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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CMS Updates Medicare Plan Finder Tool
September 24, 2019 | Legislation and Public Policy | Medicare and Medicaid | Private Insurers

As Medicare open enrollment approaches, the Centers for Medicare & Medicaid Services (CMS) announced on August 27 the launch of a redesigned Medicare Plan Finder tool. This new tool makes it easier for customers to compare pricing, coverage, and drug plans of Medicare, Medicare Advantage, Medigap, and Part D programs. The Plan Finder tool is

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OIG Approves Real Estate Transaction With a Medicare-Excluded Individual
September 23, 2019 | Ada Janocinska | Fraud and Abuse | Legislation and Public Policy | Medicare and Medicaid

The U.S. Department of Health and Human Services’ Office of Inspector General (OIG) recently issued a favorable Advisory Opinion (No. 19-05) involving a proposed transaction with an excluded individual. Healthcare entities and providers must always use caution when contemplating proposed transactions with an individual who is excluded from participating in Medicare, Medicaid or other federally

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Zocdoc Fees Get Anti-Kickback Approval
September 18, 2019 | Eric D. Fader | Fraud and Abuse | Legislation and Public Policy | Medicare and Medicaid

The online appointment booking service Zocdoc has received a favorable Advisory Opinion from the U.S. Department of Health and Human Services’ Office of Inspector General (OIG) confirming that Zocdoc’s new per-click or per-booking fee model does not violate the federal Anti-Kickback Statute (AKS). Without AKS concerns, Zocdoc may now allow Medicare, Medicaid, and other federal

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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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FCA Ruling: Proof of Falsity Needed to Show Fraud
September 16, 2019 | Geoffrey R. Kaiser | False Claims Act | Fraud and Abuse | Hospitals | Legislation and Public Policy | Litigation | Medicare and Medicaid

Last week, the 11th Circuit Court of Appeals handed down its long-awaited decision in United States v. AseraCare, Inc. The case, brought under the False Claims Act (FCA) and argued way back in March 2017, alleged that AseraCare, a for-profit multi-state hospice chain, had submitted false claims to the Medicare program for patients who were

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New Rule Augments CMS’s Fraud-Fighting Powers
September 13, 2019 | Eric D. Fader | Fraud and Abuse | Legislation and Public Policy | Medicare and Medicaid

On September 5, the Centers for Medicare & Medicaid Services (CMS) announced the issuance of a final rule that will allow the agency to deny or revoke a healthcare provider’s or supplier’s federal program enrollment if it is “affiliated” with another previously revoked organization. The rule had originally been proposed more than three years ago.

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HHS Issues Limited HIPAA Waivers in Hurricane Areas
September 12, 2019 | Eric D. Fader | Electronic Health Records | HIPAA | Legislation and Public Policy

As it had done for previous hurricanes, the U.S. Department of Health and Human Services (HHS) recently issued a HIPAA Bulletin providing for a limited waiver of HIPAA sanctions and penalties for covered entities in Puerto Rico, Florida, Georgia, South Carolina and North Carolina in the aftermath of Hurricane Dorian.

Such waivers are primarily intended

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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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HIPAA Access Violation Results in Settlement
September 10, 2019 | Eric D. Fader | Electronic Health Records | HIPAA | Hospitals | Litigation

The U.S. Department of Health and Human Services (HHS) announced on September 9 that Bayfront Health St. Petersburg (Bayfront), a 480-bed Florida hospital, has paid HHS’s Office for Civil Rights (OCR) $85,000 to settle a potential violation of HIPAA’s right of access provisions. Bayfront’s Resolution Agreement with HHS also provided for the company to enter into a one-year

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