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Business Wire
an hour ago
- Business Wire
Cardio Diagnostics Receives Gapfill Payment Rates for AI-Driven Cardiovascular Tests from the Centers for Medicare and Medicaid Services (CMS)
CHICAGO--(BUSINESS WIRE)-- Cardio Diagnostics Holdings, Inc. (Nasdaq: CDIO), an AI-powered precision cardiovascular medicine company, today announced that the Centers for Medicare and Medicaid Services (CMS), through the MolDX program, has issued preliminary gapfill payment rates of $350 for Epi+Gen CHD™ and $684.76 for PrecisionCHD™. A 'gapfill' payment rate means that pricing is determined by each Medicare contractor, including MolDX, based on cost data from Cardio Diagnostics. These preliminary payment rates, proposed as part of the calendar year 2025 gapfill pricing process, are expected to be finalized later this year and will be effective for claims with dates of service on or after January 1, 2025. The proposed rates represent a significant positive development in the Company's efforts to expand access to its advanced cardiovascular testing for Medicare beneficiaries. 'We view this as a critical step toward expanding timely access and improving care for Medicare patients' said Meesha Dogan, PhD., CEO and Co-Founder of Cardio Diagnostics. 'Many Medicare beneficiaries, who are at elevated risk for coronary heart disease, go undetected and undertreated, often resulting in avoidable heart attacks, hospitalizations, and poor outcomes.' Cardio Diagnostics clarified during a recent meeting with MolDX that initial public documentation had inadvertently transposed the pricing between the two tests, and MolDX confirmed the correct association of the proposed payment rates to their respective tests. Addressing the Leading Cause of Death Cardiovascular disease remains the leading cause of death in the United States, particularly among Americans aged 65 and older. In 2022 alone, over 700,000 Americans died from heart disease, with coronary heart disease (CHD) accounting for more than 370,000 deaths. PrecisionCHD™ is a groundbreaking AI-powered test designed to aid in the diagnosis of CHD by analyzing both genetic and epigenetic markers. Meanwhile, Epi+Gen CHD™ provides insight into a patient's three-year risk for a CHD event, such as a heart attack. Both tests are performed from a simple blood draw, enabling scalable, accessible, and non-invasive cardiovascular assessment. Both tests received dedicated CPT Proprietary Laboratory Analysis (PLA) codes from the American Medical Association, 0439U for Epi+Gen CHD and 0440U for PrecisionCHD, that were effective on April 1, 2024. About Cardio Diagnostics Cardio Diagnostics is an artificial intelligence-powered precision cardiovascular medicine company that makes cardiovascular disease prevention, detection, and management more accessible, personalized, and precise. The Company was formed to further develop and commercialize clinical tests by leveraging a proprietary Artificial Intelligence (AI)-driven Integrated Genetic-Epigenetic Engine ('Core Technology') for cardiovascular disease to become one of the leading medical technology companies for improving prevention, detection, and treatment of cardiovascular disease. For more information, please visit Forward-Looking Statements Certain statements and information included in this press release constitute 'forward-looking statements' within the meaning of the Private Securities Litigation Act of 1995. When used in this press release, the words or phrases 'will', 'will likely result,' 'expected to,' 'will continue,' 'anticipated,' 'estimate,' 'projected,' 'intend,' 'goal,' or similar expressions are intended to identify 'forward-looking statements' within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements are subject to certain risks, known and unknown, and uncertainties, many of which are beyond the control of the Company. Such uncertainties and risks include but are not limited to, our ability to successfully execute our growth strategy, changes in laws or regulations, economic conditions, and dependence on results as discussed in the Annual Report on Form 10-K for the period ended December 31, 2024, under the heading 'Risk Factors' in Part I, Item IA thereof, and other documents filed from time to time with the Securities and Exchange Commission. Such factors could materially adversely affect the Company's financial performance and could cause the Company's actual results for future periods to differ materially from any opinions or statements expressed within this press release.


Business Wire
an hour ago
- Business Wire
Digestive Care Specialists Now Offering Endoscopic Sleeve Gastroplasty (ESG) With Insurance Coverage in Germantown, Maryland.
