<h2 class="wp-block-heading"> Executive Summary</h2>



<p>This report provides a comprehensive analysis of the federal healthcare fraud case involving Dr. John R. Manning, a physician licensed in Tennessee. Dr. Manning was convicted of conspiracy to commit healthcare fraud for his role in a scheme that exploited telemedicine platforms to generate medically unnecessary prescriptions for durable medical equipment (DME), topical creams, and cancer genetic (CGx) tests. Between approximately June 2016 and April 2019, Dr. Manning signed these orders, often with little or no patient interaction, in exchange for substantial illegal kickbacks totaling over $812,000. His actions facilitated the submission of more than $41 million in fraudulent claims to Medicare, resulting in actual losses to the program exceeding $19.7 million.</p>



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<p>Dr. Manning ultimately pled guilty to the conspiracy charge and was sentenced to three years in federal prison. He was also ordered to pay full restitution for the losses incurred by Medicare and to forfeit the entirety of the kickbacks he received. The investigation, a collaborative effort between the Department of Health and Human Services Office of Inspector General (HHS-OIG), the Federal Bureau of Investigation (FBI), and local law enforcement, highlights a common pattern of fraud prevalent within the rapidly expanding telehealth sector. Key elements of the scheme included the leveraging of telemedicine companies as intermediaries, the payment of volume-based kickbacks to corrupt medical decision-making, and the targeting of specific high-reimbursement services often lacking rigorous oversight.</p>



<p>This case underscores the significant vulnerabilities within the healthcare system, particularly concerning telemedicine, and the substantial <a class="wpil_keyword_link" href="https://www.fraudswatch.com/tag/financial-fraud/amp/" title="financial" data-wpil-keyword-link="linked" data-wpil-monitor-id="1410">financial</a> burden fraud places on taxpayers. It serves as a stark example of the consequences faced by providers who violate their professional oaths and federal law for personal gain. The coordinated investigation and prosecution demonstrate the federal government&#8217;s commitment to combating healthcare fraud and protecting the integrity of federal healthcare programs. This report examines the specifics of Dr. Manning&#8217;s case, the legal framework violated, the mechanisms of the fraud, the investigative process, and the case&#8217;s broader implications for telehealth compliance, regulation, and enforcement.</p>



<h2 class="wp-block-heading"> The Case of Dr. John R. Manning: Conspiracy and Conviction</h2>



<h3 class="wp-block-heading"> Overview of Charges and Plea</h3>



<p>In July 2022, a federal grand jury in the Middle District of Tennessee returned a nine-count indictment against Dr. John R. Manning, then 61 years old, a licensed medical doctor residing in Ashland City, Tennessee.<sup></sup> The indictment charged Dr. Manning with one count of conspiracy to commit health care fraud, in violation of 18 U.S.C. § 1349, and eight counts of substantive health care fraud, under 18 U.S.C. § 1347.<sup></sup> Federal agents arrested Dr. Manning at his home shortly after the indictment.<sup></sup>  ;</p>



<p>The central allegation detailed a conspiracy spanning from approximately June 2016 through April 2019.<sup></sup> During this period, Dr. Manning was alleged to have worked with multiple &#8220;telemedicine&#8221; companies.<sup></sup> These companies served as intermediaries, arranging for physicians like Manning to sign doctor&#8217;s orders and prescriptions for various items, specifically durable <a href="https://www.fraudswatch.com/beware-of-medical-equipment-scams-in-2024-stay-informed-protect-yourself/amp/" data-wpil-monitor-id="1402">medical equipment</a> (DME), topical creams, and Cancer Genomic (CGx) testing, intended for Medicare beneficiaries.<sup></sup> The indictment asserted that Dr. Manning and his co-conspirators engaged in this conduct to enrich themselves by paying and receiving illegal kickbacks and bribes in exchange for these signed orders and prescriptions.<sup></sup> Critically, the government contended that Dr. Manning electronically signed these orders without establishing a legitimate physician-patient relationship as required, often basing his approval on only brief telephonic conversations with beneficiaries, or frequently, no conversation at all.<sup></sup> He did not physically see or examine the patients for whom he prescribed these items and services, thereby failing to make a valid assessment of medical necessity.<sup></sup> The telemedicine companies allegedly compensated Dr. Manning with a fee &#8220;per visit,&#8221; which constituted the illegal kickbacks driving his participation.<sup></sup>  ;</p>



<p>In August 2023, Dr. Manning chose to plead guilty to Count One of the indictment: conspiracy to commit health care fraud under 18 U.S.C. § 1349.<sup></sup> By entering this plea, he formally admitted to the core allegations outlined in the indictment, including his collaboration with telemedicine companies, the practice of signing medically unnecessary orders without proper patient evaluation, and the acceptance of illegal kickbacks and bribes in return for these actions.<sup></sup>  ;</p>



<p>This resolution, where a defendant pleads guilty to a single conspiracy count encompassing the entire fraudulent scheme rather than facing trial on multiple substantive counts, represents a frequently employed approach in complex white-collar criminal cases. Opting for a plea allows the defendant to potentially avoid the risk of conviction on numerous charges, which could lead to significantly longer cumulative sentences, especially given that each fraud count carried a potential penalty of up to 10 years imprisonment.<sup></sup> Furthermore, a guilty plea often signals acceptance of responsibility, a factor that can be considered favorably during sentencing under federal guidelines. From the government&#8217;s perspective, securing a conviction on the conspiracy charge achieves the primary goal of holding the defendant accountable for the overall criminal agreement, while conserving significant judicial and prosecutorial resources that a trial would demand. The conspiracy statute itself, 18 U.S.C. § 1349, carries the same statutory maximum penalty as the underlying substantive offense (in this case, health care fraud under § 1347), making it a powerful tool for prosecutors seeking an efficient yet comprehensive resolution.<sup></sup>  ;</p>



<h3 class="wp-block-heading"> Sentencing and Financial Penalties</h3>



<p>Following his guilty plea, Dr. Manning, then 64, was sentenced in early 2025 (based on press release <a href="https://www.fraudswatch.com/internet-dating-and-romance-scams/amp/" data-wpil-monitor-id="1407">dates</a> referencing &#8220;last week&#8221; relative to publication) to serve three years (36 months) in federal prison.<sup></sup>  ;</p>



<p>Beyond imprisonment, the court imposed substantial financial penalties. Dr. Manning was ordered to pay restitution totaling $19,780,565.44 directly to the Medicare program.<sup></sup> This figure precisely reflects the amount the government determined Medicare had actually paid out based on the false and fraudulent claims resulting from Manning&#8217;s improperly signed orders and prescriptions.<sup></sup>  ;</p>



