Update: Head to our resource page “Responding to COVID-19: Resources for Telehealth and Remote Patient Monitoring”

Also, read our posts “HHS Proposes New Safe Harbors Under Anti-Kickback Statute and The Stark Law,” and “Proposed Anti-Kickback Statute "Care Coordination Arrangements" Safe Harbor: Implications for Remote Patient Monitoring and Care Management Services.”

On October 9, 2019, the Department of Health and Human Services (DHHS), Office of Inspector General (OIG), and the Centers for Medicare and Medicaid Services (CMS) released a pair of proposed rules seeking to add or change certain safe harbors or exceptions to the Anti-Kickback Statute (AKS), Physician Self-Referral Prohibition law (Stark), and the Civil Monetary Penalty (CMP) law. The proposed changes to AKS, Stark, and CMP are intended to facilitate a transition to value-based healthcare by reducing the regulatory burdens currently associated with many value-based arrangements and care coordination efforts. For a general overview of the proposed rules, read our previous blog post here.

The proposed changes to the current healthcare legal and regulatory landscape are described in over 700 pages of text. If even a portion of the revisions are finalized, the implications for various stakeholder groups within the healthcare industry will be significant. Nixon Law Group is breaking down these implications for you through a series of blog posts to help you understand what might be in store for your healthcare company or medical practice – you can view previous articles in this series HERE and HERE. In this article, we focus on OIG’s proposed Patient Engagement and Support safe harbor to AKS and CMP and discuss how this new safe harbor may affect care management services vendors such as Chronic Care Management (CCM), Remote Patient Monitoring (RPM), Transitional Care Management (TCM), and Behavioral Health Integration (BHI) services vendors.

For a brief overview of AKS, CMP and safe harbors generally, please see our previous post about the “Care Coordination Arrangements” safe harbor.

Proposed Patient Engagement and Support Safe Harbor

In establishing this new safe harbor, OIG recognizes the importance of patient engagement in managing and improving patients’ own health outcomes. The proposed Patient Engagement and Support safe harbor is intended to remove or reduce current barriers presented by AKS and the beneficiary inducements portion of CMP that prevent providers and other healthcare entities from offering patients tools and supports that have the potential to improve quality, outcomes, and efficiency in healthcare. Specifically, if finalized, “remuneration” under the AKS would not include in-kind patient engagement tools or supports furnished directly by a Value-Based Enterprise (VBE) participant to a patient in a targeted patient population that are directly connected to the coordination and management of care. Per the proposed rule, these tools and supports might include health-related technology, patient health-related monitoring tools and services, or supports and services designed to identify and address a patient’s social determinants of health.

As an example, several vendors of remote patient monitoring technology and services, recently designated in the final 2020 Medicare Physician Fee Schedule as Care Management Services, have expressed interest in offering incentives to patients that could improve the patients’ care plan adherence by encouraging them to record vital sign readings at recommended intervals.  Such incentives are currently prohibited remuneration under AKS and CMP. The proposed Patient Engagement and Support safe harbor aims to change this by allowing VBE participants – which, under the proposed rule, may include vendors of Care Management Services – to offer in-kind (non-monetary) preventive items, goods, or services, that are directly connected to the coordination and management of care of a target patient population to patients for free or at a reduced cost. In addition, the proposed rule considers whether to allow VBE participants to offset patient cost-sharing requirements (e.g. patient copays) for patient engagement tools and/or services – often cited by vendors of Care Management Services as a barrier to adoption for these programs.

The proposed requirements for compliance with the Patient Engagement and Support safe harbor are as follows:

• Tools/services must be in-kind and must be provided directly to a patient by a VBE participant

• Provision of tools/services must be limited to patients within the targeted patient population

• Limited to in-kind, “preventive” items, goods, or services, or items, goods, or services such as health-related technology, patient health-related monitoring tools and services, or supports and services designed to identify and address a patient’s social determinants of health, that have a direct connection to the coordination and management of care of the target patient population

• The aggregate retail value of patient engagement tools and supports furnished by a VBE participant to a patient cannot exceed $500 on an annual basis, with certain limited exceptions

Although these are the requirements that OIG has set forth in its proposed rule, OIG states that it is open to feedback on these proposals, and specifically asks for comments on the following:

• Whether entities outside of a VBE, including pharmaceutical manufacturers, distributors and suppliers of DMEPOS, and laboratories should be allowed to provide patient engagement tools and support to patients within the VBE

• Whether this safe harbor should only be available to VBE participants who assume some financial risk

• Whether the safe harbor should protect providing certain wearable devices and/or a cell phone to patients who may need them for use of a particular application or program

• Whether cash or cash-equivalent incentives should be available to patients as a reward for engaging in certain health-related activities, and if so, under what conditions

• Whether offsetting cost sharing requirements such as patient copays should be permitted, and if so, under what circumstances

• Whether providing gift cards to certain patients to promote behavioral change should be permitted

• Whether targeted marketing to the targeted patient population for purposes of engaging them in wellness and prevention activities should be permitted

• Whether the proposed monetary limit for tools and services of $500 is appropriate, and should it apply to an individual VBE participant or the VBE as a whole

Key Takeaways

The proposed Patient Engagement and Support safe harbor signals OIG’s recognition of the value associated with encouraging patients to be more engaged in their care. Implementing patient engagement tools and services has very real potential to improve patient outcomes and lower the overall cost of care. OIG is actively seeking feedback from stakeholders regarding the details of this proposal. Now is the time to make your voice heard by submitting formal comments by December 31, 2019.  Please contact us for assistance, and read our previous post about the “Care Coordination Arrangements” safe harbor.

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