PDF Version of This Leter

December 15, 2009

Ms. Charlene Frizzera
Acting Administrator
Centers for Medicare and Medicaid Services
Department of Health and Human Services
Hubert H. Humphrey Building
Room 445-G
200 Independence Avenue, SW
Washington, DC 20201

Re: CMS-1418-P; Medicare Programs; End-Stage Renal Disease Prospective Payment System; Proposed Rule

Dear Acting Administrator Frizzera,

Dialysis Patient Citizens (DPC) is pleased to provide comments to the Centers for Medicare and Medicaid Services (CMS) on the Proposed Rule for the End-Stage Renal Disease Prospective Payment System (PPS). We also thank CMS for providing the opportunity for us, other patient organizations and patients to share a portion of our comments live at the ESRD Town Hall meeting on October 23, 2009.  As America’s largest dialysis patient organization, DPC is proud to represent over 22,000 pre-dialysis and dialysis patients and their families.  We seek to ensure that the patient’s point of view is heard and considered by policy makers on a wide variety of issues so continued progress may be made in the quality of care and life for dialysis patients.

CMS has a shared goal with DPC to promote quality care for dialysis patients, of which 87 percent of whom are Medicare beneficiaries.  However, promoting quality care involves more than simply adopting outcome measurements.  Quality in health care needs to be patient-centered and should ensure patient safety and equitable, efficient, timely and effective care.   We are concerned with the many aspects of the proposed PPS that may hinder quality care.  While CMS must comply with the law set forth in the Medicare Improvements for Patients and Providers Act (MIPPA), we urge CMS to revise their current proposal in such a way that it will also promote quality care for dialysis patients.

Therefore, we respectfully submit the following recommendations and comments on the areas we believe best address dialysis patients’ concerns.

The Proposed ESRD PPS Bundle (III):  Other Drugs and Biologicals and their Oral Equivalents (C)

Without adequate payment the inclusion of oral medications with no injectable equivalents could limit the ability for patients to receive the medications that produce the best outcomes.  In addition to reducing patient access to these medications, shifting costs to Medicare Part B may also increase patients’ out of pocket expenses, placing the most vulnerable patients under additional financial strain.

Access to Medications

• Including oral medications with no intravenous equivalent in the bundle
  
  
  • Our primary concern is including oral medications with no injectable equivalent in the PPS will result in reduced patient access to these medications, particularly if the medications prescribed are higher cost drugs.  For many patients limited access to prescribed medications will likely result in an overall decrease in quality of care and limited individual choice in the brands of medications patients feel work best.
     
  • Furthering our concern about reduced access to these medications, if included in the final PPS, is that CMS has not appropriately accounted for the actual costs of oral drugs in the proposed rule.  As currently structured and funded, the proposed bundle would provide approximately $14 per treatment for oral medications during the phase in period —much less than the $45-$100  that other organizations with experience in this area find as the range in actual costs associated with providing these drugs.  Underfunding medications does not promote efficiency; instead it encroaches on the patient-physician relationship and reduces the physician’s and facility’s ability to provide patient-centered care that is defined as “respectful of and responsive to individual patient preferences, needs, and values and ensuring that patient values guide all clinical decisions.”  Physicians in consultation with their patients should have the autonomy to prescribe the most appropriate medications to treat their patients.  If CMS includes these medications, but does not adequately reimburse clinics for the cost of these drugs under the bundle, patients’ access to the best treatments may be further limited. Specifically, clinics may only offer certain medications, which could discourage physicians from prescribing medications that may be better for the patient.  In a recent poll of renal administrators and medical directors (excluding those affiliated with large dialysis facilities), 69 percent stated the usage of oral medications included in the bundle would be restricted in some way.   CMS should ensure its payment policy does not unintentionally place patients’ health at risk because of financial concerns.
     
  • Medicare Part D does not pay for all dialysis patients’ drugs. Some patients have private drug coverage outside of Medicare through employer group health plans and retiree plans.  Additionally, because of the coverage gap in Part D, also known as the “donut hole,” some patients do not fill their prescriptions when they are unable to afford their medications.  If medications are accessible through dialysis facilities, increased utilization of medications is likely to occur and should be taken into account when establishing the dollar amount for bundled medications.
     
