My Comments to CMS for 2017 Proposed Rule for ESRD

August 23, 2016

Mr. Andy Slavitt

Acting Administrator

Centers for Medicare & Medicaid Services

Department of Health and Human Services

Attention: CMS-1628-P

P.O. Box 8010

Baltimore, Maryland 21244-8010

Dear Mr. Slavitt

I am a 3 year home dialyzer. I would not be here, if it were not for home dialysis. Although I lived with failing kidneys for over 20 years, it was never my intention to start dialysis. At 65, I had achieved most of my bucket list, and was content to go in peace. I refused to live a life hooked up to a machine. However, when I finally crashed, I had so many obligations, including my 93 year old mother with dementia, that I could not afford the luxury of dying. So be it.

Fast forward three years, and I am, literally, in peak health for my age. My labs are near perfect, kidney function is remaining at 10% (on home dialysis), I do aquatic therapy three times a week, travel, and volunteer extensively as an advocate for home dialysis. I feel better than I had for the previous 20 years, while avoiding dialysis at all costs.  I could not do this without home dialysis.

However, I never even knew home dialysis existed. During all the years of kidney failure my doctors referred me to their own clinics, where all I saw was a sea of comatose bodies. I refused to be one of them. At one point in my journey the nephrologist referred me to the surgeon to put in a PD catheter without even telling me what PD involved.

POINT 1 Education about ALL dialysis modalities MUST be made available to every patient. This is the LAW, and it must be enforced. While I want to personally thank CMS for increasing training dollars for home therapies, there needs to be more oversight for clinics to follow the mandate, offer education on ALL treatment modalities, and utilize training dollars for home therapies. Only 24% of all clinics currently offer home therapy training, less than 12% of all dialyzers are home patients, and only 2% of those are home hemo patients.

Home dialysis allows for slower, gentler treatments so my body is not in a constant state of disequilibrium, and my organs are not stunned. I currently treat for 3 hours every other day, due to excellent residual function.  I remove little if any fluid during treatments, eat a regular diet, take no phosphate binders, blood pressure medications, or any other meds, except vitamin supplements. I have not been hospitalized since starting dialysis.

I have spoken to CMS on many occasions about the importance of customizing the dialysis treatment to the patient. Unlike in-center dialysis, which is one size fits all, I am able to tailor each treatment to my physical needs. Too much fluid (say after travelling), then a few extra, longer, slower treatments to gently remove the fluid. I rarely miss a treatment, because I can schedule it around my busy life, usually late at night, but if I have a commitment, morning treatments will work. And there is no recovery time. I can complete a treatment, and head out the door.

POINT 2 A diabetic controls their treatment by regulating their blood sugar, and a dialyzor should and must be allowed the same freedom to treat accordingly. More frequent treatments, as needed, are a must for maintaining maximum health. There must not be a one size fits all dialysis treatment mentality.

While not directly related to the Proposed Rule, because this falls under the QIP, but every bit as important to achieving optimal dialysis, is the dialysis clearance measure. It is my understanding that centers are paid for treatments when patients achieve certain goals, i.e. labs within appropriate levels, acceptable clearance, no infections, etc… I have a real issue with the KT/v measures used for clearance, for many reasons.

First, there is no consistency in calculating this factor, between clinics, companies, and in the industry. For patients with residual function, clearance is very different from a dialyzor who has not had function for many years. The first may remove minimal urea and no fluid during a treatment, while the latter has a large urea burden and removes up to 5 kilos of fluid. The latter patient has an excellent clearance, while the former has a poor clearance. Which patient is actually healthier? The former, of course. Some centers will calculate a 24 hour urine function into the clearance, while others comment “you’re going to stop peeing anyway, so we just ignore it!”

Studies have shown that maintaining residual function as long as possible is key to favorable long term outcomes on dialysis, and yet patients are again being punished in order to meet arbitrary and capricious lab values that have no bearing on how well their dialysis is doing. Prescribing more dialysis and higher fluid removal, when not needed, just to achieve clearance, results in organ stunning, disequilibrium, and accelerated loss of function. This is barbaric.

POINT 3 The KT/v measure used as a criteria for dialysis adequacy to achieve clearance measures is archaic, misdirected and outdated. There are many more valuable tests to indicate optimal dialysis, that would benefit the patient, such as the  Beta-2 microglobulin, and a 24 hour urine when applicable. Although these tests are more costly, they would contribute far more accurate knowledge of the dialyzers adequacy than KT/v. We are the only country in the world that uses Kt/v to calculate dialysis adequacy, and it is ignorant at best, criminal at its worst.

 When and if a dialyzor is hospitalized, and thankfully, due to home hemo, I have not been since the onset of my dialysis, patients are placed in untenable, compromising and vulnerable positions, which ultimately can lead (and has led) to an untimely death. If a patient has an insulin pump, uses a c-pap, a colostomy kit, or other medical device, do they have it removed and replaced with a different device, prescription, and treatment? No. Yet when a dialyzor is hospitalized, the method of treatment (i.e. machine), the duration, and frequency are all arbitrarily changed to “treat the norm”. Instead, the facility (with no knowledge of the patient’s treatment history) determines what kind of dialysis the patient will receive and on what schedule, usually determined based on the convenience of staff or contractors, and not what is best for the patient.

