News & Analysis as of

Section 340B Centers for Medicare & Medicaid Services (CMS) Food and Drug Administration (FDA)

ArentFox Schiff

The 2025 Proposed Hospital Outpatient Prospective Payment System and Physician Fee Schedule Rules: What Pharma Stakeholders Need...

ArentFox Schiff on

Pharma’s favorite summer pastime is back again: reviewing the Centers for Medicare & Medicaid Services (CMS) release of the 2025 proposed Hospital Outpatient Prospective Payment System (HOPPS) and Physician Fee Schedule (PFS)...more

McGuireWoods Consulting

Washington Healthcare Update - June 2024

This Week in Washington: Senate Finance Committee Chairman sends letters concerning healthcare cybersecurity measures; House Energy and Commerce Committee Oversight and Investigations Subcommittee holds hearing on 340B...more

Alston & Bird

Health Care Week In Review: House Held Oversight Hearing on the 340B Program and HHS Expanded Certified Community Behavioral...

Alston & Bird on

Below is Alston & Bird’s Health Care Week in Review, which provides a synopsis of the latest news in health care regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies,...more

Alston & Bird

Health Care Week in Review: House Members Introduced Legislation Intended to Enhance 340 Program Transparency; HHS Released...

Alston & Bird on

Below is Alston & Bird’s Health Care Week in Review, which provides a synopsis of the latest news in health care regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies,...more

McDermott+

Breaking Down Federal Policies to Address Drug Shortages

McDermott+ on

In the wake of persistent drug shortages that compromise patient care and safety, the Biden administration and Congress have proposed policies to strengthen the pharmaceutical supply chain. Using authorities under both...more

McGuireWoods Consulting

Washington Healthcare Update - May 2024 #4

This Week in Washington: Senate Finance Committee releases draft proposal outline concerning GME program; Senate HELP Committee marks up seven healthcare bills; NIH issues first-of-its-kind policy proposal to promote equal...more

Alston & Bird

Health Care Week in Review: Senate Finance Committee Releases Plan to Address Workforce Shortages, Court Sides with Manufacturers...

Alston & Bird on

Below is Alston & Bird’s Health Care Week in Review, which provides a synopsis of the latest news in health care regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies,...more

Alston & Bird

Health Care Week in Review: HHS Finalizes 340B ADR Rule; House and Senate Hold Hearings on President’s FY 2025 HHS Budget

Alston & Bird on

Below is Alston & Bird’s Health Care Week in Review, which provides a synopsis of the latest news in health care regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies,...more

McGuireWoods Consulting

Washington Healthcare Update - February 2024 #2

This Week in Washington: Senate Finance Committee holds hearing on AI use in healthcare; CMS makes corrections to 2024 Hospital Outpatient Prospective Payment Rates; House passes ban on QALYs....more

ArentFox Schiff

CMS Issues Revised Guidance Implementing Medicare Inflation Rebates Under the Inflation Reduction Act

ArentFox Schiff on

The Centers for Medicare and Medicaid Services (CMS) continues to take steps implementing the Inflation Reduction Act of 2022 (IRA). Newly revised guidance issued on December 14, 2023, makes notable changes and clarifications...more

Alston & Bird

Health Care Week in Review: New House Speaker Elected; HRSA Issued a Notice on 340B Drug Pricing Program Requirements

Alston & Bird on

Below is Alston & Bird’s Health Care Week in Review, which provides a synopsis of the latest news in health care regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies,...more

Holland & Knight LLP

Holland & Knight Health Dose: October 17, 2023

Holland & Knight LLP on

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

Arnall Golden Gregory LLP

Healthcare Authority Newsletter - July 2023 #1

News Briefs - SCOTUS Affirmative Action Ruling May Impact Healthcare Sector - Doctors are concerned that a Supreme Court ruling issued June 29 will have far-reaching effects not only on the diversity of doctors and other care...more

Alston & Bird

Health Care Week in Review: Leqembi Approval, Administration Issues Proposed Rules

Alston & Bird on

Below is Alston & Bird’s Health Care Week in Review, which provides a synopsis of the latest news in health care regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies,...more

Foley Hoag LLP

Medicare Drug Price Negotiation Program Initial Guidance

Foley Hoag LLP on

On March 15, 2023, the Centers for Medicare & Medicaid Services (CMS) issued an initial guidance regarding the Medicare Drug Price Negotiation Program (Negotiation Program) established by the Inflation Reduction Act of 2022...more

Holland & Knight LLP

Holland & Knight Health Dose: February 7, 2023

Holland & Knight LLP on

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. This week's topics include ... ...more

Holland & Knight LLP

Holland & Knight Health Dose: October 18, 2022

Holland & Knight LLP on

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

Latham & Watkins LLP

Health Care & Life Sciences: Drug Pricing Digest - October 2022

Latham & Watkins LLP on

Drug Pricing Reform: President Biden, in remarks delivered on Sept. 27, 2022, touted insulin pricing provisions in H.R. 5376, the Inflation Reduction Act of 2022 (IRA), which became law on Aug. 16, 2022. He referred to...more

Bricker Graydon LLP

2022 Medicare OPPS/ASC Proposed Rule includes updated reimbursement rates, new policies, and reversals of recent policy changes

Bricker Graydon LLP on

On July 19, 2021, the Centers for Medicare and Medicaid Services (CMS) released the Calendar Year (CY) 2022 Hospital Outpatient Prospective System (OPPS) and Ambulatory Surgical Center (ASC) Proposed Rule (Proposed Rule). In...more

McGuireWoods Consulting

Washington Healthcare Update - June 2021 #3

This week in Washington: Supreme Court dismisses challenge to the Affordable Care Act....more

McGuireWoods Consulting

Washington Healthcare Update - May 2021 #3

This week in Washington: HHS and CMS nominations move forward....more

McGuireWoods Consulting

The Courts and Healthcare Policy

2020 saw the courts continuing to play an important role in health policy with several notable lawsuits related to the Affordable Care Act (ACA). Several other Trump administration policies were challenged, including Medicare...more

McGuireWoods Consulting

Washington Healthcare Update - December 2020 #2

McGuireWoods Consulting on

This week in Washington: Congress passes funding bill for an additional week to come up with full-year spending legislation to avoid a government shutdown....more

Alston & Bird

Alston & Bird Health Care Week in Review - December 2020 #2

Alston & Bird on

Below is Alston & Bird’s Health Care Week in Review, which provides a synopsis of the latest news in healthcare regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies, and...more

McGuireWoods Consulting

Washington Healthcare Update - October 2020 #4

McGuireWoods Consulting on

This week in Washington: Mnuchin and Pelosi continue discussions for COVID-19 stimulus package....more

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