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Ellyn L. Sternfield

Special Counsel

[email protected]

+1.202.434.7445

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Ellyn has more than 30 years of legal experience, with an extensive background in the field of government health care enforcement.

Ellyn’s experience enables her to provide valuable insight to clients facing potential state or federal investigations, or who have general compliance concerns. Ellyn currently represents a variety of health care product and service providers in federal and state administrative, civil, and criminal matters around the country. She conducts internal reviews and investigations for clients concerned about potential compliance issues, including compliance investigations having to do with data security and privacy safeguards. Ellyn advises clients of proposed or existing health care acquisitions or business arrangements, especially those involving Medicaid, Medicare, and the 340B Drug Pricing Program. Ellyn serves as a mediator in health care disputes, including state and federal false claims cases.

Prior to joining Mintz, Ellyn spent more than 15 years as the director of the Oregon Department of Justice's Medicaid Fraud Control Unit, supervising investigations and prosecutions of criminal and civil health care billing fraud and patient neglect cases in both state and federal court. Ellyn handled a wide variety of complex health care cases, and developed specialized experience in qui tam false claims actions. Ellyn was the lead state attorney in multiple “global” health care matters, heading up major false claims investigations and settlements involving national and international health care providers. Ellyn co-chaired the National Association of Medicaid Fraud Control Units (NAMFCU) Global Case Committee for more than 10 years, and was instrumental in developing the processes in use today for coordinating federal and state false claims investigations. She also developed and presented training programs for government attorneys, auditors, and investigators who investigate and pursue false claims health care cases.

Ellyn previously served as the chief of the Consumer Rights Division of the Office of the Utah Attorney General, overseeing administrative, civil, and criminal consumer-based investigations and litigation. Ellyn began her legal career as a defense attorney with the Clayton, Missouri firm of Wolff and Frankel, and remains an avid fan of the St. Louis Cardinals baseball team.

Ellyn frequently speaks and writes on health care fraud and abuse matters, and is a contributor to the Mintz Health Law & Policy Matters blog.

Education

  • Washington University (JD)
  • George Washington University (BA)

Experience

  • Advised entities on compliance in the 340B Drug Pricing Program
  • Represented national health care manufacturers and providers in multiple state and federal false claims litigation, resulting in favorable resolutions for the clients
  • Evaluated potential risks of proposed business arrangements for national health care providers
  • Advised national health care companies on state and federal regulatory matters, including potential affirmative litigation options
  • Advised a global health care company on a variety of issues in connection with its acquisition of several health plans and provider groups, including health care regulatory due diligence, health care regulatory advice regarding transaction structure and strategy, and preparation of regulatory notices and other filings.
  • Advising multiple PBMs and insurers on compliance concerns raised by state regulators pursuing inquiries on PBM and pharmacy claims processing practices, including issues specific to specialty drug arrangements, MAC pricing, and compliance with state-specific insurance requirements.

Recognition & Awards

  • HHS OIG Integrity Award (2005)
  • President's Council on Integrity and Excellence Award for Excellence (2005)
  • Multiple Oregon Department of Justice Outstanding Service Awards
  • NAMFCU President's Leadership Award
  • NAMFCU Case Leadership Award

Involvement

  • Co-chair, National Forum on Pharmaceutical Pricing Litigation, American Conference Institute (October 2012)
  • Past member, St. Louis County Metropolitan Task Force on Child Sexual Abuse
  • Member, NAMFCU Global Case Committee (1998 – 2009)
  • Co-chair, NAMFCU Global Case Committee (1999 – 2008)
  • Past president, National Association of Medicaid Fraud Control Units
  • Member, Washington University (St. Louis) Washington, DC Regional Cabinet
  • Past board member, Jewish Family and Children Services of Oregon
  • Past board member, Mittleman Jewish Community Center
  • Past chair, Mittleman Jewish Community Center Kids Corner Committee
  • Past member, Board of Advisors for St. Louis Warson House Home for Girls

