Pending Policies - Medicine
*CAREFULLY CHECK STATE REGULATIONS AND/OR THE MEMBER CONTRACT*
EXCEPTION: Illinois legislation requires coverage and reimbursement for amino-acid based elemental formulas regardless of delivery method for the diagnosis and treatment of eosinophilic disorders and short bowel syndrome when the prescribing physician has issued a written order stating that the amino acid formula is a medical necessity.
EXCEPTION: Texas legislation requires coverage and reimbursement for amino-acid based elemental formulas regardless of delivery method, when the prescribing physician has issued a written order stating that the amino acid formulas are medical necessary for the treatment of enrollees diagnosed with:
1. Immunoglobulin E and non-immunoglobulin E mediated allergies to multiple food proteins; OR
2. Severe food protein-induced enterocolitis syndromes; OR
3. Eosinophilic disorders, as evidenced by the results of biopsy; OR
4. Disorders affecting the absorptive surface, functional length, and motility of the gastrointestinal tract.
EXCEPTION: Montana legislation requires coverage and reimbursement for physician- supervised treatment of inborn errors of metabolism that involve amino acid, carbohydrate and fat metabolism and for which medically standard methods of diagnosis, treatment and monitoring exist. Benefits include expenses of diagnosing, monitoring, and controlling the disorders by nutritional and medical assessment, including but not limited to clinical services, biochemical analysis, medical supplies, prescription drugs, corrective lenses for conditions related to the inborn error of metabolism, nutritional management, and medical foods used in treatment to compensate for the metabolic abnormality and to maintain adequate nutritional status.
NOTE 1: Except as mandated by legislation cited above, nutritional supplements, including enteral formula that can be sold or dispensed without a prescription by a healthcare provider acting within the scope of their licensure under applicable state law, are not a covered benefit.
NOTE 2: Per the U. S. Food and Drug Administration, infant formula (including human milk fortifiers with or without a prescription by a healthcare provider acting within the scope of their licensure under applicable state laws) is food and therefore inclusive in the inpatient setting as part of room and board and in an outpatient setting is a non-covered benefit.
NOTE 3: Some plan benefits may require that Enteral Nutrition be covered under the prescription drug benefit.
NOTE 4: Coverage criteria for both Oral and Enteral Nutrition are applicable to all patient settings (e.g., inpatient and outpatient/home).
ORAL NUTRITION (ON)
ON formula, available only by prescription from a healthcare provider acting within the scope of their licensure under applicable state law (when used as a supplement or for dietary replacement) may be considered medically necessary for the treatment of inborn errors of metabolism when:
• Used to prevent illness resulting from a by-product of metabolism or amino acid accumulation; OR
• Required to restore an essential nutrient that is lacking because of an inborn error of metabolism.
ENTERAL NUTRITION (EN)
EN formula, available only by prescription from a healthcare provider acting within the scope of their licensure under applicable state law may be considered medically necessary when administered via a feeding tube placed by endoscopy, interventional radiology or surgery when ONE of the following criteria is met:
• Presence of nonfunctional proximal gastrointestinal tract or disease of the structures that normally allows food to reach the small bowel (e.g., head and neck cancer or tumor obstructing the esophagus or stomach, or a proximal small bowel fistula) where the tube feedings are needed to provide adequate nutrition to maintain the patient's overall health status; OR
• Presence of a central nervous system disease interfering with the neuromuscular coordination of chewing and swallowing and where a risk of aspiration exists (i.e., dysphagia secondary to cerebral vascular accident [CVA] or Parkinson’s disease).
EN formula available only by prescription from a healthcare provider acting within the scope of their licensure under applicable state law may be considered medically necessary when administered via a nasogastric or orogastric feeding tube when the following criterion is met:
• Presence of inadequate nutritional oral intake, related to a medical condition (less than 50% of the caloric needs are being met by oral intake) requiring supplementation for a limited time period (e.g., 4-6-weeks).
If less than 12 kcal/kg/day are being administered by EN in an adult, it is considered not medically necessary and is considered supplemental because it is not the primary source of caloric intake for the patient.
EN is considered experimental, investigational and/or unproven for all other indications.
Digestive enzyme cartridges (e.g. Relizorb™, Alcresta Pharmaceuticals) are considered experimental, investigational, and/or unproven for all indications, including but not limited to, patients receiving enteral tube feedings.
PARENTERAL NUTRITION (PN)
Parenteral Nutrition (PN) may be considered medically necessary in the treatment or prevention of malnutrition associated with conditions resulting with impaired gastrointestinal ingestion, digestion, absorption, or motility where EN is not possible. These conditions may include:
• Crohn’s disease; OR
• Obstruction secondary to a stricture or neoplasm affecting the esophagus, stomach, small intestine, large bowel, colon or rectum; OR
• Loss of the swallowing mechanism due to a central nervous system disorder, where there is a great risk of aspiration; OR
• Short bowel syndrome-intestinal failure; OR
• Malabsorption due to intestinal fistula(s) (PN being temporary until fistula repair or resolution); OR
• Intractable motility disorders (i.e., chronic intestinal pseudoobstruction, scleroderma, visceral organ myopathy, mitochondrial encephalopathies); OR
• Newborn infants with gastrointestinal anomalies (i.e., tracheoesophageal fistula, gastroschisis, omphalocele or intestinal atresia); OR
• Infants and young children with a diagnosis of failure to thrive, due to systemic disease or secondary to intestinal insufficiency (associated with short bowel syndrome, necrotizing enterocolitis, malabsorption, microvillus inclusion disease, or chronic idiopathic diarrhea; OR
• Patients with prolonged paralytic ileus following major surgery or multiple injuries; OR
• Severe mesenteric ischemia; OR
• Loss of mucosal surface area from radiation enteritis, chemotherapy-induced enteritis, graft versus host disease, rejection of an intestinal graft, autoimmune enteritis, refractory sprue, or other diseases that disrupt the mucosal epithelium; OR
• Radiation enteritis; OR
• Hyperemesis gravidarum when EN is not tolerated; OR
• Chyle leak; OR
• Intractable nausea, vomiting or diarrhea; OR
• Severe pancreatitis.
