Social Issues

A settlement has been reached to resolve False Claims Act Allegations against Dr. Walter Janke, his wife, Lalita Janke, and Vero Beach, Fla.-based Medical Resources L.L.C. (MR).  They are accused of submitting false diagnosis codes to Medicare.

The Jankes were the owners of America’s Health Choice Medical Plans Inc. (AHC), a Medicare Advantage Organization (MAO), approved by the federal health care program to provide health care to enrolled Medicare beneficiaries. The Jankes also owned MR, AHC’s primary care provider. AHC and MR are no longer doing business.

The United States allged that the Jankes and MR violated the False Claims Act by causing AHC to falsely increase the severity of beneficiary diagnoses to obtain higher Medicare payments. Under the Medicare Advantage Program, MAO's are paid more to provide services for members with serious and/or chronic medical conditions then they are for relatively healthy members.

In addition to suing the Jankes and MR, the United States successfully petitioned the court to freeze approximately $20 million of the Janke's assets believed to be the proceeds of their unlawful scheme. A portion of the Janke’s frozen assets, along with monies resulting from the dissolution of AHC now held in receivership by the Florida Department of Financial Services, will be used to pay the settlement.

A settlement has been reached in a whistleblower class action lawsuit brought against El Centro Regional Medical Center who is accused of defrauding Medicare.

The whistleblower will receive $375,000.

The original lawsuit was filed in May 2006. The United States alleged that the 165-bed acute care hospital fraudulently inflated its charges to Medicare patients to obtain larger reimbursements from the federal health care program. The settlement covers claims submitted by the hospital for short inpatient admissions, usually of one day or less, when the services should have been billed on an outpatient “observation” basis or as emergency room visits.

A settlement has been reached in a whistleblower class action lawsuit brought against St. Jude Medical Inc, Parma Community General Hospital, and Norton Healthcare. They are accused of violating the False Claims Act in relation to certain illegal kickbacks to secure heart-device business.

Under the terms of the settlement, St. Jude, headquartered in St. Paul, Minn., will pay $3,725,000. Parma Community General Hospital, located in Parma, Ohio, will pay $40,000, and Norton Healthcare in Louisville, Ky., will pay $133,300. The government asserted that Parma and Norton were recipients of improper rebates from St. Jude.  The reward for the whistleblower will be $640,050.

The whistleblower case was originally filed in 2006. The United States alleged that St. Jude paid illegal kickbacks to two hospitals to secure heart-device business and that these kickbacks caused false claims to be submitted to federal health care programs in violation of the False Claims Act. The kickbacks included alleged rebates that were "retroactive" and paid based on a hospital’s previous purchases of St. Jude heart-device equipment and rebates that St. Jude paid for purchases of heart-device equipment sold by its competitors to induce purchases of similar equipment from St. Jude in the future.

A settlement has been reached in a whistleblower class action lawsuit brought against Metropolitan Ambulance & First Aid Corp, Metro North Ambulance Corp, Big Apple Ambulance Service Inc, including their president, Steve Zakheim. They are accused of falsifying records to appeal a Medicare program refund demand.

The whistleblower will receive $618,450.

The original whistleblower case was filed in 2000.  The United States alleged that the companies and Zakheim used, or caused the use of, falsified records to appeal a Medicare program refund demand. Medicare had demanded the companies return millions of dollars they had been paid for medically unnecessary ambulance trips. Under Medicare rules, the companies could bill for these expensive non-emergency transports only if the patient could not be transported by any other means, such as by car or by wheelchair van. Medicare audited the companies’ past billings and concluded that the companies had charged Medicare tens of millions of dollars for ambulance trips that did not meet this standard. Medicare demanded a refund and afforded the companies an extensive informal and formal appeals process to prove that their billings were proper.

The government contended that, rather than contesting the refund demand fairly, the companies resorted to fraud when they could not otherwise prove an ambulance was medically needed. According to the suit, in their ensuing appeals, the companies used, and Zakheim caused the use of, hundreds of letters attesting to the need for an ambulance that were forged or otherwise purported to come from some neutral, disinterested health care provider when they in fact did not.

A settlement has been reached in a whistleblower class action lawsuit brought against Novartis Vaccines & Diagnostics Inc and Novartis Pharmaceuticals Corporation. They are accused of causing false claims to be submitted to federal health care programs.

According to the settlement, the United States will receive $43.5 million to resolve the federal claims, and the states will receive $29 million to settle their respective claims. The whistleblowers will receive $7.825 million of the federal share of the settlement announced today.

The original lawsuit was filed in October 2006.  The United States alleged that, between Jan. 1, 2001 and July 31, 2006, Novartis and its predecessor, Chiron Corporation, caused false claims to be submitted to federal health care programs for certain off-label uses of the cystic fibrosis drug TOBI.

The Food and Drug Administration (FDA) approved TOBI, an inhaled antibiotic, for the treatment of certain cystic fibrosis patients. The United States alleges that Chiron, and then Novartis, marketed TOBI for unapproved uses, such as diseases other than cystic fibrosis, and for cystic fibrosis patients who did not meet the parameters of the FDA-approved indication and for which TOBI was not a medically accepted use. The government alleges that this conduct caused the submission of false claims to federal health care programs.

A settlement has been reached in a whistleblower class action lawsuit brought against nine hospitals located in Alabama, Indiana, Florida, Michigan, South Carolina, New York and Minnesota. They are accused of submitting false claims to Medicare.

