NY AG Opens Antitrust Investigation Into EpiPen Maker Mylan Pharmaceuticals Inc.

September 6, 2016

The New York Attorney General is investigating whether leading EpiPen Manufacturer, Mylan Pharmaceuticals, violated New York antitrust laws by inserting anticompetitive terms into its EpiPen sales contracts with numerous local school systems. The scrutiny by New York Attorney General Eric T. Schneiderman comes as Mylan is part of the widening backlash against Mylan’s in response to its sharp increase in the price of the EpiPen, treatments for life-threatening anaphylactic shock.

Already facing class action lawsuits in Ohio and Michigan, Mylan has drawn criticism from parents, the media, Congress and regulators for increasing its standard price for the EpiPen from less than $100 in 2007 to more than $600 in 2016.

According to Attorney General Schneiderman, Mylan Pharmaceuticals may have inserted potentially anticompetitive terms into its EpiPen sales contracts with numerous local school systems.

In announcing the antitrust investigation, Attorney General Schneiderman said, “No child’s life should be put at risk because a parent, school, or healthcare provider cannot afford a simple, life-saving device because of a drug-maker’s anti-competitive practices.”  He also promised, “If Mylan engaged in anti-competitive business practices, or violated antitrust laws with the intent and effect of limiting lower cost competition, we will hold them accountable. Allergy sufferers have enough concerns to worry about—the availability of life-saving medical treatment should not be one of them. I will bring the full resources of my office to this critical investigation.”

About The Author

Foundation and the Texas Bar Foundation, current American Bar Association (ABA) International Section Life Sciences Committee Vice Chair, former scribe for the ABA Joint Committee on Employee Benefits (JCEB) Annual OCR Agency Meeting and JCEB Council Representative, former Vice President of the North Texas Health Care Compliance Professionals Association, Past Chair of the ABA Health Law Section Managed Care & Insurance Section,  the former Board President and Treasurer of the Richardson Development Center for Children Early Childhood Intervention Agency, and past  Board Compliance Chair of the National Kidney Foundation of North Texas, and Board Certified in Labor & Employment Law by the Texas Board of Legal Specialization, the author of this update, attorney Cynthia Marcotte Stamer, is AV-Preeminent (the highest) rated attorney repeatedly recognized for her nearly 30 years of experience and knowledge representing and advising healthcare, health plan and other health industry and others on these and other regulatory, workforce, risk management, technology, public policy and operations matters as a Martindale-Hubble as a “LEGAL LEADER™” and “Texas Top Rated Lawyer” in Health Care Law, Labor and Employment Law, and Business & Commercial Law and among the “Best Lawyers In Dallas” by D Magazine.

Ms. Stamer’s health industry experience includes advising hospitals, nursing home, home health, rehabilitation and other health care providers and health industry clients to establish and administer compliance and risk management policies; prevent, conduct and investigate, and respond to peer review and other quality concerns; and to respond to Board of Medicine, Department of Aging & Disability, Drug Enforcement Agency, OCR Privacy and Civil Rights, Department of Labor, IRS, HHS, DOD and other health care industry investigation, enforcement and other compliance, public policy, regulatory, staffing, and other operations and risk management concerns.

Ms. Stamer also is known for her experience in HIPAA and other privacy and data security and breach concerns.  The scribe for ABA JCEB annual agency meeting with OCR for many years, Ms. Stamer has worked extensively with health care providers, health plans, health care clearinghouses, their business associates, employers and other plan sponsors, banks and other financial institutions, and others on risk management and compliance with HIPAA, FACTA, trade secret and other information privacy and data security rules, including the establishment, documentation, implementation, audit and enforcement of policies, procedures, systems and safeguards, investigating and responding to known or suspected breaches, defending investigations or other actions by plaintiffs, OCR and other federal or state agencies, reporting known or suspected violations, business associate and other contracting, commenting or obtaining other clarification of guidance, training and enforcement, and a host of other related concerns. Her clients include public and private health care providers, health insurers, health plans, technology and other vendors, and others. In addition to representing and advising these organizations, she also has conducted training on Privacy & The Pandemic for the Association of State & Territorial Health Plans, as well as HIPAA, FACTA, PCI, medical confidentiality, insurance confidentiality and other privacy and data security compliance and risk management for Los Angeles County Health Department, ISSA, HIMMS, the ABA, SHRM, schools, medical societies, government and private health care and health plan organizations, their business associates, trade associations and others.

