Health Care

Information from our Employment & Labor Group to help you navigate COVID-19

March 19, 2020

The Families First Coronavirus Response Act (Act) was signed by President Trump on March 18, 2020.  The bill becomes law on April 2, 2020.Under the new law, certain employees will be eligible to receive paid sick and family leave through December 31, 2020 for leave related to COVID 19.  Relevant portions related to employment law are as follows: Emergency Family and Medical Leave Expansion Act This provision expands the Family Medical Leave Act (FMLA).  It applies to employers with fewer than 500 employees.  It includes employers with less than 50 employees who were previously not subject to the FMLA.  Employees who have been employed for thirty days or more are entitled to take up to twelve weeks of job-protected leave: To care for employee’s child whose school or child care facility has been closed due to the coronavirus. The first ten days can be unpaid unless the employee chooses to substitute paid time off.  After the first ten days, the employee receives two-thirds of their regular rate, capped at $200 per day.  Part-time employees will be entitled to two-thirds of their paid sick leave in the amount equal to the average amount of hours they work for the six months prior to taking Emergency FMLA, capped at $200 per day. The Secretary of Labor may exempt small businesses with fewer than 50 employees if the imposition of such requirements would jeopardize the viability of the business. Emergency Paid Sick Leave This provision applies to employers with fewer than 500 employees.  Employers will be required to provide job-protected paid sick leave to all employees who require leave for the following reasons: The employee is subject to a federal, state or local quarantine because of the coronavirus; The employee must obtain medical care if he or she is experiencing symptoms of coronavirus; The employee must comply with health care provider recommendations to self-quarantine due to the coronavirus; The employee must care for an individual who is subject  to federal, state or local quarantine or to comply with a health care provider recommendation due to the coronavirus; The employee must care for the employee’s child whose school or child care facility has been closed  due to the coronavirus; and Any other substantially similar condition specified by the Secretary of Health and Human Services in consultation with the Secretary of Treasury and the Secretary of Labor. Read More

New on the False Claims Blog: Relator Swap Leads to Case “Droppa” Under the DRUPA

2020/03/19

The perils of substituting relators in the midst of a qui tam were the highlight of this week’s decision by the Delaware Supreme Court on certification from the Third Circuit Court of Appeals in United States v. Sanofi-Aventis United States Llc, No. 256, 2019, 2020 Del. LEXIS 97 (Mar. 17, 2020), on certification from In re: Plavix Marketing, Sales Practices and Products Liability Litigation, 19-2472 (3d Cir. June 12, 2019) [hereinafter Certification]. Three individuals (two physicians and a Sanofi sales representative) formed a Delaware limited liability partnership to act as Relator, that is, “to file and prosecute” a whistleblower action under the federal False Claims Act (“FCA”), 31 U.S.C. §3729 et seq, and state analogs, against several defendants.  Sanofi-Aventis 2020 Del. Lexis at *2. The three individuals’ partnership agreement contained the following provision: “the Partnership shall not be a separate legal entity distinct from its Partners.” Id. at 4. The Third Circuit explained the likely reason for this provision: if the original partnership was a separate legal entity, the fact that it did not exist at the time the alleged fraud occurred would prevent it from being an “original source” with direct knowledge of the fraud under the pre-amendment FCA. Sanofi-Aventis 2020 Del. Lexis at *4-5, citing In re: Plavix Marketing, Sales Practices and Products Liability Litigation (No. II), 315 F.Supp. 3d 817 at 381(D.N.J. 2018), appeal docketed, No. 19-2472 (3d Cir. July 3, 2018) [hereinafter Opinion].[1] Nine days after its formation, the relator partnership filed the qui tam complaint against Sanofi-Aventis U.S. LLC, Sanofi-Aventis U.S. Services, Inc., Aventis, Inc., Aventis Pharmaceuticals, Inc., Bristol-Myers Squibb Company, and Bristol-Myers Squibb Pharmaceuticals Holding Partnership  In their complaint, the relator partnership alleged that each of the original partners were an  “original source” of the information upon which their allegations were based. While the case was pending, one of the partners left the partnership and was replaced by another physician partner. Read More

Postponed: Pietragallo Partner Chris Iacono to present at Cyberlaw Update 2020 in Pittsburgh

