Notification



Notification Issue Date:



Medicare Advantage Policy

Title:Solid Organ Transplantation and Procurement Cost of Organs and Tissues
Policy #:MA11.033b

This policy is applicable to the Company’s Medicare Advantage products only. Policies that are applicable to the Company’s commercial products are accessible via a separate commercial policy database.


The Company makes decisions on coverage based on the Centers for Medicare and Medicaid Services (CMS) regulations and guidance, benefit plan documents and contracts, and the member’s medical history and condition. If CMS does not have a position addressing a service, the Company makes decisions based on Company Policy Bulletins. Benefits may vary based on contract, and individual member benefits must be verified. The Company determines medical necessity only if the benefit exists and no contract exclusions are applicable. Although the Medicare Advantage Policy Bulletin is consistent with Medicare’s regulations and guidance, the Company’s payment methodology may differ from Medicare.

When services can be administered in various settings, the Company reserves the right to reimburse only those services that are furnished in the most appropriate and cost-effective setting that is appropriate to the member’s medical needs and condition. This decision is based on the member’s current medical condition and any required monitoring or additional services that may coincide with the delivery of this service.


This Policy Bulletin document describes the status of CMS coverage, medical terminology, and/or benefit plan documents and contracts at the time the document was developed. This Policy Bulletin will be reviewed regularly and be updated as Medicare changes their regulations and guidance, scientific and medical literature becomes available, and/or the benefit plan documents and/or contracts are changed.



Policy

Coverage is subject to the terms, conditions, and limitations of the member's Evidence of Coverage.

Solid organ transplants are considered medically necessary and, therefore, covered when performed on selected individuals who have severe diseases or irreversible organ damage and who meet the criteria established by United Network for Organ Sharing (UNOS)/Organ Procurement and Transplantation Network (OPTN) and Medicare when appropriate. The following organs are recognized as medically suitable for transplant consideration:
  • Heart
  • Heart--Lung
  • Intestinal (includes the esophagus, stomach, small or large intestine, or any portion of the gastrointestinal tract), and multivisceral (includes the stomach, duodenum, pancreas, liver, and intestine)
  • Kidney
  • Pancreas
  • Pancreas--Kidney
  • Liver
  • Liver--Kidney
  • Lung: Single/Double


Per the Organ Procurement and Transplant Network (OPTN), all multi-organ candidates must be registered on the waiting list for each required organ. The minimal acceptance criteria for each organ or multi-organ combinations must be met.

TRANSPLANT PROGRAM REQUIREMENTS

To the extent a facility operates any transplant programs, all such programs must be Medicare certified, and each program must be an Organ Procurement and Transplant Network (OPTN) member that has been certified by the United Network for Organ Sharing (UNOS), the organization that manages the nation's organ transplant system under contract with the federal government) or its successor entity. In the event that a transplant program does not have both Medicare and UNOS certification, any transplant services or transplant-related services (including pre- and post-transplant) provided by the program are considered non-covered services, and, therefore, not eligible for reimbursement.

** Pre- and post-transplant services related to a solid organ transplant include, but are not limited to, laboratory tests and radiology studies.

** Facilities performing multi-organ transplants must have a transplant program that is Medicare and UNOS certified for each organ involved, as multi-organ certification may not be available.

** Pediatric transplant programs are excluded from the Medicare certification. requirement for non-Medicare business.

COVERED TRANSPLANTS

Most Evidence of Coverage include coverage for all of the above transplants. In the absence of explicit exclusions, the transplants listed above are available under the member's Evidence of Coverage.

MEMBER AND NONMEMBER INFORMATION

A living organ donation to a Medicare transplant recipient, by a non-Medicare insured individual is covered under the Medicare medical benefit. These services include the donor's organ acquisition and procurement and inpatient stay. The donor of an organ for the Medicare transplant recipient is covered for an unlimited number of days of care in connection with the organ removal. Follow-up examinations may be covered up to 6 months following the donation of the organ, to monitor for possible complications.

TRAVEL EXPENSES

Travel and living expenses that are associated with an out-of-area transplant center, for either the donor or the recipient, are excluded from organ transplant coverage with the following exceptions:
  • Reasonable transportation and reasonable accommodations out of network, for a Medicare Advantage member, who is the recipient of the organ transplant and a companion are covered and eligible for reimbursement consideration by the Company when the transplant services are not available in-network, subject to Plan authorization.
    • However, if a Medicare Advantage member elects to receive transplant services out-of-network when the services are available in-network, the member is responsible for all associated travel expenses.
  • Travel expenses of the living donor related to the transplantation are not covered by the Company because it is a service not covered by Medicare. Therefore, it is not eligible for reimbursement consideration.

