News & Analysis as of

Department of Health and Human Services (HHS) Negotiations

Mintz - Health Care Viewpoints

CMS 2026 IRA Price Negotiations Results Likely to Create Upstream and Downstream Effects

On August 15, 2024, CMS announced the results of the first round of the negotiated prices between CMS and participating drug manufacturers for the 10 selected drugs under the Inflation Reduction Act’s (IRA) Medicare Drug...more

Cozen O'Connor

CMS Announces 120-day Exception Period for No Surprises Act Independent Dispute Resolution

Cozen O'Connor on

Under the No Surprises Act, “open negotiation” is the period of time during which payers must disclose to providers important information regarding the claim at issue. On June 14, 2024, CMS announced a 120-calendar-day...more

Ankura

Summary: The Government Accountability Office's Report on Medicare Part D Rebates

Ankura on

On September 5, 2023, the United States Government Accountability Office (GAO) published its report titled Medicare Part D: CMS Should Monitor Effects of Rebates on Plan Formularies and Beneficiary Spending.The report...more

Mintz - Health Care Viewpoints

Mintz IRA Update — Legal Challenges to the Medicare Drug Price Negotiation Program

As discussed throughout this Update, the implementation of the Medicare Drug Price Negotiation Program (the “Negotiation Program” or “Program”) has been subject to a number of legal challenges. To date, six manufacturers and...more

Mintz - Health Care Viewpoints

Mintz IRA Update — A Deeper Dive into Other Controversies of the IRA’s Medicare Drug Price Negotiation Program

The ability to directly negotiate drug prices has been a policy goal for Democrats for many years and was recently accomplished through the Inflation Reduction Act’s (“IRA”) Medicare Drug Price Negotiation Program (the...more

Mintz - Health Care Viewpoints

Mintz IRA Update — Other Key IRA Programs and Developments: The Medicare Prescription Drug Inflation Rebate Program and Maximum...

Although most of the recent focus around the implementation of the Inflation Reduction Act (“IRA”) by the press and industry stakeholders has been on the Medicare Drug Price Negotiation Program, the IRA has several other...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

Sheppard Mullin Richter & Hampton LLP

Healthcare Reforms Under the IRA: Expanding Access to Care

The Inflation Reduction Act (“IRA”) was signed into law by President Biden on August 16, 2022. The expansive legislation includes key health care provisions, including drug pricing reforms, inflationary rebates, Medicare Part...more

McDermott Will & Emery

[Webinar] Regulatory Disputes with HHS: When to Negotiate and When to Litigate - March 25th, 12:00 pm - 1:00 pm EST

McDermott Will & Emery on

For healthcare and life sciences companies, regulatory disputes with the U.S. Department of Health and Human Services (HHS) and its operating divisions can present significant economic costs and reputational risks. Efficient...more

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