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	<title>False Claims Act &#8211; Policy &amp; Medicine</title>
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	<description>Legal, Regulatory, and Compliance Issues</description>
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	<title>False Claims Act &#8211; Policy &amp; Medicine</title>
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	<item>
		<title>New York Doctor Pleads Guilty to Receiving Kickbacks in Exchange for Ordering Brain Scans</title>
		<link>https://www.policymed.com/2025/01/new-york-doctor-pleads-guilty-to-receiving-kickbacks-in-exchange-for-ordering-brain-scans.html</link>
					<comments>https://www.policymed.com/2025/01/new-york-doctor-pleads-guilty-to-receiving-kickbacks-in-exchange-for-ordering-brain-scans.html#respond</comments>
		
		<dc:creator><![CDATA[Thomas Sullivan]]></dc:creator>
		<pubDate>Fri, 31 Jan 2025 09:25:03 +0000</pubDate>
				<category><![CDATA[False Claims Act]]></category>
		<category><![CDATA[Medical Legal]]></category>
		<category><![CDATA[978 Medicare Fraud Scheme]]></category>
		<category><![CDATA[Doctor Faces Sentencing for Brain Scan Fraud Scheme]]></category>
		<category><![CDATA[Doctor Received $100 Kickbacks for Unnecessary Medical Scans]]></category>
		<category><![CDATA[DOJ Charges in Kickback Scheme: Fishberger Pleads Guilty]]></category>
		<category><![CDATA[Dr. Kenneth Fishberger Pleads Guilty in Health Care Fraud Case]]></category>
		<category><![CDATA[False Brain Scans Lead to Nearly $900K Fraudulent Claims]]></category>
		<category><![CDATA[February 2025 Sentencing for Health Care Fraud Conspiracy]]></category>
		<category><![CDATA[Fishberger’s Role in $891]]></category>
		<category><![CDATA[Health Care Fraud Conspiracy Carries 10-Year Sentence]]></category>
		<category><![CDATA[Health Care Fraud Conspiracy: Fishberger Admits Guilt]]></category>
		<category><![CDATA[Kickback Scheme Leads to Health Care Fraud Conviction]]></category>
		<category><![CDATA[Kickbacks for Medically Unnecessary Brain Scans: Doctor Guilty]]></category>
		<category><![CDATA[Medicare Fraud Case: Dr. Fishberger Ordered False Brain Scans]]></category>
		<category><![CDATA[Medicare Fraud Scheme Involving False Diagnoses Exposed]]></category>
		<category><![CDATA[Mobile Diagnostics Company Implicated in Brain Scan Fraud]]></category>
		<category><![CDATA[NEW]]></category>
		<category><![CDATA[Transcranial Doppler Scan Fraud: Fishberger Pleads Guilty]]></category>
		<guid isPermaLink="false">https://www.policymed.com/?p=17578</guid>

					<description><![CDATA[<div style="margin-bottom:20px;"><img width="1200" height="800" src="https://www.policymed.com/wp-content/uploads/2022/10/stencil.default-60.jpg" class="attachment-post-thumbnail size-post-thumbnail wp-post-image" alt="" decoding="async" fetchpriority="high" srcset="https://www.policymed.com/wp-content/uploads/2022/10/stencil.default-60.jpg 1200w, https://www.policymed.com/wp-content/uploads/2022/10/stencil.default-60-300x200.jpg 300w, https://www.policymed.com/wp-content/uploads/2022/10/stencil.default-60-1024x683.jpg 1024w, https://www.policymed.com/wp-content/uploads/2022/10/stencil.default-60-768x512.jpg 768w, https://www.policymed.com/wp-content/uploads/2022/10/stencil.default-60-450x300.jpg 450w" sizes="(max-width: 1200px) 100vw, 1200px" /></div>Recently, Dr. Kenneth Fishberger pled guilty in federal court to one count of conspiracy to commit health care fraud for receiving kickbacks in exchange for ordering medically unnecessary brain scans. From roughly June 2013 through December 2019, Fishberger – in a conspiracy with others – ordered hundreds of medically unnecessary transcranial doppler (TCD) scans in [&#8230;]]]></description>
										<content:encoded><![CDATA[<div style="margin-bottom:20px;"><img width="1200" height="800" src="https://www.policymed.com/wp-content/uploads/2022/10/stencil.default-60.jpg" class="attachment-post-thumbnail size-post-thumbnail wp-post-image" alt="" decoding="async" srcset="https://www.policymed.com/wp-content/uploads/2022/10/stencil.default-60.jpg 1200w, https://www.policymed.com/wp-content/uploads/2022/10/stencil.default-60-300x200.jpg 300w, https://www.policymed.com/wp-content/uploads/2022/10/stencil.default-60-1024x683.jpg 1024w, https://www.policymed.com/wp-content/uploads/2022/10/stencil.default-60-768x512.jpg 768w, https://www.policymed.com/wp-content/uploads/2022/10/stencil.default-60-450x300.jpg 450w" sizes="(max-width: 1200px) 100vw, 1200px" /></div><p>Recently, Dr. Kenneth Fishberger <a href="https://www.justice.gov/usao-ma/pr/new-york-doctor-charged-health-care-fraud">pled guilty in federal court</a> to one count of conspiracy to commit health care fraud for receiving kickbacks in exchange for ordering medically unnecessary brain scans. From roughly June 2013 through December 2019, Fishberger – in a conspiracy with others – ordered hundreds of medically unnecessary transcranial doppler (TCD) scans in exchange for kickbacks.</p>
<p>Fishberger and the co-conspirators, including a principal and a salesperson for a mobile medical diagnostics company that performed TCD scans, used false diagnoses to order the brain scans. Once the brain scans were ordered, a co-conspirator would submit claims to Medicare and other insurance companies (including private insurance companies) on behalf of the involved medical diagnostics company. As payment for his role in the scheme, Fishberger received roughly $100 in cash for each test. Charging documents alleged $891,978 worth of fraudulent bills submitted to Medicare and private insurance companies as a result of the scheme.</p>
<p>Fishberger’s sentencing is scheduled for February 25, 2025. The charge of conspiracy to commit health care fraud means he is facing a sentence of up to ten years in prison, three years of supervised release, and a fine of up to $250,000.</p>
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		<title>Federal Court Upholds Dismissal of Medicare Advantage False Claims Act Case</title>
		<link>https://www.policymed.com/2025/01/eighth-circuit-court-of-appeals-upholds-false-claims-act-dismissal.html</link>
					<comments>https://www.policymed.com/2025/01/eighth-circuit-court-of-appeals-upholds-false-claims-act-dismissal.html#respond</comments>
		
		<dc:creator><![CDATA[Thomas Sullivan]]></dc:creator>
		<pubDate>Fri, 10 Jan 2025 09:34:21 +0000</pubDate>
				<category><![CDATA[False Claims Act]]></category>
		<category><![CDATA[Medical Legal]]></category>
		<category><![CDATA[CMS regulations]]></category>
		<category><![CDATA[Eighth Circuit]]></category>
		<category><![CDATA[healthcare law]]></category>
		<category><![CDATA[legal precedents]]></category>
		<category><![CDATA[marketing compliance]]></category>
		<category><![CDATA[Medicare Advantage]]></category>
		<category><![CDATA[Medicare fraud]]></category>
		<category><![CDATA[NEW]]></category>
		<guid isPermaLink="false">https://www.policymed.com/?p=17259</guid>

