August 24, 2015
Mr. Andy Slavitt
Centers for Medicare & Medicaid Services
Department of Health and Human Services
P.O. Box 8010
Baltimore, Maryland 21244-8010
Re: CMS-1628-P—Medicare Program; End-Stage Renal Disease Prospective Payment System, and Quality Incentive Program
Dear Acting Administrator Slavitt:
On behalf of Home Dialyzors United (HDU), we are pleased to offer comments on the proposed rules for the calendar year (CY) 2016 End-Stage Renal Disease (ESRD) Prospective Payment System (PPS) and the payment years (PY) 2018 and 2019 ESRD Quality Incentive Program (QIP), which was published in the July 1, 2015 Federal Register, vol. 80, no. 126, pages 37806 – 37860.
HDU, a 501(c)(3) non-profit organization, is the only dialysis patient group dedicated to home dialysis. Our mission is to inspire, inform, and advocate for an extraordinary quality of life for the home dialyzor community. We know from personal experience that, with the right dialysis treatment, patients with ESRD (and their families and care partners) can lead a normal life, enjoying family and friends, and pursuing employment, education, volunteer, and leisure activities. We also know that studies have repeatedly shown that patients who dialyze at home have better treatment outcomes.
Despite these findings, 90% of patients who need dialysis are treated in-center, most spending three to four hours, three times per week, connected to a dialysis machine. The treatment itself can be disabling, stressing the heart and other vital organs and may contribute to premature death. Although some centers offer treatment shifts that start after 5:00 P.M., most patients must undergo their in-center treatments during the day, making it difficult to work or engage in other life activities. Patients are often discouraged from being active partners in their care. For example, center staff may rebuke a patient if he or she complains of feeling ill because of the speed and intensity of the treatment. With conventional dialysis treatments, many patients live to dialyze, rather than dialyzing to live.
It doesn’t have to be this way.
HDU believes that the Centers for Medicare & Medicaid Services (CMS) has an important opportunity each year to draft ESRD PPS and QIP regulations that foster improved outcomes for kidney patients and their families and at the same time reduce costs to the Medicare and Medicaid programs. Therefore, we were deeply disappointed that the proposed rules for 2016 do not address serious on-going problems with dialysis treatment. To do so, HDU suggests that CMS periodically offer a forum specifically for patients and their care partners to provide direct input on recommendations for improvements.
Specifically, as will be discussed in more detail below, the proposed PPS rule does not propose any changes to the add-on payment for home dialysis training. We specifically believe that the payment for home hemodialysis training is insufficient to cover the costs to the facility of providing that training. As a result, many patients are denied access to home hemodialysis as a treatment option.
Similarly, we believe that the QIP proposals need to include more measures that are meaningful to patients and that support centers in assessing and minimizing the impact of dialysis on the quality of life for the patient (and the patient’s family and care partners).
HDU strongly urges CMS as it finalizes the rules for the ESRD PPS CY Year 2016, and ESRD QIP for PYs 2017 and 2018, to consider how these rules can be better aligned with the CMS Quality Strategy for 2013 – Beyond (“Quality Strategy”), which was published on November 18, 2013.
CMS QUALITY STRATEGY
The CMS Quality Strategy, which was required by the Patient Protection and Affordable Care Act of 2010 (Affordable Care Act), establishes a number of goals to improve the quality of health care and reduce costs. These include the following, which have a direct bearing on how patients diagnosed with ESRD receive their dialysis treatments:
- Making care safer by reducing harm caused in the delivery of care.
- Strengthening person and family engagement as partners in care, keeping patient and family preferences central in decision processes and implementation.
- Promoting effective communication and coordination of care, in part by increasing patient self-management of health issues.
- Promoting effective prevention and treatment of chronic disease, to reduce the rates of mortality for leading causes of death.
ESRD TREATMENT AND PATIENT-CENTERED CARE
Persons diagnosed with ESRD have a range of treatment choices from conservative care without dialysis, to one of several dialysis modalities, to transplant. However, even when transplant is the goal, most patients spend many years on dialysis. There are currently 100,000 patients on the kidney waiting list, and, while the incidence of ESRD is growing, the supply of usable kidneys is declining.
