• Skip to primary navigation
  • Skip to main content
  • Skip to primary sidebar
  • Skip to footer

MassDevice

The Medical Device Business Journal — Medical Device News & Articles | MassDevice

  • Latest News
    • Cardiovascular
    • Orthopedics
  • Wall Street Beat
    • Funding Roundup
    • Mergers & Acquisitions
  • Podcasts
    • DeviceTalks Weekly
  • Resources
    • About MassDevice
    • Newsletter Signup
    • Job Board
    • Leadership in Medtech
    • Manufacturer Search
    • MedTech 100 Index
    • Videos
    • Whitepapers
  • DeviceTalks Tuesdays
  • Coronavirus: Live updates
Home » Medical device enforcement is getting more serious—particularly in Northeast

Medical device enforcement is getting more serious—particularly in Northeast

February 21, 2017 By Chris Newmarker

There has been aggressive momentum on the side of federal medical device anti-corruption enforcers, in particular in the Northeast.

Maureen Ruane and Scott McBride, Lowenstein Sandler

Northeast U.S. medtech enforcement
[Image by Grayshi, Roke, Maher-shalal-hashbaz – Own work, File:BlankMap-USA-states.PNG, CC BY-SA 3.0]
There are more questions than answers on what a new and unconventional administration in the White House will do in 2017 in many areas, no less so in medical device enforcement. One thing is certain: whatever the course, it will need to contend with aggressive momentum on the side of federal anti-corruption enforcers, in particular in the Northeast. Federal investigations and prosecutions for violations of the federal Anti- Kickback Statute (AKS), the Foreign Corrupt Practices Act (FCPA), and other anti-bribery statutes have been energetic as the U.S. Justice Dept. added resources to these efforts in recent years and enjoyed a measure of success. In international markets, device makers are compelled to contend with third-party intermediaries; supervising and controlling those entities will perpetually be a challenge. Also, as the health care industry evolves from a fee-for-service model into a more outcomes-based model, creative arrangements among providers will increase anti-bribery scrutiny. Corruption enforcement is likely to remain robust.

On the other hand, it remains to be seen whether a series of setbacks for the government in its off-label enforcement efforts—with both the courts and juries—could spell a less aggressive posture on this front in the future. At the least, companies in the government’s crosshairs have demonstrated that they are more emboldened than ever by these developments to fight allegations of illicit off-label marketing.

Anti-corruption enforcement

The Justice Dept. added resources to combat commercial corruption, which has and may inevitably continue to have an impact on the medical device industry. In November 2015, the agency announced it was increasing the size of its Fraud Section’s FCPA Unit by 50%. The FBI in turn established three new squads devoted to FCPA enforcement. Shortly thereafter, on April 5, 2016, the Justice Dept. announced a new FCPA Pilot Program, “designed to motivate companies to voluntarily self-disclose FCPA-related misconduct, fully cooperate with the Fraud Section, and, where appropriate, remediate flaws in their controls and compliance programs.” The Pilot Program allows self-disclosing companies to avoid prosecution altogether. In cases which the department determines warrant criminal prosecution of a self-disclosingg company, it will grant a fine reduction of up to 50% of the bottom of the applicable range under U.S. sentencing guidelines, and will further decline imposition of a monitor. Taken as a whole, these initiatives are plainly intended to dramatically increase the volume of FCPA matters.

Enforcement of the federal AKS will also likely remain a priority. The federal government has viewed its efforts to combat healthcare fraud as a tremendous return on investment – indeed, the Justice Dept. and the U.S. Health & Human Services Dept. have boasted publicly that for every dollar they spend on healthcare fraud investigations, they recover nearly $8 for taxpayers – and its AKS and other anti-bribery investigations should continue unabated as a result. The investigators pursuing these cases have also benefited from the Affordable Care Act, which relaxed the criminal intent standard to make AKS cases easier to prosecute. It also created the Sunshine Act, which requires healthcare companies to disclose most of their payments to physicians. The Sunshine Act has resulted in negative publicity for the industry and enabled the federal government to use the payment data to investigate corruption more effectively.

Get the full story on our sister site, Medical Design & Outsourcing.

Filed Under: Legal News, Regulatory/Compliance Tagged With: Anti- Kickback Statute, Foreign Corrupt Practices Act, Lowenstein Sandler, MedTech, U.S. Justice Dept. (DOJ)

In case you missed it

  • Once-a-week insulin dosing shows promise in studies
  • Abbott’s MitraClip doesn’t hinder oxygen levels, study shows
  • AdvaMed launches medtech podcast
  • Oncocyte acquires Chronix Biomedical
  • FDA nixes EUA for Lilly’s bamlanivimab
  • Seigla Medical gains CE mark for guide catheter extension
  • Contego Medical carotid stent wins CE mark approval
  • Pump problem prompts another Alaris recall
  • Virta Health raises $133M Series E for diabetes reversal tech
  • Canon Medical cardiac CT wins FDA clearance
  • MedTech 100 roundup: Industry skies to all-time high
  • DTW Podcast: How is Zimmer Biomet waging the ortho data war? Do medical devices carry physics-based biases?
  • Another BD Alaris infusion pump recall is Class I
  • 9 medical devices you should keep an eye out for in 2021
  • A quick history of the tech behind J&J, AstraZeneca’s COVID-19 vaccines
  • FDA finalizes rule to scale back how it regulates medtech software
  • Qorvo wins FDA nod for test that uses acoustic waves to detect COVID-19 antigens

