Mixed Success on Limiting the Impact of Guidance Documents in Enforcement Actions and False Claims Act Litigation

• May 24, 2021

• Matthew L.J.D. Dowell , Alston & Bird LLP

Providers face steep consequences for improperly billing the government for health care services and it can be difficult to stay abreast of myriad state and federal statutes and regulations. Compliance is made even harder due to the proliferation of sub-regulatory guidance by government agencies and their contractors. The Department of Health and Human Services (HHS) guidance “portal” lists more than 40,000 guidance documents, including more than 32,000 published by the Centers for Medicare & Medicaid Services (CMS). These include Medicare manuals, local coverage determinations, and other instructions published without the benefit of formal rulemaking. Recent developments from the former administration and the Supreme Court suggested that the importance of sub-regulatory guidance in enforcement proceedings might be blunted. But despite some initial promise, these efforts have provided limited benefits to health care companies. And early actions by the Biden administration suggest that some of these developments will be rolled back.

ARTICLE TAGS

• Fraud & Abuse Practice Group
• Fraud and Compliance