News & Analysis as of

Department of Health and Human Services (HHS) Healthcare Public Health Service Act

Baker Donelson

60 Days After Loper: Health Care Impact of Chevron Deference's End

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The Supreme Court of the United States issued its highly anticipated ruling in a pair of cases challenging the long-standing Chevron doctrine on June 28, 2024. Foreshadowed by decisions in recent years slighting Chevron, it...more

Wiley Rein LLP

Manufacturers Are “Winning” in the 340B Drug Discount Dispute

Wiley Rein LLP on

Section 340B of the Public Health Service Act has grown significantly since its enactment in 1992 – both in the number of covered entities eligible to participate and in the volume of drugs purchased through the program. The...more

Jones Day

Congress Authorizes Competitive Multivendor Contracts in U.S. Organ Transplant System

Jones Day on

This new legislation supports the Health Resources and Services Administration ("HRSA") modernization initiative announced in March, including several actions to strengthen accountability and transparency in the Organ...more

Burr & Forman

What the HRA is going on with HRAs?

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On June 13, the Departments of Labor, Treasury and Health and Human Services jointly released final regulations dealing with health reimbursement accounts (“HRAs”). These regulations fulfill the Trump administration’s...more

Mintz - Employment Viewpoints

Agencies Issue Final Regulations Expanding Access to Health Reimbursement Arrangements

On June 13, 2019, the Department of Health and Human Services (HHS), the Department of Labor (DOL), the Department of the Treasury (Treasury Department) and the Internal Revenue Service (IRS) (collectively, the “Departments”)...more

BakerHostetler

D.C. District Court Deals Blow to HHS 340B Program Interpretive Rule

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Court says Congress has the power to make the change that HHS attempted with its Interpretive Rule, and thus it should be left to the legislative branch. A lawsuit challenging the Interpretive Rule, filed by the...more

McGuireWoods LLP

Washington Healthcare Update

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This Week: CMS Releases Guidance on Fast Track Process for 1115 Waivers for Medicaid and CHIP... Healthcare.gov CEO Sends Letter to State Insurance Commissioners Concerning 2016 Premium Decisions... Medicare Board of Trustees...more

King & Spalding

HHS Issues Interpretive Rule Excluding Orphan Drugs from 340B Program Discounts Only for Designated Orphan Status Uses

King & Spalding on

On July 21, 2014, the Health Resources and Services Administration of HHS (HRSA) issued an interpretive rule interpreting Section 340B(e) of the Public Health Service Act as excluding from the 340B Drug Pricing Program orphan...more

Morgan Lewis

HRSA Publishes Orphan Drug Rule for 340B Program

Morgan Lewis on

Rule requires most manufacturers to change government pricing methodologies, calculations, and systems. On July 23, the Health Resources and Services Administration (HRSA) of the U.S. Department of Health and Human...more

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