Wednesday, December 16, 2009

Advocates4QualitySafeCare comments on ESRD PPS - Will this new payment system change patients lives?

Uncompensated advocates striving for quality safe care
for all patients - all health care settings
San Diego, California 92128

December 10, 2009

Ms. Charlene Frizzera
Acting Administrator
Centers for Medicare & Medicaid Services
Department of Health and Human Services
Attention: CMS-1418-P
Baltimore, MD 21244-8010

To Whom It May Concern:

My name is Roberta Mikles. I am a retired Registered Nurse, Patient Safety Advocate, daughter of a dialysis patient and spokesperson for other Advocates4QualitySafeCare. These advocates are patients, family members, health care professionals and concerned taxpayers that are all dedicated to working towards patients receiving quality safe care in all health care settings. Today, however, we are focused on dialysis care.

We appreciate the time, effort and research that CMS put forth in development of the ESRD PPS proposed rule. It is evident that CMS has, to a great extent, considered Medicare cost containment while attempting to maintain quality safe delivery of care. Three areas that we support are: (1) pay-per-treatment to allow improved quality of life for patients, (2) inclusion of Epogen in the bundle to prevent misuse, and (3) exclusion of nephrologists’ services. Although we support the aforementioned, and understand CMS’ challenge to preserve quality safe care, we have significant concerns that are focused on patients and how they will be affected (negatively) by this proposed rule. It appears that there is considerable potential for patients to be negatively affected as a result of increased administrative burdens. That additional use of patient staff time could result in possible cost-cutting in areas of delivery of care.

We do not believe that CMS had sufficient valid data when developing this proposed rule. If the bundled rate is not based on current and accurate costs, patients will suffer. There are enough delivery-of-care problems now as evidenced by Medicare survey findings, as well as providers identifying those patient safety areas (during the time frame of the patient safety coalition).

We strongly urge CMS to revise the proposed rule to prevent patients from experiencing negative outcomes and postpone the implementation date (2011) until current and accurate data is obtained and fully analyzed and studied.

Medicare should NOT reimburse providers for preventable errors that result in negative outcomes. As a result of this bundling, we might see an increase in negative outcomes.

We bring the following comments and recommendations to CMS. Some comments and recommendations might be conflicting, but we are looking at this proposed rule from different views, therefore, different recommendations providing various options to CMS.



We commend CMS on recognizing the importance of allowing payment for more than three treatments a week. We highly support Medical Education Institute’s comments and recommendations:
“Patients want to live as long and as well as possible. Some in the renal community have expressed concern that CMS has put cost before patient health and well-being by not routinely reimbursing for more frequent treatments until results of the $10 million Frequent Hemodialysis Network (FHN) studyare published (already delayed >1 year). We wonder how many patients would have kept their jobs, had fewer complications and hospitalizations, had better health-related quality of life, and survived instead of died had CMS accepted data from multiple clinical trials. and routinely reimbursed for 1-3 additional treatments per week during the study period. Even if the results of the FHN study confirm data from other studies, it appears from the rationale in the preamble that the ESRD PPS will continue to limit treatments to three times weekly unless medical necessity justifies extra treatments, placing an additional burden on already overstretched nephrologists.
Short, thrice-weekly hemodialysis treatments evolved from a historical accident,1 are not evidence-based, and should not remain the default treatment in the face of compelling evidence that the 2-day treatment gap contributes to thousands of needless deaths in the U.S. each year (sudden cardiac death rates soar to 50% higher than expected on the day after the 2-day no-treatment gap) 2 and triple in the 12 hours prior to the next treatment after that gap. (3) “


“State in this bundling policy that if FHN findings demonstrate that daily and/or nocturnal hemodialysis improves blood pressure, LVH, nutritional status, anemia, quality of life, and vascular access, reimbursement for >3 treatments per week will be allowed at the bundled rate plus any other adjustments provided in the final reimbursement policy, without additional medical justification”


Comment - EPOGEN (potential for under dosing)

We commend CMS and recognize the reasons for inclusion of Epogen in the bundled rate and trust that this will prevent the misuse and overuse which can be harmful for patients. Although we support this inclusion, we remind CMS that Epogen accounted for over 20% of (some) provider’s revenue; therefore, with the inclusion of Epogen, the following significant concerns arise that require CMS’ prudent review:

(1) Will providers administer minimum amounts of Epogen in order to meet their revenue projections? (1 a) Will these minimum doses result in patients requiring blood transfusions? (1 b) Will these minimum doses result in affecting (negatively) the patient’s well-being? It must be remembered that, for the most part, about 95% of delivered dialysis treatments are given by for-profit providers who are accountable to their shareholders. When revenue is potentially affected, providers might be tempted to administer less Epogen than they would have prior to the bundled payment.

