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Medical Devices Civil Monetary Penalty

Gardner Law

CMS Auditing Companies for Sunshine Compliance: Are You Ready?

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As the Sunshine Act reporting deadline of March 31, 2024 draws near, medical device and pharmaceutical companies are gearing up for their Sunshine Act reporting. Are you prepared for a Sunshine Act audit? Reporting...more

Sheppard Mullin Richter & Hampton LLP

OIG Permits Medical Device Manufacturer’s Cost-Sharing Subsidies for Medicare Beneficiaries in Clinical Trial

Last month, in the last advisory opinion issued by the Office of Inspector General (“OIG”) in 2023 – Advisory Opinion No. 23-11 (the “Opinion”) – OIG “blessed” an arrangement involving a medical device manufacturer (the...more

Bass, Berry & Sims PLC

Déjà vu? OIG Reiterates Concerns about Providing Free Items or Services to Federal Healthcare Program Beneficiaries

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On October 25, the U.S. Department of Health and Human Services Office of Inspector General (OIG) published Advisory Opinion 23-08, in which it refused to approve a proposal by a manufacturer and distributor of hearing...more

Stevens & Lee

OIG Issues Unfavorable Opinion on Free Gifts for Purchasing Reimbursable Devices

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The Office of Inspector General in the Department of Health and Human Services (“OIG”) recently issued Advisory Opinion 23-08 in which it concluded that a proposed arrangement involving a supplier’s durable medical equipment,...more

Harris Beach PLLC

Cochlear Implant Manufacturer Proposes to Provide Free Compatible Hearing Aids

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This opinion addresses a proposed arrangement (“Proposed Arrangement”) by the manufacturer of cochlear implants (“Requestor”), where the Requestor would provide certain patients who receive one of their implants with a free...more

ArentFox Schiff

Texas Lab Settles Unnecessary Drug Testing Allegations for $6 Million

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A laboratory company based in Texas, Genotox Laboratories Ltd., recently reached an agreement with the federal government to resolve False Claims Act and Anti-Kickback Statute violations, stemming from allegations related to...more

Fenwick & West LLP

Increased Regulatory Scrutiny on Health Technology Companies’ Use of Advertising Technologies

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The proliferation of health apps and connected devices that allow individuals to track their health conditions, treatment, medications, fitness, fertility, sleep, mental health, diet and other vital areas has led to increased...more

ArentFox Schiff

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

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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

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

Holland & Knight LLP

Healthcare Law Update: April 2021

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William F. Gould In United States v. Merino, No. 19-50291, 2021 WL 754589 (9th Cir. Feb. 26, 2021), the court of appeals reversed the conviction of Marina Merino of conspiracy to commit healthcare fraud in violation of 18...more

Cozen O'Connor

1st Amendment Win For Credit Card Surcharges| Texas Sues Over Electricity Bills | Dodgy COVID Fees

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2022 AG Elections- Former South Dakota Attorney General Steps Back into Contention for AG’s Office- •Marty Jackley, who formerly served as U.S. Attorney for South Dakota, South Dakota AG, and President of the National...more

McDermott Will & Emery

HHS Finalizes Sweeping Changes to Stark Law, Anti-Kickback Statute Regulations

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On November 20, 2020, the US Department of Health and Human Services (HHS) released final rules amending the regulations to the physician self-referral law (Stark Law) (Stark Rule) and the Anti-Kickback Statute (AKS) and...more

Rivkin Radler LLP

Medtronic Settles Kickback And Open Payments Violations For $9.2M

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The U.S. Department of Justice (DOJ) announced on October 29 that Medtronic USA Inc. agreed to pay $8.1 million to settle allegations that it violated the False Claims Act (FCA) and federal Anti-Kickback Statute by paying...more

Mintz - Health Care Viewpoints

DOJ Announces the First Open Payments Program / Sunshine Act Enforcement Action

On October 29, 2020, the Department of Justice (DOJ) announced the first publicly-available settlement involving alleged violations of CMS’s Open Payments Program, otherwise known as the Sunshine Act. The $9.2 million...more