A popular lecturer and widely published author on health industry concerns, Ms. Stamer continuously advises health industry clients about compliance and internal controls, workforce and medical  staff performance, quality, governance, reimbursement, and other risk management and operational matters. Ms. Stamer also publishes and speaks extensively on health and managed care industry regulatory, staffing and human resources, compensation and benefits, technology, public policy, reimbursement and other operations and risk management concerns. Her insights on these and other related matters appear in the Health Care Compliance Association, Atlantic Information Service, Bureau of National Affairs, The Wall Street Journal, Business Insurance, the Dallas Morning News, Modern Health Care, Managed Healthcare, Health Leaders, and a many other national and local publications.

You can get more information about her health industry experience here or contact Ms. Stamer via telephone at (469) 767-8872 or via e-mail here.

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©2016 Cynthia Marcotte Stamer, P.C. Non-exclusive license to republish granted to Solutions Law Press, Inc. All other rights reserved.

 


“Health Care Government Relations and Legislative Update” Focus On July 14 North Texas Healthcare Compliance Professional Association Meeting

July 13, 2009

NORTH TEXAS HEALTHCARE COMPLIANCE PROFESSIONAL ASSOCIATION

July 14, 2009 Meeting Reminder

Congress and federal regulators are making health care regulation and reform their latest priority.  The NTHCPA invites interested health care compliance and ethics professionals to join us on July 14, 2009 for a lively discussion about “Health Care Government Relations and Legislative Update” lead by as Sandy Pappas, from Congressman Pete Session’s Office and Cynthia Marcotte Stamer from Curran Tomko Tarski LLP.

Date:  Tuesday, July 14, 2009

Time:  2:00 p.m.

Location:  Texas Health Resources, 612 E. Lamar Blvd., Arlington, TX  76011

For additional information, please contact Cynthia Stamer at (214) 270-2402 or by e-mail at cstamer@solutionslawyer.net.

About the NTHCPA

NTHCPA exists to champion ethical practice and compliance standards and to provide the necessary resources for ethics and compliance Professionals and others in North Texas who share these principles.

The vision of NTHCPA is to be a pre-eminent compliance and ethics group promoting lasting success and integrity of organizations within North Texas.

To register or update your registration to receive notice of other upcoming events, e-mail your contact information to lfigueroa@cttlegal.com.

This communication may be considered a marketing communication for certain purposes.  If you wish to update your e-mail for purposes of or would prefer not to receive future e-mail concerning meetings or other activities of the North Texas Healthcare Compliance Professionals Association or other marketing and promotional mailings from it, please send an email with the word “unsubscribe” in its subject heading to lfigueroa@cttlegal.com


Newly Enacted FERA Amendments To False Claims Act Signal New Risks For Health Industry Organizations & Others

May 26, 2009

Health care providers and other parties covered by the False Claims Act, 31 U.S.C. § 3729 (FCA), now face expanded whistleblower and other liability under amendments to the FCA enacted under the “Fraud Enforcement and Recovery Act of 2009”(FERA).  The amendments increase the likelihood both that whistleblowers will turn in health care providers and other individuals and organizations that file false claims in violation of the FCA and the liability that violators may incur for that misconduct.

Signed into law by President Obama last Wednesday (May 20, 2009), FERA immediately upon enactment:

  • Amends the whistleblower protections afforded to employees, contractors and agents who suffer retaliation for taking lawful efforts to stop violations of the FCA and to make it easier for those individuals to pursue retaliation claims;
  • Expands liability under for making false or fraudulent claims to the federal government under the FCA;
  • Applies liability under the FCA for presenting a false or fraudulent claim for payment or approval (currently limited to such a claim presented to an officer or employee of the federal government); and
  • Requires persons who violate such Act to reimburse the federal government for the costs of a civil action to recover penalties or damages 

Concurrent with President Obama’s signature of FERA into law, the U.S. Departments of Justice (DOJ) and Health & Human Services (HHS) jointly announced the expansion of federal health care fraud enforcement efforts.  On May 20, 2009, HHS and DOJ announced their activation of a new interagency team to combat health care fraud highlights the increasing need for health care providers and health plans to review and tighten their practices for dealing with Medicare and other federal programs to survive scrutiny under federal health care fraud initiatives.  Coupled with FERA and the already significant increase in federal health care fraud detection and enforcement activities in recent years and a proposed 50 percent increase in funding for these activities included in President Obama’s Fiscal Year 2010 budget, health care providers and payers must be prepared to defend their dealing with Medicare, Medicaid and other federal health care programs.

