LCD Reference Article Response To Comments Article

Response to Comments: Cardiology Non-emergent Outpatient Stress Testing

A58657

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A58657
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Article Title
Response to Comments: Cardiology Non-emergent Outpatient Stress Testing
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Response to Comments
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03/11/2021
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The following are the comment summaries and contractor responses for First Coast Service Options Proposed Local Coverage Determination (LCD) DL38396 Cardiology Non-emergent Outpatient Stress Testing which was posted for comment on October 29, 2020 and presented at the Open Meeting on November 12, 2020. All comments were reviewed and incorporated into the final LCD where applicable.

Response To Comments

Number Comment Response
1

A comment was received from a professional society requesting to add the following language to the ‘History/Background and/or General Information’ section of the LCD: Cardiac MRI (CMR) in addition to assessing for myocardial ischemia, can also provide information about valvular function, presence of morphological abnormalities and myocardial fibrosis/scar, and assessment of dynamic obstruction without radiation exposure. This is especially valuable in patients in whom good quality echo images could not be obtained due to technically difficult acoustic windows. Current peer-reviewed literature was submitted with this comment.

We appreciate this comment and literature. After review of the submitted literature, it has been determined that the CMR can also distinguish scar from hibernating myocardium, provide information about valvular function, the presence of myocardial fibrosis, the presence of morphological abnormalities, and provide an assessment of dynamic obstruction without radiation exposure. This is especially valuable in patients in whom good quality echocardiography images could not be obtained due to technically difficult acoustic windows. Therefore, this language will be added in the finalized LCD.

2

A comment was received from a professional society requesting to add the following language to the LCD: Cardiac MRI (CMR) is a vital tool for assessment of patients with hypertrophic cardiomyopathy (HCM). CMR is indicated for diagnosis of patients suspected to have HCM especially in whom echocardiography is inconclusive. Current peer-reviewed literature was submitted with this comment.

We appreciate this comment and literature. After review of the submitted literature, it has been determined that CMR is a vital tool for assessment of patients with HCM and is indicated in patients with HCM when echocardiography is inconclusive or there are poor echocardiograph imaging windows. Therefore, this language will be added in the finalized LCD.

3

A comment was received from a professional society requesting to add ICD-10-CM code R94.31 (abnormal electrocardiogram [ECG] [EKG]) to the Group 1 ICD-10 Codes for CPT code 93015 in the associated billing and coding article for this LCD. The requestor indicated R94.31 is needed to indicate a diagnosis such as short Q waves or an abnormality that has not yet been identified on the EKG indicating a need for a stress test. No evidence was submitted with this comment.

We appreciate this comment. After review of the LCD indications, it has been determined that the indications support short Q waves or an abnormality that has not yet been identified. Therefore, ICD-10 code R94.31 will be added to the Group 1 ICD-10 Codes in the associated billing and coding article for this LCD.

4

A comment was received from a professional society suggesting that FDG PET should be considered a first-line test for the assessment of inflammation in Cardiac Sarcoidosis or when MRI is contraindicated or unavailable. They state that FDG-PET is required in cases of known or newly diagnosed cardiac sarcoidosis for anti-inflammatory therapy, as regional wall motion abnormality or late gadolinium enhancement on MRI do not distinguish inflammation from fibrosis. Additionally, FDG PET is indicated in patients with very high continuing clinical suspicion of active sarcoid after negative CMR. A high concern for active inflammation that would be a therapeutic target for treatment is the patient who does have an abnormal CMR with evidence of LGE. LGE is nonspecific and may represent chronic old fibrosis or active inflammation or some combination of the two. Follow up FDG PET is very important in these circumstances since FDG is more specific for active inflammation and positive PET gives therapeutic target for anti-inflammatory therapy (and allows a method of following therapeutic efficacy (positive PET FDG scan turns negative on anti-inflammatory therapy on serial scan). The commenter also indicated that the FDG PET for sarcoidosis does not involve a stress test but rest injections of tracer and seems out of place in this LCD. Additionally, the commenter requested that the language in the LCD be amended in regard to this comment and the appropriate indications for PET FDG in sarcoid be included with appropriate ICD 10 codes. Five references were submitted specific to this comment.

