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October 09, 2020

Health Law Weekly

COVID-19 Updates and Developments (Week of October 5)

  • October 09, 2020

Agency Action

Centers for Medicare & Medicaid Services (CMS)

October 8—Health care providers and suppliers will have additional time to repay any Medicare loans they received, CMS announced. The agency has issued $106 billion in payments to providers under the Accelerated and Advance Payment Program to help ease financial strain during the early stages of the COVID-19 public health emergency. Providers were supposed to begin repaying the loans in August but a recently enacted continuing resolution now gives them one year from the issuance date of the accelerated or advance payment before repayment begins. After the first year, CMS will automatically recoup 25% of Medicare payments otherwise owed to the provider or supplier for 11 months; recoupment then will increase to 50% for another six months. If the provider or supplier is unable to repay the total amount after 29 months, CMS will issue letters requiring repayment of any outstanding balance, subject to an interest rate of 4%, the agency said. Providers and suppliers also can request an Extended Repayment Schedule if they are experiencing financial hardships. 

Department of Health and Human Services (HHS)

October 8—Certain cooperative research conducted or supported by HHS may not have to comply with the single Institutional Review Board (IRB) requirement during the COVID-19 public health emergency under an exception determination issued by the Office for Human Research Protections (OHRP). Effective January 20, federal regulations require research projects that involve more than one institution to use a single IRB. Those regulations also allow, however, exceptions to the single IRB mandate for cooperative research. Due to the public health emergency, OHRRP issued the exception determination for the single IRB requirement under certain circumstances. “This exception represents an effort to prioritize the health and safety of both research subjects and investigators, and provides flexibility to institutions in seeking IRB review due to the unique challenges created by the COVID-19 outbreak,” OHRP said.

Centers for Disease Control and Prevention (CDC)

October 5—The CDC updated its website to acknowledge the potential for airborne transmission of COVID-19. “Some infections can be spread by exposure to virus in small droplets and particles that can linger in the air for minutes to hours. These viruses may be able to infect people who are further than 6 feet away from the person who is infected or after that person has left the space,” according to the CDC. The agency emphasized, however, that COVID-19 is mainly spread through close contact with an infected individual. The CDC noted some evidence that individuals with COVID-19 infected others who were more than six feet away, particularly in enclosed spaces with poor ventilation. Certain activities that cause an individual to breathe heavily such as exercise or singing also can increase the risk of infection, the agency said. Last month, the CDC indicated on its website the potential for airborne transmission of COVID-19 but later removed the post stating the information was in draft form and added in error. The CDC continues to list social distancing (staying at least six feet from others), wearing masks, and hand washing among the key steps to slow the spread of the virus.

Food and Drug Administration (FDA)

October 6—The FDA issued guidance for drug companies to request Emergency Use Authorization (EUA) for COVID-19 vaccines. The guidance, which is effectively immediately, describes the FDA’s current recommendations for the data needed to support the issuance of an EUA for an investigational vaccine to prevent COVID-19, including chemistry, manufacturing, and controls information; nonclinical data and information; and clinical data and information. The guidance, among other things, indicates that “[d]ata from Phase 3 studies should include a median follow-up duration of at least two months after completion of the full vaccination regimen . . . .” According to the guidance, the agency plans to convene an open session of the Vaccines and Related Biological Products Advisory Committee before issuing any EUA for a COVID-19 vaccine “to discuss whether the available safety and effectiveness data support authorization of an EUA for the specific request under review.”

National Institutes of Health (NIH)

October 6—The NIH awarded a third round of contracts valued at $98.3 million for point of care and other novel testing approaches for COVID-19. “The current round of awards support five technologies that can be delivered to the point of care and a powerful laboratory test,” said Bruce J. Tromberg, Ph.D., director of the National Institute of Biomedical Imaging and Bioengineering (NIBIB. “The technologies include an antigen test that provides results in 15 minutes, a viral RNA test deployed in mobile vans that can travel to COVID hotspots and tests that require only saliva, nasal swabs or blood from a finger prick.”

Other Developments

October 5—President Donald Trump issued an executive order to create a cabinet-level working group tasked with addressing the mental health effects of COVID-19. The order also requires federal agencies to maximize support for behavioral health treatment including telehealth, peer-to-peer, and safe in-person therapeutic services.

October 2—The National Academies of Sciences, Engineering, and Medicine released final recommendations for a framework that federal, state, and local policymakers should adopt to develop guidelines for equitable allocation of a vaccine against COVID-19. The Committee on Equitable Allocation of Vaccine for the Novel Coronavirus released a preliminary framework in September for public comment. The final Framework for Equitable Allocation of COVID-19 Vaccine adopts a four-phase approach to achieve maximum societal benefit by reducing morbidity and mortality caused by the transmission of novel coronavirus. The phases start with frontline health workers and those at highest risk of severe COVID-19 disease or death.