					<description><![CDATA[<div style="margin-bottom:20px;"><img width="1200" height="800" src="https://www.policymed.com/wp-content/uploads/2022/10/stencil.default-62.jpg" class="attachment-post-thumbnail size-post-thumbnail wp-post-image" alt="" decoding="async" srcset="https://www.policymed.com/wp-content/uploads/2022/10/stencil.default-62.jpg 1200w, https://www.policymed.com/wp-content/uploads/2022/10/stencil.default-62-300x200.jpg 300w, https://www.policymed.com/wp-content/uploads/2022/10/stencil.default-62-1024x683.jpg 1024w, https://www.policymed.com/wp-content/uploads/2022/10/stencil.default-62-768x512.jpg 768w, https://www.policymed.com/wp-content/uploads/2022/10/stencil.default-62-450x300.jpg 450w" sizes="(max-width: 1200px) 100vw, 1200px" /></div>Recently, the United States Court of Appeals for the Eighth Circuit affirmed the lower court’s dismissal of a Medicare Advantage (MA) False Claims Act (FCA) liability case. In United States  ex rel. Hold v. Medicare Managed Care Advisors, Elizabeth Holt – a relator – alleged that Medicare Medicaid Advisors Inc. (MMA), formerly named Carefree Solutions [&#8230;]]]></description>
										<content:encoded><![CDATA[<div style="margin-bottom:20px;"><img width="1200" height="800" src="https://www.policymed.com/wp-content/uploads/2022/10/stencil.default-62.jpg" class="attachment-post-thumbnail size-post-thumbnail wp-post-image" alt="" decoding="async" loading="lazy" srcset="https://www.policymed.com/wp-content/uploads/2022/10/stencil.default-62.jpg 1200w, https://www.policymed.com/wp-content/uploads/2022/10/stencil.default-62-300x200.jpg 300w, https://www.policymed.com/wp-content/uploads/2022/10/stencil.default-62-1024x683.jpg 1024w, https://www.policymed.com/wp-content/uploads/2022/10/stencil.default-62-768x512.jpg 768w, https://www.policymed.com/wp-content/uploads/2022/10/stencil.default-62-450x300.jpg 450w" sizes="auto, (max-width: 1200px) 100vw, 1200px" /></div><p>Recently, the United States Court of Appeals for the Eighth Circuit <a href="https://ecf.ca8.uscourts.gov/opndir/24/09/232564P.pdf">affirmed the lower court’s dismissal</a> of a Medicare Advantage (MA) False Claims Act (FCA) liability case. In United States  ex rel. Hold v. Medicare Managed Care Advisors, Elizabeth Holt – a relator – alleged that Medicare Medicaid Advisors Inc. (MMA), formerly named Carefree Solutions USA Inc., Carefree Insurance Inc. (Carefree)—a wholly owned subsidiary of Aetna Inc.—and the insurance carriers UnitedHealthcare Insurance Inc. (United), Humana Inc. (Humana), and Aetna Inc. (Aetna), (collectively, the “carriers”), violated the False Claims Act (FCA).</p>
<p>Holt alleged that since the start of MMA in 2006, the company has engaged in a “systematic, company-directed fraud scheme,” including falsifying CMS-mandated agent certifications and widespread violations of MA marketing regulations.</p>
<p>After filing the lawsuit, the defendants moved to dismiss the claims. The District Court agreed to dismiss Holt’s complaint because it found that no claims were submitted to the Centers for Medicare and Medicaid Services (CMS); that the alleged regulatory violations were not material to CMS’ contract with the carriers; and the complaint failed to plead with particularity, as required by the Federal Rule of Civil Procedure 9(b). Holt appealed to the Court of Appeals for the Eighth Circuit.</p>
<p>In the recent decision, the Court of Appeals for the Eighth Circuit references the definition of “claim” under the FCA, noting that in situations where a FCA case involves money demanded from a recipient of federal funds, there must be five elements satisfied for thereto be a claim under the statute: (1) a “request or demand”; (2) “made to a contractor, grantee, or other recipient” of money or property “the United States Government . . . provided”; (3) “the United States Government . . . provided any portion of the money or property requested or demanded,” or if the requestee pays the requestor before the government issues payment to the requestee, “the United States Government . . . will reimburse . . . any portion of the money or property which” the requestee pays the requestor; (4) the payment given to the requestor will “be spent or used on the Government’s behalf or to advance a Government program or interest”; and (5) the request does not violate 31 U.S.C. § 3729(b)(2)(B). Each of those elements must be pleaded with “requisite particularity.”</p>
<p>With respect to materiality, the Court cited the <em>Escobar</em> decision of the Supreme Court, which found that the “term ‘material’ means having a natural tendency to influence, or be capable of influencing, the payment or receipt of money or property.” Additionally, <em>Escobar</em> noted that in findings of materiality, the effect on the likely or actual behavior of the recipient of the alleged misrepresentation is also important. Over time, essentially three non-exhaustive factors are considered when it comes to materiality: (1) whether the government has expressly designated the legal requirement at issue as a condition of payment; (2) whether the alleged violation is minor or insubstantial or instead goes to the essence of the bargain between the contractor and the government; and (3) whether the government made continued payments, or does so in the mine run of cases, despite actual knowledge of the violation.</p>
<p>Looking specifically at the marketing scheme allegations, the Eighth Circuit found that the first <em>Escobar </em>factor – condition of payment – does not favor a finding of materiality for the marketing scheme allegations because the regulations do not expressly state, as a condition of payment, that a carrier or their agent must follow the Medicare marketing regulations to receive payment. Additionally, the alleged failure to follow marketing regulations does not go to the “essence” of CMS’s contract with the carriers. When a carrier fails to comply with the marketing requirements, “CMS may impose one or more of the sanctions” outlined in the regulations.” There is no such direction in the regulations that state CMS must sanction a carrier because the carrier’s agent committed a marketing violation. Finally, the Court found that none of the alleged violations harmed the purpose of CMS’s contract because marketing services “likely do not hinder CMS’s or a carrier’s ability to provide those medical services.”</p>
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			</item>
		<item>
		<title>California Physician and Medical Practice Reach $3.8 Million False Claims Act Settlement</title>
		<link>https://www.policymed.com/2025/01/california-physician-and-medical-practice-reach-3-8-million-false-claims-act-settlement.html</link>
					<comments>https://www.policymed.com/2025/01/california-physician-and-medical-practice-reach-3-8-million-false-claims-act-settlement.html#respond</comments>
		
		<dc:creator><![CDATA[Thomas Sullivan]]></dc:creator>
		<pubDate>Tue, 07 Jan 2025 09:31:59 +0000</pubDate>
				<category><![CDATA[False Claims Act]]></category>
		<category><![CDATA[$3.8 million settlement]]></category>
		<category><![CDATA[Alternative Medicine]]></category>
		<category><![CDATA[Center for Health & Wellbeing]]></category>
		<category><![CDATA[Defense Criminal]]></category>
		<category><![CDATA[Department of Defense]]></category>
		<category><![CDATA[Dr. Janette Gray]]></category>
		<category><![CDATA[federal health program exclusion]]></category>
		<category><![CDATA[holistic treatments]]></category>
		<category><![CDATA[hormone therapy]]></category>
		<category><![CDATA[integrative clinic]]></category>
		<category><![CDATA[IV infusion therapy]]></category>
		<category><![CDATA[medical billing fraud]]></category>
		<category><![CDATA[Medicare fraud]]></category>
		<category><![CDATA[NEW]]></category>
		<category><![CDATA[Southern District of California]]></category>
		<category><![CDATA[supplement therapy]]></category>
		<category><![CDATA[TRICARE fraud]]></category>
		<category><![CDATA[unbundling services]]></category>
		<guid isPermaLink="false">https://www.policymed.com/?p=17345</guid>

