OverviewFalse Claims Act Defense
Ropes & Gray lawyers have long been at the forefront of False Claims Act defense. Deploying resources across practices and geographies, we effectively respond to investigations and successfully contest actions being pursued by whistleblowers or the government. In litigated False Claims Act cases, arguments advanced by Ropes & Gray lawyers have generated watershed law under the federal False Claims Act in district and appellate courts around the nation.Our multi-disciplinary team has successfully handled False Claims Act cases on behalf of some of the world’s leading hospital systems, academic medical centers, pharmaceutical companies, medical device manufacturers, biotechnology firms, and other health care providers.
The management of risk assessment, governance and compliance has emerged as a major challenge for many organizations and particularly for health care entities. Our firm has long been on the cutting edge of developments in compliance and enforcement, and we routinely counsel organizations at every stage of the compliance program lifecycle – from initial development and implementation, routine assessment and audit, to periodic evaluation and revision.
Fraud & Abuse Law Counseling
We have a long standing history of advising members of the health care industry on maintaining compliance with the diverse federal and state fraud and abuse laws that regulate the operations of health care companies today. Analyzing and applying federal and state fraud and abuse laws to the operations of our clients are a core component of our health care practice.
Our representative experience includes:
- Federal and state criminal anti-kickback statutes, the federal physician anti-referral law (known as “Stark”) and state corollary statutes, as well as the impact of general fraud, corruption, conspiracy, and racketeering laws on health care industry practices
- Federal and state civil false claims acts and deceptive trade practice statutes
- Federal civil money penalty laws (including the prohibition on inducements to beneficiaries)
- State laws on compliance practices
- Federal and state privacy laws
- FDA restrictions on promotional activities
- Sarbanes-Oxley and corporate governance requirements
- Federal and state antitrust laws
False Claims Act Defense
- We have assessed compliance at community and academic hospitals and health systems nationwide, designed and implemented new comprehensive compliance plans based on these findings, and/or performed follow-up assessments and reports for the compliance committees of the governing boards.
- We have assisted various hospitals and health systems with active compliance programs in connection with annual risk assessments.
- We have evaluated and recommended improvements to the system-wide compliance program of one of the ten largest for-profit hospital chains in the country, critiquing the existing program, helping fine-tune compliance policies and procedures, and delivering a comprehensive report to the governing board.
- We have assessed the compliance program of a New York hospital system in connection with new tax-exempt bond financing.
- We have drafted a comprehensive code of conduct and related procedural manuals on topics including auditing, monitoring, education, and training, in response to a third-party assessment of a community health system located in Connecticut.
- We have performed a comprehensive compliance assessment for one of the five largest public hospital systems in the country.
- We have assessed the entire compliance program of a non-profit, academic teaching center that is the only tertiary care center available to patients across multiple southern states.
- We have assisted various academic medical centers across the country implement or improve compliance programs focused on research generally or clinical trial billing in particular.
- We have assisted a global medical device company with the enhancement of its compliance program by assessing existing compliance policies and procedures for various business units, providing recommendations for enhancing the programs and assisting with the revision of global “umbrella” compliance policies.
- We have advised a large dialysis provider on its compliance program and developed a billing compliance guide.
- We have assisted a global contract research organization in assessing whether its compliance and ethics program was structured, from an organizational and reporting perspective, in a manner that would satisfy United States government requirements for an effective compliance program, including the U.S. Sentencing Guidelines and HHS-OIG’s Voluntary Compliance Guidance.
- We have assisted a global medical device company with the initial development and implementation of a comprehensive health care compliance program, including a code of conduct and supporting policies, and provided company-wide training on the program.
- We conducted a comprehensive compliance assessment of the U.S. health care operations of a major biotechnology company; assisted with the revision of compliance policies; and also a created a compliance monitoring program for the company, identifying controls for each activity with health care compliance risk, developing monitoring activities to determine the ongoing effectiveness of the controls, and providing ongoing counsel to the company as it implements the monitoring program. We currently provide routine health care compliance advice to the company, addressing both fraud and abuse laws and federal and state marketing and disclosure laws.
- We conducted a fifty-state survey for a major pharmaceutical manufacturer that considered state law restrictions on sampling, drug distribution, drug vouchers or coupons, drug discount card programs and direct-to-consumer advertising.
- We assisted a global pharmaceutical company in the development of company policies related to activities of medical science liaisons; and interactions of sales and marketing personnel with health care professionals.
Fraud & Abuse Counseling
- We are advising a global medical device company in connection with a U.S. government investigation of the company’s marketing practices and physician relationships. As part of our representation, we identified regulatory risks arising out of the company’s consulting arrangements and assessed the company’s controls on physician relationships, and have represented the company in negotiations with the DOJ and the OIG. Anticipating a possible Corporate Integrity Agreement to resolve the enforcement matter, we have assisted the company in a CIA-readiness assessment, and in instituting compliance controls to cover identified gaps. Separately, we have advised the company on ongoing regulatory compliance matters, such as development of arrangements with hospital customers for product testing.
- Assisting leading academic medical centers in analyzing and structuring funds flow among their medical schools, medical centers, faculty physicians, and research components.
- Providing advice to hospitals, physicians, and other providers in establishing and implementing joint ventures and other collaborations.
- Implementing contracting guidelines for hospitals and other providers to apply to arrangements with vendors.
- Analyzing preferred provider arrangements among hospitals, nursing homes, home health agencies, ambulance companies, and other providers.
- Representing a health system in an investigation into whether the system’s discharge practices through which patients were discharged to the system’s own home care and sub-acute providers violated any antitrust laws.
- Representing a hospital in a nationwide investigation conducted by the FBI and OIG concerning National Medical Enterprises which focused on the proprietary of the relationship between our client and Psychiatric Institutes of America, an NME subsidiary.
- Defending a multi-hospital system against Civil False Claims Act investigation for alleged upcoding of pneumonia DRGs.
- Representing a New England hospital in connection with a Civil False Claims Act investigation of “up-coding” of clinical procedures and allegedly improper laboratory charges.
- Representing eight major academic medical centers in the West, the Midwest, the Middle Atlantic States, and New England concerning faculty physician billing practices and coding of procedures, and potential Civil False Claims Act liability.
- Representing academic medical centers and faculty practice plans around the country in extensive investigations by the OIG and the Department of Justice into physician billing under the Physician at Teaching Hospitals or “PATH” initiative.
- Representing six academic medical centers from around the country in a nationwide OIG investigation directed at whether Medicare billing for investigational cardiac devices was appropriate