Value-Based Care and Patient Safety

State of Play:   On June 5, the White House Office of Management and Budget began reviewing highly anticipated changes to the Physician Self-Referral (Stark) Law and Anti-Kickback Statute.  A proposed rule from the Centers for Medicare and Medicaid Services (CMS) is expected to come out in July, as are proposed changes from the Department of Health and Human Services’ (HHS) Office of the Inspector General (OIG) to the Anti-Kickback Statute.  Last year CMS and the OIG collected industry feedback on barriers to care coordination these laws impose.  Earlier this year, HHS Deputy Secretary Eric Hargan said he anticipated implementing Stark Law and Anti-Kickback Statute reforms by the end of this year as part of HHS’s Regulatory Sprint to Coordinated Care.  On June 26, the House Committee on Ways and Means (W&M) approved H.R. 3439, the “Protecting Patient Access to Information for Effective and Necessary Treatment Act,” which would extend funding for the Patient-Centered Outcomes Research Trust Fund (PCORI) through fiscal 2026. 

HLC Position: HLC’s proactive approach to the ongoing and intensifying debate over value-based care advocates 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, which requires modernization of the Stark Law and the Anti-Kickback Statute to ensure that crosssectoral collaboration can occur to advance value-based healthcare.  HLC continues to support “red tape” reform to help streamline, improve, and modernize healthcare regulations. 

HLC Recent Activity:

  • HLC continues to meet with key members of Congress and the administration advocating for modernization of the Stark Law and Anti-Kickback Statute to promote value-based arrangements in healthcare.
  • Building upon HLC’s opioid efforts, HLC continues sharing NDHI’s A Roadmap for Action, providing consensus opioid solutions, with policymakers where and when appropriate.  Additionally, HLC continues to collaborate with multiple organizations and participates in initiatives such as the National Academy of Medicine, the Voices for Non-Opioid Choices (Voices), and Allied Against Opioid Abuse (AAOA) to pursue private sector initiatives to curb misuse and prevent addiction.
  • In July, HLC President Mary Grealy was interviewed by AAOA on how different sectors of the healthcare system are collaborating to prevent the misuse and abuse of prescription opioids. That interview was turned into a blog post and shared via multiple social media channels.
  • HLC participates in the National Academy of Medicine’s Action Collaborative on Countering the U.S. Opioid Epidemic pain management guidelines and evidence standards workgroup.
  • On June 26, HLC wrote the House W&M Committee in support of legislation reauthorizing PCORI.
  • On June 24, HLC wrote the House Oversight and Reform Committee in support of H.R. 2569, the “Comprehensive Addiction Resources Emergency (CARE) Act,” which would increase access to evidence-based treatment and wraparound services to address the opioid crisis.
  • On June 18, HLC hosted a workgroup with HLC’s membership and other stakeholders to discuss on congressional and regulatory activities related to modernizing the Stark and Anti-Kickback Laws to better enable value-based care.
  • On June 14, HLC hosted a Capitol Hill briefing to discuss developments in value-based care and the reforms needed to realize its potential. HLC members Fairview Health Services and Johnson & Johnson were featured at the briefing.
  • On June 4, HLC wrote the House Committee on Energy and Commerce (E&C) in support of legislation reauthorizing PCORI and extending funding for the National Quality Forum (NQF).
  • On May 8, HLC submitted a statement for the Senate Finance Committee hearing, “Medicare Physician Payment Reform After Two Years, Focusing on Medicare Access and CHIP Reauthorization Act Implementation and the Road Ahead.” HLC supported changes to modernize the federal fraud and abuse legal framework to facilitate stronger provider performance.
  • On May 3, HLC signed on to letters to the Senate Finance, House Energy and Commerce, and House Ways and Means Committees in support of reauthorization of the Patient Center Outcomes Research Institute (PCORI).
  • HLC continues to coordinate with policy staff from the Third Way to ensure a bipartisan approach to congressional legislation modernizing the Stark Law and Anti-Kickback Statute.
  • HLC participated on the steering committee of the Friends of the National Quality Forum (NQF). The steering committee works to ensure adequate funding for NQF.
  • HLC continues to meet with key members of Congress and the administration to modernize the Stark Law and Anti-Kickback Statute to promote value-based arrangements in healthcare.
  • HLC commented on draft legislation by Senator Bill Cassidy (R/LA) and Senator Mark Warner (D/VA) to promote value-based arrangements in healthcare.
  • On March 13, HLC wrote in support of the House Energy and Commerce Committee hearing on “Lowering the Cost of Prescription Drugs: Reducing Barriers to Market Competition.” The letter supported modernizing the Stark Law and Anti-Kickback Statute to reflect the trend toward value-based care.
  • On March 7, HLC wrote in support of the Senate Special Committee on Aging hearing on “The Complex Web of Prescription Drug Prices.”  The letter supported modernizing the Stark Law and Anti-Kickback Statute to reflect the trend toward value-based care.
  • On March 1, HLC responded to a letter from Senator Lamar Alexander (R/TN) seeking solutions to address America’s rising healthcare cost. The letter supported modernizing the Stark Law and Anti-Kickback Statute to reflect the trend toward value-based care.
  • On February 21, HLC President Mary R. Grealy briefed the House Healthcare Innovation Caucus on the Stark Law and Anti-Kickback Statute and their relationship to value-based care.
  • On February 12, HLC wrote in support of the Ways and Means Committee hearing on “The Cost of Rising Prescription Drug Prices.” The letter supported modernizing the Stark Law and Anti-Kickback Statute to reflect the trend toward value-based care.