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Data Breach Wall of Shame: 2013's Highlights and Lessons

January 23, 2014 | Blog | By Kimberly Gold

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.
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What Do the Proposed Changes to Medicare Parts C and D Mean For Your Business?

January 22, 2014 | Blog | By Theresa Carnegie

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.
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ML Strategies Posts Weekly Health Care Reform Update on January 21, 2014

January 21, 2014 | Blog | By Theresa Carnegie

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.
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2013 Health Care Enforcement Defense Trends

January 17, 2014 | Blog

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.
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OCR Proposes HIPAA Amendments to Address Gun Violence

January 7, 2014 | Blog | By Theresa Carnegie

As we previously reported, President Obama has made it a priority to improve the National Instant Criminal Background Check System (“NICS”). 
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Changes Ahead for Laboratories Doing Business in Pennsylvania

January 6, 2014 | Blog | By Samantha Kingsbury, Karen Lovitch

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. 
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A New Year’s Resolution (and Corrective Action Plan) from OCR: Physician Practice Cited for HIPAA Violations

December 30, 2013 | Blog | By Theresa Carnegie

The Office for Civil Rights (OCR) is closing out 2013 with a reminder of the importance of an effective HIPAA compliance program. 
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CMS Announces 123 New ACOs; Doubles Down on Pioneer ACO Program

December 27, 2013 | Blog

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.
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OIG and CMS Permit EHR Donations Through 2021, Except for Labs

December 23, 2013 | Blog | By Karen Lovitch

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.
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GlaxoSmithKline Announces Further Limits on Payments to Physicians and on Sales Compensation

December 18, 2013 | Blog | By Kimberly Gold, Karen Lovitch

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.
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Unsealed Qui Tams Show That Government Declination is Not Always the End

December 5, 2013 | Blog

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.
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CMS Issues Medicare Physician Fee Schedule Without Finalizing Proposal Most Harmful to Independent Laboratories

December 3, 2013 | Blog | By Roy Albert

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.
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OIG Defines its Priorities in 2014-2018 Strategic Plan

November 25, 2013 | Blog | By Brian Dunphy

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. 
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Traps for the Unwary: The Impact of the False Claims Act on Start-Up and Venture-Stage Life Sciences Companies

November 19, 2013 | Blog | By Karen Lovitch

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.
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OIG Issues Negative Advisory Opinion Regarding Anesthesiology Provider Contract

November 15, 2013 | Blog | By Theresa Carnegie

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").
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Five Tips For Addressing Disruptive Physician Behavior

November 6, 2013 | Blog | By Theresa Carnegie

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

November 6, 2013 | Blog | By Theresa Carnegie

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.
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CMS Declares Third Party Payment of QHP Premiums Not OK

November 5, 2013 | Blog | By Theresa Carnegie

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.
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HHS Announces That ACA Exchange Plans Are Not “Federal Health Care Programs”

November 4, 2013 | Blog | By Theresa Carnegie

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.
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ML Strategies Posts Weekly Health Care Reform Update on October 28, 2013

November 1, 2013 | Blog | By Theresa Carnegie

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. 
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