On June 23, 2020, the US Departments of Labor, Health and Human Services, and Treasury issued tri-agency FAQs (Part 43) that clarify important health and welfare provisions under the Families First Coronavirus Response Act (FFCRA), which became law on March 18, 2020, and the Coronavirus Aid, Relief, and Economic Security (CARES) Act, enacted on March 27, 2020. Both laws addressed Coronavirus (COVID-19) testing and prevention coverage, as well as expansion of telehealth service availability. This is the second set of FAQs issued by the joint agencies addressing compliance with the FFCRA and the CARES Act. For more information, see our previous articles on the prior FAQ, the provisions of the FFCRA and the provisions of the CARES Act.

IN DEPTH

COVID-19 Testing Applies to Self-Insured/Self-Funded Plans

Effective March 18, 2020, the FFCRA generally requires group health plans to provide benefits for certain items and services related to diagnostic testing to detect or diagnose COVID-19 without cost sharing (including deductibles, copayments and coinsurance), prior authorization or any other medical management requirement. Per the FAQs, multiple diagnostic tests must be covered if the attending healthcare provider determines such tests are medically appropriate. If a facility fee (e.g., a fee for using facilities or equipment that an individual’s provider does not own, or that are owned by a hospital) is charged for a visit that results in an order for, or administration of, a COVID-19 diagnostic test, a plan must cover that facility fee to the extent the fee relates to furnishing or administering a COVID-19 test, or to evaluating an individual to determine her need for testing. The new FAQs also provide that plans must cover at-home testing if the physician or other provider has determined that the test is medically appropriate for the individual, including tests where the individual performs self-collection of a specimen at home. There is no limit on the number of tests a plan must cover relating to a specific individual. Any number of tests must be covered as long as the tests are diagnostic and medically appropriate for the individual, as determined by an attending healthcare provider in accordance with current accepted standards of medical practice.

The new FAQ confirms that FFCRA’s health plan provisions apply to self-insured/self-funded group health plans, which include private employment-based group health plans (plans governed by the Employee Retirement Income Security Act of 1974), non-federal governmental plans (such as plans sponsored by states and local governments) and church plans. Plans that do not cover at least two current employees, such as retiree-only plans, are not required to comply.

Types of Tests Required

The new FAQs clarify that all in vitro diagnostic tests for COVID-19 that have received an emergency use authorization from the US Food and Drug Administration (FDA) must be covered. A list of such test can be found here.

The FAQs also clarify that for purposes of covering an in vitro diagnostic test for which the developer has requested or intends to request emergency use authorization, a clinical laboratory or commercial manufacturer that is listed on FDA’s website as having provided notification under the FDA guidance can reasonably be assumed to have requested, or as intending to request, an emergency use authorization (except for laboratory-developed serology tests). Therefore, coverage must be provided for in vitro diagnostic tests for COVID-19 that are included on the FDA list.

Lastly, for purposes of covering an in vitro diagnostic test that is developed in and authorized by a state that has provided proper notification, a list of states and territories that have provided notification can be found here.

Return-to-Work Testing Need Not Be Covered

The agencies note that COVID-19 testing for surveillance or employment purposes is not required to be covered under the FFCRA. Testing conducted to screen for general workplace health and safety (such as employee return-to-work programs), for public health surveillance for COVID-19, or for any other purpose not primarily intended for individualized diagnosis or treatment of COVID-19 or another health condition is beyond the scope of the FFCRA.

Balance Billing Issues

The new FAQs provide that the agencies interpret the FFCRA and the CARES Act (as well as related guidance) as intended to protect participants from being balance billed for an applicable COVID-19 test. Under the CARES Act, a plan will reimburse a COVID-19 testing provider either a negotiated rate or an amount that equals the cash price for such service that is listed by the provider on a public website. If the provider fails to post the cash price, the parties may have to negotiate the price, and the provider may be subject to penalties for failure to comply with the CARES Act. In either case, the amount the plan or issuer reimburses the provider constitutes payment in full for the test, with no cost-sharing to the individual or other balance due. Individuals may still be subject to balance billing for items and services furnished during a visit that are not covered by the CARES Act.

Notice Requirements

The expanded coverage for COVID-19 testing continues until a “outbreak” period ends. If an employer wants to align COVID-19 testing with its other benefits upon the end of the national emergency period and impose cost sharing, prior notice to participants is required unless the notice eliminating cost sharing included information about the temporary nature of the relief.

Telehealth

The FAQs confirm that employers may offer a telehealth-only plan (including other remote care service arrangements) to employees and dependents who are not otherwise eligible for the employer’s group health plan—at least during the pandemic, with the stipulation that the telehealth-only plan cannot have pre-existing condition exclusions, cannot discriminate based on health status, cannot conduct rescissions of coverage, and is still subject to mental health parity.

Conclusion

Many of the changes required or permitted by the FFCRA and the CARES Act as highlighted in these FAQs will require amendments to plan documents and updates to summary plan descriptions. Plan sponsors should work with third-party administrators, insurers and legal counsel to ensure that these changes are implemented correctly and to review any other legal requirements that might be implicated.

Specifically, plan sponsors should work with their insurers and third-party administrators to ensure that cost sharing has been eliminated for COVID-19 testing and diagnostics. Plan sponsors also may wish to work with insurers and third-party administrators to ascertain pricing from out-of-network facilities, in light of the prohibition on balance billing. Participant communications also should be revised to reflect plan changes.