Novo Nordisk Agrees to Pay $58 Million for Failure to Comply with FDA-Mandated Risk Program

Tuesday, September 5, 2017

Payments Resolve Allegations Highlighted in DOJ Civil Complaint and Recently Unsealed Whistleblower Actions

Pharmaceutical Manufacturer Novo Nordisk Inc. will pay $58.65 million to resolve allegations that the company failed to comply with the FDA-mandated Risk Evaluation and Mitigation Strategy (REMS) for its Type II diabetes medication Victoza, the Justice Department announced today. The resolution includes disgorgement of $12.15 million for alleged violations of the Federal Food, Drug, and Cosmetic Act (FDCA) from 2010 to 2012 and a payment of $46.5 million for alleged violations of the False Claims Act (FCA) from 2010 to 2014. Novo Nordisk is a subsidiary of Novo Nordisk U.S. Holdings Inc., which is a subsidiary of Novo Nordisk A/S of Denmark. Novo Nordisk’s U.S. headquarters is in Plainsboro, New Jersey.

“Today’s resolution demonstrates the Department of Justice’s continued commitment to ensuring that drug manufacturers comply with the law,” said Acting Assistant Attorney General Chad A. Readler of the Justice Department’s Civil Division. “When a drug manufacturer fails to share accurate risk information with doctors and patients, it deprives physicians of information vital to medical decision-making.”

In a civil complaint filed today in the U.S. District Court for the District of Columbia asserting claims under the FDCA, the government alleged that, at the time of Victoza’s approval in 2010, the Food and Drug Administration (FDA) required a REMS to mitigate the potential risk in humans of a rare form of cancer called Medullary Thyroid Carcinoma (MTC) associated with the drug. The REMS required Novo Nordisk to provide information regarding Victoza’s potential risk of MTC to physicians. A manufacturer that fails to comply with the requirements of the REMS, including requirements to communicate accurate risk information, renders the drug misbranded under the law.

As alleged in the complaint, some Novo Nordisk sales representatives gave information to physicians that created the false or misleading impression that the Victoza REMS-required message was erroneous, irrelevant, or unimportant. The complaint further alleges that Novo Nordisk failed to comply with the REMS by creating the false or misleading impression about the Victoza REMS-required risk message that violated provisions of the FDCA and led some physicians to be unaware of the potential risks when prescribing Victoza.

As alleged in the government’s complaint, after a survey in 2011 showed that half of primary care doctors polled were unaware of the potential risk of MTC associated with the drug, the FDA required a modification to the REMS to increase awareness of the potential risk. Rather than appropriately implementing the modification, the complaint alleges that Novo Nordisk instructed its sales force to provide statements to doctors that obscured the risk information and failed to comply with the REMS modification. Novo Nordisk has agreed to disgorge $12.15 million in profits derived from its unlawful conduct in violation of the FDCA.

“Novo Nordisk’s actions unnecessarily put vulnerable patients at risk,” said U.S. Attorney Channing D. Phillips for the District of Columbia. “We are committed to holding companies accountable for violating the integrity of the FDA’s efforts to ensure that doctors and patients have accurate information that allows them to make appropriate decisions about which drugs to use in their care. Working with the FDA and other law enforcement partners, we have sent a strong signal to the drug industry today.”

“Novo Nordisk Inc. sales representatives misled physicians by failing to accurately disclose a potential life threatening side effect of a prescription drug, and needlessly increased risks to patients being treated with this drug,” said Assistant Director in Charge Andrew W. Vale of the FBI’s Washington Field Office. “The FBI is committed to ensuring that the private industry provides honest and accurate risk information to the public and will continue to work closely with our law enforcement partners to investigate companies who do not comply with FDA-mandated policies.”

“We need to trust that pharmaceutical companies truthfully represent their products’ potential risks,” said Special Agent in Charge Nick DiGiulio for the U.S. Department of Health and Human Services Office of the Inspector General (HHS-OIG). “We will continue to work with our partners to ensure federal health care dollars are spent only on drugs that are marketed honestly.”

