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Federal Prosecutors Bring Criminal Charges against Individual for Alleged HIPAA Violation

Federal prosecutors in the Eastern District of Texas recently brought criminal charges under the Health Insurance Portability and Accountability Act (“HIPAA”) against a former East Texas hospital employee. The former...more

Los Angeles County Sues Hospital Owner for False Surgical Implant Claims to County Workers’ Compensation Program

On July 18, 2014, the County of Los Angeles (“the County”) filed a lawsuit in Los Angeles Superior Court again Michael D. Drobot, Sr., his son Michael R. Drobot, Jr. and their controlled entities, Pacific Hospital of Long...more

DEA Schedules Tramadol As A Schedule IV Controlled Substance

On July 2, 2014, the Drug Enforcement Administration (DEA) published its Final Rule placing tramadol into Schedule IV of the Controlled Substances Act (CSA). Tramadol is a synthetic opioid analgesic used in the...more

Hospital Executive Indicted for Allegedly Lying about Meaningful Use of Electronic Health Records

A hospital executive was recently indicted for allegedly submitting a false attestation regarding a hospital’s “meaningful use” of electronic health records (“EHR”) technology through the Medicare EHR incentive program. This...more

Medical Research Fraud And HHS's Office Of Research Integrity: Watching The Watchdog

Even for those who carefully follow legal developments in the health care fraud arena, the Department of Health and Human Service’s Office of Research Integrity (“ORI”) is an agency that rarely appears on the radar. According...more

New Reprint Guidance Maintains Bipartisan Status Quo

On February 28, 2014, the FDA issued its most recent unofficial guidance on distribution by manufacturers of research concerning off-label uses. With minor textual revisions, this new Guidance essentially restates the safe...more

Avoid the Anti-Corruption “Blacklist:” Chinese Agency Guidance

On March 1, 2014, Circular No. 50, which the Chinese National Health and Family Planning Commission (NHFPC) recently promulgated to regulate the conduct of pharmaceutical and medical device companies that do business in...more

China Introduces New Health Care Sector Anti-Corruption Regulations

China Introduces New Health Care Sector Anti-Corruption Regulations As part of a concerted effort to tackle systemic commercial bribery in the country’s health care sector, China’s National Health and Family Planning...more

New UK Pharmaceutical Packaging Warnings: Lucy in the Sky with Directions for Marketing Authorisation Holders

This client alert looks at the impact of a new drug driving offence in the UK which will come into effect during 2014 as part of The Crime and Courts Act 2013 (the “CCA 2013”). It is relevant for UK Marketing Authorisation...more

China Issues New Regulations Prohibiting Commercial Bribery in the Health Care Industry

In late December, China’s National Health and Family Planning Commission ("NHFPC"), the successor organization to the Ministry of Health, issued two sets of anti-corruption regulations for the health care industry: the 2013...more

"Health Care and Life Sciences: Affordable Care Act Rollout to Impact M&A and Enforcement Activity"

Health care and life sciences companies face a variety of issues in 2014, including further difficulties with the Affordable Care Act (ACA) rollout because of legal and logistical challenges, the potential dampening of...more

Healthcare Fraud Recoveries at All-Time High Since 2009

Fiscal year 2013 marked the fourth consecutive year in which the Department of Justice has recovered at least $2 billion from cases involving charges of healthcare fraud. Make no mistake: these record-setting yields were no...more

Health Reform + Related Health Policy News - January 2014, Issue 1

In This Issue: - Top News ..Congress Approves Budget Deal with Short-Term ‘Doc Fix' ..CMS “Two-Midnight” Rule delayed until March 31, 2014 ..Individuals with Canceled Insurance Policies May Apply for...more

Hodgson Russ Helps Clients in Largest-Ever False Claims Act Settlement In Risperdal Lawsuits Against Johnson & Johnson

The Justice Department announced that Johnson & Johnson will pay $1.273 billion to the federal government and most states to settle a civil False Claims Act investigation into its off-label marketing of its antipsychotic drug...more

The Anti-Kickback Statute And The Affordable Care Act: A Law Enforcement Tool Suddenly Goes Missing

With the aggressive pursuit of cases against the pharmaceutical and device industries (including the recent $2.2 billion settlement with Johnson & Johnson), the implementation of Medicare Fraud Strike Forces in major cities...more

J&J Will Pay $2.2 Billion and Enter 5-Year CIA to Settle Off-Label and Kickback Charges

This week, the DOJ announced that J&J has agreed to pay over $2.2 billion in civil and criminal fines in one of the nation’s largest ever health care fraud settlements. As part of the resolution, J&J subsidiary Jannsen will...more

White Collar Watch - October 2013

In This Issue: - Small businesses beware: IRS deploys “big data” to scrutinize cash transactions - Google’s scanning of emails may constitute wiretapping: Federal District Court denies Google’s motion to dismiss...more

Computer Crime Insurance Coverage: Can It Cover Fraudulent Entries Submitted by an Authorized User?

In a recent decision, New York's appellate court considered whether a "Computer Systems Fraud" insurance policy rider (Policy) covered losses that Universal American suffered as a result of fraudulent claims electronically...more

Misbranded Drugs: A Danger To Physicians And Patients

Mail-order businesses, including pharmacies, bombard doctors by fax, phone, and Internet offering an assortment of name-brand medications and treatments at bargain prices. These new options tempt physicians with the promise...more

HHS Issues Privacy Rule Guidance for Law Enforcement Agencies

The Office for Civil Rights (OCR) of the Department of Health and Human Services recently announced the release of its guidance, “Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule: A Guide for Law...more

Mintz Levin Health Care Qui Tam Update -- Recent Developments and Unsealed Cases: September 2013

Trends and Analysis - ..We have identified 24 health care-related qui tam cases unsealed since last month’s Qui Tam Update. Of those, only 2 were filed in 2013. Nearly half were filed before 2011. ..Among the 24...more

D.A.R.E. to Market Off-Label Uses of Prescription Drugs? Make Sure You are in the Second Circuit: United States v. Caronia and the...

Truthful, non-misleading off-label promotion of prescription drugs is not illegal. At least, not in the Second Circuit. This, despite the billions of dollars in civil and criminal penalties assessed against pharmaceutical...more

New Survey Underscores Providers' Responsibility for Preventing Medical ID Theft

The Ponemon Institute's recent publication of its fourth annual 2013 Survey on Medical Identity Theft (Survey) confirmed what many in the healthcare industry already knew: identity theft is a serious and often overlooked...more

Mintz Levin Health Care Qui Tam Update - Recent Developments and Unsealed Cases

Trends and Analysis: ..We have identified 20 health care-related qui tam cases unsealed in July 2013. About a quarter of those were filed in 2013. ..Among the cases unsealed in July, the government has declined to...more

New Enforcement Guidance from the UK’s Information Commissioner’s Office

(LONDON) Who is on the ICO’s radar these days? August seems to be the month for getting new guidance documents out the door at the United Kingdom’s Information Commissioner’s Office. The UK ICO has just published guidance...more

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