A patient beginning dialysis, either pending a transplant or as a long-term treatment option, has a number of choices of treatment modalities, including:
- Traditional in-center (i.e., 3 days a week, 3-4 hours a day)
- Nocturnal in-center
- Continuous ambulatory peritoneal dialysis (CAPD)
- Continuous cycler-assisted peritoneal dialysis (CCPD)
- Short daily home hemodialysis
- Nocturnal home hemodialysis
Although there is no “one-size-fits-all” treatment for ESRD, we believe that many more patients would choose home dialysis, either peritoneal or home hemodialysis, if they knew these options were available and were given accurate, unbiased information about these treatments. However, there are different costs to the center associated with each modality, and because the Medicare payment rates are set on a per-treatment basis, dialysis centers (and the nephrologists who have financial interests in them), may steer patients to lower-cost (and higher profit) modalities without ensuring that patients know all of their options and are given sufficient information to make an informed choice.
The QIP is supposed to ensure that the center does not short-change patient care in its pursuit of profit, but the QIP is still a long way from ensuring that patients get high quality care that provides them with an optimal quality of life, based on the patients’ values. For example, the QIP does not differentiate when a facility supplies only one type of dialysis needle instead of acknowledging that patients’ fistulas differ and the wrong needle can cause painful infiltration and damage to the fistula wall. Similarly, the QIP measures do not capture whether a facility consistently observes required infection control protocols. (We note that, under the CMS Survey and Certification Program, dialysis facilities must be surveyed before the facility can be certified to receive Medicare payments for their services, but that subsequent surveys are not conducted as often as needed.)
PROMOTING ECONOMIC INDEPENDENCE FOR PATIENTS ON DIALYSIS
One of the common misconceptions about persons with ESRD is that their disease is so disabling that they cannot continue working at their current employment, and must either find alternate employment that is less demanding or stop working entirely and rely on disability benefits. However, the Medicare statute contemplates that persons with ESRD may be able to work and should be supported in their efforts to do so. Specifically, the statute says:
(6) It is the intent of the Congress that . . . the maximum practical number of patients who are suitable candidates for vocational rehabilitation services be given access to such services and encouraged to return to gainful employment. SSA Section 1881(c)(1)(A)(i)(6)
Although it is true that persons with ESRD may have disabilities, it does not follow that they are, in fact, disabled. Unfortunately, it is too often the treatment modality that is disabling. First of all, it is difficult to work during normal business hours if the person has to go to in-center treatment three times a week. And often the traditional treatment is sufficiently intense that the post-treatment recovery may take hours. In fact, the Social Security Administration recognizes ESRD requiring frequent dialysis as a possible qualifying condition for Social Security Disability Insurance (SSDI).
In addition, there are a number of complications that are associated with hemodialysis and that may impede the person’s ability to work. Some of these are short-term, occurring in connection with a dialysis treatment. These include:
- Low blood pressure (hypotension), which may be accompanied by shortness of breath, abdominal cramps, muscle cramps, nausea or vomiting.
- Muscle cramps.
- Physical exhaustion, preventing a return to normal activities for hours after treatment.
Others are chronic, and may result in the need for costly medical services that are paid by Medicare outside the ESRD PPS. These include:
- Heart failure or pulmonary edema, including high blood pressure (hypertension).
- Severe itching.
- Sleep problems.
- Mineral and bone disorder.
For persons receiving traditional in-center dialysis, these complications are managed through restrictions on diet and fluid intake, and medication. For persons on home dialysis, which is slower and gentler, and can be done more frequently, many of the complications are avoided, and therefore, there is no need for the dietary and fluid restrictions or additional medications. Importantly, because persons using home hemodialysis have great flexibility in scheduling treatments, they are more likely to engage in social interaction with family and friends, avoiding the isolation that can cause or contribute to depression.
BARRIERS TO HOME TREATMENT
Lack of Accurate, Meaningful Information
The Medicare law expressly favors home dialysis and transplantation as treatment options for persons with ESRD. Specifically, the statute states:
(6) It is the intent of the Congress that the maximum practical number of patients who are medically, socially, and psychologically suitable candidates for home dialysis or transplantation should be so treated. The Secretary shall consult with appropriate professional and network organizations and consider available evidence relating to developments in research, treatment methods, and technology for home dialysis and transplantation.
