News & Analysis as of

Health Care Providers Rebates

Holland & Knight LLP

CMS Releases CY 2025 Medicare Physician Fee Schedule Proposed Rule

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The Centers for Medicare & Medicaid Services (CMS) has released the calendar year (CY) 2025 Revisions to Payment Policies Under the Physician Fee Schedule (MPFS) and Other Revisions to Medicare Part B (CMS-1807-P) Proposed...more

Stevens & Lee

Two Recent Federal Court Cases Tackle Three Critical Components of the Anti-Kickback Statute

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Two recently decided federal court cases hone in on the proper interpretation and application of three critical components of the Anti-Kickback Statute (“AKS”), namely: •the requirement that a violation of the AKS must...more

American Conference Institute (ACI)

[Event] 21st Annual Rx Drug Pricing Boot Camp - May 4th - 5th, New York City, NY

The American Conference Institute is hosting the 21st Annual Rx Drug Pricing Boot Camp in New York. With both federal and state law makers engaging in greater scrutiny of prescription drug pricing, now is the time when...more

Harris Beach PLLC

OIG Enforcement Summary: August 16, 2022 – August 31, 2022

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The following is a summary of the federal Department of Health and Human Services’ Office of Inspector General (OIG) reports of fraud and abuse enforcement activity across the country. The enforcement actions reported are...more

Hogan Lovells

[Ongoing Program] Unpacking the prescription drug provisions of the Inflation Reduction Act of 2022 - Part 3: Medicare Part D...

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On August 7, 2022, the Senate passed the proposed Inflation Reduction Act of 2022, which includes a number of significant prescription drug-related provisions. The bill generally revives many of the prescription drug...more

Hogan Lovells

[Ongoing Program] Unpacking the prescription drug provisions of the Inflation Reduction Act of 2022 - Part 2: Medicare Part B and...

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On August 7, 2022, the Senate passed the proposed Inflation Reduction Act of 2022, which includes a number of significant prescription drug-related provisions. The bill generally revives many of the prescription drug...more

Hogan Lovells

[Ongoing Program] Unpacking the prescription drug provisions of the Inflation Reduction Act of 2022 - Part 1: Drug price...

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On August 7, 2022, the Senate passed the proposed Inflation Reduction Act of 2022, which includes a number of significant prescription drug-related provisions. The bill generally revives many of the prescription drug...more

Manatt, Phelps & Phillips, LLP

[Webinar] Preparing for Change: A Guide to the Inflation Reduction Act Drug Pricing Provisions - August 23rd, 1:00 pm - 2:00 pm ET

The Inflation Reduction Act (IRA) will make arguably the most significant changes to U.S. prescription drug pricing regulations ever, but certainly since the creation of the Medicaid Drug Rebate Program in 1990. For the first...more

Manatt, Phelps & Phillips, LLP

Delivering Breakthrough Treatments Affordably

Editor’s Note: In a recent webinar, Manatt Health’s Anthony Fiori, Senior Managing Director, and Alex Dworkowitz, Partner, hosted a panel of innovative thought leaders—including Dr. Sanjiv Shah, Chief Medical Officer of...more

MoFo Life Sciences

Ninth Circuit Weighs In On Fraud-On-The-FDA Theory, Marketing Devices For Off-Label Use, And Kickbacks

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The Ninth Circuit recently weighed in on the appeal of a False Claims Act lawsuit from a relator against Medtronic. In this case, the relator alleges that Medtronic, Inc.: (1) Engaged in “fraud-on-the-FDA” when obtaining...more

Bass, Berry & Sims PLC

CMS and the OIG Issue Final Rules Modernizing and Clarifying the Federal Stark and Anti-Kickback Laws

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In a coordinated effort, on November 27, 2020, the Centers for Medicare & Medicaid Services (CMS) and the Office of Inspector General (OIG) published final rules to modernize regulations implementing the federal...more

Wiley Rein LLP

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

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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

