Healthcare Providers And Self-Disclosure Of Violations

by Michael Volkov

HHS4The healthcare industry has a long history of innovative compliance policies and strategies.  The government’s role in the healthcare industry is going to grow even more after 2014, when a number of Obamacare provisions are triggered.  For healthcare companies, regulation and enforcement will increase.

The government’s enforcement programs are focused on civil False Claims Act cases and criminal fraud cases.  The government’s success in both of these areas has been the hallmark of this Administration.

The HHS-OIG has tried to build a strong voluntary disclosure program to supplement its enforcement program.   The existing disclosure program has never been very successful  Only around 800 disclosures have been made over the past 15 years.

One of the explanations for its failure to take hold is the need to secure the Justice Department’s sign off on any resolution.  Companies that participate in the program have no guarantees that the Justice Department will not launch a criminal case after reviewing a voluntary disclosure application.

In an attempt to enhance its voluntary disclosure program, HHS-OIG recently modified its voluntary disclosure procedures.  The new rules are unlikely to increase the number of voluntary self-disclosures.  The only real benefit of the new rules is the hope that a company can avoid a burdensome integrity agreement by submitting a voluntary disclosure application.

HHSThe new rules modify the eligibility requirements for self-disclosure; shorten the timeline for conducting an internal investigation; and clarify the guidelines for disclosures relating to false billing, excluded persons, anti-kickback and Stark law violations.

The self-disclosure process is available to all healthcare providers, suppliers, or other entities subject to civil monetary penalties, except for violations involving only Stark law violations.  In making a disclosure, a party now must admit that the conduct is a potential violation, identify the laws involved, agree to waive the statute of limitations, and ensure that corrective actions are being carried out or the misconduct ceased by the date of the disclosure, or no later than ninety days after disclosure of a kickback violation.

A disclosing party now will have to complete its internal investigation within ninety days of the initial submission as opposed to the prior rule of ninety days from the date of acceptance of the submission.  The new rules set forth eleven specific information requirements to be included for all submissions, including background information, estimate of damages, and a concise statement of facts relating to the conduct, the detail of which depend on the conduct involved (e.g. false billing, excluded persons, or violations of the AKS or Stark law.

The new rules also establish minimum settlement amounts – for AKS violations, $50,000, and $10,000 for all other violations.  Also, HHS-OIG will now explicitly rely on a multiplier of 1.5 for “damages” tied to the remuneration involved in an AKS or Stark law violation.

HHS1Finally, the new rules include confirmation that the Department of Justice will participate in the settlement of civil and criminal violations, and that HHS-OIG will advocate on behalf of the party in such discussions.  This could raise significant complications and potential criminal exposure for the company and individuals who may be identified in the disclosure process.  In many cases, HHS-OIG cannot protect a provider or individuals from DOJ prosecution, and specific statements made in the disclosure process could be used against the company.

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

© Michael Volkov, The Volkov Law Group | Attorney Advertising

Written by:

Michael Volkov

The Volkov Law Group on:

Readers' Choice 2017
Reporters on Deadline

"My best business intelligence, in one easy email…"

Your first step to building a free, personalized, morning email brief covering pertinent authors and topics on JD Supra:
Sign up using*

Already signed up? Log in here

*By using the service, you signify your acceptance of JD Supra's Privacy Policy.
Custom Email Digest
Privacy Policy (Updated: October 8, 2015):

JD Supra provides users with access to its legal industry publishing services (the "Service") through its website (the "Website") as well as through other sources. Our policies with regard to data collection and use of personal information of users of the Service, regardless of the manner in which users access the Service, and visitors to the Website are set forth in this statement ("Policy"). By using the Service, you signify your acceptance of this Policy.

Information Collection and Use by JD Supra

JD Supra collects users' names, companies, titles, e-mail address and industry. JD Supra also tracks the pages that users visit, logs IP addresses and aggregates non-personally identifiable user data and browser type. This data is gathered using cookies and other technologies.

The information and data collected is used to authenticate users and to send notifications relating to the Service, including email alerts to which users have subscribed; to manage the Service and Website, to improve the Service and to customize the user's experience. This information is also provided to the authors of the content to give them insight into their readership and help them to improve their content, so that it is most useful for our users.

JD Supra does not sell, rent or otherwise provide your details to third parties, other than to the authors of the content on JD Supra.

If you prefer not to enable cookies, you may change your browser settings to disable cookies; however, please note that rejecting cookies while visiting the Website may result in certain parts of the Website not operating correctly or as efficiently as if cookies were allowed.

Email Choice/Opt-out

Users who opt in to receive emails may choose to no longer receive e-mail updates and newsletters by selecting the "opt-out of future email" option in the email they receive from JD Supra or in their JD Supra account management screen.


JD Supra takes reasonable precautions to insure that user information is kept private. We restrict access to user information to those individuals who reasonably need access to perform their job functions, such as our third party email service, customer service personnel and technical staff. However, please note that no method of transmitting or storing data is completely secure and we cannot guarantee the security of user information. Unauthorized entry or use, hardware or software failure, and other factors may compromise the security of user information at any time.

If you have reason to believe that your interaction with us is no longer secure, you must immediately notify us of the problem by contacting us at In the unlikely event that we believe that the security of your user information in our possession or control may have been compromised, we may seek to notify you of that development and, if so, will endeavor to do so as promptly as practicable under the circumstances.

Sharing and Disclosure of Information JD Supra Collects

Except as otherwise described in this privacy statement, JD Supra will not disclose personal information to any third party unless we believe that disclosure is necessary to: (1) comply with applicable laws; (2) respond to governmental inquiries or requests; (3) comply with valid legal process; (4) protect the rights, privacy, safety or property of JD Supra, users of the Service, Website visitors or the public; (5) permit us to pursue available remedies or limit the damages that we may sustain; and (6) enforce our Terms & Conditions of Use.

In the event there is a change in the corporate structure of JD Supra such as, but not limited to, merger, consolidation, sale, liquidation or transfer of substantial assets, JD Supra may, in its sole discretion, transfer, sell or assign information collected on and through the Service to one or more affiliated or unaffiliated third parties.

Links to Other Websites

This Website and the Service may contain links to other websites. The operator of such other websites may collect information about you, including through cookies or other technologies. If you are using the Service through the Website and link to another site, you will leave the Website and this Policy will not apply to your use of and activity on those other sites. We encourage you to read the legal notices posted on those sites, including their privacy policies. We shall have no responsibility or liability for your visitation to, and the data collection and use practices of, such other sites. This Policy applies solely to the information collected in connection with your use of this Website and does not apply to any practices conducted offline or in connection with any other websites.

Changes in Our Privacy Policy

We reserve the right to change this Policy at any time. Please refer to the date at the top of this page to determine when this Policy was last revised. Any changes to our privacy policy will become effective upon posting of the revised policy on the Website. By continuing to use the Service or Website following such changes, you will be deemed to have agreed to such changes. If you do not agree with the terms of this Policy, as it may be amended from time to time, in whole or part, please do not continue using the Service or the Website.

Contacting JD Supra

If you have any questions about this privacy statement, the practices of this site, your dealings with this Web site, or if you would like to change any of the information you have provided to us, please contact us at:

- hide
*With LinkedIn, you don't need to create a separate login to manage your free JD Supra account, and we can make suggestions based on your needs and interests. We will not post anything on LinkedIn in your name. Or, sign up using your email address.