<p>Additionally, the court ordered Dr. Manning to pay criminal forfeiture in the form of a money judgment amounting to $812,303.41.<sup></sup> This sum corresponds exactly to the total amount of illegal kickbacks and bribes Dr. Manning admitted to receiving in exchange for his participation in the conspiracy.<sup></sup> The indictment had initially contained a forfeiture allegation seeking recovery of all property representing the proceeds of the violations.<sup></sup>  ;</p>



<p>The direct alignment between the restitution amount and the documented Medicare loss, and between the forfeiture amount and the defendant&#8217;s illicit earnings, is a critical aspect of the sentencing outcome. Restitution serves the purpose of attempting to compensate the victim – in this instance, the Medicare program and ultimately the taxpayers – for the actual financial harm caused by the fraudulent activity. Forfeiture, conversely, is designed to strip the defendant of any financial gains derived from the criminal conduct, ensuring that crime does not pay. The precision of these figures underscores the government&#8217;s dual focus in healthcare fraud cases: achieving punitive justice through incarceration while also maximizing financial recovery and preventing offenders from retaining the proceeds of their illegal actions.</p>



<p>While a three-year prison sentence for a scheme causing nearly $20 million in losses might appear relatively moderate compared to the potential statutory maximum of ten years for the conspiracy count <sup></sup>, it must be viewed within the context of the federal sentencing guidelines and the specifics of the case. Factors such as the defendant&#8217;s guilty plea, which demonstrates acceptance of responsibility, any potential cooperation offered, the defendant&#8217;s age and health, and potentially a lack of extensive prior criminal history (based on the available information), likely influenced the final sentence. Nonetheless, the sentence represents a significant period of incarceration and, as highlighted by the Acting U.S. Attorney, delivers accountability for abusing a position of trust and defrauding public funds.<sup></sup>  ;</p>



<h3 class="wp-block-heading"> Table: Key Case Facts</h3>



<p>The following table summarizes the essential details of Dr. John R. Manning&#8217;s healthcare fraud case:</p>



<figure class="wp-block-table"><table class="has-fixed-layout"><tbody><tr><th>Feature</th><th>Detail</th><th>Source(s)</th></tr><tr><td><strong>Defendant Name</strong></td><td>Dr. John R. Manning</td><td>User Query Text, <sup></sup></td></tr><tr><td><strong>Location</strong></td><td>Ashland City, Tennessee</td><td>User Query Text, <sup></sup></td></tr><tr><td><strong>Age (at Sentencing)</strong></td><td>64</td><td>User Query Text, <sup></sup></td></tr><tr><td><strong>Indicted Charges</strong></td><td>1x Conspiracy to Commit Health Care Fraud (18 U.S.C. § 1349)<;br>;8x Health Care Fraud (18 U.S.C. § 1347)</td><td>User Query Text, <sup></sup></td></tr><tr><td><strong>Guilty Plea</strong></td><td>1x Conspiracy to Commit Health Care Fraud (18 U.S.C. § 1349)</td><td>User Query Text, <sup></sup></td></tr><tr><td><strong>Prison Sentence</strong></td><td>3 Years (36 Months)</td><td>User Query Text, <sup></sup></td></tr><tr><td><strong>Restitution</strong></td><td>$19,780,565.44 (to Medicare)</td><td>User Query Text, <sup></sup></td></tr><tr><td><strong>Forfeiture</strong></td><td>$812,303.41 (Money Judgment)</td><td>User Query Text, <sup></sup></td></tr><tr><td><strong>Fraud Timeframe</strong></td><td>Approx. June 2016 – April 2019</td><td>User Query Text, <sup></sup></td></tr><tr><td><strong>Total Fraudulent Claims</strong></td><td>At least $41,083,490.62</td><td>User Query Text, <sup></sup></td></tr><tr><td><strong>Medicare Paid Amount</strong></td><td>Over $19 million / $19,780,565.44</td><td>User Query Text, <sup></sup></td></tr></tbody></table></figure>



<p><em>This table provides a concise factual summary derived from the primary case documents and press releases.</em></p>



<h2 class="wp-block-heading"> Profile of the Defendant: Dr. Manning&#8217;s Background</h2>



<h3 class="wp-block-heading"> Medical Practice and Specialization</h3>



<p>Dr. John R. Manning was identified consistently throughout the legal proceedings as a licensed medical doctor.<sup></sup> Publicly available information indicates his specialization is in Family Medicine, with one source listing a practice address in Hermitage, Tennessee, a community near Nashville.<sup></sup>  ;</p>



<p>The fact that Dr. Manning practiced Family Medicine, a field typically centered on providing comprehensive primary care within a community setting, presents a notable contrast to his involvement in a large-scale, complex <a href="https://www.fraudswatch.com/healthcare-fraud-medical-equipment-company-scheme-to-pay-kickbacks-to-doctors-and-hospitals/amp/" data-wpil-monitor-id="1400">healthcare fraud operation driven by kickbacks and medically</a> unnecessary prescriptions. This situation suggests that vulnerability to recruitment into such fraudulent schemes is not confined to physicians in traditionally high-billing or procedure-heavy specialties. It implies that physicians across various fields may be susceptible, potentially lured by the significant financial incentives offered by illicit telemedicine arrangements, which can override professional ethics and patient welfare considerations. This case challenges any narrow assumptions about the types of practitioners who might become involved in major healthcare fraud.</p>



<h3 class="wp-block-heading"> License Status and Disciplinary History</h3>



<p>At the time of his indictment in July 2022 and subsequent sentencing, Dr. Manning held an active medical license in Tennessee.<sup></sup> A search of specific Tennessee Board of Medical Examiners Disciplinary Action Reports (DAR) from November 2020 and July 2018, however, did not reveal any actions taken against <em>this specific</em> Dr. John R. Manning of Ashland City.<sup></sup> Other documents referencing disciplinary actions pertain to different individuals, different states (such as Colorado or New York), or are general resource lists, and thus are not relevant to Dr. Manning&#8217;s history prior to this federal case.<sup></sup>  ;</p>



<p>The apparent absence of significant, publicly documented disciplinary history <em>related to this <a href="https://www.fraudswatch.com/account-takeover-fraud-definition-types-prevention-and-reporting/amp/" data-wpil-monitor-id="1404">type of fraud</a></em> for Dr. Manning prior to the federal indictment is noteworthy. It could indicate that this large-scale criminal activity was his first major offense captured by regulatory or licensing bodies. Alternatively, any prior minor infractions may not have been predictive of involvement in fraud of this magnitude. This situation raises questions regarding the capacity of state licensing boards to proactively identify physicians engaging in high-risk behaviors, such as illegitimate telemedicine prescribing facilitated by kickbacks, before federal law enforcement intervention becomes necessary. While prior history in the provided documents is limited, the federal conviction itself will undoubtedly trigger severe consequences regarding his medical license, likely including suspension or revocation and mandatory exclusion from participation in federal healthcare programs like Medicare and Medicaid, a standard outcome for such convictions.<sup></sup>  ;</p>



