Source- http://www.justice.gov/opa/pr/2014/March/14-civ-270.html
Memorial Hospital (Memorial), an Ohio nonprofit corporation that operates an acute care hospital in Fremont, Ohio, has agreed to pay $8.5 million to settle claims that it violated the False Claims Act, the Anti-Kickback Statute and the Stark Statute by engaging in improper financial relationships with referring physicians, the Justice Department announced today.
“Improper financial relationships between health care providers and their referral sources can undermine physicians' judgment about patients' true health care needs and drive up health care costs for everyone,” said Assistant Attorney General for the Justice Department’s Civil Division Stuart F. Delery. "The Justice Department is firmly committed to recovering the taxpayer dollars lost due to these arrangements and making sure that all health care providers follow the rules.”
The Anti-Kickback Statute and the Stark Statute restrict the financial relationships that hospitals may have with doctors who refer patients to them. The settlement announced today involved allegations that financial relationships that Memorial had with two physicians – a joint venture between Memorial and a pain management physician and an arrangement under which an ophthalmologist purchased intraocular lenses and then resold them to Memorial at inflated prices - violated statutory requirements. These issues were disclosed to the government by Memorial.
"Physician referrals should be made exclusively based on what's best for the patient, not on financial relationships," said U.S. Attorney for the Northern District of Ohio Steven M. Dettelbach. "We hope that this settlement will once again help drive that message home."
The improper referrals at issue in this matter included Medicaid patients. Medicaid is funded jointly by the states and the federal government. The State of Ohio, which paid for some of the Medicaid claims at issue, will receive $600,383 of the settlement amount.
“The price of such arrangements can be very costly to the nation’s health care system, taxpayers and provider organizations,” said Inspector General of the U.S. Department of Health and Human Services Daniel R. Levinson. “So, we are pleased that Memorial stepped forward to disclose these improper financial relationships and is working to avoid future occurrences.”
This settlement illustrates the government’s emphasis on combating health care fraud and marks another achievement for the Health Care Fraud Prevention and Enforcement Action Team (HEAT) initiative, which was announced in May 2009 by Attorney General Eric Holder and Secretary of Health and Human Services Kathleen Sebelius. The partnership between the two departments has focused efforts to reduce and prevent Medicare and Medicaid financial fraud through enhanced cooperation. One of the most powerful tools in this effort is the False Claims Act. Since January 2009, the Justice Department has recovered a total of $19 billion through False Claims Act cases, with more than $13.4 billion of that amount recovered in cases involving fraud against federal health care programs.
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A licensed psychiatrist formerly employed by the Department of Veterans Affairs (VA) was sentenced today to serve 18 months in prison for falsely claiming to provide at-home services to Medicare beneficiaries.
Acting Assistant Attorney General Mythili Raman of the Justice Department’s Criminal Division, U.S. Attorney Loretta E. Lynch of the Eastern District of New York and Special Agent in Charge Thomas O’Donnell of the U.S. Department of Health and Human Services Office of Inspector General (HHS-OIG) made the announcement.
Dr. Mikhail L. Presman, 56, of Brooklyn, N.Y., was sentenced by Judge I. Leo Glasser in the Eastern District of New York. Presman was sentenced to serve three years of supervised release following his prison term and ordered to forfeit $1.2 million and pay restitution to Medicare.
According to court documents, from Jan. 1, 2006, through May 10, 2013, Presman submitted approximately $4 million in Medicare claims for home treatment of Medicare beneficiaries notwithstanding his full-time salaried position as a psychiatrist at the VA hospital in Brooklyn. Presman did not provide any treatment to a substantial number of the beneficiaries he claimed to have treated. For example, Presman submitted claims to Medicare for home medical visits at locations within New York City even though he was physically located in China at the time of these purported home visits. Presman also submitted claims to Medicare for 55 home medical visits to beneficiaries who were hospitalized on the date of the purported visits.
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A federal jury in Houston today convicted two owners of a former Houston mental health care company, Spectrum Care P.A. (Spectrum), several of its employees and the owners of certain Houston group care homes for their participation in a $97 million Medicare fraud scheme.
Acting Assistant Attorney General Mythili Raman of the Justice Department’s Criminal Division, U.S. Attorney Kenneth Magidson of the Southern District of Texas, Special Agent in Charge Stephen L. Morris of the FBI’s Houston Field Office and Special Agent in Charge Mike Fields of the Dallas Regional Office of HHS’s Office of Inspector General (HHS-OIG), the Texas Attorney General’s Medicaid Fraud Control Unit (MFCU), Special Agent in Charge Joseph J. Del Favero of the Chicago Field Office of the Railroad Retirement Board, Office of Inspector General (RRB-OIG) and Special Agent in Charge Scott Rezendes of Field Operations of the Office of Personnel Management’s Office of Inspector General (OPM-OIG) made the announcement following a jury trial before U.S. District Judge Vanessa Gilmore in the Southern District of Texas.
Physicians Mansour Sanjar, 81, and Cyrus Sajadi, 66, the owners of Spectrum, were each convicted of conspiracy to commit health care fraud and conspiracy to pay kickbacks as well as related counts of health care fraud and paying illegal kickbacks. Adam Main, 33, a physician’s assistant, was convicted of conspiracy to commit health care fraud and related counts of health care fraud. Shokoufeh Hakimi, 66, administrator of Spectrum, was convicted of conspiracy to commit health care fraud, conspiracy to pay kickbacks and a related count of paying an illegal kickback. Chandra Nunn, 35, a group home owner, was also convicted of conspiracy to commit health care fraud, conspiracy to pay and receive kickbacks and related counts of receiving illegal kickbacks. Sharonda Holmes, 40, a patient recruiter, was convicted of conspiracy to pay and receive kickbacks and a related count of receiving an illegal kickback. Shawn Manney, 51, a group home owner, was convicted of conspiracy to pay and receive illegal kickbacks.
According to evidence presented at trial, Sanjar and Sajadi orchestrated and executed a scheme to defraud Medicare beginning in 2006 and continuing until their arrest in December 2011. Sanjar and Sajadi owned Spectrum, which purportedly provided partial hospitalization program (PHP) services. A PHP is a form of intensive outpatient treatment for severe mental illness. The Medicare beneficiaries for whom Spectrum billed Medicare for PHP services did not qualify for or need PHP services. Sanjar, Sajadi, Main and Moore signed admission documents and progress notes certifying that patients qualified for PHP services, when in fact, the patients did not qualify for or need PHP services. Sanjar and Sajadi also billed Medicare for PHP services when the beneficiaries were actually watching movies, coloring and playing games–activities that are not covered by Medicare.
Evidence presented at trial showed that Sanjar, Sajadi and Hakimi paid kickbacks to Nunn, Holmes, Manney and other group care home operators and patient recruiters in exchange for delivering ineligible Medicare beneficiaries to Spectrum. In some cases, the patients received a portion of those kickbacks. According to evidence presented at trial, Spectrum billed Medicare for approximately $97 million in services that were not medically necessary and, in some cases, werenot provided.
Sanjar, Sajadi and Nunn are scheduled to be sentenced on Sept. 8, 2014. Main, Hakimi, Holmes and Manney are scheduled to be sentenced on Sept. 15, 2014.
