Letter from ANNA to the Centers for Medicare and Medicaid Services (CMS) regarding the Medicare Program; Conditions for Coverage for End Stage Renal Disease (ESRD) Facilities; Proposed Rule; CMS-3818-P

May 5, 2005

The Honorable Mark McClellan
Centers for Medicare and Medicaid Service
Attention:  CMS-3818-P
Room 445-G
Hubert H. Humphrey Building
200 Independence Avenue, SW
Washington, DC  20201

Re:      Comments on Conditions for Coverage for End Stage Renal Disease Facilities; Proposed Rule; CMS-3818-P

Dear Administrator McClellan:

The American Nephrology Nurses' Association (ANNA) is the professional nursing organization representing over 12,000 registered nurses (RNs) who care for patients with chronic kidney disease. The majority of our members practice in outpatient dialysis settings in a variety of roles including the provision of both direct and indirect care to patients on dialysis, management, staff training and development, and home dialysis training and support. ANNA's members represent those healthcare professionals in the closest and most frequent contact with individuals with ESRD, and as such, are heavily invested in the Proposed Rule revising the Conditions for Coverage for End Stage Renal Disease Facilities and the changes it suggests in how their practice setting will be regulated and how their patients will receive care through the Medicare program.


ANNA wholeheartedly supports the Agency's fundamental shift in its regulatory approach to create a patient outcome-oriented environment. Suggestions on how it could  be improved upon, what might be added or deleted, and which requirements are critical to patient care and safety will form the basis of the following comments. 

Before addressing the specifics of the Proposed Rule itself, we think it is important to comment that we noted a number of requirements in the Rule that are not consistent with Medicare payment policies. We believe it is incumbent upon the Agency to only establish regulatory requirements that are consistent with program payment rules or to change payment policies to support the rules. This problem was acknowledged with regard to the recommendation for Hepatitis C screening, but not with other provisions. We comment on these areas individually, but also wanted to call attention to them in a global context.

Special procedures for approving ESRD facilities

§488.60: ANNA is concerned that facilities applying for initial approval may not have the data requested by this rule, other than an attestation of compliance and of having qualified staff.


§494.10: ANNA believes that the definition of "home" should include institutional settings such as a nursing facility (NFs) and skilled nursing facility (SNFs), if that is the patient's permanent residence.

ANNA requests the inclusion of definitions of "direct supervision" and "immediate supervision." Direct supervision is cited at 494.140(e)(3).  It is important to include a definition of immediate supervision and to be clear about the distinction between the two. We suggest that "immediate supervision" means the supervisor is actually observing the task or activity as it is performed and "direct supervision" means the supervisor is on the premises but not necessarily immediately physically present where the task or activity is being performed. We think this is consistent with the intent of the Proposed Rule but these definitions will make it more clear and must be included in the Final Rule to avoid problems at the facility level in determining compliance with some of the rules.

Infection Control

ANNA agrees with the proposal to establish Infection Control as a separate condition for coverage.    

ANNA supports the inclusion of the Healthcare Infection Control Practices Advisory Committee's (HICPAC) guidelines entitled "Hand Hygiene in Healthcare Settings." In its position statement on Vascular Access and in its Standards of Practice, ANNA has recognized the "Guideline for Preventing Intravascular Device-Related Infections" as the appropriate standard of care. We encourage CMS to do likewise in the Final Rule.  

Regarding Hepatitis C screening, it is unfortunate that the Proposed Rule makes an exception to the CDC recommendations in this regard. We understand that dialysis precautions should be sufficient to prevent the spread of Hepatitis C, but we are also aware that the intra-facility spread of hepatitis C is well documented and that screening patients and staff at baseline and at reasonable intervals, such as semi-annually as CDC recommends, would alert the facilities to significant breaks in the implementation of dialysis precautions. We believe this is an instance where a negative outcome should trigger investigation and stimulate practice correction and are suggesting later in this response that Infection be added to the performance components of the QAPI program. ANNA appreciates the Agency's recognition that Medicare payment policy is not consistent with CDC recommendations in this regard and believes it is unfortunate that payment policies do not consistently support the establishment of good policy for the beneficiaries. 

ANNA agrees with incorporating the CDC "Recommendations for Preventing Transmission of Infections among Chronic Hemodialysis Patients" and the guidance that staff members caring for HbsAg-positive patients should not care for HBV-susceptible patients at the same time if the definition of "HBV-susceptible" is "an individual who has Hepatitis B antibodies < 10."

