symptoms as perceived by a prudent layperson, not the eventual diagnosis. The amendment does not create a new compliance obligation but modifies an existing definition.
"Emergency conditionEmergency condition"Emergency condition" shall have the same meaning as such term is defined by section forty-nine hundred of this chapter.Ins. Law § 338(a)(4)" means a medical or behavioral condition that, regardless of final diagnosis, manifests itself by acute symptoms of sufficient severity, including severe pain, such that a prudent layperson, possessing an average knowledge of medicine and health, could reasonably expect the absence of immediate medical attention to result in (I) placing the health of the person afflicted with such condition in serious jeopardy, or in the case of a behavioral condition placing the health of such person or others in serious jeopardy; (II) serious impairment to such person's bodily functions; (III) serious dysfunction of any bodily organ or part of such person; (IV) serious disfigurement of such person; or (V) a condition described in clause (i), (ii), or (iii) of section 1867(e)(1)(A) of the Social Security Act.
This section makes a parallel amendment to the emergency condition definition within the step therapy protocol provisions of the Insurance Law, adding "regardless of final diagnosis" to the prudent layperson standard.
In this paragraph, an "emergency conditionEmergency condition"Emergency condition" shall have the same meaning as such term is defined by section forty-nine hundred of this chapter.Ins. Law § 338(a)(4)" means a medical or behavioral condition that, regardless of the final diagnosis, manifests itself by acute symptoms of sufficient severity, including severe pain, such that a prudent layperson, possessing an average knowledge of medicine and health, could reasonably expect the absence of immediate medical attention to result in (i) placing the health of the person afflicted with such condition in serious jeopardy, or in the case of a behavioral condition placing the health of such person or others in serious jeopardy; (ii) serious impairment to such person's bodily functions; (iii) serious dysfunction of any bodily organ or part of such person; (iv) serious disfigurement of such person; or (v) a condition described in clause (i), (ii) or (iii) of section 1867(e)(1)(A) of the Social Security Act.
This section amends the emergency condition definition for group accident and health insurance policies, adding the "regardless of the final diagnosis" clause to the prudent layperson standard consistent with the other sections of the bill.
For the purpose of this provision, "emergency conditionEmergency condition"Emergency condition" shall have the same meaning as such term is defined by section forty-nine hundred of this chapter.Ins. Law § 338(a)(4)" means a medical or behavioral condition that, regardless of the final diagnosis, manifests itself by acute symptoms of sufficient severity, including severe pain, such that a prudent layperson, possessing an average knowledge of medicine and health, could reasonably expect the absence of immediate medical attention to result in (i) placing the health of the person afflicted with such condition in serious jeopardy, or in the case of a behavioral condition placing the health of such person or others in serious jeopardy; (ii) serious impairment to such person's bodily functions; (iii) serious dysfunction of any bodily organ or part of such person; (iv) serious disfigurement of such person; or (v) a condition described in clause (i), (ii) or (iii) of section 1867(e)(1)(A) of the Social Security Act.
This section amends the emergency condition definition applicable to HMO contracts, adding "regardless of the final diagnosis" to the prudent layperson standard consistent with the amendments to other Insurance Law sections.
"Emergency conditionEmergency condition"Emergency condition" shall have the same meaning as such term is defined by section forty-nine hundred of this chapter.Ins. Law § 338(a)(4)" means a medical or behavioral condition that, regardless of the final diagnosis, manifests itself by acute symptoms of sufficient severity, including severe pain, such that a prudent layperson, possessing an average knowledge of medicine and health, could reasonably expect the absence of immediate medical attention to result in (1) placing the health of the person afflicted with such condition in serious jeopardy, or in the case of a behavioral condition placing the health of such person or others in serious jeopardy; (2) serious impairment to such person's bodily functions; (3) serious dysfunction of any bodily organ or part of such person; (4) serious disfigurement of such person; or (5) a condition described in clause (i), (ii) or (iii) of section 1867(e)(1)(A) of the Social Security Act.
