Settlement Reached in Whistleblower Case Against Semler and Bard Over Fraudulent Medicare Billing
In a significant legal outcome, Semler Scientific, Inc. and Bard Peripheral Vascular, Inc. have agreed to pay a total of $36.95 million to resolve allegations from whistleblowers regarding fraudulent Medicare billing practices. This settlement comes nearly nine years after the whistleblowers, Robert Kane and Frank West, reported that both companies engaged in marketing medical devices in breach of Medicare’s stringent reimbursement criteria.
The lawsuit specifically targeted two devices marketed by Semler and Bard, known as "Flochec" and "QuantaFlo." Allegations suggest that these devices were misleadingly promoted as reimbursable for diagnosing peripheral artery disease (PAD), despite existing Medicare rules that categorically prohibit such reimbursements due to their classification as experimental.
At the center of the controversy is a technology that measures blood flow through a clip-on light sensor attached to the fingers and toes, generating photoplethysmographic waveforms. According to reports from the whistleblowers, Medicare had determined that this form of testing, classified under National Coverage Determination 20.14, does not yield reproducible measurements of blood flow and thus should not be eligible for reimbursement.
Instead of adhering to these guidelines, Kane and West allege that Semler and Bard knowingly marketed these devices in a way that misrepresented their diagnostic capabilities. The whistleblower lawsuit indicates that a study evaluating the accuracy of QuantaFlo revealed alarming results - the device falsely diagnosed over 66% of patients as having PAD, thereby potentially subjecting them to unnecessary medical interventions that could be harmful.
The implications of a false positive PAD diagnosis are severe, resulting in increased risks of coronary heart disease, heart attack, and even limb amputation. The treatments resulting from a misdiagnosis not only endanger patient health but also place a financial burden on the healthcare system.
The settlement, covering the submission of false claims against Medicare Part B, does not encompass cases against another significant defendant, UnitedHealth Group, Inc. and its subsidiary, United Healthcare Insurance Company. The case against United will continue in court, where it remains to be seen how they will be held accountable for their alleged involvement in these fraudulent practices.
According to the whistleblower allegations, once patients are diagnosed with PAD, Medicare Advantage insurers, unlike Traditional Medicare, incorporate these false diagnoses into patients' records, thereby inflating the insurers' risk scores and ultimately channeling additional taxpayer dollars to themselves. With the management of Medicare Advantage healthcare shifting to private companies, instances like this spotlight significant vulnerabilities in the oversight of patient diagnoses.
Dan Miller, lead counsel for the whistleblowers, likened the challenges posed by this litigation to a David v. Goliath scenario. Miller emphasized the need for anyone with more information regarding alleged misconduct by United to step forward and assist the case.
Returning focus to the legal repercussions, the qui tam lawsuit filed by Kane and West is a means by which individuals can report fraudulent claims and potentially share in any recovery made on behalf of the government. This points towards a broader systemic issue within healthcare billing practices, where companies might prioritize profit over patient safety.
Whistleblower cases like this not only seek to recover funds defrauded from Medicare but also shine a light on practices that could jeopardize patient health across the board. The outcome of these proceedings could serve as a crucial precedent for future fraud claims and highlight the necessity for stringent compliance with Medicare’s rules to protect both taxpayer dollars and vulnerable patients.I
As these legal battles unfold, the dedicated efforts of whistleblowers like Kane and West may help to reshape how the healthcare industry navigates billing practices, ensuring safety and integrity in patient diagnostics.
The NIH continues to support research into effective PAD treatments, cementing the need for accuracy and reliability in both diagnosis and treatment modalities. As cases like this emerge, they underline the responsibility of medical device manufacturers and healthcare providers to maintain ethical standards in their operations.
Initially filed in the Middle District of Florida, the claims made in this whistleblower suit remain allegations until proven otherwise, illustrating the importance of due process in the pursuit of justice for defrauded funds.
For more insight into this unfolding case, those interested should keep a close watch on further developments regarding United and the broader implications of medical device marketing under Medicare regulations.
The lawsuit specifically targeted two devices marketed by Semler and Bard, known as "Flochec" and "QuantaFlo." Allegations suggest that these devices were misleadingly promoted as reimbursable for diagnosing peripheral artery disease (PAD), despite existing Medicare rules that categorically prohibit such reimbursements due to their classification as experimental.
At the center of the controversy is a technology that measures blood flow through a clip-on light sensor attached to the fingers and toes, generating photoplethysmographic waveforms. According to reports from the whistleblowers, Medicare had determined that this form of testing, classified under National Coverage Determination 20.14, does not yield reproducible measurements of blood flow and thus should not be eligible for reimbursement.
Instead of adhering to these guidelines, Kane and West allege that Semler and Bard knowingly marketed these devices in a way that misrepresented their diagnostic capabilities. The whistleblower lawsuit indicates that a study evaluating the accuracy of QuantaFlo revealed alarming results - the device falsely diagnosed over 66% of patients as having PAD, thereby potentially subjecting them to unnecessary medical interventions that could be harmful.
The implications of a false positive PAD diagnosis are severe, resulting in increased risks of coronary heart disease, heart attack, and even limb amputation. The treatments resulting from a misdiagnosis not only endanger patient health but also place a financial burden on the healthcare system.
The settlement, covering the submission of false claims against Medicare Part B, does not encompass cases against another significant defendant, UnitedHealth Group, Inc. and its subsidiary, United Healthcare Insurance Company. The case against United will continue in court, where it remains to be seen how they will be held accountable for their alleged involvement in these fraudulent practices.
According to the whistleblower allegations, once patients are diagnosed with PAD, Medicare Advantage insurers, unlike Traditional Medicare, incorporate these false diagnoses into patients' records, thereby inflating the insurers' risk scores and ultimately channeling additional taxpayer dollars to themselves. With the management of Medicare Advantage healthcare shifting to private companies, instances like this spotlight significant vulnerabilities in the oversight of patient diagnoses.
Dan Miller, lead counsel for the whistleblowers, likened the challenges posed by this litigation to a David v. Goliath scenario. Miller emphasized the need for anyone with more information regarding alleged misconduct by United to step forward and assist the case.
Returning focus to the legal repercussions, the qui tam lawsuit filed by Kane and West is a means by which individuals can report fraudulent claims and potentially share in any recovery made on behalf of the government. This points towards a broader systemic issue within healthcare billing practices, where companies might prioritize profit over patient safety.
Whistleblower cases like this not only seek to recover funds defrauded from Medicare but also shine a light on practices that could jeopardize patient health across the board. The outcome of these proceedings could serve as a crucial precedent for future fraud claims and highlight the necessity for stringent compliance with Medicare’s rules to protect both taxpayer dollars and vulnerable patients.I
As these legal battles unfold, the dedicated efforts of whistleblowers like Kane and West may help to reshape how the healthcare industry navigates billing practices, ensuring safety and integrity in patient diagnostics.
The NIH continues to support research into effective PAD treatments, cementing the need for accuracy and reliability in both diagnosis and treatment modalities. As cases like this emerge, they underline the responsibility of medical device manufacturers and healthcare providers to maintain ethical standards in their operations.
Initially filed in the Middle District of Florida, the claims made in this whistleblower suit remain allegations until proven otherwise, illustrating the importance of due process in the pursuit of justice for defrauded funds.
For more insight into this unfolding case, those interested should keep a close watch on further developments regarding United and the broader implications of medical device marketing under Medicare regulations.
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