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Compliance National & Local News |
The
Office of Inspector General and other government agencies continue
to actively investigate areas of reported non-compliance. Being
aware of government auditing trends is beneficial in determining
areas for the OU Billing Compliance Office to focus on during
in-house audits. The findings of government investigations are
published on-line for public viewing.
Pharmaceutical Company to Plead Guilty to Off-Label Marketing and Kickbacks
Published on line 02/042010
Swiss drug maker Novartis has said it will plead guilty to criminal fraud charges related to the company's off-label promotion of the epilepsy drug Trileptal, and will pay a $185 million fine. Novartis' Trileptal problems are only part of the equation, however; Novartis is also being investigated for kickbacks and off-label marketing related to Diovan, Exforge, Sandostatin, Tekturna and Zelnorm. Novartis has said that it has increased its litigation reserve from $318 million to $397 million.
Also on the watch list, due to questionable marketing practices are GlaxoSmithKline, Forest Laboratories, and AstraZeneca. Each pharmaceutical company has increased their litigation reserve between $170 million to $500 million in preparation to settle off-label and kickback cases.
Michigan Health Care System Pays $669,413 to Settle False Claims Allegations
Published on line 01/042010
Genesys Health System has agreed to pay the United States $669,413 to settle a lawsuit alleging that the health care provider violated the False Claims Act by submitting false claims to Medicare. The United States Department of Justice alleged that between 2001 and 2007, Genesys violated the False Claims Act by billing Medicare for higher levels of service than were actually rendered to patients. Specifically, the government alleged that Genesys overbilled for evaluation and management services provided to cardiology patients.
This
case demonstrates the federal government, through investigative offices such as the Department of Justice, are committed to vigorously pursuing those who defraud Medicare. The allegations resolved by today’s settlement were initiated by a lawsuit filed under the qui tam or whistleblower provisions of the False Claims Act.
"With the rising cost of health care and the related pressure on the Medicare Trust Fund, the last thing our nation can afford are providers who are profiteering at the expense of patients," said Terrence Berg, U.S. Attorney for the Eastern District of Michigan. The federal government, in this case, considers upcoding of evaluation and management services as profiteering.
To access the entire press notice, please click on Michigan DOJ Release
University Pays Fine Under Civil Monetary Penalties Law
Published on line 12/15/2009
University Pediatricians, Michigan, self-disclosed conduct to the Office of Inspector General (OIG) which resulted in an agreement to pay $91,782.50 for allegedly violating the Civil Monetary Penalties Law. The OIG contend that a physician employed with University Pediatricians failed to follow policies and procedures for claims submitted to Medicare and Medicaid for services provided by Pediatric Gastroenterology Fellows under her supervision. Specifically, the physician occasionally instructed Fellows to use pre-printed forms indicating that she accompanied the Fellows during patient visits. The physician used these forms at times when she was present during patient visits, as well as at times when she was not present.
For additional details about the OIG Civil Monetary Penalties, please click on OIG False & Fraudulent Claims
OIG Reports $20.97 Billion in Savings and Recoveries in FY 2009
Published on line 11/19/2009
In its Semiannual Report to Congress, the Department of Health and Human Services (HHS) Office of Inspector General (OIG) reported savings and expected recoveries of $20.97 billion for all of FY 2009. Specifically, OIG's $20.97 billion in savings and expected recoveries includes $16.48 billion in implemented recommendations to put funds to better use, $4 billion in investigative receivables, and $492 million in audit receivables.
"We’re doing this by leveraging our audit, legal, evaluation, and investigative tools, as well as employing the latest in data analysis technology. We will remain aggressive in our mission to protect the integrity of these vital programs" said Inspector General Daniel R. Levinson.
Additionally, in FY 2009, OIG excluded 2,556 individuals and organizations from participation in Federal health care programs. OIG also reported 671 criminal actions against individuals or organizations that engaged in crimes against HHS programs and 394 civil actions, including False Claims Act.
