Gilead Reaches $97 Million FCA/AKS Settlement
September 30, 2020 | Eric D. Fader | False Claims Act | Fraud and Abuse | Litigation | Medicare and Medicaid | Pharmaceuticals
On September 23, the U.S. Department of Justice announced that pharmaceutical company Gilead Sciences, Inc. agreed to pay $97 million to resolve claims that it illegally used a foundation as a conduit to pay the copays of thousands of Medicare patients taking Gilead’s pulmonary arterial hypertension drug Letairis. In addition to the False Claims Act …
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Insurer Paid Second Largest HIPAA Settlement Ever
September 29, 2020 | Eric D. Fader | Cybersecurity | Electronic Health Records | HIPAA | Litigation | Private Insurers
The third HIPAA settlement to be announced by the U.S. Department of Health and Human Services within one week was a big one. On September 25, HHS announced that Premera Blue Cross agreed to pay $6.85 million to HHS’s Office for Civil Rights (OCR) to settle HIPAA violations arising out of a data breach that …
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OCR Updates Mobile Health App Resources
September 25, 2020 | Eric D. Fader | Cybersecurity | Electronic Health Records | HIPAA | Legislation and Public Policy | Medical Devices and Wearables | Telehealth
The U.S. Department of Health and Human Services’ Office for Civil Rights (OCR) recently unveiled a new website with updated guidance and resources for mobile health app developers regarding the HIPAA Privacy, Security, and Breach Notification Rules. The new Resources for Mobile Health Apps Developers site replaces OCR’s prior Health App Developer Portal. The new site’s Health …
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GA Orthopedic Practice in $1.5M HIPAA Settlement
September 23, 2020 | Eric D. Fader | Cybersecurity | Electronic Health Records | HIPAA | Litigation
On September 21, the U.S. Department of Health and Human Services’ Office for Civil Rights (OCR) announced a $1.5 million agreement with Athens Orthopedic Clinic PA to settle “longstanding, systemic noncompliance” with the HIPAA Privacy and Security Rules. OCR’s investigation was triggered by a 2016 data breach that affected more than 200,000 of Athens Orthopedic’s patients. …
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OCR Announces Five HIPAA “Right of Access” Settlements
September 17, 2020 | Ada (Kozicz) Janocinska | Behavioral Health | Electronic Health Records | HIPAA | Legislation and Public Policy | Litigation
On September 15, the U.S. Department of Health and Human Services’ Office for Civil Rights (OCR) announced five new settlements relating to enforcement of HIPAA’s right of access rule. Under HIPAA, patients have the right to timely access to their medical records, as recently discussed here. A HIPAA covered entity must respond to a patient’s …
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Seventh Circuit Weighs in on Government’s Right to Dismiss Qui Tam Lawsuits
September 16, 2020 | Geoffrey R. Kaiser | False Claims Act | Fraud and Abuse | Legislation and Public Policy | Litigation
In United States ex rel. Cimznhca, LLC v. UCB, Inc., the 7th Circuit Court of Appeals weighed in on a Circuit Court of Appeals dispute over the correct standard to apply to the government’s decision to dismiss a qui tam lawsuit under the False Claims Act (FCA). The authority of the government to dismiss an action, …
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Amazon Enters Health Wearables Market
September 11, 2020 | Eric D. Fader | Electronic Health Records | Home Health | Medical Devices and Wearables | Private Insurers | Telehealth
Amazon recently introduced the Halo fitness tracker, its first entry into the health wearables market currently dominated by Fitbit and the Apple Watch. Amazon’s previous efforts to move into the healthcare industry have included the acquisition of online pharmacy PillPack in 2018, the mysterious Haven initiative with Berkshire Hathaway and JPMorgan Chase, and various other …
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NJ EHR Company Reaches $500,000 FCA Settlement
September 8, 2020 | Eric D. Fader | Electronic Health Records | False Claims Act | Fraud and Abuse | Litigation | Medicare and Medicaid
The U.S. Department of Justice (DOJ) announced on August 27 that New Jersey-based Konica Minolta Healthcare Americas Inc. agreed to pay $500,000 to resolve allegations that its former subsidiary, Viztek LLC, misrepresented the capabilities of its electronic health records (EHR) software, which caused users of the software to file false claims with the federal government. …
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