This section amends the master emergency condition definition in Insurance Law Article 49 (Utilization Review), adding "regardless of the final diagnosis" to the prudent layperson standard. Because this definition is cross-referenced by § 338(a)(4), this amendment directly affects the new AI utilization review requirements.
"Emergency conditionEmergency condition"Emergency condition" shall have the same meaning as such term is defined by section forty-nine hundred of this chapter.Ins. Law § 338(a)(4)" means a medical or behavioral condition that, regardless of the final diagnosis, manifests itself by acute symptoms of sufficient severity, including severe pain, such that a prudent layperson, possessing an average knowledge of medicine and health, could reasonably expect the absence of immediate medical attention to result in (a) placing the health of the person afflicted with such condition in serious jeopardy, or in the case of a behavioral condition, placing the health of such person or others in serious jeopardy; (b) serious impairment to such person's bodily functions; (c) serious dysfunction of any bodily organ or part of such person; (d) serious disfigurement of such person; or (e) a condition described in clause (i), (ii) or (iii) of section 1867(e)(1)(A) of the Social Security Act.
This section makes the parallel amendment to the emergency condition definition in the Public Health Law's utilization review article, adding "regardless of the final diagnosis" to the prudent layperson standard.
(e)(1)(i) 14 Notice of an adverse determinationAdverse determination"Adverse determination" shall have the same meaning as such term is defined by section forty-nine hundred of this chapter.Ins. Law § 338(a)(1) made by a utilization reviewUtilization review"Utilization review" shall have the same meaning as such term is defined by section forty-nine hundred of this chapter.Ins. Law § 338(a)(7) agent shall be in writing and must include: (i) the reasons for the determination including the clinical rationale, if any, and the specific coverage or clinical criteria that were not satisfied, including explicit identification of the relevant language contained in any clinical criteria relied upon to make the adverse determinationAdverse determination"Adverse determination" shall have the same meaning as such term is defined by section forty-nine hundred of this chapter.Ins. Law § 338(a)(1) and a clear explanation of the rationale supporting the determination that such clinical criteria were deemed not satisfied;
(e)(1)(v) 15 a statement signed by the clinical peer reviewerClinical peer reviewer"Clinical peer reviewer" shall have the same meaning as such term is defined by section forty-nine hundred of this chapter.Ins. Law § 338(a)(3) that made the adverse determinationAdverse determination"Adverse determination" shall have the same meaning as such term is defined by section forty-nine hundred of this chapter.Ins. Law § 338(a)(1) containing the following information: (a) the full printed name of such clinical peer reviewerClinical peer reviewer"Clinical peer reviewer" shall have the same meaning as such term is defined by section forty-nine hundred of this chapter.Ins. Law § 338(a)(3); (b) such clinical peer reviewerClinical peer reviewer"Clinical peer reviewer" shall have the same meaning as such term is defined by section forty-nine hundred of this chapter.Ins. Law § 338(a)(3)'s national provider identification number; (c) such clinical peer reviewerClinical peer reviewer"Clinical peer reviewer" shall have the same meaning as such term is defined by section forty-nine hundred of this chapter.Ins. Law § 338(a)(3)'s credentials, including any board certifications and areas of specialty expertise and training, as applicable; (d) the taxonomy code of such clinical peer reviewerClinical peer reviewer"Clinical peer reviewer" shall have the same meaning as such term is defined by section forty-nine hundred of this chapter.Ins. Law § 338(a)(3); (e) an attestation by such clinical peer reviewerClinical peer reviewer"Clinical peer reviewer" shall have the same meaning as such term is defined by section forty-nine hundred of this chapter.Ins. Law § 338(a)(3) that they have the appropriate training and expertise in the field of medicine that is sufficient to make an informed decision regarding the medical necessity of the health care service or supply being requested on behalf of the insured and that they have no conflicts