January 08, 2015

ACR and SBI Guidance on DBT “Off Label” Use

The American College of Radiology (ACR) Commissions on Economics and Breast Imaging and SBI Board members receive questions regarding the use of new and/or modified diagnostic imaging technologies. Recently, there has been increased member interest in the use, coding and billing of digital breast tomosynthesis (DBT).

For Mammography Quality Standards Act (MQSA) purposes, the FDA considers DBT to be a new mammographic modality, separate from Full Field Digital Mammography (FFDM). Therefore, DBT required separate FDA approval.

Many vendors are working on this technology, but to date, only two have been FDA approved. Although the fundamental principles of tomosynthesis are used by all vendors, there are differences in design and operation of the two systems. The approaches they took to gain FDA approval were different. The technology and approaches of additional vendors may also differ.

Some members raised questions regarding “off-label” use of DBT including views or projections other than those specified in the vendors' initial application. FDA approval of a medical device includes approved uses that the manufacturer’s labeling should contain and the claims for the device that the manufacturer is permitted to make. Any use not included in the device labeling is considered "off-label use."

The FDA Information Sheet on Off-Label and Investigational Use Of Marketed Drugs, Biologics, and Medical Devices states: “Good medical practice and the best interests of the patient require that physicians use legally available drugs, biologics and devices according to their best knowledge and judgment. If physicians use a product for an indication not in the approved labeling, they have the responsibility to be well informed about the product, to base its use on firm scientific rationale and on sound medical evidence, and to maintain records of the product's use and effects.”

Thus, use of DBT in this manner is permissible, when the radiologist’s intent is the informed practice of medicine.

Frequently Asked Questions:

Question: My manufacturer received approval to produce synthetized planar images from DBT images. Can I obtain both MLO and CC full field digital and DBT acquisitions of each breast if I do not have the reconstruction software which can produce planar images?

Answer: Yes.

Question: Can I obtain CC DBT views if the maker of my equipment only obtained FDA approval for MLO DBT views?

Answer: Yes. Off-label use is permitted.