Insurance Circular Letter No. 3 (2023)
May 10, 2023
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, Municipal Cooperative Health Benefit Plans, and Prepaid Health Services Plans
Coverage of COVID-19 Testing and Immunization Following the Expiration of the Federal Public Health Emergency
STATUTORY AND REGULATORY REFERENCES: N.Y. Insurance Law §§ 3216, 3221, and 4303 and 11 NYCRR 52 (Insurance Regulation 62); Families First Coronavirus Response Act (“FFCRA”); Coronavirus Aid, Relief, and Economic Security Act (“CARES Act”)
I. Background and Purpose
The purpose of this circular letter is to provide guidance to insurers authorized to write accident and health insurance in this state, Article 43 corporations, health maintenance organizations, student health plans certified pursuant to New York Insurance Law § 1124, municipal cooperative health benefit plans, and prepaid health services plans (collectively, “issuers”) related to coverage of COVID-19 testing and immunizations under health insurance policies and contracts following the end of the federally declared public health emergency (“PHE”) and the expiration of the 57th and 61st emergency amendments to 11 NYCRR 52 (Insurance Regulation 62) (the “emergency regulations”). This circular letter does not apply to Child Health Plus, Essential Plan, and Medicaid managed care coverage.
The U.S. Department of Health and Human Services declared a PHE in response to the COVID-19 pandemic on January 31, 2020, and the PHE expires at the end of the day on May 11, 2023. Although certain coverage requirements under the CARES Act, Pub. L. No. 116-136 (2020), FFCRA, Pub. L. No. 116-127 (2020), and the emergency regulations are expiring at the end of the PHE on May 11, 2023, there are requirements that remain in place under federal and state laws regarding coverage of COVID-19 testing and immunizations. Issuers should process claims for COVID-19 immunizations and COVID-19 tests that are provided on or before May 11, 2023 in accordance with the federal and state requirements in place during the PHE, and issuers should look to the earliest date on which an item or service is furnished within an episode of care1 to determine the date that a COVID-19 diagnostic test is rendered, when the test involves multiple items or services. See “FAQs about Families First Coronavirus Response Act, Coronavirus Aid, Relief, and Economic Security Act, and Health Insurance Portability and Accountability Act Implementation Part 58” (“FAQs”) issued by the U.S. Departments of Labor, Health and Human Services, and the Treasury (collectively, “the federal Departments”) on March 29, 2023. Issuers should process claims for COVID-19 immunizations and COVID-19 tests that are provided after May 11, 2023 as described below.
II. Coverage of COVID-19 Testing During the PHE
In response to the PHE, the New York State Department of Financial Services (“DFS”) promulgated, on an emergency basis, the 57th Amendment to Insurance Regulation 62 starting on March 13, 2020. The regulation prohibits individual, small group, and large group health insurance policies and contracts from imposing copayments, coinsurance, or annual deductibles (“cost-sharing”) on in-network laboratory tests and visits to diagnose COVID-19, including through telehealth or at an in-network provider’s office, an in-network urgent care center, any other in-network outpatient provider setting able to diagnose COVID-19, or an emergency department of a hospital. However, an issuer may impose cost-sharing in accordance with the applicable policy or contract for any follow-up care or treatment for COVID-19, including an inpatient hospital admission, as otherwise permitted by law. Section 3202 of the CARES Act requires an issuer providing coverage of items and services2 described in § 6001(a) of division F of FFCRA to reimburse a health care provider who renders diagnostic testing for COVID-19 during the PHE, regardless of whether the provider is in-network.
In addition, guidance issued on April 11, 2020 jointly by the federal Departments states that issuers shall not impose any cost-sharing requirements, prior authorization requirements, or other medical management requirements for items and services that must be provided under § 6001(a) of FFCRA, as amended by § 3201 of the CARES Act, when medically appropriate for the individual as determined by the individual’s attending health care provider in accordance with accepted standards of current medical practice for the duration of the PHE.