Recommendation -

Develop patient-safeguards in order to prevent patients from being under dosed. With the collection of hemoglobin data from facilities, CMS should be able to determine if patients are being underdosed.

Comment - Epogen (consequences of minimum dosing)

Consequences of administration of minimum Epogen dosages will not only affect dialysis patients, but the community-at-large. A rise in the number of dialysis patients who will require blood transfusions will affect the already limited blood supply in many areas of the country, thereby affecting non-dialysis patients who might require needed blood. This situation then becomes a “community-problem”


(1) Patient-safeguards should be developed to ensure patients are not receiving minimum doses.
CMS has and will continue to have sufficient hemoglobin data from facilities to determine such.
(2) In addition, CMS should develop a tracking record for reporting those patients who required a blood transfusion. CMS needs to determine the numbers of patients requiring blood transfusions, to establish negative outcomes.
(3) Increase the penalty and develop a separate penalty if a patient is admitted to the hospital due to under treatment requiring a blood transfusion.
(4) Increase the penalty if a facility has an increase from their prior year in patients admitted to the hospital for a blood transfusion.

Note: # 3 and 4 --- Develop a grid with correlating penalties for hospital admissions. Medicare will NOT reimburse for preventable negative outcomes e.g. a patient who is hospitalized requiring a blood transfusion as a result of Epogen under dosing. The grid should include penalties for such as in #3 and 4.

Comment - Epogen - (hospitalization as result of low hemoglobin level)

We are aware of the 1999 Institute of Medicine report, “To Err is Human,“ which stated the high numbers of deaths as a result of preventable errors in hospitals. To date, the numbers have not significantly declined; therefore, do we need to unnecessarily expose this vulnerable population to further potential risk of harm? Further risk rises for this vulnerable population such as acquiring a preventable infection when hospitalized. Therefore, we must do everything possible to prevent hospitalizations especially since infection remains the number two killer of this already compromised group.


(1) Develop patient-safeguards, as above, to ensure that patients are not being under dosed.
(2) Medicare will not reimburse providers for preventable errors resulting in negative outcomes e.g. blood transfusions as a result of under dosing and low hemoglobin

Comment - Epogen - (higher hemoglobin levels required

Many patients who we have spoken to claim that they feel better and are able to function with a higher hemoglobin level, e.g. above 12. Many of these patients are employed.

In conclusion, we are surprised that even after the Congressional Hearings and investigations that there is only a “slap on the wrist,” (2% reimbursement decrease) for parameter compliance. This is insufficient to maintain compliance.


(1) Include hemoglobin levels to be higher than target maximum of 12 if there is medical justification.
(2) We urge CMS to look at further studies and research data related to higher hemoglobin levels in the dialysis patient population

Comment - Oral Medications

We oppose the inclusion of Part D oral medications in the bundled rate. We further believe that CMS did not have complete Part D data in order to determine the bundled rate for oral medications e.g. $14.00 per treatment. The amount that facilities will be receiving will not be sufficient revenue, resulting in cost-cutting in other areas e.g. dialysis supplies, staffing, etc. This will also prevent physicians from ordering, for many patients, the same medications they are presently taking. Administering less effective medications can result in negative outcomes. In addition, the inclusion of phosphate binders and calcimimetics allows and gives permission (by CMS) to providers to prescribe and administer drugs with lesser efficacy that will be provider cost effective but not patient-effective.

