RECENT HEALTH LAW NEWS


Embryo Destruction Lawsuits Open New Legal Frontier
February 21, 2019 | Katherine A. Heptig | Litigation

As of January 2019, following a months-long break in the cases due to judicial transition, at least 70 lawsuits arising from the accidental destruction of human embryos and eggs were pending in Ohio state courts. The cases highlight the complex questions surrounding the legal status of embryos and, by consequence, theories of liability for the

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Anti-Assignment Clause Bars Doctor’s Reimbursement Claim
February 20, 2019 | Rivkin Rounds Staff | Litigation | Private Insurers

Rivkin Radler’s Employee Benefit Plan Review included a summary of a case in which the U.S. Court of Appeals for the Eleventh Circuit held that an anti-assignment provision in a group health benefit plan barred direct reimbursement to an Atlanta dermatologist. The patient had executed an Assignment of Benefits in favor of the physician, a

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ONC’s Proposed Info-Blocking Rule Includes Broad Exceptions
February 20, 2019 | Eric D. Fader | Electronic Health Records | HIPAA | Hospitals | Legislation and Public Policy

The Office of the National Coordinator for Health Information Technology (ONC) and the Centers for Medicare & Medicaid Services both recently released proposed rules regulating so-called information blocking, the practice of interfering with the exchange of electronic health information (EHI). Information blocking, a violation of HIPAA, occurs most commonly when a healthcare provider terminates its

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FDA Issues Warning Letter on Unapproved Breast Implant Device
February 19, 2019 | Steven Shapiro | FDA | Litigation | Medical Devices and Wearables

Last week, the U.S. Food and Drug Administration (FDA) announced that it issued a warning letter to Mark Berman, M.D., a Beverly Hills, Calif., cosmetic surgeon, for illegally marketing an unapproved implantable device. Dr. Berman claims that the “Pocket Protector” can prevent and treat capsular contracture (tightening of scar tissue), a complication of breast implants.

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HIPAA Still Applies to Patients’ Online Reviews of Providers
February 15, 2019 | Behavioral Health | Electronic Health Records | HIPAA | Litigation

In an era of online dialogue, healthcare providers still need to remain alert regarding their obligations under the Health Insurance Portability and Accountability Act of 1996 (HIPAA). As tempting as it may be to respond to patients’ criticisms and praise online, healthcare providers, as “covered entities” under HIPAA, should think twice before clicking “post.”

It’s

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EHR Vendor to Pay $57 Million to Settle FCA Case
February 11, 2019 | Geoffrey R. Kaiser | Electronic Health Records | False Claims Act | Fraud and Abuse | Litigation | Medicare and Medicaid

On February 6, the U.S. Department of Justice announced that Greenway Health LLC, a Florida-based developer of electronic health records (EHR) software, will pay $57.25 million as part of a False Claims Act settlement. The United States had alleged that Greenway misrepresented the capabilities of its software product, called “Prime Suite,” causing healthcare providers to submit

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New Medicare App to Explain Coverage
February 6, 2019 | Hospitals | Medical Devices and Wearables | Medicare and Medicaid | Pharmaceuticals | Private Insurers

On January 28, the Centers for Medicare & Medicaid Services (CMS) announced the launch of a new mobile app called “What’s Covered” to help consumers understand which items and services are covered by Medicare. The app is part of the eMedicare Initiative, launched in October 2018 to modernize the delivery of information about the program.

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Pathology Lab Company to Pay $63.5 Million to Settle FCA Case
February 5, 2019 | Christopher J. Kutner | Electronic Health Records | False Claims Act | Fraud and Abuse | Litigation | Medicare and Medicaid

Inform Diagnostics, a Texas-based pathology laboratory company, will pay the federal government $63.5 million to resolve allegations that the company violated the False Claims Act (FCA). The U.S. Department of Justice announced the settlement on January 30.

Inform Diagnostics was alleged to have engaged in improper financial relationships with physicians, including providing them with subsidies

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FTC to Focus on Unsubstantiated Health Claims
January 30, 2019 | Steven Shapiro | FDA | Fraud and Abuse | Litigation | Pharmaceuticals

On January 28, the Federal Trade Commission (FTC) published on its Business Blog a post titled “Hey Nineteen: Nine FTC developments that could impact your business in 2019.” Of most importance to the healthcare industry is the FTC’s promise to focus on unsubstantiated health claims in advertising. The relevant paragraph of the post reads as

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Walgreens Pays $269.2 Million to Settle Fraud Allegations
January 24, 2019 | Geoffrey R. Kaiser | False Claims Act | Fraud and Abuse | Litigation | Medicare and Medicaid | Pharmaceuticals

Walgreens Boots Alliance, Inc., the operator of the Walgreens pharmacy chain, has agreed to pay $269.2 million in two settlements with the U.S. Department of Justice to resolve fraud allegations. The two cases arose from lawsuits filed by whistleblowers under the False Claims Act and were prosecuted federally by the U.S. Attorney’s Office for the Southern

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