Health Care

Health Law Handbook (2022 Edition) Pre-Publication

2022/07/15

Kevin E. Raphael, Christin M. Roberts, and Daniel P. Wotherspoon have authored the chapter “The Reverse False Claims Act: A Relatively Unknown, But Increasingly Used, Provision of the FCA” in the 2022 Health Law Handbook that will be released on October 26, 2022. You can review the pre-publication article here: The Reverse False Claims Act: A Relatively Unknown, But Increasingly Used, Provision of the FCA   Accepted for publication in the Health Law Handbook, 2022 Edition. Alice G. Gosfield, Editor, © Thomson Reuters. A complete copy of the Health Law Handbook is available from Thomson Reuters by calling 1-800-328-4880 or online at www.legalsolutions.thomsonreuters.com Read More

Marc Stephen Raspanti to speak at World Online Lawyers with Excellent Practice’s Webinar

2022/07/13

Pietragallo partner Marc Stephen Raspanti will be joined by speakers Jon May and Gabriel Albu (Europe) to speak at the World Online Lawyers with Excellent Practice’s (WOLEP) webinar on Wednesday, July 13th at 10:30am EST. They will be taking on the topic of “Whistleblower statutes in the United States and the European Union – regulations, commonalities and differences, perspectives”. Some of the issues addressed during this WOLEP webinar will be: The difference between how whistleblowers are viewed in the US and the EU The origin of whistleblower statutes in the US The movement toward greater whistleblower protections in the EU The various programs in the US that reward whistleblowers Case studies, including the representation of a European whistleblower making a disclosure to US authorities Please note that, at the end of the event there will be a Q&A session, so we urge you to tune in and join the debate!   Join the webinar here: https://us02web.zoom.us/j/3019722258?pwd=WHVFdEYwTWtLT2orTVkwYm8wZUZIUT09 Meeting ID: 301 972 2258 Passcode: wolep Read More

The emerging battle over ‘objective reasonableness’ in False Claims Act cases

2022/06/01

The Medicare and Medicaid programs are exceedingly complex, and navigating the myriad statutes, regulations, rules, and guidance presents significant challenges for all healthcare providers and compliance professionals—even the United States Supreme Court has recognized that the Medicare program is a “complex and highly technical regulatory program.”[1] This job is sometimes made even more difficult because program regulations can be ambiguous, and government officials are often unable or unwilling to provide further clarification. Add to the mix that failure to comply with Medicare and Medicaid regulations can result in False Claims Act (FCA) liability, and many healthcare providers can’t help but express frustration. A new battle emerging in the courts may afford healthcare providers some relief when confronted with ambiguous Medicare and Medicaid regulations. In United States ex rel. Schutte v. SuperValu Inc., decided on August 12, 2021, the Seventh Circuit Court of Appeals held that a defendant does not knowingly submit a false claim “if (a) it has an objectively reasonable reading of the statute or regulation and (b) there was no authoritative guidance warning against its erroneous view.”[2] In it, the Seventh Circuit joined the Third, Eighth, Ninth, and D.C. Circuits in endorsing an objective reasonableness standard under the FCA. However, the Seventh Circuit, over a vigorous dissent, went further than the other courts, which have recognized an objective reasonableness standard, setting up a battle that could significantly affect future FCA cases. Read more here, https://bit.ly/3wVbZEF Copyright 2022 Compliance Today, a publication of the Health Care Compliance Association (HCCA). Read More

Jeremy Abay to present at Seton Hall University School of Law

2022/06/14

Jeremy Abay will present “The False Claims Act and Dealing with Whistleblowers” at Seton Hall University School of Law on Tuesday, June 14, 2022. This is part of Seton Hall’s U.S. Healthcare Compliance Certificate Program (HCCP). This is a four-day program that will allow attendees to absorb all aspects of statutes, regulations, and other guidance that cover what is known as “fraud and abuse law.” Attendees will study 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

