What Healthcare Providers and Life Sciences Companies Can Expect for Enforcement in 2022

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Healthcare Providers

Pandemic Regulatory Flexibilities, Especially Telehealth

HHS offered healthcare providers unprecedented regulatory flexibility during the COVID-19 public health emergency (PHE). Many of these regulatory flexibilities are tethered to the pendency of the PHE and as a result continue to remain available to providers. The most significant shifts arose through HHS’s power under Social Security Act Section 1135 to waive or modify certain federal healthcare requirements during declared PHEs. Through waivers, the Centers for Medicare & Medicaid Services (CMS) has, among many other flexibilities, significantly altered the scope of Medicare-payable telehealth services, exempted certain financial relationships from otherwise-applicable sanctions under the Stark Law, and broadly expanded the circumstances qualifying a patient for skilled nursing facility coverage under Medicare Part A.

DOJ has reiterated that combatting and preventing COVID-19-related fraud is a priority for law enforcement, but so far, there have been relatively few announced enforcement actions relating to abuse of pandemic regulatory flexibilities. For example, last year DOJ Criminal Division announced two prosecutions for abuse of the CMS telehealth waivers as part of broader schemes to bill for medically unnecessary cancer and…

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