August 23, 2016
Mr. Andy Slavitt
Centers for Medicare & Medicaid Services
Department of Health and Human Services
P.O. Box 8010
Baltimore, Maryland 21244-8010
Re: CMS-1651-P—CMS Proposed Updates to Policies and Payment Rates for ESRD PPS, QIP, Coverage and Payment for Acute Kidney Injury, DMEPOS Competitive Bidding Program and Fee Schedule, and Comprehensive ESRD Care Model
Dear Acting Administrator Slavitt:
On behalf of Home Dialyzors United (HDU), we are pleased to offer comments on the proposals to update the Calendar Year (CY) 2017 End-Stage Renal Disease (ESRD) Prospective Payment System (PPS) and the ESRD Quality Incentive Program (QIP), which was published in the June 30 Federal Register, vol. 81, no. 126, pages 42802-42880.
HDU, a 501(c)(3) non-profit organization, is the only dialysis patient group dedicated to promoting 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, many 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. See Appendix A – Improving Patient Access to Home Dialysis (HDU, May 2016).
We also recognize that there is no one-size-fits-all mode of dialysis, and are strongly committed to ensuring that patients are fully informed as to their treatment options and how each option fits their treatment and life goals. However, we believe that a significant number of the nearly 90% of dialysis patients still receiving traditional in-center treatments three to four hours a day, three times a week, could benefit from switching to home dialysis modalities. Traditional in-center treatment itself can be disabling, stressing the heart and other vital organs and may contribute to premature death. In too many cases, patients who would like to continue working, must undergo their in-center treatments during working hours. Even if they are able to find work that accommodates their treatment schedule, many are too exhausted from their dialysis session to work. In short, too many patients are still living to dialyze, rather than dialyzing to live.
GOING FOR THE GOLD IN DIALYSIS CARE
It is fortuitous that the comment period for the proposed rule for the ESRD PPS and QIP coincides with the 2016 Olympics, because for patients and caregivers dealing with ESRD (or preferably chronic kidney failure) often requires an Olympian effort. On August 15, thousands of individual athletes from around the world converged on Rio de Janeiro to go for the Gold. They differ in the sports they pursue, the skills they bring, and the hurdles they have overcome to get to Rio.
What they have in common is that they are educated about the requirements of their events, engaged in preparing for their events, and empowered to pursue their goals through access to the best coaches, training, and equipment available.
For many kidney patients, going for the Gold in treatment means getting a transplant, and there are currently about 115,000 people waiting for this opportunity. For others, going for the Gold means having access to a treatment mode that will have the least adverse impact on their on their overall health and enjoyment of life. For all, however, the keys to winning the Gold are: (a) education about their illness and treatment options; (b) engagement as full partners with their doctors and dialysis providers in every aspect of their care; and (c) being empowered to pursue their treatment and life goals through access to the best care. See Appendix B – ESRD Treatment and Patient-Centered Care (HDU, Aug. 2016).
For a lucky few, dealing with ESRD proves to be a sprint from kidney failure to transplant, but most patients with ESRD are, or will become, long-distance hurdlers. The two biggest hurdles have been and continue to be:
- Lack of accurate, meaningful information about all of their treatment options. The Medicare Improvements for Patients and Providers Act (MIPPA) of 2008 requires that patients be educated about all treatment modalities. However, many dialysis facilities still fail to provide complete, unbiased information to their patients. For patients who could potentially benefit from home hemodialysis (HHD), including nocturnal HHD, this problem is particularly acute. Unfortunately the problem may be exacerbated by the release in the past year of the Arbor Research Collaborative for Health’s (Arbor) decision tool for dialysis patients, http://choosingdialysis.org/. Funded by a grant from the Patient-Centered Outcomes Research Institute, the tool only provides information about traditional in-center and home peritoneal dialysis (PD). Efforts by HDU and others to work with Arbor to expand the scope of the tool to include HHD were unsuccessful. HDU notes that a much more comprehensive and easy to use tool, “My Dialysis, My Choice,” developed by the Medical Education Institute, is available online at mydialysischoice.org.
- Lack of access to centers offering all dialysis modalities. Although there are dialysis centers throughout the United States, very few offer all modalities, and whether a patient has access to a particular modality is largely dependent on where the patient lives. In fact, only 24 percent of dialysis centers are certified to provide home hemodialysis training, and even fewer are actively engaged in training.
