Coverage Policy Manual
Policy #: 1997112
Category: Pharmacy
Initiated: September 1993
Last Review: July 2018
  Intradialytic Parenteral Nutrition

Description:
Malnutrition in hemodialysis patients is associated with increased morbidity and mortality. A potentially effective method of supplementation is via intradialytic parenteral nutrition (IDPN). The published reports on the use of IDPN in hemodialysis patients have shown major flaws in design, limited follow-up, and lack of details on nutritional parameters of participants before, during and after hyperalimentation; the use of intradialytic parenteral nutrition to improve nutritional parameters has been shown to be of limited benefit in most studies.
 
In hemodialysis, the intradialytic parenteral nutrition (IDPN) infusion is administered through the venous port of the dialysis tubing, typically, 30 minutes after dialysis has begun, and continued throughout the remainder of a dialysis session. In peritoneal dialysis, sometimes referred to as intraperitoneal parenteral nutrition (IPPN) or intraperitoneal nutrition (IP), parenteral nutrition is infused into the peritoneal cavity during peritoneal dialysis.
 

Policy/
Coverage:
Effective December 2009
Intradialytic parenteral nutrition meets Primary Coverage Criteria for effectiveness in improving health outcomes when it is offered as an alternative to a regularly scheduled regimen of total parenteral nutrition only in those patients who would be considered candidates for total parenteral nutrition (TPN), i.e., a severe pathology of the alimentary tract that does not allow absorption of sufficient nutrients to maintain weight and strength commensurate with the patient’s general condition.
 
Intradialytic parenteral nutrition does not meet Primary Coverage Criteria for effectiveness in improving health outcomes in those patients who would be considered a candidate for TPN, but for whom the intradialytic parenteral nutrition is not offered as an alternative to TPN, but in addition to regularly scheduled infusions to TPN.
 
For contracts without Primary Coverage Criteria, Intradialytic parenteral nutrition is considered investigational in those patients who would be considered a candidate for TPN, but for whom the intradialytic parenteral nutrition is not offered as an alternative to TPN, but in addition to regularly scheduled infusions to TPN.  Investigational services are exclusions in the member benefit certificate of coverage.
 
Intradialytic parenteral nutrition, in patients who would not otherwise be considered candidates for TPN does not meet Primary Coverage Criteria that there be scientific evidence of effectiveness in improving health outcomes.
 
Intradialytic parenteral nutrition is considered investigational in those patients who would not otherwise be considered candidates for TPN.  Investigational services are exclusions in the member benefit certificate of coverage.
 
Effective July 2005 - November 2009
Intradialytic Parenteral Nutrition (IDPN) does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness.
 
For contracts without primary coverage criteria, Intradialytic Parenteral Nutrition (IDPN) is considered investigational.  Investigational services are an exclusion in the member certificate of coverage.
 
 
Effective September 1993
Intra-dialytic Parenteral Nutrition (IDPN) is not covered due to lack of medical data attesting to the effectiveness and is considered investigational.
 
 

Rationale:
While intradialytic parenteral nutrition (IDPN) has been available for many years, there has never been a consensus regarding either its efficacy or patient selection criteria. In 1993, the Office of Health Technology Assessment, the technology assessment arm of Medicare, published a review concluding that studies of IDPN reported equivocal results and the data did not validate its efficacy.   More recently in 1999, Foulks reported on an evidenced-based evaluation of IDPN (Foulks, 1999).   The analysis concluded that the overall quality of the literature was poor; only 3 randomized studies were identified, but 1 was a feasibility study only and the other 2 had methodologic flaws or used types of IDPN that were not routinely used or were not available in the United States. The remaining literature consists of case series, which obviously cannot control for the many variables in the renal dialysis population that may contribute to increased morbidity and mortality. According to Foulks’ analysis, the majority of case series had methodologic flaws including heterogeneity in study design, patient selection criteria, types of IDPN used, and adequacy of dialysis.
 