Pamela Coyle Brecht to present at Federal Bar Association’s Qui Tam Section Roundtable

2022/06/08

Pietragallo partner Pamela Coyle Brecht will be presenting virtually on “She Persisted: How Women Have Shaped False Claims Act Law” at the Federal Bar Association’s (FBA) 2022 Qui Tam Section Roundtable Discussion. This webinar will take place at 12:00pm EST on Wednesday, June 8, 2022. Pam and her fellow panelists will focus on the innovative and critical contributions women attorneys continue to make in the area of False Claims Act Law. This roundtable will highlight the various means through which women trailblazers, including the panelists, led the way for others to apply courageous and creative interpretations of the False Claims Act in complex litigation matters. To register, visit: https://employmentlawgroup.zoom.us/webinar/register/WN_cZHBFDXETLq9H3lfEhrCow Read More

24 Pietragallo Lawyers Named in 2022 Pennsylvania and Florida Super Lawyers and Rising Stars

2022/05/23

Pietragallo is pleased to announce that 24 lawyers have been named as 2022 Super Lawyers and Rising Stars, including partner Marc Raspanti who was recognized in the Top 100 in Pennsylvania and Philadelphia. Super Lawyers is a service of Thomson Reuters legal division which compiles a list of outstanding lawyers from more than 74 practice areas. Each year, a research team at Super Lawyers conducts a multi-phase selection process reviewing independent research, peer nominations, and peer evaluations. With the objective being to provide a reliable, wide-ranging list of attorneys that can be used as a source for finding exceptional legal counsel. Pietragallo partner in our new Florida office, Tama Beth Kudman, was chosen as a 2022 Florida Super Lawyer as a top rated White Collar Crimes attorney in Palm Beach Gardens. The following were chosen as Pennsylvania Super Lawyers: Gaetan J. Alfano Joseph J. Bosick Mark Gordon P. Brennan Hart Christopher A. Iacono 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) Lourdes Sánchez Ridge Douglas K. Rosenblum Eric G. Soller Clem C. Trischler Paul K. Vey The following were chosen as Pennsylvania Rising Stars: Jeremy E. Abay Rebecca Johnson Barksdale Ashley J. Kenny John W. Kettering Alexander Owens 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 six offices throughout Pennsylvania, Florida, Ohio, and West Virginia from which we are able to serve our clients in all 50 states and the District of Columbia. Read More

Pietragallo Now in Florida

2022/05/09

Pietragallo Gordon Alfano Bosick & Raspanti, LLP is enthusiastic in announcing the opening of its Florida office in Palm Beach Gardens and announcing that Tama Beth Kudman will serve as our Managing Partner-Florida. Tama will continue to represent individuals and corporations under civil and criminal investigation and prosecution. Tama was selected by Best Lawyers as “Lawyer of the Year” for the West Palm Beach Criminal Defense sector in 2022 and the White-Collar Defense sector in 2020. She is also on the Top Lawyers list for Jupiter Magazine and Palm Beach Illustrated, 2022. Tama is a graduate of Barnard College, Columbia University and The Benjamin N. Cardozo School of Law and is barred in New York, New Jersey, and Florida. The Florida office is located at 7108 Fairway Drive, Suite 130, Palm Beach Gardens, Florida 33418.  Tama can be reached at 561-472-0811 or by email at TBK@Pietragallo.com. About Pietragallo Gordon Alfano Bosick & Raspanti, LLP Pietragallo is a multi-disciplined business and litigation law firm headquartered in Philadelphia and Pittsburgh with six offices throughout Pennsylvania, Ohio, West Virginia, and now Florida. Read More

THE REVERSE FALSE CLAIMS ACT: A Relatively Unknown, But Increasingly Used, Provision of the FCA

