Allogeneic Pancreas Transplant

POLICY NUMBER

A.7.03.02

DESCRIPTION

Transplantation of a healthy pancreas is a treatment for patients with insulin-dependent diabetes. Pancreas transplantation can restore glucose control and prevent, halt, or reverse the secondary complications from diabetes.

Solid Organ Transplantation

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 Organ Procurement and Transplantation Network and United Network of Organ Sharing.

Allogeneic Pancreas Transplant

In 2023, 46,630 transplants were performed in the United States procured from more than16,000 deceased donors and 6,900 living donors. Pancreas-kidney transplants were the fifth most common procedure, with 812 transplants performed in 2023. Pancreas-alone transplants were the sixth most common procedure, with 102 transplants performed in 2023.

Pancreas transplantation occurs in several different scenarios such as 1) a diabetic patient with renal failure who may receive a simultaneous cadaveric pancreas plus kidney transplant; 2) a diabetic patient who may receive a cadaveric or living-related pancreas transplant after a kidney transplantation (pancreas after kidney); or 3) a non-uremic diabetic patient with specific severely disabling and potentially life-threatening diabetic problems who may receive a pancreas transplant alone.

Data from the United Network for Organ Sharing and the International Pancreas Transplant Registry indicate that the proportion of simultaneous pancreas plus kidney transplant recipients worldwide who have type 2 diabetes has increased over time, from 6% of transplants between 2005 and 2009 to 9% of transplants between 2010 and 2014. Between 2010 and 2014, approximately 4% of pancreas after kidney transplants and 4% of pancreas alone transplants were performed in patients with type 2 diabetes. In 2022, patients with type 2 diabetes accounted for 22.4% of all pancreas transplants, according to data from the Organ Procurement and Transplantation Network and the Scientific Registry of Transplant Recipients.

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

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.

A combined pancreas-kidney transplant may be considered medically necessary in insulin-dependent diabetic individuals with uremia.

Pancreas transplant after a prior kidney transplant may be considered medically necessary in individuals with insulin-dependent diabetes.

Pancreas transplant alone may be considered medically necessary in individuals with severely disabling and potentially life-threatening complications due to hypoglycemia unawareness and labile insulin-dependent diabetes that persists despite optimal medical management.

Pancreas retransplant after a failed primary pancreas transplant may be considered medically necessaryin individuals who meet criteria for pancreas transplantation.

Pancreas transplant is considered investigational in all other situations.

POLICY EXCEPTIONS

Patients with peripheral neuropathy and severely disabling and potentially life-threatening complications due to Type I diabetes that persists in spite of optimal medical management will be considered on an individual basis for a solitary pancreas transplant. These potential candidates for pancreas transplant alone (PTA) should have documentation of potentially life-threatening labile diabetes as evidenced by chart notes or hospitalization for diabetic ketoacidosis.

The determination will be made through the peer review process (which includes, but is not limited to the review of peer reviewed literature, second opinions and administrative policy in existence at the time of the request for the procedure).

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.

General CriteriaPotential contraindications for solid organ transplant that are subject to the judgment of the transplant center include the following:

1. Known current malignancy, including metastatic cancer

2. Recent malignancy with high risk of recurrence

3. Untreated systemic infection making immunosuppression unsafe, including chronic infection

4. Other irreversible end-stage diseases not attributed to kidney disease

5. History of cancer with a moderate risk of recurrence

6. Systemic disease that could be exacerbated by immunosuppression

7. Psychosocial conditions or chemical dependency affecting ability to adhere to therapy.

Pancreas-Specific Criteria

Candidates for pancreas transplant alone should also meet one of the following severity of illness criteria:

• Documented severe hypoglycemia unawareness as evidenced by chart notes or emergency department visits; OR

• Documented potentially life-threatening labile diabetes, as evidenced by chart notes or hospitalization for diabetic ketoacidosis.

Additionally, most pancreas transplant individuals will have type 1 diabetes. In 2022, individuals with type 2 diabetes accounted for 22.4% of all pancreas transplants, according to data from the Organ Procurement and Transplantation Network and the Scientific Registry of Transplant Recipients.

Multiple Transplant Criteria

Although there are no standard guidelines for multiple pancreas transplants, the following information may aid in case review:

• If there is early graft loss resulting from technical factors (e.g., venous thrombosis), a retransplant may generally be performed without substantial additional risk.

• Long-term graft losses may result from chronic rejection, which is associated with increased risk of infection following long-term immunosuppression, and sensitization, which increases the difficulty of finding a negative cross-match. Some transplant centers may wait to allow reconstitution of the immune system before initiating retransplant with an augmented immunosuppression protocol.

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).

2/14/2002: Investigational definition added, table added to Code Reference section.

5/2/2002: Type of Service and Place of Service deleted.

