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Date Printed: December 18, 2017: 03:22 PM

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This medical policy (medical coverage guideline) is Copyright 2017, Blue Cross and Blue Shield of Florida (BCBSF). All Rights Reserved. You may not copy or use this document or disclose its contents without the express written permission of BCBSF. The medical codes referenced in this document may be proprietary and owned by others. BCBSF makes no claim of ownership of such codes. Our use of such codes in this document is for explanation and guidance and should not be construed as a license for their use by you. Before utilizing the codes, please be sure that to the extent required, you have secured any appropriate licenses for such use. Current Procedural Terminology (CPT) is copyright 2017 American Medical Association. All Rights Reserved. No fee schedules, basic units, relative values, or related listings are included in CPT. The AMA assumes no liability for the data contained herein. Applicable FARS/DFARS restrictions apply to government use. CPT® is a trademark of the American Medical Association. The use of specific product names is illustrative only. It is not intended to be a recommendation of one product over another, and is not intended to represent a complete listing of all products available.

02-40000-18

Original Effective Date: 07/15/02

Reviewed: 06/26/14

Revised: 07/15/14

Subject: Isolated Small Bowel Transplant

THIS MEDICAL COVERAGE GUIDELINE IS NOT AN AUTHORIZATION, CERTIFICATION, EXPLANATION OF BENEFITS, OR A GUARANTEE OF PAYMENT, NOR DOES IT SUBSTITUTE FOR OR CONSTITUTE MEDICAL ADVICE. ALL MEDICAL DECISIONS ARE SOLELY THE RESPONSIBILITY OF THE PATIENT AND PHYSICIAN. BENEFITS ARE DETERMINED BY THE GROUP CONTRACT, MEMBER BENEFIT BOOKLET, AND/OR INDIVIDUAL SUBSCRIBER CERTIFICATE IN EFFECT AT THE TIME SERVICES WERE RENDERED. THIS MEDICAL COVERAGE GUIDELINE APPLIES TO ALL LINES OF BUSINESS UNLESS OTHERWISE NOTED IN THE PROGRAM EXCEPTIONS SECTION.

Position Statement Billing/Coding Reimbursement Program Exceptions Definitions Related Guidelines
Other References Updates    

DESCRIPTION:

A small bowel transplant may be performed as an isolated procedure or in conjunction with other visceral organs, including the liver, duodenum, jejunum, ileum, pancreas, or colon. Isolated small bowel transplant is commonly performed in individuals with short bowel syndrome. This is a condition in which the absorbing surface of the small intestine is inadequate due to extensive disease or surgical removal of a large portion of small intestine. In adults, etiologies of short bowel syndrome include ischemia, trauma, volvulus, and tumors. In children, gastroschisis, volvulus, necrotizing enterocolitis, and congenital atresias are predominant causes.

The small intestine, particularly the ileum, does have the capacity to adapt to some functions of the diseased or removed portion over a period of 1 to 2 years. Prognosis for recovery depends on the degree and location of small intestine damage. Therapy is focused on achieving adequate macro- and micro-nutrient uptake in the remaining small bowel. Pharmacologic agents have been studied to increase villous proliferation and slow transit times, and surgical techniques have been advocated to optimize remaining small bowel. However, some individuals with short bowel syndrome are unable to obtain adequate nutrition from enteral feeding and become chronically dependent on total parenteral nutrition (TPN). Those with complications from TPN may be considered candidates for small bowel transplant. Complications include catheter-related mechanical problems, infections, hepatobiliary disease, and metabolic bone disease. Cadaveric intestinal transplant is the most commonly performed transplant, although there has been recent interest in using living donors.

POSITION STATEMENT:

REQUIRED: Certificate of Medical Necessity

NOTE: The attached Certificate of Medical Necessity should be completed and submitted (by transplant facility) with the request for transplant services, in order to facilitate medical review. To access the certificate of medical necessity, click on the link below, complete the required fields, and print.

A small bowel transplant using cadaveric intestine meets the definition of medical necessity in adult and pediatric individuals:

With intestinal failure (characterized by loss of absorption and the inability to maintain protein-energy, fluid, electrolyte, or micronutrient balance) (e.g., short bowel syndrome), AND

Established long-term dependency on total parenteral nutrition (TPN) and are developing or have developed severe complications due to TPN, including but not limited to:

o Multiple prolonged hospitalizations to treat TPN-related complications (e.g., repeated episodes of catheter-related sepsis)

o Development of progressive liver failure [in those receiving TPN, liver disease with jaundice (total bilirubin above 3 mg/dL) is often associated with development of irreversible progressive liver disease]

o Inability to maintain venous access

A small bowel transplant using a living donor meets the definition of medical necessity only when a cadaveric intestine is not available for transplantation in a candidate who meets the criteria noted above for a cadaveric intestinal transplant.

