American Nephrology Nurses Association

American Nephrology Nurses Association The following is a comparison of the American Nephrology Nurses Association (ANNA) May 5, 2005 public comment letter on the Conditions for Coverage for the Medicare End-Stage Renal Disease (ESRD) Facilities; Proposed Rule (CMS-3818-P) and the Centers for Medicare and Medicaid Services (CMS) Final Rule (http://www.cms.hhs.gov/quarterlyproviderupdates/downloads/cms3818p.pdf). ANNA Recommendation CMS Final Rule Definitions 494.10: ANNA believes that the definition of "home" should include institutional settings such as a nursing facility (NF) and a skilled nursing facility (SNF), if that is the patient s permanent residence. ANNA requests the inclusion of definitions of "direct supervision" and "immediate supervision." Given the variety of comments regarding NF/SNF dialysis, CMS thought it would be premature to offer a new regulation. CMS will address this issue at a later date and the current guidance for dialysis in a nursing home environment will remain in effect at this time. Infection Control 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, although they may seem highly desirable, there are no cost effective disposable blood pressure cuffs available. 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. ANNA suggests changing the language to clarify that if placed into a container, that container must be leak proof. Requiring a container introduces another piece of equipment that must be purchased and cleaned. CMS chose not to modify the language in this section. To clarify the intent behind this section, however, including addressing issues such as the use of items designated for a single user, CMS chose to expand the Centers for Disease Control and Prevention s (CDC) RR05 Recommendations for Preventing Transmission of Infections Among Chronic Hemodialysis Patients. CMS believe this document which was included in the Final Rule will address concerns and provide additional information and rationale for the recommended practices. CMS chose to keep the current language regarding leakproof containers and stated that a reuse room without a leakproof container does not adequately prevent contamination. 1

494.30(b)(2): ANNA does not agree with a requirement for an infection control officer and believes that facilities should determine such a need through its Quality Assessment and Performance Improvement Program (QAPI) program. ANNA believes that the QAPI focus should provide sufficient attention to this area. To increase facility flexibility in assigning staff roles, CMS has decided to remove the infection control officer requirement and add infection control to the QAPI condition as a required topic. This new rule requires that infection control be addressed within the action-oriented, data driver QAPI program, which is under the direction of the medical director and requires registered nurse (RN) and interdisciplinary team participation. Water Quality 494.40(c)(2): To provide clarity and maintain consistency with AAMI RD52:2004, the dialysate standard, ANNA suggests that it read, The water from the exit port of the first component or carbon tank that removes chlorine/chloramine is tested for chlorine/chloramine levels before each patient shift or at least every four hours during operation of the water treatment system. 494.40(c)(2)(ii): ANNA suggests 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. The proposed requirement regarding chlorine/chloramine testing was deleted because CMS felt 494.40(b)(2)(i) provides sufficient clarification of this issue. Physical Environment 494.60(c)(2)(i) and (ii): ANNA understands the problem of maintaining comfortable temperatures for the majority of the patients and believes that nurses already strive to keep their patients comfortable and safe during dialysis, but does not think it is consistent with an outcome focus that these provisions be included in the Final Rule. 494.60(d): ANNA believes the Final Rule should require dialysis facilities to incorporate bioterrorism preparedness procedures in their disaster plan. The Final Rule states that facilities are required to maintain a comfortable temperature within the facility and make reasonable accommodations for the patients who are not comfortable at this temperature. CMS decided to keep the list of emergencies that should be included in emergency plans for dialysis facilities. The rule states that facilities may prepare for a variety of emergencies, including bioterrorism, which was identified as a risk after the facility risk assessment. 2

