Obesity, Morbid

The whistleblower suit filed against Aledade appears to be the first to allege upcoding within accountable care organizations, which describe part of their mission as foiling wasteful spending. A Maryland firm that oversees the nation’s largest independent network of primary care medical practices is facing a whistleblower lawsuit alleging it cheated Medicare out of millions of dollars using billing software “rigged” to make patients appear sicker than they were. The civil suit alleges that Aledade Inc.’s billing apps and other software and guidance provided to doctors improperly boosted revenues by adding overstated medical diagnoses to patients’ electronic medical records. “Aledade did whatever it took to make patients appear sicker than they were,” according to the suit. For example, the suit alleges that Aledade “conflated” anxiety into depression, which could boost payments by $3,300 a year per patient. And Aledade decided that patients over 65 years old who said they had more than one drink per day had substance use issues, which could bring in $3,680 extra per patient, the suit says. The whistleblower case was filed by Khushwinder Singh in federal court in Seattle in 2021 but remained under seal until January of this year. Singh, a “senior medical director of risk and wellness product” at Aledade from January 2021 through May 2021, alleges the company fired him after he objected to its “fraudulent course of conduct,” according to the suit. He declined to comment on the suit. The case is pending and Aledade has yet to file a legal response in court. Julie Bataille, Aledade’s senior vice president for communications, denied the allegations, saying in an interview that “the whole case is totally baseless and meritless.” Based in Bethesda, Maryland, Aledade helps manage independent primary care clinics and medical offices in more than 40 states, serving some 2 million people. Aledade is one of hundreds of groups known as accountable care organizations. ACOs enjoy strong support from federal health officials who hope they can keep people healthier and achieve measurable cost savings. Aledade was co-founded in 2014 by Farzad Mostashari, a former health information technology chief in the Obama administration, and has welcomed other ex-government health figures into its ranks. In June 2023, President Joe Biden appointed Mandy Cohen, then executive vice president at Aledade, to head the Centers for Disease Control and Prevention in Atlanta. Aledade has grown rapidly behind hundreds of millions of dollars in venture capital financing and was valued at $3.5 billion in 2023. Mostashari, Aledade’s CEO, declined to be interviewed on the record. “As this is an active legal matter, we will not respond to individual allegations in the complaint,” Aledade said in a statement to KFF Health News. “We remain focused on our top priority of delivering high-quality, value-based care with our physician partners and will defend ourselves vigorously if needed in a court of law.” The lawsuit also names as defendants 19 independent physician practices, many in small cities in Delaware, Kansas, Louisiana, North Carolina, Pennsylvania and West Virginia. According to the suit, the doctors knowingly used Aledade software to trigger illegal billings, a practice known in the medical industry as “upcoding.” None has filed an answer in court. More than two dozen whistleblower lawsuits, some dating back more than a decade, have accused Medicare health plans of overcharging the government by billing for medical conditions not supported by patient medical records. These cases have resulted in hundreds of millions of dollars in penalties. In September 2023, Cigna agreed to pay $37 million to settle one such case, for instance. But the whistleblower suit filed against Aledade appears to be the first to allege upcoding within accountable care organizations, which describe part of their mission as foiling wasteful spending. ACOs including Aledade made headlines recently for helping to expose an alleged massive Medicare fraud involving urinary catheters, for instance. Finding the ‘gravy’ Singh’s suit targets Aledade’s use of coding software and guidance to medical practices that joined its network. Some doctors treated patients on standard Medicare through the ACO networks, while others cared for seniors enrolled in Medicare Advantage plans, according to the suit. Medicare Advantage is a privately run alternative to standard Medicare that has surged in popularity and now cares for more than 30 million people. Aledade has sought to expand its services to Medicare Advantage enrollees. The lawsuit alleges Aledade encouraged doctors to tack on suspect medical diagnoses that paid extra money. Aledade