A federal law enforcement action involving fraudulent genetic cancer testing has resulted in charges in five federal districts against 35 defendants associated with dozens of telemedicine companies and cancer genetic testing laboratories (CGx) for their alleged participation in one of the largest health care fraud schemes ever charged. According to the charges, these defendants fraudulently billed Medicare more than $2.1 billion for these CGx tests. Among those charged today are 10 medical professionals, including nine doctors.
The Department of Justice, Criminal Division, together with the U.S. Department of Health and Human Services Office of the Inspector General (HHS-OIG) and FBI spearheaded today’s landmark investigation and prosecution that resulted in charges against CEOs, CFOs and others.
In addition, the Centers for Medicare & Medicaid Services, Center for Program Integrity (CMS/CPI), announced today that it took adverse administrative action against cancer genetic testing companies and medical professionals who submitted more than $1.7 billion in claims to the Medicare program.
Today’s announcement is a culmination of coordinated law enforcement activities over the past month that were led by the Criminal Division’s Health Care Fraud Unit, resulting in charges against over 380 individuals who allegedly billed federal health care programs for more than $3 billion and allegedly prescribed/dispensed approximately 50 million controlled substance pills in Houston, across Texas, the West Coast, the Gulf Coast, the Northeast, Florida and Georgia, and the Midwest. These include charges against 105 defendants for opioid-related offenses, and charges against 178 medical professionals.
Today’s enforcement actions were led and coordinated by the Health Care Fraud Unit of the Criminal Division’s Fraud Section in conjunction with its Medicare Fraud Strike Force (MFSF), as well as the U.S. Attorney’s Offices for the Southern District of Florida, Middle District of Florida, Southern District of Georgia, Eastern District of Louisiana, and Middle District of Louisiana. The MFSF is a partnership among the Criminal Division, U.S. Attorney’s Offices, the FBI, DEA and HHS-OIG. In addition, the operation included the participation of various other federal, state and local law enforcement agencies, including the Louisiana Medicaid Fraud Control Unit.
The coordinated federal investigation targeted an alleged scheme involving the payment of illegal kickbacks and bribes by CGx laboratories in exchange for the referral of Medicare beneficiaries by medical professionals working with fraudulent telemedicine companies for expensive cancer genetic tests that were medically unnecessary.
Often, the test results were not provided to the beneficiaries or were worthless to their actual doctors. Some of the defendants allegedly controlled a telemarketing network that lured hundreds of thousands of elderly and/or disabled patients into a criminal scheme that affected victims nationwide. The defendants allegedly paid doctors to prescribe CGx testing, either without any patient interaction or with only a brief telephonic conversation with patients they had never met or seen.
“These defendants allegedly duped Medicare beneficiaries into signing up for unnecessary genetic tests, costing Medicare billions of dollars,” Assistant Attorney General Brian A. Benczkowski of the Justice Department’s Criminal Division. “Together with our law enforcement partners, the Department will continue to protect the public fisc and prosecute those who steal our taxpayer dollars.”
“The scope and sophistication of the health care fraud detected in Operation Double Helix and the related Operation Brace Yourself is nearly unprecedented. But the citizens of the Southern District of Georgia should know that we put together an unprecedented response,” said U.S. Attorney Bobby L. Christine of the Southern District of Georgia. “Our office charged more defendants, responsible for more health care fraud losses, than ever before in this office’s history. While these charges might be some of the first, they won’t be the last.”
“The defendants allegedly targeted elderly, disabled and other vulnerable consumers, luring them into this fraudulent scheme that affected victims nationwide and generated losses in excess of one billion dollars which spanned multiple jurisdictions,” said U.S. Attorney Peter G. Strasser for the Eastern District of Louisiana. “Schemes such as these have a profound effect on our nation, not only by the monies lost in the scheme, but also by stoking public distrust in some medical institutions. It is imperative to preserve taxpayer confidence whenever and wherever possible. Our office, along with our investigative partners, reminds seniors and their caregivers to be vigilant for fraudulent schemes. If you are aware of or believe you are the victim of a health care fraud scheme, please contact law enforcement.”
