David R. Hoffman, JD, FCPP 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 to 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 and has been retained by some of the largest providers nationally. Mr. Hoffman provides compliance advice to the largest entity in the country engaged in hospital inpatient medical necessity issues.
The firm serves as a state and federal monitor for long-term care facilities under HHS-OIG Corporate Integrity Agreements (CIAs) and settlements with United States Attorney's and state Attorney General's Offices and regulators. The firm serves as an Independent Review Organization (IRO) for Vascular Access Centers under a CIA, and previsously served as an IRO for an entity providing community-based treatment programs for alcohol and chemically dependent individuals.
Mr. Hoffman has served as a court-approved consultant to a Patient Care Ombudsman (PCO) appointed by the United States Trustee to monitor 19 nursing homes in Los Angeles, California and has previously monitored a hospital in Sun Valley, California and a physician's practice in California in this capacity. Mr. Hoffman's firm has also been retained by government entities to represent them in healthcare related issues including pharmaceutical and assisted living matters.
These government engagements also included policy-related consultation on issues about the long-term care and resident safety and fraud and abuse in community-based programs. Mr. Hoffman has also been retained by the United States Department of Justice to provide expert consultation regarding the failure of care matters in institutional settings. The firm also received state funding to enhance the hospital discharge process to advocate on behalf of vulnerable patients transferring from a hospital to an assisted living facility or personal care home.
Before creating the firm, Mr. Hoffman was an Assistant United States Attorney in the Eastern District of Pennsylvania for 12½ years. He prosecuted health care fraud matters, both civilly and criminally. Mr. Hoffman led the first health care fraud RICO prosecution in the district in a case involving multiple pharmacies and pharmacists, physicians, pharmaceutical drug representatives, and street dealers.
As a prosecutor, Mr. Hoffman successfully brought civil and criminal actions against physicians, managed care organizations, nurses, pharmacists, drug manufacturers, personal care home operators, educational institutions, hospitals, and nursing homes. Mr. Hoffman pioneered the use of the federal civil False Claims Act to address the failure of care matters.
He prosecuted 13 cases involving long-term care facilities covering thousands of nursing home residents, that 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 warranted.
In addition, Mr. Hoffman resolved allegations against the University of Pennsylvania and 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.
In 1996 and again in 2001, Mr. Hoffman was awarded the Director's 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 General's Integrity Award.
Prior to joining the U.S. Attorney's Office, Mr. Hoffman served in the Governor's Office of General Counsel as Chief Counsel for the Pennsylvania Department of Aging. At the Department, Mr. Hoffman was instrumental in drafting and implementing laws and regulations designed to protect the elderly and ensure that the PACE Program, the largest pharmaceutical program for the elderly in the country at the time, was being complied with by pharmacy providers.
Additionally, Mr. Hoffman led the development of regulations governing the implementation of the Older Adults Protective Services Act, the law enacted to protect older adults from abuse, neglect, exploitation and abandonment. Mr. Hoffman drafted legislation that improved the lives of older adults including guardianship reform legislation, the Family Caregiver Support Act, and the Older Adults Daily Living Centers legislation. Mr. Hoffman provided legal consultation to all Area Agencies on Aging in Pennsylvania regarding federal and state issues.
Before joining the Department of Aging, Mr. Hoffman was an Assistant District Attorney in Philadelphia, and also served as judicial law clerk to the Honorable Anthony J. Scirica in state and federal court.
Mr. Hoffman is a Practice Professor of Law at the Drexel University Thomas R. Kline School of Law. He also served as an Adjunct Professor of Law at the Beasley School of Law at Temple University and taught a patient safety course he developed for nursing doctoral students and law students. Mr. Hoffman has also served as a Dean's Professor at the Mayes College of Healthcare Business and Policy at the University of the Sciences.
Mr. Hoffman is a frequent lecturer for the Health Care Compliance Association and the American Health Lawyers' Association on compliance-related matters. He has authored multiple published articles on quality of care and compliance.
Mr. Hoffman is a past President of The Eastern Pennsylvania Geriatrics Society (EPGS), a multidisciplinary group of health professionals and the regional affiliate of the American Geriatrics Society (AGS).
Mr. Hoffman has been elected and inducted as a Fellow for The College of Physicians of Philadelphia, the nation's oldest medical professional organization in the country.
Mr. Hoffman is a graduate of the University of Pittsburgh and the University of Pittsburgh School of Law.