  • Underfunding care also poses equitability concerns. Higher cost patients may face barriers in receiving care at the facility of their choice as healthier lower cost patients who need fewer or less expensive medications will pose less of a financial risk to facilities.
     
•   Monitoring patients’ access to effective medications
  
  
  • In the background of the proposed rule it states, “Current quality review initiatives provide a basis for monitoring the impact of a bundled ESRD PPS after implementation, to ensure quality of care does not deteriorate in response to the system’s efficiency incentives.”  However, CMS does not currently track the use of oral medications or their impact on patient outcomes.  It is vital patients be protected from adverse outcomes that may result from reduced access to medications.  For example, the progression of bone and mineral metabolism diseases can result in patients experiencing increased bone fractures, cardiovascular complications, hospitalizations, calcification, parathyroidectomies and other adverse outcomes.

If CMS is to include oral medications without an injectable equivalent in the bundle, the Agency needs to ensure patients’ access to these medications is not restricted. 

This can be accomplished by ensuring the actual costs of providing the medications are appropriately accounted for prior to implementation and that after implementation access to medications is closely monitored.

Data for utilization of oral medications should be collected prior to implementation of the new PPS and changes in use and patients’ prescriptions should be tracked after implementation, as should the outcomes associated with the usage of these drugs.  DPC also recommends the results of this tracking be reported publicly and within a reasonable timeline – not to exceed 12 months – to ensure transparency that will help protect patients from adverse outcomes.

• New medications
  
  • Another patient concern relates to investment in research and development for new medications.  New medications are often costly when they first come onto the market.  If the PPS is to apply to new medications, this could threaten patient access to new, improved drugs and biologics that have additional health and/or quality of life benefits because the cost of the new medication is likely to be more than facilities can afford under the PPS payment. This may also discourage pharmaceutical companies from further investing in research and development related to ESRD treatment. 

CMS needs to address the issue of appropriately paying for newer medications to ensure patients have access to the most effective treatments.

• Distribution of dialysis oral medications without injectable equivalents
  
  • Because medications, which are currently provided by patients’ pharmacists, will need to be provided by dialysis clinics either directly or through a contract with the clinic and a pharmacy, patients may have to obtain their dialysis medications at a different location than where they receive their non-dialysis related drugs.  This arrangement will make it more difficult for pharmacists to monitor for potentially dangerous drug interactions.  Additionally, some patients may have to drive to multiple locations to receive all of their medications.  This poses a significant challenge for many patients who already find transportation to and from dialysis logistically difficult or financially draining.

CMS should delay including oral drugs with no injectable equivalents in the PPS, until 2014.  Alternatively, CMS should pilot the inclusion of oral medications among a sample of facilities representing different sized dialysis provider corporations and between urban and rural settings to assess how including oral medications will impact patient access to medications.

• Increased expenditures and co-insurance
  
  
  • Dialysis patients have various coinsurance arrangements and accordingly, patients will be impacted differently depending upon their coverage. Bundling of oral medications without injectable equivalents shifts costs not only from Medicare Part D for those beneficiaries who currently get their prescription drugs through Part D plans, but from  private drug coverage that beneficiaries  have either through employee group coverage or retiree health plans.  With the shifting of oral medications into Medicare Part B, many patients will see an increase in their 20 percent coinsurance responsibility. Prescription drug coverage varies widely across patients, but the implications of this cost shift will increase many patients’ coinsurance costs regardless of how their prescription drugs are currently paid for.  Below are just a few scenarios of patients’ coverage structure and how bundling may impact them:
    
    
    • For patients with Medicare Part D plans who also receive a low income subsidy (LIS) to help with their prescription drugs, the subsidy will no longer help pay for their drugs that fall within the bundle, and patients will be subjected to the 20 percent coinsurance for those medications for which they did not previously have financial responsibility.
       
