Medical Devices and Wearables


CISA Guidance Clarifies “Essential Industry” for Healthcare
March 31, 2020 | Marc S. Ullman | Behavioral Health | Home Health | Hospitals | Legislation and Public Policy | Medical Devices and Wearables | Pharmaceuticals
On March 28, the U.S. Department of Homeland Security’s Cybersecurity and Infrastructure Security Agency (CISA) issued a much-needed update clarifying what constitutes “essential industry” during the national COVID-19 response. This updated Guidance is especially important as many of the individual state declarations of emergency refer to “essential industry” without any enumeration, or specifically reference DHS-CISA agency …
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CMS and ONC Release New Interoperability Rules
March 12, 2020 | Ada Kozicz | Electronic Health Records | HIPAA | Hospitals | Legislation and Public Policy | Medical Devices and Wearables | Medicare and Medicaid | Private Insurers | Telehealth
The Centers for Medicare & Medicaid Services (CMS) and Office of the National Coordinator for Health Information Technology (ONC) have finalized two highly anticipated rules that are intended to give patients “unprecedented safe, secure access to their health data.” ONC will establish a certification process for application programming interfaces (APIs) that will meet certain interoperability …
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Medical Equipment Co. to Pay $37.5M to Settle Kickback Claims
January 17, 2020 | Eric D. Fader | False Claims Act | Fraud and Abuse | Litigation | Medical Devices and Wearables | Medicare and Medicaid
The U. S. Department of Justice (DOJ) announced on January 15 that ResMed Corp., a San Diego-based manufacturer of durable medical equipment, will pay $37.5 million to the federal government to settle five qui tam (whistleblower) cases under the False Claims Act (FCA) alleging that ResMed paid kickbacks to DME suppliers, sleep labs and other …
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DOJ Reports $3 Billion in 2019 False Claims Act Recoveries
January 14, 2020 | Eric D. Fader | False Claims Act | Fraud and Abuse | Hospitals | Litigation | Medical Devices and Wearables | Medicare and Medicaid | Pharmaceuticals
The U.S. Department of Justice (DOJ) announced last week that in the fiscal year ended September 30, 2019, it obtained more than $3 billion in total recoveries from civil cases brought under the False Claims Act (FCA). The total, a slight increase from the $2.9 billion recovered in the prior fiscal year, included both settlements …
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The Broad Reach of the Medicare Fraud Strike Forces
January 3, 2020 | Rivkin Rounds Staff | False Claims Act | Fraud and Abuse | Litigation | Medical Devices and Wearables | Medicare and Medicaid | Pharmaceuticals | Telehealth
Rivkin Radler’s Evan Krinick authored an article for the New York Law Journal, “The Broad Reach of the Medicare Fraud Strike Forces.” The article discusses recent strike force actions in New York and New Jersey that targeted a variety of healthcare fraud schemes.   …
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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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