RECENT HEALTH LAW NEWS


New Rule Requires Drug Price Disclosure in TV Ads
May 15, 2019 | Eric D. Fader | Legislation and Public Policy | Medicare and Medicaid | Pharmaceuticals
On May 8, the U.S. Department of Health and Human Services announced a final rule from the Centers for Medicare & Medicaid Services requiring pharmaceutical companies to disclose the list prices of prescription drugs in television advertisements. The rule will apply to all drugs covered by Medicare or Medicaid that cost at least $35 per …
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DOJ Issues New FCA Guidance on Cooperation Credit
May 8, 2019 | Geoffrey R. Kaiser | False Claims Act | Fraud and Abuse | Legislation and Public Policy | Litigation
On May 7, the U.S. Department of Justice (DOJ) introduced important new guidance for government attorneys explaining how DOJ will award credit to defendants who cooperate during a False Claims Act (FCA) investigation through voluntary self-disclosure, remediation (e.g., disciplining wrongdoers or others who failed in oversight, or implementing or improving an effective compliance program) and/or …
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Diagnostic Imaging Provider Pays $3 Million to Settle Data Breach
May 7, 2019 | Eric D. Fader | Cybersecurity | Electronic Health Records | HIPAA | Litigation
Touchstone Medical Imaging has agreed to pay $3 million to settle HIPAA violations after an unsecured computer server exposed the medical records of 300,000 patients on Google in 2014. The U.S. Department of Health and Human Services (HHS) announced the settlement on May 6. Touchstone, based in Franklin, Tennessee, provides diagnostic imaging services in Nebraska, …
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NYS Reaffirms Support for No-Fault Fraud Law
May 6, 2019 | Rivkin Rounds Staff | Fraud and Abuse | Legislation and Public Policy | Litigation | Private Insurers
The New York State Department of Financial Services has filed an amicus brief with the New York Court of Appeals reaffirming its position that a medical professional corporation “is not eligible for reimbursement” under the state’s No-Fault Law “if the provider fails to meet any applicable New York State or local licensing requirement necessary to …
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OCR Issues HIPAA FAQs on Software Apps
May 6, 2019 | Eric D. Fader | Cybersecurity | Electronic Health Records | HIPAA | Medical Devices and Wearables
The U.S. Department of Health & Human Services’ Office for Civil Rights (OCR) recently issued five new FAQs pertaining to software applications that obtain individuals’ electronic protected health information (ePHI). The FAQs describe various scenarios in which HIPAA covered entities may transmit ePHI to apps, including fitness trackers and other wearables. In short, a covered entity …
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Centene’s Proposed WellCare Acquisition May See DOJ Scrutiny
May 2, 2019 | Eric D. Fader | Antitrust | Fraud and Abuse | Medicare and Medicaid | Private Insurers
An April 30 article in Managed Care, “Centene, big in Medicaid managed care, wants to get even bigger,” discussed the business plans of Centene, the largest Medicaid managed care insurer in the U.S.  Rivkin Radler’s Christopher J. Kutner was quoted in the article. Centene is hoping that its proposed acquisition of WellCare Health Plans will …
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HHS Reduces Potential HIPAA Penalties
April 30, 2019 | Eric D. Fader | Cybersecurity | Electronic Health Records | HIPAA
The U.S. Department of Health and Human Services (HHS) has revised the potential monetary penalties that may be imposed on healthcare providers, health plans and business associates for HIPAA violations. HHS’s notice of enforcement discretion, issued on April 26, reduces the maximum annual penalty for less-severe violations from $1.5 million to as low as $25,000. The …
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WHO Issues Guidance on Digital Health Tools
April 25, 2019 | Cassandra Rivais DiNova | Electronic Health Records | Legislation and Public Policy | Medical Devices and Wearables | Telehealth
The World Health Organization (WHO) recently issued its first-ever recommendations on how digital health interventions may be used to improve health systems and patient care. Digital communication technologies covered by the report include apps, SMS text messages, and interactive voice response, and may involve the use of mobile devices, tablets, and desktop computers. The guidance …
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FDA Plans New Review Framework for AI-Based Medical Devices
April 24, 2019 | Eric D. Fader | FDA | Legislation and Public Policy | Medical Devices and Wearables
An April 2 Statement from Scott Gottlieb, M.D., Commissioner of the U.S. Food and Drug Administration (FDA), announced that the FDA is considering creating a new review framework to promote development of medical devices that use artificial intelligence (AI) algorithms. The FDA also released a Discussion Paper and Request for Feedback on the proposed regulatory …
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HHS Announces New Primary Care Pay Models
April 23, 2019 | Eric D. Fader | Hospitals | Legislation and Public Policy | Medicare and Medicaid | Private Insurers
On April 22, U.S. Department of Health and Human Services (HHS) officials announced the introduction of five optional value-based care models for large and small primary care physician practices. The new payment models will incorporate incentives for keeping Medicare patients healthy, as alternatives to traditional fee-for-service payment structures. Alex Azar, HHS Secretary, and Seema Verma, …
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