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Intradialytic parenteral nutrition (IDPN) is the infusion of an intravenous nutritional formula of hyperalimentation, such as amino acids, glucose, and lipids, during dialysis, to treat protein calorie malnutrition in an effort to decrease the associated morbidity and mortality experienced in patients with renal failure.
Protein calorie malnutrition occurs in an estimated 25–40% of those undergoing dialysis. The cause of malnutrition in dialysis patients is often multifactorial and may include underdialysis, chronic inflammation, protein loss in the dialysate solution (particularly in peritoneal dialysis), untreated metabolic acidosis, and decreased oral intake.
The 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 multiple 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., from 3.5 to 3.9 g/dL) have a mortality rate twice as high as those with albumin greater than 4.0 g/dL.
In 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 nutritional supplements, and then by enteral nutrition supplements or parenteral nutritional 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. 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, amino acid intraperitoneal parenteral nutrition, or intraperitoneal nutrition, parenteral nutrition is provided by using a peritoneal dialysate solution with amino acids, instead of or in addition to glucose, as the osmotic agent.
TPN 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 FDA has increased its regulatory oversight with the Drug Quality and Security Act of 2013.
Peritoneal dialysis solutions are regulated as drugs by FDA. One amino acid-based peritoneal dialysate, Nutrineal™ PD4, 1.1% Amino Acid Peritoneal Dialysis Solution (Baxter Corp.) is available commercially outside of the United States, but has not been FDA approved.
POLICYIntradialytic parenteral nutrition as 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 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 for sufficient nutrients to maintain weight and strength commensurate with the patient's general condition.
Intradialytic parenteral nutrition is considered not medically necessary 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.
Intradialytic parenteral nutrition as an adjunct to hemodialysis is considered investigational in those patients who would not otherwise be considered candidates for TPN.
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 Nervous/Mental Conditions, 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 Medically Necessary, “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.
The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.
POLICY HISTORY5/18/2006: 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.
SOURCE(S)Blue Cross Blue Shield Association policy # 8.01.44
CODE REFERENCEThis 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.