The largest study is a retrospective case series comparing the morbidity of 1,679 IDPN-treated patients with that of 22,517 nontreated patients (Chertow,1994).  This study found that dialysis patients with a serum albumin level of less than 3.4 g/dL who were treated with IDPN had significant increases in albumin and creatinine over time. In addition, these patients experienced a significant decrease in the odds ratio for death at 1 year compared to those who were not treated with IDPN. Interestingly, the odds ratio for death increased for IDB-treated patients who had an albumin level of >3.4 mg/dL. Two other uncontrolled studies also suggest an improved outcome associated with IDPN (Foulks, 1994) (Capelli, 1994).  Due to the numerous biases inherent in any uncontrolled trials, these studies cannot validate whether IDPN is associated with an improved mortality. The observed treatment effect could be related to a selection bias in which very ill patients, i.e., those expected to die, were not offered IDPN. In addition, IDPN administration may be associated with an increased attentiveness to dialysis parameters, counseling, and nutritional advice, etc. These studies suggest that being selected for IDPN may be associated with an improved mortality rate, but analysis of the direct contribution of IDPN will require controlled trials. Pupim and colleagues performed a detailed analysis of protein metabolism in 7 patients receiving IDPN during hemodialysis (Pupim et al, 2002).  These patients would not have been considered candidates for IDPN on the basis of their nutritional status. While the administration of IDPN was associated with a sharp increase in protein anabolism, the effect was only transient. An accompanying editorial points out that in patients with renal disease, malnutrition is a multifaceted problem that is not related to insufficient or improper food or diet and that probably cannot be corrected by simply supplying more or a different balance of nutrition (Mitch, 2002).
 
2005 Update
A literature search was performed for the period of 2003 through October 2005. No additional published studies were identified that would prompt reconsideration of the policy statement, which remains unchanged. As noted in the Description section, clinical guidelines published by the National Kidney Foundation have established target daily protein requirements in patients undergoing chronic dialysis (Kopple, 2001).   It has been suggested that intradialytic nutrition may be reasonable in patients who cannot meet these requirements. However, this patient population is already addressed by the published medical literature, and thus scientific evidence is inadequate to determine whether intradialytic nutrition in these patients leads to improved outcomes.
 
2006-2007 Update
A literature search was performed for the period of October 2005 through March 2007. None of the published articles identified would lead to reconsideration of the policy statement, which remains unchanged. Comparative trials are still needed to evaluate this approach and its impact on outcomes. Of potential future interest, Pupim reported that in a small series (n=8) of chronic hemodialysis patients, intradialytic oral nutrition or IDPN both led to highly positive whole-body net balance during hemodialysis Pupim et a;. 2006).
 
2008 Update
A Medline search was conducted for the period March 2007 through June 2008. A case series was published of 22 hemodialysis patients with acute illnesses (major surgery, infection) treated with IPDN for 1.5 to 48 months as nutritional supplementation (not support) (Korzets et al, 2008).  IDPN was discontinued when the following were met: weight ceased to decline, stabilized or increased; protein catabolic rate was >1.0g/kg/d; and serum albumin levels were >3.8g/dl. IDPN was well tolerated and associated with improvements from baseline of several nutritional parameters. Without a comparison group, it is impossible to conclude that the effects were due to IDPN, and therefore this study does not affect the policy statement .
 
A randomized controlled trial of 186 malnourished hemodialysis patients from 38 treatment centers in France studied the effects of adding IDPN to oral supplementation compared to oral supplementation alone (1 year of treatment with 2-year follow up) (Cano et al, 2007).  Based on intention to treat analysis, no differences were found in 2-year survival, hospitalizations, Karnofsky score, body mass index (BMI), or serum albumin and prealbumin levels between treatment groups. The study was powered to detect a 10% reduction in mortality with 78% power (5% α error). Meeting the stated nutritional goals (orally or parenterally) may have improved outcomes; an editorialist suggests that both groups had approximately 15% improved survival compared to historical controls (Ikizler, 2008).  No studies were identified addressing IDPN in peritoneal dialysis patients. The policy statements remain unchanged.
 
