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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.
  • Advised multiple pharmacy benefit managers 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

Viewpoint General
The proposed 2020 Outpatient Prospective Payment (OPPS) rule was published on August 9, 2019.  Buried in the 819 pages of proposed changes and justifications, CMS took another swing at cutting Medicare Part B reimbursement rates for 340B drugs.   CMS opened its discussion of 340B provisions in the 2020 OPPS proposed rule by first stating it was keeping in effect the 340B reimbursement cut first implemented though the 2018 OPPS rule. The 2018 OPPS rule slashed most hospitals’ Part B reimbursement for 340B drugs from Average Sales Price (ASP) plus 6% down to ASP less 22.5%, a reduction of almost 30%.
Viewpoint

Senate Finance Committee Passes Drug Pricing Bill

July 30, 2019 | Blog | By Theresa Carnegie, Ellyn Sternfield, Matt Mora, Michelle Caton, Eli Greenspan

Senators Chuck Grassley (R-IA) and Ron Wyden (D-OR), Chairman and Ranking Member (respectively) of the Senate Finance Committee, have fired the latest shot in Congress’s ongoing battle against high drug prices. Last week, the Senators introduced their much-anticipated proposal to lower drug prices: a chairman’s mark called the Prescription Drug Pricing Reduction Act (PDPRA) of 2019.

Viewpoint General

March 2019: Where Are We Now With 340B?

March 1, 2019 | Blog | By Ellyn Sternfield

What might 2019 mean for the 340B program? This post addresses the on-going litigation over the OPPS Medicare payment reduction for 340B drugs, ceiling price validation, and state initiatives related to the 340B program.
Viewpoint General
The Federal Courts gave the America Hospital Association and 340B covered entities a late Christmas present and in doing so may have dealt a blow to the Trump Administration’s initiatives aimed at controlling or reducing drug prices.


On December 27, 2018, Judge Rudolph Contreras granted the American Hospital Association’s Motion for a Permanent Injunction over CMS’ Medicare Part B reimbursement cut for 340B hospitals. As I have previously written, the vehicle for that reimbursement cut was the 2018 Outpatient Prospective Payment System (OPPS) rule, and CMS’ existing authority to adjust OPPS drug reimbursement.
Viewpoint General

Health Care Qui Tam Update

November 5, 2018 | Article | By Hope Foster, Kevin McGinty, Ellyn Sternfield, Benjamin Zegarelli

Read about health care qui tam litigation trends for the 12 months that ended on August 31 and significant cases, including two involving skilled nursing facilities.
Viewpoint General
For much of the past 18 months, the Trump Administration, and in particular CMS, have talked a good game regarding reducing pharmaceutical prices. On October 16, 2018, a key component of the Administration’s strategy was revealed in the form of CMS’ Proposed Rule requiring manufactures to include the “list price” for prescription drugs reimbursable by Medicaid or Medicare in television advertisements. While I do think that there will be new initiatives to address drug pricing, I believe most will come through the state and not the federal level. This post addresses six potential initiatives from a recently released report of the National Governors' Association.

CMS Proposes to Reduce Payments for New Drugs under Medicare Part B

July 20, 2018 | Blog | By Ellyn Sternfield, Matt Mora

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.

Court of Appeals Weighs in on 340B

July 18, 2018 | Blog | By Ellyn Sternfield

Timing is everything.  In yesterday’s post on 340B, I stated in closing: There is still one more shoe to drop.

July 2018: Where Are We Now With 340B?

July 17, 2018 | Blog | By Ellyn Sternfield

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.

News & Press

This feature story discusses how Medicaid’s unique federal-state structure is a significant challenge to recovering inappropriate payments to doctors by the states. This challenging process has led to approximately $2 billion in overpayments for the past eight years not being recovered. Mintz’s Ellyn Sternfield, a former director of the Oregon Department of Justice’s Medicaid Fraud Control Unit, provides commentary in the piece.
Mintz’s Ellyn Sternfield, a veteran government health care enforcement attorney, is among the industry sources providing commentary in this feature article discussing a "mega anti-fraud program" that could bring consistency to fraud and abuse audits for Medicare and Medicaid.
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.
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.

