In an interim final rule released this week, the Centers for Medicare & Medicaid Services (CMS) requires laboratories to report COVID-19 test results to the federal government daily and imposes monetary fines for organizations that do not comply with the rule, according to a press release from CMS.
The new rule – which will be in effect once published in the Federal Register – implements a requirement in the Coronavirus Aid, Relief, and Economic Security Act (CARES Act) that laboratories report COVID-19 test results daily to the Department of Health and Human Services (HHS).
If a laboratory does not report the required information, CMS said it will impose a civil monetary penalty in the amount of $1,000 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.
In April, CMS sent a letter to 4,700 hospitals on behalf of Vice President Mike Pence asking them to report testing data from their in-house labs. The new rule extends to all labs.
In addition to all laboratories, other organizations conducting testing for COVID-19 – such as nursing homes using point-of-care (POC) testing devices and assays – also will be required to report data on test results, CMS said.
In the new regulations, CMS also requires hospitals and critical access hospitals to report daily such data as the number of confirmed or suspected COVID-19 positive patients, ICU beds occupied with COVID-19 patients, and availability of essential supplies and equipment such as ventilators and personal protective equipment. The new rules make reporting a requirement of participation in the Medicare and Medicaid programs.
While many hospitals are voluntarily reporting this information now, not all are, according to CMS.
CMS also revised a previous policy about COVID-19 testing for Medicare beneficiaries during the public health emergency. The revised policy specifies that each beneficiary may receive one COVID-19 test without the order of a healthcare provider but must obtain an order for subsequent COVID-19 tests. CMS said the change is designed to ensure that beneficiaries receive medical attention if they need multiple tests.
