Latest Review Date: December 2023

Category: Medical                                                     

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 investigational for individuals with short bowel syndrome who are dependent on total parenteral nutrition.

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 individuals are initially fed with total parenteral nutrition (TPN) to help prevent the development of malnutrition. Some individuals may be difficult to wean from TPN. This includes individuals 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 individuals 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 individuals. The goal of these programs is to help individuals 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 individuals 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. Individuals 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, individuals 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 individuals. The most recent update of this policy includes a literature review through December 6, 2023.

Summary of Evidence

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: Special benefit consideration may apply. Refer to member’s benefit plan.

CURRENT CODING: 

CPT Codes:               

There are currently no CPT codes for this service.

REFERENCES:

1. Bharadwaj S, Tandon P, Meka K, et al. Intestinal Failure: Adaptation, Rehabilitation, and Transplantation. J Clin Gastroenterol 2016; 50:366.
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, 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.
4. FDA. Prescribing information for Zorbtive. Available at www.accessdata.fda.gov/drugsatfda_docs/label/2017/020604s074lbl.pdf.
5. 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.
6. 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):463-8.
7. Infantino BJ, Mercer DF, Hobson BD, et al. Successful rehabilitation in pediatric ultrashort small bowel syndrome. J Pediatr 2013; 163:1361.
8. IOM (Institute of Medicine). 2011. Clinical Practice Guidelines We Can Trust. Washington, DC: The National Academies Press.
9. Khalil BA, Ba'ath ME, Aziz A, et al. Intestinal rehabilitation and bowel reconstructive surgery: improved outcomes in children with short bowel syndrome. J Pediatr Gastroenterol Nutr 2012; 54:505.
10. Lauro A, Lacaille F. Short bowel syndrome in children and adults: from rehabilitation to transplantation. Expert Rev Gastroenterol Hepatol. 2019 Jan;13(1):55-70. 
11. Merritt RJ, Cohran V, Raphael BP, et al. Intestinal Rehabilitation Programs in the Management of Pediatric Intestinal Failure and Short Bowel Syndrome. J Pediatr Gastroenterol Nutr 2017; 65:588.
12. Moon J, Iyer K. Intestinal rehabilitation and transplantation for intestinal failure. Mt Sinai J Med 2012; 79:256.
13. Scolapio, JS.  Tales from the crypt, Gastroenterology, February 2003, 124(2), 561-4.
14. 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.
15. Sigalet D, Boctor D, Brindle M, et al. Elements of successful intestinal rehabilitation. J Pediatr Surg 2011; 46:150.
16. Stanger JD, Oliveira C, Blackmore C, et al. The impact of multi-disciplinary intestinal rehabilitation programs on the outcome of pediatric patients with intestinal failure: a systematic review and meta-analysis. J Pediatr Surg 2013; 48:983.
17. U.S. Preventive Services Task Force. www.uspreventiveservicestaskforce.org/BrowseRec/Search?s=short+bowel+syndrome.
18. Vugrinec Mamić M, Hojsak I, Mišak Z, Kerman V, Kolaček S. Treatment in a Tertiary Intestinal Rehabilitation Center Improves Outcome for Children With Short Bowel Syndrome. Gastroenterol Nurs. 2019 Mar/Apr;42(2):165-168. 
19. 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.
20. 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.
21. 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.

Medical Policy Group, November 2020(4): Reviewed by consensus.  No change to policy statements.

Medical Policy Group, January 2022 (5): Reviewed by consensus. Update to Key Points and References. No new published peer-reviewed literature available that would alter the coverage statement in this policy. Policy statement updated to remove “not medically necessary,” no change to policy intent.

Medical Policy Group, December 2022 (5): Reviewed by consensus. Updates to Description, Key Points, and References. Policy Statement updated to replace the word “patients” with the word “individuals.” No change to policy intent. No new published peer-reviewed literature available that would alter the coverage statement in this policy.

Medical Policy Group, December 2023 (11): Reviewed by consensus. Updates to Key Points, Benefit Application and References. No new published peer-reviewed literature that would alter the coverage statement in this policy.

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.