<h2 class="wp-block-heading"> Anatomy of the Fraud: Exploiting Telemedicine for Illicit Gains</h2>



<h3 class="wp-block-heading"> Collaboration with Telemedicine Entities</h3>



<p>Dr. Manning&#8217;s guilty plea included an admission that he worked for &#8220;multiple &#8216;telemedicine&#8217; companies&#8221;.<sup></sup> The initial indictment similarly alleged his involvement with &#8220;various telemedicine companies&#8221;.<sup></sup> These entities functioned as platforms or intermediaries that connected physicians willing to participate in the scheme with opportunities to prescribe specific items – DME, topical creams, and CGx tests – for Medicare beneficiaries targeted by the operation.<sup></sup>  ;</p>



<p>Despite the centrality of these companies to the conspiracy, the specific names of the telemedicine entities Dr. Manning worked with were not disclosed in the publicly available press releases or summaries related to his indictment and sentencing.<sup></sup>  ;</p>



<p>The operational structure described in Dr. Manning&#8217;s case aligns closely with common patterns observed in numerous telemedicine fraud investigations pursued by the Department of Justice (DOJ) and HHS-OIG. These schemes frequently involve intermediary companies that orchestrate the flow of information and payments among various players: marketing call centers that generate patient leads, physicians who provide the necessary prescriptions (often illegitimately), and the DME suppliers or clinical laboratories that ultimately bill Medicare for the items or services.<sup></sup> These intermediaries often serve to deliberately obscure the direct financial links, particularly the illegal kickback payments, between the entities billing Medicare and the prescribing physicians, thereby creating a superficial appearance of legitimacy. Dr. Manning&#8217;s admitted involvement with <em>multiple</em> such companies suggests he may have been participating in several overlapping fraudulent networks, contributing to the substantial volume of false claims generated.  ;</p>



<h3 class="wp-block-heading"> Fraudulent Prescriptions: DME, Topical Creams, and CGx Testing</h3>



<p>The fraudulent scheme centered on Dr. Manning signing medically unnecessary doctor&#8217;s orders and prescriptions for three specific categories of items: Durable Medical Equipment (DME), topical creams, and Cancer Genetic Tests (CGx).<sup></sup>  ;</p>



<p>A crucial element, admitted by Dr. Manning, was that these prescriptions were issued without the establishment of a legitimate physician-patient relationship.<sup></sup> The interactions, if they occurred at all, were limited to brief telephone calls or were entirely absent, and critically lacked any physical examination or thorough assessment of the patient&#8217;s actual medical needs.<sup></sup> This fundamental failure to engage in appropriate medical evaluation meant that the items and services prescribed could not meet Medicare&#8217;s core requirement of being &#8220;reasonable and necessary&#8221; for the diagnosis or treatment of illness or injury.<sup></sup>  ;</p>



<p>The selection of DME, compounded topical creams, and CGx tests as the vehicles for this fraud is significant and reflects broader patterns observed in healthcare fraud enforcement. These categories have historically been vulnerable due to factors such as high Medicare reimbursement rates, potentially less rigorous utilization management compared to other medical services, and evolving coverage policies.<sup></sup> Consequently, they have become frequent targets for fraudulent schemes, as evidenced by numerous enforcement actions announced by DOJ and HHS-OIG specifically involving these items.<sup></sup> Dr. Manning&#8217;s case serves as a clear example of how fraudsters exploit these known vulnerabilities.  ;</p>



<ul class="wp-block-list">
<li><strong>Durable Medical Equipment (DME):</strong> Telemedicine-related DME fraud often involves kickbacks paid to physicians for signing orders for unnecessary equipment, particularly orthotic braces. Dr. Manning&#8217;s role in signing such orders fits squarely within this archetype. </li>



<li><strong>Topical Creams:</strong> Fraud involving topical creams frequently centers on compounded medications – customized formulations often billed at exorbitant prices to Medicare Part D or other insurers. These schemes typically involve prescriptions written without genuine medical need or patient examination, sometimes based on pre-signed blank prescription pads provided to marketers. Dr. Manning&#8217;s signing of prescriptions for these creams aligns with these documented fraudulent practices. The explosive growth in Medicare Part D spending on compounded topicals raised significant fraud concerns for HHS-OIG. </li>



<li><strong>Cancer Genetic (CGx) Testing:</strong> CGx testing fraud involves ordering expensive genetic tests, often costing thousands of dollars per test, for beneficiaries without regard to medical necessity. These schemes typically rely on leads generated by telemarketers and involve kickbacks flowing between the testing laboratories, marketing entities, and the physicians who sign the orders. Medicare coverage for CGx testing is subject to specific, limited criteria, such as requiring the patient to have a personal history of relevant cancer and the test results being used to manage the patient&#8217;s condition; preventative screening for asymptomatic individuals is generally not covered. Dr. Manning&#8217;s participation in signing these orders, driven by kickbacks and without proper patient assessment, represents a direct violation of these coverage requirements and mirrors the structure of widespread CGx <a href="https://www.fraudswatch.com/most-popular-fraud-schemes/amp/" data-wpil-monitor-id="1401">fraud schemes</a> targeted by federal enforcement. </li>
</ul>



<h3 class="wp-block-heading"> The Role of Kickbacks and Bribes</h3>



<p>The engine driving Dr. Manning&#8217;s participation in the fraudulent scheme was the payment of illegal kickbacks and bribes. He explicitly admitted to signing the medically unnecessary orders and prescriptions &#8220;in exchange for illegal kickbacks and bribes&#8221;.<sup></sup> The indictment further specified that the telemedicine companies involved paid Manning a fee structured on a &#8220;per visit&#8221; basis, directly linking his compensation to the volume of orders he approved.<sup></sup>  ;</p>



<p>The financial magnitude of these illicit payments was substantial. Dr. Manning acknowledged receiving, and was ultimately ordered to forfeit, kickbacks totaling $812,303.41 over the course of the conspiracy, which lasted approximately three years.<sup></sup>  ;</p>



<p>These kickbacks represent the core corrupting influence in the scheme. By accepting payments directly tied to the number of prescriptions he signed, Dr. Manning allowed financial incentives to supplant his independent medical judgment and ethical duty to act in the best interest of patients. This type of payment structure – compensating physicians based on the volume or value of referrals or orders generated – is a quintessential violation of the federal Anti-Kickback Statute (AKS).<sup></sup> Such arrangements inherently compromise medical decision-making, creating a powerful incentive to order services regardless of whether they are medically necessary or appropriate for the patient. The significant sum of over $812,000 received by Dr. Manning underscores the high volume of fraudulent orders he must have processed during the scheme&#8217;s duration to accumulate such earnings through these illicit payments.  ;</p>



