On October 9, 2019, the Office of Inspector General (“OIG”) and the Centers for Medicare and Medicaid Services (“CMS”) published proposed rules to revise the Stark Law, Anti-Kickback Statute and Civil Monetary Penalty Statute. These statutes create criminal and civil penalties for certain financial arrangements involving providers. According to OIG and CMS, the goal of the proposed rules is to address barriers created by the rules that interfere with care coordination. The additional safe harbors were necessary to allow for coordination of patient care among providers because of the increased focus on value-based care. Value-based programs reward healthcare providers with incentive payments for quality of care. Examples of these programs include Hospital Value-Based Purchasing, Hospital Readmission Reduction Program and Hospital Acquired Conditions Reduction Program.
The proposed changes in the published rule include three new safe harbors for certain remuneration exchanged between or among participants in a value-based arrangement intended to foster better coordinated patient care. These include:
- Care Coordination Arrangements to Improve Quality Health Outcomes and Efficiency,
- Value-Based Arrangements with Substantial Downside Financial Risk, and
- Value-Based Arrangements with Full Financial Risk.
The proposed rule also offers a new safe harbor for certain tools and support furnished to patients to improve health quality outcomes and efficiency, such as health-related technology or patient health-related monitoring tools. Additionally, a new safe harbor is proposed for remuneration provided in connection with a CMS sponsored innovation model, which is intended to reduce the need for separate and distinct fraud and abuse waivers.
There is a proposed safe harbor for donations of cybersecurity technology and services as well as modifications to the existing safe harbor for electronic health records and services to add protections for certain related cybersecurity technology, to update provisions regarding intra-operability, and to remove the sunset date that previously existed.
The rule proposes a positive change to the Personal Services and Management Contracts safe harbor, by eliminating the requirement that periodic or part-time services be on a specific schedule or interval. Additionally, the safe harbor adds a provision for “outcome-based payments.” Outcome-based payments are those payments that reward the provider for improving patient or population health by achieving one or more outcome measures or that reduce payor costs while improving or maintaining the improved quality of care for patients.
Another existing provision related to warranties is updated to revise the definition of warranty and provide protection for bundled warranties for one or more items of related services. Local transportation is covered by an existing safe harbor, but the proposed change expands and modifies mileage limits for rural areas and for transportation for patients discharged from inpatient facilities.
Lastly, the Accountable Care Organization Incentive Program is added to the exception of the definition of “remuneration.”
The physician self-referral law, known as the Stark Law, has not been significantly updated since its enactment in 1989. The proposed changes seek to reduce the burden on physicians and allow for coordination of care.
Like the new safe harbors under the AKS, the proposed changes to the Stark Law include value-based arrangements. A value-based arrangement is defined as an arrangement for the provision of at least one value-based activity for a target patient population between or among the value-based enterprise (“VBE”) and one or more VBE participants or VBE participants in the same value-based activity.
Another update to the Stark Law includes a proposed change clarifying the existing provision that allows a physician in a group practice to be paid a share of the overall profits of the group that is indirectly related to the volume or value of the physician’s referrals. Additionally, there are changes to how the law treats productivity bonuses for physicians.
According to CMS, the intent of the proposed changes is to alleviate the fear physicians may have in entering into legitimate relationships to coordinate and improve care of patients.
There is only one proposed change for the Civil Monetary Penalty statute, and it adds a new statutory exception to the prohibition on beneficiary inducements for telehealth technologies furnished to certain in-home dialysis patients.
For all the proposed rules, OIG and CMS are seeking public comments, which are due December 31, 2019. For more information on the proposed rules visit https://oig.hhs.gov/compliance/safe-harbor-regulations/index.asp and https://www.cms.gov/newsroom/fact-sheets/modernizing-and-clarifying-physician-self-referral-regulations-proposed-rule.
Article contributed by Angie C. Smith, Esq. with Burr Forman.