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Source- http://www.justice.gov/opa/pr/2014/March/14-civ-252.html
Halifax Hospital Medical Center and Halifax Staffing Inc. (Halifax), a hospital system based in the Daytona Beach, Fla., area, have agreed to pay $85 million to resolve allegations that they violated the False Claims Act by submitting claims to the Medicare program that violated the Physician Self-Referral Law, commonly known as the Stark Law, the Justice Department announced today.
The Stark Law forbids a hospital from billing Medicare for certain services referred by physicians who have a financial relationship with the hospital. In this case, the government alleged that Halifax knowingly violated the Stark Law by executing contracts with six medical oncologists that provided an incentive bonus that improperly included the value of prescription drugs and tests that the oncologists ordered and Halifax billed to Medicare. The government also alleged that Halifax knowingly violated the Stark Law by paying three neurosurgeons more than the fair market value of their work.
“Financial arrangements that compensate physicians for referrals encourage physicians to make decisions based on financial gain rather than patient needs,” said Assistant Attorney General for the Justice Department’s Civil Division Stuart F. Delery. “The Department of Justice is committed to preventing illegal financial relationships that undermine the integrity of our public health programs.”
In a Nov. 13, 2013, ruling, the U.S. District Court for the Middle District of Florida ruled that Halifax’s contracts with its medical oncologists violated the Stark Law. The case was set for trial on March 3, 2014, on the government’s remaining claims against Halifax when the parties reached this settlement.
“This settlement illustrates our firm commitment to pursue health care fraud," said U.S. Attorney for the Middle District of Florida A. Lee Bentley III. “Medical service providers should be motivated, first and foremost, by what is best for their patients, not their pocketbooks. Where necessary, we will continue to investigate and pursue these violations in our district.”
As part of the settlement announced today, Halifax also has agreed to enter into a Corporate Integrity Agreement with the Department of Health and Human Services Office of Inspector General (HHS-OIG), which obligates Halifax to undertake substantial internal compliance reforms and to submit its federal health care program claims to independent review for the next five years.
“Patients deserve to know that recommendations are based on sound medical practice, not illegal financial relationships between providers,” said Inspector General for the U.S. Department of Health and Human Services Daniel R. Levinson. “Halifax now also is required to hire a legal reviewer to monitor provider arrangements and an additional compliance expert to assist the board in fulfilling its oversight obligations. Both of these independent reviewers will submit regular reports to my agency.”
The settlement announced today stems from a whistleblower complaint filed by an employee of Halifax Hospital, Elin Baklid-Kunz, pursuant to the qui tam provisions of the False Claims Act, which permit private persons to bring a lawsuit on behalf of the government and to share in the proceeds of the suit. The Act also permits the government to intervene and take over the lawsuit, as it did in this case as to some of Baklid-Kunz’s allegations. Baklid-Kunz will receive $20.8 million of the settlement.
This settlement illustrates the government’s emphasis on combating health care fraud and marks another achievement for the Health Care Fraud Prevention and Enforcement Action Team (HEAT) initiative, which was announced in May 2009 by Attorney General Eric Holder and Secretary of Health and Human Services Kathleen Sebelius. The partnership between the two departments has focused efforts to reduce and prevent Medicare and Medicaid financial fraud through enhanced cooperation. One of the most powerful tools in this effort is the False Claims Act. Since January 2009, the Justice Department has recovered a total of more than $19 billion through False Claims Act cases, with more than $13.4 billion of that amount recovered in cases involving fraud against federal health care programs.
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Source- http://www.justice.gov/opa/pr/2014/March/14-civ-251.html
Pharmaceutical manufacturer Teva Pharmaceuticals USA Inc. and a subsidiary, IVAX LLC, have agreed to pay the government and the state of Illinois $27.6 million for allegedly violating the False Claims Act by making payments to induce prescriptions of an anti-psychotic drug for Medicare and Medicaid beneficiaries . Teva Pharmaceuticals USA is located in North Wales, Pa., and IVAX LLC is a Florida company.
“The Department of Justice is committed to ensuring that pharmaceutical manufacturers who make payments to doctors to influence prescribing decisions are held accountable,” said Assistant Attorney General for the Justice Department’s Civil Division Stuart F. Delery. “Schemes such as the one alleged in this case undermine the health care system and take advantage of vulnerable patients.”
“ Pharmaceutical companies must not be allowed to improperly influence physicians’ decisions in prescribing medication for their patients,” said U.S. Attorney Zachary T. Fardon for the Northern District of Illinois. “Instead, those decisions must be made solely on the basis of the patient’s best medical interests.”
The settlement resolves allegations that Teva and IVAX made payments to an Illinois physician, Dr. Michael J. Reinstein, to induce the prescription of generic clozapine, an anti-psychotic medication. Clozapine has serious potential side effects and is generally considered a drug of last resort, particularly for elderly patients. While clozapine has been approved for treatment-resistant forms of schizophrenia, it is also reported to cause numerous side effects, including a potentially deadly decrease in white blood cells, seizures, inflammation of the heart muscle and increased mortality in elderly patients. The United States alleged that the payment scheme involving Reinstein began in August 2003, when Reinstein agreed to switch his patients to generic clozapine if IVAX, which was subsequently acquired by Teva Pharmaceuticals’ parent corporation, agreed to pay Reinstein $50,000 under a one-year “consulting agreement” and to provide other benefits to Reinstein , in violation of the federal Medicare and Medicaid Anti-Kickback Statute . In addition to direct payments to Reinstein, IVAX allegedly also provided all-expenses paid trips to Miami for Reinstein, his wife and several of his employees. Reinstein quickly became the largest prescriber of generic clozapine in the country, and prescribed the drug for many elderly patients. Allegedly, the payments and other forms of remuneration from IVAX and later Teva Pharmaceuticals continued for many years, and resulted in the submission of thousands of false claims to the Medicare Part D and Illinois Medicaid programs.
The Anti-Kickback Statute prohibits offering, paying, soliciting or receiving remuneration to induce referrals of items or services covered by Medicare, Medicaid and other federally funded programs. The Anti-Kickback Statute is intended to ensure that a physician’s medical judgment is not compromised by improper financial incentives and is instead based on the best interests of the patient.
On Nov. 15, 2012, the United States filed a civil action against Reinstein in United States v. Reinstein , alleging that he violated the False Claims Act as a result of his involvement in the payment scheme with Teva and IVAX. The civil action against Reinstein remains pending in the Northern District of Illinois.
The government’s settlement of these allegations illustrates its emphasis on combating health care fraud and marks another achievement for the Health Care Fraud Prevention and Enforcement Action Team (HEAT) initiative, which was announced in May 2009 by Attorney General Eric Holder and Secretary of Health and Human Services Kathleen Sebelius. The partnership between the two departments has focused efforts to reduce and prevent Medicare and Medicaid financial fraud through enhanced cooperation. One of the most powerful tools in this effort is the False Claims Act. Since January 2009, the Justice Department has recovered a total of more than $19 billion through False Claims Act cases, with more than $13.4 billion of that amount recovered in cases involving fraud against federal health care programs.
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Source- http://www.justice.gov/usao/mie/news/2014/2014_3_7_bpatel_etal.html
A doctor, a pharmacist and a marketer were convicted today in federal court in Detroit for health care fraud and controlled substance distribution, U.S. Attorney Barbara L. McQuade announced today.
