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L.8.01.413
Intradialytic parenteral nutrition is the infusion of an intravenous hyperalimentation formula, such as amino acids, glucose, and lipids, during dialysis, to treat protein calorie malnutrition in an effort to decrease the morbidity and mortality experienced in patients with renal failure.
Protein Calorie Malnutrition
Protein calorie malnutrition occurs in an estimated 25% to 40% of patients undergoing dialysis. The cause of malnutrition in patients on dialysis is often multifactorial and may include under dialysis, chronic inflammation, protein loss in the dialysate solution (particularly in peritoneal dialysis), untreated metabolic acidosis, and decreased oral intake.
DiagnosisThe clinical evaluation of malnutrition is multifactorial but typically includes measurement of serum albumin. Serum albumin levels correlate with nutritional status but are imperfect measures of nutrition because they can be affected by other disease states. Protein calorie malnutrition is associated with increased morbidity and mortality. For example, the risk of death is increased more than 10-fold in those whose serum albumin levels are less than 2.5 g/dL, and those with a serum albumin near the normal range (i.e., 3.5 to 3.9 g/dL) have a mortality rate twice as high as those with an albumin level greater than 4.0 g/dL.
TreatmentFor patients receiving chronic dialysis, the National Kidney Foundation currently recommends a daily protein intake of 1.2 g/kg or more in patients undergoing hemodialysis and 1.3 g/kg or more in patients undergoing peritoneal dialysis. When malnutrition is present, a stepwise approach to treatment is generally used, beginning with dietary counseling and diet modifications, followed by oral nutrition supplements, and then by enteral nutrition supplements or parenteral nutrition supplements if needed.
Intradialytic parenteral nutrition, which refers to the infusion hyperalimentation fluids at the time of either hemodialysis or peritoneal dialysis, has been investigated as a technique to treat protein calorie malnutrition in an effort to decrease the associated morbidity and mortality. Intradialytic parenteral nutrition solutions are similar to those used for total parenteral nutrition. A typical solution contains 10% amino acids, 40% to 50% glucose, 10% to 20% lipids, or a mixture of carbohydrate or lipids, depending on patient needs. In hemodialysis, the intradialytic parenteral nutrition infusion is administered through the venous port of the dialysis tubing, typically, 30 minutes after dialysis has begun, and continued throughout the dialysis session.
Total parenteral nutrition solutions are compounded by an individual pharmacy from individual ingredients (eg, dextrose, amino acids, trace elements) into a finished medication based on a prescription and are not required to have approval from the U.S. Food and Drug Administration (FDA) through a new drug application process. Compounding pharmacies have historically been subject to regulation by state pharmacy boards, although the FDA increased its regulatory oversight under the Drug Quality and Security Act of 2013.
Peritoneal dialysis solutions are regulated as drugs as defined by the FDA. One amino acid-based peritoneal dialysate, Nutrineal™ PD4, 1.1% Amino Acid Peritoneal Dialysis Solution (Baxter), is available commercially outside of the United States, but has not been FDA approved.
Intradialytic parenteral nutritionas an adjunct to hemodialysis may be considered medically necessary when it is offered as an alternative to a regularly scheduled regimen of total parenteral nutrition only in individuals 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 individual's general condition.
Intradialytic parenteral nutrition is considered investigational in individuals 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.
Intradialytic parenteral nutrition as an adjunct to hemodialysis is considered investigational in individuals who would not otherwise be considered candidates for TPN.
None
The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.
This policy only addresses intravenous parenteral nutrition as an adjunct to hemodialysis (not peritoneal dialysis).
Medically Necessary is defined as those services, treatments, procedures, equipment, drugs, devices, items or supplies furnished by a covered Provider that are required to identify or treat a Member's illness, injury or Mental Health Disorders, and which Company determines are covered under this Benefit Plan based on the criteria as follows in A through D:
A. consistent with the symptoms or diagnosis and treatment of the Member's condition, illness, or injury; and
B. appropriate with regard to standards of good medical practice; and
C. not solely for the convenience of the Member, his or her Provider; and
D. the most appropriate supply or level of care which can safely be provided to Member. When applied to the care of an Inpatient, it further means that services for the Member's medical symptoms or conditions require that the services cannot be safely provided to the Member as an Outpatient.
