Kahn Swick & Foti, LLC Closure of genetics lab and other operational improvements expected to result in approximately 70% reduction of annual capital required for operations from more than $180 million currently to targeted operating expenses of ~$50 million in 2022, Continuing to seek opportunities to generate non-dilutive capital through partnerships and strategic alternatives for non-core assets, including Avero Diagnostics, which may help fund the company, Focused on delivering on exciting 2021 and 2022 R&D pipeline with the PreecludiaTM test, gastrointestinal (GI) health, and oral biopharmaceutical program milestones Management to host webcast and conference call today at 8:30 a.m. 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. Along with our law enforcement partners, HHS-OIG will continue to ensure that those billing federal health insurance programs do so in an honest manner., DCIS Special Agent in Charge Leigh-Alistair Barzey said: Ensuring the integrity of TRICARE, the U.S. Defense Department's healthcare system for military members and their families, is top priority for the DCIS. The company is progressing towards achieving initial development milestones in the next two quarters. Incorporated in 2012, Progenity develops non-invasive molecular tests to detect genetic markers in prenatal medicine, according to its prospectus. As a result, PROGENITY received payments for non-reimbursable tests, or received substantially higher payments than it was entitled to receive. Opportunities for Non-Dilutive Capital Infusion. For the vast majority of the relevant period, PROGENITY did not limit or even monitor the total amount its sales representatives spent on a physician. Find out more about how we use your information in our privacy policy and cookie policy. Therefore, the complaint alleges, Abbott knowingly caused the submission of thousands of false claims for payments to government healthcare programs. Under the settlement approved today by U.S. District Judge Loretta A. Preska, PROGENITY will pay $19,449,316 to the United States to resolve the kickback claims and the Medicaid and VA fraudulent billing claims, and also makes extensive admissions regarding the companys conduct. The suit comes shortly after Progenity filed for an initial public offering in which it is seeking to raise up to $122.6 million. In the first half of 2022, the company anticipates the initiation of the first clinical study evaluating a therapeutic delivered with DDS. 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Nota Bene Episode 160: European Update: Oliver Heinisch and Scott Federal Communications Commission to Consider Rules and Proposals to Whats the Standard? The information is only provided as a public service. 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. Advancement of its PreecludiaTM preeclampsia rule-out test through validation and progressing physician education programs, clinical utility, health economics, and reimbursement. 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. 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 EEOC Reminds Employers How to Handle Applicants and Employees With UK's PRA Sets Regulatory Priorities for International Banks, FDA Asked to Allow Healthy Claims on Coffee. 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. The National Law Review is not a law firm nor is www.NatLawReview.com intended to be a referral service for attorneys and/or other professionals. Abbott also targeted implanting physicians through patient referrals, sham speaker program honoraria, free patient marketing and practice building, and promises to participate in future clinical trials. In connection with this settlement, the Government joined a private whistleblower lawsuit that had been previously filed under the False Claims Act, which alleged that PROGENITY engaged in illegal kickback schemes. Telephone and Texting Compliance News: Regulatory Update February 2023. 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. The company is in the midst of changing its focus and tightening its expenditures. Progenity's in-network affiliate lab, Avero Diagnostics, is approaching operating profitability, with growing revenues projected to be $35-40 million for 2021 derived from anatomic pathology,. Type Public Status Active Founded 2010 HQ NEW YORK (Reuters) -A U.S. judge on Wednesday dismissed a lawsuit accusing Bristol Myers Squibb Co of defrauding investors who stood to receive $6.4 billion had it won federal approval by . 