Incorporated in 2012, Progenity develops non-invasive molecular tests to detect genetic markers in prenatal medicine, according to its prospectus. , 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. Abbott paid kickbacks to physicians and hospitals in the form of patient referrals, patient practice building, free patient marketing service, honoraria for sham speaker programs, rewards in the form of clinical trial opportunities, marketing events and consulting services, free lavish meals, and cocktail parties to induce physicians and hospitals to use the MitraClip device. 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.. Therefore, the complaint alleges, Abbott knowingly caused the submission of thousands of false claims for payments to government healthcare programs. Form S-1/A (general form for registration of securities under the securities act of 1933) filed with the SEC <> stream The transformation is also expected to result in annualized cost savings of approximately $130 million in SG&A. Our Office will continue to hold healthcare providers accountable when they engage in fraud and other illegal conduct.. US Executive Branch Update February 28, 2023. PROGENITY knew that many patients did not meet the medical necessity criteria for NIPTs, and that it could circumvent those requirements by billing under the incorrect billing code. Progenity makes non-invasive molecular tests to detect genetic markers in prenatal medicine. 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. Our innovative R&D pipeline has always been core to our future growth plan and has the potential to transform and address significant markets by improving patient outcomes, said Harry Stylli, PhD, CEO, Chairman of the Board of Directors, and co-founder of Progenity. Get ready for your week with the weeks top business stories from San Diego and California, in your inbox Monday mornings. To ensure the most secure and best overall experience on our website we recommend the latest versions of, Internet Explorer is no longer supported. 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. EC Appeals European General Court Decision Annulling the Harmonized Weekly Bankruptcy Alert February 28, 2023. Recent FTC Enforcement Action Merits Cyber Insurance Coverage Review, Two Ways to Redefine & Achieve CRM Success. The firm also has a handful of products under development, including precision medicine treatments for gastrointestinal disorders. With topline validation anticipated in the June/July 2021 timeframe, the PreecludiaTM test is expected to target an addressable market of up to $3 billion in the U.S. alone. The National Law Review - National Law Forum LLC 3 Grant Square #141 Hinsdale, IL 60521 Telephone (708) 357-3317 ortollfree(877)357-3317. 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. Among other things, the CIA requires that for the next five years PROGENITY must retain an Independent Review Organization to annually review the accuracy of the companys claims for services furnished to federal healthcare program beneficiaries and monitor its arrangements with other individuals and entities. Opportunities for Non-Dilutive Capital Infusion. On August 19, 2021, Everest Principals filed an amended complaint on behalf of the United States government and several states (including California, Florida, Maryland, New York, Texas, and Virginia) in the ongoing anti-kickback case against Abbott Laboratories. This is possibly great news for Progenity which has been working on the drug extensively. Since that last run, Progenity reported third-quarter earnings on Nov. 10, and it had only $182,000 in revenue and a net loss of $43.7 million. SAN DIEGO, June 15, 2021 (GLOBE NEWSWIRE) -- The Shareholders Foundation . Your email address will not be published. This sales slowdown resulted in a $36.9 million loss from continuing. If you would ike to contact us via email please click here. Its shares ended trading down 3 cents at $9.01 on the Nasdaq Exchange. A Review of the Developing Legal Landscape Surrounding the "Student-Athlete" Debate. Progenity is evaluating strategic opportunities for Avero to generate non-dilutive capital that may help fund the company. Progenity said it cooperated with the Justice Department and other agencies involved in the investigation. 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. With those newly approved patents, Progenity now has a sizable GI-targeted therapeutics portfolio. | Source:
1 0 obj The company has also agreed to pay $13,150,684 to various states to resolve these claims. Public Service Announcement on Sexual Assault in Public Housing. Progenitys vision is to transform healthcare to become more precise and personal by improving diagnoses of disease and improving patient outcomes through localized treatment with targeted therapies. 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 . %PDF-1.4 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. endobj Nota Bene Episode 160: European Update: Oliver Heinisch and Scott Federal Communications Commission to Consider Rules and Proposals to Whats the Standard? Continued development of its single-molecule detection platform, the first application of which is for noninvasive prenatal testing (NIPT), with future potential applications in oncology and GI disease in support of the RSS and PIL Dx technologies. The value of these meals and happy hours exceeded Stark Law limits. $ PROG 22 replies 36 retweets 157 likes progenity @progenity 9 Nov 2021 We're excited to announce that Adi Mohanty has been named as CEO of Progenity. endobj ;D#bWjg ng %) \ag$kkTh16-w(B@}N9Y; 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. "3X(|`kA8E{ux;R)R|F. The live call may be accessed by dialing 833-519-1237 for domestic callers and 914-800-3810 for international callers and entering the conference code: 1285219. <> Most of the misconduct occurred between 2012-2018. The content and links on www.NatLawReview.comare intended for general information purposes only. Those who purchased Progenity, Inc. (NASDAQ: PROG) shares should contact the Shareholders Foundation, Inc. One former sales representative spent $65,658 on meals and alcohol for physicians during a single year. 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. 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. In some cases, you can identify forward-looking statements by terms such as may, might, will, objective, intend, should, could, can, would, expect, believe, design, estimate, predict, potential, plan or the negative of these terms, and similar expressions intended to identify forward-looking statements. 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. It is betting that its unique drug delivery system and its multiple applications will grow profits. Biora is the biotech company reimagining therapeutic delivery. The Path Forward. FY, 2021 Market Capitalization $144.8 M 2022-07-08 Company summary Overview Biora Therapeutics is a biotech company that provides reimagining therapeutic services. 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 . 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? 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 (KSF), announces that KSF has commenced an investigation into Progenity, Inc. (NasdaqGM: PROG). <> Acting U.S. Attorney Audrey Strauss said:Progenity received millions of dollars from federal healthcare programs through its fraudulent billing and kickback schemes. Looking at its 2021 third-quarter results, Progenity had revenue of $182,000, down from $463,000 in the second quarter. ZCHX!W,3)3 ruZ CNK7 8N?&UqLyT H %W$B;8`+$9G[7 HNI 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. Organizing Committee; CPD Schedule; Online CPD; IRR CPD; Confidentiality and Non-Disparagement Agreements with Non-Supervisory USCIS Confirms It Will Accept Employment-Based I-485 Applications New Jersey Enacts Bill of Rights for Temporary Workers, DOJ Implements Nationwide Voluntary Self-Disclosure Program. 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. A more recent docket listing may be available from PACER . 11 0 obj The CIA promotes compliance with the statutes, regulations, program requirements, and written directives of federal healthcare programs. The stock closed at $3.47 a share on Monday, opened at $3.96 on Tuesday, and rose to as high as $5.05 during morning trading. Policy & Medicine - Legal, Regulatory, and Compliance Issues. According to the Justice Department, Progenity misrepresented the tests it performed, resulting in overbilling Medicaid and Veterans Affairs health insurance programs. Invest better with The Motley Fool. Get stock recommendations, portfolio guidance, and more from The Motley Fool's premium services. About ProgenityProgenity, Inc. is a biotechnology company innovating in the fields of gastrointestinal health and oral biotherapeutics. 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 strategic transformation presented today seeks to significantly reduce our burn rate by eliminating major costs and reducing our cash needs considerably to a normalized rate of $4-5 million per month (before taking into account non-dilutive sources of capital). lewis.kahn@ksfcounsel.com Cost basis and return based on previous market day close. 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. ANN ARBOR, MI -- A biotechnology company in Ann Arbor announced last week that it will permanently lay off 110 employees on Aug. 6. From March 2014 through April 2016, PROGENITY fraudulently used CPT code 88271 to seek reimbursement for noninvasive prenatal tests (NIPTs) that screen for genetic disorders and abnormalities when this code misrepresented the services PROGENITY actually provided. Sales representatives informed physicians and their staff, as well as patients, that PROGENITY would waive coinsurance and deductibles, or limit the patients payment to a certain maximum out-of-pocket amount. Become a Motley Fool member today to get instant access to our top analyst recommendations, in-depth research, investing resources, and more. 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. BioSpace Layoff Tracker 2022: Axcella Therapeutics, TherapeuticsMD, Instil Bio and More Cull Staff. 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. 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. Become a Motley Fool member today to get instant access to our top analyst recommendations in-depth. 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