A small bowel transplant using living donors does not meet the definition of medical necessity in all other situations.

A small bowel transplant is considered experimental or investigational for adults with intestinal failure who are able to tolerate TPN, as there is insufficient evidence to support conclusions regarding effects on health outcomes.

A small bowel retransplant meets the definition of medical necessity after a failed primary small bowel transplant.

Potential contraindications to isolated small bowel transplant (subject to the judgment of the transplant center) include:

Known current malignancy, including metastatic cancer

Recent malignancy with high risk of recurrence

Untreated systemic infection making immunosuppression unsafe, including chronic infection

Other irreversible end-stage disease not attributed to intestinal failure

History of cancer with a moderate risk of recurrence

Systemic disease that could be exacerbated by immunosuppression

Psychosocial conditions or chemical dependency affecting ability to adhere to therapy

Transplant associated services which meet the definition of medical necessity include:

Hospitalization of the recipient for medically recognized transplants from a donor to a transplant recipient

Evaluation tests requiring hospitalization to determine the suitability of both potential and actual donors, when such tests cannot be safely and effectively performed on an outpatient basis

Hospital room, board, and general nursing in semi-private rooms

Special care units, such as coronary and intensive care

Hospital ancillary services

Physicians’ services for surgery, technical assistance, administration of anesthetics, and medical care

Acquisition, preparation, transportation, and storage of the organ

Diagnostic services

Drugs that require a prescription by federal law

BILLING/CODING INFORMATION:

CPT Coding:

44132

Donor enterectomy (including cold preservation), open, from cadaver donor (non-covered by Medicare)

44133

Donor enterectomy, open, with preparation and maintenance of allograft; partial, from living donor

44135

Intestinal allotransplantation; from cadaver donor

44136

Intestinal allotransplantation; from living donor

44715

Backbench standard preparation of cadaver or living donor intestine allograft prior to transplantation, including mobilization and fashioning of the superior mesenteric artery and vein

44720

Backbench reconstruction of cadaver or living donor intestine allograft prior to transplantation, venous anastomosis, each

44721

Backbench reconstruction of cadaver or living donor intestine allograft prior to transplantation, arterial anastomosis, each

REIMBURSEMENT INFORMATION:

None

PROGRAM EXCEPTIONS:

Federal Employee Program (FEP): Follow FEP guidelines.

State Account Organization (SAO): Follow SAO guidelines.

Medicare Advantage: The following National Coverage Determination (NCD) was reviewed on the last guideline reviewed date: Intestinal and Multi-Visceral Transplantation (260.5), located at cms.gov.

DEFINITIONS:

Congenital atresia: obstruction or closure of an orifice or tubular organ (i.e., intestine).

Enteral nutrition: tube feeding by way of the small intestine.

Enterectomy: excision of a part of the intestine; resection of the intestine.

Enterocolitis: inflammation involving the small intestine and colon.

Gastroschisis: a congenital fissure of the abdominal wall not involving the site of insertion of the umbilical cord, and usually accompanied by protrusion of the small intestine and part of the large intestine.

Hepatobiliary: pertaining to the liver, gallbladder and the biliary ducts.

Metabolic bone disease: disease of the bone caused by disruption of a normal metabolic pathway because of a genetically determined enzyme defect.

Multivisceral: many organs, especially of the abdomen.

Necrotizing: changes indicative of cell death caused by progressive deteriorating action of enzymes, affecting groups of cells or part of a structure or organ.

Parenteral nutrition: nutrition administered by injection by a route other than orally, such as subcutaneous, intramuscular, intravenous, etc.

Volvulus: intestinal obstruction due to knotting or twisting of the bowel.

RELATED GUIDELINES:

Liver Transplant, 02-40000-20
Small Bowel, Liver and Multivisceral Transplant, 02-40000-19

OTHER:

None Applicable.

