Erin M. Duffy is Vice-Chair of the Duane Morris Health Law Practice Group and a member of the firm's governing Partners Board. Ms. Duffy concentrates her practice on corporate healthcare regulatory matters. She advises clients, including hospitals, ambulatory surgery centers, medical practices, pharmacies, long-term care facilities and developmental disabilities facilities, on a wide range of issues, including fraud and abuse, privacy, medical staff relations, EMTALA, self-referral, Medicare and Medicaid reimbursement, corporate practice of medicine and fee-splitting prohibitions, and certificate of need and licensure issues. Ms. Duffy has worked extensively with healthcare providers on corporate transactions and administrative agency matters.
Areas of Practice
- Healthcare Law
- Corporate Transactional
- Federal and State Healthcare Licensure
- Medicare and Medicaid Reimbursement Issues
- Anti-kickback and Physician Self-referral Regulation (Stark)
- HIPAA and Privacy Issues
- Specialty Hospital Formation and Compliance
- Physician-Owned Healthcare Businesses
- Healthcare Litigation
- Fraud and Abuse
- False Claims Act
Represented Next Level Hospitality Services, a provider of culinary and environmental services in the senior living sector that specializes in skilled nursing and rehabilitation facilities, in connection with its multimillion-dollar sale to Aramark (NYSE:ARMK), the global leader in food, facilities management and uniforms.
Represented New York Home Health Holdings/Honor Health Network, a provider of home healthcare services, in connection with its multimillion-dollar sale by its members to Webster Capital, a financial sponsor.
Represented Hunterdon Healthcare in its joint partnership with Atlantic Health System, including development and operation of an ambulatory surgery center and imaging center.
Represented a nonprofit healthcare system in negotiating and documenting an exclusive management services/performance improvement agreement with a large orthopedic practice group.
Represented an owner/operator of three skilled nursing facilities in a joint venture and sale transaction with the largest hospital and health system in the State of New Jersey.
Represented an owner/operator of hospital systems in the purchase of a medical campus consisting of an operating hospital and a four-story medical office building located in Dallas, Texas.
Represented Century Park Capital Partners in its acquisition of Dominion Youth Services, a leading provider of behavioral health services to children and young adults across Virginia.
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.
Restructured a physician-owned ambulatory surgery center into a physician-owned specialty hospital.
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.
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.
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 Piramal Group in its acquisition of a drug manufacturing and development facility in Pennsylvania.
Sued a Pennsylvania State Agency on behalf of a provider class of women, infant and children (WIC) program providers regarding a flawed RFP process to award WIC Grants resulting in the State Agency rescinding the RFP.
Defended healthcare providers in state administrative appeals regarding reimbursement disputes.
Defending home care agency in state administrative appeals regarding proposed termination of agency’s participation in Medicaid program.
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.
Drafted comments on behalf of state associations and providers on healthcare related legislation and regulations.
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.)
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.
Drafted medical staff bylaws for numerous healthcare clients.
Drafted informed consent forms and policies for numerous healthcare clients, including those related to COVID-19 screening and testing.
Counsel to hospitals, group practices and individual physicians with respect to credentialing and peer review matters.
Counseled hospitals on complaints or allegations of EMTALA violations and EMTALA compliance.
Counseled clients regarding physician impairment, physician drug diversion and provider performance matters.
Counseled clients regarding federal and state reporting obligations related to peer review actions.
Counseled clients on privacy and confidentiality issues related to federal and state patient safety and quality improvement organizations.
Represented clients before state licensing boards.
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.
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 based on quality of care issues.
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.
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.
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).
Lead a legal team that represented coalition of doctors, medical administrators and professionals as amici before the U.S. Supreme Court in Whole Woman's Health v. Cole regarding physician admitting privileges.
Part of a legal team that represented American College of Pathologists, Funeral Consumers Alliance, and experts in pathology and healthcare administration as amici before the U.S. Court of Appeals for the Fifth Circuit in Whole Woman's Health v. Hellerstedt regarding proper disposition of pathological waste under universal standards of care
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.
Medical Staff and Physician Representation
- 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
- Vice-Chair, Health Law Practice Group, 2020-present
- Partner, 2014-present
- Associate, 2004-2013
- American Health Lawyers Association
- Board of Trustees, Academy of Notre Dame de Namur, 2010-2016
Honors and Awards
- Listed in Chambers USA: America's Leading Lawyers for Business, 2022 and 2023
- Board of Trustees, Gwynedd Mercy University, 2022-2025
- Co-author, "U.S. Supreme Court Focuses on Subjective Intent in Overturning False Claim Act Cases," Duane Morris Alert, June 9, 2023
- Co-author, "U.S. Supreme Court Gives Green Light to CMS Vaccine Mandate and Full Stop to OSHA Vaccine-or-Test Mandate, Leaving Employers to Wonder: What Now?" Duane Morris Alert, January 19, 2022
- 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
- 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, "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 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
- 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, "Reimbursement for Subject Injuries in Clinical Trials How to Avoid an 'Adverse Event' to Your Business," FDAnews Webinar, February 20, 2013