2020/04/27

The Pennsylvania Bar Institute will be holding it’s next Cyberlaw Update program on April 27, 2020 in Pittsburgh. During this program, attendees will discuss: experiences with new state and EU regulations on privacy, current security dangers and data breach responses, the impact of Artificial Intelligence (AI), cloud and other technologies in business, electronic communication and its impact on litigation and discovery, and ethical challenges with social media and the ever-changing social technology environment. Pietragallo Partner Chris A. Iacono is faculty of the program. He will co-present during a Cyber and Litigation segment titled, “Responding to Data Breaches: Legal Updates and Practical Counsel.” THIS EVENT HAS BEEN POSTPONED. PLEASE SUBSCRIBE TO OUR FIRM NEWSLETTER FOR ALERTS AND UPDATES.   Read More

Postponed: It’s Not Just Cash In a Bag: Exploring Corruption From Both Sides of the Table

2020/03/19

Corruption is in the news all-too-often today. Join Assistant U.S. Attorney Eric Gibson along with Pietragallo partners Lourdes Sánchez Ridge and John Schwab to discuss how prosecutors make charging decisions in corruption cases and the minefields that defense attorneys must navigate to prepare clients under investigation. This CLE will cover an overview of federal corruption offenses and related crimes with a focus on some recent cases and developments. Attendees will hear perspectives from both sides of the courtroom. For more information about this exciting event, which will be taking place on March 19th in our Philadelphia office, please contact a member of our Events team via email: news@pietragallo.com   This event has been postponed. Please email NEWS@pietragallo.com to subscribe to updates. Read More

Marc S. Raspanti to speak at the Federal Bar Association’s 2020 Qui Tam Conference

2020/02/27

Nationally-recognized qui tam attorney, Marc S. Raspanti, will be speaking at the Federal Bar Association’s 2020 Qui Tam Conference in Washington, DC on Thursday, February 27, 2020. This two-day conference will feature experienced FCA litigators from a variety of perspectives who will dive into advanced topics and discuss emerging trends and key developments pertaining to the False Claims Act. Mr. Marc Raspanti will be sitting on the third panel of the program and will discuss, with other experts, the topic of multi-relator cases. For more information about this event, please visit the Federal Bar Association website here. For more information about our False Claims Act and Qui Tam practice, please visit our resource center. Read More

Kevin Raphael Shares 2020 Outlook on Fraud & Abuse in Inaugural Podcast Episode

2019/12/17

Pietragallo Partner, Kevin Raphael, who works out of the Philadelphia office of Pietragallo Gordon Aflano Bosick & Raspanti, LLP recently participated in a podcast in which he shared his 2020 outlook regarding fraud and abuse in the healthcare industry. The episode, by the Fraud and Abuse Practice Group of the American Health Lawyers Association (“AHLA”), is titled, “Expert Insights – Fraud and Abuse: 2020 Outlook.” This inaugural monthly podcast, by the Fraud and Abuse Practice Group, helps listeners stay informed about fraud and abuse compliance issues and recent developments in enforcement activity. The AHLA Podcast as a whole shared its first episode on January 22, 2018. The AHLA Podcast ended its 2018 season with 15 episodes total. In 2019, the podcast nearly doubled its content for listeners including topics such as “Physician/Employee Tax Issues,” “Best Practices for IRC 4960,” and “Navigating Your Career in Health Law.” Visit the AHLA website to listen to the “Fraud and Abuse: 2020 Outlook” episode from your desk. If you would like to listen while in transit, you can also access the episode via Apple Podcast, Buzzsprout, and Google Play. For more information about the AHLA, please visit their website. For more information about Kevin Raphael, we invite you to review his biography and contact him directly. Read More

Pamela Coyle Brecht to present, “Forensic Accounting and Anti-Kickback Implications in Healthcare Transactions” in January

2020/01/21

Ms. Pamela Coyle Brecht will present, with David Glusman of Marcum, “Forensic Accounting and Anti-Kickback Implications in Healthcare Transactions” in January. You can attend this event in person or stream it live from your desktop. During this presentation, attendees will: • Learn about the issues in healthcare that can give rise to claims of fraud • Understand what fair market value means in today’s health care environment, at the state and federal levels • Review real instances of the USA pursuing fraud in healthcare and gain an understanding of the issues • Lean about the whistleblower system and Qui Tam litigation in health care To register for this event, please visit here. Read More

The Pietragallo Law Firm is recognized as a “Best Law Firm” by U.S. News & World Report