§494.30(a)(1): This language requires that items that cannot be cleaned and disinfected should be dedicated for use only by a single patient. Blood pressure cuffs are a good example of such items.  Disposal of these cloth covered cuffs after patient use is not current practice and, while it may seem highly desirable, there are no cost effective disposable blood pressure cuffs available. Current practice is to surface clean the blood pressure cuff with an approved disinfectant. There are both cost and logistical considerations in requiring a blood pressure cuff for each patient. Storage of these cuffs and the cost of purchasing a cuff per patient make it unrealistic in the dialysis setting. Units with a large patient census would not necessarily have storage space for the cuffs. The challenge of inventing an impermeable, disposable, low cost covering for the BP cuff or inventing another means of blood pressure monitoring is the conceptual alternative to the current practice but is not available at this time. 

The same section proposes that dialyzers and blood tubing that will be reprocessed have caps placed on ports and lines clamped prior to placing these in a leak proof container for transport to the reprocessing area. We would suggest changing the language to clarify that "if placed into a container, that container must be leak proof."  The practice in some facilities is to transport the dialyzer and tubing to the reuse area without the use of separate containers. Requiring a container introduces another piece of equipment that must be purchased and cleaned. 

§494.30(b)(2): In keeping with the outcome orientation of the Proposed Rule, ANNA does not agree with a requirement for an infection control officer and believes that facilities should determine such a need through their QAPI program and have therefore recommended that Infections be a required performance component of the QAPI program. While we realize that infections are a major concern, we believe that the QAPI focus should provide sufficient attention in this area.

With regard to the existing infection control standard at §405.2140(b): ANNA agrees with the proposal to delete the redundant requirement regarding reuse; and with regard to the existing standard at §405.2140(c): ANNA agrees with the deletion of the "written policy" requirement.

 Water Quality 

ANNA agrees with the proposal to establish Water Quality as a separate condition for coverage.

ANNA agrees with CMS that AAMI is the appropriate authority on water and dialysate quality and believes that the condition should endorse the entire AAMI Dialysate Standard (RD52:2004) as it is the most current standard to guide the user in selecting, maintaining, operating and monitoring water treatment components and the one most relevant to dialysis facilities.  References to older AAMI documents related to water treatment would not be needed.

Incorporating all of RD52:2004 would require, among other things:

(1) a reduction in the allowable dialysate colony counts from 2000 cfu/ml to 200 cfu/ml, which would be a significantstep toward more pure dialysate, which ANNA believes is important, given evidence demonstrating a link between ultrapure dialysate and improved patient outcomes, reduced inflammation and other disease markers; and

(2) two carbon tanks in series,with a minimum of 10 minutes Empty Bed Contact Time. We believe that most of the facilities in the US have already implemented this system to prevent the exposure of patients to chloramine.

With regard to incorporating such documents by reference, we support a more rapid adoption process to update these regulatory requirements as the AAMI recommendations are updated to reflect changes in understanding and knowledge related to dialysis water and dialysate quality. 

§494.40(c)(2): ANNA suggests clarifying the language here. The proposed language states, "The water from the exit port of the first component or carbon tank which removes chlorine/chloramine is tested for chlorine/chloramine levels, at a minimum, before each patient shift or every 4 hours, whichever is shorter, during operation of the water treatment system." To provide clarity and maintain consistency with AAMI RD52:2004, the dialysate standard, we suggest the Final Rule read, "The water from the exit port of the first component or carbon tank which removes chlorine/chloramine is tested for chlorine/chloramine levels before each patient shift or at leastevery 4 hours during operation of the water treatment system."

§494.40(c)(2)(ii): We suggest the rule should clearly state that using one test of sufficient sensitivity for total chlorine with a result of <0.10 is acceptable, rather than requiring two separate tests.

Please note that, with incorporation of the entire AAMI Standard Dialysate for Hemodialysis (RD52:2004), 494.40(c)(2) and (c)(2)(ii) could be omitted, as these issues are addressed in that standard. 

Physical Environment

Consistent with the statement on page 6201 of the Preamble that "patients should be in view of staff at all times during the treatment to ensure safety," we suggest this language be incorporated as a standard at §494.60.

§494.60(c)(2)(i) and (ii): ANNA is sympathetic to the problem of maintaining adequate and comfortable temperatures for the majority of the patients and we believe that nurses already strive to keep their patients comfortable, as well as safe, during dialysis, but we do not think it is consistent with an outcome focus that these provisions be included in the final rule.

