Administration Clarifies Scope of Covered COVID-19 Testing and Testing-Related Services

Over the last few days, the Centers for Medicare & Medicaid Services (CMS) issued several clarifications to guide the implementation of the Families First Coronavirus Response Act (FFCRA, P.L. 116-127) and the Coronavirus Aid, Relief, and Economic Security (CARES) Act (P.L. 116-136), particularly with respect to what types of diagnostic tests and services must be covered at no out-of-pocket cost to consumers enrolled in most private coverage, Medicaid, or the Children’s Health Insurance Program (CHIP).

On April 11, the CMS Center for Consumer Information and Insurance Oversight (CCIIO), in conjunction with the Departments of Treasury and Labor, issued guidance about coverage requirements for COVID-19 testing and other services applicable to private insurers (specifically, group health plans and health insurance issuers offering group or individual health insurance coverage, including on the Marketplace).1 On April 13, the CMS Center for Medicaid and CHIP Services (CMCS) followed suit with a broad set of FAQs on various Medicaid topics, including several FAQs on the scope of covered testing and testing-related services for all Medicaid beneficiaries, including individuals enrolled in the new, optional Medicaid category that covers testing and testing-related services for otherwise uninsured individuals. Both documents confirm that the Department of Health and Human Services (HHS) (and related agencies) are interpreting the broad legislative language in FFCRA and the CARES Act to include testing both for active COVID-19 cases as well as serological testing to detect antibodies against the SARS-CoV-2 virus. This clarification is important both to the extent that it establishes that antibody testing is covered and that such testing is encompassed by FFCRA’s prohibition on cost-sharing for SARS-CoV-2 and COVID-19 testing.

The two sets of guidance provide other key protections for consumers. For example, the CCIIO guidance specifies that commercial insurers must cover, without cost-sharing, influenza tests, blood tests, and other tests performed to rule out a COVID-19 diagnosis because these qualify as items and services that relate to COVID-19 testing. It also includes several other important clarifications, such as confirmation that plans and issuers must cover items and services furnished by out-of-network providers and furnished in non-traditional settings (such as drive-through screening and testing sites).

The Medicaid guidance makes clear that chest X-rays to diagnose COVID-19 are covered as testing-related services. While medically necessary X-rays are covered for Medicaid beneficiaries generally (as well as for enrollees in most commercial coverage), CMCS’ clarification confirms that uninsured individuals eligible for the new Medicaid COVID-19 optional testing category (who are eligible only for testing and testing-related services) may receive, and the federal government will reimburse states for, X-rays used to diagnose COVID-19.

Notably, CMS has yet to issue parallel clarifications regarding the scope of covered diagnostic items and services under Medicare, although the agency did release several clarifications that suggest it, too, is taking a broad view of COVID-19 testing. First, the April 6 interim final rule indicates that specimen collection fees would apply to serological tests (see Manatt’s previous Insights summary here). And updated Medicare billing guidance for providers addressed certain relevant issues, clarifying that hospitals may provide testing and other services in offsite locations or temporary expansion sites such as gymnasiums or parking lots.

1 The guidance is not applicable to short-term, limited-duration plans or to a plan or coverage in relation to its provision of excepted benefits. Additional exemptions are detailed in the CCIIO guidance.