PSYCHIATRIC EVALUATIONS

Psychiatric evaluations that are performed prior to an organ transplant are covered under the member's medical benefit. Reimbursement for the evaluation is in accordance with the provider's contract.

PROCUREMENT COST OF CADAVER ORGAN AND TISSUE

All costs incurred during organ and tissue procurement are billed to regional donor program. The transplant recipient's transplant hospital will then reimburse the donor program for the procurement costs. In turn, the hospital is reimbursed by the recipient's insurance company.

SALE OF ORGANS FOR TRANSPLANTATION

If an organ is sold rather than donated to the recipient, no benefits are provided for the purchase price of the organ.

Medicare Advantage members must have transplants performed in a Medicare-approved facility. A list of Medicare-approved facilities is available on the Centers for Medicare and Medicaid Services (CMS) Web site at: http://www.cms.gov/Medicare/Provider-Enrollment-and-Certification/CertificationandComplianc/downloads/ApprovedTransplantPrograms.pdf.

REQUIRED DOCUMENTATION

The individual's medical record must reflect the medical necessity for the care provided. These medical records may include, but are not limited to: records from the professional provider's office, hospital, nursing home, home health agencies, therapies, and test reports.

The Company may conduct reviews and audits of services to our members, regardless of the participation status of the provider. All documentation is to be available to the Company upon request. Failure to produce the requested information may result in a denial for the service.
Policy Guidelines

This policy is consistent with Medicare's coverage determination. The Company's payment methodology may differ from Medicare.

BENEFIT APPLICATION

Subject to the terms and conditions of the applicable Evidence of Coverage, solid organ transplants are covered under the medical benefits of the Company’s Medicare Advantage products when the medical necessity criteria listed in this medical policy are met.

Description

ORGAN TRANSPLANTATION

Organ and tissue transplantation is a process by which the organ and tissue are excised from a live or cadaveric donor, then implanted in a recipient. Transplants are intended to prolong survival and improve the function of individuals with severe diseases or irreversible organ damage.

The term solid organ is used to distinguish bone marrow, stem cells, and similar tissues from partial and complete organs.

Solid organs for transplantation include the heart, lung, kidney, pancreas, liver, intestine, and stomach.

Organ and tissue transplantation is a process by which the organ and tissue are excised from a living or cadaveric donor, then implanted in a recipient. Transplants are intended to prolong survival and improve the function of individuals with severe diseases or irreversible organ damage.

The Organ Procurement and Transplantation Network (OPTN) is the unified transplant network established by the United States Congress under the National Organ Transplant Act (NOTA) of 1984. The Act called for the network to be operated by a private, nonprofit organization under federal contract. The United Network for Organ Sharing (UNOS), based in Richmond, Virginia, administers the OPTN under contract with the Health Resources and Services Administration of the US Department of Health and Human Services.

OPTN is a unique public-private partnership that links all of the professionals involved in the donation and transplantation of organs in an effort to improve the effectiveness and efficiency of organ sharing. OPTN acts to bring equity in the national system of organ allocation and to increase the supply of donated organs available for transplantation.

Any operating transplant facility in the United States that provides transplant services must be an approved member of UNOS/OPTN. Requirements for each organ transplant are established by UNOS/OPTN through their policies and bylaws for facilities that apply for membership to the organization. Membership entails completion of the prescribed application process and satisfaction of applicable requirements in which the organization/facility has demonstrated compliance with all applicable UNOS membership criteria. The policies and bylaws set forth by OPTN include specific expectations about how members remain in compliance. If a Member is unable to demonstrate their ability to meet the applicable membership criteria at all times, the Member’s OPTN membership will be terminated by the OPTN, and the Member will no longer be able to provide transplant services. In addition, most transplant facilities also obtain Medicare certification for the organ transplants being performed.

