Medicare and State Healthcare Programs: Fraud and Abuse; Revisions To Safe Harbors Under the Anti-Kickback Statute, and Civil Monetary Penalty Rules Regarding Beneficiary Inducements


The National Health Council appreciates the opportunity to comment on the proposed rule released by the Office of the Inspector General (OIG) revising safe harbors under the Anti-Kickback Statute (AKS) and civil money penalties (CMPs) for beneficiary inducements.

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 envisions a society in which all people have access to quality health care that respects personal goals and aspirations and is designed around the patient experience to promote their best possible health outcomes. We generally support creation and/or clarification of safe harbors that facilitate care coordination, promote value for patients, and increase availability of lower-cost, high-quality products and services. We are 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 oppose policies that achieve savings or shift incentives at the expense of patient safety, access, affordability, or quality of care. A set of clear and meaningful patient safeguards and guarantee of proper oversight must, therefore, be an integral component of any newly-created safe harbors to the AKS.

We understand that OIG has left the issue of safe harbor protections for manufacturer inclusion in value-based arrangements for a future rulemaking. As you undertake that rulemaking process, we urge that you consider the unique circumstances people with chronic conditions face. Arrangements that mitigate the high up-front cost of emerging treatments through outcomes-based pricing and other payment models could facilitate access for patients and reduce overall health care costs. We urge the OIG to engage with the stakeholder community to identify sets of checks and balances that would enable a practical approach to identify and mitigate any risk of fraud and abuse in these arrangements.

Our comments focus on ensuring that the Administration’s final safe harbor revisions will facilitate, rather than impede, the ability of individuals with chronic conditions and their providers to design, implement, and continue treatment plans that align with the patient’s health care goals.

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