Health Care Law

At Coppersmith Brockelman, our 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, 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 and hospital systems seeking to establish biobanking programs. 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

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 also guided hospitals through the legal and health-information-management challenges in creating integrated or combined electronic medical records, in which legally separate legal entities share the same electronic medical records.

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. This includes:

  • Medical staff peer and quality review, due process, hearings and appeals.
  • Government reporting of practitioners.
  • Quality/peer review confidentiality.
  • Employed physician contracts and issues.
  • Medical staff and clinical practice-related bylaws, policies and procedures.
  • Practitioner behavior and impairment issues.
  • On-call coverage arrangements.
  • Antitrust and other legal challenges in exclusive contracts, and department closures.

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 intimately 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 and accountable care organizations.

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. The area of privacy and security is quite complex. We’ve flexed our ingenuity and know-how for clients in areas of:

  • 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.

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 health care-related legislation and rules for various clients at both state and federal levels. From participating in stakeholder processes on agency rules and policy revisions, to developing political action committees and other advocacy entities for health care clients, we constantly have our clients’ best interests in mind.

Hearing Officers, Mediators, Arbitrators

Our expertise is so admired that 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. With strong litigators on our team, we have also defended health care providers in a variety of criminal cases, including matters under the False Claims Act and other federal and state laws.

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 Board of Examiners of Nursing Care Institution Administrators and Assisted Living Facility Managers and the Arizona Radiation Regulation Agency. Our institutional clients often retain us to represent their employed or contracted practitioners and administrators in matters before health care-related boards and agencies.

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.
  • Disputes between hospitals and physicians, including medical staff disciplinary matters and exclusive contract litigation.
  • Federal/state certification and licensure proceedings.

Managed Care

We assist health care clients in managed care procurement, contracting, credentialing, and regulatory matters, as well as in litigation and resolution of disputes. Not only do we have a solid background in negotiating and developing contracts, and developing and implementing managed care credentialing programs, but we also assist health plans in peer review proceedings and regularly advise health care service organizations on insurance regulatory matters.

Stark, Anti-Kickback and False Claims Act Advice

We provide legal assistance to clients regarding compliance with the Stark self-referral law, anti-kickback laws, and the False Claims Act in connection with transactions, self-reporting questions, and investigations and legal actions related to compliance.

Attorneys

Karen Owens
Email Karen | 602-381-5463

Kristen Rosati
Email Kristen | 602-381-5464

Scott Bennett
Email Scott | 602-381-5476

Sam Coppersmith
Email Sam | 602-381-5461

Roopali Desai
Email Roopali | 602-381-5478

Andrew Gordon
Email Andrew | 602-381-5460

Kathy Steadman
Email Kathy | 602-381-5480

Naomi Jorgensen
Email Naomi | 602-381-5491

Melissa Soliz
Email Melissa | 602-381-5484