10/18/2005: Policy section updated; "Absence of HIV infection" deleted; added "HIV positivity is not an absolute contraindication to transplant. Each individual transplant center will determine patient selection criteria for HIV positive patients (7/21/2005)"; Code Reference table updated: CPT codes 48551, 48552, 48556 added; ICD-9 procedure code 00.93 added; HCPCS codes S2065, S2152 added; diagnosis codes 250-250.92, V58.67 added, 250.11, 250.13, 250.21, 250.23, 250.31, 250.41, 250.43, 250.51, 250.61, 250.63, 250.71, 250.73, 250.81, 250.83, 251.0, 251.1, 251.2 deleted.

11/8/2005: Code Reference section updated, 4^th digit added to ICD9 diagnosis codes 585.1 - 585.9; description revised.

3/13/2006: Coding updated. CPT4/HCPCS 2006 revisions added to policy.

10/23/2006: Policy reviewed, policy section re-written for clarity.

2/22/2008: Removed the following policy statement: "Pancreas retransplant after 2 or more prior failed pancreas transplants is considered investigational." No other changes made to policy statements. Code Reference section reviewed. Removed ICD-9 codes 250.00, 250.02, 250.50, 250.52, 250.60, 250.62, 250.70, and 250.72. Added ICD-9 codes 250.11, 250.13, 250.21, 250.23, 250.31, 250.33, 250.41, 250.43, 250.81, 250.83, 250.91, 250.93, and 996.86. "Allogeneic" added to policy title.

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

05/09/2011: Policy description updated regarding the number and success of pancreas transplants. "Insulin dependent" added to the first policy statement. Policy statement added to state when pancreas transplant is considered not medically necessary. Policy guidelines updated regarding candidates for pancreas transplant.

05/08/2012: Deleted the not medically necessary policy statement, which stated the following: Pancreas transplant is considered not medically necessary in patients with the following conditions: 1. Known current malignancy, including metastatic cancer; 2. Recent malignancy with high risk of recurrence; 3. Untreated systemic infection making immunosuppression unsafe, including chronic infection; or 4. Other irreversible end-stage disease not attributed to kidney or pancreatic disease. "Insulin dependent" added to the third policy statement. Policy guidelines updated regarding contraindications to transplant.

04/16/2013: Policy reviewed; no changes.

03/17/2014: Policy reviewed; no changes.

03/16/2015: Policy description updated to add pancreas transplant alone (PTA) information. Medically necessary statement revised to state that a pancreas retransplant after a failed primary pancreas transplant may be considered medially necessary in patients who meet criteria for pancreas transplantation. Added the following statement: Pancreas transplant is considered investigational in all other situations.

08/25/2015: Code Reference section updated for ICD-10.

06/01/2016: Policy number A.7.03.02 added. Policy Guidelines updated to add medically necessary and investigative definitions.

09/18/2017: Policy description updated regarding PTA and FDA regulations. Policy statements unchanged. Policy Guidelines updated regarding data from the International Pancreas Transplant Registry.

09/29/2017: Code Reference section updated to add new ICD-10 diagnosis codes E11.10 and E11.11. Effective 10/01/2017.

08/27/2018: Policy description updated regarding data for transplants performed in 2017. Added information regarding FDA regulation. Policy statements unchanged.

09/11/2019: Policy description revised. Policy statements unchanged.

09/30/2020: Policy description updated regarding solid organ transplantation and data for allogeneic pancreas transplants. Policy statements unchanged. Policy Guidelines updated regarding data for pancreas transplants. Code Reference section updated to add new ICD-10 diagnosis codes N18.30, N18.31, and N18.32, effective 10/01/2020.

12/10/2021: Policy description updated regarding transplant data for patients with Type 2 diabetes. Policy statements unchanged. Policy Guidelines updated to change "Nervous/Mental Conditions" to "Mental Health Disorders" and "Medically Necessary" to "medical necessity." Code Reference section updated to remove deleted ICD-10 diagnosis code N18.3.

10/18/2022: Policy description updated regarding new data for transplants. Policy statements updated to change "patients" to "individuals" and "diabetes mellitus" to "diabetes." Policy Guidelines updated with minor changes. Code Reference section updated to change "Covered Codes" to "Medically Necessary Codes."

10/05/2023: Policy description updated regarding new data for transplants. Policy statements unchanged.

10/22/2024: Policy description updated regarding new data for transplants. Policy statements unchanged. Policy Guidelines updated to remove obesity-related criteria and to update information regarding pancreas transplants.

SOURCE(S)

1. Blue Cross Blue Shield Association policy #7.03.02

2. Hayes Medical Technology Directory

3. TEC Assessments 1998: TBD

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.

Medically Necessary Codes

CPT copyright American Medical Association. All rights reserved. CPT is a registered trademark of the American Medical Association.