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
In recent years, states have been exploring innovative avenues to address rising healthcare costs and ensure access to affordable medication for their residents. One idea gaining traction involves pursuing authorization from...more
In the grand experiment of American democracy, it is often said that states serve as laboratories, testing policies that challenge the status quo without risking the stability of the whole. Oregon, known in recent years for...more
On February 16, the U. S. District Court for the District of Oregon struck down the state’s drug price transparency law—The Prescription Drug Price Transparency Act (the “Act”)—ruling that the Act’s annual price increase...more
Attorneys general across the country have joined in litigation related to mifepristone, a drug used for medication abortions. A case currently before the Supreme Court, FDA v. Alliance for Hippocratic Medicine, could affect...more
On October 18, 2023, AGG Healthcare of counsel Jennifer Hilliard ably reported on Georgia’s new regulation that would allow pharmacies to dispense medical marijuana to registered users. Thus, Georgia became the first state in...more
Colorado and New York are not waiting for the Fair Credit Reporting Act rulemaking to eliminate creditor use of medical debt announced by the CFPB in September 2023. As we previously blogged, in the past two years, Equifax,...more
Despite the federal ban on the sale, use, and possession of cannabis in the U.S., in October, Georgia became the first U.S. state to allow pharmacies to sell low-dose tetrahydrocannabinol (THC) products. Pursuant to statutes...more
Connecticut is the latest state to join the efforts of jurisdictions such as Oregon, Nevada, Washington D.C., and the City of Chicago, Illinois, in further regulating the activities of pharmaceutical representatives. In June,...more
The Georgia Board of Pharmacy has begun accepting applications from independent, licensed pharmacies for authorization to dispense authorized medical marijuana products, and nearly 120 pharmacies reportedly have agreed to...more
As we’ve discussed, the federal government seems to be getting on board with the legal use of psychedelics. So are many states. While states across the country are moving towards expanding legal (or at least decriminalized)...more
The New York State Department of Financial Services (DFS) recently announced the publication of proposed regulations that would increase the state’s oversight of pharmacy benefit managers (PBMs). According to DFS, the...more
McDermott’s digital health team continually monitors legal developments affecting all aspects of the remote delivery of care. This inaugural issue of our Of Digital Interest Quarterly Roundup highlights key issues and trends...more
The U.S. Food and Drug Administration’s (“FDA”) approval of the commonly-used abortion medication, Mifepristone, has been curtailed following dueling federal court decisions in Texas and Washington. Just days after a Texas...more
In a country that is still struggling with an opioid epidemic, and where there are enough rules and laws regulating the dispensing of medication to fill a tome, it makes sense that medical providers across the nation are...more
During the COVID-19 pandemic, telehealth utilization exploded. Globally, the telehealth market is valued at $83.5 billion and is expected to grow by 24% between 2023 and 2030. As services delivered via telehealth became more...more
As we ring in the new year, it is time once again to reflect on some of the most significant legal developments for drug and device companies this year. The list below is by no means exhaustive (who could forget the Rule 702...more
On November 22, 2022, 160 Florida lawmakers, many elected to the legislature for the first time, gathered in Tallahassee to be sworn in. During this constitutionally required “organization session,” the two chambers also...more
The United States Department of Justice (DOJ) has recently emphasized that Maine, New Hampshire, and Vermont are priorities for health care investigations and anticipated significant enforcement. Even well-managed (and...more
States remain at the forefront of legislative efforts on a range of issues relating to drug pricing, such as increasing price transparency, capping out-of-pocket costs for insulin, and limiting certain PBM practices. These...more
Prompted by rising rates of overdose deaths, suicides and incidence of mental illness in at-risk populations, such as children, Congress has spent the better part of the year working in a bipartisan manner to develop and...more
During a second special session, the West Virginia Legislature approved House Bill 214, revising the prescriptive authority of advanced practice registered nurses (APRNs) and physician assistants (PAs). Previously, APRNs and...more
On April 29, 2022, the Centers for Medicare and Medicaid Services (“CMS”), issued the final rule on Contract Year 2023 Policy and Technical Changes to the Medicare Advantage and Medicare Prescription Drug Benefit Programs...more
Hello readers! Today’s post focuses on a topic we’ve touched on a few times in the past – Medicaid drug formularies. Back in December 2021, the state of Oregon released a draft Medicaid waiver proposal that caught the...more
The General Assembly got back to work on Tuesday with a slate full of committee meetings to advance bills and resolutions through the legislative gauntlet. But before legislators receded into the meeting rooms in the State...more
Taking effect January 1, Oregon recently approved a temporary rule implementing SB 763, which requires licensure of pharmaceutical sales representatives who visit health care providers in the state of Oregon for 15 or more...more