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Anti-Kickback Statute › Medical Devices › Medicaid

The Anti-Kickback Statute is a United States federal criminal statute that prohibits the exchange (or the promise to exchange) of anything of value for referrals of federal healthcare program business. The... more +
The Anti-Kickback Statute is a United States federal criminal statute that prohibits the exchange (or the promise to exchange) of anything of value for referrals of federal healthcare program business. The statute aims to prevent situations where government officials channel federal healthcare dollars towards particular providers, who have offered or given the official a personal benefit. Penalties for violation of the Anti-Kickback statute apply to both sides of a prohibited transaction and can include jail time and steep monetary fines. less -
Bass, Berry & Sims PLC

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

Bass, Berry & Sims PLC on

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

Stevens & Lee on

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

King & Spalding

DOJ Announces False Claims Act Recoveries for FY 2022

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On February 7, 2023, the Department of Justice (DOJ) announced its annual False Claims Act (FCA) recoveries for fiscal year 2022. DOJ recovered $2.2 billion from a total of 351 settlements and judgments—the second-highest...more

McDermott Will & Emery

Healthcare Regulatory Check-up Newsletter | December 2022 Recap

McDermott Will & Emery on

This issue of McDermott’s Healthcare Regulatory Check-Up highlights significant regulatory activity between November 21 and December 31, 2022, including recent enforcement activity and a summary of the Office of Inspector...more

Dorsey & Whitney LLP

Recent DOJ Settlements Involving DME Manufacturers Highlight Important Anti-Kickback Considerations

Dorsey & Whitney LLP on

​​​​​​​The Department of Justice (“DOJ”) recently announced two settlement agreements, both involving durable medical equipment (“DME”) companies, following allegations that the companies had violated the Anti-Kickback...more

Mintz - Health Care Viewpoints

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

Mintz - Health Care Viewpoints on

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

Dorsey & Whitney LLP

Eighth Circuit Analyzes Scope of FCA Liability Under Anti-Kickback Statute

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​​​​​​​On July 26, 2022, the Eighth Circuit Court of Appeals issued an opinion interpreting the standard for the causal link the government must show to establish that a “false or fraudulent” claim under the False Claims Act...more

Health Care Compliance Association (HCCA)

[Event] Research Compliance Conference - June 8th - 10th, Anaheim, CA

Health Care Compliance Association (HCCA) on

Hear about the latest in research compliance - Do you want to learn… - How to prepare for upcoming changes in Medicaid? - Ways to build and maintain a better research compliance work plan for your program? - How...more

Mintz - Health Care Viewpoints

False Claims Act Settlements and Judgments Exceed $5.6 Billion in Fiscal Year 2021

Mintz - Health Care Viewpoints on

The Department of Justice announced in a February 1, 2022 press release (Press Release) that it obtained more than $5.6 billion in settlements and judgments from civil cases involving fraud and false claims in the fiscal year...more

Polsinelli

DOJ Telemedicine Offensive Pushes Forward with New Charges

Polsinelli on

For the past two years, telemedicine companies, durable medical equipment suppliers, pharmacies, and individuals and entities that market to such entities have been at the center of DOJ gunsights. In 2019, the Department...more

Holland & Knight LLP

Healthcare Law Update: April 2021

Holland & Knight LLP on

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

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

The Volkov Law Group

Merit Medical Systems Settles False Claims Act Case for $18 Million (Part I of II)

The Volkov Law Group on

Medical device maker Merit Medical Systems (“MMS”) agreed to pay $18 million to resolve allegations that the company submitted false claims to Medicare, Medicaid and TRICARE by paying kickbacks to physicians and hospitals to...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

Troutman Pepper

OIG Advisory Opinion Has Key Takeaways for Programs Designed to Assist Needy Patients

Troutman Pepper on

Can a pharmaceutical manufacturer provide free items or services to financially needy Medicare and Medicaid beneficiaries without running afoul of the Beneficiary Inducements Civil Monetary Penalty (CMP) or the Anti-Kickback...more

Holland & Knight LLP

Healthcare Law Update: December 2018

Holland & Knight LLP on

Regulation - OIG Issues Advisory Opinion Addressing Eligible Managed Care Organizations' Safe Harbor - On Oct. 11, 2018, the Office of Inspector General (OIG) for the U.S. Department of Health and Human Services (HHS)...more

Mintz - Health Care Viewpoints

Fall 2018 Agency Rule List & FDA Device Center Guidance Priorities

Mintz - Health Care Viewpoints on

On October 17th, the Administration released its semiannual forecast of the rules that the Department of Health and Human Services (HHS) will be churning out over the next year. The list includes nearly 200 rules, 23 of which...more

Bass, Berry & Sims PLC

Healthcare Fraud & Abuse Review 2017

Bass, Berry & Sims PLC on

A LOOK BACK... A LOOK AHEAD - While the uncertainty associated with legislative efforts to repeal the Patient Protection and Affordable Care Act (PPACA) dominated most of the headlines for the healthcare industry last year,...more

Troutman Pepper

Value-Based Contracting for Prescription Drugs and Medical Devices: An Innovative Solution Impaired by Outdated Regulations

Troutman Pepper on

Often lost in the cacophony of headlines surrounding rising health care costs is the promise that value-based contracting offers as a possible solution. In contrast to the traditional fee-for-service model, value-based...more

Holland & Knight LLP

Healthcare Law Update: December 2016

Holland & Knight LLP on

Prompt Payment Discounts Not an Anti-Kickback Statute Violation - In United States of Am. et al. ex rel. Ruscher v. Omnicare, No. 15-20629, 2016 WL 6407128 (5th Cir. Oct. 28, 2016), the court of appeals affirmed summary...more

Buchalter

Health Care and Life Sciences Practice Newsletter

Buchalter on

Lions and Tigers and Bears, Oh My! The Unexpected Laws that May Affect Your Telehealth Business - An increasing number of health care providers are exploring telemedicine, either as an adjunct to their primary physical...more

Thomas Fox - Compliance Evangelist

Highway 61 Revisited-Tombstone Blues and Corporate Integrity Agreements

Thomas Fox - Compliance Evangelist on

I conclude my tribute to my favorite Bob Dylan album, Highway 61 Revisited with a look at the most surreal song on the disc, Tombstone Blues. I want to use it to contrast the most excellent article that appears today as a...more

Holland & Knight LLP

Commission-Based Sales Agreements for Medical Supplies and Equipment: More Whistleblower Activity on the Horizon? - A Wide Range...

Holland & Knight LLP on

The common industry practice of compensating independent contractor sales representatives on a "percentage of sales" commission basis may be creating an enhanced risk of False Claims Act liability for illegal kickbacks in...more

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