United States: OIG Issues Request For Information On Federal Anti-Kickback And Beneficiary Inducement Issues

The Office of Inspector General (OIG) of the Department of Health Human Services (HHS) is seeking input on Medicare and State Health Care Programs: Fraud and Abuse; Request for Information Regarding the Anti-Kickback Statute and Beneficiary Inducements CMP. The OIG characterizes this request for information (RFI) as part of HHS's effort "to transform the health care system into one that better pays for value." The RFI seeks to identify ways to amend or add new safe harbors to the Anti-Kickback Statute (AKS) and exceptions to the beneficiary inducements provisions of the Civil Monetary Penalty (CMP) statute, in order to foster arrangements that promote care coordination and advance the delivery of value-based care.

The RFI seeks to identify ways to amend or add new safe harbors to the Anti-Kickback Statute (AKS)1 and exceptions to the beneficiary inducement provisions of the Civil Monetary Penalty (CMP) statute,2 in order to foster arrangements that promote care coordination and advance the delivery of value-based care. The OIG notes that, through internal discussions and input from external stakeholders, it has identified the broad reach of these provisions as "potential impediment[s] to beneficial arrangements that would advance coordinated care." 

The OIG will accept comments on the RFI until October 26, 2018.

The RFI seeks information in several broad areas, requesting that commenters provide recommendations in each case on (a) how to structure arrangements between parties to alternative payment models; (b) what changes are needed in current safe harbors and beneficiary inducement CMPs, in order to promote beneficial care coordination, patient engagement, and value-based arrangements; and (c) associated terminology for these goals. 

  1. Promoting care coordination and value-based care: The OIG seeks information regarding the structure and terms of potential arrangements involving care coordination, value-based arrangements, alternative payment models, arrangements involving innovative technology, and other novel financial arrangements. At the same time, it requests input on how these types of arrangements can prevent potential harms such as increased costs, inappropriate utilization, poor quality of care, and distorted decision making. In particular, the OIG asks what new or modified safe harbors to the AKS or exceptions to the CMP definition of remuneration are needed, and how "value" and other "critical terminology" should be defined (e.g., care coordination, clinical integration, gainsharing, outcomes-based care, risk sharing, and more).
  2. Beneficiary incentives and cost-sharing obligations: The OIG also requests information regarding the types of incentives providers, suppliers, and others would like to provide to beneficiaries, and how such incentives would contribute to or improve quality of care, care coordination, and patient engagement, including adherence to care plans.3 Furthermore, the OIG seeks information on how relieving or eliminating beneficiary cost-sharing obligations might improve care delivery, enhance value-based arrangements, and promote the quality of care.
  3. Intersection of the Stark Physician Self-Referral Law and Anti-Kickback Statute: The OIG seeks input on whether and how there should be alignment between exceptions to the Stark physician self-referral law and the AKS.
  4. Other related topics: The OIG also seeks comment in a number of related areas:
    Fraud and abuse waivers: feedback on current waivers developed to test models by the Centers for Medicare and Medicaid Innovation (CMS) and carrying out the Medicare Shared Savings Program, including whether stakeholders have found compliance with the waivers to be challenging, whether specific waiver requirements are unduly burdensome, what waiver structures or conditions work well, how the governing body concept for accountable care organizations (ACOs) is working, and what pros and cons exist for fraud and abuse protections that are uniform across different CMS models, initiatives, and programs.

    Cybersecurity-related items and services: the types of cybersecurity-related items or services that entities wish to donate or subsidize, and how existing fraud and abuse laws may pose barriers to such arrangements.

    ACO beneficiary incentive program (section 50341(b) of the Bipartisan Budget Act of 2018): information regarding "other conditions" that this new safe harbor should include as protections or safeguards.

    Telehealth (section 50302(c) of the Bipartisan Budget Act of 2018): information on how to define the new "telehealth technologies" exception in the beneficiary inducements CMP, whether the definition should also include services, and examples of those services.

* * * * *

In recent years, the OIG has received an increasing number of comments in response to its annual safe harbor solicitation that current fraud and abuse provisions impede the use of value-based or outcomes-based arrangements among providers, suppliers, manufacturers, and others. The RFI is wide-ranging and demonstrates the complexity of the issues involved. It is one of several initiatives being contemplated by the OIG in conjunction with CMS to assess issues in the current regulations that may act as barriers to coordinated care. 

 On June 20, 2018, CMS issued an RFI relating to the federal self-referral law, commonly known as the Stark law. Various industry stakeholders have argued that the Stark law is stifling innovation, and that modifications are needed in order to further needed clinical and financial integration, health care delivery, and payment reform. In response, CMS has acknowledged that the Stark law may act as a barrier to coordinated care. Comments on that RFI were due on August 24, 2018.

