Today, the Department of Health and Human Services (“HHS”), Office of Inspector General (“OIG”) and Centers for Medicare and Medicaid Services (“CMS”) released eagerly anticipated advance pre-publication copies of proposed rules that would make certain changes to the OIG’s federal Anti-Kickback Statute (“AKS”) safe harbor regulations and Civil Monetary Penalties (“CMP”) rules on beneficiary inducements, and the CMS’ regulations governing the exceptions to the Stark Law physician self-referral prohibition. The OIG proposed rules can be viewed here, and the CMS proposed rules can be viewed here. The proposed rules follow HHS’ solicitation of information via two separate notices requesting information on potential modifications to the Stark Law exceptions to promote value-based care and reduce regulatory burdens in June 2018 and potential changes to the AKS safe harbors/CMP rules in August 2018.

Overview of OIG Proposed Rules

The OIG notes in its Fact Sheet that the proposed rules should “promote coordinated patient care and foster improved quality, better health outcomes and improved efficiency. The proposed safe harbors also include multiple proposed safeguards to protect against fraud and abuse,” with the goal of reducing regulatory barriers and speeding up the transformation of healthcare delivery to a value-based system that promotes care coordination. The OIG rules include:

  • Three new safe harbors to protect remuneration exchanged in the context of value-based arrangements that promote better coordinated and managed care;
  • A new safe harbor for the provision of certain tools and supports to patients to improve quality, health outcomes and efficiency;
  • A new safe harbor to protect donations of cybersecurity technology and services (which mirrors a new Stark Law exception, mentioned below);
  • Modifications to the personal service and management contracts safe harbor to add flexibility regarding outcomes-based payments and part-time arrangements
  • Changes to the local transportation safe harbor;
  • A revision to the CMP rules’ definition of “remuneration” to include new exceptions related to beneficiary inducements for telehealth technologies for in-home dialysis patients; and
  • Changes to the EHR donation safe harbor (including removal of the sunset date), the warranties safe harbor, and the ACO Beneficiary Incentive Program safe harbor.

Overview of CMS Proposed Rules

According to the Fact Sheet on the proposed rules issued by CMS, the proposed rules contain a “comprehensive package of proposed reforms to modernize the regulations that interpret the Stark Law while continuing to protect the Medicare program and patients from bad actors. Under this proposed rule, for the first time, the regulations would support the necessary evolution of the American healthcare delivery and payment system.” Specifically:

  • New value-based arrangements exceptions that will allow providers to coordinate and improve the quality of care and lower costs. These exceptions would apply to care delivered to patients, whether or not they are Medicare beneficiaries.  CMs expects that these new exceptions will “unleash innovation.” In connection with the new exceptions, CMS is seeking additional information on whether requiring the cost of care information at the point of a referral for an item or service should be required.
  • CMS provided additional guidance and clarification on specific aspects of compliance with the Stark exceptions, including clarification of the definition of fair market value and determining who can ensure that compensation arrangements meet such standard.
  • CMS proposed a new exception for donation of cybersecurity technology that safeguards the integrity of healthcare systems, and changes to the EHR donation exception, including removing the sunset date.

Note that these proposed rules have not yet been placed on official public display or published in the Federal Register. The dates of publication are not yet known, but comments on the proposed rules and submissions of additional information requested will be due within 75 days after publication in the Federal Register.