On February 26, 2021, the federal Departments issued additional guidance, which provides, in relevant part, that FFCRA prohibits issuers from: (1) imposing medical management, including specific medical screening criteria, on coverage of COVID-19 diagnostic testing; and (2) requiring the presence of symptoms or a recent known or suspected exposure, or otherwise imposing medical screening criteria on coverage of COVID-19 diagnostic tests. Further, the guidance clarifies that when an individual receives a COVID-19 diagnostic test from a licensed or authorized health care provider, or when a licensed or authorized health care provider refers an individual for a COVID-19 diagnostic test, an issuer generally must assume that the receipt of the test reflects an “individualized clinical assessment” and the issuer should cover the test without cost-sharing, prior authorization, or other medical management requirements. The guidance also provides that issuers are permitted, but are not required, to provide coverage of testing for public health surveillance or employment purposes.
On January 10, 2022, the federal Departments issued further guidance to clarify that insureds who purchase over-the-counter (“OTC”) COVID-19 tests on or after January 15, 2022 may seek reimbursement from their issuers during the PHE. In response to industry questions, the federal Departments issued additional guidance on February 4, 2022 to further clarify requirements for coverage. On February 25, 2022, DFS issued Insurance Circular Letter No. 3 (2022), detailing the coverage requirements for diagnostic testing for COVID-19 pursuant to federal and state laws.
III. Coverage of COVID-19 Immunizations During the PHE
On December 16, 2020, DFS issued Insurance Circular Letter No. 16 (2020) detailing coverage requirements for any approved COVID-19 immunization and its administration pursuant to federal law and state law. In addition, DFS promulgated, on an emergency basis, the 61st Amendment to Insurance Regulation 62 starting on December 16, 2020, to require immediate coverage for COVID-19 immunizations under non-grandfathered3 individual, small group, and large group health insurance policies and contracts at no cost-sharing, including when obtained from an out-of-network provider.4 The CARES Act also requires issuers to cover COVID-19 immunizations and their administration at no cost-sharing under all non-grandfathered health insurance policies and contracts, including when provided by an out-of-network provider, for the duration of the PHE.
IV. Coverage of COVID-19 Testing After the Expiration of the PHE
Diagnostic testing, including laboratory tests, is an essential health benefit that must be covered under individual and small group health insurance policies and contracts. Insurance Law §§ 3221(l)(3) and 4303(e) and (f) require issuers of large group health insurance policies and contracts to make available coverage for laboratory tests, and such tests are typically covered in the base policy or contract. The required coverage of laboratory tests includes COVID-19 tests. After May 11, 2023, laboratory tests for COVID-19 and outpatient visits to diagnose COVID-19 may be subject to cost-sharing, prior authorization (unless the services are emergency services that are provided in a hospital), and medical management consistent with other such benefits covered under the policy or contract. In addition, after May 11, 2023, issuers are no longer required to provide coverage of OTC COVID-19 tests, unless a health insurance policy or contract includes such coverage.
However, on March 29, 2023, the federal Departments issued FAQs to encourage issuers to continue to provide coverage of COVID-19 tests, including OTC COVID-19 tests, without imposing cost-sharing or medical management requirements after May 11, 2023. Issuers are also not required to provide coverage for COVID-19 laboratory tests and visits to diagnose COVID-19 when rendered by an out-of-network provider after May 11, 2023 unless: the policy or contract covers out-of-network services; the issuer has approved a referral to an out-of-network provider; the services result in a surprise bill; or the services are emergency services that are provided in a hospital.