ALL of the following requirements must be met for alternative site (outpatient and home setting) PN:
1. Documentation that the patient is metabolically stable and serum potassium (K), sodium (Na), phosphate (PO4) and magnesium (Mg) are all normal and serum glucose is < 160 mg/dl;
2. Prior to initiation of PN there must be documentation that sufficient EN is not feasible (e.g. EN is contraindicated, insufficient EN is tolerated or there is insufficient bowel function to maintain or restore nutritional status with EN alone) to provide necessary energy. The patient can receive no more than 50% of their energy requirements orally or from tube feeding;
3. Documentation of a comprehensive medical, clinical and psychosocial assessment of the patient before PN can be initiated;
4. Documentation of life expectancy of at least 40 days;
5. If cancer is present, documentation of the absence of liver and/or lung metastasis
6. Documentation of a Karnofsky score of > 50;
7. Absence of severe dementia;
8. Age > 18 years if initiating PN at home (vs hospital);
9. Documentation that the central venous catheter (CVC) used for PN delivery is either single lumen, or if multilumen, that one lumen has been designated for PN;
10. The CVC tip should be verified in the inferior vena cava (IVC) or superior vena cava (SVC);
11. PN must be prescribed by a clinician with expertise in managing PN;
12. Documentation that intravenous fat emulsion infusion is at least 1g/kg/week but does not exceed 1g/kg/day;
13. Documentation that a caregiver at home or alternative site must be identified (this may be the patient themselves);
14. Documentation that patient and/or designated care giver has completed a formal teaching program that includes: a) catheter care and cleaning b) intravenous pump use c) PN solution storage, preparation of the PN solution including the addition of prescribed additives and bag spiking and d) prevention, recognition, and management of PN-related complications and that written instructions have been provided;
15. Documentation that the home environment (if discharge is to home) includes a dedicated refrigerator for PN and that there is adequate clean space for PN preparation;
16. Request is limited to a maximum of 90 days at a time; the nutrition care plan should be re-evaluated every 90 days.
If less than 12 kcal/kg/day are being administered by PN in an adult, it is considered not medically necessary and is considered supplemental because it is not the primary source of caloric intake for the patient.
Prior to continuation of PN after every 6 continuous months, for the initial two (2) years of PN, BOTH of the following must be documented:
1. Evidence of response to PN for continued use at least once every 6 months;
2. Documentation of at least one attempt to taper the PN energy and volume at least once every 6 months.
PN is considered experimental, investigational and/or unproven for all other indications.
INTRADIALYTIC PARENTERAL NUTRITION (IDPN)
Intradialytic Parenteral Nutrition (IDPN) may be considered medically necessary when provided for hemodialysis patients with severely impaired gastrointestinal function as outlined above and with malnutrition uncorrected by oral, enteral or intravenous PN. Prior to the beginning of IDPN, ALL of the following criteria must be met:
1. IDPN should not be the sole source of nutrition;
2. There must be documentation of intolerance of BOTH adequate oral and EN intake;
3. There must be documentation that the patient is malnourished.
IDPN is considered not medically necessary in patients who are considered candidates for PN in which IDPN is to be used in addition to regularly scheduled infusions of PN.
IDPN is considered not medically necessary when provided for patients with impaired nutrition due to a poor appetite but without significant gastrointestinal disease.
INTRAPERITONEAL AMINO ACIDS (IPAA)
Intraperitoneal Amino Acid (IPAA) is considered experimental, investigational and/or unproven.
Coverage for nutritional supplements or substances is considered not medically necessary when used:
• To increase protein or caloric intake (i.e. protein powders used to enhance muscle development) in addition to the patient's daily diet; OR
• For routine, pre-and post-operative care; OR
• For dietary supplements or replacements (over the counter enteral nutrition not meeting criteria); OR
• In patients with stable nutritional status, where short-term parenteral nutrition might be used for 14 days or less.
Blenderized baby food and regular shelf food used with an enteral system are considered not medically necessary.
Oral nutrition therapy is prescribed formula or medical food taken by mouth to replace or supplement an oral diet.
Inborn errors of metabolism are a group of disorders resulting in the excessive accumulation of an amino acid or other nutrients that are not metabolized correctly. Manifestations may include:
• Central nervous system dysfunction;
• Developmental delay;
• Liver dysfunction.
