Medical Education Institute’s Preliminary Comments on the ESRD Treatment Choices Model (CMS-5527-P)

This blog post was made by Beth Witten, MSW, ACSW, LSCSW on September 5, 2019.
Medical Education Institute’s Preliminary Comments on the ESRD Treatment Choices Model (CMS-5527-P)

Coauthored by Dori Schatell

On July 10, 2019, President Donald J. Trump signed an Executive Order (EO)1 with the goal of reducing the number of people who progress to kidney failure by 25% and treating 80% of those who do have kidney failure with transplants or peritoneal dialysis (PD) and home hemodialysis (HD). At MEI, we believe there are five essential ways to rapidly increase the uptake and successful adoption of PD and home HD:

  1. Help patients choose a treatment option that best fits their preferred lifestyle and values, by creating a financial incentive for managing clinician and ESRD facilities to use the My Life, My Dialysis Choice treatment matching tool with patients. Dialysis is a terrifying prospect, and far more than just a way to clean the blood—it affects every aspect of lifestyle. To engage patients in electing to take on responsibility for their own treatment, they need to know the “WIFM” (what’s in it for me?) And, the benefits must be tied to their constellation of values—not merely generic modality pros and cons. MEI’s treatment matcher does just that, and a financial incentive will drive rapid adoption of the free tool.

  2. Encourage ESRD Treatment Choices (ETC) Model-participating facilities to offer self-cannulation training and in-center self-care. MEI has found that the key difference between patients who choose home HD and those who do not is confidence. Key barriers to overcome include needle fear and intimidation by the seemingly complex HD machine. Both of these can be overcome in-center, thus speeding up home HD training—and requiring less home HD nurse training time. (For more detailed MEI home training recommendations, see this blog post).

  3. Space permitting, encourage ETC Model-participating facilities to explore training patients in small groups, vs. one-on-one. Small group training has been done successfully by some programs, and these best practices should be broadly shared as quickly as possible. One-on-one training is the least efficient use of scarce training nurse time requiring patients who want to do home dialysis, especially home HD, to wait months for training. Including other patients helps trainees (and care partners, when necessary) to see that they are not alone, and allows for peer support during a stressful time.

  4. Assure that the ETC model includes separate performance measurement for both PD and home HD. There will be a tremendous temptation for ESRD facilities and managing clinicians to drive as many patients as possible to PD, which is an excellent first treatment option, as it is quick to train for, easy to learn and do, preserves residual kidney function longer than standard in-center HD, and allows more freedom to work, travel, eat, and drink. However, PD is not for everyone, and is an inherently short-term option for most, as the peritoneum—just one cell layer thick—was never intended to filter all of the blood in the body nor to be in contact with a dextrose-containing solution, and ultimately develops fibrosis and can no longer filter. United States Renal Data System (USRDS) data report that of 32,551 patients who were on PD at 3 months, just 52.5% were still using PD 2 years later.2 Patients’ preference for the treatment that will best fit their lives and values must be honored (as above), and this includes increasing the availability of all of the forms of home HD as well as PD. Urging the USRDS to track home HD options more granularly will be helpful as well.

  5. Fund a pilot study to examine the costs and benefits of paid home dialysis helpers. In 1978, the ESRD Amendments to the Social Security Act provided 100% payment for home dialysis under certain circumstances, which could include a paid home dialysis partner. 3 Increasing costs in the ESRD program led HCFA in 1983 to abandon target rate reimbursement in favor of composite rate reimbursement—which did not include payment for a dialysis partner4, thus limiting the choices of those unable to independently perform PD or home HD or those treated by clinics that require a care partner to be present during home HD. It is well past time to try this model again—and this approach would create an additional career path for dialysis technicians, some of whom may decide to attend nursing school, which would then help to solve the dialysis nursing—and home dialysis nursing—shortage. Allowing patients to schedule home dialysis outside of work hours will allow more patients to keep their jobs or to return to work as well, improving revenue for dialysis clinics, and resulting in more taxes paid and less Social Security Disability costs.

What follows in the table below are the non-profit Medical Education Institute’s (MEI) preliminary responses to the proposed rule published in the Federal Register on July 18, 2019.5

We welcome your comments to improve our recommendations and rationale and invite you to use any that you agree with in your own comment. The deadline for comments is September 16, 2019 at 11:59 p.m. ET. Comments can be submitted at CMS asks commenters to refer to file code CMS–5527–P.

