Health Care Regulatory

From reimbursement to state and federal regulating bodies to the implications of business relationships among health care providers, we work closely with health care leaders to ensure their businesses and their staff stay within the bounds of regulatory compliance. We not only inform our clients of changes, but we also help them understand the effects those changes may have on current operations. We help our clients prepare for and take advantage of the enactment of any significant health care laws or regulations, minimizing the cost and impact of regulatory shifts. Our substantial regulatory experience includes representing our clients’ interests before various legislative, regulatory, and administrative bodies.

We routinely advise clients on the following:

• Compliance, Fraud & Abuse
• Corporate governance
• Medicare and Medicaid reimbursement issues
• Provider Enrollment and Change of Ownership
• Self-disclosures
• Survey, certification, and licensure
• 340B Drug Pricing Program
• Clinical research
• Tax and tax exemption issues
• Emergency Medical Treatment and Active Labor Act (EMTALA)
• Graduate medical education

Our attorneys have deep experience with fraud and abuse laws, including the Stark Law, the Anti-Kickback Statute, the Overpayment Statute, the Civil Monetary Penalties Law, and the False Claims Act. We are skilled at structuring and implementing contracts, transactions, and relationships, including hospital-physician relationships, to comply with these laws and meet the organization's business goals. Our team is known for identifying potential problem areas proactively and finding solutions that reduce risk.

Additionally, we help clients address fraud and abuse compliance concerns. We investigate potential violations, develop corrective action/remediation plans, and resolve problems effectively.

Our attorneys also have significant experience handling litigation related to fraud and abuse law. We have successfully worked with the Department of Justice (DOJ), the United States Attorneys’ Office, the Office of Inspector General (OIG) for the Department of Health and Human Services (HHS), and state attorney generals’ offices to resolve high-stakes cases for clients.

Our experience includes

• Structuring complex health care transactions, including hospital-physician joint ventures, physician recruitment contracts, professional services contracts, and other contractual arrangements
• Restructuring existing contracts and arrangements due to regulatory changes
• Developing alternative structures and solutions to achieve client goals while reducing the risk of violating fraud and abuse laws
• Inflation Reduction Act (IRA) opportunities
• Guiding voluntary self-disclosures of noncompliance and overpayments
• Defending clients in whistleblower (qui tam) actions
• Handling Medicare/Medicaid and commercial payor reimbursement issues
• HIPAA & Health Information Technology (HIT)
• Hospital price transparency compliance
• Leading or assisting clients with conducting internal compliance investigations of potential violations of law/compliance concerns
• Managing government-initiated matters (audits, investigations, and civil and administrative actions)
• Merit-based incentive payment system advice
• Provider information blocking advice and compliance
• Providing compliance training to board members, executives, and employees

For decades, our attorneys have counseled our clients through implementing electronic health record technology and protecting patient data. Whether obtaining incentive payments for the "meaningful use" of health records, complying with all applicable statutes and regulations, maintaining the confidentiality of health information, or developing health information exchanges, we employ experienced attorneys and have developed nationally recognized resources to help our clients achieve their privacy and security goals.

Additionally, as data privacy and security regulations expand beyond HIPAA into interoperability, we stand ready to help our clients maintain compliance. We monitor developments in privacy and security regulations and advise clients on maintaining and protecting susceptible information.