Novo Nordisk will pay an additional $46.5 million to the federal government and the states to resolve claims under the FCA and state false claims acts. This portion of the settlement resolves allegations that Novo Nordisk caused the submission of false claims from 2010 to 2014 to federal health care programs for Victoza by arming its sales force with messages that could create a false or misleading impression with physicians that the Victoza REMS-required message about the potential risk of MTC associated with Victoza was erroneous, irrelevant, or unimportant and by encouraging the sale to and use of Victoza by adult patients who did not have Type II diabetes. The Food and Drug Administration (FDA) has not approved Victoza as safe and effective for use by adult patients who do not have Type II diabetes.

As a result of today’s FCA settlement, the federal government will receive $43,129,026 and state Medicaid programs will receive $3,320,963. The Medicaid program is funded jointly by the state and federal governments.

The FCA settlement resolves seven lawsuits filed under the whistleblower provision of the federal FCA, which permits private parties to file suit on behalf of the United States for false claims and share in a portion of the government’s recovery. The civil lawsuits are captioned as follows: United States, et al. ex rel. Kennedy, v. Novo A/S, et al., No. 13-cv-01529 (D.D.C.), United States, et al. ex rel. Dastous, et al. v. Novo Nordisk, No. 11-cv-01662 (D.D.C), United States, et al., ex rel. Ferrara and Kelling v Novo Nordisk, Inc., et al., No. 1:11-cv-00074 (D.D.C.), United States, et al., ex rel. Myers v. Novo Nordisk, Inc., No. 11-cv-1596 (D.D.C.), United States, et al. ex rel Stepe v. Novo Nordisk, Inc., No. 13-cv-221 (D.D.C.), United States et al. ex rel Doe, et al. v. Novo Nordisk, Inc., et al., No. 1:17-00791 (D.D.C.), and United States ex rel. Smith, et al. v. Novo Nordisk, Inc., Civ. Action No. 16-1605 (D.D.C.). The amount to be recovered by the private parties has not been determined.

The settlements were the result of a coordinated effort among the U.S. Attorney’s Office for the District of Columbia and the Civil Division’s Consumer Protection Branch and Commercial Litigation Branch, with assistance from the FDA’s Office of Chief Counsel. The investigation was conducted by the FDA’s Office of Criminal Investigations, the FBI, HHS-OIG, the Defense Criminal Investigative Service and the Office of Personnel Management, Office of the Inspector General.

For more information about the Consumer Protection Branch and its enforcement efforts, visit its website at http://www.justice.gov/civil/consumer-protection-branch. For more information on the Commercial Litigation Branch’s Fraud Section, visit https://www.justice.gov/civil/fraud-section. For more information about the U.S. Attorney’s Office for the District of Columbia, visit https://www.justice.gov/usao-dc.

CEO Indicted For Wire Fraud And Aggravated Identity Theft

Thursday, August 10, 2017

Greenbelt, Maryland – A federal grand jury has indicted Zheng Geng, a/k/a “Jason Geng”, age 59, of Vienna, Virginia, on charges related to a scheme to defraud the United States. The indictment was returned on August 9, 2017, and unsealed today upon the arrest of Geng. Geng is the Chief Executive Officer of Xigen LLC (Xigen), which has offices in Maryland and Virginia.

The indictment was announced by Acting United States Attorney for the District of Maryland Stephen M. Schenning; Inspector General Paul Martin of the National Aeronautics and Space Administration Office of Inspector General; Inspector General Allison Lerner of the National Science Foundation Office of Inspector General; Special Agent in Charge Nick DiGiulio of the Health and Human Services Office of Inspector General; Special Agent in Charge Gordon Thompson of the U.S. Postal Service Office of Inspector General; and Special Agent in Charge Gordon B. Johnson of the Federal Bureau of Investigation, Baltimore Field Office.

