Coverage and implementation guidance for COVID-19 diagnostic testing under FFCRA and CARES Act
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Federal FAQs describing requirements that group health plans and health insurance issuers cover specified COVID-19 diagnostic tests and related services without cost-sharing, prior authorization, or other medical management during the public health emergency, and how reimbursement to providers must be handled.
No material clinical or coverage changes in this revision.
Covered Services and Policy Scope
Covered COVID-19 diagnostic testing and related services
Covered when ALL of the following are met
See Q1 for plan applicability
Coverage applies for items furnished during the emergency period
Includes serological (antibody) tests that meet the statutory/regulatory criteria
Covered without cost sharing and without prior authorization when medically appropriate per attending provider judgment
Coverage stance and emergency flexibilities
Policy stance and conditions during the COVID-19 emergency:
Departments will apply non-enforcement policies to mid-year additions or reductions in cost sharing during the emergency; plans must provide notice as soon as reasonably practicable.
Applies generally to telehealth/remote care coverage and is not limited to COVID-19-related services.
Amount, scope, and duration of services determine whether EAPs are excepted; offering COVID-19 testing alone during the emergency does not render an EAP non-excepted.
Explicit statutory treatment under excepted benefit rules.
States may also be encouraged to relax licensing laws to expand telehealth access during the emergency.
Section 6001 of the FFCRA, as amended by the CARES Act, does not apply to short-term, limited-duration insurance or to plans or coverages insofar as they provide excepted benefits. It also excludes group health plans that do not cover at least two current employees (for example, retiree-only plans). These exclusions mean that the mandatory coverage and cost‑sharing protections in section 6001 are not triggered for those plan types or situations.
The Departments will take enforcement action against any issuer or plan that attempts to limit or eliminate other benefits, or to increase cost‑sharing, in order to offset the costs of more generous COVID‑19 diagnosis or treatment benefits. Plans and issuers may not implement offsetting reductions in benefits or increased member cost‑sharing as a method to counterbalance providing required COVID‑19 related coverage during the public health emergency.
Serological (antibody) tests for COVID‑19 meet the statutory definition of an in vitro diagnostic for detection of SARS‑CoV‑2 or diagnosis of COVID‑19 and therefore are covered when they otherwise satisfy section 6001 requirements. The FDA has advised that serological tests should not be used as the sole basis for diagnosis, and clinical use should follow FDA and CDC guidance.
Indications and Settings for Testing
Diagnostic testing to detect SARS-CoV-2 or diagnose COVID-19, including molecular and serological tests when they meet criteria
Covered diagnostic indications and testing scope:
FDA considers serological tests to meet the in vitro diagnostic definition but advises they should not be used as the sole basis for diagnosis.
Related items/services covered only to the extent they relate to the furnishing/administration of the test or evaluation to determine need, per attending provider.
Coverage determination is based on attending provider's clinical judgment in accordance with accepted standards of current medical practice.
Regulatory References and Code Guidance
| 21 CFR 809.3 | Definition of in vitro diagnostic products |
| 21 U.S.C. §§ 360(k), 360c, 360e, 360bbb-3 | FDA authorities (510(k), 513, 515, 564) under which tests may be approved/authorized |
Provider Requirements, Billing, and Documentation
No prior authorization for covered COVID-19 tests
Do not require prior authorization or any other medical management requirements for COVID-19 diagnostic tests and related items and services furnished on or after March 18, 2020 during the public health emergency; these must be covered without cost-sharing or prior authorization.
- Coverage must be provided without prior authorization or other medical management requirements per section 6001 of the FFCRA and as amended by the CARES Act.
- Applies to items and services furnished on or after March 18, 2020 and during the public health emergency.
Telehealth cost-sharing and mid-year changes encouragement
Encourage offering telehealth and other remote care services without cost sharing and without medical management requirements; plans may add or reduce cost sharing mid-year during the emergency but must notify consumers as soon as reasonably practicable.
- Departments strongly encourage covering telehealth/remote care (including mental health and SUD services) without cost sharing or other medical management requirements.
- The Departments will apply non‑enforcement policies to mid‑year additions or reductions in cost sharing during the public health emergency, provided notice is given as soon as reasonably practicable; if maintained beyond the emergency, plan documents must be updated to comply with applicable requirements.
Provider clinical judgment governs related services
Determine whether tests or services furnished during a visit relate to the need for COVID-19 testing based on the clinical judgment of the attending healthcare provider; related tests must be covered without cost sharing when medically appropriate.
- Attending healthcare provider (licensed and acting within scope) decides if additional tests performed during a visit relate to furnishing or administration of the COVID-19 test or to evaluation to determine need.
