FDA’s Patient-Focused Drug Development Initiative Meeting

If you’ve received an organ transplant the Food and Drug Administration (FDA) wants to hear from you.  On September 27, 2016, FDA will hold its first to gain insight directly from patients about their experiences living with organ transplants and the medications they take to prevent organ rejection and manage related conditions.  This information will help FDA to consider issues important to patients when reviewing and considering approval of new therapies for transplant patients that may be developed in the future.  Input from these meetings will be incorporated into an official FDA report titled the Voice of the Patient.

If you are interested in participating live or via webcast here are the registration details: The public meeting will be held on September 27, 2016, from 9 a.m. to 5 p.m. Please register here for the meeting by September 20, 2016: http://organtransplantpfdd.eventbrite.com.

To keep up the momentum after the meeting, the National Kidney Foundation plans to submit written comments on this topic to FDA and we want to work with you to develop those comments. If you plan to attend the meeting either in person or via webinar, please email us at nkfadvocacy@kidney.org

You can learn more about the participation in this meeting and the questions you will be asked here: https://www.gpo.gov/fdsys/pkg/FR-2016-04-27/html/2016-09785.htm.

You can also find general information about the patient focused drug development initiative and the Voice of the Patient reports here: http://www.fda.gov/ForIndustry/UserFees/PrescriptionDrugUserFee/ucm368342.htm.

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One Family’s Story on Medicare Advantage

In 2013 my son was diagnosed with ESRD at the age of only 23.  Once diagnosed, we had to make many decisions in a very short period of time.  They included preparing for dialysis, choosing a dialysis center and type of dialysis, training for home hemo dialysis, starting dialysis, surgeries, medication management, ordering of medical dialysis supplies, getting on the transplant waitlist, searching for and ultimately finding a non-related living kidney donor, signing up for social security income, understanding and signing up for Medicare and Medicaid, understanding how Commercial Group Health insurance, Medicare Advantage plan, and Medicaid all work together.  Then post-transplant, a whole new set of issues faced us, like continued medical follow up, medical testing, immunosuppressive medications, social issues, and my son finding a job.

When he was diagnosed my son had coverage under our Commercial Group Family Insurance plan in Pennsylvania.  We had a good primary care physician that we wanted to retain as the controlling entity in our son’s care.  This doctor was “core” to guiding and overseeing the medical needs of our son.  It was important to us to remain in the network where our primary care physician was located.  The physician was a participant only in one of the insurance networks in our area, dictating where our medical insurance coverage had to remain.

In a few short years, the Commercial Group Family Coverage was going to go away as my son aged.  A Medicare Advantage Plan within the same health care network was imperative.  The key here was “securing” the Medicare Advantage plan.  Typically, Medicare Advantage plans exclude members with ESRD.  You see, our situation is unique. The ability to secure our Medicare Advantage plan was solely the result of my son already having insurance coverage with the same healthcare network. The network administrator allowed migration into the Medicare Advantage plan within the network because we were already there through the Commercial Family Group Insurance Plan.  So when we signed up for Medicare, we specifically requested the Medicare Advantage plan.

Our experience with the Medicare Advantage Plan:

Since securing the Medicare Advantage Plan our experience has been terrific.  We found excellent physicians easily within our list of network care providers.  In fact, the customer support offered through the Medicare Advantage Plan is better than that given through our Commercial Group Family Coverage plan.  We found the health care customer service representatives with the Medicare Advantage plan to be better trained in answering questions related to care and billing than those on the Commercial Group Coverage Plan side of our insurance.  The Medicare Advantage plan has definitely been a welcome cost saving decision for my son because of the many added extensions in coverage offers.

How he has made use of the additional benefits?

There are myriad benefits contained within the Medicare Advantage plan.  We learned of these services through the membership booklet provided to us at the time of enrollment.  The health plan customer service representative was extremely informative.  Many times the representative located the providers and services for us.  They conducted the outreach and arranged for providers to contact us.

