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
The Hatch-Waxman Act regulates the relationship between branded and generic drugmakers and attempts to strike a balance between two competing policy interests — encouraging pioneering drug development and facilitating market...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
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
Drug and device manufacturers doing business in Nevada have upcoming filing deadlines in March, April, and June. By June 1, 2024, compliance officers must sign and submit a certification to the Nevada Board of Pharmacy to...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
On January 30, the U.S. Court of Appeals for the Third Circuit issued a unanimous decision in favor of drug manufacturers, finding that manufacturer restrictions on the use of contract pharmacies under the 340B drug pricing...more
As federal agencies and law enforcement investigate pharmacies around the country for health care fraud and kickback schemes, pharmacies should be proactive in understanding their regulatory environment and the importance of...more
The COVID-19 pandemic has created many new enforcement priorities for the U.S. Department of Justice (DOJ). From selling ineffective personal protective equipment (PPE) to companies fraudulently seeking loan forgiveness under...more
The Health Resources and Services Administration (HRSA) has issued guidance eliminating a longstanding enforcement position that delayed the ability of hospitals participating in the 340B drug pricing program to use...more
Walmart and Johnson and Johnson, two of America’s corporate titans, each acted in ways that helped to fuel the opioid crisis that federal experts estimate claims 128 Americans’ lives each day, news media investigations show....more
The cold rain in Atlanta threw no cold water on legislative action today as the General Assembly convened for Legislative Day 15. The House and Senate each took up a handful of measures on their respective floors, including...more
Colleges and universities in Connecticut must comply with a new law that requires them to implement a policy regarding the availability and use of opioid antagonists by their students and employees not later than January 1,...more
Next week, I begin a five-part podcast series on emerging issues in healthcare compliance with Jesse Caplan, Managing Director of Corporate Oversight at Affiliated Monitors, Inc. (AMI), the sponsor of the series. Caplan has...more
In October 2018, the Canadian Agency for Drugs and Technologies in Health (CADTH) issued an interesting Environmental Scan on International Policies on the Appropriate Use of Biosimilar Drugs (Report). This Report outlines...more
• The Centers for Medicare & Medicaid Services (CMS) has issued the Calendar Year (CY) 2019 Final Rule that updates payment rates and policy changes in the Hospital Outpatient Prospective Payment System (OPPS) and Ambulatory...more
• The Centers for Medicare & Medicaid Services (CMS) has published the Calendar Year (CY) 2019 Final Rule for the Medicare Physician Fee Schedule (PFS), which includes provisions related to Medicare physician payments as well...more
Prescribers in West Virginia are bound by new restrictions set forth in the Opioid Reduction Act, aimed at combating the opioid crisis in West Virginia. The Act was enacted by the state legislature to limit patient access in...more
On September 5, 2018, the Food and Drug Administration (FDA) published a press release highlighting recent actions taken to ensure that pharmaceuticals meet high-quality standards. Currently, there are over 5,000...more
For the first time since the enactment of the Medicaid Drug Rebate Program (MDRP), the Centers for Medicare and Medicaid Services (CMS) revised the National Medicaid Drug Rebate Agreement (NDRA) entered into between drug...more
The Centers for Medicare & Medicaid Services (CMS) on Nov. 1, 2017, released the Medicare Hospital Outpatient Prospective Payment System (OPPS) and the Medicare Ambulatory Surgical Center (ASC) Payment System Final Rule for...more
Four Things Compliance Practitioner Should Know About the Eurasian Economic Union - An effective Compliance risk management at emerging markets for any business significantly depends on timeous observation of changes in...more
Polsinelli is pleased to share the June 2016 Third Party Administrator Newsletter. This newsletter covers topics throughout the year that impact TPAs. Information specific to Polsinelli's TPA practice is also included. ...more