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PBM Policy and Legislative Update — Summer 2024

Mintz’s PBM practice is pleased to present a 2024 year-to-date PBM Policy and Legislative Update. This edition builds upon prior issues and summarizes activity from January through June that impacts the PBM industry. It...more

Mintz IRA Update — IRA Litigation Update: Courts Begin to Address Legal Challenges to the Medicare Drug Price Negotiation Program

The IRA’s Medicare Drug Price Negotiation Program (the “Negotiation Program” or “Program”), which enables the federal government to negotiate prices for some of the costliest Medicare Part D drugs, has been subject to several...more

The Uncertain Landscape of Medicare Agent/Broker Compensation Rules

In the Proposed Medicare Advantage and Part D Rules for 2025, the Centers for Medicare & Medicaid Services (CMS) proposed significant changes to how Medicare Advantage organizations (MAOs) are allowed to contract with and...more

PBM Policy and Legislative Update — Winter 2024

The PBM regulatory landscape continues to evolve rapidly at both federal and state levels, making it critical for our clients involved in the PBM space to stay apprised of developments in the industry. Our team actively...more

PBM Policy and Legislative Update - Winter 2024

The PBM regulatory landscape continues to evolve rapidly at both federal and state levels, making it critical for our clients involved in the PBM space to stay apprised of developments in the industry. Our team actively...more

Mintz IRA Update — Legal Challenges to the Medicare Drug Price Negotiation Program Continue

The IRA’s Medicare Drug Price Negotiation Program (the “Negotiation Program” or “Program”), which aims to lower drug prices by enabling the federal government to negotiate prices for some of the costliest Medicare Part D...more

Mintz IRA Update — Demystifying the IRA’s Small Biotech Exception

On August 29, 2023, CMS selected the first 10 high-expenditure, single source, Medicare Part D drugs subject to negotiation under the IRA’s Medicare Drug Price Negotiation Program (the “Negotiation Program” or “Program”). In...more

Mintz IRA Update — Second Edition: Q1 2024

Mintz’s PBMs & Pharmacies practice is pleased to present the second edition of our Mintz IRA Update, a regular publication that delves into developments under the Inflation Reduction Act of 2022 (“IRA”) impacting the health...more

Safeguarding Reproductive Rights

In a defining moment for reproductive rights in America, the Supreme Court’s decision in Dobbs v. Jackson Women's Health Organization (2022) marked a pivotal turning point. This ruling, revoking the constitutional right to...more

HHS Court Filings Indicate that Agency Intends to Preserve Copay Accumulators

As we wrote about in our prior blog post, on September 29, 2023, John D. Bates of the U.S. District Court for the District of Columbia struck down a federal rule that permitted health plans and pharmacy benefit managers...more

Court Strikes Down HHS Rule on Copay Accumulators: Implications for Health Plans and PBMs

In a significant development with far-reaching implications for health plans and pharmacy benefit managers (PBMs), Judge John D. Bates of the U.S. District Court for the District of Columbia has recently struck down a federal...more

California Legislative Update Part II: Upcoming Changes for Health Facilities

Governor Gavin Newsom signed 997 bills into law in 2022, including a substantial number relating to health care. In Part II of our legislative update, we summarize many of the laws relevant to health facilities, a number of...more

With Proposal to Cap Drug Price Increases, Massachusetts Once Again Takes Center Stage in the Drug Pricing Debate

On March 17, the same day we wrote about proposed legislation in Connecticut to cap drug price increases, Governor Charlie Baker of Massachusetts included a similar proposal in his proposed budget. Similar to the Connecticut...more

Connecticut Proposal to Cap Drug Price Increases Could Portend a Shift in the Drug Pricing Debate

On March 15, 2022, a drug pricing bill proposed by Connecticut Governor Ned Lamont’s (S.B. 13) was referred to the state legislature’s nonpartisan legal counsel responsible for drafting and processing official legislation....more

CMS Proposes Changes to Medicare Advantage Regulations: Network Adequacy, Beneficiary Access, MLR Reporting, and MOOP

Continuing our series analyzing the recently proposed Contract Year 2023 Policy and Technical Changes to the Medicare Advantage and Medicare Prescription Drug Benefit Programs rules (Proposed Rule), this post focuses on a few...more

Trump Administration Releases Series of Executive Orders on Drug Pricing

The Trump Administration issued a series of Executive Orders (“EOs” or “Orders”) Friday afternoon related to drug pricing. Several of the EOs seek to restart stalled or withdrawn policy initiatives previously announced by the...more

A Review of the Affordable Care Act at 10 Years, Part 4: Alternative Payment and Delivery Models

Today's post is the last in our series on the 10-year anniversary of the Affordable Care Act (ACA). While the Congress that passed the ACA recognized that health care delivery reform was necessary, the law included few...more

A Review of the Affordable Care Act at 10 Years, Part 3: Market Reforms and Risk Adjustment

This post is the third installment in our blog series looking back the Affordable Care Act (ACA) and the 10 years since it was passed. We will cover the ACA's market reforms, including the establishment of essential health...more

A Review of the Affordable Care Act at 10 Years

Two weeks ago marked the tenth anniversary of the enactment of the Affordable Care Act (ACA). Given the ongoing COVID-19 pandemic, which Mintz has been closely monitoring, it is understandable why the anniversary has largely...more

A Review of the Affordable Care Act at 10 Years, Part 2: Medicaid Expansion

This post is the second installment in our blog series looking back on the 10-year anniversary of the Affordable Care Act (ACA) and will examine Medicaid expansion under the ACA. Medicaid is joint federal-state program that...more

A Review of the Affordable Care Act at 10 Years, Part 1: The Individual Mandate

This post is the first installment in our blog series looking back on the 10-year anniversary of the Affordable Care Act (ACA). The most controversial of the ACA's reforms has been the individual mandate, which requires that...more

Did the Tenth Circuit Just Put the Final Nail in the Coffin for Challenges to the Use of “Statewide Average Premium” in Risk...

On December 31, 2019, the Tenth Circuit Court of Appeals upheld the Department of Health & Human Services’ Affordable Care Act (ACA) risk adjustment methodology in New Mexico Health Connections v. HHS, No. 18-2186 (10th Cir....more

Compounding Pharmacy and Private Equity Firm Owner Agree to $21 Million Settlement to Resolve FCA Allegations

The Department of Justice (DOJ) recently announced that it has agreed to a $21.36 million settlement with compounding pharmacy Diabetic Care Rx LLC d/b/a Patient Care America (PCA), private equity firm Riordan, Lewis & Haden...more

CMS Proposes Changes to Medicare Advantage Program for CY 2020

CMS recently proposed several important changes for the Medicare Advantage ("MA") program that relate to payment, benefit design, and new actions to combat the opioid crisis. These changes, among others, were proposed in...more

New Mexico Court Affirms Ruling in ACA Risk Corridor Case

On October 19, 2018, a New Mexico district judge rejected a request from HHS to reconsider a February decision that had briefly led to the suspension of the ACA’s risk adjustment program. In February, District Judge James...more

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