called it finding “the gravy sitting in the [patient’s] chart,” according to the suit. The company “instructed” providers to diagnose diabetes with complications, “even if the patient’s diabetes was under control or the complicating factor no longer existed,” according to the suit. Some medical practices in Delaware, North Carolina and West Virginia billed the inflated code for more than 90% of their Medicare Advantage patients with diabetes, according to the suit. The lawsuit also alleges that Aledade “rigged” the software to change a diagnosis of overweight to “morbid obesity,” which could pay about $2,500 more per patient. Some providers coded morbid obesity for patients on traditional Medicare at 10 times the national average, according to the suit. “This fraudulent coding guidance was known as ‘Aledade gospel,’” according to the suit, and following it “paid dividends in the form of millions of dollars in increased revenue.” These tactics “usurped” the clinical judgment of doctors, according to the suit. ‘No diagnosis left behind’ In its statement to KFF Health News, Aledade said its software offers doctors a range of data and guidance that helps them evaluate and treat patients. “Aledade’s independent physicians remain solely responsible for all medical decision-making for their patients,” the statement read. The company said it will “continue to advocate for changes to improve Medicare’s risk adjustment process to promote accuracy while also reducing unnecessary administrative burdens.” In a message to employees and partner practices sent on Feb. 29, Mostashari noted that the Justice Department had declined to take over the False Claims Act case. “We recently learned that the federal government has declined to join the case U.S. ex rel. Khushwinder Singh v. Aledade, Inc. et al. That’s good news, and a decision we wholeheartedly applaud given the baseless allegations about improper coding practices and wrongful termination brought by a former Aledade employee three years ago. We do not yet know how the full legal situation will play out but will defend ourselves vigorously if needed in a court of law,” the statement said. The Justice Department advised the Seattle court on Jan. 9 that it would not intervene in the case “at this time,” which prompted an order to unseal it, court records show. Under the false claims law, whistleblowers can proceed with the case on their own. The Justice Department does not state a reason for declining a case but has said in other court cases that doing so has no bearing on its merits. Singh argues in his complaint that many “unsupported” diagnosis codes were added during annual “wellness visits,” and that they did not result in the patients receiving any additional medical care. Aledade maintained Slack channels in which doctors could discuss the financial incentives for adding higher-paying diagnostic codes, according to the suit. The company also closely monitored how doctors coded as part of an initiative dubbed “no diagnosis left behind,” according to the suit. KFF Health News is a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at KFF—an independent source of health policy research, polling, and journalism. Learn more about KFF.

PLEASANTON, Calif., Feb. 20, 2024 (GLOBE NEWSWIRE) -- ProSomnus, Inc. (NASDAQ: OSA), the leading non-CPAP therapy for the treatment of Obstructive Sleep Apnea (OSA), announced today that it will report its fourth quarter and fiscal year 2023 financial results and provide a business update before market open on Monday, March 18, 2024 at the 36th Annual ROTH Conference and via a live webcast. ProSomnus Chief Executive Officer, Len Liptak, and Chief Financial Officer, Brian Dow, will host a conference call at 5:30 a.m. Pacific Time / 8:30 a.m. Eastern Time. Following the call, management will participate in the 36th Annual ROTH Conference, being held March 17-19, 2024. Fourth Quarter and Fiscal Year 2023 Investor Call Dial-In Information Interested parties may register for the conference call using the following link: OSA Q4 2024 Financial Results Call. Alternatively, you may access the live webcast of the conference call by using the following link: OSA Q4 2024 Webcast. The links will also be posted in the Investor Relations section of the ProSomnus website at News & Events. 