On October 9, 2019, the Office of Inspector General (OIG), Department of Health and Human Services released a proposed rule updating safe harbor protections under anti-kickback statute. This proposed rule follows the OIG’s previous request for information from August 2018, and coordinates provisions with the Centers for Medicare & Medicaid Services’ (CMS) proposed rule on physician self-referral law. Comments are due on December 31, 2019.

New safe harbors proposed for Value-Based Enterprises (VBEs)

In an effort to improve coordinated and efficient quality patient care and increased health outcomes, the OIG has proposed a new value-based framework to address coordination of care for beneficiaries without implicating anti-kickback statute (AKS). As such, the OIG proposes the establishment of a Value-based enterprise (VBE) to promote innovative agreements for care coordination, improved quality and health outcomes, increased health system efficiencies, and overall lowered costs.

The OIG feels this value-based framework will enable broader adoption of alternative payment models (APMs) and adoption of value-based care.  Specifically, the OIG proposes three value-based arrangements within a VBE that would qualify for exemption from AKS:

• Care coordination to improve quality, health outcomes, and efficiency, including in-kind remuneration, services, and infrastructure;
• Value-based arrangements with substantial downside financial risk; and
• Value-Based arrangements with full financial risk.

The OIG specifically seeks comment on the creation of VBEs, but also on whether these new AKS exemptions as proposed adequately and efficiently enable the delivery of value-based care within a clinically integrated network.

Pharmaceutical Manufacturers and DME Excluded for Participation in VBE

This proposed rule expressly prohibits the following from participating within a VBE:

• Pharmaceutical manufacturers;
• Manufacturers, distributors, or suppliers of durable medical equipment, prosthetics, orthotics or supplies (DMEPOS); and
• Laboratories.

However, the OIG is considering whether new safe harbors under VBEs should only apply to independent or free-standing DMEPOS suppliers and laboratories.  The OIG is considering comments on how best to treat comprehensive health systems under these models of care coordination.

Several new safe harbors proposed aimed at fostering value-based care

In an attempt to remove potential barriers to care coordination, the OIG proposes the addition of three new safe harbors:

• Participation under CMS-sponsored Models: The OIG proposes a new safe harbor for those participating in a CMS-sponsored model, such as those models under operation by the Centers for Medicare & Medicaid Innovation Center (CMMI). This proposal will reduce the need for separate and distinct fraud and abuse waivers. Codification in statute for AKS exception for ACO Beneficiary Incentive Programs under Medicare Shared Savings Program (MSSP) is also proposed.
• Patient Engagement: The OIG proposes to allow for use of certain tools to enable greater patient engagement in their own care. The regulation cites an example of a tool as one that supports a patient’s safety at discharge, however, the OIG does not provide a specific list of tools or supports allowable.
• Donations of Cybersecurity Technology and Services: The OIG proposes a new safe harbor to allow for donations of cybersecurity technology to providers of facilities; under current statute, these donations are prohibited.

OIG proposes amendment of existing Safe Harbors

The OIG also proposes to amend several other safe harbors, also with the intention of increasing coordinated care and enabling flexibility. The OIG proposes to update the following safe harbors to allow for increased flexibility: local transportation, electronic health records (EHRs), telehealth for in-home dialysis patients, warranties, and personal services and management contracts.