The health care industry is one of the most heavily regulated industries in the United States. Physicians and other health care providers are subjected to a pervasive, ever-changing regulatory scheme, overseen by a host of federal and state agencies. Health care providers also are subject to the same laws and requirements governing businesses in other industries; as a result, many health care clients require the full spectrum of legal services.
Our health law attorneys focus their efforts on issues specific to the health care industry. Consequently, they have developed expertise in virtually every aspect of health law. They also have developed an understanding of the business of health care, which helps convert legal knowledge into sound business advice. Where appropriate, they also work closely with outside attorneys on the application of other types of law in the health care setting. This approach combines the benefits of industry specialization with the benefits of legal specialization, resulting in the delivery of high-quality, cost-effective services to our clients.
A significant part of our practice involves representing clients in the formation, operation and acquisition of health care businesses. We provide practical advice regarding regulatory compliance, antitrust and securities law, governance, operations, and the negotiation and preparation of transaction documents, working closely with our clients from the conceptual stage through closing.
Our experience includes:
- The formation, restructuring and acquisition of single and multi-specialty surgery centers, imaging centers (MRI, CT and PET) and other diagnostic and treatment health care facilities;
- Surgery center and imaging center joint ventures with for profit and nonprofit hospitals and hospital systems;
- Formation and mergers of single specialty and multi-specialty physician practices, dental practices and multi-specialty practices, including choice of entity (professional corporation versus LLC, etc.), development of governance structures, buy-sell provisions, shareholder agreements, etc.;
- A multi-specialty physician group’s acquisition of an ownership interest in a community hospital;
- Practice sales and acquisitions;
- Formation and representation of health care-related management companies;
- Formation and representation of medical research ventures.
Our attorneys have significant experience in health law transactions and fraud and abuse compliance, allowing us to evaluate and structure transactions to minimize the risk of violating state and federal laws. We also advise clients regarding fraud and abuse concerns related to existing transactions and develop compliance plans to minimize the risk of prohibited activity and conduct investigations and audits.
In the event of a violation, we assist clients in self-reporting and returning any overpayments to applicable payers, including the Medicare and Medicaid programs. When necessary, our attorneys work closely with experienced criminal defense attorneys in connection with actual or potential criminal investigations. We have successfully represented and defended clients involved in criminal, civil and administrative fraud and abuse investigations, conducted by the Office of Inspector General, Department of Justice, United States Attorney, and the Arizona Attorney General.
Our experience includes:
- Representing physicians and physician group practices in negotiating and drafting physician recruitment agreements with hospitals;
- Structuring joint ventures (including ambulatory surgery centers, imaging centers (IDTFs), and other diagnostic and therapeutic facilities) among physicians, for-profit and non-profit hospitals and management companies;
- Advising physician group practices regarding the distribution of income from ancillary services under the federal Stark Law;
- Advising businesses within the health care industry in connection with transactions and contractual relationships with health care providers and suppliers;
- Representing a large, multispecialty physician group practice under investigation by the Office of Inspector General for violating Medicare billing rules governing physicians at teaching hospitals (PATH);
- Representing a physician group practice under criminal and civil investigation for violating the federal Stark Law, Anti-Kickback Act and False Claims Act with respect to the group’s relationship with a non-profit hospital;
- Negotiating settlement and corporate integrity agreements on behalf of physicians and physician groups under investigation for fraudulent billing;
- Representing physician group practices who have entered into corporate integrity agreements regarding compliance audits conducted by the Office of Inspector General;
- Drafting and implementing compliance plans for small and large single-specialty and multi-specialty physician group practices and other health care providers, suppliers and businesses in the health care industry;
- Investigating and auditing suspected fraudulent billing practices on behalf of health care providers and suppliers;
- Representing physician group practices under civil investigation for violating the Federal Stark Law and False Claims Act with respect to the group’s ancillary designated health service venture;
- Representing physician group practices in the disclosure and repayment of AHCCCS and Medicare collections billed in error.
Our attorneys provide physicians and other professionals and health care providers with personalized attention and particular care in all aspects of the licensing process. Our experience spans nearly all of Arizona’s health care licensing agencies and includes overseeing the application process for clients with complex or problematic histories; assisting clients in the preparation of responses to licensing board complaints; advising clients in connection with formal and informal appearances before licensing boards and their investigators; guiding clients through diversion and other programs for professionals with substance abuse or other medical problems; negotiating consent agreements; and representing clients in administrative hearings and trial and appellate proceedings.
Disputes in the health care industry can arise in a variety of contexts contract breaches, employment issues, practice disbanding, insurance payment and coverage, fraud and abuse and licensing issues.
As health care attorneys representing the interests of clients in the health care industry, our practice members routinely counsel and represent clients in connection with these matters. Services vary from counseling and representing clients in dispute avoidance, mediation, arbitration, administrative investigations and hearings, grievance procedures, lawsuits and appeals. Our attorneys have years of experience and success in resolving matters before litigation as well as aggressively representing clients in litigation, if and when necessary.
Medical Research and Biotechnology
The accelerating pace of development of new drugs and medical devices has created exciting new opportunities for health care providers, entrepreneurs, pharmaceutical companies and others. Along with these new opportunities come new challenges, as the law struggles to keep pace with science. In conjunction with the firm’s intellectual property practice and others, members of the health law department work with physicians, institutions, site management companies, research organizations, medical staffs and others to identify and resolve legal issues arising from the tide of medical research and biotechnology.
Our experience includes:
- Negotiating and drafting clinical trial agreements with sponsors, institutions, CROs and principal investigators;
- Representing physicians involved in post-graduate training programs and related research projects;
- Advising clients regarding compliance with institutional review boards (IRBs), the Food and Drug Administration (FDA) and the Office for Human Resource Protections (OHRP) requirements, including requirements relating to participant informed consent; adverse events; and conflicts of interest;
- Representing principal investigators in negotiations with sponsors and institutions;
- Advising medical staffs regarding the establishment of privileging criteria for new technology and new applications of existing technology;
- Assisting clients in the development of policies and procedures designed to minimize fraud and abuse liability in connection with billing practices in clinical trial;
- Representing providers accused of unprofessional conduct in connection with experimental treatment;
- Structuring research joint ventures between physicians and other health care providers;
- Educating and advising clients regarding HIPAA compliance in the research setting.
Medical Staff Relations
In recent years, medical staffs have recognized the importance of independent legal counsel to provide advice in an increasing number of areas in which their interests may not coincide with the interests of hospital administration. Our attorneys have years of experience representing medical staffs on the full range of issues affecting the relationship with the hospital, and regularly represent them in connection with credentialing, peer review and corrective action processes. Since we do not represent hospitals, we avoid the legal, business and political conflicts of interest that arise when one law firm represents parties on both sides of these issues.
Our experience includes:
- Drafting and revising medical staff bylaws; department rules and regulations; fair hearing plans; and credentialing manuals;
- Developing and drafting of policies and procedures relating to physician health/impaired physicians; disruptive behavior; peer review; quality management and utilization management; credentialing for new technology and new applications of existing technology; information sharing; and fraud and abuse compliance;
- Representing medical staffs in peer review investigations; summary suspensions; the fair hearing process; and other types of corrective action;
- Counseling medical staffs involved in negotiations and conflicts with hospital administration on issues including: economic credentialing and conflicts credentialing; emergency department call coverage and EMTALA; control over bank accounts; and autonomy;
- Advising leadership on compliance with JCAHO standards; Health Care Quality Improvement Act and National Practitioner Data Bank obligations; and state medical board reporting obligations.