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September 25, 2020

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Update on the Provider Self-Disclosure Protocol Issued By Department of Health and Human Services (HHS)

Since we last reported on the Provider Self-Disclosure Protocol (“Protocol”) issued by the Department of Health and Human Services, Office of the Inspector General (“OIG”), the entire Protocol has been revamped.  Rather than being in the Federal Register, the Protocol is on the OIG website.  The current Protocol extends not just to providers, but also device manufacturers and pharmaceutical companies.

Because the OIG wanted to accelerate the process, the submitting party must complete corrective action before submitting the disclosure and must finish the investigation within 90 days of submission, rather than the previous 90 days from acceptance into the program.

The format for the disclosure is electronic and on the OIG website.  All of the required fields are included in the electronic format.

For billing issues, the calculation of damages changed.  Sampling can still be used, but the sample must be 100 (up from 30).  Total damages = Mean Point Estimate.  If a provider is not familiar with this concept, a statistics consultant can be retained.  No “probe” samples are allowed.  Underpayments cannot be offset against overpayments.

For excluded persons issues, a damages calculation was formally adopted and published to address persons whose services are not billed/separately reimbursed, e.g., salaried personnel.

The minimum amount of a settlement is $50,000 for Anti-Kickback Act submissions; $10,000 for all others.  Stark Law only violations should still be disclosed to the Centers for Medicare and Medicaid Services, as opposed to the OIG.

Copyright © 2020, Sheppard Mullin Richter & Hampton LLP.National Law Review, Volume IV, Number 125


About this Author

Barbara Taylor, government contracts, attorney, Sheppard Mullin, law firm
Special Counsel

Ms. Taylor is a special counsel in the Government Contracts and Regulated Industries practice group in the firm's Los Angeles office.

Ms. Taylor's practice includes complex civil litigation, corporate internal investigations, and responding to government investigations.  Her complex civil litigation practice focuses on business disputes and defense of qui tam (false claims) cases. Her internal investigations practice focuses on clients in the defense and aerospace industry regarding government contract and cost accounting issues, product quality...