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. ANNA prefers 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. 494.60(e): ANNA suggests that provisions of the Life Safety Code apply only to new facilities, those built after the Final Rule is implemented. CMS decided to require a defibrillator or an AED within the emergency equipment standard. CMS decided to exempt dialysis facilities in operation on the effective date of the Final Rule (January 1, 2008) from installing sprinkler systems if the state law permits this practice. No dialysis facility, however, may open or move to a new location without a sprinkler system after the effective date of the rule. Patient s Rights 494.70(a)(5): ANNA strongly agrees 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. ANNA suggests, however, that the wording if desired should be changed to if capable to demonstrate an expectation of patient participation in care. 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. The Final Rule states that patients have the right to participate in all aspects of their care. It may be desirable that patients participate fully in their care, although neither CMS nor a facility can demand full patient participation. The Final Rule requires that facilities inform patients of their right to have advance directives. A patient requiring assistance in advance directive preparation should look to the facility social workers for guidance. The Final Rule requires that a dialysis facility inform patients of their rights including rules and expectations regarding patient conduct and responsibilities. 3

Plan of Care 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. 494.90(a)(1): The Final Rule should include additional language that references the specific minimum Kidney Disease Outcomes Quality Initiative (KDOQI) standard(s) CMS 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. 494.90(a)(3): The Final Rule should include additional language that references the specific minimum K/DOQI standard(s) CMS intends to meet 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. There was no specific mention of bone disease in the final ruling. The Final Rules states that a reference to the 2006 KDOQI targets (Kt/V of 1.2 for hemodialysis or weekly 1.7 for peritoneal dialysis) was added. Also, CMS is allowing dialysis facilities to meet alternative equivalent professionally accepted clinical practice standards for adequacy of dialysis. This will allow for future advances in dialysis adequacy measurements. CMS chose to retain the use of serum albumin. It stated that albumin is a valid and clinically useful measure of protein-energy nutritional status in maintenance of dialysis patients. The Final Rule does not give a specific hemoglobin level. This allows physicians and clinicians to manage the patient to determine the hemoglobian/hemoatocrit level appropriate for each patient based upon the patient s comorbidities and clinical characteristics. The language here should be expanded to include these actions. ANNA 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 4

to beginning dialysis therapy until his/her hemoglobin reaches 10gm/dL. ANNA reiterates 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 ANNA questions how facilities will be reimbursed for the required monitoring of arteriovenous grafts and fistulae for stenosis. Monitoring by means of frequent physical examination according to 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. It would be ideal to have a vascular access coordinator (RN) on the interdisciplinary team. ANNA believes 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 a referral is the responsibility of the patient s attending nephrologist, who is not an employee of the facility. ANNA further agrees that for cases in which 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. CMS did not address this issue. CMS proposed clarifying what would have to be added to the plan of care to include the plan for transplantation if the patient accepted the referral, the patient s decision if an eligible patient declined the transplantation referral, or the reasons for why a patient was not being referred as a transplantation candidate, as determined during the assessment. Facilities may want to develop their own policies identifying the role of the interdisciplinary team members in performing transplant referral. The team member may be a nephrologist or other team members. In any case, the facility will be held accountable for ensuring that appropriate modalities are employed in treating chronic kidney disease patients. 5

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 in addition to the acuity level of the patients make this goal unachievable. ANNA believes that the interdisciplinary team must assist the patient in achieving the level of productive activity he or 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. The team should ensure 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 nine treatments, whichever is longer, implementing the plan of care by the conclusion of the 12 th treatment provides a more suitable timeframe for the patient starting twice weekly hemodialysis. ANNA believes 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 ANNA agrees with CMS that the plan CMS concurs with the comments that the provision of the necessary care and services for rehabilitation is beyond the range of services offered by the majority of dialysis facilities. Physical therapy, occupational therapy, and academic tutoring services (for example) cannot realistically be provided by the facility staff. Therefore, in response to comments, CMS has changed the wording of the rehabilitation status component, now at 494.90(a)(8), to read: The interdisciplinary team must assist the patient in achieving and sustaining an appropriate level of productive activity, as desired by the patient, including the educational needs of pediatric patients (patients under the age of 18 years), and make rehabilitation and vocational rehabilitation referrals as appropriate. CMS believes that it must balance the health and safety needs of the patient against the staffing limitations of the facilities. The case loads of staff and constraints of facility processes should not outweigh the need to develop and implement the plan of care within a reasonable time. If a patient has received in-center dialysis for a one-month period or 13 (thrice-weekly) hemodialysis treatments, that patient has likely been physically present in the dialysis facility for at least 40 hours. CMS believes that this should provide sufficient time for the interdisciplinary team to have completed an assessment and developed a plan of care that is ready for implementation. Thirty days is a reasonable timeframe for the initial 6

