In December, the FDA approved the first oral antiviral https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-first-oral-antiviral-treatment-covid-19 for the treatment of mild-to-moderate coronavirus disease (COVID-19) in adults and pediatric patients (12 years of age and older weighing at least 40 kilograms or about 88 pounds) with positive results of direct SARS-CoV-2 testing, and who are at high risk for progression to severe COVID-19, including hospitalization or death. A limited number of FQHCs in Pennsylvania have begun to receive a supply of oral antivirals. Pennsylvania locations with oral antivirals obtained through the PA Department of health can be found at: https://www.health.pa.gov/topics/disease/coronavirus/Pages/Prevention-Treatment.aspx#oral Scroll down the page and note there are separate links for Mulnupiravir providers and Paxlovid providers. Individuals can also search by address using this therapeutics map: https://protect-public.hhs.gov/pages/therapeutics-distribution In addition, around 200 health centers nationwide, including seven in Pennsylvania, have been invited to participate in the HRSA program to distribute oral antivirals. As supply increases, oral AVs should be a more accessible solution, but supply is currently very limited in both programs.

The COVID-19 pandemic prompted the increased and widespread use of virtual health services, including telehealth, in health centers. Learn more about the effect that the rise in the use of this technology has had on clinician engagement through a STAR Center white paper. https://chcworkforce.org/web_links/effects-of-virtual-care-delivery/

A recent study of more than one million people confirms that COVID-19 vaccines are highly effective against COVID-19-associated hospitalization and death. Highlights include that severe COVID-19-associated outcomes (0.015%) or death (0.0033%) were rare and nearly 80% of those who died had at least four risk factors. https://www.cdc.gov/mmwr/volumes/71/wr/mm7101a4.htm

Pennsylvania Governor Tom Wolf announced the state is working to increase healthcare capacity to deal with the surge of COVID-19 cases. The Pennsylvania Department of Health and the Pennsylvania Emergency Management Agency are coordinating the undertaking. The plans involve adding hospital beds within regions for 60 days to absorb patients from swamped hospitals. Additional medical support staff are to include physicians, respiratory therapists and registered nurses. Other staff will be sent directly to hospitals in need over the next three months. Certain nursing homes also will get additional beds, registered nurses and aides to allow hospitals in the area to discharge patients in need of long-term rehab or care more quickly, according to an Associated Press report.

President Biden announced that, starting January 19th, the Administration will begin distributing at-home, rapid COVID-19 tests to American homes for free at COVIDTests.gov. This program will ensure that Americans have at-home, rapid COVID-19 tests available in the weeks and months ahead—in addition to the number of other ways they can get tested. The Administration is quickly completing a contracting process for the unprecedented purchase of one billion at-home, rapid tests to distribute as part of this program. You can find more details below about how to order an at-home test, and we encourage you to share this information broadly with your communities.

• Ordering Process: Starting on January 19, Americans will be able to order a test online at COVIDTests.gov. To ensure broad access, the program will limit the number of tests sent to each residential address to four tests. Tests will usually ship within 7-12 days of ordering.
• Distribution and Delivery Process: The Administration will partner with the United States Postal Service to package and deliver tests to Americans that want them. All orders in the continental United States will be sent through First Class Package Service, with shipments to Alaska, Hawaii, and the U.S. Territories and APO/FPO/DPO addresses sent through Priority Mail.

Ensuring Equity and Reaching Hardest-Hit Communities: The Administration is taking a number of steps to ensure this program reaches our hardest-hit and highest-risk communities. This includes prioritizing processing orders to households experiencing the highest social vulnerability and in communities that have experienced a disproportionate share of COVID-19 cases and deaths, particularly during this Omicron surge; launching a free call line, so that Americans who have difficulty accessing the internet or need additional support can phone-in orders for their tests; and, working with national and local organizations with deep experience serving communities of color, people living with disabilities, and other high-risk communities to serve as navigators, raise awareness about the program, and help people submit requests.

The Centers for Medicare & Medicaid Services (CMS) has updated our Nursing Home Resource Center with two new informational products.

As of January 6, 2022, the Nursing Home Visitation FAQs have been updated to provide additional guidance about visitation during the Omicron surge. CMS has also created an infographic to graphically represent how to safely conduct visits to nursing homes during this time of spiking COVID cases around the country. These two new resources are available for nursing home providers, patients, caregivers, and CMS partners to stay informed about CMS’ latest thinking for keeping nursing homes safe in the current COVID climate.

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.