In 2018, the U.S. Department of Health and Human Services (“HHS”) launched what it calls a “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 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.
In October 2019, the HHS Office of Inspector General (“OIG”) and Centers for Medicare & Medicaid Services (“CMS”) each issued a sweeping set of proposed 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 proposed regulations related to modernizing the civil monetary penalty law governing inducements provided to Medicare and Medicaid beneficiaries (the “CMPL”). The OIG and CMS each released their final rules on November 20, 2020, which were published in the Federal Register on December 2. We are reviewing the final rules and will provide an in-depth analysis in the coming weeks. In addition, 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 Request for Information (“RFI”) in February 2019 calling for information from the public regarding ways that the Health Insurance Portability and Accountability Act (“HIPAA”) regulations could be modernized to support coordinated, value-based care. OCR will likely issue proposed rules to revise HIPAA regulations in response to comments received from the RFI at some point. 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.