From PKD Foundation, Blog, by Alexis Denny, Director of Government Affairs
Understanding new rules and regulations around kidney donation — Part One
On December 18, 2019, Alex Azar, Secretary of Health and Human Services (HHS), announced new rules designed to alleviate some issues felt by the kidney community:
A Health Resources and Services Administration (HRSA) proposal to remove financial barriers to organ donation, specifically through adjustments to how the National Living Donor Assistance Center (NLDAC) administers reimbursements to living donors.
Changes to the way organ procurement organizations (OPOs) are held accountable for their performance by increasing regulation and oversight.
Proposed changes
Back in July, the EO promised change in three places: (1) prevention and dialysis; (2) transplant and living donation; (3) innovation and treatment. The new rules laid out in December will address number two from the EO — transplant and living donation.
These new rules are part of a larger effort by the kidney advocacy community to work with the Trump Administration to increase visibility, resources, and support for chronic kidney disease and kidney transplantation. The work over the past years to engage the President, Secretary Azar, and others and the receptivity we’ve received has been a long time coming. These new rules are concrete results of this effort.
From Calgary Sun, Canada
Man donates kidney to wife of 51 years after finding out he's a perfect match
If being married for half a decade isn’t enough to prove your love, maybe donating a kidney to your spouse will do it.
When Peggy Nipper’s diseased kidney began failing — she has polycystic kidney disease (PKD), a genetic condition that causes cysts to develop in the kidneys — and dropped to 14% functionality, requiring a transplant or dialysis, her husband of 51 years, Mike, was tested to see if there was a remote possibility he matched her, according to CNN.
Turns out, Mike Nipper was a perfect match for his 74-year-old wife, a shocking turn in a process that generally takes seven years to find a compatible donor.
The couple underwent the transplant in November at the Kidney Transplant Center at St. David’s North Austin Medical Center in Texas.
“It was quite a gift,” Peggy told CNN. “I don’t think he has to give me another gift for the rest of my life. This was the ultimate present.”
For people with failing kidneys — and there are thousands of them in the United States — a kidney transplant offers a new lease on life. But like every other type of transplant, its success depends on taking drugs for life to suppress the immune system. Otherwise, the body begins rejecting the transplanted organ.
That’s basic medical science. So it makes no sense that Medicare covers these drugs for just 36 months for the majority of people who receive new kidneys. Because of this, many patients find themselves back where they started in a risky and frightening place: on dialysis and in need of a new kidney that for many will never come.
Chronic kidney disease (CKD) is the ninth leading cause of death in the United States, claiming more lives than breast cancer or prostate cancer. More than 37 million Americans are living with CKD today. Individuals with irreversible kidney failure, known as end-stage renal disease, have only two choices to survive: undergo regular and frequent dialysis or be fortunate enough to receive a kidney transplant.
Since 1973, Medicare has covered the care for individuals with irreversible kidney failure, or end-stage renal disease. Dialysis does mechanically what the kidneys do naturally: removes waste products and excess fluid from the body. Most people undergo dialysis at a hospital or dialysis center, usually three times a week for about four hours each time. Medicare spends $86,300 a year per patient on dialysis, and there is no time limit on this coverage.
Kidney transplantation is a medical success story. It can dramatically improve the recipient’s quality and length of life. But not everyone who needs a donated organ receives one. There are currently more than 103,000 individuals on the kidney transplant waiting list, while just 23,000 kidney transplants were performed in 2019.
The upfront cost of a kidney transplant is about $110,000. Afterward, coverage of immunotherapy under Medicare Part B is approximately $2,300 per year. The savings to the government of providing immunosuppressive medications are clear.
As Medicare law currently stands, patients’ lives are at risk, donor kidneys are being neglected, and taxpayer money is being squandered. It’s time for change. That’s why I’m testifying before Congress Wednesday in support of lifetime Medicare coverage of immunosuppressive medications for kidney transplant recipients.
As a transplant surgeon for nearly 20 years, I have witnessed firsthand the impact of this shortsighted policy. Patients struggle to pay for the immunosuppressive drugs needed to maintain their transplants when their Medicare coverage ends, especially lower-income patients who lack group health insurance or who do not qualify for Medicaid or other assistance. These financial pressures force some patient into rationing their immunosuppressive drugs or forgoing them altogether, either of which generally results in the failure of the transplanted kidney.