“The defendants are alleged to have capitalized on the fears of elderly Americans in order to induce them to sign up for unnecessary or non-existent cancer screening tests,” said U.S. Attorney Ariana Fajardo Orshan of the Southern District of Florida. “The genetic testing fraud schemes put personal greed above the preservation of the American health care system. The U.S. Attorney’s Office in South Florida, alongside our law enforcement and USAO partners, remains committed to protecting taxpayer dollars and the Medicare program from abuse.”
“We are honored to work every day alongside our law enforcement partners to stop the exploitation of vulnerable patients and misuse of taxpayer dollars,” said CMS Administrator Seema Verma. “In order to prevent additional financial losses, CMS has taken swift action to protect the Medicare Trust Funds from the providers who allegedly have fraudulently billed over $1.7 billion. CMS continues to use a comprehensive and aggressive program integrity approach that includes fraud prevention, claims review, beneficiary education, and targeting high-risk areas of the federal healthcare programs with new tools and innovative demonstrations.”
“Healthcare fraud and related illegal kickbacks and bribes impact the entire nation,” said Assistant Director Terry Wade of the FBI’s Criminal Investigative Division. “Fraudulently using genetic testing laboratories for unnecessary tests erodes the confidence of patients and costs taxpayers millions of dollars. These investigations revealed some medical professionals placing their greed before the needs of the patients and communities they serve. Today’s law enforcement actions reinforce that the FBI, along with its partners, will continue to pursue and stop this type of illegal activity.”
“Unfortunately, audacious schemes such as those alleged in the indictments are pervasive and exploit the promise of new medical technologies such as genetic testing and telemedicine for financial gain, not patient care,” said Deputy Inspector General for Investigations Gary L. Cantrell of HHS-OIG. “Instead of receiving quality care, Medicare beneficiaries may be victimized in the form of scare tactics, identity theft, and in some cases, left to pay out of pocket. We will continue working with our law enforcement partners to investigate those who steal from federal healthcare programs and protect the millions of Americans who rely on them.”
In the Southern District of Florida, the following defendants were charged:
Richard Garipoli, 42, of Loxahatchee, Florida, the owner of a telemedicine company Lotus Health LLC (Lotus Health), located in Loxahatchee, is charged with conspiracy to commit health care fraud, conspiracy to pay and receive kickbacks, and substantive counts of health care fraud and receiving kickbacks. The indictment charges that from January 2017 through September 2019, Garipoli, and unnamed co-conspirators, billed Medicare and Medicare Advantage plans over $326 million, for which Medicare paid over $84 million, for false and fraudulent Cancer Genomic tests (CGx Tests) that were not medically necessary, and not eligible for Medicare reimbursement. Doctors contracted with Lotus Health allegedly authorized bogus doctors’ orders that the CGx Tests were medically necessary when the doctors did not engage in treatment of the beneficiaries, had no physician-patient relationship with them, and often did not even speak with the beneficiaries for whom they ordered tests. The Indictment alleges that various companies paid kickbacks to Lotus Health in exchange for ordering and arranging for the ordering of CGx tests for Medicare beneficiaries, without regard to whether the CGx tests were medically necessary or eligible for Medicare reimbursement, and without regard for the fact that the tests were prescribed without any physician-patient relationship. Various laboratories including Clio Laboratories in Lawrenceville, Georgia and LabSolutions in Atlanta, Georgia and Easton, Pennsylvania then allegedly submitted false and fraudulent claims to Medicare and Medicare Advantage plans for the false and fraudulent CGx tests that were not medically necessary and not eligible for Medicare reimbursement. Garipoli and others allegedly concealed the submission of these false and fraudulent claims to Medicare and Medicare Advantage plans; and diverted fraud proceeds for their personal use and benefit, the use and benefit of others and to further the fraud. The case is being prosecuted by Trial Attorneys James Hayes and Tim Loper of the Criminal Division’s Fraud Section