McQuade was joined in the announcement by Acting Special Agent in Charge James V. Allen, Drug Enforcement Administration, Detroit Division, Paul R. Abbate, Special Agent in Charge, Federal Bureau of Investigation, and Lamont Pugh, III, Special Agent in Charge, Department of Health and Human Services Office of Inspector General ("HHS-OIG").
The jury returned guilty verdicts against Dr. Carl Fowler, M.D., 61, of West Bloomfield, pharmacist Mukesh Khunt, 34, of Toronto, Ontario, Canada, and Michael Thoran of Detroit. Defendants Fowler and Thoran were convicted on all three of the counts with which they were charged, conspiracies to commit health care fraud, to distribute controlled substances, and to pay or receive health care kickbacks. Defendant Khunt was convicted of six of the seven counts with which he was charged, health care fraud conspiracy, conspiracy to distribute controlled substances, and two counts health care fraud and two counts of controlled substances distribution. The jury was unable to reach a verdict on the seventh count charging a conspiracy to pay or receive health care kickbacks.
McQuade stated, “Law enforcement investigators in metro-Detroit are aggressively investigating health care fraud and detecting abuses by doctors and pharmacists. We hope that prosecutions like this one will deter medical professionals from stealing taxpayer funds intended for health care.”
The evidence presented during the three-week trial demonstrated that, from approximately January 2006 through August 2011, Canton Pharmacist Babubhai Patel owned and controlled 26 pharmacies (termed “the Patel Pharmacies” at trial), which operated in and around Detroit. The evidence also showed that Babubhai Patel’s model for turning a profit at his pharmacies was based upon large-scale health care fraud and the diversion of controlled substances. Babubhai Patel paid cash kickbacks and other things of value to physicians in exchange for those physicians writing prescriptions for expensive medications, without regard to medical necessity, that could be billed to Medicare, Medicaid, or a private insurer through one of the Patel Pharmacies. Physicians affiliated with Babubhai Patel would also write prescriptions for controlled substances for their patients, again regardless of medical necessity, which would then be filled at one of the Patel Pharmacies. These controlled substances were distributed to patients and patient recruiters as a kickback in exchange for the patients using a Patel Pharmacy. Pharmacists at the Patel Pharmacies would increase the pharmacies’ profits by billing insurers for medications never actually distributed to patients.
The evidence presented at trial showed that Fowler was one of the physicians to whom Babubhai Patel paid bribes and kickbacks in exchange for referrals of prescriptions. In exchange, Dr. Fowler wrote numerous prescriptions for expensive medications, without regard to medical necessity, that could be filled at one of the Patel Pharmacies. He also wrote unlawful prescriptions for narcotic drugs in Schedules II-V, including oxycontin and oxycondone, which were resold on the street market.
Evidence also demonstrated that Khunt, a pharmacist in Babubhai Patel’s organization, billed Medicare, Medicaid, and private insurers for expensive medications he never dispensed to patients. He also knowingly filled prescriptions for scheduled controlled substances such as vicodin that were never intended for the patients, but which were resold by marketers on the street market.
The evidence showed that Thoran was a marketer who recruited patients who were seen by cooperating doctors or clinics. After unlawful prescriptions for controlled substances were written and filled at the pharmacies, Thoran would take possession of the controlled drugs in order to sell them on the street market.
These defendants are three of 39 individuals who have been charged with offenses relating to their involvement with Babubhai Patel’s pharmacy network. All but three of the defendants have now been convicted of felonies arising out of their involvement with Babubhai Patel; 24 of those defendants entered guilty pleas, and 12, including the three defendants today, have been convicted after trial. Defendant Babubhai Patel was convicted at a trial in August 2012; he is serving a 17-year prison sentence. One defendant remains a fugitive, while two defendant’s cases remain pending, with a trial date set for July, 2014.
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Source- http://www.justice.gov/opa/pr/2014/February/14-civ-173.html
Medical device manufacturer EndoGastric Solutions Inc. has agreed to pay the government up to $5.25 million to resolve allegations that it violated the False Claims Act by misleading health care providers about how to bill federal health care programs for a procedure using a device manufactured by the company and by paying kickbacks, the Justice Department announced today. EndoGastric Solutions is located in Redmond, Wash.
“Health care providers that cause the government to pay more than it should for medical devices not only cost us money as taxpayers, they raise the cost of health care for everyone,” said Assistant Attorney General for the Justice Department’s Civil Division Stuart F. Delery. “Medical device manufacturers must deal fairly and honestly with federal health care programs if they want to participate in them.”
EndoGastric Solutions manufactures and sells a device called EsophyX that is intended to treat gastroesophageal reflux disease. The device was developed as an alternative to a more invasive procedure that requires incisions in the abdomen. The government alleged that EndoGastric Solutions knowingly caused health care providers to bill for the less invasive EsophyX procedure using codes applicable to the more invasive procedure, which provided for a higher level of reimbursement. As a result, federal health care programs allegedly paid more than they should have for the procedures using EsophyX.
The government also alleged that EndoGastric Solutions knowingly paid illegal remuneration to certain physicians for participating in patient seminars and co-marketing agreements to induce them to use EsophyX, in violation of the Federal Anti-Kickback Statute. The Anti-Kickback Statute prohibits offering or paying remuneration to induce referrals of items or services covered by federally funded health care programs. The statute is intended to ensure that physicians’ medical judgments are not compromised by improper financial incentives and are based solely on the best interests of patients.
“A medical device manufacturer violates the law when it advises physicians and hospitals to report the wrong codes to federal health insurance programs in order to increase reimbursement rates,” said U.S. Attorney for the District of Montana Michael W. Cotter. “Health care providers are required to bill federal health care programs truthfully for the work they perform.”
As part of the settlement, EndoGastric Solutions has agreed to enter into a Corporate Integrity Agreement with the Department of Health and Human Services Office of Inspector General. The agreement provides for procedures and reviews to be put in place to avoid and promptly detect conduct similar to that which gave rise to the settlement.
“Those seeking to maximize profits by encouraging others to bill government health care programs improperly should expect to pay a heavy price,” said Inspector General of the U.S. Department of Health and Human Services Daniel R. Levinson. “Law enforcement agencies will continue using all available tools to bring violators to justice.”
The civil settlement resolves a lawsuit filed in the U.S. District Court of Montana by Glenn Schmasow, a former employee of EndoGastric Solutions, under the whistleblower provision of the False Claims Act, which permits private parties to file suit on behalf of the government for false claims and to obtain a portion of the government’s recovery. Schmasow will receive up to $945,000.
This settlement illustrates the government’s emphasis on combating health care fraud and marks another achievement for the Health Care Fraud Prevention and Enforcement Action Team (HEAT) initiative, which was announced in May 2009 by Attorney General Eric Holder and Secretary of Health and Human Services Kathleen Sebelius. The partnership between the two departments has focused on efforts to reduce and prevent Medicare and Medicaid financial fraud through enhanced cooperation. One of the most powerful tools in this effort is the False Claims Act. Since January 2009, the Justice Department has recovered a total of more than $19 billion through False Claims Act cases, with more than $13.4 billion of that amount recovered in cases involving fraud against federal health care programs.
This settlement with EndoGastric Solutions was the result of a coordinated effort among the U.S. Attorney’s Office for the District of Montana, the Department of Justice’s Civil Division, the U.S. Department of Health and Human Services Office of Inspector General, the Office of Personnel Management Office of Inspector General and the Office of Program Integrity of the Department of Defense’s Defense Health Agency.
