Health Care

The differences and similarities between American and Italian healthcare fraud, waste, and abuse laws: Part 2

2021/12/01

Part 1 of this article series, published in the November 2021 issue of Compliance Today, outlined in general the American and Italian healthcare systems. Part 2 outlines America’s primary healthcare fraud laws. Part 3 of this series, to be published in the January 2022 issue of Compliance Today, will outline Italy’s fraud and abuse laws. In America, the enforcement landscape is ever evolving. Compliance within this thicket of criminal, civil, and administrative laws and regulations can prove especially challenging. The most used fraud and abuse prevention tools include the federal Anti-Kickback Statute (AKS), the federal False Claims Act (FCA), state false claims acts (FCAs), Stark Law, and more recently the Physician Payments Sunshine Act. In addition to these laws, there are two important industry codes of conduct that govern behavior: the PhRMA Code on Interactions with Health Care Professionals, which covers the pharmaceutical industry, and the AdvaMed Code of Ethics, which covers the medical device industry. Anti-Kickback Statute and its growing exceptions The AKS is a powerful federal law that seeks to prevent financial considerations from interfering with the independent medical judgment and purchasing decisions of healthcare providers.[1] In general, this law prohibits a company or individual from offering a healthcare provider, such as a doctor or hospital, incentives (referred to as “inducements”) to encourage use of its products or services.More specifically, the AKS imposes criminal penalties on any person who knowingly and willfully solicits, receives, offers, or pays any “remuneration” (including any kickback, bribe, or rebate) directly or indirectly, in cash or in kind, to any person to induce that person to either: refer an individual to a person for the furnishing of an item or service for which payment may be made in whole or in part under a federal healthcare program, or purchase, lease, order, or arrange for or recommend the purchasing, leasing, or ordering of any good, facility service, or item for which payment may be made in whole or in part under a federal healthcare program. Read More

“Investigations”, Medicare and Medicaid Fraud and Abuse, 2021 ed.

2021/10/25

Pietragallo attorneys Kevin E. Raphael, James W. Kraus, and Daniel P. Wotherspoon revised Chapter 6 “Investigations” in the Medicare and Medicaid Fraud and Abuse, 2021 ed. of Thomson Reuters’ Health Law Series. Mr. Raphael has reviewed and updated this chapter annually for the past fifteen years. Medicare and Medicaid Fraud and Abuse introduces fundamental concepts as well as detailed analysis of the aspects of Medicare and Medicaid fraud and abuse, including regulation, caselaw, advisory opinions, and more. Their chapter discusses all aspects of government investigations in healthcare, including: the key players; challenges to subpoenas; defenses; and practical advice for managing and responding to government investigations. Interested in reading a chapter? You can find the book here: https://store.legal.thomsonreuters.com/law-products/Treatises/Medicare-and-Medicaid-Fraud-and-Abuse-2021-ed-Health-Law-Series/p/106737488. Read More

The differences and similarities between American and Italian healthcare fraud, waste, and abuse laws: Part 1

2021/11/01

This is Part 1 of a three-part series discussing the similarities and differences between the US and Italian healthcare fraud, waste, and abuse laws. Part 2 of this series will be published in the December issue of Compliance Today, and Part 3 will be published in January 2022 issue of the magazine. The United States of America and the Italian Republic share many common ideals. America was named after Amerigo Vespucci, an Italian explorer.[1] The American Constitution is based on the principle of government “of the people, by the people, for the people.” The Italian Constitution embodies this same principle in the ideals of sovereignty to the people: “La sovranità appartiene al popolo.” As of 2003, almost 16 million Americans claimed to have had Italian heritage.[2] With shared values, our two countries have forged an indelible alliance. These allied nations work together as world leaders in responding to a wide variety of economic, political, medical, technological, and scientific challenges that confront a rapidly changing world. A major challenge confronting both America and Italy is providing a healthcare system that extends medical treatment that is effective, innovative, devoid of fraud, and cost efficient. While the healthcare systems in America and Italy differ in many respects, they suffer from the same obstacles: fraud, waste, and abuse. Both countries take these problems seriously. For example, in America, the federal government recovered more than $2.2 billion in 2020 alone from healthcare fraud and false claims,[3] while in Italy the National Anti-Corruption Authority (Autorità Nazionale Anticorruzione) is actively monitoring, preventing, and responding to corruption, as well as issuing anti-corruption plans. This article highlights laws enacted in America and Italy to combat fraud, waste, and abuse, showing important similarities as well as differences between these enforcement efforts. Given the close historical and commercial ties between America and Italy, including healthcare companies that regularly operate in both countries, all stakeholders involved in healthcare (i.e., Read More

Privacy, Data and Cyber Security: The Current Legal Landscape CLE (Webinar)

