Pancreas Transplant

Policy ID: S-127-018

Section: Surgery

Effective Date: July 01, 2018

Revised Date: December 27, 2023

Revision Effective Date: March 04, 2024

Last Reviewed: January 16, 2024

Applies To: Commercial and Medicaid Expansion

Description

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

Criteria

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

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

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 re-transplant after a failed primary pancreas transplant may be considered medically necessary in individuals who meet criteria for pancreas transplantation.

Pancreas transplant not meeting the criteria as indicated in this policy is considered not medically necessary.

In addition to the above criteria and subject to the discretion of the transplant center, a Hepatitis C Virus (HCV) positive donor organ maybe considered an acceptable organ option for an HCV negative adult recipient 18 years of age or older.

Procedure Codes

48550

48551

48552

48554

48556

48999

50300

50320

50323

50325

50327

50328

50329

50340

50360

50365

50370

50380

50547

S2065

General Criteria

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

Known current malignancy, including metastatic cancer; or
Recent malignancy with high risk of recurrence; or
Untreated systemic infection making immunosuppression unsafe, including chronic infection; or
Other irreversible end-stage diseases not attributed to kidney disease; or
History of cancer with a moderate risk of recurrence; or
Systemic disease that could be exacerbated by immunosuppression; or
Psychosocial conditions or chemical dependency affecting the ability to adhere to therapy; or
Human Immunodeficiency virus (HIV) disease unless ALL of the following are noted:
- CD4 count greater than 200 cells/mm; and
- Undetectable HIV-1 ribonucleic acid (RNA) viral load; and
- Three (3) or more months of stable anti-retroviral therapy; and
- Absence of opportunistic infections (e.g., aspergillus, tuberculosis, coccidiodi, other resistant fungal infections) or neoplasms (e.g., Kaposi's sarcoma) associated with HIV disease.

Pancreas-Specific Criteria

Candidates for pancreas transplant alone should also meet ONE of the following severities 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. Those transplant candidates with type 2 diabetes, in addition to being insulin-dependent, should also not be obese (body mass index should be Less than or equal to 32 kg/m ² ).

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 re-transplant 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 crossmatch. Some transplant centers may wait to allow reconstitution of the immune system before initiating re-transplant with an augmented immunosuppression protocol.

Diagnosis Codes

Covered Diagnosis Codes for Procedure Codes 48550, 48551, 48552, 48554, 48556, 48999, S2065

E10.8

E10.10

E10.11

E10.21

E10.22

E10.29

E10.36

E10.39

E10.40

E10.41

E10.42

E10.43

E10.44

E10.49

E10.51

E10.52

E10.59

E10.65

E10.69

E10.311

E10.319

E10.610

E10.618

E10.620

E10.621

E10.622

E10.628

E10.630

E10.638

E10.641

E10.649

E10.3211

E10.3212

E10.3213

E10.3291

E10.3292

E10.3293

E10.3311

E10.3312

E10.3313

E10.3391

E10.3392

E10.3393

E10.3411

E10.3412

E10.3413

E10.3491

E10.3492

E10.3493

E10.3511

E10.3512

E10.3513

E10.3591

E10.3592

E10.3593

E11.8

E11.00

E11.01

E11.10

E11.11

E11.21

E11.22

E11.29

E11.36

E11.39

E11.40

E11.41

E11.42

E11.43

E11.44

E11.49

E11.51

E11.52

E11.59

E11.65

E11.69

E11.311

E11.319

E11.610

E11.618

E11.620

E11.621

E11.622

E11.628

E11.630

E11.638

E11.641

E11.649

E11.3211

E11.3212

E11.3213

E11.3291

E11.3292

E11.3293

E11.3311

E11.3312

E11.3313

E11.3391

E11.3392

E11.3393

E11.3411

E11.3412

E11.3413

E11.3491

E11.3492

E11.3493

E11.3511

E11.3512

E11.3513

E11.3591

E11.3592

E11.3593

E13.8

E13.21

E13.22

E13.29

E13.69

T86.890

T86.891

T86.892

T86.898

T86.899

Z79.4

Z90.5

Covered Diagnosis Codes for Procedure Codes: 50300, 50320, 50323, 50325, 50327, 50328, 50329, 50340, 50360, 50365, 50370, 50380, 50547

N18.4

N18.5

N18.6

N18.9

Professional Statements and Societal Positions Guidelines

Organ Procurement and Transplantation Network-2022

The Organ Procurement and Transplantation Network updated its comprehensive list of transplant-related policies, most recently in September 2022.

