Value-Based Care and Patient Safety

State of Play: The Centers for Medicare and Medicaid Services (CMS) and the Office of the Inspector General (OIG) issued final rules to modernize the Physician Self-Referral (Stark) Law and Anti-Kickback Statute (AKS). On his first day as president, Joe Biden issued an order to halt or delay any Trump administration “midnight regulations” that have not taken effect by January 20. The Agency for Healthcare Research and Quality (AHRQ) released a report on effective strategies for reducing medical errors and increasing patient safety.  CMS Administrator Seema Verma said CMS was considering waivers to provide more regulatory flexibility to encourage greater participation in Medicare alternative payment models (APMs). Verma had announced in the fall that accountable care organizations (ACOs) generated $1.19 billion in total net savings for Medicare in 2019. CMS finalized two APMs through the Center for Medicare and Medicaid Innovation (CMMI) to encourage more value-based payment arrangements. The Medicare Payment Advisory Commission (MedPAC) discussed advanced APMs and possible improvements. The Department of Health and Human Services (HHS) issued a memorandum on agency procedures, requiring that all HHS rules must be signed by the secretary. The Food and Drug Administration (FDA) continues to monitor progress in COVID-19 vaccine trials to ensure that final products are safe and effective.

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 January 27, HLC hosted a webinar with George Washington University Professor Jane Thorpe to discuss the Stark Law and Anti-Kickback Statute final rules CMS and OIG issued.
  • On January 8, HLC wrote the Health Care Innovation Caucus regarding further improvements to the Stark Law and Anti-Kickback Statute, specifically asking Congress to include stakeholders such as medical device, pharmaceutical, and clinical laboratories in the rules’ new exceptions and safe harbors.
  • On November 25, HLC issued a press release endorsing bipartisan efforts to expand the number of value-based partnerships between healthcare stakeholders.
  • On November 20, HLC issued a press release applauding the administration for finalizing federal rules that will modernize healthcare fraud and abuse laws and clear barriers to the movement toward value-based care.
  • On November 2, HLC submitted comments on CMS’s proposed rule to grant Medicare coverage to innovative technologies and to codify a definition for “reasonable and necessary.”
  • In September, HLC worked with House and Senate offices to coordinate congressional member letters urging the Office of Management and Budget (OMB) to finalize Stark and Anti-Kickback rules to enable value-based care for patients. Some 72 members of the House and 13 senators signed these letters urging swift completion of the final rule.
  • 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.