News & Analysis as of

Health Insurance Drug Pricing

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

Quarles & Brady LLP

Manufacturer Rebate Models: The Next 340B Program Battleground

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The 340B Drug Pricing Program (“340B Program”) space continues to be a hive of activity. While 340B stakeholders continue to litigate ongoing manufacturer contract pharmacy restrictions, states legislatures are enacting...more

DLA Piper

Keeping Watch on Medicare: Formulary Assessment Shows Large Declines in Access for Certain Rare Disease Treatments

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The Inflation Reduction Act (IRA) changed how drugs are covered and reimbursed in Medicare. It is anticipated that this may lead to more restrictive formularies in drug plans....more

Holland & Knight LLP

Holland & Knight Health Dose: July 29, 2025

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This week, the U.S. House of Representatives will be out of session, as the chamber has adjourned for the August 2025 district work period. The U.S. Senate remains in session and continues to consider nominations to lead...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

Hall Benefits Law

How Plan Sponsors Can Mitigate Risk in PBM Contracts

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For employers offering benefit plans, fiduciary responsibility is not just a legal designation. Under the Employee Retirement Income Security Act of 1974, as amended, the fiduciary duty is the highest standard of care...more

Brownstein Hyatt Farber Schreck

Key Differences in Provisions Between Draft Senate and House-Passed Reconciliation Bill

Over the last week, the Senate Finance Committee and Senate Agriculture Committee released their portions of reconciliation text, which includes most of the Medicaid and food insecurity provisions. The Senate committees will...more

Hall Benefits Law

PBM Contracts Could Expose Plan Sponsors to Fiduciary Liability

Hall Benefits Law on

A plan sponsor’s fiduciary duty to be transparent in Pharmacy Benefit Manager contracts safeguards plan participants’ interests and mitigates the risk of litigation, regulatory penalties, and reputational harm, say Hall...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

Seyfarth Shaw LLP

States Seeking Remedies for the Rising Costs of Prescription Drugs

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As expected, the lawsuits have commenced following the enactment of the Arkansas legislation prohibiting pharmacy benefit managers (PBM’s) from owning or operating actual pharmacies within the state. Michigan has filed its...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

McDermott+

First Steps in Implementing the Trump Administration’s Price Transparency Agenda

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Recently, the Trump administration took steps toward implementing one of its major priorities: improving price transparency. As discussed in a previous Regs & Eggs blog post, President Trump signed an executive order (EO) on...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

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

Goodwin

Antitrust Life Sciences Quarterly Update 2025 Q1

Goodwin on

While M&A activity slowed in the first quarter of 2025, including in life sciences, there have been plenty of noteworthy developments in the antitrust space in the first 100 days of the Trump administration....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

Groom Law Group, Chartered

CMS Finalizes Annual Medicare Advantage and Part D Rulemaking Updates

In April 2025, the Centers for Medicare and Medicaid Services (“CMS”) issued multiple pieces of guidance related to Medicare Advantage plans and Medicare Part D prescription drug coverage, including the Final CY 2026 Part D...more

Bass, Berry & Sims PLC

Stuck in the Middle: Self-Funded Health Plans and Recent Challenges to State PBM Laws

In recent years, prescription drug prices have been top-of-mind for state legislators, who have responded by passing laws that seek to control that pricing in a variety of ways, including by regulating pharmacy benefit...more

Arnall Golden Gregory LLP

Healthcare Authority Newsletter - April 2025 #4

News Briefs - High Court to Hear Case Challenging ACA Free Preventive Care - The Supreme Court is set to hear arguments in a case challenging a provision of the Affordable Care Act that requires private insurers to cover...more

Seyfarth Shaw LLP

Cutting Out the Middle Man

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Arkansas has become the first state in the nation to enact legislation, effective starting in 2026, prohibiting pharmacy benefit managers (PBM’s) from owning or operating actual pharmacies within the state. We take a look at...more

Quarles & Brady LLP

Part D Pharmacies Required to Enroll in Data Exchange Module to Help Drug Price Negotiation Cash Flow Issue

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On April 15, 2025, the Centers for Medicare & Medicaid Services (“CMS”) published the Contract Year 2026 Policy and Technical Changes Final Rule which amends the regulations governing various Medicare programs, including the...more

Maynard Nexsen

JPMorgan Sued Over Management of Prescription Drug Benefits

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On March 13, 2025, several current and former participants in the JPMorgan Chase Health Care and Insurance Program for Active Employees, as well as its component Medical Plan (collectively referred to as the “Plan”) filed a...more

Lathrop GPM

Call for Additional Regulations for Health Plan Compensation Disclosures

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In an April 15 Executive Order, entitled “Lowering Drug Prices by Once Again Putting Americans First,” the Trump Administration has called attention to an ERISA disclosure required by the Consolidated Appropriations Act of...more

Jones Day

Constitutional Challenges to Inflation Reduction Act Head to Courts of Appeals

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No legislation has garnered more attention in the life sciences industry in recent past than the so-called Drug Price Negotiation Program of the Inflation Reduction Act (the "Program"). ...more

Maynard Nexsen

The Alabama Community Pharmacy Relief Act: Key Provisions and Legislative Journey

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Introduction The Alabama Community Pharmacy Relief Act, Senate Bill 252, has successfully passed the Alabama Senate and is now advancing to the House for consideration. This legislation aims to regulate pharmacy benefits...more

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