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Updates in Co-Pay Assistance and Accumulators Litigation

Key Points - A new legal challenge to OIG on Medicare Beneficiaries’ ability to receive co-pay assistance has emerged. The Supreme Court has been asked to review HHS’s prohibition of co-pay assistance programs under the...more

FDA Issues Draft Guidance on Equity, Diversity and Individual Sponsor Financial Ability Considerations in Charging for...

On August 23, 2022, the United States Food and Drug Administration (FDA or the “Agency”) published the revised draft guidance “Charging for Investigational Drugs Under an IND Questions and Answers Guidance for Industry” (the...more

Co-Pay Assistance and Accumulators in the Legal Spotlight: A Changing Landscape

Key Points - Patient outcomes studies suggest a clinical benefit of co-pay programs, and a negative impact of co-pay accumulator programs. Co-pay programs remain unavailable to participants in federal...more

HHS Invites Health Care Industry to Make Climate Pledge

Key Points - U.S. hospitals, health systems, suppliers, pharmaceutical companies and other industry stakeholders are invited to submit voluntary pledges to reduce greenhouse gas emissions and increase their climate...more

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