Updates by Reed Smith on U.S legislative and regulatory developments affecting the life sciences and health care industry sector.
Articles: 1-10 of 945
New IRS rulemaking impacts FCA settlement payment deductibility
USA - February 25 2021 Effective January 14, 2020, the Internal Revenue Service (“IRS”) implemented a final rule (the “Final Rule”) concerning the tax deductibility of…
FDA and USDA battle over regulating genetically engineered animals
USA - February 23 2021 A substantial shift for genetically engineered (“GE”) food regulation may be on the horizon thanks to a USDA proposed rule with a fast closing…
What happens when the clock strikes midnight: A Primer on “Midnight Regulations”
USA - February 10 2021 With another presidential transition in the history books, you may find it unsurprising to hear that many of us at Reed Smith are continuing to…
President Biden implements policies to expand access to health care and coverage
USA - February 8 2021 On January 28, 2021, the White House issued President Biden’s Executive Order on Strengthening Medicaid and the Affordable Care Act (the “Executive…
Department of Justice files statement of interest addressing the preemptive effect of the PREP Act
USA - January 21 2021 On the last full day of the Trump Administration, the Department of Justice (DOJ) submitted a statement of interest in litigation supporting the…
Zantac Rulings - Bare Bones
USA - January 4 2021 There were four opinions issued in the Zantac MDL on New Years Eve. We would like to tell you all…
Congress passes legislation impacting the Provider Relief Fund
USA - December 22 2020 In the evening of December 21, 2020, both Houses of Congress passed the Consolidated Appropriations Act, 2021, H.R. 133. The sprawling, 5,593-page…
HHS proposes important changes to key aspects of HIPAA Privacy Rule
USA - December 14 2020 The U.S. Department of Health and Human Services (HHS) Office for Civil Rights (OCR), the agency that enforces the Health Insurance Portability and…
Open for business in 2021
USA - December 11 2020 With 2020 coming to a close, businesses are looking ahead to 2021 and evaluating how they can stay open while keeping their employees and patrons…
Long-Awaited issuance of Section 340B ADR final rule
USA - December 10 2020 In 2010, the Affordable Care Act (ACA) directed the Secretary of Health and Human Services to issue regulations to establish an administrative…
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