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. Good News for American Businesses: H1-B Denial Rates Plummet Under USCIS Extends Comment Period for Proposed Fee Increases, OFCCP Rescinds Trump-Era Religious Exemption Rule. With those newly approved patents, Progenity now has a sizable GI-targeted therapeutics portfolio. Thomas Sullivan is Editor of Policy and Medicine, President of Rockpointe Corporation, founded in 1995 to provide continuing medical education to healthcare professionals around the world. Making the world smarter, happier, and richer. IT'S HAPPENING! Statement in compliance with Texas Rules of Professional Conduct. The Motley Fool has no position in any of the stocks mentioned. Progenity makes non-invasive molecular tests to detect genetic markers in prenatal medicine. Biora Therapeutics Announces Improved Bioavailability Results for its Systemic Delivery Platform Feb 16, 2023. Progenity is a California-based biotechnology company that develops and commercializes therapeutics for the treatment of gastrointestinal diseases. Strictly Confidential? Become a Motley Fool member today to get instant access to our top analyst recommendations, in-depth research, investing resources, and more. It spurred a lawsuit and now the FDA has, as of today, ordered side effects to be labeled on the box. Our company was founded in 2010 as Ascendant MDx, Inc., and changed its name in 2013 to Progenity, Inc. Our initial public offering was June 19, 2020. KSF serves a variety of clients including public institutional investors, hedge funds, money managers and retail investors in seeking to recover investment losses due to corporate fraud and malfeasance by publicly traded companies. 2023 Biora Therapeutics, Inc. All rights reserved. Not for sale in the U.S. Draft the To Each Their Own: Agency Must Consider Experience of Each Partner in CMS Updates List of Telehealth Services for CY 2023, What You Need to Know About the New Tariffs on Imports from Russia. {o'? Some states have laws and ethical rules regarding solicitation and advertisement practices by attorneys and/or other professionals. 4 0 obj The National Law Review is a free to use, no-log in database of legal and business articles. 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. As the government recognized, Progenity has made significant strides in compliance policies and controls, accepting full responsibility for the historical misconduct at issue, said Harry Stylli, co-founder and chief executive of the company, in a statement. It is the second time in less than a month that Progenity has taken off on a short-squeeze-fueled frenzy. Those numbers were an improvement from the $52,000 in revenue and net loss of $47 million it reported in the same period a year ago, but the company seems to be long way from making a profit. On February 4, 2021, an amended complaint was filed and on April 5, 2021, the defendants filed their motion to dismiss the case. The last time the stock was at $5 was in early April. Invest better with The Motley Fool. Government healthcare payors rely on the CPT code to determine whether the procedure or service is covered, as well as the level of reimbursement. We are grateful for their dedication and support over these past years. Proposed Nursing Home Disclosure Requirements Target Private Equity Regulation in the Post-FTX Environment: SECs Proposed Enhanced Can a Child Decide Whom They Want to Live With in Michigan? Leading with innovation also enables Progenity to exercise greater control over our costs, as a significant proportion of the companys spend is discretionary and milestone driven. x]Uxyko[M.H'kJ$LJ"'9L^uQa6(/(L!?xTJ2O}/?I$`EmDyoe.5\x!l7v.1x*=t({'M12 4A#lm` n7 5yns ya This includes more than 170 issued patents and pending applications, directed toward 17. P R O G E N I T Y, I N C . It also tried to get doctors to order Progenity tests by paying them excessive draw fees and providing meals and happy hours for physicians and their staff. One former sales representative spent $65,658 on meals and alcohol for physicians during a single year. First Offshore Wind Energy Lease Sales in the Gulf of Mexico, Telephone and Texting Compliance News: Litigation Update February 2023. Access additional case information on PACER Use the links below to access additional information about this case on the US Court's PACER system. The Path Forward. PROGENITY frequently paid physicians $20 or more for each blood draw. , a single member Delaware LLC whose sole member was employed by Abbott from August 2015 to April 2017 as a Therapy Development Specialist in its Structural Heart Division. In 2021, the company underwent a strategic transformation to focus on our innovative therapeutics pipeline, and in 2022 we became Biora Therapeutics, Inc. We are currently focused on developing therapeutics technologies that improve patients lives, through a revolutionary combination of drug therapies and smart capsule technology. Under certain state laws the following statements may be required on this website and we have included them in order to be in full compliance with these rules. <> To develop innovative smart-pill technologies that improve patients lives. Zma 2000 Male Enhancement. These fees exceeded the fair market value of the services performed. endobj h k%|~7~UZ=?