mp-152
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Inpatient Intestinal Rehabilitation Therapy

Policy Number: MP-152

Latest Review Date: July 2019

Category: Medical                                                     

Policy Grade: Effective 03/31/10:

Active Policy but no longer scheduled for regular literature reviews and updates.

POLICY:

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 is considered not medically necessary for patients with short bowel syndrome who are dependent on total parenteral nutrition and is considered investigational.

DESCRIPTION OF PROCEDURE OR SERVICE:

Short bowel syndrome (SBS) is a malabsorption syndrome that can occur after extensive small intestinal resection, significant damage to the small intestine, or poor motility. Individuals with SBS are not able to absorb enough vitamins, minerals, fats, calories, or other nutrients from food.  It is characterized by chronic diarrhea, dehydration, electrolyte abnormalities, and malnutrition as a result of severe maldigestion and malabsorption.  Common causes of SBS in adults include resection due to Crohn’s disease, a catastrophic vascular event such as mesenteric arterial embolism or venous thrombosis, volvulus, trauma, or tumor.  Most patients are initially fed with total parenteral nutrition (TPN) to help prevent the development of malnutrition.  Some patients may be difficult to wean from TPN.  This includes patients with very short remaining small bowel segments (< 60 cm), loss of colon, loss of ileocecal valve, or small bowel strictures.  This parenteral nutrition provides protein, calories, other macronutrients, and micronutrients until the bowel has had time to adapt.

After massive enterectomy, the intestine adapts to ensure more efficient absorption per unit length.  There is slight lengthening, but also diameter and villus height increase, which increases the absorptive surface.  This intestinal adaptation process continues for up to two years.  The exact mechanisms are not known, but various factors have been shown to enhance adaptation, including growth hormone, glutamine, epidermal growth factor, certain peptides and interleukins, soluble fiber, short chain fatty acids, and pancreaticobiliary secretions.  There has been a great deal of research interest in methods to increase intestinal adaptation as a nonsurgical alternative to intestinal transplantation.  Specifically, the combination of the amino acid glutamine and human recombinant growth hormone (GH), in conjunction with a high carbohydrate, low fat diet, has been studied.  Glutamine, administered either enterally or parenterally, and growth hormone, administered subcutaneously, is thought to have trophic affects on the bowel.

There are some inpatient programs specifically designed for patients with short bowel syndrome who are dependent on TPN for their nutritional needs.  The programs offer intensive counseling and tailored regimens of diet modification, glutamine, and growth hormone therapy to these patients.  The goal of these programs is to help patients either eliminate or reduce the need for total parenteral nutrition.

In 1993, the Nutritional Restart Center (NRC) for intestinal rehabilitation was started in Boston.  In 2001, the NRC transferred its treatment methodologies to the Nebraska Medical Center in Omaha, NE.  It offers patients with intestinal failure comprehensive treatment options to help them transition from TPN to a more normal oral diet.  They offer inpatient and outpatient services.  The inpatient program lasts two to four weeks and the patient undergoes detailed metabolic evaluations to determine the feasibility of an oral diet, intestinal adaptation therapy with dietary modification (a high-carbohydrate, low-fat diet), glutamine and growth hormone, and a gradual weaning of TPN, if possible.  Patients also undergo extensive counseling and education and participate in a physical rehabilitation program.  Each patient’s treatment plan is individualized to meet their specific needs to improve bowel function.  At completion of the program, patients are discharged on only the diet and supplemental glutamine.

KEY POINTS:

The early published data are almost exclusively derived from researchers working at the NRC near Boston.  Most reports were small case series with overlapping patients.

Summary

The evidence for inpatient intestinal rehabilitation consists of several industry sponsored and small studies.  Study results indicate that this type of treatment is controversial and long term results are needed to determine the effect on net health outcomes.

U.S. PREVENTIVE SERVICES TASK FORCE RECOMMENDATIONS

Not applicable.