For the definition of medical necessity, “standards of good medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. BCBSMS makes no payment for services, treatments, procedures, equipment, drugs, devices, items or supplies which are not documented to be Medically Necessary. The fact that a Physician or other Provider has prescribed, ordered, recommended, or approved a service or supply does not in itself, make it Medically Necessary.
Investigative is defined as the use of any treatment procedure, facility, equipment, drug, device, or supply not yet recognized as a generally accepted standard of good medical practice for the treatment of the condition being treated and; therefore, is not considered medically necessary. For the definition of Investigative, “generally accepted standards of medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. In order for equipment, devices, drugs or supplies [i.e, technologies], to be considered not investigative, the technology must have final approval from the appropriate governmental bodies, and scientific evidence must permit conclusions concerning the effect of the technology on health outcomes, and the technology must improve the net health outcome, and the technology must be as beneficial as any established alternative and the improvement must be attainable outside the testing/investigational setting.
5/18/2006: Approved by Medical Policy Advisory Committee (MPAC).
7/11/2008: Policy reviewed, no changes.
04/13/2010: Policy description updated. Policy statement unchanged.
08/02/2011: Policy reviewed; no changes.
07/17/2012: Policy reviewed; no changes.
10/21/2013: Policy reviewed; no changes.
06/16/2014: Policy reviewed; description updated regarding hemodialysis and peritoneal dialysis. Policy statement unchanged.
08/28/2015: Medical policy revised to add ICD-10 codes.
10/16/2015: Policy description updated regarding causes of malnutrition in dialysis patients and an approach to treatment. Medically necessary and investigational policy statements revised to clarify that the statements apply to parenteral nutrition administered during hemodialysis. Policy guidelines section updated to state that this policy only addresses intravenous nutrition as an adjunct to hemodialysis (not peritoneal dialysis). Medically necessary and investigative definitions added.
12/31/2015: Code descriptions revised for the following HCPCS codes: B5000, B5100, and B5200.
05/26/2016: Policy number A.8.01.44 added.
06/20/2017: Policy description updated regarding intradialytic parenteral nutrition as a technique to treat protein calorie malnutrition. Policy statements unchanged.
06/18/2018: Added investigational table. Code Reference section updated to add new HCPCS code Q9994, effective 07/01/2018.
07/11/2018: Policy reviewed; no changes.
12/19/2018: Code Reference section updated to add new HCPCS code B4105, effective 01/01/2019.
06/10/2019: Policy reviewed; no changes.
07/08/2020: Policy reviewed. Policy statements unchanged. Code Reference section updated to remove deleted HCPCS code Q9994.
09/30/2020: Code Reference section updated to add new ICD-10 diagnosis codes N18.30, N18.31, and N18.32, effective 10/01/2020.
08/24/2021: Policy reviewed. Policy statements unchanged. Policy Guidelines updated to change "Nervous/Mental Conditions" to "Mental Health Disorders" and "Medically Necessary" to "medical necessity."
06/22/2022: Policy reviewed. Policy statements updated to change "patients" to "individuals." Second policy statement changed from "not medically necessary" to "investigational." Policy intent unchanged.
07/17/2023: Policy description updated. Policy statements unchanged.
06/18/2024: Policy reviewed; no changes.
08/28/2024: Policy updated to change the medical policy number from “A.8.01.44” to “L.8.01.413.”
Blue Cross Blue Shield Association policy # 8.01.44
This may not be a comprehensive list of procedure codes applicable to this policy.
The code(s) listed below are ONLY medically necessary if the procedure is performed according to the "Policy" section of this document.
Code Number | Description | ||
CPT-4 | |||
HCPCS | |||
B4164, B4168, B4172, B4176, B4178, B4180, B4185, B4189, B4193, B4197, B4199, B4216, B4220, B4222, B4224, B5000, B5100, B5200 | Parenteral nutrition, code range | ||
ICD-9 Procedure | ICD-10 Procedure | ||
ICD-9 Diagnosis | ICD-10 Diagnosis | ||
585 | Chronic renal failure | N18.1 - N18.9, N18.30, N18.31, N18.32 | Chronic renal failure (code range) |
586 | Renal failure, unspecified | N19 | Unspecified kidney failure |
Investigational Codes
Code Number | Description |
CPT-4 | |
HCPCS | |
B4105 | In-line cartridge containing digestive enzyme(s) for enteral feeding, each |
ICD-10 Procedure | |
ICD-10 Diagnosis |
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