Health Care Law

Arranged and negotiated a health system’s acquisition of a minority interest in a rural hospital.

Negotiated and closed dozens of physician employment and practice acquisition transactions on behalf of hospital clients.

Successfully overturned a $10 million overpayment determination in favor of a physician-owned specialty hospital over alleged violations of the Stark Law.

 Currently serve as lead counsel to the physician compensation committee of a large health system that employs over 750 physicians. 

Structured and negotiated a health system’s joint venture arrangement with a national, for-profit oncology services provider involving the health system’s entire oncology service line and employed medical and radiation oncologists

Arranged an affiliation between a large, hospital-owned physician group and the faculty practice plan of a state-owned college of medicine

Represented a large, multi-hospital health system in connection with a complete corporate reorganization of the system from a joint operating agreement model to a fully-horizontally integrated model

Gave testimony before the Ohio House of Representatives Health Committee on behalf of a state-level hospital association regarding medical record contents (H.B. 172).

Worked closely with in-house counsel and medical staff leadership of individual hospitals and multi-hospital systems to conduct reviews of medical staff governing bylaws, policies and procedures for compliance with Medicare conditions of participation and applicable law and private accreditation standards (i.e., TJC, HFAP, DNV/NIAHO) making recommendations for standardization and industry best practices. Additionally, the team assisted with the implementation of new policies and evaluated peer review policies for effective processes, making recommendations for updates and revisions.

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.

Prepared successful provider-based and mid-build attestations for a hospital system regarding an off-campus, provider-based department and counseled the client through the process.

Managed and successfully negotiated self-disclosure by a 340B covered entity to multiple drug manufacturers and the Health Resources Services Administration.

Drafted and negotiated pharmacy services agreement and contract pharmacy agreements on behalf of a hospital system with national pharmacy providers.

Assisted a client in obtaining a favorable Office of Inspector General advisory opinion.

Advise hospitals regarding various process improvements that can enhance patient care and minimize liability risk, including developing processes and policies around both existing and new/innovative care modules.

Regularly present to medical providers for CME credit on issues of informed consent, chain of command, privileges, documentation, etc.

Frequently represent physicians and nurses during professional board interviews and investigations.

Successfully argued before the Ohio Supreme Court, establishing that the statute of repose bars medical claims not filed within four years of the time the care was provided. 

Have appeared in the highest courts in Ohio and West Virginia, as well as intermediate appellate districts throughout Ohio.

Defended hospitals, nurses, physicians and other medical providers against medical negligence and wrongful death claims in various Ohio courtrooms.

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. 

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.   

Represented a Cayman Island segregated portfolio insurance company that insures providers against professional liability and its shareholders in connection with the sale of shares to a significant Michigan-based health care company. There were numerous financial, regulatory and international law issues associated with the transaction. 

Represented hospitals in suits by practitioners contesting termination of appointment/privileges and prevailed on motions for summary judgment whereby the court granted immunity from damages under HCQIA to all defendants.

Represented a large hospital system in successfully dealing with an FTC investigation of an acquisition of a physician specialty practice group. 

Represented a trade association in resolving an FTC investigation into alleged restrictive association requirements. 

Represented a county hospital that became affiliated with a large health care system, obtaining all regulatory approvals, overseeing self-disclosure of potential Stark issues and assisting with the payoff of outstanding bonds.

Provided ongoing antitrust advice in connection with the formation of a statewide network of six regional health care systems, which is one of the larger health care joint ventures in the country. 

Advise public hospitals regarding responses to requests for a large number of public records.

Prepared an amicus brief on behalf of the American Hospital Association in support of the U.S. Department of Health and Human Services (HHS) interpretive rule providing guidance on the scope of the exclusion of orphan drugs from 340B discounts. 

Assisted in the development of a state-wide database for health care information reports, including the creation of policies and agreements and compliance with regulatory requirements (including HIPAA). Also worked to revise protocols for state-to-state relationships, the sharing of data and related data sharing agreements.

Assisted a large health system with the system-wide implementation of an electronic health records (EHR) system, ensuring legal and regulatory compliance, HIPAA security and continuity of patient care. 