Then, on July 18, 2018, the OIG submitted to the Office of Management and Budget for regulatory review a proposed rule that would have the effect of narrowing safe harbor protections under the AKS. The proposed rule, entitled "Removal of Safe Harbor Protection for Rebates to Plans or PBMs Involving Prescription Pharmaceuticals and Creation of New Safe Harbor Protection," if released, appears to follow through on various statements made by HHS Secretary Alex Azar suggesting that safe harbor protection under the AKS should be removed for prescription drug rebates; we discussed this issuance in our alert of July 20, 2018.  It is unclear what new type of safe harbor, if any, may be proposed by OIG as a replacement.

We are seeing OIG and CMS reconsideration of some of the most fundamental precepts of fraud and abuse law that currently govern the multiple arrangements throughout the health care delivery system. Interested stakeholders should avail themselves of the opportunity to advocate for new needed protections to significant, emerging value-based and other arrangements.


  1. The AKS provided criminal penalties for individuals and entities that knowingly and willfully offer, pay, solicit or receive remuneration to induce or reward the referral of business reimbursable under federal health care programs.  Certain payment practices are protected by "safe harbors."
  2. The Beneficiary Inducement provisions imposes penalties against any person who offers or transfers remuneration to a Medicare or State health care program beneficiary that the benefactor knows or should know is likely to influence the beneficiary's selection of a particular provider, practitioner, or supplier. The CMP Regulations codify certain statutory exceptions in the definition of "remuneration."
  3. Among other inquiries, the OIG solicits comments on whether the OIG Policy Statement Regarding Gifts of Nominal Value to Medicare and Medicaid Beneficiaries should be updated.

This article is presented for informational purposes only and is not intended to constitute legal advice.

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.

Similar Articles
Relevancy Powered by MondaqAI
In association with
Related Topics
Similar Articles
Relevancy Powered by MondaqAI
Related Articles
Related Video
Up-coming Events Search
Font Size:
Mondaq on Twitter
Mondaq Free Registration
Gain access to Mondaq global archive of over 375,000 articles covering 200 countries with a personalised News Alert and automatic login on this device.
Mondaq News Alert (some suggested topics and region)
Select Topics
Registration (please scroll down to set your data preferences)

Mondaq Ltd requires you to register and provide information that personally identifies you, including your content preferences, for three primary purposes (full details of Mondaq’s use of your personal data can be found in our Privacy and Cookies Notice):

  • To allow you to personalize the Mondaq websites you are visiting to show content ("Content") relevant to your interests.
  • To enable features such as password reminder, news alerts, email a colleague, and linking from Mondaq (and its affiliate sites) to your website.
  • To produce demographic feedback for our content providers ("Contributors") who contribute Content for free for your use.

Mondaq hopes that our registered users will support us in maintaining our free to view business model by consenting to our use of your personal data as described below.

Mondaq has a "free to view" business model. Our services are paid for by Contributors in exchange for Mondaq providing them with access to information about who accesses their content. Once personal data is transferred to our Contributors they become a data controller of this personal data. They use it to measure the response that their articles are receiving, as a form of market research. They may also use it to provide Mondaq users with information about their products and services.

Details of each Contributor to which your personal data will be transferred is clearly stated within the Content that you access. For full details of how this Contributor will use your personal data, you should review the Contributor’s own Privacy Notice.

Please indicate your preference below:

Yes, I am happy to support Mondaq in maintaining its free to view business model by agreeing to allow Mondaq to share my personal data with Contributors whose Content I access
No, I do not want Mondaq to share my personal data with Contributors

Also please let us know whether you are happy to receive communications promoting products and services offered by Mondaq:

Yes, I am happy to received promotional communications from Mondaq
No, please do not send me promotional communications from Mondaq
Terms & Conditions

Mondaq.com (the Website) is owned and managed by Mondaq Ltd (Mondaq). Mondaq grants you a non-exclusive, revocable licence to access the Website and associated services, such as the Mondaq News Alerts (Services), subject to and in consideration of your compliance with the following terms and conditions of use (Terms). Your use of the Website and/or Services constitutes your agreement to the Terms. Mondaq may terminate your use of the Website and Services if you are in breach of these Terms or if Mondaq decides to terminate the licence granted hereunder for any reason whatsoever.

Use of www.mondaq.com

To Use Mondaq.com you must be: eighteen (18) years old or over; legally capable of entering into binding contracts; and not in any way prohibited by the applicable law to enter into these Terms in the jurisdiction which you are currently located.

You may use the Website as an unregistered user, however, you are required to register as a user if you wish to read the full text of the Content or to receive the Services.