§494.60(d): With the current international concern about bioterrorism, ANNA believes the final rule should address this. CMS could require dialysis facilities to incorporate bioterrorism preparedness procedures in their disaster plan, including such things as a means of communication with the local civil defense organization regarding transportation routes in case of evacuations, requiring patients to have at least 7 days of critical medications on hand, etc. Such things would be necessary in case of limited access to roads or mass transport systems, water supplies, pharmacies, grocery stores, etc.

§494.60(d)(3): ANNA agrees with CMS that defibrillators should be required in all dialysis facilities, given the incidence of cardiac disease in the dialysis patient population. We prefer language that mandates automated external defibrillators (AEDs), especially in small, predominantly rural, dialysis facilities that might not have readily available emergency medical systems.  The only exception could be facilities located inside hospitals that have ready access to the hospital's emergency response team. We agree that dialysis nursing staff must be trained in the proper use of emergency equipment and emergency drugs, and note that non-automated defibrillators require staff to be certified in Advanced Cardiac Life Support (ACLS). ACLS courses are not readily available to dialysis facilities, are time consuming and costly. If CMS requires non-automated defibrillators, this would also require that there be qualified staff on-duty at all times to operate those defibrillators. This is not practical in the current environment; we support the requirement of AEDs in the final rule.

§494.60(e):  ANNA suggests that provisions of the Life Safety Code (LSC) apply only to new facilities, those built after the final rule is implemented. Dialysis facilities are often located in buildings that do not have sprinklers. Requiring such a facility to have sprinklers installed would be a prohibitively costly expectation. Enforcement of other provisions of the LSC may require major, costly modifications to a building that currently houses a dialysis facility, or lead to facility closure or relocation. 

Patients' Rights   

ANNA suggests a different approach to this entire section. We believe that, as is true for all of us, rights are accompanied by responsibilities. While we recognize that CMS does not regulate patient behavior, we would appreciate a requirement that patients be informed of their responsibilities, to include, at a minimum, coming to scheduled treatments, being on time, following dietary and fluid restrictions, and informing the care team if they are unable to have prescriptions filled or to make physician appointments. 

§494.70(a)(5): ANNA strongly agrees with the sentiment expressed in the Proposed Rule that patients must be informed about and participate in all aspects of their care, while recognizing that a facility cannot require their patients to participate in the care process. We suggest, however, that the wording "if desired" should be changed to "if capable" to demonstrate an expectation of patient participation in care. We believe that if patients and families are expected to participate they will learn more readily and will be better able to monitor received care as well as assume varying degrees of self-management. This is both a safety and a quality of life issue, and registered nurses are eager to assess for self-management capability, to teach self-management skills to capable patients, and to support patients in self-management.   

§494.70(a)(6):  The options presented should be stated more broadly to allow for new modalities that may emerge; further, the list should include the option for "No Treatment."

§494.70(a)(13): ANNA agrees with the strengthened requirements for an internal grievance process.  Most facilities already post grievance procedures in the lobby.

Patient Assessment 

ANNA agrees wholeheartedly with CMS that the inclusion of a minimum set of assessment criteria is inconsistent with the agency's stated goal of eliminating unnecessarily prescriptive and process-oriented requirements and we therefore oppose the inclusion in the final rule of a condition on Patient Assessment. CMS seems to agree that there is little need for this in the Preamble, when it states that expanding the existing requirements with regard to patient assessment should not impose any additional burdens on facilities because quality-oriented facilities already routinely perform such assessments upon initiating treatment, and most facilities already have this information in the medical record. It is unclear what evidence of need is driving this requirement, which is in direct opposition to the Agency's new fundamental shift in approach to regulating. As professional nurses we do not need to have spelled out in regulation how to conduct an assessment on a patient with renal failure.

In order to develop plans of care, each professional must go through a process that includes data gathering and begins with an assessment of the patient and of objective data related to the patient. Dialysis professionals have been doing this for over thirty years in developing care plans under the existing regulations. Federal oversight is unnecessary to ensure the professional nurse uses the nursing process, which is the foundation for all nursing care.

In the Preamble, CMS states it believes the patient assessment and patient care plan are inextricably linked, with which we wholeheartedly agree and which bolsters our suggestion that the assessment should be eliminated as a condition and subsumed under Plan of Care, since an assessment is fundamental to the establishment of any such plan.

