---
kind: "section"
citation: "42 C.F.R. § 413.400"
title: "42"
number: "413.400"
heading: "Definitions."
url: "https://uscodex.org/cfr/42/413.400"
---

# §413.400. Definitions.


As used in this subpart:

Histocompatibility laboratory means a laboratory meeting the requirements set forth in [§ 493.1227](/cfr/42/493.1227.md) of this chapter and providing the services for the acquisition of kidneys or other organs for transplantation.

Hospital-based organ procurement organization (HOPO) means an organ procurement organization that is considered a department of the TH and reports organ acquisition costs it incurs on the TH's Medicare cost report.

Independent organ procurement organization (IOPO) means an organ procurement organization that files a Medicare cost report separate from a hospital and meets all of the following:

- (1) Is not subject to the control of a hospital with respect to the hiring, firing, training, and paying of employees.
- (2) Is not considered as a department of a hospital for insurance purposes (including malpractice insurance, general liability insurance, worker's compensation insurance, and employee retirement insurance).
- (3) **Reports organ acquisition costs it incurs on the IOPO Medicare cost report.** Organ, for Medicare organ acquisition payment purposes, means:
- (1) A human kidney, liver, heart, lung, pancreas, or intestine (or multivisceral organs when transplanted at the same time as an intestine).
- (2) Pancreata procured on or after October 1, 2004, for the purpose of acquiring pancreatic islet cells for transplantation into individuals who are participating in a National Institute of Diabetes and Digestive and Kidney Diseases clinical trial in accordance with [section 733](/cfr/42/733.md) of the Medicare Prescription Drug, Improvement and Modernization Act of 2003.

  Organ procurement organization (OPO) means an organization defined in [§ 486.302](/cfr/42/486.302.md) of this chapter. OPOs can be independent or hospital based.

  Standard acquisition charge (SAC) means a charge as defined in [§ 413.404](/cfr/42/413.404.md) of this chapter.

  Transplant hospital (TH) means a hospital that furnishes organ transplants and other medical and surgical specialty services required for the care of transplant patients.

  Transplant hospital/HOPO (TH/HOPO) refers to a TH, or a TH that operates a HOPO (as previously defined in this section) and performs organ procurement activities as one entity reported on the TH's Medicare cost report.

  Transplant program means an organ-specific transplant program within a TH (as defined in this section).


## Notes

### Amendments

[86 FR 73515, Dec. 27, 2021, as amended at 87 FR 72287, Nov. 23, 2022]

### Source

Source: 86 FR 73515, Dec. 27, 2021, unless otherwise noted.

### Authority

Authority: 42 U.S.C. 1302, 1395d(d), 1395f(b), 1395g, 1395l(a), (i), and (n), 1395m, 1395x(v), 1395x(kkk), 1395hh, 1395rr, 1395tt, and 1395ww.

### Source

Source: 51 FR 34793, Sept. 30, 1986, unless otherwise noted.

### Amendments

[86 FR 73515, Dec. 27, 2021, as amended at 87 FR 72287, Nov. 23, 2022]