§ 486.302 - Definitions.

§ 486.302 Definitions.

Cross Reference

Link to an amendment published at 85 FR 77947, Dec. 2, 2020.

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 beneficiary, 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 beneficiary.

Agreement cycle refers to the time period of at least 4 years when an agreement is in effect between CMS and an OPO.

Assessment period is a 12-month period in which an OPO's outcome measures will be evaluated for performance. The final assessment period is the 12-month assessment period used to calculate outcome measures for re-certification.

Certification means a CMS determination that an OPO meets the requirements for certification at § 486.303.

Death record review means an assessment of the medical chart of a deceased patient to evaluate potential for organ donation.

Death that is consistent with organ donation means all deaths from the state death certificates with the primary cause of death listed as the ICD-10-CM codes I20-I25 (ischemic heart disease); I60-I69 (cerebrovascular disease); V-1-Y89 (external causes of death): Blunt trauma, gunshot wounds, drug overdose, suicide, drowning, and asphyxiation.

Decertification means a CMS determination that an OPO no longer meets the requirements for certification at § 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 rate is the number of donors as a percentage of the donor potential.

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 transplanted. An individual also would be considered a donor if only the pancreas is procured and is used for research or islet cell 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 means any documented indication of an individual's choice regarding his or her wishes concerning organ and/or tissue donation that was made by that individual or another authorized individual in accordance with any applicable State law.”

Donor potential is the number of inpatient deaths within the DSA among patients 75 and younger with a primary cause of death that is consistent with organ donation. For OPOs servicing a hospital with a waiver under § 486.308(e), the donor potential of the county for that hospital will be adjusted using the proportion of Medicare beneficiary inpatient deaths in the hospital compared with the total Medicare beneficiary inpatient deaths in the county.

Eligible death. An eligible death for organ donation means the death of a person -

(1) Who is 75 years old or younger;

(2) Who is legally declared dead by neurologic criteria in accordance with State or local law;

(3) Whose body weight is 5 kg or greater;

(4) Whose body mass Index (BMI) is 50 kg/m2 or less;

(5) Who had at least one kidney, liver, heart, or lung that is deemed to meet the eligible data definition as follows:

(i) The kidney would be initially deemed to meet the eligible data definition unless the donor meets one of the following:

(A) Is more than 70 years of age;

(B) Is age 50-69 years with history of Type 1 diabetes for more than 20 years;

(C) Has polycystic kidney disease;

(D) Has glomerulosclerosis equal to or more than 20 percent by kidney biopsy;

(E) Has terminal serum creatinine greater than 4/0 mg/dl;

(F) Has chronic renal failure; or

(G) Has no urine output for at least or more than 24 hours;

(ii) The liver would be initially deemed to meet the eligible data definition unless the donor has one of the following:

(A) Cirrhosis;

(B) Terminal total bilirubin equal to or more than 4 mg/dl;

(C) Portal hypertension;

(D) Macrosteatosis equal to or more than 50 percent or fibrosis equal to or more than stage II;

(E) Fulminant hepatic failure; or

(F) Terminal AST/ALT of more than 700 U/L.

(iii) The heart would be initially deemed to meet the eligible data definition unless the donor meets one of the following:

(A) Is more than 60 years of age;

(B) Is at least or more than 45 years of age with a history of at least or more than 10 years of HTN or at least or more than 10 years of type 1 diabetes;

(C) Has a history of Coronary Artery Bypass Graft (CABG);

(D) Has a history of coronary stent/intervention;

(E) Has a current or past medical history of myocardial infarction (MI);

(F) Has a severe vessel diagnosis as supported by cardiac catheterization (that is more than 50 percent occlusion or 2+ vessel disease);

(G) Has acute myocarditis and/or endocarditis;

(H) Has heart failure due to cardiomyopathy;

(I) Has an internal defibrillator or pacemaker;

(J) Has moderate to severe single valve or 2-valve disease documented by echo or cardiac catheterization, or previous valve repair;

(K) Has serial echo results showing severe global hypokinesis;

(L) Has myxoma; or

(M) Has congenital defects (whether surgically corrected or not).

(iv) The lung would be initially deemed to meet the eligible data definition unless the donor meets one of the following:

(A) Is more than 65 years of age;

(B) Is diagnosed with coronary obstructive pulmonary disease (COPD) (for example, emphysema);

(C) Has terminal PaO2/FiO2 less than 250 mmHg;

(D) Has asthma (with daily prescription);

(E) Asthma is the cause of death;

(F) Has pulmonary fibrosis;

(G) Has previous lobectomy;

(H) Has multiple blebs documented on Computed Axial Tomography (CAT) Scan;

(I) Has pneumonia as indicated on Computed Tomography (CT), X-ray, bronchoscopy, or cultures;

(J) Has bilateral severe pulmonary contusions as per CT.