should be formally revisited within three months of initial establishment. 494.90(b)(3): This goes without saying, because it is a normal element of the care planning process. RNs learn this early in their education and it does not belong in a federal regulation. 494.90(b)(4): Although ANNA agrees that monthly interactions between patients and their physicians are desirable, ANNA does not believe the dialysis facility can be expected to ensure that each patient is seen by a physician at least monthly. ANNA believes that it is highly inappropriate for CMS to suggest requiring one provider to monitor another provider that Medicare is precluded by statute from regulating. 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 Medicare Claims Processing (MCP) payment. assessment and implementation of the plan of care, in order to protect the health and safety of patients and prevent harm. Facilities may want to re-evaluate their processes, resources, and adequacy of staff if they find the 30-day deadline to be too difficult to meet. CMS has modified the requirement at 494.90(b)(2), so that the interdisciplinary team has a timeframe of the latter of 30 days or 13 hemodialysis treatments from the date of admission to complete the assessment and implement the plan of care. This provision now addresses commenter concerns regarding time lapses when a patient is in the hospital. Referrals are considered to be a part of the implementation of the plan of care and would not be a reason to allow extended time periods to complete and implement the plan of care. In addition, CMS will allow a 15 day period for the facility to implement any patient plan of care revision due to completion of a monthly assessment (done for unstable patients) or an annual assessment (completed for stable patients). This issue was not addressed in the Final Rule. CMS believes that it is in the best interest of the patient for dialysis facilities to ensure that a physician (or other practitioner, such as a physician assistant, nurse practitioner, or clinical nurse specialist) visits each month. The Dialysis Outcomes and Practice Patterns Study (DOPPS) data demonstrate that physician contact correlates with the quality of care. The G-codes, established in the Final Rule, Medicare Program; Revisions to Payment Policies under the Physician Fee Schedule for Calendar Year 2004 published November 7, 2003 (68 FR 63196, 63216), provide payment to physicians in incremental amounts depending on whether the patient was seen one, two to three, or four times during a given month. Although the payment G-codes provide some incentive for attending 7

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. ANNA suggests that, since the proposed conditions of participation for transplant centers 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, this should be reflected in the Final Rule. ANNA agrees that the dialysis facility should notify the transplant center of changes in the clinical status of patients seeking transplantation. ANNA recognizes 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, ANNA would suggest requiring notification of the transplant center of any change in the patient s status, rather than on any prescribed frequency. ANNA would also like to suggest that secure Internet access to the transplant center data base, which could be limited to the dialysis facility provider number and only to that facility s listed patients, would be an efficient way for the dialysis unit to monitor the physicians to see their dialysis patients more often, physicians may still choose not to see their patients for a month or more. In this case, the patient still receives dialysis for which the facility receives payment. CMS does not believe that requiring monthly visits infringes on how physicians practice medicine and notes that physician organizations that provided comment on the proposed rule supported the provision. CMS is retaining the proposed provision at 494.90(b)(4) to ensure that patients receive face-to-face physician (or, as discussed below, physician extender ) visits at least monthly. CMS intent is to ensure that the interdisciplinary team is aware of where the patient is in the referral and transplant evaluation process so that patients do not get lost along the way. CMS does not expect that the transplant referral tracking responsibilities borne by the dialysis facilities would duplicate the responsibilities of the transplant center. CMS expects the interdisciplinary team to be aware of whether the patient has completed the evaluation process, is wait-listed, ineligible for wait listing, or is awaiting living donation. Moreover, the dialysis facility is expected to alert the transplant center about changes in the patient s condition that would affect whether a patient was able to receive a kidney transplant. The transplantation center conditions of participation published on March 30, 2007 (72 FR 15198) require kidney transplant centers to communicate transplant patient status to the dialysis facility at 482.94(c)(1) and 482.94(c)(2) so that there is two-way communication. This issue was not addressed by CMS; however, it would have to be secure (likely an encrypted system) due to its privacy regulations. 8

