Telehealth, Digital Health, and Health Information Technology

• Structured health technology business models to comply with health care laws and regulations.
• Represented several telehealth and management company clients in responding to California Medical Board information requests and investigations.
• Managed regulatory due diligence in connection with the proposed sale of a telehealth provider.
• Successfully negotiated a software development agreement with a large health care system for a software start-up client.
• Performed regulatory due diligence for a large health care distribution company’s purchase of a health care technology company.
• Provided ongoing health care regulatory advice to an EHR company.

Hospitals, Health Systems, and Other Health Care Providers

• Represented California hospitals in evaluating, negotiating, and drafting physician agreements, including professional services agreements, administrative services agreements, call coverage, and hospital-based agreements.
• Successfully defended a hospital in a million-dollar dispute with the State of California over an incentive it had earned for being an early adopter of electronic health records (EHR). After a routine audit, the State alleged that our client had counted patients wrongly and should only have received $3.27 million of the $4.21 million it had been paid. The discrepancy turned on complex definitions about what constituted a patient day. Specifically, the State alleged that psychiatric bed days were not eligible to be counted in the total bed days for EHR purposes. We argued that the billing and cost reporting of the psychiatric bed days for our client were countable under the State’s program. The administrative law judge agreed with our position and cut the refund request down to approximately $192,000.
• Developed business associate toolkit to assist a hospital client in managing business associate relationships.
• Structured joint patient assistance program to address health information privacy and security requirements.
• Developed a toolkit to assist a hospital client in managing patients who are refusing discharge or are otherwise difficult to place in an appropriate level of care.
• Restructured management services agreements to comply with California corporate practice of medicine prohibitions.
• Investigated health care compliance implementation deficiencies for a hospital system and provided recommendations for improving the compliance program.
• Served as lead regulatory counsel to a large health system in its Chapter 11 bankruptcy case, the largest hospital bankruptcy in US history. The matter has involved corporate and regulatory support for the system’s day-to-day operations as well as extensive regulatory work on the sale of the system’s six hospitals, including counsel regarding California attorney general conditions and the approval process.
• Managed due diligence and pre- and post-acquisition notices for venture capital purchase of multiple ambulatory surgery centers and pain clinics.

Life Sciences and Medical Devices

• Negotiated settlement of disciplinary action with the California Board of Pharmacy for a medical device wholesaler.

• Evaluated medical device and biotechnology company marketing campaigns for compliance with the federal Anti-Kickback Statute and other fraud and abuse laws.
• Evaluated proposed marketing materials for stem cell products.

• Developed a 50-state, post-acquisition regulatory filing plan for a large diagnostics company.