As more healthcare providers are moving toward value-based and coordinated care arrangements, and away from fee-for-service, the federal government is also modernizing to accommodate these newer ways of doing business.
In November 2020, the Centers for Medicare & Medicaid Services (“CMS”) and the Department of Health and Human Services Office of Inspector General (“HHS-OIG”) announced two long-awaited final rules to Stark Law and Anti-Kickback Statute (“AKS”) regulations. Each offer greater clarity and flexibility for providers who may have been hesitant to engage in value-based and coordinated care. In addition, there are safe harbors and exceptions that could benefit your healthcare practice.
The HHS-OIG’s final rule is “Revisions to the Safe Harbors Under the Anti-Kickback Statute and Civil Monetary Penalty Rules Regarding Beneficiary Inducements,” while CMS’s is “Modernizing and Clarifying the Physician Self-Referral Regulations.” They are a springboard from the HHS’s 2018 “Regulatory Sprint to Coordinated Care” project, set up as a means of surveying ways to incentivizing coordinated care across the federal and commercial sectors, while also reducing the regulatory burden that would come from it.
In its final rule, CMS proclaims that its revisions will:
“[Unleash] innovation by permitting physicians and other healthcare providers to design and enter into value-based arrangements, without fear that legitimate activities to coordinate and improve the quality of care for patients and lower costs would violate the Stark Law. The exceptions apply regardless of whether the arrangement relates to care furnished to people with Medicare or to other patients.
The HHS-OIG’s final rule has a similar goal:
“[T]o remove potential barriers to more effective coordination and management of patient care and delivery of value-based care.”
To that end, each final rule sets out exceptions and safe harbors for:
There are several new Stark Law value-based definitions at play here:
While the Stark Law Final Rule contains hundreds of pages of commentary and rules, this overview highlights some of the more important ones with which practitioners should be aware:
The AKS final rule has additional new safe harbors as well as modifications to existing safe harbors that allow for greater flexibility:
As with every new rule released by CMS and HHS-OIG, there are voluminous rules, stipulations, and notes. This can make things daunting for healthcare providers who want to incorporate any modifications into their practice. But as value-based business practices become mainstream, it’s important for healthcare practices to understand the exceptions, safe harbors, definitions, and prohibited acts, in order to stay compliant with government health care program payors.
The healthcare compliance lawyers at Chapman Law Group are here to keep you apprised on what the additional flexibility in the Stark Law and the AKS does and does not offer. Because each health care provider is different, we want to be sure you’re following the correct methods in order to prevent healthcare audits and investigations from happening.
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