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
Change Healthcare, an affiliate of Optum and UnitedHealth Group, processes more than 15 billion health care transactions annually and touches one of every three patient records. On February 21, Change disconnected its...more
Each week while Congress is in session, our Policy team delivers a key update to highlight a topical benefits, health, or retirement news item from the Hill, such as a newly introduced bill, a summary of a committee hearing,...more
A Social Media prescription from America’s top doctor - Imagine sending your teen-aged kid or grandkid out every day to a full-time job in the tech industry. The hours are flexible, and they say they like it...sort of....more
The United States Court of Appeals for the Seventh Circuit, applying Illinois law, has held that a $100 million settlement between the United States government and a pharmaceutical company for claims arising under the False...more
On February 23, the Office of Inspector General (OIG) of the U.S. Department of Health and Human Services issued Advisory Opinion 23-02, approving a pharmaceutical company’s program to provide a free 14-day supply of an...more
2022 was an eventful year on the 340B front, packed with updates to consequential litigation, proposed new rules, ongoing uncertainty into the Health Resources and Services Administration's (HRSA) underlying enforcement...more
In a move akin to last-minute gift-giving, the Departments of Labor, Health and Human Services, and the Treasury (the “Departments”) released FAQ 56 on December 23, 2022, which provides relief regarding the Prescription Drug...more
Since 2021, in an effort to encourage greater transparency in the prescription drug industry, there has been a national trend toward increased state licensing and regulation of Pharmacy Benefit Managers (PBMs). PBMs are...more
On March 9, 2022, the U.S. Court of Appeals for the Ninth Circuit, in Sentynl Therapeutics, Inc. v. U.S. Specialty Ins. Co, 2022 WL 706941 (9th Cir. Mar. 9, 2022) (applying California law), affirmed a district court’s holding...more
Under legislation signed on December 31 by Governor Kathy Hochul, (S.3762/A. 1396; L2021, ch. 828), all pharmacy benefit managers operating in New York State will be required to register with the State Department of Financial...more
When can you compel arbitration of a putative class action? The law is developing quickly and still doesn’t provide a crystal clear answer. The Ninth Circuit recently weighed in on two cases examining what happens when the...more
How Can Mental Health and Substance Use Disorder (SUD) Parity Laws Help Battle the Overdose Epidemic? Learn the Answers—and Catch Up on the Most Recent State and Federal Developments—at a New Webinar from the AMA and Manatt. ...more
With healthcare playing such a central role in the election, what could the Super Tuesday results mean for healthcare stakeholders? On March 2—the day before Super Tuesday—Manatt Health will explore these questions in a new...more
With an overwhelming amount of bi-partisan support, on May 7, 2019, Georgia enacted the Pharmacy Anti-Steering and Transparency Act, O.C.G.A. §26-4-119 (the GA Act). The GA Act goes into effect as of January 1, 2020....more
The Trump Administration has put out its latest prescription to try to slash out-of-control prescription drug prices: Officials want to call medication “rebates” what they say they’ve really become — “kickbacks” — and crack...more
...The opioid crisis gripping the United States is a national tragedy affecting hundreds of thousands of lives, with a significant ripple effect on businesses and public entities. Between 1999 and 2016, opioid overdoses...more
Pharmaceutical companies at risk of opioid-related litigation should consider whether they are covered by their insurance policy. Liability insurance coverage may be available for defense costs under Comprehensive General...more
It will come as no surprise that patients who are thinking about getting certified for medical marijuana use have a number of questions relating to the cost of obtaining medical marijuana products....more
Each month, Nexsen Pruet attorney Marc Manos, a member of the SC Bar Torts and Insurance Practice Section Council, sheds light on a few recent cases from the Fourth Circuit Court of Appeals, focused in the area of Torts &...more
The U.S. Congress is fighting hard to take away your rights and the power of individual states to protect those rights. The influence of BIG BUSINESS over your elected representatives is being used protect careless and...more
The Trump administration has been vocal in its criticism of the Affordable Care Act (ACA), and already has worked with the Republican-controlled Congress to begin rolling back key provisions of the legislation. The promised...more
On January 13, 2017, the White House, the U.S. Department of Treasury ’s Office of Foreign Assets Control (OFAC) , and the U.S. Department of Commerce ’s Bureau of Industry and Security (BIS) announced a host of policy...more
California's "End of Life Option Act" (the Act) went into effect June 9, 2016—making California the fifth state (behind Oregon, Washington, Vermont and Montana) to allow terminally ill adults with fewer than six months to...more
Turns out that the Anbang Insurance Group—the powerful Chinese insurer that’s made plenty of Brief appearances for its massive bids on US hotels, among others—really does live up to its air of mystery, with many of its...more
In an effort to deal with the terrible epidemic of drug abuse and the human and economic costs of this dilemma, the state of West Virginia has brought lawsuits in several jurisdictions against pharmaceutical companies and...more