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 54 – 55: Was arrhythmia present?
Arrhythmia includes, but is not limited to, atrial fibrillation or flutter, sick sinus syndrome, and ventricular arrhythmia.
Indicate if an arrhythmia (of any kind) was present in the current reporting period.
Report Developed in the following scenarios:
- This is the first time the recipient was diagnosed with arrhythmia in the reporting period.
- Arrhythmia resolved in a prior reporting period and then recurred in the current reporting period.
If the arrhythmia 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:
- Arrhythmia was diagnosed pre-infusion and persisted into the Day 100 reporting period.
- Arrhythmia was diagnosed (or persisted) in the prior reporting period and persisted into the current reporting period.
- For cellular therapy, if the arrhythmia was diagnosed pre-infusion and persisted in 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 the arrhythmia was not present in the current reporting period or unknown if present, select Not present.
Questions 56 – 57: Specify arrhythmia
Specify the arrhythmia type. If an arrhythmia other than Atrial fibrillation or flutter, Sick sinus syndrome, or Ventricular arrhythmia, was present, select Other arrhythmia and specify.
Questions 58 – 59: Did the arrhythmia resolve?
Indicate if the arrhythmia is 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 60 – 61: Was cardiomyopathy present?
Cardiomyopathy is a disease of heart muscle that makes it more difficult for the heart to pump blood to the rest of the body.
Indicate if cardiomyopathy was present in the current reporting period.
Report Developed in the following scenarios:
- This is the first time the recipient was diagnosed with cardiomyopathy in the reporting period.
- Cardiomyopathy resolved in a prior reporting period and then recurred in the current reporting period.
If cardiomyopathy 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:
- Cardiomyopathy was diagnosed pre-infusion and persisted into the Day 100 reporting period.
- Cardiomyopathy was diagnosed (or persisted) in the prior reporting period and persisted into the current reporting period.
- For cellular therapy, if cardiomyopathy 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 cardiomyopathy was not present in the current reporting period or unknown if present, select Not present.
Questions 62 – 63: Did the cardiomyopathy resolve?
Indicate if cardiomyopathy is 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 64 – 65: Was congestive heart failure present?
Congestive heart failure (CHF) is the inability of the heart to supply oxygenated blood to meet the body’s needs, with an ejection fraction < 40%.
Indicate if congestive heart failure was present in the current reporting period. 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 congestive heart failure in the reporting period.
If congestive heart failure 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 congestive heart failure. 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 congestive heart failure was diagnosed pre-infusion and persisted into the Day 100 reporting period.
- For cellular therapy, if congestive heart failure 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 congestive heart failure if it continued from a previous reporting period into the current reporting period, even if it was present.
If congestive heart failure 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 66: Specify ejection fraction
Report the ejection fraction using the following guidelines:
- If congestive heart failure Developed, report the ejection fraction from the post-infusion diagnosis (i.e., the post-infusion ejection fraction in the current reporting period).
- If congestive heart failure Persisted pre-infusion into the Day 100 reporting period, report the ejection fraction from the pre-infusion diagnosis (i.e., the pre-infusion ejection fraction).
Question 67: Specify symptomatic or asymptomatic
Indicate if the recipient was Symptomatic or Asymptomatic in the current reporting period.
Questions 68 – 69: Did the congestive heart failure resolve?
Indicate if congestive heart failure is 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 70 – 71: Was coronary artery disease present?
Coronary artery disease is the damage or disease in the major blood vessels of the heart. Coronary artery disease is also knowns as CAD and atherosclerotic heart disease.
Indicate if coronary artery disease was present in the current reporting period.
Report Developed in the following scenarios:
- This is the first time the recipient was diagnosed with coronary artery disease in the reporting period.
If coronary artery disease 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:
- Coronary artery disease was diagnosed pre-infusion and persisted into the Day 100 reporting period.
- For cellular therapy, if coronary artery disease 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 coronary artery disease was not present in the current reporting period or unknown if present, select Not present.
Questions 72 – 73: Was unstable angina present?
Unstable angina is sometimes called acute coronary syndromes and results in unexpected chest pain due to reduce blood flow and oxygen to the heart.
Indicate if unstable angina was present in the current reporting period.
Report Developed in the following scenarios:
- This is the first time the recipient was diagnosed with unstable angina in the reporting period.
- Unstable angina resolved in a prior reporting period and then recurred in the current reporting period.
If unstable angina 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:
- Unstable angina was diagnosed pre-infusion and persisted into the Day 100 reporting period.
- Unstable angina was diagnosed (or persisted) in the prior reporting period and persisted into the current reporting period.
- For cellular therapy, if unstable angina 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 unstable angina was not present in the current reporting period or unknown if present, select Not present.
Questions 74 – 75: Did unstable angina resolve?
