Analyzed the applicability of the European Union’s General Data Protection Regulation (GDPR) to a health system’s research operations. Developed a GDPR-compliant standard operating procedure for the health system’s division that was determined to be a GDPR data processor.

Guided multiple hospitals and health systems through the Medicare appeals process for Recovery Audit Contractor (RAC) claim denials and overpayment determinations. This matter involved preparing hospitals for RAC audits and managed appeals involving a wide array of billing issues through the Administrative Law Judge hearing process and Medicare Appeals Council (MAC), when necessary.

Review clinical trial agreements and related documents, including non-disclosure agreements and informed consent forms, for hospitals engaged in the conduct of clinical research. Advises hospital on critical provisions in clinical trial agreements, including subject injury, intellectual property, publication and indemnification. The firm has also assisted clients with a variety of compliance issues related to clinical research, including the Common Rule, billing, the Sunshine Act, conflicts of interest, FDA regulations and HIPAA. 

Conduct annual assessments of health care organization compliance programs and assist in the development and implementation of compliance programs for hospitals and managed care organizations. Annual compliance program evaluations are utilized by health care organizations to set annual improvement goals and to correct any identified deficiencies. The firm also conducts compliance investigations on behalf of health care organizations when the organizations determine that an outside investigation is preferable to an investigation conducted internally by the organization’s compliance department. 

Represented a managed care organization in its negotiation of a strategic, multi-state alliance with another managed care organization. The firm represented the managed care organization during in-person and telephonic negotiations regarding the alliance and assisted in the drafting of the master alliance agreement and associated state-specific agreements. The firm also counseled the managed care organization with regard to the various legal implications of the alliance. Following the formation of the alliance, the firm has assisted the managed care organization with implementation in multiple states.

Assumed responsibility for reviewing and negotiating nearly all of a large managed care organization’s vendor contracts. This rapidly growing managed care organization enters into dozens of new vendor contracts on a weekly basis, and the firm took responsibility for the legal reviews and negotiation of these contracts, allowing the client’s internal legal team to focus on other matters. Our team worked closely with the client’s compliance, vendor management and operations staff. The contracts ranged from relatively low-value services agreements to complex, multi-million dollar agreements impacting all of the client’s lines of business.  

Drafted and filed an amicus brief on behalf of a managed care organization in an important False Claims Act case pending before the U.S. Supreme Court. The issues before the Court were whether and how the so-called “implied false certification theory” can be a basis for liability under the False Claims Act. The firm prepared an amicus brief on behalf of our client, which was very well received both by the client and petitioner’s counsel.   

Prepared and filed the application for licensure in Ohio, obtaining approval of the application. Coordinating with counsel from other states, we also advised the client on a number of strategic issues.