Health Care

A court has ruled that Merck’s production of documents to the government under a confidentiality agreement during the Vioxx investigation waived any confidentiality or privilege; documents that Merck had previously disclosed to the government under a confidentiality agreement must now be produced to private party plaintiffs in pending securities litigation.

Pitfalls in Healthcare Mergers and Acquisitions - Emerging Issues (The Health Lawyer, October 2012), is a must read for anyone contemplating, in the midst of, or even recovering from, a healthcare merger or acquisition.

Last Friday, the Office of Inspector General (OIG) issued Advisory Opinion No. 12-19 approving three of four proposed arrangements involving a pharmacy’s provision of free or below market items and services to community homes where the pharmacy’s patients reside.

The U.S. Court of Appeals for the 2nd Circuit upheld a First Amendment challenge to the federal prosecution of pharmaceutical salesperson Alfred Caronia for off-label marketing. Given the number of off-label marketing cases pursued by the government in recent years, this decision could have major repercussions. 

ML Strategies has posted its weekly Health Care Reform Update.  This publication provides timely and concise information on  implementation of the Affordable Care Act, and other state and federal administrative and legislative activities related to health care reform.

On November 26th, the U.S. Department of Health and Human Services Office for Civil Rights (OCR) released guidance on the methods that covered entities and business associates can use to de-identify protected health information (PHI) in accordance with the Health Insurance Portability and Accountability Act of 1996 (HIPAA) Privacy Rule.

On November 14th, the U.S. Department of Justice (“DOJ”) and the U.S. Securities and Exchange Commission (“SEC”) published A Resource Guide to the U.S. Foreign Corrupt Practices Act, their long-awaited, highly anticipated guidance on the FCPA.

ML Strategies has posted its weekly Health Care Reform Update.  This publication provides timely and concise information on  implementation of the Affordable Care Act, and other state and federal administrative and legislative activities related to health care reform.

My Mintz Levin colleague, Stephen Bentfield, and Alex Hecht of ML Strategies provide their perspective on the future direction of the Affordable Care Act (ACA) during President Obama’s second term in a Law360 article entitled What Obama’s Re-Election Means for Health Care Policy.

Massachusetts voters passed a referendum question eliminating state criminal and civil penalties for the medical use of marijuana by patients with certain “debilitating medical conditions,” including cancer, glaucoma, HIV, AIDS, hepatitis C, Crohn’s disease, Parkinson’s disease, ALS, or multiple sclerosis.

Yesterday the Centers for Medicare & Medicaid Services (CMS) published a final rule with comment period implementing the Medicare Physician Fee Schedule for 2013, and it covers a number of  issues of interest to independent laboratories.

As discussed in our recent post on the new Medicare Advantage (MA) star ratings, there is ongoing controversy regarding HHS’s Medicare Advantage Quality Bonus Payment Demonstration Project.

New England Compounding Center (NECC) distributed contaminated syringes that caused a meningitis outbreak – killing fifteen people in fifteen states. Officials estimate that as many as 14,000 patients may have received injections of steroids compounded by NECC from contaminated syringes.

Earlier today, CMS made available its 2013 Medicare Health Plan Quality and Performance Ratings, also called “Star Ratings.” The Star Ratings will assist enrollees during the annual enrollment period that extends from October 15, 2012 to December 7, 2012 and will also play a significant role in determining reimbursement rates for Medicare Advantage Plans.

Yesterday the U.S. Department of Health and Human Services Office of Inspector General (OIG) released the results of a study entitled CMS Response to Breaches and Medical Identity Theft. 

The OIG held a roundtable meeting with representatives from 32 companies that have entered into Corporate Integrity Agreements (CIAs) since 2009. Following from the August 7, 2012, roundtable meeting, this week the OIG published a roundtable paper Focus on Compliance: The Next Generation of Corporate Integrity Agreements. 

Last week, the OIG published its FY 2013 Work Plan. The Work Plan summarizes new and ongoing reviews and activities that the OIG plans to pursue with respect to HHS programs and operations during FY 2013 and beyond.

I recently co-chaired an American Conference Institute (ACI) forum on Pharmaceutical Pricing Litigation, which featured a number of key players who provided their unique perspectives on state and federal litigation involving pharmaceutical manufacturers and their products.

Earlier this week, New York State Governor Andrew Cuomo vetoed legislation that would have brought the State’s restrictions on physician self-referrals (the State Law) in line with the federal ban on self-referrals, which is commonly known as the Stark Law.  

As reported in an earlier post, the U.S. Department of Health and Human Services Office of Inspector General (OIG) has released its Work Plan for Fiscal Year 2013 (Work Plan).