The clinical manifestations in many of these disorders can be prevented if diagnosis is achieved early and appropriate treatment with dietary protein/amino acid restriction is initiated immediately. These disorders are named for the accumulating amino acid and include (but are not limited to):
• Phenylketonuria (PKU);
• Methylmalonic acidemia.
For some of the inborn errors of metabolism, special formulas and medical foods have been developed, which eliminate the amino acid that cannot be metabolized from the protein component of the food.
Enteral nutrition (EN) is the provision of nutrients via the gastrointestinal tract when the oral cavity is bypassed as a means of nutrient ingestion. Nutrients may be consumed orally or be infused via nasoenteric (nasogastric, nasoduodenal, or nasojejunal) feeding tubes or via gastrostomy or jejunostomy tubes. EN is preferred over parenteral nutrition (PN) because it is safer and less expensive unless there are contraindications or access cannot be obtained. Nasoenteric feedings tubes are preferred for short-term feedings (< 30 days) and gastrostomy or jejunostomy tubes are preferred for long-term feedings. Formula is typically provided using intermittent gravity or bolus feeding when delivered to the stomach and via a pump when delivered into the small bowel. The only absolute contraindication to EN is mechanical obstruction of the gastrointestinal tract. (1)
In 2015, the U.S. Food and Drug Administration (FDA) approved Relizorb™ (Alcresta Pharmaceuticals) under the De Novo product classification. Relizorb™ is a single use digestive enzyme cartridge indicated for use in adults to break down enteral formula for those patients with absorptive issues. (i.e., Cystic fibrosis patients requiring enteral feeds). The device fits in line with enteral feeding systems and consists of an outer casing containing an inert polymer with a covalently bound enzyme through which nutritional formula is directed. It is designed to hydrolyze fat present in the enteral formula from triglycerides into fatty acids and monoglycerides to allow for their absorption by the body. This breakdown of fats is intended to mimic the function of the enzyme lipase in patients who do not excrete sufficient levels of pancreatic lipase. (2) In 2016, Relizorb™ was approved by the FDA through the premarket approval process (K161247). There were no changes to device design, technology or functionality. (3)
PN is the provision of nutrition support intravenously. PN is used for patients with medical conditions that impair gastrointestinal absorption where oral or enteral nutrition is not possible or appropriate. PN is also used for intermittent periods of time to reinforce the nutritional status of severely malnourished patients with medical or surgical conditions. PN consists of:
• Dextrose monohydrate (carbohydrate);
• Free amino acids (protein);
• Electrolytes: (sodium, potassium, magnesium, chloride, phosphate);
• Trace elements (zinc, copper, selenium, possibly chromium);
• Lipid (fat);
PN at home or other alternative sites typically is administered nightly over 10-16 hours (up to 20 hours in infants), depending on the patient’s nutritional needs, medical status, tolerance and the components of the prescribed formula. A nutrition care plan is developed for the patient that includes the nutritional support prescription and should be reviewed every 3 months. (4) PN should not be initiated or the patient discharged from an inpatient facility when there are electrolyte abnormalities; specifically, hypokalemia, hypomagnesemia, and/or hypophosphatemia due to the risk of refeeding syndrome. (5) Patients should be metabolically stable, physically/emotionally able to cope with PN, and have an adequate home or otherwise living environment. (6)
An infusion pump is always used to guarantee a safe, steady rate of administration. The pumps are programed to taper off the PN, usually over the last 60 minutes of infusion. (7) PN is infused via a central venous catheter (CVC), which should be either a PICC (percutaneously inserted central catheter) or a subcutaneously-tunneled catheter (Hickman, Broviac Groshong and similar devices) or a subcutaneously-inserted port (Port-a-Cath, PowerPort, SmartPort, IsoMed and similar devices). Preferably the catheter has a single lumen, but if multilumen, one lumen should be dedicated to PN in order to decrease the risk of a catheter-related bloodstream infection (CRBSI).
Common complications of PN include infection (CRBSI, exit site infections and infections of the subcutaneous tunnel), occlusion (thrombotic and non-thrombotic form lipid or protein precipitation), hepatic derangements (intestinal failure-associated liver disease [IFALD]), biliary derangements (calculous and acalculous cholecystitis), renal disease (nephrolithiasis and PN-associated nephropathy) and metabolic bone disease (osteoporosis, osteomalacia). (8) IFALD may result in the need for isolated intestine or combined intestine/liver transplant. Liver disease is more common among those patients that receive > 1g/kg/day of lipid emulsion. (9)
PN with dialysis can be grouped into categories based on the mode of dialysis and is delivered simultaneously during dialysis. The current categories are Intradialytic Parenteral Nutrition (IDPN), Intraperitoneal Amino Acid (IPAA), and Intraperitoneal PN. IDPN is the infusion of a supplemental intravenous nutritional formula, usually amino acids and dextrose, occasionally with lipid, during the dialysis treatment. IPAA is infused with dialysate fluid, and allowed to dwell with the dialysate fluid for optimal fluid infusion of the amino acids. The peritoneal route is limited in the volume amount available for nutrition due to the capacity of the peritoneal cavity.
This policy was originally created in 1990. This section of the current policy has been substantially revised, and has been updated with searches of the MEDLINE database through June 2017. Following is a summary of the key literature to date.
Oral Nutrition (ON)
Due to legislative mandates and contract limitations inborn errors of metabolism are included in coverage.
