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340B Drug Pricing Program Compliance
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Hospice Audit Series: Beyond Part D, OIG Scrutinizes the Hospice Industry to the Tune of $6.6 Billion
PODCAST: Williams Mullen's Benefits Companion - New Prescription Drug and Health Coverage Reporting Requirements
I Wish I Knew What I Know Now: Conversations with AGG on FDA Issues - Fee Waivers for Small Businesses: Who Qualifies for the Small Business User Fee Waiver for Drugs and Biologics and How to Apply
I Wish I Knew What I Know Now: Conversations with AGG on FDA Issues - 2020 Year in Review on FDA’s Enforcement of Rx Drug Promotions & Trends
Part Two: The MFN Drug Pricing Rule and the Rebate Rule: Where Do We Go From Here?
Part One: Two new Medicare Drug Pricing Rules in One Day: What are the MFN and the Rebate Drug Pricing Rules?
On the Ballot 2020: Health Care Policy Outlook - Diagnosing Health Care Podcast
Key Considerations for Reshoring U.S. Drug Manufacturing
I Wish I Knew What I Know Now: Conversations with AGG on FDA Issues - Quality Agreements for FDA-Regulated Products: Looking Under the Hood
Product Launching in the Era of COVID-19 - Diagnosing Health Care Podcast
Podcast: Non-binding Guidance: FDA Regulatory and Patent Implications of the Transition Provision of the Biologics Price Competition and Innovation Act
Holland & Knight Health Dose is an in-depth weekly dose of legislative and regulatory insights to keep stakeholders abreast of happenings in Washington, D.C., impacting the health sector....more
The Inflation Reduction Act of 2022 made significant design changes to Medicare Part D effective January 1, 2025. The changes will cause an increase in the actuarial value of Medicare Part D coverage, which will impact...more
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
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
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
News Briefs - State Governments Taking Steps to Make Rules on Healthcare AI - In the absence of federal guardrails on artificial intelligence in healthcare, state governments are figuring out their own rules of the road....more
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
Last week, former Wells Fargo employees filed a class action lawsuit against Wells Fargo and its health plan fiduciaries alleging that Wells Fargo’s self-funded health plan violated ERISA by paying its pharmacy benefits...more
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
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
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
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
News Briefs - Texas Federal Court Ruling Puts Noncompete Ban on Hold - A Texas federal court issued a preliminary injunction against the Federal Trade Commission's noncompete ban, which if implemented would allow existing...more
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
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
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
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
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
Americans spend more than $3 trillion per-year on healthcare-related expenses. Of that, the National Health Care Anti-Fraud Association estimates that between $60-250 billion is lost to fraud every year....more
We Americans pay more for prescription medications than just about anywhere else on the globe. And Big Pharma keeps jacking prices higher....more
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
The upcoming election, and the approaching end of the President’s four-year term, introduce additional dynamics into the agencies’ rulemaking process and even the guidance process. From now through the November election, the...more
Under the Consolidated Appropriations Act of 2021 (“CAA”), employer-sponsored group health plans, including medical-only plans, must submit information about their prescription drugs and health care spending. This submission...more
While the sweltering roil of temporary regulatory changes related to the COVID-19 pandemic may have cooled and the initial burst of SECURE 2.0 steam begins to dissipate, sponsors of employee benefit plans should keep their...more