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 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 advanced 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. CMS agrees that it is a reasonable expectation that dialysis patients be educated regarding the risks and benefits of various access types because of the impact of a vascular access on the patient s morbidity and mortality risks. Comments on this and other sections of these conditions strongly support adding a requirement ensuring that patients must be educated regarding the risks, benefits, and outcomes of various access types. These comments are in keeping with the National Fistula First quality initiative. Additionally, the Institute of Medicine (IOM) has encouraged the empowerment of patients to improve the quality of the healthcare system. Therefore, CMS has added new language to the Patient Plan of Care condition at 494.90(d), patient education and training, requiring that the plan of care include education and training on the benefits and risks of various vascular access types. CMS has also added infection prevention and personal care, and home dialysis and self-care training to this provision in response to comments discussed under the Infection Control and Care at Home sections. 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. CMS appreciates the positive response from commenters. All the ESRD conditions for coverage must be met regardless of whether the setting is in-center or at home. CMS has added language to clarify this in the first paragraph of 494.100, requiring that dialysis facilities meet all applicable conditions of this part. CMS expects that under these new regulations, dialysis facilities would make any necessary changes to ensure that all patients receive the same quality of care regardless of the location of the service. CMS has increased the home dialysis focus of these conditions by making Care at Home a separate condition for coverage. 9

494.100(a)(2): ANNA agrees that initial home training of the patient and caregiver should be conducted by a qualified registered nurse and ANNA agrees 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. ANNA questions 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 35 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 The existing requirement at 405.2162(c) mandates that an RN be in charge of self-care training. CMS believes that an RN, as an experienced health professional, fully understands the complexity of and the rationale for the dialysis process, and is the best-suited expert to conduct self-care training to patients. The requirement serves to protect the health and safety of the patient. Therefore, CMS has retained the proposed RN requirement in the Final Rule at 494.100(a)(2), which stipulates that the RN must conduct the home training. The RN may use other members of the clinical dialysis staff to assist in providing the home training, but the RN is responsible for ensuring that the training is in accordance with the requirements at 494.100. In addition, CMS has modified the provision at proposed 494.100(a), which would have required that the interdisciplinary team be responsible for providing the self-dialysis training to home patients, to clarify that the role of the interdisciplinary team is to oversee the home dialysis training. Patient education and training are addressed in the Patient Plan of Care condition, which now requires that the care plan include education and training regarding home dialysis and self care, when appropriate, at 494.90(d). All dialysis patients, whether home or in-center, are to receive counseling regarding nutrition and psychosocial wellbeing ( 494.90(a)(2) and (6), respectively). CMS concurs with the comments and believes it is redundant to include these topics under the self-care training standard at 494.100(a). Therefore, CMS has removed implementation of a nutritional care plan at proposed 494.100(a)(3)(iii) and how to achieve and maintain emotional and social well-being at proposed 494.100(a)(3)(iv). Support services at standard (c) are required for all home patients, regardless of the setting or geographical location. At 494.100(c)(1)(i), dialysis facility staff are required to periodically monitor the patient s home 10

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. ANNA suggests the following: 494.100(c)(1)(i) and (ii) remain as they are and the other subsections be deleted since they are not necessary. 494.100(c)(2) is also unnecessary because 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 they have provided to home dialysis patients who are being supported by the facility. adaptation and visit the patient s home setting in accordance with the plan of care. All patients have the right to receive equal care that protects their health and safety, and CMS cannot establish a mandate that would allow discrimination in any form. CMS appreciates the positive comments regarding the need for facilities to provide support services for the home patient. Home dialysis patients who receive all equipment, supplies and support services from their ESRD facility are considered Home Dialysis Method I. Under Method II, a durable medical supply company provides all necessary equipment and supplies to the home dialysis patient, and a dialysis facility provides support services to the patient. To be responsive to commenters, CMS has added the terms renting and leasing to the Final Rule at 494.100(c)(1)(vi), which now requires services provided by the facility to include, purchasing, leasing, renting, delivering, installing, repairing and maintaining medically necessary home dialysis supplies and equipment (including supportive equipment) prescribed by the attending physician. In the proposed rule at 494.100(c)(1)(vii), facilities are required to identify a plan and arrange for emergency back-up dialysis services in the event that they may be needed. CMS believes this requirement addresses the commenter s concern, while providing flexibility for facilities. Emergency preparedness is also addressed in the Final Rule at 494.60(d), which requires facilities to implement processes and procedures to manage medical and non-medical emergencies that are likely to threaten the health or safety of the patients, the staff, or the public. 11