Therefore, ANNA proposes that the language identifying the interdisciplinary team at §494.80 be moved to the introductory language at §494.90 and that §494.80(a) be deleted. The requirement at §494.80(b) regarding the frequency of assessments for new patients and the language at §494.80(d) regarding patient reassessment should be incorporated into §494.90(b) under the implementation of the plan of care. We believe the language at §494.80(c) related to assessment of treatment prescription is already addressed at §494.90(a)(1).

With regard to the language identifying the members of the interdisciplinary team currently at §494.80, ANNA requests clarification of the first sentence with regard to the "inclusion of the patient (if the patient chooses) or the patient's designee." We have two concerns here.  First, in the final rule please clarify whether this means either the patient or the patient's designee MUST participate, keeping in mind that some patients are not willing and some of them have no designee.  Secondly, we would like to see the wording changed to "if the patient is capable." If the patient is capable but refuses, it is not appropriate to require a designee to take his place. However, if the patient is incapable, a surrogate is appropriate. The use of the word surrogate would make this clear.

Understanding that the list of members of the interdisciplinary team is presented as a minimum requirement, ANNA suggests including "non-physician provider" (which can be an advanced practice nurse or a physician's assistant, as recognized in Medicare statute) as an optional part of the team. These professionals are recognized providers, are increasingly used in nephrology settings, and can represent the patient's physician to the extent allowed by law in any state.

With regard to proposed §494.80(d)(2)(iv), which we are suggesting be moved to §494.90(b), ANNA has some concerns with this criterion for instability: "Poor nutritional status, with unmanaged anemia and inadequate dialysis." We believe that documented poor nutritional status is appropriate for this category, but do not believe it should be linked with unmanaged anemia and inadequate dialysis. Since there is already a proposed requirement for inadequate dialysis to be assessed on an ongoing basis, we suggest that (iv) should state "Poor nutritional status" and (v) should be added and should state "Unmanaged anemia."

Plan of Care 

ANNA supports combining the elements of the existing long-term program into the patient plan of care. 

With regard to the proposal that outcomes specified in the patient plan of care must allow the patient to achieve "current evidence-based community-accepted standards," we want to express concern that, while we support requirements for facilities to organize their work in general, and to plan patient care in particular, with the goal of patients meeting at least minimum threshold values of established standards of care, we find this language in the proposed rule too vague.  Specifically, "community-accepted" is not appropriate language for the Final Rule. Such language could allow facilities across the country to treat patients differently in terms of the outcomes expected of them.

We suggest more specific language that would recognize The National Kidney Foundation's Kidney Disease Outcome Quality Initiative (K/DOQI) or other standards that may be developed by recognized healthcare standard-setting organizations through a rigorous scientific process that has involved experts in the renal field and that have been endorsed and embraced by the renal community. Currently these standards are the K/DOQI guidelines, so we have chosen to reference them in our comments that follow.

§494.90(a): ANNA suggests that "bone disease management" should be incorporated into the plan of care and read: "The interdisciplinary team must provide the necessary care and services to achieve a stable skeleton and avoid the consequences of secondary hyperparathyroidism. Calcium, phosphorous and other laboratory tests related to achieving these outcomes should be measured as recommended in clinical performance measures and minimal thresholds should be met." The Final Rule should include additional language that references the specific minimum K/DOQI standard(s) the Agency intends to be met for bone disease management.

§494.90(a)(1): The Final Rule should include additional language that references the specific minimum K/DOQI standard(s) the Agency intends to be met for hemo and peritoneal dialysis adequacy.

§494.90(a)(2): ANNA believes that albumin is a poor measure of patient nutritional status as it is affected by fluid overload, infection, liver disease, inflammatory conditions etc. A global assessment tool taking into account several markers should be used. We would suggest using Normalized Protein Catabolic Rate (NPCR) as an additional outcome measure.

We note the language of the rule requires the interdisciplinary team to "provide the necessary care and services to achieve and sustain an effective nutritional status" and must point out that there is no covered Medicare benefit for any "care and services" that would achieve this end. The team can monitor nutritional status but is handicapped in affecting any outcome measure that would be decided upon. This has been well documented in the Clinical Performance Measure project that has shown no improvement in serum albumin since the initiation of the Core Indicators Project in 1994. This reality should be reflected in the construction of the Final Rule, and the language in the first sentence must be limited to read, "The interdisciplinary team must monitor the patient's nutritional status."