We remind CMS of the recent exposure of Quest subsidiary, Nichols Institute Diagnostics Inc. and problems with medical test kits. These test kits were sold to labs across the country from 2000 to 2006 in spite of inaccurate test results, thereby putting hundreds of thousands of dialysis patients at risk. Further, some dialysis patients underwent unnecessary surgery to remove their parathyroid and therefore were administered unnecessary treatment.
We do not need further negative consequences for dialysis patients. Not being able to take the most effective drugs might do harm.

We recognize that there are some patients who do not have supplemental insurance and have been paying out of pocket, large amounts, for their medications. The 20% coinsurance that they will have to pay now might be a decreased amount, thereby being better for them. On the other hand, those patients who have been covered by Part D will now have a coinsurance payment that might be larger. We ask CMS if data was obtained prior to this proposed rule that included information on patients who would benefit and those who would not? This could be a crucial determinant of how patients will be affected.

Medicare beneficiaries have a right to Medication Therapy Management. This can only be accomplished if patients have all their medications filled at the same pharmacy. Patients need to continue to have a choice of where to have their prescriptions filled. Many have long time patient-pharmacist relationships that they trust.

Inclusion of oral medications without appropriate oversight can lead to negative outcomes for patients. Granted that the ESRD Conditions mandate quality measures of bone and mineral metabolism to be included in the QI process; however, it is our experience, after facility survey reviews, that many facilities, although having a QI process required by their own facility policies/procedures, did not implement such. Therefore, we have grave concerns in spite of Condition mandates and urge CMS to address such. We are aware of the HR 3962 mandates (inclusion of binders and calcimimetics); however, we remind CMS that quality measures need to be included in order to ensure patient safety. We, further remind CMS, again, of the recent whistleblower case related to parathyroid testing problems that placed patients in harmful situations. We do not need more problems. e.g. additional unnecessary parathyroidectomies, therefore, oversight with quality measures is imperative.


(1) Exclude oral medications until complete data is obtained and analyzed to determine negative consequences for patients and providers
(1a) actual cost of medications that patients are presently prescribed
(1b) study and obtain data on the number of patients who will benefit versus the
number who will not (those with no insurance who pay out of pocket who will
have a lesser amount to pay versus those who have no copay
who will have a copay)
(2) If calcimimetics and phosphate binders remain in the bundle, data collection on parathyroidectomy surgery and vascular calcification levels.
(3) If calcimimetics and phosphate binders remain in the bundle, include quality measures of bone and mineral metabolism.
(4) If oral medications remain in the bundle CMS should include patient-safeguards so that all patients have the opportunity to receive the same drugs with the same efficacy.



CMS has included anemia management and dialysis adequacy in the QIP; however, is this enough to determine quality care? NO, it is not. It is fully understood the reasons for inclusion of these two, as well as further QIP development; however, we believe CMS has needed data readily available to them to include other quality measures. Being aware of the slowness of improving oversight of dialysis facilities, we urge CMS to include additional quality measures to ensure patient safety.

(1) Include additional quality measures to ensure patients are receiving quality safe care.


It is shameful that infection remains, after many years, the number two cause of death among this vulnerable population. We do not believe that preventable acquired infections have ever been sufficiently addressed in dialysis units. It is our understanding that under the new Conditions the most frequently cited deficiencies are related to ineffective infection control practices, e.g. the most basic practices of hand washing, changing gloves and surface cleaning between patients. These continued problems with staff not implementing correct practices to ensure safe care MUST be addressed. This is the time to do so to protect patients. We believe that CMS has sufficient data that inclusion of such will decrease infection rates. The question we must ask is, “How many patients would have not acquired an infection should there have been increased oversight in this area?” and “How many patients would not have died as the result of a preventable infection?”


(1) Include infection rates in the QIP
(2) Develop an incentive program for those facilities that decrease their infection rates
(3) Increase the 2% (decrease reimbursement) if facilities are cited for infection control deficiencies during surveys.
(4) Increase 2% if facility infection rates increase from prior year.
(5) Mandate facilities to participate in the CDC’s surveillance programs for infection prevention


The ESRD Conditions identify patient-level indicators that are to be included in the facility’s Quality Improvement Program of which Mineral Metabolism and Renal Bone Disease are included. However, although this has already been identified as mandated tracking, there is no way to know if facilities are in compliance due to the lack of timely inspections in many states. Additionally, in our review of many facility survey reports, deficiencies were cited for facilities not adhering to their own QI policies and procedures. Therefore, it is even more essential that Bone and Mineral quality measures be included in the proposed QIP. Renal bone disease is also included in the comprehensive assessment (ESRD Conditions). Therefore, we ask, “Is this not important enough to include in the QIP?“ There must be oversight to ensure patient safety.


