Medical Practice Formation, Dissolution and Management including operating agreements, employment arrangements, vendor agreements, licensing and certification, and all related issues for physician clinics.
General Legal Advice including real estate, tax, labor / employment issues, business issues of all kinds.
Regulatory Compliance: We have a wealth of knowledge regarding the somewhat counterintuitive laws that govern all arrangements between hospitals and physicians and other aspects of physician practice, and have developed tools and significant expertise to keep our clients compliant on the front end. We specialize in practical and reasonable compliance planning and advice, and we have developed efficient practices for evaluating and addressing compliance problems as they arise. We also have expertise in helping hospitals and clinics through the analysis of how to handle violations of these laws, including direct experience with government investigations and with the self-disclosure process.
Health Care Information/ Technology: Technology and sharing of data across organizations has become increasingly complex and we understand the business of providing medical care in this electronic, technology-driven environment, from both the provider and vendor. We are nationally recognized for our experience in health technology and electronic medical records issues. Quarles attorneys advise clients on compliance with the HIPAA Privacy and Security Rules, as amended by the HITECH Act. We have created and helped to implement HIPAA privacy and security programs for numerous clients. We have developed a library of HIPAA policies and procedures as well as necessary template forms and agreements to address all aspects of HIPAA compliance.
Privacy/ Data Breach: We assist numerous clients with security breaches and the inadvertent disclosure of confidential information including but not limited to protected health information. We assist clients in every aspect of managing the breach, including analyzing the scope of the disclosure, developing strategies to mitigate the security breach, notifying affected individuals, preparing media statements, and responding to inquiries from government agencies.
Finance: Our attorneys have experience representing and counseling on all aspects of health care finance, lending and debt restructure. We understand the needs of the industry and possess the skills and knowledge to assist clients on a wide variety of transactions.
Intellectual Property: Quarles & Brady has enormous experience serving the intellectual property needs of research institutions and academic medical centers. We understand the organizational issues involved with large patent and trademark portfolios.
Medical Staff/ Peer Review: We have worked with large and small health systems to structure their medical staff and bylaws and related documents in a strategic and user-friendly way that allows collaborative relationships with clear leadership roles and goals, and very clear processes for peer review and corrective action. We pride ourselves in our depth of experience and our practical approach to these matters.
Licensure/ Accreditation/ Certification: We have a wealth of knowledge in the licensing process for hospitals and clinics with state agencies, Medicare, Medicaid, and The Joint Commission.
Corporate Mergers And Acquisitions: We have a team of corporate lawyers with health care expertise who have helped our hospital clients with all sizes and varieties of consolidation, merger, purchase and sale of corporate entities, as well as creative ventures between physician groups and others. We have a proven track record in this regard.
Pharmacy/ DEA: We have a thriving practice in the pharmaceutical industry as well as a DEA practice that services all clients including health delivery systems - from developing policies, addressing diversion issues, addressing DEA licensing issues, or handling DEA investigations - our team includes prior DEA prosecutors who know the ins and outs of the industry and how our health care clients can best protect themselves.
Litigation: We have a team of litigators with specific expertise in health care litigation including government compliance actions, qui tam relator suits, and a list too extensive to include here. We are happy to provide a list of cases or representative experience with various health related litigation.
Government Variances: The Quarles team has repeatedly and successfully obtained variances from state and federal regulatory agencies. Often, these variances enable our clients to utilize new technology that regulatory schemes have not yet envisioned. Some of these variances have resulted in new rulemaking to enable widespread use of technology for the benefit of patients.
Internal Audits: Quarles’ attorneys have overseen health care regulatory internal audits as well as the multiple steps involved with the Self-Disclosure Protocol. We have negotiated with the OIG and U.S. attorneys in voluntary self-disclosures, including establishing the necessity of payment plans for repaying overpayments, which included undertaking the massive effort required to establish financial hardship, making decisions on when to waive attorney-client privilege and negotiation of penalty amounts.
PRRB: We have appealed on behalf of groups before the Provider Reimbursement Review Board (PRRB), concerning Medicare disproportionate share hospital adjustment.