    • Some patients receive financial help for their dialysis medications through prescription assistance programs.  This assistance helps patients get through the Part D donut hole.  When these medications are moved to Medicare Part B, it is possible patients will no longer have assistance with these extras costs.  Additionally, there is no catastrophic limit on Medicare Part B coinsurance like there is on Medicare Part D out of pocket expenditures, thus patients could find themselves in greater financial distress if medication costs are shifted from Medicare Part D to Medicare Part B.
       
    • Approximately 40 percent of Medicare beneficiaries are dually eligible for Medicare and Medicaid.  Medicaid does not currently pay for these prescription drugs and shifting them into the bundle increases the secondary costs many Medicaid plans currently cover.  It is unknown if states would be willing to cover these increased costs, potentially leaving the drugs further underfunded.
      
      
      • The same situation applies to patients with Medigap or private plans that may not recognize the additional drug costs as “renal dialysis services” or be willing to change their current reimbursement structure to account for the shift. 

Shifting costs to further disadvantage lower income patients and taking away benefits offered from private drug coverage plans or other sources that provide financial assistance programs for some patients is not equitable.  Before CMS includes oral drugs with no injectable equivalents into the PPS, the agency should ensure patients with Medicaid or Medigap plans receive coverage for medications added to the PPS and that there are adequate safeguards for patients who receive an LIS or who will be overburdened by an increase in the 20 percent coinsurance.   All patients should have the continued right to have a choice in the medications they receive.

The Proposed ESRD PPS Bundle (III):  Diagnostic Laboratory Tests (D)

Laboratory tests for the treatment of ESRD

• There is much confusion about which lab tests will be included in the bundle including who will be able to order lab tests for dialysis patients that are not directly related to their ESRD and where these labs will need to be drawn. 
  
  
  • In many cases, physicians who receive monthly capitation payments (MCP) may also act as their patients’ primary care physician. These relationships often provide better care coordination which promotes efficient and timely care.  Patients do not have to see multiple physicians resulting in extra costs to Medicare and to themselves.   Patients can have all lab tests for dialysis (such as tests that check levels related to bone and mineral metabolism, albumin, anemia and others)  – and labs not related to the treatment of ESRD (such as cholesterol, and other tests needed to check for co-morbid conditions) ordered by the MCP in the role of the primary care physician.  However, the proposed rule does not specify which labs will be included in the bundle.  As a result of this ambiguity, many patients may have to see other physicians to have labs ordered. This would result in less coordination in the timing of lab draws potentially requiring additional needle sticks for patients and a greater loss of blood, which may complicate anemia management, damage their vascular access or threaten their vasculature which may be needed for future vascular access creation.    There is also the danger that patients will not be able to see other physicians to get necessary tests ordered, which can lead to other conditions going undetected. This arrangement would be less efficient, timely and patient-centered in the provision of care.
     
  • The frequency of which lab tests will be drawn is also another concern patients may have.  If a patient has a condition that requires close monitoring, then the patient may benefit from having labs drawn more often until the condition is properly managed.  Under a bundled payment, facilities may be more restrictive in drawing additional, necessary labs that would provide valuable information to the physician as to whether additional medications or treatments are needed to improve the patient’s condition or whether the condition has been optimally managed and the additional medication or treatment is no longer necessary.
     
  • Many patients are also concerned as to how lab tests needed for a transplant will be handled. 

DPC recommends CMS define the specific list of lab tests that will be included in the bundle.  This list should be updated regularly to account for new developments in patient care.  This would provide the clearest approach so that patients, physicians and facilities will be made aware of what labs will be paid for in the bundle.  Labs ordered by MCPs both from the list of those included in the bundle and labs left outside of the bundle – and are therefore separately billable – should still be permitted to be drawn in the dialysis facility.

Labs drawn to test patients for transplantation should be separately billable as including them in the bundle could be a conflict of interest for dialysis facilities.

The Proposed ESRD PPS Bundle (III):  Self Dialysis Training (E. 2.)

