News & Analysis as of

Pharmacy Benefit Manager (PBM) Compliance

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

Mintz - Health Care Viewpoints

PBM Policy and Legislative Update — Winter 2025

The PBM regulatory landscape is rapidly evolving 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 as they happen. Our team...more

Mintz - Health Care Viewpoints

EnforceMintz — Medicare Advantage and Part D Programs to Remain in the Enforcement Spotlight in 2025

As government scrutiny and enforcement targeting the Medicare Advantage (Medicare Part C) program continued in 2024, the industry’s response to agency actions escalated. Last year also resulted in the first sizable Part D...more

Mintz - Health Care Viewpoints

It’s Been a Long Time Coming: Massachusetts Health Care Market Review 2.0

The latest entrant in a national wave of policymakers enacting health care market oversight laws that have a significant impact on providers and investors, Massachusetts Governor Maura Healey has signed into law House Bill...more

McAfee & Taft

Challenge to copay assistance strategy, another PBM ERISA preemption lawsuit, and other compliance issues for 2025

McAfee & Taft on

The end of 2024 gave group health plan sponsors several new lawsuits to watch in 2025. Gurwitch v. SAVE ON SP LLC - On December 26, 2024, a class action complaint was filed in the U.S. District Court for the Northern District...more

Smart & Biggar

Evolving pharmacy landscape signals more stringent regulatory scrutiny of “patient steering”

Smart & Biggar on

The pharmacy landscape has evolved considerably over the past year, shining a spotlight on pharmacy “patient steering”, the practice of directing patients to certain preferred pharmacies. Though Quebec has long required that...more

Ankura

New Health Information Technology Standards for Medicare Part D

Ankura on

On June 17, 2024, the final rule for Medicare Part D introduced new health IT standards, mandating the adoption of NCPDP SCRIPT Standard version 2023011 by January 1, 2028, while the NCPDP Formulary and Benefit (F&B) Standard...more

McAfee & Taft

Employee benefit rules: The gifts that keep on giving

McAfee & Taft on

As employers look back at 2023 and ahead to 2024, there are so many compliance-related items to consider relating to their employee benefit plans.  The rules employers are supposed to be complying with keep growing and...more

J.S. Held

AHLA Takeaway: Healthcare Executives, Is Your House In Order?

J.S. Held on

Walking away from the American Health Law Association’s annual conference, I’m feeling energized from (re)connecting with friends and colleagues, inspired by the complex and transformational work being done throughout the...more

Snell & Wilmer

Five Facts About the Annual Gag Clause Prohibition Compliance Attestation

Snell & Wilmer on

Effective December 27, 2020, the Consolidated Appropriations Act, 2021 (“CAA”), as part of its transparency in health care protections, prohibits group health plans and issuers from entering into agreements that directly or...more

McDermott Will & Emery

[Webinar] 340B… Or Not 340B: Oversight, Compliance and Enforcement - July 15th, 9:00 am - 10:00 am PT

McDermott Will & Emery on

The 340B Program has gained national attention over the last decade, in part due to the opportunities it provides to generate revenue for participating entities without risk of significant enforcement penalties for...more

Oberheiden P.C.

Pharmacy Compliance: Will Your Pharmacy’s Policies and Protocols Withstand a DEA or PBM Audit?

Oberheiden P.C. on

Compliance is a key aspect of operating a successful pharmacy in the United States. This is true for pharmacies that bill federal healthcare benefit programs (i.e. Medicare, Medicaid, and Tricare) and private payors, and it...more

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