News & Analysis as of

Office of Management and Budget Proposed Rules Prescription Drugs

McDermott+

CY 2026 MA and Part D Final Reg: Policies Under Consideration

McDermott+ on

Last week, the contract year (CY) 2026 Medicare Advantage (MA) and Part D final reg entered the clearance process at the Office of Management and Budget (OMB). As mentioned in a previous Regs & Eggs blog post, OMB’s review is...more

Mintz - Health Care Viewpoints

FDA Opens a Pilot Program to Scrutinize Certain Laboratory Developed Tests, But Will It Generate Sufficient Interest?

The U.S. Food and Drug Administration (FDA) announced a new pilot program on June 21, 2023 that gives sponsors of oncology products the opportunity to submit validation and performance data for laboratory developed tests...more

McGuireWoods Consulting

Washington Healthcare Update - March 2022 #3

This Week in Washington: President Biden Signs Omnibus Appropriations Package into Law to Fund the Federal Government Through FY 2022...more

Latham & Watkins LLP

Healthcare & Life Sciences: Drug Pricing Digest - May 2021 #2

Latham & Watkins LLP on

PhRMA Suit Challenges Co-Pay/Accumulator Portion of December 2020 Medicaid Rule - On May 21, 2021, Pharmaceutical Research and Manufacturers of America (PhRMA) filed suit in the US District Court for the District of...more

McGuireWoods Consulting

Washington Healthcare Update February 2019 #4

Upcoming Hearings - Tuesday, Feb. 26, 2019 - Senate Finance Committee: “Drug Pricing in America: A Prescription for Change, Part II” - The second hearing in a series on drug pricing in the Senate Finance Committee...more

Foley & Lardner LLP

Health Care Policy Happenings - September 2018 #2

Foley & Lardner LLP on

Here are some key health care policy headlines from the past week that you may have missed. Congress - Legislation and Committee Activity - Bloomberg: Opioids Compromise Already in the Works in Congress – Congress is...more

Foley & Lardner LLP

The Battle Over Drug Pricing: First Shot Targets Pharmacy Benefit Managers

Foley & Lardner LLP on

On July 18, 2018, the federal Department of Health and Human Services (HHS) sent a proposed rule to the Office of Management and Budget (OMB) for review and clearance. While the substance of the proposed rule is not yet...more

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