RECENT HEALTH LAW NEWS

On October 2, the U.S. Department of Justice (DOJ) announced that Phamatech, Inc. and its CEO have agreed to pay $3,043,484 to settle alleged False Claims Act (FCA) allegations. San Diego-based Phamatech, a medical technology company that manufactures diagnostic devices and provides laboratory testing, allegedly submitted false claims to Medicare for drug-testing services.

In addition

Health insurer Anthem, Inc. has finally reached a settlement with a coalition of 41 states plus the District of Columbia, and a separate settlement with California, to resolve state attorney general investigations of a data breach that occurred in 2014. Anthem has agreed to pay the states a total monetary penalty of $48.2 million.

The

On September 22, the U.S. Food and Drug Administration (FDA) announced the launch of its Digital Health Center of Excellence within the Center for Devices and Radiological Health. The FDA called this an important step toward its goal of advancing digital health technology, including mobile health (mHealth), health information technology, wearable devices, telehealth, and personalized

In the words of the American Association of Naturopathic Physicians: “Since March, the Federal Trade Commission (FTC) and Food and Drug Administration (FDA) have been aggressive in policing online language about COVID—and with good reason! Fraudulent products and false claims abound.” In one such instance, discussed here, the U.S. Department of Justice charged a physician with

A September 30 article in Managed Care Executive, “Are we there yet? A look at 4 value-based care programs,” offered a snapshot of four value-based care programs being undertaken by the Centers for Medicare & Medicaid Services (CMS) and Blue Cross Blue Shield of Massachusetts. Rivkin Radler’s Chris Kutner was quoted in the article.

Chris gave

On October 1, the U.S. Department of Health and Human Services announced $20 billion in additional funding as part of its Phase 3 Provider Relief Fund. This large push from the government is meant to (a) ensure that all eligible providers who received prior provider relief distributions have a balanced equitable payment equal to 2%

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

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

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

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.