[Code of Federal Regulations]

[Title 42, Volume 4]

[Revised as of October 1, 2006]

From the U.S. Government Printing Office via GPO Access

[CITE: 42CFR486.302]



[Page 642-644]

 

                         TITLE 42--PUBLIC HEALTH

 

  CHAPTER IV--CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF 

                  HEALTH AND HUMAN SERVICES (CONTINUED)

 

PART 486_CONDITIONS FOR COVERAGE OF SPECIALIZED SERVICES FURNISHED BY 

 

Subpart G_Requirements for Certification and Designation and Conditions 

              for Coverage: Organ Procurement Organizations

 

Sec.  486.302  Definitions.



    As used in this subpart, the following definitions apply:

    Adverse event means an untoward, undesirable, and usually 

unanticipated event that causes death or serious injury or the risk 

thereof. As applied to OPOs, adverse events include but are not limited 

to transmission of disease from a donor to a recipient, avoidable loss 

of a medically suitable potential donor for whom consent for donation 

has been obtained, or delivery to a transplant center of the wrong organ 

or an organ whose blood type does not match the blood type of the 

intended recipient.

    Agreement cycle refers to the time period of at least 4 years when 

an agreement is in effect between CMS and an OPO.

    Certification means a CMS determination that an OPO meets the 

requirements for certification at Sec.  486.303.

    Death record review means an assessment of the medical chart of a 

deceased patient to evaluate potential for organ donation.

    Decertification means a CMS determination that an OPO no longer 

meets the requirements for certification at Sec.  486.303.

    Designated requestor or effective requestor is an individual 

(generally employed by a hospital), who is trained to handle or 

participate in the donation consent process. The designated requestor 

may request consent for donation from the family of a potential donor or 

from the individual(s) responsible for making the donation decision in 

circumstances permitted under State law, provide information about 

donation to the family or decision-maker(s), or provide support to or 

collaborate with the OPO in the donation consent process.

    Designation means CMS assignment of a geographic service area to an 

OPO. Once an OPO is certified and assigned a geographic service area, 

organ procurement costs of the OPO are eligible for Medicare and 

Medicaid payment under section 1138(b)(1)(F) of the Act.

    Donation service area (DSA) means a geographical area of sufficient 

size to ensure maximum effectiveness in the procurement and equitable 

distribution of organs and that either includes an entire metropolitan 

statistical area or does not include any part of such an area and that 

meets the standards of this subpart.

    Donor means a deceased individual from whom at least one 

vascularized organ (heart, liver, lung, kidney, pancreas, or intestine) 

is recovered for the purpose of transplantation.

    Donor after cardiac death (DCD) means an individual who donates 

after his or her heart has irreversibly stopped beating. A donor after 

cardiac death may be termed a non-heartbeating or asystolic donor.

    Donor document is any documented indication of an individual's 

choice in regard to donation that meets the requirements of the 

governing state law.

    Eligible death for organ donation means the death of a patient 70 

years old or younger, who ultimately is legally declared brain dead 

according to hospital policy independent of family decision regarding 

donation or availability of next-of-kin, independent of medical examiner 

or coroner involvement in the case, and independent of local acceptance 

criteria or transplant center practice, who exhibits none of the 

following:

    (1) Active infections (specific diagnoses).

    (i) Bacterial:

    (A) Tuberculosis.

    (B) Gangrenous bowel or perforated bowel and/or intra-abdominal 

sepsis.

    (ii) Viral:



[[Page 643]]



    (A) HIV infection by serologic or molecular detection.

    (B) Rabies.

    (C) Reactive Hepatitis B Surface Antigen.

    (D) Retroviral infections including HTLV I/II.

    (E) Viral Encephalitis or Meningitis.

    (F) Active Herpes simplex, varicella zoster, or cytomegalovirus 

viremia or pneumonia.

    (G) Acute Epstein Barr Virus (mononucleosis).

    (H) West Nile Virus infection.

    (I) Severe acute respiratory syndrome (SARS).

    (iii) Fungal:

    (A) Active infection with Cryptococcus, Aspergillus, Histoplasma, 

Coccidioides.

    (B) Active candidemia or invasive yeast infection.

    (iv) Parasites: active infection with Trypanosoma cruzi (Chagas'), 

Leishmania, Strongyloides, or Malaria (Plasmodium sp.).

    (v) Prion: Creutzfeldt-Jacob Disease.

    (2) General:

    (i) Aplastic Anemia.

    (ii) Agranulocytosis.

    (iii) Extreme Immaturity (<500 grams or gestational age of <32 

weeks).

    (iv) Current malignant neoplasms except non-melanoma skin cancers 

such as basal cell and squamous cell cancer and primary CNS tumors 

without evident metastatic disease.

    (v) Previous malignant neoplasms with current evident metastatic 

disease.

    (vi) A history of melanoma.

    (vii) Hematologic malignancies: Leukemia, Hodgkin's Disease, 

Lymphoma, Multiple Myeloma.

    (viii) Multi-system organ failure (MSOF) due to overwhelming sepsis 

or MSOF without sepsis defined as 3 or more systems in simultaneous 

failure for a period of 24 hours or more without response to treatment 

or resuscitation.

    (ix) Active Fungal, Parasitic, viral, or Bacterial Meningitis or 

encephalitis.

    (3) The number of eligible deaths is the denominator for the 

donation rate outcome performance measure as described at Sec.  

486.318(a)(1).

    Eligible donor means any donor that meets the eligible death 

criteria. The number of eligible donors is the numerator of the donation 

rate outcome performance measure.

    Entire metropolitan statistical area means a metropolitan 

statistical area (MSA), a consolidated metropolitan statistical area 

(CMSA), or a primary metropolitan statistical area (PMSA) listed in the 

State and Metropolitan Area Data Book published by the U.S. Bureau of 

the Census. CMS does not recognize a CMSA as a metropolitan area for the 

purposes of establishing a geographical area for an OPO.

    Expected donation rate means the donation rate expected for an OPO 

based on the national experience for OPOs serving similar hospitals and 

donation service areas. This rate is adjusted for the following hospital 

characteristics: Level I or Level II trauma center, Metropolitan 

Statistical Area size, MS Case Mix Index, total bed size, number of 

intensive care unit (ICU) beds, primary service, presence of a 

neurosurgery unit, and hospital control/ownership.

    Observed donation rate is the number of donors meeting the 

eligibility criteria per 100 deaths.

    Open area means an OPO service area for which CMS has notified the 

public that it is accepting applications for designation.

    Organ means a human kidney, liver, heart, lung, pancreas, or 

intestine (or multivisceral organs when transplanted at the same time as 

an intestine).

    Organ procurement organization (OPO) means an organization that 

performs or coordinates the procurement, preservation, and transport of 

organs and maintains a system for locating prospective recipients for 

available organs.

    Re-certification cycle means the 4-year cycle during which an OPO is 

certified.

    Standard criteria donor (SCD) means a donor that meets the 

eligibility criteria for an eligible donor and does not meet the 

criteria to be a donor after cardiac death or expanded criteria donor.

    Transplant hospital means a hospital that provides organ transplants 

and other medical and surgical specialty services required for the care 

of transplant patients. There may be one or



[[Page 644]]



more types of organ transplant centers operating within the same 

transplant hospital.

    Urgent need occurs when an OPO's noncompliance with one or more 

conditions for coverage has caused, or is likely to cause, serious 

injury, harm, impairment, or death to a potential or actual donor or an 

organ recipient.



             Requirements for Certification and Designation