Medicaid Payment Oversight Found Lacking

June 8, 2018 | Bloomberg BNA Health Care Daily Report

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.

Medicaid Wastes Billions Despite Warnings

May 16, 2018 | Bloomberg Law

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.

Feds Cracking Down on State Medicaid Programs

April 2, 2018 | Bloomberg BNA Health Care Policy Report

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.

Lawmakers Set to Probe Medicaid Fraud and Waste

March 22, 2018 | Bloomberg BNA Health Care Daily Report

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.

Are Medicare Anti-Fraud Efforts Flawed?

October 12, 2017 | Bloomberg BNA

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.

HHS Watchdog to Probe Medicaid Health Homes Program

September 20, 2017 | Bloomberg BNA

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).

Is Medicaid Doing All It Can To Stop Fraud?

September 14, 2017 | Bloomberg BNA Health Care

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.

Medicare to Narrow Scope of Health-Care Provider Audits

August 23, 2017 | BNA Health Care Daily Report

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.

Health-Care Watchdog to Review Medicaid Opioid Claims

July 18, 2017 | http://healthlawrc.bna.com/hlrc/4225/split_display.adp?fedfid=116854215&vname=hcenotallissues&wsn=497202000&searchid=30211157&doctypeid=10&type=oadate4news&mode=doc&split=0&scm=4225&pg=0 Bloomberg BNA Health Law Reporter

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.

Consolidation Comes to Health-Care Anti-Fraud Contractors

February 23, 2017 | Bloomberg BNA Health Law Resource Center

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.

Health Fraud Rule Withdrawal May Hurt Enforcement Efforts

February 1, 2017 | Bloomberg BNA Health Care Daily Report

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.

Medicare Drug Benefit's Catastrophic Spending Up Sharply

January 6, 2017 | http://healthlawrc.bna.com/hlrc/4225/split_display.adp?fedfid=102968952&vname=hcenotallissues&wsn=499011000&searchid=29107881&doctypeid=10&type=oadate4news&mode=doc&split=0&scm=4225&pg=0 Bloomberg BNA Health Care Daily Report

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.

Government Watchdog Taking Close Look at Medicaid Drug Rebates

December 27, 2016 | https://www.bna.com/government-watchdog-taking-b73014449111/ Bloomberg BNA Health Care Blog

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.

Medicaid Drug Rebate Program Under OIG's Watchful Eye

December 9, 2016 | http://healthlawrc.bna.com/hlrc/4225/split_display.adp?fedfid=101589513&vname=hcenotallissues&wsn=499199500&searchid=28984780&doctypeid=10&type=oadate4news&mode=doc&split=0&scm=4225&pg=0 Bloomberg BNA Health Care Daily Report

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.  

Pharmacy Cost-Sharing Waivers OK in New Fraud Rule

December 6, 2016 | http://healthlawrc.bna.com/hlrc/4225/split_display.adp?fedfid=101453038&vname=hcenotallissues&jd=a0k5j6n5e4&split=0 Bloomberg BNA Health Care Daily Report

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).

Medicare Still Making Improper Payments on Behalf of Prisoners

October 7, 2016 | Bloomberg BNA Health Care Daily Report

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.

Senators Ask DOJ to Investigate EpiPen-Maker Mylan

September 28, 2016 | http://healthlawrc.bna.com/hlrc/4225/split_display.adp?fedfid=98006720&vname=hcenotallissues&jd=a0k1w6h2u9&split=0 Bloomberg BNA Health Care Daily Report

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.

Republicans Seek Probe Into EpiPen's Medicaid Rebate Status

September 13, 2016 | http://healthlawrc.bna.com/hlrc/4225/split_display.adp?fedfid=97221688&vname=hcenotallissues&jd=a0k1b5y7g7&split=0 Bloomberg BNA Health Care Daily Report

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.

Final Rule Boosts Health-Care Penalties to Reflect Inflation

September 2, 2016 | http://healthlawrc.bna.com/hlrc/4225/split_display.adp?fedfid=96655900&vname=hcenotallissues&wsn=487132500&searchid=28354085&doctypeid=10&type=oadate4news&mode=doc&split=0&scm=4225&pg=0 Bloomberg BNA Health Care Daily Report

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
Panelist
Moderator
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