With a bold finish, the Department of Health and Human Services (HHS) crossed the finish line of its race to modernize and clarify the regulations interpreting the federal physician self-referral law (Stark) and anti-kickback statute (AKS) through final rules released Nov. 20, 2020. With one exception, the Stark and AKS rules, based on October 2019 proposals, are effective on Jan. 19, 2021 – the day before the presidential inauguration. A separate AKS rule released the same day revises the discount safe harbor and creates new safe harbors focused on pharmaceutical distribution models. This rule follows a February 9, 2019 proposed rule and a July 24, 2020 Executive Order directing that HHS complete the rulemaking.
Through its Regulatory Sprint to Coordinated Care, HHS has acted to support innovative arrangements to improve quality outcomes, produce health system efficiencies, lower costs and promote care coordination, with an overarching goal of transforming the healthcare system into one that better pays for value. The Centers for Medicare & Medicaid Services (CMS) and the Office of the Inspector General (OIG) coordinated closely on the rules, which finalize proposed protections for value-based arrangements, with some modifications, and also clarify and revise existing Stark and AKS requirements that are viewed as barriers to coordinated and value-based care or that simply cause undue confusion and burden. The OIG additionally acknowledged that these “[f]lexibilities to engage in new business, care delivery and digital health technology arrangements with lowered compliance risk may assist industry stakeholders in their response to and recovery from the current public health emergency resulting from the [COVID-19] pandemic.” Continue Reading