State of Play: The transition to value-based care has been widely recognized and supported by Congress and the administration. Integral to widespread adoption of value-based care by providers and other stakeholders is the revision of the Physician Self-Referral (Stark) Law and the federal Anti-Kickback Statute. The Centers for Medicare and Medicaid Services (CMS) received over 300 comments after it asked providers how it should amend the Stark Law, which has been criticized for thwarting alternative payment models and other care arrangements. The Department of Health and Human Services (HHS) Office of Inspector General (OIG) also issued a request for information on how it can modify or add new safe harbors to the Anti-Kickback Statute to prevent providers in value-based pay models from facing civil money penalties. Some changes will require congressional action; however, it is uncertain if this issue will be a priority for the incoming Democratic majority in the House of Representatives for the 116th Congress.
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. HLC also supports modernization of Stark physician self-referral and Anti-Kickback laws to ensure that crosssectoral collaboration can occur to advance value-based healthcare. HLC supports innovative liability reform that provides safe harbors for medical professionals utilizing evidence-based medical practices.
HLC Recent Activity:
- On December 18, HLC hosted health policy staff from Senator Bill Cassidy’s (R-LA) and Senator Mark Warner’s (D-VA) office and the Stark/Anti-Kickback Statute Workgroup to discuss legislative work to promote value-based arrangements in healthcare.
- On December 11, HLC met with HHS Deputy Secretary Eric Hargan to discuss the administration’s “Regulatory Sprint to Coordinated Care” and modernization of the Stark Law and Anti-Kickback Statute.
- HLC continues to lead a coalition of multiple stakeholders working to modernize the current legislative and regulatory landscape surrounding the Stark Law and Anti-Kickback Statute.
- On October 25, HLC submitted comments to the OIG’s request for information regarding the Anti-Kickback Statute. HLC’s comments support modernization, but not elimination of the Anti-Kickback Statute to allow for more rapid adoption of value-based care arrangements.
- On October 3, HLC wrote in support of the Senate Special Committee on Aging’s hearing on “Patient Focused Care: A Prescription to Reduce Health Care Costs.” The letter supported modernizing the Stark Law and Anti-Kickback Statue to reflect the trend toward value-based care.
- On August 24, HLC submitted comments to Centers for Medicare and Medicaid (CMS’) request for information regarding the physician self-referral (Stark) law. HLC’s comments support modernization, but not elimination, of the Stark law to allow for more rapid adoption of value-based care arrangements.
- On August 3, HLC wrote to Representatives Mike Kelly (R-PA), Ron Kind (D-WI), Markwayne Mullin (R-OK) and Ami Bera (D-CA), expressing support for the congressional Health Care Innovation Caucus, dedicated to pursuing innovation in healthcare. HLC’s letter focused on modernizing the healthcare fraud and abuse legal framework, addressing Medicaid best price as a barrier to innovation, supporting more value-based models from the Center for Medicare and Medicaid Services’ (CMS) Center for Medicare and Medicaid Innovation (CMMI), and harnessing technology to enable innovating toward value-based care.
- On August 1, HLC delivered a multistakeholder letter to all members of Congress, urging the House and Senate to take action to address barriers that the Stark law and Anti-Kickback statute pose to enabling broader adoption of value-based arrangements.
- On July 31, HLC wrote the Senate Health, Education, Labor, and Pensions (HELP) Committee in support of its hearing on “Reducing Healthcare Costs: Decreasing Administrative Spending.” The letter supported modernizing the Stark law and Anti-Kickback statute and increasing transparency of healthcare price and quality information.
- On July 19, HLC hosted Robert Dubois, M.D., Ph.D., of the National Pharmaceutical Council, who discussed NPC’s focus on the role and value of innovative pharmaceuticals in improving patient health. Dubois highlighted “Going Below the Surface,” an initiative aimed at optimizing healthcare spending to deliver more value.
- On July 17, HLC sponsored a briefing on legislation that would provide medical liability safe harbors for healthcare providers who utilize established clinical guidelines in treating patient, the “Saving Lives, Savings Costs Act” (H.R. 1565).
- On July 17, HLC wrote Ways and Means Health Subcommittee Chairman Peter Roskam (R-IL) and Ranking Member Sander Levin (D-MI) requesting inclusion of HLC’s policy recommendations for the hearing, “Modernizing Stark Law to Ensure the Successful Transition from Volume to Value in the Medicare Program,” and included HLC’s white paper and supporting materials that describe the issue and potential solutions.
- On July 17, HLC wrote the House Energy and Commerce Committee in support of its examination of efforts to improve cost transparency for consumers.
- On July 16, HLC responded to HHS regarding the administration’s Drug Pricing Blueprint to lower drug prices and reduce out-of-pocket costs. The letter supported the modernization of the Stark law and Anti-Kickback statute to enable value-based arrangements.
- On July 6, HLC wrote HHS Deputy Secretary Eric Hargan on the agency’s request for information to develop a workgroup to facilitate a constructive high level dialogue between HHS leadership and those focused on innovating and investing in the healthcare industry. The letter highlighted the success of the National Dialogue for Healthcare Innovation.
- HLC continues to educate members of Congress and other policymakers about the need for comprehensive Stark law and Anti-Kickback reform, garnering additional congressional supporters. HLC members met with CMS Administrator Seema Verma, Senate Finance Committee Chairman Orrin Hatch (R-UT), and White House Domestic Policy Council Director Andrew Bremberg to discuss Stark law and Anti-Kickback reform and other topics.
- Throughout the summer, HLC convened its Stark and Anti-Kickback Workgroup to discuss the current legislative and regulatory landscape surrounding the Stark law and Anti-Kickback statute’s impact on value-based arrangements.