Insurance Circular Letter No. 16 (2020)

December 16, 2020

STATUTORY AND REGULATORY REFERENCES: N.Y. Insurance Law §§ 3216, 3221, and 4303; Coronavirus Aid, Relief, and Economic Security Act, codified at 15 U.S.C. § 9001 et seq.; 85 Fed. Reg. 71142 (November 6, 2020); Executive Orders 202 and 202.82

I. Background and Purpose

In response to the coronavirus disease 2019 (“COVID-19”) pandemic, the federal Department of Health and Human Services declared a public health emergency, and Governor Cuomo declared a disaster emergency pursuant to Executive Order 202 (“EO 202”). It is anticipated that the federal Food and Drug Administration will approve for use one or more versions of an immunization for COVID-19 under an emergency use authorization, which the Advisory Committee on Immunization Practices (“ACIP”) of the Centers for Disease Control and Prevention (“CDC”) will then recommend. New York State is working to establish an infrastructure of persons and locations to administer COVID-19 immunizations throughout the state (collectively, “providers”). Immunizing millions of New Yorkers may require recruiting and training additional personnel to administer the immunization. Mobile immunization units may also be necessary to control the spread of COVID-19 and increase access to immunizations in certain areas of the state. The success of New York’s mass immunization efforts depends on the health insurance industry and providers working together to ensure that millions of New Yorkers have timely access to life-saving preventive care.

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^[1] (collectively, “issuers”) related to coverage of COVID-19 immunizations and their administration under health insurance policies and contracts. The Insurance Law requires issuers to cover immunizations without cost-sharing under health insurance policies and contracts. In addition, the federal Departments of Health and Human Services, Treasury, and Labor (the “federal Departments”) have issued Interim Final Rule 85 Fed. Reg. 71142 (November 6, 2020) (“federal rules”) interpreting the immunization requirements of the Coronavirus Aid, Relief, and Economic Security Act (“CARES Act”), codified at 15 U.S.C. § 9001 et seq. The Department of Financial Services (“DFS”) expects full adherence to state and federal requirements for coverage of any approved COVID-19 immunization and its administration, as described below.

II. Discussion

1. State Law Requiring Coverage

   The Insurance Law requires issuers to cover immunizations for children and adults that are provided by in-network providers. For children who are 19 years old or younger, Insurance Law §§ 3216(i)(17)(B)(ii) and (iii), 3221(l)(8)(B)(ii) and (iii), and 4303(j)(2)(B) and (C) require medical, major medical, and comprehensive health insurance policies and contracts to cover immunizations, at no cost-sharing, if determined to be a necessary immunization by the Superintendent of Financial Services (“Superintendent”) in consultation with the Commissioner of Health. As discussed in Insurance Circular Letter No. 3 (2020), if an immunization becomes available for COVID-19 and is recommended for children who are 19 years old and younger, the Superintendent has determined that issuers must immediately cover the immunization at no cost-sharing for such children.

   Regardless of the age of the patient, Insurance Law §§ 3216(i)(17)(E), 3221(l)(8)(E) and (F), and 4303(j)(3) further require health insurance policies and contracts that provide hospital, surgical, or medical care coverage, except for a grandfathered health plan,^[2] to cover, at no cost-sharing, preventive care and screenings that have in effect a rating of “A” or “B” in the current recommendations of the United States Preventive Services Taskforce (“USPSTF”) and immunizations that have in effect a recommendation from ACIP. If the USPSTF or ACIP recommends an immunization for COVID-19, issuers, including grandfathered health plans, must cover the immunization immediately at no cost-sharing.

   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.

   As discussed above, additional providers and alternate sites of care may be needed to assist in the mass immunization effort. If Governor Cuomo authorizes the expansion of the scope of practice for a provider to administer the COVID-19 immunization or authorizes the use of an alternate site of care, issuers should cover immunizations administered by that provider or at the alternate site of care in accordance with this circular letter.

2. CARES Act and Federal Rules
   1. Coverage for Administration of COVID-19 Immunizations

      The CARES Act requires issuers to cover COVID-19 immunizations and their administration at no cost-sharing under all non-grandfathered group and individual comprehensive health insurance policies and contracts once recommended by ACIP. The federal rules further provide that issuers must cover the administration of the immunization by any provider enrolled in the CDC COVID-19 Vaccination Program. Coverage at no cost-sharing is required regardless of how the immunization and administration are billed, and even if multiple doses are required to provide a complete immunization. The federal rules clarify that coverage is required, without cost-sharing, for the administration of the immunization even if a third party, such as the federal government, pays for the cost of the immunization.

   2. Out-of-Network Coverage

      The federal rules require COVID-19 immunizations and their administration to be covered when provided by out-of-network providers for the duration of the public health emergency for COVID-19. The federal rules dictate that reimbursement for out-of-network providers must be made in an amount that is reasonable, as determined by comparison to prevailing market rates. The federal rules indicate that the federal Departments will consider the amount of payment to be reasonable if the issuer pays the provider the amount that would be paid under Medicare for the item or service. The federal Departments are seeking comment on this approach prior to adopting final rules. The federal requirement for out-of-network coverage ends when the public health emergency is terminated.

   3. Provider Balance Billing

      Providers that participate in the CDC COVID-19 Vaccination Program agree to administer a COVID-19 immunization regardless of an individual’s ability to pay or health insurance coverage status. Additionally, providers may not seek any reimbursement, including through balance billing, from an immunization recipient.

   4. Effective Date of Coverage of COVID-19 Immunizations and Administration

      The CARES Act requires coverage of any COVID-19 immunization and its administration within 15 business days after the immunization has been recommended by ACIP. However, given the severity of the COVID-19 pandemic and the urgent need for insureds to obtain the immunization, issuers should cover any COVID-19 immunization immediately upon ACIP’s recommendation rather than wait 15 business days.

III. Coordination and Communication

Issuers should be assessing their readiness, and taking all steps necessary for implementation, to ensure that insureds have access to coverage for COVID-19 immunizations and their administration without cost-sharing. Issuers should provide insureds with information about coverage for COVID-19 immunizations and their administration at no cost-sharing and explain how to access the immunizations. In addition, issuers should provide timely information to providers describing how to submit claims for reimbursement for COVID-19 immunizations (unless the immunizations are paid for by a third party, such as the federal government) and their administration, including at any alternate sites of care, and reminding providers that they are prohibited from balance-billing insureds. Furthermore, within five days of this circular letter, issuers should provide to DFS, at the e-mail address below, the name and contact information of a contact person responsible for communicating with DFS regarding implementation of coverage for COVID-19 immunizations and their administration.

IV. Conclusion

As New York State continues to be a nationwide leader in taking effective action to end this public health crisis, collaboration among issuers and providers is imperative. In this effort, issuers must be prepared to implement coverage of COVID-19 immunizations as soon as they become available to ensure that millions of New Yorkers have timely access to life-saving preventive care. Due to the extraordinary circumstances surrounding the approval and distribution of COVID-19 immunizations, issuers will need to work with all available providers, including providers who are out-of-network, to ensure a successful mass immunization effort.

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

Very truly yours,

Lisette Johnson
Chief, Health Bureau

^[1] The reference to prepaid health services plans only includes commercial insurance coverage written by such plans. The New York State Department of Health will be issuing guidance separately addressing Medicaid managed care, Child Health Plus, and the Essential Plan.

^[2] 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), 4303(j)(4).