We have enrolled in a health club—it is free and offers skilled personal training which recognizes the limitations of being an ESRD patient.  Our son has also used the dental and vision care coverage offered through the Medicare Advantage plan.   Prescription medication coverage has been essential and the Medicare Advantage plan benefits are great.  He has had no issues with securing and paying for his medications.  The plan has made it easy and convenient to use their services.

 Barriers at transplantation or trouble accessing in-network providers?

The reason our primary care physician is able to successfully manage and oversee the care of my son is the health care network uses an electronic information portal.  All doctors, hospitals, laboratories and even the patient can share and view data.  The only exception to this was while on dialysis, even though our dialysis center and nephrologist were considered “in-network” providers, they were not on that electronic system for medical record sharing.  To compensate, each month the caregiver (me) would fax an update of lab results and clinic visits to the primary care physician which would then be scanned into my son’s electronic file and thus viewable by all parties involved with his care in our Medicare Advantage Plan network.  Additionally, the primary care physician’s office was located in the same building on the same floor as the nephrologist’s office and they communicated on a regular basis regarding my son’s progress and care.

The other concern we experienced was being able to wait list at multiple transplant centers.  Being in a Medicare Advantage plan, we had to accept the limitation of using only the doctors and facilities within our network of care.  Many people might find this a true barrier to finding their “gift of life” transplant. We accepted this requirement. Luckily, we reside in a large metropolitan area and with a good Medicare Advantage Plan Network, so we had no trouble in gaining access to in-network providers.  Our primary care physician played a key role in seeing we were provided with top notch medical care.

While Medicare Advantage plans are not all equal and may not be the best choice for every ESRD patient we are happy with our decision to enroll our son in this plan.  We hope other dialysis patients will have this option in the future, which is why we support the ESRD Choice Act (H.R. 5659).

Bobbie ReedAbout Bobbie Reed

Bobbie became a Kidney Advocacy Committee liaison after her eldest son, Alex, was diagnosed with ESRD shortly after graduating from college in 2013.

 

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Meeting Your Legislators in August!

By Haley Newkirk, Kidney Advocacy Committee Liaison

Newkirk, Haley Sen Gardner 8.10.15This week, Congress began Recess and will be home in your state until September 6th.   This will provide us the perfect opportunity to meet with our Senators and Representative in their district offices and continue to educate them about issues related to kidney disease.

Last year, I was able to meet with staff members for my Representative and both Colorado Senators over the course of a few months. Although I was not able to meet directly with the legislators, I found that their staffs were engaged and curious about the issues. One of the many benefits of these local meetings is that the staff really know the people and communities they work in. One staff member had spoken to a Denver man who had lost insurance coverage for his transplant medications that same morning, and she thanked us for helping her understand how critical it was that she help him find the resources he needed to avoid rejection and keep his kidney.

No meeting was quite like another. One staff member was a health aide, and we spent half an hour discussing specific medical issues in our state and improving supports for those affected. Another staff member was focused on public outreach and spoke with my NKF region’s Executive Director, Shannon Clark about NKF’s KEEP Healthy screenings and how to better engage the African American community. Bringing the big, broad federal initiatives close to home with our personal stories and those of our fellow constituents provokes real conversation and ignites legislators’ interests in real policy changes.

Teaming up made a big difference for me. I was fortunate enough to have Shannon come to all three meetings. Not only was she a great support for my first-timer nerves, she contributed very useful, relevant details about specific events and programs in our state. We were able to debrief and learn together from one meeting to the next, and it helped me build a relationship with my local NKF office that has stayed strong ever since.

I hope that you will join me this summer in this important opportunity to ensure that our legislators understand the impact their work in Washington, DC has on our lives in their home states—it’s easier than you think!

Tips on setting up a District meeting:

  1. Look at your legislator’s website (House/Senate) and locate the closest district office to where you live or work.
  2. Email their scheduler (often through their website) and ask to schedule a meeting with your legislator in their district office. Depending on the form, you may have the chance to briefly share a little about your personal involvement. If you have any problems, please contact NKF’s staff at nkfadvocacy@kidney.org.  They will be able to assist you!
  3. Let NKF’s advocacy team know once a meeting has been scheduled so that they can provide you with talking points on legislative priorities, fact sheets on kidney disease in your state, and other helpful materials. They can be reached at nkfadvocacy@kidney.org.
  4. Work with NKF’s advocacy staff to let your local NKF office know about any scheduled meetings. If available, they may want to join you for meetings—but if they are unable to attend they still may be able to provide you with details about programs and events happening in your state or region, as well as providing some additional team support!
  5. Confirm your meeting a few days before the scheduled date.