Proposal Summary6 MEI Recommendation & Rationale

§512.325 Participant selection and geographic areas

Under the proposed rule, all Medicare-certified ESRD facilities and Medicare-enrolled Managing Clinicians located within a selected geographic area will be required to participate. CMS will select a random sample of 50% of hospital referral regions stratified by Census-defined regions (Northeast, South, Midwest and West) as well as all HRRs for which at least 20% of component zip codes are located in Maryland with the goal of increasing home dialysis from 12% to 19% by 2026.


  • We recommend that the geographic areas from which Participants are selected be ESRD Networks instead of Hospital Referral Regions (HRRs).

  • We recommend that ESRD facilities be randomly selected from facilities already certified to provide home training and support.


  • Selecting Participants from ESRD Network areas is consistent with what the United States Renal Data System reports annually, would expand on the quality improvement activities for home dialysis and transplant that ESRD Networks are already doing, and will allow for better data comparisons over time.

  • Facilities that are not certified for home dialysis training and support* will need the costly infrastructure required at 42 CFR 494, for staffing, space, agreements to obtain equipment and supplies, home dialysis policies and procedures, patient training materials, and more. Home training nurses must minimally have an RN with 12 months as a nurse and 3 months in PD and/or HD; state regulations may be more stringent. In addition, the RN must be able to effectively teach patients (topics are listed at 42 CFR 494.100(a)(3)). To apply for certification, a facility must have on its census at the time of survey at least one patient trained in the home dialysis treatment for which certification is requested. Expecting this to occur before January 1, 2020 may be unrealistic.

    * Per Dialysis Facility Compare, of the 7,512 facilities as of July 24, 2019, 3,997 offer PD (53%), 2,177 (29%) offer home HD training and 2,067 (27.5%) offer both.7

  • Non-certified facilities will need to recruit experienced home training nurses—and there is a shortage. Choosing non-certified clinics would intensify competition and might encourage recruitment of minimally experienced RNs for home training positions, which could limit the ability to troubleshoot problems, adversely impact home dialysis retention and harm patients’ health and survival.

  • Non-certified facilities will have small PD programs, which have poorer patient outcomes. PD programs treating ≤50 patients had significantly more patients switch from PD to HD and more cardiovascular events than those treating >50.8 PD programs with <20 patients had a 68% higher rate of PD technique failure.9 While we recall studies that found concerns with small home HD programs as well, we were unable to find them.

  • Non-certified facilities may have Medical Directors who are less knowledgeable about and supportive of home dialysis. Historically, physicians have referred a limited number of patients for PD and/or home HD. One barrier may be their training in and comfort with any chronic dialysis—even in-center. Only about 5% of questions on the American Board of Internal Medicine nephrology board exam are on dialysis. Inadequate training in home hemodialysis in and post medical school can adversely affect physician referral to and utilization of home hemodialysis.10 A survey of nephrologists found that those who said they were very well trained in dialysis at the time of certification or they had sought additional training in dialysis were significantly more likely to treat PD patients.11 Unless this barrier is addressed, Managing Clinicians may fall short as gatekeepers for home dialysis options.

§512.330 Beneficiary Notification

(a) General. ETC Participants must prominently display informational materials in each of their office or facility locations where beneficiaries receive treatment to notify beneficiaries that the ETC Participant is participating in the ETC Model. CMS provides the ETC Participant with a template for these materials, indicating the required content that the ETC Participant must not change and places where the ETC Participant may insert its own original content…”


We agree that ETC participants need to display information about their participation in the ETC Model. Notification should be provided in the patient’s primary language, at a reading level they can understand, and with accommodations for patients who cannot see well enough to read the notification.


The Plain Writing Act of 201012 requires government publications to be written in plain language. The Americans with Disabilities Act requires government and public accommodations—including healthcare settings—to meet the communication needs of people with disabilities the same as those who are not disabled.13

§512.340 Payments subject to the facility HDPA

“CMS adjusts the Adjusted ESRD PPS per Treatment Base Rate by the Facility HDPA on claim lines with Type of Bill 072X, and with condition codes 74, 75, 76, or 80, when the claim is submitted by an ESRD facility that is an ETC

Participant with a claim through date during a calendar year (CY) subject to adjustment as described in § 512.350 and the beneficiary is 18 years of age or older during the entire month of the claim.”


  • We agree that facilities should receive the home dialysis payment adjustment (HDPA).

  • We support CMS paying the HDPA on ESRD facilities’ claims to Medicare as a secondary payer.

  • CMS should adjust the full PPS payment per treatment by the HDPA.