GERMANTOWN, Md.--(BUSINESS WIRE)--Digestive Care Specialists is proud to announce the launch of its Endoscopic Sleeve Gastroplasty (ESG) program in Germantown, Maryland, offering patients a minimally invasive weight loss option with insurance coverage options now available. ESG is an outpatient procedure that helps patients lose 18-20% of their weight without incisions or surgery. Share ESG is an advanced, non-surgical weight loss procedure that uses an endoscopic suturing device to reduce stomach volume, helping patients achieve 18-20% total body weight loss without incisions or removal of stomach tissue. The procedure is performed entirely through the mouth, resulting in faster recovery times, minimal downtime, and fewer risks compared to traditional bariatric surgeries. 'We are thrilled to provide this life-changing procedure to our patients struggling with obesity,' said Dr. Halim Charbel, MD, Gastroenterologist and Endoscopic Weight Loss Specialist at Digestive Care Specialists. 'ESG bridges the gap between medical weight loss and surgical options, giving patients an effective, minimally invasive tool to achieve their health goals.' Insurance Coverage Now Available Medicare now covers ESG for patients meeting bariatric surgery criteria (BMI ≥40, or BMI ≥35 with an obesity-related condition such as diabetes, hypertension, or sleep apnea). Commercial insurance carriers may cover ESG on a case-by-case basis, depending on plan requirements, prior authorizations, and appeals submitted by the medical practice. 'We are excited that Medicare coverage is now in place for ESG, and we are working closely with commercial insurers to obtain approval for eligible patients,' Dr. Charbel added. 'Our team supports patients through every step – from insurance authorization to nutritional counseling and long-term follow-up.' About Digestive Care Specialists Digestive Care Specialists is a leading gastroenterology practice in Maryland, specializing in advanced endoscopic weight loss procedures, general gastroenterology, and digestive health optimization. The team is committed to providing compassionate, evidence-based care to help patients achieve better health and quality of life. The ESG procedure is performed at Holy Cross Germantown Hospital.


Business Wire
2 hours ago
- Business Wire
KindlyMD and Nakamoto Announce the Filing of the Definitive Information Statement in Connection with Proposed Merger
SALT LAKE CITY--(BUSINESS WIRE)--Kindly MD, Inc. (NASDAQ: NAKA) ('KindlyMD'), a leading provider of integrated healthcare services, and Nakamoto Holdings Inc. ('Nakamoto'), a Bitcoin-native holding company, today announced that it has filed its definitive information statement with the U.S. Securities and Exchange Commission ('SEC') in connection with the proposed merger with Nakamoto. KindlyMD and Nakamoto expect to close the transaction on or around August 11, 2025, subject to other customary closing conditions. 'Filing the definitive information statement is a critical milestone for this merger and accelerates our mission of acquiring one million Bitcoin,' said David Bailey, Founder and CEO of Nakamoto. 'I'm very proud of the teams' collaboration at Nakamoto and KindlyMD to get us one step closer to closing the merger. Our shared enthusiasm for Bitcoin paired with our expertise in structuring this opportunity for public markets has created a strong foundation for the combined company's future.' 'We are proud to reach this important milestone alongside Nakamoto,' said Tim Pickett, Founder and CEO of KindlyMD. 'Our shareholders now have the opportunity to be part of a groundbreaking shift in how public companies approach treasury management, with Bitcoin at the center.' Holders of a majority of the outstanding common stock of KindlyMD previously approved the merger and related transactions through a written consent. About KindlyMD KindlyMD is a patient-first healthcare and healthcare data company redefining value-based care and patient-centered medical services. KindlyMD leverages data analysis to deliver evidence-based, personalized solutions in order to reduce opioid use, improve health outcomes faster, and provide algorithmic guidance on the use of alternative medicine in healthcare. KindlyMD provides a patient-focused healthcare experience that integrates traditional medical evaluation and management with mental health integration and compliant alternative medicine education and inclusion. It focuses on creating personalized care plans for each individual that get people back to work and life faster, reduce opioid use, and yield high patient satisfaction. Its specialty outpatient clinical services are reimbursed by Medicare, Medicaid, and commercial insurance contracts as well as offered on a fee-for-service basis. For more information, please visit About Nakamoto Nakamoto is a Bitcoin treasury company building a global portfolio of Bitcoin-native companies. Nakamoto plans to establish the first publicly traded conglomerate of Bitcoin companies by accumulating Bitcoin in its treasury and by leveraging its treasury to acquire and develop an ecosystem of Bitcoin companies across finance, media, advisory and more. The company aims to provide commercial and financial infrastructure for the next generation of capital markets. For more information, please visit Additional Information and Where to Find It In connection with the merger, PIPE Financing and the initial PIPE financing and debt financing announced on May 12, 2025 and the PIPE financing announced on June 19, 2025 (collectively, the 'Transactions'), KindlyMD has filed with the SEC a definitive information statement (the 'information statement'), and KindlyMD will file other documents regarding the Transactions with the SEC. INVESTORS