David Gilboa at Mintz

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

8/1/2024 / Centers for Medicare & Medicaid Services (CMS) , Drug Pricing , Pharmacy Benefit Manager (PBM) , Prescription Drugs , Supply Chain , Telehealth , Transparency

Mintz IRA Update — The Consequences and Costs of Redesigning the Part D Program

The passage of the Inflation Reduction Act of 2022 (IRA) marked a significant milestone in Congress’s ongoing efforts to address escalating health care costs. While the IRA aims to rein in government spending on Medicare and...more

7/16/2024 / Beneficiaries , Centers for Medicare & Medicaid Services (CMS) , Drug Pricing , Health Insurance , Health Plan Sponsors , Inflation Reduction Act (IRA) , Manufacturers , Medicare Part D , Out-of-Pocket Expenses , Reimbursements

House Committee Proposes to Extend Medicare Telehealth Flexibilities, Eyes PBM Reform to Offset Expenses

On May 8, 2024, the U.S. House of Representatives Ways & Means Committee passed a bipartisan bill entitled the “Preserving Telehealth, Hospital and Ambulance Access Act” by a vote of 41-0, which will potentially have...more

5/16/2024 / Drug Pricing , Enforcement , Medicare , Pharmacy Benefit Manager (PBM) , Prescription Drugs , Telehealth

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

5/3/2024 / Electronically Stored Information , Employee Retirement Income Security Act (ERISA) , Fiduciary Duty , Pharmacy Benefit Manager (PBM) , Price Gouging , Section 340B , Sherman Act , Transparency

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

4/10/2024 / Competition , Healthcare , Inflation Reduction Act (IRA) , Pharmacy Benefit Manager (PBM) , Prescription Drugs , Price Gouging , Proposed Legislation , Rebates , Transparency

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

12/5/2023 / Affordable Care Act , Co-payments , Department of Health and Human Services (HHS) , Enforcement Actions , Interim Final Rules (IFR) , Pharmacy Benefit Manager (PBM) , Prescription Drugs

The LDT Debate: Unpacking Public Responses to FDA’s Proposed Rule

The U.S. Food and Drug Administration (FDA) recently released a proposed rule that would seek to regulate laboratory developed tests (LDTs) as medical devices under the Federal Food, Drug, and Cosmetic Act (FDCA). This rule...more

11/21/2023 / Coronavirus/COVID-19 , Federal Food Drug and Cosmetic Act (FFDCA) , Food and Drug Administration (FDA) , HELP , Laboratory Developed Tests , Proposed Rules , Trade Associations

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

10/10/2023 / Centers for Medicare & Medicaid Services (CMS) , Co-payments , Department of Health and Human Services (HHS) , Health and Welfare Plans , Health Care Providers , Healthcare , Out-of-Pocket Expenses , Pharmacy Benefit Manager (PBM)

Transforming Primary Care: CMS Launches Making Care Primary (MCP) Model

The Centers for Medicare & Medicaid Services (CMS) announced a new primary care model—the Making Care Primary (MCP) Model—geared towards smaller, independent primary care practices and organizations that want to participate...more

8/9/2023 / ACOs , Centers for Medicare & Medicaid Services (CMS) , Fee-for-Service , Health Care Providers , Infrastructure , Medicaid , Medicare Shared Savings Program , Performance Incentives , Value-Based Care

David Gilboa

Mintz

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