SSA Section 1881(c)(1)(A)(i)(6)
Although the Medicare law, and Medicare’s Conditions for Coverage for dialysis centers, require centers to provide patients with information about all dialysis modalities, including those that the center does not offer, many patients report that they were not told about home dialysis. In a survey of HDU members, a significant number of respondents said that their centers:
- Did not tell them of all treatment options (39%).
- Did not take into account their interests and goals (such as returning to work, pursuing education, and resuming normal daily activities) (38%).
- Did not give them information about where they could get home dialysis training, when the patient’s center did not offer this (41%).
- Did not make a plan for home dialysis training when that was the patient’s expressed choice (28%)
- Did not present modality options to them in a way that was unbiased and addressed their personal needs (59%).
- Did not offer them rehabilitation services to help them maintain, return to, or achieve their desired life activities (66%).
In addition, even when a center offered rehabilitation services to a patient, the center rarely made referrals for the patient or assisted the patient in getting access to these services, nor did the center assess whether the patient’s needs for rehabilitation had been met.
For patients, choosing the right dialysis modality for them in light of all of their circumstances and values can be complicated. There are a number of decision aids. For example, the Medical Education Institute, a private nonprofit organization, has developed a decision aid, available at www.mydialysischoice.org that encompasses all dialysis modalities and evaluates them in light of their impact on a wide range of activities and interests – working, travel, pet ownership, dietary restrictions, medications, costs, etc. This decision aid allows the patient to choose a modality that will most closely align with the patient’s values and priorities.
We note that there is also a decision aid being developed by Arbor Research under a contract with the Patient-Centered Outcomes Research Institute (PCORI). Unfortunately, although PCORI’s mandate is to provide patients with “information about which approaches to care might work best, given their particular concerns, circumstances, and preferences,” HDU has been advised that this decision aid will consider only in-center and peritoneal dialysis; home hemodialysis is not included.
Lack of Access to Centers Offering HHD Training
Although there are dialysis centers throughout the United States, not all offer all modalities. In fact, only 24 percent of dialysis centers are certified to provide home hemodialysis training, and even fewer are actively engaged in training. Whether a patient has access to a particular modality is largely dependent on where the patient lives. The impact of location on access is illustrated in the table below, based on information from Medicare’s Dialysis Compare.
COMPARISON OF AVAILABILITY OF MODALITIES FOR THREE SAMPLE LOCATIONS
AND ZIP CODE
|Bethesda, MD||< 10 miles||22||7||17||4|
|20817||< 25 miles||88||21||51||21|
|< 50 miles||157||33||77||32|
|Kearneysville, WV||< 10 miles||1||0||0||0|
|25430||< 25 miles||3||2||2||2|
|< 50 miles||18||4||11||8|
|Davenport, IA||< 10 miles||8||0||3||0|
|52803||< 25 miles||8||0||3||0|
|< 50 miles||15||0||3||0|
SPECIFIC CONCERNS ABOUT THE PROPOSED RULES
ESRD PPS – The Add-on Payment for Home Dialysis Training
HDU is very disappointed that the proposed changes for CY 2016 do not even mention the add-on payment for home hemodialysis training, much less offer a proposal on which we could comment. However, we believe it is urgent that CMS, in crafting the final language for the CY 2016 PPS, address the appropriateness of the home dialysis training add-on payment.
We note that the amount of the add-on payment for home hemodialysis training is an issue that HDU has raised repeatedly over the years.
In the final ESRD PPS rule for CY 2015, CMS stated at page 66120:
… [W]e received a several thousand-signature petition requesting that CMS include “full coverage of home hemodialysis patient training under Medicare. We note that we made no proposals in our CY 2015 ESRD PPS proposed rule regarding these issues, and therefore we are not finalizing a modification to them in this final rule. We will, however, consider the comments set forth in the petition and in other public comments in the future.
In addition, when the final CY 2015 payment rule was under development, CMS officials told HDU representatives that the agency would be looking at revising all of the payment adjustments in developing the CY 2016 proposed rule.