Jamie Simmons, 62, a resident of South Carolina, and the owner of telemedicine companies MedSymphony LLC (MedSymphony) and Meetmydocc LLC (Meetmydoc) in Ft. Lauderdale Florida, is charged with conspiracy to commit health care fraud, conspiracy to pay and receive kickbacks, and substantive counts of health care fraud and receiving kickbacks. The indictment alleges that from January 2018 through September 2019, Simmons, and unnamed co-conspirators, billed Medicare and Medicare Advantage plans over $56 million, for which Medicare paid over $17 million, for false and fraudulent Cancer Genomic tests (CGx Tests) that were not medically necessary, and not eligible for Medicare reimbursement. Doctors contracted with MedSymphony authorized bogus doctors’ orders that the CGx Tests were medically necessary when the doctors did not engage in treatment of the beneficiaries, had no physician-patient relationship with them, and often did not even speak with the beneficiaries for whom they ordered tests. The Indictment alleges that various companies paid kickbacks to MedSymphony through Meetmydoc in exchange for ordering and arranging for the ordering of CGx tests for Medicare beneficiaries, without regard to whether the CGx tests were medically necessary or eligible for Medicare reimbursement, and without regard for the fact that the tests were prescribed without any physician-patient relationship. Various laboratories then submitted false and fraudulent claims to Medicare and Medicare Advantage plans for the false and fraudulent CGx tests that were not medically necessary and not eligible for Medicare reimbursement. Simmons and others allegedly concealed the submission of these false and fraudulent claims to Medicare and Medicare Advantage plans; and diverted fraud proceeds for their personal use and benefit, the use and benefit of others and to further the fraud. The case is being prosecuted by Trial Attorneys James Hayes and Tim Loper.
Minal Patel, 40, of Atlanta, Georgia was charged based on his role in an alleged scheme to solicit medically unnecessary CGx tests from Medicare beneficiaries through telemarketing and “health fairs.” The tests were then approved by telemedicine doctors who allegedly did not engage in treatment of the beneficiaries, and often did not even speak with the beneficiaries for whom they ordered tests. Patel, the owner of LabSolutions in Georgia and Pennsylvania, then paid the telemarketers illegal kickbacks and bribes in exchange for the doctor’s orders and medically unnecessary tests. LabSolutions billed Medicare for more than $494 million. In addition, the government seized approximately $30 million in bank accounts from Patel, as well as luxury vehicles, including a Ferrari and a Range Rover. The case is being prosecuted by Trial Attorneys Tim Loper and James Hayes.
In the Eastern District of Louisiana, the following defendant was charged:
Khalid Satary, 47, of Suwanee, Georgia was charged based on his role in an alleged scheme to solicit medically unnecessary cancer genetic (CGx) tests from Medicare beneficiaries through telemarketing and “health fairs.” The tests were then approved by telemedicine doctors who did not engage in treatment of the beneficiaries, and often did not even speak with the beneficiaries for whom they ordered tests. Satary, the owner of several labs in Georgia, Oklahoma and Louisiana, and his co-conspirators, through companies they controlled, then paid the telemarketers illegal kickbacks and bribes in exchange for the doctor’s orders and medically unnecessary tests. The labs included Performance Laboratories in Oklahoma, Lazarus Services in Louisiana, and Clio Labs in Georgia. Performance Labs, Clio Labs and Lazarus Services collectively billed Medicare for more than $547 million. In addition, the government seized 16 bank accounts and restrained real estate from Satary. The case is being prosecuted by Trial Attorneys Timothy Loper and Jared Hasten.
In the Southern District of Georgia, 19 defendants were charged:
Anthony T. Securo, 56, of Columbus, Georgia, was indicted by a federal grand jury in Savannah, Georgia, for his role in a scheme to bill Medicare and other health benefit programs for medically unnecessary durable medical equipment. According to the indictment, Securo, a medical doctor, signed thousands of orders for durable medical equipment for Medicare beneficiaries he claimed to be “treating,” but in fact never even met. These thousands of items were billed to Medicare for more than $23 million. According to the indictment, Securo ordered these medically unnecessary items after having short telephone conversations with the patients, but then signed medical records stating that Securo had performed examinations or physical tests of the patients that were never actually performed.
