Extending Medicare Coverage for Preventive and Other Services (2000) / Chapter Skim
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5 Immunosuppressive Drugs for Transplant Patients
5 Immunosuppressive Drugs for Transplant Patients
Pages 99-126
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From page 99... ...
Immunosuppressive drugs are essential for these dual protections, but their high cost means that most transplant recipients need financial assistance to pay for them. Immunosuppressive drugs prescribed to recipients of solid organ transplants represent one of the few exceptions to the statutory exclusion of Medicare coverage for outpatient drugs.
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From page 100... ...
As this chapter and Appendix D describe, the former is well documented but the latter is not. The special status of immunosuppressive drugs for transplant recipients has evolved through a complex series of incremental exceptions to the basic framework of Medicare coverage established in 1965.
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From page 101... ...
Likewise, immunosuppressive therapy became much more expensive, in part because the new drug regimens were very costly to patients and in part because the drugs would be used for many years as survival times lengthened. As the combination of the longer survival of transplant recipients and the heavy financial burden for immunosuppressive drugs became increasingly understood, Congress in 1986 authorized Medicare coverage of immunosuppressive drugs for one year following a Medicare-covered transplant.2 This coverage was extended to three years (on a phased-in basis)
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From page 102... ...
This would limit Medicare costs but continue to discourage employment and provide an incentive for transplant recipients to establish and maintain eligibility for coverage by reason of disability. ASSESSMENT APPROACH Following the approach described in Chapter 2, the committee explored the evidence base related to the effectiveness of immunosuppressive drugs and the effect of current time limits on Medicare's coverage of these drugs.
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From page 103... ...
103 ICY so ~ .6 ~ Ct .5 C ~ 50 o .
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From page 104... ...
, nearly two-thirds of those receiving kidney transplants had glomerular diseases (diseases of the basic filtering unit of the kidney) , diabetes, or hypertensive nephrosclerosis.
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From page 105... ...
It has also created a new but almost always more tolerable—type of burden, the continued need for immunosuppression to manage the continued risk of graft rejection. Need for Immunosuppression As described in more detail in Appendix D, Part 1, it quickly became apparent based on observations from animal research and early organ transplants in humans that the survival and functioning of grafted organs required suppression of the recipient's natural immune response to the graft.
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From page 106... ...
Most patients, however, cannot cease immunosuppressive therapy without serious risk of graft rejection.3 Although research has demonstrated the effectiveness of immunosuppressive drugs, they are not 100 percent effective. Some patients still experience acute rejection of their graft despite immunosuppressive therapy, and others suffer chronic rejection that may eventually lead to graft failure.4 Acute rejection is most common in the first few months after the transplant.
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From page 107... ...
Waiting Lists for Transplantation The increased transplant success rate has meant that renal transplantation became a better treatment for ESRD than dialysis. For kidneys and other organs as well, increased success has made the supply of donated organs a critical concern.
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From page 108... ...
108 Cq V: Cal U
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From page 109... ...
More than two-thirds of transplant recipients now survive at least five years. Of the four classes of drugs that have contributed to the major improvements in graft and patient survival in recent years, products in one class (antilymphocyte agents)
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From page 110... ...
The major benefits of immunosuppressive drugs for transplant recipients are clear: longer survival and improved quality of life (Wolfe et al., 1999~. A functioning renal graft has the great advantage of working all the time, rather than periodically like dialysis, so the transplant patient generally feels healthier and has fewer dietary restrictions.
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From page 111... ...
A study cited earlier from one transplant center suggests that noncompliance is a significantly more important cause of graft loss in patients who have had a successful transplant than has previously been appreciated (Gaston, 1998~. The compliance responsibilities of transplant patients are formidable.
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From page 112... ...
This suggests that compliance might be increased by more frequent contact with health care workers.7 Maintaining such contact may be a greater problem for those renal transplant recipients who reach not only the three-year coverage limit for immunosuppressive drugs but also the three-year limit on Medicare coverage overall, including coverage for physician visits.8 Patient compliance is a concern in many areas of medicine, not just transplantation. Urquhart (1996)
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From page 113... ...
Any additional problems, infections, or side effects would result in additional costs. An important question for this study is whether longer coverage of immunosuppressive drugs will result in better outcomes for transplant recipients.
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From page 114... ...
