Erin M. Duffy is vice chair of the firm's Health Law Practice Group. Ms. 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
Represented Piramal Group in its acquisition of a drug manufacturing and development facility in Pennsylvania.
- Represented a Wisconsin pathologist physician group practice with respect to a payor aggressively seeking to recoup purported overpayments made to the group, resulting in the payor not recovering the overpayments.
- Counsel to statewide classes of pathologists in Illinois, Texas and Tennessee asserting class action claims in three separate class action arbitrations against health insurance companies arising out of improper reimbursement for the professional component of clinical pathology services provided to beneficiaries enrolled in the insurer’s health care plans.
- Represented a Missouri pathology group in litigation with payor in dispute over the billing of the professional component of clinical pathology services, which resulted in the client obtaining a $3 million settlement.
- Represented a Florida physician group practice with respect to a payor aggressively seeking to recoup purported overpayments for the professional component of clinical pathology services made to the group, resulting in the payor recovering considerably less than the amount it initially sought.
- Represented 22 physician group practices in a dispute with a payor regarding the payor’s failure to compensate the group practices for the professional component of clinical pathology services.
- Represented a Missouri pathology group in a dispute with a payor over the billing of the professional component of clinical pathology services, resulting in the payor agreeing to sign the previously negotiated and abandoned participation agreement.
- Represented Hunterdon Healthcare in its joint partnership with Atlantic Health System, home to seven award-winning New Jersey hospitals.
- Represented Texas Hospice Holdings, LLC, a multi-state hospice facility operator, in connection with the sale of all of its outstanding equity to Amedisys Inc., a publicly-held hospice company.
- Represented Iroko Pharmaceuticals, LLC in connection with a $140 million secured loan facility with CRG, a healthcare investment fund, and the simultaneous pay-off of Iroko's loan facility with another lender.
- Obtained on behalf of a physician a decision relieving the client of a demanded $700,000 in Medicare overpayment obligation under the Centers for Medicare & Medicaid Services (CMS) Victimized Provider Project and Safeguard Services (SGS), a Medicare program integrity contractor.
- Representing Virtua Health Inc. and Capital Health System Inc. in a case against the state of New Jersey, seeking to hold unconstitutional as "special legislation" a law that transfers the right to provide emergency medical services from Virtua and Capital to other hospitals without regard to the established regulatory structure.
- Obtained summary judgment on behalf of Virtua Health, Inc., a health system of four hospitals in southern New Jersey, against Deborah Heart and Lung Center, a specialty hospital in southern New Jersey, in federal antitrust litigation in which the court held Deborah failed to show any adverse effect on competition in the market.
- Represented a national pharmacy in a transaction which granted an option to a strategic to purchase the business for an aggregate purchase price of $230 million.
- Obtained settlement in a complex litigation on behalf of the Hospital and Healthsystem Association of Pennsylvania (HAP) with the Commonwealth of Pennsylvania, in which the Commonwealth agreed to repay or credit to hospitals and physicians $200 million in overpayments of state-mandated assessments intended to finance the Medical Care Availability and Reduction of Error (MCARE) Fund for professional liability claims.
- 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 18 skilled-nursing facilities, five 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.
- New Jersey
- Supreme Court of the United States
- Temple University Beasley School of Law, J.D., cum laude
- St. Joseph's University, B.A., summa cum laude
- 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, 2011-2014
- 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
- Quoted, "Insurers Will Owe Massive MLR Rebates Next Year, Even if 2020 Is Normal," Modern Healthcare, November 11, 2020
- Co-author, "Could COVID-19 Data Help Medical Device Manufacturers Accelerate the FDA Approval Process?" Wharton Health Care Management Alumni Association, November 9, 2020
- Co-author, "FDA Issues Temporary Policy on Distribution of Drug Samples During COVID-19," Duane Morris Alert, June 18, 2020
- Co-author, "Pennsylvania Governor Announces Three-Phase System for Reopening the Commonwealth," Duane Morris Alert, April 23, 2020
Co-author, "Class Action ADA Lawsuit Filed Against Hospital - A Sign of More to Come?" Duane Morris Alert, September 19, 2019
Co-author, "CMS Issues Proposed Regulations to Expand Open Payments System Reporting," Duane Morris Alert, August 26, 2019
Co-author, "OIG Proposal to Restrict Discount Safe Harbor Likely to Disrupt the Prescription Drug Distribution Chain," Duane Morris Alert, February 7, 2019
Co-author, "SUPPORT Act Expands Sunshine Act Disclosure Requirements," Duane Morris Alert, October 25, 2018
Co-author, "New SAMHSA Rule Allows Disclosure of Patient Substance Use for Payment, Healthcare Operations," Duane Morris Alert, February 1, 2018
- Co-author, "Are Pharmacy Benefit Managers' Cost-Containment Claims a Shell Game?", The Corporate Counselor, April 2017
- Co-author, "The 60-day Overpayment Rule: Strict Standards Enforced in First Legal Case," Compliance Today, April 2015
- "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
- Panelist with AdvaMed, "COVID-19 and the Medtech Industry Response," Philadelphia Alliance for Capital and Technologies (PACT) Virtual Event, April 23, 2020
Panelist, "Population Health: Why Care Management is Good Business," PACT Digital Health, Philadelphia, November 20, 2019
- Panelist, "The Impact of Changing Payment Models on Private Equity Investments in Health Care," Duane Morris LLP and Parthenon-EY event, New York, February 10, 2016
- Speaker, "Legal and Technical Perspectives of Recent Topics in Health IT and HIPAA," Philadelphia Bar Association Cyberspace and E-Commerce Committee CLE Program, June 27, 2014
- Speaker, "'Wait, Is This Money Mine?' Overpayments Under the Affordable Care and False 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