Promoting self care for dialysis patients is a part of the DPC mission.  We are happy CMS shares this vision and supports more patients having the ultimate opportunity to do self care – the ability to receive dialysis treatment at home. Our members who utilize home therapies have reported an increase in quality of life, enhanced health outcomes and greater flexibility to live closer to normal lives since beginning home dialysis. DPC is also pleased with CMS’s commitment to establishing a formal plan to monitor the expanded bundled payment system’s effect on home dialysis utilization rates as recommended by the Government Accounting Agency (GAO) in their Study on Home Dialysis . 

We are particularly pleased CMS valued all modalities equally, by establishing a single base rate; however, we are concerned with a few incorrect assumptions CMS has made in regards to home dialysis.

• Foremost, by including home training costs in the bundle, CMS assumes there will be “increased flexibility to dialysis centers for greater use of less costly PD and alternative treatment regimens such as nocturnal dialysis, home hemodialysis using compact portable dialysis machines and shorter but more frequent dialysis sessions.”   However, including training in the bundle does not necessarily encourage facilities to create more training programs or expand current ones because they will be paid at the same rate whether or not they provide home training.  Also, spreading out the training costs among all patients does not appropriately account for the upfront investment facilities will have when training patients for home dialysis.
   
• Second, CMS states one reason new patients may have higher costs than those who have been on dialysis for longer than 120 days is that they may be training for home dialysis.  However, this is likely not the case, as most patients do not begin or complete training for Peritoneal Dialysis (PD) or home hemodialysis (HHD) until after their first 120 days on dialysis. Also, beneficiaries who begin dialysis at ages lower than 65 will only be covered by Medicare for the last 30 of the 120 day period, so facilities will not receive the increased Medicare reimbursement for 90 days. Therefore, the new patient adjustor CMS has proposed adding to the payment for patients who are on dialysis for the first 120 days does not appropriately pay for home training either.
   
• Additionally, many patients change their modalities as new options and equipment become available or when their medical conditions, lifestyle or preferences change.  On our Board of Directors alone, our nine patient Board members have averaged over two different ways of dialyzing each.  Patients should have the option to begin a home therapy when it best suits their individual needs, but without proper funding for home training, patients fear they will lose this option, or they may never have the option to dialyze at home if a training program does not become available in their area.
   
• There are also circumstances where patients may require re-training. CMS currently recognizes the need for retraining for a specific list of reasons due to changes in modality, care partner, dialysis setting, equipment and medical condition. Retraining for these reasons assures that patients remain safe and that their partners are able to care for them appropriately.   Further training may also be needed to improve the patient’s future outcomes, restore confidence in their ability to do self care and ultimately allow them to remain at home with their dialysis.
   
• A successful training program is labor intensive.  The Medicare Conditions for Coverage require registered nurses to provide and oversee the dialysis training. 

Nurses work one on one with patients and their home care partners to ensure they learn the skills necessary to be successful and confident to persist on home dialysis.  This personalized training is costly, but it is extremely important for patient safety.

DPC recommends CMS not spread home dialysis training costs among all dialysis patients and instead establish a payment that is applied to the patients who actually undergo training at the time of initiation. This payment should also appropriately take into account the resources required to teach patients to dialyze at home safely. Training payments should be available at any point in the patient’s tenure with ESRD. If the re-training of a patient is necessary to assist them in improving their home care, reimbursement should also allow for these incidences.
 
The Proposed ESRD PPS Bundle (IV:) Unit of Payment

• DPC commends CMS for maintaining per-treatment as the unit of payment. A per-treatment reimbursement, opposed to per-month or per-week payment, allows patients greater flexibility to receive their dialysis outside of their regular facility.  While living life on dialysis is not easy and most patients must fit their lives around dialysis, having the freedom to travel and dialyze in other locations allows patients to live closer to normal lives.  A per-month or per-weekly unit of payment would add further complication that may hinder patients’ ability to receive dialysis in other clinics when they travel.

Therefore, DPC thanks CMS and encourages CMS to keep per-treatment as the unit of payment.

• We also thank CMS for continuing reimbursement with medical justification of more frequent treatments.  This continued flexibility allows patients and physicians to work together to develop treatment regimens that are most optimal for patients’ health.