2021/11/11

Companies and consumers alike are under perpetual assault from bad actors as IoT, work from home, and cloud migration – all intended to improve productivity – have expanded the cyber attack surface. The continually evolving privacy legislation and cyber regulation requires companies to adapt and comply with collection, use, retention, and disclosure of personal information, and requires the implementation of internal controls, systems, and policies to better protect information from cyber criminals. During this one hour CLE hosted webinar we will discuss: An overview of the current state of U.S. privacy law, including state privacy legislation, breach notification, and enforcement Overview of the legal framework in data security Cybersecurity threats and the attendant risk Regulatory frameworks and the future of managing security in large supply chains Best practices for companies to launch or improve their security program Click here to register. Zoom details to follow. *Attendance is limited. When Thursday, November 11, 2021 12:00 p.m. – 1:00 p.m. EST Host Christopher A. Iacono, Partner Martin T. Shepherd, Partner Credit CLE credit in PA is currently pending approval. Read More

Pietragallo Partner James W. Kraus Admitted to the American College of Trial Lawyers

2021/10/04

Pietragallo is pleased to announce that partner James W. Kraus has become a Fellow of the American College of Trial Lawyers (the College), one of the premier legal associations in North America.  The induction ceremony took place during the College’s 2021 Annual Meeting in Chicago, IL. Founded in 1950, the College is composed of preeminent members of the trial bar from the United States and Canada and is recognized as the leading trial lawyers organization in both countries. Fellowship is extended by invitation only and only after careful investigation, to experienced trial lawyers who have mastered the art of advocacy and whose professional careers have been marked by the highest standards of ethical conduct, professionalism, civility and collegiality. Membership in the College cannot exceed 1% of the total lawyer population of any state or province. There are currently approximately 5,800 members in the United States and Canada, including active Fellows, Emeritus Fellows, Judicial Fellows (those who ascended to the bench after their induction) and Honorary Fellows. Jim has spent over 20 years focusing on white collar criminal defense, government enforcement, internal investigations, health care litigation and commercial litigation. He has extensive trial experience in a wide variety of complex matters, including health care litigation, securities matters, preliminary injunction proceedings, and criminal trials in both state and federal court. He has also handled environmental litigation and regulatory enforcement matters. Prior to joining private practice, he served as a JAG criminal prosecutor with the U.S. Army’s 4th Infantry Division. In addition to his work in the courtroom, Jim has represented clients in response to investigations by the U.S. Department of Justice, the Securities and Exchange Commission, and other government agencies. About Pietragallo Gordon Alfano Bosick & Raspanti, LLP Pietragallo Gordon Alfano Bosick & Raspanti, LLP is a multi-disciplined business and commercial litigation firm headquartered in Pittsburgh with five offices throughout Pennsylvania, Ohio, and West Virginia from which we serve our clients in all 50 states and the District of Columbia. Read More

Michael Morse to Present at American Bar Association Physicians Legal Issues: Healthcare Delivery & Innovation Virtual Conference

2021/09/24

Michael A. Morse will present “With Friends Like These…The Attorney-Physician Expert Witness Relationship” at the American Bar Association Physicians Legal Issues: Healthcare Delivery & Innovation Virtual Conference on Friday, September 24, 2021 This live, interactive webinar will cover critical topics, including new payment models, compliance issues, enforcement trends, contracting, tips for managing transactions, cybersecurity, the implications of new technologies, and workplace issues for physicians. Speakers will share practical and viable improvement techniques to help you work more efficiently while restoring your sense of purpose. Mr. Morse’s panel will discuss how to find an appropriate expert witness, maintain attorney-client privilege, and guard against Daubert challenges from an attorney’s perspective. His panel also analyzes the physician expert viewpoint, including determining if a case is a good fit, the typical process for expert witness engagement, and preparation tips for deposition and trial testimony. For more information about Physicians Legal Issues: Healthcare Delivery & Innovation Virtual Conference please visit here. Read More

20 Pietragallo Lawyers Named in 2022 The Best Lawyers in America and Ones to Watch

2021/08/19

Pietragallo Gordon Alfano Bosick & Raspanti, LLP is pleased to announce that 20 lawyers have been named as 2022 The Best Lawyers in America and 2022 Ones to Watch, including two lawyers who were recognized for Bet-the-Company Litigation. Best Lawyers employs a sophisticated, conscientious, rational, and transparent survey process designed to elicit meaningful and substantive evaluations of the quality of legal services. Recognition by Best Lawyers is based entirely on peer review. The following were chosen as The Best Lawyers in America: Gaetan Alfano (Bet-the-Company Litigation) Pamela Coyle Brecht Phillip R. Earnest Mark Gordon James W. Kraus James F. Marrion Shelly R. Pagac Richard J. Parks William Pietragallo, II (Bet-the-Company Litigation) Francis E. Pipak, Jr. Kevin E. Raphael Marc Stephen Raspanti Douglas K. Rosenblum Eric G. Soller Clem C. Trischler Peter St. Tienne Wolff The following were chosen as The Best Lawyers in America: Ones to Watch: John Kettering Leslie A. Mariotti Peter W. Nigra Frank H. Stoy   About Pietragallo Pietragallo Gordon Alfano Bosick & Raspanti, LLP is a multi-disciplined business and commercial litigation firm headquartered in Pittsburgh with five offices throughout Pennsylvania, Ohio, and West Virginia from which we serve our clients in all 50 states and the District of Columbia. Read More

