Acting U.S. Attorney Audrey Strauss said:Progenity received millions of dollars from federal healthcare programs through its fraudulent billing and kickback schemes. Policy and Medicine Compliance Update September 2021 Issue Reviews State Pricing Policies, Sakler Settlement, Compliance via Faith, DOJs Focus on Telemedicine, Biden Administration Announces Drug Pricing Plan, Advanced Bionics to Pay More than $12 Million Over False Claims Allegations, Three California Providers Settle $22.5 Million Settlement for Submission of False, Sutter Health Reaches $13 Million Settlement Over False Claims Act Allegations, DOJ Continues to Prosecute False Claims Act Cases. In August 2020, the Company disclosed that an audit uncovered it had overbilled the U.S. government by $10.3 million more than previously disclosed due to the incorrect use of a billing code, the same discontinued legacy billing practices that the Company had previously represented had been remediated.. Biora is the biotech company reimagining therapeutic delivery. By creating innovative smart pills designed for targeted drug delivery to the GI tract and systemic, needle-free delivery of biotherapeutics, we are developing therapies to improve patients lives. Organizing Committee; CPD Schedule; Online CPD; IRR CPD; Cost Realignment. <> Criminal Referrals and OSHA Violations, Part III: Industry Standards Oregon House Revenue Committee Set to Hear More About Pro-Taxpayer Buying or Selling a Small Business Government Contractor? On June 19, Progenity priced its initial public stock offering at $15 per share, raising more than $100 million. This includes more than 170 issued patents and pending applications, directed toward 17. To achieve this vision, simplify its business model, and unlock shareholder value, the company will seek to reallocate resources to R&D and materially reduce operating expenditures by approximately 70%. If you would ike to contact us via email please click here. It develops and designs oral biotherapeutics. A lawsuit filed Wednesday in federal court is seeking millions of dollars in damages from the city of Hollywood, its police, fire and beach safety departments and three individual police officers . This sales slowdown resulted in a $36.9 million loss from continuing. It spurred a lawsuit and now the FDA has, as of today, ordered side effects to be labeled on the box. Progenity is a California-based biotechnology company that develops and commercializes therapeutics for the treatment of gastrointestinal diseases. First, from January 2012 through March 2016, PROGENITY paid draw fees to physicians or physician offices for blood specimens collected for PROGENITY tests. Investors, who purchased shares of Progenity, Inc. (NASDAQ: PROG), have certain options and should contact the Shareholders Foundation at mail@shareholdersfoundation.comor call +1(858) 779-1554. Second, from 2012 through 2018, PROGENITY sales representatives provided food and alcohol to physicians and their staff at gatherings, including happy hours and birthday or holiday parties, that often involved little or no educational content. Progenity, a San Diego biotechnology company that went public last month, will pay $49 million as part of a settlement for overbilling federal health insurance programs and paying kickbacks to physicians who ordered the companys prenatal genetic tests. Prior to founding Rockpointe, Thomas worked as a political consultant. The National Law Review - National Law Forum LLC 3 Grant Square #141 Hinsdale, IL 60521 Telephone (708) 357-3317 ortollfree(877)357-3317. Statement in compliance with Texas Rules of Professional Conduct. The Shareholders Foundation, Inc. is not a law firm. Creditor Stung By Academy Of Motion Picture Arts And Sciences Bylaws. California Assembly Bill Pushes for Womens Designated Restrooms on Mississippi Legislature Takes Up Pass-Through Entity Election FTC Signals Increased Scrutiny of Technology Sector Through Understanding the Corporate Transparency Act and Ensuring Compliance. SAN DIEGO, CA / ACCESSWIRE / July 6, 2021 / The Shareholders Foundation, Inc. announces an update in the lawsuit that is pending for certain investors in shares of Progenity, Inc. (NASDAQ: PROG). We expressly disclaim any obligation to update or alter any statements whether as a result of new information, future events or otherwise, except as required by law. Learn More. {o'? Invest better with The Motley Fool. Third, from January 2012 through April 2018, to market its expensive tests, PROGENITY routinely reduced or waived coinsurance and deductible payments without making the required individualized determination of financial need or reasonable collection efforts. Alec Baldwin and "Rust" movie productions were named in a negligence lawsuit filed by three former crew members who say they witnessed the on-set shooting death of cinematographer Halyna Hutchins . The relator also alleges that despite Abbotts controls that are reportedly in place to prevent these kickback activities, when the Relator lodged complaints with Abbotts Office of Ethics & Compliance and Employee Relations Department with specific details about the practice-building activities and kickback