Editorial Note on Part 413
Editorial Note: Nomenclature changes to part 413 appear at 76 FR 50537, August 22, 2014.

§ 413.402 Organ acquisition costs. ( a ) *Costs related to organ acquisition.* Costs recognized in paragraph (b) of this section are allowable costs incurred in the acquisition of organs intended for transplant, including those organs that are subsequently determined unsuitable for transplant and furnished for research from a living donor or a deceased donor by the hospital, or from a deceased donor by an OPO. Additionally, there are administrative and general costs that may be allowable and included on the cost report for an OPO or a TH.
( b ) *Types of costs.* Organ acquisition costs are as follows: ( 1 ) Tissue typing, including tissue typing furnished by independent laboratories.
( 2 ) Donor and beneficiary evaluation.
( 3 ) Other costs associated with excising organs, such as general routine and special care services (for example, intensive care unit or critical care unit services), provided to the living or deceased donor.
( 4 ) Operating room and other inpatient ancillary services applicable to the living or deceased donor.
( 5 ) Organ preservation and perfusion costs.
( 6 ) Organ Procurement and Transplantation Network registration fees, and the reasonable and necessary cost of other fees, such as the registration fees for a kidney paired exchange, to register candidates for organ transplants. These allowable registry fees must support or promote organ transplantation and must not be duplicative in nature.
( 7 ) Surgeons' fees for excising deceased organs (currently limited to $1,250 for kidneys).
( 8 ) Transportation of the: ( i ) Excised organ to the TH; and
( ii ) Deceased donor to procure organs when it is necessary to preserve clinical outcomes or to avoid loss of potentially transplantable organs.
( 9 ) Costs of organs acquired from other hospitals or organ procurement organizations.
( 10 ) Hospital costs normally classified as outpatient costs applicable to organ excisions (services include donor and recipient tissue typing, work-up, and related services furnished prior to inpatient admission).
( 11 ) Costs of services applicable to organ excisions which are rendered by residents and interns not in approved teaching programs.
( 12 ) All pre-admission services applicable to organ excisions, such as laboratory, electroencephalography, and the costs of physicians' services.
( c ) *Living donor complications.* ( 1 ) *Living kidney donor complications.* Living kidney donor complications directly related to the kidney donation, which occur after the date of the donor's discharge, must not be reported as kidney acquisition costs on the Medicare cost report. (A) Medicare covers reasonable costs incurred for living kidney donor complications only if they are directly related to a kidney donation for a covered transplant into a Medicare beneficiary. (B) Living kidney donor complications are paid through the claims processing system under Medicare Part A or Part B, as applicable for the services provided, with no donor liability for deductibles or coinsurance. Living kidney donor complications are billed under the Medicare Beneficiary Identifier of the transplant recipient.
( 2 ) *Living non-renal donor complications.* Hospital costs incurred for living non-renal donor complications directly related to the non-renal organ donation, which occur after the date of the donor's discharge are not paid through the claims processing system but are reported as organ acquisition costs on the hospital's Medicare cost report. (A) Medicare covers reasonable hospital costs incurred for living non-renal organ donor complications only if they are directly related to a non-renal organ donation for a covered transplant into a Medicare beneficiary. (B) Hospital costs incurred for living non-renal organ donor complications are reported as organ acquisition costs on the Medicare cost report, and paid through the cost report on a reasonable cost basis.
( d ) *Costs not related to organ acquisition.* ( 1 ) Items or services that are not related or reasonable to acquire an organ for transplantation, non-allowable administrative and general costs, or costs that are not related to patient care, are not considered organ acquisition costs.
( 2 ) Examples of items or services that are not organ acquisition costs include, but are not limited to the following: ( i ) Donor burial and funeral expenses.
( ii ) Transportation costs of the deceased donor after organ procurement for funeral services or for burial.
( iii ) Transportation costs for a living donor.
( iv ) Fees or in-center payments for donor referrals.
( v ) Costs associated with and incurred for OPO-sponsored seminars where continuing education credits are given and where the attendee is not on the OPO's staff (as described at § 486.326(b)).
( vi ) Unreasonable costs incurred for administrator's duties associated with professional organizations.
[86 FR 73515, Dec. 27, 2021, as amended at 87 FR 72288, Nov. 23, 2022]