According to the six-count indictment, Geng devised a scheme between 2005 to 2016 to defraud the United States by submitting false and fraudulent grant applications under the Small Business Innovation Research (SBIR) Program. The SBIR program aims to stimulate United States technological innovation. A further aim is to foster and encourage participation in technical innovation by socially and economically disadvantaged small businesses that in some instances are at least 51-percent owned and controlled by women. Geng prepared materially fraudulent proposals for awards, subsequent reports, and related communications under the programs.

To support the applications, Geng submitted endorsements for his grant applications using the identities of people without their permission, or misrepresenting their positions within Xigen. In addition, he submitted endorsements that misrepresented active affiliations with various universities including, Harvard University Medical School and Johns Hopkins University School of Medicine, and budgeted funds for subcontractors without their knowledge and without providing them with budgeted funds. With this false information, the United States government approved SBIR program awards and grants through the Department of Health and Human Service’s National Institutes of Health and the National Aeronautics and Space Administration. The awards totaled over $1.8 million.

According to court documents, Geng used the rewarded funds for his own personal use and the use of his family members and associates.

“The NASA Office of Inspector General will continue to aggressively investigate those who undermine and defraud NASA programs and operations,” said Inspector General Martin. “The NASA OIG appreciates the efforts of the entire investigative and prosecution team during this multi-year investigation, and we look forward to continued cooperation with our law enforcement partners in this and related matters.”

Allison Lerner, Inspector General for the National Science Foundation said, “The SBIR program is a valuable tool for advancing promising new technologies. My office will continue to vigorously pursue attempts to defraud scarce research dollars intended to promote economic growth through innovative SBIR investments.”

“The United States Department of Health and Human services provides research grant funds to qualified small businesses; we cannot tolerate the theft of taxpayer funds meant for honest research projects” said Nick DiGiulio, Special Agent in Charge for the Inspector General’s Office of the US Department of Health and Human Services.

Geng faces a maximum sentence of 20 years in prison and a $250,000 fine for wire fraud and a 2-year mandatory minimum consecutive sentence for each of the aggravated identity theft charges.

An indictment is not a finding of guilt. An individual charged by indictment is presumed innocent unless and until proven guilty at some later criminal proceedings.

Acting United States Attorney Stephen M. Schenning commended the NASA Office of Inspector General, the National Science Foundation Office of Inspector General, the HHS Office of Inspector General, U.S. Postal Service Office of Inspector General and the FBI for their work in the investigation. Mr. Schenning thanked Assistant U.S. Attorneys Phil Selden and Jennifer Sykes, who are prosecuting the case and Assistant U.S. Attorney David Salem who also helped investigate this case.

Contact ELIZABETH MORSE at (410) 209-4885

www.justice.gov/usao/md       

Woman Pleads Guilty to Medicaid Fraud and Identity Theft Charges

Wednesday, August 9, 2017

A Richmond woman pleaded guilty today healthcare fraud and aggravated identity theft.

According to court documents, Chermeca Harris, 36, was a Medicaid beneficiary and would misrepresent her health condition to health care providers, such as hospitals and ambulance services, in order to obtain health care benefits. Specifically, Harris would falsely represent that she was suffering from sickle cell anemia and was having a sickle cell crisis in order to obtain pain killing drugs, such as dilaudid, which she wanted to receive intravenously through the neck. In fact, doctors tested Harris in January 2016, and determined she did not have sickle cell anemia. The hospitals involved were Virginia Commonwealth University Medical Center, Chippenham, Bon Secours St. Mary’s, Memorial Regional, John Randolph Medical Center, and Henrico Doctor’s. According to court documents, it was a further part of the scheme that Harris also falsely represented her identity. On some occasions she used the name of M.M., and on other occasions she used the name of R.J.; both Medicaid recipients. She also falsely stated to investigating federal agents that her name was M.M. and that she had sickle cell anemia.