					<description><![CDATA[<div style="margin-bottom:20px;"><img width="1200" height="800" src="https://www.policymed.com/wp-content/uploads/2023/10/stencil.default-2023-10-23T203038.225.jpg" class="attachment-post-thumbnail size-post-thumbnail wp-post-image" alt="" decoding="async" loading="lazy" srcset="https://www.policymed.com/wp-content/uploads/2023/10/stencil.default-2023-10-23T203038.225.jpg 1200w, https://www.policymed.com/wp-content/uploads/2023/10/stencil.default-2023-10-23T203038.225-300x200.jpg 300w, https://www.policymed.com/wp-content/uploads/2023/10/stencil.default-2023-10-23T203038.225-1024x683.jpg 1024w, https://www.policymed.com/wp-content/uploads/2023/10/stencil.default-2023-10-23T203038.225-768x512.jpg 768w, https://www.policymed.com/wp-content/uploads/2023/10/stencil.default-2023-10-23T203038.225-450x300.jpg 450w" sizes="auto, (max-width: 1200px) 100vw, 1200px" /></div>The Center for Health &#38; Wellbeing and Dr. Janette Gray reached a $3.8 million settlement with the United States Attorney’s Office for the Southern District of California, resolving False Claims Act allegations. Dr. Gray and the clinic portrayed themselves as an “alternative,” “integrative,” and “holistic” clinic, staffed by myriad health professionals, including medical doctors, nurse [&#8230;]]]></description>
										<content:encoded><![CDATA[<div style="margin-bottom:20px;"><img width="1200" height="800" src="https://www.policymed.com/wp-content/uploads/2023/10/stencil.default-2023-10-23T203038.225.jpg" class="attachment-post-thumbnail size-post-thumbnail wp-post-image" alt="" decoding="async" loading="lazy" srcset="https://www.policymed.com/wp-content/uploads/2023/10/stencil.default-2023-10-23T203038.225.jpg 1200w, https://www.policymed.com/wp-content/uploads/2023/10/stencil.default-2023-10-23T203038.225-300x200.jpg 300w, https://www.policymed.com/wp-content/uploads/2023/10/stencil.default-2023-10-23T203038.225-1024x683.jpg 1024w, https://www.policymed.com/wp-content/uploads/2023/10/stencil.default-2023-10-23T203038.225-768x512.jpg 768w, https://www.policymed.com/wp-content/uploads/2023/10/stencil.default-2023-10-23T203038.225-450x300.jpg 450w" sizes="auto, (max-width: 1200px) 100vw, 1200px" /></div><p>The Center for Health &amp; Wellbeing and Dr. Janette Gray reached <a href="https://www.justice.gov/usao-sdca/pr/san-diego-physician-and-medical-practice-pay-38-million-resolve-false-claims-act">a $3.8 million settlement</a> with the United States Attorney’s Office for the Southern District of California, resolving False Claims Act allegations.</p>
<p>Dr. Gray and the clinic portrayed themselves as an “alternative,” “integrative,” and “holistic” clinic, staffed by myriad health professionals, including medical doctors, nurse practitioners, naturopathic doctors, chiropractors, acupuncturists, and mental health professionals, along with ancillary medical and administrative staff. The Center and Dr. Gray promoted IV infusion therapy, hormone/supplement therapy, and a variety of other alternative treatments.</p>
<p>The government alleged that Gray and the Center for Health &amp; Wellbeing in San Diego billed Medicare and TRICARE from 2012 to 2022 for services that were not covered under either program by misrepresenting the services provided to patients, disguising the provider rendering the services, billing for medically unnecessary services, and/or unbundling services. Unbundling services involves billing for a procedure or service in parts, instead of under a single code.</p>
<p>Included in the settlement is the requirement that Gray be excluded from participating in Medicare, Medicaid, and other federal health programs for five years. As we often see in these settlements, the claims resolved are allegations and there has been no determination of liability.</p>
<p>“The civil settlement holds Dr. Gray and her former medical practice accountable for questionable actions that circumvented the TRICARE billing guidelines and allowed them to receive payments for services that should not have been reimbursed by TRICARE, costing American taxpayers millions of dollars,” <a href="https://www.justice.gov/usao-sdca/pr/san-diego-physician-and-medical-practice-pay-38-million-resolve-false-claims-act">said Bryan D. Denny</a>, Special Agent in Charge of the Department of Defense Office of Inspector General, Defense Criminal Investigative Service (DCIS), Western Field Office.  “DCIS and its partners will always aggressively investigate those who defraud TRICARE, because those deceptive actions ultimately harm those defending our country and their families.”</p>
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			</item>
		<item>
		<title>Third Quarter False Claims Act Roundup</title>
		<link>https://www.policymed.com/2024/12/third-quarter-false-claims-act-roundup.html</link>
					<comments>https://www.policymed.com/2024/12/third-quarter-false-claims-act-roundup.html#respond</comments>
		
		<dc:creator><![CDATA[Thomas Sullivan]]></dc:creator>
		<pubDate>Tue, 31 Dec 2024 09:35:40 +0000</pubDate>
				<category><![CDATA[False Claims Act]]></category>
		<category><![CDATA[2024 Healthcare Settlements]]></category>
		<category><![CDATA[Anti-Kickback Statute]]></category>
		<category><![CDATA[CVS Subsidiary]]></category>
		<category><![CDATA[DaVita]]></category>
		<category><![CDATA[Dialysis Provider Settlements]]></category>
		<category><![CDATA[Dr. Andrew Gomes]]></category>
		<category><![CDATA[False Claims Settlements]]></category>
		<category><![CDATA[Federal Healthcare Programs]]></category>
		<category><![CDATA[Health Insurance Fraud]]></category>
		<category><![CDATA[healthcare compliance]]></category>
		<category><![CDATA[healthcare fraud]]></category>
		<category><![CDATA[healthcare law]]></category>
		<category><![CDATA[Improper Billing]]></category>
		<category><![CDATA[Insurance Agent Referrals]]></category>
		<category><![CDATA[Medicare Advantage]]></category>
		<category><![CDATA[Medicare fraud]]></category>
		<category><![CDATA[National Interventional Radiology Partners]]></category>
		<category><![CDATA[NIRP]]></category>
		<category><![CDATA[Oak Street Health]]></category>
		<category><![CDATA[PAD]]></category>
		<category><![CDATA[Peripheral Arterial Disease]]></category>
		<category><![CDATA[prescription fraud]]></category>
		<category><![CDATA[Settlements]]></category>
		<category><![CDATA[Vascular Access Centers]]></category>
		<category><![CDATA[Walgreens]]></category>
		<category><![CDATA[Walgreens Boots Alliance]]></category>
		<guid isPermaLink="false">https://www.policymed.com/?p=17394</guid>

					<description><![CDATA[<div style="margin-bottom:20px;"><img width="1200" height="800" src="https://www.policymed.com/wp-content/uploads/2023/01/stencil.default-76.jpg" class="attachment-post-thumbnail size-post-thumbnail wp-post-image" alt="" decoding="async" loading="lazy" srcset="https://www.policymed.com/wp-content/uploads/2023/01/stencil.default-76.jpg 1200w, https://www.policymed.com/wp-content/uploads/2023/01/stencil.default-76-300x200.jpg 300w, https://www.policymed.com/wp-content/uploads/2023/01/stencil.default-76-1024x683.jpg 1024w, https://www.policymed.com/wp-content/uploads/2023/01/stencil.default-76-768x512.jpg 768w, https://www.policymed.com/wp-content/uploads/2023/01/stencil.default-76-450x300.jpg 450w" sizes="auto, (max-width: 1200px) 100vw, 1200px" /></div>Q3 of 2024 – like many quarters before – brought a smattering of False Claims Act settlements, encompassing a variety of allegations. As we often see, there were several settlements resolving allegations involving violations of the Anti-Kickback Statute. One of those settlements involved dialysis provider DaVita. DaVita agreed to pay more than $34 million to [&#8230;]]]></description>
										<content:encoded><![CDATA[<div style="margin-bottom:20px;"><img width="1200" height="800" src="https://www.policymed.com/wp-content/uploads/2023/01/stencil.default-76.jpg" class="attachment-post-thumbnail size-post-thumbnail wp-post-image" alt="" decoding="async" loading="lazy" srcset="https://www.policymed.com/wp-content/uploads/2023/01/stencil.default-76.jpg 1200w, https://www.policymed.com/wp-content/uploads/2023/01/stencil.default-76-300x200.jpg 300w, https://www.policymed.com/wp-content/uploads/2023/01/stencil.default-76-1024x683.jpg 1024w, https://www.policymed.com/wp-content/uploads/2023/01/stencil.default-76-768x512.jpg 768w, https://www.policymed.com/wp-content/uploads/2023/01/stencil.default-76-450x300.jpg 450w" sizes="auto, (max-width: 1200px) 100vw, 1200px" /></div><p>Q3 of 2024 – like many quarters before – brought a smattering of False Claims Act settlements, encompassing a variety of allegations. As we often see, there were several settlements resolving allegations involving violations of the Anti-Kickback Statute.</p>
<p>One of those settlements involved dialysis provider DaVita. <a href="https://www.policymed.com/2024/09/davita-reaches-34-million-false-claims-act-settlement.html">DaVita agreed to pay more than $34 million</a> to resolve allegations that it provided illegal remuneration to physicians in exchange for their referrals. The government alleged that DaVita bought a competitor’s dialysis clinics and products in exchange for sending Medicare patient prescriptions to DaVita Rx and that DaVita provided free management services to vascular access centers, all in an attempt to induce physicians to provide referrals of dialysis patients.</p>
<p>Another such settlement involved National Interventional Radiology Partners (NIRP) and its founding physician. NIRP and Dr. Andrew Gomes <a href="https://www.policymed.com/2024/10/doj-announces-8-8-million-fca-and-aks-statute-settlement-with-nirp.html">agreed to pay $8.8 million</a> to resolve allegations that they violated the False Claims Act and Anti-Kickback Statute by illegally paying physicians for referrals to clinics to surgically treat patients with peripheral arterial disease (PAD). Gomes allegedly told investing physicians that if they referred patients to receive revascularization surgery at the facility, the surgical centers would become profitable, and then able to be sold for a profit – resulting in a return on their investment in the clinics.</p>
<p>Oak Street Health marked another settlement, <a href="https://www.policymed.com/2024/11/cvs-subsidiary-reaches-60-million-settlement-over-false-claims-act-allegations.html">a $60 million settlement</a> resolving allegations that the CVS subsidiary unlawfully compensated third-party insurance agents for making referrals or recommendations of their clients to Oak Street. The government specifically alleged that Oak Street paid insurance agents to contact seniors who were eligible for Medicare Advantage and market Oak Street’s services, referring interested seniors to Oak Street.</p>
<p>Turning away from Anti-Kickback Statute and turning toward improper billing, Walgreen Co. and Walgreens Boots Alliance Inc. <a href="https://www.policymed.com/2024/11/walgreens-reaches-106-8-million-false-claims-act-settlement-with-the-united-states.html">reached a $106.8 million settlement</a>, resolving allegations that the company billed government healthcare programs for prescriptions that were never actually picked up by patients. The government alleged that from 2009 to 2020, Walgreens submitted false claims to federal government programs for prescriptions that it processed, but that were never picked up by patients.</p>
<p>Additional False Claims Act settlements from Q3 2024 and beyond are covered <a href="https://www.policymed.com/category/false-claims-act">here</a>.</p>
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		<title>DOJ Resolves More than $1 Billion in False Claims Act Settlements in First Half of 2024</title>
		<link>https://www.policymed.com/2024/12/doj-resolves-more-than-1-billion-in-false-claims-act-settlements-in-first-half-of-2024.html</link>
					<comments>https://www.policymed.com/2024/12/doj-resolves-more-than-1-billion-in-false-claims-act-settlements-in-first-half-of-2024.html#respond</comments>
		