Source- http://www.justice.gov/usao/ils/News/2014/Mar/03072014_Sidener%20Press%20Release.html
Stephen R. Wigginton, United States Attorney for the Southern District of Illinois, announced today that on March 7, 2014, William Dale Sidener, 31, of Ramsey, Illinois, was sentenced on the one-count indictment charging that he engaged in a scheme to commit health care fraud in the United States District Court in East St. Louis, Illinois. The district court sentenced Sidener to serve three years of probation, with the three months to be in home confinement. The district court also ordered Sidener to pay $4,677.75 in restitution to the Illinois Department of Human Services and pay a special assessment of $100.00.
During his plea hearing, Sidener admitted that he had submitted false and fraudulent bills in relation to his alleged performance of personal assistant services in the Home Services Program, a Medicaid Waiver Program designed to allow individuals to stay in their homes instead of entering a nursing home. Sidener admitted to falsely billing the program between November 2012 and February 2013, when he moved away from the person for whom he was supposed to be caring. As a result, Sidener improperly received $4,677.00 in payments for services not performed.
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Source- http://www.justice.gov/usao/nys/pressreleases/March14/panosspyrossentencing.php
Preet Bharara, the United States Attorney for the Southern District of New York, announced that DR. SPYROS PANOS, an orthopedic surgeon, was sentenced today in White Plains federal court before U.S. District Judge Nelson S. Roman to serve 54 months in prison for operating a long-running health care fraud scheme in which PANOS defrauded Medicare, the New York State Insurance Fund, and numerous private health insurance providers (the “Health Insurance Providers”) out of over $2.5 million by systematically lying about the nature and scope of the surgical procedures that he performed. In addition, PANOS was ordered to forfeit $5 million. He was ordered to surrender to start serving his prison term in 30 days.
Manhattan U.S. Attorney Preet Bharara said: “Dr. Panos’s fraud was extensive, costing millions of dollars to federal, state, and private health insurance providers when he billed for thousands of surgical procedures that he falsely described or did not perform at all.”
According to the Information and other documents filed in this case:
PANOS was a board certified orthopedic surgeon licensed to practice medicine in the State of New York who was part a medical group with offices in Dutchess County, New York, (the “Medical Group”) and performed orthopedic surgical procedures (“Surgical Procedures”) at hospitals in Poughkeepsie, New York. From at least 2006 through July 2011, PANOS maintained a high-volume orthopedic practice, which enabled him to carry out his fraud scheme on a large scale. Panos performed thousands of Surgical Procedures, and often as many as 20 or more in a single day, for which he and the Medical Group submitted claims in excess of $35 million to Health Insurance Providers. Health Insurance Providers paid the Medical Group in excess of $13 million on these claims.
To receive payments for Surgical Procedures from the Health Insurance Providers, PANOS was required to submit, and caused the Medical Group to submit, information to the Health Insurance Providers regarding the nature and details of the Surgical Procedures. With respect to many of the Surgical Procedures he performed, PANOS furnished, and caused the Medical Group to furnish, false information to Health Insurance Providers that resulted in the Health Insurance Providers paying the Medical Group at least $2.5 million more than PANOS and the Medical Group were entitled to receive based on the true nature and details of the Surgical Procedures PANOS performed. Among PANOS’s false representations were the following:
a. PANOS claimed he performed open surgeries, when in fact PANOS performed the surgeries arthroscopically;
b. PANOS claimed he used certain techniques and procedures during the course of the Surgical Procedures, when in fact PANOS did not, either because they were not medically necessary or because PANOS used other techniques and procedures that would have resulted in lower payments, if any, from the Health Insurance Providers; and
c. PANOS removed body tissue, known in the medical field as loose bodies, in excess of certain size criteria, when in fact PANOS either removed no loose bodies or removed loose bodies that were smaller than the thresholds set by the Health Insurance Providers for payment.
PANOS, was compensated handsomely -- during the years 2007 through 2011, he was paid over $7.5 million by the Medical Group, a number that was inflated as a result of his fraud scheme.
Beginning in or about December 2010, PANOS attempted to conceal his scheme by, among other things, falsely representing to the Medical Group that the Fraudulent Claims were the result of clerical errors.
PANOS, 45, of Hopewell Junction, New York, also agreed to the entry of a $5 million order of forfeiture against him As a result of his conviction, PANOS is subject to mandatory exclusion from participation in any federal health care program, including Medicare and Medicaid. Following the uncovering of the scheme, Panos surrendered his New York State medical license. Judge Roman ordered PANOS to serve two years of supervised release upon completion of his prison term.
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A former Detroit-area physician pleaded guilty today for his role in an $11.5 million health care fraud scheme.
Acting Assistant Attorney General Mythili Raman of the Justice Department’s Criminal Division, U.S. Attorney Barbara L. McQuade of the Eastern District of Michigan, Special Agent in Charge Paul M. Abbate of the FBI’s Detroit Field Office and Special Agent in Charge Lamont Pugh III of the U.S. Department of Health and Human Services Office of Inspector General (HHS-OIG) Chicago Regional Office made the announcement.
Jose Mercado-Francis, 60, formerly of Brownstown Township, Mich., pleaded guilty before U.S. District Judge Nancy G. Edmunds in the Eastern District of Michigan to one count of conspiracy to commit health care fraud.
According to court documents, Mercado-Francis admitted that, beginning in approximately September 2009 and continuing through February 2012, he held himself out as a licensed physician and purported to provide physician home services to Medicare beneficiaries, when actually his medical license had been revoked and he was not licensed to practice medicine in Michigan.
Court documents allege that Mercado-Francis operated his scheme out of a medical practice known as House Calls Physicians P.L.L.C., which was located in Allen Park, Mich., and owned by a co-conspirator. Mercado-Francis prepared medical documentation that licensed physicians signed as if they had provided services to Medicare beneficiaries, when, in fact, they had not. The services were then billed to Medicare as if the licensed physicians had performed them.
Court documents further allege that, between approximately May 2008 and October 2012, House Calls Physicians billed Medicare more than $11.5 million for the cost of physician home services. Of that amount, Dr. Mercado-Francis caused the submission of approximately $1.1 million in false and fraudulent physician services claims.
At sentencing, which will be scheduled at a later date, Mercado-Francis faces a maximum penalty of 10 years in prison and a $250,000 fine.
This case is being investigated by the FBI and HHS-OIG and was brought as part of the Medicare Fraud Strike Force, under the supervision of the Criminal Division’s Fraud Section and the U.S. Attorney’s Office for the Eastern District of Michigan. This case is being prosecuted by Trial Attorney Matthew C. Thuesen of the Fraud Section.
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Source- http://www.justice.gov/opa/pr/2014/February/14-civ-216.html
Omnicare Inc., an Ohio-based long-term care pharmacy, has agreed to pay the government $4.19 million to settle allegations that it engaged in a kickback scheme in violation of the False Claims Act, the Justice Department announced today. Omnicare provides pharmaceuticals and services to long-term care facilities and residents and other senior populations.
The settlement resolves allegations that Omnicare solicited and received kickbacks from the drug manufacturer Amgen Inc. in return for implementing “therapeutic interchange” programs that were designed to switch Medicaid beneficiaries from a competitor drug to Amgen’s product Aranesp. The government alleged that the kickbacks took the form of performance-based rebates that were tied to market-share or volume thresholds, as well as grants, speaker fees, consulting services, data fees, dinners and travel.