Harris was charged as part of the largest ever health care fraud enforcement action by the Medicare Fraud Strike Force, involving 412 charged defendants across 41 federal districts, including 115 doctors, nurses and other licensed medical professionals, for their alleged participation in health care fraud schemes involving approximately $1.3 billion in false billings. Of those charged, over 120 defendants, including doctors, were charged for their roles in prescribing and distributing opioids and other dangerous narcotics. Thirty state Medicaid Fraud Control Units also participated in today’s arrests. In addition, HHS has initiated suspension actions against 295 providers, including doctors, nurses and pharmacists.

Harris pleaded guilty to healthcare fraud on the Medicaid program and aggravated identity theft. She faces a mandatory minimum of two years in prison and a maximum penalty of 12 years in prison, when sentenced on October 26. Actual sentences for federal crimes are typically less than the maximum penalties. A federal district court judge will determine any sentence after taking into account the U.S. Sentencing Guidelines and other statutory factors.

Dana J. Boente, U.S. Attorney for the Eastern District of Virginia; Adam S. Lee, Special Agent in Charge of the FBI’s Richmond Field Office; and Nick DiGiulio, Special Agent in Charge, Philadelphia Regional Office of Inspector General of Department of Health and Human Services, made the announcement after the plea was accepted by Magistrate Judge David J. Novak. Assistant U.S. Attorney David T. Maguire is prosecuting the case.

A copy of this press release is located on the website of the U.S. Attorney’s Office for the Eastern District of Virginia. Related court documents and information is located on the website of the District Court for the Eastern District of Virginia or on PACER by searching for Case No. 3:17-cr-77.

Denver Woman Sentenced To 46 Months’ Imprisonment For Health Care Fraud

Wednesday, July 26, 2017

HARRISBURG- The United States Attorney’s Office for the Middle District of Pennsylvania announced that Tammie Sensenig, age 46, of Denver, Pennsylvania was sentenced July 25, 2017, by United States District Court Judge William C. Caldwell to serve 46 months’ imprisonment for health care fraud.

According to United States Attorney Bruce D. Brandler, as a result of prior convictions relating to Medicaid fraud, Sensenig was excluded from providing healthcare to Medicaid beneficiaries. In order to obtain a position as a behavioral health consultant, Sensenig made false representations, including a forged background check, in order to hide her ineligible status. As a result, Medicaid paid approximately $84,500 for her services.

“We are pleased that Sensenig will be spending over three and a half years in prison”, said Nick DiGiulio, Special Agent in Charge of the Inspector General’s Office for the U.S. Department of Health and Human Services. “And we will continue to do whatever it takes to keep criminals out of our health care system and to return stolen funds to our benefit programs.”

The charges were the result of an investigation conducted by the Pennsylvania Office of Attorney General Medical Fraud Control Section and United States Department of Health and Human Services Office of Inspector General. Assistant U.S. Attorney Chelsea Schinnour prosecuted the case.

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Three Sentenced for Roles in Healthcare Conspiracy

Thursday, July 13, 2017

Deborah Branch, Bryan Harr, Melissa Harr Will All Serve Time in Federal Prison

Abingdon, VIRGINIA – Three Bristol, Virginia residents, who were previously convicted of healthcare fraud, were sentenced today in Federal Court, Acting United States Attorney Rick A. Mountcastle, Virginia Attorney General Mark R. Herring and Nick DiGiulio, Special Agent in Charge, Philadelphia Regional Office for U.S. Health and Human Services – Office of Inspector General announced.

Deborah Branch, 65, was sentenced today to 72 months in federal prison. In a pair of separate hearings today, Bryan Harr, 41, was sentenced to 48 months in federal prison and Melissa Harr, 49, was sentenced to 48 months in federal prison. The three previously pled guilty to federal healthcare conspiracy charges. Branch additionally pled guilty to wire fraud.

