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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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Archive by category: Fraud and AbuseReturn

What is the Physician Self-Referral (Stark) law?

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The Physician Self-Referral Law, 42 U.S.C. § 1395nn (the “Stark law”) is a federal health care fraud and abuse law that prohibits a physician from making referrals for certain designated health services payable by Medicare to an entity with which they (or an immediate family member) has a "financial relationship."
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| Categories: Fraud and Abuse
Both the Anti-Kickback Statute and Stark law prohibit the exchange of remuneration for patient referrals to Federal health care programs, but there are significant differences.
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| Categories: Fraud and Abuse
Yes. On March 13, 2020, U.S. Department of Health and Human Services Secretary Alex Azar issued a statement waiving and/or modifying the requirements under section 1135 of the Social Security Act. Afterwards, on March 30, 2020 CMS issued blanket waivers to permit certain financial relationships and referrals related to the COVID-19 pandemic that would otherwise be sanctioned by the Physician Self-Referral Law.
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| Categories: Fraud and Abuse
No. However, “parties utilizing the blanket waivers must make records relating to the use of the blanket waivers available to the Secretary upon request.”
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| Categories: Fraud and Abuse
The blanket waivers apply only if: (i) the providers are acting in good faith to provide care in response to the COVID-19 pandemic; (ii) the financial relationship or referral is protected by one of CMS’ 18 permitted relationships; and (iii) the government does not determine that the financial relationship creates fraud and abuse concerns.
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| Categories: Fraud and Abuse
The blanket waivers only apply to financial relationships and referrals that are related to COVID-19 "related purposes" and must be directly between the entity and the physician or the physician organization or the immediate family member of the physician.
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| Categories: Fraud and Abuse
The blanket waivers do not apply to all relationships or waive the Stark law completely. Instead, the waivers apply only to one of eighteen (18) enumerated relationships.
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| Categories: Fraud and Abuse
The Centers for Medicare & Medicaid Services provides an extensive list of examples of how these waivers play out in real world applications under part III of the blanket waiver.
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| Categories: Fraud and Abuse
The blanket waivers require that the arrangement not create fraud and abuse concerns. Unfortunately, the blanket waivers document does not provide further guidance about how CMS may use this language to limit the applicability of the blanket waivers.
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| Categories: Fraud and Abuse
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.
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| Categories: Fraud and Abuse

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