Erin M. Duffy concentrates her practice on corporate healthcare regulatory matters. She advises clients, including hospitals, medical practices, pharmacies, long-term care facilities and developmental disabilities facilities, on a wide range of issues, including fraud and abuse, self-referral, Medicare and Medicaid reimbursement, corporate practice of medicine and fee-splitting prohibitions, and certificate of need and licensure issues. She is also experienced in handling healthcare information technology matters, including mobile (MHealth) and electronic health records.
Ms. Duffy is a graduate of Temple University Beasley School of Law and St. Joseph's University.
Areas of Practice
· Healthcare Law
- Federal and State Healthcare Licensure
- Medicare and Medicaid Reimbursement Issues
- Anti-kickback and Physician Self-referral Regulation (Stark)
- HIPAA and Privacy Issues
- Special Hospital Formation and Compliance
- Physician-Owned Healthcare Businesses
- FDA and FTC Advertising and Promotional Issues
- MHealth Technology
· Healthcare Litigation
- Fraud and Abuse
- False Claims Act
· Obtained on behalf of the Hospital and Healthsystem Association of Pennsylvania (HAP) a ruling from the Commonwealth Court of Pennsylvania that held that the Pennsylvania Insurance Department had overbilled healthcare providers more than $100 million over three years to fund a program that provides excess coverage for medical malpractice claims under the state's Medical Care Availability and Reduction of Error Act (MCARE).
· Represented a non-profit health system in acquisition of a for-profit hospital and related ancillary businesses, such as diagnostic imaging, sleep lab, home health and physician practices.
· Represented a non-profit health system in its divestiture of a for-profit DME subsidiary.
· Represented a healthcare management company with regard to drafting an assumption of risk and release of liability agreement concerning an application designed to demonstrate rehabilitative exercises and therapies and track patient process.
· Restructured two physician-owned specialty hospitals and a physician group practice into a unified health care system, including corporate, licensing and regulatory issues.
· Represented a holding company in the simultaneous acquisition of eighteen skilled-nursing facilities, 5 personal care homes and four home health agencies, including all licensing and regulatory issues.
· Obtained a complete reversal of a Medicaid Recovery Audit Contractor (RAC) audit alleging that a developmental disabilities company improperly billed for patient days when patients were temporarily hospitalized.
· Counseled third-party administrator on compliance issues related to state and HIPAA Breach Notification requirements in all 50 states as a result of a data breach involving personally identifiable health information.
· Conducted internal investigation of a hospital's policies, procedures and employment practices following the arrest of a non-employed physician on sexual abuse charges. (Jane Doe 30, et al. v. Earl Bradley, M.D., et al.)
· Appellate Counsel, Cooper Univ. Hospital v. Jacobs (N.J.), represented hospital defending Certificate of Need (CON) to participate in elective angioplasty demonstration project against appeal by competing hospital.
· Counsel, U.S. ex rel. Kite v. Lourdes Health System, et al., (D.N.J.), defense of hospitals regarding allegations of improper receipt of outlier reimbursement from Medicare.
· Duane Morris LLP
- Partner, 2014-present
- Associate, 2004-2013
· Food and Drug Law Institute
- Editorial Advisory Board, Food and Drug Law Journal
Honors and Awards
· Pennsylvania Rising Star, 2011-2013
· Academy of Notre Dame de Namur
- Trustee, 2008-present
- Member, Finance Committee, 2005-2008
Civic and Charitable Activities
· Public Interest Law Center of Philadelphia
- Member, Medicaid Policy Circle
· "Refill Reminder Exception to the Privacy Rule Created by the HITECH Act," Duane Morris Alert, September 26, 2013
· Co-author, "mHealth Revenue Models: Finding the Right One for the Right App," mHealth Newsletter, June 26, 2013; republished by Law360, July 17, 2013
· Co-author, "FDA Enforcement Action Against uChek: Does It Signal an Agency Wake-up Call for Non-compliant Mobile Medical Apps?" Duane Morris Alert, June 3, 2013
· " United States v. Caronia: A Brief Look at the Broader Implications for the Food Industry," FDLI Update, March/April 2013
· Co-author, "Overview of 2013 Amendments to HIPAA Privacy, Security, Breach Notification and Enforcement Rules," Duane Morris Alert, January 29, 2013
· Author, "New HIPAA Breach Notification Rule May Prove Costly for HIPAA-Covered Entities," Duane Morris Alert, January 25, 2013
· "Chapter 1040 - Ambulance Services," BNA's Health Care Compliance Guide, 2012 and 2013 editions
· Co-author, "CMS: Proposed Rule for States on Medicaid Fee-for-Service Rate-Setting Procedures," Duane Morris Alert, May 12, 2011
· Co-author, "New HIPAA and HITECH Regulations Are Coming," Duane Morris Alert, December 21, 2009
· Co-author, "How Hard Should It Be to Imprison Someone for Telling the Truth?" FDLI Update, September/October 2009
· Co-author, "Compliance with New HIPAA and FTC Health Breach Notification Rules: What Healthcare Entities and Businesses Need to Know," Duane Morris Alert, August 28, 2009
· Co-author, "The First Amendment and Off-Label Promotion: Why the Court in United States v. Caronia Got it Wrong," Health Care Law Monthly, April 2009
· Co-author, "The Debate Over Reference Checks: What to share about former employees," Modern Healthcare, June 2008
Selected Speaking Engagements
· Speaker, "'Wait, Is This Money Mine?' Overpayments Under the Affordable Care and Flase Claims Act," The Hospital & Healthsystem Association of Pennyslvania Webinar, January 14, 2014
· Presenter, "Introduction to Drug Law and Regulation: The Legal Framework for Drug Regulation," The Food and Drug Law Institute, November 7, 2013
· Speaker, "FDA Regulation of Promotion & Advertising Social Media & Internet, California Healthcare Institute, June 25, 2013
· Presenter, "Violations and Enforcement," Food and Drug Law Institute's Conference on Introduction to Drug Law and Regulation: The Legal Framework for Drug Regulation, Washington, D.C., April 4, 2013
· Presenter, "Reimbursement for Subject Injuries in Clinical Trials How to Avoid an 'Adverse Event' to Your Business," FDAnews Webinar, February 20, 2013
· Presenter, "Introduction to Medical Device Law and Regulation: How the Government Regulates the Medical Device Industry," Washington D.C., March 12, 2012