According to the OPTN Bylaws Appendix D, the OPTN does not grant designated transplant program approval for any type of vascularized organ transplantation for which the OPTN has not established specific criteria. In order to perform vascularized organ transplantation procedures for which there are no OPTN-established criteria, including multi-visceral transplants, e.g., combination liver-kidney transplant, a hospital must be a transplant hospital member and have current approval as a designated transplant program for at least one of the organ types involved in multi-visceral transplant. In the case of abdominal multi-visceral organ transplants, the transplant hospital must have approval as a designated liver transplant program.

PROCUREMENT COSTS OF ORGANS AND TISSUES

The regional donor program coordinates the recovery of organs and tissues for transplant from living or cadaveric donors. The donor program is responsible for the identification and care of organ donors; organ retrieval, preservation, and transportation; and data follow-up regarding cadaveric organ donors. The reimbursement process for organ and tissue recovery is managed by the regional donor program.
References

Centers for Medicare and Medicaid Services (CMS). Hospital Conditions of Participation: Requirements for Approval and Re-Approval of Transplant Centers To Perform Organ Transplants; [CMS Web site]. Effective 6/28/2007. Updated 07/19/2017. Available at:http://www.cms.gov/Medicare/Provider-Enrollment-and-Certification/CertificationandComplianc/Transplant.html. Accessed October 26, 2018.

Centers for Medicare and Medicaid Services (CMS). Medicare Approved Facilities. [CMS Web site]. Revised: 10/19/2018. Available at: https://www.cms.gov/Medicare/Provider-Enrollment-and-Certification/CertificationandComplianc/Downloads/ApprovedTransplantPrograms.pdf. Accessed October 26, 2018.

Centers for Medicare and Medicaid Services (CMS). Transplant - Laws and Regulations. Available at: http://www.cms.gov/Medicare/Provider-Enrollment-and-Certification/GuidanceforLawsAndRegulations/Transplant-Laws-and-Regulations.html. Accessed October 26, 2018.

Medicare Department of Health & Human Services (DHHS) Centers for Medicare & Provider Reimbursement Manual Medicaid Services (CMS) Part 1 - Chapter 31, Organ Acquisition Payment Policy Transmittal 471. April 1, 2016. Available at:
https://www.cms.gov/Regulations-and-Guidance/Guidance/Transmittals/downloads/R471pr1.pd Accessed October 26, 2018.

Organ Procurement and Transplantation Network (OPTN). [OPTN Web site]. 11/18/05. Available at: http://optn.transplant.hrsa.gov/. Accessed October 26, 2018.

United Network for Organ Sharing (UNOS). [UNOS Web site]. 2018. Available at: http://www.unos.org/. Accessed October 26, 2018.



Coding

Inclusion of a code in this table does not imply reimbursement. Eligibility, benefits, limitations, exclusions, precertification/referral requirements, provider contracts, and Company policies apply.

The codes listed below are updated on a regular basis, in accordance with nationally accepted coding guidelines. Therefore, this policy applies to any and all future applicable coding changes, revisions, or updates.

In order to ensure optimal reimbursement, all health care services, devices, and pharmaceuticals should be reported using the billing codes and modifiers that most accurately represent the services rendered, unless otherwise directed by the Company.

The Coding Table lists any CPT, ICD-9, ICD-10, and HCPCS billing codes related only to the specific policy in which they appear.

CPT Procedure Code Number(s)

MEDICALLY NECESSARY


THE FOLLOWING CODE IS USED TO REPRESENT PHYSIOLOGICAL SUPPORT:

01990

HEART TRANSPLANT

Donor

33940
33944

Recipient

33945

HEART-LUNG TRANSPLANT

Donor

33930
33933

Recipient

33935

INTESTINAL TRANSPLANT

Donor

44132
44133
44715
44720
44721

Recipient

44135
44136
44137

KIDNEY TRANSPLANT

Donor

50300
50320
50323
50325
50327
50328
50329
50547

Recipient

50340
50360
50365
50370

PANCREAS TRANSPLANT

Donor

48550
48551
48552

Recipient

48554
48556

LIVER TRANSPLANT

Donor

47133
47140
47141
47142
47143
47144
47145
47146
47147

Recipient

47135

THE FOLLOWING CODE IS USED TO REPRESENT LIVER ALLOTRANSPLANTATION; HETEROTOPIC, PARTIAL OR WHOLE, FROM CADAVER OR LIVING DONOR, ANY AGE

47399:

LUNG TRANSPLANT

Donor

32850
32855
32856

Recipient

32851
32852
32853
32854

EXPERIMENTAL/INVESTIGATIONAL

0494T
0495T
0496T



Professional and outpatient claims with a date of service on or before September 30, 2015, must be billed using ICD-9 codes. Professional and outpatient claims with a date of service on or after October 1, 2015, must be billed using ICD-10 codes.