“This case shows that fraud committed against our federal and state health care benefit programs is more than just simple theft of government money, there is a sinister side to the greed that fuels the criminal acts of defendants like these,” Acting United States Attorney Mountcastle said today. “This type of greed brings physical and emotional devastation upon the innocent, vulnerable victims for whom essential services are denied, simply to satiate the greed of these defendants. In this case, children were forced to live in filth in a room without electricity. The United States Attorney’s Office, and our partners at the Virginia Attorney General’s Office, Health and Human Services and others, will continue to aggressively pursue fraudsters, like Branch and the Harrs, whose criminal actions bring harm to vulnerable victims.”

“Anyone who diverts public funds for their private benefit is stealing from all of us and undermining an important system that provides thousands of Virginians with needed medical services,” said Attorney General Mark Herring. “A situation where people steal that money at the expense of their own disabled child is even more horrifying and unacceptable, and I’m glad to see these criminals brought to justice today. My award-winning Medicaid Fraud Unit and I will be relentless in holding accountable those who try to take advantage of our health care system.”

“It is shocking to imagine parents who would for many years neglect their disabled child and allow him to suffer horribly while they worked to steal taxpayer money meant to pay for the child’s much needed care,” said Special Agent in Charge Nick DiGiulio of the United States Department of Health and Human Services, Office of Inspector General. “We are satisfied that justice was served today, and we will continue to work with our law enforcement partners to jail heartless criminals who prey on beneficiaries and our health care system.”

According to evidence presented at previous hearings, Bryan Harr Sr. and his wife, Melissa Harr, hired Branch to work with one of their children, who suffers from intellectual and physical disabilities and who qualifies for services paid for by Virginia Medicaid, including personal assistance, respite and residential support services. These services are available to qualified individuals pursuant to Virginia Medicaid’s Intellectual Disability (ID) waiver program. The ID waiver program is designed to provide critical services that enable a recipient to remain at home instead of being placed in an institution. Recipients or their guardians are permitted to hire workers of their own choosing to provide these services, which are paid for by Virginia Medicaid. Branch was paid through two different Virginia Medicaid contractors: Public Partnerships, LLC and ResCare (formerly known as Creative Family Solutions).

From January 2010 until September 2015, Branch, with the knowledge of Melissa Harr and Bryan Harr Sr., submitted time sheets claiming Branch was providing services for Harr’s disabled son when she was not. In exchange for assisting Branch in being paid for work she did not do, Branch paid the Harrs approximately $200 every two weeks. Virginia Medicaid’s Department of Medical Assistance Services (DMAS) paid out $350,641.02 to the contractors based on these time sheets, of which $207,854.43 was paid to Branch. More importantly, the Harr’s disabled son did not receive the services he legitimately needed pursuant to the ID waiver program.

The investigation of the case was conducted by the Medicaid Fraud Control Unit of the Virginia Attorney General’s Office, the U.S. Department of Health and Human Services Office of Inspector General, and the Bristol Virginia Police Department. Special Assistant United States Attorney Janine M. Myatt, a Virginia Assistant Attorney General, prosecuted the case for the United States.

Defunct Philly Hospice’s Owners/Operators to Pay Millions to Settle Civil False Claims Suit

Thursday, July 6, 2017

PHILADELPHIA – Acting United States Attorney Louis D. Lappen announced today that Matthew Kolodesh, Alex Pugman, Svetlana Ganetsky, and Malvina Yakobashvili have agreed to pay millions of dollars to settle False Claims Act allegations that they and their now-defunct company, Home Care Hospice, Inc. (HCH), falsely claimed and received taxpayer dollars for hospice services that were either unnecessary or never provided. Previously, a federal jury found Kolodesh guilty on, and Pugman and Ganetsky pleaded guilty to, related criminal charges.