Quality Assessment and Performance Improvement (QAPI) 494.110(a)(1): ANNA agrees with the inclusion of a condition requiring a QAPI 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 and infection. CMS has clarified the meaning of interdisciplinary team under the Patient Assessment ( 494.80) and Plan of Care ( 494.90) conditions. The first sentence of the QAPI condition in the proposed rule required an interdisciplinary QAPI program. CMS has modified this requirement in the Final Rule to make clear that the professional members of the interdisciplinary team (physician, RN, social worker, and dietitian) must participate in the QAPI program. The facility has the option of including facility patients when appropriate. The first sentence of 494.110 now reads: The dialysis facility must develop, implement, maintain, and evaluate an effective, data-driven quality assessment and performance improvement program with participation by the professional members of the interdisciplinary team. The proposed QAPI elements included adequacy of dialysis, nutritional status, anemia management, vascular access, medical injuries and medical errors identification, hemodialyzer reuse program, and patient satisfaction and grievances. The majority of comments strongly supported the QAPI topics that CMS proposed to be included in the facility QAPI program. CMS has added mineral metabolism and renal bone disease to the list of QAPI topics in this Final Rule at 494.110(a)(2)(iii) because of its importance to quality dialysis care, its association with cardiac health, and the strong support received from commenters. Renal bone disease and mineral metabolism are routine components of dialysis facility Quality Initiative (QI) programs and are easily monitored via lab values. CMS has recently pilot tested mineral metabolism/bone disease clinical performance measures and has added these as new ESRD clinical performance measures. CMS has also added infection 12

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. Such paperless technology could initially be expensive, however, ANNA does not believe it is reasonable to expect that facilities could afford it. 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. control at 494.110(a)(2)(ix), as discussed above in connection with 494.30, Infection Control condition. CMS encourages dialysis facilities to include social services and other suggested QAPI topics in their programs when appropriate, but are not requiring these additional topics. The facilities should identify additional QAPI components when they prioritize improvement activities in accordance with standard 494.110(c). CMS expects the dialysis facilities to devote the needed resources to their QAPI programs, which will be based on such prioritization of facilities needs. There were no specific comments on the affordability of such an instrument. There is no comment on this issue but ANNA was not recommending a change. Special Purpose Renal Dialysis Facilities 494.120: ANNA believes that if the vacation 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. CMS appreciates the positive comments on the proposed language regarding special purpose dialysis facility vacation camps. Although CMS received a suggestion to delete vacation camps in the Final Rule, the majority of comments regarding vacation camps were positive. Thus, CMS will adopt vacation camp requirements in the Final Rule at 494.120. CMS also received some positive remarks regarding the approval period of eight months, discussed at proposed 494.120(a), which will also be adopted in the Final Rule. CMS addressed the Medical Director and referenced 494.150(a) but did not specifically address other qualified personnel. 13

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. 494.140(b)(3)(i): ANNA strongly opposes the language allowing Licensed Practical Nurses (LPN) and Licensed Vocational Nurses (LVN) 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. CMS agrees that it may not be possible to consult with the patient s physician during a disaster. To allow greater flexibility, in the event of disasters or emergencies, CMS has modified the wording in the Final Rule at 494.120(d) to indicate that the facility must contact the patient s physician if possible prior to initiating dialysis in the special purpose renal dialysis facility. Additionally, CMS will retain the requirement for physician contact as proposed, because CMS believes this language will allow more flexibility for facilities. Very few commenters disagreed with the proposed experience qualifications for RNs; therefore, CMS will adopt the requirement for 12 months of nursing experience and three to six months of dialysis experience (depending on the role of the RN) in this Final Rule. A single RN may fulfill multiple nursing roles in the dialysis facility if he or she possesses the appropriate qualifications for each role and if this does not jeopardize the facility s ability to meet the staff requirement at 494.180(b)(1). CMS has revised the requirement formerly found at subpart U ( 405.2162), so that an RN must be present in the facility, and an LPN could still act as a charge nurse if he or she met the proposed qualifications. CMS did not intend for a LPN to supervise an RN, as suggested by the commenters. The RN must be present in the facility when patients are being treated, as required at 494.180(b)(2). An LPN might act as the charge nurse but would not necessarily be supervising an RN. All dialysis nurses must adhere to their state practice requirements. CMS has modified 494.140(b)(3)(iii) to clarify this by adding language to indicate that, if the charge nurse is a LPN or LVN, that he or she must work under the supervision of a registered nurse when required by the state nursing practice act provisions. 14

