Mr. David R. Hoffman

David R. Hoffman is President of David Hoffman & Associates, PC, a national healthcare consulting firm located in Philadelphia, Pennsylvania. This firm, created in September 2005, is dedicated to assisting healthcare providers comply with regulatory requirements and ensuring patient safety through legal and clinical compliance. The firm has been consulting with long-term care and assisted living providers in integrating clinical and regulatory issues into effective compliance programs. The firm serves as Federal and state Monitor pursuant to Corporate Integrity Agreements (CIAs) and settlement agreements mandated by state Attorneys General Offices. The firm also serves as an Independent Review Organization (IRO) for healthcare entities. Mr. Hoffmans firm has been retained by government entities to assist them in healthcare related issues including pharmaceutical and long-term care matters. These government engagements also include policy-related consultation on issues pertaining to long-term care and resident safety. Prior to creating his firm, Mr. Hoffman served as an Assistant United States Attorney in the Eastern District of Pennsylvania for 12 years. He prosecuted healthcare fraud matters, both civilly and criminally. As a federal prosecutor, Mr. Hoffman successfully brought civil and/or criminal actions against physicians, managed care organizations, nurses, pharmacists, drug manufacturers, personal care home operators, educational institutions, hospitals and nursing homes. Mr. Hoffman prosecuted 13 cases involving long-term care facilities utilizing the federal civil False Claims Act to address failure of care. These cases, covering thousands of nursing home residents, resulted in Consent Orders and Settlement Agreements mandating, among other requirements, corporate compliance programs that address clinical issues, diabetes monitoring, nutrition and wound care standards, and pain management protocols. As part of all of these settlements, the nursing homes were mandated to be monitored by geriatric nurse practitioners and medical experts as necessary. Mr. Hoffman maintained his involvement in ensuring resident safety by continued oversight of the monitoring project and intervention through court filings when warranted. Mr. Hoffman also successfully prosecuted failure of care cases in personal care homes, hospitals and community-based homes for those with developmental disabilities. In February 2005, Mr. Hoffman resolved allegations against the University of Pennsylvania and the Children's National Medical Center and three physician researchers emanating from a gene therapy study that ended with the death of Jesse Gelsinger. This settlement recovered over a million dollars from the institutions and incorporated systemic changes designed to protect human research participants. Additionally, significant research-related restrictions were imposed on the individual physician researchers. Mr. Hoffman worked closely with representatives of the FDA and NIH in resolving the allegations and developing the investigators restrictions to ensure that all federal interests were addressed. In 1996 and again in 2001, Mr. Hoffman was awarded the Directors Award from the United States Department of Justice Executive Office for United States Attorneys for his work in protecting the elderly from abuse and neglect. He also was awarded the 1999 and 2005 Department of Health and Human Services Inspector Generals Integrity Award.