Practice Areas & Industries: Duane Morris LLP


Healthcare Fraud and AbuseReturn to Practice Areas & Industries

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Practice/Industry Group Overview

What governmental agencies once regarded as simple billing errors are now routinely pursued as fraud and abuse. As efforts of state and federal government and private payors have grown more aggressive in their pursuit of healthcare providers on alleged fraud and abuse issues, the need for seasoned counsel has grown acute. The difference between a simple billing error, a civil False Claims Act prosecution and criminal indictment often depend upon counsel's advocacy.

Our lawyers regularly represent every type of healthcare provider. We are retained by pharmaceutical companies and pharmacies, hospital associations, hospitals and doctors, laboratories and clinics. Our clients also include medical device manufacturers and managed care companies. We regularly handle matters in state and federal trial and appellate courts, as well as before regulatory agencies and professional boards.

Duane Morris Capabilities

Duane Morris healthcare lawyers working on fraud and abuse matters are not merely former prosecutors with familiarity of criminal statutes. We employ a team approach that utilizes not only the skills and relationships of our former prosecutors, but also the knowledge and background of lawyers with extensive experience in complex Medicare and Medicaid reimbursement regulations, including Stark and Antikickback Statute matters. Quality of care cases are defended by lawyers and ancillaries with clinical experience.

Our lawyers develop and implement fraud and abuse compliance programs for all types and sizes of healthcare providers and have extensive experience in negotiating and monitoring corporate integrity agreements.

Our lawyers pride themselves in finding creative solutions for their clients' problems. One of our lawyers has been successful in persuading the government to forego federal false claims prosecution for mediation. Another was involved in the first voluntary disclosures on both the East and West coasts.


Services Available

Group Presentations
Duane Morris Associate John Kahn Will Speak at the New Jersey State Bar Association's Transition Into Practice Series (TIPS) Program, March 19, 2014
Duane Morris Attorneys Erin Duffy and Michael Mustokoff to Present at the "'Wait, Is This Money Mine?' Overpayments Under the Affordable Care and Flase Claims Act" Webinar, January 14, 2014
Past Seminar Materials
Duane Morris Partner William Weiner to Speak at the National Business Institute's Health Law 2014 Seminar, March 21, 2014
Articles Authored by Lawyers at this office:

FDA Releases Draft Guidance on Bioequivalence Requirements for ANDA Applicants
, December 11, 2013
On December 4, 2013, the U.S. Food and Drug Administration (FDA) issued a draft guidance on demonstrating bioequivalence for drugs submitted under an Abbreviated New Drug Application (ANDA). Entitled Bioequivalence Studies with Pharmacokinetic Endpoints for Drugs Submitted Under an ANDA, the new...

FDA Proposed Rule Would Require Generics to Update Label Warnings Even Before Branded Pharmaceuticals Do
, November 15, 2013
On Wednesday, November 13, 2013, the U.S. Food and Drug Administration (FDA) will publish a proposed rule in the Federal Register that will mandate that generic drug firms update their labels for drugs under approved Abbreviated New Drug Applications (ANDAs) to add warnings, precautions, adverse...

Mobile Medical Apps Guidance
, October 08, 2013
Mobile health ("mHealth") application ("app") developers, manufacturers, investors, healthcare providers and others received welcome news late last month when the U.S. Food and Drug Administration ("FDA") published its long-awaited final guidance on mobile medical...

Refill Reminder Exception to the Privacy Rule Created by the HITECH Act
, September 30, 2013
The passing of the Health Information Technology for Economic and Clinical Health Act (HITECH) resulted in multiple changes regarding existing protection of protected health information (PHI) under the Health Insurance Portability and Accountability Act (HIPAA). Part of this was to limit the use of...

WellPoint Pays HHS $1.7 Million to Settle HIPAA Security Violations
, July 18, 2013
On July 8, 2013, health insurer WellPoint, Inc. entered into a Resolution Agreement with the U.S. Department of Health and Human Services, Office for Civil Rights (HHS), agreeing to pay HHS $1.7 million to resolve an HHS complaint regarding violations of the HIPAA Privacy and Security Rules during...

IRS Publishes Notice Providing Transition Relief in Response to ACA Delay
, July 12, 2013
As outlined in our prior Alert, the Obama administration recently announced a one-year delay in the effective date of three key provisions of the Patient Protection and Affordable Care Act (ACA): (1) the annual information reporting requirements applicable to insurers, self-insuring employers and...

Supreme Court Rules on Higher Causation Standard in Employer Retaliation Claims Under Title VII
, June 27, 2013
On June 24, 2013, the U.S. Supreme Court handed down a 5-4 ruling that will have significant implications for employee plaintiffs and employers where a claim of employer retaliation under Title VII is at issue. In University of Texas Southwestern Medical Center v. Nassar, M.D., the Supreme Court...

Final HIPAA Wellness Program Regulations Issued Under Affordable Care Act
, June 12, 2013
On June 3, 2013, the United States Department of Labor, Department of Health and Human Services, Internal Revenue Service, Employee Benefits Security Administration and Department of the Treasury (collectively "the Departments") published in the Federal Register final guidance regarding...

State Medicaid Fraud Control Units' Data Mining Likely to Increase Through Federal Funding
, June 12, 2013
On May 17, 2013, the Office of Inspector General, U.S. Department of Health and Human Services (OIG), announced a final regulation that would permit, effective June 17, 2013, state Medicaid fraud control units (MFCU) to use federal matching funds to pay for data mining activities to detect...

FDA Enforcement Action Against uChek: Does It Signal an Agency Wake-up Call for Non-compliant Mobile Medical Apps?
, June 07, 2013
In late May, the U.S. Food and Drug Administration took regulatory action against a mobile medical application or "mHealth" app for the first time. In its "It Has Come to Our Attention" letter to Biosense Technologies Private Limited, FDA contended that the company's new urine...

U.S. Supreme Court Endorses Employer Efforts to "Pick Off" Named Plaintiff in FLSA Collective Action, but Declines to Resolve Circuit Split Regarding Mootness Issue
, April 24, 2013
On April 16, 2013, the United States Supreme Court in Genesis HealthCare Corp. v. Symczyk, 569 U.S. --- (2013) (No. 11-1059), held that a trial court properly dismissed as moot a Fair Labor Standards Act (FLSA) overtime collective action where the employer had made an offer of judgment to the named...

HIPAA Marketing and Sale Provisions: Legal Potholes for Providers, Payors, Advertisers, Data Aggregators, Market Researchers and Others
, April 22, 2013
The privacy and security standards under the Health Insurance Portability and Accountability Act of 1996 ("HIPAA") and its regulations (the "HIPAA Rules") were designed to protect personal health information ("PHI") from unfettered use for commercial purposes. The...