Medical Records 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. ANNA believes 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. CMS has revised the language at 494.170(d), which now reads: When a dialysis patient is transferred, the dialysis facility releasing the patient must send all requested medical record information to the receiving facility within one working day of the transfer. Our goal is to minimize the potential for communication breakdowns between facilities and ensure that patients continue to receive the necessary care and services. CMS is therefore requiring only that the minimum amount of medical information be forwarded as appropriate. Some information, such as recent lab results, may not be readily available within one day. This minimum information would likely include the physician orders, the patient assessment, and the patient plan of care, insurance information, the last three recent dialysis run sheets, and other pertinent information as necessary. Facilities may wish to create a standard medical record information transfer form as part of their policies and procedures regarding the transfer of patients, but CMS is not mandating it. Governance 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 improved quality of care. Literature describing acuitybased staffing indicates outcomes of improved quality of care and the reduction of staff burnout, resulting in lower rates of staff absenteeism and turnover. As stated earlier, the majority of commenters supported the medical director condition for coverage. No evidence was submitted to support removing the condition for coverage from the Final Rule. Several responsibilities addressed in the proposed condition are included in the existing regulation at 405.2161(b), and thus medical directors have previously been expected to ensure that the needs of the patient are properly addressed. CMS does not believe that the duties of the medical director are too burdensome, therefore, the proposed language will be retained in the Final Rule. The public comments were split on the acuity- 15

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 ANNA is most pleased to see it. It must remain in the Final Rule. based staffing plan issue. Clearly staffing is of concern to many commenters. Although commenters agreed with the intent of the proposed adequate staff provision at 494.180(b)(1), there was discontent related to how this provision would be interpreted and enforced. First, CMS would like to clarify that the adequate staff standard applies to all clinical patient care staff, including nurses, technicians, social workers, and dietitians who provide services to the dialysis patients. To clarify that the adequate staffing standard applies to all clinical staff, CMS has added language to the requirement at 494.180(b)(1), requiring that the RN, social worker and the dietitian be available to meet patient clinical needs. CMS does not agree with these commenters that the RN shortages would create an access to care problem. Therefore, CMS is retaining the requirement that an RN be present in the facility at all times that patients are being treated so that a nurse would be available who has the experience and training to react to patient care emergencies that could occur in this increasingly older and medicallycomplex patient population will be available. CMS believes that the RN has a key role in patient assessment and supervising LPNs, LVNs, and PCTs, and is the appropriate staff member to be responsible for the nursing care provided. An RN may also be needed to answer clinical questions from patients and caregivers. The rapidly changing demographics of the dialysis patient population has resulted in an older, sicker patient population with more serious comorbid conditions and elevated potential for medical emergencies. An RN has the professional training and expertise to properly react to emergencies. Therefore, CMS believes that having an RN on the premises when treatment is being provided is a necessary health and safety measure for all patients. CMS agrees with commenters that large dialysis facilities caring for large numbers of dialysis patients simultaneously could require 16