<h2 class="wp-block-heading"> The Investigation: Uncovering the Conspiracy</h2>



<h3 class="wp-block-heading"> Lead Agencies: HHS-OIG and FBI Nashville</h3>



<p>The investigation into Dr. Manning&#8217;s activities was spearheaded by two primary federal agencies: the U.S. Department of Health &; Human Services &#8211; Office of Inspector General (HHS-OIG) and the Federal Bureau of Investigation (FBI), specifically its Nashville Field Office.<sup></sup>  ;</p>



<p>This joint investigative approach is the <a href="https://www.fraudswatch.com/biometric-techniques-enhancing-security-standards-in-high-performance-enterprise/amp/" data-wpil-monitor-id="1405">standard operating procedure for major federal healthcare fraud</a> cases across the United States. The collaboration leverages the distinct strengths and expertise of each agency. HHS-OIG possesses deep institutional knowledge of federal healthcare programs like Medicare and Medicaid, specialized skills in analyzing complex billing data and medical claims, and specific statutory authorities related to healthcare fraud and abuse.<sup></sup> The FBI contributes its broad federal criminal investigative jurisdiction, extensive resources for conducting complex financial investigations, expertise in uncovering conspiracies, and tactical capabilities.<sup></sup> This partnership creates a formidable investigative force capable of tackling sophisticated, large-scale healthcare fraud operations like the one involving Dr. Manning.  ;</p>



<h3 class="wp-block-heading"> Investigative Collaboration</h3>



<p>In addition to the lead federal agencies, the investigation benefited from the assistance of the Cheatham County Sheriff’s Office.<sup></sup> Dr. Manning&#8217;s residence in Ashland City falls within Cheatham County, Tennessee.  ;</p>



<p>The involvement of local law enforcement underscores the multi-jurisdictional nature of these investigations and the value of federal-state-local partnerships. Local agencies often provide crucial on-the-ground support, which may include executing search warrants or arrest warrants (Dr. Manning was arrested at his home by federal agents, potentially with local assistance) <sup></sup>, conducting surveillance, gathering local intelligence, or facilitating interviews. This cooperation ensures that investigations can proceed efficiently across different jurisdictional boundaries.  ;</p>



<h3 class="wp-block-heading"> Prosecution Team</h3>



<p>The successful prosecution of Dr. Manning was handled by a team comprising attorneys from both the local U.S. Attorney&#8217;s Office for the Middle District of Tennessee and the Department of Justice&#8217;s central Criminal Division. Specifically, Assistant U.S. Attorney Robert S. Levine represented the local office, while Trial Attorney Kathryn Furtado from the Criminal Division’s Fraud Section in Washington D.C. also participated.<sup></sup> An earlier press release concerning the indictment also mentioned the involvement of Trial Attorney Leslie Fisher from the Fraud Section.<sup></sup>  ;</p>



<p>This collaborative prosecution structure, combining local and national resources, is common in significant healthcare fraud cases, particularly those that are part of larger national enforcement initiatives or involve complex, multi-state schemes. The U.S. Attorney&#8217;s Office provides essential knowledge of the local district, court procedures, and community context, along with primary prosecutorial resources. The DOJ Criminal Division&#8217;s Fraud Section contributes specialized expertise in litigating complex healthcare fraud statutes, coordinating national enforcement strategies (such as the large-scale takedowns targeting telemedicine fraud), and providing additional trial resources when needed.<sup></sup> This joint approach ensures that cases like Dr. Manning&#8217;s receive the focused expertise and resources required for a successful outcome.  ;</p>



<h2 class="wp-block-heading"> Legal Dimensions: Statutes, Plea, and Sentencing</h2>



<p>The prosecution of Dr. John R. Manning centered on federal statutes designed to combat fraud against government healthcare programs. Understanding these laws is crucial to appreciating the legal basis for his conviction and sentence.</p>



<h3 class="wp-block-heading"> Health Care Fraud (18 U.S.C. § 1347)</h3>



<p>The primary substantive offense alleged in the indictment execute, a scheme or artifice intended to either (1) defraud any health care benefit program, or (2) obtain, by means of false or fraudulent pretenses, representations, or promises, any money or property owned by, or under the control of, such a program, in connection with the delivery or payment of health care benefits, items, or services.<sup></sup>  ;</p>



<p>To secure a conviction under § 1347, the government must prove beyond a reasonable doubt that the defendant devised or participated in a scheme to defraud or obtain money/property through falsity, that the scheme related to a healthcare benefit program (like Medicare), and that the defendant acted knowingly and willfully in executing or attempting to execute the scheme.<sup></sup> A significant aspect of this statute is that it does <em>not</em> require the government to prove that the defendant had actual knowledge of § 1347 itself or possessed the specific intent to violate this particular law.<sup></sup> It is sufficient to prove that the defendant knowingly and willfully engaged in the fraudulent conduct.  ;</p>



<p>Dr. Manning&#8217;s conduct, as admitted in his plea, directly aligns with the elements of § 1347. By systematically signing orders for DME, creams, and CGx tests that he knew were not medically necessary (due to lack of patient contact and assessment) and doing so in exchange for kickbacks, he knowingly executed a scheme to cause the submission of false claims to Medicare for payment.<sup></sup> The eight substantive fraud counts in his indictment were based on specific instances of this conduct.  ;</p>



<p>Violations of § 1347 carry substantial penalties. A standard conviction is punishable by up to 10 years of imprisonment per count and significant fines (up to $250,000 for individuals and $500,000 for organizations).<sup></sup> The potential prison sentence increases to a maximum of 20 years if the fraud results in serious bodily injury to a patient, and to life imprisonment if the fraud results in death.<sup></sup>  ;</p>



<h3 class="wp-block-heading"> Conspiracy to Commit Health Care Fraud (18 U.S.C. § 1349)</h3>



<p>Dr. Manning ultimately pled guilty to conspiracy to commit health care fraud under 18 U.S.C. § 1349. This statute specifically addresses attempts and conspiracies to commit any offense defined within Chapter 63 of Title 18, which includes § 1347 health care fraud.<sup></sup>  ;</p>



<p>The core elements the government must prove for a § 1349 conspiracy conviction are: (1) that an agreement existed between two or more persons to commit the underlying offense (in this case, health care fraud under § 1347); (2) that the defendant knew the unlawful purpose of this agreement; and (3) that the defendant joined the agreement voluntarily and with the intent to help achieve its unlawful purpose.<sup></sup> There is some legal discussion on whether § 1349 requires proof of an &#8220;overt act&#8221; taken in furtherance of the conspiracy, similar to the general federal conspiracy statute (18 U.S.C. § 371). Some sources suggest § 1349 does <em>not</em> require an overt act, making the agreement itself the primary focus <sup></sup>, while others mention an overt act as an element.<sup></sup> Regardless, the essence of the charge lies in the illicit agreement and the defendant&#8217;s intentional participation.  ;</p>