Cost Regression Used to Develop Proposed Payment Adjustment Factors (VIII): Proposed Patient Level Adjustment (B. 6.)

The Omission of Race as an Adjustor

• The inclusion of certain case mix adjustors is important for patients to have equal access to care, particularly for patients who may have higher costs associated with their care.  After CMS recognized race to be a factor in higher costs, the omission of a race adjustor is concerning.  Without an adjustor for race, facilities will receive less payment for treating minority patients who most likely have higher costs. The absence of a race adjustor could lead to an increase in disparate care.
   
• Additionally, race is not randomly distributed among facilities; it is concentrated in certain communities and geographic locations.  Dialysis facilities often treat patients in their own communities, which makes it easier for patients to have convenient access to care.  As a result of this distribution in the population, many clinics treat predominately minority patients.  Unfortunately, often times these facilities are also dependent primarily on Medicare reimbursement to keep their doors open.  There may be few, if any, patients with private insurance in these clinics—making it difficult for facilities to be sustainable.  If these facilities do not receive payments that more adequately reflect the costs of the patients they treat, they may be forced to close their doors – further exasperating racial disparities in health.
   
• By CMS’s own admission “…patients who are costlier than average to dialyze may face difficulties gaining access to care because a fixed composite payment rate could create a disincentive to treat such patients.”  This is the reason CMS sites utilizing case mix adjustors in the first place and why it is of utmost importance that an adjustor be applied for race to address the higher costs seen in minorities, particularly African Americans.  While CMS may believe adjusting for co-morbidities will address the variability between patients of different races it is not feasible, and there is not enough scientific evidence for CMS to account for every underlying cause of utilization differences among races. 

Therefore, we feel CMS would be able to more appropriately address the potential for greater disparities in care if it were to include an adjustor for race.

XV. Quality Incentive Program

DPC looks forward to a quality incentive program (QIP) that protects and improves upon dialysis patients’ care.  Outcomes for dialysis patients in the U.S. are among some of the worst when compared to other industrialized nations.   There is definitely room for improvement, and we hope the QIP CMS develops will be a step forward in providing incentives to clinics to achieve reductions in patient mortality and allow for improvements in  health and quality of life.

• Anemia Management
  
  
  • Most patients with kidney failure suffer from anemia.  Anemia is a dangerous condition that results in increased hospitalizations, higher mortality rates and increased blood transfusions.  It also significantly decreases the quality of life for patients, often leaving them too fatigued or weak to continue working or performing other functions necessary to have a normal quality of life.
     
  • The proposed guideline for measuring anemia management states patients’ hemoglobin should be maintained between 10g/dl and 12g/dl, which is in line with the Food and Drug Administration (FDA) recommended range and consistent with the requirement in MIPPA. CMS is considering implementing a quality measure that may reduce the bundled payment if a patient’s hemoglobin falls below 10 g/dl or above 12g/dl. Since a bundled payment is expected to reduce dosing of ESAs and thus patients’ hemoglobin levels, DPC believes a reduction in payment through the QIP should only be applied if patients’ hemoglobin falls below 10 g/dl. The proposed PPS poses the risk of an increase in patients with hemoglobin levels below 10g/dl.  Therefore, only a quality measure that puts a check on underutilization is necessary since overutilization is already checked by bundling the medication. This would keep intact the goal of maintaining the majority of patients’ hemoglobin levels between 10g/dl and 12g/dl. 

DPC agrees with CMS’s proposal to add a quality measure for hemoglobin less than 10 g/dl.  In addition, we request transfusions also be added as a quality measure to further ensure patients’ anemia is not undertreated.  We do not believe the measure of hemoglobin above 12 g/dl is a necessary measure in a bundled payment system. 

• Dialysis Adequacy (Urea Reduction Ratio [URR])
  
  
  • CMS recommends a QIP that measures dialysis adequacy; however, we are concerned the proposed measure of URR does not accurately reflect dialysis adequacy for those who undergo more frequent dialysis.  More frequent dialysis has been associated with improved patient outcomes and many patients report a better quality of life with more frequent dialysis. As a result, we believe the QIP should not unintentionally provide a disincentive for facilities to offer more frequent dialysis options.

