Feature: As Maryland stent investigations continue, more oversight is needed
After 585 patients at the St. Joseph Medical Center (SJMC) in Towson, Md., received word that their cardiac stent procedures may have been unwarranted, Maryland attorneys filed a 19-page lawsuit against the facility alleging that Mark G. Midei, MD, director of the SJMC cath lab violated the Maryland Medical Practice Act. The court documents accuse Midei of performing “hundreds, if not thousands, of unnecessary cardiac stent procedures on patients.” Now, this case and others like it have left most wondering what this will mean for the industry.

On November 10, 2008, the Maryland Board of Physicians received two complaints from patients alleging that Midei may have committed "medical fraud" by placing stents in coronary arteries with "insignificant blockages." On July 21, 2009, SJMC assured the Board of Physicians that Midei’s privileges were temporarily suspended.

A statement released by the 354-bed SJMC reassured patients who may have been treated and received these stents that they were at no immediate risk and vowed that they were taking immediate steps to correct the problem.

Still, the Maryland Board of Physicians launched an investigation into Midei’s stent procedures performed at SJMC. Records were seized from the provider and brought to a peer review board for evaluation. If found guilty Midei could be subject to suspension, have his license revoked, be slapped with fines or be put on probation, according to the court filings.

Earlier this month a private hearing was held with members of the board and Midei to discuss the charges—results of neither the case, nor future actions were disclosed.

On February 16, 2009, the investigation was expanded when Del. Peter A. Hammen, D-Baltimore City, chair of the Health and Government Operations Committee, asked the Maryland Department of Health and Mental Hygiene to conduct a full on investigation of  the stenting procedures performed throughout the state of Maryland during the past five years.

The Baltimore Sun reported that stenting procedures brought in an estimated $222 million to Maryland hospitals in the past fiscal year alone. Data have shown that drug-eluting stents cost hospital labs an estimated $2,500 per stent.

According to Centers for Medicare & Medicaid Services (CMS) hospital Inpatient Prospective Payment System (IPPS) final rule for the 2010 fiscal year, treating patients who are free from major cardiovascular complications with coronary DES provides a hospital with a reimbursement of $10,810. Reimbursement rates for bare-metal stents are $9,520.

Implanting a DES in patients who have major complications provide the hospital with a $17,500 reimbursement; these rates for bare-metal stents are estimated to be $16,066. The majority of patients in need of a coronary stent receive DES—an estimated 70 percent.

Clinically, cardiologists perform stenting when patients experience stenosis of at least 70 percent; however, the Sun reported that court documents charged that some of Midei’s patients were told they had blockages of 90 percent, but in reality, these "blockages" may have been much less severe and non-significant.

Mark A. Turco, MD, an interventional cardiologist within the state of Maryland, in an interview told Cardiovascular Business that imaging modalities such as IVUS and the clinical trial results of the FAME and FAME-II trial have helped interventionalists properly decipher which patients should be recommended for a stenting procedure. The use of fractional flow reserve (FFR) measurements to guide intervention, which uses a coronary pressure guidewire can help gauge appropriateness in each individual patient and measure whether a stenosis is “hemodynamically significant.”

Turco said, “These tools along with the patient’s symptoms and history and non-invasive tests should help clearly identify when it is appropriate for a stent to be placed in an artery.

“With regard to the bigger picture and how the events unfolding in Maryland might impact the field … we do worry as a profession that things may expand well beyond Maryland,” said Turco. “We need to identify ways for physicians to do a good job of oversight of our field, while at the same time being sure we work in coordination with governmental agencies to produce a system that will provide the safest, cost-effective and best medical care for our patients”.

In 2002, a similar situation occurred in California where the FBI launched an investigation of the Shasta Regional Medical Center, formally known as the Redding Medical Center, in Redding, Calif., after learning that Drs. Chae-Hyun Moon and Fidel Realyvasquez blocked the peer review at the hospital, which resulted in hundreds of patients undergoing unnecessary cardiac bypass and valve surgery.

To prevent future cases like this, Turco offered that there should be more of an emphasis placed on improving the peer review process. Currently, each institution has their own peer review process, and while Turco said he couldn’t speak directly on the process at SJMC, he said that these review processes are usually run by the cath lab director and overseen by a larger peer group within each institution, usually involving cardiac surgeons, internal medicine and specialists.

While Turco said that the “peer review process may have broken down a bit,” he said that peer review should be conducted by interventional cardiologists, in addition to further oversight from either medical societies or outside institutions in order to make certain that “an institution is not cherry picking cases and to ensure that physicians who fall outside of the bell shaped curve are properly disciplined.

“One possible way to make this occur is to have each cath lab accredited by our governing medical societies with on-going and spot reviews,” he said.

Additionally, Turco said it’s important that the medical societies continue to publish appropriateness documents demonstrating how interventional cardiologists can practice high-quality patient care and what the consequences are for those who do not uphold the strictest ethical standards. "Further, we need databases that will allow us to report our data to governmental agencies so they can get all of the needed information.

“I’m sure there are outliers within the field of medicine and it is up to us with the peer review process to identify those outliers and deal with them,” said Turco. ”For the sake of our patients we must do the best possible job.”

Various agencies and commissions throughout the state of Maryland are doing their part to ensure optimal care, including the Health Services Cost Review Commission (HSCRC), which collects patient level data on admissions, outpatient episodes and procedures annually. “From these data sets, it is possible to identify aggregate utilization patterns that may be indicative of overuse of certain invasive cardiac procedures,” wrote John M. Colmers, secretary, Health & Mental Hygiene.

Colmers also indicated that HSCRC will continue to review these data and work with federal and state officials to ensure these data are accurately reported and “reflective of medically appropriate clinical decision making and resource use.”

Additionally, all Maryland hospitals will be required to submit and report cath lab data to the Commission on PCI using the American College of Cardiology’s National Cardiovascular Data Registry CathPCI Registry and ACTION Registry.

“These two data sets will strengthen the Commission’s ability to establish and monitor adherence to accepted performance benchmarks, publicly report risk-adjusted outcome measures, and inform policymakers on priorities for quality improvement,” Colmers wrote.

“We all want what is best for the patient; we all want to be sure that physicians all over the country are following the highest ethical standards and certainly are complying with the appropriateness criterion that has been set out,” said Turco.

After multiple attempts, the Maryland Board of Physicians declined to comment further on the case due to the ongoing investigation.