BlueCross and BlueShield of Montana Medical Policy/Codes
Intestinal Rehabilitation Therapy
Chapter: Medicine: Treatments
Current Effective Date: October 25, 2013
Original Effective Date: October 25, 2013
Publish Date: July 25, 2013
Revised Dates: This policy is no longer scheduled for routine literature review and update.
Description

Massive loss of intestinal surface area results in short bowel syndrome, characterized by malabsorption of fluids, electrolytes, and other nutrients.  Common causes of short bowel syndrome include resection related to volvulus, thrombosis of the superior mesenteric artery, Crohn’s disease, or trauma.  While some adaptation of remaining intestinal surface (characterized by elongation and dilation of remnant bowel) can improve nutrient absorption, patients with less than 60 cm of functional jejunum or ileum typically require permanent total parenteral nutrition (TPN).  While intestinal transplantation is one alternative, there has been recent interest in methods to increase intestinal adaptation as a non-surgical alternative.  Specifically, intestinal adaptation is thought to be related to exposure of the remaining mucosa to luminal nutrients, the presence of enteric hormone and pancreatic-biliary secretion, and the trophic effects of various extrinsic growth factors and growth hormone.  For example, the amino acid glutamine administered either enterally or parenterally, is known to induce a nutritive or regenerative effect on the bowel. Growth hormone is also thought to have a nutritive effect on the bowel.

Specialized inpatient programs have been developed to offer intensive counseling and tailored regimens of diet modification, glutamine, and growth hormone therapy to patients with short bowel syndrome. The goal of these programs is to either eliminate or reduce the need for total parenteral nutrition.  The Nutritional Restart Center near Boston, Massachusetts (www.nrcenter.com), offers an inpatient program of two to four weeks, during which time the patient undergoes detailed metabolic evaluations to determine the feasibility of an oral diet, intestinal adaptation therapy with dietary modification (diet high in complex carbohydrates and low in fat), glutamine and growth hormone, and a gradual weaning of total parenteral nutrition, if possible.  Patients also receive extensive counseling and education, and participate in a physical rehabilitation program.  At completion of the program, the patients are discharged on only the restricted diet and the supplemental glutamine.  The Nutritional Restart Center also offers outpatient and home-based services to patients requiring continued treatment.  The University of Nebraska, in conjunction with the Nutritional Restart Center, maintains an affiliated Inpatient Intestinal Rehabilitation Program in Omaha.

Policy

Each benefit plan or contract defines which services are covered, which are excluded, and which are subject to dollar caps or other limits.  Members and their providers have the responsibility for consulting the member's benefit plan 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 or contract, the benefit plan or contract will govern.

Investigational

Blue Cross and Blue Shield of Montana (BCBSMT) considers an inpatient program of intestinal rehabilitation, consisting of metabolic evaluation, patient counseling and education, nutritional counseling, physical therapy, and treatment with growth hormone and glutamine experimental, investigational and unproven in patients with short bowel syndrome who are dependent on total parenteral nutrition.

Rationale

The published data are almost exclusively derived from researchers working at the Nutritional Restart Center near Boston.  Most reports consist of small case series, many with presumably overlapping patients.  One case series consists of 45 patients with short bowel syndrome maintained on long-term parenteral nutrition.  These patients were treated with growth hormone, glutamine, and a modified diet for four weeks and then followed up for an average of 1.8 years. After four weeks of therapy, 58% no longer required TPN.  At follow-up, the percentage of patients not receiving TPN fell to 40%.  A review article published in the same year included 67 adults receiving TPN, and presumably includes overlapping patients.  At completion of the four-week program, the TPN requirement for each patient was noted as discontinued (52%), reduced (38%), or no change (10%).  Over an unspecified follow-up period, there was some attrition of the treatment effect.

The relative contributions of the pharmacologic, dietary and counseling/education aspects of the overall program cannot be determined.  Specifically, some researchers have questioned whether the treatment effect was primarily due to meticulous dietary counseling as opposed to any effect from glutamine or growth hormone.  For example, Scolapio conducted a randomized six-week double-blind, placebo-controlled trial of eight patients who alternatively received growth hormone, glutamine supplementation, and a high carbohydrate, low-fat diet which alternated with a placebo treatment.   Active treatment was associated with an increased body weight and lean body mass, decreased percent of body fat without increase in fluid, or macronutrient absorption. All patients receiving active treatment developed peripheral edema, suggesting that an increase in extra cellular fluid may have been responsible for the positive findings.  In addition, after discontinuation of growth hormone, the weight returned to baseline.  In another blinded crossover study of eight patients, Szkudlarek and colleagues examined the effect of growth hormone and glutamine supplementation on intestinal function.  Unlike the above study, the patients did not receive a high carbohydrate, low-fat diet.  Growth hormone with glutamine was not associated with improved intestinal absorption of energy, carbohydrate, sodium, potassium, calcium, or magnesium.

An additional research question is the contribution of an intensive inpatient program, compared to similar elements of the program offered in an outpatient setting. This issue has not been addressed in the published literature.

An updated search of the medical literature found that there is no consistent definition or components of intestinal rehabilitation nor is there long-term health outcomes measured for intestinal rehabilitation.  Studies continued to assess the relative contributions of growth hormone, glutamine, glucagon-like peptide-two, and diet but did not assess the optimal treatment settings or components of intestinal rehabilitation according to patient characteristics.

