CMS Increases Reporting Requirements for Labs, Hospitals

The Centers for Medicare and Medicaid Services published an Interim Final Rule requiring clinical laboratories on August 25, to revise current COVID-19 reporting requirements. The final rule, which is now in effect, alters the Clinical Laboratory Improvement Amendments of 1988 regulations to require all laboratories—including Certificate of Waiver laboratories—to report SARS-CoV-2 test results to HHS. Under the new rule, laboratories are expected to report all negative and positive SARS-CoV-2 results, regardless of test method used. The new rule also changes test order requirements. It also requires hospitals, critical access hospitals and long-term care facilities to provide more detailed reporting information on COVID-19 patients. 

Under the Coronavirus Aid, Relief, and Economic Security (CARES) Act, “every laboratory that performs or analyzes a test that is intended to detect SARS-CoV-2 or to diagnose a possible case of COVID-19 shall report the results from each such test, to the Secretary of Health and Human Services in such form and manner, and at such timing and frequency, as the Secretary may prescribe until the end of the” Public Health Emergency (PHE).

In the final rule, CMS states, “Assuring a rapid and thorough public health response to the COVID-19 pandemic relies on having complete and comprehensive laboratory testing data, including standardized test results, relevant demographic details, and additional information that can improve both the response to SARS-CoV-2 and treatment of COVID-19. These data can contribute to understanding disease incidence and trends: initiating epidemiologic case investigations, assisting with contact tracing, assessing availability and use of testing resources, and identifying supply chain issues for reagents and other material. Laboratory testing data, in conjunction with case reports and other data, also provides vital guidance for mitigation and control activities.”

In guidance released on June 4, HHS outlined the data reporting requirements, including data elements HHS expects laboratories to submit. That guidance requires that laboratories report data for all testing completed, for each individual tested, within 24 hours of results being known or determined, on a daily basis to the appropriate state or local public health department based on the individual’s residence.” 

Test Order Policy Changes:  Under the new rule, CMS will now allow Medicare patients to receive one COVID-19 diagnostic test and one otherwise covered test for influenza or a similar respiratory condition without a physician or other practitioner’s order. Previously, CMS was providing coverage of multiple COVID-19 tests without a physician order.

Where to Report Data: Laboratories can submit COVID-19 testing data in either of the following ways:

• Laboratories can report to state and local public health authorities in accordance with applicable state or local law.
• Laboratory testing data can be submitted to state and local public health departments through a centralized platform, such as the Association of Public Health Laboratories’ AIMS platform.
• Laboratory data can be submitted through a state or regional Health Information Exchange (HIE).

Data will be de-identified prior to being provided to CDC.

Penalties:  Under the new rule, CMS can impose civil monetary penalties on laboratories of $1,000 for the first day of non-compliance, with fines of $500 for each additional day of non-compliance, with a maximum penalty of $10,000 for each violation or for each day of substantial noncompliance.  Hospitals that fail to consistently report test result could be deemed non-compliant with Medicare Condition of Participation requirements and could be terminated from the Medicare program. The Rule provided for a one-time, three-week grace period to begin reporting the required data; however, the grace period has since ended.

ASCP will be providing formal comments on the new rule prior to its November 2 comment deadline. Anyone wishing to provide comments to CMS on the new rule can do so here. If you would like to share these comments with ASCP, please send them to matthew.schulze@ascp.org.

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