The Coppersmith Brockelman health care practice is nationally recognized. Our team is highly experienced in navigating the complex business, regulatory and operational issues facing health care institutions, health care providers, health plans, and the businesses that serve them. We can help with the following areas (in alphabetical order):
BIOBANKING, CLINICAL RESEARCH & HEALTH SERVICES RESEARCH
Our lawyers have worked extensively with a wide range of health care clients – such as academic medical centers, hospitals, and clinics – on a broad variety of issues related to clinical research, including:
- Clinical research compliance including conflict of interest, adverse event reporting, FDA and OHRP audits and investigations, IRB compliance, and participant informed consent;
- Hospital-physician financial arrangements in clinical research, including Stark and Anti-Kickback compliance;
- Clinical trials contracting;
- Genomics and genetic privacy; and
- Creating biobanks and data repositories for research, and negotiating biospecimen distribution and research collaboration agreements.
CORPORATE GOVERNANCE
Our depth of knowledge in corporate governance and compliance issues allows us to serve as principal outside counsel to providers, managed care organizations, and governmental entities on a regular basis. In this role, we advise on general corporate and structural matters and tax-exempt entity issues for numerous nonprofit organizations.
DATA PRIVACY, SECURITY, INTEROPERABILITY AND GOVERNANCE
Coppersmith Brockelman has a nationally recognized legal practice in data privacy, security, interoperability and governance. We advise on a wide range data-related issues, including HIPAA compliance, the federal Information Blocking Rule, ONC Certification Program requirements, CMS interoperability mandates, state interoperability laws, data breaches, artificial intelligence, “Big Data,” digital health, compliance with FTC regulations, FERPA, state laws, and EU GDPR compliance, health information networks/health information exchange, patient safety organizations, and health IT and data services contracting. Please see link to the description of our data practice.
FRAUD & ABUSE
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. In 2023, we successfully obtained a favorable OIG Advisory Opinion that provided important guidance on physician compensation structures.
GOVERNMENT INVESTIGATIONS
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 Office of Inspector General, the Office for Civil Rights, the Office for Human Research Protections, the Food & Drug Administration, and state attorneys general.
GOVERNMENTAL HEALTH CARE ENTITIES
We represent several hospital districts and have represented other health care-related special taxing districts with lease negotiations, intergovernmental agreements, Open Meeting Law and public records issues, tax and budget matters, and election issues.
HEALTH CARE ANTITRUST
We advise clients with state and federal health care antitrust concerns in connection with medical staff contracting arrangements, closed departments, and other antitrust concerns involving hospitals and practitioners.
HEALTH CARE OPERATIONS
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 Manual, published in collaboration with the Arizona Hospital and Healthcare Association. Our work includes:
- Medicare certification, EMTALA, state licensure, and Joint Commission accreditation, including deficiency statements, survey and re-survey preparation, compliance and enforcement advice, and revocation and civil monetary penalty proceedings;
- Corporate, real estate and tax exemption issues, including transactions and regulatory compliance;
- Employment issues, including physician and other practitioner employment and its intersection with peer review proceedings;
- Patient issues such as informed consent, refusal of care, surrogacy, end-of-life, and immigration status;
- Quality improvement programs and patient safety initiatives;
- Government reporting obligations; and
- Reproductive health issues.
HEALTH POLICY & GOVERNMENT RELATIONS
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.
HEARING OFFICERS, MEDIATORS, ARBITRATORS
Several of our lawyers are experienced hearing officers, arbitrators, and mediators with certification from the American Health Law Association in health care-related matters.
LICENSURE & REGULATION OF PRACTITIONERS
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.
LITIGATION & ADMINISTRATIVE PROCEEDINGS
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:
- Business litigation;
- Employment and practitioner service contract disputes;
- Medical malpractice claims of negligent credentialing/supervision;
- Matters before state and federal administrative tribunals;
- Commercial contract disputes with vendors, third-party payors and others;
- Peer review hearings and judicial review.;
- Exclusive contract, department closure litigation;
- Medicare and AHCCCS certification;
- State licensure proceedings;
- False Claims Act litigation;
- Telecommunication Consumer Protection Act litigation;
- Administrative proceedings relating to Certificates of Necessity; and
- Appeals of civil monetary penalties imposed by government agencies.
MANAGED CARE
We represent managed care organizations in complying with federal and state requirements, with corporate governance matters, and in handling complex disputes among plans, providers, and regulators.
PEER REVIEW & ENTITY/PHYSICIAN CLINICAL RELATIONSHIPS
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:
- Medical staff peer review and quality management, investigations, due process, in-hospital hearings and appeals, and judicial review;
- Government reporting of practitioners.;
- Quality/peer review confidentiality;
- Employed practitioner contracts and issues;
- Drafting and application of medical staff and clinical practice-related bylaws, policies, and procedures;
- Development and application of managed care credentialing and quality review hearing procedures;
- Practitioner behavior, age, and impairment issues;
- EMTALA and on-call coverage arrangements; and
- Antitrust and other legal challenges, exclusive contracts, and department closures.
REPRODUCTIVE HEALTH LAW IN THE WAKE OF THE DOBBS DECISION
We advise health care providers on compliance with federal and state law in the wake of the Dobbs decision, including difficult legal issues surrounding abortion and other types of reproductive health care in a rapidly changing legal landscape. Our expertise in data privacy (including cross-border data sharing of reproductive health records), consent and privacy issues related to treatment of minors (including Arizona’s Parents Bill of Rights), Title X, telehealth law, licensing requirements, and EMTALA help inform our reproductive health law practice. In addition to our outstanding health care regulatory practice, Coppersmith Brockelman’s political, election, and constitutional law practice litigates reproductive rights issues of statewide importance in trial and appellate courts and advises clients on reproductive rights ballot initiatives and other election-related issues.
TELEHEALTH
We assist with telehealth program development and implementation, including providing guidance regarding physician licensure issues, remote prescribing, data 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.
Attorneys
Sam Coppersmith
Email Sam | 602-381-5461
John Kelly
Email John | 602-381-5497
Karen Owens
Email Karen | 602-381-5463
Kristen Rosati
Email Kristen | 602-381-5464
Melissa Soliz
Email Melissa | 602-381-5484
Marki Stewart
Email Marki | 602-381-5496
Erin Dunlap
Email Erin |314-255-5988
Ben Yeager
Email Ben | 602-381-5488