| ADVOCATES4QUALITYSAFECARE Uncompensated advocates striving for quality safe care for all patients - all health care settings San Diego, California 92128 RMiklesRN@aol.com 858-675-1026
Ms. Charlene Frizzera 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. PAY PER TREATMENT Comment 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: Recommendation(s): “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” INCLUSION OF MEDICATIONS IN BUNDLED RATE 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)
Recommendations: (1) Patient-safeguards should be developed to ensure patients
are not receiving minimum doses. 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.
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. Recommendation: (1) Develop patient-safeguards, as above, to ensure that
patients are not being under dosed. 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. Recommendations: (1) Include hemoglobin levels to be higher than target
maximum of 12 if there is medical justification. 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. http://www.phillipsandcohen.com/CM/NewsSettlements/NewsSettlements516.asp
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. Recommendation: (1) Exclude oral medications until complete data is obtained
and analyzed to determine negative consequences for patients and providers
Comment 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. INFECTION RATES: 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?” Recommendations: (1) Include infection rates in the QIP BONE and MINERAL METABOLISM 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. Recommendations: (1) Include Bone and Mineral Metabolism quality measures
in the QIP Hospitalizations: Comment 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. Recommendation: (1) Include quality measure of ‘hospitalization
rates’ in QIP. Patient Satisfaction Comment 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. Recommendations: (1) Include patient satisfaction in the quality indicators 2% REIMBURSEMENT REDUCTION - PENALTY 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? Recommendations: (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. HOME DIALYSIS Comment 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. Recommendations (1) Exclude home dialysis training from the bundled rate INCLUSION OF LAB TESTS Comment 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.
Comment 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. Recommendations (1) Determine small volume facilities by number of patients.
PATIENT-LEVEL ADJUSTMENTS Comment 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,
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. 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 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.
We, again, thank CMS for the opportunity to respond to this proposed rule and offer our help in continuing to revise same. Respectfully, Roberta Mikles, RN BA
ADDENDUM Advocates4QuAalitySafeCare December 12, 2009 Ms. Charlene Frizzera To Whom It May Concern: The below page did not transmit, please include in our comments. RURAL FACILITIES AND SDO Comment: 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.
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. Recommendation (1) Revision of the bundled rate to ensure provider-equity
Respectfully, Roberta Mikles, RN BA
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