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
Viewpoints
Biden Administration Throws Down Its First Gauntlet on 340B
May 18, 2021 |Blog
340B Administrative Dispute Resolution Goes Live Amid a Flurry of 340B Litigation
January 18, 2021 |Blog
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.
Events
The number of False Claims Act cases brought against health care and life sciences companies is growing. "Qui Tam Relators: What You Need to Know" helps health care and life sciences companies position themselves to avoid such suits and handle them when necessary.
"Patient Assistance Programs & Government Enforcement: What You Need to Know" will discuss issues related to patient assistance programs and guidance documents issued by the Office of the Inspector General (OIG).
Viewpoints
Biden Administration Throws Down Its First Gauntlet on 340B
May 18, 2021 | Blog | By Ellyn Sternfield
On May 17, 2021, the Biden Administration took its first major action impacting the 340B Drug Discount Program. In a forceful statement, the Administration made plain its views on a major controversy that has pitted drug manufacturers against 340B covered entities for the past year - proclaiming that drug manufacturers are violating the 340B statute by restricting covered entity access to 340B discounts for drugs dispensed through 340B contract pharmacies.
Read more
340B Administrative Dispute Resolution Goes Live Amid a Flurry of 340B Litigation
January 18, 2021 | Blog | By Daryl Berke, Ellyn Sternfield
The U.S. Department of Health and Human’s Services (HHS) Health Resources and Services Administration’s (HRSA) long-awaited administrative dispute resolution (ADR) final rule went into effect last week, on January 13, 2021. The ADR regulations, which have lingered in HHS since 2010, arrive amid increasing tensions and a flood of 340B-related litigation between covered entities, manufacturers, and HHS.
Read more
HHS Finalizes Highly Anticipated Final Rules Amending Anti-Kickback Statute and Stark Law Regulations, Part II: Beneficiary Inducement
December 1, 2020 | Blog | By Karen Lovitch, Ellyn Sternfield, Rachel Yount, Jane Haviland
While health care entities often want to provide free or discounted items or services to patients (e.g., free transportation, co-payment waivers, free supplies), these free or discounted items or services pose risk under both the federal Anti-Kickback Statute (AKS) and the civil monetary penalty rules regarding beneficiary inducements (Beneficiary Inducements CMP), so minimizing risk when providing such items or services is important. Fortunately, as announced last week, the Department of Health and Human Services (HHS) Office of Inspector General (OIG) issued a final rule making sweeping changes to the regulations implementing the AKS and the Beneficiary Inducements CMP, many of which will result in greater flexibility and reduced administrative burdens for the health care industry.
Read more
Post-Election 2020 - Health Care Preview
November 23, 2020 | Blog | By Alexander Hecht, Anthony DeMaio, Brett Else, Tara E. Dwyer, Ellyn Sternfield
With the presidential transition underway, we now look forward to what the Biden administration will seek to accomplish, particularly in the realm of health care policy.
Read more
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.
Read more
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.
Read more
Bipartisan Group of Senators Introduces Legislation to Waive 340B Eligibility Requirements Due to COVID-19
July 21, 2020 | Blog | By Ellyn Sternfield, Daryl Berke
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.
Read more
CMS Proposes Rule to Pave the Way for Value-Based Drug Purchasing
June 26, 2020 | Blog | By Theresa Carnegie, Ellyn Sternfield
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.”
Read more
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.”
Read more
340B Ceiling Price Transparency – HRSA Now Requiring Pharmaceutical Manufacturers to Issue Refunds to Covered Entities for Overcharges
February 24, 2020 | Blog | By Ellyn Sternfield, Daryl Berke
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.
Read more
News & Press
Here’s Why Your Tax Dollars Are Overpaying for Medicaid
January 2, 2019
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.
Medicare Herds Four Anti-Fraud Programs Under One Roof
November 8, 2018
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.
States Seek More Power to Fight Medicaid Home Patient Abuse
September 20, 2018
Lawmakers to Grade New Medicaid Anti-Fraud Strategy
August 20, 2018
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.
Enforcement Threat Grows for Hospital Opioid Theft
August 20, 2018
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
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
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
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
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
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
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
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.
Fraud and Abuse: Tool to Thwart Medicaid Fraud Used Sparingly by States
September 13, 2017
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
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
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
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
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
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
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
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
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
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
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.
Proposed Rule Would Bolster Medicaid Fraud Program
September 19, 2016
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
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
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.
Medicare Gets Big Bang for Its Buck by Fighting Fraud
July 20, 2016
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.
Government Cites Leap in Medicare Spending on Opioids
June 27, 2016
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.
OIG Report Finds Indications of Fraud in Home Health
June 24, 2016
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.
Health-Care Fraud Recoveries Soar in 2016
June 13, 2016
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.
Report Calls for More Guidance on Medicaid Hospital Payments
March 14, 2016
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.
Medicaid Program Integrity Bill
March 7, 2016
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
May
8
2018
3rd Annual Mintz /ML Strategies Pharmacy & Pharmaceutical Industry Summit
Mintz and ML Strategies
Boston, MA
Panelist
Panelist
Moderator
Panelist
Speaker
Speaker
Panelist
Speaker
Nov
12
2015
4th Annual Pharmacy Benefit Oversight & Compliance Conference
CBI
16770 North Perimeter Drive Scottsdale, AZ
Panelist
Aug
5
2015
Panelist
Jun
11
2015
Panelist
Panelist
Mar
6
2015