- Coverage for related services must be provided without cost sharing and without prior authorization when medically appropriate, per accepted standards of current medical practice.
Medical management considerations for telehealth
Where possible, for telehealth and remote care services plans are encouraged to forgo medical management requirements to promote access, including for mental health and substance use disorder services.
- Departments urge ensuring access to a robust suite of telehealth and remote care services and recommend covering these services without cost sharing or other medical management requirements.
- States are encouraged to relax licensing laws during the emergency to expand telehealth access.
Documentation of clinical relationship to testing — note on required documentation
Document that items and services furnished during a visit that result in an order for or administration of a COVID-19 diagnostic test relate to the furnishing/administration of the test or evaluation to determine need, as determined by the individual's attending healthcare provider.
- The attending healthcare provider must determine and document medical appropriateness in accordance with accepted standards of current medical practice.
- Plans must cover those related items and services without cost sharing when so determined by the attending provider.
Prohibition on cost-sharing and utilization management
Do not impose cost-sharing (deductibles, copayments, coinsurance), prior authorization, or other medical management requirements for items and services required under section 6001(a) of the FFCRA, as amended.
- 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.
- This prohibition stems from section 6001(a) of the FFCRA and CARES Act amendments.
Offsetting benefit reductions prohibited — enforcement focus
Do not reduce or eliminate other benefits or increase cost-sharing to offset the costs of expanded COVID-19 diagnosis/treatment benefits; such offsetting actions are subject to enforcement by the Departments.
- The Departments will take enforcement action against issuers or plans that limit or eliminate other benefits or increase cost‑sharing to offset more generous COVID‑19‑related benefits.
- Plans and issuers must not use offsetting benefit reductions as a means to finance increased COVID‑19 coverage.
Notice and plan-document update expectations
Provide notice of benefit changes (for example, adding telehealth coverage or reducing cost sharing) as soon as reasonably practicable; if changes are maintained beyond the emergency period, update plan documents and terms of coverage to comply with applicable requirements.
- Although the Departments apply non‑enforcement relief for advance notice during the emergency, plans and issuers must still notify consumers promptly of changes.
- Plans that keep changes beyond the emergency period must comply with all requirements to update plan documents (e.g., section 2715(d)(4) advance notice relief is temporary).
Orders, Attending Provider Role, and Telehealth Ordering
Ordering must follow attending provider determination
Tests and related services must be ordered or administered based on the attending healthcare provider's determination that they relate to the furnishing or administration of a COVID‑19 diagnostic test or to the evaluation of the individual for the need for the test; the attending provider must be licensed and acting within scope of license.
- Who can order: the individual's attending healthcare provider as defined in the guidance.
Encouragement of telehealth access; no extra ordering restrictions
The Departments encourage broader access to telehealth and other remote care services and do not specify additional provider ordering restrictions for COVID‑19 testing beyond the attending provider determination described in the guidance.
- States are encouraged to consider relaxing licensing laws during the emergency to enable more providers to offer telehealth services.
Frequency and Appropriateness Determinations
Exclusions and Non-Applicability
Tests and related services required by section 6001 are not covered for plans or coverages that are excluded from the statute — including short‑term, limited‑duration insurance and plans providing excepted benefits. Similarly, group health plans that do not cover at least two current employees (for example, retiree‑only plans) fall outside the section 6001 coverage requirement.
Within the portions of the source document provided there are no explicit laboratory tests or clinical indications listed as not covered. The guidance instead specifies plan‑level exclusions (e.g., short‑term or excepted benefits) and focuses coverage obligations on tests meeting the statutory/regulatory criteria.
Key Term Definitions
Covered COVID‑19 diagnostic testing comprises in vitro diagnostic products intended to detect SARS‑CoV‑2 or diagnose COVID‑19, which includes molecular tests and serological (antibody) tests when they meet the statutory and regulatory criteria. Coverage extends to tests and related items and services furnished during an attending provider’s visit (including in‑person, telehealth, urgent care, and emergency department encounters) and in non‑traditional settings such as drive‑through testing, as long as the testing and related services relate to furnishing or administering the test or to evaluating the individual for the need for the test.
Document Changes and Effective Dates
Background timing and applicability: the coverage requirements apply to items and services furnished on or after March 18, 2020 and during the public health emergency declared under section 319 of the Public Health Service Act. The Departments have also issued non‑enforcement flexibility for mid‑year additions of telehealth or cost‑sharing reductions during the emergency, but expect plans to provide notice as soon as reasonably practicable and to update plan documents if changes are maintained beyond the emergency period.
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