The Department of Health and Human Services (HHS) and The Centers for Medicare and Medicaid Services (CMS) published two final rules last week, targeting the reduction of regulatory barriers to care coordination and increased flexibility for provider participation in value-based arrangements. The final rules also aim to ease compliance requirements that have, in the past, made it difficult for providers to participate in value based care models, while maintaining a focus on prevention of fraud and abuse.

      • Stark Final Rule : details exceptions to the Stark Law for value based care arrangements and provides key guidance in response to stakeholder comments
      • AKS Final Rule: creates new safe harbors and modifies several existing safe harbors

The final rules aim to facilitate a transition to outcome-based care in Federal healthcare programs, but also apply to the commercial sector. The CMS final rule “modifies existing policies to ease unnecessary regulatory burden on physicians and other healthcare providers while reinforcing the “Stark Law” goal of reducing referrals for more expensive or unnecessary services resulting from the financial interest of the referring physician. In the November 20th HHS press release, HHS Secretary Alex Azar remarked, “Today, we’ve completed historic reforms to regulations that have stood in the way of creativity and innovation by American healthcare providers for far too long. These new regulatory reforms will mean better care, including innovative arrangements with digital technology that may help patients receive care during the COVID-19 pandemic.”

The regulatory changes focus on three areas of rule relaxation:

  1. Encouragement of greater engagement between hospitals, physicians and patients with the goal of managing care and chronic illness
      • HHS example:  a hospital may wish to provide support and to reward institutional post-acute providers for achieving outcome measures that effectively and efficiently coordinate care across care settings and reduce hospital readmissions.  Such measures would be aligned with a patient’s successful recovery and return to living in the community. 
  1. Advancing the use of technology in care coordination
      • HHS example: medical device manufacturers and DME companies may participate in protected care coordination digital health technology arrangements with less “downside” financial risk parties must assume to qualify for safe harbors. In addition, expanded safe harbors for cybersecurity related services, hardware and technology are included.
      • HHS example: A primary care physician or other provider may wish to furnish a smart tablet that is capable of two-way, real-time interactive communication between the patient and his or her physician.  The patient’s access to a smart tablet could facilitate communication through telehealth and the provision of in-home services.
      • HHS example: A health system furnishes cybersecurity technology to physician practices to reduce harm from cyber threats to all their systems
  1. Greater communication across providers for care coordination and cost containment
      • HHS example: To improve patient transitions from one care delivery point to the next, a hospital may wish to provide physician offices with care coordinators that furnish individually tailored case management services for patients requiring post-acute care.

The final rules facilitate a broad range of potential arrangements to meet these objectives. CMS promises to monitor value-based care arrangements and encourages provider organizations to focus compliance activities on understanding and training stakeholders on the new rules, perform data analytics on critical measurement criteria, manage cybersecurity threats and involve compliance in the process of reviewing arrangements under the new regulations.

Read OIG’s final rule and fact sheet – PDF.

Read CMS’s final rule and fact sheet.



Blog by Amie Martin, OTR/L, CHC, RAC-CT, Proactive Medical Review

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