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. Although 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 the presence of more than one RN; however, CMS is not mandating more than one RN. The presence of one RN is a minimum requirement and large dialysis facilities have the flexibility to schedule more than one RN if patient acuity and the number of patients dialyzing at one time necessitates it. The provision at 494.180(b)(2) regarding RN presence during dialysis is applicable to incenter dialysis and does not apply to times when peritoneal dialysis patients are selfdialyzing at home. Although an RN may not be available at the dialysis center at all times that a patient is performing home dialysis, there must be an emergency plan for when home patients have an urgent situation, as required at 494.180(g). CMS has clarified the RN presence requirement by modifying 494.180(b)(2)(i), to require that a registered nurse be present in the facility at all times that in-center dialysis patients are being treated. CMS has also added the phrase responsible for the nursing care provided to further clarify the role of the RN on duty. CMS appreciates the support for the PCT training requirements. CMS discussed PCT qualifications earlier in this preamble under Personnel Qualifications. CMS has relocated the PCT training requirements from 494.180(b)(5) and 494.180(b)(6), to 494.140(e)(3) and 494.140(e)(4) so that all of PCT qualifications may be found in one section of these conditions. CMS is requiring national PCT certification in this Final Rule. The certification exam would serve as a measure of PCT competency and facilities would not be in the position of instituting their own certification programs. CMS does not agree that there is a need to expand the PCT training subject matter list. The proposed PCT training program (proposed at 494.180(b)(5)) included the following: 1. Care of patients with kidney failure, including interpersonal skills; 2. Possible complications of dialysis; 17

Education and Testing (C-NET). More information can be obtained about this examination at the NNCC website, www.nncc-exam.org. ANNA agrees that the skills and competencies of patient care technicians are a major patient concern and applaud these steps to mandate a standard minimum program. ANNA urges CMS to take the additional step of requiring 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. ANNA further supports 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. 3. Care of patients with kidney failure (proposed 494.180(b)(5)(ii)) would include psychosocial and nutritional aspects of care. 4. Interpersonal skills training would include professional conduct and interactions during challenging situations; and 5. Complications of dialysis (proposed 494.180(b)(5)(iv)) was already addressed in the proposed training topics list. As discussed in the Personnel Qualifications section of this preamble, CMS has moved the training list to 494.140(e)(3). The training program must be approved by the medical director and the governing body. CMS is requiring certification of PCTs to ensure competency. The proposed rule preamble (70 FR 6202) stated: We would not expect a patient to be involuntarily discharged from a dialysis facility for failure to follow the instructions of a facility staff member. Facilities are expected to make good faith efforts to mitigate problems and prevent an involuntary discharge. The proposed circumstances under which involuntary discharge would be permissible, laid out at 494.180(f)(1) through 494.180(f)(4) were: 1. Lack of payment; 2. Facility closes; 3. Transfer is necessary for the patient s welfare because the facility can no longer meet the patient s documented medical needs; and 4. Facility has reassessed the patient and determined that the patient s behavior is disruptive and abusive to the extent that the delivery of care to the patient or the ability of the facility to operate effectively has been seriously impaired. The proposed provision regarding the hospital agreement is less prescriptive than part 405, subpart U requirement formerly found at 405.2160. Instead of including processoriented requirements, CMS proposed a 18

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 RNs to whom such data collection is frequently assigned. requirement that was aligned with its intent to ensure access to suitable inpatient care for dialysis patients. CMS agrees with the commenter that dialysis care should be available in any hospital with which an agreement is made. CMS has revised the Final Rule to require that dialysis facilities must have an agreement with a hospital that can provide routine and emergency dialysis services, and to specify this in the agreement. The provision at 494.180(g)(3) now reads: The dialysis facility must have an agreement with a hospital that can provide inpatient care, routine and emergency dialysis and other hospital services, and emergency medical care which is available 24 hours a day, seven days a week. The proposed rule would require the electronic submission of data necessary for CMS administration of the Medicare ESRD program. These electronic data specifically include administrative data including, but not limited to the following: 1. CMS 2728, Medical Evidence/Medicare entitlement form data and CMS 2746; 2. ESRD death notification data, and the United States Renal Data System data); 3. Existing ESRD Clinical Performance Measures (CPM) data (CMS 820 and CMS 821); and 4. Any data necessary for future performance measures developed in accordance with the voluntary consensus standards process identified by the Secretary of Health and Human Services. This final regulation requires facilities to provide data and other information that are necessary to support the administration of the ESRD program. To increase efficiencies and improve the usefulness of these data, CMS is requiring electronic submission of necessary administrative data and specified data for calculation of ESRD CPMs. This electronic data collection is consistent with the IOM s recommendation that the 19