Offering ESRD facilities every possible adjustment with the added cost of training for home dialysis, especially for home HD, may create a sufficient financial incentive to motivate staff to encourage more patients to consider home dialysis.

§ 512.345 Payments subject to the clinician HDPA.

“CMS adjusts the amount otherwise paid under Part B with respect to MCP claims on claim lines with CPT codes 90965 and 90966 by the Clinician HDPA when the claim is submitted by a Managing Clinician who is an ETC Participant with a claim through date during a CY subject to adjustment as described in § 512.350 and the beneficiary is 18 years of age or older during the entire month of the claim.”


We agree that Managing Clinicians should receive the HDPA on top of the MCP, and support CMS paying the HDPA on MCP claims to Medicare as a secondary payer.


Offering managing clinicians every possible adjustment with the added cost of training for home dialysis, especially for home HD, may create enough of a financial incentive to motivate ESRD facility staff to encourage more patients to consider home dialysis.

§512.360 Beneficiary population and attribution

“To help ensure that this protection [beneficiary freedom of choice] is not undermined by the testing of the two proposed Innovation Center models, we are proposing to codify at

§ 512.120(a)(1) a requirement that model participants and their downstream participants not restrict a beneficiary’s ability to choose his or her providers or suppliers.”

“The model participant…must not commit any act or omission, nor adopt any policy that inhibits beneficiaries from exercising their freedom to choose to receive care from any Medicare-participating provider or supplier, or from any health care provider who has opted out of Medicare. “


  • We agree with the proposed rule that beneficiaries attributed to dialysis facilities and Managing Clinicians should be receiving dialysis for ESRD (not acute kidney failure), have Original Medicare Part B, be 18 or older, reside in the U.S., and not have dementia. Age alone is NOT a reason to exclude patients from home dialysis (PD or home HD), and dementia should require a diagnosis in the medical record based on testing by a qualified practitioner.

  • CMS should encourage ETC Participants to use the Method to Assess Treatment Choices for Home Dialysis (MATCH-D) to determine which dialysis patients to exclude.14


  • The MATCH-D was developed and reviewed by home dialysis thought leaders and is in widespread use in the U.S.

  • Cognitive challenges in seniors may have treatable causes other than dementia. Medication interactions, urinary tract infections, or other illness can cause dementia-like symptoms.

  • People of all ages have the right to know about and choose home dialysis. Seniors can be capable of performing home PD or HD. As of December 31, 2016, of the 119,093 prevalent patients who were age 75 or older and treated with dialysis or transplant, nearly 7% (7,825) were on PD or home hemodialysis and almost 12% (13,859) had transplants.15

§512.365 Performance assessment

Home dialysis rate, ESRD facilities: “The denominator is the total dialysis treatment beneficiary years for attributed beneficiaries during the MY…The numerator is the total number of home dialysis treatment beneficiary years for attributed beneficiaries during the MY..”

Home dialysis rate, managing clinicians: “The denominator is the total dialysis treatment beneficiary years for attributed ESRD Beneficiaries during the MY…The numerator is the total number of home dialysis treatment beneficiary years for attributed ESRD Beneficiaries during the MY.”

Transplant rate, ESRD facilities: “The denominator is the total dialysis treatment beneficiary years for attributed ESRD Beneficiaries during the MY…The numerator is the total number of attributed ESRD Beneficiaries who received a kidney transplant or a kidney-pancreas transplant at any time during the MY.”

Transplant rate, Managing Clinicians: “The denominator is the total dialysis treatment beneficiary years for attributed ESRD Beneficiaries during the MY, plus the total number of attributed beneficiary years for pre-emptive transplant beneficiaries during the MY. The numerator is the total number of attributed ESRD Beneficiaries who received a kidney transplant or a kidney-pancreas transplant during the MY, plus the number of pre-emptive transplant beneficiaries attributed to the Managing Clinician for the MY.


  • We recommend use of the My Life, My Dialysis Choice treatment matching tool with all dialysis patients who can comprehend it within the first month of dialysis and at least annually thereafter.

  • We recommend assessing home dialysis performance using the percent of home dialysis (PD and home HD) patients who remain on their home modality for at least 6 months.

  • We recommend assessing transplant performance for dialysis clinics and managing clinicians by using the percent of prevalent patients under age 75 who are on the transplant waitlist, which compares facilities to a national percentage as a benchmark.


  • My Life, My Dialysis Choice (free) is non-commercial, evidence-based, meets the IPDA criteria for decision aids, and the only U.S. tool that helps people match dialysis options to their values and lifestyle. The tool is endorsed by the American Association of Kidney Patients and Home Dialyzors United. Fresenius adopted this tool company-wide for in-center hemodialysis patients. MEI pilot data (unpublished) found significant increases in interest in home therapies when the tool was used.

