2004S-0170 - Medicare Prescription Drug, Improvement, and Modernization Act of 2003, Section 1013: Suggest Priority Topics for Research
FDA Comment Number : EC1
Submitter : Dr. Mark Schnitzler Date & Time: 04/19/2004 03:04:59
Organization : Washington University
Category :
Issue Areas/Comments
It has been shown that organ transplant recipients face considerable consequences if they fail to or are unable to properly take their prescribed immunosuppressive medications. (For a review of this see Butler, Roderick, Mullee, Mason, and Peveler. Transplantation 2004;77:769-777.) We know that economic constraints contribute to perhaps 50% of the inability to take medications as prescribed. (See Chisholm. Drugs 2002; 62(4): 567-575; Kory Transplant Proc 1999; 31: 14-15S; Kennedy, and Erb. Am J Public Health. 2002 Jul;92(7):1120-4; Paris W, Dunham S, Sebastian A, Jacobs C, Nour B. J Transpl Coord 1999 Sep;9(3):149-52.) We have shown that the end of immunosuppression coverage is associated with considerable risk of kidney transplant failure, return to dialysis and death. (Woodward, Schnitzler, Lowell, Spitznagel, Brennan. Am J Transplantation 2001;1:69-73.) We have also shown that it would be cost-effective and in the best interests of society to guarantee life- time coverage of immunosuppression for kidney transplant recipients. (See Yen, Hardinger, Brennan, and Schnitzler. Am J Transplantation 2003;3(S5):334.) This is driven by the tremendous expense associated with returning a kidney transplant recipient to dialysis coupled with the fact that return to dialysis makes an uninsured kidney transplant recipient Medicare eligible again. Therefore, if administered properly, perhaps as secondary coverage, guaranteed life-time immunosuppression coverage may in fact reduce the Medicare budget while preserving transplant function and saving the lives of transplant recipients.

Under previous law as well as the Medicare Prescription Drug, Improvement, and Modernization Act of 2003, the guarantee of immunosuppression coverage ends with the end of Medicare eligibility. Patients are at risk of periods when personal economic constraints may lead to failure to properly take prescribed immunosuppression. Further, the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 provides more extensive coverage than previously available to transplant recipients, coving a wide array of the expensive medications these patients require. As such, loss of eligibility is expected to create a greater economic shock for a transplant patient perhaps placing them at greater risk of failing to take prescribed medications.

Observational, theoretical, and interventional research is required to understand the interaction between the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 and Medicare coverage limitations as they impact the transplant population, both for kidney recipients and Medicare eligible recipients of other organ transplants. This also raises the question of life-time coverage for non- immunosuppressants in transplant recipients. Although limited action has been taken on existing opportunities to mitigate the negative impact of coverage limitations, these opportunities have been shown to exist. Finally, evaluation of changes in existing opportunities in the design of Medicare requlations and identification of new opportunities is required if we are to most efficiently and effectively administer health coverage to transplant recipients.