§494.90(a)(3): The Final Rule should include additional language that references the specific minimum K/DOQI standard(s) the Agency intends to be met for anemia management.

According to the K/DOQI guidelines, patients with hemoglobin and hematocrit in the range specified in the Proposed Rule are evaluated for cause and appropriate treatment for their anemia, including erythropoietin therapy. The language here should be expanded to include these actions.  We must also comment here that Medicare payment policy runs contrary to this goal, in that erythropoietin cannot be initiated on a patient who was not treated with erythropoietin prior to beginning dialysis therapy until his/her hemoglobin reaches 10gm/dL. We reiterate that these regulations should be consistent with Medicare payment policies or that payment policies should be changed to support these regulations.

§494.90(a)(4): ANNA agrees that the interdisciplinary team must provide the necessary care and services to achieve and sustain vascular access for all patients, but we question how facilities will be reimbursed for the required "monitoring of arteriovenous grafts and fistulae for stenosis" Monitoring by means of frequent physical examination as per the K/DOQI guidelines is certainly a necessary expectation but, if in this context, "monitoring" means mechanical surveillance such as transonic flow measurements, there is no Medicare reimbursement for such services. The only "monitoring" of a vascular access that could have been envisioned when the composite rate payment was developed over three decades ago was done by a professional with eyes, ears (stethoscope), and fingertips.  If frequent physical exam is what is meant by monitoring in §494.90(a)(4), ANNA has no problem with it, but that should be made clear. If the intent is more than that, the requirement should be deleted from the Final Rule, unless payment policy can be changed to allow reimbursement for more sophisticated "monitoring."

It would be ideal to have a vascular access coordinator (RN) on the interdisciplinary team. We believe that such a role would be very cost effective in a globally-capitated disease management system, but doubt that many facilities could hire a dedicated vascular access coordinator in the current reimbursement environment.  

§494.90(a)(5): ANNA agrees that the transplant status must be part of the plan of care condition and agrees with CMS that the transplant surgeon need not be involved with the facility interdisciplinary team unless a possible candidate has been identified. ANNA shares CMS' concern that all appropriate potential transplant recipients be referred and followed, but points out that such referral is the responsibility of the patient's attending nephrologist, who is not an employee of the facility. We further agree that in cases when the patient meets the transplantation criteria but declines referral, there must be documentation in the patient plan of care that the patient has made an informed decision to decline renal transplantation. 

§494.90(a)(6): ANNA applauds the rationale in the preamble for rehabilitation and strongly supports the philosophy of self-management. Unfortunately the current caseloads for all members of the interdisciplinary team plus the acuity level of the patients make this goal unachievable. We believe that the interdisciplinary team must assist the patient in achieving the level of productive activity he/she desires by providing educational materials and referrals to community services.  Physical and occupational therapists would be needed to implement, monitor, and evaluate exercise regimens.  Except for making appropriate referrals, ANNA believes this requirement goes beyond the scope of the role of a dialysis facility and suggests that it be deleted from the list of minimum elements in the plan of care and that appropriate referrals be addressed under Social Services. In relation to the schooling needs of pediatric patients, again this would be evaluated during the psychosocial assessment but it is beyond the scope of the interdisciplinary team of a dialysis facility to provide for the general education of these patients. However, the team needs to assure that the dialysis schedule and related appointments of patients attending school are tailored to meet their needs.  

§494.90(b)(2): ANNA believes that the timeframe for implementation of the plan of care for new patients should be measured by the number of treatments rather than the number of days because of the potential for missed treatments. Therefore, if the care planning process is completed in 21 days or 9 treatments, whichever is longer, implementing the plan of care by the conclusion of the 12th treatment provides a more suitable timeframe for the patient starting thrice weekly hemodialysis. We believe 30 days would suffice for the peritoneal dialysis patient. Once established, a plan of care is a dynamic document, changing as the patient's needs and outcomes change, but we agree with CMS that the plan should be formally revisited within three months of initial establishment.

§494.90(b)(3): This goes without saying, as it is a normal element of the care planning process.  Registered nurses learn this early in their education and it does not belong in federal regulation.

