An interim final rule released by the Centers of Medicare & Medicaid Services (CMS) earlier this week mandates that in order to participate in Medicare and Medicaid, hospitals must report daily COVID-19 data to the federal government.
The rule from CMS, released Aug. 25, announced sweeping regulatory changes that require 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 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).
Per the emergency regulations, hospitals and critical access hospitals will be required to report daily important data that CMS says is 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, according to CMS, “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.”
CMS Administrator Seema Verma said in a statement, “These new rules represent a dramatic acceleration of our efforts to track and control the spread of COVID-19. 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.”
More specifically, 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, according to CMS.
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.
Regarding nursing homes, CMS previously provided re-opening recommendations to nursing homes and states, calling for baseline testing of all residents and staff, and routine testing of staff. 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, federal officials stated. The 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, they added in the rule. CMS now also 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, according to the regulation.
What’s more, 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,” according to the agency.
Already, Rick Pollack, president and CEO of the American Hospital Association, called the new approach from CMS “heavy-handed” and “disturbing,” noting that the agency announced the rules in “final form without consultation or the opportunity to provide feedback through appropriate administrative procedures prior to it becoming effective.” Pollack said that the result “could jeopardize access to care and leave patients and communities without vital health services from their local hospital during a pandemic.”
He added, “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.” In some cases, Pollack noted, hospitals were submitting data, but the data were not making it through the HHS-approved data pipeline.
The association’s president concluded by emphatically stating, “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.”
Last month, the Trump administration announced it would be ordering hospitals to share this critical COVID-19 data information directly with HHS rather than to the CDC, which had previously been the method. At the time, HHS said called the CDC’s system inadequate and said the two systems would be linked. However, just a few days ago it appeared that HHS again reversed course, returning the responsibility for data collection back to the CDC.
CMS will accept public comments on the interim final rule for 60 days after it is published in the Federal Register. The requirements are slated to take effect once the interim final rule is published in the Federal Register and remain in place until the federally declared public health emergency ends.