United States: OIG Issues Updated Provider Self-Disclosure Protocol

Last Updated: June 10 2013
Article by Jeffrey E. Rogers

On April 17, 2013, the Office of Inspector General of the U.S. Department of Health & Human Services (OIG) released an update to its Provider Self-Disclosure Protocol (SDP). The original SDP had been published in October 1998 (63 Fed. Reg. 58399) (Oct. 30, 1998)) for the purpose of providing a process by which healthcare providers could voluntarily report and resolve instances of potential fraud involving federal healthcare programs. According to the release, the OIG has resolved more than 800 disclosures over the last 15 years, with recoveries exceeding $218 million, including the settlement of 235 cases since 2008.

In 2006, 2008 and 2009, the OIG issued open letters to healthcare providers regarding various aspects of the 1998 SDP, and in June 2012 the OIG solicited public comments about the SDP. This recent update is a result of the OIG's consideration of those comments and its reevaluation of the 1998 SDP. The updated SDP completely supersedes the 1998 SDP and the open letters.

The updated SDP addresses the following areas: (1) the benefits of disclosure; (2) eligibility criteria and guidance; and (3) requirements of provider submissions, including specific requirements for submissions involving false billing, excluded persons, the Anti-Kickback Statute and the Stark Law.

Benefits of Disclosure

In this update, the OIG again emphasizes the importance of integrity when dealing with federal healthcare programs and it identifies certain specific benefits of disclosure. First, the update recognizes the OIG's belief that a good faith disclosure typically indicates an effective compliance plan. In furtherance of this recognition, the OIG has instituted a presumption against the requirement of corporate integrity agreements in exchange for a release of the OIG's permissive exclusion authority.

Second, the update recognizes the OIG's general practice of imposing a minimum multiplier of 1.5 times single damages to dispose of civil monetary penalty matters, rather than higher multipliers, which are normally used in resolving government-initiated investigations.

Third, use of the SDP may mitigate potential exposure for failure to return a Medicare or Medicaid overpayment within 60 days after the date on which the overpayment is identified or any corresponding cost report is due. According to the update, CMS proposes to suspend a provider's obligation to return overpayments until such time as a settlement agreement is reached or the provider withdraws or is removed from the SDP. This constitutes an extension of the position the OIG announced in February 2012, which was to suspend the obligation to report overpayments only to the time that the OIG acknowledged the provider's submission to the SDP.

Fourth, the OIG commits to continue to reduce the time for its processing of SDP submissions. In furtherance of this commitment, the OIG is reducing the time in which a provider must complete its internal investigation and damages calculation time from 90 days of a provider's acceptance into the SDP to 90 days from the date of the provider's initial submission. While perhaps well intentioned, the shortening of this period could provide challenges for providers where the circumstances of misconduct are far reaching or otherwise less than clear.

Eligibility Criteria and Guidance

The update restates that the SDP is not limited to any particular industry but is available to all segments, including, for example, pharmaceutical and medical device manufacturers. The update reiterates that the SDP should not be used to report mere overpayments, and that it is intended to address only those matters potentially involving federal criminal, civil or administrative laws for which civil monetary penalties are authorized. The update also reiterates that the SDP is not available for conduct that is solely violative of the Stark Law. Rather, Stark Law violations should be disclosed pursuant to CMS's Self-Referral Disclosure Protocol . As a corollary to CMS's proposal that the 60-day time period for repayment of an identified overpayment be tolled, the OIG expects that disclosing parties have a good faith willingness to resolve liability within the six-year statute of limitations of the civil monetary penalty law. Thus, as a condition of the OIG's acceptance into the SDP, the OIG will require parties to waive and not plead the statute of limitations or similar defenses to any administrative action filed by the OIG. In addition, the update admonishes disclosing parties to ensure that the conduct has ended and corrective action has been taken prior to submission of the SDP. With respect to improper kickback arrangements, the provider should ensure that such arrangements are terminated prior to or no later than 90 days of submission.

Content of SDP Submissions

Under the revised SDP, providers who are unable to complete their internal investigations prior to submission must certify that they will complete it within 90 days of the date of initial submission. This is a shorter than the original time provided in the SDP, which required completion within 90 days of acceptance by the OIG of the provider into the SDP program. The updated protocol describes 11 specific areas that are required to be included in the provider's submission. These include a concise statement of all details of relevant conduct and transactions; identification of the relevant federal criminal, civil and administrative laws; identification of the healthcare programs affected by the conduct; an estimate of damages; a description of any corrective action that was undertaken upon discovery of the conduct; and a statement as to whether the particular matter is currently being investigated by any government agency or contractor.

The update also addresses certain specific areas such as false billing, excluded persons, kickbacks and physician self-referrals. Specifically, the update changes the requirements for damage estimates in false billing matters, including an increase in the sample size from 30 units to at least 100 items. With respect to matters involving excluded persons, the update requires that the provider identify the excluded individual, the individual's provider number and the individual's job duties. The provider is also required to summarize the background checks that had been completed during the period of employment, the provider's screening process and any corrective action. In addition, the update provides a specific method for calculating damages involving excluded individuals.