REFERENCES:

  1. American Gastroenterological Association medical position statement: Short Bowel Syndrome and Intestinal Transplantation. Gastroenterology 2003 Apr; 124(4): 1105-10 (reviewed annually). (Accessed 05/23/14).
  2. American Society of Transplantation position statements. Accessed 05/27/10.
  3. Benedetti E, Holterman M, Asolati M, Di Domenico S, Oberholzer J, Sankary H, Abcarian H, Testa G. Living related segmental bowel transplantation: from experimental to standardized procedure. Ann Surg. 2006 Nov;244(5):694-9.
  4. Blue Cross Blue Shield Association Medical Policy – Small Bowel Transplant 7.03.04, December 2013.
  5. Blue Cross Blue Shield Association TEC Assessments (1995, Tab # 27; 1999, Tab # 9).
  6. Centers for Medicare & Medicaid Services (CMS) Medicare Program Memorandum Transmittal AB-00-58, Intestinal Transplantation (04/12/01).
  7. Centers for Medicare & Medicaid Services (CMS), National Coverage Determination for Intestine/Multivisceral Transplants, Publication 100-3, Section 260.5 (05/11/06). (Accessed 05/22/14).
  8. Centers for Medicare & Medicaid Services (CMS), Program Memorandum, Transmittal AB-02-040, Change Request 1629 (03/27/02).
  9. ECRI Windows to Medical Technology. “Intestine and Intestine-Liver Transplantation: Update” (04/00)
  10. Fine RN. Growth following solid organ transplantation in childhood. CLINICS 2014;69(S1):3-7.
  11. HAYES, Inc. Medical Technology Directory: Small Bowel Transplantation (02/01) Lansdale, PA: Hayes, Inc; update report 05/01/03.
  12. HAYES, Inc. Medical Technology Directory; Small Bowel-Liver and Multivisceral Transplants. Lansdale, PA: Hayes, Inc; (02/28/05; updated 04/10/08.)
  13. Hilmi IA, Planinsic RM, Nicolau-Raducu R, Damian D, Al-Khafaji A, Sakai T, Abu-Elmagd K. Isolated small bowel transplantation outcomes and the impact of immunosuppressants: Experience of a single transplant center. World J Transplant. 2013 Dec 24;3(4):127-33.
  14. Intestinal Transplant Association (ITA), Information for Patients and Families: Suitability to be Considered for Intestinal Transplant, accessed at intestinaltransplantassociation.com 05/27/10.
  15. Mazariegos GV, Steffick DE, Horslen S, et al, Intestine Transplantation in the United States, 1999-2008, American Journal of Transplantation 2010; 10(Part 2): 1020-1034. (Accessed 05/24/14).
  16. National Digestive Diseases Information Clearing House How is short bowel syndrome treated? February 2009.
  17. O'Keefe SJ, Buchman AL, Fishbein TM, et al. Short bowel syndrome and intestinal failure: consensus definitions and overview. Clin Gastroenterol Hepatol 2006; 4(1): 6-10.
  18. Organ Procurement and Transplantation Network. Organ Datasource: Intestine. Accessed at http://optn.transplant.hrsa.gov/latestData/viewDataReports.asp on 05/23/14.
  19. Organ Procurement and Transplantation Network. Policy Management. Accessed at http://optn.transplant.hrsa.gov/policiesAndBylaws/policies.asp on 05/23/14.
  20. Suki Subramanian, MD. Small Bowel Transplantation for the Treatment of Crohn’s Disease. Gastroenterol Hepatol (N Y). Aug 2012; 8(8): 545–547.
  21. Testa G, Panaro F, Schena S, Holterman M, Abcarian H, Benedetti E. Living related small bowel transplantation: donor surgical technique. Ann Surg. 2004 Nov;240(5):779-84.
  22. United Network of Organ Sharing (UNOS) policy. Intestinal Organ Allocation. Updated 06/02/08. Accessed 05/26/10.
  23. Yildiz BD. Where are we at with short bowel syndrome and small bowel transplant. World J Transplant. 2012 Dec 24;2(6):95-103.

COMMITTEE APPROVAL:

This Medical Coverage Guideline (MCG) was approved by the BCBSF Medical Policy & Coverage Committee on 06/26/14.

GUIDELINE UPDATE INFORMATION:

07/15/01

Medical Coverage Guideline reformatted.

03/15/02

Medical Coverage Guideline reviewed – no changes.

04/15/03

Reviewed; no changes.

04/15/04

Scheduled review; added investigational statement for small bowel transplants in HIV-positive recipients; formatting changes.

01/01/05

HCPCS coding update: added 44137, 44715, 44720, and 44721.

04/15/05

Scheduled review; no change in coverage statement.

06/15/05

Revision of guideline, consisting of removal of investigational statement regarding HIV-positive recipients.

06/15/06

Scheduled review; no change in coverage statement.

06/15/07

Scheduled review; reformatted guideline; updated references.

07/15/08

Scheduled review; add intestinal failure language to position statement. Update references.

07/15/09

Scheduled review; no change in position statement. Update references.

07/15/10

Annual review: position statements maintained and references updated.

10/15/10

Revision; related ICD-10 codes added.

07/15/14

Scheduled review. Revised MCG title, description, position statement, CPT coding, program exceptions, and definitions. Updated references.

Date Printed: December 18, 2017: 03:22 PM