Philip H. Lebowitz practices primarily in the area of healthcare law and litigation. Mr. Lebowitz provides regulatory and general counseling to healthcare providers, including hospitals, pharmaceutical and medical device companies, health care consultants, and physicians. His healthcare experience includes litigation and legal counseling regarding antitrust, fraud and abuse, HIPAA and privacy, reimbursement, managed care contracting, specialty hospital development, pharmaceutical and medical device marketing and pricing, False Claims Act, credentialing and privileges disputes, and clinical trial research contracting, compliance and ethical issues. Mr. Lebowitz also represents medical device manufacturers in state administrative proceedings regarding regulations, including workers compensation, affecting the use and reimbursement of device products, and startup healthcare businesses regarding issues posed by physician ownership.
In the healthcare litigation area, Mr. Lebowitz has defended government and qui tam investigations and has represented hospitals and other healthcare providers in litigation against managed care companies regarding reimbursement and other issues. He also has handled breach of contract disputes, certificate of need, electronic discovery and "litigation hold" issues, nonprofit hospital sales to for-profit entities regarding court approval, and other regulatory challenges as well as research misconduct matters. He also has litigated restraint of trade antitrust issues involving hospitals, nursing homes and physician groups.
Mr. Lebowitz has written numerous articles and lectured extensively on healthcare issues. He is experienced in both mediation and arbitration forms of alternative dispute resolution (ADR) and is a member of the Dispute Resolvers panel of the American Health Lawyers Association. He has been designated among the Pennsylvania Super Lawyers in Healthcare Law.
Mr. Lebowitz is admitted to practice in Pennsylvania and several federal district courts and courts of appeals and the United States Supreme Court. He served a judicial clerkship to the Hon. Barbara B. Crabb, Chief Judge, U.S. District Court, Western District of Wisconsin. Mr. Lebowitz is a 1981 cum laude graduate of the University of Wisconsin Law School, where he was a member of the Order of the Coif and a member of the Wisconsin Law Review, a 1975 graduate of Rhode Island School of Design (M.F.A.) and a cum laude graduate of Harvard University.
· 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 health care 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).
· Obtained on behalf of Virtua Health, Inc. a decision from the New Jersey Superior Court, Appellate Division, affirming the award of a certificate of need (CON) to Virtua for it to participate in a multi-state study of the safety and efficacy of performing elective angioplasty at hospitals without cardiac surgery capability on-site.
· After a two-day hearing before a register of wills, defeated a challenge to a charitable testamentary gift made to nonprofit hospital, in which a business client of the decedent claimed he was the intended beneficiary of a large portion of the estate evidenced by a list of tangible items that he claimed was intended by the decedent as a codicil to his will.
· Lead Counsel, Barnert Hospital v. AmeriChoice of New Jersey (AAA arbitration), represented hospital in reimbursement dispute with payer.
· Litigation counsel, In re Friends Hospital (Philadelphia Orphan's Court), represented non-profit hospital in hearing regarding sale of assets to for-profit entity.
· Lead Counsel, U.S. ex rel. Rahman v. Colkitt, No. 01-2386 (D.Md.), defense of public company and major shareholder regarding whistleblower and U.S. claims of improper billing by radiation therapy facilities.
· Lead Counsel, defense of hospital in response to subpoena and investigation by U.S. Department of Justice involving antitrust issues.
· Lead Counsel, defense of healthcare consultant in U.S. Department of Justice investigation of consultant activities involving hospital billing of Medicare.
· Lead 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.
· 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.
· Lead counsel, defense of Office of Inspector General (OIG) investigation, represented physician against improper billing allegations involving radiation therapy.
· Lead counsel, Besler, Inc. v. Texas Health Resources (S.D. Tex), represented healthcare consultant in breach of contract action.
· Lead counsel, Vantage Health Plan, Inc v. Glenwood Regional Medical Center (private arbitration), represented hospital in breach of contract action against managed care company.
· Appellate Counsel, In re Application of Virtua-West Jersey Hospital Voorhees for Certificate of Need, New Jersey Supreme Court, represented hospital in an appeal of Certificate of Need award regarding designation as regional perinatal center.
· Defense Liaison Co-Counsel, In re Orthopedic Bone Screw Products Liability Litigation, MDL-1014 (E.D.Pa), represented key defendant in 5,000 medical device products liability cases.