DIALYSIS FOLLOWS THE PATIENT (OR SHOULD)
On November 18, 2013, CMS published it Quality Strategy for 2013 – Beyond (“Quality Strategy”). The Quality Strategy, which was required by the Patient Protection and Affordable Care Act of 2010 (Affordable Care Act), establishes a number of goals for improving the quality of health care and reducing 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.
HDU strongly encourages CMS to develop a policy that “Dialysis follows the patient,” across all inpatient and residential settings receiving Medicare or Medicaid payments. While we recognize that such a policy is beyond the scope of the proposed rule, HDU believes this policy is critical to fulfilling all four goals in the Quality Strategy.
Under current practice, when a patient on dialysis is admitted to a hospital, skilled nursing facility, or other inpatient or residential setting, the facility determines what kind of dialysis the patient will receive and on what schedule.
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. For adult patients who wish to continue the type of treatment and schedule they have followed at home, being required to adhere to a fixed, one-size-fits-all regimen in the inpatient or residential setting can undermine the relationships between the patients and their care teams. For pediatric patients, many of whom receive PD at home, administered by a parent or familiar caregiver, the change in routine can exacerbate the trauma of hospitalization.
HDU notes that CMS has published a proposed rule, Reform Requirements for Long-Term Care Facilities, CMS-3260-P, which would require these facilities to offer dialysis services “in accordance with professional standards of practice and the residents’ choices.” 80 Federal Register 42167, 42199 (July 16, 2015). HDU strongly urges CMS to finalize this language as soon as possible, and to adopt similar language in the Conditions of Participation or Conditions of Coverage for other facilities.
SPECIFIC COMMENTS ABOUT THE PROPOSED RULE
- Proposed Payment for Excess Treatments
Under current regulations, CMS limits payment for HD to three treatments a week, unless the Medicare Administrative Contractor (MAC) determines in individual circumstances that additional treatments are medically necessary. The MACs pay for medically necessary excess treatments at the full ESRD rate. The proposed rule observes that dialysis facilities are increasingly offering HD treatments more frequently than three times per week without demonstrating the medical necessity of the more frequent treatments, and that there is variation among the MACs as to whether to pay for these additional treatments. CMS is now proposing to pay for excess treatments that lack medical necessity justification, based on a rate equivalent to the weekly payment for standard treatments.
HDU strongly believes that in light of the significant medical benefits to patients of more frequent dialysis, CMS should not distinguish between excess treatments that are deemed “medically necessary” and those that are not.
Studies consistently find that patients who undergo traditional dialysis have worse clinical outcomes than those who have slower, more frequent, and gentler treatment regimens. The decision about the frequency of dialysis should be left to the patient and the patient’s treating physician, in light of the patient’s total circumstances and fully informed treatment choices.
- Add-on Payment for Home Dialysis Training
Because HDU has raised repeatedly raised concerns about the adequacy of the training add-on payment, we are very pleased that CMS is proposing to increase the add-on payment for home and self-dialysis training the current $50.16 to $95.57. In discussing the proposal to increase the home dialysis training add-on payment, the proposed rule acknowledges that currently available data are inadequate to determine actual training costs, and that the proposed payment increase is intended to serve as a proxy until more data are available. As stated on page 42815 of the proposed rule:
Based on our analysis of ESRD facility claims and cost reports… , we are pursuing changes which we believe will enable us to use the data to set the home dialysis training add-on payment adjustment in the future. Although we have already begun the process to implement changes to the cost report and claims, it will take several years for the changes to be implemented and yield data we could use as the basis for a change in the home training add-on payment adjustment. However, each year since implementation of the ESRD PPS in 2011, we have received public comments about the inadequacy of the home dialysis training add-on payment adjustment. In addition, we are committed to ensuring that all beneficiaries who are appropriate candidates for home dialysis have access to these treatment options, which generally improve beneficiaries’ quality of life. For these reasons, we looked for a reasonable proxy for the home training add-on so that we could provide additional payments to support home dialysis in the interim until we are able to make changes to the home dialysis training add-on based on claim and cost report data.
HDU applauds CMS’s commitment to improving the data collected on claims and cost reports, and looks forward to working with CMS in this process. However, we believe that the proposed proxy amount is still inadequate to cover the true costs to facilities for HHD training for the reasons set out below.
Group Training Sessions for Home Dialysis:
CMS says on page 42813 of the proposed rule, second column:
Home HD patients also acknowledged that the training they received took place in a group setting, indicating perhaps that the amount of hands-on RN training time gradually decreased over the course of training, so that by the end of training, the patient was able to perform home dialysis independently.
