We are asked regularly about whether COVID Diagnostic or Antibody testing at InOut Labs is covered by insurance. InOut Labs does not process insurance, but you may have success filing it on your own. We’ll provide you with documentation you can use.
The CARES Act appears to make reimbursement for out of network COVID-19 viral and antibody testing mandatory. See below for details and references.
From the CARES ACT
PART II–ACCESS TO HEALTH CARE FOR COVID-19 PATIENTS
Subpart A–Coverage of Testing and Preventive Services
(Sec. 3201) This section expands the scope of available diagnostic testing for COVID-19 (i.e., coronavirus disease 2019) that private health insurance plans must cover. Specifically, it requires coverage of tests that have not been approved by the FDA if
- the developer of such a test requests, or intends to request, emergency use authorization, unless such request is denied or is not submitted within a reasonable time;
- the test is developed and authorized in a state that has notified HHS that the state intends to review such tests; or
- HHS has issued guidance that such test is appropriate.
(Sec. 3202) This section specifies the process for private health insurance plan issuers to reimburse providers of COVID-19 diagnostic tests. Specifically, a reimbursement rate negotiated for such test prior to the public health emergency declared on January 31, 2020, continues to apply for the duration of the emergency. If a reimbursement rate was not negotiated prior to the emergency declaration, an issuer may either negotiate such rate or pay the provider’s cash price.
Additionally, test providers must publish the cash price of tests on their websites; HHS may assess a civil penalty for violations of this requirement.
Q3. What items and services must plans and issuers provide benefits for under section 6001 of the FFCRA?
Section 6001(a) of the FFCRA, as amended by section 3201 of the CARES Act, requires plans and issuers to provide coverage for the following items and services:
(1) An in vitro diagnostic test as defined in section 809.3 of title 21, Code of Federal Regulations, 12 (or its successor regulations) for the detection of SARS-CoV-2 or the diagnosis of COVID-19, and the administration of such a test, that—
A. Is approved, cleared, or authorized under section 510(k), 513, 515, or 564 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. §§ 360(k), 360c, 360e, 360bbb3);
B. The developer has requested, or intends to request, emergency use authorization under section 564 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.360bbb–3), unless and until the emergency use authorization request under such section 564 has been denied or the developer of such test does not submit a request under such section within a reasonable timeframe;
C. Is developed in and authorized by a State that has notified the Secretary of HHS of its intention to review tests intended to diagnose COVID–19; or
D. Other tests that the Secretary of HHS determines appropriate in guidance.
Q4. Do “in vitro diagnostic tests” described in section 6001(a)(1) of the FFCRA, as amended by section 3201 of the CARES Act, include serological tests for COVID-19?
Yes. Serological tests for COVID-19 are used to detect antibodies against the SARS-CoV-2 virus, and are intended for use in the diagnosis of the disease or condition of having current or past infection with SARS-CoV-2, the virus which causes COVID-19. The Food and Drug Administration (FDA) currently believes such tests should not be used as the sole basis for diagnosis.13 FDA has advised the Departments that serological tests for COVID-19 meet the definition of an in vitro diagnostic product for the detection of SARS-CoV-2 or the diagnosis of COVID-19.14 Therefore, plans and issuers must provide coverage for a serological test for COVID-19 that otherwise meets the requirements of section 6001(a)(1) of the FFCRA, as amended by section 3201 of the CARES Act. 15
Q6. May a plan or issuer impose any cost-sharing requirements, prior authorization requirements, or medical management requirements for benefits that must be provided under section 6001(a) of the FFCRA, as amended by section 3201 of the CARES Act?
No. Section 6001(a) of the FFCRA provides that plans and issuers shall not impose any cost-sharing requirements (including deductibles, copayments, and coinsurance), prior authorization requirements, or other medical management requirements for these items and services. These items and services must be covered without cost sharing when medically appropriate for the individual, as determined by the individual’s attending healthcare provider in accordance with accepted standards of current medical practice.
Q7. Are plans and issuers required to provide coverage for items and services that are furnished by providers that have not agreed to accept a negotiated rate as payment in full (i.e., out-of-network providers)?
Yes. Section 3202(a) of the CARES Act provides that a plan or issuer providing coverage of items and services described in section 6001(a) of the FFCRA shall reimburse the provider of the diagnostic testing as follows:
1. If the plan or issuer has a negotiated rate with such provider in effect before the public health emergency declared under section 319 of the PHS Act, such negotiated rate shall apply throughout the period of such declaration.
2. If the plan or issuer does not have a negotiated rate with such provider, the plan or issuer shall reimburse the provider in an amount that equals the cash price for such service as listed by the provider on a public internet website, or the plan or issuer may negotiate a rate with the provider for less than such cash price. Section 3202(b) of the CARES Act also requires providers of diagnostic tests for COVID-19 to make public the cash price of a COVID-19 diagnostic test on the provider’s public internet website. Section 3202(b) of the CARES Act also grants the Secretary of HHS authority to impose civil monetary penalties on any provider that does not comply with this requirement and has not completed a corrective action plan, in an amount not to exceed $300 per day that the violation is ongoing.
From Health Affairs
Items and services must be covered without cost-sharing even when provided in non-traditional health care settings, such as drive-through testing centers. The Departments construe the word “visit” broadly to include both traditional and non-traditional health care settings. However, the guidance does not clarify whether cost-sharing protections extend to fees that a provider might charge due to a non-traditional (or simply a non-hospital) setting, such as a facility fee.
According to the CMS guidance, private health plans must now cover diagnostic testing as well as relevant tasks and medical equipment. This means that they cannot place any cost-sharing, prior authorization, or medical management stipulations on these services or products.
Covered procedures and items include
- Urgent care visitsEmergency department visits
- Telehealth visits
- In-person office visits
- FDA-authorized coronavirus tests
- Coronavirus tests for which developers have requested emergency authorization
- State-developed and state-authorized coronavirus tests
- Coronavirus antibody testing