The Department of Health and Human Services Office of Inspector General (OIG) recently released a proposed rule soliciting recommendations for new Anti-Kickback Statute (AKS) safe harbors, modifications to existing safe harbors, and new OIG Special Fraud Alerts.

There is some speculation that the Trump administration’s efforts to ease regulatory burdens will include supporting innovation and care coordination, and protecting value-based payment models in the health care industry. As a result, the OIG may well be receptive to proposed safe harbors in these areas and health care providers, as well as drug and device manufacturers, should consider submitting proposals. One area worth exploring is whether the OIG would be willing to consider new or expanded safe harbors designed to protect arrangements related to cost-sharing waivers, shared revenue models, or bundled discount or rebate arrangements that otherwise “fall out” of the discount safe harbor to the AKS because they are reimbursed under different payment methodologies. Safe harbors related to value based contracts, pricing, and warranties are being promoted by certain associations, but may benefit from additional support or insights from industry stakeholders. The OIG will be accepting proposals until February 26, 2018.

How Safe Harbors Become Safe Harbors

The AKS imposes criminal liability and civil penalties on individuals and entities that knowingly and willfully offer, pay, solicit, or receive remuneration to induce referrals for federal health care programs, including Medicare and Medicaid. Due to concern that beneficial or relatively innocuous commercial arrangements could be subject to AKS liability, safe harbors were implemented to protect specific payment and business practices, and arrangements that fully comply with all the requirements of an appropriate safe harbor are not subject to AKS liability. The OIG annually solicits input from the health care industry on current practices that could justify the development of new safe harbors or the modification of existing safe harbors.

In reviewing proposals, the OIG has stated that it will consider numerous factors, including whether the proposals will increase or decrease access to, or the quality of, health care services, patient freedom of choice, competition among health care providers, costs to the federal health care programs, the ability of health care facilities to provide services to medically underserved areas or populations, and any potential financial benefit to health care professionals or providers related to decisions to order, or arrange for the referral of, health care items or services to a particular practitioner or provider.

OIG Also Wants Input on Alerts

In addition, the OIG periodically issues Special Fraud Alerts that provide guidance to the health care industry on topics or practices that the OIG considers suspect or of particular concern. The OIG also is seeking input from health care industry stakeholders on new issues or concerns that, in light of the volume or frequency of the questionable conduct, warrant a Special Fraud Alert.

Taking Advantage of the Opportunity

The OIG’s solicitation for AKS safe harbor recommendations provides an excellent opportunity for stakeholders to shape the structure of safe harbors related to health innovation, care coordination, and value based payment models, which the Trump administration has stressed and encouraged for the industry. In addition, the OIG solicitation affords stakeholders the opportunity to highlight additional trends throughout the health care industry, which might warrant an AKS safe harbor or additional OIG guidance, such as product support services provided to patients that promote health and might be deemed to have a “low risk of harm.” Stakeholders should take advantage of the solicitation and provide comments, as this is a rare and welcome direct dialogue with OIG outside of the advisory opinion process.