AND SECURITY HOLDERS ARE URGED TO READ THE INFORMATION STATEMENT, AS MAY BE AMENDED OR SUPPLEMENTED FROM TIME TO TIME, AND OTHER RELEVANT DOCUMENTS FILED BY KINDLYMD WITH THE SEC BECAUSE THEY WILL CONTAIN IMPORTANT INFORMATION ABOUT KINDLYMD AND NAKAMOTO, THE TRANSACTIONS, THE RISKS RELATED THERETO AND RELATED MATTERS. A definitive information statement will be mailed to shareholders of KindlyMD. Investors will be able to obtain free copies of statement, as may be amended from time to time, and other relevant documents filed by KindlyMD with the SEC (when they become available) through the website maintained by the SEC at Copies of documents filed with the SEC by KindlyMD, including the information statement (when available), will be available free of charge from KindlyMD's website at under the 'Investors' tab. Forward-Looking Statements All statements, other than statements of historical fact, included in this release that address activities, events or developments that Kindly MD or Nakamoto expects, believes or anticipates will or may occur in the future are forward-looking statements. Words such as 'estimate,' 'project,' 'predict,' 'believe,' 'expect,' 'anticipate,' 'potential,' 'create,' 'intend,' 'could,' 'would,' 'may,' 'plan,' 'will,' 'guidance,' 'look,' 'goal,' 'future,' 'build,' 'focus,' 'continue,' 'strive,' 'allow' or the negative of such terms or other variations thereof and words and terms of similar substance used in connection with any discussion of future plans, actions, or events identify forward-looking statements. However, the absence of these words does not mean that the statements are not forward-looking. These forward-looking statements include, but are not limited to, statements regarding the proposed merger and related transactions, (collectively, the 'Transactions') the expected closing of the proposed Transactions and the timing thereof and as adjusted descriptions of the post-transaction company and its operations, strategies and plans, integration, debt levels and leverage ratio, capital expenditures, cash flows and anticipated uses thereof, synergies, opportunities and anticipated future performance, including the management team and board of directors of the combined company and expected use of proceeds from the Transactions, and any post-closing transactions contemplated between the combined company and BTC Inc (and/or UTXO, LLC through BTC Inc). Information adjusted for the proposed Transactions should not be considered a forecast of future results. There are a number of risks and uncertainties that could cause actual results to differ materially from the forward-looking statements included in this release. These include the risk that Kindly MD and Nakamoto businesses (which may include the businesses of BTC Inc and/or UTXO in the future, as applicable) will not be integrated successfully and the risk that Kindly MD or the applicable governing bodies of BTC Inc and/or UTXO may not pursue or approve the terms of an acquisition of BTC Inc and/or UTXO; the risk that cost savings, synergies and growth from the proposed transaction may not be fully realized or may take longer to realize than expected; the possibility that shareholders of Kindly MD may not approve the issuance of new shares of Kindly MD common stock in the Transactions or that shareholders of Kindly MD may not approve the Transactions; the risk that a condition to closing of the Transactions may not be satisfied, that either party may terminate the merger agreement, the subscription agreements of the convertible debt purchase agreement or that the closing of the Transactions might be delayed or not occur at all; potential adverse reactions or changes to business or employee relationships, including those resulting from the announcement or completion of the Transactions; the parties do not receive regulatory approval of the Transactions; the occurrence of any other event, change, or other circumstances that could give rise to the termination of the merger agreement relating to the Transactions; the risk that changes in Kindly MD's capital structure and governance could have adverse effects on the market value of its securities; the ability of Kindly MD and Nakamoto to retain customers and retain and hire key personnel and maintain relationships with their suppliers and customers and on Kindly MD and Nakamoto's operating results and business generally; the risk the Transactions could distract management from ongoing business operations or cause Kindly MD and/or Nakamoto to incur substantial costs; the risk that Kindly MD may be unable to reduce expenses or access financing or liquidity; the impact of any related economic downturn; the risk of changes in governmental regulations or enforcement practices; and other important factors that could cause actual results to differ materially from those projected. All such factors are difficult to predict and are beyond Kindly MD's and Nakamoto's control, including those detailed in Kindly MD's Annual Reports on Form 10-K, Quarterly Reports on Form 10-Q, Current Reports on Form 8-K, and such other documents of Kindly MD filed, or to be filed, with the SEC that are or will be available on Kindly MD's website at and on the website of the SEC at All forward-looking statements are based on assumptions that Kindly MD and Nakamoto believe to be reasonable but that may not prove to be accurate. Any forward-looking statement speaks only as of the date on which such statement is made, and neither Kindly MD or Nakamoto undertakes any obligation to correct or update any forward-looking statement, whether as a result of new information, future events or otherwise, except as required by applicable law. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof.