- CMS is now requiring hospitals to report COVID-19 data such as number of confirmed and suspected COVID-19 positive patients, ICU beds occupied and availability of supplies including ventilators and personal protective equipment. Previously, the submissions were voluntary, the agency said Tuesday.
- The penalty for not reporting the data or correcting deficiencies is withdrawal from the Medicare and Medicaid programs, which are huge sources of funding that hospitals rely on for survival, according to the interim final rule.
- The American Hospital Association quickly slammed the regulation, calling it "heavy-handed" and requesting it be reversed immediately. "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," the group said in a statement.
Controversy has swirled around COVID-19 data reporting, which experts agree is vital for understanding the scope of outbreaks and how medical facilities in hotspots are able to handle them.
In July, HHS suddenly switched the reporting protocols and instructed hospitals to send the information straight to the department instead of using a long-established program from the Centers for Disease Control and Prevention.
Public health groups protested the change, saying it would likely hamstring the pandemic response. Leaders of the House Committee on Energy and Commerce requested the Government Accountability Office review the decision and its impact, writing of concerns about transparency and burden on hospitals.
In its argument against the latest requirement, AHA said 94% of hospitals are reporting information to the federal government currently. The group also pushed back on the lack of opportunity to comment before the final rule was rolled out.
"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," AHA said.
CMS said the regulation is necessary "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."
It defended the lack of a usual notice and comment period by citing the urgency of the public health emergency and said the information will help public health officials detect outbreaks and save lives.
CMS estimates the new reporting requirement will take a total of more than 3 million hours across all hospitals and cost them $212.2 million annually — $38,488 per hospital assuming one and a half hours per day at a daily wage rate (including overhead and fringe benefits) of $70.48.
The new rule also has requirements for nursing homes and labs, as well as revising a policy that had stated Medicare beneficiaries needed a practitioner order for covering any COVID-19 tests. Now, members may receive one test without an order. "This change helps ensure that beneficiaries receive appropriate medical attention if they need multiple tests," CMS said. "It is also designed to stop fraudsters from performing or billing for unnecessary tests."
Also, CMS will cover tests ordered by a pharmacist or other healthcare professional authorized by state law.
Nursing homes are now required to offer tests to residents who show symptoms or when there is an outbreak at a facility. Those that don't comply could face civil monetary fines.
The rule also implements a requirement from the Coronavirus Aid, Relief, and Economic Security Act that all laboratories conducting COVID-19 testing report results to HHS daily after a one-time three week grace period. Labs that don't comply will be fined $1,000 for the first day and $500 for each day after.
CMS estimates the requirement could cost labs as much as $4.2 billion annually and between $145 million and $176 million in one-time costs.