Facility/Institutional inpatient claims with a date of discharge on or before September 30, 2015, must be billed with ICD-9 codes. Facility/Institutional inpatient claims with a date of discharge on or after October 1, 2015, must be billed with ICD-10 codes.


ICD - 10 Procedure Code Number(s)

N/A


Professional and outpatient claims with a date of service on or before September 30, 2015, must be billed using ICD-9 codes. Professional and outpatient claims with a date of service on or after October 1, 2015, must be billed using ICD-10 codes.

Facility/Institutional inpatient claims with a date of discharge on or before September 30, 2015, must be billed with ICD-9 codes. Facility/Institutional inpatient claims with a date of discharge on or after October 1, 2015, must be billed with ICD-10 codes.


ICD -10 Diagnosis Code Number(s)

N/A


HCPCS Level II Code Number(s)



LIVER - KIDNEY TRANSPLANT

RECIPIENT
S2152 Solid organ(s), complete or segmental, single organ or combination of organs; deceased or living donor(s), procurement, transplantation, and related complications including: drugs; supplies; hospitalization with outpatient follow-up; medical/surgical, diagnostic, emergency, and rehabilitative services; and the number of days of pre- and post-transplant care in the global definition

LUNG TRANSPLANT

DONOR
S2061 Donor lobectomy (lung) for transplantation, living donor

RECIPIENT
S2060 Lobar lung transplantation

MULTIVISCERAL TRANSPLANT

DONOR
S2055 Harvesting of donor multivisceral organs, with preparation and maintenance of allografts; from cadaver donor

RECIPIENT
S2054 Transplantation of multivisceral organs

PANCREAS - KIDNEY TRANSPLANT

RECIPIENT
S2065 Simultaneous pancreas kidney transplantation

SMALL INTESTINE AND LIVER TRANSPLANT

RECIPIENT
S2053 Transplantation of small intestine, and liver allografts

SOLID ORGAN TRANSPLANT (SINGLE OR MULTIPLE ORGANS)

RECIPIENT
S2152 Solid organ(s), complete or segmental, single organ or combination of organs; deceased or living donor(s), procurement, transplantation, and related complications including: drugs; supplies; hospitalization with outpatient follow-up; medical/surgical, diagnostic, emergency, and rehabilitative services; and the number of days of pre- and post-transplant care in the global definition

THE FOLLOWING CODE IS ELIGIBLE FOR MEDICARE ADVANTAGE MEMBERS FOR REASONABLE TRANSPORTATION AND ACCOMMODATIONS

S9975 Transplant related lodging, meals and transportation, per diem


Revenue Code Number(s)



0362 Operating Room Services—Organ Transplant—Other than Kidney

0367 Operating Room Services—Kidney Transplant

0810 Acquisition of Body Components—General

0811 Acquisition of Body Components—Living Donor

0812 Acquisition of Body Components—Cadaver Donor

0813 Acquisition of Body Components—Unknown Donor

0819 Acquisition of Body Components—Other Donor

Coding and Billing Requirements


Cross References




Policy History

MA11.033b
09/11/2019This policy has been reissued in accordance with the Company's annual review process.
12/05/2018The policy has been reviewed and reissued to communicate the Company's continuing position on Solid Organ Transplantation and Procurement Cost of Organs and Tissues.
01/01/2018This policy was expanded to communicate Company's position's on procurement cost of organs and tissues.

The following CPT code was removed from this policy:
  • 50380

The following code was added to this policy to represent physiological support::
  • 01990

The following codes were added to the policy as experimental/investigational:
  • 0494T, 0495T, 0496T

MA11.033a
01/01/2016This version of the policy will become effective 01/01/2016.

The following: CPT code has been deleted from this policy and is being replaced with the following Not Otherwise Classified (NOC) code:

Deleted: 47136
Replaced with: 47399

MA11.033
02/04/2015The policy has been reviewed and reissued to communicate the Company’s continuing position on solid organ transplants.
01/01/2015This is a new policy.





Version Effective Date: 01/01/2018
Version Issued Date: 12/31/2017
Version Reissued Date: 09/12/2019