As part of its ongoing efforts across many channels to expand Americans’ access to free testing, the Biden-Harris Administration is requiring insurance companies and group health plans to cover the cost of over-the-counter, at-home COVID-19 tests, so people with private health coverage can get them for free starting January 15.  The new coverage requirement means that most consumers with private health coverage can go online or to a pharmacy or store, buy a test, and either get it paid for up front by their health plan, or get reimbursed for the cost by submitting a claim to their plan. This requirement incentivizes insurers to cover these costs up front and ensures individuals do not need an order from their health care provider to access these tests for free.

Beginning January 15, 2022, individuals with private health insurance coverage or covered by a group health plan who purchase an over-the-counter COVID-19 diagnostic test authorized, cleared, or approved by the U.S. Food and Drug Administration (FDA) will be able to have those test costs covered by their plan or insurance. Insurance companies and health plans are required to cover 8 free over-the-counter at-home tests per covered individual per month. That means a family of four, all on the same plan, would be able to get up to 32 of these tests covered by their health plan per month. There is no limit on the number of tests, including at-home tests, that are covered if ordered or administered by a health care provider following an individualized clinical assessment, including for those who may need them due to underlying medical conditions.

“Under President Biden’s leadership, we are requiring insurers and group health plans to make tests free for millions of Americans. This is all part of our overall strategy to ramp-up access to easy-to-use, at-home tests at no cost,” said HHS Secretary Xavier Becerra. “Since we took office, we have more than tripled the number of sites where people can get COVID-19 tests for free, and we’re also purchasing half a billion at-home, rapid tests to send for free to Americans who need them. By requiring private health plans to cover people’s at-home tests, we are further expanding Americans’ ability to get tests for free when they need them.”

Over-the-counter test purchases will be covered in the commercial market without the need for a health care provider’s order or individualized clinical assessment, and without any cost-sharing requirements such as deductibles, co-payments or coinsurance, prior authorization, or other medical management requirements.

As part of the requirement, the Administration is incentivizing insurers and group health plans to set up programs that allow people to get the over-the-counter tests directly through preferred pharmacies, retailers or other entities with no out-of-pocket costs.  Insurers and plans would cover the costs upfront, eliminating the need for consumers to submit a claim for reimbursement. When plans and insurers make tests available for upfront coverage through preferred pharmacies or retailers, they are still required to reimburse tests purchased by consumers outside of that network, at a rate of up to $12 per individual test (or the cost of the test, if less than $12). For example, if an individual has a plan that offers direct coverage through their preferred pharmacy but that individual instead purchases tests through an online retailer, the plan is still required to reimburse them up to $12 per individual test. Consumers can find out more information from their plan about how their plan or insurer will cover over-the-counter tests.

“Testing is critically important to help reduce the spread of COVID-19, as well as to quickly diagnose COVID-19 so that it can be effectively treated. Today’s action further removes financial barriers and expands access to COVID-19 tests for millions of people,” said CMS Administrator Chiquita Brooks-LaSure.

State Medicaid and Children’s Health Insurance Program (CHIP) programs are currently required to cover FDA-authorized at-home COVID-19 tests without cost-sharing. In 2021, the Biden-Harris Administration issued guidance explaining that State Medicaid and Children’s Health Insurance Program (CHIP) programs must cover all types of FDA-authorized COVID-19 tests without cost sharing under CMS’s interpretation of the American Rescue Plan Act of 2019 (ARP). Medicare pays for COVID-19 diagnostic tests performed by a laboratory, such as PCR and antigen tests, with no beneficiary cost sharing when the test is ordered by a physician, non-physician practitioner, pharmacist, or other authorized health care professional. People enrolled in a Medicare Advantage plan should check with their plan to see if their plan offers coverage and payment for at-home over-the-counter COVID-19 tests.

This effort is in addition to a number of actions the Biden Administration is taking to expand access to testing for all Americans. The U.S. Department of Health and Human Services (HHS) is providing up to 50 million free, at-home tests to community health centers and Medicare-certified health clinics for distribution at no cost to patients and community members. The program is intended to ensure COVID-19 tests are made available to populations and settings in need of testing. HHS also has established more than 10,000 free community-based pharmacy testing sites around the country.  To respond to the Omicron surge, HHS and FEMA are creating surge testing sites in states across the nation.

For more information, please see these Frequently Asked Questions, https://www.cms.gov/files/document/11022-faqs-otc-testing-guidance.pdf

For additional details on the requirements, visit https://www.dol.gov/sites/dolgov/files/EBSA/about-ebsa/our-activities/resource-center/faqs/aca-part-51.pdf

The Flex Monitoring Team (FMT) has released a new data report, Critical Access Hospitals’ Initial Response to COVID-19 by System Affiliation. This report presents data on the initial response to COVID-19 in system-affiliated and independent Critical Access Hospitals (CAHs). The data come from a survey of CAH CEOs in eight states about their response to COVID-19 from February to August 2020, and findings include information on COVID-19 case volume, personal protective equipment (PPE) supply, and the perceived impact of being a system-affiliated or independent CAH on their overall response to COVID-19.