We therefore recommend CMS exclude patients who undergo more frequent dialysis and home dialysis from the data collected to assess the QIP penalty for facilities on URR.

• Additional measures
  
  
  • DPC supports CMS’s vision for a “robust, comprehensive” quality incentive program to improve the quality of care and quality of life for dialysis patients.  We believe it is of utmost importance CMS at least begin tracking and reporting on other aspects related to patient outcomes that may occur as an unintended consequence of the bundled payment.  As we have highlighted in our concerns above, a bundled payment could result in unintended negative outcomes for patients.  At a minimum, we believe additional measures on outcomes related to bone and mineral disease and transfusions used for the treatment of anemia are vital measures that CMS should begin collecting data and tracking now to ensure patients are not being under or inappropriately treated as a result of the bundled payment. 

In addition to bone and mineral disease measurements and transfusions related to anemia, we believe in order to improve the quality of care dialysis patients receive, additional measures should also be collected and monitored now so they may be included in the QIP in the near future.  We suggest the following areas:

• General outcomes for hospitalizations and mortality
• Disproportionate outcomes in minority populations – particularly in the areas of anemia management and bone and mineral disease –  as data suggests African Americans, in particular, require greater treatment in these areas
  
• Vascular access
  
• Patient satisfaction with the care they receive

Additionally, depression among dialysis patients is a real concern as it relates to their well-being and overall health.  Studies have shown that depression is associated with increased mortality and hospitalization. We believe a future QIP measure that addresses the high rates of depression among dialysis patients and encourages referrals for appropriate treatment of depression should be further explored.

• Public reporting of quality measures
  
  
  • For patients to make informed decisions on where they dialyze, public reporting of how dialysis facilities rate when it comes to quality of care and outcomes is important.  Yet, the current Dialysis Facility Compare (DFC) website lags two years in reporting data. This information is incomplete and misleading for patients seeking to make informed decisions on where they should receive dialysis care.

With the implementation of the QIP, we hope patients will have access to timely data on the key measures so they have the ability to make informed choices in where they receive their dialysis care.

In closing, we would like to acknowledge our support of comments submitted by other coalitions of which we actively participated in construction of and are signatories on:

As a member of Kidney Care Partners (KCP) – an alliance of members of the kidney care community that includes patient advocates, dialysis care professionals, providers, facilities and manufacturers dedicated to improving the quality of care for individuals with both CKD and ESRD – we support the recommendations and suggestions submitted by KCP and make reference to data and information collected by this coalition in our comments. 

Additionally, we participated as a member of the Home Hemodialysis Working Group (HHWG) – a network of patient organizations and providers dedicated to the promotion of hemodialysis and the benefits that it provides – we as co-signors further support the recommendations and suggestions submitted by the HHWG.

We thank you for the opportunity to provide comments on the proposed PPS, which we believe once final, will have a profound impact on the quality of care patients receive.  We would like to again emphasize the need for the final PPS to ensure patients are at the center of their care and that their quality of life and care are put first, ahead of payment. 

Patients should be able to choose among the medication and treatment options that best serve their needs, preferences and values.  We believe patients that are empowered to take an active role in their care will have better outcomes and enhanced quality of life.  In this regard, we would also like to extend an offer to work with CMS to develop a patient satisfaction measure (as referenced in MIPPA), which would give dialysis patients a voice in how they feel the about the quality of the care they receive.  In addition to being a part of the future QIP, this input could provide CMS with insight into the impact the new bundled payment system has on patients’ quality of life and care.

Sincerely,

 
Myron Zayon                                   
President                         
Dialysis patient since 2000                           

Chad Lennox
Executive Director

Micah Naftalin                      
Vice President                       
Dialysis patient since 2003   

Nancy Scott
Secretary and Education Committee Chair
Dialysis patient since 2004

Chuck Leggett                      
Treasurer                       
Kidney transplant recipient               
Dialysis patient from 1995 to 2005

Erich Ditschman
Public Policy Committee Chair
Dialysis patient since 2001