Thursday, October 27, 2016

Organ recipients share their experiences with FDA to promote innovation in immunosuppressive therapies

Organ recipients share their experiences with FDA to promote innovation in immunosuppressive therapies

By Kevin Longino, CEO and Leilah Sampson, Kidney Advocacy Committee Patient Liaison
leilah-sampson-and-kevin-longino-9-28-16As kidney transplant recipients and advocates we were enthusiastic and hopeful to learn that the Food and Drug Administration (FDA) had scheduled a public meeting for organ transplant recipients to share their experiences with scientists and decisions makers in new drug development as part of the Patient Focused Drug Development Initiative.  For the past few years the National Kidney Foundation (NKF) has advocated for FDA to include organ recipients as part of this initiative, so we were pleased that our advocacy efforts were successful.  However, we also know following the meeting much more advocacy will be needed to advance solutions to the issues that organ recipients raised during the meeting and the National Kidney Foundation is committed to this effort.  First and foremost, if you are reading this and have not submitted your own comments on the questions raised during the meeting you can do so here.  Additionally, since we were selected as panelists we wanted to share our thoughts and experiences at the meeting.
Prior to the event, we were asked to respond to ten questions divided into two topics on life post organ transplant. The first topic was titled, “Disease Symptoms and Daily Impacts That Matter Most to Patients”.  This topic focused mainly on how your symptoms (post transplant) affected you emotionally and physically in completing daily tasks. The second topic titled, “Patients’ Perspectives on Transplant and Treatment Options” focused more on how you are managing your post transplant treatment regimen. As we mentioned, you can submit your own responses to these questions as well and we encourage you to do so.
Leilah participated in the panel on topic one, as one of five panelists and the only adult kidney transplant recipient alongside of the Pediatric kidney representative and lung, liver, and heart recipients.  In preparation for the meeting, Leilah met with FDA staff in charge of the meeting who expressed appreciation for her honesty about her post transplant experience not being “rainbows and sunshine”, but more so trial and error. They also felt because she was a transplant newbie; she could represent a fresh perspective that would help balance the other seasoned panelists perspectives. FDA briefed Leilah on what to expect when she arrived and to prepare a narrative style version of her comments (as patients get nervous on the panel). Leilah set the intention for her speech to reflect her life of self compassion and honoring her transplant process.
When we arrived at the campus we were appreciative to see so many patients, caregivers, researchers and FDA staff all committed to hearing the voices of organ transplant recipients. The first half of the day was all patient discussion on comorbidities, daily challenges, medications and side-effects post-transplant. Many recipients, like Leilah, shared their experiences having depression and anxiety post transplant. Many also highlighted social stigma as the public expecting them to be “cured” from disease with their new organ, when in reality the need to take multiple medications at specific times of the day, and that had various side-effects reminded them they were still not “normal”. Some participants indicated hesitancy to discuss symptoms post transplant with their healthcare professionals as they had received comments back that they should learn to adapt and instead focus on the fact they were still alive and no longer on dialysis.
Polling questions were asked of the audience and multiple choice responses given as options, but throughout the polling there were a significant number of patients who experienced challenges not captured by the multiple choice responses and instead indicated “other” experiences during the polling.  Some of the comments raised in those “other” categories included: fear of rejection, but also fear of infection, skin cancer, and other cancers due to immunosuppression therapies – many participants had also experienced these complications.
The addition of the afternoon sessions was different than past PFDD meetings for other conditions. The afternoon included scientific presentations and panels on non-adherence to transplant regimens and interventions to improve adherence.  Most of the patients participating in person indicated that while they faced challenges with taking multiple medications, overall they were adherent. Although they also recognized they were perhaps not reflective of all organ transplant recipients.  Webinar participants indicated through polling a greater difficulty with adherence than those participating in person. We and other participants discussed how we were active in working with our care team to modify dosing of medications to reduce side effects.  Kevin specifically indicated a need to have personalized immunosuppressive regimens, which could improve both adherence and reduce side effects.  We and other participants also acknowledged a need for greater psychosocial support from our care team post-transplant.  Of course, we were all supportive of one organ recipient’s comment on the need to have one magic combination pill that we only have to take once a day – oh and it could come with no side effects too.
We were surprised to see so little interaction from the FDA staff. They fulfilled their duty of hearing the voices of the patients. After a long day of discussions, presentations, and polling about symptoms and the impact of organ transplant regimens on patients; we left better educated but even more motivated. More importantly, we left with the obligation to spread what we learned from the research and opinions of other seasoned organ transplant patients to the pre-transplant community. I think we all agreed that laying the foundation for post-transplant life begins with implementing support and coping skills long before transplantation occurs. Although we have only scratched the surface of trying to understand how to better support organ transplant patients; we are pleased to know that the FDA, among many other organizations, are opening their ears to hear from us – the patients.  If you are an organ recipient please do take the time to send your responses to the FDA by November 27, 2017, they are listening and comments will be included in the final report.  You can also view the presentations and listen to the recorded meeting here.

