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
As the life sciences, medtech, and diagnostic industries continue to expand and grow increasingly complex, so does the legal, regulatory, and compliance landscape. ...more
The Health Insurance Portability and Accountability Act of 1996 as amended and implemented through regulations at 45 C.F.R. §§ 160 and 164 (“HIPAA”) regulates the privacy and security of health information. For drug and...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
Join Gardner Law for a half-day CLE event in person at the Capital Factory in Austin, TX or attend virtually. Prepare for the regulatory rodeo with confidence by learning how to navigate regulatory, compliance, and privacy...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
Holland & Knight Health Dose is an in-depth weekly dose of legislative and regulatory insights to keep stakeholders abreast of happenings in Washington, D.C., impacting the health sector....more
Last week, the Department of Health and Human Services (HHS) released a final rule intended to implement a 2020 modification to the federal substance use disorder (SUD) privacy statute. The final rule more closely aligns the...more
As the life sciences industry continues to expand and grow increasingly complex, so does its legal, regulatory, and compliance landscape. To help companies and investors navigate the many evolving and emerging laws and...more
The Federal Trade Commission earlier this month undertook an enforcement action against online pharmacy and telehealth provider GoodRx, in the latest example of the agency seriously pursuing its role as the nation’s de facto...more
The Federal Trade Commission (FTC) announced on February 1, 2023 that it has settled, for $1.5M, its first enforcement action under its Health Breach Notification Rule against GoodRx Holdings, Inc., a telehealth and...more
AMA Provides a No Surprises Tool-Kit - As most health care providers know by now, the No Surprises Act (NSA) prohibits out-of-network health care providers from balance billing commercially insured patients, in certain...more
The Centers for Medicare and Medicaid Services (CMS) requested an audit by the Office of Inspector General of Medicare Part D eligibility transactions (E1) transactions....more
We are pleased to provide you with the third annual installment of our Life Sciences and Health Care Horizons guide. For each of these guides, we have asked our industry thought leaders throughout the world to write about...more
Pot is hot - Medical Marijuana use continues to grow in Ohio, with the Board of Pharmacy citing 73,376 registered patients and 590 physicians with Certificates to Recommend as of December 2019. Medical Marijuana sales...more
On January 27, 2020, the Department of Justice (DOJ) announced a $145 million settlement with Practice Fusion Inc., an electronic health records (EHR) software company, that resolves parallel criminal and civil investigations...more
In 2019, U.S. Department of Justice (DOJ) enforcement activity targeting drug and device manufacturers jumped sharply over the prior year, reflecting an increased focus on fraud and abuse in the life sciences sector. More...more
Report on Patient Privacy Volume 19, Number 11. (November 2019) ? The biggest threat to protected health information comes from carelessness within your organization, according to a brief from the Clearwater...more
According to reports, a Georgia-based physician who previously pleaded guilty to criminal violations of the Health Insurance Portability and Accountability Act (HIPAA) received six months of probation from a Massachusetts...more
In 2016, 11.5 million Americans were misusing prescription opioids, with the abuse reaching epidemic levels in 2017. The opioid crisis has accelerated the need for healthcare stakeholders to play a more active role in...more
We recognize that many of our clients sponsor ERISA welfare benefit plans and are currently undergoing their open enrollment process and issuing related participant communications. To assist our clients with that process, we...more
With the ever-growing opioid crisis and the President’s call to action to address that crisis, primary care, pain management and behavioral health providers in particular may be faced with privacy issues dealing with a...more
With an increased focus on opioid use and addiction, the Department of Health and Human Services (“HHS”) Office of Civil Rights (“OCR”) has issued guidance related to the Health Insurance Portability and Accountability Act of...more
In the wake of the national opioid overdose crisis, the Office for Civil Rights (OCR) has provided clarification on when covered entities are permitted to disclose patient information during opioid emergencies....more
Arnall Golden Gregory LLP's Food and Drug Newsletter is a monthly update of legal and regulatory issues that affect the FDA-regulated community, including regular updates on legislative initiatives from AGG’s Washington, DC...more