2009 Update
The policy was updated with a MEDLINE search for the period June 2008 through November  2009.  The policy statement is being changed to include coverage for IDPN when it is offered as an alternative to a regularly scheduled regimen of total parenteral nutrition in patients who would be considered candidates for total parenteral nutrition (TPN).
 
Predictors of IDPN response on hypoalbuminemia was examined in a study of 196 hypoalbumineic maintenance hemodialysis (MHD) patients who underwent IDPN (Dezfuli, 2009).  The study suggested that IDPN treatment can improve hypoalbuminemia in MHD patients, and that the likelihood and magnitude of response to IDPN in these patients is associated with the baseline severity of hypoalbuminemia. The authors suggest this association may be useful in risk stratification of malnourished dialysis patients and recommend that their findings be confirmed through further controlled trials. This information raises new questions for study, but does not affect the policy statements.
 
The National Kidney Foundation (NKF) updated their pediatric nutrition guideline to recommend a trial of IDPN to augment inadequate nutritional intake for malnourished children (BMI-for-height-age below the fifth percentile) receiving maintenance hemodialysis (MHD) who are unable to meet their nutritional requirements through oral and tube feeding.
 
 
2011 Update
A literature search using MEDLINE was performed through March 2011. Dukkipati and colleagues conducted a systematic review of IDPN for the treatment of malnutrition in hemodialysis patients (Dukkipati, 2010).  The authors identified only 3 RCTs and found the data were insufficient to conduct a meta-analysis and to demonstrate net benefits in health outcomes with the use of IDPN. The authors recommend further clinical trials on IDPN are needed, and those trials should measure survival, quality of life, and nutritional status.
 
The German Association for Nutritional Medicine guidelines indicate “IDPN should only be carried out when modifiable causes of malnutrition are excluded and enhanced oral or enteral supply is unsuccessful or cannot be carried out.” (Druml, 2009) These guidelines note the “following international criteria for malnutrition have been suggested, even though they are not based on firm evidence:
 
  • Middle predialysis serum albumin <3.4 g/l for >3 months
  • Middle predialysis serum creatinine <8.0 mg/l for > 3 months
  • Weight loss >10% of ideal body weight or >20% of normal body weight (no time limit)
  • Clinical examination indicates moderate to severe malnutrition
  • Dietary history indicating protein intake <0.8 g/kg, reduced calorie intake <25 kcal/kg
  • Subjective Global Assessment (SGA) “C”= severe malnutrition
 
IDPN should be considered when three of the above-mentioned criteria are associated with the following conditions:
  • Aborted attempts to increase oral/enteral food intake
  • Refusal of enteral gavage”
 
Ongoing Clinical Trials
A search of online site: clinicaltrials.gov identified only one multicenter German study on IDPN, NCT00501956, which is no longer recruiting patients. In this study, 130 malnourished hemodialysis patients will be randomized to receive hemodialysis without IDPN or hemodialysis with 16 weeks of IDPN during each dialysis session followed by 12 weeks without IDPN. The estimated completion date was listed as December 2010.
 
Due to the limited availability of data on IDPN in patients who would not otherwise be considered TPN candidates, the impact on net health outcomes is unknown. The coverage statement is unchanged.  
 
2012 Update
A literature search was conducted through September 2012.  There was no new information identified that would prompt a change in the coverage statement.
 
2013 Update
A literature search was conducted using the MEDLINE database through September 2013.  No new information was identified that would prompt a change in the coverage statement. The following is a summary of the key identified literature.
  
2014 Update
A literature search conducted through June 2014 did not reveal any new information that would prompt a change in the coverage statement. The key identified literature is summarized below.
 
