Jaime L.M. Jones

Representative matters handled by Jaime include the following:

Enforcement Matters

• Representation of a healthcare provider in a DOJ False Claims Act investigation spanning the company’s patient services nationwide and raising allegations of violations of the Anti-Kickback Statute, Beneficiary Inducement Statute, and coding and billing issues. 
• Representation of a pharmacy provider in a DOJ and state AG investigation related to Usual & Customary pricing allegations.
• Representation of a national Medicare Advantage provider practice related to alleged upcoding and resulting violations of the False Claims Act, resulting in the successful and first provider-side resolution of such claims.
• Representation of a healthcare provider management services organization in a False Claims Act investigation related to the medical necessity of certain procedures for which the client provided oversight and billing services.
• Representation of numerous pharmaceutical companies in DOJ False Claims Act investigations focused on promotional speaker programs.
• Representation of two multinational pharmaceutical companies in criminal and civil investigations by the U.S. Attorneys’ Offices for the District of Massachusetts and the Eastern District of New York of alleged fraud on the FDA and Patent and Trademark Office as a predicate to FCA liability.
• Representation of a national provider practice in a DOJ investigation of alleged upcoding of emergency services.
• Representation of a global pharmaceutical company in a DOJ criminal investigation involving allegations off-label promotion and risk minimization. 
• Representation of a biologic manufacturer in a parallel civil and criminal investigation of alleged off-label promotion. 
• Representation of a pharmacy provider in connection with a DOJ False Claims Act investigation related to alleged violations of the AKS in connection with the provision of patient financial hardship waivers and other billing issues and in connection with the pharmacy’s adherence programs funded by pharmaceutical manufacturers.
• Representation of a pharmaceutical manufacturer in a criminal investigation into alleged violations of cGMP regulations. 
• Representation of a national provider of behavioral health services in a False Claims Act investigation based on allegations that therapy services provided were not properly documented, supervised, or were medically unnecessary.
• Representation of a global medical device and diagnostics testing company in an FCPA matter arising from certain arrangements and operations in Brazil.
• Represented GE Healthcare in connection with an investigation of the company’s pricing and promotion of a radiopharmaceutical product. 
• Representation of a global pharmaceutical manufacturer in a False Claims Act investigation related to alleged violations of cGMP requirements at its primary manufacturing site.
• Representation of a global drug and medical device manufacturer in a DOJ criminal investigation related to alleged violations of the AKS in connection with certain arrangements with physician key opinion leaders and promotional speakers.  
• Representation of a global pharmaceutical company in a DOJ investigation focused on whether certain bundled discounts were structured outside of the discount safe harbor to the AKS and caused the submission of false claims by hospitals.
• Representation of a global medical device manufacturer in an FCPA investigation related to the company’s arrangements with certain physicians in Israel.
• Represented a major pharmaceutical company in a civil investigation by DOJ and the U.S. Attorney’s Office in Chicago involving allegations of off-label promotion. The result was the closure of the investigation without any government action. 
• Represented a major pharmaceutical company in a civil and criminal investigation by the U.S. Attorney’s Office in Los Angeles involving allegations of off-label promotion and kickbacks. The result was the closure of the investigation and a declination to intervene in the underlying qui tam. 
• Represented a medical device manufacturer in an investigation by FDA’s Office of Criminal Investigations of manufacturing quality issues. The government closed the investigation. 
• Represented a major pharmaceutical company in an investigation by the U.S. Attorney’s Office for the Southern District of New York into allegations related to sampling practices and government price reporting. 
• Representation of a major pharmaceutical company in connection with investigations related to product diversion. 
• Represented an institutional healthcare provider in OIG investigations, qui tam matter, and other enforcement and compliance-related matters based on alleged quality of care and coding and billing issues. 
• Representation of three global pharmaceutical manufacturers in False Claims Act investigations related to alleged fraud in their price reporting.
• Represented a food manufacturer and distributor in connection with a seizure action and criminal investigation. The seizure action was resolved with a consent decree without injunctive provisions. 

False Claims Act Litigation

• United States ex rel. Proctor v. Safeway, Inc. and U.S. ex rel. Schutte v. SuperValu, Inc., Nos. 21-1326, 22-111 (S. Ct.) – representation of pharmacy respondents in the Supreme Court to resolve the question whether and when a defendant’s contemporaneous subjective understanding or beliefs about the lawfulness of its conduct are relevant to whether it ‘knowingly’ violated the False Claims Act.
• United States ex rel. Siegel v. Novo Nordisk, Inc. – defense of a drug manufacturer in a False Claims Act suit alleging off-label promotion and violations of the Anti-Kickback Statute in connection with certain patient support programs. Case narrowed from claims based on alleged nationwide conduct to claims arising from one state.
• Defense of private equity funds in federal and state court qui tam litigation arising from allegations regarding asset management fees charged to public investors. Motions to dismiss are pending in both suits.
• United States ex rel. Patel v. GE Healthcare, Inc. – defense of a drug manufacturer in a qui tam action alleging off-label compounding of radiopharmaceuticals and pricing and price reporting fraud. Suit dismissed with prejudice.
• United States ex rel. Sanchez v. AHS – defense of an inpatient behavioral health provider in a False Claims Act suit alleging billing fraud and non-compliance with state licensure requirements. Case successfully limited to a small number of patients and settled without imposition of a Corporate Integrity Agreement.
• United States ex rel. Kennedy v. Aventis Pharmaceuticals Inc. – defense of a pharmaceutical manufacturer in a qui tam action alleging off-label promotion and anti-kickback violations. Qui tam claims based on inpatient services, reimbursed under a prospective payment system, dismissed.
• United States ex rel. Grant v. Thorek Hospital – defense of a hospital in a qui tam action alleging government program fraud. Claims dismissed with prejudice.

Corporate Integrity Agreements

• Led the negotiations for DaVita of its groundbreaking corporate integrity agreement. 
• Represented an institutional provider in corporate integrity agreement negotiations. 
• Successfully convinced OIG that a corporate integrity agreement was not warranted in connection with numerous significant civil settlements on behalf of life sciences manufacturers and healthcare providers. 
• Represented a pharmaceutical manufacturer in negotiations to amend its existing corporate integrity agreements. 

State AG Investigations

• Representation of a global drug manufacturer in an investigation by California into alleged violations of the California Insurance Fraud Prevention Act arising from alleged actions to delay generic competition and resulting impact to commercial payers.
• Represented a major pharmaceutical manufacturer in state attorneys’ general investigations regarding fraudulent marketing practices and risk minimization in violation of the states’ consumer protection laws. 
• Represented a major pharmaceutical manufacturer in state attorneys’ general investigations regarding alleged kickback violations. 
• Represented a large academic medical center in connection with an investigation of state qui tam claims related to alleged non-compliance with applicable quality of care regulations.