Allegations were made of kickbacks in the form of co-pay waivers.
Late last month, US WorldMeds, a pharmaceutical manufacturer, agreed to pay the U.S. Department of Justice (DOJ) $17.5 million to resolve two whistleblowers’ claims that it violated the False Claims Act (FCA) by paying kickbacks to patients and doctors to boost sales of two of their drugs, Apokyn, a drug used to treat Parkinson’s disease, and Myobloc, a drug used to assist in certain high-risk pregnancies. This settlement illustrates the sheer variety of forms alleged kickbacks paid to physicians can take and how lucrative they can be.
Broadly speaking, the Anti-Kickback Statute prohibits healthcare providers, including pharmaceutical companies, from paying or receiving kickbacks, remuneration, or anything of value to induce patients to purchase or use a company’s drugs. The law seeks to prevent physicians from prescribing medically unnecessary medications. The Anti-Kickback Statute is also intended to ensure that a physician’s medical judgment is not compromised by financial incentives and is solely based on the best interests of the patient.
The DOJ settlement with US WorldMeds resolves allegations surrounding two basic schemes. The first scheme allegedly sought to induce patients to purchase Apokyn by offering them waivers of co-pays, a fee that Medicare beneficiaries are required to pay for medications. These fees are generally paid in the form of a co-payment of a deductible, and they are legally mandated. Drug makers reimbursing patients for these costs, however, can run afoul of the Anti-Kickback Statute.
After US WorldMeds raised prices of Apokyn in 2012, many patients’ co-pays exceeded $5,000 a year. At the same time, US WorldMeds allegedly funded a third-party foundation that paid the co-pays of many patients with the goal of increasing the sales of Apokyn at the new, higher rate. US WorldMeds was the foundation’s only donor.
For the second scheme, US WorldMeds allegedly provided certain physicians with kickbacks that were meant to induce them to prescribe more Apokyn and Myobloc. According to the complaint, the doctors were paid excessive consulting and speaker fees and also were bought lavish meals, private plane rides to Hawaii, and all-expenses-paid trips with their spouses to the Kentucky Derby, where one doctor was seated in the US WorldMeds company box. The schemes were alleged to be both large, long-running, and nationwide.
In addition to paying $17.5 million, US WorldMeds entered into a five-year corporate integrity agreement with the government. Under the terms of the agreement, US WorldMeds will need to hire an outside independent review organization to monitor its promotional activities and its interactions with third-party charities.
These alleged fraud schemes were revealed in two different lawsuits brought by two whistleblowers, Brian Bennett, a former national sales director, and Dr. Robert Chinnapongse, a former senior medical director at US WorldMeds. The whistleblowers will receive an award of more than $3 million under provisions of the FCA’s qui tam, which allow private persons to file suit against entities that defraud the government and if their suits are successful, whistleblowers are entitled to receive between 15 and 25 percent of the government’s recovery.
The US WorldMeds whistleblowers alleged further wrongdoing, such as off label marketing of the drugs for cosmetic dental use. Those allegations, however, have not been resolved.
As these cases demonstrate, the vigilant and discerning eyes of pharmaceutical employees are essential in combating the increasing number of alleged frauds involving kickbacks, given that business relationships such as the one between US WorldMeds and physicians are often opaque and require the perspective of company insiders.
Let me open by saying I am so happy to be here. For those of you who watched the live version of last week’s Monitor
Imagine the frustration you might feel if, after you negotiate a settlement, under which you are paying a departing employee a respectable sum of money,
Please log in to your account to comment on this article.
Join Beth Wolf, MD, CPC, CCDS, for an in-depth webcast on the FY2025 spinal fusion MS-DRG updates. Discover key changes in DRG classification, understand impacts on documentation and CMI, and learn strategies to ensure compliance.
Join Angela Comfort, DBA, MBA, RHIA, CDIP, CCS, CCS-P, as she presents effective strategies to strengthen collaboration between CDI, coding, and quality departments in acute care hospitals. Angela will also share guidance on implementing cross-departmental meetings, using shared KPIs, and engaging leadership to foster a culture of collaboration. Attendees will gain actionable tools to optimize documentation accuracy, elevate quality metrics, and drive a unified approach to healthcare goals, ultimately enhancing both patient outcomes and organizational performance.
Optimize your outpatient clinical documentation and gain comprehensive knowledge from foundational practices to advanced technologies, ensuring improved patient care and organizational and financial success. This webcast bundle provides a holistic approach to outpatient CDI, empowering you to implement best practices from the ground up and leverage advanced strategies for superior results. You will gain actionable insights to improve documentation quality, patient care, compliance, and financial outcomes.
Enhancing outpatient clinical documentation is crucial for maintaining accuracy, compliance, and proper reimbursement in today’s complex healthcare environment. This webcast, presented by industry expert Angela Comfort, DBA, RHIA, CDIP, CCS, CCS-P, will provide you with actionable strategies to tackle complex challenges in outpatient documentation. You’ll learn how to craft detailed clinical narratives, utilize advanced EHR features, and implement accurate risk adjustment and HCC coding. The session also covers essential regulatory updates to keep your documentation practices compliant. Join us to gain the tools you need to improve documentation quality, support better patient care, and ensure financial integrity.
Dr. Ronald Hirsch provides critical details on the new Medicare Appeal Process for Status Changes for patients whose status changes during their hospital stay. He also delves into other scenarios of hospital patients receiving custodial care or medically unnecessary services where patient notifications may be needed along with the processes necessary to ensure compliance with state and federal guidance.
Healthcare organizations face complex regulatory requirements under the No Surprises Act and Price Transparency rules. These policies mandate extensive fee disclosures across settings, and confusion is widespread—many hospitals remain unaware they must post every contracted rate. Non-compliance could lead to costly penalties, financial loss, and legal risks. Join David M. Glaser Esq. as he shows you how to navigate these regulations effectively.
Protect your facility from unwanted audits! Join Becky Jacobsen, BSN, RN, MBS, CCS-P, CPC, CPEDC, CBCS, CEMC, and take a deep dive into both the CMS and AMA guidelines for reporting post operative pain blocks. You’ll learn how to determine if the nerve block is separately codable with real life examples for better understanding. Becky will also cover how to evaluate whether documentation supports medical necessity, offer recommendations for stronger documentation practices, and provide guidance on educating providers about documentation requirements. She’ll include a discussion of appropriate modifier and diagnosis coding assignment so that you can be confident that your billing of post operative pain blocks is fully supported and compliant.
During this RACmonitor webcast Dr. Ronald Hirsch spotlights the areas of the OIG’s Work Plan and the findings of their most recent audits that impact utilization review, case management, and audit staff. He also provides his common-sense interpretation of the prevailing regulations related to those target issues. You’ll walk away better equipped with strategies to put in place immediately to reduce your risk of paybacks, increased scrutiny, and criminal penalties.
Copyright © 2024 RACmonitor. Powered by MedLearn Media.
Happy National Doctor’s Day! Learn how to get a complimentary webcast on ‘Decoding Social Admissions’ as a token of our heartfelt appreciation! Click here to learn more →
CYBER WEEK IS HERE! Don’t miss your chance to get 20% off now until Dec. 2 with code CYBER24
