The Office of Inspector General (“OIG”) has filed a Request for Information Regarding the Anti-Kickback Statute and Beneficiary Inducements CMP (the “OIG RFI”), scheduled to be published August 27. The unpublished OIG RFI can be found here.

The Federal anti-kickback statute (“AKS”) provides criminal penalties for individuals or entities that knowingly or willfully offer, pay, solicit or receive remuneration to induce or reward the referral of business reimbursable under the Federal healthcare programs. The OIG promulgated safe harbors that, if met, protect certain arrangements and payment practices from criminal prosecution under the AKS, the imposition of civil monetary penalties (“CMPs”), program exclusion or liability under the False Claims Act. Additionally, the OIG has authority under Section 1128A(a)(5) of the Social Security Act to impose CMPs and seek exclusion against any person who offers or transfers remuneration to a Medicare or State healthcare program beneficiary that the offeror/transferor knows or should know is likely to influence the beneficiary’s selection of a particular provider, practitioner, or supplier of any item or service for which payment may be made, in whole or in part, by Medicare or a State health care program.

According to the OIG RFI, the OIG “seeks to identify ways in which it might modify or add new safe harbors to the anti-kickback statute and exceptions to the beneficiary inducements civil monetary penalty (CMP) definition of ‘remuneration’ in order to foster arrangements that would promote care coordination and advance the delivery of value-based care, while also protecting against harms caused by fraud and abuse.” The OIG seeks stakeholder feedback on three broad topics: (i) the structure of arrangements between parties that participate in alternative payment models (“APMs”) or other novel financial arrangements designed to promote care coordination and value; (ii) the need for new or revised safe harbors and exceptions to the definition of “remuneration” under the beneficiary inducements CMP to promote beneficial care coordination, patient engagement, and value-based arrangements; and (iii) terminology related to APMs, value-based arrangements, and care coordination.

The complete list of requests for information begins in Section III of the OIG RFI (page 7 in the unpublished OIG RFI, here). Of note, the requests include, but are not limited to the following:

1. Potential arrangements that the industry is interested in pursuing, such as care coordination, value-based arrangements, APMs, arrangements involving innovative technology, and other novel financial arrangements that may implicate the AKS or beneficiary inducements CMP.
2. What, if any, additional or modified safe harbors to the AKS or exceptions to the definition of “remuneration” under the beneficiary inducements CMP may be necessary to protect arrangements that the industry is interested in pursuing and any key provisions that should be included in the additional or modified safe harbor or exception.
3. How “value” could be defined and used in a safe harbor or exception.
4. In the context of health care delivery reform, payment reform, and the AKS, please share thoughts on definitions for critical terminology.
5. Are there opportunities where OIG could clarify its position through guidance as opposed to regulation?
6. What types of incentives are providers, suppliers and others interested in providing to beneficiaries, how would such incentives contribute to or improve quality of care, care coordination, and patient engagement, and whether the types of providers, suppliers or other entities that furnish the incentives matter from an effectiveness and program integrity perspective.
7. Identify any risks or benefits, and safeguards to mitigate those risks, from the following types of potential remuneration: cash equivalents, gift cards, in-kind items and services, nonmonetary remuneration.
8. Should OIG amend its “Office of Inspector General Policy Statement Regarding Gifts of Nominal Value to Medicare and Medicaid Beneficiaries” to increase “nominal value” from no more than $15 per item or $75 in the aggregate per patient on an annual basis?
9. How might relieving or eliminating beneficiary cost-sharing obligations improve care delivery, enhance value-based arrangements, and promote quality of care.
10. Provide feedback on the current waivers developed for the purposes of testing models by the CMS Innovation Center and carrying out the Medicare Shared Savings Program.
11. What types of cybersecurity-related items or services do entities wish to donate or subsidize, and how do existing fraud and abuse laws pose barriers to such arrangements.
12. Are there any “other conditions” that should be included in a proposed AKS safe harbor related to the statutory exception to AKS for incentive payments made to a Medicare fee-for-service beneficiary by an ACO under an ACO Beneficiary Incentive Program. 

The OIG recognizes that the Centers for Medicare and Medicaid Services issued a Request for Information Regarding the Physician Self-Referral Law (the “CMS RFI”) (our summary of the CMS RFI can be found here), and indicates that it will review comments submitted in response to the CMS RFI; however, the OIG suggests that individuals resubmit any relevant comments to this OIG RFI in order to ensure their responses are considered by the OIG.

To ensure consideration, comments must be received by 5:00 p.m. 60 days after publication (projected to be October 26, 2018).

Additional Information

Should you have any questions about the OIG RFI, the Federal Anti-Kickback Statute, the Beneficiary Inducements CMP, or how these laws may apply to you or your organization, please do not hesitate to contact any member of Kutak Rock’s National Healthcare Group to assist.