Amy
Garrigues

Advised and led international cancer care company through emergence from Chapter 11 bankruptcy restructuring, compliance with Corporate Integrity Agreement, successful completion of a Corrective Action Plan with the Office of Civil Rights, resolution of various significant, complex litigation matters involving fiduciary duties, noncompete laws, constitutional challenges, civil and criminal antitrust, managed care disputes, and the federal False Claims Act; formation of joint ventures with hospital partners and oral pharmacy; negotiation of a National Security Agreement; and completion of $1B sale process during the COVID-19 pandemic.

Led a significant number of confidential internal investigations on behalf of well-known academic medical center, university, publicly traded healthcare companies and other healthcare clients on highly sensitive matters carrying potential civil and criminal liability under healthcare, antitrust, physician misconduct, and other laws.

Routinely advises on government inquiries, potential compliance matters, potential violations of the federal Anti- Kickback Statute and/or the Stark Law, potential Medicare reimbursement matters, potential falsification of reports and claim submission or other documents, grant funding allocation issues and other matters.

Served as lead regulatory transactional counsel in significant private equity acquisitions of healthcare providers and IT companies and in corresponding entry into credit and other financing agreements.

Lead counsel on behalf of various hospitals and health systems in resolution of multiple False Claims Act inquiries and lawsuits related to various fraud and abuse, Medicare and Medicaid reimbursement issues, and associated retaliation claims.

Represented an academic medical center in government inquiries and successful resolution of False Claims Act litigation related to teaching physician supervision and medical direction of anesthesia services.

Represented an international cancer care company in resolution of False Claims Act cases involving allegations related to medical necessity of lab tests, compliance with meaningful use and EHR incentive programs, Stark and Anti-Kickback compliance in physician compensation and group practice matters.

Represented numerous providers in connection with negotiation and successful implementation of Corporate Integrity Agreements.

Represented hospitals and health systems in connection with Office of Inspector General billing and compliance audits and other inquiries.

Represented a large health system in connection with litigation with the Department of Health and Human Services related to a potential writ of mandamus to compel ALJ hearings within the prescribed regulatory time frame.

Represented multiple healthcare providers in multiple hearings related to compliance with EMTALA.

Represented multiple hospitals and health systems across the country in connection with self-disclosures to the government under the federal Stark and Anti-Kickback Laws and related resolutions.

Represented hospitals in connection with ambulatory surgery center private placements.

Represented multiple hospitals and health systems in Stark and AKS matters that resulted in decisions that activities were reasonably compliant and a self-disclosure was not warranted.

Conducted internal investigations at hospitals, academic medical centers and other healthcare provider clients related to a number of allegations potentially implicating the FCA, including but not limited to those covering: (i) allegations of Stark and anti-kickback noncompliance related to physician compensation; (ii) allegations of receipt of improper benefits from a medical device company; (iii) allegations of improper receipt of products from pharmaceutical companies and potential provision of free services to government beneficiaries; (iv) allegations of noncompliance by former executives post-termination; (v) allegations of distributing free items to referring physicians; (vi) allegations of lack of physician presence in the operating room setting; (vii) receipt of meaningful use payments; and (viii) improper inpatient billing for certain services.