Tips during your meeting:

  1. Be prepared with background on the elected official, thoughtful arguments, specific points, good data, and a clear agenda.
  2. Tell your personal story. You want to be remembered and they do want to hear your story.  Limit your story to about 2 minutes, and explain why the policy issue you are there to discuss is so important to you personally and how the legislator can make a difference for you and others like you.
  3. Numbers are your friend. Legislators and their staff love statistics as much as a constituent’s story.  How many people in your state have kidney disease or are on dialysis? How many are on the wait list?  What is the cost of dialysis vs a transplant after the first year?  NKF can provide you with all of the necessary information for your meeting.
  4. Keep it simple. They may not know much about or have real life experience with chronic kidney disease, dialysis, donation, and transplantation.  Avoid acronyms, vernacular, and keep the language you use as basic and as non-technical as possible.
  5. Be respectful to the legislator and his or her staff members.
  6. Leave behind materials that reiterate the points you made in your meeting. NKF has a set of materials that you can use for this purpose.
  7. Leave your contact information so your legislator or their staff can contact you with any questions.

After the Meeting:

  1. Promptly follow-up with an e-mail to your legislator’s office to reinforce your comments. Thank them for their time and provide any additional information that you agreed to get to them.  Use this opportunity to cultivate your relationship.
  2. Report to NKF to let us know how your meetings went. Did they ask any questions you were unable to answer?  Did your Members voice their support?

Remember – you are a constituent and they work for you!

About Haley Newkirk

Haley is almost eight years post-transplant and an active advocate for kidney patients and families with the National Kidney Foundation. She and her fabulous kidney, Stan, enjoy mountain adventures, Colorado sunshine, and tacos.

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Patients to Lead National Research Priorities for Kidney Disease

The National Kidney Foundation announced today that it will be organizing the first-ever Patient Centered Outcomes Research Stakeholders’ Conference.  This conference will bring together 100 patients, caregivers, stakeholders and academics to identify patient-centered research priorities—and challenges—for kidney disease.  It will allow patients with chronic kidney disease, for the first time, to be at the forefront of deciding national research priorities.  The conference will be held in conjunction with the National Kidney Foundation Spring Clinical Meetings in Orlando during April 2017.

The Stakeholders’ Conference will be facilitated by both a patient and researcher and will feature patient, caregiver and researcher panel discussions and break-out group sessions.  Attendees will gain insight into the experiences of patients, caregivers and researchers; learn more about the importance of patient centered outcomes research (PCOR), and identify best practice strategies for actively engaging patients in kidney disease research.

“The Stakeholders’ Conference will help address the gap in kidney disease research,” said Kathryn Pucci, vice president of education for the National Kidney Foundation (NKF).  “Our goal at NKF is to transform the process in which the healthcare community views patients from passive, to active and engaged partners in the healthcare decision making process, and centers them as key collaborators in research and in policies which directly impact them.”

As part of NKF’s commitment, NKF has also committed to provide a minimum of $40,000 towards funding a 2018 Kidney Disease Patient Centered Research Grant.  The grant will focus on the top kidney disease priorities identified by patients at the Conference.

The Stakeholders Conference is funded through a Patient-Centered Outcomes Research Institute (PCORI) Eugene Washington PCORI Engagement Award.  If you have questions, or are interested in participating in the Conference, please visit www.kidney.org/pcori.

