Value-Based Care and Patient Safety

State of Play:  The Centers for Medicare and Medicaid Services (CMS) has waived quality reporting requirements in the wake of the national emergency concerning the novel coronavirus disease (COVID-19).  The White House Office of Management and Budget (OMB) is reviewing a proposed rule on Medicaid value-based drug payment to help states creating such arrangements to control costs.  Several legal and practical barriers complicate value-based arrangements, including the Physician Self-Referral (Stark) Law, the Anti-Kickback Statute, and Medicaid best price.  CMS reports there are 517 accountable care organizations (ACOs) in the Medicare Shared Savings Program this year, about the same number as last year.  The Center for Medicare and Medicaid Innovation (CMMI) has released data on the Comprehensive End-Stage Renal Disease Care (CEC) Model.  The CMMI report indicates beneficiaries with end- stage renal disease (ESRD) reduced spending while improving quality outcomes during the first two years of the model.  A bipartisan, bicameral group of lawmakers has formed the Personalized Medicine Caucus to raise awareness about precision medicine. 

HLC Position:  HLC takes a proactive approach to encourage adoption of value-based care, advocating 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 Physician Self-Referral (Stark) Law and the Anti-Kickback Statute to ensure that crosssectoral 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:

  • HLC continues to build support among members of Congress and other policymakers regarding the need for comprehensive Stark and Anti-Kickback modernization, garnering additional congressional supporters.
  • On February 18, HLC submitted a statement for the House Ways and Means Subcommittee on Health hearing, “More Cures for More Patients: Overcoming Pharmaceutical Barriers.” HLC supported changes to modernize the federal fraud and abuse legal framework to encourage innovation, competition, and a collaborative environment for payers, providers, manufacturers, and patients.
  • In December, HLC commented on the Office of Inspector General and CMS proposed rules on modernizing the Anti-Kickback Statute and Stark Law proposed rules, noting provisions that would most support value-based care and identifying outstanding issues not addressed in the proposed rules.
  • On December 13, HLC hosted a Capitol Hill briefing in collaboration with the Problem Solvers Caucus to discuss ways to appropriately remove barriers to value-based care. HLC members Medtronic and Premier healthcare alliance were featured at the briefing.
  • In December, HLC responded to the OIG and CMS proposed rules on modernizing the Anti-Kickback Statute and Stark Law, respectively. HLC identified the provisions that most support value-based care and identified outstanding issues not addressed in the proposed rules, such as the importance of including manufacturers in those arrangements.
  • On November 4, HLC signed letters to the Senate Finance, House Energy and Commerce (E&C), and House Ways and Means (W&M) Committees in support of reauthorization of the Patient Centered Outcomes Research Institute (PCORI).
  • On October 28, HLC hosted collaborative stakeholders and staff from CMS and OIG, who gave an overview of the Stark Law and AKS proposed rules.
  • On October 10, HLC responded to a CMS request for information (RFI) on Development of a CMS Action Plan to Prevent Opioid Addiction and Enhance Access to Medication-Assisted Treatment (MAT). HLC shared its comprehensive package of proposals – consisting of legislative recommendations, regulatory reforms, and private sector-initiated actions – to address the opioid crisis.
  • On October 9, HLC hosted a call with HHS Deputy Secretary Eric Hargan and HLC member CEOs regarding the announcement of new proposed rules to modernize the Stark Law and AKS.
  • 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.