Health Care

On January 17, 2014, the Centers for Medicare & Medicaid Services (CMS) announced that it will release Medicare expenditure data on specific physicians under the Freedom of Information Act (FOIA). 

Since 2009, the HHS Office for Civil Rights (“OCR”) has posted all large data breaches – those that involve 500 or more individuals – online on its so-called “Wall of Shame.”  In 2013, 160 large data breaches were reported to OCR and posted on the Wall of Shame.

On January 10, the Centers for Medicare & Medicaid Services published proposed rules labeled as “policy and technical” changes to the Medicare Advantage (Part C) and Medicare Prescription Drug Benefit (Part D) Programs.

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.

In 2013, federal and state enforcement agencies again took aim at the health care industry. Enforcement efforts targeted the domestic and international activities of health care providers, facilities, manufacturers, and other entities' from all angles through civil actions, False Claims Act cases, securities fraud investigations, and criminal prosecutions.

As we previously reported, President Obama has made it a priority to improve the National Instant Criminal Background Check System (“NICS”). 

New legislation enacted last month will change the way many laboratories do business in Pennsylvania. Senate Bill 1042 (SB 1042), which amends Pennsylvania’s Clinical Laboratory Act (the Act), now prohibits several practices that are common across the clinical laboratory industry, including placement of laboratory employees in physician offices. 

The Office for Civil Rights (OCR) is closing out 2013 with a reminder of the importance of an effective HIPAA compliance program. 

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.

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.