§494.90(b)(4): While ANNA agrees that monthly interactions between patients and their physician are desirable, we do not believe the dialysis facility can be expected to ensure that all patients are seen by a physician at least monthly. Furthermore, we believe it is highly inappropriate for CMS to suggest requiring one provider to monitor another provider that Medicare is precluded by statute from regulating. The first sentence of Title XVIII, Section 1801, [42 U.S.C. 1395] states: "Nothing in this title shall be construed to authorize any Federal officer or employee to exercise any supervision or control over the practice of medicine or the manner in which medical services are provided, or over the selection, tenure, or compensation of any officer or employee of any institution, agency, or person providing health services; or to exercise any supervision or control over the administration or operation of any such institution, agency, or person." ANNA strongly suggests that the language at (b)(4) be eliminated from the Final Rule and further suggests that this language is no longer necessary given the recent changes in the physician's MCP payment. 

§494.90(c): ANNA agrees that the interdisciplinary team or, more specifically, a designated member of the team, will be responsible for tracking the results of each kidney transplant referral until the patient evaluation is complete. We suggest that, since the proposed conditions of participation for transplant centers published in the Federal Register on February 4, 2005, require those centers to notify a patient's usual dialysis facility of the patient's transplant status post referral, and about any changes in their status, that this should be reflected in the final rule. We agree that the dialysis facility should notify the transplant center of changes in the clinical status of patients seeking transplantation.  We recognize that when such changes are not communicated in a timely manner, unnecessary delays in the organ placement process may be incurred, potentially negatively impacting the transplant outcome.  Recognizing the need for timeliness, we would suggest requiring notification of the transplant center of any change in the patient's status, rather than on any prescribed frequency. We would also like to suggest that secure internet access to the transplant center data base, which could be limited to thedialysis facility provider number and only to that facility's listed patients, would be an efficient way for the dialysis unit to monitor the waiting list as well as to alert the transplant center about changes in a patient's clinical status.

§494.90(d): ANNA supports the requirement for a patient education program. Nurses are teachers and we know that the informed patient is more likely to self-monitor and self-manage to the fullest extent possible. To add more substance to other areas in the Conditions, ANNA strongly suggests that (1) education and training on the risks, benefits and outcomes of various access types be included here because patients have the right to know the risks and benefits of each type of vascular access, particularly of the one they are currently using; and (2) "advance care planning" be added here since patients should not only be informed about their right to establish an advance directive at initiation of therapy, but they should also receive ongoing education about the importance of this as part of the plan of care and their participation in it.

Care At Home 

§494.100: ANNA strongly agrees that home dialysis patients receive the comparable quality of care and attention that the in-center patient receives.

§494.100(a)(2): ANNA agrees that initial home training of the patient and caregiver should be conducted by a qualified registered nurse and we agree with the qualifications.

§494.100(a)(3): ANNA agrees with CMS that specifying the topics for a training program appears to be inconsistent with the goal of reducing the process-oriented requirements and therefore opposes their inclusion. We question what evidence exists that led the agency to prescribe the elements of training, in direct opposition to the expressed new fundamental shift in approach to regulating.  Nephrology professionals can be expected to design and carry out home training as they have for the past thirty-five years.

§494.100(c): Most of the requirements in this standard are already required of the facility with respect to ALL patients receiving care and services through the facility; therefore, ANNA does not see the need to restate them in this section. The structure seems to distinguish the home dialysis patients from the facility's entire population, when the stated goal is to provide equivalent services to the home dialysis population. We suggest the following: §494.100(c)(1)(i) and (ii) remain as is and the other subsections be deleted as they are not necessary. §494.100(c)(2) is also unnecessary as the facility will maintain a medical record for its home patients and, as stated, §444.330(a)(2) requires Durable Medical Equipment (DME) suppliers to provide the facility with a record of items and services it has provided to home dialysis patients who are being supported by the facility.

With regard to dialysis of residents of a NF or SNF or other institutional settings, ANNA agrees with the designation of such institutional settings as a patient's "home" if that is their permanent residence. ANNA is pleased to see the discussion of issues related to dialyzing the frail institutionalized elderly included in the Preamble, but notes there is nothing in the Proposed Rule about this. We take that as an invitation to continue to communicate with the Agency about this important subject since the incidence of ESRD is highest in the age groups that predominate in these types of settings.

ANNA also believes the modality of choice for the frail elderly should be peritoneal dialysis, as is the case in many other countries, and encourages the Medicare program to develop payment policies that support that goal.

