OIG Revises Health Care Fraud Self-Disclosure Protocol

On November 8, 2021, the US Division of Health and Human Companies (HHS) Workplace of Inspector Common (OIG) issued an replace to the Health Care Fraud Self-Disclosure Protocol (SDP). This replace revises and renames the Supplier Self-Disclosure Protocol final up to date by OIG in 2013. The modifications are principally procedural in nature and replace the SDP based mostly on legislative changes to penalty quantities.


OIG not too long ago posted revisions to the SDP, which was first revealed within the 1998 Federal Register as a course of by means of which healthcare suppliers, suppliers and different entities topic to civil financial penalties can voluntarily self-disclose issues involving potential fraud stemming from participation in federal healthcare applications. Pursuant to the SDP, examples of what will be appropriately disclosed embrace, however usually are not restricted to, submissions of improper claims to federal healthcare applications, potential violations of the federal Anti-Kickback Statute and the doctor self-referral regulation (in any other case often called the Stark regulation), and employment or contracting with excluded people on OIG’s Listing of Excluded People and Entities.

The SDP’s objective is to facilitate compliance with federal healthcare program necessities by providing entities topic to civil financial penalties the chance to make good religion disclosures of potential fraud and keep away from the prices and disruptions related to government-directed investigations and civil or administrative litigation.

The timelines, content material necessities and strategies used to calculate damages are constant between the 2013 and 2021 variations of the SDP. The 2021 SDP modifications are as follows:

  • OIG elevated the minimal quantities required to settle below the SDP to match new statutory minimal penalty quantities as set forth below the amendments to Part 50412 of the Bipartisan Price range Act of 2018, which elevated most civil financial penalties in part 1128A(a) of the Social Safety Act (42 USC 1320a-7a) for false claims from $10,000 to $20,000, and for Anti-Kickback Statute-related conduct from $50,000 to $100,000.

  • OIG now requires SDP submissions to be made by means of the OIG’s web page and on-line portal, fairly than by sending a letter to OIG.

  • OIG clarified that the SDP is just not the suitable mechanism to report grant- or government-contract-related conduct. In 2019, OIG created the Grant Self-Disclosure Program for grant recipients to make use of for grant-related points. In 2014, OIG issued steerage to HHS contractors to reveal compliance points utilizing the Contractor Self-Disclosure Program.

  • OIG clarified {that a} reporting social gathering should point out in its disclosure whether or not it’s topic to a company integrity settlement. OIG additionally clarifies that reportable occasions (as outlined by the company integrity settlement) will be disclosed below the SDP.

  • OIG made clarifying revisions to the present language that confirmed that in some cases, the US Division of Justice could select to take part within the settlement of SDP circumstances and resolve the matter below the False Claims Act.

  • OIG clarified {that a} social gathering disclosing below the SDP should embrace damages to every affected federal healthcare program individually and the sum of all damages to all affected federal healthcare applications.

The newest revisions to the SDP are a part of OIG’s ongoing analysis of the disclosure course of. OIG beforehand issued Open Letters to Health Care Suppliers in 2006, 2008 and 2009 and solicited public remark previous to the 2013 model of the SDP, which amended and changed the 1998 Federal Register Discover and Open Letters.

The SDP has been lively since its inception. OIG said that it has resolved greater than 2,200 disclosures between 1998 and 2020, leading to recoveries of greater than $870 million to the federal healthcare applications. Between 2016 and 2020, OIG resolved greater than 330 settlements by means of the SDP. In line with OIG’s web page, OIG has entered into greater than 600 settlements since 2013 with organizations that self-disclosed conduct by means of the SDP, with settlements as excessive as $20.9 million.

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