History/Background and/or General Information
The technological approach of multi-slice imaging along with the enhanced imaging techniques has allowed for the generation of three-dimensional (3D) images known as 3D reconstruction or 3D rendering. Three-dimensional imaging has been applied to ultrasound, echocardiography, computed tomography (CT), magnetic resonance imaging (MRI), and other tomographic modalities. Applications of this technology include, for example, coronary artery imaging, visualization of central nervous system vasculature, and enhanced imaging of the thorax which includes, for example, aortic aneurysms, embolic disease, and inflammatory and neoplastic lesions.
Covered Indications
Three-dimensional imaging is medically reasonable and necessary only if the outcome will potentially impact the diagnosis or clinical course of the patient. Providers are encouraged to obtain additional information from referring providers and/or patients or medical records to determine the medical necessity of studies performed. Referring physicians are required to provide appropriate diagnostic information to the performing provider.
As with any diagnostic testing, the procedure should be furnished in accordance with accepted standards of medical practice based on the patient’s diagnosis, signs, and symptoms. This additional procedure applied to a base procedure must meet but not exceed the patient’s medical need.
Three dimensional rendering codes should be reserved for situations where the additional image is necessary for a complete depiction of an abnormality from the 2D study or for surgical planning.
For non-hospital based outpatient services, it is expected that the ordering/referring physician/non-physician practitioner generate a written order/referral indicating the medical necessity for the additional 3D imaging. In addition, it is expected that the interpreting physician maintain a copy of the test results and interpretation along with a copy of the ordering/referring physician/non-physician practitioner’s order for the study. The interpreting physician’s report should address the medical necessity identified by the ordering/referring physician/non-physician practitioner. In the event it is deemed by the interpreting physician that a 3D interpretation is urgently needed and the ordering/referring physician/non-physician practitioner is not immediately available, the interpreting physician must document the following on the radiology report: the time of the study; specific medical need for the study; and a legible summary of the findings that were urgently transmitted to the ordering/referring physician/non-physician practitioner whose name is on the order for the study.
For hospital based services (inpatient/outpatient), it is expected that there should be an order for the 3D image. In the absence of the order for the 3D image, if the hospital’s interpreting physician deems that the 3D interpretation is needed, he or she should clearly state in the interpretation the medical necessity for this separate service, in addition to the base procedure.
Limitations
3D rendering with interpretation and reporting requiring and not requiring image post processing will not be considered medically reasonable and necessary if equivalent information obtained from the test has already been provided by another procedure (ultrasound, MRI, angiography, etc.) or if it could be provided by a standard CT scan (two-dimensional) without reconstruction.
3D rendering with interpretation and reporting during a radiation oncology episode of care is included in 3D simulation when applicable or IMRT plan when applicable and, therefore, should not be billed.
Three-dimensional imaging will not be covered when performed based on internal protocols of the testing facility; a referral for one 3D imaging is not a blanket referral for all studies. In most cases, it is expected that the provider treating the patient specifically orders the procedure in writing and that the order should be on record for each 3D imaging performed.
For guidance regarding ordering tests, provider qualifications and supervision of diagnostic testing, please refer to 42 CFR §410.32 - Diagnostic x-ray tests, diagnostic laboratory tests, and other diagnostic tests: Conditions.
For guidelines regarding conditions of participation, please refer to 42 CFR §482.26 - Condition of participation: Radiologic services.
As published in the CMS IOM Publication 100-08, Medicare Program Integrity Manual, Chapter 13, Section 13.5.4, an item or service may be covered by a contractor LCD if it is reasonable and necessary under the Social Security Act Section 1862 (a)(1)(A). Contractors shall determine and describe the circumstances under which the item or service is considered reasonable and necessary.