To access the OIG summary, please click on Press Release. To access the OIG full report, please click on Semiannual Report
Radiologist Indicted for Fraudulent Practices
Published on line 11/19/2009
An Atlanta-based radiologist was arraigned on November 5, 2009 on federal charges of wire fraud, mail fraud, health care fraud, and obstruction of justice. The indictment alleges that the company owned by the radiologist, provided radiologist coverage – interpreting x-rays and other films – to various hospitals in the Southeast that otherwise typically lacked full-time radiology coverage. Hospital staff took the film, which he and other radiologists at his company would access remotely via computer. The radiologist was supposed to review the film, prepare and sign a report expressing his or her medical conclusions, and transmit it electronically back to the hospital.
However, the indictment alleges that from May 2007 through January 2008, the radiologist signed and submitted thousands of reports in his name without even reviewing the films that were the subjects of the reports. Rather, he had non-physician technicians known as radiology practice assistants review the film and prepare the reports. In some cases, radiologist directed the company staff to simply sign for him, and transmit the report as it he had prepared it. In other cases, the radiologist only accessed the system for the purpose of signing and submitting the reports.
This case is being investigated by Special Agents of the Federal Bureau of Investigation and the U.S. Department of Health and Human Services, Office of Inspector General. The charges carry a maximum sentence of up to 20 years in prison and a fine of up to $250,000 for each count.
To access the Department of Justice press release, please click on Indicted Radiologist
Feds Leaning on Technology to Target Fraud
Published on line 10/14/2009
The Centers for Medicare and Medicaid Services (CMS) is hard at work creating a giant, comprehensive repository of claims and payment data from all federal health programs, including Medicaid. This will allow the government to run analytics on hundreds of millions of claims to sport aberrations and trends, a program dubbed One PI, for program integrity. It's a tool the government believes will help rein in the massive amounts of money spent on claims that are wasteful or flat-out criminal.
To learn more about the auditing program, please click on One PI
Arkansas Doctor Indicted on Health Care Fraud Charges
Published on line 10/14/2009
A federal grand jury on Thursday indicted a Pine Bluff, Arkansas doctor on fraud and other charges for allegedly providing women intrauterine devices that were not approved for sale in the U.S., then charging the state Medicaid program for a more expensive approved version. The allegations follow a Federal Drug Administration's criminal investigation and, pursued the case with Arkansas Medicaid program investigators.
During a search warrant at the doctor's former office at the Arkansas Center for Women, federal agents found "several non-approved versions of the Bayer manufactured IUD, Mirena," according to the U.S. Department of Justice news release. The doctor allegedly billed Medicaid for the more expensive, FDA-approved version of the Mirena when he was using the cheaper, non-FDA approved version.
Patients who received the unapproved versions were told by authorities to contact their primary care physicians.
"The regulatory process involved in approving new drugs exists for the sole purpose of protecting the public," said Steve Holt, Special Agent in Charge, U.S. Food and Drug Administration, Kansas City Field Office. "The agency will continue to investigate and prosecute individuals who attempt to put profits before the public health by causing the distribution of drugs that do not comply with FDA's laws and regulations."
The doctor faces one count of misbranding in violation of the Food, Drug & Cosmetic Act, one count of health care fraud and three counts of money laundering, according to a news release from the U.S. Attorney's Office in Little Rock. The maximum statutory penalty for misbranding is 3 years imprisonment and a $10,000 fine. The maximum statutory penalty for health care fraud and for each count of money laundering is 10 years imprisonment and a $250,000 fine, which the doctor may be sentenced to if convicted.
To access the entire press release, please click on Indicted Doctor
Kyphoplasty and Medical Necessity Focus of Medicare Audits
Published on line 10/08/2009
Department of Justice (DOJ) is expanding their investigation of kyphoplasty procedures, which initially resulted in the $75 million dollar settlement of the qui tam whistleblower lawsuit against Medtronic Spine (formerly Kyphon). The Department of Justice has begun issuing subpoenas requesting information regarding inpatient kyphoplasty admissions dating back through 1999. So far, 9 hospitals have settled with the DOJ totaling close to $10 million recovered.
The original "qui tam" (whistleblower) lawsuit said that, from 2000 to 2008, patients who had a certain type of spinal surgery known as "kyphoplasty" were unnecessarily kept overnight at the hospital and then classified as inpatient cases to boost the revenues. The lawsuit said, and the government agreed, that the minimally invasive procedure can usually be performed safely on an outpatient basis. The lawsuit also demonstrated that Medtronic had engaged in a marketing scheme to induce unnecessarily admits on patients who could have safely undergone kyphoplasty in the outpatient setting.