of interest that would interfere with their ability to make an impartial determination based on the merits of the specific patient case; (f) documentation of the amount of time such clinical peer reviewerClinical peer reviewer"Clinical peer reviewer" shall have the same meaning as such term is defined by section forty-nine hundred of this chapter.Ins. Law § 338(a)(3) spent evaluating the medical record or other information related to the review before confirming the adverse determinationAdverse determination"Adverse determination" shall have the same meaning as such term is defined by section forty-nine hundred of this chapter.Ins. Law § 338(a)(1); (g) an indication of whether such clinical peer reviewerClinical peer reviewer"Clinical peer reviewer" shall have the same meaning as such term is defined by section forty-nine hundred of this chapter.Ins. Law § 338(a)(3) reviewed a prepared summary of the patient's medical records or the patient's actual medical records in making their adverse determinationAdverse determination"Adverse determination" shall have the same meaning as such term is defined by section forty-nine hundred of this chapter.Ins. Law § 338(a)(1); and
(e)(1)(vi) 16 a statement as to whether an artificial intelligence-based algorithmArtificial intelligence-based algorithm"Artificial intelligence-based algorithm" means any algorithm-based system that can, for a given set of human-defined objectives, make predictions, recommendations and/or decisions influencing real or virtual environments. An artificial intelligence-based algorithm uses machine and human-based inputs to: (A) perceive real and virtual environments; (B) abstract such perceptions into models through analysis in an automated manner; and (C) use model inference to formulate options for information or action.Ins. Law § 338(a)(2), as such term is defined by section three hundred thirty-eight of this chapter, was used in the utilization reviewUtilization review"Utilization review" shall have the same meaning as such term is defined by section forty-nine hundred of this chapter.Ins. Law § 338(a)(7) process, and a plain language explanation as to how such artificial intelligence-based algorithmArtificial intelligence-based algorithm"Artificial intelligence-based algorithm" means any algorithm-based system that can, for a given set of human-defined objectives, make predictions, recommendations and/or decisions influencing real or virtual environments. An artificial intelligence-based algorithm uses machine and human-based inputs to: (A) perceive real and virtual environments; (B) abstract such perceptions into models through analysis in an automated manner; and (C) use model inference to formulate options for information or action.Ins. Law § 338(a)(2) was employed and where the insured and health care providerHealth care provider"Health care provider" shall have the same meaning as such term is defined by section thirty-two hundred twenty-four-a of this chapter.Ins. Law § 338(a)(5) can find more information about the specific usage of such artificial intelligence-based algorithmArtificial intelligence-based algorithm"Artificial intelligence-based algorithm" means any algorithm-based system that can, for a given set of human-defined objectives, make predictions, recommendations and/or decisions influencing real or virtual environments. An artificial intelligence-based algorithm uses machine and human-based inputs to: (A) perceive real and virtual environments; (B) abstract such perceptions into models through analysis in an automated manner; and (C) use model inference to formulate options for information or action.Ins. Law § 338(a)(2).
This section amends the content of written adverse determination notices issued by utilization review agents under the Insurance Law. It adds two new required elements: a signed statement by the clinical peer reviewer who made the determination — including their full name, NPI number, credentials, taxonomy code, an attestation of training and impartiality, documentation of time spent reviewing, and an indication of whether they reviewed actual medical records or a summary — and a statement disclosing whether an AI-based algorithm was used, with a plain language explanation of how it was employed and where to find more information. The section also strengthens existing requirements by mandating identification of the specific clinical criteria not satisfied and a clear rationale for the determination.