Practice Guidelines and Position Statements: ON
American Academy of Pediatrics (AAP)
The AAP Policy Statement published in 2003, reaffirmed 2006 states the following: “Metabolic diseases include inborn errors of amino acid metabolism such as phenylketonuria, maternal phenylketonuria, maple syrup urine disease, homocystinuria, methylmalonicacidemia, propionicacidemia, isovalericacidemia, and other disorders of leucine metabolism; glutaric aciduria type I and tyrosinemia types I and II; and urea cycle disorders.” (11)
“These are all disorders treatable by dietary modifications, which can prevent complications like severe mental retardation and death.” (11)
Enteral Nutrition (EN) and Parenteral Nutrition (PN)
EN and PN therapies are seen as valuable adjunctive treatments in the management of select patients requiring nutritional support to prevent or treat the adverse effects of malnutrition. To determine the type of nutritional support and accurately calculate the patient's nutritional needs review of the following data is necessary:
• Patient age and gender;
• Review of pre-existing medical conditions and history;
• Know the source and amount of exogenous nutrient losses;
• Body mass index determination.
Generally, a daily caloric intake of 110-120 kcal/kg/day for pre-term infants, 90-100 kcal/kg/day for full term infants, 75-90 kcal/kg/day for children aged 1-7 years, 60-75 kcal/kg/day for children aged 7-12 years, 30-60 kcal/kg/day for children aged 12-18 years, and 25-30 kcal/kg/day for adults is sufficient to maintain body weight. (10) Protein requirements generally range from 3-4 g/kg/day in pre-term infants to 0.8-2.0 g/kg/day in adults. (12)
PN may lengthen survival and improve quality of life in some palliative care patients. If they are to benefit from this therapy they must be physically and emotionally capable of participating in their own care, have a life expectancy of at least 40 days, (12) if cancer, no liver metastasis, (13) and have a Karnofsky Performance Scale score of at least 50 (for patients aged 16 years and older). (7, 13) There is no conclusive evidence supporting the use of nutrition support (EN or PN) in patients with severe dementia. (14) The majority of patients that require long-term PN are those with short bowel syndrome (SBS) - intestinal failure. It is noted that not all patients with SBS will require PN and others that require it initially, may be successfully weaned from it. SBS-intestinal failure is characterized by surgical resection, congenital defect, or disease-associated loss of absorption and is characterized by the inability to maintain protein-energy, fluid, electrolyte, or micronutrient balances when on a conventionally accepted, normal diet. (15) 50% of adult patients (73% of children) with SBS-intestinal failure and 25-50% of adult patients (25-38% of children) with chronic intestinal pseudoobstruction may be weaned from home parenteral nutrition (HPN) within 2 years of the start of HPN. (6)
The use of PN is not without risk, catheter-related infection is the most common and serious complication for adult patients receiving HPN. The central venous catheter (CVC) connection/ hub must be meticulously cleaned prior to connection of PN as well as disconnection in order to avoid development of a catheter-related bloodstream infection (CRBSI), and patients/caregivers must be educated in proper technique to disinfect the hub. (6, 7, 16, 17) In addition, there is an increased risk of infection when there is more than one CVC lumen and thus it is preferred that one lumen be designated for PN if a multilumen catheter is clinically indicated. (6, 18) The risk of infection is decreased with lower hospital pre-discharge blood glucose. (19) The risk of infection is also decreased through a rigorous aseptic cleaning of the junction (hub) between the catheter connector and attached tubing or syringe prior to connection and disconnection. (20) A formal teaching program should be completed for the patient and/or caregiver that includes a) catheter care and cleaning, b) intravenous pump use, c) prevention, recognition, and management of PN-related complications. (13) Patients that receive both oral and written instructions on catheter care have a lower risk of PN-related infection. (21) There is an increased risk of venous thrombosis if the tip of the PN CVC is not located within the distal superior vena cava (SVC) at the junction of the right atrium, (4, 6, 7, 22, 23) and a post procedure radiograph is mandatory to ensure proper position. (23)
Digestive Enzyme Cartridges
The U.S. Food and Drug Administration (FDA) approval for Relizorb™, a digestive enzyme cartridge, was based on well-established pre-clinical porcine models that mimics the inability to digest and absorb fat.
A search of ClinicalTrials.gov, identified 1 randomized, double-blind, crossover trial with an open-label safety evaluation period. (24) This clinical trial enrolled 34 subjects (pediatric and adult) and 33 completed the study. Subjects with confirmed exocrine pancreatic insufficiency used an enteral feeding digestive enzyme cartridge (Relizorb™) connected to enteral pump set. The objective of this study was to evaluate the safety, tolerability, and fat absorption of a new in-line digestive cartridge (Relizorb™) that hydrolyzes fat in enteral formula provided to patients with cystic fibrosis (CF). The authors concluded that the use of this in-line digestive cartridge was safe and well tolerated, and resulted in significantly increased levels of plasma omega-3 FA used with enteral formula, suggesting an overall increased fat absorption. This study is supported by the product manufacturer, Alcresta Pharmaceuticals (NCT02598128). (25) The authors discussed the major limitations of this study which include: small study sample size and a longer-term study is currently ongoing to assess the effects of sustained digestive cartridge use, particularly without concomitant pancreatic enzyme replacement therapy (PERT) use.
