Friday, June 3, 2016

New bill would allow pilot programs to test non-cash incentives to promote organ donation

New bill would allow pilot programs to test non-cash incentives to promote organ donation

U.S. Representative Matt Cartwright, D-Pa., introduced legislation on May 26 that aims to clarify the legality of providing reimbursement to living organ donors. The Organ Donor Clarification Act of 2016 clarifies that pilot programs that provide non-cash incentives and reimbursements for expenses to organ donors are not preempted by federal criminal law.
Currently, organ transplantation is governed by the National Organ Transplant Act (NOTA) of 1984, which prohibits buying or selling organs for “valuable consideration.”
Read also: Financial incentives for organ donation a polarizing issue, but it’s time to test the waters 
“Confusion about what constitutes valuable consideration has hampered donation by scaring people away from reimbursing living organ donors for things like medical expenses and lost wages,” said Cartwright.  “Both are legal under NOTA, but the law’s lack of clarity and its criminal penalties have created uncertainty and prevented reimbursements in many cases.
The Organ Donor Clarification Act would clarify that certain reimbursements are not valuable consideration but are reimbursements for expenses a donor incurs, including:
  • Reimbursement for travel, lodging, food during travel, and other expenses related to donation.
  • Provision of or reimbursement for dependent care needs related to donation.
  • Reimbursement for lost wages related to donation.
  • Medical expenses related to donation and all related follow up care including preventative follow up care and medication.
  • Paperwork or legal costs related to donation.
  • Any insurance policy against the risk of death or disability as a result of donating an organ or the longer-term health effects of having donated an organ.
The bill would also allow government-run pilot programs to test the effect of providing non-cash incentives to promote organ donation.  These pilot programs would have to pass ethical board scrutiny, be approved by HHS, distribute organs through the current merit based system, and last no longer than five years.
Read also: Progress in kidney transplantation: 3 recommendations 
The legislation has been endorsed by the following organizations: Americans for Tax Reform, American Foundation for Donation and Transplantation, American Medical Association, Fair Allocations in Research Foundation, Transplant Recipients International Organization, WaitList Zero.
The National Kidney Foundation issued the following statement expressing concern over language in the bill:
“The National Kidney Foundation (NKF) strongly supports removing barriers to living organ donation, and believes that all expenses related to the donation should be covered so that neither the organ donor, nor the organ recipient, bears any financial costs.While we appreciate Representative Cartwright for his efforts to increase organ donation, NKF is opposed to two provisions in The Organ Donation Clarification Act of 2016:
1. The authorization of pilot programs that, under the language in the bill, could include financial incentives or benefits for organ donation. NKF opposes financial payments that are above and beyond the reimbursement of donation-related expenses.
2. The authorization of non-cash benefits, as the bill does not define what a “non-cash benefit” is thus leaving the interpretation too open and subject to abuse.  “

The Wearable Artificial Kidney Trial

Nursing and kidney research: The Wearable Artificial Kidney trial

Nancy Colobong Smith, MN, ARNP, CNN, a Renal and Transplant Clinical Nurse Specialist at the University of Washington Medical Center discusses her work on developing a wearable artificial kidney