In addition, 18 other defendants were charged in the Southern District of Georgia by way of criminal information. The 18 other defendants include two “telemedicine” physician recruiters, seven physicians, two nurse practitioners, two individuals who brokered the sale of physician orders, one company that brokered the sale of physician orders, and four durable medical equipment companies. In total, the 19 defendants charged in the Southern District of Georgia were responsible for over $400 million in genetic testing, durable medical equipment, and pain cream billing to Medicare, according to court documents. The cases are being prosecuted by Assistant U.S. Attorneys J. Thomas Clarkson Jonathan A. Porter of the Southern District of Georgia
In the Northern District of Texas, the following defendant was charged:
Daniel R. Canchola, M.D., 49, Flower Mound Texas, a physician, was charged for his alleged referral of Medicare beneficiaries for medically unnecessary “cancer screening,” or “CGx,” genetic tests. Canchola received illegal kickbacks and bribes for the CGx orders he signed, and he did so without examining or speaking to patients and in the absence of any physician-patient relationship. Oftentimes the beneficiaries for whom Canchola ordered CGx tests never received their test results. From in or about January 2018 through in or about March 2019, Canchola caused the submission of over $69 million in false and fraudulent claims to Medicare. The case is being prosecuted by Trial Attorney Brynn Schiess of the Fraud Section.
Sekhar Rao, M.D., 48 of Austin, Texas, and Vinay Parameswara, M.D., 46, of Austin, Texas, were charged for their role in alleged referrals of TRICARE beneficiaries for medically unnecessary “cancer screening” genetic tests and toxicology tests. Rao and Parameswara did not examine or speak with the beneficiaries they signed testing orders for and there was no physician-patient relationship between the physicians and these beneficiaries. Tests were repeated many times and beneficiaries often did not receive the results of their tests. From in or about May 2014 and until in or about June 2016, Rao, Parameswara and others caused the submission of over $36 million in false and fraudulent claims to TRICARE. The case is being prosecuted by Assistant Chief Adrienne Frazior of the Fraud Section.
In the Middle District of Florida, the following defendant was charged:
Ivan Andre Scott, 34, Kissimmee, Florida, a marketer, was charged for his role in an alleged $2.8 million scheme to provide Medicare beneficiary information to doctors and telemedicine companies, that could then be billed for medically unnecessary genetic testing. The case is being prosecuted by Trial Attorney Alejandro J. Salicrup of the Fraud Section.
In the Middle District of Louisiana, the following defendants were charged:
Mark Allen, 51, of Greer, South Carolina, and Kevin Hanley, 42, of Prairieville, Louisiana, were charged for their roles in an alleged scheme to solicit medically unnecessary cancer genetic (CGx) tests from Medicare beneficiaries, have the tests approved by telemedicine doctors who did not engage in treatment of the beneficiaries, and submit claims through clinical testing laboratories that paid kickbacks in exchange for the referrals. Allen and his co-conspirators, through companies they controlled, solicited the tests and arranged for approvals by telemedicine providers. They then transmitted the test samples and orders to labs in Louisiana, including Acadian Diagnostic Laboratories LLC, where Hanley was the CFO, and elsewhere. Acadian, through Hanley and others, paid kickbacks to companies controlled by Allen and others to obtain the referrals, and submitted claims to Medicare for the tests. Acadian and other labs billed Medicare for more than $240 million. The case is being prosecuted by Trial Attorneys Tim Loper, Justin Woodard and Gary Winters of the Fraud Section and Assistant U.S. Attorney Kristen Craig of the Middle District of Louisiana.