scheme, Relator received no response or indication that an investigation would be conducted to address these practices, thereby signaling a lack of any effective enforcement of the supposed compliance policies and procedures. The Company and certain of its executives have been sued in a securities class action lawsuit, charging them with failing to disclose material information during the Class Period, violating federal securities laws, which is ongoing. Specifically, the plaintiff alleges that the Registration Statement failed to disclose,inter alia, the following adverse facts that existed at the time of the IPO, rendering numerous statements provided therein materially false and misleading, that Progenity had overbilled government payors by $10.3 million in 2019 and early 2020 and, thus, had materially overstated its revenues, earnings and cash flows from operations for the historical financial periods provided in the Registration Statement, that Progenity would need to refund this overpayment in the second quarter of 2020 (the same quarter in which the IPO was conducted), adversely impacting its quarterly results, and that Progenity was suffering from accelerating negative trends in the second quarter of 2020 with respect to the Companys testing volumes, revenues and product pricing. Progenity. Telephone and Texting Compliance News: Regulatory Update February 2023. One example of a management tactic used to get patient referrals for the implanting doctors cited in the complaint was known as Fill and Empty the Funnel. Abbotts National Sales Director would carry a large red funnel to sales meetings and repeatedly say fill and empty the funnel to instruct the sales and marketing team how to promote the MitraClip device: the team was to fill the funnel with patients referred by non-implanting physicians who were induced to refer with free meals, cocktail parties, and dinner events and then empty the funnel by inducing implanting physicians with the same tactics to treat the referred patients with the MitraClip device. Admits to Fraudulently Using Wrong Billing Code, Paying Draw Fees to Physicians, and Providing Meals and Happy Hours to Physicians and Their Staff, Jim Margolin, Nicholas Biase Do Issuers Fail To File Form Ds Because They Fear Trolls? It has gone from having $91.5 million in cash last Dec. 31 to $65.9 million at the end of June, to $54.1 million at the end of September. No attorney-client or confidential relationship is formed by the transmission of information between you and the National Law Review website or any of the law firms, attorneys or other professionals or organizations who include content on the National Law Review website. Continued development of oral biopharmaceuticals delivery system (OBDS) programs designed for optimized systemic uptake focusing on monoclonal biotherapeutics based on promising preclinical data. Friday Development: New Sanctions and Export Controls to Address Weekly IRS Roundup February 20 February 24, 2023, Everything to Know About Unbundled Legal Services. Our Office will continue to hold healthcare providers accountable when they engage in fraud and other illegal conduct., HHS-OIG Special Agent in Charge Scott J. Lampert said: Kickbacks and fraudulent billing schemes undermine the integrity of our healthcare system, compromise patient care, and increase the financial burden on taxpayers. These fees exceeded the fair market value of the services performed. Most of the misconduct occurred between 2012-2018. Under the settlement approved on July 23, 2020, PROGENITY will pay $19,449,316 to the United States to resolve kickback and fraudulent billing claims. In the complaint, Abbott is accused of participating in a scheme of kickbacks to doctors and hospitals to boost the use of their MitraClip device used in heart procedures to repair leaks to the mitral valve. Lewis Kahn, Managing Partner If you require legal or professional advice, kindly contact an attorney or other suitable professional advisor. We also appreciate the healthcare providers, patients, and other stakeholders that have placed trust in us at critical life moments for more than a decade.. The Path Forward. California Law May Limit Hospitals Ability to Adopt The Joint Ankura CTIX FLASH Update - February 28, 2023, Ankura Cyber Threat Investigations and Expert Services. 11 0 obj The CIA promotes compliance with the statutes, regulations, program requirements, and written directives of federal healthcare programs. Jim Halley has no position in any of the stocks mentioned. June 11, 2021 10:50 PM Eastern Daylight Time NEW ORLEANS-- ( BUSINESS WIRE )--Former Attorney General of Louisiana, Charles C. Foti, Jr., Esq., a partner at the law firm of Kahn Swick & Foti, LLC. And PROGENITY had agreements with several physicians that it would not collect any payments from their patients. Will the U.S. Supreme Court Make Marijuana Legal? %PDF-1.4 Biora Therapeutics Announces Improved Bioavailability Results for its Systemic Delivery Platform Feb 16, 2023. You can change your choices at any time by visiting your privacy controls. In total, PROGENITY expended millions of dollars on food and drinks for physicians and their staff during this