That said, ANNA believes the dialysis facility approved for home training should retain oversight responsibility for the patient and the caregiver as per current home training/home dialysis standards, regardless of whether the caregiver is a paid employee of the training facility, the institution, the patient, or a DME company.  We believe that, in recognition of the fact that these patients may have limited skills and abilities, the requirement to train the patient should be waived. Likewise, in recognition of the limited space in such institutional settings, the requirement for one dialysis machine per patient should be waived, and we do not believe that would equate to the creation of a dialysis facility. ANNA does not believe that such institutions should be required to meet these Conditions for Coverage just because they house home dialysis patients. Financial practicalities preclude requiring a nurse to perform all dialysis treatments in these settings, although at times that will be the case. We recommend that a standard be developed based on input from the renal care community that would address the decision-making as to patient-level characteristics that affect the type of caregiver required. ANNA believes that experienced dialysis clinicians (and the experience should be defined) should be able to dialyze multiple patients in the same room, depending on the patients' acuity and stability, as long as personnel from the institution are available to help provide routine medical tasks unrelated to dialysis, like taking vital signs, if and when needed.

These are our initial thoughts on this subject and, as mentioned, we look forward to continuing our dialogue with the Agency on this important subject before a Final Rule is promulgated.


§494.110(a)(1): ANNA agrees with the inclusion of a condition requiring a "Quality Assessment and Performance Improvement" program to demonstrate commitment to improved health outcomes and prevent and reduce medical errors.

§494.110(a)(2): ANNA agrees with all items listed in the rule for performance components but requests the addition of "bone disease management" as well as "infection."

§494.110(a)(2)(vii): With regard to the use of a common instrument for assessing patients' experience of care, ANNA believes this makes a lot of sense and should pose only a minimal time burden for the facilities. However, such paperless technology could initially be expensive and we do not believe it is reasonable to expect that facilities could afford it.  

Regarding how facilities will "assess the effectiveness of their internal grievance adjudication process, track the outcomes of patient grievances, and identify meaningful criteria for evaluation and tracking purposes," ANNA suggests there should be a standardized tool for patient satisfaction and grievance reporting. It could be brief and concise, and facility specific questions could be added to the standardized tool for internal use.  Please note that we believe this patient satisfaction tool should be administered routinely, not just in response to a grievance. Prevention of grievances should be the goal.

§494.110(c): ANNA applauds the requirement for prioritizing improvement activities and having a plan for immediate correction of identified problems that jeopardize patients' health and/or safety. 

Special Purpose Renal Dialysis Facilities

§494.120: ANNA believes that if the camp is doing dialysis on site, the facility should also meet the requirements for qualified personnel as in the rule §494.150 (a) Medical Director (b) Nursing Services (e) Patient Care Technicians, and (f) water treatment system technicians.  

§494.120(d): ANNA agrees that the rule for physician contact is ideal but during natural disasters such as hurricanes, it may be impossible to contact the patient's attending physician. There should be a provision for another physician to provide direction of care in such extenuating circumstances.

Personnel Qualifications 

ANNA agrees with the preamble statements about dialysis technicians, but believes it is more appropriate to say they are the predominant direct patient caregivers in most dialysis facilities. The recognition that they function as extensions of the facility's professional nursing staff is also very helpful. 

ANNA further agrees with CMS that it is essential that a registered nurse provide the "hands-on" direct supervision to technicians during the clinical component of their training, provided direct supervision is defined as we have suggested in the definitions comments at §494.10. Facilities would not have the staff to permit RNs to provide immediate supervision of these technician trainees. Please refer to our distinction between these definitions at §494.10.

ANNA does not believe there is a need for clinical pharmaceutical services beyond continuing staff education on new products for both incenter and home dialysis patients. RNs are the appropriate professionals to monitor patients' medications and do patient teaching. We believe it could be confusing to the patient to further fragment care by introducing another discipline into the patient care scenario. RN workloads could be reduced and patient care improved with regard to medication management by the use of technology for dose conversion, verification, labeling, documentation, and checking for drug-drug interactions. ANNA looks forward to working with CMS, networks or others in the renal community in this regard.

ANNA looks forward to reimbursement methodologies that incorporate pay for performance and that promote the use of disease management models. In those scenarios, Advance Practice Nurses will more likely be employed to function as case managers and we believe patient care and outcomes will improve and hospitalizations will decrease.

§494.140(b)(3)(i): ANNA strongly opposes the language allowing LPN/LVNs to function as charge nurses. The role of a charge nurse is to supervise and direct the clinical activity while patients are dialyzing at a facility. Most states define the role of licensed practical/vocational nurses along these lines: the provision of care, under the supervision of a physician practicing medicine, or a registered nurse practicing nursing in accordance with applicable provisions of law. In no state in the United States can an LPN/LVN supervise an RN, and these proposed conditions require the presence of an RN when patients are dialyzing. Given this reality, the conditions cannot permit LPN/LVNs to be charge nurses.

