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            Florida Medicare Coverage of Immunosuppresive Drugs

Medicare Immunosuppressive Drug & Vitamin Supplier

 

After you get a kidney transplant, you will need to take immunosuppressive drugs for the rest of your life. How Medicare covers immunosuppressive drugs after your transplant depends on why you are entitled to Medicare and when you received your transplant.

Medicare Part B will cover your immunosuppressive drugs after a kidney transplant once you leave the hospital for the rest of your life if:

  • You had Part A when you got the kidney transplant
  • You got the transplant in a Medicare-covered facility
  • You qualify for Medicare based on age or disability and have Part B when you get the drug

Medicare Part B will cover your immunosuppressive drugs after you leave the hospital following a kidney transplant for 36 months if:

  • You had Part A when you got the transplant
  • You got it at a Medicare-certified facility
  • You have Medicare Part B when you get the prescription filled and
  • You are entitled to Medicare solely because of ESRD: If you have had a successful kidney transplant, your Medicare coverage will end 36 months after you had the transplant and Medicare will no longer cover your immunosuppressive drugs. A transplant is considered successful if it lasts for 36 months without rejection.

Note: If you did not have Medicare when you had a transplant, you can enroll retroactively in Part A if it is within a year of your transplant.

Medicare Part D coverage

Part D will cover your immunosuppressive drugs for ESRD if they are not covered by Part B because you did not have Medicare at the time of your kidney transplant. All Part D formularies must include immunosuppressive drugs. Step therapy is not allowed once you are stabilized on your immunosuppressant drug. However, prior authorization can apply to verify that Part B won’t cover your drugs even after you are stabilized on them. Double-check to make sure the drugs you need are covered with the fewest restrictions and that your plan includes your pharmacy as a preferred network pharmacy.

If you have employer coverage 

If you have employer insurance (current employer, retiree or COBRA) Medicare coverage of immunosuppressant drugs might be different. For the first 30 months of your Medicare eligibility, your employer insurance will pay primary and Medicare will pay secondary. This means that your employer insurance should cover the cost of your immunosuppressive drugs until you reach the end of your 30-month coordination period and Medicare begins to pay first. If you are unsure about how Medicare will work with your employer insurance, contact your employer’s benefits administrator or call 1-800-MEDICARE.

Vitamins for dialysis patients

After each dialysis session, someone with ESRD needs to take various vitamins since dialysis removes vitamins from the blood. Medicare will not usually cover these vitamin supplements.

  • Part B does not provide coverage for vitamins.
  • If the vitamins require a prescription, Part D plans with basic coverage will not cover them.  However, some Part D plans offer enhanced coverage that specifically covers these vitamins. You typically pay more for enhanced Part D plans. Make sure you check the plan formulary and contact the plan before joining to ensure it will cover all the vitamins you need. You should confirm each year, during Fall Open Enrollment that the plan will continue to cover your vitamins.

The Medicare Prescription Drug Benefit Manual mandates that Part D plan sponsors include all or substantially all immunosuppressant drugs on their formularies. However, presence of a drug on a plan formulary does not mean the drug will be approved for coverage for an individual beneficiary. 

The Medicare Prescription Drug Benefit Manual mandates that Part D plan sponsors approve coverage for drugs when they are used for a medically accepted indication. Medically accepted indications are defined as those per FDA-approved indications or as supported by CMS-approved compendia. 

While the FDA-approved indications and CMS-approved compendia mention some transplant indications for immunosuppressant drugs, they do not allow for all clinically appropriate uses. 

Three key patient populations are currently suffering as a result of these coverage gaps. Affected patients are those who rely on Medicare Part D coverage for their immunosuppressant drugs and: 

  • Have a lung transplant. Every lung transplant recipient requires immunosuppressant drugs to avoid rejection, maintain lung function, and survive. No immunosuppressant drug is FDA-approved for lung transplant and only tacrolimus and cyclosporine are listed in the CMS-approved compendia as appropriate for off-label use in lung transplant. 
  • Have a heart transplant complicated by cardiac allograft vasculopathy (CAV; a type of chronic rejection). The International Society for Heart and Lung Transplantation recommends using sirolimus or everolimus for treatment of CAV. Neither of these medications are FDA-approved or listed in the CMS-approved compendia for this use. 
  • Have a transplant of any type complicated by an inability to take traditional immunosuppressant drugs. Each immunosuppressant drug carries a risk for unique side effects, and patients occasionally cannot tolerate the preferred medication or regimen. Restricting use to indications that are FDA-approved or mentioned in the CMS-approved compendia severely limits treatment options for patients who struggle with immunosuppressant drug toxicities. 

How Many People Are Affected?

72.3% of liver transplant recipients, 65.3% of heart transplant recipients, and 59.7% of lung transplant recipients have insurance other than Medicare at the time of their transplant. When these patients turn 65 and become eligible for Medicare, they will rely on Medicare Part D Plans for immunosuppressant drug coverage and will be at risk for coverage denials for their life-saving medications. 

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