Achieving KDIGO guideline recommendations in the bundling era

Editor's Note: CEs

Readers can earn continuing education contact hours for reading this article and completing this downloadable evaluation form. Following are the learning objectives:

1. Identify how changes in dialysis reimbursement for oral drugs may expand the role of interdisciplinary team (IDT) members related to treatment of bone and mineral disorder.

2. Discuss how patient participation in goal setting and self-management can help achieve good patient outcomes and acceptable provider quality scores within the Quality Incentive Program.

3. Identify at least two strategies for enhancing patient understanding/adherence to regimens related to bone and mineral disorder.

Contact hours for continuing education are provided by Nephrology Clinical Solutions. Provider approved by the California Board of Registered Nursing, Provider # 14961, for 1.2 Contact Hour.

Abstract

The increasing prevalence of end-stage renal disease and planned expansion of the Medicare bundled payment system will place a greater financial burden on dialysis providers. Management of chronic kidney disease mineral and bone disorder (CKD-MBD) is dependent on interdisciplinary team (IDT) interventions such as dietary modification, medication, and adequate dialysis therapy. Optimizing adherence to diet and medications requires an educated and motivated IDT, patient, and patient support system. The financial constraints of bundling will increase the roles of social workers and dietitians in promoting therapy adherence. Innovative and relevant tactics provide opportunity to overcome monotonous routines, encourage adherence to diet and complex polypharmacy regimens, and achieve recommended biochemical targets as outlined in Kidney Disease Improving Global Outcomes Guideline for Chronic Kidney Disease (KDIGO) – CKD-MBD.

Introduction

More than 16 million adults in the United States have stage 3–5 chronic kidney disease (CKD).¹ The end-stage renal disease (ESRD; CKD Stage 5) population is expected to increase to 700,000 by 2015 — imposing a significant  burden on renal services. As CKD progresses, comorbidities often contribute to, or result from, deteriorating renal function (e.g., hypertension, diabetes, anemia, malnutrition, and metabolic bone disease). ² An important concomitant of progressive CKD is CKD mineral and bone disorder (CKD-MBD), a systemic disorder characterized by abnormal serum calcium, phosphorus, fibroblast growth factor-23 (FGF-23), and parathyroid hormone (PTH), abnormal vitamin D metabolism, bone abnormalities, and vascular calcification. Hyperphosphatemia in CKD is associated with vascular calcification, and dietary intervention and phosphate binder treatment are both used to control serum phosphorus. Management of ESRD and its comorbidities therefore requires a multidisciplinary team approach.

Since 2011, dialysis providers have borne costs for intravenous drugs and any oral equivalents under the Medicare Improvements for Patients and Providers Act “bundled” payment system. Bundling will eventually expand to include oral-only ESRD drugs. Although the January 2013 “fiscal cliff” legislation postponed the inception of oral bundling until 2016, dialysis organizations are already preparing. Bundling, intended to reduce costs and improve quality, may also constrain medical decisions and/or risk unintended consequences from cost-containment efforts.³ Renal team care utilizing diet, education, and adherence assistance will be essential to maximize patient outcomes cost-effectively. This review explores interdisciplinary team management of CKD-MBD in dialysis clinics and discusses strategies to uphold KDIGO guideline recommendations while navigating the financial and logistical challenges of oral drug bundling.

Management issues in CKD-MBD

ESRD management requires renal replacement therapy, regular monitoring, and pharmacologic treatment of CKD-MBD, hypertension, and anemia.⁴ Dialysis alone (except long nocturnal hemodialysis) seldom normalizes hyperphosphatemia in ESRD without added interventions of reducing dietary phosphorus intake and using binders. ^5,6