We appreciate this comment and references. In response to this comment, the following language will be added to the finalized LCD: The PET MPI can be safely performed on patients with intracardiac devices and advanced renal disease and is considered to be an appropriate tool to predict and assess response under therapy. The indications for PET MPI will be revised to indicate the following will be considered medically reasonable and necessary: Utilization of PET MPI in the determination of cardiac involvement using fluorodeoxyglucose (F-18 FDG) to diagnose cardiac sarcoidosis in patients who are unable to undergo MRI, have inconclusive MRI findings, or when high probability of disease exists even after a negative MRI. Examples of patients who are unable to undergo MRI include, but are not limited to, patients with metal implants. Also, utilization of PET MPI using fluorodeoxyglucose (F-18 FDG) to determine response to immunosuppressive therapy in patients diagnosed with cardiac sarcoidosis. Additionally, in response to the commenter regarding the PET for sarcoidosis not being a stress test; it is acknowledged that this test is not a stress test but is billed with the same CPT codes used for stress tests.

5

A comment was received from a professional society requesting revision of the language in the ‘Provider Qualifications’ section of the LCD to indicate that non-physician practitioners may perform and supervise exercise stress testing consistent with their authority under state law. References were included with this comment for 42 CFR §410.32(b)(2)(v) and the CMS IOM Publication 100-02, Medicare Benefit Policy Manual, Chapter 15, Section 80.

We appreciate this comment. It was certainly not our intent to restrict non-physician practitioners’ scope of care. Consistent with the regulations, the language in the ‘Provider Qualifications’ section of the LCD has been revised to refer to the applicable regulations for supervision requirements.

6

A comment was received from a stake holder and a professional society requesting additional clarification for indications listed under bullet #1 in section ‘Stress testing with cardiac imaging will be considered medically reasonable and necessary for’.

We appreciate this comment. After review of the indications referred to in this comment and the associated evidence related to these indications in this LCD, we agree that clarification is warranted. Therefore, clarification will be provided in the finalized LCD. In addition, any required dual diagnosis coding is addressed in the associated billing and coding article for this LCD. Furthermore, the medical record will need to support the indication and medical necessity.

7

A comment was received from a stake holder requesting the addition of ICD-10 codes I20.9 (angina pectoris, unspecified) and R07.9 (chest pain, unspecified) to the associated billing and coding article for this LCD. No additional information was provided.

We appreciate this comment. After review of the indications referred to in this comment and the associated evidence related to these indications in this LCD, it has been determined that ICD-10 codes I20.9 and R07.9 will be added to the associated billing and coding article for this LCD.

8

A comment was received from a professional society indicating that all stress imaging studies work toward a goal of diagnosis and risk stratification of patients with known or suspected coronary artery disease, but in clinical everyday practice the choice of stress imaging testing (and the mode of stress) is specific to each patient based on medical decision making and a dialogue between the physician and patient. It is vitally important that the ability of the treating physician to choose the appropriate test for their patient be preserved (i.e., no forced test substitutions).

We appreciate this comment. We recognize that the medical decision making regarding the appropriate testing is a decision that must be made between the provider and the patient.

9

A comment was received from a stakeholder requesting to add an indication for new-onset atrial fibrillation to the proposed LCD. The commenter also requested that ICD-10 codes I48.0, I48.2 and I48.91 be added to the associated billing and coding article for this LCD for the requested indication. Additionally, the commenter requested the addition of ICD-10 codes R07.9 (chest pain, unspecified) and I25.5 (ischemic cardiomyopathy) to the associated billing and coding article for this LCD. Two full-text peer-reviewed articles were submitted with this comment and one reference, which was unavailable.

We appreciate this comment. After review of the submitted literature, the indication for new-onset atrial fibrillation is supported in the literature and will be added to the finalized LCD. The finalized billing and coding article will include ICD-10-CM codes I48.0 and I48.19 to support the additional indication. After review of the LCD indications, it has been determined that ICD-10 codes R07.9 (chest pain, unspecified) and I25.5 (ischemic cardiomyopathy) are appropriate to support the indications in the LCD and will be added to the associated billing and coding article for this LCD.

10

A comment was received from a professional society indicating that according to the Appropriate Use Criteria for Multimodality Imaging in the Assessment of Cardiac Structure and Function in Nonvalvular Heart Disease, MPI may be appropriate in the initial evaluation of a symptomatic patient with atrial fibrillation/flutter (not for purposes of precardioversion evaluation). In cases where the patient has atrial fibrillation doctors often need to rule out ischemia where they are considering giving the patient antiarrhythmic drugs. Considering the criteria for Mulitmodality Imaging in the Assessment of Cardiac Structure and Function in Nonvalvular Heart Disease, the commenter requested that ICD-10-CM codes for atrial fibrillation be added to the associated billing and coding article for this LCD. Two references were submitted specific to this comment.

We appreciate this comment. In response to this comment, language will be added to the finalized LCD to indicate that new onset atrial fibrillation (with no prior cardiac evaluation) will be considered medically reasonable and necessary for stress testing with or without cardiac imaging. The associated billing and coding article for this LCD will be revised to include ICD-10 codes I48.0 and I48.19.

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