KEY WORDS:

Intestinal rehabilitation, short bowel syndrome (SBS), growth hormone (GH), glutamine (GLN), high carbohydrate, low fat diet (HCLF), Zorbtive™

APPROVED BY GOVERNING BODIES:

Zorbtive is a recombinant human growth hormone indicated for the treatment of short bowel syndrome in adult patients receiving specialized nutritional support.

BENEFIT APPLICATION:

Coverage is subject to member’s specific benefits.  Group specific policy will supersede this policy when applicable.

ITS: Home Policy provisions apply

FEP contracts: FEP does not consider investigational if FDA approved and will be reviewed for medical necessity. Special benefit consideration may apply.  Refer to member’s benefit plan.

CODING: 

CPT:               

There are currently no CPT codes for this service.

REFERENCES:

  1. Byrne TA, Wilmore DW, et al.  A new treatment for patients with short-bowel syndrome-growth hormone, glutamine, and a modified diet, Annals of Surgery, September 1995, Vol. 222, No. 3, pp. 243-255.
  2. Byrne TA, Wilmore DW, et al.  Bowel rehabilitation:  An alternative to long-term parenteral nutrition and intestinal transplantation for some patients with short bowel syndrome, Transplant Proceedings, May 2002; 34(3): 887-90.
  3. Byrne TA, Wilmore DW.  Does growth hormone and glutamine enhance bowel absorption?, Gastroenterology, May 1998, Vol. 114, No. 5, pp. 1110-1116.
  4. Byrne TA, Wilmore DW, et al.  Growth hormone, glutamine, and a modified diet enhance nutrient absorption in patients with severe short bowel syndrome, Journal of Parenteral and Enteral Nutrition, July 1995, Vol. 19, No. 4, pp. 296-302.
  5. Byrne TA, Wilmore DW, Iyer K, Dibaise J, et al.  Growth hormone, glutamine, and an optimal diet reduces parenteral nutrition in patients with short bowel syndrome:  A prospective, randomized, placebo-controlled, double-blind clinical trial.  Ann Surg, November 2005; 242(5): 655-661.
  6. FDA. Prescribing information for Zorbtive. Available at https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020604s074lbl.pdf.
  7. Fishbein TM, 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, July 2002; 6(4): 554-62.
  8. Guo M, Li Y, Li J. Effect of growth hormone, glutamine, and enteral nutrition on intestinal adaptation in patients with short bowel syndrome. Turk J Gastroenterol. 2013;24(6):463-
  9. Jeppesen PB, et al.  Effect of high-dose growth hormone and glutamine on body composition, urine creatinine excretion, fatty acid absorption, and essential fatty acids status in short bowel patients:  A randomized, double-blind, crossover, placebo-controlled study, Scandinavian Journal of Gastroenterology, January 2001, 36(1): 48-54.
  10. Li-Ling, Irving M.  The effectiveness of growth hormone, glutamine, and a low-fat diet containing high-carbohydrate on the enhancement of the function of remnant intestine among patients with short bowel syndrome:  A review of published trials, Clinical Nutrition, June 2001; 20(3): 199-204.
  11. Sawyer M, Sawyer E, et al.  Short bowel syndrome, www.emedicine.com/med/topic2746.htm.
  12. Scolapio JS, et al.  Effect of growth hormone, glutamine, and diet on adaptation in short-bowel syndrome:  A randomized, controlled study, Gastroenterology, October 1997, Vol. 113, pp. 1074-1081.
  13. Scolapio, JS.  Effect of growth hormone, glutamine, and diet on body composition in short bowel syndrome:  A randomized, controlled study, Journal of Parenteral and Enteral Nutrition, Nov-Dec 1999, Vol. 23, No. 6, pp. 309-3
  14. Scolapio, JS.  Tales from the crypt, Gastroenterology, February 2003, Vol. 124, pp. 561-571.
  15. Scolapio, JS.  Treatment of short bowel syndrome, Current Opinion in Clinical Nutrition and Metabolic Care, November 2001; 4(6): 557-60.
  16. Seguy D, et al.  Low dose growth hormone in adult home parenteral nutrition-dependent short bowel syndrome patients:  A positive study, Gastroenterology, February 2003; 124(2): 293-302.
  17. Szkudlarek J, 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, placebo controlled study, Gut, August 2000; 47(2): 199-205.
  18. U.S. Preventive Services Task Force. https://www.uspreventiveservicestaskforce.org/BrowseRec/Search?s=short+bowel+syndrome.
  19. Wilmore DW, Byrne TA, et al.  Factors predicting a successful outcome after pharmacologic bowel compensation, Annals of Surgery, September 1997; 226(3): 288-293.
  20. Wilmore DW.  Indications for specific therapy in the rehabilitation of patients with the short-bowel syndrome, Best Practice and Research Clinical Gastroenterology, December 2003; 17(6): 895-906.
  21. Wu GH, et al.  Effects of bowel rehabilitation and combined trophic therapy on intestinal adaptation in short bowel patients, World Journal of Gastroenterology, November 2003; 9(11): 2601-4.
  22. Zhu W, et al.  Rehabilitation therapy for short bowel syndrome, Chinese Medical Journal, May 2002; 115(5): 776-8.