One study involved twelve adults with short bowel syndrome who were dependent on a home-based, high carbohydrate parenteral nutrition diet.  Patients were randomized in a double-blind placebo-controlled crossover study.  Patients received daily low-dose growth hormone and placebo for a two- to three-week period, separated by a one-week washout period.  Treatment with growth hormone increased intestinal absorption of energy, nitrogen, carbohydrates, and fats. The increased food absorption represented 37% +/- 16% of total parenteral energy delivery.  Body weight, lean mass, and D-xylose absorption increased.  However, the study did not assess long-term health outcomes beyond the immediate study period.

One study assigned 59 patients with life-threatening complications of intestinal failure to three treatment options. Sixty-eight percent of patients were considered appropriate candidates for intestinal transplants, 10% were managed with rehabilitation, and 17% were maintained on optimized parenteral nutrition.  All patients managed with rehabilitation were weaned from parenteral nutrition within six months.

Wu and colleagues assessed bowel rehabilitation combined with nutritional therapy and found that 33 of 38 patients maintained body weight and serum albumin concentrations after an average follow-up of 5.9+/-4.3 years for the 33 survival patients.  Nutrient absorption in eight patients treated with growth hormone and glutamine seemed to increase, but the effects occurred only during the treatment period and were not sustained.

The Federal Drug Administration (FDA) label for Zorbtive indicates growth hormone has been shown in human clinical trials to enhance the Tran mucosal transport of water, electrolytes, and nutrients.  The FDA approval for Zorbtive was based on the results of a randomized, controlled, Phase III clinical trial in which patients dependent on intravenous parenteral nutrition who received Zorbtive (either with or without glutamine) over a four-week period had significantly greater reductions in the weekly total volume of intravenous parenteral nutrition required for nutritional support. However, the effects beyond four weeks were not evaluated nor were the treatment locations (inpatient vs. outpatient) identified.

The FDA has noted growth hormone for patients with short bowel syndrome should be limited to patients receiving specialized nutritional support in conjunction with optimal management of short bowel syndrome.  Specialized nutritional support may consist of a high-carbohydrate, low-fat diet adjusted for individual patient requirements. Optimal management may include dietary adjustments, enteral feedings, parenteral nutrition, fluid and micronutrient supplements.  Zorbtive is administered daily at 0.1mg/kg subcutaneously up to eight mg/day.  Administration of Zorbtive for longer than four weeks has not been adequately studied per the FDA indications.

Coding

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. 

ICD-9 Codes
579.0, 579.9
Procedural Codes: None
References
  1. Byrne, T.A., Persinger, R.L., et al.  A new treatment for patients with short-bowel syndrome. Growth hormone, glutamine, and a modified diet.  Annals of Surgery (1995) 222(3):243-55.
  2. Wilmore, D.W., Byrne, T.A., et al.  Short bowel syndrome: new therapeutic approaches.  Current Problems in Surgery (1997) 34(5):389-444.
  3. Scolapio, J.S.  Effect of growth hormone, glutamine, and diet on body composition in short bowel syndrome: a randomized, controlled study.  JPEN Journal of Parenteral and Enteral Nutrition (1999) 23(6):309-13.
  4. Szkudlarek, J., Jeppesen, P.B., et al.  Effect of high dose growth hormone with glutamine and no change in diet on intestinal absorption in short bowel patients: a randomized double blind, crossover, and placebo controlled study.  Gut (2000) 47(2):199-205.
  5. Fishbein, T.M., Schiano, T., et al.  An integrated approach to intestinal failure: results of a new program with total parenteral nutrition, bowel rehabilitation, and transplantation.  Journal of Gastrointestinal Surgery (2002) 6(4):554-62.
  6. Seguy, D., Vahedi, K., et al.  Low-dose growth hormone in adult home parenteral nutrition-dependent short bowel syndrome patients: a positive study.  Gastroenterology (2003) 124(2):293-302.
  7. Scolapio, J.S.  Tales from the crypt (editorial).  Gastroenterology (2003) 124(2):561-4.
  8. Wu, G.H., Wu, Z.H., et al.  Effects of bowel rehabilitation and combined trophic therapy on intestinal adaptation in short bowel patients. World Journal of Gastroenterology (2003) 9(11):2601-4.
  9. DiBaise, J.K., Young, R.J., et al.  Intestinal rehabilitation and the short bowel syndrome: part 1.  American Journal of Gastroenterology (2004 July) 99(7): 1386-95.
  10. DiBaise, J.K., Young, R.J., et al.  Intestinal rehabilitation and the short bowel syndrome: part 2.
  11. American Journal of Gastroenterology (2004 September) 99(9): 1823-32.
  12. Inpatient Intestinal Rehabilitation Therapy.  Chicago, Illinois: Blue Cross Blue Shield Association Medical Policy Reference Manual (2005 January) Medicine 2.01.48.
  13. Fishbein, T.M., and C.S. Matsumoto.  Intestinal replacement therapy:  timing and indications for referral of patients to an intestinal rehabilitation and transplant program.  Gastroenterology (2006 February) 130(2 Supplement 1): S147-51.
History
July 2013  New 2013 BCBSMT medical policy. 
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Intestinal Rehabilitation Therapy