36th Annual ROTH Conference ProSomnus’s Chief Executive Officer, Len Liptak, and Chief Financial Officer, Brian Dow, will engage in a fireside chat and investor meetings during the 36th Annual ROTH Conference. Details of the fireside chat presentation will be available in the Investor Relations section of the ProSomnus website at the link above. About ProSomnus ProSomnus (NASDAQ: OSA) is the leading non-CPAP therapy for the treatment of Obstructive Sleep Apnea, a serious medical disease affecting over 1 billion people worldwide, that is associated with comorbidities including heart failure, stroke, hypertension, morbid obesity, and type 2 diabetes. ProSomnus intraoral medical devices are engineered to precisely track the treatment plan and anatomy for each patient. Non-invasive, patient preferred and easy to use, ProSomnus devices have demonstrated excellent efficacy, safety, adherence, and overall outcomes in a growing body of clinical investigations. ProSomnus precision intraoral devices are FDA-cleared, patented, and covered by commercial medical insurance, Medicare, TRICARE and many Government-sponsored healthcare plans around the world, representing over 200 million covered lives. To learn more, visit . Investor Contact Mike Cavanaugh ICR Westwicke Phone: +1.617.877.9641 Email: Mike.Cavanaugh@westwicke.com Media Contact Heather Whalen ProSomnus Phone: +1.925.360.2990 Email: HWhalen@ProSomnus.com

PLEASANTON, Calif., Jan. 30, 2024 (GLOBE NEWSWIRE) -- ProSomnus, Inc. (NASDAQ: OSA) (the “Company”), the leading non-CPAP Obstructive Sleep Apnea (OSA) therapy™, announced today that the United States Food and Drug Administration (the “FDA”) has accepted, and is in the process of reviewing, the Company’s premarket notification for its ProSomnus® EVO® precision medical device for the treatment of patients with severe obstructive sleep apnea. “The acceptance of our 510(k) submission for substantive review represents a significant step towards expanding access to care for the millions of patients with Obstructive Sleep Apnea who prefer a safe, effective and convenient treatment alternative to CPAP or invasive procedures,” commented Len Liptak, ProSomnus Chief Executive Officer. “We look forward to working closely with the FDA throughout this review process as we look to expand the labeling for our precision Oral Appliance Therapy device.” The Company’s premarket notification 510(k) submission included a robust clinical data dossier demonstrating the safety and efficacy of its ProSomnus EVO precision medical device relative to the performance goals indicated in pre-submission meetings and reference devices. The clinical data submitted by the Company in support of its 510(k) submission included data on 92 patients with severe OSA from two prospective clinical studies. The mean age of patients was 52 (26-77); Mean body mass index (“BMI”) was 31.4 (19.8-45.9); Baseline mean apnea-hypopnea index (“AHI”) was 47.5 (30.1-106.9); and Mean baseline oxygen desaturation index (“ODI”) was 47.1 (16.7-107.9). When compared to baseline measurements: 75% of patients successfully achieved the AHI target of AHI < 20 and a 50% reduction from baseline; 91% of patients successfully achieved the ODI target of 25% improvement from the baseline; 82% of patients achieved the sleep apnea specific hypoxic burden target of < 60 % min / hr.; and 89% of patients achieved a 45% improvement in AHI or improved their OSA severity by at least one strata. With ProSomnus treatment, compared to baseline, patients experienced: a mean AHI improvement of 66%; a mean ODI improvement of 60%; and a mean improvement in sleep apnea specific hypoxic burden of 69%. These results were achieved without patient preselection or excluding patients with concentric collapse airway pro “We believe the clinical data from treating patients with severe Obstructive Sleep Apnea combined with an excellent safety pro from hundreds of thousands of real-world cases, positions us well for obtaining severe indication clearance from the FDA,” noted Dr. John Remmers, MD, ProSomnus Chief Scientist. “FDA clearance for the use of the ProSomnus EVO precision medical device in the treatment of severe OSA patients has the potential to open a new, safer, more effective and less invasive treatment modality for such patients that does not exist today.” Pursuant to Section 510(k), following acceptance, the FDA will conduct its substantive review of the submission, which may include a request for additional information from the Company. FDA guidance indicates that the FDA seeks to complete its review of 510(k) submissions within 90 calendar days of date of receipt, excluding time required by the Company to respond to additional information requests. The time required to respond to any such requests will depend on the nature of the request. About ProSomnus ProSomnus (NASDAQ: OSA) is the leading non-CPAP therapy for the treatment of Obstructive Sleep Apnea, a serious medical disease affecting over 1 billion people worldwide, that is associated with comorbidities including heart failure, stroke, hypertension, morbid obesity, and type 2 diabetes. ProSomnus intraoral medical