For patients who have been dialyzing at home successfully, a change in their dialysis treatments can have significant adverse effects on their recovery and overall health.   This often continues when they are discharged to a rehab, LTC or SNF facility. At a time when the patient is already physically compromised, often due to reasons not related to dialysis, their treatment is randomly changed, resulting in their inability to respond to other treatments or heal, lengthening the hospitalization, and often weakening the patient’s condition.

POINT 4 Treatment MUST follow the patient. Dialyzors must be allowed to continue with their prescribed treatment method and prescription, unless otherwise medically indicated (and this must not be changed merely for the convenience of the hospital or facility).

 Finally, while I have only been a dialyzor for a short time, it will be part of my life for my remaining years. While I may have purposely ignored dialysis in the years prior to my “crash”, because I viewed it as an untenable treatment in which I refused to participate, in reality, home hemo has given my life a new and healthier purpose. From day one, I was engaged in my care, trying to learn everything I could and asking questions. I met with constant resistance from my health care team. They did not want me educated, nor empowered. They wanted me “compliant”. When asked if I wanted to attend my care plan meeting, and I responded yes, they said, but no one ever does! And I was never asked to participate again.

However, I am 100% empowered and engaged in my own care, reading my labs, often before my health care team does, suggesting changes in treatment. I do 100% of my treatment myself, by choice. I live alone, and have no care partner. I don’t want anyone involved with my treatment but me. I schedule my own visits to the Access Center and vascular surgeon, and have never been wrong about the need for angioplasty or revision. Clinics don’t like this, they encourage the patient to be an inactive participant in their care, requiring a “partner” do their treatments, just like in-center. For the best possible outcome, patients must “own” their illness, and responsibility for their treatment, not be made to check their independence at the door for the convenience of the dialysis clinic and staff.

Other quality of life measures that are critical to improving dialyzor outcomes are access to physical therapy and vocational rehabilitation. Too often, once a patient gets in-center, and the resulting complications from inadequate dialysis set in, they end up losing physical capacity. Even with home dialysis, I began to notice muscle wasting (although I am almost 64, I refuse to accept the need for a mobility device, recognizing that if I don’t use it I will lose it).

Since initiating dialysis, I had requested a referral to physical therapy numerous times, and it was denied (for no obvious reason) until I threatened to go to a wheelchair. After only a month of aquatic therapy, I had improved physical conditioning by more than 100% and continue with weekly classes to this day. The cost to Medicare was insignificant, and far less than a mobility device, so why is this not offered to dialysis patients? This referral cost my dialysis clinic nothing, and ultimately saved Medicare $1000’s, so why is it not readily offered nor made available to patients?

Vocational rehabilitation is another referral that is too often ignored as well. When patients, especially home dialyzers, receive optimal dialysis, they often feel well enough to remain or return to the work force in some capacity. Re-training and special accommodations through the local Vocational Rehabilitation office are designed to help with that, and again, often ignored by clinic social workers. Because I had used the Vocational Rehabilitation services during my years with ESRD, and remained functionally employed through most of the 20 years of CKD, I immediately sought their counsel again, after I realized how much better I felt on dialysis. They provided some classes to update my social media skills, a computer, and I (at 63) I have at least been able to obtain occasional part time employment, and work as an advocate on behalf of home dialyzers. My clinic social worker wasn’t even aware that this service existed at the local VoRehab office.

Most dialyzors don’t even realize these referral services are available to them, and simply succumb to inactivity, loss of mobility, and disability. CMS needs to include these quality of life criteria in order for clinics to receive an acceptable, much less maximum, rating; they must be able to prove that they actively educate and refer patients to these rehabilitative services. With almost half a million dialyzers in the United States, keeping patient’s mobile and working must be a priority for everyone.

POINT 5 Patient education, empowerment and engagement are a must if a dialyzor wants to experience the best possible outcome for their dialysis treatments. Physicians, nurses, clinics and staff must be taught to value an educated and engaged patient, and not be threatened by, nor to retaliate (which sadly occurs all too often) on someone who wants to be involved in their treatment. Patients must be made aware of and have access to referral services such as Physical Therapy and Vocational Rehabilitation, and not be encouraged to quit work, become inactive, or accept an inferior quality of life. Patients must never be told “That’s life on dialysis, just accept it!”.

 I want to thank CMS for allowing me the opportunity to comment on the ESRD and QIP proposed rules.  I believe that making it possible for more patients like myself to dialyze at home, either using PD or HHD, promotes patient engagement and offers a better quality of life.  If there is a cost to increasing the HHD payment and training rate, it will be more than offset by better care and improved quality of life, including reducing the need for physician visits, including referrals to specialists for resulting comorbidities from inadequate dialysis, hospitalizations, medications, and other health care services. Finally, I believe that with access to better kidney care, optimal dialysis, and referral services (that have no impact on the ESRD PPS yet offer many cost-saving advantages) many more patients would choose to continue working and remain active, and would choose to do so.

I look forward to continuing to work closely with CMS in the future to provide input on the patient experience and quality incentives that will improve the ESRD patient’s experience of care while on dialysis, and quality of life when not.

Sincerely,

Nieltje Gedney

Home Dialyzor

PO Box 281 Kearneysville WV 25430

304-279-3192

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