“Kickbacks are designed to influence decisions by health care providers, such as which drugs to prescribe,” said Assistant Attorney General for the Justice Department’s Civil Division Stuart F. Delery. “Americans who rely on federal health care programs, particularly vulnerable patients in skilled nursing facilities, are entitled to feel confident that decisions about their medical care are not tainted by improper financial arrangements.”
“The District of South Carolina has devoted significant resources over the last three years to pursuing claims under the False Claims Act, and this settlement is the latest example of this office’s successful efforts,” said U.S. Attorney for the District of South Carolina William Nettles. “I am very proud of the work this office has done in this area.”
This civil settlement resolves a lawsuit filed under the qui tam, or whistleblower, provision of the False Claims Act, which allows private citizens with knowledge of false claims to bring civil actions on behalf of the government and to share in any recovery. The relator’s share in this case is $397,925.
“Kickbacks corrode our federal health care programs,” said Derrick L. Jackson, Special Agent in Charge of the Office of Inspector General, U.S. Department of Health and Human Services in the region covering South Carolina. “OIG is committed to unveiling these illegal reciprocal relationships, and companies making or receiving such payments can expect serious consequences.”
The settlement with Omnicare Inc. was the result of a coordinated effort among the Civil Division, the U.S. Attorney’s Office for the District of South Carolina and the U.S. Department of Health and Human Services Office of Inspector General.
This settlement illustrates the government’s emphasis on combating health care fraud and marks another achievement for the Health Care Fraud Prevention and Enforcement Action Team (HEAT) initiative, which was announced in May 2009 by Attorney General Eric Holder and Secretary of Health and Human Services Kathleen Sebelius. The partnership between the two departments has focused efforts to reduce and prevent Medicare and Medicaid financial fraud through enhanced cooperation. One of the most powerful tools in this effort is the False Claims Act. Since January 2009, the Justice Department has recovered a total of more than $19 billion through False Claims Act cases, with more than $13.4 billion of that amount recovered in cases involving fraud against federal health care programs.
The claims settled by this agreement are allegations only; there has been no determination of liability.
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The owner of two Flint, Mich., adult day care centers was sentenced today for his leadership role in a $3.2 million Medicare fraud scheme.
Acting Assistant Attorney General Mythili Raman of the Justice Department’s Criminal Division, U.S. Attorney for the Eastern District of Michigan Barbara L. McQuade, Special Agent in Charge Paul M. Abbate of the FBI’s Detroit Field Office and Special Agent in Charge Lamont Pugh III of the U.S. Department of Health and Human Services Office of Inspector General (HHS-OIG) Chicago Regional Office made the announcement.
Glenn English, 53, was sentenced by United States District Judge Victoria A. Roberts in the Eastern District of Michigan to serve 96 months in prison. In addition to his prison term, English was sentenced to serve three years of supervised release and was ordered to pay $988,529 in restitution.
On Oct. 18, 2013, English and co-defendant Richard Hogan were found guilty by a federal jury for their roles in organizing and directing a psychotherapy fraud scheme through New Century Adult Day Program Services LLC and New Century Adult Day Treatment Inc. (together, New Century). English was convicted of one count of conspiracy to commit health care fraud and seven counts of health care fraud, and Hogan was convicted of one count of conspiracy to commit health care fraud.
Evidence presented at trial showed that from 2009 through 2012, New Century operated as an adult day care center that billed Medicare for psychotherapy services. English was New Century’s owner and chief executive officer. New Century brought in mentally disabled residents of Flint-area adult foster care (AFC) homes, as well as people seeking narcotic drugs, and used their names to bill Medicare for psychotherapy that was not provided. English and his co-conspirators lured drug seekers to New Century with the promise that they could see a doctor there who would prescribe to them the narcotics they wanted if they signed up for the psychotherapy program. New Century used the signatures and Medicare information of these drug seekers and AFC residents to claim that it was providing them psychotherapy, when in fact it was not.
The evidence also showed that English directed New Century employees to fabricate patient records to give the false impression that psychotherapy was being provided. English also instructed New Century clients to pre-sign sign-in sheets for months at a time for dates they were not there, and used these signatures to claim to Medicare that these clients had been provided services.
The evidence at trial showed that in little more than two years, New Century submitted approximately $3.28 million in claims to Medicare for psychotherapy that was not provided. Medicare paid New Century $988,529 on these claims.
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Source- http://www.justice.gov/usao/nj/Press/files/Goldberg,%20Charles%20Plea%20News%20Release.html
NEWARK, N.J. – An internist with a practice in Montclair, N.J., admitted today accepting bribes in exchange for test referrals as part of a long-running scheme operated by Biodiagnostic Laboratory Services LLC (BLS), of Parsippany, N.J., its president and numerous associates, U.S. Attorney Paul J. Fishman announced.
Charles Goldberg, 60, of West Orange, N.J., pleaded guilty before U.S. District Judge Stanley R. Chesler in Newark federal court to an information charging him with one count of accepting bribes.
Including Goldberg, 23 people – 12 of them physicians – have pleaded guilty in connection with the bribery scheme, which its organizers have admitted involved millions of dollars in bribes and resulted in more than $100 million in payments to BLS from Medicare and various private insurance companies.
According to documents filed in these and related cases and statements made in court:
Goldberg admitted accepting bribes of $1,800 per month through a sham lease agreement with BLS, which identified the waiting room, bathroom and one examination room in Goldberg’s office as being leased.
The bribery count to which Goldberg pleaded guilty carries a maximum potential penalty of five years in prison and a $250,000 fine. He will be sentenced on a date to be determined. As part of his guilty plea, Goldberg agreed to forfeit $58,000, representing the bribes he received from BLS.
The BLS investigation has recovered more than $7 million to date through forfeiture.
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Source- http://www.justice.gov/usao/ut/news/2014/02-26.html
SALT LAKE CITY - A federal grand jury returned an indictment Wednesday charging Charles Fredrick McCusker, age 62, of Salt Lake City, a licensed Utah psychologist, with health care fraud and mail fraud in connection with a health care fraud scheme the indictment alleges caused federal and private benefit programs to pay more than $1.3 million for services not provided to patients. The indictment alleges the conduct occurred from around 2007 to around August 2013.
The indictment, which includes 18 counts of health care fraud and 16 counts of mail fraud, follows a coordinated investigation by the FBI, the U.S. Health and Human Services’ Office of Inspector General, the Utah Insurance Fraud Division, the Utah Attorney General’s Office, and the U.S. Attorney’s Office. The indictment follows a state felony information filed on February 20, 2014, charging McCusker with 25 second degree felonies alleging identity fraud, insurance fraud, and pattern of unlawful conduct.
According to the indictment, McCusker conducted business as Health Balance International and New Life Balance in Salt Lake City.
The indictment alleges McCusker executed a scheme to defraud health care benefit programs by billing private insurers and government health care programs for services not provided to patients, resulting in payments to which he was not entitled.
McCusker, the indictment alleges, obtained health insurance information from patients under the guise that he would bill health care benefit programs only for services actually provided. As further steps in the scheme to defraud, McCusker did not meet at all with some patients nor did he provide any follow up services. Despite that fact, the indictment alleges, McCusker fraudulently billed patients’ health care programs for services he did not provide.
