The Biden Administration recently announced plans to require commercial insurers to cover over-the-counter and at-home COVID-19 tests. Commercial insurers are currently required to cover in vitro diagnostic (IVD) products that test for COVID-19. Most often, this has taken the form of clinical laboratory testing wherein the lab or other provider…
On November 15, 2021, the Department of Health and Human Services (HHS) issued a press release explaining the agency’s intent to withdraw a policy established during the Trump Administration that limited the Food and Drug Administration’s (FDA) ability to regulate COVID-19 laboratory-developed tests (LDTs). The new policy allows the FDA…
After a hiatus during the height of the COVID-19 pandemic, Medicare audits have resumed in full force. Providers and suppliers should be prepared to respond to audits that were paused during the pandemic, the initiation of new audits, and audits relating to the various pandemic relief programs. In early 2020,…
On November 5, 2021, the Centers for Medicare and Medicaid Services (CMS) released an interim final rule with comment period to require COVID-19 vaccination for staff of certain healthcare providers. The rule applies only to certain providers, but is expansive in scope where it is applicable. Under the rule, affected…
UnitedHealth Group has agreed to reprocess the entirety of its commercial claims related to COVID-19 vaccine administration. The move comes after federal investigators concluded that UnitedHealth, as the nation’s largest insurer, paid “millions” of providers 40% less than the Medicare rate for vaccinating patients. According to a letter from the…
In response to the mounting nationwide shortage of healthcare workers, one state will allow certain healthcare workers to practice solely on out-of-state licenses. This move may signal similar actions by other states and could have wide-ranging implications for the delivery of healthcare services. During the height of the COVID-19 pandemic,…
On September 30, 2021, the Department of Health and Human Services’ (HHS) Office for Civil Rights (OCR) issued guidance to help consumers, businesses, and healthcare entities understand when the Health Insurance Portability and Accountability Act of 1996 (HIPAA) Privacy Rule applies to disclosures and requests for information about an individual’s…
The Department of Justice (DOJ) recently announced a plea agreement regarding an alleged $73 million scheme to defraud Medicare that illustrates some of the pitfalls of compliance with the Anti-Kickback Statute (AKS). DOJ alleged that the owners of a clinical laboratory, Panda Conservation Group, LLC, and a telemedicine company, 1523…
On September 10, 2021, the U.S. Department of Health and Human Services (HHS) announced that it would make $25.5 billion in new funding available for healthcare providers affected by the COVID-19 pandemic. This funding includes allocations of $8.5 billion in funding from the American Rescue Plan (ARP) for providers who…
Demonstrating its commitment to audit Provider Relief Fund (PRF) recipients, the Department of Health and Human Services (HHS) has hired several outside contractors to provide audit or program integrity services relating to the PRF. The PRF is a $175 billion fund created by Congress through the CARES Act and administered…