Tuesday, October 18, 2016


Please sign and share:
Pass The Comprehensive Immunosuppressive Drug Coverage for Kidney Transplant Patients Act !
From the NKF:
On September 22nd, Representatives Burgess (R-TX), Kind (D-WI), Harper (R-MI), Meehan (R-PA), Herrerra Beutler (R-WA), Cooper (D-TN), Griffith (R-VA), and McDermott (D-WA) re-introduced the Comprehensive Immunosuppressive Drug Coverage for Kidney Transplant Patients Act (H.R. 6139).  H.R. 6139 will serve as a safety net by assisting kidney transplant recipients obtain the life-saving immunosuppressive medications that are necessary to maintain the viability of their new transplant.
Individuals with end-stage renal disease (ESRD), who require dialysis or a transplant to survive, are eligible for Medicare regardless of age or other disability.  If these ESRD patients remain on dialysis, there is no time limit on their Medicare eligibility.  However, despite quality of life benefits and the cost-effectiveness associated with transplantation compared to kidney dialysis, recipients who are not aged or disabled retain Medicare eligibility only for 36 months following their transplant.  As a result, they often face the challenge of finding affordable coverage that allows them to obtain medications required to maintain their new kidney.  If the transplanted kidney fails, they must return to dialysis and wait again in the hopes of receiving another transplant.  Both of these options are more costly and more detrimental to patient health than maintaining the new kidney.
The Comprehensive Immunosuppressive Drug Coverage for Kidney Transplant Patients Act would extend Medicare for immunosuppressive medications indefinitely, ensuring patients have access to these lifesaving medications.  Only immunosuppressive coverage would be extended and all other Medicare coverage would end 36 months post-transplant, as it does now.  The legislation also requires group health plans to maintain coverage of immunosuppressive drugs if they presently include this benefit.  By supporting lifetime immunosuppressive coverage, Congress will help improve long-term transplant outcomes, reduce the number of kidney patients who require another transplant, and enable more patients to choose transplantation.
Please contact your Representatives and urge them to cosponsor the Comprehensive Immunosuppressive Drug Coverage for Kidney Transplant Patients Act to help transplant recipients keep access the medications they need to maintain their new kidney.

“Extending Medicare coverage of immunosuppressive drugs for kidney transplant recipients is a critical step to ensuring a patient’s best chance of success post-transplant.” – Kevin Longino, CEO of the National Kidney Foundation."
Link to Petition

From the American Transplant Association: Comprehensive Immunosuppressive Drug Coverage for Kidney Transplant Patients Act

Comprehensive Immunosuppressive Drug Coverage for     Kidney Transplant Patients Act
Why is this legislation necessary?

•Since 1972, Medicare has covered people with irreversible kidney failure, or end-stage renal disease (ESRD). There is no Medicare time limit for a patient dialysis patient. However, kidney transplant recipients lose their Medicare coverage 36 months
after a transplant.

•Extending immunosuppressive coverage beyond the 36 month limit would decrease the risk of allograft failure due to patients not taking their immunosuppression following loss of immunosuppressive coverage. When renal allografts fail, patients require dialysis and may be candidates for retransplantation, both of which would be covered by Medicare. In addition, transplant recipients have a higher quality of life, and are more likely to return to work than
dialysis patients.

•In 1972, it was estimated that the program would cost $250 million. In 2008, the Medicare ESRD program cost nearly $27 billion.

•This legislation will allow individuals who are eligible for immunosuppressive drugs whose insurance benefits under Part B have ended due to their 36 months running out to remain in
the program only for the purpose of receiving immunosuppressive drugs. If they have group health insurance with this benefit, they would not qualify for coverage beyond the 36 months. Cost benefits for the continuation of immunosuppressant coverage:

•Medicare spends $77,500 per year on a dialysis patient, which Medicare covers indefinitely;

•Medicare incurs an average first year cost of more than $100,000 for renal transplantation and will pay for both dialysis and                          re-transplantation in the case of organ failure;

•However, Medicare only spends an average of $19,100 on a kidney transplant recipient per year after the year of the transplant.

How is the premium determined for individuals eligible due to ESRD?

•A monthly premium rate will be determined based on the monthly actuarial rate for enrollees age 65 and over;

How does this affect those with private insurance?

•Coverage by private insurance varies widely; this legislation ensures Medicare is still the payer of last resort and will not usurp coverage offered by private insurers.

Does this open transplant recipients up to the full benefits of Medicare?

•No, this legislation would only eliminate the time limitation and extend coverage for transplant recipients for the purpose of immunosuppressive drugs only. Beneficiaries would pay the Part
B premium. All other Medicare coverage would end
36 months after the transplant.

