August 26, 2020 – The Centers for Medicare & Medicaid Services (CMS) announced sweeping regulatory changes that require labs and other healthcare providers to test staff and offer testing to residents for COVID-19. Labs and nursing homes using point-of-care (POC) testing devices will be required to report diagnostic test results as required by the CARES Act (Coronavirus Aid, Relief, and Economic Security Act). The new rules also require hospitals to provide COVID-19 cases and related data to the U.S. Department of Health and Human Services (HHS).
CMS said in a press release that the new requirements “will support federal and state efforts to identify early spread of the virus and allocate personal protective equipment (PPE) and other resources.”
New reporting requirements for labs
CMS’ new rule implements a CARES Act requirement that laboratories report COVID-19 test results daily to the HHS Secretary.
All laboratories conducting COVID-19 testing and reporting patient-specific results – including hospital labs, nursing homes, and other facilities conducting testing for COVID-19 – will be required to comply.
CMS will impose a civil monetary penalty of $1,000 a day for the first day, and $500 for each subsequent day for laboratories that do not report the required information.
Labs will have a one-time, three-week grace period to begin reporting required test data.
New testing requirements for nursing homes
The earlier recommendation to routinely test staff is now a requirement for participation in the Medicare and Medicaid programs under CMS’ authority through the Social Security Act. CMS recommendations for the frequency of staff testing will be based on the degree of community spread, to be announced shortly through guidance, that indicate the facility may be at increased risk for COVID-19 transmission.
CMS now requires that nursing homes will offer tests to residents when there is an outbreak or residents show symptoms.
The Administration is holding nursing homes accountable for the testing requirement by directing surveyors to inspect nursing homes for adherence to the new testing requirements. Facilities that do not comply with the new requirements will be cited for non-compliance and may face enforcement sanctions based on the severity of the noncompliance, such as civil money penalties in excess of $400 per day, or over $8,000 for an instance of noncompliance.
Hospitals must report data to HHS
The emergency regulations will also require hospitals and critical access hospitals to report daily important data critical to support the fight against COVID-19, including, but not limited to elements such as the number of confirmed or suspected COVID-19 positive patients, ICU beds occupied, and availability of essential supplies and equipment such as ventilators and PPE.
The new rules make reporting a requirement of participation in the Medicare and Medicaid programs. Hospitals will face possible termination of Medicare and Medicaid payment if unable to correct reporting deficiencies.