		<dc:creator><![CDATA[Thomas Sullivan]]></dc:creator>
		<pubDate>Wed, 18 Dec 2024 09:48:40 +0000</pubDate>
				<category><![CDATA[False Claims Act]]></category>
		<category><![CDATA[Baylor St. Luke’s Medical Center]]></category>
		<category><![CDATA[ChristianaCare settlement]]></category>
		<category><![CDATA[clinical trial billing]]></category>
		<category><![CDATA[cybersecurity focus]]></category>
		<category><![CDATA[Daniel Hurt settlement]]></category>
		<category><![CDATA[DOJ Enforcement]]></category>
		<category><![CDATA[Endo Health Solutions opioid litigation]]></category>
		<category><![CDATA[FCA collections 2024]]></category>
		<category><![CDATA[Federal Debt Collection Procedures Act]]></category>
		<category><![CDATA[genomic test fraud]]></category>
		<category><![CDATA[Gibson Dunn update]]></category>
		<category><![CDATA[H. Lee Moffitt Cancer Center]]></category>
		<category><![CDATA[healthcare settlements]]></category>
		<category><![CDATA[legislative updates]]></category>
		<category><![CDATA[life science industry]]></category>
		<category><![CDATA[Lincare billing violations]]></category>
		<category><![CDATA[Medicare cost reports]]></category>
		<category><![CDATA[NEW]]></category>
		<category><![CDATA[New York-Presbyterian kickbacks]]></category>
		<category><![CDATA[Opana ER]]></category>
		<category><![CDATA[policy developments]]></category>
		<category><![CDATA[significant legal decisions]]></category>
		<category><![CDATA[Silver Lake Hospital]]></category>
		<category><![CDATA[teaching physician regulations]]></category>
		<guid isPermaLink="false">https://www.policymed.com/?p=17204</guid>

					<description><![CDATA[<div style="margin-bottom:20px;"><img width="1200" height="800" src="https://www.policymed.com/wp-content/uploads/2023/01/stencil.default-76.jpg" class="attachment-post-thumbnail size-post-thumbnail wp-post-image" alt="" decoding="async" loading="lazy" srcset="https://www.policymed.com/wp-content/uploads/2023/01/stencil.default-76.jpg 1200w, https://www.policymed.com/wp-content/uploads/2023/01/stencil.default-76-300x200.jpg 300w, https://www.policymed.com/wp-content/uploads/2023/01/stencil.default-76-1024x683.jpg 1024w, https://www.policymed.com/wp-content/uploads/2023/01/stencil.default-76-768x512.jpg 768w, https://www.policymed.com/wp-content/uploads/2023/01/stencil.default-76-450x300.jpg 450w" sizes="auto, (max-width: 1200px) 100vw, 1200px" /></div>Gibson Dunn recently published a mid-year update on the False Claims Act (FCA) collections for the first half of the year, noting that “[t]he first half of 2024 is a reminder that [the flow of enforcement] can surge at any moment, bringing with it massive settlements.” The update notes that the Department of Justice (DOJ) [&#8230;]]]></description>
										<content:encoded><![CDATA[<div style="margin-bottom:20px;"><img width="1200" height="800" src="https://www.policymed.com/wp-content/uploads/2023/01/stencil.default-76.jpg" class="attachment-post-thumbnail size-post-thumbnail wp-post-image" alt="" decoding="async" loading="lazy" srcset="https://www.policymed.com/wp-content/uploads/2023/01/stencil.default-76.jpg 1200w, https://www.policymed.com/wp-content/uploads/2023/01/stencil.default-76-300x200.jpg 300w, https://www.policymed.com/wp-content/uploads/2023/01/stencil.default-76-1024x683.jpg 1024w, https://www.policymed.com/wp-content/uploads/2023/01/stencil.default-76-768x512.jpg 768w, https://www.policymed.com/wp-content/uploads/2023/01/stencil.default-76-450x300.jpg 450w" sizes="auto, (max-width: 1200px) 100vw, 1200px" /></div><p>Gibson Dunn recently published a <a href="https://www.gibsondunn.com/false-claims-act-2024-mid-year-update/">mid-year update</a> on the False Claims Act (FCA) collections for the first half of the year, noting that “[t]he first half of 2024 is a reminder that [the flow of enforcement] can surge at any moment, bringing with it massive settlements.” The update notes that the Department of Justice (DOJ) continues to focus on cybersecurity and has reached False Claims Act settlements across multiple industries, using various legal theories.</p>
<p>As we often see from FCA recoveries, most of the $1 billion in settlements involve health care and life science industry entities. Starting the year strong was a <a href="https://www.justice.gov/usao-de/pr/christianacare-pays-425-million-resolve-health-care-fraud-allegations-0">$42.5 million settlement</a> between the DOJ and ChristianaCare, a healthcare facility operator based in Delaware. The settlement resolved claims that the company provided ancillary service providers (i.e., nurse practitioners and physician assistants) to help with patients as an inducement to non-employee physicians to refer patients to the company’s hospitals.</p>
<p>That same day, Florida non-profit cancer treatment and research center, the H. Lee Moffitt Cancer Center &amp; Research Institute Hospital, agreed to pay <a href="https://www.justice.gov/usao-mdfl/pr/florida-research-hospital-agrees-pay-more-195-million-resolve-liability-relating-self">$19.5 million</a>, resolving allegations that it billed federal health care programs for items and services used in clinical trial research that it should have billed to non-government sponsors.</p>
<p>In mid-January, Columbus LTACH d/b/a Silver Lake Hospital, a long-term care hospital based in New Jersey, reached an <a href="https://www.justice.gov/usao-nj/pr/new-jersey-hospital-and-investors-pay-united-states-306-million-alleged-false-claims#:~:text=Alleged%20False%20Claims-,New%20Jersey%20Hospital%20and%20Investors%20to%20Pay%20United,Million%20for%20Alleged%20False%20Claims&amp;text=NEWARK%2C%20N.J.%20%E2%80%93%20A%20New%20Jersey,violations%2C%20U.S.%20Attorney%20Philip%20R">$18.6 million settlement</a> to resolve FCA allegations. Certain Silver Lake investors agreed to pay $12 million plus interest for alleged violations of the Federal Debt Collection Procedures Act (FDCPA). In this case, the government alleged that the hospital manipulated the cost outlier payment system for supplemental reimbursement by increasing its charges more than its costs and beyond what the hospital would be able to repay once Medicare cost reports were reconciled to its charges.</p>
<p>In February, medical device company Lincare admitted that it received reimbursements for claims that did not comply with billing rules and continued to seek payments in instances where it was aware that patients were not using its respiratory equipment. In connection with the admission, Lincare <a href="https://www.justice.gov/usao-sdny/pr/us-attorney-announces-255-million-settlement-durable-medical-equipment-supplier">agreed to pay $25.5 million</a>.</p>
<p>Endo Health Solutions, Inc., reached a settlement valued at up to <a href="https://www.justice.gov/opa/pr/opioid-manufacturer-endo-health-solutions-inc-agrees-global-resolution-criminal-and-civil">$464.9 million</a> over the course of ten years, resolving criminal and civil investigations related to the company’s sales and marketing of its opioid, Opana ER with INTAC.</p>
<p>New York-Presbyterian/Brooklyn Methodist reached a <a href="https://www.justice.gov/usao-edny/pr/new-york-presbyterianbrooklyn-methodist-hospital-settles-health-care-fraud-claims-173">$17.3 million settlement</a> with the DOJ over allegations that contractual arrangements with physicians at a chemotherapy infusion center were actually unlawful “kickbacks.” Under the contracts, the physician compensation was linked to the number of referrals the physicians made for services at the infusion center. Additionally, the settlement resolved claims that physicians at the infusion center did not adequately supervise chemotherapy services.</p>
<p>May brought a <a href="https://www.justice.gov/usao-nj/pr/florida-businessman-daniel-hurt-pay-over-27-million-medicare-fraud-connection-cancer">$27 million settlement</a> with the DOJ and Florida businessman Daniel Hurt, resolving allegations that he and several of his companies (including Fountain Health Services LLC, Verify Health, Landmark Diagnostics LLC, First Choice Laboratory LLC and Sonoran Desert Pathology Associates LLC) conspired with others to violate the FCA by submitting false claims to – and receiving payments from – Medicare for cancer genomic tests that were not medically necessary and that were obtained through illegal kickbacks.</p>
<p>Finally, at the end of June, Baylor St. Luke’s Medical Center, Baylor College of Medicine, and Surgical Associates of Texas jointly reached a <a href="https://www.justice.gov/usao-sdtx/pr/texas-medical-center-institutions-agree-pay-15m-record-settlement-involving-concurrent">$15 million settlement</a> with the DOJ, resolving claims that they billed for concurrent heart surgeries in violation of the teaching physician and informed consent regulations of Medicare.</p>
<p>In addition to an overview on enforcement activity, the <a href="https://www.gibsondunn.com/false-claims-act-2024-mid-year-update/">update</a> also includes an overview of legislative and policy developments (at both the federal and state levels) as well as some significant legal decisions from the first half of the year.</p>
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		<title>QOL Medical and Their CEO Settle for $4.7 Million Over Alleged Kickback Scheme Involving Genetic Testing and Drug Claims</title>
		<link>https://www.policymed.com/2024/11/qol-medical-and-their-ceo-settle-for-4-7-million-over-alleged-kickback-scheme-involving-genetic-testing-and-drug-claims.html</link>
					<comments>https://www.policymed.com/2024/11/qol-medical-and-their-ceo-settle-for-4-7-million-over-alleged-kickback-scheme-involving-genetic-testing-and-drug-claims.html#respond</comments>
		