Phosphate binder use is indicated in the United States for hyperphosphatemic dialysis patients and has been shown to reduce mortality when introduced within the first 90 days.⁷ Many clinicians do not intervene until serum phosphate levels become abnormal (>5.0 or 5.5 mg/dL [>1.61 or 1.77 mmol/L]) late in the disease. KDIGO guidelines recommend maintaining serum phosphorus levels within the normal range in stages 3–5 of CKD not on dialysis and “toward normal” for dialysis patients (see Table 1). Binder choice may influence outcomes depending on calcium balance (see Table 2). KDIGO guidelines recommend restricting the dose of calcium-based binders in patients with persistent/recurrent hypercalcemia, persistently low PTH, arterial calcification, or adynamic bone disease.⁴ Excess calcium supplementation is associated with excessive total calcium loads, increased all-cause mortality, cardiovascular disease, and cardiovascular calcification.⁸ Clinicians should consider the current Institute of Medicine upper limits of calcium intake (see Table 3) and remember that dialysate calcium, calcium-based phosphate binders, and vitamin D analogs may contribute to positive calcium balance.⁹ Rapid PTH fluctuations and seasonal variations in vitamin D levels may also affect serum calcium.

As of 2015, the Final Rule of the Medicare ESRD Quality Incentive Program (QIP) will mandate reporting monthly serum phosphate and calcium levels for ≥ 96% of in-center patients treated at least seven times and all home dialysis patients for whom the facility submits claims.¹⁰ Hypercalcemia will become a clinical measure (3-month rolling average of uncorrected serum calcium >10.2 mg/dL) for payment year 2016.

Compliance issues

Some 40% of hemodialysis recipients do not adhere to their medication regimens,¹¹ reflecting responses to pill burden, difficulty swallowing, inconvenience, expensive co-payments,^12-14 as well as possible incomprehension of regimens. Patients may feel cumulatively burdened by self-management of multiple comorbidities, medication regimens, and dialysis treatments. Once dialysis providers are required to pay for all oral ESRD medications, drug non-adherence will become a source of financial loss for providers as well as medical risk. Dietary non-adherence also can increase costs by increasing binder requirements. Thus, promoting adherence to medication and diet modifications becomes even more important as providers strive to balance costs while achieving optimal clinical outcomes.

The IDT and the critical role of the social worker

The renal IDT is led by the nephrologist, who prescribes dialysis and other treatments, guards against drug-related kidney risks, and reinforces dialysis adherence. Patient dissatisfaction with nephrologists contributes to poor dialysis attendance; regular follow-up can help maintain compliance.¹⁵ Additional team members include the nurse, dietitian, social worker, and patient-care technician (see Figure 1). For successful dialysis outcomes, patients and their care partner(s) should be educated and encouraged to participate actively in ESRD and CKD-MBD management. Families or care partner(s) can support patients’ self-care, adherence, and adaptation.

Team-based interventions can include sit-down rounds, walk-rounds, and educational events or contests. The Centers for Medicare and Medicaid Services (CMS) requires clinics to provide patients the opportunity to attend care planning conferences (in-person, chairside, or by teleconference).¹⁶ At sit-down rounds, the team convenes (with or without the patient) to assess the patient’s status, review medical records, and discuss discipline-specific concerns. This approach improved albumin levels and quality target achievement in the ESRD Quality (EQUAL) cohort study.¹⁷ Walk-rounds through the unit demonstrate team unity, enhance communication, raise patients’ awareness, and engage patients in goal-setting and problem solving. Education can be planned using a rotating “theme of the month.” “Toilet trainers” — posters displayed in clinic restrooms — can reinforce educational concepts.

Coordinated IDT care has been shown to improve dialysis outcomes. Nephrologists typically visit dialysis clinics periodically, but are not necessarily working onsite, whereas dietitians, nurses, and social workers are present in the dialysis clinic. Dialysis practices with below-expected standard mortality ratios, compared with facilities with above-expected mortality, reported more activated and engaged patients, stronger physician communication and interpersonal relationships, more resourceful and knowledgeable dietitians, and better overall coordination and staff management.¹²

The roles of the renal dietitian and social worker, legislated since 1976, are expanded with increased CMS oversight and requirements. ¹³ Social worker, dietitian and nurse assessment of patients is required within 30 days of dialysis initiation, at 90 days, and annually thereafter. Patients who are deemed unstable by the IDT require monthly assessment.