Recent Insights

News & Press

Events

Viewpoints

In an attempt to lower drug prices, CMS released a proposed rule last week to reduce payments for new drugs under the Part B program.
Timing is everything.  In yesterday’s post on 340B, I stated in closing: There is still one more shoe to drop.
It seems like every week, there are multiple new developments in the 340B program. While it has just been a few weeks since my last 340B blog post, since that time we have had another Senate hearing, a new GAO Report, a new House hearing, and introduction of more than a dozen new bills in Congress.
State Medicaid Agencies have historically engaged in an epic balancing act.  Federal law requires State Medicaid Agencies to ensure beneficiaries have access to medically necessary services.  Federal law also requires State Medicaid Agencies to safeguard their Medicaid Programs against fraud, waste or abuse in billing for Medicaid services.
It has been a few weeks since the publication of the Trump Administration’s Blueprint to Lower Drug Prices, and Secretary Azar’s  Request for Information (RFI) on the Blueprint.  We previously posted about the Blueprint’s focus on the 340B Drug Discount Program.
On Wednesday May 9th, I was floored when the Administration released the Spring 2018 Unified Agenda of Regulatory and Deregulatory Actions, which contained this nugget: by December 2018, HRSA will publish its 340B Omnibus Guidance. Readers of our blog know that, as we predicted, this so-called Mega-Guidance was withdrawn in January 2017 without ever seeing the light of day.
There are now multiple proposals in the House and Senate for substantive changes to the 340B Drug Discount Program. The odds of a legislative “fix” to 340B are increasing. But independent of congressional action, is CMS signaling that additional changes to 340B may be coming?
In January 2018, in the wake of the publication of the House Energy and Commerce Committee’s Review of the 340B Drug Discount Program, I wrote that it was too soon to know whether 2018 will be a game-changing year for the 340B Program. In sum, there were just too many moving parts to discern whether there was a path forward for legislative change.
I previously said that the year 2014 may be a game-changer for the 340B Drug Discount Program. Increasing HRSA audits, a lawsuit over the 340B Orphan Drug Rule, and HRSA’s promise to issue a 340B mega-regulation, all pointed to major changes in how the 340B Program operates. 
On November 1, 2017, CMS announced that it is in fact cutting Medicare Part B reimbursement for 340B drugs to the tune of $1.6 billion. To be accurate, what CMS announced is its intent to finalize proposed rule changes to the Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems Quality Reporting Program.

