News & Analysis as of September 20, 2024

Hospitals

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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 -

OIG Determines That Providing Free Hearing Aids to Bimodal-Hearing Candidates Implicates the Anti-Kickback Statute and Beneficiary...

Arnall Golden Gregory LLP on 11/3/2023

On October 20, 2023, the Office of Inspector General of the Department of Health and Human Services (“OIG”) issued an unfavorable Advisory Opinion No. 23-08 to a supplier of cochlear implants coupled with external sound...more

False Claims Act Settlements to Know from Q2 2023

Bass, Berry & Sims PLC on 7/18/2023

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

Healthcare Regulatory Check-up Newsletter | January 2023 Recap

McDermott Will & Emery on 3/9/2023

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

11th Annual Healthcare Fraud & Abuse Review 2022

Bass, Berry & Sims PLC on 2/13/2023

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

New Safe Harbors Offer Opportunities for Innovative Arrangements, Including Digital Health

ArentFox Schiff on 2/17/2021

Recent updates to the federal Anti-Kickback Statute give providers additional flexibility to enter into innovative arrangements, but before doing so, providers must ensure they understand the safe harbor requirements...more

OIG Approves Warranty Program for Surgical Devices and Wound Care Products in Advisory Opinion 18-10

Baker Donelson on 11/30/2018

In Advisory Opinion 18-10, issued September 10, 2018, the OIG permitted a manufacturer of surgical devices and wound care products to implement a warranty program under which the manufacturer's hospital customers could...more

OIG Opinion Illustrates the Need for New AKS Safe Harbors

Mintz - Health Care Viewpoints on 10/17/2018

The Department of Health and Human Services Office of the Inspector General (OIG) has issued Advisory Opinion No. 18-10 (Opinion) in response to a proposal by a surgical device and wound care product manufacturer...more

OIG Advisory Opinion Approves Surgical Device Warranty Program Intended to Reduce Readmissions

Robinson+Cole Health Law Diagnosis on 9/20/2018

On September 17, 2018, the Office of Inspector General (OIG) of the Department of Health and Human Services published a favorable Advisory Opinion allowing a manufacturer of surgical devices and wound care products to offer a...more

Healthcare Fraud & Abuse Review 2017

Bass, Berry & Sims PLC on 3/13/2018

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

FCA Issues to Watch: Intersection of the FCA and the Anti-Kickback Statute

Bass, Berry & Sims PLC on 5/31/2017

In the recent past, the government has racked up a number of FCA settlements based on alleged violations of the Anti-Kickback Statute (AKS). This focus undoubtedly will remain a high enforcement priority....more

Healthcare Fraud and Abuse Review 2016

Bass, Berry & Sims PLC on 4/13/2017

Bass, Berry & Sims is pleased to announce the release of its fifth annual Healthcare Fraud and Abuse Review 2016. The Review, compiled by the firm’s Healthcare Fraud Task Force, is an industry-leading guide to healthcare...more

Pharmaceutical Manufacturers and Healthcare Leaders cite Fraud and Abuse Laws as Obstacle to Value-Based Arrangements

Mintz - Health Care Viewpoints on 3/16/2017

As the healthcare industry moves towards value-based purchasing, pay-for-performance, and other payment reform models, industry leaders have identified federal fraud and abuse laws as a barrier to full implementation of such...more

Mintz Levin Health Care Qui Tam Update - Recently Unsealed Whistleblower Cases: June 2015

Mintz on 6/8/2015

Trends & Analysis: ..We have identified 33 health care–related qui tam cases that have been unsealed in whole or in part since the cases covered in our last Qui Tam Update. In addition, we have also identified one case...more

Department of Justice Files First False Claims Act Lawsuit Against Physician-Owned Distributorship

Davis Wright Tremaine LLP on 9/26/2014

On Sept. 8, 2014, the United States Department of Justice (DOJ) filed a 98-page civil complaint alleging that investment returns, paid to a Michigan spinal surgeon and other physicians by a spinal implant company partially...more

Health Care: As Sunshine Act Deadlines Approach Physicians and Hospitals Should Prepare for Transparency in Their Financial...

Bond Schoeneck & King PLLC on 7/28/2014

On September 30, 2014, in accordance with the Federal Sunshine Act (the Sunshine Act), the Centers for Medicare and Medicaid Services (CMS) will publically disclose payments and "other transfers of value" by pharmaceutical,...more

OIG Report Concludes that Physician-owned Distributors Increase Utilization

Baker Donelson on 11/8/2013

In response to the U.S. Senate Committee on Finance’s continued questioning of physician-owned distributorships (PODs), the U.S. Department Health and Human Services Office of the Inspector General issued its long-awaited...more

OIG Calls PODs "Inherently Suspect"

Baker Donelson on 3/29/2013

Making its most strongly worded statement to date, the Department of Health and Human Services Office of Inspector General (OIG) issued a Special Fraud Alert on Physician-Owned Entities on March 26, 2013, calling...more

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