V. Coverage of COVID-19 Immunizations After the Expiration of the PHE
Insurance Law §§ 3216(i)(17)(B)(ii) and (iii), 3221(l)(8)(B)(ii) and (iii), and 4303(j)(2)(B) and (C) require individual, small group, and large group health insurance policies and contracts, including grandfathered health plans, to cover immunizations at no cost-sharing when obtained from an in-network provider for children through the attainment of 19 years of age, if determined to be a necessary immunization by the Superintendent of Financial Services (“Superintendent”) in consultation with the Commissioner of Health (“Commissioner”). The Superintendent, in consultation with the Commissioner, previously determined that immunizations covered under the law are those recommended by the Advisory Committee on Immunization Practices (“ACIP”) effective as of the date of the recommendation, which includes COVID-19 immunizations. For adults 19 years of age and older, Insurance Law §§ 3216(i)(17)(E), 3221(l)(8)(E) and (F), and 4303(j)(3) require health insurance policies and contracts that provide hospital, surgical, or medical care coverage, except for grandfathered health plans, to cover immunizations that have in effect a recommendation from ACIP at no cost-sharing when obtained from an in-network provider, which includes COVID-19 immunizations. The Insurance Law’s prohibition on cost-sharing for immunizations for children and adults extends to any charge for administration of the immunization, any charge for the office visit when the primary purpose of the visit is the immunization or when the other services provided are preventive care services that are required to be covered under Insurance Law §§ 3216(i)(17), 3221(l)(8), and 4303(j) at no cost-sharing, and any related facility fee. After May 11, 2023, issuers are not required to cover COVID-19 immunizations when rendered by an out-of-network provider, unless the policy or contract otherwise provides such out-of-network coverage.
Issuers should notify insureds of the date when they will begin to impose cost-sharing requirements, prior authorization, or other medical management requirements on COVID-19 tests and when they will no longer cover OTC COVID-19 tests, to the extent the foregoing actions are permitted under a health insurance policy or contract. Issuers should also notify insureds of the date when they will no longer routinely cover COVID-19 immunizations and COVID-19 tests when obtained from an out-of-network provider. Issuers should use the methods they would typically employ to notify insureds, including posting this information on their websites. Issuers should also follow the FAQs issued by the federal Departments with respect to the notice.
After May 11, 2023, issuers must still cover COVID-19 immunizations for children through the attainment of 19 years of age under all policies and contracts, and issuers must cover COVID-19 immunizations for adults under non-grandfathered policies and contracts. Issuers may not impose cost-sharing on in-network COVID-19 immunizations, and issuers are not required to cover COVID-19 immunizations out-of-network unless the policy or contract otherwise provides such out-of-network coverage. After May 11, 2023, issuers may also impose cost-sharing on COVID-19 diagnostic testing and related outpatient visits if otherwise permitted under a health insurance policy or contract. Also, issuers are not required to cover out-of-network COVID-19 diagnostic testing and related visits, unless otherwise covered under a health insurance policy or contract, or unless one of the requirements for an out-of-network coverage exception is met. In addition, issuers are not required to cover OTC COVID-19 tests unless a health insurance policy or contract includes such coverage, although issuers are strongly encouraged to continue to provide such coverage.
Please direct any questions regarding this circular letter by email to [email protected].
Very truly yours,
Bureau Chief, Health Bureau
1 For example, when a health care provider collects a specimen to perform a COVID-19 diagnostic test on the last day of the PHE but the laboratory analysis occurs on a later date, issuers should treat both the specimen collection and laboratory analysis as if they were furnished during the PHE and are therefore subject to the FFCRA and CARES Act requirements.
2 Under § 6001(a) of FFCRA, items and services include: (1) in vitro diagnostic products for the detection of SARS–CoV–2 or the diagnosis of the virus that causes COVID-19 that are approved, cleared, or authorized under section 510(k), 513, 515 or 564 of the Federal Food, Drug, and Cosmetic Act, and the administration of such in vitro diagnostic products; and (2) items and services furnished to an individual during health care provider office visits (which includes in-person visits and telehealth visits), urgent care center visits, and emergency room visits that result in an order for or administration of an in vitro diagnostic product, but only to the extent such items and services relate to the furnishing or administration of such product or to the evaluation of such individual for purposes of determining the need of such individual for such product.
3 “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.
4 This regulatory requirement is in addition to Insurance Law requirements that issuers cover in-network immunizations for children that are recommended by the Advisory Committee on Immunization Practices (“ACIP”) through attainment of age 19 at no cost-sharing, including under grandfathered plans.