		<dc:creator><![CDATA[Thomas Sullivan]]></dc:creator>
		<pubDate>Tue, 26 Nov 2024 09:04:12 +0000</pubDate>
				<category><![CDATA[Anti Kickback]]></category>
		<category><![CDATA[DOJ]]></category>
		<category><![CDATA[False Claims Act]]></category>
		<category><![CDATA[Diagnostic Testing]]></category>
		<category><![CDATA[DOJ Enforcement]]></category>
		<category><![CDATA[healthcare compliance]]></category>
		<category><![CDATA[Healthcare Fraud Prevention]]></category>
		<category><![CDATA[Kickback Allegations]]></category>
		<category><![CDATA[NEW]]></category>
		<category><![CDATA[pharmaceutical ethics]]></category>
		<category><![CDATA[QOL Medical Settlement]]></category>
		<category><![CDATA[Sucraid]]></category>
		<guid isPermaLink="false">https://www.policymed.com/?p=17364</guid>

					<description><![CDATA[<div style="margin-bottom:20px;"><img width="184" height="184" src="https://www.policymed.com/wp-content/uploads/2024/11/Lab-Tests.jpg" class="attachment-post-thumbnail size-post-thumbnail wp-post-image" alt="" decoding="async" loading="lazy" srcset="https://www.policymed.com/wp-content/uploads/2024/11/Lab-Tests.jpg 184w, https://www.policymed.com/wp-content/uploads/2024/11/Lab-Tests-150x150.jpg 150w, https://www.policymed.com/wp-content/uploads/2024/11/Lab-Tests-100x100.jpg 100w" sizes="auto, (max-width: 184px) 100vw, 184px" /></div>QOL Medical, LLC, and its CEO Frederick E. Cooper have agreed to a $4.7 million settlement with the Department of Justice (DOJ). The settlement resolves allegations that the company provided kickbacks to healthcare providers to induce prescriptions of their drug, Sucraid. This drug is FDA-approved for Congenital Sucrase-Isomaltase Deficiency (CSID), a rare genetic condition that [&#8230;]]]></description>
										<content:encoded><![CDATA[<div style="margin-bottom:20px;"><img width="184" height="184" src="https://www.policymed.com/wp-content/uploads/2024/11/Lab-Tests.jpg" class="attachment-post-thumbnail size-post-thumbnail wp-post-image" alt="" decoding="async" loading="lazy" srcset="https://www.policymed.com/wp-content/uploads/2024/11/Lab-Tests.jpg 184w, https://www.policymed.com/wp-content/uploads/2024/11/Lab-Tests-150x150.jpg 150w, https://www.policymed.com/wp-content/uploads/2024/11/Lab-Tests-100x100.jpg 100w" sizes="auto, (max-width: 184px) 100vw, 184px" /></div><p>QOL Medical, LLC, and its CEO Frederick E. Cooper have agreed to a $4.7 million settlement with the Department of Justice (DOJ). The settlement resolves allegations that the company provided kickbacks to healthcare providers to induce prescriptions of their drug, Sucraid. This drug is FDA-approved for Congenital Sucrase-Isomaltase Deficiency (CSID), a rare genetic condition that hampers the digestion of sugar.</p>
<p>The allegations against QOL Medical highlight a new practice within the pharmaceutical industry sector: offering free diagnostic tests as incentives for prescribing specific medications. According to the DOJ, QOL provided complimentary Carbon-13 (C13) breath testing kits to healthcare providers. These kits were intended for patients exhibiting common gastrointestinal symptoms, ostensibly to diagnose CSID. However, the DOJ claimed that the test was also sensitive to other conditions that could yield similar test results, suggesting that the tests were not as definitive as QOL portrayed.</p>
<p>QOL&#8217;s approach to marketing Sucraid was also under scrutiny. The company allegedly paid a laboratory to conduct the tests and share the results, not only with the ordering healthcare providers but also with QOL. This information included the provider&#8217;s name and details about the patient&#8217;s age, gender, symptoms, and test outcomes—data that was then reportedly used by QOL&#8217;s sales team to target their pitches effectively.</p>
<p>The sales tactics employed by QOL were particularly aggressive. The DOJ highlighted instances where sales representatives were instructed to follow up on positive test results with healthcare providers to promote Sucraid prescriptions. This strategy was supported by training materials that inaccurately touted the C13 test&#8217;s ability to conclusively diagnose CSID, according to the DOJ a claim not necessarily backed by scientific evidence.</p>
<p>This settlement brings to light several critical issues within pharmaceutical marketing and diagnostic testing practices:</p>
<ol>
<li><strong>Accuracy and Misrepresentation</strong>: The DOJ criticized the reliability of the C13 test, concerned about potential false positives and the broad interpretation of results to favor QOL&#8217;s drug.</li>
<li><strong>Privacy and Ethical Marketing</strong>: The use of detailed patient data to drive targeted sales strategies raises significant ethical and privacy concerns, reflecting a growing scrutiny of how sensitive health information is handled in the industry.</li>
<li><strong>Corporate Misconduct</strong>: The government&#8217;s disapproval extends to the misrepresentation of a product&#8217;s benefits, especially when driven by a coordinated company effort, as was evidenced in QOL&#8217;s case.</li>
</ol>
<p>The settlement also includes provisions for cooperation with ongoing regulatory requirements, separation of costs related to the settlement from future billing, and several protections and releases for the involved parties, ensuring compliance with federal healthcare program standards.</p>
<p>The QOL Medical case serves as a cautionary tale for the pharmaceutical industry and executive&#8217;s, as it is rare for the executives to also have to pay in these types of settlements not to overstate claims or provide tests and utilize those results in targeting.</p>
<p>Additional Resources</p>
<p><a href="https://www.justice.gov/opa/pr/pharmaceutical-company-qol-medical-and-ceo-agree-pay-47m-allegedly-paying-kickbacks-induce">DOJ Press Release</a></p>
<p><a href="https://www.justice.gov/opa/media/1377141/dl">QOL Medical Settlement Agreement</a></p>
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		<title>Walgreens Reaches $106.8 Million False Claims Act Settlement with the United States</title>
		<link>https://www.policymed.com/2024/11/walgreens-reaches-106-8-million-false-claims-act-settlement-with-the-united-states.html</link>
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		<dc:creator><![CDATA[Thomas Sullivan]]></dc:creator>
		<pubDate>Thu, 14 Nov 2024 09:52:13 +0000</pubDate>
				<category><![CDATA[False Claims Act]]></category>
		<category><![CDATA[corporate responsibility]]></category>
		<category><![CDATA[federal health care programs]]></category>
		<category><![CDATA[government settlements]]></category>
		<category><![CDATA[health care billing]]></category>
		<category><![CDATA[health care integrity]]></category>
		<category><![CDATA[HHS-OIG enforcement]]></category>
		<category><![CDATA[legal settlement]]></category>
		<category><![CDATA[Medicaid fraud]]></category>
		<category><![CDATA[Medicare fraud]]></category>
		<category><![CDATA[NEW]]></category>
		<category><![CDATA[pharmacy compliance]]></category>
		<category><![CDATA[prescription fraud]]></category>
		<category><![CDATA[Walgreens]]></category>
		<guid isPermaLink="false">https://www.policymed.com/?p=17210</guid>

