Q&A Guidance on Health Insurance Laws passed in 2021-2023 related to opioid treatment programs, PrEP, colorectal cancer screening, rabies treatment, prescription drug coverage, and the Donate Life Registry.

(This guidance does not apply to Child Health Plus, Essential Plan, and Medicaid managed care coverage.  Contact the NYS Department of Health for information on the requirements for those coverages.)

Opioid Treatment Program

Chapter 734 of the Laws of 2022 applies to health insurance policies and contracts issued by insurers, Article 43 corporations, HMOs, Municipal Cooperative Health Benefit Plans authorized by Article 47 of the Insurance Law, and Institutions of Higher Education authorized pursuant to Section 1124 of the Insurance Law.  The law prohibits health insurance policies and contracts that provide coverage for treatment at an opioid treatment program from imposing a co-payment during the course of treatment for an insured.

Q.1. Does the prohibition on copayments for treatment at an opioid treatment program apply to coinsurance?
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Yes. The prohibition on copayments for treatment at an opioid treatment program applies to coinsurance as well.

Q.2. Does the prohibition on copayments and coinsurance for treatment at an opioid treatment program apply to in-network services only?
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Yes. The prohibition on copayments and coinsurance for treatment at an opioid treatment program applies to in-network services only.

Q.3. Does the prohibition on copayments and coinsurance for treatment at an opioid treatment program apply to deductibles?
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No. If a health insurance policy or contract contains a deductible (including an HSA eligible high deductible health plan), treatment at an opioid treatment program may be subject to the deductible. After the deducible is met, the prohibition on copayments and coinsurance applies.

Q.4. Does the prohibition on copayments and coinsurance for treatment at an opioid treatment program extend to opioid treatment medication provided at an opioid treatment program for home use?
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Yes. The prohibition on copayments and coinsurance applies to medication provided at an opioid treatment program for home use.

Q.5. Does the prohibition on copayments and coinsurance for treatment at an opioid treatment program extend to opioid treatment medication, such as buprenorphine or suboxone, that is prescribed on an outpatient basis?
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Yes, to the extent that the opioid treatment medication, such as buprenorphine or suboxone, is obtained at an opioid treatment program. However, a health insurance policy or contract is not prohibited from imposing the applicable prescription drug copayment or coinsurance to opioid treatment medication obtained at a pharmacy, rather than at an opioid treatment program.

Q.6. Does the prohibition on copayments and coinsurance for treatment at an opioid treatment program extend to medication obtained at a retail pharmacy?
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No. The prohibition on copayments and coinsurance does not apply to medication obtained at a retail pharmacy.

Q.7. Is the law limited to methadone treatment programs?
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No. Opioid treatment programs involve treatment with an opioid agonist medication, which may include methadone, buprenorphine, or suboxone.

Coverage of PrEP and PEP

Chapter 721 of the Laws of 2022, as amended by Chapter 79 of the Laws of 2023, applies to large group health insurance policies and contracts issued by insurers, Article 43 corporations, HMOs, Municipal Cooperative Health Benefit Plans authorized by Article 47 of the Insurance Law, and Institutions of Higher Education authorized pursuant to Section 1124 of the Insurance Law.  The law requires large group health insurance policies that cover prescription drugs to cover pre-exposure prophylaxis (PrEP) and post-exposure prophylaxis (PEP) for the prevention of HIV.

Q.1. Are insurers required to cover PrEP under individual, small group, and large group health insurance policies and contracts (including prior to the passage of Chapter 721 of the Laws of 2022, as amended by Chapter 79 of the Laws of 2023)?
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Yes. Insurers are required to cover preventive services in accordance with the A and B recommendations of the United States Preventive Services Task Force (USPSTF) under non-grandfathered individual, small group, and large group health insurance policies and contracts at no-cost sharing (and this requirement was extended to large-group grandfathered plans pursuant to Chapter 721 of the Laws of 2022, as amended by Chapter 79). The USPSTF issued an “A” rated recommendation that clinicians offer PrEP with effective antiretroviral therapy to persons who are at high risk of HIV acquisition.

Q.2. Are insurers required to cover the prescription drugs used for PEP under individual, small group, and large group health insurance policies and contracts (including prior to the passage of Chapter 721 of the Laws of 2022, as amended by Chapter 79 of the Laws of 2023)?
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Yes. Insurers are required to cover at least one drug in every class of drugs under individual, small group, and large group health insurance policies and contracts that provide coverage for prescription drugs. However, cost-sharing may be imposed.

