News & Analysis as of

Pharmaceutical Industry Health Insurance

Alston & Bird

Health Care Week in Review: Agencies issued Requirements Related to the Mental Health Parity and Addiction Equity Act final rules;...

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Below is Alston & Bird’s Health Care Week in Review, which provides a synopsis of the latest news in health care regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies,...more

Manatt, Phelps & Phillips, LLP

Oregon PDAB Discusses Draft UPL Report

On August 21, Oregon’s Prescription Drug Affordability Board (PDAB) reviewed a draft upper payment limit (UPL) constituent engagement report, which captured feedback from patients, providers, health plans, manufacturers, and...more

Brownstein Hyatt Farber Schreck

Emerging Class Action Litigation Trend Over Excessive PBM Fees

A new litigation trend is emerging regarding fiduciaries of health plans and their duties to prudently evaluate fees being charged by pharmacy benefit managers (“PBM”). Two Fortune 50 employers, Johnson & Johnson and Wells...more

Manatt, Phelps & Phillips, LLP

Maryland PDAB Releases Draft Upper Payment Limit Action Plan

On August 9, Maryland’s Prescription Drug Affordability Board (PDAB) released its draft action plan for establishing upper payment limits (UPLs) for drugs identified as causing or likely to cause affordability challenges. The...more

Manatt, Phelps & Phillips, LLP

CMS Announces Part D Premium Parameters, New Policy to Stabilize Standalone Part D Premiums

The Centers for Medicare & Medicaid Services (CMS) released the Part D national average bid amount and Part D base beneficiary premiums for 2025. These figures set the premium costs and government subsidies for Medicare...more

WilmerHale

The Interplay: Key Decisions at the Intersection of Antitrust and Life Sciences - July 2024

WilmerHale on

Federal Circuit Allows Teva Patents to Remain in Orange Book.  - The Federal Circuit recently granted Teva Pharmaceutical’s motion for a stay of removal of its patents from the Orange Book in its ongoing dispute with...more

Manatt, Phelps & Phillips, LLP

CMS Finalizes Part D Cost-Sharing Smoothing Guidance

The Centers for Medicare & Medicaid Services (CMS) finalized the second part of its guidance on implementation of the IRA’s Medicare Prescription Payment Plan (MPPP), known informally as Part D monthly out of-pocket...more

The Volkov Law Group

The Continuing Plague of Healthcare Fraud

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Healthcare fraud is an ever-growing constant in our economy.  It is a battle that presents new and exponential challenges.  The U.S. Department of Justice, the HHS-Office of Inspector general and State Attorneys’ General all...more

Goodwin

FTC Issues Interim Report on Ongoing Study of Pharmacy Benefit Managers

Goodwin on

On July 9, 2024, the Federal Trade Commission (“FTC”) released an interim report describing their ongoing study of pharmacy benefit managers (“PBMs”) and their impact on access to and affordability of medicines....more

Alston & Bird

Health Care Week in Review: CMS Releases Final Medicare Prescription Payment Plan Part 2 Guidance

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Below is Alston & Bird’s Health Care Week in Review, which provides a synopsis of the latest news in health care regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies,...more

Arnall Golden Gregory LLP

OIG Issues Favorable Advisory Opinion Involving Financial Risk Mitigation Arrangements for High-Cost Rare Disease Drug

On June 20, 2024, the U.S. Department of Health and Human Services Office of Inspector General (“OIG”) posted Advisory Opinion 24-04, a favorable opinion analyzing a refund and discount program designed to alleviate the...more

Manatt, Phelps & Phillips, LLP

CMS and ONC Issue Final Rule on E-Prescribing

On June 17, CMS and the Office of the National Coordinator for Health Information Technology (ONC) issued a final rule implementing new standards for e-prescribing under Medicare Part D. ...more

Bass, Berry & Sims PLC

OIG Advisory Opinion 24-03 Greenlights Travel and Lodging Assistance for Gene Therapy Patients

Bass, Berry & Sims PLC on

On June 17, the U.S. Department of Health and Human Services Office of Inspector General (OIG) posted Advisory Opinion 24-03, approving an arrangement under which a pharmaceutical manufacturer provides travel, lodging, and...more

Manatt, Phelps & Phillips, LLP

Patient Impact of the Inflation Reduction Act - Administrative Options to Address Changed Incentives for Formulary and Utilization...