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NKF Signs Letter Opposing Proposed Elimination of State Health Insurance Assistance Programs

Understanding Medicare can be confusing and overwhelming.   Eligibility dates, options for supplemental plans, Advantage plans, and prescription coverage can be daunting.  State Health Insurance Assistance Programs (SHIPs) have helped Medicare beneficiaries navigate the complexities of the Medicare system. On June 16th, the Senate Appropriations Committee approved their FY 2017 budget, which would eliminate funding for State Health Insurance Assistance Programs (SHIPs).  This move would result in 55 million people being left without access to the only free and personalized counseling service to help Medicare beneficiaries.

Many kidney patients rely on the assistance that SHIPs provide. SHIPs offers free advice on how to resolve billing, fraud and abuse issues, choose from an array of drug and health insurance plans, challenge coverage denials, and receive financial subsidies for premiums, co-payments and deductibles. They also provide personalized counseling and host Medicare enrollment clinics, informational meetings, and answer questions over toll-free telephone help lines.

In 2015, the 3,300 SHIPs served more than seven million Americans, through more than 15,000 counselors in all 50 states, Puerto Rico, Guam, DC and the Virgin Islands.  SHIPs offer increasingly critical services that cannot be supplied by 1-800 MEDICARE, on-line or written materials, or other outreach activities. Approximately one-third of referrals to SHIP originate from Medicare Advantage and Part D prescription drug plans, local and state agencies, the Centers for Medicare& Medicaid Services, the Social Security Administration, and members of Congress and their staff.

The National Kidney Foundation (NKF) wants to protect this important service for all Medicare recipients.  Therefore, NKF and other patient advocacy organizations have signed on to a letter to express their opposition to the Senate’s budget cut and are asking the House to, at a minimum, keep SHIP funding at its current level.  This letter was sent to key members of the U.S. House of Representatives and was authored by the National Council on Aging.

If you have ever used a SHIP, please include your story in the comment section below.  Also you can write your U.S. Representatives an ask them to act to maintain funding for SHIPs through the Medicare Rights Center

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Kidney donation should be a blessing, not a curse! Support the Living Donor Protection Act!

By Cynthia Puryear

I will never forget the day or my exact location when I received the call from my sister in Arkansas telling me she had taken our mom to the doctor, and it wasn’t good news. It was my shocking introduction to chronic kidney failure, and my mom was slowly progressing to End-stage Renal Disease (ESRD). It was a blessing that our mom had no other ailments or serious medical conditions, so we were able to move forward with the transplantation discussions. She also had 10 children willing to donate a kidney. Out of 10 children, I was going to defer to my siblings to donate since I had a toddler. Fast forward, many of siblings did not get beyond the pre-screen for various reasons. Ultimately, there were only two matches, and one healthy enough to donate – me! My Christmas gift to my mother was a new kidney.

Why Living Donation Matters!

My mother was fortunate enough to receive a transplant from a family member, and never had to be on an organ waiting list. Sadly, many others are not as lucky. In hindsight, did I think about what that would mean for me in the future? Never. Would I do it all over again? Absolutely yes, and without hesitation! Did I ever think that if I needed insurance in the future, I would be discriminated against as an organ donor? Absolutely not! But sadly, discrimination against organ donors is very real with higher premiums or even denial of insurance based solely on their donor status.

Contact Your Congressman to Support the Living Donor Protection Act (H.R. 4616/S. 2584)!

Help us today by contacting your congressman! During February, the Living Donor Protection Act was introduced in Congress to protect living organ donors by prohibiting insurance companies from charging higher premiums, and from denying or limiting life, disability and long-term care insurance to living donors (the Affordable Care Act prohibits discrimination in the availability or pricing of health insurance), and also provides Family and Medical Leave Act protection. I’ve heard some of the discrimination stories – insurance challenges, not enough leave time, and more. With over 100,000 people waiting to receive a kidney transplant, we cannot risk losing potential donors. There is a great need for living donors, and we must help protect potential donors and make this process simple by assisting them in their efforts to save another’s life. We’re talking about the gift of life to another individual!

As a living donor, this is very personal because potential donors may not know the cost repercussions and discrimination they may incur post donation. Now is the time to move the Living Donor Protection Act forward in Congress. Take a look at the U.S House of Representatives sponsors, and U.S. Senate sponsors. If your congressman is a sponsor, send them a thank-you note. If they are not a sponsor, visit our Advocacy Action Center and ask them to support this important legislation.