In addition, as part of the Northeast Regional Takedown announced on Sept. 26, the District of New Jersey announced charges against the following:
Matthew S. Ellis, MD, 53, of Gainesville, Florida; Edward B. Kostishion, 59, of Lakeland, Florida; Kyle D. Mclean, 36, of Arlington Heights, Illinois; Kacey C. Plaisance, 38, of Altamonte Springs, Florida; Jeremy Richey, 39, of Mars, Pennsylvania; and Jeffrey Tamulski, 46, of Tampa, Florida. Kostishion, Plaisance, and Richey operated Ark Laboratory Network LLC (Ark), a company that purported to operate a network of laboratories that facilitated genetic testing. Ark partnered with Privy Health, Inc., a company that McLean operated, and another company to acquire DNA samples and Medicare information from hundreds of patients through various methods, including offering $75 gift cards to patients, all without the involvement of a treating health care professional. Ellis, a physician based in Gainesville, served as the ordering physician who authorized genetic testing for hundreds of patients across the country that he never saw, examined, or treated. These included patients from New Jersey and various other states where Ellis was not licensed to practice medicine. Through this process, Ellis, Kostishion, Plaisance, and McLean submitted and caused to be submitted fraudulent orders for genetic tests to numerous clinical laboratories. These orders falsely certified that Ellis was the patients’ treating physician and, in many cases, contained false information indicating that a patient had a personal or family history of cancer, when, in fact, the patient had no cancer history whatsoever. In 2018 alone, Medicare paid clinical laboratories at least approximately $4.6 million for genetic tests that Ellis ordered in this manner. In addition, Kostishion, Plaisance, Richey, and Tamulski entered into kickback agreements with certain clinical laboratories under which the laboratories would pay Ark a bribe in exchange for delivering DNA samples and orders for genetic tests. The bribe payments were based on the percentage of Medicare revenue that the laboratories received in connection with the tests. Among other things, Kostishion, Plaisance, Richey, and Tamulski concealed these kickback arrangements through issuing sham invoices to laboratories that purportedly reflected services provided at an hourly rate even though the parties had already agreed upon the bribe amount, which was based on the revenue the laboratories received. In 2018, the clinical laboratories paid Ark at least approximately $1.8 million in bribes. The case is being prosecuted by Assistant U.S. Attorney Bernard Cooney of the District of New Jersey.
A complaint, information or indictment is merely an allegation, and all defendants are presumed innocent until proven guilty beyond a reasonable doubt in a court of law.
The Fraud Section leads the Medicare Fraud Strike Force. Since its inception in March 2007, the Medicare Fraud Strike Force, which maintains 15 strike forces operating in 24 districts, has charged nearly 4,000 defendants who have collectively billed the Medicare program for more than $16 billion. In addition, the HHS Centers for Medicare & Medicaid Services, working in conjunction with the HHS-OIG, are taking steps to increase accountability and decrease the presence of fraudulent providers.
Justice News A federal law enforcement action involving fraudulent genetic cancer testing has resulted in charges in five federal districts against 35 defendants associated with dozens of
DNA Data Banks, Criminal Investigations, and Civil Liberties
Sheldon Krimsky and Tania Simoncelli
Columbia University Press
National DNA databanks were initially established to catalogue the identities of violent criminals and sex offenders. However, since the mid-1990s, forensic DNA databanks have in some cases expanded to include people merely arrested, regardless of whether they’ve been charged or convicted of a crime. The public is largely unaware of these changes and the advances that biotechnology and forensic DNA science have made possible. Yet many citizens are beginning to realize that the unfettered collection of DNA profiles might compromise our basic freedoms and rights.
Two leading authors on medical ethics, science policy, and civil liberties take a hard look at how the United States has balanced the use of DNA technology, particularly the use of DNA databanks in criminal justice, with the privacy rights of its citizenry. Krimsky and Simoncelli analyze the constitutional, ethical, and sociopolitical implications of expanded DNA collection in the United States and compare these findings to trends in the United Kingdom, Japan, Australia, Germany, and Italy. They explore many controversial topics, including the legal precedent for taking DNA from juveniles, the search for possible family members of suspects in DNA databases, the launch of “DNA dragnets” among local populations, and the warrantless acquisition by police of so-called abandoned DNA in the search for suspects. Most intriguing, Krimsky and Simoncelli explode the myth that DNA profiling is infallible, which has profound implications for criminal justice.
