On August 25, 2020, the Centers for Medicare & Medicaid Services (CMS) promulgated regulatory changes via an interim final rule dated August 21, 2020,[1] requiring nursing homes to test staff and offer testing to residents for COVID-19. Laboratories and nursing homes using point-of-care testing devices will be required to report diagnostic test results as required by the CARES 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).
The CMS Newsroom reports, “These new requirements strongly support the Trump Administration’s efforts to boost surveillance of the virus and double down on its commitment to keep nursing home residents safe. The requirements will support federal and state efforts to identify early spread of the virus and allocate personal protective equipment (PPE) and other resources. … President Trump previewed CMS’s testing requirement in July along with the announcement that rapid, point-of-care diagnostic devices would be distributed to all nursing homes across the country that are certified to perform these types of tests. … ‘From the beginning of this pandemic, President Trump has worked tirelessly to protect our vulnerable elderly in nursing homes. The provisions in today’s rule on nursing homes represent his expectation that CMS pull every available regulatory lever to maximize nursing home residents’ safety and quality of life. These Americans and their families, who have already gone through so much, deserve nothing less.’
“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. These elements are essential for planning, monitoring, and resource allocation during the COVID-19 Public Health Emergency (PHE). While many hospitals are voluntarily reporting this information now, not all are. The new rules make reporting a requirement of participation in the Medicare and Medicaid programs. This reporting is needed to support broader surveillance of COVID-19.”[2]
Rick Pollack, the President and CEO of the American Hospital Association, issued a statement, also dated August 25, 2020.[3] “While hospitals and health systems remain focused on patient care, they’re also committed to providing our government with the public health data it needs. However, a new heavy-handed regulatory approach put forward by the Administration threatens to expel hospitals from the Medicare program. This disturbing move, announced in final form without consultation, or the opportunity to provide feedback through appropriate administrative procedures prior to it becoming effective, could jeopardize access to care and leave patients and communities without vital health services from their local hospital during a pandemic.
“Hospitals and health systems consistently have put forward a good faith effort to report the data needed to battle COVID-19 under very trying circumstances, despite the ever-changing requests from the government on data reporting. Since February, the government has made at least six changes to how they want hospitals to report data. The vast majority of hospitals — 94 percent — are reporting information, according to the federal government.
“To close the gap in participation, the AHA has been working in partnership with HHS to help hospitals understand the changing data collection requirements. Among other actions, we have: provided HHS with updated contact information for some hospitals; identified closed or merged hospitals in HHS’s outdated data that would adversely affect its efforts; and formed teams at the state level to reach out to hospitals to help understand any barriers to participation. In some cases, we also found hospitals were submitting data, but the data were not making it through the HHS-approved data pipeline.
“America’s hospitals remain fully committed to ensuring that the federal government gets the data it needs. It’s beyond perplexing why CMS would use a regulatory sledgehammer–threatening Medicare participation–to the very organizations that are on the frontlines in the fight against COVID-19. This rule should be reversed immediately.”[4]
An ”interim final rule” is a rule issued by a federal agency which becomes effective immediately upon publication and without the opportunity for affected persons to comment. Ordinarily, under the Administrative Procedure Act, 5 U.S.C. § 551, et seq., notices of proposed rules are published in the Federal Register with an opportunity for the public to comment. Nursing homes and hospitals were not provided the opportunity to comment on the August 25, 2020 interim final rule.
[1] https://www.cms.gov/files/document/covid-ifc-3-8-25-20.pdf.
[2] https://www.cms.gov/newsroom/press-releases/trump-administration-strengthens-covid-19-surveillance-new-reporting-and-testing-requirements.
[3] https://www.aha.org/press-releases/2020-08-25-statement-cms-interim-final-rule-data-collection-and-medicare-conditions.
[4] Id.