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The Department of Health and Human Services (HHS) published two final rules that aim to reduce regulatory barriers to care coordination and accelerate the transformation of the healthcare system into one that pays for value and promotes the delivery of coordinated care.
The rules provide greater flexibility for healthcare providers to participate in value-based arrangements and to provide coordinated care for patients. The final rules also ease unnecessary compliance burden for healthcare providers and other stakeholders across the industry, while maintaining strong safeguards to protect patients and programs from fraud and abuse.
The HHS Office of Inspector General (OIG) issued the final rule “Revisions to the Safe Harbors Under the Anti-Kickback Statute and Civil Monetary Penalty Rules Regarding Beneficiary Inducements,” and the Centers for Medicare and Medicaid Services (CMS) issued the final rule “Modernizing and Clarifying the Physician Self-Referral Regulations.” These rules are part of HHS’s Regulatory Sprint to Coordinated Care, which has examined federal regulations that potentially impede healthcare providers’ efforts that otherwise would advance the transition to value-based care and improve the coordination of patient care across care settings in Federal healthcare programs and the commercial sector. In addition to advancing value-based care, the CMS final rule clarifies and modifies existing policies to ease unnecessary regulatory burden on physicians and other healthcare providers while reinforcing the physician self-referral law’s (often called the “Stark Law”) goal of protecting patients from unnecessary services and being steered to less convenient, lower quality, or more expensive services because of a physician’s financial self-interest.
The new and amended regulations related to the federal Anti-Kickback statute and the civil monetary penalties law issued by OIG address stakeholder concerns that these laws unnecessarily limit the ways in which healthcare providers can coordinate care with and for federal healthcare program beneficiaries. OIG’s final rule modifies and clarifies the agency’s proposed rule in response to comments, as explained in the preamble to the final rule.
For example, OIG’s final rule clarifies how medical device manufacturers and durable medical equipment companies may participate in protected care coordination arrangements that involve digital health technology, and the final rule lowers the level of “downside” financial risk parties must assume to qualify under the new safe harbor for value-based arrangements that involve substantial downside financial risk. In recognition of the urgent problem of cyber threats to the healthcare industry, the rule also broadens the new safe harbor for cybersecurity technology and services to protect cybersecurity-related hardware.
OIG’s final rule, and the CMS final rule to the extent the Stark Law is applicable, would facilitate a range of arrangements to improve the coordination and management of patient care and the engagement of patients in their treatment if all applicable regulatory conditions are met, including the following examples:
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