For pancreas registration:

'Each candidate registered on the pancreas waiting list must meet one of the following requirements:
- Be diagnosed with diabetes
- Have pancreatic exocrine insufficiency
- Require the procurement or transplantation of a pancreas as part of a multiple organ transplant for technical reasons.'
For combined kidney plus pancreas registration: 'Each candidate registered on the kidney-pancreas waiting list must be diagnosed with diabetes or have pancreatic exocrine insufficiency with renal insufficiency.'

The American Society of Transplantation-2017

The American Society of Transplantation (2017) convened a consensus conference of experts to address issues related to the transplantation of hepatitis C virus (HCV) non-viremic recipients. Key findings and recommendations are:

Definition of HCV positive
- HCV viremic reflecting a positive NAT should be adopted Data interpretation
Data interpretation
- HCV antibody status alone limits interpretation of outcomes of transplantation of HCV 'positive' organs
Transmission and Treatment
- Highest risk for unexpected HCV transmission is associated with organ donation from a person who injected drugs within the eclipse or pre-viremic period
OPTN policy
- No current policies prevent transplantation of HCV-viremic organs into HCV non-viremic recipients
Ethical considerations
- Transplantation of HCV-viremic organs into HCV non-viremic recipients should be conducted under site specific IRB approved protocols with multi-step informed consent.

ND Committee Review

Internal Medical Policy Committee 1-19-2021 Multiple changes:

Title Change,
Multiple revisions throughout the policy;
Added multiple new procedure codes,
Added additional Diagnosis codes.

Internal Medical Policy Committee 1-20-2022 Annual Review

Internal Medical Policy Committee 11-29-2022 Policy reviewed.

Internal Medical Policy Committee 11-15-2023 Annual Review - no changes in criteria

Internal Medical Policy Committee 1-16-2024 Revision - Effective March 04, 2024

Added criteria for HIV; and
Updated references.

Links

References (PDF)

Disclaimer

Current medical policy is to be used in determining a Member's contract benefits on the date that services are rendered. Contract language, including definitions and specific inclusions/exclusions, as well as state and federal law, must be considered in determining eligibility for coverage. Members must consult their applicable benefit plans or contact a Member Services representative for specific coverage information. Likewise, medical policy, which addresses the issue(s) in any specific case, should be considered before utilizing medical opinion in adjudication. Medical technology is constantly evolving, and the Company reserves the right to review and update medical policy periodically.

Policy ID: S-127-017

Section: Surgery

Effective Date: July 01, 2018

Revised Date: January 25, 2021

Revision Effective Date: March 01, 2021

Last Reviewed: November 15, 2023

Archived Date: March 03, 2024

Applies To: Commercial and Medicaid Expansion

Description

Criteria

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

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

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

Pancreas transplant not meeting the criteria as indicated in this policy is considered not medically necessary.

Procedure Codes

48550

48551

48552

48554

48556

48999

50300

50320

50323

50325

50327

50328

50329

50340

50360

50365

50370

50380

50547

S2065

General Criteria

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

Known current malignancy, including metastatic cancer; or
Recent malignancy with high risk of recurrence; or
Untreated systemic infection making immunosuppression unsafe, including chronic infection; or
Other irreversible end-stage diseases not attributed to kidney disease; or
History of cancer with a moderate risk of recurrence; or
Systemic disease that could be exacerbated by immunosuppression; or
Psychosocial conditions or chemical dependency affecting the ability to adhere to therapy.

Pancreas-Specific Criteria

Candidates for pancreas transplant alone should also meet ONE of the following severities 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.

