The U.S. Department of Health and Human Services Office of the Inspector General (OIG) issued an April report recommending improvements the Centers for Medicare & Medicaid Services (CMS) could make to improve clinical diagnostic laboratory test (CDLT) rate setting during future public health emergencies (PHE).

The audit comes after rate setting in March 2020, at the start of the COVID-19 PHE, that utilized the CMS interim rate-setting policy for Medicare Administrative Contractors (MACs). According to the OIG, CMS had to take additional action beyond its standard rate-setting procedures to set and adjust rates for CDLTs. As a result, CMS did not enable MACs to set rates that adequately covered the cost of conducting COVID-19 viral tests for all laboratories.

The report in brief states that CMS could improve its communication with laboratory associations and MAC pricing coordinators and improve its procedures for MACs to set interim CDLT rates in response to a PHE. In their current forms, neither the Clinical Laboratory Fee Schedule nor its implementing regulations address how pricing coordinators could set rates for new CDLTs ahead of the public consultation rate-setting process.

OIG recommends CMS establish better procedures for communicating with stakeholders involved in setting new CDLT rates and improve its existing procedures for setting and adjusting rates for new CDLTs during a PHE. The latter recommendation may require seeking legislative authority.

In the report in brief, the OIG writes, “CMS did not explicitly state its concurrence or nonconcurrence with our recommendations but stated that it will take our findings and recommendations into consideration for future PHEs.”

 

Sources:

https://oig.hhs.gov/reports-and-publications/all-reports-and-publications/cms-could-improve-its-procedures-for-setting-medicare-clinical-diagnostic-laboratory-test-rates-under-the-clinical-laboratory-fee-schedule-for-future-public-health-emergencies/

https://oig.hhs.gov/documents/audit/9857/A-01-21-00506RIB.pdf