I can recall several patients who had to choose between paying their mortgage or utility bills and paying for their transplant-saving medication. Many of my colleagues report that they encounter patients in similar situations. A 2012 New England Journal of Medicine article reported that nearly 70% of kidney transplant programs reported either a death or transplant loss due to patients’ inability to pay for their antirejection medications.
The 36-month limitation on coverage also has a detrimental effect on living kidney donations. Patients are reluctant to ask a friend or family member to be a living donor if they fear they will be unable to afford their antirejection medications long term. As an advocate for increasing kidney donation, I have trouble asking living donors or donor families to give the most amazing “gift of life” knowing that Medicare will cut off necessary immunosuppressive coverage after three years.
In May of 2019, the Department of Health and Human Services conducted an analysis that indicated potentially significant cost savings from extending immunosuppressive coverage for kidney transplant patients by averting future dialysis and re-transplantation. The Centers for Medicare and Medicare’s Office of the Actuary concluded that extending coverage could save Medicare up to $300 million over ten years.
In December 2019, Reps. Ron Kind (D-Wis.) and Michael Burgess (D-Texas) introduced the Comprehensive Immunosuppressive Drug Coverage for Kidney Transplant Patients Act (H.R. 5534). This legislation would extend Medicare coverage of immunosuppressive medications for kidney transplant recipients for life.
By providing this coverage of last resort, Congress can help reduce the likelihood of the failure of transplanted kidneys, minimize the need for repeat transplants, enable more patients to pursue transplants, and save taxpayers money on the potential cost of re-transplantation. Most importantly, this measure also honors the gift of kidney donation for those who gave selflessly so others may have a second chance at life.
The current 36-month coverage policy for immunosuppressive drugs is not medically, economically, or ethically justified. Congress must fix it.
Matthew Cooper, M.D., is the director of kidney and pancreas transplantation at Medstar Georgetown Transplant Institute, professor of surgery at Georgetown University School of Medicine, and a board member of the National Kidney Foundation. He reports receiving consulting and research fees from several companies that manufacture immunosuppressive drugs. More information about H.R. 5534 is available at Honor the Gift, a patient-centered campaign for extending Medicare coverage of kidney transplant antirejection medications sponsored by CareDx, a precision medicine company focused on improving transplant outcomes.
PKD Research
From PKD Foundation
We’re looking for patients who meet the following:
- Males and females between the ages of 18 to 50
- Have been diagnosed with ADPKD
- Kidney function between 45 to 90 mL/min/1.73m2 eGFR
- Not currently taking Tolvaptan
Other eligibility criteria will apply.
Participation in STAGED-PKD is divided into two separate stages, each lasting up to 26 months and will include taking an oral study medication daily. The investigational drug, study-related procedures, and doctor visits will be provided at no cost.
Link to More Information about this study.
Clinical Studies webpage link at PKD Foundation.
Take part in clinical research!
Local doctors are currently conducting a Phase 3 trial of an investigational oral therapy for individuals at risk of rapidly progressive Autosomal Dominant Polycystic Kidney Disease (ADPKD); the purpose of the trial is to determine if GZ/SAR402671, an investigational medication, is as safe and effective as a possible treatment for ADPKD.
ABOUT THIS STUDY The Phase 3 trial, known as the STAGED-PKD study, will be run in 2 parts and aims to enroll 640 people across approximately 80 international sites located in the Americas, Europe and Asia-Pacific. The company expects to complete the trial by 2023. The study is divided into 2 separate stages. Each stage will consist of a 30-day screening period, a 2-week period where placebo is taken, a 24-month study treatment period, and a 4-week post-study treatment follow up period. The total length of participation and treatment in the study will be the same in Stage 1 and Stage 2 (up to 26 months participation for each stage). Stage 1 of the study enrollment is currently ongoing. Participants are randomly assigned to 1 of 3 study groups and will take the oral study medication GZ/SAR402671 (8mg or 15mg), or matching placebo, once daily over the duration of approximately 24 months. After Stage 1 of the study finishes, Stage 2 will start. Patients in Stage 2 will receive either placebo or GZ/SAR402671at the highest dose determined in Part 1 to be safe and effective.