Two uncontrolled studies suggest an improved outcome associated with IDPN (Foulks, 1994; Capelli, 1994). Because of the numerous biases inherent in any uncontrolled trial, these studies cannot validate whether IDPN is associated with an improved mortality. The observed treatment effect could be related to a selection bias in which very ill patients, ie, those expected to die, were not offered IDPN. In addition, IDPN administration may be associated with an increased attentiveness to dialysis parameters, counseling, and nutritional advice, etc. These studies suggest that being selected for IDPN may be associated with an improved mortality rate, but analysis of the direct contribution of IDPN will require controlled trials.
 
No studies were identified addressing IDPN in peritoneal dialysis patients.
 
Ongoing and Unpublished Clinical Trials
A search of online site, ClinicalTrials.gov on April 8, 2014, identified only 1 multicenter study on IDPN, NCT00501956, which has been completed. In this study, 140 malnourished hemodialysis patients were randomized to receive hemodialysis without IDPN or hemodialysis with 16 weeks of IDPN during each dialysis session followed by 12 weeks without IDPN. The study completion date was December 2010; the results have not been published.
 
In addition, results from 1 comparative study that addressed changes of serum prealbumin levels of IDPN in malnourished hemodialysis patients have been published in abstract form in 2012. No full-length publication is available for this study. Statistical calculation was undertaken for 32 patients per study group. IDPN was reported to lead to a significant increase of prealbumin during the 16-week course of treatment (26.31 mg/L), compared with the noninterventional control group (1.84 mg/L, p=0.02). Because of the small sample size, there was a lack of statistical power to evaluate responsiveness of the secondary end points in this study (eg, albumin, transferrin, quality of life) (Marsen, 2012).
 
The American Society for Parenteral and Enteral Nutrition issued 2010 Clinical Guidelines: Nutrition Support in Adults in Acute and Chronic Renal Failure. They issued a level C (supported by at least 1 level II investigation) that stated that IDPN should not be used as a nutritional supplement in malnourished chronic kidney disease-V hemodialysis patients. The rationale was that a large RCT found that mortality rates did not differ between malnourished patients receiving IDPN versus malnourished patients who received oral supplements with no IDPN. An additional concern was that IDPN is limited by the need to complete the entire nutrient infusion during the hemodialysis treatment, which may cause adverse effects because of the rapid infusion of glucose and lipids. They further recommended larger RCTs in malnourished patients to ensure that a clinical benefit does not exist (ASPEN, 2010).
 
2015 Update
A literature search conducted through June 2015 did not reveal any new information that would prompt a change in the coverage statement.  
 
2017 Update
A literature search conducted through June 2017 did not reveal any new information that would prompt a change in the coverage statement. The key identified literature is summarized below.
 
In 2010, Sigrist and colleagues reported results from a systematic review of IDPN for patients with chronic kidney disease (Sigrist, 2010). Reviewers evaluated RCTs and systematic reviews of RCTs that specifically enrolled malnourished patients on hemodialysis who had been randomized to IDPN (including full IDPN or amino acids plus carbohydrates only) or to any form of enteral or oral nutrition. Three studies met reviewers’ inclusion criteria, only 1 of which reported mortality as an outcome. The data were insufficient to conduct a meta-analysis, and reviewers concluded that the evidence from clinical studies was insufficient to demonstrate either a net benefit or a net harm associated with the providing IDPN to malnourished hemodialysis patients.  
 
2018 Update
A literature search was conducted through June 2018.  There was no new information identified that would prompt a change in the coverage statement.