Wednesday, August 31, 2016


How does one normally become aware of  Polycystic Kidney Disease?  In my case, I became aware through my Father. I’m 62 now.  This is about the same age my Dad was when he first told me he had PKD.  He had been to the Mayo Clinic for a checkup, and he reported to me that he had “kidney disease.”  He went on, “let me put it this way, the doctors said I won’t live to be a hundred.”  In the years that followed he became dizzy, had difficulty standing and maintaining his balance.  In a very short time, he was on dialysis.  By 1983, he was gone.  He spent the last month of his life in the hospital, St. Margaret’s in Hammond, Indiana.  He died a slow, lingering death of congestive heart failure and uremic poisoning all secondary to PKD.   I learned that as a child, his entire family had been quarantined as a result of small pox, and almost all of my family on my Father’s side had died as a result of what was originally termed as “environmental PKD,” or due to a scarring of the kidneys that later turned into cysts and infection.
One thing about this, I had a cousin Rich, who did not live with this group, and he too died from PKD related causes.  He was in his 30’s when he died, he had just married and this came as quite a shock to the rest of us.  They termed this, “Childhood PKD” and told the rest of us it was an aberration.
When my Dad told of us diagnosis, I was in law school, when he died I was already working my second attorney job.  Very shortly after his death, I went into the hospital in Valparaiso, Indiana, what was then called Porter Memorial, with chest pains.  My PCP told me that my cysts were so large they could be seen on a plain x-ray.  So much for the environmental/childhood theories.  To say this came as a blow, was an understatement.  I watch my Dad die and I felt my future was cast in cement. 
I did a lot of things wrong after that, but more importantly were the things I did that were right.  I not had the local nephrologists my Dad had in NW Indiana, but also retained nephrologists at IU Health at Indiana University.  I was put on a renal diet right way.  I was given high blood pressure medication.  I saw them every six months, where they did a urine test and a blood test on every visit.  I was able to put dialysis for a long time, over 30 years.  I was horribly frightened of dialysis because of what I saw when I sat with my Dad.  But because I had followed medical advice and had excellent care, my dialysis was not unreasonably difficult. 
Others were not so lucky.  I became a kidney advocate and this is what I plan to do the rest of my life.  I like helping others , especially my friends with PKD! 

On April 27, 2016, I became the first Myers ever to have a kidney transplant at my lucky place, IU Health in Indianapolis.

For PKD Awareness Day, I want to remind everyone to get tested.  It is a simple and inexpensive blood and urine test that takes no time at all, but can make a world of difference. If PKD runs in your family, like mine, don’t hesitate to get checked out.  Be PKD aware!