Section Summary: Digestive Enzyme Cartridges
There is insufficient published literature with the use of digestive enzyme cartridges. Larger randomized controlled trials are needed to support the safety, efficacy and the health impact on humans.
Intradialytic Parenteral Nutrition (IDPN)
This medical policy focuses on studies evaluating whether IDPN as an adjunct to hemodialysis improves outcomes for individuals who may be at risk for malnutrition but who would not otherwise receive parenteral nutrition.
In 1993, the Office of Health Technology Assessment published a review that concluded existing studies of IDPN had reported equivocal results and the data did not validate its efficacy. (26) Subsequently, in 1999, Foulks conducted on an evidenced-based evaluation of IDPN. (27) The analysis concluded that the overall quality of the literature was poor; although 3 randomized controlled trials (RCTs) were identified, 1 was excluded because it was a crossover study and assessed the feasibility of using the IDPN technique while the other 2 had methodologic flaws or used types of IDPN not routinely used or unavailable in the United States. The remaining literature consisted of case series, which cannot control for known and unknown prognostic factors that can affect study outcomes. According to Foulks’s analysis, most case series had methodologic flaws, including heterogeneity in study designs, patient selection criteria, types of IDPN used, and adequacy of dialysis. Dukkipati et al. conducted a systematic review of IDPN for the treatment of malnutrition in hemodialysis patients in 2010. (28) Reviewers identified 3 RCTs and found the data insufficient to conduct a meta-analysis or to demonstrate a net benefit in health outcomes with the use of IDPN. They concluded that further clinical trials on IDPN were needed and should measure survival, quality of life, and nutritional status. In 2010, Sigrist et al. reported results from a systematic review of IDPN for patients with chronic kidney disease. (29) 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.
Marsen et al. (2017) reported on the results of an RCT of 107 patients on maintenance hemodialysis suffering from protein-energy wasting syndrome. (30) Patients were randomized to IDPN 3 times weekly plus standardized nutrition counseling or standardized nutrition counseling only. Patients were included if they were moderately or severely malnourished (Subjective Global Assessment score B or C) and had 2 or more of the following markers: albumin levels less than 35 g/L, prealbumin levels less than 250 mg/L, and phase angle alpha levels less than 4.5. The trial assessed intermediate outcomes (change in serum prealbumin from baseline to week 16). The proportion of patients that showed at least 15% or more increase in prealbumin levels compared to baseline was higher in the IDPN group (41.0%) than in the control group at 16 weeks (20.5%; p<0.05), with sustained response thereafter. Quality of life scores, as measured by 12-Item Short-Form Health Survey, did not differ statistically between the 2 treatment arms.
Cano et al. (2007) reported on the results of an RCT of 186 malnourished hemodialysis patients from 38 treatment centers in France. Patients were randomized to IDPN plus oral supplementation or to oral supplementation alone (1 year of treatment with 2 years of follow-up). (31) Malnutrition was defined as the presence of 2 or more of the following markers: body mass index less than 20 kg/m2, body weight loss within 6 months greater than 10%, serum albumin levels less than 35 g/L, and serum prealbumin levels less than 300 mg/L. Based on intention-to-treat analysis, no differences were found in 2-year survival, hospitalizations, Karnofsky Performance Status score, body mass index, and serum albumin and prealbumin levels between treatment groups. The trial 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 suggested that both groups achieved about a 15% improvement in survival compared with historical controls. (32)
Multiple nonrandomized studies published before the 2017 Marsen RCT have reported on predictors of outcomes for patients treated with IDPN. (33-40) The largest study (1994) is a retrospective case series that compared morbidity rates in 1679 IDPN-treated patients with those of 22,517 untreated patients. (33) In this series, Chertow et al. reported that patients with a serum albumin level of less than 3.4 g/dL experienced a significant decrease in the odds ratio (OR) for death at 1 year compared with those who were not treated with IDPN. The OR for death increased for IDPN-treated patients who had an albumin level of greater than 3.4 mg/dL. Predictors of IDPN response were examined in a 2009 study of 196 hypoalbuminemic patients receiving maintenance hemodialysis who underwent IDPN. (36) The study suggested that IDPN treatment could improve hypoalbuminemia in patients receiving maintenance hemodialysis and that the likelihood and magnitude of response to IDPN in these patients was associated with the baseline severity of hypoalbuminemia. Two other uncontrolled studies have also suggested improved outcomes associated with IDPN. (38, 39) Because of the numerous biases inherent in any uncontrolled trial, these studies cannot validate whether IDPN is associated with lowered mortality rates. 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 might be associated with an increased attentiveness to factors such as dialysis parameters, counseling, and nutritional advice. These studies suggest that being selected for IDPN may be associated with reduced mortality rate, but analysis of the direct contribution of IDPN requires controlled trials.
A search of ClinicalTrials.gov in March 2017 did not identify any ongoing or unpublished trials that would likely influence this review.