Get Active on Social Media!

One of the most powerful ways to educate elected officials and raise public awareness about the Living Donor Protection Act is to share our story through social media.  The power of social media gives us “real time” and “instant” opportunities to help amplify this great life-saving message by articulating the need to affect public policy and get our elected officials involved.  So, send a tweet, or post a Facebook message to educate your elected officials on the Living Donor Protection Act, kidney disease, and invite them to a local NKF event.

About Cynthia

Cynthia Puryear is a living donor and is an Executive Committee member of the NKF Living Donor Council, and holds an appointment on the Advisory Council on Organ Transplantation (ACOT).

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New Living Organ Donation Collaboration Announced at White House Organ Summit

Johns Hopkins University, National Kidney Foundation and Novartis team up to help patients

find living donors

The White House-hosted Organ Summit is an essential step towards increasing access to organ transplants and reducing the organ waiting list.  At the Organ Summit, the Administration and private entities will announce a new set of actions that will build on the Administration’s previous accomplishments to improve outcomes for individuals waiting for organ transplants and improve support for living donors.

At the White House Organ Summit today the National Kidney Foundation (NKF) announced a new collaboration with Johns Hopkins University and Novartis to nationally launch the Live Donor Champion Program.  Developed by transplant surgeon Dr. Dorry Segev at Johns Hopkins University, the Live Donor Champion Program aims to overcome common barriers to finding a living kidney donor—a need for more education about living donation; and a reluctance to start a conversation about donation among transplant candidates.

Working with Johns Hopkins University and Novartis, National Kidney Foundation will use its vast networks to disseminate a comprehensive set of educational resources to transplant centers nationwide.  The Champions program will teach people how to use their own personal connections and social networks to raise awareness about the need for kidney donors; and help to identify potential live donor candidates for a family member, friend or themselves.

Click for the full press release.   You can also watch the White House Organ Summit live.

Update:

View the White House’s Fact Sheet on commitments made by the Administration.

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Nutrition, Sign-Ons, and Social Media

In May, the FDA’s announced final changes to the Nutrition Facts Label found on packaged foods; this will have a huge impact on kidney disease patients!  Beginning on July 28, 2018, manufacturers must list the amount of potassium and calcium contained in packaged foods, making it easier for kidney patients to track their intake of both of these minerals since too much potassium and calcium can negatively impact kidney patients’ health.

Sign-ons for the Living Donor Protection Act (H.R. 4616/S. 2584) have continued to come in; thanks for Kidney Sign
everyone’s efforts in encouraging your Members to join this important legislation.  This month, three additional Senators and five additional Representatives signed onto the legislation, bringing the total to 6 Senators and 29 Representatives.  See the blog “Off to a Great Start” or these links to the House and Senate for full sponsor lists, bill text, and other information.

Finally, we hosted our first Advocacy in Action Blog guest writer, Jim Myers.  Titled, “Why We Need to be Active on Social Media,” Jim wrote about the need for advocates to be active on social media, how to use this outlet to impact public policy, and what types of platforms we can use to further our message.  Congratulations again to Jim on receiving a kidney transplant on April 27th!  We look forward to continuing this new tradition of guest bloggers in June.  Stay tuned!

If you have an interest in helping NKF engage policy makers on the issues important to kidney disease patients, or volunteering time to help educate elected officials, please contact Andrew Fullerton at Andrew.Fullerton@kidney.org.

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Advocacy Win on Food Labeling

By Judy Kirk, MS, RD, CSR, CDN
Chair of the National Kidney Foundation’s Council on Renal Nutrition

On May 20, 2016 the FDA announced its final changes to Nutrition Facts Label found on packaged foods.  This not only great news for the general public looking to make healthier food choices, but a great win for kidney patients who often find it challenging to know how much potassium and calcium are in the foods they buy.  The new labeling requires food manufacturers to list the amounts of potassium and calcium on the nutrition label beginning July 28, 2018. The timeline gives food manufacturers time to implement these monumental changes.

