ChrisDeMeo

In-House Counsel Experience

• Served as contracted associate general counsel for nonprofit health system. Managed compliance, transactional, litigation, integrated care network, physician relations, litigation, contracting, operations matters for six hospitals (including one joint-venture and two physician-owned hospitals), two community emergency centers, and multiple outpatient facilities.

Compliance

• Represented business associate and covered entity in breach notification and reporting for breach involving over 60,000 individuals.
• Advised hospitals, physicians, ancillary providers, and device manufacturers on HIPAA compliance for breach risk analysis, marketing rules, business associate relationships, Security Rule risk assessment compliance, Privacy Rule disclosure, and authorization compliance.
• Advised physician organizations on state and federal Anti-Kickback Statute and Stark law compliance for in-office ancillary service programs and investment opportunities.
• Advised medical device distributors on Sunshine Act Compliance and reporting.
• Advised hospital on Stark Law and Anti-Kickback Statute compliance for physician relationships.
• Represented hospitals in self-disclosures under CMS and OIG protocols related to potential violations of Stark Law and Anti-Kickback Statute.

Transactional

• Negotiated professional services agreement to staff and administer outpatient cancer center. The client was a governmental entity, which necessitated public hearings for approval of the contract. In addition disputes regarding the contract led to an inquiry by County Commissioners into the legality of the selection process and significant media coverage. The contracting party was also a governmental entity and a nationally recognized comprehensive cancer center. The parties also completed significant legal and commercial due diligence on radiation delivery, as well as compliance with federal and state health care law. The agreement is multitiered with advancing levels of service at certain milestones and covers multiple facilities.
• Represented physician organization in formation of joint venture for delivery of physician services to North Texas health system, including preparation and negotiation of governance documents for entity, ancillary service contracts for affiliate organizations, and physician service agreement with health system.
• Represented physician organization in development of ambulatory surgery center with preparation and negotiation of transaction, and organizational and governance documents for facility.
• Represented medical device manufacturer in device and associated SaaS license agreements for clinical trials in US and master supply agreements in US, Canada, UK, EU, and European Economic Area, including advising on FDA, HIPAA, and EU device safety and information privacy laws.

Litigation

• Represented physician groups as defendants in qui tam False Claims Act lawsuits alleging violations of Anti-Kickback Statute, Stark law, and Texas Medicaid laws.
• Represented stand-alone emergency clinic in multifaceted state licensing and federal provider-based certification litigation involving two federal court civil actions and one state court civil action with claims of fraud by major private insurer and breach of contract against sponsoring hospital under provider-based emergency department management agreement.
• Represented free-standing emergency center in fraudulent lien litigation throughout state.