Free COVID-19 Vaccines and Diagnostic Testing

Holland & Hart - Health Law Blog

Holland & Hart - Health Law Blog

Over a year after the declaration of a nationwide public health emergency due to the Coronavirus Disease 2019 (“COVID-19”) pandemic, providers are in a position to offer patients a variety of COVID-19 medical services, including diagnostic testing, disease treatment, and vaccinations. Payment obligations for these COVID-19 services have continued to spark questions from providers, patients, and insurers with respect to mandatory coverage requirements and permissive coverage limitations.

The Families First Coronavirus Response Act (“FFCRA”) and Coronavirus Aid, Relief, and Economic Security (“CARES”) Act require group health plans and health insurance issuers offering group or individual health insurance coverage to provide benefits for certain items and services related to testing, diagnosis, and treatment of COVID-19 after March 18, 2020, through the end of the public health emergency.

On February 26, 2021, the U.S. Departments of Labor, Health and Human Services, and the Treasury (the “Departments”) issued a third Joint Agency FAQ addressing coverage requirements for items and services related to COVID-19 diagnostic testing and qualifying preventative services, including vaccines. This guidance further clarifies and builds upon the Departments’ earlier Joint Agency FAQ documents, published April 11, 2020, and June 23, 2020, which were discussed in our previous article, COVID-19 Testing: Who Pays?

COVID-19 Diagnostic Testing

Specific to COVID-19 diagnostic testing, plans are required to cover fees incurred in the administration of a COVID-19 diagnostic test, including facility fees, without cost-sharing, prior authorization, or medical management requirements.

In the new guidance, the Departments clarify that when an individual receives a COVID-19 diagnostic test from a licensed or authorized healthcare provider, even at a state or locality-administered testing site (e.g., drive-through testing), plans and issuers “must assume that the receipt of the test reflects an ‘individualized clinical assessment’ and the test should be covered without cost sharing, prior authorization, or other medical management requirements.” It is impermissible for plans and issuers to require the presence of symptoms or a recent known or suspected COVID-19 exposure before covering a diagnostic test.

The Centers for Medicare and Medicaid Services (“CMS”) issued a press release related to this most recent FAQ, further clarifying the requirement that COVID-19 diagnostic testing be covered: “For example, covered individuals wanting to ensure they are COVID-19 negative prior to visiting a family member would be able to be tested without paying cost sharing.”

Clarified guidance does not impact the Departments’ previous guidance confirming that plans and issuers are not required to cover testing for groups of asymptomatic individuals without COVID-19 exposure for public health surveillance or employment purposes.

COVID-19 Vaccines

The CARES Act requires group health plans and health insurance issuers offer group or individual health insurance to cover, without cost-sharing, any qualifying COVID-19 preventative services. Preventative services include items, services, or immunizations intended to prevent or mitigate COVID-19. For an immunization to be covered, it must have a recommendation from the Advisory Committee on Immunization Practices (“ACIP”) of the Centers for Disease Control and Prevention (“CDC”). As of February 28, 2021, three vaccines that have received ACIP recommendation – those manufactured by Pfizer, Moderna, and Johnson & Johnson.

Plans and issuers are required to begin covering vaccines within 15 business days of ACIP making its recommendation. This coverage requirement became effective on January 5, 2021, for the Pfizer BioNTech vaccine; and on January 12, 2021, for the Moderna vaccine. The Johnson & Johnson vaccine coverage requirement will become effective March 19, 2021.

In addition to covering qualifying vaccines, plans and issuers must also cover vaccine administration fees. This applies regardless of whether another source is billed or pays for the vaccine itself. Further, plans may not deny coverage of a vaccine on the basis that an individual received a vaccine prior to any state or local prioritization category.

Uninsured Patients

For patients that are uninsured, healthcare providers are reminded that a portion of the Provider Relief Fund (“PRF”) established under the CARES Act is available to reimburse providers for COVID-19 testing and testing-related visits, treatment for individuals with a COVID-19 diagnosis, and COVID-19 vaccination administration fees for uninsured patients. This reimbursement is available without regard to the immigration status of the uninsured patient through the Health Resources and Services Administration (“HRSA”) COVID-19 Uninsured Program.

For additional information about coverage requirements, visit the FAQ published February 26, 2021, or the earlier FAQs June 23, 2020 and April 11, 2020.

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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