2019/11/01

U.S. News & World Report recognizes Pietragallo Gordon Alfano Bosick & Raspanti, LLP as a 2020 Tier 1 Metro “Best Law Firm” in six practice areas in Pittsburgh and Philadelphia. These six practice areas are: Commercial Litigation (PGH & PHL) Bet-the-Company Litigation (PGH) Health Care Law (PHL) Medical Malpractice Law – Defendants (PGH) Personal Injury Litigation – Defendants (PGH) and Workers’ Compensation Law – Employers (PGH). In addition to the Tier 1 Metro ratings, Pietragallo was named a Tier 2 Metro “Best Law Firm” in Pittsburgh in the practice of Product Liability Litigation – Defendants. Pietragallo has also been named as Tier 2 across the nation in Commercial Litigation and Tier 3 nationally for our work in Health Care Law. The U.S. News & World Report’s “Best Law Firms” rankings are based on a rigorous evaluation process that includes the collection of client and lawyer evaluations, peer review from leading attorneys in their field, and review of additional information provided by law firms as part of the formal submission process. Clients were asked to provide feedback on firm practice groups, addressing: expertise, responsiveness, understanding of a business and its needs, cost-effectiveness, civility, and whether they would refer another client to the firm.  Lawyers also voted on expertise, responsiveness, integrity, cost-effectiveness, whether they would refer a matter to a firm, and if they consider a firm a worthy competitor. Firms included in the 2020 “Best Law Firms” list are recognized for professional excellence with persistently impressive ratings from clients and peers. Achieving a tiered ranking signals a unique combination of quality law practice and legal expertise. For more information on the 2020 “Best Law Firms” and Pietragallo’s ratings, please visit http://bestlawfirms.usnews.com. Read More

Pamela Coyle Brecht to Present at PBI’s Health Law Institute 2020

2020/03/11

Pietragallo Gordon Alfano Bosick & Raspanti, LLP Partner Pamela Coyle Brecht will be presenting at the Pennsylvania Bar Institute’s (“PBI”) Health Law Institute on March 11-12, 2020. Ms. Brecht’s session topic is, “The False Claims Act Update.” The PBI notes that the Health Law Institute is, “The event of the year for every health law professional.” The Health Law Institute 2020 brings health law professionals comprehensive update, insights and practical advice – and the opportunity to tailor your own personalized agenda through numerous breakout session options in addition to the plenary sessions. For more information about the Health Law Institute 2020, please visit the PBI’s website. For more information about the Chair of our False Claims Act group, Pamela Coyle Brecht, please visit her biography or contact her directly. Read More

CMS And HHS-OIG Issue Proposed Stark Law Exceptions And Anti-Kickback Safe Harbors To Facilitate Movement Toward Coordinated Care And Value-Based Reimbursements

2019/10/18

What Happened: As federal payors move away, with increasing speed, from fee-for-service payments toward value-based payment reforms, CMS and HHS-OIG released, on October 9, 2019, proposed Stark Law Exceptions and Anti-Kickback Statute Safe Harbors to better permit health care providers to engage in coordinated care reimbursed by these value-based payments.  The proposed Rules remove “potential barriers to more effective coordination and management of patient care and delivery of value-based care that improves quality of care, health outcomes, and efficiency.”  HHG-OIG proposed Rule at 5. In summary, the proposed Rules create several new terms, all which define aspects of the value-based changes central to the proposed Rules’ purpose.  The proposed Anti-Kickback Statute Rule creates six new Safe Harbors to the Anti-Kickback Statute, modifies four existing Safe Harbors, and provides clarification on certain statutory requirements.  CMS’s proposed Stark Law Rule creates value-based Exceptions to Stark and provides additional guidance related to the Stark Law’s application to value-based care and clarifies its application to existing Exceptions.  The proposed Rules, if adopted, will impact hospitals, physician groups, other care providers along the continuum of care, and vendors providing support services to healthcare providers, including EHR, security technology, and transport services.  Importantly, the application of these proposed Rules is limited in many regards as to pharmaceutical companies, durable medical equipment distributors and suppliers, and laboratories.  HHS-OIG is still contemplating whether to also exclude medical device manufacturers, PBMs and pharmacies from its proposed Rule’s application. The government has solicited comments to these proposed Rules, and there is a 75-day deadline for interested parties to submit comments.  After review of the comments, it is expected that final Rules will be published in 2020. The Devil is in the Details: I. The Anti-Kickback Statute Proposed Rule A. The New Terminology In order to integrate value-based care and value-based reimbursement into the existing Anti-Kickback Statute framework, HHG-OIG has defined six new terms, all of which play integral roles in the new Value-Based Safe Harbors created by the proposed Rule.  Read More

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