On August 25, 2020, the Centers for Medicare & Medicaid Services (CMS) issued a press release regarding the strengthening of COVID-19 surveillance and the publication of interim final rule CMS-30401-IFC.  Although the press release mainly addresses nursing home surveillance, it also discusses a significant policy change to COVID-19 testing coverage for Medicare beneficiaries.  

In a May 8, 2020, interim final rule, CMS allowed for broad COVID-19 testing for Medicare beneficiaries without a physician or other practitioner order, citing “the critical importance of expanding COVID-19 testing.”  However, under the recently amended interim rule, Medicare will cover only a single COVID-19 diagnostic test without an order from a physician or other practitioner order.  Subsequent tests will require a physician or other practitioner’s order.  CMS’ policy revision is due to the potential of fraud, waste, and abuse.  Interestingly, CMS also cites “public health and safety issues that would arise from beneficiaries being subjected to repeated testing without proper medical attention or oversight, including public health issues with the ongoing spread of COVID-19” for its policy change.  CMS’ policy change impacts only Medicare beneficiaries. 

On August 21, 2020, Chilivis Grubman attorneys wrote about a directive issued by the U.S. Department of Health and Human Services (HHS) that allowed certain state-licensed pharmacists to order and administer vaccines to individuals older than three.  CMS’ interim final rule, CMS-30401-IFC, also permits Medicare coverage of COVID-19 tests ordered by a pharmacist or other healthcare professional.  However, unlike HHS’ directive related to pharmacists administering vaccines, which preempted state and local rules, pharmacists ordering COVID-19 tests under CMS’ interim final rule are subject to local rules and laws.  Pharmacists and other healthcare professionals must be authorized to order diagnostic testing in their local jurisdiction.  The CMS press release provided this link to download the entire interim final rule.  

The attorneys at Chilivis Grubman represent clients of all types and sizes, including individual providers, in connection with a wide variety of regulatory and compliance matters, including government investigations, audits, licensing board actions, and litigation.  If you need assistance with such a matter, please contact us today.