devices are engineered to precisely track the treatment plan and anatomy for each patient. Non-invasive, patient preferred and easy to use, ProSomnus devices have demonstrated excellent efficacy, safety, adherence, and overall outcomes in a growing body of clinical investigations. ProSomnus precision intraoral devices are FDA-cleared, patented, and covered by commercial medical insurance, Medicare, TRICARE and many Government-sponsored healthcare plans around the world, representing over 200 million covered lives. To learn more, visit . Important Notice Regarding Forward-Looking Statements This Press Release contains certain “forward-looking statements” within the meaning of the Securities Act of 1933 and the Securities Exchange Act of 1934, both as amended. Statements that are not historical facts, including statements about the timing, outcome and impact of the FDA’s review of the Company’s 510(k) submission for the severe OSA indication, are forward-looking statements. The words “expect,” “believe,” “estimate,” “intend,” “plan” and similar expressions indicate forward-looking statements, although not all forward-looking statements contain these or similar identifying words. These forward-looking statements are not guarantees of future performance and are subject to various risks and uncertainties, assumptions (including assumptions about general economic, market, industry, and operational factors), known or unknown, which could cause the actual results to vary materially from those indicated or anticipated. Such risks and uncertainties include, but are not limited to: changes in the timelines and potential outcomes of regulatory clearance and/or approval processes; securing and maintain regulatory clearances, approvals and compliance in jurisdiction in which the Company intends to offer its products, competitive industries in which the Company operates and variations in operating performance across competitors; changes in laws and regulations affecting ProSomnus’s business; the risk of downturns in the market and ProSomnus’s industry; risks related to ProSomnus’s limited operating history and history of losses; the timing of expected business milestones; ProSomnus’s ability to implement its business plan and scale its business, which includes the recruitment of healthcare professionals to prescribe and dentists to deliver ProSomnus oral devices; the understanding and adoption by dentists and other healthcare professionals of ProSomnus oral devices for mild-to-moderate OSA; the understanding and adoption by dentists and other healthcare professionals of ProSomnus oral devices for severe OSA if clearance for such indication be secured from the FDA; expectations concerning the effectiveness of OSA treatment using ProSomnus oral devices and the potential for patient relapse after completion of treatment; the potential financial benefits to dentists and other healthcare professionals from treating patients with ProSomnus oral devices; ProSomnus’s ability to properly train dentists in the use of the ProSomnus oral devices and other services it offers in their dental practices; ProSomnus’s ability to formulate, implement and modify as necessary effective sales, marketing, and strategic initiatives to drive adoption of its devices; the viability of ProSomnus’s intellectual property and intellectual property created in the future; acceptance by the marketplace of the products and services that ProSomnus markets; government regulations and ProSomnus’s ability to obtain applicable regulatory approvals and comply with government regulations, including under healthcare laws and the rules and regulations of the U.S. Food and Drug Administration; the extent of patient reimbursement by medical insurance in the United States and internationally; and the outcome of any legal proceedings that may be instituted against the Company. A further list and description of risks and uncertainties can be found in the Company’s Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission (the “SEC”) on November 14, 2023. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those indicated or anticipated by such forward-looking statements. Accordingly, you are cautioned not to place undue reliance on these forward-looking statements. Forward-looking statements relate only to the date they were made, and the Company and its subsidiaries undertake no obligation to update forward-looking statements to reflect events or circumstances after the date they were made except as required by law or applicable regulation. Investor Contact Mike Cavanaugh ICR Westwicke Phone: +1.617.877.9641 Email: Mike.Cavanaugh@westwicke.com Media Contact Heather Whalen ProSomnus Phone: +1.925.360.2990 Email: HWhalen@ProSomnus.com