With respect to antikickback violations, the updated SDP provides examples of the types of information it is looking for, including how fair market value was determined, why payments were made from referral sources and whether payments were made for services not performed. The submission also requires that the provider submit an estimate of the amount paid for services associated with violations of the antikickback statute, and the disclosing party must also include the amount of remuneration involved in each arrangement. The updated SDP reiterates that it is not available for violations that are solely of the Stark Law, but is available for conduct that implicates both the antikickback statute and the Stark Law.


The updated SDP stresses that cooperation from the reporting provider is critical to a speedy resolution and beneficial result. It encourages disclosing parties to address potential criminal conduct, and it advises that as in civil cases, the OIG will advocate for a disclosing party when the Department of Justice is considering whether to prosecute. The updated SDP requires a minimum settlement amount of $50,000 for antikickback-related matters, and a minimum of $10,000 for all other matters. If the disclosing party maintains that it is financially unable to pay a settlement, the OIG will require the provider to submit and certify to the truthfulness of extensive financial information, including audited financial statements and tax returns.

As the government continues to significantly expand its fraud-fighting efforts, the SDP protocol becomes an increasingly important alternative to treble damages under the False Claims Act, penalties under the civil monetary penalties laws and criminal prosecution. Providers should seek out experienced and skilled counsel to deal with the OIG and, when appropriate, the Department of Justice. Prompt evaluation of the circumstances, assessment of potential liabilities and well-planned communication with the OIG can help mitigate these substantial risks.

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

To print this article, all you need is to be registered on Mondaq.com.

Click to Login as an existing user or Register so you can print this article.

In association with
Related Video
Up-coming Events Search
Font Size:
Mondaq on Twitter
Register for Access and our Free Biweekly Alert for
This service is completely free. Access 250,000 archived articles from 100+ countries and get a personalised email twice a week covering developments (and yes, our lawyers like to think you’ve read our Disclaimer).
Email Address
Company Name
Confirm Password
Mondaq Topics -- Select your Interests
 Law Performance
 Law Practice
 Media & IT
 Real Estate
 Wealth Mgt
Asia Pacific
European Union
Latin America
Middle East
United States
Worldwide Updates
Check to state you have read and
agree to our Terms and Conditions

Terms & Conditions and Privacy Statement

Mondaq.com (the Website) is owned and managed by Mondaq Ltd and as a user you are granted a non-exclusive, revocable license to access the Website under its terms and conditions of use. Your use of the Website constitutes your agreement to the following terms and conditions of use. Mondaq Ltd may terminate your use of the Website if you are in breach of these terms and conditions or if Mondaq Ltd decides to terminate your license of use for whatever reason.

Use of www.mondaq.com

You may use the Website but are required to register as a user if you wish to read the full text of the content and articles available (the Content). You may not modify, publish, transmit, transfer or sell, reproduce, create derivative works from, distribute, perform, link, display, or in any way exploit any of the Content, in whole or in part, except as expressly permitted in these terms & conditions or with the prior written consent of Mondaq Ltd. You may not use electronic or other means to extract details or information about Mondaq.com’s content, users or contributors in order to offer them any services or products which compete directly or indirectly with Mondaq Ltd’s services and products.


Mondaq Ltd and/or its respective suppliers make no representations about the suitability of the information contained in the documents and related graphics published on this server for any purpose. All such documents and related graphics are provided "as is" without warranty of any kind. Mondaq Ltd and/or its respective suppliers hereby disclaim all warranties and conditions with regard to this information, including all implied warranties and conditions of merchantability, fitness for a particular purpose, title and non-infringement. In no event shall Mondaq Ltd and/or its respective suppliers be liable for any special, indirect or consequential damages or any damages whatsoever resulting from loss of use, data or profits, whether in an action of contract, negligence or other tortious action, arising out of or in connection with the use or performance of information available from this server.

The documents and related graphics published on this server could include technical inaccuracies or typographical errors. Changes are periodically added to the information herein. Mondaq Ltd and/or its respective suppliers may make improvements and/or changes in the product(s) and/or the program(s) described herein at any time.


Mondaq Ltd requires you to register and provide information that personally identifies you, including what sort of information you are interested in, for three primary purposes:

  • To allow you to personalize the Mondaq websites you are visiting.
  • To enable features such as password reminder, newsletter alerts, email a colleague, and linking from Mondaq (and its affiliate sites) to your website.
  • To produce demographic feedback for our information providers who provide information free for your use.

Mondaq (and its affiliate sites) do not sell or provide your details to third parties other than information providers. The reason we provide our information providers with this information is so that they can measure the response their articles are receiving and provide you with information about their products and services.

If you do not want us to provide your name and email address you may opt out by clicking here .