Some patients may be able to work and find employment that offers health benefits. However, the structure of existing public programs provides incentives for patients to retain their status as disabled to avoid losing Medicare coverage.
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From page 115... ...
Not surprisingly, no randomized studies compare the results for patients provided coverage and those not provided coverage for immunosuppressive drugs. One analysis based on a sample of 1990 Medicare records for 7,949 renal transplant patients showed that the rate of graft loss decreased steeply during the first six months after the operation (risk of rejection is highest just after the operation is performed)
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From page 116... ...
Medicare pays expenses of care, during rejection, $54,217 per year l EXTENDING MEDICARE COVERAGE Patient finds funding and may keep kidney, but may have impoverished family 1 1 1 \ \ _ Medicare maintenance ends, patient searches for other funding 3 years pass after transplant | Medicare pays maintenance; l | $8,905 per year l 1 1 I Patient receives kidney transplant, Medicare pays $92,100 per year in year of operation I Patient begins dialysis, goes on organ waiting list Patient has ESRD, loses kidney function / FIGURE 5-2 Possible consequences when a Medicare-eligible kidney transplant patient reaches the end of coverage and cannot locate other funds for immunosuppressive drugs. NOTE: Amounts represent costs to Medicare per patient in 1994.
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From page 117... ...
When Medicare coverage was available for only one year, the high- and low-income transplant recipients had similar rates of graft survival at one year, but the high-income group had significantly better rates of graft survival at three years. When Medicare coverage was extended to three years, the high- and low-income groups had similar rates of survival at both one and three years posttransplant (Woodward et al., 1999~.
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From page 118... ...
The Balanced Budget Act of 1997 provided that the Health Care Financing Administration limit payments to the lower of the billed charge or 95 percent of the average wholesale price. Congress could also establish a cap on Medicare payments per patient per year, with patients responsible for any amounts over the cap.
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From page 119... ...
It includes one estimate that assumes coverage for immunosuppressive drugs is extended only for transplant recipients eligible for Medicare by reason of age or disability. A second estimate assumes that the drug coverage is also extended for currently covered "ESRD only" renal transplant recipients who lose other Medicare coverage after three years because they are not either disabled or at least age 65.
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From page 121... ...
The cost estimates assume that only a subset of renal transplant recipients who suffer graft failure after three years do so for reasons related to cost. As described earlier and in Appendix D, various factors contribute to graft rejection including lack of patient adherence to demanding drug regimens.
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From page 122... ...
The committee was not asked to estimate savings to the federal-state Medicaid program that might result from elimination of Medicare's time limit on immunosuppressive drugs. In 1996, the CBO estimated that the federal share of Medicaid expenditures for Medicare-Medicaid-eligible beneficiaries would be reduced $6 million per year in 2000 and 2001 if the time limit on coverage of immunosuppressive drugs was eliminated for Medicare-eligible transplant patients (CBO, 1996~.
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From page 123... ...
In Kidney Failure and the Federal Government, the IOM committee then in place recommended that all ESRD patients who are citizens or resident aliens of the United States be eligible for Medicare coverage, that the time limit on coverage for immunosuppressive drugs be eliminated, and that other Medicare benefits also be extended to these patients without time limits. The earlier report did not address transplants of organs other than the kidney.
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From page 124... ...
The committee found strong evidence that organ transplants, the majority of which are kidney transplants, are increasingly common, with more than 20,000 performed per year and approximately 80,000 patients now living with functioning grafts. The committee found further strong evidence that virtually all transplant recipients require immunosuppressive drugs to avoid immunologic rejection of their grafts.
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From page 125... ...
Several other recent publications report encouraging results with telephone and/or other electronic contacts both to monitor clinical signs and to encourage compliance with drug regimens (Alemi et al., 1996, Finkelstein et al., 1996; Friedman et al., 1996, 1998, Hetzer et al., 1998~; although other reports indicate that some applications have been less successful with some patient groups (Alemi et al., 1997~. The committee also encourages the National Kidney Foundation and George Mason University in their survey of kidney transplant patients.
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From page 126... ...
Given this evidence and the existing Medicare policy of supporting organ transplants, the rationale for eliminating the current time limits for coverage of immunosuppressive drugs for all solid organ transplant recipients is strong. Although people who lose coverage often find ways to obtain sufficient drugs to maintain immunosuppression, experience and limited evidence suggest that some grafts and some lives are eventually lost for lack of coverage.
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