Indicate if unstable angina 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.
Question 76: Did the recipient experience a myocardial infarction?
Myocardial infarction (MI) is an obstruction in the coronary artery resulting in damage / necrosis to the cardiac muscle.
Indicate if the recipient experienced a myocardial infarction in the current reporting period. The intent of this question is to capture each instance of a myocardial infarction occurring in the reporting period.
If the recipient did not have a myocardial infarction in the current reporting period or is unknown, select No.
Question 77: Date of myocardial infarction onset
Specify the date of the myocardial infarction. If multiple myocardial infarctions occurred in one day, only one instance is required to capture the myocardial infarctions occurring that day; multiple instances for the same day are not required.
For more information regarding reporting partial or unknown dates, see General Instructions, General Guidelines for Completing Forms.
Questions 78 – 79: Was hypertension (HTN) requiring therapy present?
Hypertension, also known as high blood pressure, is a condition where the blood pressure against the artery walls is too high, which increases the risk of stroke and heart disease.
Indicate if hypertension requiring therapy was present in the current reporting period.
Report Developed in the following scenarios:
- This is the first time the recipient was diagnosed with hypertension requiring treatment in the reporting period.
- Hypertension requiring treatment resolved in a prior reporting period and then recurred in the current reporting period.
If hypertension requiring 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:
- Hypertension requiring treatment was diagnosed pre-infusion and persisted into the Day 100 reporting period.
- Hypertension requiring treatment was diagnosed (or persisted) in the prior reporting period and persisted into the current reporting period.
If hypertension requiring treatment was not present in the current reporting period or unknown if present, select Not present.
Questions 80 – 81: Was the recipient still receiving therapy for HTN at the date of contact for this reporting period?
Specify if the recipient was still receiving treatment for hypertension 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 82 – 83: Did HTN requiring therapy resolve?
Indicate if hypertension requiring therapy 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 84 – 85: Was pericarditis present?
Pericarditis is the swelling and irritation of pericardium.
Indicate if pericarditis was present in the current reporting period.
Report Developed in the following scenarios:
- This is the first time the recipient was diagnosed with pericarditis in the reporting period.
- Pericarditis resolved in a prior reporting period and then recurred in the current reporting period.
If pericarditis 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:
- Pericarditis was diagnosed pre-infusion and persisted into the Day 100 reporting period.
- Pericarditis was diagnosed (or persisted) in the prior reporting period and persisted into the current reporting period.
- For cellular therapy, if pericarditis 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 pericarditis was not present in the current reporting period or unknown if present, select Not present.
Questions 86 – 87: Did pericarditis resolve?
Indicate if pericarditis 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 88 – 89: Was heart valve disease present?
Heart valve disease is the presence of one or more of the following:
- Moderate or severe degree of valve stenosis or insufficiency as determined by an echo, whether the valve is mitral, aortic, tricuspid, or pulmonary
- Prosthetic mitral or aortic valve
- Symptomatic mitral valve prolapse
Indicate if heart valve disease was present in the current reporting period.
Report Developed in the following scenarios:
- This is the first time the recipient was diagnosed with heart valve disease in the reporting period.
- Heart valve disease resolved in a prior reporting period and then recurred in the current reporting period.
If heart valve disease 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:
- Heart valve disease was diagnosed pre-infusion and persisted into the Day 100 reporting period.
- Heart valve disease was diagnosed (or persisted) in the prior reporting period and persisted into the current reporting period.
- For cellular therapy, if heart valve disease 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 heart valve disease was 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) |
|---|---|---|---|---|
| Q64 – 65 | 4/24/2026 | Add | Clarified intent of question and when to report ‘not present’: Congestive heart failure (CHF) is the inability of the heart to supply oxygenated blood to meet the body’s needs, with an ejection fraction < 40%. Indicate if congestive heart failure was present in the current reporting period. 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 congestive heart failure 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 |
| Q70 | 4/24/2026 | Modify | Replaced Reporting Multiple CAD blue box with Reporting Coronary Artery Disease (CAD) red warning box: |
Due to change in instruction |
| Q70 | 4/24/2026 | Modify | Updated instructions for reporting persistent and developed in Q70: Coronary artery disease is the damage or disease in the major blood vessels of the heart. Coronary artery disease is also knowns as CAD and atherosclerotic heart disease. Indicate if coronary artery disease was present in the current reporting period. Report Developed in the following scenarios: – This is the first time the recipient was diagnosed with coronary artery disease in the reporting period. – If coronary artery disease 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: – Coronary artery disease was diagnosed pre-infusion and persisted into the Day 100 reporting period. – – For cellular therapy, if coronary artery disease 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 coronary artery disease was not present in the current reporting period or unknown if present, select Not present. |
Due to change in instruction |
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