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| Medical Policy: | S-127-012 |
| Topic: | Solitary Pancreas Transplantation |
| Section: | Surgery |
| Effective Date: | February 27, 2017 |
| Issue Date: | July 23, 2018 |
| Last Reviewed: | July 2018 |
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This policy is designed to address medical guidelines that are appropriate for the majority of individuals with a particular disease, illness, or condition. Each person's unique clinical circumstances may warrant individual consideration, based on review of applicable medical records.
| Policy Position Coverage is subject to the specific terms of the member’s benefit plan. |
A solitary pancreas transplant may be considered medically necessary when the following criteria are met:
- Pancreas transplant after a prior kidney transplant (PAK) for patients with insulin dependent diabetes; or
- Pancreas transplant alone (PTA) for patients with severely disabling and potentially life-threatening complications due to hypoglycemia unawareness and labile insulin dependent diabetes that persists in spite of optimal medical management.
If patients has type 2 diabetes mellitus, must be insulin-dependent and have body mass index equal to or less than 32.
The following pancreas transplants are considered experimental/investigational and, therefore, not covered, due to the lack of evidence based literature:
- living donor pancreas transplantation:
- partial pancreas transplantation; or
- segmental pancreas transplantation
Relative contraindications for pancreas transplantation include, but not limited to the following:
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Known current malignancy, including any metastatic cancer; or
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Recent malignancy with high risk of recurrence; or
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Ongoing or recurring infections that are not effectively treated; or
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Serious cardiac or other ongoing insufficiencies that create an inability to tolerate transplant surgery; or
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Demonstrated patient noncompliance, which places the organ at risk by not adhering to medical recommendations; or
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Potential complications from immunosuppressive medications are unacceptable to the patient; or
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AIDS (diagnosis based on CDC definition of CD4 count, 200 cells/mm³) unless the following are noted:
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CD4 count greater than 200 cells/mm³ for greater than six (6) months; or
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HIV-1 RNA undetectable; or
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On stable anti-retroviral therapy greater than three (3) months; or
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No other complications from AIDS (e.g., opportunistic infection, including aspergillus, tuberculosis, coccidioidomycosis, resistant fungal infections, Kaposi’s sarcoma or other neoplasm).
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Systemic disease that could be exacerbated by immunosuppression; or
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Psychosocial conditions or chemical dependency affecting ability to adhere to therapy.
Documentation demonstrating medical necessity and a clear reason to circumvent these contraindications will be required with evaluation of this service.
Retransplantation
Pancreas retransplant (PRTx) after a failed primary pancreas transplant may be considered medically necessary provided the individual meets the transplant criteria above.
Also, a third or subsequent pancreas transplant is considered not medically necessary in all cases.
See Medical Policy Bulletin S-126 for information on simultaneous Pancreas/Kidney transplantation (SPK).
See Medical Policy Bulletin S-124 for information on Kidney Transplantation.
See Medical Policy Bulletin E-42 for information on artificial pancreas device systems.
| Place of Service: Inpatient |
| The policy position applies to all commercial lines of business |
| Denial Statements |
Services that do not meet the criteria of this policy will not be considered medically necessary. A network provider cannot bill the member for the denied service unless: (a) the provider has given advance written notice, informing the member that the service may be deemed not medically necessary; (b) the member is provided with an estimate of the cost; and (c) the member agrees in writing to assume financial responsibility in advance of receiving the service. The signed agreement must be maintained in the provider’s records.
Services that do not meet the criteria of this policy will be considered experimental/investigational (E/I). A network provider can bill the member for the experimental/investigational service. The provider must give advance written notice informing the member that the service has been deemed E/I. The member must be provided with an estimate of the cost and the member must agree in writing to assume financial responsibility in advance of receiving the service. The signed agreement must be maintained in the provider’s records.
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Medical policies do not constitute medical advice, nor are they intended to govern the practice of medicine. They are intended to reflect Highmark's reimbursement and coverage guidelines. Coverage for services may vary for individual members, based on the terms of the benefit contract.
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The Claims Administrator/Insurer complies with applicable Federal civil rights laws and does not discriminate on the basis of race, color, national origin, age, disability, or sex. The Claims Administrator/Insurer does not exclude people or treat them differently because of race, color, national origin, age, disability, or sex. The Claims Administrator/ Insurer:
- Provides free aids and services to people with disabilities to communicate effectively with us, such as:
- Qualified sign language interpreters
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- Provides free language services to people whose primary language is not English, such as:
- Qualified interpreters
- Information written in other languages
If you believe that the Claims Administrator/Insurer has failed to provide these services or discriminated in another way on the basis of race, color, national origin, age, disability, or sex, you can file a grievance with: Civil Rights Coordinator, P.O. Box 22492, Pittsburgh, PA 15222, Phone: 1-866-286-8295, TTY: 711, Fax: 412-544-2475, email: CivilRightsCoordinator@highmarkhealth.org. You can file a grievance in person or by mail, fax, or email. If you need help filing a grievance, the Civil Rights Coordinator is available to help you.
You can also file a civil rights complaint with the U.S. Department of Health and Human Services, Office for Civil Rights electronically through the Office for Civil Rights Complaint Portal, available at https://ocrportal.hhs.gov/ocr/portal/lobby.jsf, or by mail or phone at:
U.S. Department of Health and Human Services
200 Independence Avenue, SW
Room 509F, HHH Building
Washington, D.C. 20201
1-800-368-1019, 800-537-7697 (TDD)
Complaint forms are available at http://www.hhs.gov/ocr/office/file/index.html.
Insurance or benefit/claims administration may be provided by Highmark, Highmark Choice Company, Highmark Coverage Advantage, Highmark Health Insurance Company, First Priority Life Insurance Company, First Priority Health, Highmark Benefits Group, Highmark Select Resources, Highmark Senior Solutions Company or Highmark Senior Health Company, all of which are independent licensees of the Blue Cross and Blue Shield Association, an association of independent Blue Cross and Blue Shield plans.
Highmark retains the right to review and update its medical policy guidelines at its sole discretion. These guidelines are the proprietary information of Highmark. Any sale, copying or dissemination of the medical policies is prohibited; however, limited copying of medical policies is permitted for individual use.