POLICY HISTORY:

Medical Policy Group, March 2004

Medical Policy Administration Committee, March 2004

Available for comment April 6-May 20, 2004

Medical Policy Group, March 2006 (1)

Key Points updated, March 2008 (1)

Medical Policy Group, March 2010 (1) Policy retired, no further updates, non-covered

Medical Policy Group, March 31, 2010; Active Policy but no longer scheduled for regular literature reviews and updates.

Medical Policy Group, July 2019 (4): Updates to Description, Key Points, and References.  No change to policy statement.

 

This medical policy is not an authorization, certification, explanation of benefits, or a contract. Eligibility and benefits are determined on a case-by-case basis according to the terms of the member’s plan in effect as of the date services are rendered. All medical policies are based on (i) research of current medical literature and (ii) review of common medical practices in the treatment and diagnosis of disease as of the date hereof. Physicians and other providers are solely responsible for all aspects of medical care and treatment, including the type, quality, and levels of care and treatment.

 

This policy is intended to be used for adjudication of claims (including pre-admission certification, pre-determinations, and pre-procedure review) in Blue Cross and Blue Shield’s administration of plan contracts.

The plan does not approve or deny procedures, services, testing, or equipment for our members. Our decisions concern coverage only. The decision of whether or not to have a certain test, treatment or procedure is one made between the physician and his/her patient. The plan administers benefits based on the member’s contract and corporate medical policies. Physicians should always exercise their best medical judgment in providing the care they feel is most appropriate for their patients. Needed care should not be delayed or refused because of a coverage determination.

As a general rule, benefits are payable under health plans only in cases of medical necessity and only if services or supplies are not investigational, provided the customer group contracts have such coverage.

The following Association Technology Evaluation Criteria must be met for a service/supply to be considered for coverage:

1. The technology must have final approval from the appropriate government regulatory bodies;

2. The scientific evidence must permit conclusions concerning the effect of the technology on health outcomes;

3. The technology must improve the net health outcome;

4. The technology must be as beneficial as any established alternatives;

5. The improvement must be attainable outside the investigational setting.

 

Medical Necessity means that health care services (e.g., procedures, treatments, supplies, devices, equipment, facilities or drugs) that a physician, exercising prudent clinical judgment, would provide to a patient for the purpose of preventing, evaluating, diagnosing or treating an illness, injury or disease or its symptoms, and that are:

1. In accordance with generally accepted standards of medical practice; and

2. Clinically appropriate in terms of type, frequency, extent, site and duration and considered effective for the patient’s illness, injury or disease; and

3. Not primarily for the convenience of the patient, physician or other health care provider; and

4. Not more costly than an alternative service or sequence of services at least as likely to produce equivalent therapeutic or diagnostic results as to the diagnosis or treatment of that patient’s illness, injury or disease.