The U.S. Food and Drug Administration has issued an emergency use authorization (EUA) for the first COVID-19 diagnostic test for self-testing at home and that provides rapid results. The Lucira COVID-19 All-In-One Test Kit is a molecular (real-time loop mediated amplification reaction) single use test that is intended to detect the novel coronavirus SARS-CoV-2 that causes COVID-19. It is approved for self-collected nasal swab samples in individuals age 14 and older who are suspected of COVID-19 by their health care provider. It is also authorized for use in point-of-care (POC) settings (e.g., doctor’s offices, hospitals, urgent care centers and emergency rooms) for all ages but samples must be collected by a healthcare provider when the test is used at the POC to test individuals younger than 14 years old. The test is currently authorized for prescription use only. Read more here.

The Centers for Medicare and Medicaid Services (CMS) has issued an interim final rule establishing vaccine-related coverage provisions for Medicare, Medicaid, CHIP and private insurance. The new interim final rule, published Nov. 6 in the Federal Register, states that providers can receive free vaccines from the federal government but will be prohibited from charging consumers for the administration. Under Medicare there would be no cost-sharing for COVID-19 vaccines. For individuals without health coverage, providers can be reimbursed through HRSA’s COVID-19 Claims Reimbursement Program. NACHC believes vaccine administration requirements could present costs to health centers and that state Maintenance of Effort requirements could adversely impact FQHC reimbursements and will be submitting comments. NACHC has written this memo in response to the rule. CMS issued toolkits aimed at State Medicaid Agencies, providers who will administer the vaccine and health insurance plans. The deadline for comments on the rule is Jan. 4, 2021.

The Pennsylvania Department of Health this week began distribution of the sixth allotment of COVID-19 antigen test kits provided by the federal government to Clinical Laboratory Improvement Amendments (CLIA)-certified institutions in Bedford, Cambria, Franklin, Lancaster and Lehigh counties. Last week, 139,200 tests were distributed to 70 facilities in Armstrong, Dauphin, Delaware and Indiana counties. Additional tests will be provided to healthcare providers in those counties in the coming weeks. Archived lists of distributions since week one can be found on the Department of Health’s Coronavirus Symptoms & Testing webpage under the Antigen Tests subhead.

Check out this interactive map to find out and to see if your health center testing sites are accurately reflected. Click on any of the blue or yellow pins for identification of the site and a link to additional information on the provider. To add, modify or close a testing site, submit this form.

For the last few weeks, Congressional leadership, including Senate Majority Leader Mitch McConnell (R-KY) and House Speaker Nancy Pelosi (D-CA), have indicated a desire to pass a full-year omnibus appropriations bill ahead of the December 11, 2020, funding cliff rather than another short-term continuing resolution. Last week, Senate Republicans released their spending package which has helped kickstart negotiations on the full-year spending package. Following meetings between Republican leadership and White House Chief of Staff Mark Meadows this week, Roll Call has begun reporting that the President Trump is open to signing a full-year package. Negotiations are ongoing, and NRHA will keep members apprised of developments via NRHA Connect.

For more timely updates, follow @NRHA_Advocacy on Twitter! If you have any questions, comments, or suggestions, NRHA wants to hear them.

Large urban hospitals are rushing to buy expensive ultra-cold freezers to store what’s likely to be the first approved COVID-19 vaccine. But most rural hospitals can’t afford these high-end units, meaning health workers and residents in those communities may have difficulty getting the vaccines. “Hundreds of rural, small towns all across the U.S. have a higher percentage of elderly, low-income [residents], a higher percentage of the community with multiple chronic health issues,” says NRHA CEO Alan Morgan. “In this financial environment, you can imagine that there is simply no consideration of rural hospitals purchasing storage equipment for this ultra-cold distribution.” In an interview that aired on CBS This Morning, NRHA member Tim Size spoke to the need for equitable vaccine access in rural America. He stated, “If, basically, rural is getting the message, ‘We will start with urban,’ even it is for reasonable logistical reasons, it’s bad optics. I don’t think anybody wants to give the message that rural America, rural Wisconsin is second-class.”