  • Using the home dialysis rate—as proposed—may have the unintended consequence of pushing unwilling patients to do home dialysis—and may lead to poor retention, “failure,” and demoralization. Home dialysis training is highly stressful, and patients are most likely to give up and go back in-center during the first 3 months at home. Using a retention rate of 6 months will encourage increased use of home therapies in a sustainable way.

  • Dialysis facilities only have control over how many dialysis patients are educated and referred‚ not how many are ultimately transplanted. Factors affecting patient transplants out of the ESRD facility’s control include supply of kidneys, blood type and tissue matching and antibodies, comorbidities, transplant programs’ exclusion criteria, insurance/financial barriers, etc.

  • Managing Clinicians can bill Medicare for Kidney Disease Education, which includes discussion of treatment options. Managing Clinicians and their staff have a responsibility to first consider patients’ values in treatment options discussions, to provide education about all dialysis and transplant options, and to encourage CKD patients they treat to reach out to potential living kidney donors.

§512.370 Benchmarking and scoring

Achievement scoring: CMS assesses ETC Participant performance on the home dialysis rate and transplant rate against benchmarks constructed based on the home dialysis rate and transplant rate among ESRD facilities and Managing Clinicians located in comparison geographic areas during the benchmark year.”

Improvement scoring: “CMS assesses ETC Participant improvement on the home dialysis rate and transplant rate against benchmarks constructed based on the ETC Participant’s historical performance on the home dialysis rate and transplant rate during the benchmark year. CMS uses the following scoring methodology to assess an ETC Participant’s improvement score.”

Modality performance scoring: CMS calculates the ETC Participant’s MPS as the higher of ETC Participant’s achievement score or improvement score for the home dialysis rate, together with the higher of the ETC Participant’s achievement score or improvement score for the transplant rate, weighted such that the ETC Participant’s score for the home dialysis rate constitutes 2⁄3 of the MPS and the ETC Participant’s score for the transplant rate constitutes 1⁄3 of the MPS.”


  • We support the achievement and improvement scores for home dialysis and transplant and assessing each ETC Participant against applicable benchmarks. However, for the transplant rate, we support benchmark, achievement, and improvement scoring for ESRD facilities be based on the percent of prevalent patients under age 75 on the transplant waitlist.

  • We see no added value in a modality performance score (MPS) that is a combination of the higher of the home dialysis and transplant achievement and improvement scores, and recommend eliminating it.

  • We recommend that ETC Participants post the benchmark score and their achievement and improvement scores in a prominent place in the dialysis clinic and home training area where it can be seen by all patients and visitors.


  • The percent of prevalent patients under age 75 on the transplant waitlist is a performance measure over which ESRD facilities and Managing Clinicians have greater control than transplant rates. Facility-specific waitlist data for the percentage of prevalent patients under age 75 are collected and reported in the Dialysis Facility Reports, so annual data and improvement could easily be monitored.

  • Home dialysis and transplant waitlist achievement scores and performance scores are singularly sufficient in monitoring ETC Participants’ outcomes, and each modality can and should stand alone.

  • Posting scores provides transparency for patients.

§512.385 PPA Exclusions

ESRD facilities: “CMS excludes an ESRD facility that has fewer than 11 attributed beneficiary years during a MY from the applicability of the Facility PPA for the corresponding PPA Period.”

Managing clinicians: “CMS excludes a Managing Clinician who falls below the low-volume thresh-hold described in this paragraph during a MY from the applicability of the Clinician PPA for the corresponding PPA Period.”


  • We agree with the methodology to calculate the PPA and schedules.

  • We agree with the proposed rule regarding excluding ESRD facilities with fewer than 11 beneficiary attributed years in a measurement year.


Patients receiving dialysis in very small facilities must still receive education about all options for ESRD treatment, be evaluated for home dialysis, and if interested, be referred to facilities certified for home dialysis training and support with experienced home training nurses and more home patients.3,4

§512.390 Notification and targeted review

Notification: “CMS will notify each ETC Participant, in a form and manner determined by CMS, of the ETC Participant’s attributed beneficiaries, MPS, and PPA for a PPA Period no later than one month before the start of the applicable PPA Period.”

Targeted review: “An ETC Participant may request a targeted review of the calculation of the MPS. Requests for targeted review are limited to the calculation of the MPS...”


