False Claims Investigations, Litigation, and Compliance Counseling: Our Health Care Industry Team can provide you with advice and counsel on health care compliance and fraud and abuse matters encompassing virtually every aspect of the health care industry. We have provided compliance counsel and representation for publicly traded, privately held, not-for-profit, and governmental entities, including hospitals, health plans, nursing homes, medical transportation providers, physician organizations, university systems, pharmaceutical manufacturers, dialysis suppliers, medical device companies, and others involved in health care delivery.
Our attorneys can assist you in establishing and evaluating compliance programs and advise you on important issues related to the federal False Claims Act, fraud and abuse matters, and other compliance-related investigations and initiatives, including the assessment of appropriate infrastructures, development of written policies and procedures, development of compliance training, and the design and implementation of monitoring and reporting systems. We are well known for our advocacy of integrating quality of care issues into compliance program activities. Our team understands the options for self-disclosure and often assists in the design of remedial actions when compliance issues are identified. We also work with our Labor & Employment lawyers to counsel you on to how to minimize whistleblower risks.
In addition to our prevention-focused assistance in establishing compliance programs, our attorneys — several of whom are former federal prosecutors and HHS attorneys — are poised to respond to government investigations on your behalf.
Anti-Kickback and Self-Referral (Stark) Advice, Investigation, and Self-disclosure (SRDP): As a health care entity, you are expected to be knowledgeable regarding the increasingly complex and ever-changing health care fraud and abuse laws governing physician (and other) financial relationships. Foley’s Health Care attorneys provide counsel on compliance with federal and state anti-kickback statutes and physician self-referral laws (Stark). We structure and document transactions, and design compliance policies and procedures to enable your compliance with the fraud and abuse rules. We also can counsel you in connection with unwinding transactions and ventures to address evolving standards in a constantly changing regulatory environment.
Corporate Integrity Agreement (CIA) Negotiation and Ongoing Compliance: Your health care entity will be well served by internal programs that promote compliance with the increasingly complex and ever-changing reimbursement laws and health care fraud and abuse interpretations, particularly if you are interacting with the Medicare and Medicaid programs. Our Health Care Industry Team will assist you in developing proactive and effective compliance programs, and in negotiating and implementing corporate integrity agreements (CIAs) as part of the resolution of False Claim Act cases, civil money penalty cases, and self-disclosures.
Effective compliance programs and productive CIAs integrate operational components with government expectations. Foley has significant industry experience in private, government, and trade association sectors, which brings unique perspectives and tested approaches to these processes. This experience gives us a clear understanding of the organizational and legal parameters associated with compliance plan design and CIA negotiations, and allows us to develop practical approaches and solutions for you.
Antitrust: Joint ventures of all types require careful antitrust analysis to mitigate risk from government enforcement or private lawsuits initiated on antitrust grounds. Individual state unfair competition and business tort laws also may pose challenges for planned mergers. We have a dedicated team of lawyers who focus on antitrust issues that can arise from mergers, acquisitions, and joint venture activities in the health care industry. We represent health plans, hospitals, medical groups, preferred provider organizations, physician-hospital organizations (PHOs), and independent practice associations (IPAs) in government antitrust investigations and as litigants in private antitrust and unfair competition litigation. We counsel payors and providers on antitrust issues relating to the structure and operation of contracting networks, including physician-hospital organizations and provider-owned health plans.
Our Health Care attorneys can provide antitrust assistance to you, ranging from the earliest merger counseling questions, pre-merger notification clearance, and day-to-day operations to full-scale merger investigations, structuring large transactions, and litigation with antitrust enforcement authorities. Although our goal is to avoid litigation, when litigation is the only option, we provide you with knowledgeable and vigorous representation in all types of antitrust claims.