<p>By pleading guilty, Dr. Manning admitted to entering into such an agreement with others – presumably individuals associated with the telemedicine companies and potentially other participants in the scheme – with the shared unlawful goal of defrauding Medicare through the submission of false claims generated via medically unnecessary prescriptions exchanged for kickbacks.<sup></sup>  ;</p>



<p>Crucially, § 1349 mandates that any person who attempts or conspires to commit an offense under Chapter 63 &#8220;shall be subject to the same penalties as those prescribed for the offense, the commission of which was the object of the attempt or conspiracy&#8221;.<sup></sup> Therefore, the penalties for conspiracy to commit health care fraud are identical to those for the substantive offense under § 1347: up to 10 years imprisonment, potential enhancements for injury or death, and substantial fines.  ;</p>



<h3 class="wp-block-heading"> Potential Anti-Kickback Statute (AKS) Implications (42 U.S.C. § 1320a-7b(b))</h3>



<p>While Dr. Manning was not formally charged under the Anti-Kickback Statute (AKS), his admitted conduct clearly implicates this critical healthcare fraud law. The AKS is a criminal statute that makes it illegal to knowingly and willfully solicit, receive, offer, or pay any remuneration (including kickbacks, bribes, or rebates, directly or indirectly, overtly or covertly, in cash or in kind) to induce or reward referrals of individuals for, or the purchasing, leasing, ordering, or arranging for or recommending purchasing, leasing, or ordering of, any good, facility, service, or item for which payment may be made in whole or in part under a Federal health care program.<sup></sup>  ;</p>



<p>Dr. Manning&#8217;s admission that he received payments characterized as &#8220;illegal kickbacks and bribes&#8221; and &#8220;fee[s] per visit&#8221; specifically <em>in exchange for</em> signing the orders and prescriptions that were subsequently billed to Medicare falls squarely within the AKS&#8217;s prohibition against receiving remuneration for ordering services payable by a federal program.<sup></sup>  ;</p>



<p>The fact that the AKS was not charged as a separate count does not diminish its relevance. Conduct violating the AKS often forms the foundational predicate for charges under other statutes, including § 1347 health care fraud and the False Claims Act. Claims submitted to Medicare that are tainted by an AKS violation are considered false or fraudulent claims as a matter of law.<sup></sup> Therefore, the kickbacks Manning received were not merely incidental; they were the mechanism that rendered the subsequent Medicare claims fraudulent. Prosecutors possess discretion in selecting the charges they bring. In this instance, focusing on the overarching conspiracy (§ 1349) and the resulting fraudulent claims (§ 1347 counts in the indictment) may have been deemed a more encompassing or strategically advantageous approach, treating the kickback arrangement as the <em>means</em> by which the broader fraud was executed. The elements of § 1347/§ 1349 might also have been viewed as more straightforward to prove in court compared to navigating the specific intent requirements and potential safe harbor defenses associated with the AKS.  ;</p>



<h3 class="wp-block-heading"> Analysis of Guilty Plea and Sentencing Outcome</h3>



<p>Dr. Manning&#8217;s guilty plea to the single conspiracy count effectively resolved the entire nine-count indictment.<sup></sup> This outcome avoided a potentially resource-intensive trial and signified his acceptance of criminal responsibility for the overarching agreement to defraud Medicare. The 3-year sentence reflects a balancing of various factors under the federal sentencing guidelines. Mitigating factors likely included his guilty plea, potentially his age and health, and the lack of severe prior disciplinary actions noted in the available background information. Aggravating factors undoubtedly included the enormous scale of the financial loss to Medicare (nearly $20 million), the extended duration of the conspiracy (almost three years), the breach of trust inherent in his position as a physician, and the calculated nature of the scheme involving kickbacks. The substantial restitution and forfeiture orders serve the critical functions of compensating the victim program and ensuring that Dr. Manning is stripped of all financial gains derived from his criminal conduct.<sup></sup>  ;</p>



<p>The following table compares the key federal statutes implicated in this case and similar telemedicine fraud scenarios:</p>



<figure class="wp-block-table"><table class="has-fixed-layout"><tbody><tr><th>Feature</th><th><strong>18 U.S.C. § 1347</strong></th><th><strong>18 U.S.C. § 1349</strong></th><th><strong>42 U.S.C. § 1320a-7b(b) (AKS)</strong></th></tr><tr><td><strong>Crime</strong></td><td>Health Care Fraud</td><td>Conspiracy / Attempt (to commit § 1347 fraud)</td><td>Anti-Kickback Statute</td></tr><tr><td><strong>Key Elements</strong></td><td>Scheme to defraud/obtain money via falsity; Connection to healthcare benefits/payment; Knowing &; willful execution/attempt</td><td>Agreement between ≥2 persons to commit § 1347 fraud; Defendant&#8217;s knowledge of unlawful purpose; Intentional joining</td><td>Knowing &; willful solicitation/receipt/offer/payment of remuneration; To induce/reward referrals/orders for federally payable items/svcs</td></tr><tr><td><strong>Intent Standard</strong></td><td>Knowing &; Willful execution of scheme; <em>Specific intent/knowledge of § 1347 not required</em></td><td>Intent to agree &; further unlawful purpose of the conspiracy</td><td>Knowing &; Willful violation of AKS</td></tr><tr><td><strong>Penalties (Primary)</strong></td><td>Up to 10 yrs prison (enhancements for injury/death); Fines ($250k/$500k Ind/Org)</td><td>Same as underlying offense (§ 1347: Up to 10 yrs, fines, etc.)</td><td>Up to 5 yrs prison per violation (Note: recent changes may increase); Fines ($25k+); Exclusion from federal programs</td></tr><tr><td><strong>Typical Role in Telemedicine Fraud</strong></td><td>Substantive charge for submitting/causing false claims based on unnecessary/kickback-tainted orders</td><td>Overarching charge linking multiple participants (marketers, doctors, companies, labs/suppliers) in the scheme</td><td>Often the underlying violation; Kickbacks drive medically unnecessary orders, making resulting claims false/fraudulent under § 1347/FCA</td></tr></tbody></table></figure>



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<p><em>Sources: <sup></sup>&#8211;<sup></sup>&#8211;<sup></sup>&#8211;<sup></sup>-.<sup></sup> Penalties are subject to statutory updates and sentencing guideline applications.</em>  ;</p>



<h2 class="wp-block-heading"> Contextualizing the Case: Telemedicine Fraud in the United States</h2>



<p>Dr. Manning&#8217;s case is not an isolated incident but rather reflects broader trends and significant challenges associated with the rapid growth of telehealth services in the United States. Understanding this context is essential for appreciating the case&#8217;s significance and the ongoing efforts to combat fraud in this domain.</p>



<h3 class="wp-block-heading"> Common Schemes and Tactics</h3>



<p>Federal investigations and enforcement actions have revealed recurring patterns and tactics employed in telemedicine-related fraud schemes. Dr. Manning&#8217;s conduct incorporated several of these common elements:</p>