Alliance Family of Companies and Ancor Capital Partners Pay $15.3M to Settle False Claims Suits

2021/07/22

The Department of Justice and the United States Attorney’s Office for the Southern District of Texas, has announced the settlement of six qui tam cases filed in Houston, Dallas, and Philadelphia.  The first of the six whistleblower cases was filed in the Southern District of Texas by Dr. Bhuvana Mandalapu and Dr. Ramakrisha Chava, two Texas-based physicians, against Defendants Alliance Family of Companies and Ancor Holdings LP (d/b/a Ancor Capital Partners).[1] Alliance Family of Companies (“Alliance”), based in Irving, Texas, was one of the largest providers of in-home neurological diagnostic electroencephalogram (“EEG”) services in the United States.[2]  Ancor Capital Partners, based in Southlake, Texas, is a private equity firm that invested in Alliance in 2017. Drs. Mandalapu and Chava alleged in their Qui Tam lawsuit that, since 2013: Alliance paid independent-contractor neurologists to interpret EEG tests and provided these test-interpretation reports for free to non-neurologist referring physicians to enable them to bill the professional component for the test interpretations, in return for these non-neurologist physicians ordering the EEG tests from Alliance, in violation of the Anti-Kickback Statute (“AKS”), 42 U.S.C. § 1320a-7b(b); Alliance chose the neurologists that it paid to provide interpretations of tests ordered by other physicians in return for those neurologists ordering EEG tests for their own patients from Alliance, in violation of the AKS; Alliance falsely billed Current Procedural Terminology (“CPT”) code 95957 for every video ambulatory EEG test performed when it did not perform the work required for the billing of the code; and Alliance falsely billed CPT code 95951 when its procedures met the requirements only for the lower-reimbursed CPT code 95953. Drs. Mandalapu and Chava also alleged in their Qui Tam lawsuit that Ancor Capital Partners, through its due diligence during the sale of Alliance, learned about Alliance’s payment of kickbacks and other false claims and, after the sale, it allowed that conduct to continue. Read More

Pamela Brecht to present at Seton Hall University School of Law

2021/06/15

Pamela C Brecht, Chair of the firm’s Qui Tam & False Claims Act practice, will present “The False Claims Act and Dealing with Whistleblowers” at Seton Hall University School of Law on Tuesday, June 15, 2021. This four-day healthcare compliance certificate program immerses attendees in the statutes, regulations, and other guidance that comprise the body of law known as “fraud and abuse law.” Attendees examine health care-related laws and regulations alongside other compliance, ethics and integrity officers, legal counsel, health care consultants, and regulatory and medical affairs professionals. For more information about Seton Hall University School of Law’s U.S. Healthcare Compliance Certificate Program please visit their website. Read More

24 Pietragallo Lawyers Named in 2021 Pennsylvania Super Lawyers and Rising Stars

2021/06/08

Including Recognition in Top 100 in Pennsylvania and Top 100 In Philadelphia Pietragallo Gordon Alfano Bosick & Raspanti, LLP is pleased to announce that 24 attorneys have been named as 2021 Super Lawyers and 2021 Rising Stars, including two attorneys who were also recognized in the Top 100 in Pennsylvania and Top 100 in Philadelphia. Super Lawyers is a service of Thomson Reuters legal division which compiles a list of outstanding lawyers from more than 70 practice areas. Each year, a research team at Super Lawyers conducts a multi-phase selection process reviewing independent research, peer nominations, and peer evaluations. The following were chosen as Pennsylvania Super Lawyers: Gaetan J. Alfano (Top 100 in Philadelphia) Joseph J. Bosick Mark Gordon Christopher A. Iacono P. Brennan Hart James W. Kraus Michael A. Morse Shelly R. Pagac William Pietragallo, II Francis E. Pipak, Jr. Kevin E. Raphael Marc S. Raspanti (Top 100 in Pennsylvania and Top 100 in Philadelphia) Douglas K. Rosenblum John A. Schwab Eric G. Soller Clem C. Trischler Paul K. Vey The following were chosen as Pennsylvania Rising Stars: Jeremy E. Abay John R. Brumberg Sarah R. Goodman Joseph L. Gordon John W. Kettering Peter W. Nigra Peter St. Tienne Wolff About Pietragallo Pietragallo Gordon Alfano Bosick & Raspanti, LLP is a multi-disciplined business and commercial litigation firm headquartered in Pittsburgh with five offices throughout Pennsylvania, Ohio, and West Virginia from which we serve our clients in all 50 states and the District of Columbia. Read More

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“Investigations”, Medicare and Medicaid Fraud and Abuse, 2021 ed.
November 9, 2021
Pietragallo attorneys Kevin E. Raphael, James W. Kraus, and Daniel P. Wotherspoon revised Chapter 6 “Investigations” in the Medicare and Medicaid Fraud and Abuse, 2021 ed. Read More
Pietragallo Partner James W. Kraus Admitted to the American College of Trial Lawyers
October 4, 2021
Pietragallo is pleased to announce that partner James W. Kraus has become a Fellow of the American College of Trial Lawyers (the College), one of the premier legal associations in North America.  Read More
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