Hinshaw attorneys regularly advise clients on structuring transactions and day-to-day business operations to ensure compliance with the Anti-Kickback Statute, the False Claims Act and the Ethics in Patient Referral Act, and corresponding state laws, as well as many other state and federal regulatory requirements. Our consultation and advice includes planning and structuring transactions, advising on potential fraud and abuse and self-referral concerns, conducting legal audits, and providing compliance and disclosure advice. Our proactive approach helps clients minimize risk and exposure to audits, investigations, or regulatory challenges.
Activities that are particularly likely to trigger fraud and abuse and other compliance issues that we regularly assist clients with include:
- Joint ventures
- Billing practices
- Physician compensation and financial arrangements
- Pharmacy regulatory compliance
- Provider/physician relationships
We recognize that all providers need compliance advice and compliance plans, regardless of whether they are engaging in these types of transactions, and we tailor our counsel to the needs of each client.
Developing and Maintaining Compliance Programs
The Affordable Care Act as well as emphasis by the government on enforcement and recovering monetary damages—coupled with increased investigations by the Centers for Medicare and Medicaid Services, the Office of Inspector General, and local U.S. Attorneys Offices and state attorneys' general and Medicaid and related agencies—mandate that providers have robust compliance programs. Hinshaw's health care attorneys counsel clients on corporate compliance and governance standards and related issues, including structuring effective corporate compliance programs, as well as ongoing monitoring to proactively assist clients in the monitoring and fostering ethically and regulatory compliant workplaces, as well as in the prevention and detection of improper conduct. We also provide audit guidance, assist with the development of policies and procedures, and conduct investigations or other measures to assist in the reduction of exposure to risk and enforcement challenges. Our attorneys have experience with the full spectrum of issues related to compliance programs, including:
- Performing needs assessments
- Designing, evaluating and performing risk assessments
- Designing, reviewing, and advising on and assisting with the implementation and operation of compliance program efforts
- Conducting audits of compliance programs and compliance efforts
- Conducting investigations
- Advising on the need for and facilitating disclosure to appropriate government agencies
Hinshaw's health care attorneys have experience navigating the both state and federal laws that govern health care providers. We also are prepared to assist providers with multistate operations in addressing the legal issues that can arise in this context.
Multidisciplinary Approach to White Collar Issues
Working with our White Collar Crime and Internal Investigations Practice—which includes former U.S. Attorneys and former Assistant U.S. Attorneys—we conduct internal investigations for not-for-profit and for-profit health care providers, assist in civil investigation demands, forfeiture, government investigations, handle qui tam litigation, and provide assistance in determining when and how to self-disclose. This unique aspect sets our health care practice apart, allowing our health care attorneys to work in concert with former prosecutors well versed in criminal and civil matters, to better serve the needs of our clients.