The Health and Human Services (HHS) Office of Inspector General (OIG) published today a request for information (RFI) seeking ways in which it might modify or add new safe harbors to the federal Anti-Kickback Statute (AKS) and exceptions to the definition of “remuneration” in the beneficiary inducement provision of the Civil Monetary Penalties (CMP) Law to foster compliant arrangements that promote “efficient, well-coordinated, patient centered care.” The RFI is similar to a RFI issued by the Centers for Medicare & Medicaid Services (CMS) in June 2018 related to the Physician Self-Referral (“Stark”) Law. This RFI complements the “Regulatory Sprint to Coordinated Care” announced recently by HHS.

The OIG has requested comments to the following topics:

  1. Promoting care coordination and value-based care, including (i) potential arrangements that the industry is interested in pursuing related to care coordination, value-based arrangements, alternative payment models, arrangements involving innovative technology, and other novel financial arrangements that may implicate the AKS or CMP Law; (ii) what, if any, additional or modified safe harbors or exceptions to the AKS or CMP Law may be necessary to protect such arrangements and any key provisions that should be included; (iii) how ‘‘value’’ could be defined and used in a safe harbor or exception; (iv) thoughts on definitions for critical terminology for such arrangements; and (v) whether there are opportunities for the OIG to clarify its position through guidance as opposed to regulation.
  2. Beneficiary engagement, including input regarding (i) beneficiary incentives provided by providers, suppliers, and others, such as how these incentives would contribute to or improve quality of care, care coordination, and patient engagement and the associated risks or benefits of beneficiary incentives; and (ii) cost-sharing obligations, including how cost-sharing obligations may improve care delivery, enhance value-based arrangements, and quality of care and the associated risks or benefits of waiving cost-sharing obligations.
  3. Experiences from other current fraud and abuse waiver programs.
  4. Input regarding cybersecurity-related items and services.
  5. Input regarding “other conditions” that should be considered when OIG implements the new statutory exception under the ACO Beneficiary Incentive Program through a safe harbor.
  6. Input regarding implementation of a statutory exception in the CMP Law related to certain ‘‘telehealth technologies’’ provided on or after January 1, 2019, including applicable protections or safeguards that the OIG should consider.
  7. Input regarding alignment of the Stark Law and AKS, including when the Stark Law exceptions and AKS safe harbors should align, and when Stark Law exceptions related to care coordination or value-based care should not have a corresponding safe harbor to the AKS.

All interested parties should submit comments to the RFI by October 26, 2018. The OIG has urged interested parties that submitted relevant comments to the CMS RFI regarding the Stark Law to resubmit such comments to this RFI.