IDPN/IPN Therapy in the Treatment of Malnutrition

Our Approach | Tailored Therapies | Outcomes | Reimbursement Issues | Summary


History of the Therapy/Background

Epidemiologic and clinical evidence would suggest that, approximately 40% of the Chronic Kidney Disease (CKD-5) dialysis population exhibit some degree of malnutrition , 10% of whom are severely malnourished and may be appropriate for IDPN/IPN therapy. Multiple epidemiological studies have also shown a strong association between baseline serum Albumin and prospective mortality in Chronic Kidney disease stage 5 (CKD-5) patients requiring maintenance dialysis. Two recently published studies show that over time, an increase in protein intake and an increase in serum Albumin were both associated with significantly better survival.

Despite this evidence and prevalence of malnutrition problems encountered in the CKD-5 population, attempts over the past 15 years to improve patients' nutritional status have not yielded significant results. Despite traditional interventions, such as: individualized nutritional counseling; aggressive treatment of co-morbid conditions; utilization of caloric and protein supplements, appetite stimulants and enteral nutrition support, poor nutritional status — especially protein malnutrition — remains a major risk factor for both morbidity and mortality for this population.

Based on experience with parenteral feeding in the hospital setting, efforts to supplement the nutritional intake of dialysis patients by providing nutrients during the dialysis procedure were attempted. As a result, IDPN and IPN became an established therapy to replete malnourished CKD-5 dialysis patients in the early 1990s. Initial clinical experience was positive with regard to both efficacy and its potential to improve morbidity and mortality in this population. However, concerns over the cost of therapy and the lack of any large, well-designed prospective studies to prove the therapy’s impact led Medicare to severely restrict availability of these therapies.

In the late 1990s, Medicare would only cover IDPN/IPN therapy in those patients with clearly documented severe GI pathology accompanied by proven malabsorption of vital nutrients. This statutory restriction essentially eliminated access to therapy except for an extremely small group of patients. As a result, IDPN and IPN became viewed as a therapy of last resort for patients in the final stages of morbid malnutrition.

Today, however, with the recognition of the scope and magnitude of the problem and the increasing evidence of the positive impact of these therapies, a much more positive reimbursement environment exists. Medicare Part D Plans and many commercial payers provide coverage for IDPN/IPN therapy, making it accessible to most malnourished patients who can benefit by receiving it during dialysis.

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Our Approach

Pentec Health provides a scientific, patient-specific approach to IDPN/IPN therapies. This program provides the clinical expertise to appropriately qualify patients and track their responses to therapy over the course of treatment. Pentec Health believes that the primary population for whom IDPN/IPN therapy is most beneficial includes patients who have demonstrable severe protein malnutrition. As a result, documented inadequate protein intake over an extended length of time, markers of protein stores (primarily serum albumin) continue to decline despite aggressive attempts to improve protein intake. As previously noted, the patient populations with a progressive drop in these levels have been shown to have a significantly increased risk of death. We believe that the administration of adequate parenteral protein supplementation will, in a significant percentage of these patients, improve their diminished protein stores and positively impact hospitalization and survival rates.

The other population that warrants consideration for IDPN therapy includes patients with documented severe energy malnutrition. Patients with very low BMI, or those who have demonstrated progressive significant weight loss over time despite aggressive dietary management or attempts at appetite stimulation are also at increased risk and are appropriate candidates for therapy.

Beyond these populations, there are subgroups of patients with markers of malnutrition that may require further assessment to determine appropriateness of IDPN therapy. These are patients with severe concurrent medical problems that complicate the interpretation of the markers of protein malnutrition or contribute significantly to weight loss and protein depletion. These conditions would include active cancer, AIDS, nephrotic levels of proteinuria, active infection or obvious active inflammatory conditions like collagen vascular disorders. In these patients, the physician should make a determination regarding the value of supplementation.

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Tailored Therapies

For the most part, previous approaches to IDPN therapy were a "one-size-fits-all" prescribing practice. Although providers of the therapy did at times customize the therapy at the request of the physician, generally the patients received a set formulation containing standard amounts of dextrose, amino acids and lipids regardless of the patient's weight, dialysis time and complicating co-morbid conditions. Our approach provides formulations that take these clinical variables into account in order to best fit the patient’s individual needs and condition. Our formula recommendations utilize appropriate substrate utilization parameters and infusion limitations. In addition, Pentec Health formulations address distinct differences between nutritonal needs of those patients who exhibit protein malnutrition and those patients who exhibit calorie malnutrition. This approach maximizes patient responsiveness to therapy and significantly improves tolerance.

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Outcomes

Pentec Health has committed significant resources to our outcomes program. It is essential to continuously improving patient health. Throughout this process, we capture clinical data: pre-therapy, to establish a baseline for each patient, during therapy to monitor patient response and post-therapy to measure the long-term impact on nutritional status. We firmly believe the use of outcomes data will provide the scientific feedback necessary to refine our therapies and promote the highest level of efficacy of IDPN and IPN therapy.

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Reimbursement Issues

Medicare Part D has changed the reimbursement criteria for IDPN/IPN therapies. This has materially increased the number of patients that now have access to these therapies. Previously, Medicare Part B required proof of GI impairment (proven by fecal fat studies, motility studies, etc.) leading to malabsorption before IDPN or IPN therapy would be a covered. The new Part D criteria varies by plan, but typically requires proof of depleted protein reserves reflected by low Albumin levels with documented failure of dietary counseling and oral supplementation. Pentec Health has been working with virtually all Part D plans since January 2006. We have developed a deep understanding of each plan’s coverage criteria and can work with patients, dietitians and physicians to ensure appropriate coverage for those in need.

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Summary

• Clinical evidence would suggest that, at a minimum, 40 percent of the CKD-5 dialysis population suffer from protein and/or energy malnutrition, and the approximately 10% of whom are severely malnourished would be appropriate for IDPN/IPN therapy;

• Large epidemiological studies have clearly demonstrated that Albumin levels below 3.5 strongly correlate with increased risk of hospitalization and morbidity;

• Despite awareness of the problem of malnutrition, attempts over the past 15 years to improve nutritional outcomes has not led to any significant improvement;

• Without the benefit of any large-scale prospective studies, the available research on IDPN and IPN therapies shows promising results;

• Medicare Part D has changed the reimbursement criteria for IDPN/IPN therapies. This has materially increased the number of patients that now have access to these therapies;

• Pentec Health has recently released the initial results of its outcomes study, showing a marked improvement in Albumin levels across their current patient population;

• Patients meeting appropriate clinical criteria for protein and or energy malnutrition should be referred for IDPN/IPN therapy.

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