In 1985 the Task Force on Organ Transplantation, which was created by the National Organ Transplant Act in 1984, recommended in its report to Congress that it pay for coverage of immunosuppressive drugs for kidney transplants and discussed in detail alternatives for access to immunosuppressive medications. The Task Force determined that 25% of the transplant population had no private insurance or Medicaid coverage for immunosuppression. The Task Force also concluded that this factor influenced the selection of patients for kidney transplants. The recommendations were limited to kidney transplants because at that time Medicare only covered kidney transplants, but the report recommended that, should the federal government fund other organ transplants in the future, coverage for immunosuppressive medications should be included for those transplant types as well.

In addition, the report recommended that private insurance cover the cost of medications. Medicare began covering kidney transplants and dialysis in 1973 when Congress amended the Social Security Act and created the ESRD Program. Medicare eventually began covering heart transplants in 1987, liver transplants in 1991, and lung transplants in 1995 for those recipients receiving Social Security Disability Income (SSDI) or Social Security Retirement (SSR) after age 65. Coverage for pancreas transplants was added to the ESRD Program in 1999.

In 1986, Congress directed Medicare to begin funding 80% of the cost of immunosuppressive drugs for one year following a kidney transplant under Medicare Part B. But as more recipients with functioning grafts exceeded the one-year post-transplant milestone, those on Medicare were without coverage due to the time limit on their immunosuppressive benefit. Congress was persuaded to phase in additional coverage to 36 months by 1995. The immunosuppressive medication coverage was extended further to 44 months in 2000, but only for those Medicare beneficiaries currently entitled to Medicare due to disability or age 65 or over. Kidney transplant recipients who were entitled to Medicare solely as the result of their ESRD were always limited to Medicare entitlement for only three years post transplant. Therefore, kidney transplant recipients not entitled to Medicare because of SSDI or who are not age 65 by the time their ESRD-Medicare terminates are limited to 36 months of medication coverage. The medication benefit ends when the kidney transplant recipient is no longer entitled to Medicare (36 months). Recipients of heart, lung, and liver transplants must have been enrolled in Medicare and have had Medicare pay for the transplant to be eligible for the immunosuppressive drug benefit. Social Security Retirement (SSR) recipients between the ages of 62-65 years old are not entitled to Medicare and therefore do not have the immunosuppressive medication benefit.

Understanding the Benefit

The impact of the new Medicare immunosuppressive drug benefit can probably best be understood by examining several different patient scenarios:

* Over 65, SSR: Kidney, heart, lung, or liver transplant. A patient is 66 years old and is entitled to Medicare because she receives Social Security Retirement and is over 65 years old. The patient receives a transplant that is paid for by Medicare. She will have the Medicare immunosuppressive medication benefit for the life of her transplant.

* Any age, Medicare: Transplant several years ago. If Medicare originally paid for the transplant and the recipient has continued to be Medicare eligible but lost the immunosuppressive drug benefit due to a previous time limit, then he or she would be eligible to have the benefit restored.

* Under 65, SSDI: Heart, lung, or liver transplant. A young person receives a heart, lung or liver transplant. The recipient has Medicare because he has received Social Security Disability Income for over two years. Medicare pays for the transplant and as a result the recipient receives the immunosuppressive medication benefit for as long as he is entitled to Medicare due to disability or age.

* Under 65, ESRD-Medicare: Kidney transplant. A young person receives dialysis treatment for three years before receiving a kidney transplant. Medicare is now primary and the employer group insurance is secondary. The Medicare immunosuppressive drug benefit covers the first 80% of costs and the employer group insurance should cover the remainder. This recipient will lose the ESRD Medicare entitlement three years following transplant. Unless this recipient becomes eligible for Medicare due to Social Security Disability Income, he will not have the Medicare medication benefit again until he receives SSR Medicare at 65 years old.

* Under 65, gap in Medicare: Medicare paid for kidney transplant. If the recipient was originally entitled to Medicare as a result of ESRD and later began to receive SSDI, there may be a gap in Medicare coverage at three years post transplant, since individuals receiving SSDI must wait two years for their Medicare entitlement due to disability. Recipients should contact the Social Security Administration or their Medicare pharmacy regarding their specific circumstances.

* Under 65, no ESRD-Medicare: Kidney transplant. A young person receives a kidney transplant before initiating dialysis. His employer group insurance is the primary payer and his ESRD-Medicare is secondary. Since the employer group insurance is paying for the immunosuppressive medications, Medicare pays nothing. The ESRD-Medicare entitlement, and the immunosuppressive medication benefit, will end three years after transplant. Since the recipient is working and not disabled, he will not be eligible for Medicare coverage and the medication benefit again until he becomes entitled to SSR-Medicare (at age 65 years old).