Photo: Stephen Brashear
What is involved in setting up a research trial involving new technology? A key part of the process is recruiting patients and, just as important, monitoring their success––and setbacks––during the trial.
Nurses can play an important role in helping to make clinical trials successful. We talked with Nancy Colobong Smith, MN, ARNP, CNN, a Renal and Transplant Clinical Nurse Specialist at the University of Washington Medical Center (UWMC) in Seattle, about her work on developing a wearable artificial kidney. Results from the first clinical trial were recently presented at the American Nephrology Nurses’ Association annual meeting in Louisville. The University of Washington and Kidney Research Institute partnered in the research.
NN&I: tell us your background. How did you get involved in kidney research? Are you also doing direct patient care at UW?
Nancy Colobong Smith, MN, ARNP, CNN: I started working at UWMC as a staff nurse on a medical surgical, liver and kidney transplant unit 20 years ago. The UWMC has a unique model where they train experienced staff nurses to provide primary care and dialysis for inpatients. I first trained in peritoneal dialysis and then hemodialysis and pheresis. I eventually became assistant nurse manager of the transplant unit, and then went back to school to earn my masters of nursing with a dual focus as an acute care nurse practitioner and clinical nurse specialist. I currently have a blended role where I oversee the dialysis program as a clinical nurse specialist (CNS) and consult on the management of post-transplant diabetes as a nurse practitioner. My current role involves more quality improvement, education, and training, although I do some direct patient care when I manage diabetes or assist with complex dialysis patients. 
The UWMC is an academic medical center, meaning that there is research all around. My first exposure was as a staff nurse when inpatients were enrolled in a study. The research coordinators were available to support us in making sure that protocols were followed and the needed data collected. Later, when staff had clinical questions and we found limited evidence in the literature to support practice, we partnered with a researcher at the UW School of Nursing to develop our own study. From there projects developed organically from shared interest or expertise.
NN&I: How do you split those roles?
Smith:  This is something that I have to manage with each new project – research or otherwise. There are always projects that are interesting and I am passionate about so I need to balance that with the everyday work that needs to get done. I am fortunate to have a supportive manager and colleagues. We help cover for each other when we can, and help each other problem solve when we can’t. For the WAK project, it was easier. It was a large, well known trial and everyone I worked with was happy to participate, even if that meant supporting me at times when I wasn’t always available.    
NN&I: Do you think research is a growing field and offers rewards for renal nurses?
Smith:  Absolutely!  As the health care profession and the public focus more on quality, outcomes, and evidence-based care, research continues to grow. Research starts with a question, and there are still many questions that need answers. The rewards come with finding the answer, and knowing that you are providing better care or new options for patients.
NN&I: Give us a short overview of the WAK trial: its mission, the protocol, and accomplishments to date.
Smith:  The first WAK trial in the United States was the third WAK trial overall.
The goal was to establish the ability of the WAK to deliver continuous dialysis safely for 24 hours, and to determine the clearance of urea and other electrolytes over the 24-hour period. The previous European WAK trials had subjects wear the device for 6-8 hours.
The protocol involved subjects coming to UWMC for a standard hemodialysis procedure, having a short break, and then wearing the WAK for 24 hours. During the time at UWMC, subjects were closely monitored (vital signs, labs, and telemetry). Subjects were also interviewed before and after using the WAK, and completed a dialysis modality satisfaction survey after standard dialysis at their outpatient dialysis center and after wearing the WAK.
Five subjects were able to wear the WAK for the complete 24 hours. Two subjects wore the WAK for less than 24 hours. One came off early due to clotting and the other one due to technical complications such as kinking and the inability of the bubble traps to keep up with the carbon dioxide production. Part of what makes the WAK portable is the device’s ability to regenerate dialysate utilizing sorbent cartridges. One of the natural byproducts of this process is carbon dioxide, which is safely trapped in the bubble trap and vented into the atmosphere. These complications were consistent with the European trials findings. In this stage in the trial, regulatory bodies required that we use the same device as the one used in the European trials.
After seven patients, we completed the trial. Overall we found that the WAK is safe and well tolerated. The subjects’ labs values were maintained despite very liberal diets. Subjects also reported greater treatment satisfaction with the WAK compared to conventional hemodialysis.
NN&I: What was your role in helping to recruit patients for the trial. Was it difficult? What were some of the characteristics you were looking for in each candidate? Did you reject some patients?
Smith:  Since we were partnering with the Kidney Research Institute, we had amazing research coordinators who recruited patients for the trial.
The study had specific inclusion criteria which was sometimes challenging to meet. A total of 246 patients were screened in order to find 10 patients who met criteria and were able to be consented. In the end, 7 patients were enrolled in the trial and underwent therapy with the WAK.       
NN&I: Nurses are excellent nurturers. Did you use those skills during the trial as patients worked to adhere to the protocols? How would you describe their mood and attitude during the trial? Were there some tough times to get through?
Smith:  Nurses have many skills and roles that contribute to research. Some examples are patient advocate, mentor, educator, clinical expert, planner, leader, and nurturer. Overall the study participants were very excited to be the first people in the United States to wear the WAK.
It was fun to watch them enjoy foods that they are not usually able to eat because of their kidney disease. They would ask about their lab results and were so happy to see that their labs were stable, even though they were eating foods higher in potassium and phosphate.
We recognized that sometimes it was challenging to have 2-3 members of the research team with the patient for 24 hours. It was a group effort to keep engaged with the more social participants, and allow the ones who needed more quiet time the space to have that despite the labs and monitoring required by the protocol.
NN&I: What would you say was the most rewarding part of the trial for you as a nurse?
Smith:  The last statistics I remember from the USRDS had approximately 650,000 in the US receiving dialysis, and 100,000 waiting for a kidney transplant.
The most rewarding part for me in the trial was knowing that we were giving people hope for a future with more options of dialysis modalities. These new options may allow people more normalized diets, and the chance to receive dialysis therapy while walking, dancing, and enjoying their lives more fully. The best moments were watching the patients take their first walk with the WAK, and order their meals. It really is the simple pleasures that are the best.     
NN&I: What are the next steps for the device and follow-up trials?
Smith:  The next steps include technical revisions to the WAK circuit to make it smaller, lighter, and more patient manageable. There are plans being made for follow up trials that extend the time that subjects are wearing the device, as well as taking the WAK out of the hospital and into the home setting.

Fresenius Medical Care creates regenerative medicine subsidiary

Fresenius Medical Care creates regenerative medicine subsidiary

Getty Images/iStockphoto/ThinkStock
Fresenius Medical Care has established a subsidiary focusing on regenerative medicine. Unicyte AG will pursue research into kidney and liver diseases, diabetes and cancer, and will work with additional partners when needed to advance these projects, the company said in a release.
Fresenius Medical Care has collaborated with the University of Turin since 2003. The first result of their joint research under the direction of Prof. Giovanni Camussi, Scientific Director of the university’s Torino Stem Cell Project, was the isolation and characterization of a human stem cell population from an adult liver. These liver stem cells are easy to isolate, capable of being multiplied without limit and transferrable into various other cell types, making them a potential option for regenerative medicine.
Other discoveries were functional pancreatic islets (which mimic the function of pancreatic cells) for the treatment of diabetes, and stem cell-derived extracellular vesicles (particles that support communication between cells) for the treatment of kidney and liver diseases as well as cancer. The first research results were converted recently into preclinical development projects.
The company said it will pursue the development projects up until the stage of clinical studies on humans. The long-term goal is to improve the lives of kidney and liver disease, diabetes and cancer patients.
“This is an outstanding example of collaboration between industry and science,” said Gianmaria Ajani, Rector of the University of Turin. “It is not only driving the development of new technologies, but is providing an educational opportunity for young people. Unicyte will attract more international sponsors and investors, and in this way secure, long-term jobs can be created.”

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