Value-Based Care and Patient Safety

State of Play:  The White House Office of Management and Budget (OMB) is reviewing a final rule to modernize the Physician Self-Referral (Stark) Law and the Anti-Kickback Statute. The Centers for Medicare and Medicaid Services (CMS) has created the “Office of Burden Reduction and Health Informatics,” which will focus on reducing the administrative burden imposed on healthcare providers by the programs CMS oversees. The Centers for Disease Control and Prevention (CDC) updated its testing guidelines so that only individuals showing signs of COVID-19 should get tested. The Food and Drug Administration (FDA) continues to assess potential COVID-19 treatments to ensure they are safe for patients.  

HLC Position:  HLC takes a proactive approach to encourage adoption of value-based care, advocating for regulatory reform as essential to removing barriers and spurring accelerated healthcare innovation. HLC supports value-based delivery and payment arrangements to encourage innovation that improves the patient experience. This requires continued modernization of the Stark Law and the Anti-Kickback Statute to ensure that cross-sectoral collaboration can occur to advance better care coordination.  While HLC was pleased the Department of Health and Human Services (HHS) released proposed regulations to modernize these laws, more is still needed from Congress to bring about change that cannot be achieved through regulation. HLC continues to support “red tape” reform to help streamline, improve, and modernize healthcare regulations. 

HLC Recent Activity:

  • On August 5, HLC spearheaded a letter to the Trump administration, signed by 123 organizations, urging OMB to finalize the Stark and Anti-Kickback rules to enable value-based care for patients.
  • HLC organized a meeting with officials from OMB, its Office of Information and Regulatory Affairs (OIRA), and other federal agencies to advocate the importance of finalizing the Stark and Anti-Kickback rules as quickly as possible. HLC members in attendance explained that finalizing these rules will bring patients and caregivers better value medical care.
  • HLC continues to host an “all comers” workgroup on Stark and Anti-Kickback modernization. Close to 70 organizations participate in the activities of this workgroup.
  • In May, HLC’s policy committee hosted the chief executive officer of the Society to Improve Diagnosis in Medicine (SIDM). HLC members were apprised of the state of diagnostic error in the United States and efforts to improve diagnosis for COVID from test results, as well as broadly across all health conditions.
  • On April 1, HLC wrote CMS to express support for appropriate Medicare reimbursement for life-saving Chimeric Antigen Receptor (CAR) T-cell therapies to ensure patient access to this critical cancer therapy.