In other instances, McCusker met with a patient only once and provided no follow up services. Despite that fact, the indictment alleges, McCusker falsely billed the patients’ health care benefit programs for follow up services not provided. On other occasions, McCusker provided services to patients on several occasions but fraudulently billed these patients’ health care benefit programs for numerous additional services not provided.
According to the indictment, McCusker fraudulently submitted claims to health care benefit programs seeking reimbursement for services he did not provide. Those claims were processed and paid by health care benefit programs.
A summons will be issued to McCusker to appear in federal court. The potential maximum penalty for each count of health care fraud is 10 years and the penalty for each mail fraud count is 20 years.
Indictments are not findings of guilt. Individuals charged in indictments are presumed innocent unless or until proven guilty in court.
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Source- http://www.justice.gov/usao/ma/news/2014/February/WilkingSpencerpleaPR.html
BOSTON - The former medical director of a Waltham-based home health agency pleaded guilty today for his role in a home health fraud scheme which cost Medicare over $27 million.
Dr. Spencer Wilking, 65, of Concord, pleaded guilty today before U.S. District Judge Joseph L. Tauro to health care fraud. Sentencing is scheduled for May 20, 2014. The statutory maximum penalty for the crime is 10 years in prison, three years of supervised release, a fine of $250,000 or twice the gross loss to the Medicare program or twice the gross gain to Wilking (whichever is greater), restitution to Medicare, forfeiture of any proceeds of the offense, and exclusion from the Medicare program.
From at least April 2011 through March 2012, Wilking was employed as the Medical Director for MJG Management Company, d/b/a At Home VNA (AHVNA), a home health agency located in Waltham. During this period, Wilking signed certifications and recertifications to provide AHVNA home health services to hundreds of Medicare beneficiaries who did not qualify for services under the Medicare program. To qualify for home health services under the Medicare program, the beneficiary had to be: (1) confined to his/her home, (2) in need of skilled nursing services, physical therapy, or speech therapy on an intermittent basis or occupational therapy on a continuing basis, and (3) under the care of the physician who established the plan of care for home health services.
Prior to initially certifying eligibility, Wilking had to document that he, or another qualified health care provider, had a “face-to-face encounter” with the beneficiary, which showed that the patient was homebound and in need of home health services. Despite these legal requirements, Wilking certified hundreds of Medicare beneficiaries for home health services by AHVNA, without conducting a “face-to-face encounter” with the beneficiary, the vast majority of whom were not referred to AHVNA by their primary care physician or another physician who had examined the patient. Instead, Wilking typically certified services after spending a minimal amount of time reviewing patient assessment forms that were prepared by AHVNA nurses and/or participating in brief discussions about the patients with the nurses and/or AHVNA’s Clinical Director, Janice Troisi. Had Wilking reviewed the patient files, he would have discovered that many of the files contained information demonstrating that many of the patients were not homebound because, for example, they worked, took vacations, and spent substantial time outside the home. The patient files also contained information demonstrating that many patients had not requested home health services and/or were not provided with skilled nursing services.
Wilking’s certifications and recertifications allowed AHVNA to bill Medicare Part A for payment for these home health services. In addition, Wilking, billed Medicare Part B for both the certifications and subsequent recertifications. During the relevant time period, Medicare paid AHVNA over $1 million for the services certified by Wilking where the patients had not had the required face to face encounter with a physician. In addition, during the same period, Medicare paid nearly $30,000 to Wilking for certifying and recertifying the patients. Finally, between April 2011 and April 2012, AHVNA paid Wilking approximately $42,000 to serve as the company’s medical director.
In September 2013, the owner of AHVNA Michael Galatis, 62, of Natick and the Clinical Director, Janice Troisi, 64, of Revere, were charged with conspiracy to commit health care fraud and 11 counts of health care fraud. Galatis was also charged with seven counts of money laundering. According to the indictment, between 2007 and 2012, Galatis and Troisi conspired to fraudulently induce the Medicare program to pay for home health care services that, by and large, the Medicare beneficiaries did not need nor want. They trained AHVNA nurses to recruit Medicare beneficiaries who lived in residential facilities for senior citizens by asking if they were insured by Medicare, and if so, if they would like to have a nurse visit them in their home. The indictment also alleges that they trained the nurses to manipulate the patients’ initial assessments to make it appear as though the patients qualified for home health services pursuant to Medicare’s guidelines, when that was often not the case. The home health certifications and plans of care were then signed by Wilking, who certified that the patients were homebound and in need of skilled services, when, in fact, the overwhelming majority of AHVNA’s patients were not homebound and did not need home health services. During the course of the conspiracy, AHVNA submitted more than $27 million in false and fraudulent claims to Medicare, and Medicare paid AHVNA more than $20 million.
Both Galatis and Troisi have entered not guilty pleas. If convicted, they each face up to 10 years in prison, three years of supervised release, a $250,000 fine or twice the gross loss to the Medicare program or twice the gross gain to the defendant (whichever is greater), restitution to Medicare, forfeiture of any proceeds of the offenses, and exclusion from the Medicare program.
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Source- http://www.justice.gov/opa/pr/2014/February/14-civ-200.html
Diagnostic Imaging Group (DIG) has agreed to pay a total of $15.5 million to resolve allegations that its diagnostic testing facility falsely billed federal and state health care programs for tests that were not performed or not medically necessary and by paying kickbacks to physicians. Assistant Attorney General for the Justice Department’s Civil Division Stuart F. Delery, U.S. Attorney for the District of New Jersey Paul J. Fishman and U.S. Attorney for the Eastern District of New York Loretta E. Lynch announced the settlement today.
DIG has agreed to pay $13.65 million to the federal government and an additional total of $1.85 million to New York and New Jersey. DIG operates a chain of diagnostic testing facilities through its subsidiary, Doshi Diagnostic Imaging Services, which is headquartered in Hicksville, N.Y. DIG previously operated chains in New Jersey and Florida through subsidiaries Doshi Diagnostic Imaging Services of New Jersey and Signet Diagnostic Imaging Services.
“When health care providers pay kickbacks and submit false claims to Medicare, they not only deplete the Medicare Trust Fund, they undermine the integrity of the health care system,” said Assistant Attorney General Delery. “The Justice Department will relentlessly pursue those who misuse federal health care funds for their own profit.”
“Health care providers who make decisions based on profit instead of medical need compromise patient safety and confidence,” said U.S. Attorney Fishman. “Unnecessary tests and the payment of kickbacks also siphon precious resources from our health care system. The settlement we’re announcing today is an appropriate response to these unacceptable practices.”
The settlement announced today resolves allegations that DIG submitted claims to Medicare, as well as the New Jersey and New York Medicaid Programs, for 3D reconstructions of CT scans that were never performed or interpreted. Additionally, DIG allegedly bundled certain tests on its order forms so that physicians could not order other tests without ordering the additional bundled tests, which were not medically necessary. Today’s settlement also resolves allegations that DIG paid kickbacks to physicians for the referral of diagnostic tests. According to the government, the kickbacks were in the form of payments that DIG made to physicians ostensibly to supervise patients who underwent nuclear stress testing. These payments allegedly exceeded fair market value and were, in fact, intended to reward physicians for their referrals.
“Patients deserve testing decisions based solely on medical need, not doctors’ pocketbooks,” said U.S. Attorney Lynch. “We will continue to work with our federal and state law enforcement partners to investigate vigorously allegations of fraud on federal programs like Medicare and to pursue those who seek to fraudulently deplete the Medicare Trust Fund.”