2022/04/27

Volumes have been written about the False Claims Act as a tool to pursue fraud against the government in circumstances where the defendant has allegedly made false statements to receive money from the government.  For purposes of our discussion here, we refer to this aspect of the False Claims Act as “affirmative false claims.”  Westlaw and Lexis are replete with cases addressing the government’s and relators’ claims seeking recovery for affirmative false claims allegedly perpetrated by defendants.  While there are still cases exploring the parameters of materiality and “objective falsity,” much about the False Claims Act’s affirmative false claims provisions is settled law. Not so the reverse false claims provision of the False Claims Act.  The reverse false claims provision permits the government or relators to pursue defendants who are alleged to have hidden or reduced an obligation to pay the government through false statements, or who have violated the 60-day payment rule’s obligation to return “identified overpayments.”   These claims typically have been raised in the context of cost reporting, Medicare Part C, or related to alleged failures to fulfill obligations under the 60-day payment rule.  The government and relators have increasingly relied on the reverse false claims provision to support stand-alone claims or have used it in conjunction with affirmative false claims.  However, because the reverse false claims provision is very lightly used compared to affirmative false claims provisions, there is a dearth of case law defining it or exploring its parameters.   The case law that does exist is primarily from district courts and, as the survey of case law contained herein illustrates, there is little guidance from the Circuit Courts or the U.S. Supreme Court.[1] In this chapter, we cover the legislative history of the reverse false claims provision, the impact of the 2009 Fraud Enforcement and Recovery Act’s significant amendments to the reverse false claims provision, a survey of relevant reverse false claims cases, and finally, a discussion of the practical implications of the reverse false claims provision of the False Claims Act for members of the healthcare industry and legal practitioners that represent them. Read More

Martin Shepherd and Christopher Iacono to speak at PLAN Cyber Security Webinar

2022/04/28

Pietragallo partners Martin Shepherd and Christopher Iacono will be presenting on Privacy, Data and Cyber Security: The Current Legal Landscape for PLAN (Professional Liability Attorney Network) on April 28, 2022. This webinar will discuss the continually evolving privacy legislation and cyber regulation requiring 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. Martin and Chris will be discussing: 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 For more information, or if you’d like to attend, please visit: https://www.planattorney.org/webinar/52 Read More

The Physician Payments Sunshine Act and the Future of Healthcare Transparency: Part 2

March 2, 2022

This is part 2 of a two-part article series. Part 1 was published in the February 2022 issue of Compliance Today and discussed the issues in the healthcare industry that led to the enactment of The Physician Payments Sunshine Act, it’s key statutory language, the potential penalties, and the Act’s evolution. The Physician Payments Sunshine Act (PPSA) took effect in 2013.[1] It requires medical product manufacturers to disclose to the Centers for Medicare & Medicaid Services (CMS) payments or transfers of value made to physicians or teaching hospitals. PPSA also requires manufacturers and group purchasing organizations to disclose any physician’s ownership or financial interest in those companies. The disclosed data is published annually in a publicly searchable database.[2] The rationale behind the public availability of the data is to empower patients through transparency to mitigate the putative effect of financial incentives on clinical behavior and the public and prevent physician-industry conflicts of interest. Part 1 of this article[3] offers a comprehensive analysis of the major healthcare regulatory enforcement statutes and their continuingly expansive use. First, it considers the issues in the healthcare industry that led to the enactment of the PPSA are relevant to an understanding of the current law and its growing enforcement. Next, it discusses PPSA key statutory language and its evolution and considers the impact from a fraud and abuse standpoint. Part 2 of this article reviews the significance of the first examples of Department of Justice enforcement of the act, as well as the likely increase of private PPSA enforcement. Other sunshine acts, including state and international acts, are also highlighted. Finally, an examination of the future of transparency statutes, including the Hospital Price Transparency regulation,[4] the newest major transparency statute proposed; the Prescription Drug Price Transparency Act; and the Transparency in Coverage statute, which support the notion that transparency is a trend in the healthcare industry that will withstand the test of time. Read More

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