Isolated Small Bowel Transplant

POLICY NUMBER

A.7.03.04

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 patients with short bowel syndrome. Small bowel/liver transplants and multivisceral transplants are considered in the  Small Bowel/Liver and Multivisceral Transplant  medical policy.

Solid Organ Transplant

Solid organ transplantation offers a treatment option for patients with different types of end-stage organ failure that can be lifesaving or provide significant improvements to a patient’s quality of life. Many advances have been made in the last several decades to reduce perioperative complications. Available data supports improvement in long-term survival as well as improved quality of life particularly for liver, kidney, pancreas, heart, and lung transplants. Allograft rejection remains a key early and late complication risk for any organ transplantation. Transplant recipients require life-long immunosuppression to prevent rejection. Patients are prioritized for transplant by mortality risk and severity of illness criteria developed by the Organ Procurement and Transplantation Network (OPTN) and United Network of Organ Sharing (UNOS).

Short Bowel Syndrome

Short bowel syndrome 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 the small intestine. The spectrum of clinical disease is widely variable from only single micronutrient malabsorption to complete intestinal failure, defined as the reduction of gut function below the minimum necessary for the absorption of macronutrients and/or water and electrolytes. In adults, etiologies of short bowel syndrome include ischemia, trauma, volvulus, and tumors. In children, gastroschisis, volvulus, necrotizing enterocolitis, and congenital atresia are predominant causes. Although the actual prevalence of short bowel syndrome is not clear primarily due to under-reporting and a lack of reliable patient databases, its prevalence is estimated to be 30 cases per million in the U.S.

TreatmentThe small intestine, particularly the ileum, can 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 focuses on achieving adequate macro- and micronutrient 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 patients with short bowel syndrome are unable to obtain adequate nutrition from enteral feeding and become chronically dependent on total parenteral nutrition (TPN). For patients with short bowel syndrome, the rate of parenteral nutrition dependency at 1, 2, and 5 years has been reported to be 74%, 64%, and 48%, respectively. Patients with complications from TPN may be considered candidates for a small bowel transplant. Complications include catheter-related mechanical problems, infections, hepatobiliary disease, and metabolic bone disease. While cadaveric intestinal transplant is the most commonly performed transplant, there has been recent interest in using living donors.

Intestinal transplants (including multivisceral and bowel/liver) represent a small minority of all solid organ transplants. In 2023, 95 intestinal transplants were performed in the United States. The number of new patients added to the intestinal transplant waiting list as of 6/27/2024 was 192.

Solid organ transplants are a surgical procedure and, as such, are not subject to regulation by the U.S. Food and Drug Administration.

The U.S. Food and drug Administration regulates human cells and tissues intended for implantation, transplantation, or infusion through the Center for Biologics Evaluation and Research, under Code of Federal Regulation Title 21, parts 1270 and 1271. Solid organs used for transplantation are subject to these regulations.

POLICY

No benefits will be provided for a covered transplant procedure unless the Member receives prior authorization through case management from Blue Cross & Blue Shield ofMississippi.

Small Bowel Transplant coverage is as follows:

1. Small Bowel Transplant using a cadaveric intestine may be considered medically necessary 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), who have established long-term dependence on total parenteral nutrition (TPN) and are developing or have developed severe complications due to TPN.

2. A Small Bowel Transplant is considered investigational for adult and pediatric individuals with intestinal failure who are able to tolerate TPN.

3. Small Bowel Transplant using living donors may be considered medically necessaryonly when a cadaveric intestine is not available for transplantation in an individual who meets the criteria noted above for a cadaveric intestinal transplant.

4. Small bowel transplant using living donors is considered investigational in all other situations.

5. A small bowel retransplant may be considered medically necessary after a failed primary small bowel transplant.

HIV positivity is not an absolute contraindication to transplant. Each individual transplant center will determine patient selection criteria for HIV positive patients.

The Following may be used as a Guideline for Patient Selection Criteria:

Coverage is not provided for:

• Services for which the cost is covered/funded by governmental, foundation, or charitable grants

• Organs sold rather than donated to the recipient

• An artificial organ

POLICY EXCEPTIONS

None

POLICY GUIDELINES

The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.

Potential contraindications for solid organ transplant subject to the judgment of the transplant center include the following:

• Known current malignancy, including metastatic cancer

• Recent malignancy with a high risk of recurrence

• Untreated systemic infection making immunosuppression unsafe, including chronic infection

• Other irreversible end-stage diseases 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.

Small Bowel-Specific Criteria

Intestinal failure results from surgical resection, congenital defect, or disease-associated loss of absorption and is characterized by the inability to maintain protein-energy, fluid, electrolyte, or micronutrient balance. Short-bowel syndrome is one cause of intestinal failure.