“Paying physicians for their referrals and submitting false claims to increase Medicare and Medicaid reimbursements – as was alleged in this case – simply cannot be tolerated,” said Inspector General of the U.S. Department of Health and Human Services Daniel R. Levinson. “Besides levying a hefty penalty, the settlement requires an independent organization to review Diagnostic Imaging Group’s claims for five years and to send reports to the government.”
The allegations resolved by today’s settlement were raised in three lawsuits filed under the qui tam, or whistleblower, provisions of the False Claims Act. The Act allows private citizens with knowledge of fraud to bring civil actions on behalf of the government and to share in any recovery. The three whistleblowers, Mark Novick, M.D., Rey Solano and Richard Steinman, M.D., will receive $ 1.5 million , $ 1.07 million and $ 209,250 , respectively, as part of today’s settlement.
This settlement illustrates the government’s emphasis on combating health care fraud and marks another achievement for the Health Care Fraud Prevention and Enforcement Action Team (HEAT) initiative, which was announced in May 2009 by Attorney General Eric Holder and Secretary of Health and Human Services Kathleen Sebelius. The partnership between the two departments has focused efforts to reduce and prevent Medicare and Medicaid financial fraud through enhanced cooperation. One of the most powerful tools in this effort is the False Claims Act. Since January 2009, the Justice Department has recovered a total of more than $19 billion through False Claims Act cases, with more than $13.4 billion of that amount recovered in cases involving fraud against federal health care programs.
This case was handled by the Civil Division of the Department of Justice, the U.S. Attorney’s Office for the District of New Jersey and the U.S. Attorney’s Office for the Eastern District of New York. The settlement is the culmination of an investigation conducted jointly by special agents of the Department of Health and Human Services Office of Inspector General and the FBI with contributions from the Railroad Retirement Board.
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Source- http://www.justice.gov/usao/flm/press/2014/Feb/20140225_Chun.html
Tampa, Florida – United States Attorney A. Lee Bentley, III announced today that a Florida-based physician, Dr. Steven Chun, has agreed to pay $750,000 to resolve allegations that he and his clinic billed Medicare for physician office visits that he did not perform.
The United States alleges that, between 2006 and 2011, Dr. Chun owned and operated a clinic, first in Sarasota and then in Bradenton, called Sarasota Pain Associates. The United States alleges that, beginning in 2006, Dr. Chun billed Medicare for office visits at the highest levels possible, falsely claiming to have conducted comprehensive examinations of patients with complex problems. In fact, those patients visited Sarasota Pain Associates for scheduled procedures for which Dr. Chun was paid. In addition to getting paid for those procedures, Dr. Chun billed and was paid by Medicare for examinations that he did not in fact perform.
"This settlement is a significant achievement by our Civil Division, which showed great determination in pursuing a troubling pattern of billing fraud," said U.S. Attorney A. Lee Bentley, III. "This case should send a message that we will not tolerate this kind of health care fraud in the Middle District of Florida."
"Count on my agency to aggressively pursue cases whether the target is a large corporation or a single provider," said Christopher B. Dennis, Special Agent in Charge of the U.S. Department of Health and Human Services Office of Inspector General Miami region. "Besides a significant payment, Dr. Chun has agreed to let an independent organization review his claims for three years and then report to the government."
The allegations covered by the settlement were raised in a lawsuit filed by Cathia Gavin and Penelope Thomas, who both formerly worked as nurses for Dr. Chun. The suit was filed under the qui tam or whistleblower provisions of the False Claims Act, which permit private parties to sue on behalf of the United States for the submission of false claims and to receive a share of any recovery. The False Claims Act authorizes the United States to intervene in such lawsuits and take over primary responsibility for settling or litigating them.
In addition to the $750,000 payment, Dr. Chun will enter into a three-year Integrity Agreement with the U.S. Department of Health and Human Services, Office of Inspector General. The agreement requires Dr. Chun to attend training courses provided by the Centers for Medicare and Medicaid Services and to conduct an independent external review of his coding, billing, and claims submission to federal health care programs.
This settlement illustrates the government’s emphasis on combating health care fraud. One of the most powerful tools in this effort is the False Claims Act. Since January 2009, the Justice Department has recovered a total of more than $17 billion through False Claims Act cases, with more than $12.2 billion of that amount recovered in cases involving fraud against federal health care programs.
The investigation of this matter reflects a coordinated effort among the Commercial Litigation Branch of the Justice Department’s Civil Division, the U.S. Attorney’s Office for the Middle District of Florida, and the U.S. Department of Health and Human Services’ Office of Inspector General.
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Source- http://www.justice.gov/usao/ias/news/2014/Twyner%20-%20Guilty%202-21-2014.html
DES MOINES, IA - The United States Attorney for the Southern District of Iowa, Nicholas A. Klinefeldt, announces that Lafayette James Twyner, Jr., age 64, a former doctor in Newton, Iowa, pleaded guilty in United States District Court on February 21, 2014, to one count of health care fraud and one count of illegal distribution of a schedule III controlled substance resulting in death, announced United States Attorney Nicholas A. Klinefeldt. If approved by the district court at sentencing, the plea agreement calls for Twyner to serve a total of 8 years of incarceration, which will include 5 years in prison and 3 years of home and/or community confinement.
“The illegal distribution and abuse of prescription drugs is a significant problem,” explained Klinefeldt. “Our office, and the federal, state, and local law enforcement agencies that assisted with this prosecution, take seriously our duty to protect the public from such practices,” he added.
Federal law permits doctors, pharmacists, and other health care professionals with U.S. Drug Enforcement Administration registrations to lawfully dispense controlled substances if they are doing so in the usual course of their professional practices and for a legitimate medical purpose, but makes it illegal for them to knowingly issue a prescription to someone who is abusing or diverting a drug.
The indictment, filed October 23, 2012, charges Twyner with prescribing controlled substances in a manner likely to cause, and that did cause, dependence, addiction, and in one case, death, as well as failing to change his prescribing practices, even after being made aware of obvious signs of patient drug abuse and diversion. Additionally, the indictment alleges he caused various insurance companies to be billed for prescriptions and services that were not for a legitimate medical purpose.
Twyner surrendered his registration to prescribe controlled substances to the U.S. Drug Enforcement Administration in April 2011, shortly after a federal search warrant was executed at the location of now-defunct Urgent Care Clinic in Newton, where he then practiced medicine. According to public records from the Iowa Board of Medicine, Twyner, who was first licensed in Iowa in 1976, surrendered his license to practice medicine in 2012, and agreed to pay a $10,000 fine. Twyner was cited by the Iowa Board of Medicine for “engaging in a pattern of willful and repeated violation of the laws and rules governing the practice of medicine in Iowa, placing patients at risk of serious harm, when he prescribed excessive controlled substances to numerous patients, including patients with known drug histories.”
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Source- http://www.justice.gov/opa/pr/2014/February/14-civ-187.html
Pharmaceutical company Endo Health Solutions Inc. and its subsidiary Endo Pharmaceuticals Inc. (Endo) have agreed to pay $192.7 million to resolve criminal and civil liability arising from Endo’s marketing of the prescription drug Lidoderm for uses not approved as safe and effective by the Food and Drug Administration (FDA), the Justice Department announced today. The resolution includes a deferred prosecution agreement and forfeiture totaling $20.8 million and civil false claims settlements with the federal government and the states and the District of Columbia totaling $171.9 million. Endo Pharmaceuticals Inc. is a Delaware corporation headquartered in Malvern, Pa.