period. The draw fees paid by PROGENITY exceeded the fair market value of the services performed when collecting blood specimens. Founded in 1993 by brothers Tom and David Gardner, The Motley Fool helps millions of people attain financial freedom through our website, podcasts, books, newspaper column, radio show, and premium investing services. Labor Board Flip-Flops Again on Severance FRB Governor Bowman Speaks on Bank Regulation and Supervision. Investors, who purchased shares of Progenity, Inc. (NASDAQ: PROG), have certain options and should contact the Shareholders Foundation at mail@shareholdersfoundation.com or call +1 (858). With those newly approved patents, Progenity now has a sizable GI-targeted therapeutics portfolio. The company misrepresented the tests it performed, and tried to get doctors to order Progenity tests by paying them excessive fees and providing meals and happy hours for them and their staff. As a result of fraudulently using CPT code 88721 and misrepresenting the type of test performed when submitting claims for payment to Medicaid and the VA for NIPTs, PROGENITY received payments for non-reimbursable tests, or received substantially higher payments than it was entitled to receive for the genetic testing services provided. Currently limited by Federal law to investigational use only. SAN DIEGO, June 15, 2021 (GLOBE NEWSWIRE) -- The Shareholders Foundation . In total, PROGENITY paid over $1.7 million in draw fees during this period. The relator notes that through a pervasive kickbacks scheme developed by Abbott management and ratified at the highest levels of the Company, Abbott is developing a loyal stable of referring and implanting physicians and hospitals. To carry out its referral scheme, Abbott allegedly targets non-implanting physicians (physicians who are not certified to implant the MitraClip device) and induces them through free lunches, cocktail parties, and dinner conferences to refer their cardiac patients to Abbotts targeted implanting physicians and hospitals for the transcatheter mitral valve repair (TMVR) procedure using the MitraClip device. In light of the impact of this strategic transformation, the company is withdrawing previously announced financial guidance for 2021. Challenges to the No Surprises Act Continue: The Latest includes a Navigating Permissive State Laws in Light of the Federal Information FDA Publishes List of 2023 Priority Guidance Topics. All statements, other than statements of historical facts included in this press release, including statements regarding the Companys transformation activities and expected benefits and costs savings; potential benefits from a strategic and cost realignment, including potential future growth; potential future strategic transactions; potential addressable market sizes; our ability to deliver value for shareholders; the timing for future milestones, including the commencement of clinical trials and validation of Preecludia; the potential for our innovation pipeline; the development of our DDS and OBDS platforms; the potential benefits of the DDS and OBDS platforms; the development pipeline of therapeutic candidates that use the DDS and OBDS platforms; and the development of drug-device combination products, are forward-looking statements. Biora Therapeutics Announces Bioavailability Results for Oral Delivery of GLP-1 Receptor Agonist Feb 23, 2023. Progenity said it cooperated with the Justice Department and other agencies involved in the investigation. The company is in the midst of changing its focus and tightening its expenditures. The plaintiff alleges that the Registration Statement that was filed in connection with Progenitys June 2020 initial public offering ("IPO") was negligently prepared and, as a result, contained untrue statements of material fact, omitted material facts necessary to make the statements contained therein not misleading, and failed to make the necessary disclosures required under the rules and regulations governing its preparation. The lawsuit further alleges that PROGENITY provided illegal kickbacks in the form of excessive draw fees to physicians, meals and happy hours for physicians and their staff, and the improper reduction or waiver of patient coinsurance and deductible payments. Customer Reviews: Five-Star Enforcement and the Expanding Regulations. :K6|0: On February 4, 2021, an amended complaint was filed and on April 5, 2021, the defendants filed their motion to dismiss the case. A Review of the Developing Legal Landscape Surrounding the "Student-Athlete" Debate. The company said it has stopped the business and billing practices that came under fire, as well as enhanced its internal controls and compliance procedures. You may occasionally receive promotional content from the San Diego Union-Tribune. By progressively concentrating resources on the PreecludiaTM test, GI health, and oral biopharmaceuticals opportunities, Progenity hopes to unlock significant value for shareholders and improve patient outcomes. Uncategorized. To learn more about KSF, you may visit www.ksfcounsel.com. ^M! It is not intended as legal advice and should not be relied upon. 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