<ol class="wp-block-list">
<li><strong>Kickbacks for Orders:</strong> The most prevalent tactic involves paying physicians or other qualified practitioners kickbacks, often disguised as legitimate payments (e.g., &#8220;telemedicine consult fees,&#8221; &#8220;medical director fees,&#8221; &#8220;payment per chart review&#8221;), in exchange for ordering or prescribing medically unnecessary items or services. This directly compromises medical judgment. </li>



<li><strong>Aggressive Telemarketing and Patient Recruitment:</strong> Schemes frequently rely on marketing companies or call centers that use aggressive and sometimes deceptive tactics to contact Medicare beneficiaries (often via cold calls), persuade them to accept items or services they do not need, and obtain their personal health information and Medicare numbers. </li>



<li><strong>Lack of Valid Patient-Provider Relationship:</strong> A hallmark of these schemes is the absence of a legitimate clinical relationship. Orders are often signed based on minimal (e.g., brief phone call) or no interaction between the practitioner and the patient, making a valid assessment of medical necessity impossible. </li>



<li><strong>Targeting Specific High-Reimbursement Items:</strong> Fraudsters often focus on items known for high reimbursement rates and potentially lower scrutiny, such as DME (especially orthotic braces), expensive compounded topical creams, and genetic tests (CGx and Pharmacogenomic/PGx testing). </li>



<li><strong>Use of Intermediary Telemedicine Companies:</strong> Sophisticated schemes often involve layers of companies – telemedicine platforms, marketing organizations, lead generators – that act as brokers, facilitating the flow of patient information and kickbacks while attempting to obscure the direct illegal financial relationships. </li>



<li><strong>Billing Fraud:</strong> Beyond unnecessary orders, telehealth fraud can involve improper billing practices such as upcoding (billing for a higher level of service than provided), billing for phantom visits that never occurred, unbundling services, or billing for services provided by ineligible personnel or from non-approved locations (particularly relevant before pandemic waivers). </li>
</ol>



<p>In July 2022, HHS-OIG issued a Special Fraud Alert specifically warning practitioners about potentially fraudulent arrangements involving telemedicine companies. This alert highlighted several &#8220;suspect characteristics&#8221; or red flags that should prompt caution:</p>



<p><strong>Table: OIG Special <a href="https://www.fraudswatch.com/chatgpt-4-scams-red-flags-examples-reporting/amp/" data-wpil-monitor-id="1408">Fraud Alert &#8211; Telemedicine Red Flags</a> (July 2022)</strong></p>



<figure class="wp-block-table"><table class="has-fixed-layout"><tbody><tr><th>Indicator / Suspect Characteristic</th><th>Relevance to Manning Case</th></tr><tr><td>Patients are identified/recruited by the telemedicine company, telemarketers, sales agents, etc. (often via ads for &#8220;free&#8221; items).</td><td>Yes. Orders signed based on brief/no contact implies patients were recruited externally, not presenting organically to Manning for care.</td></tr><tr><td>Practitioner is compensated based on the volume of items/services ordered or prescribed (e.g., fee per &#8220;visit&#8221; or per order).</td><td>Yes. Indictment alleged payment &#8220;per visit&#8221;; Manning admitted receiving kickbacks tied to orders.</td></tr><tr><td>Practitioner lacks sufficient contact with or information from the patient to meaningfully assess medical necessity.</td><td>Yes. Core allegation admitted by Manning – brief/no calls, no exam.</td></tr><tr><td>Telemedicine company primarily furnishes/arranges for only one product or a single class of high-cost products (e.g., DME, CGx).</td><td>Yes. Manning&#8217;s prescriptions focused specifically on DME, topical creams, and CGx tests, aligning with targeted fraud schemes.</td></tr><tr><td>Company claims to only serve non-federal beneficiaries but actually bills federal programs (or vice versa).</td><td>Not explicitly detailed in Manning&#8217;s case specifics, but a common deceptive tactic in broader schemes.</td></tr><tr><td>Limited or no expectation/ability for the practitioner to follow up with patients after ordering items/services.</td><td>Implied. Lack of initial relationship and focus on volume suggests follow-up care was not part of the arrangement.</td></tr></tbody></table></figure>



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<p><em>Sources:.<sup></sup></em> This table distills key warning signs identified by HHS-OIG, many of which were present in the Manning case, offering practical indicators for compliance vigilance.  ;</p>



<h3 class="wp-block-heading"> Regulatory and Enforcement Challenges</h3>



<p>The proliferation of telemedicine fraud is intertwined with several regulatory and enforcement challenges:</p>



<ul class="wp-block-list">
<li><strong>Rapid Expansion vs. Oversight:</strong> The dramatic increase in telehealth utilization, particularly catalyzed by the COVID-19 pandemic, involved necessary waivers and flexibilities implemented by CMS and HHS to ensure access to care. These changes relaxed long-standing restrictions on eligible locations (allowing home-based visits), service types, provider types, and technology modalities (including audio-only). While crucial for continuity of care, this rapid deregulation outpaced the development and implementation of corresponding program integrity safeguards, creating new opportunities for exploitation. </li>



<li><strong>Verification Difficulties:</strong> The inherent remote nature of telehealth makes it more difficult for payers and investigators to verify that services were actually rendered as billed, that the patient interaction was substantive, and that the ordered items/services were truly medically necessary compared to traditional in-person encounters. </li>



<li><strong>Licensure and Geographic Complexity:</strong> While temporary waivers eased state licensure barriers during the public health emergency, the underlying state-based licensure system presents ongoing complexities for legitimate multi-state telehealth providers and potential loopholes for fraudulent operators. </li>



<li><strong>Identifying Fraudulent Actors:</strong> Distinguishing legitimate telehealth innovation and utilization from sophisticated fraud schemes (&#8220;telefraud&#8221;) requires significant analytical effort. Furthermore, identifying the specific corporate entities, particularly intermediary telemedicine companies, involved in fraudulent billing can be challenging within existing claims data systems. </li>



<li><strong>Data Analysis Lag:</strong> Program integrity efforts often rely on analyzing claims data after payments have been made. This retrospective approach means fraudulent schemes can operate and cause significant losses before being detected and stopped. </li>
</ul>



<p>A key dynamic emerging from this context is the &#8220;pandemic paradox&#8221;: the very measures implemented to expand telehealth access during a public health crisis inadvertently created a more fertile ground for fraud.<sup></sup> Relaxed rules lowered barriers, the surge in volume made anomalies harder to spot initially, and fraudsters quickly adapted their schemes to exploit the new environment. While Dr. Manning&#8217;s fraud began before the pandemic, the accelerated adoption and deregulation during COVID-19 undoubtedly amplified the scale and visibility of telehealth fraud nationwide, prompting a corresponding intensification of enforcement efforts.<sup></sup>  ;</p>