The expanded protections afforded under FERA to whistleblowers and others suffering retaliation for opposing or reporting illegal actions can be expected to serve as a key tool in these efforts. These new retaliation safeguards are designed further increase the likelihood that employees and other insiders will help government officials ferret out false claims and other fraud. Specifically with regard to retaliatory action claims Section 4(d) of FERA amends 31 U.S.C.§ 3730(h) to provide for the recovery of “all relief necessary to make that employee, contractor, or agent whole” where that individual is discharged, demoted, suspended, threatened, harassed, or in any other manner discriminated against in the terms and conditions of employment because of lawful acts he does or takes on behalf of an individual in furtherance of other efforts to stop a violation of the FCA. 

FERA expressly provides that relief to victims of retaliation will include “reinstatement with the same seniority status that employee, contractor, or agent would have had but for the discrimination, 2 times the amount of back pay, interest on the back pay, and compensation for any special damages sustained as a result of the discrimination, including litigation costs and reasonable attorneys’ fees.” 

The FERA amendments to the FCA, the new TEAMS enforcement effort announced simultaneously with its signature into law mean that health care industry organizations and others covered by the FCA must implement appropriate fraud prevention, detection, redress and other procedures to help defend against possible FCA or other health care fraud claims and investigations.

The attorneys at Curran Tomko Tarski, LLC have extensive experience representing and advising health industry and other clients against FCA and other federal health care and fraud laws. 

For More Information

We hope that this information is useful to you. If you need assistance with auditing or defending health care fraud concerns or other health care compliance, risk management, transactions or operations concerns, please contact Curran Tomko Tarski LLP Partners Cynthia Marcotte Stamer at (214) 270-2402, CStamer@CTTLegal.com; Michael T. Tarski at (214) 270-1420 or MTarski@CTTLegal.com; Edwin J. Tomko at (214) 270-1405 or ETomko@CTTLegal.com.

You can review other recent health care and internal controls resources and additional information about the health industry and white collar experience of the Curran Tomko Tarski LLP attorneys at http://www.CTTLegal.com. If you or someone else you know would like to receive future updates about developments on these and other concerns, please be sure that we have your current contact information – including your preferred e-mail – by creating or updating your profile at CTTLegal.com or e-mailing this information to CStamer@CTTLegal.com.


Stamer To Discuss “Making Gainsharing Work: Managing Physician Performance” At June 17, 2009 Dallas Bar Association Health Law Section Meeting

May 26, 2009

Health care organizations, health plans and regulars increasingly point to gainsharing and pay-for-performance strategies as key to securing needed key physician buy-in and performances to achieve desired health care quality and cost objectives.  Using physician gainsharing to promote desired performances within the bounds of the law without undesirable side effects involves more than staying within the STARK exceptions and anti-kickback safe harbors. 

Curran, Tomko Tarski, LLP attorney Cynthia Marcotte Stamer will discuss key strategies and processes for designing and administering legally defensible pay-for-performance and other gainsharing arrangements that promote desired outcomes in operation at the Dallas Bar Association Health Law Section meeting on June 17, 2009. 

Former Chair of the ABA Health Law Section Managed Care & Insurance Interest Group, attorney and author Cynthia Marcotte Stamer is nationally and internationally recognized for her legal work, publications and programs, and advocacy on health industry performance management and other health industry matters.  Ms. Stamer works extensively with health care organizations, managed care and health insurance organizations, governments and others to manage performance and legal risks.  Board Certified in Labor & Employment Law by the Texas Board of Legal Specialization, Ms. Stamer combines her more than 22 years of health industry regulatory and risk management experience with an in-depth knowledge of workforce management and regulation to help clients manage performance and legal and operational risks.  Her experience includes advising public and private health industry clients domestically and internationally on a wide range of matters.  A widely published author and popular speaker, Ms. Stamer’s insights on health industry matters also are quoted in HealthLeaders, Managed Care Executive, the Wall Street Journal and many other national popular, business and industry publications.