We recommend eliminating the MPS score.


We find no value in combining the two modality scores and believe that combining them risks losing important data on each modality.

§512.395 Quality measures

“CMS conducts data collection and measure calculation using claims data and other Medicare administrative data, including enrollment data:

(a) Standardized Mortality Ratio (SMR); NQF #0369.

(b) Standardized Hospitalization Ratio (SHR); NQF #1463.


  • We agree that CMS should collect data on the Standardized Mortality Ratio and Standardized Hospitalization Ratio.

  • CMS should also collect data on change of modality from any home option to in-center dialysis, by having facilities conduct an “exit interview” with each patient after a switch.


Collecting patient-reported data will allow for assessment of contributing factors and patterns that may be actionable by the ETC Participant, such as a problematic home trainer; unclear home training materials; lack of after-hours support; challenges with pain, equipment, or supplies, and so forth.

§512.397 ETC Model Medicare program waivers

The following provisions are waived solely for purposes of testing the ETC Model.

Medicare payment waivers…to the extent necessary to make the payment adjustments under the ETC Model described in this subpart.

Beneficiary cost sharing. The payment adjustments… do not affect the beneficiary cost-sharing amounts for Part B services furnished by ETC Participants under the ETC Model.

Kidney Disease Education (KDE) waivers.

(1) …Allow KDE services to be provided by clinical staff under the direction of and incident to the services of the Managing clinician who is an ETC Participant;

(2) …Permit beneficiaries diagnosed with CKD Stage V or within the first 6 months of receiving a diagnosis of ESRD to receive the KDE benefit;

(3) Waives the requirement that the content of the KDE sessions include the management of co-morbidities…unless such content is relevant for the beneficiary;

(4) CMS waives the requirement that an outcomes assessment designed to measure beneficiary knowledge about chronic kidney disease and its treatment be performed by a qualified clinician…provided that such outcomes assessment is performed within one month of the final KDE session by qualified staff.


  • We agree that beneficiary Part B cost sharing should be based on the ESRD PPS without the HDPA adjustment.

  • We agree that cost sharing for Managing Clinicians should be based on the MCP without the HDPA adjustment.

  • We strongly agree with CMS’ plan to expand the clinicians who can provide Kidney Disease Education (KDE) services to dietitians and social workers and recommend requiring that they have at least 12 months clinical experience in nephrology.

  • We strongly support CMS’ plan to include those diagnosed with Stage 5 CKD and those in the first 6 months of an ESRD diagnosis as eligible for KDE services.

  • Dialysis facilities should remain exempt from payment for KDE services.

  • We strongly oppose waiver of the requirement to educate patients diagnosed with Stage 5 CKD or ESRD about comorbidities management.

  • CMS should fund a study on barriers to use of the KDE benefit to identify how help patients slow CKD, delay kidney failure, and choose less costly options of home dialysis and transplantation if their kidneys fail.


  • Patients should not face higher out-of-pocket costs from dialysis facilities as a result of CMS’ testing of the ETC Model.

  • Patients should not face higher out-of-pocket costs from Managing Clinicians as a result of CMS’ testing of the ETC Model.

  • Nephrology is complex; it takes time for clinicians to get up to speed.

  • Patients require education to self-manage kidney failure effectively, and this should not be limited to stage 4 CKD. However, ESRD facilities are already required to provide fact-based education about modalities and settings in the ESRD Conditions for Coverage and are reimbursed under the ESRD PPS for doing that.

  • At any stage of kidney disease, teaching patients how to self-manage comorbidities is important.16 There are no criteria listed for when education on managing CKD and comorbidities is or is not needed, so waiving this requirement for Managing Clinicians risks patients not getting critical information that they may need. Maintaining residual kidney function is key to better health and survival. Choosing PD, taking prescribed ACE inhibitors and ARBs for blood pressure, and avoiding nephrotoxins and hypovolemia17 can help patients retain their residual kidney function longer. Historically, Medicare has paid too few claims for KDE services for Stage 4 CKD patients.18 Patients who receive CKD education are more likely to choose home dialysis.19,20 ,21

Beneficiary Protections

The preamble describes beneficiary protections that are not included in the proposed rule:

  • Patients cannot opt out of the ETC payment adjustment model if they receive treatment from an ETC Participant. However, patients have freedom of choice of providers and modalities.

  • Materials and activities cannot be “materially inaccurate or misleading.” CMS will provide a template about the model.

  • The preamble states that ETC Participants cannot provide incentive payments to patients to encourage them to choose a modality unless that payment is allowed by law.