· Lead Counsel, In re EquiMed Securities Litigation (E.D.Pa.), represented defendant officer/director in action involving healthcare practice management company.
· Lead Counsel, Pennsylvania Psychiatric Society v. Green Spring Health Services, et. al., (W.D.Pa.), represented medical association in action against managed care companies.
· Lead Counsel, Merrill Cohen, Trustee v. Douglas Colkitt, M.D., (bankruptcy adversary proceeding) D.Md., represented owner of debtor company and affiliated companies.
· Appellate Counsel, Fox Chase Cancer Center v. Shalala (E.D.Pa.), represented hospital on appeal of adverse ruling regarding payment for cost of graduate medical education.
· Compliance with Corporate Integrity Agreement (CIA) and Integrity Agreement (IA).
· Establishment of physician-owned orthopedic specialty hospital, including corporate, licensing and regulatory issues.
· Development and implementation of strategy on behalf of medical device company to change state workers' compensation reimbursement regulations.
· Due process hearings regarding revocation and suspension of staff privileges of physicians by hospital and ambulatory surgery center (ASC).
· Appeal to state board of medicine of license revocation due to personal misconduct.
· Institution misconduct hearing regarding misrepresentation of data by clinical trial researcher.
· Represented hospital and researcher in response to FDA Warning letter regarding off-label use.
· Establishment of physician-owned distribution company for medical devices.
· Regulatory counseling regarding physician ownership in medical device company.
Areas of Practice
· Healthcare Law
- Managed Care Contracting
- Sale of Physician Practices
- Network Formation
- Special Hospital Formation
- Physician Licensure
- Physician-Owned Healthcare Businesses
- Records Privacy Issues
- HIPAA and Reimbursement Issues
- Anti-kickback and Physician Self-referral Regulation (Stark)
- Joint Negotiations with Third-party Payers
- Antitrust Implications of Joint Ventures
- Pharmaceutical and medical device regulations
- Clinical Research and Human Subject Protection
· Healthcare Litigation
- Fraud and Abuse
- False Claims Act
- Privileges Disputes
- Ethics Proceedings
· "Increased Government Scrutiny of Physician-Owned Device Distributorships," Duane Morris Alert, April 3, 2013
· "Litigation Can Pay Off," Modern Healthcare, June 2011
· "Third Circuit Overturns Dismissal of Whistleblower Action: Ensure That Physician-Hospital Written Agreements Are In Effect," Duane Morris Alert, January 29, 2009
· "Government Spotlight on Physicians' Consulting Arrangements with Device Makers," Journal of Medical Practice Management, July/August 2008
· Co-author, "Don't Let Disruptive Physicians Hurt Your Accreditation," Modern Healthcare, August 2008
· Co-author, "New Case Adopts "Common Sense" Approach to Academic Medical Center Stark Exception," Duane Morris Alert, May 2, 2008
· "Orthopedic Surgeons Should Prepare For Scrutiny," Health Law 360, April 8, 2008
· "HIPAA Violation May Form Basis for Lawsuit," Health Law 360, March 12, 2007
· "Hospital Study May Proceed," New Jersey Law Journal, February 12, 2007
· "New Jersey Hospitals Present Unique Outlier Cases," New Jersey Law Journal, July 10, 2006
· "Investing in Surgeon-Owned Device Companies: Is It Worth the Risk?" Orthopedic Product News, September/October 2005
· "Protecting Privacy and Encouraging Research," Successful Clinical Trials Management, June 2005.
