COVID-19 regulatory updates for this week are provided below and include information from CMS, HHS, CDC, and the FDA.
Friday’s CMS Lessons from the Front Lines: COVID-19 call (Friday, May 29th from 12:30 p.m. – 2 p.m. Eastern) was cancelled. CMS will resume the call series next Friday, June 5. Members with COVID-19 questions should submit them COVID-19@cms.hhs.gov.
CMS updated their COVID-19 frequently asked questions (FAQs) on Medicare Fee-for-Service billing. The FAQs cover all topics including billing for testing, treatment, and different types of settings, and clarifies provisions from the Coronavirus Aid, Relief, and Economic Security (CARES) Act. CMS is thoroughly assessing the legislation, and new and revised FAQs will be released as implementation plans are announced.
The Department of Health and Human Services (HHS) has announced a 45 day deadline extension for providers on the front lines of the COVID-19 response who are receiving payments from the Provider Relief Fund to accept the Terms and Conditions for payments. This announcement means providers have now been granted 90 days from the date they received a payment to accept HHS Terms and Conditions or return the funds. Congress has allocated $175 billion to the Provider Relief Fund. HHS began distributing funds to Medicare providers in April and has since distributed additional funds for hospitals in hotspots, rural providers, skilled nursing facilities, and to the Indian Health Service.
The Centers for Disease Control and Prevention (CDC) recently released interim guidelines for COVID-19 antibody testing in clinical and public health settings, and updated their information on test for past infection (antibody test). Data that will inform serologic testing guidance is rapidly evolving.
Recommendations on the use of serologic tests to determine protective immunity and infectiousness among persons recently infected with COVID-19 will be updated as new information becomes available. To learn more about the percentage of people who have been infected with COVID-19 and to better understand how the virus is spreading through the U.S. population over time the CDC is partnering with commercial laboratories to conduct a large-scale geographic seroprevalence survey that will first test clinical blood specimens from Washington State and the New York City metro region. The CDC also plans to expand the seroprevalence survey to an additional eight states, including California, Connecticut, Florida, Louisiana, Minnesota, Missouri, Pennsylvania and Utah.
The Food and Drug Administration (FDA) recently updated FAQs on COVID-19 testing to clarify information about at-home self-collection and what tests should no longer be distributed for COVID-19.
The FDA also issued two guidance documents (one new guidance and one revised guidance) for industry to help address potential shortages of face masks, surgical masks, respirators, and face shields for use during the COVID-19 public health emergency. These guidelines help to address potential shortages by facilitating the safe reuse and conservation of surgical masks and respirators for medical purposes through the use of decontamination and bioburden reduction systems, and provide recommendations of alternatives and updated options for when FDA-cleared or NIOSH-approved N95 respirators are not available.