On November 20, 2020, the Health and Human Services’ Office of Inspector General (OIG) issued a fact sheet and final rule that removes potential regulatory barriers to care coordination and value-based care created by certain key healthcare laws and associated regulations, including the anti-kickback statute (AKS) and Beneficiary Inducements Civil Monetary Penalty (CMP).1 The changes adopted by this rule are related to the OIG’s proposed rule (October 2019) and they coordinate with a peer-rule issued by the Centers for Medicare & Medicaid Services’ (CMS) on the physician self-referral law.

The final rule implements seven new safe harbors, modifies four existing safe harbors, and codifies one new exception under the Beneficiary Inducements CMP.

Final Rule Provisions

• Value-Based Arrangements – three new safe harbors for certain remuneration exchanged between or among eligible participants in a value-based arrangement that fosters better coordinated care
• Patient Engagement and Support – new safe harbor for certain tools and supports furnished to patients to improve quality, health outcomes, and efficiency
• CMS-Sponsored Models – new safe harbor for certain remuneration provided in connection with a CMS-sponsored model (as defined in the Final Rule), which should reduce the need for separate and distinct fraud and abuse waivers for new CMS-sponsored models
• Cybersecurity Technology and Services (CT&S) – new safe harbor for donations of CT&S
• Electronic Health Records Items and Services – modifies existing safe harbor for electronic health records items and services to add protections for certain related cybersecurity technology, to update provisions regarding interoperability, and to remove the sunset date
• Outcomes-Based Payments & Part-Time Arrangements – modifies existing safe harbor for personal services and management contracts to add flexibility for certain outcomes-based payments & other arrangements
• Warranties – modifies existing safe harbor for warranties to revise the definition of “warranty” and provide protection for bundled warranties for one or more items and related services
• Local Transportation – modifies existing safe harbor for local transportation (§ 1001.952(bb)) to expand and modify mileage limits for rural areas and for transportation for patients discharged from an inpatient facility or released from a hospital after being placed in observation status for at least 24 hours
• Accountable Care Organization (ACO) Beneficiary Incentive Programs – codifies statutory exception to the definition of “remuneration” related to beneficiary incentives through the Medicare Shared Savings Program
• Telehealth for In-Home Dialysis – amends the definition of “remuneration” in the CMP rules at interpreting and incorporating a new statutory exception to the prohibition on beneficiary inducements for “telehealth technologies” furnished to certain in-home dialysis patients