Overview
Our health care practice attorneys counsel our clients on corporate compliance and governance standards and related issues. We provide advice and assistance in structuring effective corporate compliance and ethics programs as well as ongoing monitoring and oversight to proactively assist health care clients in the prevention and detection of improper conduct. We also provide audit guidance, assistance in the development of policies and procedures and conduct internal investigations and other measures to assist in the reduction of exposure to risk and enforcement challenges. Our practice group is also well equipped to provide guidance and counsel on director and officer responsibilities and good governance practices. Furthermore, our group regularly assists audit and compliance committees and independent directors, in compliance reviews and has experience in conducting internal and external investigations in the post-Sarbanes Oxley enforcement climate.
Specifically, we have provided counsel on the following types of matters:
- Assisting sponsors of ERISA self-insured health plans
- Corporate structure and governance practices
- U.S. Sentencing Guidelines
- Effective corporate compliance and ethics programs
- Voluntary disclosures
- Internal investigations and remedial actions
- Responding to enforcement inquiries and investigations
- Compliance audits and checks
- Development of policies and procedures
Enforcement Investigations & Proceedings
Our practice group includes attorneys who have defended health care clients in criminal, civil and regulatory enforcement inquiries and proceedings, including parallel civil actions. The continuing controversy and regulatory enforcement challenges confronting the health care industry have resulted in our defense of managed care organizations, physician groups, hospitals, academic medical centers, health systems and other industry clients in significant enforcement investigations and proceedings.
Our experience includes:
- Attorneys General consumer fraud probes
- Medicare and Medicaid fraud and abuse matters
- Civil monetary penalty matters
- Compliance investigations and audits
- False Claim Act matters
- “Whistleblower” and qui tam litigation
- Internal investigations and voluntary disclosures
- OIG, DOJ, DEA, FDA and other federal enforcement investigations
- Grand jury and parallel civil investigations
- Defense of fraud and abuse investigations and enforcement proceedings
- Anti-kickback and Stark Law matters
- Defective pricing and consumer fraud issues
- Medical device and drug marketing and pricing issues
- Price fixing, market allocation and other antitrust claims
Our representative projects include:
- Representation of health care corporations and executives in FDA, DOJ and state investigations pertaining to the marketing of pharmaceutical drugs.
- Defense of a physician group in DOJ and OIG investigation pertaining to qui tam filing and allegation of improper billing and coding.
- Internal investigation and disclosure to governmental authorities of financial arrangements with referral sources.
- Internal investigation of a large pharmacy and durable medical equipment supplier regarding potential overpayment matters.
- Defense of False Claim Act allegations pertaining to hospital-ambulance transport arrangements.
- Developing compliance plans that meet the guidelines provided by the U.S. Department of Health and Human Services, Office of Inspector
General (OIG) and tailoring such plans to meet clients needs and organizational structure.
- Negotiating corporate integrity agreements and assisting clients in proffers and in voluntary self-disclosure matters pursuant to the Voluntary Self-Disclosure Protocol of the OIG.