The Medicare statute directs CMS to ensure that as many patients as can be treated at home should be so treated, and CMS’s own ESRD Conditions of Coverage require that dialysis centers make patients aware of all treatment modalities, including modalities, such as home dialysis, that the center may not offer.
The ESRD Conditions of Coverage specify the requirements for home dialysis training as follows:
- 494.100 Condition: Care at home.
- Standard: Training. The interdisciplinary team must oversee training of the home dialysis patient, the designated caregiver, or self-dialysis patient before the initiation of home dialysis or self-dialysis (as defined in §494.10) and when the home dialysis caregiver or home dialysis modality changes. The training must—
(1) Be provided by a dialysis facility that is approved to provide home dialysis services;
(2) Be conducted by a registered nurse who meets the requirements of §494.140(b)(2); and
(3) Be conducted for each home dialysis patient and address the specific needs of the patient, in the following areas:
(i) The nature and management of ESRD.
(ii) The full range of techniques associated with the treatment modality selected, including effective use of dialysis supplies and equipment in achieving and delivering the physician’s prescription of Kt/V or URR, and effective administration of erythropoiesis-stimulating agent(s) (if prescribed) to achieve and maintain a target level hemoglobin or hematocrit as written in patient’s plan of care.
(iii) How to detect, report, and manage potential dialysis complications, including water treatment problems.
(iv) Availability of support resources and how to access and use resources.
(v) How to self-monitor health status and record and report health status information.
(vi) How to handle medical and non-medical emergencies.
(vii) Infection control precautions.
(viii) Proper waste storage and disposal procedures.
The Conditions of Coverage training standards apply to both peritoneal and home hemodialysis. Although it takes longer and costs more to train a patient to do home hemodialysis than to do peritoneal dialysis, the add-on payment adjustment is the same per treatment. In addition, because patients who perform peritoneal dialysis tend to be new dialysis patients, the centers that offer peritoneal dialysis may receive a new patient payment adjustment for the first 120 days after the onset of dialysis. Patients who choose home hemodialysis, on the other hand, have usually been on either in-center or peritoneal dialysis, and therefore, the center receives only the add-on payment for home dialysis training.
In recent years, the number of patients who are using peritoneal dialysis has increased, while the number doing home hemodialysis has remained flat. Currently, only one center in four is certified to offer home hemodialysis training, and far fewer actually offer this to their patients.
In the meantime, HDU members complain that even when a center is certified to provide training, they experience long delays from the time they request training to the time their training is scheduled, and that patients with higher paying commercial insurance are given priority in training over Medicare patients.
QIP – Need to Address Services to Home Dialysis Patients
In a press release accompanying the first QIP final rule on December 29, 2010, CMS described the QIP as “designed to promote high-quality dialysis services at Medicare facilities by linking CMS payments directly to facility performance on quality measures.” The same release quoted then-CMS Administrator, Dr. Donald Berwick, as calling the QIP “a landmark advance for improving the quality and safety of care that Medicare beneficiaries receive while on dialysis treatment. Since most patients with ESRD are also Medicare beneficiaries, the ESRD QIP is an especially powerful tool in transforming care in America’s dialysis centers.”
Nonetheless, while the costs to Medicare of dialysis treatments have been reduced under the ESRD PPS, the quality of care, when viewed from the standpoint of patients and their families and care partners has not shown a significant improvement. Although the data show a modest decline in inpatient hospitalizations related to dialysis, this decline is similar to declines in inpatient stays for other reasons, suggesting that it is related to the migration of care from inpatient stays to outpatient and physician office services.
HDU strongly encourages CMS to include more measures that are important to patients in the QIP – that is, to move ESRD care from adequate dialysis to optimal care. For example, for many patients, traditional in-center dialysis, which occurs during the workday, precludes maintaining gainful employment. In fact, many patients on dialysis qualify for Social Security Disability Insurance payments, based on a finding that they have a condition that will last longer than a year and that prevents them not only from performing the work they had been performing, but also from pursuing alternate employment.
In fact, many persons with ESRD would prefer to work for a living, rather than living on disability benefits, but they do not have access to dialysis that will support their efforts to work. Moreover, persons with ESRD who are able to earn a living are also able to pay income taxes. In other words, patients who can dialyze at home, at their own rates of speed and dialysis intensity, and on their own schedules, may save the government thousands of dollars in health care spending and disability payments over the time of their treatment. See Attachment B for an example of the financial impact of better dialysis care, based on an actual patient’s experience.
