BY KEN LITTLE
Three former partners in the McLeod Cancer and Blood Center in Johnson City agreed earlier this week to pay settlements totaling $4.25 million to resolve allegations that they violated the False Claims Act.
According to a news release from the U.S. Attorney's Office, the allegations were that the physicians knowingly submitted false claims for misbranded, unapproved chemotherapy drugs administered through the clinic,
Many Greene County residents received treatment at the Johnson City clinic.
Dr. William R. Kincaid, 68, the managing partner of McLeod Cancer and Blood Center, pleaded guilty in December 2012 to receiving misbranded drugs with intent to defraud or mislead in violation of the federal Food, Drug and Cosmetics Act.
Kincaid was sentenced on June 10 in U.S. District Court in Greeneville to serve two years in federal prison.
He will also be excluded from federal health care programs for a period of 10 years, according to the news release.
CIVIL SETTLEMENT AMOUNTS
Kincaid's portion of the civil settlement is $2.55 million.
He remains free on bond pending designation by the U.S. Bureau of Prisons of a federal correctional facility where he will serve his sentence.
Doctors Millard R. Lamb and Charles O. Famoyin, former minority owners in East Tennessee Hematology-Oncology Associates, doing business as McLeod Cancer and Blood Center, are each responsible for payments of $850,000, the release said.
Lamb and Famoyin were not criminally charged.
Federal prosecutors alleged that the doctors violated the False Claims Act by submitting false claims to the Medicare and TennCare/Medicaid programs for misbranded or unapproved chemotherapy drugs administered through the clinic.
McLeod Cancer and Blood Center provided care and treatment for patients with cancer and blood diseases.
The news release said that, beginning in 2007, the Center began obtaining drugs from a Canadian business, Quality Specialty Products (QSP).
The drugs had been obtained from foreign sources and had not been approved by the U.S. Food and Drug Administration (FDA) for distribution or use in the U.S.
After nurses at the Center raised concerns in late 2007 and early 2008 about chemotherapy drugs with foreign labeling, the clinic stopped ordering drugs from QSP.
In August 2009, Kincaid and Michael Combs, the McLeod Center's business manager, met with a QSP representative and began ordering misbranded unapproved drugs, court documents state.
SHIPPED TO BUSINESS
Kincaid directed Combs to have the drugs shipped to a storage business in Johnson City of which Kincaid was part-owner.
The drugs were received at the storage business and then taken to Combs' McLeod Cancer Center office, court documents state.
The misbranded drugs were then placed by a pharmacy technician into the clinic's drug storage and control system, where they were mingled with FDA-approved drugs from legitimate sources.
FDA-approved drugs obtained from legitimate U.S. drug manufacturers and distributors were still shipped directly to the McLeod Center and not to the storage business, court documents state.
Combs, 32, of Piney Flats, entered a guilty plea last year to receiving misbranded drugs and was sentenced in March by U.S. District Judge J. Ronnie Greer to three years of probation and 250 hours of community service.
Prosecutors said that the Center obtained unapproved drugs from about September 2007 to early 2008, and from August 2009 to February 2012.
OVER $2 MILLION
More than $2 million worth of misbranded drugs were provided to the Center's patients, court documents state.
Medicare, TennCare, and other government health benefits programs were billed about $2.3 million for the unapproved drugs, documents state.
Kincaid made an initial payment of $500,000 as part of the settlement agreement, the news release said.
"Medical practices that administer prescription drugs from non-FDA-approved foreign sources are putting patients at risk of exposure to counterfeit, contaminated, ineffective and potentially dangerous medications.
"This case is an example of the efforts the government will continue to make to minimize the chance of patients receiving such unsafe medication as well as to ensure that Medicare and other health benefit programs do not pay for unapproved drugs," U.S. Attorney Bill Killian was quoted in the release.
A Greeneville doctor and his wife were named in June in a 38-count U.S. District Court indictment in an unrelated case that includes allegations similar to those made against Kincaid.
Dr. Anindya K. Sen and his wife, Patricia Posey Sen, were charged with conspiracy to commit health care fraud, conspiracy to commit offenses against the U.S., introduction into interstate commerce of a misbranded drug, and knowingly importing merchandise contrary to law.
Sen is managing physician and president of the East Tennessee Cancer & Blood Center (ETCBC), with offices at 1406 Tusculum Blvd. and in Johnson City. Patricia Sen, his wife, is ETCBC practice manager.
ETCBC is also named as a defendant.
The Sens strongly maintain their innocence and have entered not guilty pleas in federal court.