· "Opting Out of Aetna's Class Action Settlement," Physician's News Digest, July 2003
· "Survey of Provider Litigation Against Managed Care Companies," The Legal Intelligencer, March 5, 2003
· "Third Circuit: Physicians May Assert Rights Through Associations," BNA, Inc. Health Plan & Provider Report, Vol. 8, No. 19, May 8, 2002
· "Pharmaceutical Marketing Practices - A New Focus of Fraud Enforcement," Journal of Health Care Compliance, Vol. 4, No. 2, March/April, 2002
· "Federal Government Eyes Drug Marketing Practices," Northeast Network Healthcare Review (Northern New England), Vol. 15, No. 3, March 19-April 22, 2002; Northeast Network Healthcare Review (Southern New England), Vol. 15, No. 3, March 26-April 30, 2002
· "Pricing Pressures: States Take Action," Pharmaceutical Executive, Vol. 22, No. 3, March 2002
· "Pharmaceutical Marketing Practices Face New Scrutiny," Healthcare Risk Management, Vol. 24, No. 2, February 2002
· "The HIPAA Privacy Rule: Clinical Laboratories Must Comply," American Clinical Laboratory, Vol. 21, No. 1, January/February, 2002
· "Questions and Answers About the Prompt Payment Law," Bulletin - Allegheny County Medical Society, January 26, 2002
· "Fraud Enforcement of Rx Marketing Practices," Physician's News Digest, Vol. XV, No. 4, January 2002
· "Allowing Sales Representatives in the OR Creates New Liability Issues," Medical Products Sales, November/December 2001
· "Stark" Reality: Self-Referral Rule Holds Risk and Opportunity," Radiology Management, Vol. 23, No. 5, September/October 2001
· "An Overview of the Stark Law," American Clinical Laboratory, Vol. 20, No. 7, August 2001
· "Health Insurance Portability and Accountability Act: What It Means to Case Managers," Inside Case Management, Vol. 8, No. 5, August 2001
· "Antitrust Issues Regarding Physicians' Response to Increased Malpractice Insurance Rates," Group Practice Journal, Vol. 50, No. 6, June 2001
· "The HIPAA Privacy Rule: Its Effect on Diabetes Treatment," Diabetes Technology & Therapeutics, Vol. 3, No. 2, Summer 2001
· "Medicare Prescription Drug Dilemma," Managed Healthcare News, May 2001
· "Antitrust Issues Confronting Physicians," Vol. XIV, No. 6, Physician's News Digest, March 2001
· "Implementing HIPAA Privacy Regulations," ADVANCE HIPAA HQ (Website), March 12, 2001
Selected Speaking Engagements
· Panelist, "HIPAA Compliance During Litigation and Discovery," Strafford Webinar, September 12, 2012
· Speaker, "Medicare Outlier Investigation: A Case Study," 15th Annual Pennsylvania Health Law Institute, March 12, 2009
· "New Stark Law Developments for 2009: What Every Hospital Needs to Know," Hospital & Healthsystem Association of Pennsylvania Audioconference, January 28, 2009
· Panelist, "Physician-Vendor Relationships Under Heightened Government Scrutiny," Stafford Publications Teleconference, July 17, 2008 and January 14, 2009
· Speaker, "Consultant Liability under the False Claims Act", Fraud & Compliance Forum, American Health Lawyers Association/Health Care Compliance Association, October 7, 2008
· Panelist, "HIPAA Privacy and Security: Prepare for New CMS and OIG Reviews," Stafford Publications Teleconference, April 15, 2008
· Speaker, "Stark Law Update: Phase III Changes," Hospital and Healthsystem Association of Pennsylvania, Audio Conference, November 14, 2007
· Panelist, "Are Specialty Hospitals So Special Anymore?" 13th Annual Health Law Institute, March 13-14, 2007
· Speaker, "When Clinical Researchers Have Consulting Contracts With Hedge Funds and Other Investment Companies," 12th Annual Health Law Institute, March 15-16, 2006
· Speaker, "Exclusive Provider Agreements: Multiple Perspectives," 11th Annual Health Law Institute, March 15-16, 2005
· Speaker, "Protecting Privacy and Encouraging Research," HCCA/AHA HIPAA Forum, San Diego, California, December 10-12, 2003
· Speaker, "Negotiating Indemnification Clauses for Practical Effect" and Panelist, "Interpreting the Intricacies of Indemnification Agreements," National Conference on Contracting and Negotiating Clinical Trials, Philadelphia, Pennsylvania, April 29-30, 2003
· Speaker, "Litigation by Health Care Providers Against Managed Care: Failures & Successes," 9th Annual Health Law Institute, March 12-13, 2003
· Speaker, "HIPAA Part I - The Basics; HIPAA Part II - Who's Really Affected by HIPAA?" Advance Magazine, Career Connections and Continuing Education Conference, March 20, 2002
· Panelist, "Indemnification Issues: Sponsor, CRO and Site Perspectives," Strategic Research Institute's 9th Contracting & Negotiation Clinical Trials Conference, March 12, 2002
· Speaker, "Protection of Human Research Subjects," Pennsylvania Bar Institute's 8th Annual Health Law Institute, March 12, 2002
· Speaker, "Issues in Hospital Compliance in Year 2001 (Compliance, Fraud and Abuse Issues)," Pennsylvania Association for Healthcare Quality, Spring Conference, April 20, 2001