More than 636,000 Americans are living with kidney failure, which is known as End Stage Renal Disease (ESRD). The only treatment available is a kidney transplant or renal dialysis. Many individuals with ESRD suffer from multiple co-morbidities. Ensuring care is properly managed and coordinated is critically important for those suffering with complex conditions. Under current law, individuals who become eligible for Medicare because they are diagnosed with ESRD are prohibited from enrolling in a Medicare Advantage (MA) plan. Since 2000, the Medicare Payment Advisory Commission (MedPAC) has recommended that Congress eliminate this restriction. Many patients would benefit from access to MA plans because many of these plans provide patients with coordinated care, access to additional benefits and services, and the most affordable coverage option. No other Medicare beneficiaries are prohibited because of their health status from having the choice to join MA plans. Patients with ESRD deserve the same choices as other Medicare beneficiaries. Congressmen, Jason Smith (MO), John Lewis (GA), Gus Bilirakis (FL), Kurt Schrader (OR), and Tom Marino (PA) have introduced common-sense, bipartisan legislation, H.R. 5659, the ESRD Choice Act, that would eliminate the restriction against ESRD beneficiaries enrolling in a MA plan. MA Plans Provide Care Coordination and the Best Coverage Option for Individuals with ESRD • The ESRD Disease Management Demonstration found that Medicare beneficiaries with ESRD in managed care have clinical outcomes that are as good as or better than they would have in Medicare fee-for-service (FFS). The vast majority of individuals with ESRD on dialysis are living with multiple chronic conditions, making care coordination clinically important. • Care delivery models are changing to promote coordinated care. Medicare should ensure that individuals with chronic illnesses, including ESRD, have access to such coordination. • Although the Center for Medicare and Medicaid Innovation has proposed to implement a Comprehensive ESRD Care Initiative, the ESRD Seamless Care Organization (ESCO) model will not be available to all Medicare beneficiaries with ESRD. • The additional MA benefits and services offered vary by plan, but may include case management services, disease management programs, nurse help hotlines, and tools to address disparities in care for minorities, who comprise a disproportionate proportion of ESRD patients. These are services that ESRD beneficiaries do not receive in Medicare FFS. MA Plans are the Most Affordable Coverage Option for Individuals with ESRD • CMS requires MA plans to limit the out-of-pocket costs to $6,700 annually and the average out-of-pocket cost limit in a MA plan is $5,223. FFS Medicare, on the other hand, does not have limits on out-of-pocket costs. • In 2010, ESRD beneficiaries spent an average of $6,918 annually on health care. • For dialysis patients without supplemental insurance coverage, out-of-pocket health care costs can exceed $9,000 per year. Less than half of states require insurers to offer at least one kind of Medigap policy to Medicare ESRD beneficiaries younger than age 65. In states where Medigap coverage is not available, MA coverage would help ensure affordable coverage for individuals with ESRD. • Approximately one-third of Medicare beneficiaries with ESRD have incomes that make them eligible for Medicaid. MA is an important source of coverage for low-income beneficiaries. Among Medicare beneficiaries enrolled in MA plans, 27 percent have an income less than $10,000, and 33 percent have an income between $10,000-$20,000. ESRD Patients Deserve Choice and Benefit from Care Coordination • Individuals who were enrolled in an MA plan before they were diagnosed with ESRD are allowed to remain in MA. In 2014, approximately 15 percent of Medicare beneficiaries with ESRD on dialysis were enrolled in MA plans. Data suggest that plan spending on beneficiaries with ESRD is within the expected range of spending for MA beneficiaries with chronic conditions. • Inpatient hospital care accounted for 35 percent of the per patient Medicare spending on ESRD beneficiaries in 2011. Studies have shown that beneficiaries enrolled in MA plans have 30-day hospital readmission rates that are 13 to 20 percent lower than Medicare fee-for-service (FFS) beneficiaries. We encourage all Members of Congress to cosponsor and support H.R. 5659 that lifts this outdated prohibition and provides increased choices of care for ESRD patients. ESRD patients are the only group of beneficiaries in Medicare prohibited from enjoying the benefits of Medicare Advantage. MA plans provide coordinated care, which is critically important for beneficiaries with kidney failure, who often must manage multiple complex chronic conditions. Care and outcomes for dialysis patients can be improved with access to care coordination through participation in MA.

Sunday, August 21, 2016



The ESRD Choice Act of 2016
The American Nephrology Nurses Association (ANNA) is a professional nursing organization of approximately 9,000 registered nurses practicing in nephrology, transplantation, and related therapies. ANNA promotes excellence in and appreciation of nephrology nursing so we can make a
positive difference for people with kidney disease.

Every year, a significant number of Americans are diagnosed with kidney disease. More than 26 million individuals have kidney disease and more than 661,000 have kidney failure, known as end-stage renal disease (ESRD).
Three treatment options exist for those suffering from kidney disease and
ESRD: hemodialysis, peritoneal dialysis, or transplantation.

Given the limited availability of kidneys for transplantation, the majority of ESRD patients rely on dialysis care. Nearly all ESRD patients are Medicare beneficiaries. However, under current law, ESRD patients are prohibited from enrolling in Medicare Advantage (MA) plans, which offer more flexible and
integrated managed care coverage than traditional Medicare.

Moreover, MA plans include financial protections like out-of-pocket maximums, which are especially important to low-income beneficiaries
in need of ESRD care.

ESRD is the only pre-existing condition specified by the Centers for Medicare
and Medicaid Services(CMS) as a broad disqualifier for MA enrollment.

The Expanding Seniors Receiving Dialysis Choice Act of 2016 (H.R. 5659), introduced by Rep. Jason Smith (R-MO-8) on July 7, 2016, would remove the
prohibition on current ESRD patients from enrolling in MA insurance plans
for plan years beginning on or after January 1, 2020. The bill also would
streamline payments for kidney acquisition costs within Medicare.

Finally, the bill would require the Administrator of CMS to provide a report to Congress on the effects of the legislation by April 1, 2022.
There is broad group of national stakeholders that support this legislation, including patient groups, advocacy organizations, and health professional provider associations and societies. Additionally, the Medicare Payment Advisory Commission (MedPAC) supports allowing ESRD patients the choice to enroll in MA plans, having first recommended it in 2004 and again in
its March 2016 Report to Congress.

Recommendation: ANNA urges Members of Congress to cosponsor the
Expanding Seniors Receiving Dialysis Choice Act of 2016(H.R. 5659). The bill will increase access to high quality care by removing the prohibition on current ESRD patients from enrolling in MA insurance plans.

If you have questions about these issues, please contact ANNA’s Health Policy Consultant Jim Twaddell (202/230-5130,

Sources:, “Who Can Join a Medicare Advantage Program?” July 2016.;

National Kidney Foundation, “Fast Facts,” April 2016.

MedPAC, “The Medicare Advantage program: Status Report,” March 2016. Pg. 363.