News & Analysis as of

Drug Pricing Medicare Part D Office of Management and Budget

Mintz

Mintz IRA Update — Demystifying the IRA’s Small Biotech Exception

Mintz on

On August 29, 2023, CMS selected the first 10 high-expenditure, single source, Medicare Part D drugs subject to negotiation under the IRA’s Medicare Drug Price Negotiation Program (the “Negotiation Program” or “Program”). In...more

McDermott+

Regs During an Election Year: What’s on the Menu?

McDermott+ on

Last week, McDermott+Consulting launched an election 2024 resource page, where you can find a 2024 health policy outlook and other insights into the November election. While regulations aren’t necessarily top-of-mind when...more

Wiley Rein LLP

The IRA’s Negotiation Process ICR and Revised Negotiation Program Guidance

Wiley Rein LLP on

On July 25, 2023, the Centers for Medicare & Medicaid Services (CMS) republished its Drug Price Negotiation Process Information Collection Request (Negotiation Process ICR). The Negotiation Process ICR, which was originally...more

Goodwin

CMS Issues First Request for Public Comments on the Medicare Drug Price Negotiation Program “Small Biotech” Exception - Due March...

Goodwin on

The Inflation Reduction Act’s (“IRA”) drug price negotiation provisions have captured the pharmaceutical and biotech industry’s attention. In part, the IRA allows the Centers for Medicare & Medicaid Services (“CMS”) to...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

McGuireWoods Consulting

Washington Healthcare Update February 2019 #3

Upcoming Hearings - Tuesday, Feb. 26, 2019 - Senate Finance Committee: “TBA Hearing on Drug Pricing” - The second hearing in a series on drug pricing in the Senate Finance Committee will include the testimonies of...more

Holland & Knight LLP

Trump Administration Fiscal Year (FY) 2019 Budget and Healthcare Programs

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The Trump Administration on Feb. 12 released its Fiscal Year (FY) 2019 budget request, titled "An American Budget." Unlike last year's budget, which was released in late May, the release of this budget conforms to the typical...more

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