Tape Measure next to Nutrition Facts

Calcium and potassium are vitally important to those at risk and with kidney disease.  For those with hypertension, which affects 73 million Americans and can lead to kidney disease, increasing potassium and calcium intake might lower blood pressure. Eating more potassium-rich foods can prevent or delay the onset of high blood pressure.  However, for the 26 million Americans with chronic kidney disease, too much potassium and calcium can have a negative impact on their health.  They must reduce their dietary intake of both of those nutrients.

NKF has a long history of advocating for clearer food labeling.  Most recently our efforts have included testifying at an FDA hearing on the topic, writing letters in response to the proposal, teaming up on the issue with the American Academy of Nutrition and Dietetics and building coalition support from the kidney community to support these changes.

While we are disappointed that phosphorus was not also included on the labeling, we will continue to push the FDA to also require added phosphates be listed and to call for more research to investigate the link between phosphate additives and overall health of Americans.

To learn more about NKF’s advocacy on food labeling and the importance of these efforts to kidney health, visit our past blogs on the topic:

 

 

 

 

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WHY WE NEED TO BE ACTIVE ON SOCIAL MEDIA

By Jim Myers, Kidney Advocacy Committee Liaison

WHY WE NEED TO BE ACTIVE ON SOCIAL MEDIA

Social media is a fun and interesting way to communicate.  It is also a great tool for raising awareness for kidney disease! Why use social media?  It is one of the most authentic ways to communicate to your legislators.  Additionally, it is also a great way to amplify your message.  During an average 8 hour day at a kidney table, I might see 50 people.  Over the same period of time on social media, I reach over 10,000 people, sometimes as many as 100,000 persons in a week!

USING SOCIAL MEDIA TO AFFECT PUBLIC POLICY

Most elected officials use multiple social media accounts, including Facebook, Instagram, LinkedIn, and Twitter. The form and content of communication is only limited by your imagination. Many kidney organizations have public policy action pages to help you advocate and shape public policy, like this one from the National Kidney Foundation, that also allow you to “tell your story” to your elected officials.

You can use social media to:

  • Inform, discuss, update, and influence others about kidney disease policy and legislation
  • Develop a collective voice and collaborate
  • Share knowledge about kidney disease
  • Influence the behavior and decisions of your elected officials

You can also use social media to invite elected and government officials to join events such as:

There are subtle differences between how each social media platform can be used to reach elected officials.  Facebook is useful in providing information, photos, and video, as well as sending requests and messages of appreciation. Twitter is effective for engaging in a conversation with your elected official.  Commenting on Instagram can help put a face to your name and issue.

Blogs are also a great tool to express your point of view or share an idea. You can use them to create original content, add photos and video, or host an opinion poll.  Free, quick and easy, blogs platforms, such as WordPress and Tumblr, can give you instant visibility. Make sure you ask all your friends to like your blog and Facebook pages, and comments, and to share them. You can also share the page with general public, on other kidney pages, and in kidney groups to raise your circulation.

By establishing constant contact with your elected officials and their staff, you can become a trusted source of information related to kidney issues and legislation. This trusted relationship can help you get attention when sharing content (I like to send my government officials links to posts on the NKF’s Advocacy in Action blog) or when you ask them to co-sponsor a bill.

Using other media to promote a bill or issue

There are several websites that help you prepare, solicit, and transmit petitions that are designed to promote a kidney disease bill or important kidney issue. They include:

No matter what form of advocacy you choose, social media can make you more effective and give you a broader reach than other forms of advocacy.

Questions? Contact me at kidneystories@hotmail.com or www.facebook.com/jamesmyers3

About Jim

James Myers is the Statewide Advocate for the National Kidney Foundation for the State of Indiana.  He is a member of the Kidney Advocacy Committee.  He is the inaugural winner of the 2016 Social Media Advocate Award for the American Association of Kidney Patients.  On April 27, 2016, he received a kidney transplant!  http://www.chicagotribune.com/suburbs/post-tribune/opinion/ct-ptb-davich-kidney-donor-found-st-0508-20160506-story.html

 

 

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