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Medicare Part D Food and Drug Administration (FDA)

McDermott+

McDermott+ Check-Up: September 20, 2024

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Senate Judiciary Human Rights and the Law Subcommittee Holds Hearing on Georgia Abortion Ban. The field hearing examined how Georgia’s abortion ban impacts women’s health, and featured patient and physician witnesses. ...more

Alston & Bird

Health Care Week in Review: CMS Released Negotiated Medicare Part D Prices for 10 Drugs and ARPA-H Awarded $150 Million in Funding...

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

Akin Gump Strauss Hauer & Feld LLP

Happy Birthday Two You, IRA: Drug Pricing Dynamics to Watch as Maximum Fair Price Announcements Loom

This week marks the second anniversary of the enactment of the Inflation Reduction Act, a partisan law that ushered in sweeping Medicare price setting reforms. The Biden-Harris Administration is poised to announce the first...more

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

McDermott Will & Emery

Healthcare Regulatory Check-up Newsletter | April 2024 Recap

McDermott Will & Emery on

This issue of McDermott’s Healthcare Regulatory Check-Up highlights regulatory activity for April 2024. We discuss several US Department of Health and Human Services (HHS) agency actions, including the Calendar Year (CY) 2025...more

Akin Gump Strauss Hauer & Feld LLP

Anti-Obesity Medications: Noteworthy Developments as Policymakers Weigh Coverage Considerations

Key Points - GLP-1 agonists have ushered in a new era in anti-obesity medication policy considerations against the backdrop of a continued focus by policymakers on both drug access and pricing. CMS has taken steps to clarify...more

McGuireWoods Consulting

Washington Healthcare Update - April 2024

This Week in Washington: Senate HELP Committee Chairman requests comments on Long COVID draft proposal; CMS announces proposed Transforming Episode Accountability Model; CMS releases FY2025 Inpatient and Long-Term Care...more

Alston & Bird

Health Care Week in Review: CMS Finalizes Rules for Medicare Advantage, Part D, and Affordable Care Act (ACA) Marketplaces

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+

Medicare Coverage of Wegovy Raises Questions Regarding the Affordability and Accessibility of Novel Medications

McDermott+ on

Last week, the Centers for Medicare & Medicaid Services (CMS) announced that it would allow health plans under Medicare Part D (the Medicare prescription drug benefit) to cover Wegovy and other weight-loss medications if they...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

McGuireWoods Consulting

Washington Healthcare Update - December 2023 #3

McGuireWoods Consulting on

This Week in Washington: House passes Lower Costs, More Transparency Act and SUPPORT Act Reauthorization; Senate HELP Committee reports SUPPORT Act Reauthorization and three other bills out of committee; ONC releases final...more

Hogan Lovells

CMS Issues Revised Medicare Part B and Part D Inflation Rebate Guidance

Hogan Lovells on

On December 14, 2023, the Centers for Medicare & Medicaid Services (CMS) published two “revised” guidance documents implementing the Medicare Part B and Part D inflation rebate provisions of the Inflation Reduction Act of...more

McGuireWoods Consulting

Washington Healthcare Update - November 2023 #2

McGuireWoods Consulting on

This Week in Washington: Senate Finance Committee reports out Better Mental Health Care, Lower-Cost Drugs and Extenders Act; Senate confirms NIH Director; House Speaker Proposes Laddered Continuing Resolution....more

Alston & Bird

Health Care Week In Review: Senate Finance Committee Advanced Bipartisan Healthcare Legislation, CMS Released Medicare Advantage...

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

ArentFox Schiff

Fast 5: Five Quick Regulatory Takeaways for Pharmaceutical Companies

ArentFox Schiff on

Here we are in fourth quarter of 2023 already! As companies start wrapping up 2023 and preparing and modeling for 2024, we thought it was a good time to highlight five regulatory developments, changes, or challenges on the...more

Alston & Bird

Health Care Week in Review: House Energy and Commerce Subcommittee on Health Held Hearing on Medicare Proposals, CMS Released 2024...

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: Rep. McCarthy Ousted as Speaker of the House; CMS Announces Drug Manufacturer Participation in...

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

Manatt, Phelps & Phillips, LLP

Anti-Obesity Medications as Medicare Part D Drugs - Legal and Health Policy Rationales

Obesity is a complex, multifactorial disease that has serious health consequences, affects millions of Americans and drives hundreds of billions of dollars in annual health care spending. Scientific understanding of the...more

Mintz - Health Care Viewpoints

Mintz IRA Update — Basics of the Medicare Drug Price Negotiation Program

The Inflation Reduction Act (“IRA”) was passed just over a year ago with a goal of lowering high drug costs for Medicare beneficiaries and reducing costs incurred by Medicare. A central piece to achieving the IRA’s goal of...more

Goodwin

Generic and Biosimilar Drugs Save $408B For America’s Patients and Healthcare System in 2022

Goodwin on

On September 6, 2023, the Association for Accessible Medicines (AAM) released its 2023 U.S. Generic & Biosimilar Medicines Savings Report highlighting the significant economic contributions of generic and biosimilar...more

Wilson Sonsini Goodrich & Rosati

HHS Names the First 10 Drugs for Medicare Price Negotiation

Listening Sessions on Drug Price Negotiations Will Be Live Streamed and Opened to the Public This Fall - In this Alert, we provide an update regarding the first 10 drugs for Medicare price negotiation selected under the...more

Alston & Bird

Health Care Week in Review: CMS Announces Details to Pay Drug Costs on Installment Plan

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

MoFo Life Sciences

Medicare Drug Price Negotiation Program Final Guidance

MoFo Life Sciences on

On June 30, 2023, the Centers for Medicare and Medicaid Services (CMS) released its much-anticipated final guidance (“Final Guidance”) for the Medicare Drug Price Negotiation Program (“Negotiation Program”) through the...more

McGuireWoods Consulting

Washington Healthcare Update - August 2023

This Week in Washington: HHS announces lowest national uninsured rate, CDC recommends RSV antibody for infants, CMS releases rules on inpatient and long-term care hospitals and skilled nursing facilities...more

Holland & Knight LLP

Holland & Knight Health Dose: June 20, 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

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