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
Employer group health plans must make an annual disclosure of the plan's prescription drug and healthcare spending to the Centers for Medicare & Medicaid Services (CMS). The disclosure, called the Prescription Drug Data...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
Many plan sponsors have read about the lawsuit filed against Johnson & Johnson alleging that it breached its fiduciary duties with regard to the prescription drug component of its group health plan, causing participants to...more
An employer health plan is the latest target of class action litigation seeking redress for the alleged conduct of the plan's pharmacy benefit manager ("PBM")....more
February 29 brings two annual deadlines for employers that sponsor a group health plan for their employees. Medicare Part D—Creditable Coverage Disclosure to CMS - An employer with a group health plan that provides...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
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
The United States Department of Health and Human Services (HHS) has filed court pleadings stating that it does not intend to initiate enforcement actions against plans that maintain copay accumulator programs....more
Does your company's health plan provide prescription drug coverage? If so, you have until October 15, 2023 to send a notice to individuals who are enrolled in Medicare Part A or Part B and are eligible for the company's...more
Well, it was good while it lasted. On September 27th, the Departments issued new FAQs regarding implementation of provisions of The Transparency in Coverage Final Rules (TiC Final Rules). ...more
Employers, this is your annual reminder that the Centers for Medicare & Medicaid Services (CMS) requires sponsors of group health plans to notify eligible individuals whether the employer’s prescription drug coverage is...more
In a win for self-funded (i.e., self-insured) health plans subject to the Employee Retirement Income Security Act of 1974, as amended (ERISA), the Tenth Circuit recently ruled that ERISA preempts provisions of an Oklahoma law...more
On December 23, 2022, the Departments of Labor, Health and Human Services and Treasury (the “Departments”) issued FAQs providing relief from prescription drug and health care spending reporting requirements. The FAQs are...more
On December 23, 2022, federal agencies released ACA and CAA Implementation FAQ Part 56, which extends the December 27, 2022 deadline for Prescription Drug Data Collection Reporting (“RxDC Reporting”) through January 31, 2023,...more
On December 23, 2022, the Departments of Labor, Health and Human Services and the Treasury (collectively, the “Departments”) provided welcome relief in the form of an FAQ regarding the Prescription Drug Data Collection (RxDC)...more
Employers have a reprieve from the challenging December 27, 2022, deadline for reporting 2020 and 2021 prescription drug cost information to the U.S. Department of Health and Human Services (HHS). ...more
The Consolidated Appropriations Act (CAA) adopted a new prescription drug reporting mandate on November 12, 2021. The mandate requires group health plans and group health insurers to submit prescription drug and health care...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
As group health plan sponsors, employers are responsible for ensuring compliance with the prescription drug data collection (RxDC) reporting requirements added to ERISA by the Consolidated Appropriations Act of 2021 (CAA). ...more
Does your company's health plan provide prescription drug coverage? If so, you have until October 15, 2022 to send a notice to individuals who are enrolled in Medicare Part A or Part B and are eligible for the company's...more
Employers and their benefit administrators have more detail and a more convenient way to submit “top 50” lists and other data - but no more time to comply with - daunting prescription drug cost reporting requirements in the...more
On this episode of Williams Mullen's Benefits Companion, host Brydon DeWitt discusses the Biden administration’s interim final rule that requires health plans to report prescription drug and health coverage costs and its...more
Marietta Memorial Hospital v. Davita Inc., No. 20-1641: This case, involving the Medicare Secondary Payer Act, presents the following questions...more