Supplement No. 3 to Insurance Circular Letter No. 21 (2017)

January 30, 2025

TO: All Insurers Authorized to Write Accident and Health Insurance in New York State, Article 43 Corporations, Health Maintenance Organizations, Student Health Plans Certified Pursuant to Insurance Law § 1124, and Municipal Cooperative Health Benefit Plans

RE: Health Insurance Coverage and Prior Authorization Prohibition for Pre-Exposure Prophylaxis (“PrEP”) for the Prevention of Human Immunodeficiency Virus (“HIV”) Infection

STATUTORY AND REGULATORY REFERENCES:  N.Y. Ins. Law §§ 3216, 3221, and 4303 and 11 NYCRR § 52.76

I. Purpose

The purpose of this circular letter is to provide guidance to insurers authorized to write accident and health insurance in New York State, Article 43 corporations, health maintenance organizations, student health plans certified pursuant to Insurance Law § 1124, and municipal cooperative health benefit plans (collectively “issuers”) regarding New York State Insurance Law requirements for coverage of PrEP under comprehensive health insurance policies and contracts.  This circular letter supplements Insurance Circular Letter No. 21 (2017) issued on December 1, 2017 and Supplement No. 2 to Insurance Circular Letter No. 21 (2020) issued on October 8, 2020.  This circular letter replaces Supplement No. 1 to Insurance Circular Letter No. 21 (2019), which has been withdrawn.

II. Prior Authorization

As discussed in Insurance Circular Letter No. 21 (2017), issuers and their utilization review agents previously were permitted to impose reasonable prior authorization requirements on PrEP if any such requirement would not create an unacceptable barrier to coverage for individuals and coverage determinations were made in a non-discriminatory manner.  However, effective December 25, 2024, Insurance Law §§ 3216(i)(39), 3221(l)(22), and 4303(vv) prohibit issuers that provide coverage for antiretroviral prescription drugs prescribed for the treatment or prevention of HIV or acquired immunodeficiency syndrome (“AIDS”), including PrEP, from subjecting such drugs to prior authorization.  This prohibition applies to the prescription drugs covered under a health insurance policy or contract that are on an issuer’s formulary, including brand name prescription drugs and generic prescription drugs.  Therefore, effective December 25, 2024, issuers and their utilization review agents may not impose prior authorization requirements on any such prescription drugs on their formularies.  To the extent Insurance Circular Letter No. 21 (2017) states otherwise, it should no longer be followed.

III. Required Coverage of All FDA-Approved Formulations

Insurance Law §§ 3216(i)(17)(E), 3221(l)(8)(E) and (F), and 4303(j)(3) require comprehensive health insurance policies and contracts, other than grandfathered health plans,¹ to cover items or services that have in effect a rating of “A” or “B” in the current recommendations of the United States Preventive Services Taskforce (“USPSTF”) without imposing deductibles, copayments, or coinsurance (“cost-sharing”).  Insurance Law §§ 3221(l)(21) and 4303(tt) require large group comprehensive health insurance policies and contracts, including grandfathered plans, to cover PrEP for the prevention of HIV and post-exposure prophylaxis to prevent HIV infection.  These sections of the Insurance Law further require such coverage to be provided under large group comprehensive health insurance policies and contracts at no cost-sharing when PrEP or post-exposure prophylaxis have in effect a rating of “A” or “B” in the current recommendations of the USPSTF.  Supplement No. 1 to Insurance Circular Letter No. 21 (2019) advised issuers that 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.²

In June 2019, when the USPSTF first issued an “A” rated recommendation for PrEP and the specified baseline and monitoring services that are essential to the efficacy of PrEP, there was only one formulation for PrEP approved by the United States Food and Drug Administration (“FDA”) (i.e., TDF/FTC; brand name Truvada®).  However, on August 22, 2023, the USPSTF updated its recommendation with respect to PrEP and identified two additional FDA-approved formulations of PrEP:  (1) Emtricitabine/tenofovir alafenamide (TAF/FTC; brand name Descovy®), the second daily oral medication approved by the FDA for PrEP; and (2) Cabotegravir (brand name Apretude®), the first long-acting injectable PrEP medication approved by the FDA.  Therefore, the August 22, 2023 USPSTF recommendation for PrEP specifies three formulations of medications approved by the FDA for use as PrEP.  Issuers, other than individual and small group grandfathered health plans, must therefore cover the three FDA-approved PrEP formulations (two oral and one injectable), along with the specified baseline and monitoring services, without cost-sharing, consistent with the August 22, 2023 USPSTF recommendation.

According to guidance issued by the U.S. Centers for Medicare & Medicaid Services on October 21, 2024, issuers must cover, without cost-sharing, the three FDA-approved PrEP formulations, along with the specified baseline and monitoring services for plan years beginning on or after one year from the issue date of the recommendation (in this case, beginning on or after August 31, 2024).³ However, New York imposes a shorter time frame for implementation. Issuers are reminded that 11 NYCRR § 52.76(a)(2) requires issuers to update coverage requirements for preventive care and screenings upon any policy or contract issuance or renewal that occurs six months after the date the recommendation or guideline is issued or revised. Since the USPSTF recommendation was considered issued as of August 31, 2023, issuers must provide coverage for the recommended two new FDA-approved formulations of PrEP, along with the specified baseline and monitoring services, without cost-sharing for policies or contracts issued or renewed on and after February 29, 2024, rather than on or after August 31, 2024.  The guidance issued by the U.S. Centers for Medicare & Medicaid Services on October 21, 2024 also makes it clear that issuers are not permitted to use medical management techniques, such as step therapy, to direct individuals prescribed PrEP to utilize one formulation over another.

IV. Conclusion

In accordance with Insurance Law §§ 3216(i)(39), 3221(l)(22), and 4303(vv), issuers that provide coverage for antiretroviral prescription drugs prescribed for the treatment or prevention of HIV or AIDS, including PrEP, are prohibited from subjecting any such drugs on their formulary to prior authorization.  Issuers, other than individual and small group grandfathered health plans, must also cover the three FDA-approved PrEP formulations specified in the August 22, 2023 USPSTF recommendation for PrEP, along with the specified baseline and monitoring services, without cost-sharing.  In addition, issuers are not permitted to use medical management techniques, such as step therapy, to direct individuals prescribed PrEP to utilize one formulation over another. Coverage for the two new FDA-approved formulations of PrEP, along with the specified baseline and monitoring services, must be provided upon any policy or contract issuance or renewal that occurs on or after February 29, 2024.

Please direct any questions regarding this circular letter by email at [email protected].

Very truly yours,

Lisette Johnson
Bureau Chief, Health Bureau

¹ A “grandfathered health plan” means coverage provided by an issuer in which an individual was enrolled on March 23, 2010, for as long as the coverage maintains grandfathered status in accordance with 42 U.S.C § 18011(e).  See Ins. Law §§ 3216(i)(17)(F), 3221(l)(8)(G), and 4303(j)(4).

² Pursuant to 45 C.F.R. § 156.122, individual and small group health insurance policies and contracts must also cover at least the greater of one drug in every United States Pharmacopeia (“USP”) category and class of drugs or the same number of drugs in each category and class as the New York benchmark plan. Therefore, these policies and contracts must cover prescription drugs for post-exposure prophylaxis, but cost-sharing may be imposed if the drug is not prescribed in alignment with the current USPSTF “A” or “B” recommendation.

³ Generally, USPSTF recommendations are considered to be issued on the last day of the month in which the USPSTF publishes or otherwise releases the recommendation. See 75 FR 41726, 41729 (July 19, 2010).