Kidney Transplant

This model focuses on providing incentives to selected kidney transplant hospitals to increase transplantation and is designed to support greater care coordination, improved patient-centeredness in the process of being waitlisted for and receiving a kidney transplant, and greater access to kidney transplants.

Through the IOTA Model payments and policies, CMS aims to increase the care delivery capabilities and efficiency of kidney transplant hospitals selected for participation, with the goal of improving quality of care while reducing unnecessary spending. The IOTA Model only affects payments in Original Medicare and does not affect payments or services for Medicare Advantage Plans, Medicare Prescription Drug Plans, or private health insurance plans.

As a patient, the IOTA Model does not change your existing Medicare benefits, choices, or protections. We cannot limit your choice of health care providers or Medicare-covered medically necessary services or treatment options. You still have the right to visit any doctor, hospital, or other provider that accepts Original Medicare at any time, just like you do now.

Medicare shares information about your care with your health care providers such as dates and times you visited a health care provider and your medical conditions. Sharing your data helps make sure all the providers involved in your care have access to your health information when and where they need it.

We value your privacy. IOTA participants must put important safeguards in place to make sure all your health care information is safe. We respect your choice on how your health care information is used for care coordination and quality improvement.

If you don’t want Medicare to share your health care data information, call 1-800-MEDICARE (1-800-633-4227). Tell the representative that your health care provider is part of the IOTA Model, and you don’t want Medicare to share your health care information. Beneficiaries who are deaf, hard of hearing, deaf-blind, or have speech disabilities should call 1-877-486-2048.

As a Medicare patient, you can choose or change your provider at any time. Your nephrologist is the health care provider responsible for coordinating your overall care for your kidney-related disease. Your nephrologist can help you make informed decisions about your health care, track your treatment, and monitor your health outcomes.

If you have questions or concerns about the quality of care or other services you receive from your provider, you can contact 1-800-MEDICARE (1-800-633-4227). TTY users can call 1-877-486-2048. You may also visit the website: https://www.Medicare.gov.

If you suspect Medicare fraud or abuse from your IOTA provider or any Medicare provider, we encourage you to make a report by contacting the HHS Office of Inspector General (1-800-HHS-TIPS).

If you believe your privacy rights have been violated, you may file a privacy complaint with CMS (visit Medicare.gov, or call 1-800-MEDICARE) or with the U.S. Department of Health and Human Services (HHS), Office for Civil Rights (visit hhs.gov/hipaa/filing-a-complaint). Filing a complaint won’t affect your coverage under Medicare.

Inclusion criteria:

• Diagnosis of irreversible kidney failure classified as CKD stage IV or V.
• Underlying kidney diseases/conditions associated with the need for kidney transplant may include hypertension, diabetes, glomerulonephritis, systemic lupus erythematosus, polycystic kidney disease, Goodpasture’s syndrome, chronic pyelonephritis, interstitial nephritis, post-streptococcal glomerulonephritis, Wegener’s granulomatosis, hemolytic uremic syndrome, unresolved acute tubular necrosis, focal segmental glomerulosclerosis, membranous glomerulonephritis, IgA nephropathy, drug toxicity, and other chronic irreversible kidney failure conditions.
• Kidney transplantation is indicated when chronic irreversible kidney failure is diagnosed.
• Patients are generally considered for evaluation when creatinine clearance is less than 30 cc/minute.
• Patients begin to accrue waiting time when creatinine clearance is less than 20 cc/minute.
• Patients usually require dialysis when creatinine clearance is less than 10 cc/minute.
• The patient’s likelihood of compromised quality of life is significantly greater without transplantation than with transplantation.
• The condition that led to the patient’s kidney problem is unlikely to cause rapid deterioration of the newly transplanted kidney.
• Following successful transplantation, the patient will be able to rehabilitate and return to a functional status that provides improved quality of life consistent with the expectations of the patient and family.
• No systemic illness exists independent of kidney dysfunction that would severely compromise survival.
• All alternative medical and surgical therapies have been considered and excluded as suitable options to improve quality of life.Adequate social, family, and financial support exists to support the patient in all phases of transplantation.

Relative contraindications:

• Severe malnutrition, including poor wound healing or risk of cutaneous infection.
• Functional status that impairs the individual’s ability to perform activities of daily living.
• Active alcohol or illegal substance abuse, or prior alcohol or illegal substance abuse with less than 6 months abstinence and without successful rehabilitation and continuing aftercare; alcohol or substance abuse consult may be required.
• Inability to understand the procedure and potential risks associated with it.
• History of non-compliance with medical care felt by the transplant team to be severe enough to adversely affect clinical outcomes.
• Inadequate funding for any part of the transplant process, including post-transplant housing, medications, and ancillary support as determined by the transplant team.
• Inadequate support system to assist with care before and after transplant.
• Current psychiatric disorder, especially one likely to interfere with compliance.
• Poor life expectancy due to other medical conditions.
• Diagnosis of HIV.
• Peripheral vascular disease.
• Pulmonary hypertension.
• Thrombotic microangiopathy.
• Calciphylaxis.
• Child’s A cirrhosis of the liver.
• BMI greater than 40 kg/m2 with comorbidities.
• Atypical Hemolytic-Uremic Syndrome (aHUS).
• Treated or controlled sickle cell disease.
• Lives more than 9 hours of driving distance from the transplanting center.

Absolute contraindications:

• Malignancy within the past 2 years, other than certain tumors such as skin or kidney.
• Active infections the medical team deems would affect the outcome of the transplant.
• Active immunological diseases such as Wegener’s, lupus, and Goodpasture’s syndrome.
• Child’s B/C cirrhosis with documented portal hypertension.
• Cardiovascular or pulmonary disease sufficiently severe to preclude surgery.
• Uncontrolled sickle cell disease.
• Severe osteoporosis with symptomatic compression fractures.
• Neurological diagnosis or impairment that would prevent successful post-transplant outcomes.
• Ongoing illegal substance abuse that will impact the success of kidney transplant.
• BMI greater than 45 kg/m2 for any patient.
• Severe peripheral vascular disease.