News & Analysis as of

Medicare Drug Pricing Healthcare

Jones Day

HHS Pilot Program to Evaluate 340B Drug Pricing Program Rebate Models

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The Health Resources and Services Administration ("HRSA") plans to implement a limited pilot program that will allow approved manufacturers to issue post-purchase rebates for 340B covered outpatient drugs rather than upfront...more

BakerHostetler

Analysis of Healthcare Changes Under the 2025 Tax Legislation

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The Legislation combines spending and policy priorities from 11 congressional committees and will reshape federal policy across nearly every sector of the U.S. economy. With respect to healthcare, more than 35 provisions...more

McDermott+

McDermott+ Check-Up – August 1, 2025

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Senate HELP Committee advances legislation, examines healthcare affordability. The legislation would reauthorize expiring programs, including the Over-the-Counter Monograph Drug User Fee Program. Senate Appropriations...more

Robinson+Cole Health Law Diagnosis

HHS Publishes 340B Guidance Proposing Rebate Pilot Program

On July 31, 2025, the Department of Health and Human Services (HHS) announced a much-anticipated 340B Rebate Model Pilot Program (Pilot Program) via guidance (Guidance) that will be formally published on August 1, 2025. The...more

Jones Day

Congress Expands Orphan Drug Exemptions From Medicare Price Negotiations

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The One Big Beautiful Bill Act ("OBBB") expands exemptions for orphan drugs from mandatory Medicare price negotiations and modifies their eligibility timeline....more

Latham & Watkins LLP

Healthcare Life Sciences Drug Pricing Digest - July 2025 #2

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The Centers for Medicare & Medicaid Services (CMS) released the calendar year 2026 Physician Fee Schedule (PFS) proposed rule, which was published in the Federal Register on July 16, 2025. The comment period ends on September...more

McDermott Will & Schulte

Reducing hospital payments: CMS proposes expanded site-neutral payment policy for drug administration services

Consistent with recent attention from Congress and rhetoric from the Trump administration, the Calendar Year 2026 Medicare Hospital Outpatient Prospective Payment System (OPPS) proposed rule (the Proposed Rule) includes...more

Holland & Knight LLP

CMS Releases CY 2026 Outpatient Prospective, ASC Payment System Proposed Rule

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The Centers for Medicare & Medicaid Services (CMS) on July 15, 2025, issued the Hospital Outpatient Prospective Payment (OPPS) and Ambulatory Surgical Center (ASC) Payment Systems proposed rule, which proposes updates to the...more

McGuireWoods Consulting

Proposed Rule For The 2026 Medicare Physician Fee Schedule Released

On July 14, 2025, the Centers for Medicare and Medicaid Services (CMS) released its proposed physician fee schedule (PFS) rule. After five years of Medicare reimbursement reductions, CMS proposes a 3.8% increase in physician...more

Alston & Bird

Getting the Band Back Together: DOJ and HHS Launch New False Claims Act Enforcement Working Group

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The Department of Health and Human Services and the Department of Justice have formed a False Claims Act (FCA) enforcement working group to target health care fraud. Our Health Care Litigation Group highlights what industry...more

Stevens & Lee

HHS and DOJ Announce False Claims Act Joint Working Group and Identify Enforcement Priorities

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The U.S. Department of Justice (DOJ) and the Department of Health and Human Services (HHS) announced on July 2 their formation of a False Claims Act Working Group. The announcement and the formation of the Working Group...more

Troutman Pepper Locke

DOJ-HHS Establishes New Working Group to Enhance FCA Enforcement

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On July 2, 2025, the U.S. Department of Justice (DOJ) announced the formation of a new working group in collaboration with the U.S. Department of Health and Human Services (HHS) focused on the enforcement of the False Claims...more

Skadden, Arps, Slate, Meagher & Flom LLP

HHS and DOJ Launch FCA Working Group With New Joint Enforcement Priorities

On July 2, 2025, the Department of Health and Human Services (HHS) and the Department of Justice (DOJ) announced the reinvigoration of their False Claims Act (FCA) enforcement efforts through the formation of a joint FCA...more

WilmerHale

DOJ and HHS Announce New False Claims Act Working Group

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On July 2, 2025, the Department of Justice (“DOJ”) and the Department of Health and Human Services (“HHS”) announced a joint DOJ-HHS False Claims Act Working Group (the “Working Group”) that will focus on enhanced enforcement...more

Epstein Becker & Green

DOJ, HHS Announce Revamped False Claims Act Working Group

Now in its sixth month, the second Trump administration has made clear that the False Claims Act (FCA) will remain a central tool in its efforts to combat fraud, waste, and abuse across federal programs....more

Husch Blackwell LLP

DOJ and HHS Launch New False Claims Act Working Group: What The Healthcare Industry Needs to Know

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On July 2, 2025, the Department of Justice (DOJ) and the Department of Health and Human Services (HHS) announced the creation of the DOJ-HHS False Claims Act Working Group, a high-level interagency initiative aimed at...more

Goodwin

Health Headlines: June 2025

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Welcome to the seventh issue of Health Headlines, a newsletter created by lawyers in our Healthcare practice. Iowa Governor Kim Reynolds signed Senate File 383 into law, placing new restrictions on pharmacy benefit...more

Jones Day

Medicare's Innovation Center Charts New Direction: Part 3 – Drugs, Devices, and Data

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The Center for Medicare and Medicaid Innovation ("CMMI") is set to reshape value-based care. In the third of a three-part series highlighting this new direction, this summary is focused on CMMI's efforts regarding drugs,...more

Brownstein Hyatt Farber Schreck

Summary of Health Care Provisions in the “One Big Beautiful Bill Act”

On May 22, the U.S. House of Representatives passed the One Big Beautiful Bill Act (H.R. 1), an extensive budget reconciliation package that advances President Trump’s plan to enact his economic agenda. After a series of...more

Miles & Stockbridge P.C.

2025 Health Care Laws in Maryland: Improving Access & Affordability

The Maryland General Assembly’s 2025 legislative session concluded with a few impactful health care bills. The two bills below, signed into law by Gov. Wes Moore on Tuesday, represent significant steps in improving health...more

Alston & Bird

Health Care Week in Review | President Trump Announces Actions to Lower Prescription Drug Costs; House Committees Mark Up Their...

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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

Skadden, Arps, Slate, Meagher & Flom LLP

Trump Attempts To Rein In Drug Prices With Most-Favored-Nation Approach

On May 12, 2025, President Donald Trump signed the executive order (EO) “Delivering Most-Favored-Nation Prescription Drug Pricing To American Patients.” The EO sets forth policy positions that attempt to further rein in drug...more

McDermott+

McDermott+ Check-Up: May 9, 2025

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THIS WEEK’S DOSE - - Republicans Advance Reconciliation Debate. Work continued behind the scenes among Republicans to reach consensus on Medicaid policies, with a House Energy and Commerce Committee markup announced for May...more

Alston & Bird

Health Care Week in Review | White House Issues Executive Orders on Biosecurity and Domestic Drug Production; House Committee...

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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 Will & Schulte

New EO Targets Prescription Drug Costs – and Drug Manufacturers, Hospitals, and Health Centers

On April 15, 2025, President Trump signed an executive order (EO) aimed at addressing the cost of prescription drugs. This EO, titled “Lowering Drug Prices by Once Again Putting Americans First,” outlines specific directives...more

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