(1) Include Bone and Mineral Metabolism quality measures in the QIP
(2) If calcimimetics and phosphate binders are left in the bundle, tracking of parathyroidectomies should be done.



We believe that CMS has sufficient hospitalization data to include such in the quality measures. Increasing oversight by inclusion of hospitalizations will result in increased patient safety and delivery of quality care. In review of some survey findings it was evident that hospitalizations were a result of preventable errors.


(1) Include quality measure of ‘hospitalization rates’ in QIP.
(2) Include tracking of reasons for hospitalizations

Patient Satisfaction


It is our belief that patients, as the complete their facility patient satisfaction survey, often do not identify those ‘real’ concerns regarding care. Many patients have told us that they are not comfortable completing the facility patient satisfaction survey. When asked ‘why’ their responses are as follows: (1) lack of confidentiality as a result of (a) not being able to send survey in sealed envelop to another location other than handing back to staff (b) upon completion placing survey in container within their facility (c) staff standing next to them as they fill out survey, (2) fear that there will be retaliation for stating their concerns regarding delivery of care as a result of (2a) bringing forth concerns with no facility action taken (2b) staff demonstrating either covert of overt behavior indicating that patient should not bring forth concerns.

It is important for patients to be able to bring forth concerns, especially in a survey and that this information be kept confidential.


(1) Include patient satisfaction in the quality indicators
(2) Standardize procedure for patient satisfaction surveys to ensure accuracy and consistency.


The 2% penalty is a “slap on the wrist“. Dialysis Facility Compare clearly shows that there are many facilities that were either lower or higher than state and/or national percentages. Dialysis facility survey findings have also indicated cited deficiencies for that related to anemia management. Therefore, does this area not warrant more concern?


(1) Increase the 2% penalty to a higher number when providers under-treat or do not treat a patient’s anemia, e.g. when hemoglobin levels are below 10 and remain under ten for specified time frame.
(2) Increase the 2% penalty when providers over-treat a patient’s anemia, e.g. when hemoglobin levels fall over the parameter unless there is medical justification e.g. post-hospitalization.



We oppose the inclusion of home dialysis training in the bundled payment. We fear the inclusion of home training will be a disservice to patients. Patients, being responsible for their own life, must be fully educated and trained. It is somewhat disappointing that home dialysis training is not considered to be that important, e.g. having an attached adjustor. When considering the time it takes to train a new dialysis technician in order to ensure that patients receive safe care, even more consideration should be given to those who take full charge of their own dialysis treatment administration. CMS has proposed that the bundled rate shall be increased for the first four months, some of this amount to cover home dialysis training. However, most patients do not start home dialysis within the first four months. The sad reality is that many units do not and with the proposed rule even more will not encourage home dialysis due to poor reimbursement. We remind CMS that longer and more frequent home dialysis has proved to give patients a better quality of life, reduce medication use, reduce hospitalizations and increase survival. Considering patient survival is one of the aspects of CMS’ Dialysis Facility Compare, it would be prudent to address home dialysis differently than is in the proposed rule. Home dialysis is cost saving for Medicare and has not been adequately addressed. It makes sense that if patients take fewer medications with less hospitalizations, that this in itself saves millions of dollars. Therefore, we strongly urge CMS to realize that home dialysis plays a major role in reducing Medicare costs while improving patient lives.


(1) Exclude home dialysis training from the bundled rate
(2) Add adjustor for home dialysis to include training at a rate that is equivalent to, for example, training/teaching of dialysis technicians
(3) Add adjustor for those facilities that maintain patients on home dialysis for six months
(4) Add adjustor for patient outcomes
(5) If home dialysis remains in the bundled rate for the first four months, CMS should implement immediately a formal plan to monitor, e.g. increased oversight to determine if the number of home patients is decreasing or increasing and to determine how patients are being affected by the bundled rate.



