Today, the Centers for Medicare & Medicaid Services (CMS) announced sweeping regulatory changes that require nursing homes to test staff and offer testing to residents for coronavirus disease 2019 (COVID-19). Laboratories and nursing homes using point-of-care testing devices will be required to report diagnostic test results as required by the Coronavirus Aid, Relief, and Economic Security Act (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).
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.
“These new rules represent a dramatic acceleration of our efforts to track and control the spread of COVID-19,” said CMS Administrator Seema Verma. “Reporting of test results and other data are vitally important tools for controlling the spread of the virus and give providers on the front lines what they need to fight it.”
New testing requirements for nursing homes
CMS is again acting to safeguard nursing home residents from the ongoing threat of COVID-19 by revising its infection-control regulations for long-term care facilities to require nursing homes to test their staff for COVID-19.
The new rules follow a series of actions designed to increase testing in nursing homes. In April, CMS called on Governors to create a testing plan for their nursing homes, provided new payment for collection of lab samples in nursing homes as well as increasing payment for certain tests. In May, CMS provided re-opening recommendations to nursing homes and states which called for baseline testing of all residents and staff, and routine testing of staff.
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.”
That recommendation for testing staff routinely is now a requirement for participation in the Medicare and Medicaid programs under CMS’ authority through the Social Security Act to adequately protect the health, safety, welfare, and rights of residents. 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. This is part of CMS’ continued efforts to help nursing homes to control the spread of the virus.
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.
The Administration is helping facilities offset the cost of testing through new funding from the Provider Relief Fund, authorized under the CARES Act. On July 22, 2020, President Trump announced the release of an additional $5 billion from the Provider Relief Fund to help nursing homes address critical needs, including hiring additional staff, increasing testing, and providing additional services, such as technology so residents can connect with their families if they are not able to visit. The $5 billion comes on top of a previous $4.9 billion allocation of Provider Relief Funds to nursing homes made in May.
Hospitals must report data
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.
In March, Vice President Mike Pence sent a letter to all hospitals requesting that they provide the results of COVID-19 tests performed in their in-house laboratories to help better understand and track disease patterns. CMS’ new rules require such reporting of test results in order to ensure a more complete picture in the nationwide surveillance of COVID-19, as well as a more efficient allocation of PPE and other vital supplies. Hospitals will face possible termination of Medicare and Medicaid payment if unable to correct reporting deficiencies.
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. If a laboratory does not report the required information, CMS will impose a civil monetary penalty in the amount of $1,000 a day for the first day, and $500 for each subsequent day. Labs will have a one-time, three-week grace period to begin reporting required test data. This requirement complements existing HHS guidance requiring laboratories to report test results and additional information, such as demographic data.
This change allows CMS to take enforcement action against laboratories that fail to provide the required data, which is needed by federal, state, and local officials to conduct effective surveillance of the COVID-19 pandemic.
Physician and pharmacist orders for tests
CMS is also revising its previous policy that covered repeated COVID-19 testing for Medicare beneficiaries without practitioner orders during the PHE. The revised policy specifies that each beneficiary may receive one COVID-19 test without the order of a physician or other health practitioner, but Medicare will require such an order for all further COVID-19 tests. This change helps ensure that beneficiaries receive appropriate medical attention if they need multiple tests. It is also designed to stop fraudsters from performing or billing for unnecessary tests.
To help ensure that beneficiaries have broad access to testing, CMS is also paying for tests when ordered by a pharmacist or other healthcare professional authorized under applicable state law to order diagnostic laboratory tests. Medicare makes payment for services of pharmacists and certain other healthcare professionals only when they have an arrangement with a physician or other billing practitioner. The changes being made allow Medicare to continue to pay for these tests during the PHE when they are ordered by pharmacists and other healthcare professionals without such an arrangement.
In addition to today’s announcement regarding testing and reporting, earlier this week, CMS released guidance for state Medicaid agencies on new flexibilities CMS has made available under emergency authorities to increase reimbursement for nursing facilities that implement specific infection control practices, such as designating a quarantine or isolation wing for COVID-19 patients. These can be temporary rate enhancements tailored to the specific needs of the state and community, and the guidance highlights case studies in states who have taken advantage of this flexibility.
Providers and stakeholders seeking assistance or more information on the interim final rule and the comment period should visit CMS’ Coronavirus Waivers & Flexibilities page for additional information, including fact sheets for changes for each provider type. More information can be found on the COVID-19 Emergency page: https://www.cms.gov/about-cms/emergency-preparedness-response-operations/current-emergencies/coronavirus-waivers
To view the new rule, visit https://www.cms.gov/files/document/covid-ifc-3-8-25-20.pdf
Contact: CMS Media Relations: CMS Media Inquiries
Get CMS news at cms.gov/newsroom, sign up for CMS news via email and on @CMSgov
###