HDU believes that the proposals for the PY 2017 and 2018 QIP, take steps in the right direction to strengthen the QIP, but still have a long way to go to make value-based payment for dialysis services a reality.
HDU supports the proposals in the PY 2016 QIP to continue including pain assessment and depression screening as reporting measures. However, we continue to believe that these measures need to be further developed, to ensure that the assessment looks at the psychosocial and quality of life issues that may contribute to the patient’s depression or pain, and that appropriate follow-up steps are taken to help relieve the depression and pain. Because home dialysis has been shown to improve patient scores in these areas, it is critical that follow-up include an assessment of the patient’s interest in home dialysis and assistance with moving to home dialysis if that is the patient’s wish.
HDU notes that as the number of measures in the QIP increases, the impact of any one measure is diluted. Therefore, HDU also supports the proposal to replace the four existing measures for dialysis adequacy with a single dialysis adequacy measure,
However, HDU is concerned that the proposal to use the CAHPS® In-Center Hemodialysis Survey as the basis for a measure for patient satisfaction ignores the experiences of home dialysis patients. Patients who are dialyzing at home still see a nephrologist and still interact with the center at least once a month. Therefore, most of the questions in the In-Center Hemodialysis Survey – such as those about the patient’s experience with the nephrologist and with dialysis center staff — are equally applicable to home dialyzors.
While surveys like the CAHPS® In-Center Hemodialysis Survey are designed to measure the patient’s satisfaction with the quality of treatment, they do not address the larger question of the patient’s goals for treatment, and assess how well the dialysis care supports the achievement of those goals. There have been numerous articles discussing the types of measures that would foster better, patient-centered care. These measures would give greater weight to the patient experience and engagement, to clinical care coordination, to the assessment and alleviation of symptoms of ESRD, and to helping patients with poor prognoses choose the care that best meets their needs. For a more thorough discussion, see Moss and Davison, How the ESRD Quality Incentive Program Could Potentially Improve Quality of Life for Patients on Dialysis, www.cjasn.org, Vol. 10, pp. 888-893, May 2015.
Finally, HDU urges CMS to restore a measure establishing a minimal standard for anemia management. In the first QIP, centers were measured on how well they kept a patient’s hemoglobin within specified ranges. In subsequent years, the QIP looked only at whether a patient was being over-treated, but not whether he or she is being under-treated. As the Medicare Payment Advisory Commission noted in its March 2015 Report to Congress, the use of erythropoietin stimulating agents (ESAs) has declined dramatically under the ESRD PPS, but the report does not evaluate whether a decline of this magnitude is consistent with good patient care. We are particularly concerned that in the month between visits to the center, a patient’s anemia can progress from an acceptable level under the QIP, to a level that is disabling. The QIP should ensure that patients dialyzing at home are given appropriate anemia treatment.
NEED FOR IMPROVED OPPORTUNITIES FOR DIRECT PATIENT INPUT
During the rulemaking for the first year of the ESRD PPS and QIP, CMS held a town hall meeting that provided patients with an opportunity to talk about what was most important to them. In response to that meeting, CMS took payment for home dialysis training out of the bundle paid to all facilities, and created a separate add-on payment for home dialysis training that would go only to facilities actually providing that training. We were very pleased with this decision, even though we continue to believe that the actual payment amount is inadequate.
We believe that patient input is critical to developing ESRD regulations that improve patient outcomes, but while patients have a lot to say, the formal regulatory process does not encourage informal input. We also believe that better, more efficient dialysis care can reduce spending not only on dialysis services, but also reduce the need for treatment of complications of dialysis, such as heart disease and infections. In addition, many patients are unable to work, not because of their kidney disease diagnosis, but because of the way dialysis treatments are usually delivered.
HDU would strongly encourage CMS to look at the example provided by the Food and Drug Administration (FDA), which has partnered with the American Society of Nephrology, to create the Kidney Health Initiative (KHI). At a KHI meeting in Baltimore on August 12 – 13, 2015, patients on dialysis met with FDA officials, device innovators, and health care professionals to discuss how to take patient preferences into account in stimulating medical device development. The sessions were structured to specifically elicit patient comments on their experiences of care and their suggestions for improvement. Such face-to-face meetings are invaluable, but too rare.