Q.3. Are insurers required to cover PrEP and PEP injectable drugs under individual, small group, and large group health insurance policies and contracts (including prior to the passage of Chapter 721 of the Laws of 2022, as amended by Chapter 79 of the Laws of 2023)?
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Yes. Injectable drugs provided during an office visit are covered if medically necessary, including PrEP and PEP. If PrEP is provided in accordance with the A and B recommendations of the USPSTF, cost-sharing may not be imposed (including under large group grandfathered plans pursuant to Chapter 721 of the Laws of 2022, as amended by Chapter 79).

Q.4. Does Chapter 721 of the Laws of 2022, as amended by Chapter 79 of the Laws of 2023, apply to individual and small group policies and contracts?
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No. The law is only applicable to large group policies and contracts.

Q.5. Does Chapter 721 of the Laws of 2022, as amended by Chapter 79 of the Laws of 2023, apply to grandfathered large group policies and contracts?
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Yes. The law applies to grandfathered large group policies and contracts.

Q.6. What PrEP and PEP coverage requirements are imposed by Chapter 721 of the Laws of 2022, as amended by Chapter 79 of the Laws of 2023?
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The law requires comprehensive large group health insurance policies and contracts, including grandfathered plans, to cover PrEP and PEP. If PrEP is provided in accordance with the A and B recommendations of the USPSTF, cost-sharing may not be imposed.

Colorectal Cancer Screening

Chapter 739 of the Laws of 2022, as amended by Chapter 78 of the Laws of 2023, requires large group health insurance policies and contracts issued by insurers, Article 43 corporations, HMOs, Municipal Cooperative Health Benefit Plans authorized by Article 47 of the Insurance Law, and Institutions of Higher Education authorized pursuant to Section 1124 of the Insurance Law to cover colorectal cancer screening in accordance with the American Cancer Society guidelines without copayments, coinsurance, or deductibles (“cost-sharing”).

Q.1. Are non-grandfathered large group policies and contracts required to follow the recommendations of the United States Preventive Services Task Force (USPSTF) or the American Cancer Society guidelines with respect to colon cancer screening?
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Non-grandfathered large group policies and contracts are required to follow the recommendations of both the USPSTF and the guidelines of the American Cancer Society with respect to colon cancer screening and provide such coverage without cost-sharing.

Q.2. Are grandfathered large group policies and contracts required to follow the recommendations of the United States Preventive Services Task Force (USPSTF) or the American Cancer Society guidelines with respect to colon cancer screening?
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Grandfathered large group policies and contracts are required to follow the recommendations of the American Cancer Society with respect to colon cancer screening and provide such coverage without cost-sharing.

Are insurers required to cover colon cancer screening under individual and small group health insurance policies and contracts?
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Yes.  Insurers are required to cover preventive services in accordance with the A and B recommendations of the United States Preventive Services Task Force (USPSTF) for non-grandfathered plans at no-cost sharing.  The USPSTF issued a “B” rated recommendation for colorectal cancer screening in adults aged 45 to 49 years and an “A” rated recommendation for colorectal cancer screening in adults aged 50 to 75 years.

(Non-grandfathered plan means: (i) a health insurance policy created or purchased after March 23, 2010, and (ii) a health insurance policy created or purchased on or before March 23, 2010 that subsequently lost its grandfathered status.)

Q.4. What are the notification requirements in Chapter 739 of the Laws of 2022, as amended by Chapter 78 of the Laws of 2023?
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ANSWER TEXT TO SHOW OR HIDE

The law requires insurers, Article 43 corporations, and HMOs to notify insureds covered under individual, small group, and large group policies or contracts at least annually of colorectal cancer screenings covered under the health insurance policy or contract.  This includes Institutions of Higher Education authorized pursuant to Section 1124 of the Insurance Law issuing blanket policies.

In addition, the law also requires insurers, Article 43 corporations, and HMOs to notify insureds covered under large group policies or contracts of the most recently published guidelines of the American Cancer Society for colorectal cancer screening that are covered under the health insurance policy or contract.  The notice must be provided by mail, unless the insured consents to another type of notification, including electronic notification. 