Served as lead counsel to an Ohio-based health network in developing a unique physician-led management services organization (MSO) providing day-to-day operation and management of multiple breast health centers. This unique MSO also developed a clinically integrated incentive strategy within the network of primary care and OB-GYN physicians to implement a physician-designed evidence-based patient protocol to enhance breast health, early detection and prevention in the health network's market area. 

Assisted with transitioning all assets of a not-for-profit developmental disability service provider to another not-for-profit developmental disability service provider, forming one of the largest developmental disabilities service providers in Ohio in terms of revenue and consumers served.  

Developed a peer review process for physicians employed by hospital-affiliated entities and created documents that permitted the sharing of peer review information between the hospital and the affiliated entity.

Developed a template for medical staff bylaws for the Ohio Hospital Association and individual medical staff governing documents for hospitals and for systems with more than one hospital to assure compliance with federal, state and private regulations as well as best practices.

Advised hospitals responding to meaningful use audits of the Centers for Medicare & Medicaid Services (CMS) electronic health record incentive payment program, which required analyzing compliance with regulatory requirements for receiving such payments, assisting with preparation of responses and guiding hospitals through the audit appeal process, when necessary.

Successfully defended, through appeal to the United States Court of Appeals for the Sixth Circuit, a qui tam action brought under the False Claims Act on behalf of a hospital system who was alleged to have violated the Health Information Technology for Economic and Clinical Health (HITECH) Act by improperly certifying its compliance with the HITECH Act in exchange for receiving meaningful use payments.

Assisted an independent, government-owned community hospital in its pursuit of a unique and strategic partnership to keep it viable and positioned to survive the pressures of a reforming health care delivery system. This process involved soliciting and evaluating proposals from potential strategic partners, engaging with consultants, advising on legal issues related to the hospital's government ownership, and, ultimately, preparing and negotiating the strategic affiliation agreement. 

Successfully defended a hospital and its employees in a jury trial case where a patient's estate claimed that the patient had received deficient care and had been discharged from the hospital prematurely. The patient's estate claimed that the patient died from a massive internal bleed that additional hospitalization would have prevented. Following a week and a half trial, the jury returned a defense verdict. 

Represent large teaching hospitals and other non-teaching hospitals on Medicare reimbursement matters and cost report appeals, which include appeals of administrative agency decisions and various court appearances.

Worked with an operator of long-term acute care hospitals to resolve a dispute with an insurance carrier regarding Medicare and Medicaid plan payments. We identified the source of payment discrepancies, corrected prior incorrect billings and put appropriate measures in place to prevent future occurrences. 

Negotiated a settlement of Medicare reimbursement underpayments with the federal government on behalf of two large health systems.

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.

Acted as borrower's counsel for a municipal hospital in the issuance of $35 million in revenue bonds.

Acted as borrower's counsel for a municipal hospital in the issuance of $35 million in revenue bonds.

Represented governmental hospital and acted as borrower's counsel in $25 million hospital revenue bond financing, successfully negotiating a unique provision that permitted the hospital to convert to private nonprofit status in the future without having to obtain the consent of the bondholders.

Served as lead counsel in the acquisition of a nonprofit health system by a health corporation, negotiating the transaction, drafting all corporate documents, conducting due diligence review and completing all regulatory filings.

Serve as counsel to the Ohio Health Information Partnership and assist with all aspects of its operation of a health information exchange (CliniSync).

Trial Counsel for local county boards serving persons with developmental disabilities in defense of an action brought by private providers seeking to eliminate service contracts between county boards and private providers as mandated by state and federal Medicaid law. 

Served as trial counsel to county boards and individual taxpayers to enjoin Ohio Department of Job and Family Services administrative rules that set Medicaid reimbursement rates in excess of the provider's usual and customary rate.

Represented a hospital in overturning disallowance of residents in IME count based on nature of residency program activities. 

Advised hospitals on potential False Claims Act exposure; also represented the Ohio Hospital Association and the American Hospital Association in successfully challenging the government's use of the False Claims Act in Ohio's laboratory unbundling litigation.

Represented a hospital in ordering the government to update reasonable compensation equivalent (RCE) limits.