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The Past, Present, and Future of Government Regulation of Off-Label Communications – Part 5
October 26, 2017| Blog|
New Qui Tam Update from Mintz’s Health Care Enforcement Defense Group
September 27, 2017 | Blog | By Carrie Roll
Earlier this month, Mintz’s Health Care Enforcement Defense Group published its most recent Health Care Qui Tam Update that looks at 23 health care-related qui tam cases unsealed in June 2017. The Update provides an in-depth analysis of six cases in which the government intervened, and discusses why these cases are notable in the health care industry.
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FDA Commissioner Announces Stem Cell Enforcement Shift, Plans to Develop Comprehensive Regenerative Medicine Policies
September 5, 2017 | Blog | By Joanne Hawana
In a major public move that has been long-awaited by proponents of evidence-based stem cell science, FDA Commissioner Scott Gottlieb issued a lengthy statement on August 28, 2017 “on the FDA’s new policy steps and enforcement efforts to ensure proper oversight of stem cell therapies and regenerative medicine.”
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The Four Things That Surprised Us in the EpiPen False Claims Settlement
August 23, 2017 | Blog
On August 17, 2017, the U.S. Department of Justice (DOJ) announced that it had reached a $465 million false claims settlement with Mylan, the manufacturer of EpiPen, over the company’s alleged underpayment of Medicaid Drug Rebates for EpiPen.
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Mintz’s Health Care Enforcement Defense Group Publishes New Qui Tam Update
August 8, 2017 | Blog | By Samantha Kingsbury
Last week, Mintz’s Health Care Enforcement Defense Group published a new Qui Tam Update, which analyzes 21 health care-related False Claims Act qui tam cases unsealed in May 2017.
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DOJ and OIG Announce Largest Ever National Health Care Fraud Takedown; Focus on Opioids
July 21, 2017 | Blog | By Eoin Beirne
Continuing its annual tradition, the U.S. Department of Justice (“DOJ”) and the U.S. Department of Health and Human Services (“HHS”) announced last week the largest ever health care fraud enforcement action by the Medicare Fraud Strike Force. As part of the national health care fraud takedown, the government charged 412 defendants with approximately $1.3 billion in alleged fraud.
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Join us July 12th - Webinar on Qui Tam Relators
June 26, 2017 | Blog
Whistleblowers remain a steady source of False Claim Act (FCA) suits against health care and life science companies each year. Join our upcoming webinar - “Qui Tam Relators: What You Need to Know” on July 12 at 1pm ET.
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Private Needle Exchange Programs Do Not Require Local Approval: Massachusetts Supreme Judicial Court Weighs In
June 19, 2017 | Blog
Last week, in a case being watched locally and nationally, the Massachusetts Supreme Judicial Court ("SJC") ruled that local government approval is not required for the operation of a private needle exchange program and that the Town of Barnstable cannot bar such a program from operating.
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Antitrust Suit Against Michigan Hospital Moves Forward After Federal District Court Denies Both Sides’ Motions for Summary Judgment
June 9, 2017 | Blog | By Samantha Kingsbury
Earlier this week, my colleagues Bruce Sokler, Robert Kidwell, Dionne Lomax, and Farrah Short published an alert about the federal district court for the Eastern District of Michigan’s recent decision to deny both the government’s and defendant hospital’s respective motions for summary judgment in a suit filed by the Department of Justice and the Michigan Attorney General in 2015.
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OIG Publishes Semiannual Report to Congress
June 9, 2017 | Blog | By Ryan Cuthbertson
Earlier this month, the Office of the Inspector General for the Department of Health and Human Services (“OIG”) published its Semiannual Report to Congress covering the period from October 1, 2016 to March 31, 2017. The report describes OIG’s work and accomplishments during the 6-month reporting period.
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The Latest in the Epipen Medicaid Drug Rebate Saga – Where Are We Now?
June 6, 2017 | Blog
The latest installment in the ongoing saga over EpiPen Medicaid Drug Rebates came on May 31, 2017, when Senator Charles Grassley issued a press release stating that between 2006-2016 taxpayers may have overpaid for EpiPen by as much as $1.27 billion, “far more” than the announced-but-never-confirmed or finalized $465 million DOJ settlement with Mylan.
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Seven Takeaways from the ABA National Institute On Health Care Fraud
May 25, 2017 | Blog
On May 17, 2017 the American Bar Association convened its 27th National Institute on Health Care Fraud. I have attended many of the past annual meetings, and always enjoy the presentations and the opportunity to network with colleagues from all sides of the aisle. And I always come away with a few nuggets to share with those who did not attend.
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Join us for our Upcoming Webinar: Patient Assistance Programs & Government Enforcement: What You Need to Know
April 27, 2017 | Blog | By Lauren Moldawer
Patient assistance programs have been a staple within the health care industry for over a decade. These programs, operated by 503(c)(3) charities, may receive funding from pharmaceutical manufacturers or other providers to offer assistance to low-income patients in affording their medications, co-payments, deductibles, premiums, or other related services.
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Five Trends in False Claims Act Enforcement: Take Two
April 17, 2017 | Blog | By Theresa Carnegie
In July 2015, we posted about the N.Y. Attorney General’s False Claims Act (FCA) settlements with Trinity HomeCare and its related entities, and how the case provided insight into the future of FCA enforcement. We identified five key trends based on the settlements.
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Join Mintz and ML Strategies for the 2nd Annual Pharmacy Summit
April 3, 2017 | Blog | By Lauren Moldawer
Mintz and ML Strategies will be hosting the 2nd Annual Pharmacy Industry Summit on April 5th and 6th! The Summit will bring together stakeholders and thought leaders from across the industry to discuss legal and policy challenges facing manufacturers, PBMs, payors, pharmacies, and providers.
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Changes Needed to Stark Law Advisory Opinion Process
March 29, 2017 | Blog
The Stark Law has caused angst for many a physician and many a health care lawyer over the years. The Stark Law has also troubled hospital and health system CEOs looking for ways to align incentives with physicians. Some stakeholders say Congress should do away with the myriad statutes and regulations that comprise the strict liability federal law banning physician self-referral.
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New York Medical Society Warns Providers to Avoid Percentage-Based Fees
March 21, 2017 | Blog
A series of recoupment letters from the New York State Medicaid Fraud Control Unit (MFCU) to healthcare providers who have management or billing company arrangements based on a percentage of collections has prompted the Medical Society of the State of New York (MSSNY) to warn its members that such arrangements are fraudulent under Medicaid law.
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President’s Budget Blueprint Increases Funds For Health Care Fraud Enforcement
March 16, 2017 | Blog | By Brian Dunphy
The President has released a “budget blueprint” for fiscal year 2018. Although there are many aspects of the budget blueprint to digest, several budget items signal that government health care fraud enforcement remains a priority under the new administration.
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New Qui Tam Update from Mintz’s Health Care Enforcement Defense Group - March 2017
March 16, 2017 | Blog | By Ryan Cuthbertson
Earlier this month, Mintz’s Health Care Enforcement Defense Group published its most recent Health Care Qui Tam Update that looks at 18 health care-related qui tam cases unsealed in October and November of 2016.
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Viewpoint Editors
Karen S. Lovitch
Chair, Health Law Practice & Co-Chair, Health Care Enforcement Defense Practice
Joanne S. Hawana
Member
Rachel E. Yount
Of Counsel
Pat G. Ouellette
Associate
Stephnie A. John
Associate
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