News & Analysis as of

Physicians Medical Devices

Arnall Golden Gregory LLP

Healthcare Authority Newsletter - September 2024 #1

News Briefs - HHS Drops Appeal of Court's Ruling in Hospital Web Tracking Case - The Department of Health and Human Services is dropping its appeal of a June U.S. District Court ruling that vacated the government's...more

Faegre Drinker Biddle & Reath LLP

Yes, Michigan Applies the Learned Intermediary Doctrine

For decades, both state and federal courts in Michigan have routinely applied the learned intermediary doctrine in products liability cases involving prescription medical products. Under the doctrine, a manufacturer’s duty to...more

Morrison & Foerster LLP

Himes v. Somatics – California’s New Causation Standard for the Learned Intermediary Doctrine

In Himes v. Somatics, LLC, No. S273887, 2024 WL 3059637 (Cal. June 20, 2024), the Supreme Court of California delivered a win to the defense, upholding the learned intermediary doctrine in cases involving prescription drugs...more

Alston & Bird

Health Care Week in Review: CMS Issues Calendar Year 2025 Proposed Medicare Payment Rules for Physicians and Hospitals

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Below is Alston & Bird’s Health Care Week in Review, which provides a synopsis of the latest news in health care regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies,...more

Bass, Berry & Sims PLC

12th Annual Healthcare Fraud & Abuse Review - A Critical Resource for Healthcare Providers

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We are pleased to bring you our 12th annual Healthcare Fraud & Abuse Review. Our Review provides comprehensive coverage of the most significant civil and criminal enforcement issues facing healthcare providers. Each year, we...more

Gardner Law

[Hybrid Event] MASTERING TOMORROW'S HEALTHCARE TECH: A CUTTING-EDGE APPROACH TO REGULATORY, COMPLIANCE, AND PRIVACY DEMANDS -...

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FDA law firm Gardner Law and EU-based Fieldfisher discuss regulatory, compliance, and privacy matters relevant to high-tech healthcare products. - - Harnessing AI and Connected Devices in Medical Innovation in an...more

Epstein Becker & Green

Physicians Beware! Groups Providing DME, Prosthetic Devices, and Other Medical Supplies to Their Medicare Patients Risk Violating...

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When the COVID-19 Public Health Emergency (“PHE”) ended on May 11, 2023, many physician groups furnishing certain medical equipment, devices, and/or supplies to their Medicare patients became in violation of the federal...more

Arnall Golden Gregory LLP

Healthcare Authority Newsletter - August 2023 #1

News Briefs - More States Introducing 'Conscience' Healthcare Bills - A new Montana law will provide sweeping legal protections to healthcare practitioners who refuse to prescribe marijuana or participate in procedures and...more

Bass, Berry & Sims PLC

False Claims Act Settlements to Know from Q2 2023

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There have been several noteworthy False Claims Act (FCA) settlements in the second quarter of 2023.  Four of these settlements have come in over $20 million. This post summarizes key settlements of interest....more

Arnall Golden Gregory LLP

Healthcare Authority Newsletter - May 2023 #5

News Briefs - Inflation Causes Many Patients to Skip Doctors' Appointments - As prices go up generally, patients stay away from their physicians, according to federal analysts. In 2022, 28 percent of adults went without some...more

Womble Bond Dickinson

Artificial Intelligence - The Promise of Early Disease Diagnosis and Improved Treatment and the Potential of Liability

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If there is one thing that everyone can agree on, it is that health is an important factor in life. In 2021, over 3 million people died in the United States with heart disease and cancer topping the list....more

Bass, Berry & Sims PLC

False Claims Act Settlements to Know from Q1 2023

On February 7, the Department of Justice (DOJ) issued a press release indicating that settlements and judgments under the False Claims Act (FCA) exceeded $2.2 billion in the fiscal year ending September 30, 2022. Of this...more