We oppose the inclusion of all lab tests in the bundled rate. It is our understanding, according to Section 623(E)(1)(B) of the MMA, that the intent was only to include lab tests directly related to the use of IV drugs, e.g. Epogen and Vitamin D. CMS has included all laboratory tests which we oppose. We appreciate the fact that CMS is charged with reducing Medicare costs, while preserving quality safe care, however, we strongly believe that the inclusion of lab tests will result in (1) needed lab tests not being ordered, (2) patients will experience negative outcomes as a result of not having needed lab work performed., (3) potential - treatment errors as a result of not ordering adequate tests, and (4) potential - patient complications as a result of inadequate testing. The inclusion of all lab tests places the physician in a constrained position to order needed labs especially if there is any type of pressure from profit-making providers, or those providers who are barely making ends meet. Medicare beneficiaries should be able to obtain the same services e.g. according to this proposed rule, Medicare beneficiaries with ESRD requiring dialysis will not be afforded the same ability to have needed labs as non-ESRD patients, thereby setting up a system of discrimination. Patients who before did not have a copay for lab tests will now be responsible for 20% which might result in financial burden for many patients who already might be on limited/fixed incomes. This penalizes patients who have an illness - ESRD.

The following was stated in the recent published Semiannual Report to Congress DHHS, OIG, April 1, 2009 - September 30, 2009 in regards to dialysis facilities incorrectly billing for lab tests.
“Based on our sample results, we estimated that the intermediary overpaid dialysis facilities $3.9 million for laboratory tests provided to ESRD beneficiaries during CYs 2004-2006” This is absolutely appalling. And, this is just another example of why there now needs to be Medicare cost containment.. The correction of this situation is going to place increased administrative burdens on facilities as related to training staff in correct procedures, hiring staff, etc., This is going to take away from patient care time. Are patients paying for someone else’s mistakes?

FACILITY-LEVEL ADJUSTMENTS - Determination of Small Volume Facilities


We oppose the number of treatments listed in the bundle to determine small volume facility. There are too many variables, e.g. patients hospitalized, patients who travel, patient-visitors (traveling), and missed treatments. Determination of small volume facilities by patient census is a more stable method. Providers, in order to maintain their small volume status and receive the 20% increase, might not offer more treatments, or may even offer fewer treatments than 3x/week. If the 20% is decreased to 10% there will be no incentive to decrease patient treatments.


(1) Determine small volume facilities by number of patients.
(2) If the determination remains based on number of treatments the 2% increase should be decreased to 10% (minimum required by law).



Medicare’s intent was not to show discrimination towards one group of beneficiaries versus another, e.g. patients with kidney failure versus those who do not have kidney failure. It appears that this proposed rule penalizes ESRD beneficiaries who have co morbid conditions, e.g. with increased bundled payments comes increased copayments. One question that must be asked is, “Do other non-ESRD beneficiaries with comorbid conditions have higher copays because of their comorbid conditions? NO. Some patients due to numerous adjusters will have large copayments that could result in financial devastation.

Further concern is that patients who are on limited/fixed incomes might not be able to pay this new copayment which would mean that they could be involuntarily discharged. CMS has, by this proposed rule, set the patient up to be involuntarily discharged. CMS wrote the language in the ESRD Conditions which clearly state that a patient can be involuntarily discharged for non-payment. This is frightening for many patients to think that CMS who is suppose to ensure quality safe care and protect beneficiaries is setting them up for discharge. The reality of continued involuntary discharges is alive within the community. A major problem that we foresee is the following. Again, a reality, but many facility staff and/or physicians have not taken a liking to those patients and/or family members who speak up, ask many questions regarding delivery of care, bring forth concerns related to delivery of incorrect practices, etc. These individuals, who just want to protect themselves from preventable errors, or become more educated (it is their life), or to work with staff as a team, are often labeled e.g. ‘troublemaker’, ‘problem patient’ or ‘problem family’, ‘challenging patient’, ‘annoying’, etc. They are not seen as part of the team to help staff prevent errors, or even to become involved in their own care. These patients and/or families, who especially have brought forth concerns related to delivery of care, have been negatively looked upon by staff. Therefore, if, for example, one of these aforementioned patients is unable to pay their bill, they are immediately set up for an involuntary discharge. This is a sad reality. This area, as others, must have prudent review otherwise patients lives are at stake.

