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.
Big Data
Our lawyers have worked extensively with a wide range of health care clients on a broad variety of Big Data issues, including:
- Advising clients on the appropriate use of health information for data analytics, research, quality improvement initiatives, care coordination platforms, and other uses of large, longitudinal, multi-party data sets.
- Leveraging our relationships with statisticians and other leading experts to weigh in on de-identification services.
- Advising clients on collaboration agreements related to sharing data in compliance with federal and state laws.
Biobanking
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:
- Advising on human subject research protection and HIPAA compliance.
- Drafting informed consents and biobanking-related agreements, such as material transfer agreements.
- Advising on business planning and contracting with biospecimen sources.
- Negotiating biospecimen distribution and research collaboration agreements.
Clinical & Health Services Research
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:
- Clinical research compliance including conflict of interest, research misconduct, 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.
- Use of biobanks and data repositories for research.
Corporate Governance
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.
Electronic Health Records & Information Blocking
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.
False Claims Act
Our lawyers have successfully defended clients in government investigations as well as lawsuits under the federal False Claims Act.
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.
Government Contracts & Bid Protests
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.
Health Care Antitrust
We regularly represent clients with state and federal health care antitrust concerns in transactional and contested matters, including:
- Advising on contracting arrangements, closed departments, and other antitrust concerns involving hospitals, physicians, and payors.
- Assessing price fixing, group boycott, and market share issues.
- Defending private and governmental antitrust actions under federal and state laws.
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 and Health Information Resource 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, and revocation and civil monetary penalty proceedings.
- Corporate, real estate and tax exemption issues, including transactions and regulatory compliance.
- Employment issues, including physician employment and its intersection with peer review proceedings.
- Self-funded insurance plan and other insurance regulatory matters.
- 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.
Health Information Exchanges
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 Information Privacy & Security
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:
- Handling Office for Civil Rights (OCR) investigations and enforcement proceedings.
- Advising clients on handling data breaches, including some involving millions of individuals, determining federal and 50-state reporting obligations, OCR and state Attorney General investigations resulting from breaches, and patient reporting.
- Structuring complex data sharing arrangements to support Accountable Care Organizations and Clinically Integrated Networks.
- Advising clients on use of Big Data, including establishing clinical data repositories for research and data analytics, and guiding clients through de-identification of patient health information.
- Advising clients on participating in integrated medical records systems, where legally separate entities share the same electronic health records.
- Drafting HIPAA compliance policies for entities and business associates.
- Negotiating HIPAA business associate agreements.
- Advising clients on compliance with 42 C.F.R. Part 2, the federal Confidentiality of Substance Use Disorder Patient Record regulations.
- Advising clients on applicability of the General Data Protection Regulation (GDPR) and California Consumer Privacy Act (CCPA).
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 Lawyers Association in health care-related matters.
Investigations & Criminal 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.
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 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 (TCPA) litigation.
- Administrative proceedings relating to Certificates of Necessity.
- Appeals of civil monetary penalties imposed by government agencies.
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 physician 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.
- Antitrust and other legal challenges, exclusive contracts, and department closures.
- Advising health care service organizations on insurance regulatory matters.
Opioids/Substance Use Disorder/42 C.F.R Part 2 Compliance
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.
Telemedicine
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.
Attorneys
Karen Owens
Email Karen | 602-381-5463
Kristen Rosati
Email Kristen | 602-381-5464
Sam Coppersmith
Email Sam | 602-381-5461
Erin Dunlap
Email Erin |314-255-5988
Andrew Gordon
Email Andrew | 602-381-5460
Melissa Soliz
Email Melissa | 602-381-5484
Marki Stewart
Email Marki | 602-381-5496
Ben Yeager
Email Ben | 602-381-5489