The settling facilities and the amount being paid by each to the United States are Ball Memorial Hospital, Muncie, Ind. ($1,995,431); Bethesda Memorial Hospital, Boynton Beach, Fla. ($356,079); Bloomington Hospital, Bloomington, Ind. ($1,443,848); Genesys Regional Medical Center, Grand Blanc, Mich. ($931,742); Huntsville Hospital, dba The Health Care Authority of the City of Huntsville, Huntsville, Ala. ($1,992,756); Palmetto Health dba Palmetto Health Baptist Hospital, Columbia, S.C. ($1,861,083.14); St. Elizabeth Medical Center, Utica, N.Y. ($195,976); St. Mary’s of Michigan Hospital, Saginaw, Mich. ($260,065.21); and United Hospital, St. Paul, Minn. ($428,656).  The whistleblowers will receive approximately $1.5 million as their share of the settlement proceeds.

The original whistleblower case was filed against multiple facilities and filed in 2008.  The United States specifically alleged that these nine hospitals overcharged Medicare between 2000 and 2008 when performing kyphoplasty, a minimally-invasive procedure used to treat certain spinal fractures that often are due to osteoporosis. In many cases, the procedure can be performed safely as a less costly out-patient procedure, but the government contends that the hospitals performed the procedure on an in-patient basis in order to increase their Medicare billings. 

The settlement with these facilities follows the settlements that the government reached in May and September 2009 with nine other hospitals for alleged kyphoplasty-related Medicare fraud claims, as well as the government’s May 2008 settlement with Medtronic Spine LLC, corporate successor to Kyphon Inc. Medtronic Spine paid $75 million to settle allegations that the company defrauded Medicare by counseling hospital providers to perform kyphoplasty procedures as an in-patient procedure, even though in many cases the minimally-invasive procedure should have been done on an out-patient basis.

A settlement has been reached in two whistleblower class action lawsuits brought against Schwarz Pharma Inc who is accused of causing false claims to be submitted to federal health care programs.

The federal share of the settlement is $12,243,836 and the state Medicaid share is $9,756,164. The two whistleblowers will receive a total of $1,836,575 from the federal share and additional amounts from the state share.

The United States allegations were in reference to Schwarz Pharama Inc's drugs, Deponit and Hyoscyamine Sulfate Extended Release (Hyoscyamine Sulfate ER). 

Deponit is a nitroglycerin skin patch that has been used to prevent angina. Hyoscyamine Sulfate ER is an antispasmodic medication that has been used to treat various stomach, intestinal, and urinary tract disorders that involve cramps, colic, or other painful muscle contractions. While the active ingredients in Deponit and Hyoscyamine Sulfate ER had been in products on the market for many years, the Food and Drug Administration made determinations in 1997 and 1999 that resulted in the drugs being ineligible for reimbursement by government health care programs such as Medicaid.

The United States alleged that Schwarz misrepresented the regulatory status of both drugs and failed to advise CMS that these unapproved drugs did not qualify for coverage under federal health care programs. As a result, the government contends, Schwarz knowingly caused false claims to be submitted for Deponit and Hyoscyamine Sulfate ER. Ultimately, neither Deponit nor Hyoscyamine Sulfate ER ever received full regulatory approval for safety and effectiveness, and neither product is currently on the market.

A settlement has been reached in a whistleblower class action lawsuit brought against Alpharma Inc who is accused of paing health care providers to induce them to promote or prescribe their drug, Kadian.

According to the settllement, the United States will receive $33.6 million to resolve the federal claims and the states will receive approximately $8.9 million to settle their respective claims. The whistleblower will receive $5.33 million out of the federal share of the recovery.

The original case was filed in September of 2006.  The United States alleged that, between January 1, 2000 and December 29, 2008, Alpharma paid health care providers to induce them to promote or prescribe Kadian, and made misrepresentations about the safety and efficacy of the drug, which is used to treat chronic moderate to severe pain. A

A settlement has been reached in a whistleblower class action lawsuit brought against Robert Wood Johnson University Hospital Hamilton fraudulently inflating its charges to Medicare. 

Whistleblowers that filed two lawsuits that these allegations are based upon will receive $1,111,250 of the total recovery.

The first of the lawsuits was filed in November 2002. The United States alleged that the hospital inflated its charges to obtain supplemental outlier payments for cases that were not extraordinarily costly and for which outlier payments should not have been paid. The United States intervened in both lawsuits in January 2008. 

In addition to its standard payment system, Medicare provides supplemental reimbursement, called "outlier payments," to hospitals and other health care providers in cases where the cost of care is unusually high. Congress enacted the supplemental outlier payments system to ensure that hospitals have the incentive to treat inpatients whose care requires unusually high costs.

A settlement has been reached in a whistleblower class action lawsuit brought against Dr. Todd J. Scarbrough and Melbourne Internal Medicine Associates P.A. (MIMA), who are accused of submitting false claims to Medicare and the military’s health care program - TRICARE.

The whistleblower will receive $2.64 million of the settlement.

The case was originally filed in July 2008.  The United States alleged MIMA Cancer Center had defrauded the federal health care programs by improperly inflating claims through various schemes specifically designed to cloak the fraudulent practices. In particular, the MIMA Cancer Center billed for services not supervised, duplicate and unnecessary services, services not rendered and upcoded services - a practice in which provider services are billed for higher procedure codes than were actually performed. The United States’ investigation found that MIMA executives had knowledge of a substantial number of the fraudulent billing practices at the facility, but had failed to stop the fraudulent billing.