Kolodesh was HCH’s de facto co-owner; Pugman was HCH’s Executive Director and co-owner; Ganetsky was HCH’s Development Executive; and Yakobashvili was HCH’s CEO and President. Kolodesh and Yakobashvili are husband and wife, as are Pugman and Ganetsky.

The civil settlements with Kolodesh, Pugman, and Ganetsky specifically resolve False Claims Act allegations that HCH and they, between January 2003 and September 2008: knowingly submitted false claims and records (including fabricated records) to Medicare for purported hospice care for patients who were not terminally ill and thus not eligible for the Medicare hospice benefit; and/or knowingly submitted or caused the submission of false claims and records (including fabricated records) to Medicare for crisis care services that were not necessary or not actually provided; and, as a result of this conduct, violated the False Claims Act and cost the Medicare Program millions of dollars. The settlements with these defendants, as well as Yakobashvili, also resolve federal common law allegations that all five defendants were unjustly enriched as a result of such conduct.

As part of the settlements, the United States will retain the full value of multiple financial accounts that were restrained in a related civil injunction action filed by the United States in the Eastern District of Pennsylvania. The estimated current value of those interests is approximately $8.8 million. The defendants have further agreed: (1) to make cash payments to the government ($400,000 from Pugman and Ganetsky, and $425,000 from Kolodesh and Yakobashvili); and (2) to transfer to the United States various assets, including Pugman’s and Kolodesh’s interests in condominium properties that they co-own.

Under qui tam (whistleblower) provisions of the federal False Claims Act, certain private citizens may bring civil actions on behalf of the United States and may share in any recovery. This suit was originally filed on behalf of the United States by Maureen Fox and Cathy Gonzales, former HCH employees who discovered the alleged fraud. The settlements announced today include False Claims Act whistleblower awards for Ms. Gonzales and for the Estate of Ms. Fox, who passed away after filing suit.

As the result of the United States’ related criminal investigation, 22 persons employed by or associated with HCH were criminally convicted in the Eastern District of Pennsylvania.

“The Medicare hospice benefit is intended to provide patients nearing the end of life with pain management and other palliative care to make them as comfortable as possible,” Lappen said. “Too often, however, we hear reports of companies that abuse this critical service by enrolling patients who do not qualify for the hospice benefit, do not provide claimed services, or who push patients into services they don’t need in order to get higher government reimbursements. The Department of Justice, including this office, will take swift action to protect the public welfare and taxpayer dollars and to make sure that Medicare benefits are available to those truly in need.”

“Medicare, a crucial component of our nation’s health care system, draws from a finite pool of funds,” said Michael Harpster, Special Agent in Charge of the FBI’s Philadelphia Division. “The defendants siphoned money earmarked for dying patients’ hospice care, and built their bank accounts on taxpayers’ backs. The FBI will continue to investigate and hold accountable those defrauding the U.S. government.”

“Today’s settlement returns over $8 million to our nation’s Medicare program. This money was wrongfully paid as a result of fraudulent billings and part of a massive criminal conspiracy that preyed on a program that comforts beneficiaries at the end of their lives,” said Nick DiGiulio, Special Agent in Charge of the Inspector General’s Office of the United Stated Department of Health and Human Services in Philadelphia. “In addition to this civil settlement, this investigation resulted in the criminal prosecution of 22 individuals for health care fraud or other charges. We will continue to work with our law enforcement partners and the dedicated federal prosecutors in the Eastern District of Pennsylvania to use every available tool to jail those who steal from federal health care programs and recoup cash and assets illegally acquired.”

The case was investigated by the Office of Inspector General of the U.S. Department of Health and Human Services (HHS), and the Organized Crime Section of the Federal Bureau of Investigation. The civil case was handled at the U.S. Attorney’s Office by Assistant United States Attorneys Eric D. Gill, Gerald B. Sullivan, and Colin C. Cherico. Assistance was provided by the HHS Office of Counsel to the Inspector General and the Commercial Litigation Branch of the U.S. Department of Justice’s Civil Division.

