The purpose of this section is to capture any impairments or disorders present during the current reporting period, regardless of treatment or intervention, unless otherwise specified. Review each impairment or disorder description to determine whether treatment or intervention is required for reporting the condition.
Questions 119 – 120: Was diabetes / hyperglycemia requiring chronic treatment present?
Diabetes / hyperglycemia is also known as high blood glucose levels.
Indicate if diabetes / hyperglycemia requiring chronic treatment was present in the current reporting period.
Report Developed in the following scenarios:
- This is the first time the recipient was diagnosed with diabetes / hyperglycemia requiring chronic treatment in the reporting period.
- Diabetes / hyperglycemia requiring chronic treatment resolved in a prior reporting period and then recurred in the current reporting period.
If diabetes / hyperglycemia requiring chronic treatment Developed, report the onset date. If the diagnosis was determined at an outside center and no documentation of a clinical, pathological, or laboratory assessment is available, the dictated date of diagnosis within a physician note may be reported.
For more information regarding reporting partial or unknown dates, see General Instructions, General Guidelines for Completing Forms.
Report Persisted in the following scenarios:
- Diabetes / hyperglycemia requiring chronic treatment was diagnosed pre-infusion and persisted into the Day 100 reporting period.
- Diabetes / hyperglycemia requiring chronic treatment was diagnosed (or persisted) in the prior reporting period and persisted into the current reporting period.
- For cellular therapy, if diabetes / hyperglycemia requiring chronic treatment was diagnosed pre-infusion and persisted into the one-year reporting period (without resolution since the pre-infusion diagnosis) as this form will not come due until the one-year reporting period.
If diabetes / hyperglycemia requiring chronic treatment was not present in the current reporting period or unknown if present, select Not present.
Questions 121 – 122: Was the recipient still receiving therapy for diabetes / hyperglycemia at the date of contact for this reporting period?
Specify if the recipient was still receiving treatment for diabetes / hyperglycemia at the contact date for the current reporting period.
If the recipient was no longer receiving treatment at the contact date, select No and specify the therapy completion date.
For more information regarding reporting partial or unknown dates, see General Instructions, General Guidelines for Completing Forms.
Questions 123 – 124: Did diabetes / hyperglycemia requiring chronic treatment resolve?
Indicate if diabetes / hyperglycemia chronic treatment resolved during the reporting period. If Yes, report the resolution date. The resolution date is the date when the notes specify the condition as resolved and / or medications to treat the condition were completed.
For more information regarding reporting partial or unknown dates, see General Instructions, General Guidelines for Completing Forms.
Questions 125 – 126: Was growth hormone deficiency / short stature present?
Growth hormone deficiency / short stature is a condition in which the body does not produce enough growth hormone / a reduced overall rate of growth.
Indicate if growth hormone deficiency / short stature was present in the current reporting period. The intent of this question is only to capture the first occurrence of the impairment / disorder in the recipient’s post-infusion course. The impairment / disorder should be reported once, in the reporting period in which it first meets the criteria for reporting. After the impairment / disorder is reported once post-infusion, it should never be reported again.
Report Developed in the following scenarios:
- This is the first time the recipient was diagnosed with growth hormone deficiency / short stature in the reporting period.
If growth hormone deficiency / short stature Developed, report the onset date. If the diagnosis was determined at an outside center and no documentation of a clinical, pathological, or laboratory assessment is available, the dictated date of diagnosis within a physician note may be reported.
Do not report a recurrence of growth hormone deficiency / short stature. Only the first occurrence is captured.
For more information regarding reporting partial or unknown dates, see General Instructions, General Guidelines for Completing Forms.
Report Persisted in the following scenarios:
- Growth hormone deficiency / short stature was diagnosed pre-infusion and persisted into the Day 100 reporting period.
When this is diagnosed post-infusion, do not report growth hormone deficiency / short stature if it continued from a previous reporting period into the current reporting period, even if it was present.
If growth hormone deficiency / short stature was reported as Developed or Persisted in a prior reporting period (regardless of it recurred), not present in the current reporting period or unknown if present, select Not present.
Question 127: Was therapy given for hormone deficiency / short stature?
Specify if therapy was given for hormone deficiency / short stature in the current reporting period.
If therapy was not received or is unknown, select No.
Questions 128 – 129: Was the recipient still receiving therapy for hormone deficiency / short stature at the date of contact for this reporting period?
Specify if the recipient was still receiving hormone deficiency / short stature treatment at the contact date for the current reporting period.
If the recipient was no longer receiving treatment at the contact date, select No and specify the therapy completion date.
For more information regarding reporting partial or unknown dates, see General Instructions, General Guidelines for Completing Forms.
Questions 130 – 131: Was hypothyroidism requiring replacement therapy present?
Hypothyroidism is a decreased activity of the thyroid gland. Diagnosis of hypothyroidism includes high levels of thyroid-stimulating hormone (TSH). Symptoms include fatigue, depression, weakness, weight gain, musculoskeletal pain, decreased taste, hoarseness, and / or puffy face.
