CMS Makes COVID-19 Data Reporting a Condition of Participation

COVID-19 data reporting will no longer be voluntary for hospitals participating in Medicare and Medicaid programs, according to a new interim final rule from CMS.

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The rule released yesterday updated Medicare and Medicaid Conditions of Participation to require hospitals and critical access hospitals to report positive cases of COVID-19, ICU bed capacity, availability of essential supplies, and other COVID-19 data to the agency on a daily basis.

Many hospitals have already been reporting the information to CMS on a voluntary basis, but the new interim final rule is making consistent COVID-19 reporting during the public health emergency compulsory.

Hospitals that fail to consistently report the data to CMS throughout the emergency period could face expulsion from Medicare and/or Medicaid, as well as other enforcement and payment actions, such as penalties, CMS stated in the interim final rule.

“These new rules represent a dramatic acceleration of our efforts to track and control the spread of COVID-19,” CMS Administrator Seema Verma, stated in the rule’s announcement. “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.”

The requirement will go into effect when the rule is published on the Federal Register. There will not be a normal notice-and-comment process for this rule considering the urgency of the COVID-19 public health emergency, CMS said.

“We believe that these reporting requirements are necessary for CMS to monitor whether individual hospitals and CAHs are appropriately tracking, responding to, and mitigating the spread and impact of COVID-19 on patients, the staff who care for them, and the general public,” the agency stated in the rule.

But hospitals and health systems are calling the requirement “heavy-handed” and “disturbing.”

“America’s hospitals remain fully committed to ensuring that the federal government gets the data it needs,” Rick Pollack, president and CEO of the American Hospital Association (AHA), said in a statement. “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.”

About 94 percent of hospitals are reporting COVID-19 data despite frequent changes requested by the federal government for data reporting, the Association said.

“However, a new heavy-handed regulatory approach put forward by the Administration threatens to expel hospitals from the Medicare program,” Pollack stated. “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.”

The AHA is calling on CMS to immediately reverse the rule.

The interim final rule will also require nursing homes participating in Medicaid and Medicare to test their staff for COVID-19. Laboratories, including those in hospitals, will also have to report COVID-19 tests daily to HHS, per new Clinical Laboratory Improvement Amendments requirements detailed in the rule.

Nursing homes and laboratories found not complying with the new rules will face a penalty.

CMS stated that nursing homes will face enforcement sanctions “based on the severity of the noncompliance,” which could mean civil monetary penalties over $400 per pay, or over $8,000 for a single instance of noncompliance.

Non-compliant laboratories will face a $1,000 fine a day for the first day it does not report the required information. Fines will then drop to $500 for each subsequent day of noncompliance.

CMS is granting laboratories a one-time, three-week grace period from the time of the rule’s publication to start reporting required test data.

Like hospital COVID-19 data reporting, testing nursing home staff was also a recommendation prior to the interim final rule. But CMS noted in the interim final rule that civil monetary penalties “have been an extremely useful tool in the enforcement of reporting requirements for nursing homes, helping to achieve 98 percent compliance.”

The agency lacks the authority to impose such penalties against hospitals and critical access hospitals. But the rule stated that it will “utilize all enforcement and payment authorities available to incentivize and promote compliance with all health and safety requirements, as allowed by statute and regulation.”

CMS also intends to “stop fraudsters from performing or billing for unnecessary tests” by revising the Medicare coverage policy for COVID-19 tests.

The rule states that each beneficiary may now receive one COVID-19 test without the order of a physician or other healthcare practitioner. Medicare will require an order for all further COVID-19 tests.

To view the complete interim final rule, click here.