Social workers assist patients to obtain financial resources for dialysis and treatment costs by accessing private insurers, facilitating Medicare and Medicaid enrollment, and accessing pharmaceutical patient assistance programs. Nephrologists and dialysis administrators rely on social workers to navigate systems such as insurance structures or formulary tiers. The effects of the bundle on oral-drug patient-assistance programs, where patient enrollment is often guided by the social worker, remain to be determined. It is unlikely assistance will continue for those with Medicare part D or Medicare as their primary coverage, but these programs remain important for the 20% of dialysis patients using private insurance, where significant co-payments still exist. Social workers’ roles within the IDT have expanded to address multiple aspects of the patients' dialysis experience. Social worker counseling has been shown to improve outcomes in dialysis patients, with reports of reduced fluid weight gains,¹⁸ improved adherence to fluid restrictions,¹⁹ improved blood pressure, increased medication compliance,²⁰ and improved quality of life.^21-23

Aside from the typical and expected financial assistance avenues of support, social workers also help patients adapt to lifestyle changes, cope with medical issues, and regain independence. Social workers’ skill set within the IDT helps the patient secure optimal health by facilitating patient–IDT communication. Social workers can refocus caregivers on individual patients’ experiences, present struggles, priorities and goals. For example, a young man whose primary concern is sexual dysfunction may not be ready to address his phosphorous intake or medication adherence. An elderly woman may not consider a slightly lower blood phosphorus level (perceived as an abstract goal) worth giving up her daily ice cream treat (a tangible pleasure adding to quality of life). The team must consider her unique situation and quality of life expectations when they approach her about change. Social workers’ focus on relationships with patients as unique individuals provides valuable insight to the other team members as they provide care. Social workers’ aptitudes include working with patients to determine their current stage of acceptance, and analyzing patients’ willingness and level of involvement through directed conversation. They also utilize motivational interviewing to assess barriers while encouraging patients’ involvement in their own care.

Psychosocial support may include evaluation, treatment, and counseling referrals to alleviate depression, which is highly prevalent in patients with chronic diseases (including CKD) and predicts poor outcomes.^24,25 Other practical support may include transportation problem solving, physical activity planning, and assistance with resuming employment or education. Importantly, social workers can identify sources of non-adherence, which are often complex, warranting in-depth exploration and problem solving.

The team approach

Innovative and creative team approaches are even more important under the bundle to minimize non-adherence, which can increase costs and compromise outcomes. Not all methods will work for every patient. Patients may tire of persistent reminders, and professionals may lose hope for change. Mutual burnout can harm patient-care team relations and deplete motivation on both sides. A promising remedy for burnout is the “structured pause” For example, social workers and/or other team members will agree not to discuss a specific issue, such as limiting phosphorus intake, for one month providing that the patient will allow this discussion again after the pause. The patient remains welcome to approach any team member(s) at any time. This tactic allows professionals to renew their perspective and provides a respite for the patient. Obviously, critical or dangerous situations override the agreement.

Any perceived "victim-blaming" response to non-adherence can impair the patient–professional relationship.²⁶ Optimal CKD-MBD management may differ from patient to patient, but should always include unique treatment goals tailored to the individual patient. Social workers encourage the IDT to "start where the patient is.” If the team fails to consider the patient’s priorities, the variety and number of interventions are unlikely to influence behavior.

Concordance, where the patient and professional negotiate and mutually agree to treatment goals, is preferable to simply reinforcing the same advice at each one-to-one session.²⁷ Patients often have life goals that influence their attitude toward treatment, for example, to maintain a health status that qualifies for a transplant or allows them to attend a grandchild’s wedding. Social workers have the skills to elicit patients’ goals and level of motivation, which can be integrated into the IDT’s joint efforts to achieve therapeutic goals.