Q.5. Do the notification requirements in Chapter 739 of the Laws of 2022, as amended by Chapter 78 of the Laws of 2023, apply to Municipal Cooperative Health Benefit Plans authorized by Article 47 of the Insurance Law?
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No. The law does not address Municipal Cooperative Health Benefit Plans.

Q.6. Does inclusion of the benefit in the health insurance policy or contract satisfy the requirement to provide insureds with annual notice of the colorectal cancer screening covered under the health insurance policy or contract and the requirement to provide insureds with annual notice of the most recently published guidelines of the American Cancer Society for colorectal screening for large group policies or contracts?
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No. The law requires insurers to provide insureds with annual notice of the colorectal cancer screening covered under the insured’s health insurance policy or contract. The law also requires insurers to provide insureds with annual notice of the most recently published guidelines of the American Cancer Society for colorectal cancer screenings for large group policies or contracts. The law requires that notice must be delivered by United States postal mail unless the insured consents to another method of notification, including electronic notification. Simply including the benefits in the health insurance policy or contract does not satisfy the notice requirements under the law.

Rabies Treatment

Chapter 655 of the Laws of 2022 amends the Public Health Law and provides that treatment for rabies exposure authorized by the county health authority shall satisfy preauthorization requirements under health insurance policies and contracts issued by insurers, Article 43 corporations, HMOs, Municipal Cooperative Health Benefit Plans authorized by Article 47 of the Insurance Law, and Institutions of Higher Education authorized pursuant to Section 1124 of the Insurance Law.

Q.1. Are insurers required to cover post-exposure treatment for rabies which has not been authorized by the county health authority?
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Insurers are required to cover medically necessary treatment regardless of whether or not such treatment has been authorized by the county health authority. If the treatment is authorized by the county health authority, the insurer is precluded from conducting a medical necessity review.

Patient Rx Information and Choice Expansion Act

Chapter 826 of the Laws of 2022, as amended by Chapter 63 of the Laws of 2023, requires an insurer, Article 43 Corporation, HMO, or pharmacy benefit manager (PBM) providing PBM services to any of those entities, upon request of an insured, the insured’s health care provider, or an authorized third party on the insured’s behalf to provide an insured with coverage and cost-sharing data for a prescribed drug and clinically appropriate alternatives.

Q.1. Does providing data on therapeutically equivalent generics satisfy the requirement to provide data regarding clinically appropriate alternatives? 
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Insurers should provide data on all clinically appropriate alternatives including, but not limited to, therapeutically equivalent generics.

Q.2. Does the law apply to Municipal Cooperative Health Benefit Plans authorized by Article 47 of the Insurance Law and Institutions of Higher Education authorized pursuant to Section 1124 of the Insurance Law?
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No. The law does not address Municipal Cooperative Health Benefit Plans and Institutions of Higher Education authorized pursuant to Section 1124 of the Insurance Law.

Financial Assistance for Prescription Drugs

Chapter 736 of the Laws of 2022, as amended by Chapter 117 of the Laws of 2023, applies to health insurance policies or contracts issued by insurers, Article 43 corporations, HMOs, Municipal Cooperative Health Benefit Plans authorized by Article 47 of the Insurance Law, and Institutions of Higher Education authorized pursuant to Section 1124 of the Insurance Law that provide coverage for prescription drugs.  The law requires insurers to apply any third-party payments, financial assistance, discount, voucher, or other price reduction instrument for out-of-pocket expenses made on behalf of an insured individual for the cost of prescription drugs to the insured's deductible, copayment, coinsurance, out-of-pocket maximum, or any other cost-sharing requirement when calculating such insured individual's overall contribution to any out-of-pocket maximum or any cost-sharing requirement.  The law applies to a prescription drug that is either (A) a brand-name drug without an AB rated generic equivalent, as determined by the United States Food and Drug Administration (“FDA”); or (B) a brand-name drug with an AB rated generic equivalent, as determined by the FDA, and the insured has access to the brand-name drug through prior authorization by the insurer or through the insurer's appeal process, including any step-therapy process; or (C) a generic drug the insurer will cover, with or without prior authorization or an appeal process.

Q.1. Does this law apply to prescription drugs covered under the medical benefits section of the insured’s health insurance policy or contract?
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Yes. The law applies to prescription drugs covered under the insured’s health insurance policy or contract, regardless of the section of the policy or contract where the benefits are covered.