					<description><![CDATA[<div style="margin-bottom:20px;"><img width="1200" height="800" src="https://www.policymed.com/wp-content/uploads/2022/11/stencil.default-68.jpg" class="attachment-post-thumbnail size-post-thumbnail wp-post-image" alt="" decoding="async" loading="lazy" srcset="https://www.policymed.com/wp-content/uploads/2022/11/stencil.default-68.jpg 1200w, https://www.policymed.com/wp-content/uploads/2022/11/stencil.default-68-300x200.jpg 300w, https://www.policymed.com/wp-content/uploads/2022/11/stencil.default-68-1024x683.jpg 1024w, https://www.policymed.com/wp-content/uploads/2022/11/stencil.default-68-768x512.jpg 768w, https://www.policymed.com/wp-content/uploads/2022/11/stencil.default-68-450x300.jpg 450w" sizes="auto, (max-width: 1200px) 100vw, 1200px" /></div>Walgreens Boots Alliance Inc. and Walgreen Co. (collectively, “Walgreens”) agreed to pay $106.8 million in two settlements (here and here) to resolve allegations that Walgreens violated the False Claims Act and various state statutes when billing government health care programs for prescriptions that were never dispensed to patients. According to the government, between 2009 and [&#8230;]]]></description>
										<content:encoded><![CDATA[<div style="margin-bottom:20px;"><img width="1200" height="800" src="https://www.policymed.com/wp-content/uploads/2022/11/stencil.default-68.jpg" class="attachment-post-thumbnail size-post-thumbnail wp-post-image" alt="" decoding="async" loading="lazy" srcset="https://www.policymed.com/wp-content/uploads/2022/11/stencil.default-68.jpg 1200w, https://www.policymed.com/wp-content/uploads/2022/11/stencil.default-68-300x200.jpg 300w, https://www.policymed.com/wp-content/uploads/2022/11/stencil.default-68-1024x683.jpg 1024w, https://www.policymed.com/wp-content/uploads/2022/11/stencil.default-68-768x512.jpg 768w, https://www.policymed.com/wp-content/uploads/2022/11/stencil.default-68-450x300.jpg 450w" sizes="auto, (max-width: 1200px) 100vw, 1200px" /></div><p>Walgreens Boots Alliance Inc. and Walgreen Co. (collectively, “Walgreens”) agreed to pay $106.8 million in two settlements (<a href="https://www.justice.gov/opa/media/1367797/dl?inline">here</a> and <a href="https://www.justice.gov/opa/media/1367792/dl?inline">here</a>) to resolve allegations that Walgreens violated the False Claims Act and various state statutes when billing government health care programs for prescriptions that were never dispensed to patients.</p>
<p>According to the government, between 2009 and 2020, Walgreens submitted false claims to Medicare, Medicaid, and other federal health care programs for prescriptions that it processed but were never picked up by the patients. This means that Walgreens received tens of millions of dollars for prescriptions from federal health care programs that were never actually provided to health care beneficiaries.</p>
<p>Under one of the settlements, Walgreens did receive credit for disclosure, cooperation, and remediation. For example, Walgreens implemented enhancements to its electronic pharmacy management system to prevent this from happening again in the future and also self-reported some of the conduct resolved. Additionally, because Walgreens previously refunded $66,314,790 related to the settled claims, it will receive a credit for that amount.</p>
<p>This settlement resolves three cases pending in District Courts throughout the country – the District of New Mexico, the Eastern District of Texas, and the Middle District of Florida. The claims were initially brought by two former Walgreens employees – a district pharmacy supervisor and a pharmacy manager. The federal share of the settlement is $91,881,530, and $14,933,259 will be returned to individual states through separate settlement agreements with Medicaid participating states.</p>
<p>As we often see, the settlements are not an admission of liability by Walgreens nor a concession by the United States that its claims are not well founded.</p>
<p>“Federal health care programs provide critical health care services to millions of Americans,” <a href="https://www.justice.gov/opa/pr/walgreens-agrees-pay-1068m-resolve-allegations-it-billed-government-prescriptions-never">said Principal Deputy Assistant Attorney General Brian M. Boynton</a>, head of the Justice Department’s Civil Division. “We will hold accountable those who abuse these programs by knowingly billing for goods or services they did not provide.”</p>
<p>“Medicare enrollees, and consumers at-large, rely on pharmacies for critical medications that sustain their quality of life, and providers who prey upon public health care programs to increase profit margins must be held accountable,” <a href="https://www.justice.gov/opa/pr/walgreens-agrees-pay-1068m-resolve-allegations-it-billed-government-prescriptions-never">said Deputy Inspector General for Investigations Christian J. Schrank</a> of the Department of Health and Human Services Office of Inspector General (HHS-OIG). “HHS-OIG is unwavering in its commitment to protecting taxpayer-funded healthcare programs and ensuring those that threaten their integrity are held liable for their actions.”</p>
<p>&#8220;Due to a software error, we inadvertently billed some government health care programs for a relatively small number of prescriptions our patients submitted but never picked up,&#8221; <a href="https://www.reuters.com/legal/government/walgreens-paying-1068-million-settle-us-charges-over-prescription-billing-fraud-2024-09-13/">Walgreens said in a statement picked up by Reuters</a>. &#8220;We corrected the error, reported the issue to the government and voluntarily refunded all overpayments.&#8221;</p>
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		<title>Acadia Healthcare Reaches $19.85 Million Settlement to Resolve False Claims Act Allegations</title>
		<link>https://www.policymed.com/2024/11/acadia-healthcare-reaches-19-85-million-settlement-to-resolve-false-claims-act-allegations.html</link>
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		<dc:creator><![CDATA[Thomas Sullivan]]></dc:creator>
		<pubDate>Tue, 12 Nov 2024 09:47:45 +0000</pubDate>
				<category><![CDATA[DOJ]]></category>
		<category><![CDATA[False Claims Act]]></category>
		<category><![CDATA[Acadia Healthcare settlement]]></category>
		<category><![CDATA[compliance responsibilities]]></category>
		<category><![CDATA[DOJ agreement]]></category>
		<category><![CDATA[False Claims Act violation]]></category>
		<category><![CDATA[federal and state claims resolution]]></category>
		<category><![CDATA[healthcare provider standards]]></category>
		<category><![CDATA[HHS-OIG enforcement]]></category>
		<category><![CDATA[inadequate staffing]]></category>
		<category><![CDATA[inadequate supervision]]></category>
		<category><![CDATA[inadequate training]]></category>
		<category><![CDATA[inpatient behavioral health]]></category>
		<category><![CDATA[Medicaid fraud]]></category>
		<category><![CDATA[medically unnecessary services]]></category>
		<category><![CDATA[Medicare fraud]]></category>
		<category><![CDATA[NEW]]></category>
		<category><![CDATA[non-compliance with regulations]]></category>
		<category><![CDATA[patient care commitment]]></category>
		<category><![CDATA[patient harm]]></category>
		<category><![CDATA[TRICARE fraud]]></category>
		<category><![CDATA[whistleblower involvement]]></category>
		<guid isPermaLink="false">https://www.policymed.com/?p=17215</guid>