The civil claims asserted against HCH, Kolodesh, Pugman, Ganetsky, and Yakobashvili are allegations only, and there has been no determination of civil liability. The civil qui tam suit is docketed in the Eastern District of Pennsylvania as U.S.A. et al. ex rel. Fox and Gonzales v. Home Care Hospice, Inc, et al., No. 06-cv-4679.

The Eastern District of Pennsylvania is one of 10 federal districts that formed an Elder Justice Task Force as a part of the U.S. Department of Justice’s Elder Justice Initiative. (The office announced its task force here in March 2016, and maintains a publicly accessible website here.) The task force seeks to enhance government protection of vulnerable, elderly Pennsylvanians from harm and to ensure the integrity of government health care spending.

U.S. Renal Care to Pay $7.3 Million to Resolve False Claims Act Allegations

U.S. Renal Care, headquartered in Plano, Texas, has agreed to pay $7.3 million to resolve allegations that Dialysis Corporation of America (DCA) violated the False Claims Act by submitting false claims to the Medicare program for more Epogen than was actually administered to dialysis patients at DCA facilities, the Justice Department announced today.  U.S. Renal Care, which acquired DCA in June 2010, owns and operates more than 100 freestanding outpatient dialysis facilities throughout the United States.

Epogen is an intravenous medication that is used to treat anemia, a common condition afflicting patients with end-stage renal disease.  Epogen vials contain a small amount of medication in excess of the labeled amount, known as “overfill,” to compensate for medication that may remain in the vial after extraction and in the syringe upon administration.  The United States contends that from January 2004 through May 2011, DCA billed for 10-11% overfill whenever it administered Epogen.  However, because of the types of syringes DCA used, the United States alleges that DCA was not able to withdraw and administer 10-11% overfill every time it administered Epogen to patients, and thus submitted false claims to Medicare that overstated the amount of Epogen that it was actually providing.

“Today’s settlement shows that the Justice Department will aggressively pursue those health care providers who cut corners at the expense of the American taxpayers, such as by billing for items and services that were not provided,” said Stuart F. Delery, Acting Assistant Attorney General for the Justice Department’s Civil Division.  “We will continue to protect scarce Medicare dollars.”

“Medical care providers who submit false claims for services and products that were not actually delivered threaten the financial viability of the Medicare Trust Fund,” said Rod J. Rosenstein, U.S. Attorney for the District of Maryland.

“Health providers billing for phantom services cheat taxpayers, cheat programs straining to pay for vitally needed care, and cheat patients who pay inflated copayments,” said Nick DiGiulio, Special Agent in Charge, Office of Inspector General, U.S. Department of Health and Human Services for the region including Maryland.  “We will continue to work with the Department of Justice to ensure health professionals get reimbursed only for services they actually provide”

This resolution is part of the government’s emphasis on combating health care fraud and another step for the Health Care Fraud Prevention and Enforcement Action Team (HEAT) initiative, which was announced by Attorney General Eric Holder and Kathleen Sebelius, Secretary of the Department of Health and Human Services in May 2009. 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 that effort is the False Claims Act, which the Justice Department has used to recover $10.2 billion since January 2009 in cases involving fraud against federal health care programs. The Justice Department’s total recoveries in False Claims Act cases since January 2009 are over $14.2 billion.

The allegations settled today arose from a lawsuit filed by Laura Davis against DCA 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 United States and share in any recovery.  Ms. Davis will receive $1,314,000 as part of today’s settlement.

This case was handled by the Civil Division of the Department of Justice and the U.S. Attorney’s Office for the District of Maryland with assistance from the Office of Inspector General for the Department of Health and Human Services.  The claims settled by this agreement are allegations only, and there has been no determination of liability.  The whistleblower suit is captioned United States ex rel. Laura Davis v. Dialysis Corporation of America, No. 1:08-cv-2829 (D. Md.).