The “Regulatory Sprint to Coordinated Care” – Overview and Links to Further Resources from Dorsey & Whitney
In 2018, the U.S. Department of Health and Human Services (“HHS”) launched the “Regulatory Sprint to Coordinated Care” to accelerate a transformation of the healthcare system, with a focus on removing “unnecessary obstacles” to coordinated care (the “Regulatory Sprint”). Several HHS agencies requested comments and information from the public and have published new or proposed regulations as part of the Regulatory Sprint on areas that have historically been viewed as barriers to innovative care coordination arrangements—namely, healthcare fraud and abuse and health information privacy.
On November 20, 2020, the HHS Office of Inspector General (“OIG”) and Centers for Medicare & Medicaid Services (“CMS”) each issued a sweeping set of final regulations that introduced significant new value-based terminology, safe harbors and exceptions, as well as clarifications of existing requirements, under the federal anti-kickback statute (“AKS”) and federal physician self-referral law (“Stark Law”), respectively. Additionally, the OIG issued final regulations related to modernizing the civil monetary penalty law governing inducements provided to Medicare and Medicaid beneficiaries (the “CMPL”). The final OIG and CMS rules are effective on January 19, 2021, with the exception of changes to the Stark “group practice” definition, which do not go into effect until January 1, 2022.
There are hundreds of pages of preamble guidance and revised regulation text setting forth these sweeping changes to the Stark Law, AKS and CMPL regulations from CMS and OIG. To help you digest these materials, a team of attorneys from Dorsey & Whitney’s Healthcare Transactions and Regulations Practice Group has published two white papers, which are available at the links below. In addition, we have posted at a link below the playback of a webinar we hosted about the final rules on January 6, 2021. The white papers and webinar playback provide an in-depth summary of the changes to these regulations, including key provisions from CMS and OIG preamble guidance. Finally, we have posted below redlines comparing the existing Stark Law, AKS and CMPL regulations to the revised version of each of these regulations in the final rules.
With respect to health information privacy, the HHS Office for Civil Rights (“OCR”) issued a Notice of Proposed Rulemaking (“NPRM”) on December 10, 2020 which proposes changes to the Health Insurance Portability and Accountability Act (“HIPAA”) and to the Health Information Technology for Economic and Clinical Health Act (“HITECH”) Privacy Rule. Additionally, the HHS Substance Abuse and Mental Health Services Administration (“SAMHSA”) published final rules to revise regulations related to the privacy of substance use disorder treatment records in July 2020.
These changes in federal regulations are anticipated to make a significant impact on healthcare providers and other stakeholders that may have been reticent to initiate certain care coordination arrangements because of perceived regulatory barriers and lack of regulatory clarity. In addition, clarifications to existing regulations impact stakeholders beyond their involvement in care coordination arrangements.
The team of attorneys in Dorsey & Whitney’s Healthcare Transactions and Regulations Practice Group will continue to closely monitor these changes, and post updates and analysis below as new information becomes available.
A Massive Number of New Health Law Regulatory Proposals as Part of the “Regulatory Sprint to Coordinated Care”: Proposed Changes to the Stark Law, Anti-Kickback Statute, Beneficiary Inducement CMP, Privacy Laws Governing Substance Use Disorder Records, and the Stark Law Advisory Opinion Process