  • Under anti-discrimination laws (Rehabilitation Act of 1973 and the Americans with Disabilities Act or 1990), ETC Participants can’t screen out or provide unequal services to patients with dementia or cognitive impairment who wish to do home dialysis or have a transplant.


  • The beneficiary protections listed in the preamble should be stated in the rule—along with descriptions of how CMS will monitor ESRD Participants to assure that these protections are honored.

  • The geographic area from which Providers are selected should have sufficient options for patients to choose an ESRD facility and nephrologist who is not an ETC Participant.

  • CMS must institute a way to ensure that information about modalities provided by ETC participants is values-based, accurate, and compete, and all patients must be informed that the ETC Participant is participating in a model that promotes home dialysis and transplant.

  • Patients must be able to choose a modality without undue influence.

  • No patient, including those with dementia or cognitive impairment should face discrimination in a choice of treatment. CMS should monitor ETC Participants for discriminatory practices.


  • Unless the final rule includes a section devoted to beneficiary protections that explicitly states those protections from the preamble at a minimum, ETC Participants could knowingly or unwittingly violate those patient protections.

  • Patients should not have to travel long distances or incur large transportation costs to obtain treatment from an ETC non-participant.

  • We have had multiple reports of ESRD facilities encouraging patients to forego Medicare and pay for insurance plans that are more lucrative for a provider. If incentive payments to patients are not precluded, some ESRD facilities might offer them to get the higher HDPA.

  • Although prohibited by law, discrimination may occur in dialysis and transplant based on both unconscious and conscious biases. Patients with dementia or cognitive impairment may have paid or unpaid helpers who are willing and able to perform their home dialysis treatments and should not be precluded from doing so.

Requested Comments on Assumptions in the Model

“Factors underlying this assumption about the home dialysis growth rate include; known limitations that may prevent patients from being able to dialyze at home, such as certain common disease types that make peritoneal dialysis impractical (for example, obesity); current equipment and staffing constraints; and the likelihood that a patient new to maintenance dialysis starts dialysis at home compared to the likelihood that a current dialysis patient who dialyzes in center switches to dialysis at home...

Individual ESRD facilities or Managing Clinicians were assumed to achieve anywhere from zero to 100 percent of such maximum growth in any given year. Thus, the average projected growth for the share of maintenance dialysis provided in the home was 1.5 percentage points per year. Projected forward, this would result in home dialysis ultimately representing approximately 19 percent of overall maintenance dialysis in selected geographic areas by 2026.”


Many commonly believed contraindications for home dialysis are not evidence-based and must be dispelled.


If ESRD staff and physicians knew that their beliefs are not confirmed by research, even more patients might be able to do PD22 and home HD23 than are assumed by this Model.

“Qualified (kidney) donors may apply for financial assistance through the National Living Donor Assistance Center (NLDAC), which administers federal funding received from HRSA under the federal Organ Donation Recovery and Improve-ment Act.... Approved applicants can receive up to $6,000 to cover travel, lodging, meals, and incidental expenses…Additional methods are necessary to decrease financial disincentives for kidney donors and their recipients who exceed the means testing criteria of the NLDAC.”


According to the FAQs on the National Living Donor Assistance Center website, 24 only a recipients’ income—not a donor’s—must be below 300% of the federal poverty level to be eligible for help with travel, lodging, meals, and incidental expenses. We recommend revising the regulation that established the NLDAC to allow reimbursement of a donor’s lost wages, and providing additional federal funds to the NLDAC to cover reimbursement for lost wages.


Removing financial barriers that preclude living donation and making people whole may help willing recipients who would not otherwise be able to donate, and increase the rate of kidney transplantation.

Page 34574

“The approximately $33,000 in savings per beneficiary over 10 years for LDKT compared to maintenance dialysis is likely a lower bound since living donation would help reduce the number of beneficiaries under the age of 65 who would be eligible for Medicare enrollment.”


Individuals of any age who start dialysis or get a transplant as a first treatment can be eligible for Medicare. If a patient starts home training or gets a transplant first, Medicare can go into effect the first month of dialysis or transplant. 25 All patients, including those with group health plans, should be encouraged to enroll in Medicare to have coverage (secondary if the patient has a group health plan) during the month of a transplant to protect their right to ever use Part B to cover immunosuppressants.26


At most, Medicare would be responsible only to pay post-transplant care for 36 months for patients <65 who do not qualify for Medicare due to another disability besides ESRD. If those patients worked and had employer-group health plans, Medicare would rarely owe anything as a secondary payer. Employment is not mentioned other than as it relates to secondary payer. One effort that could save Medicare money and raise revenues in Social Security and Medicare through taxes would be to promote efforts to help CKD and ESRD patients keep their jobs.