If you do not wish to receive any future announcements of products and services offered by Mondaq by clicking here .

Information Collection and Use

We require site users to register with Mondaq (and its affiliate sites) to view the free information on the site. We also collect information from our users at several different points on the websites: this is so that we can customise the sites according to individual usage, provide 'session-aware' functionality, and ensure that content is acquired and developed appropriately. This gives us an overall picture of our user profiles, which in turn shows to our Editorial Contributors the type of person they are reaching by posting articles on Mondaq (and its affiliate sites) – meaning more free content for registered users.

We are only able to provide the material on the Mondaq (and its affiliate sites) site free to site visitors because we can pass on information about the pages that users are viewing and the personal information users provide to us (e.g. email addresses) to reputable contributing firms such as law firms who author those pages. We do not sell or rent information to anyone else other than the authors of those pages, who may change from time to time. Should you wish us not to disclose your details to any of these parties, please tick the box above or tick the box marked "Opt out of Registration Information Disclosure" on the Your Profile page. We and our author organisations may only contact you via email or other means if you allow us to do so. Users can opt out of contact when they register on the site, or send an email to unsubscribe@mondaq.com with “no disclosure” in the subject heading

Mondaq News Alerts

In order to receive Mondaq News Alerts, users have to complete a separate registration form. This is a personalised service where users choose regions and topics of interest and we send it only to those users who have requested it. Users can stop receiving these Alerts by going to the Mondaq News Alerts page and deselecting all interest areas. In the same way users can amend their personal preferences to add or remove subject areas.


A cookie is a small text file written to a user’s hard drive that contains an identifying user number. The cookies do not contain any personal information about users. We use the cookie so users do not have to log in every time they use the service and the cookie will automatically expire if you do not visit the Mondaq website (or its affiliate sites) for 12 months. We also use the cookie to personalise a user's experience of the site (for example to show information specific to a user's region). As the Mondaq sites are fully personalised and cookies are essential to its core technology the site will function unpredictably with browsers that do not support cookies - or where cookies are disabled (in these circumstances we advise you to attempt to locate the information you require elsewhere on the web). However if you are concerned about the presence of a Mondaq cookie on your machine you can also choose to expire the cookie immediately (remove it) by selecting the 'Log Off' menu option as the last thing you do when you use the site.

Some of our business partners may use cookies on our site (for example, advertisers). However, we have no access to or control over these cookies and we are not aware of any at present that do so.

Log Files

We use IP addresses to analyse trends, administer the site, track movement, and gather broad demographic information for aggregate use. IP addresses are not linked to personally identifiable information.


This web site contains links to other sites. Please be aware that Mondaq (or its affiliate sites) are not responsible for the privacy practices of such other sites. We encourage our users to be aware when they leave our site and to read the privacy statements of these third party sites. This privacy statement applies solely to information collected by this Web site.

Surveys & Contests

From time-to-time our site requests information from users via surveys or contests. Participation in these surveys or contests is completely voluntary and the user therefore has a choice whether or not to disclose any information requested. Information requested may include contact information (such as name and delivery address), and demographic information (such as postcode, age level). Contact information will be used to notify the winners and award prizes. Survey information will be used for purposes of monitoring or improving the functionality of the site.


If a user elects to use our referral service for informing a friend about our site, we ask them for the friend’s name and email address. Mondaq stores this information and may contact the friend to invite them to register with Mondaq, but they will not be contacted more than once. The friend may contact Mondaq to request the removal of this information from our database.


From time to time Mondaq may send you emails promoting Mondaq services including new services. You may opt out of receiving such emails by clicking below.

*** If you do not wish to receive any future announcements of services offered by Mondaq you may opt out by clicking here .


This website takes every reasonable precaution to protect our users’ information. When users submit sensitive information via the website, your information is protected using firewalls and other security technology. If you have any questions about the security at our website, you can send an email to webmaster@mondaq.com.

Correcting/Updating Personal Information

If a user’s personally identifiable information changes (such as postcode), or if a user no longer desires our service, we will endeavour to provide a way to correct, update or remove that user’s personal data provided to us. This can usually be done at the “Your Profile” page or by sending an email to EditorialAdvisor@mondaq.com.

Notification of Changes

If we decide to change our Terms & Conditions or Privacy Policy, we will post those changes on our site so our users are always aware of what information we collect, how we use it, and under what circumstances, if any, we disclose it. If at any point we decide to use personally identifiable information in a manner different from that stated at the time it was collected, we will notify users by way of an email. Users will have a choice as to whether or not we use their information in this different manner. We will use information in accordance with the privacy policy under which the information was collected.

How to contact Mondaq

You can contact us with comments or queries at enquiries@mondaq.com.

If for some reason you believe Mondaq Ltd. has not adhered to these principles, please notify us by e-mail at problems@mondaq.com and we will use commercially reasonable efforts to determine and correct the problem promptly.