Waning Success on Limiting the Impact of Guidance Documents in Enforcement Actions and False Claims Act Litigation
This Bulletin is brought to you by AHLA’s Fraud and Abuse Practice Group.
- March 15, 2022
- Matthew L.J.D. Dowell , Alston & Bird LLP
Although it can be difficult to stay abreast of myriad state and federal statutes and regulations, providers face steep consequences for improperly billing the government for health care services. Compliance is made even more complex due to the proliferation of sub-regulatory guidance by government agencies and their contractors. The Department of Health and Humans Services (HHS) guidance “portal” lists more than 47,000 guidance documents, including nearly 39,000 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. Efforts by the Trump 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 provided limited benefits to health care companies and several have been or will be rolled back by the Biden administration.
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