  1. Trump DJ. Executive Order on Advancing American Kidney Health. (Accessed 7/14/2019)

  2. United States Renal Data System, Annual Data Report, 2018, Table D12.

  3. Committee on Finance United States Senate. Proposed Prospective Reimbursement Rates for the End Stage Renal Disease Program under Medicare. 1982. (Accessed 9/6/2019)

  4. Eggers PW. Trends in Medicare reimbursement for end stage renal disease 1974-1979. Health Care Financ Rev. 1984 6(1):31-38.

  5. Medicare Program; Specialty Care Models To Improve Quality of Care and Reduce Expenditures. 84 Fed, Reg. 138 (July 18, 2019)

  6. Medicare Program; Specialty Care Models To Improve Quality of Care and Reduce Expenditures, 84 Fed Reg 138 (July 18, 2019), Page 34572.

  7. Dialysis Facility Compare.

  8. Plantinga LC, Fink NE, Finkelstein FO, Powe NR, Jaar BG. Association of peritoneal dialysis clinic size with clinical outcomes. Perit Dial Int. 2009 May-Jun;29(3):285-91.

  9. Huisman RM, Nieuwenhuizen MG, Th de Charro F. Patient-related and centre-related factors influencing technique survival of peritoneal dialysis in The Netherlands. Nephrol Dial Transplant. 2002 Sep;17(9):1655-60.

  10. Glickman JD, Seshasai RK. Home hemodialysis education during postdoctoral training: Challenges and innovations. Semin Dial. 2018 Mar;31(2):111-114.

  11. Merighi JR, Schatell DR, Bragg-Gresham JL, Witten B, Mehrotra R. Insights into nephrologist training, clinical practice, and dialysis choice. Hemodial Int. 2012 Apr;16(2):242-51.

  12. Plain Writing Act of 2010. Pub L 111-274 (2010).

  13. Department of Justice, Civil Rights Division, Disability Rights Section. ADA Requirements: Effective Communication.

  14. Medical Education Institute. Method to Assess Choices for Home Dialysis.

  15. United States Renal Data System. 2018 USRDS annual data report: Epidemiology of kidney disease in the United States. National Institutes of Health, National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, MD, 2018. Table D.11.

  16. Schatell, D. What is evidence-based kidney patient education.

  17. François K, Bargman JM. Evaluating the benefits of home-based peritoneal dialysis. Int J Nephrol Renovasc Dis. 2014 Dec 4;7:447-55.

  18. Witten, B. Patient education: why do so few CKD patients receive patient education.

  19. King K, Witten B, Brown JM, Whitlock RW, Waterman AD. The Missouri Kidney Program's Patient Education Program: a 12-year retrospective analysis. Nephrol News Issues. 2008 Nov;22(12):44-5, 48-52, 54.

  20. Shukla AM, Easom A, Singh M, Pandey R, Rotaru D, Wen X, Shah SV. Effects of a Comprehensive Predialysis Education Program on the Home Dialysis Therapies: A Retrospective Cohort Study. Perit Dial Int. 2017 Sep-Oct;37(5):542-547.

  21. Weinhandl E, et al. The kidney disease education benefit and home dialysis utilization. Presented at the Annual Dialysis Conference; March 16-19, 2019; Dallas.

  22. Lee MB, Bargman JM. Myths in peritoneal dialysis. Curr Opin Nephrol Hypertens. 2016 Nov;25(6):602-608. Review.

  23. Koester L. Exploring the reasons for the tiny percentage of patients on home hemodialysis. Nephrol Nurs J. 2013 Jan-Feb;40(1):43-8; quiz 49.

  24. National Living Donor Assistance Center. FAQs.

  25. Social Security Program Operations Manual. HI 00801.215 HI 00801.215 Date of Entitlement - General Policy.

  26. Social Security Program Operations Manual. HI 00801.248 Effect of Immunosuppressive Drug Coverage on Filing for R-HI and R-SMI.


