Cardio groups ask Maryland legislature to consider upping cath-lab oversight in wake of overstenting debacle

Reed Miller

March 02, 2011

Annapolis, MD - Two major cardiovascular professional societies are taking the unusual step of asking a state government for more oversight of their practice to restore what they perceive to be sinking public confidence in cardiovascular interventionalists.

Maryland State House, Annapolis

Speaking on behalf of the Society for Cardiovascular Angiography and Interventions (SCAI), Dr Mark Turco (Washington Adventist Hospital, Takoma Park, MD) told heartwire that after the allegations surfaced against interventionalist Dr Mark Midei (St Joseph Medical Center, Towson, MD) and Dr John R Mc L ean (Peninsula Regional Medical Center, Salisbury, MD), many patients began telling their physicians that they did not have confidence in stents.

"Interventional cardiology is a big user of healthcare dollars, and we're concerned that the public has a perception that we are often moved to treat patients on the basis of relationships with [drug and device] vendors," Turco said. Turco is also president-elect of the Maryland chapter of the American College of Cardiology (ACC).

Dr Sam Goldberg (Bethesda, MD), current ACC Maryland chapter president, told heart wire , "When the news broke about the inappropriate use of stenting at St Joe's hospital in 2009 and 2010, I felt that we needed to be proactive in dealing with this issue, so we started reviewing what our own physicians do and what kind of oversight we have, and . . . I felt we needed some greater oversight."

Today, Goldberg and Turco testified before committees of the Maryland General Assembly to pass the Maryland Cardiovascular Patient Safety Act (Senate Bill 742, House Bill 690). They met with the House of Delegates Health and Government Operations Committee a few hours after addressing the Senate Finance Health Subcommittee.

"Rarely do [doctors] develop our own legislation," Turco testified before both committees. "And rarely do we advocate for more oversight! The fact that we have done both shows how strongly we feel about the need for this legislation."

Rarely do [doctors] develop our own legislation. And rarely do we advocate for more oversight!

The bills, if passed into law, would launch three new initiatives. It would mandate that the Maryland Health Services Cost Review Commission use data in the Maryland Health Care Commission's CATH-PCI and ACTION registries, along with administrative data, to get the most accurate picture of cath-lab practices.

The bills also call for the creation of a system of independent peer review and external oversight that would audit a cath lab's practices to ensure that they are consistent with the current professional guidelines and in patients' best interest. "Looking into the [current] in-hospital peer-review process, which is a legally protective process that is done within the hospital . . . I saw that there were very few guidelines about how it's done, and it's an inherently biased process because you have cardiologists who all know each other reviewing each other, and some are business partners and colleagues, and it's very difficult for them to be very critical of some things. I felt we needed some greater oversight," Goldberg said.

The bills also calls for all cath labs in the state of Maryland to be accredited by a nationally recognized accreditation body such as the fledgling Accreditation for Cardiovascular Excellence (ACE) set up by SCAI. Mary Heisler, executive director of ACE, also testified before both legislative committees. She said that her group could accredit a Maryland hospital to run a cath lab for under $25 000 a year. "While we recognize this is a difficult economic time, this will avoid the problems that just cost [St Joseph hospital] $22 million," she said. "This fee is the equivalent to the reimbursement a hospital receives for approximately two stent procedures."

Denise Matricciani, vice president for government relations for the Maryland Hospital Association (MHA), testified that her organization broadly supports the aims of the bills but that the MHA does not support mandating accreditation at this time. She pointed out that ACE has not yet performed the kinds of surveys of appropriateness envisioned by the bills' supporters and that there are no data yet to support the effectiveness of its process. Also, the MHA is not convinced that an accreditation process would do much to stop inappropriate procedures.

"Accreditation may have merit in the future; we just don't believe that mandatory accreditation is appropriate at this juncture," she told the house committee. She also refuted the insinuation of the ACC representatives that the MHA's opposition is based only on cost concerns.

Matricciani outlined some of the efforts her group is undertaking to root out waste and abuse and improve public confidence in cath labs. For example, the MHA recently created a Necessary Care Work Group, with medical directors and quality leaders, to study and make recommendations to the Department of Health and Mental Hygiene (DHMH) and the legislature on issues related to inappropriate PCIs and other medical procedures.

The group also created Guidelines to Ensure the Appropriateness of PCI Procedures. "As this body has witnessed over the years, we can do a lot with our members in terms of doing what's right," Matricciani told the house committee. "These guidelines strive to assure patients, the public, and practitioners that stent placements are appropriate and necessary and right for the patient."

In his testimony before both committees, Turco argued that internal efforts by the hospitals to oversee the cath labs will not be sufficient to prevent problems like those at Peninsula and St Joseph.

"To those who would advocate for the same old system with 'suggested regulation' rather than legislation to fix problems, I would ask—can you explain why and how that regulation would be enforced? And I would ask, if it is so easy to just regulate, why has it not been done in the past, and how have we found ourselves in this situation today?"

He continued: "Accreditation will provide needed oversight for hospitals, while removing much of the variability in care from one center to another." He added that although accreditation of cath labs would be a new requirement and possible burden on hospitals, the hospitals are already accustomed to handling a variety of accreditation processes for other procedures and departments, so preparing for cath-lab accreditation would not be overly burdensome.

Turco also told heart wire that he believes that regulation of cath labs and medicine in general is probably only going to increase in the future regardless, so it behooves the hospitals and the physicians to be proactive in proposing an oversight system to legislators instead of waiting for outsiders to impose one on them.


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