“FDA’s drug approval process is designed to ensure that companies market their products for uses that are proven to be safe and effective,” said Assistant Attorney General for the Justice Department’s Civil Division Stuart F. Delery. “We will hold accountable those who circumvent that process in pursuit of financial gain.”
In a criminal information filed today in the Northern District of New York, the government charged that, between 2002 and 2006, Endo Pharmaceuticals Inc. introduced into interstate commerce Lidoderm that was misbranded under the Federal Food, Drug and Cosmetic Act (FDCA). The FDCA requires a company, such as Endo Pharmaceuticals Inc., to specify the intended uses of a product in its new drug application to the FDA. Once approved, a drug may not be introduced into interstate commerce for unapproved or “off-label” uses until the company receives FDA approval for the new intended uses. During the period of 2002 to 2006, Lidoderm was approved by the FDA only for the relief of pain associated with post-herpetic neuralgia (PHN), a complication of shingles. The information alleges that, during the relevant time period, the Lidoderm distributed nationwide by Endo Pharmaceuticals Inc. was misbranded because its labeling lacked adequate directions for use in the treatment of non-PHN related pain, including low back pain, diabetic neuropathy and carpal tunnel syndrome. These uses were intended by Endo Pharmaceuticals Inc. but never approved by the FDA. The information further alleges that certain Endo Pharmaceuticals Inc. sales managers provided instruction to certain sales representatives concerning how to expand sales conversations with doctors beyond PHN and encouraged promotion of Lidoderm in workers’ compensation clinics.
In a deferred prosecution agreement to resolve the charge, Endo Pharmaceuticals Inc. admitted that it intended that Lidoderm be used for unapproved indications and that it promoted Lidoderm to health care providers for those unapproved indications. Under the terms of the deferred prosecution agreement, Endo Pharmaceuticals Inc. will pay a total of $20.8 million in monetary penalties and forfeiture. Endo Pharmaceuticals Inc. further agreed to implement and maintain a number of enhanced compliance measures, including making publicly available the results of certain clinical trials and requiring an annual review and certification of its compliance efforts by the Chief Executive Officer of its parent company, Endo Health Solutions. The deferred prosecution agreement will not be final until accepted by the U.S. District Court for the Northern District of New York.
“The safety and efficacy of drugs must be shown by science, not sales pitches,” said U.S. Attorney for the Northern District of New York Richard S. Hartunian. “Drugs marketed for intended uses not approved by the FDA are misbranded because their labeling lacks adequate directions for those uses. This settlement emphasizes that public health is protected by labeling based on product performance, rather than profitability, and promotes enhanced efforts to ensure compliance with all requirements.”
In addition, Endo agreed to settle its potential civil liability in connection with its marketing of Lidoderm. The government alleged that, from March 1999 through December 2007, Endo caused false claims to be submitted to federal health care programs, including Medicaid, a jointly funded federal and state program, by promoting Lidoderm for unapproved uses, some of which were not medically accepted indications and, therefore, were not covered by the federal health care programs. Of the $171.9 million Endo has agreed to pay to resolve these civil claims, Endo will pay $137.7 million to the federal government and $34.2 million to the states and the District of Columbia.
“Off-label marketing can undermine the doctor-patient relationship and adversely influence the clear and honest judgment of doctors that their patients rely on and trust,” said U.S. Attorney for the Eastern District of Pennsylvania Zane D. Memeger. “Pharmaceutical companies have a legal obligation to promote their drugs for only FDA-approved uses. This obligation takes precedence over the company’s bottom line.”
“The settlement announced today demonstrates the government’s continued scrutiny of pharmaceutical companies that interfere with FDA’s mission of ensuring that drugs are safe and effective for the American public,” said Special Agent in Charge of the FDA’s Office of Criminal Investigations’ New York Field Office Mark Dragonetti. “We will continue to work with our law enforcement partners to investigate and prosecute pharmaceutical companies that disregard the drug approval process and jeopardize the public health by engaging in the nationwide distribution of misbranded products.”
“Endo Pharmaceutical enriched themselves at the expense of the public,” said Special Agent in Charge Andrew W. Vale of the Albany Division of the Federal Bureau of Investigation. “Patients will search for drug therapies to assist in pain management, and they deserve the right to drugs approved for such use. The FBI will continue to work with our federal partners to investigate companies such as Endo Pharmaceuticals to ensure patients are safe.”
Also as part of the settlement, Endo Pharmaceuticals Inc. has agreed to enter into a Corporate Integrity Agreement (CIA) with the Department of Health and Human Services Office of Inspector General that requires Endo to implement measures designed to avoid or promptly detect conduct similar to that which gave rise to this resolution. Among other things, the CIA requires Endo to implement an internal risk assessment and mitigation program and requires numerous internal and external reviews of promotional and other practices. The CIA also requires key executives and individual board members to sign certifications about compliance, and it requires the company to publicly report information about its financial arrangements with physicians.
“By marketing Lidoderm for uses not covered by federal health care programs, Endo profited at the expense of taxpayers and could have put patients at risk,” said Inspector General of the U.S. Department of Health and Human Services Daniel R. Levinson. “Under our CIA, Endo agrees to promote its products legally, while board members and top executives are specifically held accountable for compliance.”
The civil settlement resolves three lawsuits pending in federal court in the Eastern District of Pennsylvania under the qui tam, or whistleblower, provisions of the False Claims Act, which allow private citizens to bring civil actions on behalf of the government and to share in any recovery. The actions were filed by Peggy Ryan, a former Lidoderm sales representative, Max Weathersby, another former Lidoderm sales representative and Gursheel S. Dhillon, a physician. The whistleblowers’ share of the settlement has not been determined.
This settlement illustrates the government’s emphasis on combating health care fraud and marks another achievement for the Health Care Fraud Prevention and Enforcement Action Team (HEAT) initiative, which was announced in May 2009 by Attorney General Eric Holder and Secretary of Health and Human Services Kathleen Sebelius. The partnership between the two departments has focused efforts to reduce and prevent Medicare and Medicaid financial fraud through enhanced cooperation. One of the most powerful tools in this effort is the False Claims Act. Since January 2009, the Justice Department has recovered a total of more than $19 billion through False Claims Act cases, with more than $13.4 billion of that amount recovered in cases involving fraud against federal health care programs.
The civil settlement was handled by the U.S. Attorney’s Office for the Eastern District of Pennsylvania and the Civil Division’s Commercial Litigation Branch. The criminal case was handled by the U.S. Attorney’s Office for the Northern District of New York and the Civil Division’s Consumer Protection Branch. These matters were investigated by the Federal Bureau of Investigation, the Food and Drug Administration Office of Criminal Investigation, the Department of Health and Human Services Office of Inspector General Office of Investigations, the Defense Criminal Investigative Service of the Department of Defense, the U.S. Postal Service Office of Inspector General and the Office of Personnel Management Office of Inspector General with assistance from the Department of Health and Human Services Office of Counsel to the Inspector General and Office of General Counsel and Center for Medicare and Medicaid Services, the Food and Drug Administration’s Office of Chief Counsel and the National Association of Medicaid Fraud Control Units.
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