Supplement No. 3 to

Insurance Circular Letter No. 1 (2003)

December 18, 2019

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 for Contraceptive Services

STATUTORY REFERENCES: N.Y. Insurance Law §§ 3216, 3221, and 4303; Chapters 25 and 57 of the Laws of 2019; 42 U.S.C. §§ 18011(e) and 18022

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 New York Insurance Law (“Insurance Law”) § 1124, and municipal cooperative health benefit plans (collectively, “issuers”) regarding the changes that Chapters 25 and 57 of the Laws of 2019 (“Chapters 25 and 57”) made to the contraceptive coverage provisions in Insurance Law §§ 3216, 3221, and 4303. Issuers must comply with the new requirements for contraceptive services with respect to health insurance policies or contracts issued, amended, renewed, effective, or delivered on or after January 1, 2020. This circular letter supplements Insurance Circular Letter No. 1 (2003) issued on January 31, 2003, Supplement No. 1 to Insurance Circular Letter No. 1 (2003) issued on January 21, 2017, and Supplement No. 2 to Insurance Circular Letter No. 1 (2003) issued on May 1, 2019.

II. Discussion

Chapters 25 and 57 amended Insurance Law §§ 3216(i)(17)(E), 3221(l)(16), and 4303(cc) to require issuers that provide medical, major medical, or similar comprehensive-type coverage, including grandfathered health plans,¹ to provide coverage for all contraceptive drugs, devices, and products approved by the U.S. Food and Drug Administration (“FDA”). This includes all FDA-approved over-the-counter contraceptive products as prescribed or as otherwise authorized under state or federal law that are provided for in comprehensive guidelines supported by the Health Resources and Services Administration (“HRSA”) as of January 21, 2019. ² Coverage must also allow for the dispensing of the entire 12-month supply of a contraceptive at the same time.

Where the FDA has approved one or more therapeutic and pharmaceutical equivalent versions of a contraceptive drug, device, or product, the issuer is not required to include all of the therapeutic ³ and pharmaceutical equivalent ⁴ versions in its formulary, so long as at least one is included and covered without cost-sharing. If the therapeutic and pharmaceutical equivalent versions of a drug, device, or product are not available or are deemed medically inadvisable, the issuer must provide coverage for an alternate therapeutic and pharmaceutical equivalent version of the contraceptive drug, device, or product without cost-sharing. If the insured’s attending health care provider, in his or her reasonable professional judgment, determines that the use of a non-covered therapeutic or pharmaceutical equivalent of a drug, device, or product is warranted, the health care provider’s determination shall be final. Issuers should use the exception form being developed by the Superintendent of Financial Services.

Further, Chapters 25 and 57 require issuers to provide coverage for emergency contraception without cost-sharing when provided pursuant to a prescription or order under Education Law § 6831 or when lawfully provided over-the-counter. Over-the-counter contraceptive products are those products provided for in the HRSA guidelines as of January 21, 2019.

In addition to the contraceptive drugs, devices, products, and services discussed above, issuers that provide medical, major medical, or similar comprehensive-type coverage must also provide coverage for: voluntary sterilization procedures pursuant to 42 U.S.C. § 18022 and identified in the comprehensive guidelines supported by HRSA; patient education and counseling on contraception; and follow-up services related to contraceptive drugs, devices, products, and procedures, including but not limited to, management of side effects, counseling for continued adherence, and device insertion and removal.

Pursuant to Chapter 25, issuers may not impose a deductible, coinsurance, copayment, or any other cost-sharing requirements on the coverage outlined above. Furthermore, issuers may not impose any restrictions or delays on contraceptive coverage, including preauthorization requirements, step therapy protocols, or quantity limits on a 12-month supply or less.

III. Conclusion

Pursuant to Chapters 25 and 57, an issuer must provide coverage for all FDA-approved contraceptive drugs, devices, and other products, including over-the-counter contraceptive drugs, devices and products; voluntary sterilization procedures pursuant to 42 U.S.C. § 18022 and identified in the comprehensive guidelines supported by HRSA; patient education and counseling on contraception; follow-up services related to contraceptive drugs, devices, products and other procedures, including but not limited to, management of side effects, counseling for continued adherence, and device insertion and removal; and prescription and over-the-counter emergency contraception. However, where the FDA has approved one or more therapeutic and pharmaceutical equivalent versions of a contraceptive drug, device, or product, the issuer is not required to include all of the therapeutic and pharmaceutical equivalent versions in its formulary, so long as at least one is included and covered without cost-sharing. The aforementioned contraceptive drugs, devices, products, and procedures must be covered without any cost-sharing, including any deductible, coinsurance, or copayment. Issuers must allow for the dispensing of the entire 12-month supply of a contraceptive at the same time. Furthermore, issuers may not impose any restrictions or delays on the coverage, such as preauthorization requirements, step therapy protocols, or quantity limits on a 12-month supply or less. Issuers must ensure that health insurance policies or contracts issued, amended, renewed, effective, or delivered on or after January 1, 2020 comply with the new requirements outlined in this letter. The Department of Financial Services will continue to monitor compliance with all contraceptive coverage requirements and may take action against an issuer for any failure to adhere to all statutory or regulatory requirements for contraceptive coverage.

Please direct any questions regarding this circular letter to Robin Wheeler Feane, Associate Attorney, by mail at New York State Department of Financial Services, Health Bureau, One Commerce Plaza, 19th Floor, Albany, NY 12257, or by email at [email protected].

Very truly yours,

 

Lisette Johnson
Chief, Health Bureau

 

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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). Ins. Law §§ 3216(i)(17)(F), 3221(l)(8)(G), and 4303(j)(4).

² The HRSA guidelines do not include contraceptives for men.

³ The FDA considers drugs to be therapeutically equivalent if they are: 1) pharmaceutical equivalents; and 2) assigned by the FDA the same therapeutic equivalence codes starting with the letter “A.” For information on the FDA’s assignment of therapeutic equivalence codes, see the FDA’s Glossary of Terms.

⁴ The FDA considers drugs to be pharmaceutically equivalent if they: 1) contain the same active ingredients; 2) are of the same dosage form and route of administration; and 3) are identical in strength or concentration. Pharmaceutically equivalent drug products may differ in characteristics such as shape, release mechanism, labeling (to some extent), scoring, and excipients (including colors, flavors, and preservatives). See the FDA’s Glossary of Terms.