Team acknowledgment of a patient’s effort to change behavior or adhere to medical advice motivates further efforts. Lack of desired adherence or behavior change indicates that additional underlying issues may need to be uncovered and addressed. It is common for those on dialysis to feel a sense of loss and have a desire to exert some control over their lives. This need for control may manifest itself as “resistance" to IDT advice and attention. Health care, especially in chronic illness, is often associated with paternalistic mindsets. The upcoming reimbursement structure and bundling rules may even create frustration toward those who are non-adherent to medications or treatment. It is important to remember that those on dialysis, like most people, may wish to be autonomous, and maintain stewardship of their own lives. An example is a case where upon kidney failure, a 20-year-old woman was immediately started on peritoneal dialysis and referred for transplant. The doctor assumed this was the appropriate course for this patient without fully engaging her in the decision. She did poorly at following her treatment regimen, and failed to complete required testing for transplant. Once the patient was engaged in her health care decisions, she decided to try in-center hemodialysis and postpone her pursuit of a transplant. Her health, mood, and overall outlook improved significantly. She continues to educate herself and to make decisions in her own time. In this case, the social worker helped the IDT provide education and rationale without being forceful. With expanded knowledge and empowerment, the patient began to adhere to IDT recommendations.

Non-adherence is also often attributed to depression, psychological problems, or issues at home.²⁸ However, provision of personally relevant information is also important. Simply telling a patient that his/her phosphorus levels are too high may not motivate behavior change. Asking, “Did you know continued high blood phosphorus levels may lead to the need for surgery?” may more directly express the risk. Another approach is to relay the experience of another patient (without personal identifying details) who was successful in making a change or solving a similar issue. The IDT might learn how to engage the patient by asking questions such as, “What would you tell another patient who was struggling with high blood phosphorus levels?" or “How would you teach another patient about limiting dietary phosphorus?" Another patient can be enlisted to share his/her experience and success. It is important to guide peer-to-peer interactions to allow sharing of experience without giving absolute medical advice.

Creative, but not time-intensive, interventions can humanize the staff and make them more approachable. An author’s IDT organized a staff conga line through the clinic — complete with music and masks — during the week of the monthly laboratory testing. The dancing entertained patients, motivated them to attend treatment, and led to some improved adherence patterns. It also motivated the staff by breaking monotonous routines, providing some exercise, and relieving stress.

Social workers and dietitians work closely on renal IDTs, often sharing office space. While nurses are also a critical part of the team, they may have less time for collaboration due to direct patient care responsibilities. IDT collaboration is crucial in CKD-MBD management to reinforce medications and treatment adherence within bundled reimbursement. The dietitian is often the first to address and reinforce diet and medication education based on laboratory results. The social worker complements those interventions by identifying and addressing potential barriers to treatment adherence, which the patient may not reveal to their physician. The decision-making and behavior of many CKD patients is based on beliefs and information that may be inconsistent, even contrary, to CKD recommendations (e.g., need for extra calcium to prevent osteoporosis).²⁹ Therefore, it is important to communicate, at a patient-specific level, the consequences of non-adherence to treatment, medications, and dietary advice as well as to provide rationales for all recommendations.

Patients must understand that management of CKD-MBD is multifaceted and includes extended or more frequent dialysis sessions, modified dietary phosphorus intake including avoidance of food additives, and regular ingestion of phosphate binders with meals and snacks. Each of these interventions requires ongoing education and follow-up.

Phosphate binder adherence can be improved with flexible dosing options and binder formulations, such as chewable, liquid, powder, or pills. Non-tablet binder options, such as sevelamer carbonate powder for oral suspension (in 60 mL water) or liquid calcium acetate, may help promote adherence. Investigational premixing of sevelamer carbonate powder with foods or beverages for various time periods in vitro has been shown to bind phosphate at simulated small intestinal pH levels;³⁰ some patients in an academic renal center who were intolerant or nonadherent to on-label sevelamer powder dosing (suspension in 60 mL cool water) have tried off-label sprinkling of the powder onto foods. Non-tablet chewable phosphate binders eliminate the need for added fluid and alleviate some of the pill burden.