Executive Summary- The Inflation Reduction Act (IRA) makes significant changes to the Medicare Part D prescription drug benefit and also directs the Centers for Medicare and Medicaid Services (CMS) to enforce...more

Alston & Bird

Health Care Week in Review: Senate Democrats Released Draft Legislation to Prevent Labor and Delivery Unit Closures; CMS Announced...

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Below is Alston & Bird’s Health Care Week in Review, which provides a synopsis of the latest news in health care regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies,...more

Polsinelli

Recent Regulatory Actions Against Unlicensed Pharmacy Benefit Managers in West Virginia

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The West Virginia Office of the Insurance Commissioner (“WV OIC”) recently took regulatory actions against four unaffiliated Pharmacy Benefit Managers (“PBMs”) that were operating in West Virginia without a PBM license. These...more

Akerman LLP - Health Law Rx

When a Gift Becomes a Kickback: Gifts from Florida Pharmacies to Long-Term Care Facilities

The Florida Board of Pharmacy permits pharmacies serving residents and patients at long-term care facilities (nursing homes, ALFs, homes for DD residents, etc.) as either Special Closed System Pharmacies or Community...more

Nelson Hardiman, LLP

Cracking the Whip: The FTC’s Clampdown on Healthcare Marketing

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The American reverence for entrepreneurial spirit and free enterprise is reflected in the profound influence of capitalism on our healthcare system. In contrast to many other advanced industrialized countries with state-run...more

Patrick Malone & Associates P.C. | DC Injury...

Better Health Care Newsletter - May 2024

We Americans pay more for prescription medications than just about anywhere else on the globe. And Big Pharma keeps jacking prices higher....more

McDermott Will & Emery

CMS Advises Preparatory Steps for Anticipated PrEP Coverage Transition to Medicare Part B

McDermott Will & Emery on

On April 15, the Centers for Medicare & Medicaid Services (CMS) released a fact sheet on the potential national coverage determination (NCD) for pre-exposure prophylaxis (PrEP) using antiretroviral drugs to prevent HIV. CMS...more

Alston & Bird

Health Care Week in Review: CMS Issues Rules on FY 2025 Payment Rates; Medicaid Enrollment; and Short-Term, Limited Duration...

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Below is Alston & Bird’s Health Care Week in Review, which provides a synopsis of the latest news in health care regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies,...more

Epstein Becker & Green

Last Call for Comments on Bipartisan Discussion Draft SUSTAIN Act: Shaping 340B for the Future

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Only a few days remain for stakeholders—which includes drug manufacturers, patients, health care providers, pharmacies and others— to take advantage of a rare opportunity to influence the statutory contours of the 340B Drug...more

Alston & Bird

Health Care Week in Review: House Passes Appropriations Bill and Senate Expected to Vote Shortly, CMS Unveils the ACO Primary Care...

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Below is Alston & Bird’s Health Care Week in Review, which provides a synopsis of the latest news in health care regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies,...more

Polsinelli

Medicare Changes to Make Drug Coverage More Manageable in 2025

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Within the last few months, the Centers for Medicare and Medicaid Services (CMS) has issued guidance that will reduce the financial burdens of paying for prescription drug coverage for Medicare patients. The guidance outlines...more

Polsinelli

Florida Legislative Session 2024: Health Care Highlights

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The Florida Regular Legislative Session began on January 9, 2024, and ended on March 8, 2024. Below is a summary of relevant health care laws that will be effective July 1, 2024, if they are approved by Governor DeSantis....more

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