A lack of a high school education was the most important predictor of COVID-19 vaccine hesitancy in 3,142 U.S. counties, finds a study yesterday in the American Journal of Infection Control. Of all reasons cited for COVID-19 vaccine hesitancy, a lack of trust in the vaccines (55%) was the most common, followed by worries about side effects (48%) and low trust in the government (46%). Five of the 10 most common reasons given for vaccine hesitancy were related to a lack of knowledge about potential side effects, benefits, effectiveness and risks of being unvaccinated.

Health Resources and Services Administration is accepting requests for claims reimbursement to healthcare providers, generally at Medicare rates, for testing uninsured individuals for COVID-19, for treating uninsured individuals with a COVID-19 primary diagnosis and for COVID-19 vaccine administration to the uninsured. Applications are accepted on an ongoing basis. A separate program, the HRSA COVID-19 Coverage Assistance Fund, is available to reimburse providers for COVID-19 vaccine administration to underinsured individuals whose health plan either does not include COVID-19 vaccination as a covered benefit or covers COVID-19 vaccine administration but with cost-sharing.

Following the recent statement from the National Institutes of Health (NIH) COVID-19 Treatment Guidelines Panel regarding therapies for the COVID-19 Omicron variant, CMS created HCPCS code J0248 for VEKLURY™ (remdesivir) antiviral medication when administered in an outpatient setting. This code is available for use by all payers and is effective for dates of service on or after December 23, 2021:

• Long descriptor: Injection, remdesivir, 1 mg
• Short descriptor: Inj, remdesivir, 1 mg

Medicare Administrative Contractors (MACs) determine Medicare coverage when there is no national coverage determination, including in cases when providers use FDA-approved drugs for indications other than what is on the approved label. The MACs consider the major drug compendia, authoritative medical literature and accepted standards of medical practice to determine medical necessity when considering coverage. Therefore, the MACs will determine Medicare coverage for HCPCS code J0248 for VEKLURY™ (remdesivir) administered in an outpatient setting.

Your MAC will share coverage and claims processing information for J0248. Contact your MAC if you have questions about coverage.

The Centers for Disease Control and Prevention (CDC) has released another COVID-related rural resource that may be of interest.  A “Rural Considerations” addendum was recently added to its field guide for conducting a Rapid Community Assessment (RCA).

An RCA is a process for quickly collecting community insights about a public health issue in order to inform program design. The assessment involves reviewing existing data and conducting community-based interviews, listening sessions, observations, social listening, and surveys.  In addition to the rural considerations addendum, the CDC RCA webpage provides an assessment guide and tools for those who wish to better understand their community’s needs regarding COVID-19 vaccine acceptance and uptake among adults, adolescents, and children.  Addendums for conducting RCAs in tribal communities and among adolescent populations were also recently posted to the webpage.

The original COVID-19 Vaccination Field Guide: 12 Strategies for Your Community presents evidence-based strategies being applied in communities across the country to increase COVID-19 vaccine confidence and uptake. To help rural communities apply these strategies, the addendum includes rural considerations and examples for the 12 strategies based on successes in the field and input from health departments and rural health organizations.

State and local health departments, community- and faith-based organizations, and local nonprofits are encouraged to try a combination of these strategies to increase vaccination rates.  Please share widely!  Questions may be directed to ruralhealth@cdc.gov.

The Pennsylvania House of Representatives unanimously approved a legislative amendment that would create a $10 million program to assist counties that want to distribute at-home COVID-19 tests. The amendment was added to HB 2033, that extends reporting requirements for state labs that conduct COVID-19 tests. The amended bill still must make its way through the Senate before it can reach the desk of Gov. Tom Wolf. According to the amendment, the Pennsylvania Department of Health would buy the test kits. Counties would then have 30 days to apply by stating how many tests they need and detailing how they plan to distribute them.

The federal government is committed to ensuring that residents and staff in long-term care settings, such as nursing homes, assisted living, residential care communities, group homes and senior housing, have access to COVID-19 vaccines to receive primary series and booster shots.

Long-term care providers are encouraged to consider the option that works best for their residents and staff when coordinating access to COVID-19 vaccines, either in the local community or on-site. The CDC has additional details on these options. Find Medicare billing and payment information.

As a reminder, through enforcement discretion, CMS will allow Medicare-enrolled immunizers, including but not limited to pharmacies working with the United States, to bill directly and receive direct reimbursement from the Medicare program for vaccinating Medicare skilled nursing facility residents.