Latest Publications

Share:

In the Wake of Harvey and Irma, OCR Reminds Providers of HIPAA Rules

As Texas, Florida, and the Caribbean rebuild after the latest string of deadly hurricanes and prepare for the possibility of future storms, the U.S. Department of Health and Human Services (HHS) Office for Civil Rights (OCR)...more

Implied False Certification Theory Fails in FCA Case Against Billing Agent

A court in the Southern District of New York (“SDNY” or the “Court”) recently released an important decision applying the Supreme Court’s landmark Escobar ruling to a qui tam action involving percentage fee arrangements for...more

DOJ and OIG Announce Largest Ever National Health Care Fraud Takedown; Focus on Opioids

Continuing its annual tradition, the U.S. Department of Justice (“DOJ”) and the U.S. Department of Health and Human Services (“HHS”) announced last week the largest ever health care fraud enforcement action by the Medicare...more

OCR Publishes Checklist and Infographic for Cyber Attack Response

OCR released a simple checklist and infographic last week to assist Covered Entities and Business Associates with responding to potential cyber attacks. As cybersecurity remains a pressing concern for health care entities,...more

Memorial Hermann’s Use of Patient Name in Press Release Leads to $2.4 Million HIPAA Settlement

The U.S. Department of Health and Human Services Office for Civil Rights (OCR) announced another large HIPAA-related settlement last week with Memorial Hermann Health System (Memorial Hermann), the largest not-for-profit...more

FDA User Fee Legislation Moves Forward in Senate with Multiple Policy Riders On-Board

On May 11, 2017, the Senate Health, Education, Labor and Pension (HELP) Committee voted in support of the FDA Reauthorization Act of 2017, or FDARA, now formally moving through the legislative process as S. 934. The committee...more

New State Substitution Laws, and a Busy Spring for Biosimilars

We recently updated our chart that tracks state biosimilar substitution laws to include new laws in Iowa and Montana. These new laws bring the total number of states with biosimilar substitution laws to 27, plus Puerto Rico....more

Mintz Levin Health Care Qui Tam Update - Recently Unsealed Whistleblower Cases: March 2017

Trends & Analysis - ..This issue looks at 18 health care–related qui tam cases that were unsealed in whole or in part in late October through November 2016. ..The cases identified were filed in federal district courts...more

Mintz Levin Health Care Qui Tam Update: Recently Unsealed Whistleblower Cases

Featured Unsealed Cases United States ex rel. Thomas v. Best Choice Home Health Care Agency, Inc., No. 2:13-cv-02209 (D. Kan.) - Complaint Filed: May 6, 2013 - Complaint Unsealed: October 24, 2016...more

Trump Executive Orders Create Uncertainty for Health Care & Pharmaceutical Industries

As we’ve previously discussed on Health Law and Policy Matters, agencies within the Department of Health and Human Services (DHHS) pushed through several final rules towards the end of the Obama Administration. However, since...more

Recent HIPAA Enforcement Actions

The U.S. Department of Health and Human Services, Office for Civil Rights (OCR) recently announced the first ever settlement related to a Covered Entity’s untimely breach notification in violation of HIPAA. Presence Health,...more

President Obama Signs 21st Century Cures Act; Creates Accelerated Approval Pathway for Regenerative Medicine

On Tuesday, President Obama signed the 21st Century Cures Act (the “Act”) into law. The Act is a massive piece of legislation that has implications for many different aspects of the interconnected medical research, product...more

OCR Reminds Companies that Authentication is Key

In non-election news, the Office for Civil Rights (OCR) at the Department of Health and Human Services recently released its November Cyber Awareness Newsletter. This month’s newsletter focuses on the topic of...more

September Privacy and Security Updates

Although National Cyber Security Month isn’t until October, September has brought plenty of privacy and security updates that health care companies need to be aware of. In this post, we review guidance from the Office for...more

FDA Approves Third Biosimilar Product

As we predicted in a previous post, FDA approved a new biosimilar product, Sandoz’s Erelzi (etanercept-szzs), which is a biosimilar to Amgen’s Enbrel (etanercept), on August 30th. FDA’s decision comes shortly after its...more

Biosimilar FDA Approvals on the Horizon As More States Enact Substitution Laws

In a sign of growing scientific acceptance and understanding of the biosimilar regulatory pathway, FDA’s Arthritis Advisory Committee (AAC) voted unanimously last month in favor of approving two new biosimilar products –...more

CMS Releases Proposed Outpatient Payment System Rule for 2017, Leaving Hospitals Unhappy

Last week, the Centers for Medicare and Medicaid Services (CMS) released its proposed rule for the Hospital Outpatient Prospective Payment System (OPPS) and the Ambulatory Surgical Center (ASC) Payment System for 2017. CMS...more

OCR Continues to Emphasize Individuals’ Rights to Access Health Information

Earlier this month, the U.S. Department of Health and Human Services Office for Civil Rights (OCR) announced the release of three YouTube videos and an infographic on individuals’ rights to access health information. In...more

18 Results
/
View per page
Page: of 1

"My best business intelligence,
in one easy email…"

Your first step to building a free, personalized, morning email brief covering pertinent authors and topics on JD Supra:
Sign up using*

Already signed up? Log in here

*By using the service, you signify your acceptance of JD Supra's Privacy Policy.
*With LinkedIn, you don't need to create a separate login to manage your free JD Supra account, and we can make suggestions based on your needs and interests. We will not post anything on LinkedIn in your name. Or, sign up using your email address.