In fact, the ESRD Conditions of Coverage appear to contemplate that training, whether for PD or HHD, will involve one nurse training one patient (and a care partner) at a time, and that the nurse will be present, observing and available to assist, throughout the duration of a treatment that includes training. The language of the ESRD Conditions for 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. [Emphasis added.]
Although patients often receive pre-dialysis education in group settings, we know of no one who has been trained to perform HHD in a group setting in recent years. If CMS has received comments to the contrary, such instances should be extremely rare in light of the Conditions of Participation and should not affect the calculation of the costs of HHD training.
Payment Incentives for Peritoneal Dialysis v. Home Hemodialysis:
As CMS recognized, it takes longer and costs more to train a patient to do HHD than to do PD. Nonetheless, the add-on payment adjustment is the same per treatment. According to the proposed rule (page 42813, second column), CMS made this decision to “incentivize the use of PD when medically appropriate.” It should be noted that dialysis facilities often train patients to perform PD in the first 120 days of dialysis, and, therefore, their centers receive the new patient payment adjustment in lieu of other add-on payments. Patients who choose HHD, on the other hand, have usually been on either in-center or doing PD, and therefore, the only incentive for the center to offer home dialysis training is the add-on payment.
HDU urges CMS to set payment rates for home dialysis training based on the actual costs of the training for each mode of home dialysis, rather than using the payment rates to create incentives favoring one modality over another.
Assumptions Underlying Calculation of the Home Training Add-on Payment Rate
The proposed rule states on page 42813:
It has never been our intention that the training add-on payment adjustment would reimburse a facility for all of its costs associated with home dialysis training treatments. Rather, for each home dialysis training treatment, Medicare pays the ESRD PPS base rate, all applicable case-mix and facility-level adjustments, and outlier payments plus a training add-on payment of $50.16 [for 2016] to account for RN time devoted to training. The home dialysis training add-on payment provides ESRD facilities with payment in addition to the ESRD PPS payment amount.. Therefore, the ESRD PPS payment amount plus the $50.16 training add-on payment should be considered the Medicare payment for each home dialysis training treatment and not the home dialysis training add-on payment alone.
We believe that the training add-on payment should reflect the full costs to the facility of providing home dialysis training. Moreover, we disagree with CMS’s policy to pay the same rate for both PD and HHD training, since this may create a payment incentive to choose one modality over another. Nonetheless, accepting CMS’s rationale for considering payment for home dialysis training as including the facility’s adjusted base rate plus the training add-on payment, we believe the methodology for calculating this contains several errors that, if corrected, would create a more accurate proxy.
First of all, the 67 percent/33 percent weighting used in the calculation, appears to assume that all PD training treatments receive the dialysis add on payments, when, in fact, most are paid under the new patient adjustment. If we assume, for illustration purposes, that 57 percent of PD training is paid under the new patient adjustment, and only 10 percent is paid with the training add-on payment, the calculation changes as follows:
.10 x 2 hours for PD = 0.2 hours + .90 x 4 hours for HHD = 3.6 hours
Weighted total hours 3.8 hours x 35.93 = $136.53, an increase of $86.37 over the current payment rate
Second, CMS has based its calculation on the current hourly rate for a registered nurse of $35.93, using Bureau of Labor Statistics data for 2015, adjusted for inflation to 2017 dollars. However, the hourly cost of an employee to an employer is higher than the wage rate, and includes such items as fringe benefits, employer taxes, etc.
HDU strongly urges CMS to recalculate the proxy to take into account (1) only those PD training sessions that actually receive the training add-on payment rather than those that are paid under the new patient adjustment, and (2) the fully loaded costs to the employer for an hour of registered nursing time.
III. QIP – Application to Home Dialysis Patients
When Congress mandated the creation of the ESRD PPS and QIP, it intended to achieve the twin goals of lowering costs and improving quality of treatment. HDU continues to urge CMS to include more measures that are important to patients in the QIP – that is, to raise the standard for ESRD care from adequate dialysis to optimal dialysis, based on the patient’s treatment and life goals.
Although HDU cautions that as the number of measures in the QIP increases, the impact of any one measure is diluted, HDU supports the pain assessment and depression screening reporting measures as steps toward patient-centered measures. However, we strongly emphasize that these measures need to be further developed to ensure that the facility assesses the psychosocial and quality of life issues that may contribute to the patient’s depression or pain. In addition, we believe the measure should ensure that appropriate follow-up steps are taken to help relieve pain and depression. Because HHD has been shown to improve patient scores in these areas, it is critical that follow-up include assessing the patient’s interest in HHD and assisting the patient with the transition to HHD if that is the patient’s wish.