The bundle and its impact on KDIGO recommendations

Resource concerns for dialysis providers relate to waste of drugs, equipment expense, drug administration costs, and delivery of quality care. The Prospective Payment System bundle was introduced in 2011 as an incentive to control costs, promote quality of care, and reduce overutilization of drugs (see Table 4).³¹ Medicare provides a single bundled per-session payment covering all renal dialysis services (including drugs and diagnostic tests). This replaced the previous system whereby Medicare had paid facilities a composite rate for most items and services, but paid separately for certain tests and drugs. In 2014, the bundle excludes oral-only drugs, but in 2016, phosphate binders, calcimimetics, and any other related oral drugs will be included (Update: this requirement has now been moved to 2024).  Certain expensive laboratory tests, such as PTH and ferritin, have been performed less regularly.³² Some dialysis organizations may exert pressure to prescribe less expensive medications, and most will be likely to establish formularies at least partially based on costs. It is important to weigh all costs and benefits (short- and long-term) when making regimen decisions. Immediate savings may be outweighed by the development of side effects or comorbidities that require hospitalization, surgery, or expensive additional therapies. For example, the exposure to increased loads of elemental calcium from less expensive calcium-based binders may exacerbate hypercalcemia, arterial calcification, adynamic bone disease, or persistently low PTH, which may be associated with costly negative outcomes. Conversely, calcium-free binders may cost more initially, but could reduce extraskeletal calcifications and associated costs.³³ Commonly used non-calcium binders, such as sevelamer (hydrochloride or carbonate) and lanthanum carbonate, have demonstrated reductions in vascular calcification and atherosclerosis in uremic animal models^34,35 and reductions in the progression of coronary and aortic calcification in hemodialysis patients.^33,36 There are also reports suggesting that sevelamer may be associated with pleiotropic effects potentially beneficial to comorbidities such as diabetes and hyperlipidemia.^37-40 Sevelamer has been reported to bind dietary-derived advanced glycation end products and to reduce the rate of advanced glycation end-product-induced kidney damage in diabetic patients.³⁷ Sevelamer has also been speculated to protect against atherogenesis in kidney and other vasculature because it has been shown to lower low-density lipoprotein cholesterol and inflammatory markers,³⁸ to increase clearance of uremic toxins,³⁹ and to reduce circulating FGF-23.⁴⁰ Elevated FGF-23, which increases as CKD progresses, is associated with left ventricular hypertrophy,⁴¹ and predicts CKD progression⁴² and mortality.⁴³ Any potential for improving outcomes becomes important with CKD-MBD, as it could translate into improved cost effectiveness and reduced hospitalization rates.^{44, 45} More studies are recommended to confirm whether beneficial changes in these surrogate markers translate into improved clinical outcomes. One of the most important considerations should be to continue utilizing the method or medication that works best for the patient in meeting their phosphorous goals, and which is associated with fewer side effects.

Successful treatment of CKD-MBD requires that the renal IDT understand the complexity of the disease, the importance of surrogate laboratory markers, and the multiplicity of treatments. There are varied dietary sources and bioavailability of calcium, phosphorus, and nutritional vitamin D. The effects of intravenous or oral administration of active vitamin D or its analogs add to the complexity of monitoring and treating CKD-MBD, as does the use of calcimimetics.

Dietitians are forced to rely upon weak surrogate laboratory markers and inadequate nutrient analysis to evaluate results of their efforts. A recent study demonstrated that serum calcium is not a reliable indicator of total calcium load.⁴⁶ It is known that food nutrient databases and food labels are inadequate to assess phosphorus intake, especially from food additives. Dietitians face conflicting demands for ensuring adequate protein intake while limiting the dietary phosphorus load. Enhancing patients’ awareness of high-phosphorus foods and of the differences in phosphorus absorption between animal, plant, and additive sources improves phosphorus control,⁴⁷ but remains challenging given the lack of transparency by the food industry and inadequate food labeling requirements. Adequate renal dietitian (and social worker) staffing is critical as providers seek better management of CKD-MBD, including enhanced patient adherence to medication, diet, and treatment regimens. Improved survival rates have been demonstrated in centers with approximately one dietitian for every 60 patients.¹²

Improving access to medications is also increasingly relevant under the bundling payment system. Today Medicare patients are covered for part D medications such as phosphate binders and calcimimetics; however, this will no longer be the case once these drugs are included in the bundle and dialysis providers become responsible for the cost. Various large dialysis organizations are developing infrastructures for medication provision and management in preparation for this change. Bundling of the oral drugs is intended to enhance monitoring of prescription patterns, improve adherence, and ensure optimal cost-effective management of bundled medications. Medication therapy management (MTM) programs (e.g. DaVita Rx) provide follow-up with patients to reinforce adherence, provide feedback to clinicians about non-adherence, and provide understanding of factors affecting adherence. Inclusion of medication management tracking in chairside computer systems could provide real-time, point-of-service oversight of medication adherence. The bundle will increase the importance of MTM programs, while patient assistance programs are likely to be changed or eliminated. Similar to concerns about limits on expensive laboratory testing, there is concern that bundling of oral drugs may prompt providers to initiate strict formularies to limit the use of expensive drugs.

