In 2018, the Department of Health and Human Services (the “Department”) launched what it calls a “Regulatory Sprint to Coordinated Care” to accelerate a transformation of the health care system, with a focus on removing “unnecessary obstacles” to coordinated care (the “Regulatory Sprint”). Numerous federal agencies have requested comments and information from the public and have published proposed regulations as part of the Regulatory Sprint on areas that have historically been viewed as barriers to innovative care coordination arrangements.
For example, the Office of Inspector General (“OIG”) and the Centers for Medicare & Medicaid Services (“CMS”) each issued a sweeping set of proposed regulations that introduce significant new value-based terminology, safe harbors and exceptions to the federal anti-kickback statute (“AKS”) and federal physician self-referral law (“Stark Law”). Additionally, the OIG has called for comments and issued proposed regulations related to modernizing the civil monetary penalty law governing inducements provided to Medicare and Medicaid beneficiaries (the “CMPL”). The Office for Civil Rights (“OCR”) is also involved, and has called 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. Additionally, the Substance Abuse and Mental Health Services Administration (“SAMHSA”) published proposed regulations related to the privacy of substance use disorder treatment records, and CMS published proposals to revise its Stark advisory opinion process. We anticipate many more proposals and changes into the future as part of this initiative.
These changes in federal regulations are anticipated to make a significant impact on health care 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, and may indeed further spur the transition to a value-based health care delivery system.