However, HDU continues to be concerned that using 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, we continue to believe that CMS should adopt a measure that addresses the larger question of the patient’s goals for treatment, and assesses 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 again strongly 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. 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.
IMPROVING OPPORTUNITIES FOR DIRECT PATIENT INPUT
We continue to believe that patients and care partners must have the opportunity to be engaged in the process of developing ESRD regulations, including establishing new quality measures that are truly meaningful to their quality of life, if the ESRD PPS and QIP are to achieve the twin goals of reducing costs and improving care.
We suggest that this engagement begin early in the rulemaking cycle to help shape the proposed rule, rather than waiting to submit comments after formal proposals have been published in the Federal Register. We believe that a less formal interaction, similar to what occurs at Kidney Health Initiative (KHI) meetings would prove fruitful for all sides. The KHI is a successful public-private partnership that encourages and facilitates patient and care partner involvement in exploring what kinds of kidney research would make the greatest difference for kidney patients. At KHI meetings, we have seen patients, government officials, and representatives of industry engaging in lively, candid, and mutually enlightening conversations. We were especially pleased, incidentally, to see that CMS representatives were present and active participants in the most recent KHI meeting, and hope they will continue to attend.
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 PD or HHD, promotes patient engagement and offers a better quality of life. We also believe that although there may be a cost to increasing the HHD payment rate, it will be more than offset by better care, including reducing the need for physician, hospital, and other health care services, and allowing patients to thrive with fewer medications. Finally, we believe that with access to better kidney care, many more patients would choose to continue working and would be able to do so.
We look forward to working 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)
Pat Colongione, Treasurer (Former Care Partner)
Vanessa Evans, Secretary (Home Dialyzor)
Ellen Griffith Cohen, J.D., (HDU Advisory Board, Living Donor Transplant Recipient)
APPENDIX A – Improving Patient Access to Home Dialysis (HDU, May 2016)
APPENDIX B – ESRD Treatment and Patient-Centered Care (HDU, Aug. 2016)
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 (as required by statute), 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. 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, and with the recent approval of nocturnal dialysis, it is now 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. Efforts to improve patient awareness of treatment choices too often ignore HHD as a treatment option. 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 (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.
- 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.
Inadequate Reimbursement for Home Training:
Although CMS has increased the payment to centers to train patients for home dialysis to $50.16 from the original $33.44 per training session, the payment amount is still not adequate to pay for the typical 4-5 hours per day, 3-4 week training typically needed for HHD, and thus, provides a disincentive for centers to offer HHD. Moreover, CMS has stated that a portion of home dialysis training costs was taken out of the bundled payment to create a separate payment for home dialysis training, HDU does not understand why any payment for home dialysis training should be included in the bundle and received by facilities that do not offer this training. 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.
Lack of Access in Rural Areas to Home Dialysis Modalities
Rural areas are traditionally underserved, and, according to the Medicare Payment Advisory Commission’s most recent report, the number of rural centers is decreasing. Recent advances in telemedicine will help this underserved population. In the 2016 Physician Fee Schedule final rule, CMS created 12 new codes for physicians to use to bill for telemedicine visits to home dialysis patients. HDU commends this action. However, despite comments urging CMS to allow nephrologists to bill the new Chronic Care Management Codes for coordinating services to ESRD patients, the final rule continues to exclude nephrologists from billing these codes, leaving dialysis patients who have multiple chronic conditions to coordinate their own care. The lack of care coordination for patients with multiple chronic conditions has been a major issue for a lot of dialyzors, including home dialyzors.
The GAO Report:
The Government Accountability Office (GAO) Report, Medicare Payment Refinements Could Promote Increased Use of Home Dialysis, GAO-16-125, released in October 2015, acknowledges that home hemodialysis offers patients a better quality of life and improvements in physical and mental health. The report identifies specific statutory provisions and regulatory decisions in the physician payment policies under Medicare’s Physician Fee Schedule, and facility payment policies under the End-Stage Renal Disease Prospective Payment System, that create incentives to use in-center rather than home dialysis modalities.
HDU was pleased to be the only patient organization invited to offer comment and review the draft document. The GAO recommendations include increasing the accuracy of cost report data, especially for home hemodialysis. The report also acknowledges the shortcomings of the Kidney Disease Education Benefit. HDU encourages support for education far earlier in the disease and appropriate reimbursement for both early education providers and for home dialysis training
The Food and Drug Administration’s Partner Requirement:
The FDA clearances for dialysis machines to be used in the home require that the patient have a care partner 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 with or without a care partner, as their training and comfort level dictates. 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.
