Centers for Medicare & Medicaid Services’ (CMS’) Proposed Medicare Program Rule; Modernizing and Clarifying the Physician Self-Referral Regulations


The National Health Council appreciates the opportunity to comment on the Centers for Medicare & Medicaid Services’ (CMS’) proposed rule modernizing and clarifying the physician self-referral (Stark Law) regulations.

Founded in 1920, the NHC brings diverse organizations together to forge consensus and drive patient-centered health policy. The NHC provides a united voice for the more than 160 million people with chronic diseases and disabilities and their family caregivers. Made up of more than 140 diverse national health-related organizations and businesses, the NHC’s core membership includes the nation’s leading patient advocacy organizations, which control its governance and policy-making process. Other members include health-related associations and nonprofit organizations including the provider, research and family caregiver communities; and businesses representing biopharmaceutical, device, diagnostic, generic, and payer organizations.

The NHC is committed to ensuring that patients, particularly those with chronic conditions and complex care needs, have access to care consistent with their health care goals, and strongly opposes policies that achieve savings or shift incentives at the expense of patient safety, access, affordability, or quality of care. Given that the proposed revisions to safe harbor protections under the Anti-Kickback Statute (AKS) promulgated through a separate Office of Inspector General (OIG) rulemaking and CMS’ Stark Law proposed rule include significant value-based arrangement proposals, we have attached our OIG comment letter for your reference.

The NHC appreciates the Administration’s efforts to facilitate transformation toward a value-based healthcare delivery and payment system that relies on improved care coordination to improve patient outcomes while maintaining or reducing costs of care. We recognize that the regulatory framework implementing the Stark Law has become burdensome for providers and impedes adoption of the care coordination efficiencies inherent to successful value-based arrangements. We support pragmatic solutions that balance Medicare program integrity concerns with provider burden reduction and enhance access to and quality of care for patients with chronic conditions.

We have focused our comments primarily on the proposed Stark exceptions related to value-based arrangements, and the oversight and patient protections required to mitigate the potential for unintended consequences impacting patient access to care that aligns with their health care goals.

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