* Almost 65, ESRD-Medicare: Kidney transplant. A patient in his early 50s receives dialysis for three years and then receives a kidney transplant at 59 years old. Medicare is primary and the employer group is secondary. The ESRD Medicare entitlement and the immunosuppressive medication benefit end three years following the transplant. Unless the recipient continues coverage under his employer group insurance, he will need to pay out of pocket. If the recipient becomes eligible for Medicare as the result of Social Security Disability Income, then he will continue to have the immunosuppressive medication benefit because he will later become entitled to Social Security Retirement at 65 years old.

* Under 65, no Medicare: Heart, lung or liver transplant. A young person receives a heart, lung, or liver transplant. The transplant is covered by the employer group insurance or Medicaid, but the patient does not have Medicare. Several years later the patient becomes entitled to Medicare because she receives Social Security Disability Income. This recipient is not eligible for the immunosuppressive medication benefit because Medicare did not pay for the transplant.

The effective date of the extended immunosuppressive drug coverage was December 21, 2000 when it was signed by then-President Clinton. However, the implementation date of the coverage was April 1, 2001. Although claims cannot be processed until after April 1, they can be filed immediately and will be retroactive to December 21, 2000. According to estimates from the Institute of Medicine, more than 34,000 Medicare beneficiaries will have extended immunosuppressive drug coverage in 2001, growing to more than 44,500 people in 2004. The BIPA does not expand Medicare entitlement to more people; it extends a benefit for those already entitled to Medicare. It extended the Medicare immunosuppressive medication benefit to cover the most vulnerable – the aged and disabled. Expanding the entitlement to those who have lost or never had Medicare, because they do not receive Social Security Disability Income or Social Security Retirement, is much more problematic. But the National Kidney Foundation has pledged to make this a goal to pursue.

Who REALLY gets lifetime drug coverage?

One of the issues remaining for the transplant recipient is: How will he or she pay for or obtain all of the medications needed after the transplant (not just the immunosuppression)? This has become a very important issue, since one of the leading causes of transplant failure is “non adherence” with medication. As a result, transplant centers continue to be pressured to select transplant candidates who will take their medication as directed post transplant. But how can transplant recipients take their medications as prescribed if they can’t obtain them?

Studies have shown that transplant patients are more likely to be adherent with their immunosuppression than with their other medications. This is probably the result of the importance placed on immunosuppression and the extended Medicare coverage for the medication. But with the increased side effects of immunosuppression, other medications that are designed to treat these side effects are becoming just as important. As the Task Force on Organ Transplantation reported to Congress in 1985, patient selection for transplant continues to be impacted by the availability of medications following transplant, not just the immunosuppression. There are reports that some transplant centers are requiring proof of ability to pay for ancillary medications before the patient will be considered for transplant. Many patients have employer group or individual health insurance plans that provide low co-payment and affordability of medications. Other patients are enrolled in state Medicaid and local public health programs that also provide medications. Others can receive their medication from federal programs such as military and Veteran’s Administration hospitals or Indian Health Services. These patients rarely have difficulty obtaining their medications, at least in the short term. Others receive their medications from state or charitable organizations, but these funds are having difficulty meeting the demand. However, some Medicare beneficiaries continue to have challenges obtaining their transplant medications. This group includes patients who were privately insured at the time of their transplant but later became eligible for Medicare and are not eligible for the immunosuppressive medication benefit. It also includes recipients who are enrolled in Medicare HMOs with limited medication coverage. The recipient with Medicare and no secondary insurance must cope with the 20% of the cost of their immunosuppressive medications not covered by Medicare, approximately $300-$400 per month. The other medications that transplant recipients must take in addition to anti-rejection drugs may total $1,000 to $3,000 per month. What can be done for this group?

Fortunately, the pharmaceutical companies have created patient assistance programs to provide their specific medication to patients who are without insurance or other methods to pay for them. Although these programs were designed as providers “of last resort,” they have made it possible for thousands of transplant patients to obtain medications that they would otherwise not have received. Unfortunately, many of these patients are now dependent on these programs and there are no other resources available. The accompanying application forms, eligibility rules, and re-enrollment processes of the pharmaceutical companies are inefficient and have created an unexpected workload on transplant centers and physician’s offices. And there does not appear to be an end in sight. In some areas, transplant centers have become so overwhelmed by the eligibility forms and constant re-enrollment deadlines that they are ruling out these marginally covered patients.

Perhaps it is time for a new public-private partnership. The United Network for Organ Sharing (UNOS), in partnership with the HHS Division of Transplantation, is currently examining the problems of access to transplantation – in particular for those from lower socioeconomic groups and racial and ethnic minorities. One suggestion under consideration is the development of a task force between UNOS, HHS, industry organizations, and other community organizations such as the National Kidney Foundation to review and make recommendations regarding the patient assistance programs. The burden on transplant patients, their physicians, and transplant centers could be significantly relieved if the entire process could be simplified. The development of one form, consistent eligibility criteria, and a standardized re-enrollment process developed jointly between the pharmaceutical companies and UNOS and NKF would significantly improve access to transplantation.

The public-private partnership was effective in extending Medicare coverage for immunosuppressive medications. It could also be helpful in addressing the remaining medication needs of transplant recipients. – Charlie Thomas