(5)(a)(i) 17 Notice of an adverse determinationAdverse determination"Adverse determination" shall have the same meaning as such term is defined by section forty-nine hundred of this chapter.Ins. Law § 338(a)(1) made by a utilization reviewUtilization review"Utilization review" shall have the same meaning as such term is defined by section forty-nine hundred of this chapter.Ins. Law § 338(a)(7) agent shall be in writing and must include: (i) the reasons for the determination including the clinical rationale, if any, and the specific coverage or clinical criteria that were not satisfied, including explicit identification of the relevant language contained in any clinical criteria relied upon to make the adverse determinationAdverse determination"Adverse determination" shall have the same meaning as such term is defined by section forty-nine hundred of this chapter.Ins. Law § 338(a)(1) and a clear explanation of the rationale supporting the determination that such clinical criteria were deemed not satisfied;
(5)(a)(v) 18 a statement signed by the physician who made the adverse determinationAdverse determination"Adverse determination" shall have the same meaning as such term is defined by section forty-nine hundred of this chapter.Ins. Law § 338(a)(1) containing the following information: (A) the full printed name of such physician; (B) such physician's national provider identification number; (C) such physician's credentials, including any board certifications and areas of specialty expertise and training, as applicable; (D) the taxonomy code of such physician; (E) an attestation by such physician that they have the appropriate training and expertise in the field of medicine that is sufficient to make an informed decision regarding the medical necessity of the health care service or supply being requested on behalf of the insured and that they have no conflicts of interest that would interfere with their ability to make an impartial determination based on the merits of the specific patient case; (F) documentation of the amount of time such physician spent evaluating the medical record or other information related to the review before confirming the adverse determinationAdverse determination"Adverse determination" shall have the same meaning as such term is defined by section forty-nine hundred of this chapter.Ins. Law § 338(a)(1); (G) an indication of whether such physician reviewed a prepared summary of the patient's medical records or the patient's actual medical records in making their adverse determinationAdverse determination"Adverse determination" shall have the same meaning as such term is defined by section forty-nine hundred of this chapter.Ins. Law § 338(a)(1); and
(5)(a)(vi) 19 a statement as to whether an artificial intelligence-based algorithmArtificial intelligence-based algorithm"Artificial intelligence-based algorithm" means any algorithm-based system that can, for a given set of human-defined objectives, make predictions, recommendations and/or decisions influencing real or virtual environments. An artificial intelligence-based algorithm uses machine and human-based inputs to: (A) perceive real and virtual environments; (B) abstract such perceptions into models through analysis in an automated manner; and (C) use model inference to formulate options for information or action.Ins. Law § 338(a)(2), as such term is defined by section three hundred thirty-eight of this chapter, was used in the utilization reviewUtilization review"Utilization review" shall have the same meaning as such term is defined by section forty-nine hundred of this chapter.Ins. Law § 338(a)(7) process, and a plain language explanation as to how such artificial intelligence-based algorithmArtificial intelligence-based algorithm"Artificial intelligence-based algorithm" means any algorithm-based system that can, for a given set of human-defined objectives, make predictions, recommendations and/or decisions influencing real or virtual environments. An artificial intelligence-based algorithm uses machine and human-based inputs to: (A) perceive real and virtual environments; (B) abstract such perceptions into models through analysis in an automated manner; and (C) use model inference to formulate options for information or action.Ins. Law § 338(a)(2) was employed and where the insured and health care providerHealth care provider"Health care provider" shall have the same meaning as such term is defined by section thirty-two hundred twenty-four-a of this chapter.Ins. Law § 338(a)(5) can find more information about the specific usage of such artificial intelligence-based algorithmArtificial intelligence-based algorithm"Artificial intelligence-based algorithm" means any algorithm-based system that can, for a given set of human-defined objectives, make predictions, recommendations and/or decisions influencing real or virtual environments. An artificial intelligence-based algorithm uses machine and human-based inputs to: (A) perceive real and virtual environments; (B) abstract such perceptions into models through analysis in an automated manner; and (C) use model inference to formulate options for information or action.Ins. Law § 338(a)(2).
This section makes parallel amendments to the adverse determination notice requirements in the Public Health Law's utilization review provisions. It mirrors the Insurance Law amendments: adverse determination notices must now include the specific clinical criteria not satisfied with explicit language identification, a signed statement by the physician who made the determination with their full credentials and attestations, and a statement disclosing whether an AI-based algorithm was used with a plain language explanation. The physician-signed statement provisions here use "physician" rather than "clinical peer reviewer" as in the Insurance Law counterpart.
This act shall take effect on the sixtieth day after it shall have become a law. Effective immediately, the addition, amendment and/or repeal of any rule or regulation necessary for the implementation of this act on its effective date are authorized to be made and completed on or before such effective date.
The act takes effect on the sixtieth day after becoming law. Rulemaking authority is granted immediately upon enactment to allow the Superintendent to prepare implementing regulations before the operative date.