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Abstract

  1. Top of page
  2. Abstract
  3. Does Size Matter?
  4. The Final Rule
  5. Regulation and Authority
  6. Volume Versus Out comes
  7. References

A new study challenges the CMS decision to lower a center's annual number of acceptable heart transplants, but does lower volume really mean increased mortality?

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Does Size Matter?

  1. Top of page
  2. Abstract
  3. Does Size Matter?
  4. The Final Rule
  5. Regulation and Authority
  6. Volume Versus Out comes
  7. References

The relationship between low volume and patient outcome in transplantation has long been a topic of research and discussion, as well as an emotional issue affecting center prestige and income. Although some studies have pointed to improved survival and fewer complications in centers with a high volume,1–4 there are those who contend that volume and outcome alone don't address crucial issues such as access to transplantation, socioeconomic status, and transplant rates for under-represented minorities.

Although the debate pertains to all areas of transplantation, heart procedures drew national attention earlier this year when a team from Johns Hopkins School of Medicine presented their research findings at the 44th Annual Meeting of the Society of Thoracic Surgeons in Fort Lauderdale, Fla. In a review of 14,401 heart-transplant patient records in the U.S. between 1999 and 2006, the researchers found that death rates at one month and one year after transplantation increased steadily at hospitals that performed fewer than 14 heart transplants a year. While the overall average death rate at one year after surgery was 12.6%, patients had a 16% greater chance of dying in a hospital that performed fewer than five heart transplants per year and had the best chances of survival in centers that performed more than 40 heart transplants per year.

The Final Rule

  1. Top of page
  2. Abstract
  3. Does Size Matter?
  4. The Final Rule
  5. Regulation and Authority
  6. Volume Versus Out comes
  7. References

The Final Rule Conditions of Participation published last year by the Centers for Medicare & Medicaid Services (CMS) required a minimum volume of 10 heart transplants a year for CMS approval and reapproval. Prior to the Final Rule, the minimum CMS heart transplant requirement was 12. “Our results clearly demonstrate that current standards have been arbitrarily set too low,” says John Conte, MD, director of Heart and Lung Transplantation at The Johns Hopkins Hospital in Baltimore. “I have no idea why they would lower it. If anything, they ought to raise it.”

Jeannie Miller, acting director of the Clinical Standards Group in the CMS Office of Clinical Standards and Quality, was one of the Final Rule authors. She notes that the original minimum requirement of 12 was arbitrarily set and that the current designation of 10 was chosen because “we wanted to stay as close to the current requirements as we could so as not to have a negative impact on centers. We were concerned that if we had too high a volume requirement, it could impede beneficiary access to transplants and transplant services.”

The statistics gathered by the Johns Hopkins team indicate that 45% of all heart transplant hospitals (including those not receiving federal reimbursement) perform fewer than 10 transplants a year. Hamilton says that, “based on the new rule and strengthened CMS oversight, we believe that by the end of 2008 transplant centers will have made strides to increase their volume, and there will be fewer transplant programs performing less than 10 transplants per year.”

Regulation and Authority

  1. Top of page
  2. Abstract
  3. Does Size Matter?
  4. The Final Rule
  5. Regulation and Authority
  6. Volume Versus Out comes
  7. References

Authority over heart transplant programs has been in a transitional process from the previous National Coverage Determinations (NCD) regulations to the new Conditions of Participation, says Hamilton. Under the NCD, CMS requested via letter that several programs submit Corrective Action Plans, under which those programs now operate. “CMS is tracking and reviewing, on a periodic basis, the volume and outcome data of transplant programs,” he says.

Although federal reimbursement and regulation fall under the purview of CMS, transplant center oversight is also provided by the Membership Professional Standards Committee (MPSC) of OPTN/UNOS. The MPSC meets four times a year to review transplant center data provided by the Scientific Registry of Transplant Recipients. When a program is identified as functionally inactive (e.g., a heart, liver or kidney transplant is not performed within a three-month period), the MPSC sends a letter of inquiry to request confirmation and information, plus an action plan. The time period for corrective action varies according to the specific circumstances, with the worst end point being withdrawal of OPTN/UNOS membership—a designation that usually leads to center closure.

“Historically, the vast majority of these program withdrawals are due to functional inactivity or poor outcomes addressed within the MPSC,” says MPSC staff member David M. Kappus. He explains that a center may withdraw an organ-specific (such as liver or kidney) transplant program from UNOS/OPTN until identified deficiencies are corrected. The center then has the option of reactivating that service.

Volume Versus Out comes

  1. Top of page
  2. Abstract
  3. Does Size Matter?
  4. The Final Rule
  5. Regulation and Authority
  6. Volume Versus Out comes
  7. References

MPSC chairman Robert S.D. Higgins, MD, chairman of cardiovascular-thoracic surgery at Rush University Medical Center in Chicago says, “I think we have to be balanced in our approach and think about the whole story as it relates to quality of care. Setting arbitrary volume numbers without thinking about all the other elements that go into it may or may not be effective in doing that.”

Dr. Higgins's own heart transplant program is one that fell under the CMS minimum in recent years, largely due to personnel changes within the program. At the same time, quality remained high. Between 2004 and 2007, the center reported a relatively low volume but a 100% survival rate. He stresses that an analysis of survival and volume should also take into account patient socioeconomic status, regional distribution and differences, insurance status and underrepresented minorities.

Dr. Conte agrees that some low-volume centers do well, “but all you're seeing is the outcome. What you're not seeing are the patients they turn down because they are high risk, or the organs they turn down. If I were going to start a system tomorrow, I would mandate that programs do 50 transplants a year,” he adds. “But that's not going to happen. Not because of the physicians, but because of the hospital administrators who see this as a way to market their hospital as providing these services.”

Dr. Higgins agrees. “A transplant program has a marquee value, a halo effect, ” he says. “Ultimately, it provides the institution with a sense of being a center of excellence for high-end procedures. I have personally tried to build relationships with other centers, yet institutional autonomy usually prevails.”

Timothy Pruett, MD, president of UNOS/OPTN, puts the volume/outcomes debate into perspective: “The difficulty of trying to say that volume per se is a sole variable oversimplifies the problem. In the long haul, we have to make sure that we continue to encourage access to care. And, with the low-volume centers, we should learn why they are low volume. Is it the transplant center site or the availability of organs? We struggle with these issues, and the general public wants us to come up with reasonable explanations.”

An analysis of survival and volume should also take into account patient socioeconomic status, regional distribution and differences, insurance status, and under-represented minorities

—Robert Higgins, MD

References

  1. Top of page
  2. Abstract
  3. Does Size Matter?
  4. The Final Rule
  5. Regulation and Authority
  6. Volume Versus Out comes
  7. References