Fraud and Abuse
Ober|Kaler is widely recognized as one of the leading law firms in the nation on health care fraud and abuse matters. Our Health Law Group advises some of the largest health care organizations in the country. We help clients structure business arrangements that comply with the Stark and anti kickback laws and we defend them in government investigations of health care fraud and abuse.
Ober|Kaler’s Health Law Group structures business arrangements to ensure compliance and minimize risks under the fraud and abuse laws applicable to federal health care programs, including Medicare and Medicaid. Our attorneys have a deep understanding of the laws and guidance surrounding the Stark self-referral law, the Antikickback statute and the civil money penalty laws, as well as their interrelationship with the reimbursement laws and the False Claims Act. In addition to structuring new business arrangements, we analyze existing business arrangements for potential violations of the fraud and abuse laws and develop strategies for addressing past violations.
Our experience with and understanding of these laws is extensive. One of our principals, formerly with the Office of General Counsel of the Department of Health and Human Services (HHS), was closely involved in the drafting of the Medicare and Medicaid Patient and Program Protection Act of 1987. Another principal drafted fraud alerts, safe harbors and advisory opinions while with the Office of Counsel to the HHS Inspector General. Ober|Kaler attorneys frequently lead seminars and participate in panel discussions concerning Medicare and Medicaid fraud and abuse issues. Four of our principals have been selected as “Outstanding Healthcare Fraud and Compliance Lawyers” by Nightingale’s Healthcare News. This experience and knowledge allows us to identify and assess issues that are important to our clients and helps us guide clients in structuring legal, economically viable arrangements.
Ober|Kaler attorneys bring extensive background and experience to issues related to pricing arrangements, and in the case of devices or supplies sold to health care providers, the application of the safe harbor for discounts to such arrangements. We provide timely advice that reflects the rapidly changing legal landscape related to arrangements between health care manufacturers and providers. We regularly advise clients regarding relationships between pharmaceutical and medical device manufacturers and health care providers that are designed to control potential conflicts of interest, reduce risks and promote organizational integrity. These arrangements range from sophisticated, collaborative relationships with academic medical institutions to the provision of drug samples to individual physicians. Our advice reflects the federal government’s increased use of traditional enforcement tools such as the Antikickback Statute and Self-Referral Law in monitoring such arrangements, as well as specific enforcement mechanisms.
The firm has extensive experience with the advisory opinion process, both at Office of Inspector General (OIG) of HHS and Centers for Medicare & Medicaid Services (CMS). Members of the firm worked for many years to educate the government to the potential benefits of advisory opinions, which are now a permanent part of the fraud and abuse landscape. We were among the first to submit requests for advisory opinions.
Members of the firm have crafted many successful advisory opinion strategies, including drafting a balanced, persuasive request and then working closely with government lawyers to convince them that there was not a substantial risk of fraud and abuse. In addition, we assist clients in evaluating the prospects for obtaining favorable advisory opinions. Our experience and credibility allows us to successfully shepherd requests through the advisory opinion process.
Ober|Kaler has a strong background in the development and implementation of compliance programs that follow OIG guidelines and comply with the Federal Sentencing Guidelines and civil duties under federal law. Our attorneys are well-versed in the interpretation and use of compliance programs developed by various non-governmental organizations such as the PhRMA Code, IFPMA Code and AdvaMed Code, and we monitor developments and their potential impact on our clients’ activities.
We have assisted in the development and implementation of compliance programs for virtually every type of health care provider, including:
- Clinical laboratories
- Skilled nursing facilities
- Institutional pharmacies
- Hospital systems
- Major teaching hospitals, community hospitals and various subsidiaries
- Home health agencies
- Providers of Medicare Part B services and supplies
- Physician groups
- National professional societies and trade associations
Our involvement ranges from working with the client to formalize and document existing compliance activities, to developing an entire compliance program specifically designed to fit the client’s organizational structure and culture. We work with health care organizations in evaluating the effectiveness of existing compliance programs and assist them in developing program enhancement recommendations to their governing boards.
In addition, we assist clients in the development and implementation of compliance procedures and help them address any problems revealed through their compliance activities, including making voluntary disclosures when appropriate.
Fraud and Abuse Defense
Ober|Kaler is recognized across the U.S. for its experience in conducting internal investigations and defending health care organizations against allegations of fraud and abuse. We counsel clients that have chosen to make voluntary disclosures when they discover issues, as well as provide defense in investigations and prosecutions involving fraud and abuse.
We represent corporate and individual providers in responding to subpoenas, grand jury investigations, criminal prosecutions and administrative proceedings. In fact, we have been involved in – or principally responsible for – handling some of the largest health care investigations in the country. Because we maintain productive working relationships with principal officials in key law enforcement agencies, our attorneys have been able to favorably resolve many issues on behalf of our clients.