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. A recent study by Urquhart-Secord et al in the AJKD cited the following: Patient priorities for outcomes emphasize quality of life over outcomes that are frequently reported in hemodialysis trials: biochemical markers, mortality, and adverse events. In view of this mismatch, researchers should consider interventions that are likely to improve patients’ overall well-being and measure and report patient-important outcomes.
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.
ESRD TREATMENT AND PATIENT-CENTERED CARE
Individuals 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 115,000 patients on the kidney waiting list, and, while the incidence of ESRD is growing, the supply of usable kidneys is declining.
When dialysis is the choice, either pending a transplant or long-term, there are, in theory, a number of treatment modalities, including:
- Traditional in-center (i.e., 3 days a week, 3-4 hours a day) hemodialysis (HD)
- Nocturnal in-center HD
- Continuous ambulatory peritoneal dialysis (CAPD)
- Continuous cycler-assisted peritoneal dialysis (CCPD)
- Short daily home HD (HHD)
- Nocturnal HHD
The Medicare law expressly favors home dialysis and transplantation as treatment options for individuals 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)
However, dialysis centers incur different costs for each modality, while Medicare payment rates are based on a single traditional in-center HD treatment. Payment for PD, which is performed daily, is paid at the HD equivalent amount. As a result, many dialysis centers (and the nephrologists who have financial interests in them), do not offer all treatment modalities. Those that offer several modalities often steer patients to their lower-cost (and higher profit) modalities.
In fact, only 24 percent of dialysis centers are certified to provide HHD training, and the data show that 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|
MEDICARE CONDITIONS FOR DIALYSIS COVERAGE
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:
- 494.70 Condition: Patients’ rights.
The dialysis facility must inform patients (or their representatives) of their rights (including their privacy rights) and responsibilities when they begin their treatment and must protect and provide for the exercise of those rights.
(a) Standard: Patients’ rights. The patient has the right to –
(1) Respect, dignity, and recognition of his or her individuality and personal needs, and sensitivity to his or her psychological needs and ability to cope with ESRD;
(2) Receive all information in a way that he or she can understand;
…(5) Be informed about and participate, if desired, in all aspects of his or her care, and be informed of the right to refuse treatment, to discontinue treatment, and to refuse to participate in experimental research;
….(7) Be informed about all treatment modalities and settings, including but not limited to, transplantation, home dialysis modalities (home hemodialysis, intermittent peritoneal dialysis, continuous ambulatory peritoneal dialysis, continuous cycling peritoneal dialysis), and in-facility hemodialysis. The patient has the right to receive resource information for dialysis modalities not offered by the facility, including information about alternative scheduling options for working patients;
However, 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%).
CHOOSING THE RIGHT DIALYSIS MODALITY
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 patients to choose a modality that will most closely align with their values and priorities.
PROMOTING ECONOMIC INDEPENDENCE FOR PATIENTS ON DIALYSIS
One of the common misconceptions about individuals 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.
Although it is true that individuals with ESRD may have disabilities, it does not follow that they are actually 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 individual 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 individuals receiving traditional in-center dialysis, these complications are managed through restrictions on diet and fluid intake, and medication. For individuals 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 individuals 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.
One of the major justifications that Congress gave for creating the Medicare ESRD program was make it possible for individuals with ESRD to be able to work and to ensure that they are 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)
Despite the statutory language, two-thirds of the patients in the HDU survey responded that their center did not offer them rehabilitation services to help them maintain, return to, or achieve their desired life activities. Even when a center offered rehabilitation services, it rarely made referrals for the patient or assisted the patient in getting access to these services, nor did it assess whether the patient’s needs for rehabilitation had been met.
HDU firmly believes that adopting an ESRD treatment model that focuses on patient-centered care would lead to an increase in patients using home dialysis modalities, especially HHD. As research has repeatedly shown, these modalities offer patients better treatment outcomes with fewer complications, and a better quality of life. In addition, patients who need dialysis often would prefer to work (and pay taxes) than to rely on disability payments. HDU also believes that investing in patient-centered ESRD treatment would have net economic benefits for the larger economy. These would include lower health care spending for physicians, hospitals, and other items and services required to treat the complications of dialysis, as well as lower disability and other social safety net payments, that would more than offset any increase in the costs of the ESRD PPS program.