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 or with the prior written consent of Mondaq. You may not use electronic or other means to extract details or information from the Content. Nor shall you extract information about users or Contributors in order to offer them any services or products.

In your use of the Website and/or Services you shall: comply with all applicable laws, regulations, directives and legislations which apply to your Use of the Website and/or Services in whatever country you are physically located including without limitation any and all consumer law, export control laws and regulations; provide to us true, correct and accurate information and promptly inform us in the event that any information that you have provided to us changes or becomes inaccurate; notify Mondaq immediately of any circumstances where you have reason to believe that any Intellectual Property Rights or any other rights of any third party may have been infringed; co-operate with reasonable security or other checks or requests for information made by Mondaq from time to time; and at all times be fully liable for the breach of any of these Terms by a third party using your login details to access the Website and/or Services

however, you shall not: do anything likely to impair, interfere with or damage or cause harm or distress to any persons, or the network; do anything that will infringe any Intellectual Property Rights or other rights of Mondaq or any third party; or use the Website, Services and/or Content otherwise than in accordance with these Terms; use any trade marks or service marks of Mondaq or the Contributors, or do anything which may be seen to take unfair advantage of the reputation and goodwill of Mondaq or the Contributors, or the Website, Services and/or Content.

Mondaq reserves the right, in its sole discretion, to take any action that it deems necessary and appropriate in the event it considers that there is a breach or threatened breach of the Terms.

Mondaq’s Rights and Obligations

Unless otherwise expressly set out to the contrary, nothing in these Terms shall serve to transfer from Mondaq to you, any Intellectual Property Rights owned by and/or licensed to Mondaq and all rights, title and interest in and to such Intellectual Property Rights will remain exclusively with Mondaq and/or its licensors.

Mondaq shall use its reasonable endeavours to make the Website and Services available to you at all times, but we cannot guarantee an uninterrupted and fault free service.

Mondaq reserves the right to make changes to the services and/or the Website or part thereof, from time to time, and we may add, remove, modify and/or vary any elements of features and functionalities of the Website or the services.

Mondaq also reserves the right from time to time to monitor your Use of the Website and/or services.


The Content is general information only. It is not intended to constitute legal advice or seek to be the complete and comprehensive statement of the law, nor is it intended to address your specific requirements or provide advice on which reliance should be placed. Mondaq and/or its Contributors and other suppliers make no representations about the suitability of the information contained in the Content for any purpose. All Content provided "as is" without warranty of any kind. Mondaq and/or its Contributors and other suppliers hereby exclude and disclaim all representations, warranties or guarantees with regard to the Content, including all implied warranties and conditions of merchantability, fitness for a particular purpose, title and non-infringement. To the maximum extent permitted by law, Mondaq expressly excludes all representations, warranties, obligations, and liabilities arising out of or in connection with all Content. In no event shall Mondaq 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 of the Content or performance of Mondaq’s Services.


Mondaq may alter or amend these Terms by amending them on the Website. By continuing to Use the Services and/or the Website after such amendment, you will be deemed to have accepted any amendment to these Terms.

These Terms shall be governed by and construed in accordance with the laws of England and Wales and you irrevocably submit to the exclusive jurisdiction of the courts of England and Wales to settle any dispute which may arise out of or in connection with these Terms. If you live outside the United Kingdom, English law shall apply only to the extent that English law shall not deprive you of any legal protection accorded in accordance with the law of the place where you are habitually resident ("Local Law"). In the event English law deprives you of any legal protection which is accorded to you under Local Law, then these terms shall be governed by Local Law and any dispute or claim arising out of or in connection with these Terms shall be subject to the non-exclusive jurisdiction of the courts where you are habitually resident.

You may print and keep a copy of these Terms, which form the entire agreement between you and Mondaq and supersede any other communications or advertising in respect of the Service and/or the Website.

No delay in exercising or non-exercise by you and/or Mondaq of any of its rights under or in connection with these Terms shall operate as a waiver or release of each of your or Mondaq’s right. Rather, any such waiver or release must be specifically granted in writing signed by the party granting it.

If any part of these Terms is held unenforceable, that part shall be enforced to the maximum extent permissible so as to give effect to the intent of the parties, and the Terms shall continue in full force and effect.

Mondaq shall not incur any liability to you on account of any loss or damage resulting from any delay or failure to perform all or any part of these Terms if such delay or failure is caused, in whole or in part, by events, occurrences, or causes beyond the control of Mondaq. Such events, occurrences or causes will include, without limitation, acts of God, strikes, lockouts, server and network failure, riots, acts of war, earthquakes, fire and explosions.

By clicking Register you state you have read and agree to our Terms and Conditions