Individuals who are developing or have developed severe complications due to total parenteral nutrition (TPN) include, but are not limited to, the following: multiple and prolonged hospitalizations to treat TPN-related complications (especially repeated episodes of catheter-related sepsis) or the development of progressive liver failure. In the setting of progressive liver failure, small bowel transplant may be considered a technique to avoid end-stage liver failure related to chronic TPN, thus avoiding the necessity of a multivisceral transplant. In those receiving TPN, liver disease with jaundice (total bilirubin >3 mg/dL) is often associated with the development of irreversible, progressive liver disease. The inability to maintain venous access is another reason to consider small bowel transplant in those who are dependent on TPN.

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 Mental Health Disorders, 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 medical necessity, “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.

POLICY HISTORY

8/1998: Approved by Medical Policy Advisory Committee (MPAC).

1/17/2001: Code reference section updated.

5/2001: Reviewed by MPAC; changed to investigational status.

7/16/2001: Policy exception for FEP added.

8/2001: Reviewed by MPAC; medically necessary indication added.

2/13/2002: Investigational definition added, Prior written approval added.

3/6/2002: Prior authorization through case management added.

5/7/2002: Type of Service and Place of Service deleted.

5/28/2002: Code Reference section updated, CPT code range 44132-44136 listed separately.

7/21/2005: Policy updated: "HIV positivity is not an absolute contraindication to transplant. Each individual transplant center will determine patient selection criteria for HIV positive patients." added.

10/19/2005: Code Reference table updated: Non-Covered table added, CPT codes 44137, 44715, 44720, 44721 added to covered table, 44133, 44136 added to non-covered table, 44120, 44121, "with preparation and maintenance of allograft;" deleted; ICD-9 procedure codes 00.91, 00.92 added to non-covered table, 00.93 added to covered table.

12/31/2008: Policy reviewed, prior authorization of evaluation removed.

4/22/09: Policy reviewed, no changes.

12/07/2009: Policy Description Section revised as follows: Additional information on small bowel syndrome, living donors, and complications of small bowel transplants added. Link added to related policy, Small Bowel/Liver Transplants and Multivisceral Transplants. Policy Statement Section revised as follows: Evidence of impending end-stage liver failure removed from the medically necessary criteria for cadaveric small bowel transplants. Intestinal failure and developing or already developed severe complications due to TPN added to medically necessary criteria for cadaveric small bowel transplants. Added verbiage "with intestinal failure" to investigational criteria. Small bowel transplants from living donors changed from investigational to may be considered medically necessary only when cadaveric transplants are not available, but all other situations for small bowel transplants from living donors is considered not medically necessary. Guideline added for patient selection criteria. Non-coverage information added. Coding Section revised as follows: CPT4 codes 44133, 44136, and ICD9 procedure codes 00.91, 00.92 moved from Non-Covered Codes Table to Covered Codes Table. CPT4 code 44175 corrected to 44715. CPT4 code 44137 removed from Covered Codes Table. ICD9 procedure codes 46.62 and 45.63 added to Covered Codes Table. Non-Covered Codes Table removed. Verbiage added "*Some covered procedure codes may have multiple descriptions. Coverage will only be made for covered codes when used for services outlined within the policy statement section."

12/01/2011: Policy reviewed; no changes.

12/12/2012: Policy reviewed; no changes.

01/22/2014: Added the following policy statement: A small bowel retransplant may be considered medically necessary after a failed primary small bowel transplant.

10/30/2014: Added "Isolated" to the policy title. Pediatric patients added to the investigational policy statement on patients with intestinal failure who are able to tolerate TPN.

08/28/2015: Code Reference section updated for ICD-10. Removed outdated references from the Sources section.

02/15/2016: Policy description updated to add information regarding the small intestine and prognosis for recovery. Policy statements unchanged. Policy guidelines updated regarding intestinal failure and to add medically necessary and investigational definitions.

06/01/2016: Policy number A.7.03.04 added.

01/19/2017: Policy description updated regarding FDA regulation. Policy statements unchanged.

09/18/2017: Policy description updated regarding 2016 data. Policy statements unchanged.

08/27/2018: Policy description updated regarding FDA regulation of human cells and tissues. Policy statements unchanged.

09/12/2019: Policy reviewed; no changes.

09/11/2020: Policy description updated regarding solid organ transplantation and short bowel syndrome. Policy statements unchanged. Policy Guidelines updated regarding potential contraindications for solid organ transplant.

12/10/2021: Policy description updated regarding intestinal transplants. Policy statements unchanged. Policy Guidelines updated regarding patients with complications due to total parenteral nutrition. Changed "Nervous/Mental Conditions" to "Mental Health Disorders" and "Medically Necessary" to "medical necessity."

10/18/2022: Policy description updated regarding new data for intestinal transplants. Policy statements and Policy Guidelines updated to change "patients" to "individuals."

10/05/2023: Policy description updated regarding new data for transplants. Policy statement updated to change "not medically necessary" to "investigational."

10/18/2024: Policy description updated regarding intestinal transplants. Policy statements unchanged.

SOURCE(S)

1. Blue Cross Blue Shield Association policy # 7.03.05

2. Blue Cross Blue Shield Association policy # 7.03.04

CODE REFERENCE

This 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.

Covered Codes

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