News & Press

This feature story discusses the efforts hospitals are undertaking to combat drugs from being stolen amid a growing opioid crisis. The story notes that hospitals are facing consequences such as potentially heavy penalties and possible legal action. Mintz’s Ellyn Sternfield, a veteran government health care enforcement attorney, is among the industry sources providing commentary.
This story previews testimony from the Centers for Medicare & Medicaid Services Administrator on a recently rolled-out strategy designed to reduce Medicaid fraud and abuse. Mintz’s Ellyn Sternfield, a veteran government health care enforcement attorney, is among the industry sources providing commentary.
Mintz’s Ellyn Sternfield provides commentary on a recent Government Accountability Office report based on 10 state and federal audits and investigations uncovering approximately $68 million in overpayments to managed care organizations (MCOs) and unallowable costs that weren't accounted for.
Special Counsel Ellyn Sternfield, a veteran in government health care enforcement matters, provides commentary in this article discussing failed attempts to eliminate improper Medicaid program payments to states which has resulted in billions of dollars wasted.
This article discusses the impact of increased scrutiny of state Medicaid programs by the Health and Human Services (HHS) Office of Inspector General (OIG). Ellyn Sternfield, an experienced health care enforcement attorney, provides commentary on the government’s heightened efforts.
Mintz Special Counsel Ellyn Sternfield, a veteran health care attorney, provides commentary in this article on news that two subcommittees of the House Oversight Committee have been tasked with looking into how improper Medicaid payments can be reduced.
Mintz is advising a consortium of investors led by TPG Capital and Welsh, Carson, Anderson & Stowe in their acquisition of Kindred Healthcare, Inc. The definitive agreement totals approximately $4.1 billion in cash including the assumption or repayment of net debt.
This Bloomberg BNA article looks at the effectiveness and benefits of Medicare’s Fraud Prevention System. Experienced health care attorney Ellyn Sternfield, who has an extensive background in the field of government health care enforcement, is among the industry sources providing commentary.
Washington, D.C. health care attorney Ellyn Sternfield is quoted in a Bloomberg BNA article covering a new Medicaid home health program that is to be reviewed by the Health and Human Services (HHS), Office of the Inspector General (OIG).
Ellyn Sternfield, a health law in the Mintz Washington, D.C. office, is quoted in a Bloomberg Law Health Care article discussing the findings of an HHS Office of the Inspector General report on whether or not Medicaid agencies are exerting enough effort to prevent fraud.
Ellyn Sternfield is quoted in a Bloomberg BNA article on the subject of payment suspensions within individual Medicaid agencies under investigation for fraud, and its frequency of use by the states.
Ellyn Sternfield, a Health Law attorney and Special Counsel in the Mintz Washington, DC office, is quoted in a BNA Health Care Daily Report article discussing Medicare’s taking Targeted Probe and Educate (TPE) audits nationwide to reduce provider burdens.
Ellyn Sternfield, a Health Law attorney and Special Counsel in the Mintz Washington, D.C. office, is quoted in a Bloomberg BNA Health Law Reporter article discussing new plans for the Office of Inspector General (OIG) of the Department of Health and Human Services.
Ellyn Sternfield, a Health Law attorney and Special Counsel of the Mintz Washington, D.C. office, was featured in a Bloomberg BNA article discussing the decline in health care fraud recoveries in the first half of the Fiscal Year 2017.
Health Care Member Ellyn Sternfield is among commenters in this piece, which details the Trump administration’s proposed budget blueprint for 2018 and the increase in funds to fight health-care fraud.
Ellyn Sternfield, a Member with extensive background in the field of government health care enforcement, provides commentary in this feature article discussing a possible decrease in government spending allocated to Anti-Fraud contractors.
This article notes that due to the Trump administration’s delay of a program integrity final rule fraud enforcement could become more of a challenge. Mintz health care attorneys Ellyn Sternfield and Tom Crane weigh in on the issue.
This Bloomberg BNA Health Law Daily Report feature story notes that federal payments for Medicare’s catastrophic coverage have more than tripled. Health care attorney Ellyn Sternfield is among the industry sources quoted.
Ellyn Sternfield, a Mintz Health Law attorney and Special Counsel, is quoted in this Bloomberg BNA Health Care Blog on the Health and Human Services Office of Inspector General’s (OIG) announcement on its reviews of Medicaid’s drug rebate program.
Washington, D.C. health care attorney Ellyn Sternfield is quoted in a Bloomberg BNA Health Care Daily Report article on the Health and Human Services Office of Inspector General’s (OIG) surveillance of Medicaid’s drug rebate program to keep tabs on spikes in costs.  
Mintz Special Counsel Ellyn Sternfield is quoted in this Bloomberg BNA Health Care Daily Report article on the final rule from the Department of Health and Human Services Office of Inspector General (OIG).
Ellyn Sternfield, a Health Law attorney and Mintz Special Counsel, is quoted in this Bloomberg BNA Health Care Daily Report article on Medicare’s ongoing issue with improper payments.
Ellyn Sternfield, a Mintz Special Counsel, is quoted in this Bloomberg BNA Health Care Daily Report article on the Department of Justice's request to look into how Mylan classified EpiPens – as generic drugs – for purposes of the Medicaid drug rebate program in 2007.
Ellyn Sternfield, a Health Law attorney and Special Counsel at Mintz, is quoted in this Bloomberg BNA Health Care Daily Report article discussing a proposed rule that would strengthen Medicaid’s fraud program.
Ellyn Sternfield, a Mintz Special Counsel, is quoted in this Bloomberg BNA Health Care Daily Report article on claims by congressional Republicans that Medicaid’s classification of EpiPens as “generic” lowered company rebates paid to the program.
Ellyn Sternfield, a Health Law attorney and Special Counsel in the Mintz Washington, DC office, is quoted in this Bloomberg BNA Health Care Daily Report article on a boost to health-care penalties to reflect inflation was brought about by a final court ruling.
Ellyn Sternfield, a Health Law attorney and Special Counsel in the Mintz Washington, DC office, is quoted in this Bloomberg BNA Health Care Daily Report discussing the impacts of Medicare upping their investment in its fight against health care fraud.
Ellyn Sternfield, a Health Law attorney and Special Counsel in the Mintz Washington, DC office, is quoted in this Bloomberg BNA Health Care Daily Report article on hospitals’ claims that payment reforms are being blocked by fraud and abuse laws.  
Ellyn Sternfield, a Mintz Special Counsel, is quoted in this Bloomberg BNA Health Care Daily Report article on the noticeable spike in Medicare spending on opioids. The Health and Human Services Office of Inspector General may be called upon to keep a keen eye out for fraud and abuse.  
Mintz Health Law attorney and Special Counsel Ellyn Sternfield is quoted in a Bloomberg BNA Health Care Daily Report article covering the recent Health and Human Services Office of Inspector General report on home health fraud cases.
Mintz Health Law attorney and Special Counsel Ellyn Sternfield is quoted in a Bloomberg BNA Health Care Blog piece notes a significant increase in health care fraud recoveries in 2016 to date.
Ellyn Sternfield, a Mintz Special Counsel, is quoted in this Bloomberg BNA Health Care Daily Report article on the Health and Human Services Office of Inspector General’s claims that recoveries achieved for health-care fraud and abuse are elevated in the fiscal year 2016.  
Ellyn Sternfield is quoted in this Bloomberg BNA Health Care Daily Report article on the Government Accountability Office’s claim about the Centers for Medicare & Medicaid Services’ provider enrollment screening process.
Mintz Special Counsel and Health Law attorney Ellyn Sternfield is quoted in this Bloomberg BNA Health Care Daily Report article on Medicaid’s final rule on managed care, which will drop fraud activity from the Medical Loss Ratio.
Mintz Washington, D.C. Special Counsel and Health Law attorney Ellyn Sternfield is quoted in this BNA’s Health Care Policy Report article discussing recommendations for increased guidance on regulating Medicaid hospital payments.
This Bloomberg BNA Health Care Daily Report article discusses the Medicaid Integrity Bill focused on combating fraud, waste, and abuse. Mintz Special Counsel Ellyn Sternfield provides commentary.

Events

Speaker
Panelist
Jul
12
2017
Moderator
Panelist
Speaker
Speaker
Nov
12
2015

4th Annual Pharmacy Benefit Oversight & Compliance Conference

CBI

16770 North Perimeter Drive Scottsdale, AZ

Panelist
Jun
11
2015
Panelist
Panelist
Mar
6
2015

16th Annual Conference on Emerging Issues in Healthcare Law

American Bar Association

Disney's Yacht Club Resort Lake Buena Vista, FL