News & Analysis as of

Office of Management and Budget Drug Pricing

Mintz

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

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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?

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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

Holland & Knight LLP

Holland & Knight Health Dose: December 12, 2023

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Holland & Knight Health Dose is an in-depth weekly dose of legislative and regulatory insights to keep stakeholders abreast of happenings in Washington, D.C., impacting the health sector....more

Wiley Rein LLP

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

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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

MoFo Life Sciences

Biden Administration Executive Order On Promoting Competition In The American Economy: Drug Pricing And Healthcare Industry...

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On July 9, 2021, President Biden enacted a sweeping executive order creating a “whole‑of-government competition policy.” Morrison & Foerster outlined the administration’s policy in a recent client alert that provides a...more

Latham & Watkins LLP

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

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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

ArentFox Schiff

Senate Finance Committee Holds Confirmation Hearing For Top Biden HHS Nominees

ArentFox Schiff on

Deputy Secretary and CMS Administrator Picks Would Fill Two Critical Policy Positions - On Thursday, the Senate Finance Committee held a confirmation hearing for two of the most important health policy officials nominated...more

McGuireWoods Consulting

Washington Healthcare Update - March 2021 #5

Congress - House - Representatives Propose a Permanent Extension of CHIP Funding - The House Energy and Commerce Committee is looking at ways to strengthen the Affordable Care Act (ACA) and expand Medicaid coverage. A...more

K&L Gates LLP

340B Update: HRSA Moves Forward with 340B ADR Rule as Covered Entities Challenge Contract Pharmacy Actions

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In this episode of Triage, Andrew Ruskin and Victoria Hamscho provide an update on recent developments in the 340B Program and, in particular, on two recent legal challenges covered entities brought in response to drug...more

McGuireWoods Consulting

Washington Healthcare Update - October 2020 #1

This week in Washington: The Continuing Resolution (CR) to fund the government until Dec. 11 was signed by President Trump; House passes COVID-19 stimulus bill....more

Blank Rome LLP

Executive Order Regarding Domestic Production and Purchase of Essential Medicines: A Lot to Unpack and More Than Meets the Eye

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On August 6, 2020, President Trump issued another Executive Order (“EO”) that will likely have dramatic and long-lasting effects on the pharmaceutical industry. The impact of the EO may be far greater than currently...more

McGuireWoods Consulting

Washington Healthcare Update - October 2019 #1

This week in Washington: The House and Senate are in recess. Congress House Senate Administration Proposed Regulations/Guidance Final Rules/Guidance Reports House Bipartisan Legislation Introduced on Accurate Provider...more

McGuireWoods Consulting

Washington Healthcare Update April 2019 #3

Congress - Hearings/Markups - Senate Finance Committee: "Drug Pricing in America: A Prescription for Change, Part III" - Tuesday, April 9, 2019: The Senate Finance Committee continued its drug pricing series by...more

McGuireWoods Consulting

Washington Healthcare Update April 2019 #2

Coming Week’s Highlights: Congress will continue to examine drug pricing; on Tuesday, the Senate Finance Committee will hold the third in a series of hearings, this one focused on pharmacy benefit managers (PBMs). The House...more

McGuireWoods Consulting

Washington Healthcare Update March 2019 #4

Upcoming Hearings - Tuesday, March 26, 2019 - House Committee on the Budget: “Department of Health and Human Services FY2020 Budget” - The House Committee on the Budget will hold a hearing examining the proposed...more

McGuireWoods Consulting

Washington Healthcare Update March 2019 #1

Upcoming Hearings - Tuesday, March 5, 2019 - Senate Committee on Health, Education, Labor and Pensions (HELP): “Vaccines Save Lives: What is Driving Preventable Disease Outbreaks?” - The Senate Committee on Health,...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

Mintz - Health Care Viewpoints

Health Care Weekly Preview from ML Strategies – October 2018 #3

Last week concluded the Senate’s time in Washington prior to the lame duck session. With both the House and the Senate back home and focused on campaigning, we turn our attention to action from the Administration. As of...more

Akin Gump Strauss Hauer & Feld LLP

What's New In Washington - September 2018

Following a truncated August recess, the House and the Senate returned to Washington after Labor Day with a full plate of legislative items to address prior to the end of the fiscal year on September 30. That list includes...more

Foley & Lardner LLP

Health Care Policy Happenings - September 2018 #2

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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

Clark Hill PLC

Window On Washington - Vol. 2, Issue 32

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Outlook for This Week in the Nation's Capital - Appropriations. The Senate is expected to begin work this week on its next minibus appropriations bill- a package that would contain the Defense and Labor-HHS spending bills....more

Foley & Lardner LLP

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

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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

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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