=}deSz~I*+/{fO_$|Oe*f#{'nh1gifI3`K"Id)4)el`]xxm2BPM[i 5YR&a+WF-0g nZF =qCS'h 6*1q1] tj6HXjEtEIjAA_XyB n \)Z&emDG'&TbiPfdRqc3c|@rBN3J4 '3p#+g13uQ`AzmfdY/5cIeR)vx For example, PROGENITY did not (i) reliably track the amount it spent on meals and happy hours for physicians or their staff, (ii) maintain accurate sign-in sheets reflecting attendance at PROGENITY-sponsored gatherings, (iii) keep records of materials or topics that were discussed during PROGENITY-sponsored gatherings, and (iv) implement and enforce limits on the total nonmonetary compensation that could be provided to physicians. According to the Justice Department, Progenity misrepresented the tests it performed, resulting in overbilling Medicaid and Veterans Affairs health insurance programs. By clicking Accept all you agree that Yahoo and our partners will process your personal information, and use technologies such as cookies, to display personalised ads and content, for ad and content measurement, audience insights, and product development. Litigation Setback for Employers Under Illinois Biometric Information Senate Committee Holds Hearing on Future of Low Carbon Transportation North Carolina Senate Passes Compassionate Care Act at Exactly 4:20 States and Feds Signal Big Changes to Telehealth Prescribing. KSF has offices in New York, California and Louisiana. Shareholders Foundation, Inc. SAN DIEGO, Nov. 17, 2020 (GLOBE NEWSWIRE) -- The Shareholders Foundation, Inc. announces that a lawsuit was filed for certain investors in NASDAQ: PROG shares. Shareholders Foundation, Inc. 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. Desperate Times, Desperate Measuring Cups FTC Brings Enforcement Trending in Telehealth: February 20 26, 2023, IRS Sets Deadline For Using 401(K) Plan Forfeitures, How Generative AI Generates Legal Issues in the Games Industry, DOJ Announces New Nationwide Voluntary Self-Disclosure Policy. These tests. Progenitys continuous pursuit of innovative solutions seeks to provide near-term commercial applications while also developing the drug delivery systems of the future, with critical near-term milestones across its PreecludiaTM pre-eclampsia rule-out test, Drug Delivery System (DDS) platform, and Oral Biopharmaceutical Delivery System (OBDS). Why Shares of Progenity Are Down More Than 11% on Wednesday, Why Progenity Stock Was Up More Than 24% Friday, Why Progenity Stock Is Soaring on Tuesday, 2 FAANG Stocks Billionaires Are Selling in Droves and 1 They Can't Stop Buying, 1 Unstoppable Growth Stock to Buy Hand Over Fist, According to Wall Street, This State Has the Highest Real Estate Taxes (and It's Not Even Close), Join Over Half a Million Premium Members And Get More In-Depth Stock Guidance and Research, Motley Fool Issues Rare All In Buy Alert, Copyright, Trademark and Patent Information. There is plenty of potential in the biotech company's pipeline as it has a portfolio of 180 patents and more than 220 pending patent applications. ET / 5:30 a.m. PT. . The companys tests include fetal chromosome detection for various conditions such as Down Syndrome; pre-pregnancy tests for genetic mutations that can cause diseases; a heredity test that screens for elevated risk of cancer, and other genetic tests for rare diseases. 3 0 obj Progenitys innovation pipeline has the potential to address markets collectively valued at greater than $200 billion. # leadership # innovation $ PROG 14 replies 59 retweets 258 likes progenity @progenity 4 Nov 2021 The lawsuit alleges that PROGENITY overbilled Medicaid and the VA by fraudulently using a billing code that misrepresented the tests being provided as well as the company providing illegal kickbacks to physicians in the form of meals, happy hours and the improper reduction or waive of patient co-insurance and deductible payments. In total, PROGENITY paid over $1.7 million in draw fees during this period. EC Appeals European General Court Decision Annulling the Harmonized Weekly Bankruptcy Alert February 28, 2023. Why Progenity Stock Is Up More Than 34% Tuesday By Jim Halley - Nov 16, 2021 at 1:57PM Key Points The company is in the midst of changing its focus and tightening its expenditures. Its shares ended trading down 3 cents at $9.01 on the Nasdaq Exchange. Multiple Concussions Result in Greater Cognitive Deficits, DOL Issues Internal Guidance on Telework Under the FLSA & FMLA, USPTO Launches Cancer Moonshot Expedited Examination Pilot Program. If you have information that would assist KSF in its investigation, or have been a long-term holder of Progenity shares and would like to discuss your legal rights, you may, without obligation or cost to you, call toll-free at 1-877-515-1850 or email KSF Managing Partner Lewis Kahn (lewis.kahn@ksfcounsel.com), or visit https://www.ksfcounsel.com/cases/nasdaqgm-prog/ to learn more. As part of the strategic transformation, Progenity will continue to evaluate its operations to better position the business for future growth and continued innovation. Progenity will discontinue providing genetic laboratory-developed test services through its Ann Arbor, Michigan CLIA-certified laboratory and cease offering its Preparent Carrier Test, Innatal Prenatal Screen, Riscover Hereditary Cancer Test, and Resura Prenatal Test. In addition, PROGENITY has agreed to pay $16.4 million to resolve similar fraudulent billing claims related to TRICARE and the Federal Employees Health Benefits Program through a separate civil settlement. Key clinical milestones are expected in the next 2-3 quarters. Milestones are expected in the first half of 2022, the company anticipates initiation. Labeled on the box Decision Annulling the Harmonized Weekly Bankruptcy Alert February 28,.! 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