  • Celyna

    Oct 09, 2019 9:30 AM

    Agree with Cathy that 80% is such unrealistic number. If you take statistics for 5-10 years you'll understand that increase in 5-10% can really be, but not in 2 times!
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  • Cathy

    Sep 09, 2019 1:47 AM

    Hi David,
    Positive changes have already occurred at my unit in East New York Brooklyn. My patients are predominately African American and have waited on average 8-10 years for a transplant. We averaged 1-2 transplants a year despite having 40 patients on the active list.
    For the past few years we have joined together with Clergy, community centers and schools to discuss prevention and also the importance of organ donation. Since 2017, we have had over 20 patients transplanted. We have no definite correlation between the out reach and the positive outcomes. But we are excited. Our new HD center opened this year and patients are showing interest.
    I like the idea of incenter self care as a stepping stone to HD.
    We did it in the 80’s and it helped.
    Is it difficult to get permission to do self training ?
    Is self cannulation considered self care ?
    Thanks Cathy Reydel
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    • Beth Witten

      Sep 09, 2019 2:55 PM

      Hi Cathy,
      There is no separate certification required for a clinic to offer self-care or parts of self-care. Self-cannulation is only one part of self-care. True self-care would be allowing patients to do their own treatment as they do at home only in a clinic. A clinic can be paid for self-care training just like it's paid for home training if the clinic is certified for home training and support for that type of treatment and teaches the self-care patient the same things they would teach if the patient was going home.
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      • Cathy

        Sep 10, 2019 2:01 AM

        Thanks Beth.
        We ran a self care unit in the 70’s. I loved working there.
        If I can just get my patients over the hump of self cannulation, I know we can get more folks home.
        Thanks for the information.
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  • David Rosenbloom

    Sep 07, 2019 7:46 PM

    Thank you Beth and Dori for an excellent review and critique of the Executive Order on Advancing American Kidney Health of July 10th. While it is a laudable goal, I believe it's targets for HHD are unrealistic given the lack of prior interest in HHD by the medical community, and poor incentives for providing adequate training and payment for HHD nurses and in-home patient assistants. The proposed regulations only seem to be clouding the issue of adequate preparation and planning for such momentous change in treatment of ESRD. It is long overdue, but wishful thinking is no substitute for changing a treatment system so heavily invested in bricks and mortar and not people, and dominated by large providers motivated by profit and not health outcomes.
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    • Dori Schatell

      Sep 07, 2019 8:22 PM

      Well, David, as my daughter likes to say, "You're not wrong..." The purpose of these models is to create incentives for the big guys to change their practices, and both of them have already begun AND were on board for this initiative. So, that's promising. Will it work? I have a crystal ball in my garage, but haven't ever found the "on" switch. ;-)
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  • Dori Schatell

    Sep 07, 2019 6:27 PM

    Well, no one would argue that it's not ambitious! Is it possible? I guess we'll see. As with anything, the devil is in the details. CMS tends to focus on "models", and they say they have things like "rapid change cycles." Have these ever been demonstrated to work? I don't know.
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  • Cathy

    Sep 07, 2019 3:35 AM

    Does anyone really believe this goal is attainable?
    I hope we decrease the prevalence of ESRD by any percentage we can. ESRD grows by 10-15 percent a year. I would be happy if we could at lease prevent any increase.
    The 80% of patients on transplant, HD or PD is a fantasy.
    80% is an unrealistic number. Doomed for failure.
    Without paid assistance at home this will never happen. I was a HD nurse in 1978. We had no choice. There were not enough IC seats. We were happy as Nurses and PCT’s to provide dialysis in the patients home. We were compensated. There was no shortage of help willing to be paid to provide home care.
    Many of my patients are not interested in Transplant because they do not want to lose Medicare and disability payments. Disability pays ESRD patients at the highest rate available at 70 years old. Many are not employable and are afraid to lose their disability in 36 months. Who will pay for my immunosuppressives? They ask.
    I have no answer for them.
    The President means well, but has he really investigated this with people in the ESRD community ?
    If so, did he speak with those of us with boots on the ground ? The patients and staff who live this everyday.
    Quite frankly when everyone around me panicked over this , I had to laugh.
    I remember all the transplant promises made during President Obama’s last year in office. A questionnaire we completed with our patients, about how Black patients felt about transplant, their feelings and fears regarding transplant went to the President. Grandiose promises from every major Pharmacy chain and hospital were made.
    Big meetings on Capital Hill. It fizzled out in a year. I haven’t heard a thing about it.
    I’m trying to be optimistic. But Davita and Fresenius are opening on every corner of the five boroughs of NYC. Apparently the CON is a thing of the past for the chains.
    Every Nursing Home is opening dialysis units where they are dialyzing patients who aren’t even oriented and may not be benefiting from dialysis.
    The President is taking about shrinking OPD, yet all I see is OPD expansion.
    What are you thinking about this ?
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