Medical Records 

ANNA appreciates the elimination of the requirement for a medical records supervisor.

§494.170(d): ANNA believes that requiring all medical records be sent within one working day of a patient's transfer is unrealistic and unnecessary. We believe that only those records that a medical care provider and the facility require to adequately assess and treat the patient safely are necessary upon transfer. Those would include at least the current care plan, one month of treatment records, current physician orders, and medication list. Some patients have received dialysis treatment in a single center for many years, and requiring the entire medical record is unreasonable and burdensome in these circumstances


§494.180(b)(1): ANNA wholeheartedly endorses the inclusion of a requirement for an acuity-based staffing plan to ensure that every dialysis facility has "adequate and appropriate staffing" to meet the needs of its patients.  The utilization of an acuity based system to determine the adequacy and appropriateness of the numbers and skill mix of staff required to deliver care would provide for improved quality of care. Literature describing acuity-based staffing indicates outcomes of improved quality of care and the reduction of staff burnout, resulting in lower rates of staff absenteeism and turnover.  

With regard to the concern about "cherry picking" as a result of using minimum standards for accountability purposes, ANNA believes this risk could be minimized by the adoption of a true patient-level acuity-based reimbursement system including an acuity-based staffing model. This would encourage facilities to accept and properly care for patients who are more resource intensive or more difficult to manage and who are less likely to achieve acceptable levels on the performance measures.   In the past ANNA developed the basis for a staffing-acuity model; we would welcome the opportunity to collaborate with CMS to update and refine this model to meet the intent of this proposed rule.

§494.180(b)(2): ANNA strongly supports this proposed requirement. Dialysis patients are, after all, receiving nursing care for the duration of their stay in the dialysis facility such that a registered nurse must be present. This is a long overdue requirement and we are most pleased to see it. It must remain in the final rule

§494.180(b)(5)(i) through (viii): ANNA agrees that the patient care technician training program should incorporate, at a minimum, these content areas, and most already do. ANNA strongly recommends a requirement that all patient care technicians should be certified through a nationally recognized certification program.  Successful completion of a standardized certification exam would validate the success of the training program and would provide assurance to the public and to patients that all patient care technicians have a certain minimal level of preparation.  While there are currently three national certification exams available for dialysis technicians, only one is designed to test at the competency level.  The other two exams are higher levels and may be difficult for the entry-level technician.  The competency level exam is the Certified Clinical Hemodialysis Technician (CCHT) offered by the Nephrology Nursing Certification Commission (NNCC) in cooperation with the Center for Nursing Education and Testing (C-NET).  More information can be obtained about this examination at the NNCC website, www.nncc-exam.org.   We agree that the skills and competencies of patient care technicians are a major patient concern and applaud these steps to mandate a standard minimum program. We urge CMS to take the additional step to require validation of minimal competency by requiring certification of patient care technicians.

§494.180(c): ANNA agrees with CMS on the proposal to delete process requirements for medical staff appointments and add a new governing body requirement to inform the facility's medical staff regarding the facility's patient care policies and the facility's QAPI Program. 

§494.180(f)(4): ANNA supports and appreciates the guidance provided for involuntary discharge of a patient. We further support the statement about facility accountability for personnel adherence to the patient discharge or transfer policies and procedures.

§494.180(g)(3): ANNA thinks it is reasonable to remove the requirement for an affiliation agreement with an ESRD certified hospital and the substitution of an agreement with a (any) hospital that can provide inpatient care. 

§494.180(h): ANNA believes that whatever can be done to reduce the burden of information collection by automated systems, universal data collection tools, and quarterly collections, would certainly reduce the burden for registered nurses to whom such data collection is frequently assigned. 

ANNA wishes to thank CMS for the opportunity to review and provide comment on these proposed Conditions for Coverage. The order of the content and the references to the existing regulations along with the proposed changes enabled us to understand and reflect on the benefits of the proposed changes. We are impressed with the patient focus of the proposed conditions and believe that the final rule, incorporating our suggested amendments, will lead to greater facility flexibility to focus on improving patient outcomes. 

Very truly yours,

Suzann VanBuskirk, BSN, RN, CNN
President 2005-06

Lesley Dinwiddie, MSN, RN, FNP, CNN
President 2004-05

cc:  ANNA Board of Directors