As part of the Health and Human Services Department’s (“HHS”) “Regulatory Sprint to Coordinated Care” efforts aimed at alleviating unnecessary regulatory barriers to coordinated care while protecting against fraud and abuse, the Office of Inspector General (“OIG”) issued a Request for Information (“RFI”) on August 27, 2018, requesting public input on the following items:
- Care Coordination and Value-Based Care. The OIG is considering new safe harbors to the anti-kickback statute and/or new exceptions to the definition of “remuneration” under the civil monetary penalties statute (“CMP”) (or modifications to existing safe harbors and exceptions) for certain financial arrangements that promote care coordination and value-based care.
- Beneficiary Incentives. The OIG is also considering new regulations on incentives providers may offer to beneficiaries that would “contribute to or improve quality of care, care coordination, and patient engagement, including adherence to care plans.” Additionally, the OIG is requesting input on using in-kind items and services, nonmonetary remuneration, gift cards or cash equivalents as incentives in this context, and whether the current “nominal value” amounts of $15 per item/$75 annually should be increased.
- Cost Sharing Obligations. The OIG would like input on how reducing or eliminating beneficiary cost-sharing obligations could “improve care delivery, enhance value-based arrangements, and promote quality of care.” The OIG notes it also intends to review relevant comments on the Stark Law submitted in response to a separate RFI issued by the Centers for Medicare & Medicaid Services (“CMS”) on June 25, 2018. CMS has also requested comments by September 10, 2018 on other proposed regulations to implement the recent Stark Law liberalizations of the writing and signature requirements for certain physician arrangements. These RFIs and other requests for public comment on related laws seem to be part of a larger trend by the Trump administration to increase flexibility and minimize unnecessary barriers within the fraud-and-abuse regime.
The OIG is accepting comments on the August 27, 2018 RFI through October 26, 2018.
The OIG has also requested input on (i) how current fraud and abuse waivers could be improved; (ii) donations of cybersecurity-related items and services by entities to providers with which entities are sharing information; (iii) the new anti-kickback safe harbor, yet to be implemented, regarding incentive payments by an ACO to a Medicare fee-for-service beneficiary; and (iv) the new “telehealth technologies” CMP exception relating to individuals with end-stage renal disease.