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Drug Pricing Reporting Requirements Prescription Drugs

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

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

McDermott Will & Schulte

CMS CY 2026 proposed rules: 340B in PFS and OPPS

On July 15, 2025, the Centers for Medicare & Medicaid Services (CMS) released the CY 2026 Outpatient Prospective Payment System (OPPS) proposed rule. The proposed rule includes a provision that would increase the reduction in...more

Bricker Graydon LLP

Is My Group Health Plan Covered by State PBM Reporting Laws?

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State laws seeking to regulate pharmacy benefit managers (PBMs) have increased significantly over the past few years. As it stands, all 50 states have laws that regulate PBMs in some way, but all are unique. However, most of...more

Sheppard Mullin Richter & Hampton LLP

HRSA Announces New Requirements for FQHCs to Provide Insulin and Epinephrine at or below 340B Price

On June 24, HRSA announced that it had issued new grant award terms to its HRSA-funded health centers to provide insulin and injectable epinephrine at or below the 340B price paid by the health center for the drugs. HRSA...more

Quarles & Brady LLP

Indiana Senate Bill 140 Signed into Law Imposing Reforms on Pharmacy Benefit Managers

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Indiana recently enacted significant new legislation that will impact how pharmacy benefit management services are provided in Indiana. Senate Bill 140 (SB 140), signed into law during the 2025 legislative session, imposes...more

Goodwin

State Drug Transparency Laws - 2025 Update

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We previously reported on an uptick in the passage of state drug price transparency legislation. What follows is an update to that report. As of April 2025, approximately 23 states had passed drug price transparency laws....more

Lathrop GPM

Administration Issues Cross-Agency Guidance Targeting Health Care Pricing and Focusing on Hospitals and Health Plans

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On May 22, 2025, the U.S. Department of Health and Human Services, Department of Treasury and Department of Labor (the “Agencies”) announced new steps intended to “strengthen healthcare price transparency.” ...more

Venable LLP

June 1, 2025 Prescription Drug Reporting Deadline for Group Health Plans

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Employer group health plans must make an annual disclosure of the plan's prescription drug and healthcare spending to the Centers for Medicare & Medicaid Services (CMS). The disclosure, called the Prescription Drug Data...more

McGuireWoods Consulting

Senate Health Education Labor and Pensions Committee Releases Report on 340B Program and Recommendations for Change

When Sen. Bill Cassidy became Chairman of the U.S. Senate Health, Education, Labor and Pensions Committee this year, he stated one of his priorities was reforming the 340B Program. On April 24, 2025, he released a majority...more

Smart & Biggar

PMPRB announces Anie Perrault as acting Chairperson and releases latest expenditure report on private drug plan costs and...

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On March 6, 2025, the Patented Medicine Prices Review Board (PMPRB) announced that Thomas Digby stepped down from his role as Chairperson of the PMPRB. Vice-Chairperson Anie Perrault is now serving as acting Chairperson until...more

Mintz

Mintz IRA Update — Operationalizing the Medicare Prescription Payment Plan and Medicare Inflation Rebate Program

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In addition to the Part D Benefit Redesign, the IRA’s Medicare Prescription Payment Plan (MPPP) went into effect beginning January 1, 2025. The MPPP requires Part D Sponsors (PDPs) to allow Part D beneficiaries to pay for...more

Mintz - Health Care Viewpoints

Massachusetts Aligns with National Trends and Enacts Sweeping Legislation to Regulate Pharmaceutical Benefit Managers

On the heels of a nationwide push to regulate pharmacy benefit managers (PBMs), Massachusetts enacted a landmark piece of legislation to increase transparency and oversight within the pharmaceutical supply chain, specifically...more

Wiley Rein LLP

Proposed State and Federal PBM Legislation: Is There Reason for Action Now?

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Legislation aiming to reform the regulation of pharmacy benefit managers (PBMs) remains on the horizon on both the federal and state levels. In particular, 2023 was a fertile year for PBM legislative initiatives....more

Akin Gump Strauss Hauer & Feld LLP

The Road Ahead for Private Equity: Reflections and Predictions

The year 2023 will be remembered as a challenging one for private equity (PE), with complexities to navigate on many fronts. Traditional debt financing was expensive and scarce, expectations on valuations were tricky to...more

Sheppard Mullin Richter & Hampton LLP

Oregon Prescription Drug Price Transparency Act in Limbo

On February 16, the U. S. District Court for the District of Oregon struck down the state’s drug price transparency law—The Prescription Drug Price Transparency Act (the “Act”)—ruling that the Act’s annual price increase...more

ArentFox Schiff

Federal Court Ruling Suspends Compliance with Certain Reporting Obligations Under Oregon Drug Price Transparency Program

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Earlier this month, the US District Court for the District of Oregon issued a declaratory judgment invalidating a key component of the Oregon Drug Price Transparency Program. The Oregon Drug Price Transparency Program was...more

Cornerstone Research

5 Questions with Sayeh Nikpay: The 340B Drug Pricing Program

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A periodic feature by Cornerstone Research, in which our affiliated experts, senior advisors, and professionals, talk about their research and findings. We interview Professor Sayeh Nikpay of the School of Public Health,...more

Goodwin

Government Continues to Explore Role of 340B Contract Pharmacies

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The 340B Drug Pricing Program (the “Program”) allows certain healthcare providers (“covered entities”) to purchase pharmaceuticals from drug manufacturers at discounted rates. Some covered entities do not have an internal...more

Morgan Lewis

New Jersey Latest to Join States Signing Drug Price Transparency Reporting Measures into Law

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Following in the footsteps of other states, New Jersey’s state legislature has recently signed into law three bills for containing prescription drug costs. One bill—Senate Bill 1615—is likely to have a particularly sweeping...more

Mintz - Health Care Viewpoints

Pharmacy Benefit Managers are on the Federal Government’s Radar: Senate, House, and Agency Proposals Seek to Increase PBM...

In conjunction with the surge in state legislative efforts to regulate the pharmacy benefit manager (PBM) industry, Congress and federal agencies have ramped up PBM oversight efforts as part of the ongoing battle to lower...more

Ogletree, Deakins, Nash, Smoak & Stewart,...

CMS Updates Could Help Employers on Second Round of Drug Cost Reporting

Employers facing a June 1, 2023, deadline for 2022 prescription drug cost reporting have important new clarification on issues such as plans that cover more than one employer, average monthly premium calculations, and medical...more

Blank Rome LLP

Nevada Publishes 2023 Drug Price Transparency Lists

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On January 31, 2022, the Nevada Department of Health and Human Services (“DHHS”) released its annual drug lists in accordance with its Drug Transparency Reporting Program. DHHS published four drug lists: List #1 Essential...more

Ogletree, Deakins, Nash, Smoak & Stewart,...

Federal Regulators Offer Employer Health Plans Last-Minute Relief on Prescription Drug Reporting

Employers have a reprieve from the challenging December 27, 2022, deadline for reporting 2020 and 2021 prescription drug cost information to the U.S. Department of Health and Human Services (HHS). ...more

Goodwin

Pharma Manufacturer Federal Government Price Reporting: Recent Litigation and Settlements

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​​​​​​​Litigation involving drug price reporting under the Medicaid Drug Rebate Program (MDRP)  has been very active in 2022. Most recently, on August 3, 2022, an Illinois federal jury levied a $61 million verdict against Eli...more

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