Section Summary: Intradialytic Parenteral Nutrition (IDPN)
A well-conducted, adequately powered RCT designed to evaluate the effects of 1 year of IDPN plus oral supplements failed to show any incremental benefit in mortality or hospitalization rates at 2 years compared with oral supplements alone. Other RCTs have used nutritional or inflammation outcomes to assess the impact of IDPN indicators, rather than the more important outcomes of morbidity, mortality, and quality of life. Further, there were multiple limitations related to trial designs and interpretation of results from RCTs published between 1989 and 2006. These limitations include lack of power to demonstrate benefits, heterogeneity in trial patient populations resulting from variation in diagnostic criteria for protein-energy wasting, comorbid conditions, dialysis practices, and composition and doses of IDPN solutions. Published systematic reviews, which included RCTs but could not pool data, also concluded that the available studies are inadequate to demonstrate a benefit from IDPN for patients who would not qualify for parenteral nutrition.
Practice Guidelines and Position Statements: IDPN
National Kidney Foundation
The 2001 clinical guidelines from the National Kidney Foundation (NKF) established target daily protein requirements in patients undergoing chronic dialysis. (45) In 2009, NKF updated its pediatric nutrition guideline to recommend a trial of intradialytic parenteral nutrition (IDPN) to augment inadequate nutritional intake for malnourished children (body mass index for height and age <5th percentile) receiving maintenance hemodialysis who are unable to meet their nutritional requirements through oral and tube feeding. (41)
German Association for Nutritional Medicine
The German Association for Nutritional Medicine’s guidelines indicated that “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.” (42) These guidelines noted: “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.
Each benefit plan, summary plan description or contract defines which services are covered, which services are excluded, and which services are subject to dollar caps or other limitations, conditions or exclusions. Members and their providers have the responsibility for consulting the member's benefit plan, summary plan description or contract to determine if there are any exclusions or other benefit limitations applicable to this service or supply. If there is a discrepancy between a Medical Policy and a member's benefit plan, summary plan description or contract, the benefit plan, summary plan description or contract will govern.
Approved services for Nutritional Support (those meeting criteria) may include:
• cost of nutritional solutions
• cost of rental and/or purchase of infusion pumps
• cost of supplies and/or equipment required for effective delivery of nutrients
• home visits by a Medical Practitioner administering skilled care.
Disclaimer for coding information on Medical Policies
Procedure and diagnosis codes on Medical Policy documents are included only as a general reference tool for each policy. They may not be all-inclusive.
The presence or absence of procedure, service, supply, device or diagnosis codes in a Medical Policy document has no relevance for determination of benefit coverage for members or reimbursement for providers. Only the written coverage position in a medical policy should be used for such determinations.
Benefit coverage determinations based on written Medical Policy coverage positions must include review of the member’s benefit contract or Summary Plan Description (SPD) for defined coverage vs. non-coverage, benefit exclusions, and benefit limitations such as dollar or duration caps.
The following codes may be applicable to this Medical policy and may not be all inclusive.
B4034, B4035, B4036, B4102, B4103, B4104, B4105, B4149, B4150, B4152, B4153, B4154, B4155, B4157, B4158, B4159, B4160, B4161, B4162, B4164, B4168, B4172, B4176, B4178, B4180, B4185, B4189, B4193, B4197, B4199, B4216, B4220, B4222, B4224, B5000, B5100, B5200, B9002, B9004, B9006, E0781, S9335, S9340, S9341, S9342, S9343, S9364, S9365, S9366, S9367, S9368, S9433, S9434, S9435, S9810, [Deleted 1/2017: B9000], [Deleted 1/2019: Q9994]
ICD-9 Diagnosis Codes
Refer to the ICD-9-CM manual
ICD-9 Procedure Codes
Refer to the ICD-9-CM manual
ICD-10 Diagnosis Codes
Refer to the ICD-10-CM manual
ICD-10 Procedure Codes
Refer to the ICD-10-CM manual
The information contained in this section is for informational purposes only. HCSC makes no representation as to the accuracy of this information. It is not to be used for claims adjudication for HCSC Plans.
The Centers for Medicare and Medicaid Services (CMS) does have a national Medicare coverage position.
A national coverage position for Medicare may have been changed since this medical policy document was written. See Medicare's National Coverage at <http://www.cms.hhs.gov>.
1. American Gastroenterological Association Medical Position Statement: Guidelines for the use of Enteral nutrition. Gastroenterology. Apr 1995; 108:280-1301. PMID 7698595
2. FDA - De Novo classification: RelizorbTM. Food and Drug Administration - Center for Devices and Radiological Health (2015). Available at <https://www.accessdata.fda.gov> (accessed - 2017 June 30).
3. FDA - Premarket Approval: Relizorb™. Food and Drug Administration - Center for Devices and Radiological Health (2016). Available at <https://www.accessdata.fda.gov> (accessed - 2017 June 30).
4. Durfee SM, Adams SC, Arthur E, et al. A.S.P.E.N. Standards for nutrition support: Home and alternate site. Nutr Clin Pract. 2014; 29:542-55. PMID 24964788
5. Walmsley RS. Refeeding syndrome: screening, incidence, and treatment during parenteral nutrition. J Gastroenterol Hepatol. 2013; 28:S113-7. PMID 24251716
6. Pironi L, Arends J, Bozzetti F, et al. ESPEN guidelines on chronic intestinal failure in adults. Clin Nutr. 2016; 35:247-307. PMID 26944585
7. Worthington P, Bechtold M, Bingham A, et al. When is parenteral nutrition appropriate? JPEN. 2017; 41:324-377. PMID 28333597
8. Buchman AL. Complications of long-term home total parenteral nutrition: their identification, prevention and treatment. Dig Dis Sci. 2001; 46:1-18. PMID 11270772
9. Cavicchi M, Beau P, Crenn P, et al. Prevalence of liver disease and contributing factors in patients receiving home parenteral nutrition for permanent intestinal failure. Ann Intern Med. 2000; 132:525-32. PMID 10744588