Prescription Drug Availability at Retail Pharmacy

Chapter 827 of the Laws of 2021 applies to health insurance policies or contracts issued by insurers, Article 43 corporations, HMOs, Municipal Cooperative Health Benefit Plans authorized by Article 47 of the Insurance Law, and Institutions of Higher Education authorized pursuant to Section 1124 of the Insurance Law.  The law requires that insurers permit an insured to obtain a mail order prescription drug at a participating retail pharmacy that agrees to the same reimbursement rate as the mail order pharmacy.  Chapter 827 removed previous requirements from the law that permitted an insurer to require that a retail pharmacy agree “in advance through a contractual network arrangement” and to “the same applicable terms and conditions” as a mail order or specialty pharmacy.

Q.1. If a non-mail order retail pharmacy agrees to accept the same reimbursement amount, must it do so for all covered drugs?
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No, the law does not specify that a non-mail order retail pharmacy must agree to accept the same reimbursement for all covered drugs.

Q.2. If insurers require non-mail order retail pharmacies to agree in advance, how will they know whether a particular non-mail order pharmacy has agreed to accept the same reimbursement rate as the mail order or specialty pharmacy?
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The law does not determine the process between the insurers and pharmacies. Insurers should work with the non-mail order pharmacies to develop a mechanism at the time of sale to determine whether or not the pharmacy accepts the same rate.

Q.3. Are insurers prohibited from imposing any participation standards for pharmacies dispensing specialty drugs?
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No. Insurers may impose participation standards on network pharmacies. However, Chapter 827 removed the ability of an insurer to require that a retail pharmacy agree to the same applicable terms and conditions as a mail order or specialty pharmacy.

Q.4. Does the law require insurers to allow all network mail order pharmacies to dispense all drugs that can be dispensed by other network mail order or non-retail pharmacies?
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No. The law applies to participating non-mail order retail pharmacies and does not apply to other pharmacies. The law does not require insurers to allow members to fill prescriptions at any network mail order pharmacy that agrees to the same reimbursement rate.

Q.5. Does the law require insurers to allow insureds to fill prescriptions at an in-network, out-of-state, non-mail order retail pharmacy?
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Yes. The law does not limit applicability to in-network retail pharmacies located in New York.

Donate Life

Chapter 758 of the Laws of 2022, as amended by Chapter 29 of the Laws of 2023, requires that during the enrollment, renewal, or setting up of an online member service portal process, space be provided for an insured to register or decline registration in the New York State Donate Life Registry (the Registry) for organ, eye and tissue donations for individual and group accident and health insurance policies issued pursuant to Article 42 of the Insurance Law, and individual contracts issued pursuant to Article 43 of the Insurance Law, and  HMO contracts issued pursuant to Article 44 of the Public Health Law.  Approval Memorandum No. 65, signed by the Governor on December 22, 2022, moves the effective date of the bill 18 months forward to June 23, 2024.

Q.1. What is the insurer required to do with the information if an insured checks “yes” as it relates to their organ donor preference?
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For coverage issued outside of the New York State of Health (NYSOH) Marketplace, insurers should contact the New York State Donate Life Registry (ny.gov) at [email protected] with any questions and to determine how the Registry would like to be notified of people that are being added to the registry by this new method.

For coverage offered on the NYSOH Marketplace, the organ donor opt-in information is asked at initial application, when a consumer updates their application, and at manual renewal.  The information is transferred by NYSOH to the Registry on a daily basis.

Q.2. Does the law apply to Municipal Cooperative Health Benefit Plans authorized by Article 47 of the Insurance Law?
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No. The law does not address Municipal Cooperative Health Benefit Plans.

Q.3. Does the law apply to Institutions of Higher Education authorized pursuant to Section 1124 of the Insurance Law?
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Yes. The law applies to Institutions of Higher Education authorized pursuant to Section 1124 of the Insurance Law.

Q.4. What is the insurer’s obligation when it receives an enrollment application and neither “Yes” nor “Skip this question” is marked as it relates to organ donation preference? Can the insurer proceed with processing the application?
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Insurers are not required to follow-up with an applicant when neither “Yes” nor “Skip this question” is marked as it relates to organ donation, and insurers should proceed with processing an enrollment application when the question is not answered by an applicant.