News & Analysis as of

Centers for Medicare & Medicaid Services (CMS) Prescription Drugs Draft Guidance

Goodwin

IRA Litigation Updates: D.N.J. Rejects Challenges from BMS and Janssen; Four Cases Now on Appeal

Goodwin on

On April 29th, the district court for the district of New Jersey (J. Quraishi) granted summary judgment for the Government in two cases, brought by BMS and Janssen, challenging the IRA’s Drug Price Negotiation Program....more

Hogan Lovells

CMS Issues Draft Guidance on Inflation Reduction Act (IRA) Drug Price Negotiation Program for 2027

Hogan Lovells on

On May 3, 2024, the Centers for Medicare & Medicaid Services (CMS) issued draft guidance for initial price applicability year (IPAY) 2027 of the Drug Price Negotiation Program established by the IRA. Notwithstanding the...more

King & Spalding

CMS Issues Draft Guidance for Implementing Medicare Prescription Payment Plan for 2025

King & Spalding on

On August 21, 2023, CMS issued the first of two draft guidance documents for implementing the Medicare Prescription Payment Plan that was established by section 11202 of the Inflation Reduction Act (IRA) and signed into law...more

McGuireWoods Consulting

Washington Healthcare Update - November 2021 #2

This week in Washington: Congressional Democrats reach drug pricing agreement; bipartisan infrastructure bill goes to President Biden’s desk with budget reconciliation bill delayed....more

King & Spalding

FDA Issues Proposed Rule and Draft Guidance on Drug Importation

King & Spalding on

In late December 2019, the Food and Drug Administration (FDA), an agency operating within the Department of Health and Human Services (HHS), issued two documents—a Proposed Rule and a Draft Guidance—intended to establish two...more

McGuireWoods Consulting

Washington Healthcare Update - November 2019 #4

McGuireWoods Consulting on

This week in Washington: The House and Senate are out for Thanksgiving recess this week. Congress - Hearings/Markups - House Committee on the Judiciary: “The Patent Trial and Appeal Board and the Appointments Clause:...more

Holland & Knight LLP

Healthcare Law Update: October 2019

Holland & Knight LLP on

In recent years, the healthcare industry has been turning greater attention to the need to engage or involve patients in developing new technologies and systems to improve healthcare delivery. These patient engagement...more

McGuireWoods LLP

Washington Healthcare Update

McGuireWoods LLP on

This Week: House Ways & Means Committee Holds Markup; Makes Significant Legislative Changes to Health Care Bills... Senate Finance Committee Holds Markup on Medicare Appeals Process Bill... CMS Issues Final Rule on...more

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