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 re-transplant 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 crossmatch. Some transplant centers may wait to allow reconstitution of the immune system before initiating re-transplant with an augmented immunosuppression protocol.

Diagnosis Codes

Covered Diagnosis Codes for Procedure Codes 48550, 48551, 48552, 48554, 48556,48999, S2065

E10.8

E10.10

E10.11

E10.21

E10.22

E10.29

E10.36

E10.39

E10.40

E10.41

E10.42

E10.43

E10.44

E10.49

E10.51

E10.52

E10.59

E10.65

E10.69

E10.311

E10.319

E10.610

E10.618

E10.620

E10.621

E10.622

E10.628

E10.630

E10.638

E10.641

E10.649

E10.3211

E10.3212

E10.3213

E10.3291

E10.3292

E10.3293

E10.3311

E10.3312

E10.3313

E10.3391

E10.3392

E10.3393

E10.3411

E10.3412

E10.3413

E10.3491

E10.3492

E10.3493

E10.3511

E10.3512

E10.3513

E10.3591

E10.3592

E10.3593

E11.8

E11.00

E11.01

E11.10

E11.11

E11.21

E11.22

E11.29

E11.36

E11.39

E11.40

E11.41

E11.42

E11.43

E11.44

E11.49

E11.51

E11.52

E11.59

E11.65

E11.69

E11.311

E11.319

E11.610

E11.618

E11.620

E11.621

E11.622

E11.628

E11.630

E11.638

E11.641

E11.649

E11.3211

E11.3212

E11.3213

E11.3291

E11.3292

E11.3293

E11.3311

E11.3312

E11.3313

E11.3391

E11.3392

E11.3393

E11.3411

E11.3412

E11.3413

E11.3491

E11.3492

E11.3493

E11.3511

E11.3512

E11.3513

E11.3591

E11.3592

E11.3593

E13.8

E13.21

E13.22

E13.29

E13.69

T86.890

T86.891

T86.892

T86.898

T86.899

Z79.4

Z90.5

Covered Diagnosis Codes for Procedure Codes: 50300, 50320, 50323, 50325, 50327, 50328, 50329, 50340, 50360, 50365, 50370, 50380, 50547

N18.4

N18.5

N18.6

N18.9

Professional Statements and Societal Positions Guidelines

Organ Procurement and Transplantation Network-2020

The Organ Procurement and Transplantation Network updated its comprehensive list of transplant-related policies, most recently in July 2020.

For pancreas registration:

“Each candidate registered on the pancreas waiting list must meet one of the following requirements:
- Be diagnosed with diabetes
- Have pancreatic exocrine insufficiency
- Require the procurement or transplantation of a pancreas as part of a multiple organ transplant for technical reasons."
For combined kidney plus pancreas registration: "Each candidate registered on the kidney-pancreas waiting list must be diagnosed with diabetes or have pancreatic exocrine insufficiency with renal insufficiency."

The American Society of Transplantation-2017

Definition of HCV positive
- HCV viremic reflecting a positive NAT should be adopted Data interpretation
Data interpretation
- HCV antibody status alone limits interpretation of outcomes of transplantation of HCV "positive" organs
Transmission and Treatment
- Highest risk for unexpected HCV transmission is associated with organ donation from a person who injected drugs within the eclipse or pre-viremic period
OPTN policy
- No current policies prevent transplantation of HCV-viremic organs into HCV non-viremic recipients
Ethical considerations
- Transplantation of HCV-viremic organs into HCV non-viremic recipients should be conducted under site specific IRB approved protocols with multi-step informed consent.

ND Committee Review

Internal Medical Policy Committee 1-19-2021 Multiple changes:

Title Change,
Multiple revisions throughout the policy;
Added multiple new procedure codes,
Added additional Diagnosis codes.

Internal Medical Policy Committee 1-20-2022 Annual Review

Internal Medical Policy Committee 11-29-2022 Policy reviewed.

Internal Medical Policy Committee 11-15-2023 Annual Review - no changes in criteria

Links

References (PDF)

Disclaimer

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