CMS has linked payment to established QIP performance standards. For payment year 2016, the QIP includes eight clinical measures and three reporting measures; one measure in each category pertains to CKD-MBD. Hypercalcemia, defined as a three-month rolling average of total uncorrected serum calcium > 10.2 mg/dL, is a 2016 clinical measure, and mineral metabolism testing (monthly monitoring of serum phosphorus) is a 2016 reporting measure. ⁴⁸  Dialysis clinics will be required to qualify for at least one reporting measure and to have 11 cases for at least one clinical measure. These requirements for the assessment of serum calcium and phosphorus are not fully aligned with the testing frequencies that are recommended by the KDIGO guidelines.⁴ Additionally, there is concern that the QIP has not set specific phosphate target levels. Further details of 2016 QIP measures (including clinical aspects other than mineral management) are shown in Table 4.

In summary, bundling is expected to increase the roles of IDT members in the dialysis clinic to optimize resources and improve outcomes by fostering adherence to diet, dialysis, and medication regimens related to CKD-MBD. Medication therapy management programs, increased physician attention, and delivery of oral medications to patients at dialysis clinics or at home may improve patient adherence. Bundling and the QIP are expected to further stimulate the trend toward increased duration and quality of dialysis to improve metabolic parameters and ease the financial burden of CKD-MBD-related medications. Concerns that dialysis facilities might “cherry pick” healthier, better insured or more adherent patients to reduce costs and risks⁴⁹ have thus far been unfounded. Since 2011, bundling of intravenous medications and oral equivalents has positively changed dialysis outcomes and practice patterns, including improved dialysis adequacy, reductions in average erythropoiesis-stimulating agent doses, and doubled use of oral active vitamin D and its analogs (although intravenous active vitamin D/analogs are still more widely used). Bundling is likely to have a range of impacts on patient outcomes, including some positive effects stemming from increased attention to adherence (including counseling from social workers and dietitians) and redesign of care processes. In spite of the financial constraints of bundling, dialysis providers will continue to strive toward following evidence-based guidelines and best practices. Medication and therapy choices will be made with consideration for risk versus benefit and patient outcomes will remain as the primary priority in decision making.

Conclusion

Dietary modification and the complex polypharmacy associated with dialysis treatments and CKD morbidities necessitate a coordinated approach involving every member of the renal interdisciplinary team, including the patient and their family/caregivers. Successful long-term outcomes and an acceptable quality of life require an optimal treatment regimen that is tailored to each individual patient’s needs. Once providers are obliged to pay for oral-only ESRD medications, adherence and medication inventory monitoring will become financially, as well as medically, vital. The social worker and dietitian will have increasingly important roles to foster adherence to dialysis treatments, dietary recommendations, and medication regimens. Discrepancies between evidence-based guidelines and QIP requirements must be clarified. The impact of bundling oral-only ESRD drugs on clinical practice and patient outcomes needs continued assessment. Additionally, objective measures demonstrating the benefit of interdisciplinary interventions will help dialysis providers justify appropriate resources such as adequate staffing. Traditional interventional tactics may need to be modified or even completely retired in favor of more creative methods that promote optimal patient health in the new fiscal environment. The ultimate goal of ESRD care is to ensure the best possible clinical outcomes, with high regard for quality of life. -by Linda McCann, RD, CSR; Meghan Hoefs, MSW, LSW

Acknowledgments

The authors developed the manuscript’s conception and design, provided additional substantive scientific revisions at multiple stages, and approved the final version for publication. They acknowledge the editorial assistance of Stuart Murray, MSc, of Envision Scientific Solutions, which was contracted by Sanofi to provide publication support services.

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