In Genetic Justice, the authors provide a thorough discussion of the concerns they believe the DNA revolution and the use of DNA databases in law enforcement pose. While I do not agree with all of their policy conclusions, I commend the authors for their bold and uncompromising positions. Providing discussion of these sensitive criminal justice matters is critical for generating the best tools to serve society while maintaining those precious rights that we enjoy. I recommend the book to all who seek a better understanding of the impact of the genomic age on the criminal justice process. Bruce Budowle, executive director, Institute of Investigative Genetics, University of North Texas Health Science Center at Fort Worth
Essential reading for anyone concerned with balancing public safety and personal freedom. The proliferation of DNA databases is not simply ‘all good’ or ‘all bad.’ Genetic Justice admirably deconstructs opposing arguments and then erects an inspiring yet realistic vision of justice. Peter Neufeld and Barry Scheck, codirectors of the Innocence Project
Genetic Justice provides a lucid assessment of forensic DNA data banking that counters our CSI-infatuated culture in which DNA testing is assumed to be infallible. The authors reveal the serious threats that misuses of modern genetic technology and DNA databases can pose to cherished constitutional rights. This book is essential reading for all who care about pursuing justice while ensuring fairness to our diverse citizenry and the protection of our individual right to privacy. Nadine Strossen, New York Law School and former president, American Civil Liberties Union
Genetic Justice illuminates every important controversy in the way DNA has entered the criminal justice system: from arguments about a universal DNA databank to the efficacy of DNA dragnets, from whether the state has the right to search your ‘abandoned DNA’ to the pros and cons of familial searching. Moreover, it accomplishes this in an engaging style that requires no technical background. A vital reference work for the next decade. Troy Duster, New York University
Sheldon Krimsky is one of the most intelligent and creative multidisciplinary scholars working in bioethics, genetics and society, science studies, and biotechnology. He always knows how to pick topics that are socially significant and require careful public attention. Phil Brown, author of Toxic Exposures: Contested Illnesses and the Environmental Health Movement
Firmly grounded in science, this inquiry proves that while DNA can be dramatic in its disclosures, it is not to be used lightly, as is so often depicted in crime stories. Booklist
A thoughtful and informative read James A. Cox, Midwest Book Review
For anyone concerned about DNA technology, evolving concepts of justice, or the erosion of the basic freedoms of our democracy, Genetic Justice is a book not to miss. Doug Pet, Biopolitical Times
The book offers a lucid and accurate presentation of DNA forensic technology that will be useful to any nonspecialist. Michael A. Goldman, Science
Genetic Justice constitutes the single most comprehensive articulation of the civil-liberties concerns associated with law-enforcement DNA databases and should, therefore, serve as a touchstone for debates about the spread of DNA profiling. Simon A. Cole, American Scientist
Engaging and informative. Charalambos P. Kyriacou, Times Higher Education
Thoroughly researched and well referenced, Genetic Justice distinguishes itself as an interesting and informative book on the history of the development of DNA testing, forensic DNA databanks, and the justice system’s evolving approaches. Ananda M. Chakrabarty, BioScience
required reading Richard Lewontin, New York Review of Books
An important strength of this timely,engaging, and readable book—and what distinguishes it from some others—is the clarity with which it demonstrates how genomics findings in one discipline. are applied to others. Lundy Braun, PsycCRITIQUES
I highly recommend this book to anyone interested in and concerned about the balance between the protection of rights such as privacy and autonomy and public safely and criminal justice imperatives. Wilhelm Peekhaus, Science and Society
- Read the authors’ Los Angeles Times op-ed DNA and justice denied.
- Read a review from Biopolitical Times.
Winner, 2011 Gold Medal – Independent Publisher Book Award for Current Events
About the Author
Sheldon Krimsky is professor of urban and environmental policy and planning and adjunct professor of public health and community medicine at Tufts University. He is author or coeditor of eleven books, most recently Race and the Genetic Revolution: Science, Myth, and Culture.
National DNA databanks were initially established to catalogue the identities of violent criminals and sex offenders. However, since the mid-1990s, forensic … | CUP