Amanda Enyeart
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Amanda Enyeart maintains a general health industry and regulatory practice, focusing on fraud and abuse, information technology and digital health matters. Amanda advises health care industry clients in all aspects of software licenses and other agreements for the acquisition electronic health record (EHR) systems and other mission critical health IT. Amanda’s health care IT transactional experience also includes advising clients with respect to software development, maintenance, service and outsourced hosting arrangements, including cloud-computing transactions. Read Amanda Enyeart's full bio.
Practice Reminder: Research Misconduct can be a Source of False Claims Act Liability
By Amanda Enyeart and Drew Elizabeth McCormick on Dec 10, 2018
Posted In Uncategorized
The October issue of the journal Science features a series of short articles highlighting a database containing a list of more than 18,000 scientific papers and conference abstracts that have been retracted over the past several decades. An analysis of the database shows that nearly 60 percent of retraction notices mentioned fraud or other kinds...
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Seventh Circuit Reevaluates and Adopts More Stringent FCA Causation Standard
By Amanda Enyeart on Nov 13, 2017
Posted In Damages and Penalties, Materiality
On October 23, 2017, the US Court of Appeals for the Seventh Circuit reversed itself by determining that proximate cause—and not the “but-for” causation test that the court adopted 25 years ago—is the appropriate standard to determine causation in a claim under the False Claims Act (FCA). United States v. Luce, No. 16-4093 (7th Cir....
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Ninth Circuit Remands False Claims Act Case against Tribal College for Determination of Sovereign Status
By Amanda Enyeart on Jul 20, 2017
Posted In Uncategorized
On July 10, 2017, US Circuit Court of Appeals for the Ninth Circuit reversed a December 3, 2014, district court dismissal of False Claims Act (FCA) claims against Salish Kootenai College (College), a tribal college of the Salish Kootenai Tribes (Tribe). United States ex rel. Cain v. Salish Kootenai College, Inc. (July 10, 2017). The...
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District Court Finds Oregon University Immune to FCA Suit Brought by Federal Government
By Amanda Enyeart on Apr 27, 2017
Posted In Uncategorized
On April 11, 2017, the US District Court for the District of Oregon sided with the Oregon Health and Sciences University (OHSU), finding that as an arm of the state, OHSU is not subject to liability under the False Claims Act (FCA) even when the claim is brought by the federal government. In United States...
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Federal Health Care Fraud and Abuse Enforcement Made a Strong Showing in FY 2016
By Amanda Enyeart on Jan 31, 2017
Posted In Uncategorized
According to a report released last week, the Health Care Fraud and Abuse Control Program (HCFAC) returned over $3.3 billion to the federal government or private individuals as a result of its health care enforcement efforts in fiscal year (FY) 2016, its 20th year in operation. Established by the Health Insurance Portability and Accountability Act...
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CMS Reissues Stark Rules Restricting Certain Unit-based Rental Rate Arrangements and Issues Two Stark Updates
By Amanda Enyeart and Daniel H. Melvin on Nov 16, 2016
Posted In Anti-Kickback Statute / Stark Law, Stark
On November 15, 2016, as part of its 2017 Medicare Physician Fee Schedule update, the Center for Medicare and Medicaid Services reissued its prohibition on certain unit-based rental arrangements with referring physicians, adopted updates to the list of CPT/HCPCS codes defining certain of the Stark Law’s designated health services and implemented a minor technical change...
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Fifth Circuit Upholds Omnicare Decision for Lack of Supporting Evidence of Kickback Violation
By Amanda Enyeart on Nov 7, 2016
Posted In Anti-Kickback Statute / Stark Law
On October 28, 2016 in an unpublished opinion, the Fifth Circuit Court of Appeals affirmed the decision of the US District Court for the Southern District of Texas that granted summary judgment to Omnicare, Inc. in a qui tam action. We discussed the decision of the district court here. The relator alleged, among other claims,...
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Ninth Circuit Court Overturns District Court on Sufficiency of Pleading under Rule 9(b), Remands for Amendment
By Amanda Enyeart on Aug 19, 2016
Posted In Medical Necessity, Rule 9(b) Particularity
The US Court of Appeals for the Ninth Circuit issued an opinion overturning a district court’s grant of summary judgment against a False Claims Act (FCA) relator in United States ex rel. Driscoll v. Todd Spencer M.D. Medical Group, Inc. on August 9, 2016. The case involved allegations by Scott Driscoll, M.D., a radiologist who...
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Congress Examining Stark Law Reform This Year
By Amanda Enyeart, Daniel H. Melvin and Eric B. Gordon, MD on Jul 19, 2016
Posted In Anti-Kickback Statute / Stark Law, Government investigation, Stark
On July 12, 2016, the US Senate Finance Committee held a hearing to “examine ways to improve and reform the Stark Law” as a follow up to releasing a white paper on June 30 titled Why Stark, Why Now? Suggestions to Improve the Stark Law to Encourage Innovative Payment Models. The white paper summarizes comments...
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District Court Dismisses FCA Claims Based on Fraudulent Off-Label Promotion for Lack of Particularity
By Amanda Enyeart on Jun 7, 2016
Posted In Anti-Kickback Statute / Stark Law, Medical Necessity, Retaliation, Rule 9(b) Particularity
On May 23, 2016, the US District Court for the District of Massachusetts dismissed several of the claims in a False Claims Act (FCA) whistleblower suit against Medtronic, Inc. and its wholly-owned subsidiary Medtronic MiniMed, Inc. (Medtronic) related to its insulin pumps and integrated diabetes management systems. In United States ex rel. Witkin v. Medtronic,...
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