CMS Rolls Out New Organ Transplant Rules

CMS on Thursday announced new standards for organ donation programs that would remove federal funding from failing programs, the Los Angeles Times reports. The rules, which took two years to finalize, aim to prevent "poor or marginal performers" from receiving Medicare funding, according to a report that accompanied the new rules.

Under the new rules, transplant programs would be required to do the following to continue to receive funding:

Perform an average of 10 transplants a year;
At least match expected survival rates, accounting for the national average and unique situations in programs and patients;
Reveal to potential recipients how many patients and organs have survived or functioned at least one year after surgery, along with how many were expected to do so;
Notify patients in programs with only one transplant surgeon that the surgeon might not be available at the time of the transplant, in addition to stating whether provisions have been made to find a substitute surgeon (Weber/Ornstein, Los Angeles Times, 3/23);
Use donor advocates to inform living donors about medical and psychological risks; the surgical procedure, including post-operative treatment; and availability of alternative treatments for the recipient;
Use donor advocates to inform living donors that donation-related future health problems might not be covered by the donor's health insurance and that they might have problems obtaining health, disability or life insurance in coming years (Meckler, Wall Street Journal, 3/23); and
Immediately alert Medicare if the program is not meeting these standards.

Under old rules, which were not strictly enforced, heart and liver centers were required to perform 12 transplants annually; lung and intestine centers were required to perform 10; and kidney centers had to perform 15 transplants within four years of opening. Centers also had to meet set survival rates without taking into account complicating factors.

A Times analysis determined that if the new rules were strictly applied today, 64 transplant centers -- nearly 13% of the nation's 500 programs -- would lose approval and funding, including 29 centers for heart transplants, 21 for kidney, seven for liver, six for lung and one for intestinal transplants.

Implementation

The CMS transplant rules will take effect in 90 days. Centers will have six months to seek approval of their programs, and those that do not meet the minimum requirements will have a "reasonable time period" to correct problems. Once approved, centers will be up for review every three years. Medicare officials expect 2% of centers, or 10 per year, to lose certification (Los Angeles Times, 3/23).

Leslie Norwalk, acting administrator of CMS, said, "This is a major milestone in our efforts to make sure that people needing transplants get the best possible care" (Wall Street Journal, 3/23).

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