On April 27, 2023, Washington Governor Jay Inslee signed the My Health My Data Act (the “Act”) into law, establishing new limits on the collection, use and sharing of “consumer health data” and creating numerous compliance...more
2022 marked a historic year for climate change action in the Executive Branch. The Biden-Harris administration continued to deploy a “whole-of-government” approach to combating climate change, securing over $300 billion in...more
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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
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Patient advocacy groups have filed suit challenging the legality of the 2020 HHS Final Rule permitting co-pay accumulator adjustment programs.
The Second Circuit has upheld HHS’ prohibition of co-pay...more
On August 23, 2022, the United States Food and Drug Administration (FDA or the “Agency”) published the revised draft guidance “Charging for Investigational Drugs Under an IND Questions and Answers Guidance for Industry” (the...more
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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
On May 17 the Senate Health, Education, Labor and Pensions (HELP) Committee released a bipartisan legislative discussion draft of the Food and Drug Administration (FDA) Safety and Landmark Advancements Act (FDASLA), which...more
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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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The OASH under HHS is soliciting input from the public on its 2022 Environmental Justice Strategy and Implementation Plan Draft Outline. Comments are due to HHS by May 19, 2022.
The 2022 HHS Environmental...more
With 2022 underway, the Biden-Harris administration is continuing to implement its “whole-of-government” response to climate change. In 2021, the administration focused on building public-private partnerships on clean energy,...more
2/8/2022
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