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Health Care Providers Prescription Drugs Rebates

Dinsmore & Shohl LLP

HRSA Announces Pilot Program for 340B Rebate Models

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On the heels of multiple lawsuits disrupting drug manufacturers’ efforts to convert the 340B Program into a rebate-based model, the Health Resources and Services Administration (HRSA) released a Notice[1] announcing the...more

McDermott Will & Schulte

This Week in 340B: February 11 – 17, 2025

Find this week’s updates on 340B litigation to help you stay in the know on how 340B cases are developing across the country. Each week we comb through the dockets of more than 50 340B cases to provide you with a quick...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

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...

Hogan Lovells on

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

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

Cooley LLP

Blog: White House Withdraws Rebate Rule

Cooley LLP on

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

Holland & Knight LLP

Administration Proposes Changes to the Drug Rebate Program

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On Jan. 31, 2019, the Department of Health and Human Services' (HHS) Office of the Inspector General (OIG) issued a long-awaited proposed rule that would, if finalized, remove the existing legal "safe harbor" that protects...more

K&L Gates LLP

K&L Gates Triage: 340B Update: State Medicaid 340B Billing Requirements

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In the midst of the ongoing federal conversation surrounding the 340B Drug Pricing Program, individual states are implementing a number of regulatory efforts related to the 340B Program at an increasingly fast pace. These...more

Holland & Knight LLP

White House Unveils Proposal on Drug Pricing

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On Feb. 9, 2018, the Trump Administration released a 30-page report analyzing domestic and global factors influencing drug pricing. The report by the Council of Economic Advisers (CEA) is expected to inform the HHS' Fiscal...more

Mintz - ML Strategies

Health Care Update - November 2015

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Ways & Means Leadership Changes – Health Policy Implications Looming: As Congress pushes forward with a two-year budget deal, and new Speaker Paul Ryan begins his tenure as the top Republican in the House of...more

McDermott Will & Emery

Congress Take Step Toward Site-Neutral Medicare Payments in Bipartisan Budget Act of 2015

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On October 28, 2015, the U.S. House of Representatives approved legislation that, if enacted, would, among other things, substantially alter how and how much Medicare pays for outpatient services furnished by hospitals. The...more

Baker Donelson

HRSA Issues Long-Awaited 340B Program Omnibus Guidance Proposal

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After much anticipation, the Health Resources and Services Administration (HRSA) late last week released its 340B Drug Pricing Program Omnibus Guidance Proposal (the Proposal). HRSA indicates that its goal in issuing the...more

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