COVID-19: Frequently Asked Questions

Below are some of the most frequently asked questions CMA has received during the COVID-19 outbreak. By default, the most recent answers will appear up top. You can also filter the FAQ by category. We will update this resource regularly.

More questions? Email communications@cmadocs.org.

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Has the Federal Anti-Kickback Statute been waived because of the COVID-19 pandemic?

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Yes. On April 3, 2020, the U.S. Department of Health and Human Services (HHS) Office of Inspector General (OIG) issued a policy statement of enforcement discretion regarding applicable sanctions under the Federal Anti-Kickback Statute (42 U.S.C. Section 1320a-7b). The Policy Statement is designed to bring Anti-Kickback Statute enforcement in line with the CMS’ blanket waivers regarding sanctions under Stark Law.

The Policy Statement says OIG will not impose sanctions under the Anti-Kickback Statute with respect to remuneration that is covered by Section II.B(1)-(11) of CMS’s blanket waivers. The Policy Statement is silent on Section II.B(18) of the blanket waiver which suspends the writing and signature requirements for certain Stark law exceptions.

The Policy Statement does not expand the CMS blanket waivers. The OIG expressly points out that the enforcement discretion does not apply to “arrangements… that are not covered by the Blanket Waivers (e.g., direct financial relationships between pharmaceutical or device manufacturers and physicians or between providers where there is no physician involved).”

The Policy Statement only applies to conduct on or after April 3, 2020, while CMS’s blanket waivers are retroactive to March 1, 2020. The Policy Statement remains in effect till the termination of CMS’ blanket waivers.

Additional questions regarding this matter can be directed to OIGComplianceSuggestions@oig.hhs.gov.

Source: OIG Policy Statement

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