(a) General.
(1) Procuring an organ is not a covered service when performed independent of a Medicare covered transplant, however, the reasonable costs to procure an organ are reimbursable when billed in connection with a Medicare covered transplant.
(2) The SAC represents the average of the total organ acquisition costs associated with procuring either cadaveric donor organs or living donor organs, by organ type.
(3) When a TH/HOPO or IOPO furnishes an organ to another TH/HOPO or IOPO, it bills its SAC to the TH/HOPO or IOPO receiving the organ.
(b) THs/HOPOs SACs.
(1) A TH/HOPO must develop a SAC for each organ type (for example heart, liver, or lung).
(2) When a TH/HOPO furnishes an organ to another transplant hospital or IOPO, it must bill the receiving transplant hospital or IOPO its SAC by organ type, or the hospital's standard departmental charges that are reduced to cost.
(3) A transplant hospital must establish SACs for living donor organs. A TH/HOPO must establish SACs for cadaveric donor organs.
(i) Living donor SAC for transplant hospitals -
(A) Definition. The living donor SAC is an average organ acquisition cost that a transplant hospital incurs to procure an organ from a living donor.
(B) Establishment of living donor SAC. A transplant hospital must establish a living donor SAC (living SAC) before the transplant hospital bills its first living donor transplant to Medicare.
(C) Calculating the living donor SAC -
(1) Initial living donor SAC. A transplant hospital calculates its initial living donor SAC for each living organ type as follows:
(i) By estimating the reasonable and necessary organ acquisition costs it expects to incur for services furnished to living donors, and pre-admission services furnished to recipients of living donor organs during the hospital's cost reporting period.
(ii) By dividing the estimated amount described in paragraph (b)(3)(i)(C)(1)(i) of this section by the projected number of usable living donor organs to be procured by the transplant hospital during the transplant hospital's cost reporting period.
(2) Subsequent living donor SAC. A transplant hospital calculates its subsequent years' living donor SAC for each living organ type as follows:
(i) By using the transplant hospital's actual organ acquisition costs for the living donor organ type from the prior year's Medicare cost report, adjusted for any changes in the current year.
(ii) Dividing the costs in paragraph (b)(3)(i)(C)(2)(i) of this section by the actual number of usable living donor organs procured by the transplant hospital during that prior cost reporting period.
(D) Costs used to develop the living donor SAC. Costs that may be used to develop the living donor SAC include, but are not limited to the following:
(1) Costs of tissue typing services, including those furnished by independent laboratories.
(2) Costs of physician pre-admission transplant evaluation services.
(3) Registry fees as specified at § 413.402(b)(6) of this subpart.
(4) Costs for donor and recipient evaluations and workups furnished prior to admission for transplantation.
(5) Other costs associated with procurement, for example, general routine and special care services (for example, intensive care unit or critical care unit services), related to the donor.
(6) Costs of operating room and other inpatient ancillary services related to the donor.
(7) Organ preservation and perfusion costs.
(8) Transportation costs of the excised organ as specified in § 413.402(b)(8)(i) of this subpart.
(ii) Cadaveric donor SAC for THs/HOPOs -
(A) Definition. The cadaveric donor SAC is an average cost that a TH/HOPO incurs to procure a cadaveric donor organ.
(B) Calculating the cadaveric SAC -
(1) Initial cadaveric donor SAC. A TH/HOPO calculates its initial cadaveric SAC for each cadaveric organ type as follows:
(i) By estimating the reasonable and necessary costs it expects to incur to procure cadaveric organs, combined with the expected costs of acquiring cadaveric organs from OPOs or other transplant hospitals.
(ii) By dividing the estimated amount described in paragraph (b)(3)(ii)(B)(1)(i) of this section by the projected number of usable cadaveric organs to be procured by the TH/HOPO within the transplant hospital's cost reporting period.
(2) Subsequent cadaveric donor SAC. A TH/HOPO calculates its subsequent years' cadaveric donor SAC for each cadaveric organ type as follows:
(i) By using the transplant hospital's actual organ acquisition costs for the cadaveric donor organ type from the prior year's Medicare cost report, adjusted for any changes in the current year.
(ii) By dividing the costs in paragraph (b)(3)(ii)(B)(2)(i) of this section by the actual number of usable cadaveric donor organs procured by the TH/HOPO during that prior cost reporting period.
(C) Costs to develop the cadaveric donor SAC. Costs that may be used to develop the cadaveric donor SAC include, but are not limited to the following:
(1) Costs of organs acquired from other transplant hospitals or OPOs.
(2) Costs of transportation as specified in § 413.402(b)(8) of this subpart.
(3) Surgeons' fees for excising cadaveric organs (currently limited to $1,250 for kidneys).
(4) Costs of tissue typing services, including those furnished by independent laboratories.
(5) Organ preservation and perfusion costs.
(6) General routine and special care service costs (for example, intensive care unit or critical care unit services related to the donor).
(7) Operating room and other inpatient ancillary service costs.
(c) Independent OPO SACs -
(1) Non-renal SAC. An IOPO establishes non-renal SACs based on its costs of procuring non-renal organs for each organ type, by -
(i) Estimating the reasonable and necessary costs it expects to incur for services furnished to procure cadaveric donor non-renal organs during the IOPO's cost reporting period; and
(ii) Dividing the amount estimated in paragraph (c)(1)(i) of this section by the projected number of cadaveric donor non-renal organs the IOPO expects to procure within its cost reporting period.
(iii) An IOPO may adjust its non-renal SACs during the year if necessary to account for cost changes.
(2) Kidney SAC.
(i) General. An IOPO's Medicare contractor establishes the kidney SAC based on an estimate of, initial year projected or subsequent years' actual, reasonable and necessary costs the IOPO expects to incur to procure cadaveric kidneys during the IOPO's cost reporting period, divided by the, initial year projected or subsequent years' actual, number of usable cadaveric kidneys the IOPO expects to procure.
(ii) Initial year. The Medicare contractor develops the IOPO's initial kidney SAC based on the IOPO's budget information.
(iii) Subsequent years. The kidney SAC for subsequent years is computed using the IOPO's costs related to kidney acquisition that were incurred in the prior cost reporting period and dividing those costs by the number of usable cadaveric kidneys procured during that cost reporting period. The SAC is the basis for the interim payments by the transplant hospital to the IOPO, as set forth in § 413.420(d).
(iv) The IOPO's Medicare contractor may adjust the kidney SAC during the year, if necessary, for cost changes.
(v) The IOPO cannot use or change its kidney SAC without the contractor's approval.
(3) Billing SACs for organs generally. When an IOPO obtains an organ from another IOPO, the receiving IOPO is responsible for paying the procuring IOPO's SAC. The receiving IOPO uses its SAC for each organ type and not the procuring IOPO's SAC when billing the transplant hospital receiving the organ.