<h3 class="wp-block-heading"> National Enforcement Trends and Statistics (DOJ/HHS-OIG Actions)</h3>



<p>In response to the growing threat, federal law enforcement agencies, led by DOJ and HHS-OIG, have made combating telehealth fraud a major national priority. This is evidenced by a series of large-scale, coordinated enforcement actions (&#8220;takedowns&#8221;) announced annually, often involving significant numbers of defendants and billions of dollars in alleged fraud losses:</p>



<ul class="wp-block-list">
<li><strong>Escalating Takedowns:</strong> Starting around 2019 with operations targeting DME (Operation Brace Yourself) and genetic testing (Operation Double Helix) , subsequent national takedowns in 2020, 2021, 2022, 2023, and 2024 have consistently featured telemedicine as a primary focus, charging hundreds of individuals and alleging cumulative fraud losses exceeding billions of dollars.
<ul class="wp-block-list">
<li>The 2021 action involved 138 defendants and $1.4 billion in alleged losses, with $1.1 billion linked to telemedicine schemes. </li>



<li>The 2022 action charged 36 defendants with schemes totaling over $1.2 billion, heavily focused on telemedicine, CGx, and DME. Dr. Manning&#8217;s indictment occurred within this timeframe and context. </li>



<li>The 2023 action involved 78 defendants and $2.5 billion in alleged false billings, again with a significant telemedicine component ($1.1 billion). </li>



<li>The 2024 action announced charges against 193 defendants for schemes allegedly causing over $2.75 billion in losses, with $1.1 billion attributed to telemedicine and clinical laboratory fraud. This takedown also included novel charges against executives of a digital health company for alleged unlawful distribution of controlled substances via telehealth. </li>
</ul>
</li>



<li><strong>Financial Recoveries:</strong> Beyond criminal charges, these efforts result in substantial financial recoveries through criminal restitution, forfeiture, civil settlements under the False Claims Act, and administrative penalties. HHS-OIG alone reported expectations to recover over $7 billion in FY 2024 from its combined <a href="https://www.fraudswatch.com/medicaid-fraud-dr-ghodrat-pirooz-sholevar-settles-for-900k-after-overbilling-for-mental-health-services/amp/" data-wpil-monitor-id="1406">audit</a> and investigative work. </li>



<li><strong>Use of Data Analytics:</strong> Agencies are increasingly relying on sophisticated data analytics, including <a href="https://www.fraudswatch.com/google-ai-secrets-at-risk-linwei-ding-faces-14-counts-of-espionage-and-trade-secret-theft-in-china-scheme/amp/" data-wpil-monitor-id="1403">artificial intelligence</a> and machine learning techniques, to proactively identify aberrant billing patterns, high-risk providers, and emerging fraud schemes. HHS-OIG&#8217;s analysis identifying 1,714 providers with high-risk telehealth billing patterns during the pandemic&#8217;s first year is a prime example of this approach. </li>
</ul>



<p>This clear escalation in enforcement activity, marked by larger and more frequent national takedowns specifically targeting telemedicine fraud, demonstrates the federal government&#8217;s determined response to the perceived scale of the threat. The focus <a href="https://www.fraudswatch.com/grandparent-scams-in-2024-navigating-the-evolving-tactics-of-fraudsters/amp/" data-wpil-monitor-id="1409">evolves to match new tactics</a> (e.g., moving from DME to CGx to controlled substances), and the increasing use of data analytics signals a shift towards more proactive detection. Dr. Manning&#8217;s prosecution fits seamlessly into this national landscape, representing a significant individual case within a much broader pattern of telehealth abuse and the corresponding robust enforcement reaction.</p>



<h2 class="wp-block-heading"> Significance and Impact of the Manning Case</h2>



<p>The conviction and sentencing of Dr. John R. Manning carry significant implications, both financially for the Medicare system and symbolically as a message to the healthcare community.</p>



<h3 class="wp-block-heading"> Financial Impact on Medicare and Taxpayers</h3>



<p>The most direct impact of Dr. Manning&#8217;s fraudulent activities was the substantial financial loss imposed upon the Medicare program. His actions led to the improper payment of $19,780,565.44 by Medicare for medically unnecessary DME, topical creams, and CGx tests.<sup></sup> The total value of the fraudulent claims submitted as a result of his participation exceeded $41 million.<sup></sup>  ;</p>



<p>Federal officials explicitly connected this loss to the burden placed on taxpayers who fund the Medicare program. Acting United States Attorney Robert E. McGuire characterized Manning&#8217;s actions as having &#8220;bilked the taxpayers out of almost $20 million&#8221;.<sup></sup> Similarly, FBI Special Agent in Charge Joseph E. Carrico noted that healthcare fraud &#8220;hurts all of us and drives up health care costs&#8221;.<sup></sup>  ;</p>



<p>While national enforcement actions often cite fraud losses in the billions, the nearly $20 million loss attributed to the actions of a single physician in the Manning case provides a tangible and stark illustration of the significant financial drain that healthcare fraud imposes on the system. It highlights how individual actors, particularly those in positions of trust like physicians, can facilitate enormous losses when participating in organized schemes. The court&#8217;s order for full restitution directly links the criminal conviction to the effort to recover these misappropriated taxpayer funds, reinforcing the economic imperative behind aggressive fraud enforcement.</p>



<h3 class="wp-block-heading"> Deterrence and Message to Healthcare Providers (Official Statements)</h3>



<p>Beyond the financial recovery, the prosecution and sentencing of Dr. Manning were clearly intended to send a strong deterrent message to other healthcare providers. The public statements made by officials involved in the case emphasized themes of accountability, breach of trust, and the consequences of prioritizing greed over patient welfare.</p>



<ul class="wp-block-list">
<li><strong>Abuse of Trust:</strong> Acting U.S. Attorney McGuire pointedly stated that Dr. Manning &#8220;ignored his oath to help people,&#8221; directly addressing the violation of professional ethics inherent in the crime. </li>



<li><strong>Accountability:</strong> McGuire underscored that the sentence ensures Dr. Manning &#8220;faces accountability for his actions&#8221; and provides &#8220;some justice for [taxpayers] being taken advantage of&#8221;. </li>



<li><strong>Warning to Providers:</strong> HHS-OIG Special Agent in Charge Kelly Blackmon issued a clear warning: &#8220;Health care providers that participate in the federal health care system are required to obey the laws and regulations meant to protect the integrity of the Medicare and Medicaid program&#8230; [We] will continue to work with our law enforcement partners and hold providers accountable when they do not follow the law&#8221;. </li>



<li><strong>Commitment to Fighting Fraud:</strong> FBI SAC Carrico reiterated the Bureau&#8217;s commitment, alongside partners, to &#8220;identify, investigate and bring to justice the criminals who, driven by greed, manipulate the system for personal benefit&#8221;. </li>
</ul>



