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Orphan Drugs Drug Pricing Centers for Medicare & Medicaid Services (CMS)

Latham & Watkins LLP

Healthcare Life Sciences Drug Pricing Digest - July 2025

Latham & Watkins LLP on

On July 4, 2025, President Trump signed into law the One Big Beautiful Bill Act, his signature policy legislation. Two aspects of this legislation are particularly relevant for drug pricing....more

Cornerstone Research

Potential Unintended Economic Impacts of the Inflation Reduction Act on the Pharmaceutical Industry

Cornerstone Research on

The Inflation Reduction Act (IRA) was signed into law in August 2022 with the goal of curbing inflation by, among other things, lowering prescription drug prices. Notable prescription drug provisions of the IRA include the...more

MoFo Life Sciences

Medicare Drug Price Negotiation Program Final Guidance

MoFo Life Sciences on

On June 30, 2023, the Centers for Medicare and Medicaid Services (CMS) released its much-anticipated final guidance (“Final Guidance”) for the Medicare Drug Price Negotiation Program (“Negotiation Program”) through the...more

Wiley Rein LLP

Submitting Comments on the Inflation Reduction Act’s Medicare Drug Price Negotiation Program Guidance

Wiley Rein LLP on

The Inflation Reduction Act of 2022 (IRA) establishes the Medicare Drug Price Negotiation Program (“Negotiation Program”), which permits the government to negotiate drug prices for certain high expenditure, single source...more

Mintz - Health Care Viewpoints

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

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

BakerHostetler

Capitol Hill Healthcare Update

BakerHostetler on

SHUTDOWN SHOWDOWN: CHIP, OTHER HEALTH PROVISIONS AT RISK AS DEADLINE NEARS - Renewal of the Children’s Health Insurance Program and a host of other healthcare provisions hang in the balance as congressional Republicans...more

Mintz - Health Care Viewpoints

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

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

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