McDermott Will & Emery

Federal Jury Returns $43 Million Verdict for Kickback Scheme in Violation of the False Claims Act

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After a rare False Claims Act (FCA) trial—especially one premised on violations of the Anti-Kickback Statute (AKS)—a federal jury in Minnesota returned a $43 million verdict against Precision Lens, a distributor of medical...more

Husch Blackwell LLP

Trial Lost, $400+ Million Liability Looming: Quick Takeaways From a Recent False Claims Act Jury Trial

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On February 27, 2023, a jury in Minnesota federal court rendered a verdict in favor of the United States and against a surgical product distributor following a False Claims Act jury trial that lasted six weeks. The jury...more

McDermott Will & Emery

Healthcare Regulatory Check-up Newsletter | January 2023 Recap

This issue of McDermott’s Healthcare Regulatory Check-Up highlights significant regulatory activity and developments occurring in January 2023, including several criminal and civil enforcement actions related to the federal...more

Bass, Berry & Sims PLC

[Webinar] Healthcare Fraud & Abuse Annual Review - February 22nd, 10:00 am - 12:00 pm CST

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Bass, Berry & Sims will release its 11th Annual Healthcare Fraud & Abuse Review in early February 2023. As a companion to the Review, we will host a complimentary webinar on Wednesday, February 22, 2023, from 10:00 a.m.-12:00...more

Bass, Berry & Sims PLC

11th Annual Healthcare Fraud & Abuse Review 2022

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We are pleased to bring you our 11th annual Healthcare Fraud & Abuse Review. Our Review provides comprehensive coverage of the most significant civil and criminal enforcement issues facing healthcare providers. Each year, we...more

Holland & Knight LLP

Holland & Knight Health Dose: October 11, 2022

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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. This week's topics include ... ...more

Mintz - Health Care Viewpoints

California Passes New Law Requiring Physicians and their Employers to Notify Patients about the Open Payments Database

A new California law (AB 1278) will require physicians and their employers to provide patients with several forms of notices about the Open Payments database, starting January 1, 2023. The law is intended to increase...more

Faegre Drinker Biddle & Reath LLP

“Alternative Avenues” Argument in Failure-to-Warn Cases Adding an Additional Wrinkle to Medical Device Litigation

A developing line of cases across the nation may have large implications for medical device manufacturers defending against failure-to-warn claims. While a treating physician’s failure to read or rely on the manufacturer’s...more

Health Care Compliance Association (HCCA)

Report on Patient Privacy Volume 22, Number 9. Privacy Briefs: September 2022

Report on Patient Privacy 22, no. 9 (September, 2022) - More than 92% of patients believe privacy is a right and their health data should not be available for purchase, according to a survey from the American Medical...more

Sheppard Mullin Richter & Hampton LLP

OIG Issues Favorable Advisory Opinion for Physician-Owned Medical Device Company

On April 25, 2022, the Office of Inspector General (“OIG”) issued Advisory Opinion No. 22-07 which evaluated the risk of fraud and abuse under the federal anti-kickback statute (“AKS”) posed by an arrangement involving...more

McDermott Will & Emery

Healthcare Regulatory Check-up Newsletter | May 2022 Recap

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This issue of McDermott’s Healthcare Regulatory Check-Up highlights notable enforcement activity between April 21 and May 20, 2022, including a telemedicine case involving $64 million in false and fraudulent claims. We also...more

Stevens & Lee

OIG Anti-Kickback Opinion Examines Physician Ownership of Medical Device Manufacturer and Referrals

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The Office of Inspector General (“OIG”) in the Department of Health and Human Services has longstanding concerns regarding physician-owned entities that derive revenue from selling items ordered by their physician owners for...more

Holland & Knight LLP

OIG OKs Physician Ownership of Medical Device Company

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The U.S. Department of Health and Human Services Office of Inspector General (OIG) issued an Advisory Opinion on April 20, 2022, regarding physician ownership in a medical device company. The Advisory Opinion is significant...more

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