HHS Office of Inspector General Requests Input on Reducing Anti-Kickback and Civil Monetary Penalty Burdens

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The Department of Health & Human Services (HHS) Office of Inspector General (OIG) has issued a new request for information (RFI) relating to reducing impediments to care coordination under the Anti-Kickback Statute (AKS) and the beneficiary inducements section of the Civil Monetary Penalties law (CMP).

In particular, the RFI solicits input on the following:

  • Promoting Care Coordination: Arrangements industry is interested in pursuing that may implicate AKS or CMP and how “value” could be defined or used in a safe harbor;
  • Beneficiary Engagement: Types of incentives providers, suppliers and others are interested in providing to beneficiaries. Additionally, the OIG requests input on the risks/benefits from cash equivalents, gift cards, in-kind items and services, whether non-monetary compensation amounts should be increased and whether cost-sharing should be reduced or eliminated;
  • Fraud & Abuse Waivers: Feedback on current waivers in CMS Innovation Center and Medicare Shared Savings Programs (MSSP) and how those could be improved;
  • Cybersecurity: Donations or subsidies of cybersecurity related items and services and related fraud and abuse concerns;
  • Accountable Care Organizations: Additional conditions on the exception for Accountable Care Organizations (ACOs);
  • Telehealth: Whether “telehealth technologies” excepted from the definition of remuneration under the CMP should include services and which services should be included; and
  • Stark and AKS Alignment: How to better align the Physician Self-Referral Law and the Anti-Kickback Statute to further value-based care.

HHS is also specifically interested in any special considerations for rural providers and others serving underserved populations, including American Indian and Alaska Native communities.

The RFI is part of the HHS’s “Regulatory Sprint to Coordinated Care,” a recent effort to remove unnecessary government obstacles to care coordination. Care coordination is a key component in HHS’s transformation from fee-for-service payments to value-based payments. According to the RFI, the OIG identified the broad reach of the AKS and the CMP as a potential impediment to beneficial arrangements that would advance coordinated care. The OIG therefore seeks input on safe harbors to the AKS and the exceptions to the CMP as they relate to the goals of the Regulatory Sprint.

The agency’s focus on reduced regulatory burdens stems from President Donald Trump’s Executive Order 13771, which seeks to “manage the costs associated with the governmental imposition of private expenditures required to comply with Federal regulations.” Following the release of this order, HHS and its divisions began meeting with stakeholders to discuss physician burden and regulatory relief.

The RFI is another in a series of HHS initiatives aimed at reducing regulatory burdens:

  • The Patients over Paperwork Initiative, whereby CMS officials have been visiting physician practices across the country to gather information on the administrative duties required of health care professionals.
  • Reduction of undue impact and burden associated with the Physician Self-Referral Law (also known as the “Stark Law”) (issued July of 2018).
  • Reduction of Affordable Care Act Burdens. In June of 2017, CMS published an RFI aimed at reducing the regulatory burdens imposed by the Patient Protection and Affordable Care Act and improving healthcare choices to empower patients.
    Comments on the RFI must be received no later than 5 p.m. on October 26, 2018. In commenting, refer to file code OIG–0803–N. The RFI appeared in the August 27, 2018 Federal Register (found here). The HHS/OIG press release may be found here.

 

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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