					<description><![CDATA[<div style="margin-bottom:20px;"><img width="1200" height="800" src="https://www.policymed.com/wp-content/uploads/2023/01/stencil.default-76.jpg" class="attachment-post-thumbnail size-post-thumbnail wp-post-image" alt="" decoding="async" loading="lazy" srcset="https://www.policymed.com/wp-content/uploads/2023/01/stencil.default-76.jpg 1200w, https://www.policymed.com/wp-content/uploads/2023/01/stencil.default-76-300x200.jpg 300w, https://www.policymed.com/wp-content/uploads/2023/01/stencil.default-76-1024x683.jpg 1024w, https://www.policymed.com/wp-content/uploads/2023/01/stencil.default-76-768x512.jpg 768w, https://www.policymed.com/wp-content/uploads/2023/01/stencil.default-76-450x300.jpg 450w" sizes="auto, (max-width: 1200px) 100vw, 1200px" /></div>Acadia Healthcare Company, Inc., has reached a settlement agreement with the United States Department of Justice (DOJ) to resolve allegations that it violated the False Claims Act and certain state statutes by knowingly billing for medically unnecessary inpatient behavioral health services, or for services that did not meet federal and state regulations. Acadia owns and [&#8230;]]]></description>
										<content:encoded><![CDATA[<div style="margin-bottom:20px;"><img width="1200" height="800" src="https://www.policymed.com/wp-content/uploads/2023/01/stencil.default-76.jpg" class="attachment-post-thumbnail size-post-thumbnail wp-post-image" alt="" decoding="async" loading="lazy" srcset="https://www.policymed.com/wp-content/uploads/2023/01/stencil.default-76.jpg 1200w, https://www.policymed.com/wp-content/uploads/2023/01/stencil.default-76-300x200.jpg 300w, https://www.policymed.com/wp-content/uploads/2023/01/stencil.default-76-1024x683.jpg 1024w, https://www.policymed.com/wp-content/uploads/2023/01/stencil.default-76-768x512.jpg 768w, https://www.policymed.com/wp-content/uploads/2023/01/stencil.default-76-450x300.jpg 450w" sizes="auto, (max-width: 1200px) 100vw, 1200px" /></div><p>Acadia Healthcare Company, Inc., has reached a <a href="https://www.justice.gov/opa/media/1370996/dl">settlement agreement</a> with the United States Department of Justice (DOJ) to resolve allegations that it violated the False Claims Act and certain state statutes by knowingly billing for medically unnecessary inpatient behavioral health services, or for services that did not meet federal and state regulations. Acadia owns and operates inpatient behavioral health facilities throughout the United States.</p>
<p>The United States alleged that from 2014 to 2017, Acadia knowingly submitted false claims for payment to Medicare, Medicaid, and TRICARE for inpatient behavioral health services that were not reasonable or medically necessary. Specifically, Acadia allegedly admitted beneficiaries who were not eligible for inpatient treatment and failed to properly discharge patients when they no longer needed inpatient treatment, resulting in inappropriate lengths of stay.</p>
<p>Acadia further allegedly knowingly failed to provide adequate staffing, training, and/or supervision of staff, which resulted in assaults, elopements, suicides, and other harm. Acadia also allegedly failed to provide inpatient acute care in accord with federal and state regulations, including failing to provide active treatment, failing to develop and/or update individualized assessments and treatment plans, failing to provide adequate discharge planning, and failing to provide required individual and group therapy.</p>
<p>Acadia will pay $16,663,918 to the United States to resolve liability under the federal False Claims Act and an additional $3,186,082 to Florida, Georgia, Michigan, and Nevada, to resolve state law claims. The claims were originally brought under the <em>qui tam </em>provisions of the False Claims Act by former employees of Acadia. The whistleblowers will receive $3,166,144.42 from the federal portion of the settlement for their role.</p>
<p>“Medical providers who participate in federally funded health care programs must follow the law when billing Medicare, Medicaid and Tricare,” <a href="https://www.justice.gov/opa/pr/acadia-healthcare-company-inc-pay-1985m-settle-allegations-relating-medically-unnecessary">said Special Agent in Charge Tamala E. Miles of the Department of Health and Human Services Office of Inspector General (HHS-OIG)</a>. “This settlement illustrates HHS-OIG’s commitment to protecting the integrity of these taxpayer-funded programs and the well-being of enrollees seeking treatment. Working closely with the United States Attorney’s Office and other law enforcement partners, we will continue to thoroughly investigate such fraudulent billing schemes.”</p>
<p>In a separate, but possibly related matter, Acadia released a statement regarding a recent government investigation into the company following complaints made by patients at Acadia facilities. &#8220;Ensuring we provide the highest quality of care is personal for me and the number one priority for my colleagues across the Company,&#8221; <a href="https://finance.yahoo.com/news/acadia-healthcare-issues-statement-respect-123000399.html">said Acadia Chief Executive Officer Chris Hunter</a>. &#8220;We take seriously our patient care and compliance responsibilities and understand how critical it is to provide these services with excellence and compassion. We&#8217;re committed to taking action on incidents that fall short of our rigorous standards and are making investments necessary to establish Acadia as the leading behavioral healthcare provider for high-acuity and complex needs patients.&#8221;</p>
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		<title>CVS Subsidiary Reaches $60 Million Settlement Over False Claims Act Allegations</title>
		<link>https://www.policymed.com/2024/11/cvs-subsidiary-reaches-60-million-settlement-over-false-claims-act-allegations.html</link>
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		<dc:creator><![CDATA[Thomas Sullivan]]></dc:creator>
		<pubDate>Mon, 11 Nov 2024 09:38:53 +0000</pubDate>
				<category><![CDATA[DOJ]]></category>
		<category><![CDATA[False Claims Act]]></category>
		<category><![CDATA[$60 million settlement]]></category>
		<category><![CDATA[Brian M. Boynton]]></category>
		<category><![CDATA[Client Awareness Program]]></category>
		<category><![CDATA[CVS Health]]></category>
		<category><![CDATA[federal health care programs]]></category>
		<category><![CDATA[insurance agents]]></category>
		<category><![CDATA[Kickbacks]]></category>
		<category><![CDATA[Medicare Advantage]]></category>
		<category><![CDATA[Medicare Part B]]></category>
		<category><![CDATA[Medicare Part C]]></category>
		<category><![CDATA[NEW]]></category>
		<category><![CDATA[Oak Street Health]]></category>
		<category><![CDATA[Qui tam]]></category>
		<category><![CDATA[Whistleblower]]></category>
		<guid isPermaLink="false">https://www.policymed.com/?p=17208</guid>

					<description><![CDATA[<div style="margin-bottom:20px;"><img width="1200" height="800" src="https://www.policymed.com/wp-content/uploads/2024/04/stencil.default-2024-04-30T195641.091.jpg" class="attachment-post-thumbnail size-post-thumbnail wp-post-image" alt="" decoding="async" loading="lazy" srcset="https://www.policymed.com/wp-content/uploads/2024/04/stencil.default-2024-04-30T195641.091.jpg 1200w, https://www.policymed.com/wp-content/uploads/2024/04/stencil.default-2024-04-30T195641.091-300x200.jpg 300w, https://www.policymed.com/wp-content/uploads/2024/04/stencil.default-2024-04-30T195641.091-1024x683.jpg 1024w, https://www.policymed.com/wp-content/uploads/2024/04/stencil.default-2024-04-30T195641.091-768x512.jpg 768w, https://www.policymed.com/wp-content/uploads/2024/04/stencil.default-2024-04-30T195641.091-450x300.jpg 450w" sizes="auto, (max-width: 1200px) 100vw, 1200px" /></div>Oak Street Health, a wholly-owned subsidiary of CVS Health since 2023, has agreed to pay $60 million to resolve allegations that it violated the False Claims Act (FCA) by paying kickbacks to third party insurance agents in exchange for their recruiting of seniors to Oak Street Health’s primary care clinics. The United States alleged that [&#8230;]]]></description>
										<content:encoded><![CDATA[<div style="margin-bottom:20px;"><img width="1200" height="800" src="https://www.policymed.com/wp-content/uploads/2024/04/stencil.default-2024-04-30T195641.091.jpg" class="attachment-post-thumbnail size-post-thumbnail wp-post-image" alt="" decoding="async" loading="lazy" srcset="https://www.policymed.com/wp-content/uploads/2024/04/stencil.default-2024-04-30T195641.091.jpg 1200w, https://www.policymed.com/wp-content/uploads/2024/04/stencil.default-2024-04-30T195641.091-300x200.jpg 300w, https://www.policymed.com/wp-content/uploads/2024/04/stencil.default-2024-04-30T195641.091-1024x683.jpg 1024w, https://www.policymed.com/wp-content/uploads/2024/04/stencil.default-2024-04-30T195641.091-768x512.jpg 768w, https://www.policymed.com/wp-content/uploads/2024/04/stencil.default-2024-04-30T195641.091-450x300.jpg 450w" sizes="auto, (max-width: 1200px) 100vw, 1200px" /></div><p>Oak Street Health, a wholly-owned subsidiary of CVS Health since 2023, has agreed to pay <a href="https://www.justice.gov/opa/media/1369171/dl">$60 million</a> to resolve allegations that it violated the False Claims Act (FCA) by paying kickbacks to third party insurance agents in exchange for their recruiting of seniors to Oak Street Health’s primary care clinics.</p>
<p>The United States alleged that prior to CVS’ ownership, in 2020, Oak Street Health developed a program to increase membership – the Client Awareness Program. Under the Program, at the direction of Oak Street Health, third-party insurance agents would contact seniors who were eligible for (or already enrolled in) Medicare Advantage and then delivered marketing messages to them that were designed to create interest in Oak Street Health. Agents would then refer interested seniors to an Oak Street Health employee through a three-way phone call or an electronic submission.</p>
<p>Oak Street would typically pay agents $200 per beneficiary referred or recommended to the company, incentivizing the agents to make referrals and recommendations to Medicare beneficiaries based on financial motivations for themselves – not the best interest of the senior patients.</p>
<p>According to the government, thousands of Medicare beneficiaries and a small number of Illinois Medicaid beneficiaries received Government-reimbursed care at Oak Street Health, as a result of the Client Awareness Program.</p>
<p>The settlement resolves allegations that from September 2020 through December 2022, Oak Street Health knowingly submitted (and caused the submission of) false claims to Medicare arising from kickbacks as detailed above. The DOJ notes that these claims are in violation of the False Claims Act because a Medicare beneficiary was referred or recommended to Oak Street Health under an illegal kickback scheme and they signed up for a capitated arrangement with Oak Street Health under Medicare Part C. Oak Street Health also submitted false claims directly to the Federal Government when a beneficiary received care at Oak Street Health under Medicare Part B.</p>
<p>Of the $60 million settlement, $30 million is restitution. The bulk of the settlement is considered the Federal Settlement Amount while only $69,557.76 is the state portion.</p>
<p>The claims were originally brought under the <em>qui tam </em>provisions of the False Claim Act by a whistleblower, who will receive $9.9 million for his actions. As we often see, Oak Street Health did not admit to any wrongdoing, nor is the settlement any indication that the claims of the United States and the State of Illinois are not well-founded.</p>
<p>“Health care providers that attempt to profit from kickbacks will be held accountable,” <a href="https://www.justice.gov/opa/pr/oak-street-health-agrees-pay-60m-resolve-alleged-false-claims-act-liability-paying-kickbacks">said Principal Deputy Assistant Attorney General Brian M. Boynton</a>, head of the Justice Department&#8217;s Civil Division. “We are committed to rooting out illegal practices committed by Medicare Advantage providers, insurance agents and brokers that undermine the interests of federal health care programs and the patients they serve.”</p>
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		<title>St. Peter’s Health Reaches $10.8 Million False Claims Act Settlement for Actions Taken by Oncologist</title>
		<link>https://www.policymed.com/2024/10/st-peters-health-reaches-10-8-million-false-claims-act-settlement-for-actions-taken-by-oncologist.html</link>
					<comments>https://www.policymed.com/2024/10/st-peters-health-reaches-10-8-million-false-claims-act-settlement-for-actions-taken-by-oncologist.html#respond</comments>
		