10. Energy. J Pediatr Gastroenterol Nutr. 2005; 41:S5-S11.
11. Greer FR. American Academy of Pediatrics Policy Statement. Reimbursement for Foods for Special Dietary Use. Pediatrics. May 2003; 111(5):1117-1119. Reaffirmed 2006. PMID 12728102
12. Guidelines for the Use of Parenteral and Enteral Nutrition in Adult and Pediatric Patients. Journal of Parenteral and Enteral Nutrition, American Society of Parenteral and Enteral Nutrition (2002 Jan/Feb) 26(1 Supplement): 1-138.
13. Staun M, Pironi L, Bozzetti F, et al. ESPEN guidelines on parenteral nutrition: home parenteral nutrition (HPN) in adult patients. Clin Nutr. Aug 2009; 28(4):467-79. PMID 19464089
14. Volkert D, Chourdakis M, Faxen-Irving G, et al. ESPEN guidelines on nutrition in dementia. Clin Nutr. Dec 2015; 34:1-22. PMID 26522922
15. O’Keefe SJ, Buchman AL, Fishbein TM, et al. Short bowel syndrome and intestinal failure: consensus definitions and overview. Clin Gastroenterol Hepatol. Jan 2006; 4(1):6-10. PMID 16431298
16. Dreesen M, Foulon V, Spriet I, et al. Epidemiology of catheter-related infections in adult patients receiving home parenteral nutrition: a systematic review. Clin Nutr. Feb 2013; 32(1):16-26. PMID 22959630
17. Buchman AL, Moukarzel A, Goodson B, et al. Catheter-related infections associated with home parenteral nutrition and predictive factors for the need for catheter removal in their treatment. JPEN. Jul-Aug 1994; 18(4):297-302. PMID 7933434
18. Buchman AL, Opilla M, Kwasny M, et al. Risk factors for the development of catheter-related bloodstream infections in patients receiving home parenteral nutrition. JPEN J Parenter Enteral Nutr. Aug 2014; 38(6):744-9. PMID 23744839
19. Zhao VM, Griffith DP, Blumberg HM, et al. Characterization of post-hospital infections in adults requiring home parenteral nutrition. Nutrition. Jan 2013; 29(1):52-9. PMID 22858199
20. Do AN, Ray BJ, Banerjee SN, et al. Bloodstream infection associated with needleless device use and the importance of infection-control practices in the home health care setting. J Infect Dis. Feb 1999; 179(2):442-8. PMID 9878029
21. Santarpia L, Pasanisi F, Alfonsi I, et al. Prevention and treatment of implanted central venous catheter (CVC)-related sepsis: a report after six years of home parenteral nutrition (HPN). Clin Nutr. Jun 2002; 21(3):207-11. PMID 12127928
22. Kakzanov V, Monagle P, Chan AK. Thromboembolism in infants and children with gastrointestinal failure receiving long-term parenteral nutrition. JPEN. Jan-Feb 2008; 32(1):88-93. PMID 18165453
23. Pittirutti M, Hamilton H, Biffi R, et al. ESPEN guidelines on parenteral nutrition: central venous catheters (access, care, diagnosis and therapy of complications). Clin Nutr. Aug 2009; 28(4):365-77. PMID 19464090
24. Freedman S, Orenstein D, Black P, et al. Increased Fat Absorption from Enteral Formula Through an In-Line Digestive Cartridge in Patients with Cystic Fibrosis. J Pediatr Gastroenterol Nutr. Jul 2017; 65(1):97-101. PMID 28471913
25. Safety, Tolerability and Fat Absorption Using Enteral Feeding In-Line Enzyme Cartridge (RelizorbTM). Available at <http://www.clinicaltrials.gov> (accessed - 2017 June 30). NCT02598128.
26. Office of Health Technology Assessment (OHTA). Intradialytic parenteral nutrition for hemodialysis patients. Health Technology Review, No. 6, August, 1993. AHCPR Pub. No. 93-0068. Available at < http://www.ncbi.nlm.nih.gov> (accessed - 2012 May).