CPT/HCPCS:
90935Hemodialysis procedure with single evaluation by a physician or other qualified health care professional
90937Hemodialysis procedure requiring repeated evaluation(s) with or without substantial revision of dialysis prescription
90940Hemodialysis access flow study to determine blood flow in grafts and arteriovenous fistulae by an indicator method
90945Dialysis procedure other than hemodialysis (eg, peritoneal dialysis, hemofiltration, or other continuous renal replacement therapies), with single evaluation by a physician or other qualified health care professional
90947Dialysis procedure other than hemodialysis (eg, peritoneal dialysis, hemofiltration, or other continuous renal replacement therapies) requiring repeated evaluations by a physician or other qualified health care professional, with or without substantial revision of dialysis prescription
B4164Parenteral nutrition solution: carbohydrates (dextrose), 50% or less (500 ml = 1 unit), home mix
B4168Parenteral nutrition solution; amino acid, 3.5%, (500 ml = 1 unit) - home mix
B4172Parenteral nutrition solution; amino acid, 5.5% through 7%, (500 ml = 1 unit) - home mix
B4176Parenteral nutrition solution; amino acid, 7% through 8.5%, (500 ml = 1 unit) - home mix
B4178Parenteral nutrition solution: amino acid, greater than 8.5% (500 ml = 1 unit), home mix
B4180Parenteral nutrition solution: carbohydrates (dextrose), greater than 50% (500 ml = 1 unit), home mix
B4185Parenteral nutrition solution, per 10 grams lipids
B4189Parenteral nutrition solution: compounded amino acid and carbohydrates with electrolytes, trace elements, and vitamins, including preparation, any strength, 10 to 51 g of protein, premix
B4193Parenteral nutrition solution: compounded amino acid and carbohydrates with electrolytes, trace elements, and vitamins, including preparation, any strength, 52 to 73 g of protein, premix
B4197Parenteral nutrition solution; compounded amino acid and carbohydrates with electrolytes, trace elements and vitamins, including preparation, any strength, 74 to 100 grams of protein - premix
B4199Parenteral nutrition solution; compounded amino acid and carbohydrates with electrolytes, trace elements and vitamins, including preparation, any strength, over 100 grams of protein - premix
B4216Parenteral nutrition; additives (vitamins, trace elements, Heparin, electrolytes), home mix, per day
B4220Parenteral nutrition supply kit; premix, per day
B4222Parenteral nutrition supply kit; home mix, per day
B4224Parenteral nutrition administration kit, per day
B5000Parenteral nutrition solution: compounded amino acid and carbohydrates with electrolytes, trace elements, and vitamins, including preparation, any strength, renal - Amirosyn RF, NephrAmine, RenAmine - premix
B5100Parenteral nutrition solution compounded amino acid and carbohydrates with electrolytes, trace elements, and vitamins, including preparation, any strength, hepatic-HepatAmine-premix
B5200Parenteral nutrition solution compounded amino acid and carbohydrates with electrolytes, trace elements, and vitamins, including preparation, any strength, stress-branch chain amino acids-FreAmine-HBC-premix

References: Cano NJ, Fouque D, Roth H, et al.(2007) Intradialytic parenteral nutrition does not improve survival in malnourished hemodialysis patients: a 2-year multicenter, prospective, randomized study. J Am Soc Nephrol. 2007 Sep;18(9):2583-91.

Capelli JP, Kushner H, Camiscioli TC et al.(1994) Effect of intradialytic parenteral nutrition on mortality rates in end stage renal disease care. Am J Kidney Dis 1994; 23(6):808-16.

Chertow GM, Ling J, Lew NL et al.(1994) The association of intradialytic parenteral nutrition administration with survival in hemodialysis patients. Am J Kidney Dis 1994; 24(6):912-20.

Dezfuli A, Scholl D, Lindenfeld SM et al.(2009) Severity of hypoalbuminemia predicts response to intradialytic parenteral nutrition in hemodialysis patients. J Ren Nutr 2009; 19(4):291-7.

Druml W, Kierdorf HP.(2009) Working group for developing the guidelines for parenteral nutrition of The German Association for Nutritional Medicine. Parenteral nutrition in patients with renal failure - Guidelines on Parenteral Nutrition, Chapter 17. Ger Med Sci 2009; 7:Doc11.