Indicate if hypothyroidism requiring replacement therapy was present in the current reporting period. The intent of this question is only to capture the first occurrence of the impairment / disorder in the recipient’s post-infusion course. The impairment / disorder should be reported once, in the reporting period in which it first meets the criteria for reporting. After the impairment / disorder is reported once post-infusion, it should never be reported again.
Report Developed in the following scenarios:
- This is the first time the recipient was diagnosed with hypothyroidism requiring replacement therapy in the reporting period.
If hypothyroidism requiring replacement therapy Developed, report the onset date. If the diagnosis was determined at an outside center and no documentation of a clinical, pathological, or laboratory assessment is available, the dictated date of diagnosis within a physician note may be reported.
Do not report a recurrence of hypothyroidism requiring replacement therapy. Only the first occurrence is captured.
For more information regarding reporting partial or unknown dates, see General Instructions, General Guidelines for Completing Forms.
Report Persisted in the following scenarios:
- For transplant, if hypothyroidism requiring replacement therapy was diagnosed pre-infusion and persisted into the Day 100 reporting period.
- For cellular therapy, if hypothyroidism requiring replacement therapy was diagnosed pre-infusion and persisted into the one-year reporting period (without resolution since the pre-infusion diagnosis) as this form will not come due until the one-year reporting period.
When this is diagnosed post-infusion, do not report hypothyroidism requiring replacement therapy if it continued from a previous reporting period into the current reporting period, even if it was present.
If hypothyroidism requiring replacement therapy was reported as Developed or Persisted in a prior reporting period (regardless of it recurred), not present in the current reporting period or unknown if present, select Not present.
Questions 132 – 133: Was pancreatitis present?
Pancreatitis is the inflammation of the pancreas.
Indicate if pancreatitis were present in the current reporting period. The intent of this question is only to capture the first occurrence of the impairment / disorder in the recipient’s post-infusion course. The impairment / disorder should be reported once, in the reporting period in which it first meets the criteria for reporting. After the impairment / disorder is reported once post-infusion, it should never be reported again.
Report Developed in the following scenarios:
- This is the first time the recipient was diagnosed with pancreatitis in the reporting period.
If pancreatitis Developed, report the onset date. If the diagnosis was determined at an outside center and no documentation of a clinical, pathological, or laboratory assessment is available, the dictated date of diagnosis within a physician note may be reported.
Do not report a recurrence of pancreatitis. Only the first occurrence is captured.
For more information regarding reporting partial or unknown dates, see General Instructions, General Guidelines for Completing Forms.
Report Persisted in the following scenarios:
- For transplant, if pancreatitis was diagnosed pre-infusion and persisted into the Day 100 reporting period.
- For cellular therapy, if pancreatitis was diagnosed pre-infusion and persisted into the one-year reporting period (without resolution since the pre-infusion diagnosis) as this form will not come due until the one-year reporting period.
When this is diagnosed post-infusion, do not report pancreatitis if it continued from a previous reporting period into the current reporting period, even if it was present.
If pancreatitis was reported as Developed or Persisted in a prior reporting period (regardless of it recurred), not present in the current reporting period or unknown if present, select Not present.
Section Updates:
| Question Number | Date of Change | Add/Remove/Modify | Description | Reasoning (If applicable) |
|---|---|---|---|---|
| Q125 | 4/24/2026 | Add | Clarified intent of question and when to report ‘not present’: Indicate if growth hormone deficiency / short stature was present in the current reporting period. The intent of this question is only to capture the first occurrence of the impairment / disorder in the recipient’s post-infusion course. The impairment / disorder should be reported once, in the reporting period in which it first meets the criteria for reporting. After the impairment / disorder is reported once post-infusion, it should never be reported again. ; If growth hormone deficiency / short stature was reported as Developed or Persisted in a prior reporting period (regardless of it recurred), not present in the current reporting period or unknown if present, select Not present. | Added for clarification |
| Q130 | 4/24/2026 | Add | Clarified intent of question and when to report ‘not present’: Indicate if hypothyroidism requiring replacement therapy was present in the current reporting period. The intent of this question is only to capture the first occurrence of the impairment / disorder in the recipient’s post-infusion course. The impairment / disorder should be reported once, in the reporting period in which it first meets the criteria for reporting. After the impairment / disorder is reported once post-infusion, it should never be reported again. ; If hypothyroidism requiring replacement therapy was reported as Developed or Persisted in a prior reporting period (regardless of it recurred), not present in the current reporting period or unknown if present, select Not present. | Added for clarification |
| Q132 – 133 | 4/24/2026 | Add | Clarified intent of question and when to report ‘not present’: Indicate if pancreatitis were present in the current reporting period. The intent of this question is only to capture the first occurrence of the impairment / disorder in the recipient’s post-infusion course. The impairment / disorder should be reported once, in the reporting period in which it first meets the criteria for reporting. After the impairment / disorder is reported once post-infusion, it should never be reported again. ; If pancreatitis was reported as Developed or Persisted in a prior reporting period (regardless of it recurred), not present in the current reporting period or unknown if present, select Not present. | Added for clarification |
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