Feedback Sought Regarding the Anti-Kickback Statute and the Civil Monetary Penalties Law

The Department of Health and Human Services ("HHS") Office of Inspector General ("OIG") issued a request for information ("RFI") on August 27, 2018 (this "August RFI"), seeking input on ways to modify or add new safe harbors to the Anti-Kickback Statute ("AKS") and exceptions to the beneficiary inducement provision of the Civil Monetary Penalties ("CMP") "remuneration" definition. The OIG's goal is to balance the advancement of coordinated care and delivery of value-based care, while protecting these areas from fraud and abuse. This August RFI is similar to the RFI issued in June by the Centers for Medicare & Medicaid Services ("CMS") related to the Physician Self-Referral Law (“Stark”) ("June RFI"). See previous article, CMS Request for Information – Stark Law.

The OIG has requested public comment on four (4) topics:

    1.  Promoting care coordination and value-based care. Specifically, comments on arrangements that the industry is interested in pursuing. Examples include: coordination, value-based, alternative payment models, innovative technology, and other financial arrangements. Second, OIG requests feedback on additional provisions or modified safe harbors or exceptions necessary to protect these arrangements. Third, input on the definition and use of ‘‘value’’ in a safe harbor or exception. Similarly, the OIG requests feedback on defining critical terminology for health care delivery reform and payment reform. Finally, the OIG requests comment on areas to clarify its positions through guidance.

    2.  Beneficiary engagement. The OIG seeks input on the types of incentives provided by providers, suppliers, and others, and how cost-sharing obligations may improve care delivery, value-based arrangements, and quality of care.

    3.  Other Related Topics of Interest. The OIG requests input on three (3) other related topics to AKS and CPM. Examples of these topics include:

    (a) Current fraud and abuse waiver programs;

    (b) Cybersecurity-related items and services;

    (c) Bipartisan Budget Act of 2018 exceptions related to:

        (i) ACO Beneficiary Incentive Program; and

        (ii) Telehealth

    4.  The Intersection of Stark and AKS. Finally, the OIG requests feedback on circumstances in which the Stark exceptions and AKS safe harbors should align and alternatively, when Stark exceptions related to care coordination or value-based care should not have corresponding safe harbors to the AKS.

Because of this RFI's similarity to that of the CMS June RFI, the OIG urges parties to resubmit any comments previously submitted to the CMS June RFI. All Public comments must be received at one of the addresses below, no later than 5 p.m. on October 26, 2018.

Email: http://www.regulations.gov

Regular Mail, Hand Delivery, or Courier:
Susan Edwards, Office of Inspector General
Department of Health and Human Services
Attention: OIG-0803
N, Room 5513, Cohen Building,
330 Independence Avenue SW
Washington, DC 20201