HDU recommends that CMS hold a Town Hall Meeting with patients and their families and care partners as it considers the final rule for 2016, and that such meetings be held as a regular part of the rulemaking process in the future.
We appreciate the opportunity to comment on the ESRD and QIP proposed rules. We believe that making it possible for more patients to dialyze at home, either using peritoneal dialysis or home hemodialysis, promotes patient engagement and offers a better quality of life. We also believe that although there may be a cost to increasing the home hemodialysis payment rate, it will be more than offset by better care, including reducing the need for physician and hospital services, and allowing patients to thrive with fewer medications.
We look forward to working more closely with CMS in the future to develop payment rates and quality incentives that will improve the ESRD patient’s experience of care while on dialysis.
Denise Eilers, BSN, RN, President (Former Care Partner)
Nieltje Gedney, Vice President (Home Dialyzor)
Amanda Wilson, Secretary (Home Dialyzor)
Pat Colongione, Treasurer (Former Care Partner)
Ellen Griffith Cohen, J.D., (HDU Advisory Board, Pre-dialysis)
- HDU Position Paper, Improving Patient Access to Home Dialysis, July 2015
- HDU Fact Sheet, Home Dialysis Cost Effectiveness: One Patient’s Experience
IMPROVING PATIENT ACCESS TO HOME DIALYSIS
Numerous studies have shown that patients with End-Stage Renal Disease (ESRD) who dialyze at home, using either peritoneal dialysis (PD) or home hemodialysis (HHD) have a much better quality of life and excellent treatment outcomes, including increased survival rates and fewer hospitalizations. For most patients with ESRD, dialysis is the primary option when renal replacement therapy (RRT) is needed, and the overwhelming majority of these patients undergo dialysis in outpatient dialysis centers. Few of these centers offer home dialysis, and of those that do, most only offer PD. In fact, only 2 percent of dialyzors in the U.S. currently use HHD.
Home Dialyzors United (HDU) is working to improve access to home dialysis for all patients who wish to use this method of RRT, to promote unbiased education about all modality choices, and to ensure that efforts to promote the quality of dialysis treatment focus on improving the patient’s experience of care, treatment outcomes, and ability to lead a normal life.
Benefits of Home Dialysis
Home dialysis puts individuals with ESRD (and their families or care partners) in control of their treatment decisions. Home dialyzors are engaged in actively managing their disease rather than passively receiving medical services. Home dialyzors have flexibility in determining when and how to dialyze, more freedom to spend with family and friends, and more energy to pursue their interests, whether those include working, attending school, volunteering, or engaging in recreational activities and travel.
From a purely physiological standpoint, home dialysis is clearly superior. A functioning human kidney continuously filters the blood 24 hours a day, or 168 hours per week. However, the great majority of individuals with ESRD receive in-center treatments, three times a week for between three and four hours per treatment, or approximately nine to 12 hours per week. By contrast, home dialysis makes it possible to dialyze for longer periods at a slower, gentler pace, more closely approximating natural kidney function. Frequent, slower home dialysis is also less stressful on the patient’s heart, lowering the risk of premature death, and increasing the likelihood of survival to transplant, if that is the patient’s treatment goal. In addition, home dialyzors require fewer medications and fewer hospital services. Finally, although there are upfront costs to training a patient to dialyze at home, once the patient has been trained, the costs per treatment are lower.
Barriers to Increasing Use of Home Dialysis
Lack of Information about Home Therapies
Although the Social Security Act specifies that Congress intends for any patient who is a suitable candidate for home dialysis to be so treated, and Medicare requires centers to educate patients about all treatment options, too many patients are unaware that they can dialyze at home. According to the most recent information:
- Only 12% of patients report being educated about HHD.
- Only 24% of centers are certified to offer home hemodialysis (HHD and not all centers that are certified to offer HHD actually do so.), This means that access to HHD may depend on such arbitrary factors as where the patient lives.
- Rural areas are traditionally underserved, and, according to the Medicare Payment Advisory Commission’s most recent report, the number of rural centers is decreasing.
