Category: Government Enforcement

Health System Agrees to Pay $800,000 following Improper Disclosure of Medical Records

This week, Parkview Health System, Inc. (“Parkview”) agreed to pay $800,000 and enter into a Corrective Action Plan to settle allegations that Parkview violated the Health Insurance Portability and Accountability Act of 1996 (“HIPAA”).  In 2008, Parkview took custody of between 5,000 and 8,000 medical records of patients for a retiring physician in order […]

HHS Issues Reports on HIPAA Breaches and HIPAA Compliance

Last week, the U.S. Department of Health and Human Services (“HHS”) released two reports to Congress, pursuant to its obligations under the Health Information Technology for Economic and Clinical Health Act (the “HITECH Act”): a report on Breaches of Unsecured Protected Health Information for 2011 – 2012 (the “Breach Report”) and a […]

HHS Attorney Advises to Expect More Aggressive HIPAA Enforcement

Jerome Meites, a chief regional civil rights counsel for the U.S. Department of Health and Human Services (“HHS”), provided important insight into upcoming HIPAA enforcement at the recent American Bar Association conference in Chicago .  Since June 2013, over $10 million has been paid by entities to settle alleged HIPAA violations.  Mr. Meites predicted that, […]

Two New York Providers Reach Largest HIPAA Settlement with OCR To Date

Earlier this week, the U.S. Department of Health and Human Services’ Office for Civil Rights (“OCR”) reached settlements with New York and Presbyterian Hospital (“NYP”) and Columbia University (“CU”) for alleged violations of the Health Insurance Portability and Accountability Act of 1996 (“HIPAA”).  The entities operate a shared data network […]

LITIGATION ROUND-UP

Settlements BioScrip agreed to pay $15 million to settle a False Claims Act (FCA) suit alleging that it received kickbacks from Novartis Pharmaceuticals related to its distribution of Exjade through its legacy specialty pharmacy operations.  The Department of Justice (DOJ) alleged that Novartis directed BioScrip to increase patient refills on Exjade and, over the next several years as BioScrip increased its Exjade refill […]

County Pays $215,000 to Resolve Alleged HIPAA Non-Compliance

On March 7, 2014, the U.S. Department of Health and Human Services’ Office for Civil Rights (“OCR”) announced that Skagit County, Washington, has agreed to pay $215,000 and enter into a three year corrective action plan in order to settle alleged violations of the Health Insurance Portability and Accountability Act […]

FDA Revises Draft Reprint Guidance: Includes New Recommendations for Clinical Practice Guidelines

In today’s Federal Register, the U.S. Food and Drug Administration (“FDA”) announced the availability of a revised draft guidance document titled: “Distributing Scientific and Medical Publications on Unapproved New Uses – Recommended Practices” (the “Revised Draft Reprint Guidance”).  This revises the FDA’s 2009 draft guidance document on the subject, which was […]

Government’s Annual Health Care Fraud Results Released: $4.3 Billion Recovered in 2013

The Department of Health and Human Services (DHHS) and The Department of Justice (DOJ) Health Care Fraud and Abuse Control (HCRAC) Program Annual Report for Fiscal Year 2013 (Report) was released this week.  The Report states that the DHHS and DOJ recovered $4.3 billion in health care fraud judgments and settlements in fiscal year 2013.  […]

Government to Resume HIPAA Compliance Audits in 2014

This week at the Healthcare Information and Management Systems Society (“HIMSS”) Conference, Susan McAndrew, the Deputy Director for Information Privacy at the U.S. Department of Health and Human Services’ Office for Civil Rights (“OCR”), announced that OCR is planning to resume its HIPAA compliance audit program in 2014.  As a […]

Three More Manufacturer Settlements in Vermont

As we told you here, the Vermont Office of the Attorney General (“VT AG”) previously published 25 enforcement actions taken against manufacturers of pharmaceutical, biological and medical devices for failing to comply with the state’s Prescribed Products Disclosure Law, 18 V.S.A. §§ 4631, 4632.  The VT AG also posted three more recent […]