Stent committee recommends increased oversight

A state advisory group on Thursday recommended legislative changes to bolster oversight of coronary stent placements amid widespread concerns about unnecessary medical procedures, but it stopped short of proposing that state law regulate physician reviews in hospitals.

The omission drew sharp criticism from two national cardiology groups, which noted in a joint letter to the Maryland Health Care Commission that "inadequate, voluntary, internal review" was to blame for the failure at St. Joseph Medical Center in Towson. That's where Dr. Mark Midei was found to have overestimated patients' arterial blockage to justify the implantation of unnecessary stents for years without being discovered.

"Good hospitals have nothing to hide or fear (bad ones do)," the presidents for the American College of Cardiology and the Society for Cardiovascular Angiography and Interventions said in the letter. They added that voluntary oversight is no guarantee of "equal, high-quality" health care.

The advisory group was assembled in July, more than 18 months after Midei's case became public, leading many hospitals throughout Maryland — including St. Joseph — to revamp their internal quality control policies.

The state also launched an investigation into unnecessary stenting, concerned that physicians at other hospitals might be putting the devices, which prop open blocked arteries, into patients who didn't need them.

One of the advisory committee members, John C. Wang, of Union Memorial Hospital in Baltimore, was recently accused in three legal filings of improper stenting; he was not at the presentation Thursday and Union has declined to comment on his behalf.

The advisory group studied the issue of stent oversight for roughly five months. They submitted a draft report to the Maryland Health Care Commission, which must now evaluate the recommendations and pass a final version on to the General Assembly by the end of the year.

Among the statutory changes proposed are:

•Giving the Health Care Commission "direct authority" to regulate stent services

•Requiring "continuing evaluation" of hospitals with stent programs and forcing them to comply with certain standards in order to retain their stent practices

•Allowing the commission to receive and share sensitive health information for investigative purposes.

The group also recommended that a national cardiology data registry be used to monitor stent trends and that guidelines be kept current. But they neglected to address physician review, noting significant "tension" when it comes to balancing the patient safety roles of public agencies and clinical practitioners.

Hospitals that accept federal Medicare payments are required to perform in-house "peer reviews" of cases to ensure that quality standards are followed. The case selection for years was driven by adverse events, but since Midei's investigation that's started to change.

He was found by the Maryland Board of Physicians to have falsified patient records to justify the placement of unnecessary stents.

The devices can be life-saving in an emergency situation, and they do improve symptoms of blocked arteries, such as chest pain. But they carry increased risks of blood clots and complications, and haven't been shown to prolong life or prevent heart attacks on an elective basis. Professional guidelines recommend an artery be significantly blocked before a stent is inserted.

Midei is accused of claiming a patient's artery was considerably blocked when it wasn't, according to an independent review of his records initiated after allegations of unnecessary procedures were made against him.

He is said to have evaded discovery at St. Joseph in large part because his procedures were without complication, and therefore not selected for review. That's leading more hospitals to initiate a random review process, which will soon be required under a law passed earlier this year.

The details are being worked out by the Office of Health Care Quality within the Department of Health and Mental Hygiene, commission members said, explaining that they didn't believe the commission should also suggest legislative regulation of the peer review process.

The professional cardiology groups disagreed, however, claiming that two Maryland senators directed the commission to develop recommendations that address "the form and scope of peer review that should be required" for stent services.

Both the American College of Cardiology and the Society for Cardiovascular Angiography and Interventions had been pushing for the state to adopt a mandatory accreditation process, sponsored by the two organizations, that would have required, among other things, external peer review.

But the proposal failed to garner support in the legislature earlier this year. The stent advisory committee also recommended that such accreditation "remain optional" in its report to the Health Care Commission Thursday.

Ben Steffen, acting executive director of the Maryland Health Care Commission, said the committee proposals were a "first step" in the process, and acknowledged that they were vague. It's the "role of the commission" and legislature to develop specifics, he said.

A report to the Maryland legislature last year concluded that state regulators were largely powerless to prevent medical fraud. Laws prevented information sharing among investigating agencies, and staff numbers were too low to adequately address the issue.

"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," the report, signed by then state Health Secretary John M. Colmers, said.

That led to the passage of several laws over the past legislative session to increase patient protections, and the charge to the Health Care Commission to recommend further changes.

Commission members plan to spend the weekend considering the advisory group's recommendations, and said they will hold a public meeting Dec. 22 to discuss changes.

Stent committee recommendations

•The state health commission should, by law, have "direct authority" over stent services.

•Hospitals that stent should undergo regular evaluation and comply with set standards.

•The commission should be permitted to share and receive sensitive information for investigative purposes.