(6) If a deceased person meets the criteria specified in paragraphs (1) through (5) of this definition, the death of the person would be classified as an eligible death, unless the donor meets any of the following criteria:

(i) The donor was taken to the operating room with the intent for the OPO to recover organs for transplant and all organs were deemed not medically suitable for transplantation; or

(ii) The donor exhibits any of the following active infections (specific diagnoses) of -

(A) Bacterial: Tuberculosis, Gangrenous bowel or perforated bowel or intra-abdominal sepsis;

(B) Viral: HIV infection by serologic or molecular detection, Rabies, Reactive Hepatitis B Surface Antigen, Retroviral infections including Viral Encephalitis or Meningitis, Active Herpes simplex, varicella zoster, or cytomegalovirus viremia or pneumonia, Acute Epstein Barr Virus (mononucleosis), West Nile (c) Virus infection, SARS, except as provided in paragraph (8) of this definition.

(C) Fungal: Active infection with Cryptococcus, Aspergillus, Histoplasma, Coccidioides, Active candidemia or invasive yeast infection;

(D) Parasites: Active infection with Trypanosoma cruzi (Chagas'), Leishmania, Strongyloides, or Malaria (Plasmodium sp.); or

(E) Prion: Creutzfeldt-Jacob Disease.

(7) The following are general exclusions:

(i) Aplastic anemia, Agranulocytosis;

(ii) Current malignant neoplasms except non-melanoma skin cancers such as basal cell and squamous cell cancer and primary CNS tumors without evident metastatic disease;

(iii) Previous malignant neoplasms with current evident metastatic disease;

(iv) A history of melanoma;

(v) Hematologic malignancies: Leukemia, Hodgkin's Disease, Lymphoma, Multiple Myeloma;

(vi) Active Fungal, Parasitic, Viral, or Bacterial Meningitis or Encephalitis; and

(vii) No discernable cause of death.

(8) Notwithstanding paragraph (6)(ii)(B) of this definition, an HIV positive organ procured for the purpose of transplantation into an HIV positive recipient would be an exception to an active infection rule out, consistent with the HIV Organ Policy Equity Act (the Hope Act).

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 expected donation rate per 100 eligible deaths that is the rate expected for an OPO based on the national experience for OPOs serving similar eligible donor populations and donation service areas. This rate is adjusted for the distributions of age, sex, race, and cause of death among eligible deaths.

Kidney transplantation rate is the number of kidneys transplanted from kidney donors in the DSA as a percentage of the donor potential.

Lowest rate among the top 25 percent will be calculated by taking the number of total DSAs in the time period identified for establishing the threshold rate. The total number of DSAs will be multiplied by 0.25 and rounded to the closest integer (0.5 will round to the higher integer). The donation rates and organ transplantation rates in each DSA will be separately ranked and the threshold rate will be the rate that corresponds to that integer when counting down the ranking.

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). The pancreas counts as an organ even if it is used for research or islet cell transplantation.

Organ type	Number of organs transplanted
(1) Right or Left Kidney	1
(2) Right and Left Kidney	2
(3) Double/En-Bloc Kidney	2
(4) Heart	1
(5) Intestine	1
(6) Intestine Segment 1 or Segment 2	1
(7) Intestine Segment 1 and Segment 2	2
(8) Liver	1
(9) Liver Segment 1 or Segment 2	1
(10) Liver Segments 1 and Segment 2	2
(11) Right or Left Lung	1
(12) Right and Left Lung	2
(13) Double/En-bloc Lung	2
(14) Pancreas (transplanted whole, research, islet transplant)	1
(15) Pancreas Segment 1 or Segment 2	1
(16) Pancreas Segment 1 and Segment 2	2

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 beneficiaries for available organs.

Organ transplantation rate is the number of organs transplanted from donors in the DSA as a percentage of the donor potential. Organs transplanted into patients on the OPTN waiting list as part of research are included in the organ transplantation rate. The organ transplantation rate will be risk-adjusted for the average age of the donor potential using the following methodology:

(1) The age groups used for the adjusted transplantation rates are: <1, 1-5, 6-11, 12-17, 18-24, 25-29, 30-34, 35-39, 40-44, 45-49, 50-54, 55-59, 60-64, 65-69, 70-75.

(2) Calculate a national age-specific transplantation rate for each age group.

An expected transplantation rate for each OPO is calculated as ∑(g=1)Gdg*Rg/∑gdg, where dg is the number of potential donors in the OPO in age group g, Rg is the age-specific national transplantation rate in age group g, and ∑gdg is the OPO's total number of individuals in the donor potential. This can be interpreted as the overall expected transplantation rate for an OPO if each of its age-specific transplantation rates were equal to the national age-specific.

(3) Calculate the age-adjusted organ transplantation rate as (O/E)*P, where O is the OPO's observed unadjusted transplantation rate, E is the expected transplantation rate calculated in Step 2, and P is the unadjusted national transplantation rate.

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 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 beneficiary.

[71 FR 31046, May 31, 2006, as amended at 77 FR 29031, May 16, 2012; 81 FR 79880, Nov. 14, 2016; 84 FR 61492, Nov. 12, 2019; 85 FR 77947, Dec. 2, 2020]