News & Analysis as of September 4, 2025

Orphan Drugs

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Medicaid is a partnership program between states and the federal government to provide healthcare coverage for lower income individuals, people with disabilities, older people, and certain families with... more +

Impact of the One Big Beautiful Bill Act on the Life Sciences Industry

Ballard Spahr LLP on 8/27/2025

On July 4, 2025, President Trump signed the One Big Beautiful Bill Act (OBBBA) into law. The act extends several provisions of the Tax Cuts and Jobs Act, expands Health Savings Account (HSA) eligibility, and creates new...more

This Year May be a Game Changer for 340B Drug Discount Program, Take Two

Mintz - Health Care Viewpoints on 1/18/2018

I previously said that the year 2014 may be a game-changer for the 340B Drug Discount Program. Increasing HRSA audits, a lawsuit over the 340B Orphan Drug Rule, and HRSA’s promise to issue a 340B mega-regulation, all pointed...more

Witnesses at Congressional Hearing on 340B Urge Congress To Give HRSA Broader Regulatory Authority

Mintz - Health Care Viewpoints on 7/26/2017

On July 18, 2017, just days after CMS went public with its proposal to reduce Medicare Part B reimbursement to certain 340B covered entities, Congress held its first hearing on 340B Program Oversight since March 2015. A...more

HRSA Publishes Proposed 340B Drug Pricing Program Omnibus Guidance - Comments Due to HRSA on or before Tuesday, October 27, 2015

King & Spalding on 9/8/2015

On Friday, August 28, 2015, the Health Resources and Services Administration (“HRSA” or “the Agency”) published in the Federal Register Notice of its proposed “omnibus” or “mega” guidance (“Proposed Guidance”) regarding...more

Washington Healthcare Update

McGuireWoods LLP on 7/21/2015

This Week: Senate Reauthorizes Older Americans Act; Bill Heads to the House... White House Holds 2015 Conference on Aging and Launches Several New Administration Healthy Aging Initiatives Enveloping Alzheimer’s, Dementia,...more

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