- As a result, fewer than 2% of patients with ESRD are currently doing HHD, although many nephrologists believe that a much higher percentage of patients would be good candidates for HHD and, according to surveys of nephrologists, most would choose home dialysis for themselves or family members.
Moreover, efforts to improve patient awareness of treatment choices too often ignore HHD as a treatment option. For example, in January 2013, the Patient-Centered Outcomes Research Institute (PCORI)* contracted with Arbor Research to create a decision tool to help dialysis patients make an informed decision about RRT. In preparing the study, entitled “Empowering Patients on Choices for Renal Replacement Therapy” (EPOCH-RRT) Study,” Arbor looked at in-center treatment and PD, but did not consider HHD. HDU strongly urges that omitting HHD violates PCORI’s mandate, and its stated mission to provide patients with “information about which approaches to care might work best, given their particular concerns, circumstances, and preferences.”
The Partner Requirement:
The FDA clearances for dialysis machines to be used in the home require that the patient have a care partner who is also trained to operate the equipment and who can assist in emergencies. This requirement prevents people who live alone (or whose care partner is temporarily absent) from doing HHD, and may place an undue burden on the family unit. HDU believes that a dialyzor should be able to choose to perform HHD without a care partner. The center should discuss with the patient the risks of dialyzing alone, assess the dialyzor’s ability to perform his or her own treatments without assistance, and discuss alternate safety precautions available to the patient if the patient chooses to forego having a care partner.
Inadequate Reimbursement for Home Training
Recently, CMS increased the payment to centers to train patients for home dialysis to $50.16 from $33.44 per training session. While this is a step in the right direction, it is still not adequate to pay for the typical 4-5 hours per day training for three to four weeks typically needed for HHD, and thus, provides a disincentive for centers to offer HHD. In the short run, the payment for HHD training should be increased; in the long run, we would be happy to work with CMS on other potential training and payment models.
Patient Centric Quality Measures
HDU is also concerned about the quality measures used to evaluate care given to chronic kidney failure patients, and to adjust payments to individual dialysis centers. While biochemical data are important in the clinical management of ESRD, they have little relevance to promoting the quality of life for patients and their families. HDU believes that the goal of treatment for ESRD, like the goal of treatment for other medical conditions, should be to provide optimal care, not just adequate dialysis.
* * *
Home Dialyzors United (HDU), a 501(c)(3) non-profit organization, is the only dialysis patient group dedicated to home dialysis. We believe that patients with end-stage renal disease (ESRD) and their families and care partners can lead a normal life, enjoying family and friends and pursuing employment, education, volunteer, and leisure activities. We further believe that Congress, the Centers for Medicare & Medicaid Services (CMS), which pays the largest share of the costs of dialysis treatment, and the Food and Drug Administration (FDA), which regulates devices used in dialysis, all have a role to play in eliminating the barriers that prevent more individuals with ESRD from getting optimal care.
Home Dialysis Cost Effectiveness
Employed while on Home Hemodialysis 1980-2004
Weekly paycheck deductions as of October 2004:
$ 106.50 Social Security
+ 24.91 Medicare
+ 223.56 Federal Withholding (and often paid additional
$ 354.97 Subtotal (Federal deductions for 1 week)
+ 101.00 Iowa taxes
$ 455.97 Total Federal & state deductions per week
X 52 weeks
$23,710.44 Total deductions per year
– $21,840.00 Approx. Medicare cost of HHD for 1 year
156 treatments @ $140/treatment
(Note: $140= $123 base payment +$17.00 for laboratory tests,
$ 1,870.44 Surplus of taxes over Medicare payment
+$ 9,600.00 Savings to Social Security Disability
(Based on average $800/month in 2004)
$11,470.44 Total savings to government for a single patient for 1 year
X 25 Total years of employment while on home hemodialysis
$286,000.00 Total savings to the government for JE
 CMS Press Release, CMS Implements Value-Based Purchasing for Dialysis Facilities, Dec. 29, 2010.
 PCORI is a nonprofit, nongovernmental organization created by the Affordable Care Act and funded from general Treasury Revenues, the Medicare Trust Fund, and a tax on private insurers.