<p>Publicizing convictions like Dr. Manning&#8217;s, accompanied by strong official statements emphasizing the breach of professional duty and the certainty of consequences (including imprisonment, substantial financial penalties, and loss of livelihood), serves a critical deterrent function. It aims to dissuade other practitioners from engaging in similar conduct by demonstrating that such actions will be detected and severely punished. The consistent messaging from the U.S. Attorney&#8217;s Office, HHS-OIG, and the FBI reinforces the coordinated and serious approach federal agencies take toward combating healthcare fraud, particularly schemes exploiting vulnerable programs like Medicare through mechanisms such as telemedicine.</p>



<h2 class="wp-block-heading"> Conclusion and Expert Recommendations</h2>



<h3 class="wp-block-heading"> Summary of Findings</h3>



<p>The case of Dr. John R. Manning provides a significant example of large-scale healthcare fraud perpetrated through the misuse of telemedicine. A licensed family physician, Dr. Manning conspired with multiple telemedicine companies to sign medically unnecessary orders for DME, topical creams, and CGx tests for Medicare beneficiaries with whom he had little or no clinical interaction. His motivation was financial gain, receiving over $812,000 in illegal kickbacks for his participation. This conspiracy resulted in over $41 million in fraudulent claims submitted to Medicare and actual losses exceeding $19.7 million.</p>



<p>Dr. Manning&#8217;s guilty plea to conspiracy to commit health care fraud led to a sentence of three years in federal prison, full restitution to Medicare, and forfeiture of his illicit earnings. The investigation was a collaborative effort by HHS-OIG and the FBI, assisted by local law enforcement, reflecting the standard multi-agency approach to complex healthcare fraud. The case involved clear violations of federal law, primarily 18 U.S.C. § 1349 (Conspiracy to Commit Health Care Fraud) and the underlying conduct described in 18 U.S.C. § 1347 (Health Care Fraud), with the illegal kickbacks violating the principles of the Anti-Kickback Statute.</p>



<p>Crucially, Dr. Manning&#8217;s actions mirror common tactics seen in nationwide telemedicine fraud schemes, including the use of intermediary companies, volume-based kickbacks corrupting medical judgment, targeting of high-reimbursement items, and a fundamental lack of medical necessity due to inadequate patient evaluation. The case occurred against a backdrop of rapidly expanding telehealth use and evolving regulatory oversight, highlighting the vulnerabilities that enforcement agencies are actively working to address through increased scrutiny and coordinated takedowns.</p>



<h3 class="wp-block-heading"> Implications for Compliance and Risk Management in Telehealth</h3>



<p>The Manning case and the broader trends in telemedicine fraud underscore the critical need for robust compliance programs and heightened vigilance among all participants in the telehealth ecosystem:</p>



<ul class="wp-block-list">
<li><strong>Heightened Scrutiny:</strong> Healthcare providers, telehealth platform companies, and associated entities like laboratories and DME suppliers must recognize that telehealth arrangements are under intense scrutiny from federal and state regulators and enforcement agencies. Compliance programs must specifically address the unique risks inherent in remote care delivery.</li>



<li><strong>Practitioner Due Diligence:</strong> Physicians and other practitioners considering affiliations with telemedicine companies must exercise extreme caution. Thorough due diligence is essential before entering any arrangement. This includes scrutinizing the company&#8217;s business model, patient recruitment methods, compensation structures, patient interaction protocols, and the types of services being promoted. Arrangements involving compensation tied directly to the volume of orders or prescriptions are exceptionally high-risk and likely violate the AKS. Practitioners should heed the red flags identified by HHS-OIG. </li>



<li><strong>Establishing Medical Necessity:</strong> The cornerstone of compliant healthcare is medical necessity. In telehealth, this requires ensuring sufficient patient interaction (ideally audio-visual, though audio-only may be permissible under specific, documented circumstances) and access to adequate clinical information to make an informed medical judgment. Brief, superficial encounters or reliance solely on information provided by marketers are insufficient. Rigorous documentation supporting the medical necessity for every item or service ordered via telehealth is paramount. </li>



<li><strong>Anti-Kickback Statute Adherence:</strong> All financial relationships between telehealth participants must be carefully structured to comply with the AKS. Any remuneration flowing between parties involved in referrals or ordering (e.g., platforms, marketers, providers, suppliers, labs) must fit squarely within a designated AKS safe harbor to avoid potential liability. Relying on claims that an arrangement &#8220;carves out&#8221; federal beneficiaries is often insufficient and may be viewed as sham compliance. </li>



<li><strong>Compliance Training:</strong> Regular, targeted training for providers and administrative staff on telehealth-specific compliance requirements, fraud indicators (including OIG red flags), documentation standards, and the potential legal and professional consequences of non-compliance is indispensable. </li>
</ul>



<h3 class="wp-block-heading"> Potential Regulatory Considerations</h3>



<p>As policymakers navigate the post-Public Health Emergency landscape for telehealth, several regulatory considerations emerge, aimed at balancing the recognized benefits of telehealth access with the need for robust program integrity:</p>



<ul class="wp-block-list">
<li><strong>Permanent Policy Development:</strong> Decisions regarding which pandemic-era telehealth flexibilities should become permanent require careful consideration. Regulators like CMS and state medical boards must establish clear, sustainable rules that support continued access while mitigating fraud risks. </li>



<li><strong>Enhanced and Targeted Oversight:</strong> CMS should continue to enhance its monitoring of telehealth billing patterns, utilizing advanced data analytics to identify outliers and high-risk providers or practices for targeted review, as recommended by HHS-OIG. This includes focusing on providers with unusually high volumes of specific services, billing at the highest levels consistently, or exhibiting other suspect patterns. </li>



<li><strong>Increased Transparency:</strong> Mechanisms to improve transparency in Medicare billing data, potentially allowing for clearer identification of the specific telehealth companies or platforms involved in facilitating services, could significantly aid oversight and accountability efforts. </li>



<li><strong>Clearer Guidance:</strong> Ongoing clear guidance from CMS and HHS-OIG regarding compliant telehealth arrangements, particularly addressing new technologies, evolving business models (like platform-based care), and specific high-risk areas (like remote prescribing), is needed to help legitimate providers navigate the complex regulatory environment. </li>
</ul>



<p>Ultimately, the challenge lies in fostering the innovation and improved access that telehealth offers <sup></sup> while implementing adaptive and effective safeguards against the types of fraud and abuse exemplified by the Dr. John R. Manning case. A risk-based regulatory and enforcement approach, informed by data analytics and focused on known vulnerabilities, combined with clear expectations for industry compliance, appears necessary to ensure the sustainable and trustworthy integration of telehealth into the healthcare system.  ; Sources used in the report<a rel="noreferrer noopener" href="https://www.medifind.com/specialty/primary-care/US/TN/Mount%20Juliet"></a></p>