The Coppersmith Brockelman health care practice is nationally recognized. Our firm’s team is highly experienced in navigating the complex business, regulatory and operational issues facing health care providers and institutions, health plans, and the businesses serving them.
Our lawyers have worked extensively with a wide range of health care clients on a broad variety of Big Data issues, including:
We routinely provide counsel to academic medical centers, hospital systems, and research companies related to biobanking and the use of biospecimens for research. Our counsel includes:
Our lawyers have worked extensively with a wide range of health care clients – academic medical centers, hospitals, and clinics – on a broad variety of issues related to clinical research, including:
Our depth of knowledge in corporate governance and compliance issues allows us to serve as principal outside counsel to providers, governmental entities, and managed care organizations on a regular basis. In this role, we also advise on general corporate and structural matters and exempt entity issues for nonprofit organizations. We are proud to provide practical, client focused service in all these roles.
Our team is highly experienced with issues relating to health care institution electronic health record roll-outs, including subsidizing physician EHR purchasing and licensing in compliance with the Stark and Anti-Kickback Laws. We have guided clients through the legal and health-information-management challenges related to integrated or combined electronic medical records. We also advise clients on health information sharing requirements and the prohibition on information blocking under the 21st Century Cures Act.
Our lawyers have successfully defended clients in government investigations as well as lawsuits under the federal False Claims Act.
We assist clients in complying with federal and state fraud and abuse laws, including the Stark Law, Anti-Kickback Statute (AKS), False Claims Act, Eliminating Kickbacks in Recovery Act (EKRA), Civil Monetary Penalties Law, and state laws relating to self-referrals, kickbacks, fee splitting, and other types of business conduct. We conduct internal investigations to help clients identify and prevent any potentially illegal conduct, assist in determining whether conduct should be self-disclosed to government regulators and, when necessary, help clients with such disclosures. We also work with clients to respond to government investigations and audits and defend clients in administrative and court proceedings and court when required.
Our lawyers have represented health plans in some of Arizona’s largest and most difficult health care procurement processes and bid protest proceedings. These matters include both protesting and defending contract awards before agencies, administrative hearings at the Arizona Office of Administrative Hearings, and subsequent court proceedings. More specifically, we have addressed a wide variety of issues such as bidding procedures, conflicts of interest, scoring of bids, bidder responsibility and qualifications, statutory interpretation, scope of agency discretion, and similar complex problems.
We regularly represent clients with state and federal health care antitrust concerns in transactional and contested matters, including:
We are deeply familiar with the legal and practical issues involved in running health care operations at hospitals, clinics, ambulatory surgery centers and physician practices. Recognizing the fundamental links between effective operations, patient outcomes, and a provider’s success, we have authored successive editions of the Arizona Consent and Health Information Resource Manual, published in collaboration with the Arizona Hospital and Healthcare Association. Our work includes:
We helped create Arizona’s health information exchange (HIE), not only writing the Arizona HIE laws, but also guiding efforts through the integration of behavioral and physical health information. We are using our skills to advise other HIEs across the country and many hospitals participating in HIEs. We have also created private health information exchanges to support clinical integration initiatives, accountable care organizations, and care coordination.
Health care organizations and their business associates take information privacy and security very seriously. We share the same concern and authored the “HIPAA Privacy Tool Kit,” an extensive compliance manual and policies/forms for HIPAA compliance. We have guided dozens of clients through complex HIPAA and other health information privacy and security compliance:
We frequently work with health care trade associations, health care coalitions, and other groups to develop health policy initiatives and federal and state legislation and rulemakings. For example, we regularly advise the Arizona Hospital and Healthcare Association on proposed state and federal legislation and rules, and we draft and respond to health care-related legislation, rules and initiatives for various clients at both state and federal levels. We also participate in stakeholder processes on agency rules and policy revisions and develop political action committees and other advocacy entities for health care clients.
Several of our lawyers are experienced hearing officers, arbitrators, and mediators with certification from the American Health Lawyers Association in health care-related matters.
We help health care clients in performing internal investigations and in responding to investigations by federal and state agencies, including the U.S. Department of Justice, the FBI, the Office of Inspector General, and state attorneys general. With strong litigators and a criminal defense lawyer on our team, we have also defended health care providers in a variety of criminal cases.
Our familiarity with licensure and regulation makes us ideal partners in representing providers, practitioners, and administrators before a variety of Arizona health professions licensure boards and agencies, ranging from the Arizona Medical Board, the Arizona Board of Osteopathic Examiners, and the Arizona State Board of Nursing, to the Arizona State Board of Pharmacy, the Arizona Board of Examiners of Nursing Care Institution Administrators and Assisted Living Facility Managers, and the Arizona Department of Health Services Bureau of Radiation Control. Our institutional clients often retain us to represent their employed or contracted practitioners and administrators in matters before health care-related boards and agencies. We also advise practitioners and their institutions on compliance with various licensing laws and regulations, including those regarding the use of opioids.
While our philosophy is to help clients resolve disputes amicably, some matters require litigation or contested administrative proceedings to reach a fair conclusion. We represent our health care clients in:
On a daily basis, we advise hospitals, clinics, medical staffs, practitioners and their groups, managed care organizations, and other entities on ongoing clinical operations as well as the development of medical staff/entity relationships and functions. We have deep experience in the following areas, among others:
We regularly advise clients, ranging from health care providers and health plans to health information exchanges and health IT vendors, on substance abuse-related legal issues. In particular, we have substantial experience addressing the application of 42 C.F.R. Part 2 —the federal Confidentiality of Substance Use Disorder Patient Record regulations (“Part 2”). We also advise on state and other federal laws and regulations regarding the use of opioids in medical treatment.
We assist with telemedicine program development and implementation, including providing guidance regarding physician licensure issues, remote prescribing, privacy and security, fraud and abuse in the context of telemedicine arrangements, and navigating complex reimbursement rules for telemedicine encounters. We also have experience dealing with the unique state law issues that affect multi-state telemedicine practices.