The liability of physicians may represent a key component of this investigation as well. Individual physicians are at risk for investigation under the False Claims Act. Physicians performing kyphoplasty services must clearly document the medical necessity for patients that will be admitted to the hospital. The medical record should be very specific as to the needs of the patient and not admitted on a routine basis for the procedure alone.
For additional information on the lawsuit, please click on Kyphoplasty
Pain Management Center to Pay DOJ to Resolve Medicare Fraud Allegations
Published on line 09/17/2009
A Las Vegas pain management center and five of its health care professionals have entered into a settlement agreement with the U.S. Department of Justice (DOJ) to resolve civil allegations of health care fraud to the Medicare system.
The settlement agreement, effective August 19, 2009, states that the pain management center, one anesthesiologist, two chiropractors and two physicians assistants agree to pay $167,095.94 to resolve allegations by the United States that they submitted claims to Medicare for procedures that were not considered covered benefits under Medicare policies.
The settlement agreement arose out of a civil complaint filed in U.S. District Court on June 8, 2009, against the anesthesiologist. That complaint alleged that from January 1, 2000, through the present, the pain management center and the other settling parties presented false or fraudulent claims for reimbursement to Medicare for a procedure known as Vertebral Axial Decompression (VAX-D). The U.S. Department of Health and Human Services, which administers the Medicare program, had determined that the VAX-D procedure was not medically reasonable and necessary under any circumstances, and was not a covered Medicare benefit. The complaint alleged that the anesthesiologist used codes for other services covered by Medicare in order to disguise the fact that he and others were providing non-covered services.
To access the entire press release, please click on Pain Management Center
Pfizer To Pay $2.3 Billion For Fraudulent Marketing
Published on line 09/02/2009
WASHINGTON – American pharmaceutical giant Pfizer Inc. and its subsidiary Pharmacia & Upjohn Company Inc. (hereinafter together “Pfizer”) have agreed to pay $2.3 billion, the largest health care fraud settlement in the history of the Department of Justice, to resolve criminal and civil liability arising from the illegal promotion of certain pharmaceutical products, the Justice Department announced today. The department said the $2.3 billion settlement included a $1.2 billion criminal fine, the largest criminal fine in U.S. history. The agreement also included a criminal forfeiture of $105 million. Whistleblower lawsuits filed under the qui tam provisions of the False Claims Act that are pending in the District of Massachusetts, the Eastern District of Pennsylvania and the Eastern District of Kentucky triggered this investigation.
Pharmacia & Upjohn Company has agreed to plead guilty to a felony violation of the Food, Drug and Cosmetic Act for misbranding Bextra with the intent to defraud or mislead. Bextra is an anti-inflammatory drug that Pfizer pulled from the market in 2005. Under the provisions of the Food, Drug and Cosmetic Act, a company must specify the intended uses of a product in its new drug application to FDA. Once approved, the drug may not be marketed or promoted for so-called “off-label” uses – i.e., any use not specified in an application and approved by FDA. Pfizer promoted the sale of Bextra for several uses and dosages that the FDA specifically declined to approve due to safety concerns. The company will pay a criminal fine of $1.195 billion, the largest criminal fine ever imposed in the United States for any matter. Pharmacia & Upjohn will also forfeit $105 million, for a total criminal resolution of $1.3 billion.
In addition, Pfizer has agreed to pay $1 billion to resolve allegations under the civil False Claims Act that the company illegally promoted four drugs – Bextra; Geodon, an anti-psychotic drug; Zyvox, an antibiotic; and Lyrica, an anti-epileptic drug – and caused false claims to be submitted to government health care programs for uses that were not medically accepted indications and therefore not covered by those programs. The civil settlement also resolves allegations that Pfizer paid kickbacks to health care providers to induce them to prescribe these, as well as other, drugs. The federal share of the civil settlement is $668,514,830 and the state Medicaid share of the civil settlement is $331,485,170. This is the largest civil fraud settlement in history against a pharmaceutical company.
As part of the settlement, Pfizer also has agreed to enter into an expansive corporate integrity agreement with the Office of Inspector General of the Department of Health and Human Services. That agreement provides for procedures and reviews to be put in place to avoid and promptly detect conduct similar to that which gave rise to this matter.
