The Centers for Medicare & Medicaid Services (CMS) proposed a rule late last year to harmonize the standard it would apply for providers to identify and refund overpayments with the “knowledge” standard under the False Claims Act (FCA) and the Civil Monetary Penalties Law. Though this proposal purportedly ensures that a lack of “reasonable diligence” cannot create civil liability, it would create significant confusion as to how CMS expects providers and Medicare Advantage organizations (MAOs) to “identify” and quantify potential overpayments before triggering the 60-day period to refund them. The proposed rule, if adopted, would likely become part of the framework for the Department of Justice and Department of Health & Human Services’ Office of Inspector General when evaluating potential liability for the alleged failure to return overpayments.

This blog highlights a recently unsealed qui tam case brought by relator GNGH2, Inc against 15 entities that allegedly operated nursing homes in the Bronx, New York and in Florida and various health care staffing agencies. 

A spurt of letters from California Attorney General, Rob Bonta, to leaders of hospitals and other health care facilities sent on August 31, 2022 signaled the kickoff of a government probe into bias in health care algorithms that contribute to material health care decisions. This blog post highlights the California Office of the Attorney General’s initiative to address disparities in health care and what this probe may mean for the use algorithms and AI in health care. 

Disclosing known or suspected fraud to regulators can have its benefits.  As reported in a previous post, the Department of Justice (DOJ) issued policy guidance in 2019 on providing credit in False Claims Act (FCA) settlements to corporations for “disclosure, cooperation, and remediation” (the Policy Guidance).  Since then, the industry has been watching to see how  DOJ implements this Policy Guidance. 

Two settlements announced earlier this month seem to demonstrate that DOJ is applying the Policy Guidance in resolving FCA cases.  Although the facts of these two settlements differ significantly, they highlight the benefits of self-disclosure, cooperation with the government in its investigation, and proactive efforts to remediate non-compliance.

On May 4, 2022, the U.S. Food and Drug Administration (FDA) for the first time issued warning letters related to products containing delta-8 tetrahydrocannabinol (delta-8 THC).  FDA has previously sent warning letters to other companies illegally selling unapproved and misbranded cannabidiol, or CBD, products that claimed to treat illness in violation of the Federal Food, Drug, and Cosmetic Act (FD&C Act), as we have discussed in prior posts (one example here).  In a separate recent slew of CBD-related actions, it issued warning letters jointly with the Federal Trade Commission (FTC) to seven companies for selling CBD products with claims that they will treat or prevent COVID-19. This blog post will define delta-8 THC and analyze the FDA's warning letters.