Akin Gump Strauss Hauer & Feld LLP

Battle Lines Drawn with Release of Speaker’s Drug Pricing Plan

[co-authors: Sean Feely, Senior Public Policy Specialist and Julie E. Nolan, Senior Policy Advisor] • On September 19, Speaker Pelosi released a drug pricing plan that includes proposals for Medicare direct price...more

Foley Hoag LLP - Medicaid and the Law

Senate Finance Committee Proposes Significant Drug Pricing Reforms in Medicaid

On July 25, 2019 the Senate Finance Committee voted to advance their long-awaited drug pricing package to the Senate floor (we anticipate a Floor vote sometime this Fall). The Prescription Drug Pricing Reduction Act (PDPRA)...more

Cooley LLP

Blog: White House Withdraws Rebate Rule

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Earlier this morning, the White House announced that they were scrapping a proposed rule (the rebate rule) that, among other items, would have [would eliminate the current safe harbor protection under the Anti-Kickback...more

Bricker Graydon LLP

OIG says Part D contracts cost Medicare as much as $75 million in lost drug manufacturer rebates in one year

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The Department of Health and Human Services (HHS) Office of Inspector General (OIG) released a report on July 1, 2019, finding that Medicare Part D contracts between Medicare Prescription Drug Plan sponsors and drug...more

Verrill

OIG Proposes Revisions to Anti-Kickback Safe Harbor Regulations Affecting Prescription Drug Rebates

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Recently, the U.S. Department of Health and Human Services (“HHS”) Office of Inspector General (“OIG”) published a proposed rule (“Proposed Rule”) in the Federal Register to amend the federal anti-kickback statute safe harbor...more

Arnall Golden Gregory LLP

HHS Proposes Anti-Kickback Safe Harbor Revisions that Would Impact Drug Manufacturer Rebates to Health Plans, MCOs, and Pharmacy...

On January 31, 2019, the Department of Health and Human Services (HHS) Office of the Inspector General (OIG) proposed a new rule that would amend the safe harbor regulations under the Federal anti-kickback statute (42 U.S.C....more

Sheppard Mullin Richter & Hampton LLP

HHS Proposes Rule to Eliminate Safe Harbor for PBM Drug Rebates

On February 6, 2019, the Office of the Inspector General of the U.S. Department of Health and Human Services (the “OIG”) published in the Federal Register a proposed rule (the “Proposed Rule”) that, if made final in its...more

Robinson+Cole Health Law Diagnosis

HHS Proposes to Amend AKS Safe Harbors to Exclude PBM Rebates and Incentivize Consumer Drug Discounts

On February 6, 2019, the Department of Health and Human Services (HHS) Office of Inspector General (OIG) published a proposed rule (Proposed Rule) that would amend the safe harbor regulations under the Federal Anti-Kickback...more

Epstein Becker & Green

HHS OIG Proposes Anti-Kickback Safe Harbor Amendments to Regulate and Restrict the Provision of Manufacturer Remuneration to Plan...

On January 31, 2019, the Department of Health and Human Services (“HHS”) Office of Inspector General (“OIG”) issued a proposed rule (“Proposed Rule”) that would restrict safe harbor protection under the federal Anti-Kickback...more

Dorsey & Whitney LLP

Drug Rebates Threatened Under Proposed Anti-kickback Rule

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The Office of Inspector General of the Department of Health and Human Services (“OIG”) released a proposed rule to eliminate safe harbor protection under the anti-kickback statute for drug price reductions that pharmaceutical...more

Skadden, Arps, Slate, Meagher & Flom LLP

Sweeping Changes Proposed to Safe Harbors for Drug Discounts to Health Plans

The Department of Health and Human Services (HHS) has published a proposed rule that would make sweeping changes to the discount and rebate arrangements between drug manufacturers on the one hand and Medicare Part D plans and...more

Bass, Berry & Sims PLC

OIG Proposed Rule Seeks to Address Drug Pricing Concerns – But Will It?

In an effort to respond to prescription drug pricing concerns, on January 31, 2019, the Office of Inspector General (OIG) of the U.S. Department of Health and Human Services (HHS) released a highly anticipated, 123-page...more

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