K&L Gates LLP

K&L Gates Triage: Q&A: What Sponsors and Investigators Need to Know about FDA’s ClinicalTrials.gov Reporting Requirements

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FDA’s recent release of new guidance on civil money penalties for the failure to submit required information to the ClinicalTrials.gov data bank may indicate a renewed interest in the enforcement of these requirements. On...more

King & Spalding

Federal Government Takes Steps Toward Enforcement of ClinicalTrials.gov Requirements

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Time Is Ripe To Update SOPs And To Ensure Compliance with Results Submission Requirements - In recent days, the federal Department of Health and Human Services (“HHS”) clarified the requirements for submission of certain...more

Skadden, Arps, Slate, Meagher & Flom LLP

Enforcement Spotlight: US Prosecutors Continue To Target Medical Technology Companies

Health care fraud continues to be a top enforcement priority for U.S. prosecutors, and nowhere is this more true than for the medical technology sector. From 2014-2019, the U.S. Department of Justice (DOJ) brought enforcement...more

Health Care Compliance Association (HCCA)

Justice Department recovers more than $3 billion from False Claims Act cases in FY 2019

Compliance Today (March 2020) - In January, Assistant Attorney General Jody Hunt of the U.S. Department of Justice’s Civil Division announced that it “obtained more than $3 billion in settlements and judgments from civil...more

Robins Kaplan LLP

Financial Daily Dose 1.31.2020 | Top Story: IBM CEO Ginni Rometty is Out After Eight Years at the Helm

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In a week that’s already seen plenty of C-suite shakeups, we’ve learned that Ginni Rometty is stepping down from her role as CEO at IBM. The company’s cloud computing chief, Arvind Krishna, will take over for her, though...more

Foley & Lardner LLP

OIG Greenlights Digital Health Program Offering Free Smartphones to Patients

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Last week, the federal HHS Office of Inspector General (OIG) gave the greenlight to allow a virtual care company and pharmaceutical manufacturer to loan patients free smartphones, so the patients (which include Medicare...more

Mintz - Health Care Viewpoints

OIG Advisory Opinion Allows Smartphone Loan for Needy Patients Taking Digital Drug

Last week, the Office of the Inspector General for the Department of Health and Human Services (OIG) issued a favorable Advisory Opinion regarding a proposal by a pharmaceutical manufacturer (Manufacturer) to loan a...more

King & Spalding

OIG Issues Advisory Opinion Giving the Green Light to a Pharmaceutical Manufacturer’s Plan to Provide Limited Functionality...

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On January 24, 2019, OIG issued Advisory Opinion No. 19-02, analyzing a proposed arrangement in which a pharmaceutical manufacturer would loan smartphones to patients who meet certain poverty level requirements in order to...more

Holland & Knight LLP

OIG Approves Pharmaceutical Manufacturer’s Loaning of Smartphones to Support Digital Medicine (DM)

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On Jan. 29, 2019, the Office of Inspector General (OIG), in Advisory Opinion 19-2, issued its first opinion on the new "promotes access to care" exception to the beneficiary inducement Civil Monetary Penalties (CMP) law and...more

Akin Gump Strauss Hauer & Feld LLP

OIG Approves Manufacturer Loaning Smartphones as Appropriate Patient Assistance to Support Digital Medicine

On January 29, the Health and Human Service Office of Inspector General (OIG) released new guidance that sheds further light on the types of patient assistance that may be provided under the “Promotes Access to Care”...more

Robinson+Cole Health Law Diagnosis

OIG Advisory Opinion Allows Medical Device Supplier to Provide Sample Products to Patients

On May 7, 2018, the Health and Human Services Office of Inspector General (OIG) issued a favorable Advisory Opinion in which it permitted a medical device company (Requestor) to provide free sample ostomy products and...more

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