Further concern surrounds such as a case-mix adjustor for recovering alcoholic when, in fact,
more care is needed post hospitalization e.g. paperwork (mandated assessement, etc by Conditions), assessment/evaluations, possible ongoing treatment changes involving staff time.

Facilities are going to encounter a huge administrative burden with this case-mix adjustment model. Staff training and education will have to take place in order to ensure accuracy in data. Computer programs to support such will add cost and training of staff as well. More administrative costs for CROWNWeb again using more administrative resources. This increase in staff time and administrative burden, might result in added costs for the facility. This could result and likely will in cutting corners in the area of delivery of care. There are already enough problems with the delivery of care system as evidenced by survey findings and identified problems (by providers) as a result of the safety coalition .Therefore, cutting corners in the area of delivery of care will place patients in an even more compromised situation with potential for negative outcomes.

The complexity of this case-mix model is based on data that we believe is not always correct. The end result of this case-mix model poses potential negative outcomes for patients from financial to physical, therefore, CMS needs to re-evaluate this model.
CMS has led us to believe that the data obtained on the form 2728 is obtained by a nephrologist. This form is more than likely completed by someone who is not medically trained. Therefore, the data provided to CMS could be inaccurate, missing or forms incompletely filled out. This data must be correct otherwise patients will be affected.

Another equivalent concern is that of facility staffing and patient selection. If facilities are able to choose which patients they admit this could result in only providing treatment for the sickest of patients, with more comorbid conditions in order to increase revenue. This is a potentially dangerous situation. With the limited number of Registered Nurses in each facility, some with minimal dialysis experience or even medical experience, with no on-site physician, and with dialysis technicians providing most of the treatments, often with no medical background, along with a ’cookie-cutter’ training, we can only expect negative outcomes. (we are aware of those deficiencies related to insufficient training and education, etc., therefore, do we need more problems?) We are treading thinly in this area as evidenced by many facility survey findings and situations patients are placed in. We urge CMS to reconsider this case-mix model as there appears to be more negative than positive when it comes to patients and their safety
If providers ‘cherry-pick’ the most profitable patients, then other patients stand to lose. We must be ensured that all patients have access to care.

More concern surrounds the 120 adjustor. At the beginning of dialysis patients are receiving more acute intensive care with more complications that could happen. This critical time affecst all patients, Medicare beneficiaries or not. The present proposed rule excludes more than half of these patients. This time period could mean a patient’s life. Further concern lies in the area of providers inappropriately placing patients in home treatment in order to be Medicare eligible. This inappropriate placement could also mean a patient’s life especially if they are not medically stable at initiation of treatment. This adjustor must include all patients and not just Medicare beneficiaries.


(1) Increase the bundled payment and decrease the case-mix adjustors (those that require additional administrative time e.g. documentation, etc. that will result in a more equal system.
(1a) Add those monies devoted to other case-mix adjustors in the bundled rate so that patient care will not be affected due to increased administrative burdens.. If CMS is not agreeable to this, we believe CMS should compromise and Increase the bundled payment and decrease case-mix adjustors to include only those that affect costs, thereby resulting in a more equal system.
(2) CMS should provide to all facilities an electronic calculator to ensure consistency among providers
(3) Before initiating this model (2011) a study should be conducted to determine who is completing these forms and their experience/training. Included in this study should be a random selection of forms, coinciding with interviewing patients/families, and physicians, along with medical records reviews.
(4) Remove the 120 case-mix adjustor and include these monies in the bundled rate.
(5) Develop a mechanism to ensure that all patients have access to care.

