Medicare wants to improve care while protecting living donors.


New regulations for organ transplantation issued by the Centers for Medicare & Medicaid Services (CMS) emphasize survival rates and protecting the rights of living donors.

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“This is a major milestone in our efforts to make sure that people needing transplants get the best pos-sible care, while giving transplant centers and physicians comprehensive and reliable guidance,” says Leslie V. Norwalk, CMS acting administrator.


The regulations “both improve the current transplant outcome measure requirements and strengthen the protection of the health and safety of patients and living donors,” she adds. Donors must be warned, for example, that they may not be able to obtain health insurance for any complications that may develop later.


Jeffrey S. Crippin, MD, president of the American Society of Transplantation, believes the rules will not necessitate many changes. “The data submission is really not different from what transplant centers do now,” he said.


Mohamed El-Ghoroury, MD, trans- plant services director at St. JohnHospital in Detroit, agrees. “All of the regulations are already being [followed] in medium and large programs,” he says. “They’re just not mandated. The new rules will elevate all programs to the same level and connect documentation to payment.”


The regulations, which set standards for Medicare funding, apply to kidney, heart, lung, liver, and intestine transplant centers and call for certification every three years. They require that:

  • Centers perform at least 10 transplants annually, although new kidney transplant centers may get initial approval if they do three transplants within their first 12 months.
  • The one-year survival rate for both patients and organs at least match expected survival rates
  • as calculated by the United Network for Organ Sharing (UNOS).
  • Potential recipients be told how many patients and organs have survived a year after surgery—and how many were expected to.
  • Centers with only one trans-plant surgeon inform patients of contingency plans should
  • the surgeon be unavailable for the operation.
  • Medicare be notified immediately if the center can’t meet the standards.

Tying funding to survival rates could discourage transplants for high-risk patients, one expert warns. “Outcomes have never been a limiting factor before,” cautions Herwig-Ulf Meier-Kriesche, MD, medical director of renal and pancreatic transplantation at the University of Florida College of Medicine in Gainesville.


“Centers will always have to be aware of where their outcome [status is] at a given moment. They will think hard to build in a certain security margin. They won’t want to come too close and be pushed over the edge.”


Socioeconomic status and comorbidities are the biggest factors in determining outcomes, Dr. Meier-Kriesche observes. “If you go into hospital with private payers and a wealthy patient population you’re going to see good outcomes, as op-posed to an inner-city, poorer population.”


To achieve good outcomes, patients must be able to comply with post-transplant therapeutic regimens. “Often patients in certain populations discover they don’t have the money to pay for their medications,” he says. Innovative surgeries such as ABO incompatible transplants and cross-match positive transplants are intrinsically risky, and centers may be less likely to perform them, he adds.


“The government wants to have more responsible spending. That’s very reasonable. Ultimately, it means they want better outcomes,” Dr. Meier-Kriesche says. “But the government doesn’t want to officially say you can’t give transplants to poor or old people, so they are indirectly shifting responsibility onto the centers.”


Drs. Crippin and El-Ghoroury disagree. The regulations “only hold the centers responsible for one-year graft and patient survivals, not three- or five-year survival,” Dr. El-Ghoroury says. “I don’t think that’s out of line. As a transplant physician, you would want to make sure a patient is likely to survive at least a year before you recommend the transplant in the first place.”


“CMS is not asking for a higher survival rate, just that you meet the expected survival rate,” Dr. Crippin says. “It’s not going to have that much impact, because that’s how centers have operated for some time. Plenty of centers do high-risk transplants and they will continue, even if patients are on Medicare.”


Live-donor protection

The regulations, which took two years to draft, are also the first to protect the interests of living donors. In addition to providing independent advocates for them on the transplant team, the rules detail the information they must be given in order for a person to consent. Donors must be told:

  • About the evaluation process; surgical procedure, including postop treatments; and alternative treatments for the recipient.
  • About their own medical and psychological risks.
  • Outcome statistics, both nationally and at the particular center, for donors and recipients.
  • That future health problems related to the donation may not be covered by insurance, and
  • that they may have trouble get-ting health, disability or life insurance policies.
  • That they can change their mind about donating at any time.

Many centers are already in compliance, Dr. Crippin and Dr. El-Ghoroury say. “There’s been concern about living donors who feel they get pushed into a corner by the system,” Dr. Crippin says. “The point of the requirements and the donor advocate is to ensure they understand that, at any time up to the surgery, they have a chance to say no. It’s not that patients are being railroaded, but CMS is asking for an identifiable process and an identifiable advocate.”


“Again, the new rules mandate what medium and large programs already doing,” Dr. El-Ghoroury says. “They just require documentation, so there’s a clear paper trail when CMS comes in to re-certify.”


For example, St. John has an orientation program in place for prospective donors. The big change will be drafting a specific consent form, says Dr. El-Ghoroury, who de-scribed St. JohnHospital’s 60 transplants a year as a medium-sized program. The hospital had been using a general informed-surgical-consent document.


Neither doctor expects the rules to discourage many living donors. “If they have a clear understanding of process, maybe some patients will say no,” Dr. Crippin says. “My feeling is it won’t drop by anything like 50%, but we may lose a few.”