27. Foulks CJ. An evidence-based evaluation of intradialytic parenteral nutrition. Am J Kidney Dis. Jan 1999; 33(1):186-92. PMID 9915289
28. Dukkipati R, Kalantar-Zadeh K, Kopple JD. Is there a role for intradialytic parenteral nutrition? A review of the evidence. Am J Kidney Dis. Feb 2010; 55(2):352-64. PMID 19854550
29. Sigrist MK, Levin A, Tejani AM. 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
30. Marsen TA, Beer J, Mann H, et al. Intradialytic parenteral nutrition in maintenance hemodialysis patients suffering from protein-energy wasting. Results of a multicenter, open, prospective, randomized trial. Clin Nutr. Feb 2017; 36(1):107-117. PMID 26708726
31. Cano NJ, Fouque D, Roth H, et al. Intradialytic parenteral nutrition does not improve survival in malnourished hemodialysis patients: a 2-year multicenter, prospective, randomized study. J Am Soc Nephrol. Sep 2007; 18(9):2583-91. PMID 17656473
32. Ikizler TA. Parenteral nutrition offers no benefit over oral supplementation in malnourished hemodialysis patients. Nat Clin Pract Nephrol. Feb 2008; 4(2):76-7. PMID 17998928
33. Chertow GM, Ling J, Lew NL, et al. The association of intradialytic parenteral nutrition administration with survival in hemodialysis patients. Am J Kidney Dis. Dec 1994; 24(6):912-20. PMID 7985668
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|12/15/2017||Document updated with literature review. The following changes were made to coverage: 1) Added “enteral formula” to Note 1. 2) Added Note 2 to address human milk fortifiers. 3) Added Note 4 to clarify coverage for oral and enteral nutrition is applicable to all patient settings. 4) Enteral nutrition section: a) Added “proximal small bowel fistula” to list of examples of diseases of the structures that normally allows food to reach the small bowel; b) Added “Parkinson’s disease” as cause of dysphagia; c) added or “orogastric” to statement on nasogastric tubes; d) Added statement considering enteral nutrition NMN if not the primary source of caloric intake; e) Added an EIU statement for all other indications. 5) Parenteral nutrition section was completely revised. 6) Revised all criteria from the MN statement in the intradialytic parenteral nutrition section. 7) Replaced wording by physician's prescription in the coverage section to available only by prescription from a healthcare provider acting within the scope of their licensure under applicable state law.|
|3/15/2017||Document updated with literature review. The following change(s) were made to Coverage: 1) Removed Total Parenteral Nutrition initiation criteria specific to serum albumin, body weight, blood urea nitrogen, and phosphorus; 2) Modified Parenteral Nutrition statement of medical necessity; and 3) Changed “Total Parenteral Nutrition” to “Parenteral Nutrition”.|
|10/15/2016||Document updated with a literature review specific to digestive enzyme cartridges. The following statement was added to Coverage: Digestive enzyme cartridges (e.g. Relizorb™, Alcresta Pharmaceuticals) is considered experimental, investigational, and/or unproven for all indications, including but not limited to, patients receiving enteral tube feedings .|
|6/1/2015||Document updated with literature review. The following was added to the coverage section: Enteral Nutrition (EN) formula (available only by physician’s prescription) may be considered medically necessary when administered via a nasogastric feeding tube when the following criterion is met: Presence of inadequate nutritional oral intake, related to medical condition (less than 50% of the caloric needs are being met by oral intake) requiring supplementation for a limited time period (e.g. 4-6-weeks).|
|1/1/2013||CPT/HCPCS code(s) updated|
|8/15/2011||CPT/HCPCS code(s) updated|
|9/1/2009||Adding Legislation for Texas to reflect legislative mandates for payment of (1) immunoglobulin E and non-immunoglobulin E mediated allergies to multiple food proteins; (2) severe food protein-induced enterocolitis syndrome; (3) eosinophilic disorders, as evidenced by the results of a biopsy; and (4) impaired absorption of nutrients caused by disorders affecting the absorptive surface, functional length, and motility of the gastrointestinal tract. The coverage required under Subsection (a) [1-4] is required if the treating physician has issued a written order stating that the amino acid-based elemental formula is medically necessary for the treatment of an enrollee who is diagnosed with a disease or disorder listed in Subsection (a) [1-4].|
|1/1/2009||New CPT/HCPCS code(s) added|
|5/15/2008||Policy reviewed without literature review; new review date only. This policy is no longer scheduled for routine literature review and update.|
|1/1/2008||Revised/updated entire document|
|2/1/2007||Revised/updated entire document|
|1/1/2006||CPT/HCPCS code(s) updated|
|1/1/2005||CPT/HCPCS code(s) updated|
|9/1/2004||Revised/updated entire document|
|2/1/2002||New CPT/HCPCS code(s) added|
|5/1/1996||Revised/updated entire document|
|7/1/1993||Revised/updated entire document|
|5/1/1990||New medical document|
|Title:||Effective Date:||End Date:|
|Alternative Modes of Nutrition in the Outpatient and Home Setting||03-15-2017||12-14-2017|
|Alternative Modes of Nutrition in the Outpatient and Home Setting||10-15-2016||03-14-2017|
|Alternative Modes of Nutrition in the Outpatient and Home Setting||06-01-2015||10-14-2016|
|Alternative Modes of Nutrition in the Outpatient and Home Setting||01-01-2013||05-31-2015|
|Alternative Modes of Nutrition in the Outpatient and Home Setting||08-15-2011||12-31-2012|
|Alternative Modes of Nutrition in the Outpatient and Home Setting||09-01-2009||08-14-2011|
|Alternative Modes of Nutrition in the Outpatient and Home Setting||05-15-2008||08-31-2009|
|Alternative Modes of Nutrition in the Outpatient and Home Setting||01-01-2008||05-14-2008|
|Alternative Modes of Nutrition in the Outpatient and Home Setting||02-01-2007||12-31-2007|
|Alternative Modes of Nutrition in the Outpatient and Home Setting||10-15-2006||01-31-2007|
|Alternative Modes of Nutrition in the Outpatient and Home Setting||09-20-2004||10-14-2006|
|Parenteral, Enteral Nutrition (PEN) Therapy||05-01-1996||09-19-2004|