Dukkipati R, Kalantar-Zadeh K, Kopple JD.(2010) Is there a role for intradialytic parenteral nutrition? A review of the evidence. Am J Kidney Dis 2010; 55(2):352-64.

Foulks CJ(1999) An evidence-based evaluation of intradialytic parenteral nutrition. Am J Kidney Dis 1999; 33(1):186-92.

Foulks CJ.(1994) The effect of intradialytic parenteral nutrition on hospitalization rate and mortality in malnourished hemodialysis patients. J Ren Nutr 1994; 4(1):5-10.

Foulks CJ.(1994) The effect of intradialytic parenteral nutrition on hospitalization rate and mortality in malnourished hemodialysis patients. J Renal Nutr 1994; 4(1):5-10.

Ikizler TA.(2008) Parenteral nutrition offers no benefit over oral supplementation in malnourished hemodialysis patients. Nat Clin Pract Nephrol. 2008 Feb;4(2):76-7.

KDOQI Work Group.(2009) KDOQI Clinical Practice Guideline for Nutrition in Children with CKD: 2008. Am J Kidney Dis 2009; 53(3 Suppl 2):S11-104.

Kopple JD, Foulks CJ, Piraino B et al.(1995) Proposed Health Care Financing Administration guidelines for the reimbursement of enteral and parenteral nutrition. Am J Kidney Dis 1995; 26(6):995-7.

Kopple JD, Foulks CJ, Piraino B et al.(1995) Proposed Health Care Financing Administration guidelines for the reimbursement of enteral and parenteral nutrition. Am J Kidney Dis 1995; 26(6):995-7.

Kopple JD.(2001) The National Kidney Foundation K/DOQI clinical practice guidelines for dietary protein intake for chronic dialysis patients. Am J Kidney Dis 2001; 38(4 suppl 1):S68-73.

Korzets A, Azoulay O, Ori Y, et al.(2008) The use of intradialytic parenteral nutrition in acutely ill haemodialysed patients. J Ren Care. J Ren Care. 2008 Mar;34(1):14-8.

Marsen TA, Degenhardt S, Hoffmann C et al.(2012) Intradialytic parenteral nutrition (IDPN) leads to sustained increase of serum prealbumin (PA) levels in malnourished hemodialysis (HD) patients a prospective, multicenter, open, phase-IV-study. Clin Nutr Suppl 2012; 7(1):15.

Mitch WE.(2002) Malnutrition: a frequent misdiagnosis for hemodialysis patients. J Clin Invest 2002; 110(4):437-9.

Office of Health Technology Assessment (OHTA). Intradialytic parenteral nutrition for hemodialysis patients. Health Technology Review, No. 6, August, 1993. (AHCPR Pub. No. 93-0068 accessible at http://hstat.nlm.nih.gov/hq/Hquest/screen/directaccess/db/147)

Pupim LB, Flakoll PJ, Brouillette JR et al.(2002) Intradialytic parenteral nutrition improves protein and energy homeostasis in chronic hemodialysis patients. J Clin Invest 2002; 110(4):483-92.

Pupim LB, Majchrzak KM, Flakoll PJ et al.(2006) Intradialytic oral nutrition improves protein homeostasis in chronic hemodialysis patients with deranged nutritional status. J Am Soc Nephrol 2006; 17(11):3149-57.

Schulman, Wingard, Hutchinson, et al.(1993) The Effects of Recombinant Human Growth Hormone and Intradialytic Parenteral Nutrition in Malnourished Hemodialysis Patients. Am J Kidney Dis 1993; 21:527-34.

Sigrist MK, Levin A, Tejani AM.(2010) Systematic review of evidence for the use of intradialytic parenteral nutrition in malnourished hemodialysis patients. J Ren Nutr. Jan 2010;20(1):1-7. PMID 19788956


Group specific policy will supersede this policy when applicable. This policy does not apply to the Wal-Mart Associates Group Health Plan participants or to the Tyson Group Health Plan participants.
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