Health Care

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

The Physician Payments Sunshine Act and the Future of Healthcare Transparency: Part 1

2022/02/02

Part 2 of this article series will be published in the March 2022 issue of Compliance Today and focus on examples of enforcement actions and examine the future of transparency statutes. 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. The act 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. This two-part article provides a comprehensive analysis of the major healthcare regulatory enforcement statutes and their continuingly expansive use. First, we’ll reference the issues in the healthcare industry that led to the enactment of the PPSA that are relevant to an understanding of the current law and its growing enforcement. Next, we’ll discuss key statutory language and PPSA’s evolution. Then, we’ll consider the impact from a fraud and abuse standpoint, which is important to appreciate the significance of the first examples of Department of Justice enforcement of the act that follow, as well as the likely increase of private PPSA enforcement. We’ll also highlight other sunshine acts, including state and international ones. Finally, we’ll examine the future of transparency statutes, including the Hospital Price Transparency regulation,[3] 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. The lead-up to the enactment of the Physician Sunshine Act After years of calls for the healthcare industry to shift toward a more transparent and consumer-friendly environment, the Patient Protection and Affordable Care Act (ACA) passed in 2010, including the PPSA codified at 42 U.S.C. Read More

Pamela Coyle Brecht to present at Federal Bar Association’s 2022 Qui Tam Conference

2022/02/24

On Thursday, February 24, 2022 Pietragallo partner Pamela Coyle Brecht will be presenting on “Private Equity – The Newest Face at the FCA Table” at the Federal Bar Association’s 2022 Qui Tam Conference. This annual event provides timely perspectives from all sides of the FCA ecosystem: prosecutors, relator-side attorneys, defense counsel, inspectors general, federal judges, and in-house counsel. For more information and to register, visit: https://www.fedbar.org/event/quitam22/ Read More

Pamela Coyle Brecht to present at Marcum Corporate Compliance & Fraud Summit

2021/10/07

On October 7th, Pietragallo partner Pamela Coyle Brecht will be a panelist at the Marcum Corporate Compliance & Fraud Summit. Pam, and her co-panelist David Glusman, Partner at Marcum LLP will be discussing Forensic Accounting in Healthcare. During our session, you’ll be introduced to anti-kickback and fraud and abuse issues in healthcare. Join us for this two-day virtual webinar and register here, https://lnkd.in/deYRtj3C Read More

Pamela Coyle Brecht to present at Pennsylvania Bar Institute’s A Day on Health Law 2021

2021/10/28

On Thursday, October 28, 2021, Pietragallo partner Pamela Coyle Brecht will present a “False Claims Act Update” at Pennsylvania Bar Institute’s A Day on Health Law webinar. A Day on Health Law is a one-day, six-hour spin-off of PBI’s annual Health Law Institute. The Health Law Institute brings health law professionals comprehensive updates, insights and practical advice and the opportunity to tailor your own personalized agenda through numerous breakout session options in addition to the complete sessions. To join Pam and an outstanding roster of healthcare professionals visit: https://lnkd.in/gfRu_EwJ Read More

Pamela Coyle Brecht to present at Health Care Compliance Association’s 2022 Managed Care Compliance Conference

2022/01/31

On Monday, January 31, 2022, Pietragallo partner Pamela Coyle Brecht will be presenting on “The Dos and Don’ts of Medicare Advantage and Medicaid Managed Care: Lessons from Recent Enforcement Activity” at the HCCA’s Managed Care Compliance Conference. This is an annual event for individuals who manage compliance at health plan providers. Learn the latest practices, share strategies, and connect with peers and mentors who face similar challenges. For more information and to register, visit: https://lnkd.in/gyjX4U7X Read More

The differences and similarities between American and Italian healthcare fraud, waste, and abuse laws: Part 3

2022/01/03

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, published in the December 2021 issue, outlined America’s primary healthcare fraud laws. Part 3 of this series outlines the Italian healthcare enforcement regime, criminal law, and the Anti-Corruption Act. Italian enforcement against fraud and corruption, including in the healthcare field, has traditionally been reserved to criminal courts, with no specific effort to coordinate or combine these actions through civil remedies. In light of the largely state-funded healthcare system in Italy, government corruption is in the foreground of efforts to detect and prevent fraud, waste, and abuse in healthcare. Egregious scandals erupted in Italian healthcare sectors, especially in the 1990s. Perhaps the most notorious case involved Dr. Duilio Poggiolini, the Ministry of Health’s general manager of the pharmaceutical department whose fortune included gold, jewels, and paintings of enormous value.[1] Poggiolini was charged and arrested for using his position for personal benefit, and his sentence of seven and a half years in prison was reduced on appeal.[2] The scandal surfaced during an investigation, called “mani pulite,” by a pool of public prosecutors operating out of the Milan criminal court. They were able to pierce the veil of silence that long protected government corruption. While its success resulted from significant cooperation and solidarity among the prosecutors, their coordination was not officially structured as an institutional team. Italy’s criminal law Italian criminal law always has included crimes of government corruption. The Italian Criminal Code has been amended periodically, not only to increase the sanctions (as, for example, in the latest “Spazza-Corrotti” amendments in 2019), but also with the aim of criminalizing more subtle corruption than an outright offer of cash in exchange for favorable treatment by a public official. Read More

In Post-Pandemic Era, What Will Return to Office Look Like?

2021/12/20

Pietragallo attorney Kevin E. Raphael was featured in a recent Pennsylvania Bar News feature on “In Post-Pandemic Era, What Will Return to Office Look Like?” Mr. Raphael first spoke on the topic on the “Business and Practice of Law Post-COVID: How will it Change?” webinar conference for the Pennsylvania Bar Association’s Large Law Firm Committee in mid-November. Interested in reading the piece? You can find it here: https://www.pabar.org/members/barnews/2021/BarNews_1216.pdf Read More

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

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