“This historic settlement will return nearly $1 billion to Medicare, Medicaid, and other government insurance programs, securing their future for the Americans who depend on these programs,” said Kathleen Sebelius, Secretary of Department of Health and Human Services. “The Department of Health and Human Services will continue to seek opportunities to work with its government partners to prosecute fraud wherever we can find it. But we will also look for new ways to prevent fraud before it happens. Health care is too important to let a single dollar go to waste.”
“Although these types of investigations are often long and complicated and require many resources to achieve positive results, the FBI will not be deterred from continuing to ensure that pharmaceutical companies conduct business in a lawful manner,” said Kevin Perkins, FBI Assistant Director, Criminal Investigative Division.
“The off-label promotion of pharmaceutical drugs by Pfizer significantly impacted the integrity of TRICARE, the Department of Defense’s healthcare system,” said Sharon Woods, Director, Defense Criminal Investigative Service. “This illegal activity increases patients’ costs, threatens their safety and negatively affects the delivery of healthcare services to the over nine million military members, retirees and their families who rely on this system. Today’s charges and settlement demonstrate the ongoing commitment of the Defense Criminal Investigative Service and its law enforcement partners to investigate and prosecute those that abuse the government’s healthcare programs at the expense of the taxpayers and patients.”
To access the press release from the Dept. of Health & Human Service, please click on Pfizer Settlement
To access the Office of Inspector General Corporate Integrity Agreement, please click on Pfizer CIA
Covenant Medical Center Pays $4.5 Million for Health Care Fraud
Published on line 09/02/2009
Covenant Medical Center in Waterloo, Iowa has agreed to pay the United States $4.5 million to settle allegations of health care fraud relating to the center's financial relationships with five doctors, the Department of Justice announced Tuesday. The investigation by the U.S. Justice Department and the Department of Health and Human Services began in 2005.
The United States alleged Covenant violated the law by paying commercially unreasonable compensation far above fair market value to five employed physicians who referred their patients to Covenant for treatment. These physicians were among the highest paid hospital-employed physicians not just in Iowa, but in the entire United States.
Neither Covenant nor the government would name the five doctors. But a Covenant spokesman said the doctors in question are two orthopedic surgeons, two neurosurgeons and a gastroenterologist. The hospital’s highest-paid physician, a gastroenterologist was part of the inquiry and was paid $1.8 million in 2008, but it’s unclear whether the next four highest-paid physicians were part of the inquiry.
The issue came to light several years ago when leaders of an independent medical practice, Cedar Valley Medical Specialists, complained that Covenant was offering inflated pay to doctors. For example, Covenant's top-paid doctors were making more than triple what their counterparts were making at the acclaimed Mayo Clinic in Minnesota.
Cedar Valley Medical Specialists' leader noted then that Covenant was paying more to individual doctors than it was spending on charity care for uninsured patients. Like nearly all Iowa hospitals, Covenant is classified as a charity that is exempt from most taxes because of the assistance it purportedly provides to the poor. The specialists' group filed a lawsuit against Covenant, which it settled last year.
This settlement resolves allegations that Covenant Medical Center submitted false claims to Medicare by engaging in financial relationships with five physicians that were prohibited under the Stark Law. The Stark Law prohibits a hospital from profiting from referrals of patients by a physician when the hospital and physician have an improper compensation arrangement. An arrangement is improper if a physician is paid above fair market value for their services and that compensation is not commercially reasonable. The purpose of the Stark Law is to ensure physicians' medical judgments are not compromised by improper financial incentives and are
based solely on the best interests of the patient.
In a settlement agreement, Covenant denied any wrongdoing but agreed to pay the United States $4.5 million plus interest to settle the government's claims. Covenant believes the government did not produce any evidence that Covenant had engaged in wrongdoing or illegal conduct. Officials at Covenant Medical Center say they made a business decision to settle to avoid the uncertainty of litigation, disruption, and high expense associated with protracted litigation with the government, despite their belief that Covenant's compensation to its physicians was reasonable and fell within fair market value.
To access the complete news article, please click on Covenant Hospital
To access the Department of Justice release, please click on DOJ Settlement
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