Health Care

Accountable Care Organizations (ACOs) continue to figure big in CMS’s health care reform agenda. On December 20th, the agency’s Innovation Center published a Request for Information (Pioneer RFI) seeking input on how to create the next generation of the Pioneer ACO program that began two years ago.

At long last, the Office of Inspector General for the Department of Health and Human Services (OIG) and the Centers for Medicare & Medicaid Services (CMS) have finalized regulations amending the Anti-Kickback Statute safe harbor and the Stark Law exception, respectively, for donation of electronic health records (EHR) items and services.

On December 18, 2013, New York State Governor Andrew Cuomo signed the Nonprofit Revitalization Act of 2013 (the Act) into law, triggering the first overhaul of the New York Not-for-Profit Corporation Law (N-PCL) in more than 40 years.

GlaxoSmithKline (“GSK” or the “Company”) announced yesterday that it will stop paying health care professionals to promote its drug products and will no longer tie the compensation of its worldwide sales force to individual sales targets.

Mintz Levin's most recent Qui Tam Update authored by our Health Care Enforcement Defense Practice provides focused analysis of four health care-related qui tam cases in which the government declined to intervene, including one that may be accepted for argument in front of the United States Supreme Court.

On the day before Thanksgiving and a little over one month after the end of the government shutdown, the Centers for Medicare & Medicaid Services (“CMS”) published a rule finalizing revisions to payment policies under the Medicare Physician Fee Schedule (“MPFS”) and other revisions to Medicare Part B for calendar year 2014.

Outlining its high-level priorities and goals for the next five years, the U.S. Department of Health and Human Services (HHS) Office of Inspector General (OIG) published its Strategic Plan for 2014-2018.  In the Strategic Plan, OIG identified four broad goals:  (i) fight fraud, waste, and abuse; (ii) promote quality, safety, and value; (iii) secure the future; and (iv) advance excellence and innovation. 

A government investigation or enforcement action can disrupt a business, delay the launch of a new product, or threaten funding. Life sciences companies that participate in federal grant programs need to be aware of the risks associated with non-compliance with rules and regulations governing those programs.

On November 12, 2013, the Office of Inspector General ("OIG") released Advisory Opinion 13-15 concluding that a proposed arrangement between an anesthesiology group and a hospital-based psychiatry group could potentially generate prohibited remuneration under the federal Anti-Kickback Statute ("Kickback Statute").

Recently, a colleague and I spoke at the NAMSS 37th Educational Conference & Exhibition to nearly 200 medical directors, chief medical officers, and credentialing staff about what constitutes disruptive physician conduct in the hospital setting, and what hospitals can do to manage it.

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.

On the heels of HHS's recent announcement that qualified health plans (QHPs) purchased through the Affordable Care Act (ACA) insurance exchanges are not "federal health care programs" for purposes of the federal anti-kickback statute.

In a surprising move late last week, HHS Secretary Kathleen Sebelius announced that qualified health plans (QHPs) purchased through the Affordable Care Act’s (ACA) insurance exchanges are not “federal health care programs” for purposes of the federal anti-kickback statute.

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

On October 16, 2013, a New York federal district court granted a partial motion to dismiss a class action suit brought against the New York City Health & Hospitals Corp.

On October 11, 2013, CMS posted the 2014 Medicare Health Plan Quality and Performance Ratings, which are commonly referred to as “Star Ratings.” CMS released the 2014 Star Ratings several days later than originally scheduled, worrying some Plan Sponsors and analysts.

In the early morning of October 1, 2013, the U.S. federal government officially went dark. The shutdown came in the aftermath of the Senate’s decisive vote to reject a House plan that would have kept the government funded for several more months but delayed implementation of key portions of the Affordable Care Act (ACA) for one year.

Health care employers concerned that former employees may misappropriate the company’s confidential information to support qui tam lawsuits under the False Claims Act (“FCA”) received guidance from a recent court decision. 

Last week, Democrat and Republican leaders of both houses of Congress agreed to the terms of a bill that would give the U.S. Food and Drug Administration (FDA) greater authority to regulate drug compounding and would revamp the way drugs are tracked from the manufacturer to the pharmacy. 

Plaintiffs’ firms looking to capitalize on the growth in whistleblower litigation are turning to smart phone technology to try to gain a competitive edge. Well known Delaware plaintiffs’ class action law firm Grant & Eisenhofer is attempting to enlarge its footprint in the burgeoning qui tam litigation field with a new smart phone app called, “Whistleblower Laws.