In conclusion, we do not believe that this proposed rule is in the best interest of those Medicare beneficiaries or others, as all patients will be affected by this rule, not only Medicare recipients. The increased administrative burden that will be place upon providers will result in less attention to the patient (ALL patients) which can result in increased negative outcomes. We remind CMS that the State Survey Agencies, many, are not able to not only survey timely, but investigate complaints timely. Therefore, this continues to place patients at risk. The Networks do not have the authority as do SSA which poses yet further problems. The bottom line is that CMS must include quality measures to protect patients because for years oversight has been ineffective e.g. lack of timely surveys, lack of timely complaint investigations and lack of adequate sanctions. We can no longer continue to place this vulnerable population at risk. This proposed rule is a major change that will affect lives and we must make sure that we get it right the first time. We encourage CMS to publish an Interim Final Rule to allow for further comments. Not knowing how our federal health care reform will affect this vulnerable population puts even more stress on the importance of getting this right ---- protecting patients while continuing to allow facilities to operate. We further request that CMS postpone the 2011 implementation date in order to ensure that patients are fully protected.

We, again, thank CMS for the opportunity to respond to this proposed rule and offer our help in continuing to revise same.

The following was sent in separately



We are deeply concerned about small dialysis providers and rural facilities and have good reason to think that closures could come sooner than later due to bundling. The administrative burden that will be encountered as a result of bundling will not be beneficial for patients. The need to hire more staff, train new staff and pay more in salaries because experienced staff are not available in the area will place undue hardships on this group of facilities. Small and rural facilities do not financially operate at the same level as do some MDOs or LDOs. Even some MDOs might have financial problems resulting in closure. Because of bundling, we believe that patients will be negatively affected e.g. having to drive longer distances e.g. over a couple of hours to obtain life-sustaining treatment due to closures. Even at present, some patients travel this distance. Closures could result in some patients not having access to treatment. Particular attention and greater consideration needs to be given to this new payment method.

Further, many of these facilities are in medically underserved areas, often with many of these patients having no insurance and being indigent. Many of these patients already travel hours just to be able to live. No one should have to go through that.

We urge CMS to pay close attention to that which Dr. Sumit Mohan stated (below).

Dr. Sumit Mohan, MD (Columbia University/Harlem Hospital) recently presented at the American Society of Nephrology’s 42nd Annual Meeting and Scientific Exposition in San Diego, CA the following “Our facility-level analysis suggests considerable geographic variation in the impact of bundled payments on dialysis centers across the country.” He further stated, “Dialysis centers in the east and southeast are particularly likely to feel an adverse financial impact.” Having heard this, we, Advocates4QualitySafeCare, are even more concerned that dialysis delivery of care will deteriorate. We further are concerned that patients will not have access to a facility where they will receive their life-sustaining treating. You, CMS, must not let this happen.

Dr. Mohan, also stated, “Our analysis suggested unanticipated geographic variation in facility reimbursement payments." “The percentage of dialysis centers likely to receive lower payments under the new plan varied widely between states. Estimates suggested that in several states, no dialysis centers would be at risk of receiving lower reimbursements. In contrast, in one state (Delaware), 100 percent of centers are likely to see an adverse financial impact.
The plan would have a greater financial impact on dialysis centers in some parts of the country, especially the south and east. On average, 59 percent of dialysis centers would be affected in states east of the Mississppi River, compared to 33 percent in states west of the Mississippi. "The impact appeared to disproportionately affect the South census region, which also has the highest intensity of poverty,"


(1) Revision of the bundled rate to ensure provider-equity

In conclusion, with the above stated by Dr. Mohan, we urge CMS to put themselves in the patient’s shoes and remember - lives are at stake here. Spend a week with an individual who does incenter dialysis and observe that which many patients experience. Please, CMS, walk with caution as one day it could be a loved one of yours at the end of this new payment method.


Roberta Mikles, RN BA
San Diego, CA


Roberta Mikles, RN BA
Patient Safety Advocate
San Diego, CA


1. Blagg CR. The early history of dialysis for chronic renal failure in the United States: a view from Seattle. Am J Kidney Dis. 2007 Mar;49(30:482-96
2. Bleyer AJ, Russell GB, Satko SG. Sudden and cardiac death rates in hemodialysis patients. Kidney Int. 1999 Apr;55(4):1553-9
3. Bleyer AJ, Hartman J, Brannon PC, Reeves-Daniel A, Satko SG, Russell G. Characteristics of sudden death in hemodialysis patients. Kidney Int. 2006 Jun;69(12):2268-73

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