 Ms. Stamer is scheduled to begin her remarks at Noon on June 17, 2009 at the offices of the Dallas Bar Association located at 2101 Ross Avenue, Dallas, Texas 75201.  For additional information, call the Dallas Bar Association at 214-220-7400 or see http://www.dallasbar.org.


Connecticut Man Pleads Guilty To Multi-Million Dollar Tax Fraud Conspiracy Involving False Charges For Hospital Maintenance & Insulation Services

April 4, 2009

A Connecticut resident faces  five years in prison, three years of supervised release and a $250,000 fine after pleading guilty this week to conspiracy to aid another in filing false tax returns between approximately 2000 and February 2005 through a fraudulent check cashing scheme for the owner of a corporation that was engaged in the business of providing maintenance and insulation services to New York Presbyterian Hospital (NYPH).  The action reflects the risks to individuals and businesses that illegally claim tax deductions, bill for services or violate other federal criminal laws.

Krzysztof Koczon plead guilty in U.S. District Court in Manhattan to charges he provided false documentation to co-conspirators indicating that he had performed construction services and received more than $2.3 million in checks from the co-conspirators as payment for the construction services, the Department of Justice announced Thursday, April 2, 2009.   Koczon cashed the checks but returned the bulk of the money to the co-conspirators in exchange for a fee. The co-conspirators then took false deductions for those payments made to Koczon’s businesses.

The tax fraud conspiracy that Koczon is charged with carries a maximum penalty of five years in prison, three years of supervised release and a $250,000 fine. The maximum fine may be increased to twice the gain derived from the crime or twice the loss suffered by the victims of the crime, if either of those amounts is greater than the statutory maximum fine.

In April 2007, as part of the same investigation, Michael Theodorobeakos and two maintenance and insulation companies he co-owned–Monosis Inc. and STU Associates Inc. pleaded guilty to conspiring to rig bids on the supply of maintenance and insulation services to NYPH and Mount Sinai Medical Center (Mount Sinai). In addition, Michael Vignola and Mister AC Ltd. pleaded guilty in November 2007 to conspiring to rig bids on heating, ventilation and air conditioning (HVAC) services provided to NYPH and paying kickbacks to former NYPH purchasing officials. In April 2008, Aaron S. Weiner pleaded guilty to participating in a conspiracy wherein Weiner acted as a conduit in another million-dollar kickback scheme also involving one of the same former NYPH purchasing officials involved with the Vignola kickback schemes. On March 25, 2009, Mariusz Debowski pleaded guilty to participating in the same tax fraud conspiracy at NYPH.

These charges arose from an ongoing federal antitrust investigation of fraud, bribery, tax-related offenses and bidding irregularities relating to contracts administered by the Facilities Operations Department and the Engineering Department at NYPH and the Engineering Department at Mount Sinai conducted by the Antitrust Division’s New York Field Office, the FBI and the Internal Revenue Service Criminal Investigation’s New York Field Office.

Cynthia Marcotte Stamer, Ed Tomko and other members of Curren Tomko and Tarski LLP are experienced with assisting health industry and other clients establish and administer internal and external fraud and other controls, investigate potential fraud or other misconduct, defend Federal or state criminal or civil investigations, audits and prosecutions.  If your organization needs assistance with assessing or managing its compliance responsibilities or liabilities under health care, employment, environmental, antitrust, securities or other federal or state laws, wishes to inquire about compliance audit or training or other services; or would like to review or engage and experience of Ms. Stamer, Mr. Tomko or other Curren Tomko Tarski LLP attorneys, please contact Ms. Stamer at cstamer@cttlegal.com, (214) 270-2402;  or Mr. Tomko at etomko@cttlegal.com, (214) 270-1405, or see CTTLegal.com or CynthiaStamer.com.

 


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