		<dc:creator><![CDATA[Thomas Sullivan]]></dc:creator>
		<pubDate>Tue, 29 Oct 2024 08:22:46 +0000</pubDate>
				<category><![CDATA[False Claims Act]]></category>
		<category><![CDATA[compliance program enhancement]]></category>
		<category><![CDATA[Dr. Tom Weiner]]></category>
		<category><![CDATA[federal medical care programs]]></category>
		<category><![CDATA[healthcare fraud]]></category>
		<category><![CDATA[healthcare settlement]]></category>
		<category><![CDATA[hospital financial reserves]]></category>
		<category><![CDATA[Jesse Laslovich]]></category>
		<category><![CDATA[legal settlement in healthcare]]></category>
		<category><![CDATA[Medicaid]]></category>
		<category><![CDATA[Medicare]]></category>
		<category><![CDATA[NEW]]></category>
		<category><![CDATA[oncologist over-billing]]></category>
		<category><![CDATA[overprescription of medications]]></category>
		<category><![CDATA[physician compensation audits]]></category>
		<category><![CDATA[restitution]]></category>
		<category><![CDATA[self-disclosure by hospital]]></category>
		<category><![CDATA[St. Peter's Health]]></category>
		<category><![CDATA[United States Attorney for Montana]]></category>
		<category><![CDATA[upcoding claims]]></category>
		<guid isPermaLink="false">https://www.policymed.com/?p=17104</guid>

					<description><![CDATA[<div style="margin-bottom:20px;"><img width="1200" height="800" src="https://www.policymed.com/wp-content/uploads/2022/10/stencil.default-60.jpg" class="attachment-post-thumbnail size-post-thumbnail wp-post-image" alt="" decoding="async" loading="lazy" srcset="https://www.policymed.com/wp-content/uploads/2022/10/stencil.default-60.jpg 1200w, https://www.policymed.com/wp-content/uploads/2022/10/stencil.default-60-300x200.jpg 300w, https://www.policymed.com/wp-content/uploads/2022/10/stencil.default-60-1024x683.jpg 1024w, https://www.policymed.com/wp-content/uploads/2022/10/stencil.default-60-768x512.jpg 768w, https://www.policymed.com/wp-content/uploads/2022/10/stencil.default-60-450x300.jpg 450w" sizes="auto, (max-width: 1200px) 100vw, 1200px" /></div>St. Peter’s Health in Helena, Montana recently reached a $10.8 million False Claims Act settlement over self-reported False Claims Act violations in which the company falsely billed several federal medical care programs on behalf of Tom Weiner, an oncologist. Weiner faces a separate federal civil lawsuit over allegations that he over-billed the government and overprescribed [&#8230;]]]></description>
										<content:encoded><![CDATA[<div style="margin-bottom:20px;"><img width="1200" height="800" src="https://www.policymed.com/wp-content/uploads/2022/10/stencil.default-60.jpg" class="attachment-post-thumbnail size-post-thumbnail wp-post-image" alt="" decoding="async" loading="lazy" srcset="https://www.policymed.com/wp-content/uploads/2022/10/stencil.default-60.jpg 1200w, https://www.policymed.com/wp-content/uploads/2022/10/stencil.default-60-300x200.jpg 300w, https://www.policymed.com/wp-content/uploads/2022/10/stencil.default-60-1024x683.jpg 1024w, https://www.policymed.com/wp-content/uploads/2022/10/stencil.default-60-768x512.jpg 768w, https://www.policymed.com/wp-content/uploads/2022/10/stencil.default-60-450x300.jpg 450w" sizes="auto, (max-width: 1200px) 100vw, 1200px" /></div><p>St. Peter’s Health in Helena, Montana recently reached a <a href="https://dailymontanan.com/wp-content/uploads/2024/08/fully_executed_settlement_agreement_v.1.pdf">$10.8 million False Claims Act settlement</a> over self-reported False Claims Act violations in which the company falsely billed several federal medical care programs on behalf of Tom Weiner, an oncologist. Weiner faces a <a href="https://dailymontanan.com/wp-content/uploads/2024/08/1.pdf">separate federal civil lawsuit</a> over allegations that he over-billed the government and overprescribed medications to patients.</p>
<p>The government alleged that between January 1, 2015, and December 31, 2020, St. Peter’s Health, when relying on Dr. Weiner’s documentation and certification, submitted claims that were false. The United States contends that St. Peter’s Health knew or should have known that Dr. Weiner was upcoding claims or submitting non-payable claims that did not meet the requirements of a significant, separately identifiable service, and therefore, St. Peter’s Health violated the False Claims Act by submitting those claims to Federal Health Care Programs.</p>
<p>Weiner served as the chief medical oncologist at St. Peter’s Cancer Treatment Center, working at the Center from 1996 until his suspension and ultimate firing in 2020. Weiner was the sole medical oncologist physician at the Center during the last four years of his career. According to the civil lawsuit, he would see between 50 and 70 patients most days.</p>
<p>St. Peter’s entered into the settlement agreement after self-reporting overpayment concerns about Weiner’s service billings. For example, he may administer chemotherapy to a patient and submit claims for other services that were performed on the same day that were either never performed or were coded at a higher level of service than what was provided. Based on Weiner’s billing levels, the hospital paid Weiner a greater amount, making him one of the top-paid employees at the hospital.</p>
<p>United States Attorney for Montana, Jesse Laslovich, gave credit to St. Peter’s for self-disclosing the misconduct and initiating an internal investigation (and providing those results to the government). St. Peter’s also provided more documentation than what was requested and made officers and other employees available for interviews. Since uncovering these issues, St. Peter’s has enhanced its compliance program. These actions mitigated the amount that St. Peter’s will pay under the settlement agreement.</p>
<p>Laslovich noted that it took four years to reach the settlement because of the complexity of the case and lack of resources within his office. He noted that the investigation by his office did not result in anyone else being connected to the scheme and that the majority of the settlement money would be going back to the Department of Health and Human Services (HHS) on behalf of Medicare and Medicaid – which paid out the bulk of the falsely billed income.</p>
<p>St. Peter’s Health CEO Wade Johnson believes that the issue was isolated to Weiner and that the settlement amount would come out of the hospital’s reserves, not its operations or planning funds. He further commented that to avoid such a problem in the future, St. Peter’s now performs pre-audits of its billing processes and has a committee that audits physician compensation.</p>
<p>The total settlement amount &#8211; $10,844,201 – includes $9,988,970.15 in restitution and is to be paid by St. Peter’s Health no later than 30 days after the settlement date.</p>
<p>“Today’s settlement, in my view, is not an indictment on the quality of care being provided by St. Peter’s Health, as well as their doctors and providers, nor is it a reflection of the current leadership of St. Peter’s health, as this leadership team voluntarily self-disclosed the misconduct,” Laslovich said.</p>
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