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Medicare Fraud Medical Devices

Holland & Knight LLP

HHS and DOJ Revitalize False Claims Act Working Group

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The U.S. Department of Health and Human Services (HHS) and U.S. Department of Justice (DOJ) on July 2, 2025, announced their intent to strengthen the DOJ-HHS False Claims Act Working Group. The announcement emphasized...more

Davis Wright Tremaine LLP

CMS Launches WISeR Model to Curb Overuse of Medicare Services

The Centers for Medicare and Medicaid Services (CMS) is looking to reduce the volume of "low value" services furnished to Original Medicare beneficiaries through the recently announced Wasteful and Inappropriate Service...more

Hendershot Cowart P.C.

Qlarant, Novitas Audits Escalate as Medicare Skin Substitutes Spending Hits $1.6 Billion, CMS Seeks Evidence of Clinical...

Hendershot Cowart P.C. on

The wound care industry faces unprecedented scrutiny as Medicare Part B expenditures for skin substitutes exceeded $1.6 billion in the fourth quarter of 2023 alone. The spending surge has triggered a wave of skin substitute...more

Cooley LLP

Fourth Circuit Ruling Guts the Practice of Medicine Defense in FDA Cases

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Last week, the US Court of Appeals for the Fourth Circuit in United States v. Jackson upheld a doctor’s conviction under Section 301(k) of the Federal Food, Drug, and Cosmetic Act (FDCA), 21 USC § 331(k) (Section 301(k)), for...more

McGuireWoods LLP

Medical Device Legal News with Sam Bernstein: Episode 11

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A former DePuy Synthes sales representative is arrested for allegedly defrauding a hospital into submitting claims for products not actually used in surgery; A number of additional clinics enter into settlements to resolve...more

ArentFox Schiff

Investigations Newsletter: Medical Device Company to Pay Over $700,000 To Resolve Criminal Allegations

ArentFox Schiff on

Medical Device Company to Pay Over $700,000 To Resolve Criminal Allegations - On January 4, 2023, a criminal information was filed in the Southern District of Illinois, in which Jet Medical Inc. (Jet), a medical device...more

ArentFox Schiff

Investigations Newsletter: DOJ Files Complaint in AWP False Claims Act Suit Against Pharmaceutical Ingredient Seller 

ArentFox Schiff on

DOJ Files Complaint in AWP False Claims Act Suit Against Pharmaceutical Ingredient Seller - On November 8, 2021, the Department of Justice (DOJ) announced that it intervened in a qui tam suit and filed a False Claims Act...more

ArentFox Schiff

OIG Issues Fraud Alert: Should Pharma and Device Companies Cease Speaker Programs?

ArentFox Schiff on

The Department of Health and Human Services Office of the Inspector General (OIG) published a Special Fraud Alert on November 16, 2020 (the Alert) regarding a common practice within the pharmaceutical and medical device...more

Holland & Knight LLP

Healthcare Law Update: October 2020

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Earlier this year, the Office of the National Coordinator for Health Information Technology (ONC) published a final rule (ONC Rule) addressing interoperability, information blocking and patient access to data. The ONC Rule...more

ArentFox Schiff

Investigations Newsletter: Medical Device Manufacturer Settles Improper Payment Allegations for $18 Million

ArentFox Schiff on

Medical Device Manufacturer Settles Improper Payment Allegations for $18 Million - Merit Medical Systems Inc. (MMSI), a Utah-based medical device maker, will pay $18 million to settle allegations that it engaged in a...more

Rivkin Radler LLP

HHS, DOJ Release Fraud and Abuse Report

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The U.S. Department of Health and Human Services (HHS) and Department of Justice (DOJ) have released the 2019 annual report for their Health Care Fraud and Abuse Control Program. The government recovered almost $3.6 billion,...more

Health Care Compliance Association (HCCA)

Report on Medicare Compliance Volume 28, Number 37. News Briefs - October 2019 #2

California physician Donald Woo Lee was found guilty Oct. 17 for his role in providing medically unnecessary procedures to Medicare beneficiaries, upcoding, and repackaging single-use catheters for re-use, the Department of...more

ArentFox Schiff

Investigations Newsletter: Podiatrist Sentenced to Prison for Fraudulent Billing Scheme

ArentFox Schiff on

Podiatrist Sentenced to Prison for Fraudulent Billing Scheme - On July 19, 2019, a New York podiatrist was sentenced to 366 days in prison, assessed a $50,000 fine, ordered to pay $869,651 in restitution and forfeit...more

McGuireWoods LLP

Washington Healthcare Update

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This Week: FDA Begins Device User Fee Talks with Patients and Consumers Sept. 15... CMS Extends Partial Enforcement Delay of Two-Midnight Policy Through 2015... Alaska Legislature Sues Governor Over Medicaid Expansion....more

McGuireWoods LLP

Washington Healthcare Update

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This Week: Leading Up to the SCOTUS King v. Burwell Decision... House Votes to Repeal the Medical Device Tax... CMS Announces It Will Bolster Transitional Reinsurance Payments... MedPAC Releases June Report to Congress....more

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