State health regulators have launched an investigation into a second Maryland hospital suspected of performing unnecessary medical procedures like those alleged at St. Joseph Medical Center in Towson, according to a report released Wednesday.
The report concludes, however, that regulators are largely powerless to prevent medical fraud even when they suspect it.
The latest investigation began after regulators reviewed data that shows how frequently Maryland hospitals use cardiac stents to treat heart patients. Dr. Mark Midei, former head of the cardiac lab at St. Joseph, is accused of placing stents in hundreds patients who did not need them, and the data shows the Towson hospital is among the top stent-placement centers in the state.
The report did not name the second targeted hospital, and officials declined to elaborate.
Government officials want to investigate still more hospitals, and found data that suggests a "detailed clinical investigation is warranted," the report says. It also says additional probes have been prevented by "unanticipated difficulties" in their ability to gather information.
"State regulatory agencies alone are not currently equipped, either with sufficient resources or with sufficient scope of authority, to prevent this type of problem from recurring at other hospitals," says the report, signed by state Health Secretary John M. Colmers.
An earlier Baltimore Sun analysis of data from the state's Health Services Cost Review Commission showed that St. Joseph and two other hospitals — Union Memorial in Baltimore and Washington Adventist Hospital in Takoma Park — consistently outpaced all other Maryland facilities in the use of stents, exceeding the state average by 20 percent to 30 percent over the past five years.
Representatives from Union Memorial and Washington Adventist issued statements to The Sun this week, in preparation for the report's release, saying they are focused on patient health and that neither has been contacted in connection with any state investigation.
"All of our procedures, including the stent procedures, are performed according to best practices within the cardiology profession," the statement from Union Memorial said.
Washington Adventist representatives said they "continuously monitor, review and evaluate our procedures to validate the quality and medical necessity of stent placement."
The report's findings are the product of a seven-month investigation into unnecessary medical procedures at Maryland hospitals, spurred by Midei's case. It was produced by several state agencies — including the Office of the Inspector General, the Physicians' Board, the Maryland Health Care Commission and the cost review commission — and calls for several procedural and legislative changes that could enhance the agencies' powers.
Among them is a recommendation to increase information-sharing. Current state laws prevent the disclosure of doctors' names in certain types of investigations to all but a select few agencies – rules that have hindered efforts to regulate medical care, the report says.
It also recommends revamping hospital "peer review" practices to ensure that clinical reviews are conducted whenever suspicious circumstances like a high volume of procedures are encountered, not simply in cases where an error or injury is reported.
"There's lots of room for improvement in patient safety and outcomes in our health care system," Colmers said in an interview, calling the review and subsequent report a first step in restoring confidence in the state's health care system.
"We had hoped that we would be a little bit further along in some of the data analysis work," Colmers said.
Maryland Del. Peter A. Hammen, who chairs the House of Delegates' Health and Government Operations Committee, ordered the state inquiry after reading about Midei in The Sun. The U.S. Senate Finance Committee ordered a similar investigation, which is continuing.
Hammen said he plans to assemble a public working group over the next month to review the recommendations.
"Expect some legislation to come out of this next session," he said, adding that "these are very complex issues."
Midei is one of several physicians in Maryland and around the country accused of overusing stents, which are inserted into blood vessels to bypass blockages.
Earlier this month, a Salisbury cardiologist was indicted on charges of federal health care fraud for billing patients thousands of dollars for hundreds of allegedly unwarranted procedures, including stent placements. Last year, a Louisiana cardiologist was sentenced to 10 years in prison in a similar case.
"Maryland is just the tip of the iceberg," said medical malpractice attorney Jay Miller, who says he represents more than 190 of Midei's stent patients. "This [will turn out to be] a national problem."
Miller recently placed advertisements in The Sun seeking stent patients from other hospitals, claiming his office has "uncovered information that this was not limited to St. Joseph's Hospital and Dr. Midei."
St. Joseph said it continues "to review all current interventional cardiologists practicing at St. Joseph Medical Center through our monthly internal peer review." Midei, who earned $1.3 million from St. Joseph in fiscal year 2009, has denied all allegations of wrongdoing and hired a well-known plaintiffs' attorney, Stephen L. Snyder, to represent him.
Midei is accused of altering patient records to make it appear that their arteries were blocked and needed stenting. The hospital claims that a subsequent review of patient records showed blockages that were far smaller than Midei noted.
The doctor's supporters have said that he placed stents based on a patient's clinical symptoms, in addition to other factors
The report released Wednesday distinguishes between overuse based on a "lack of awareness" or "disagreement with the [recommended clinical] guidelines" versus "illegal behavior, including fraud and deliberate falsification."
It concludes that regulatory agencies are largely helpless in preventing the fraudulent medical procedures, absent new legislation and intervention from federal and state law enforcement agencies.
"Even if regulatory agencies are granted more resources and authority, law enforcement agencies will remain better equipped to detect and deter cases of purposeful fraud, where efforts are made to hide fraudulent activity," the report states.
The report recommends on-site review of hospitals that might be overperforming certain procedures, though it says state regulators only have the resources for "periodic 'spot check' reviews.' "
"It's impossible to police every physician's office or health care facility," Colmers said. "But there are ways in which you can, if you think there are issues, focus your attention."
Stent Probe Timeline
January 2008: Dr. Mark Midei leaves MidAtlantic Cardiovascular Associates to become a full-time employee of St. Joseph Medical Center, scuttling MidAtlantic's $25 million merger deal with MedStar Health, which owns Union Memorial Hospital.
June 2008: St. Joseph, MidAtlantic and MedStar's Union Memorial Hospital receive subpoenas from the federal agency that investigates Medicare fraud.
May 2009: A patient of Midei's, later identified as a hospital employee, lodges a complaint alleging that Midei performed inappropriate medical procedures, sparking an internal review at the hospital. Midei is suspended and later loses his privileges to practice medicine at St. Joseph.
July 2009: St. Joseph claims to have reached agreement with the federal government to settle any potential claims related to its dealings with MidAtlantic.
December 2009: St. Joseph begins sending letters to roughly 600 of Midei's patients telling them they might have had unneeded stents implanted in their coronary arteries and suggesting they see a doctor.
February 2010: Del. Peter A. Hammen asks the state health department to initiate a review of what happened at St. Joseph and to investigate whether unnecessary invasive procedures are taking place at other state hospitals. The U.S. Senate Finance Committee, which oversees Medicare and Medicaid programs also opened an investigation in search of fraud.
May 2010: State regulatory documents indicate that Midei was able to avoid St. Joseph's peer review process because, as a department head, he chose which cases would be reviewed.
June 2010: State regulators reviewing billing records determine that other doctors in Maryland have suspiciously high rates of placing stents. The regulatory board responsible for licensing doctors in Maryland files administrative charges against Midei, beginning a process that could strip him of the authority to practice medicine in the state.
Sept. 1, 2010: Salisbury cardiologist John R. McLean is indicted for health care fraud in connection with the alleged placement of unneeded coronary stents in hundreds of patients.
Sept. 21, 2010: The health agency committee investigating unnecessary procedures in Maryland submits its findings to the legislature.
Strengthen and change the focus of hospital peer review standards to include review of volume and medical necessity.
Broaden the types of events included in reporting requirements under the Maryland Patient Safety Regulations.
Increase permissible sharing of information among the investigatory agencies.
Regulatory agencies should be granted permission to discuss complaints that cross agency jurisdictions.