RSS From Medical Design & Outsourcing

  • In situ cure technology molds next-gen medical implants
    Innovation in silicone technology has moved beyond defining specific material characteristics and into offering implantable devices that cure and form into shape inside the human body. Benny David, NuSil from Avantor Medical device manufacturers have long relied on highly purified silicone elastomers to fabricate components or entire devices for implantation. Now, recent innovations offer manufacturers… […]
  • How to prevent and troubleshoot short shots in medtech molding
    Deliberate processes to identify and remediate the problem can yield high-quality products and keep patients safe. Shane Vandekerkhof, RJG Short shots are among the most common and visually obvious quality issues most molders face, but they can cause fatal flaws in medical devices. Imagine if a luer lock connector was short. You run the risk… […]
  • AdvaMed launches medtech podcast
    AdvaMed today announced the launch of a new podcast, MedTech POV. AdvaMed president and CEO Scott Whitaker hosts the podcast, which covers the intersection of medtech and policy from a variety of perspectives. Each episode will feature discussions with medtech and healthcare policy leaders on issues that are driving the day — from business to… […]
  • This wearable could signal cytokine storms
    Researchers at the University of Texas at Dallas have developed a sweat sensor that could detect cytokine storms in patients suspected of having COVID-19 and other illnesses. Early on in the pandemic, doctors found that patients who developed a surge of pro-inflammatory immune proteins, called “cytokine storms,” were more often the sickest and at the… […]
  • How to evaluate laser performance for medical device manufacturing
    Laser processing provides automation and efficiencies that help meet FDA regulations and produce superior medical device components. David Locke, ACSYS Lasertechnik US Laser systems have become essential to the production of better-designed medical devices. The precision, repeatability and scale needed to manufacture next-generation medical products rely heavily on the advantages that lasers bring to contract… […]
  • EPA delayed notifying residents of ethylene oxide emissions
    The EPA delayed notifying neighbors of an Illinois medical device sterilization plant of ethylene oxide (EtO) emissions the agency measured in 2018, according to an inspector general’s report released yesterday. The report also says that “leadership” in the agency’s Office of Air and Radiation also failed to conduct public meetings with residents either near the… […]
  • 9 medical devices you should keep an eye out for in 2021
    The medical device industry weathered the COVID-19 pandemic well — and is now set to roll out a host of innovations in 2021. Economists generally expect the U.S. to see a boom as we emerge from the pandemic and resulting recession. Medtech companies appear set to ride the wave this year, with plans to seek… […]
  • Greenlight Guru to provide QMS to NIH diagnostics program
    NIH has chosen Greenlight Guru to provide quality management software for its COVID-19 rapid diagnostics program. The agency launched the Rapid Acceleration of Diagnostics (RADx) program in March 2020 to speed the development, commercialization and implementation COVID-19 testing technologies. As the only QMS provider currently available to all projects in the RADx program, Greenlight Guru… […]
  • MicroCare names CFO
    MicroCare (New Britain, Conn.) has announced the appointment of John Stardellis as the company’s new chief financial officer (CFO). Stardellis joins MicroCare with more than 20 years’ experience in a variety of finance, policy and operational leadership roles. Most recently, he served as CFO at i-Health, a division of DSM Nutritional Products. “John’s track record with… […]
  • Mayo Clinic helps launch two new companies for improved diagnostics
    Mayo Clinic announced that it is introducing a new technology platform to support two new companies it has launched. Rochester, Minn.–based Mayo Clinic’s Remote Diagnostics & Management Platform (RDMP) is designed to connect data with new AI algorithms and augment human decision-making within existing clinical workflows, according to a news release. Get the full story… […]
  • Intertek gains FDA nod for premarket device testing
    Intertek has won accreditation under an FDA pilot program for testing laboratories, the company said this week. The accreditation authorizes Intertek’s 12 “medical centers of excellence” to perform premarket testing of devices for the U.S. market. The Accreditation Scheme for Conformity Assessment pilot program is a voluntary program developed to provide increased confidence in testing… […]

Primary Sidebar

DeviceTalks by MassDevice · How Zimmer Biomet is competing in ortho’s data race; Do medical devices carry physics-based biases?

MEDTECH 100 INDEX

Medtech 100 logo
Market Summary > Current Price
The MedTech 100 is a financial index calculated using the BIG100 companies covered in Medical Design and Outsourcing.
Need Medtech news in a minute?
We Deliver!

MassDevice Enewsletters get you caught up on all the mission critical news you need in med tech. Sign up today.

Tweets by @MassDevice
MDO ad

Footer

MASSDEVICE MEDICAL NETWORK

DeviceTalks
Drug Delivery Business News
Medical Design & Outsourcing
Medical Tubing + Extrusion

MASSDEVICE

Subscribe to MassDevice
Advertise with us
About
Contact us

Add us on Facebook Follow us on Twitter Connect with us on LinkedIn Follow us on YouTube

Copyright © 2021 · WTWH Media LLC and its licensors. All rights reserved.
The material on this site may not be reproduced, distributed, transmitted, cached or otherwise used, except with the prior written permission of WTWH Media.

Advertise | Privacy Policy | RSS