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Pharmaceutical Industry › Rulemaking Process › Medicare

Brownstein Hyatt Farber Schreck

Most-Favored-Nation Drug Pricing in the U.S.

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On May 12, President Trump issued an Executive Order (EO) on drug pricing: “Delivering Most-Favored-Nation Prescription Drug Pricing to American Patients.” The EO requires a 30-day government negotiation with drug companies...more

Hogan Lovells

White House raises more questions than answers in Executive Order directing Most Favored Nation drug pricing

Hogan Lovells on

On May 12, 2025, the White House issued an Executive Order (EO) entitled “Delivering Most Favored Nation Prescription Drug Pricing to American Patients.” The EO directs the Secretary of Health and Human Services (HHS) to...more

McDermott Will & Schulte

Trending in Telehealth: July 11 – 17, 2023

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Trending in Telehealth is a new series from the McDermott digital health team in which we highlight state legislative and regulatory developments that impact the healthcare providers, telehealth and digital health companies,...more

Wiley Rein LLP

Part Two: The MFN Drug Pricing Rule and the Rebate Rule: Where Do We Go From Here?

Wiley Rein LLP on

In part two, Wiley Health Care Practice partners Dot Powell-Woodson and Rachel Alexander continue their discussion of the Most-Favored Nations (MFN) Rule and the Rebate Rule and look at the potential impacts of these Final...more

Wiley Rein LLP

Part One: Two new Medicare Drug Pricing Rules in One Day: What are the MFN and the Rebate Drug Pricing Rules?

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In part one, Wiley Health Care Practice partners Dot Powell-Woodson and Rachel Alexander break down the background, substance, and procedural issues of the two Final Drug Pricing Rules released on November 30, 2020: the...more

Holland & Knight LLP

HHS Releases Four Major Rules to Lower Drug Prices, Amend Anti-Kickback and Stark Laws

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The U.S. Department of Health and Human Services (HHS) issued four major rules on Nov. 20, 2020, which was the final day for the Trump Administration to issue a rule with a 60-day implementation period for it to take effect...more

Akin Gump Strauss Hauer & Feld LLP

What's New in Washington - September 2020

Akin Gump Strauss Hauer & Feld LLP on

As the November elections rapidly approach, Congress faces a number of key legislative deadlines, including the need to fund federal agencies and extend expiring federal programs at the conclusion of the current fiscal year...more

Polsinelli

CMS Delays Price Transparency, Doubles Down on Site-Neutral and 340B Payment Policies in CY 2020 OPPS Final Rule

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Late last week, the Centers for Medicare & Medicaid Services (“CMS”) released the CY 2020 Hospital Outpatient Prospective Payment System (“OPPS”) final rule [CMS-1717-FC]. While many hospitals had hoped for relief from recent...more

Dorsey & Whitney LLP

Court Invalidates Final Rule Requiring Advertisements to List Drug Prices Finding that CMS Exceeded Its Statutory Authority

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In a much anticipated decision, a federal judge ruled this week that the Trump Administration’s rule requiring drug manufacturers to list drug prices in television advertisements exceeds the agency’s authority. Back in May...more

Robinson+Cole Health Law Diagnosis

CMS Amends Regulations to Lower Drug Prices and Reduce Out-Of-Pocket Expenses in Medicare Advantage and Part D Prescription Drug...

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The Centers for Medicare and Medicaid Services (CMS) announced a final rule, to be published on May 23, 2019, amending the Medicare Advantage program (Part C) and Prescription Drug Benefit program (Part D) regulations. ...more

Gray Reed

Proposed Revisions To The Anti-Kickback Regulatory Discount Safe Harbor: What Does This Mean For The Drug Industry And For Your...

Gray Reed on

Continuing the Trump administration’s efforts to lower drug prices and reduce patient out-of-pocket costs, on February 6,2019, the U.S. Department of Health and Human Services Office of Inspector General (“HHS”) released a...more

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