RECENT HEALTH LAW NEWS


NYS Senate Bill Would Expand Medical Marijuana Program
May 21, 2019 | Cannabis | Hospitals | Legislation and Public Policy | Pharmaceuticals

On May 10, a new bill was introduced into the New York Senate to expand the state’s medical marijuana program. The overall goal of the bill is to reduce the burdens on patients seeking access to medical marijuana.

The current version of the applicable statute requires that a medical condition be designated as “serious” in

Read More
Share this article:
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

Read More
Share this article:
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

Read More
Share this article:
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,

Read More
Share this article:
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

Read More
Share this article:
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

Read More
Share this article:
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

Read More
Share this article:
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

Read More
Share this article:
WHO Issues Guidance on Digital Health Tools
April 25, 2019 | 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

Read More
Share this article:
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

Read More
Share this article:
Authors
show more

Get legal updates and news delivered to your inbox