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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

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CMS Proposes Additional Cuts to Part B Reimbursement of 340B Drugs

August 7, 2020 | Blog | By Ellyn Sternfield, Daryl Berke

On August 4th, the Department of Health and Human Services (HHS) Centers for Medicare and Medicaid Services (CMS) published the 2021 Hospital Outpatient Prospective Payment System (OPPS) proposed rule. The rule proposes to cut Medicare Part B reimbursement for 340B drugs by an additional 6% in 2021 and comes days after the D.C. Court of Appeals upheld a 340B rate reduction of nearly 30% in the 2018, 2019, and 2020 OPPS rules. The agency is relying on data collected through a recent 340B acquisition cost survey to justify the additional rate reduction.
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340B Rate Cuts Are Legal, D.C. Circuit Court Holds

August 4, 2020 | Blog | By Ellyn Sternfield, Daryl Berke

This week, the Friday surprise came courtesy of the D.C. Court of Appeals. In a long-awaited split decision, the court ruled that the U.S. Department of Health and Human Services (HHS) acted lawfully when it reduced Medicare Part B reimbursement to hospitals for 340B drugs by nearly 30%. The reduction in Part B reimbursement was originally proposed in the 2018 Outpatient Prospective Payment Services (OPPS) rule. HHS estimated it would reduce total Part B spending by $1.6 billion annually, and save Medicare beneficiaries millions in copayments. Covered entities sued to overturn the rate cut, and litigation has been ongoing since the rate cut was implemented in early 2018.
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On July 2, a bipartisan group of six senators introduced legislation to waive 340B eligibility requirements for hospitals participating in the program during the COVID-19 pandemic. S. 4160 permits hospitals that are 340B-eligible based on their disproportionate share (“DSH”) adjustment percentage to maintain eligibility even if their DSH adjustment percentage falls below the requisite threshold.
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CMS Proposes Rule to Pave the Way for Value-Based Drug Purchasing

June 26, 2020 | Blog | By Theresa Carnegie, Ellyn Sternfield, Michelle Caton

The Centers for Medicare & Medicaid Services (CMS) has taken another step to further the adoption of value-based purchasing within the health care industry. (Readers may recall the Department of Health & Human Services’ two proposed rules – one from CMS and another from the Office of Inspector General – issued late last year, aimed at reducing barriers to value-based arrangements, which we discussed here.) CMS released its new proposed rule to “support state flexibility to enter into innovative value-based purchasing arrangements (VBPs) with manufacturers, and to provide manufacturers with regulatory support to enter into VBPs with payers, including Medicaid.”
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Five Suggested Updates for 340B Covered Entities Facing COVID-19 Challenges

April 2, 2020 | Blog | By Ellyn Sternfield, Daryl Berke

The Health Resources and Services Administration (HRSA) recently published guidance regarding the evolving impact of COVID-19 on 340B stakeholders. This new guidance is one part of the U.S. Department of Health and Human Services’ broader effort to maximize regulatory flexibility for health care providers scrambling to meet patient needs during the COVID-19 crisis. While HRSA’s new guidance begins by acknowledging “it is appropriate to take into account the realities of the COVID-19,” HRSA offers little in the way of substantive relief when it comes to 340B. Long on generalities and short on specifics, HRSA merely advises entities to ensure they “have policies and procedures in place to address the proper dispensing of 340B drugs.”
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As regular readers of our blog know, the Centers for Medicare & Medicaid Services (CMS) intensified its push for drug pricing transparency in 2019. In 2020, we see a continuation of those efforts, and their impacts on the 340B program are now starting to reveal themselves. On January 1, 2019, the Health Resources & Services Administration (HRSA) finally implemented the ceiling price and manufacturer civil monetary penalties (CMPs) regulations that the agency proposed in 2017. The regulations implement certain provisions of the Affordable Care Act and were initially scheduled to go into effect on February 28, 2017, but were repeatedly delayed.
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On December 16, 2019, a nationwide coalition of hospitals sued HHS to block implementation of the 340B rate cuts contained in the 2020 Hospital Outpatient Prospective Payment System (“OPPS”) Final Rule. As detailed in our prior blog post, the 2020 OPPS Final Rule reduces by nearly 30% the Medicare Part B reimbursement for certain drugs provided by hospitals to outpatient beneficiaries that are acquired through the 340B Program. The final rule purports to continue the reimbursement cuts for 340B drugs first implemented in 2018, despite the fact that those cuts (and the 2019 OPPS rule continuing those cuts) are the subject of ongoing litigation in which the cuts were determined to be unlawful. For a detailed walk-through of the 2020 OPPS Final Rule and litigation up to this point, please see our prior three blog posts here, here, and here. 
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The Centers for Medicare and Medicaid Services (CMS) recently published the 2020 Hospital Outpatient Prospective Payment System (OPPS) rule, which finalizes a proposed reduction in Medicare Part B reimbursement for certain drugs provided by hospitals to outpatient beneficiaries that are acquired through the 340B drug discount program. Through the final rule, CMS purports to continue Medicare reimbursement cuts for 340B drugs first implemented in 2018, despite the fact that those cuts (and the 2019 OPPS rule continuing those cuts) are the subject of ongoing litigation in which the cuts were determined to be unlawful. That ruling, and a Court-imposed stay of the cuts, are the subject of a just-argued appeal.  For a detailed walk-through of the litigation up to this point, please see our prior blog post.
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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%.
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Senate Finance Committee Passes Drug Pricing Bill

July 30, 2019 | Blog | By Theresa Carnegie, Ellyn Sternfield, Michelle Caton

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.

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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.
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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.
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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.
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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