Podcast — Drug Pricing: How Are Payers Responding to the IRA?
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 203: Manufacturing Specialty Drugs for Rare Diseases in North Carolina with Paul Testa of Kyowa Kirin
The DEA Is Knocking at Your Door . . . Are You Prepared? – Diagnosing Health Care
The Latest on Healthcare Enforcement
340B Drug Pricing Program Compliance
Podcast: The Legal Battle Over Mifepristone - Diagnosing Health Care
[Podcast] Food for Thought and Thoughts on Food: What to Expect in 2023
Podcast: Post-Dobbs Access to Reproductive Health Care and Abortion-Inducing Drugs - Diagnosing Health Care
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 116: Michael Carlin, Manager, Engage HCP by TrialCard
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
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
On Thursday, the U.S. Supreme Court rejected a challenge to the U.S. Food and Drug Administration (FDA) approval of the drug mifepristone, which is used as part of a two-drug protocol to induce abortion. The Court ruled that...more
ACI’s Advanced Forum on Managed Care Disputes and Litigation offers an unparalleled learning experience, specifically designed for the MCO legal community. Attend and develop winning legal strategies and business best...more
History of 401(k) Plan Excessive Fee Cases. Once the Department of Labor’s participant fee disclosure rules for retirement plans became effective in 2012, the plaintiffs’ bar latched onto recordkeeping and investment fees...more
Employers that cover Florida employees under their prescription drug plans are now prohibited from imposing mandatory mail-order requirements and are required to provide a sixty-day continuity of care period following midyear...more
The Lower Costs More Transparency Act of 2023, passed by the House 320-71 on Monday, December 11, 2023, would institute new transparency and pricing rules on pharmacy benefit managers (PBMs) and hospitals. The bill would...more
On November 15, 2023, the Centers for Medicare & Medicaid Services (CMS) issued a proposed rule titled Contract Year 2025 Policy and Technical Changes to the Medicare Advantage Program, Medicare Prescription Drug Benefit...more
The time may have come to add a welfare plan committee to your company’s governance of employee benefit plans. New legal obligations and other developments impose fiduciary risks for welfare plans similar to what already...more
“Didn’t we just do this?” might be the first question asked by many health plan sponsors and administrators when gearing up to complete 2022 prescription drug reporting by June 1, 2023. The answer to that question is both...more
Last Friday, the United States Supreme Court stayed a federal district court order that suspended the U.S. Food and Drug Administration’s approval of the drug mifepristone, which is used as part of a two-drug regimen to...more
Plan sponsors are ultimately responsible for compliance with the Prescription Drug Data Collection (RxDC) required reporting for their group health plans—and there’s no time to waste since the reporting is due by December 27,...more
The Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA) requires employers that offer prescription drug coverage to update the Centers for Medicare & Medicaid Services (CMS) regarding the creditable...more
There are many new and expanding legal requirements for group health plans and issuers of group health plan coverage to pay attention to this year. Many of these requirements were enacted as part of the Consolidated...more
Can’t attend the conference in-person? The virtual Managed Care Compliance Conference, February 8–9, allows you to hear from industry professionals just like you—all from the comfort of your home or office. Geared towards...more
The federal government will delay for six months its enforcement of key portions of the Transparency in Coverage (TiC) final rule that goes into effect on January 1, 2022. The change was announced in guidance issued jointly...more
Attend our annual event for those who manage compliance at health plan providers. Explore topics and issues that are pertinent to industry professionals like you. Learn the latest practices, share strategies, and connect with...more
Welcome to Goodwin’s ERISA Litigation Update. Litigation involving ERISA-governed benefits plans has exploded in recent years. Lawyers in our award-winning ERISA Litigation practice have extensive experience litigating these...more
From Pricing to Compliance to Coordinated Care, a Wide Range of Critical Areas Saw Regulatory Changes in 2020 That Will Impact the Health Care and Life Sciences Industries in 2021—and Beyond. Find Out How Your Organization...more
Over the past year, we saw significant developments in managed care regulation at the federal and state levels, and we anticipate the rapid pace of change to continue in 2021. In this webinar, attendees will hear an analysis...more
On October 29, 2020, the US Departments of Health and Human Services, Labor and Treasury (collectively, the Departments) issued the Transparency in Coverage final rule (the Rule), along with a fact sheet, setting forth...more
In this session, health law policy authorities discussed changes likely in 2021 in a Biden Administration and how these changes will impact business objectives and strategies for health industry stakeholders...more
Are you prepared for the critical impacts of the US election outcome to you and your business in 2021 and beyond? Join McDermott’s lawyers and our policy and lobbying team for perspective on the effects of administration...more
Citing the high cost of insulin as a common barrier to proper diabetes treatment, CMS has announced a new model to allow beneficiaries additional Part D plan options with lower out-of-pocket costs for insulin. Under the Part...more
On February 5, 2020, CMS issued a proposed rule advancing multiple updates and changes to Medicare Advantage (MA) and Medicare prescription drug benefit (Part D) programs (Proposed Rule). Unlike in past years, CMS will not...more
The House and Senate continue to focus on prescription drug pricing though it is unclear whether any of the proposals currently pending in either chamber will become law. On December 6th, Senators Grassley and Wyden...more