ELYRIA, Ohio -- A Lorain County hospital and a group of Northeast Ohio cardiologists have agreed to pay the federal government $4.4 million to settle allegations that, for years, they billed Medicare for implanting heart stents in patients who did not need them.

The nonprofit hospital, EMH Elyria Medical Center, a nonprofit hospital in Lorain County, will pay more than $3.8 million; North Ohio Heart Center Inc., a physician practice with offices west of Cleveland will pay $541,870, according to a statement released Friday afternoon by the U.S. Justice Department (see the USDOJ news release in the document viewer below).

The settlement specifically resolves allegations that between 2001 and 2006 the hospital and the doctors' group performed angioplasty and stent placement procedures on patients who had heart disease but whose blood vessels were not blocked enough to require those procedures.

"Billing Medicare for cardiac procedures that are not necessary or appropriate contributes to the soaring costs of health care and puts patients at risk," Stuart Delery, Principal Deputy Assistant Attorney General of the Justice Department’s Civil Division, said in a written statement.

"Most doctors do act responsibly, but these few didn't," Steven Dettelbach, U.S. Attorney for the Northern District of Ohio, said in a phone interview. "I think what's important to remember is that patient health and taxpayer health have to come before profit and greed.

"Costs that are unnecessary in the medical system and then asking for reimbursement from the Medicare program results in increased costs for everyone.

"We need to, in this day and age of looking at where we can tighten our belts, to start by attacking waste, fraud and abuse."

The claims resolved by the settlement are allegations only and there has been no determination of liability, the Justice Department said in its statement.

The $4.4 million settlement resulted from a whistleblower complaint filed by Kenny Loughner, the former manager of EMH’s catheterization and electrophysiology laboratory, who will receive $660,859 for the tip. Federal law allows whisteblowers to receive a portion of the money the governement recovers as a result of their actions.

"It is in the best interest of all concerned to settle this matter and move forward," Dr. Donald Sheldon, president and chief executive officer of EMH Healthcare, said in a written statement.

"Clinicians often have different views on treatments and methodologies for heart procedures," he wrote. "In this inquiry, the government took the view that a small percentage of cases were not severe enough to warrant the procedure.

"We have cooperatively come to a settlement that reflects repayment of some of the medical costs associated with those procedures. No patients, to our knowledge, were ever at risk and there is no question that the patients treated had heart disease and some degree of blockage."

Later in a telephone interview, Sheldon also said the hospital system has been conducting internal and external reviews since 2006, when it first became aware of questions regarding the procedures.

Most of the cardiologists who practice at the hospital are with North Ohio Heart.

Elyria-based North Ohio Heart Center became a part of the hospital system and its doctors became hospital employees in 2010. At the same time, it changed its name to North Ohio Heart.

Dr. John Schaeffer, chairman and president of North Ohio Heart, reiterated that the settlement is not an admission of wrongdoing.

"We agreed to settle because of a difference of opinion in a small number of cases regarding Medicare benefit coverage reimbursement," Schaeffer said in a telephone interview.

"It was never about the quality. All the patients have had good outcomes."

Schaeffer also said North Ohio Heart was an early adopter of what was then new technology.

"It's very important to note that his settlement is only about whether or not Medicare covered some procedures we did six to 10 years ago that were considered cutting edge at the time.

"As the physicians on the ground when these decisions were made and the procedures were performed, we felt confident we were making the correct choices for our patients. We still do and we are gratified that NOHC has passed every Medicare audit ever done -- whether regarding stent procedures or any other service."

North Ohio Heart has 23 cardiologists who practice at eight offices in Cuyahoga, Lorain, Medina, Erie and Huron counties.

The investigation was jointly handled by the U.S. Attorney’s Office for the Northern District of Ohio, the Justice Department’s Civil Division, the Office of the Inspector General of the Department of Health and Human Services and the Federal Bureau of Investigation.

The resolution is part of the government’s effort to fight health care fraud and part of the Health Care Fraud Prevention and Enforcement Action Team initiative announced by Attorney General Eric Holder and Kathleen Sebelius, Secretary of the Department of Health and Human Services in May 2009.

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