Medical Devices and Wearables


Life Spine Settles FCA Kickback Case for $6 Million
October 31, 2019 | Eric D. Fader | Affordable Care Act | False Claims Act | Fraud and Abuse | Litigation | Medical Devices and Wearables | Medicare and Medicaid
Spinal implant manufacturer Life Spine Inc. and two of its executives have settled their False Claims Act case by agreeing last week to pay the federal government $6 million. As discussed here, the company and executives had been accused of paying kickbacks to surgeons to use the company’s products. In addition to paying $5.5 million …
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Hospital to Pay $20 Million to Settle Whistleblower Case
October 29, 2019 | Eric D. Fader | False Claims Act | Fraud and Abuse | Hospitals | Litigation | Medical Devices and Wearables | Medicare and Medicaid
The U.S. Department of Justice (DOJ) announced on October 28 that Sanford Health, a hospital in Sioux Falls, South Dakota, will pay $20.25 million to settle a whistleblower lawsuit alleging violations of the False Claims Act and federal Anti-Kickback Statute. Two surgeons at the hospital filed the suit alleging that the hospital allowed another surgeon …
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Wave of DOJ Actions Targets Healthcare Fraudsters
October 3, 2019 | Eric D. Fader | False Claims Act | Fraud and Abuse | Home Health | Litigation | Medical Devices and Wearables | Medicare and Medicaid | Pharmaceuticals | Telehealth
The U.S. Department of Justice (DOJ) kicked its healthcare fraud enforcement activities into high gear last week, unveiling charges against hundreds of individuals and companies for paying kickbacks and billing for unnecessary drugs, supplies and tests. The cases, which alleged nearly $1.5 billion in fraudulent claims to Medicare, Medicaid and private insurers, targeted specialty pharmacies, …
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Robot Assistant Dispenses Meds, and More
September 26, 2019 | Eric D. Fader | Home Health | Medical Devices and Wearables | Telehealth
Last week, Pillo Health announced a collaboration with Stanley Black & Decker to assist elderly people and their caregivers. The companies’ Pria “personal medication assistant” (or, alternatively, “smart healthcare companion”) can dispense a week’s worth of pills on a prearranged schedule and also provides alerts, two-way video calling capability, and real-time monitoring via a mobile …
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Kaiser to Present at PLI Life Sciences Program
September 17, 2019 | Rivkin Rounds Staff | Cybersecurity | Electronic Health Records | FDA | False Claims Act | Fraud and Abuse | Legislation and Public Policy | Litigation | Medical Devices and Wearables | Medicare and Medicaid | Pharmaceuticals | Private Insurers
On October 10, Rivkin Radler’s Jeff Kaiser will be a panelist at the Practising Law Institute (PLI) program, “Life Sciences 2019: Navigating Legal Challenges in the Drug and Device Industries.” Jeff will speak on “Enforcement Trends Impacting the Drug and Device Industries,” including developments under the False Claims Act, federal Anti-Kickback Statute, off-label promotion, and …
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Tech Giants Continue Healthcare Advances
September 11, 2019 | Eric D. Fader | Electronic Health Records | Hospitals | Medical Devices and Wearables | Telehealth
Mayo Clinic announced a 10-year strategic partnership with Google that aims to “accelerate the pace of health care innovation through digital technologies.” Mayo Clinic intends to use advanced cloud computing, data analytics, machine learning and artificial intelligence (AI) to improve its delivery of care, including, for example, using AI-enabled digital diagnostics to advance virtual care. …
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Fader to Speak at IONM Conference
August 29, 2019 | Rivkin Rounds Staff | Hospitals | Medical Devices and Wearables
Rivkin Radler’s Eric Fader will be speaking at the American Society of Neurophysiological Monitoring’s Fall Symposium in Boston, September 14-15. The Symposium’s theme is “Improving the Quality of Neuromonitoring Practice” and Eric’s presentation will be entitled “Current Legal Issues in IONM: Minimizing Risks.” Eric is one of the few healthcare attorneys in the U.S. with …
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Kickback Charges Lead to False Claims Act Case
August 27, 2019 | Eric D. Fader | Affordable Care Act | False Claims Act | Fraud and Abuse | Litigation | Medical Devices and Wearables | Medicare and Medicaid
The Manhattan U.S. Attorney’s Office recently announced that the U.S. Department of Justice has intervened in a whistleblower suit against Life Spine Inc., an Illinois-based manufacturer of spinal implants, devices and equipment. The lawsuit, which seeks damages and civil penalties under the False Claims Act (FCA), claims that Life Spine paid millions of dollars in …
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LabCorp Offers Self-Directed Blood Testing (but not in NY/NJ)
July 24, 2019 | Eric D. Fader | Home Health | Medical Devices and Wearables
LabCorp announced on July 22 that it is now offering blood tests directly to consumers online. The clinical lab giant’s “Pixel by LabCorp” platform previously offered self-directed test kits for colorectal cancer and diabetes screening, as well as lipid panels. The service is not currently offered in New York, New Jersey, Maryland or Rhode Island. …
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CVS Announces Home Dialysis Machine Trials
July 22, 2019 | Eric D. Fader | FDA | Home Health | Medical Devices and Wearables | Pharmaceuticals | Private Insurers
On July 17, CVS Health Corp. announced the beginning of human trials of a new home dialysis machine called the HemoCare Hemodialysis System. The company’s CVS Kidney Care unit hopes to shift some of the $35 billion market for end-stage kidney care from outpatient dialysis clinics to patients’ homes. The HemoCare device was designed by …
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