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Xoran’s Position Statement on CBCT Reimbursement

Reimbursement for CBCT and MDCT Imaging Procedures for ENT and Allergy Should be Treated Equally

Xoran Technologies LLC (Xoran) has issued this Position Statement as a result of recent changes in reimbursement by BCBS of Alabama for in-office CBCT procedures for ENT and Allergy. There are too many misconceptions, false claims, and misunderstandings that influenced that decision, and we were compelled to speak up.

As the innovator and U.S. market leader in CBCT since 2001, Xoran understands and supports the diagnostic needs of physicians and patients in ENT and Allergy. Xoran’s CBCT systems are FDA cleared as medical-grade CT systems and accredited by the Intersocietal Accreditation Commission (IAC). Xoran adheres to guidance from the American Academy of Otolaryngology—Head and Neck Surgery’s (AAO-HNS) Position Statement on Point of Care Imaging in Otolaryngology, which states:

We maintain that point-of-care imaging represents a modality of service that is in line with the Institute of Medicine’s six dimensions of high-quality care; care that is safe, timely, effective, efficient, equitable, and patient centered.1

Each of these six dimensions are reflected in the use of in-office, point-of-care CBCT by ENT and Allergy physician specialists. As such, it is Xoran’s position that reimbursement for CBCT scans performed by these physicians at the patient’s point of care in their offices should be treated equally as MDCT scans performed for the same purposes in a hospital or imaging center.

1. CBCT is not of lesser quality than MDCT for ENT and Allergy procedures.2,3,4
Any misconception that in-office CBCT is of “lesser quality” than MDCT for ENT and Allergy procedures is simply not true. In studies to evaluate MDCT and multi-slice spiral CT with cone beam CT (CBCT) for head and neck and sinus imaging, CBCT has been found to provide good diagnostic image quality, while keeping radiation dose low. , The same is true for temporal bone imaging.4

2. Patient benefits of point-of-care CBCT cannot be ignored. 5,6,7,8,9,10,11,12,13,14,15
Objective data demonstrates that patients benefit from the use of CBCT over MDCT, when diagnostic scans are performed by their treating physician at their point-of-care.

a. Lower radiation dose—Lower radiation dose is better. Although CT is often necessary for diagnosis, all CT systems are based on the use of x-rays, which expose patients to ionizing radiation. Providers are required by federal law to use ALARA (as low as reasonably achievable) dose based on the specific diagnostic purpose of the scan. The U.S. Code of Federal Regulations (10 CFR 20.1003) specifies that providers must consider “…the state of technology…” and “…the economics of improvements in relation to benefits to the public health and safety…”.5

When performing CT scans at the patient’s point-of-care using CBCT, the patient receives a lower effective dose:
i. per each study; ENT and Allergy procedures performed with CBCT generally have lower dose than equivalent procedures performed by MDCT;6,7,8,9,10
ii. Xoran’s MiniCAT CBCT scans performed for diagnosis at the patient’s point of care can also be used in subsequent image guided surgery (IGS) procedures, so no rescan is necessary;
iii. Xoran’s MiniCAT CBCT scans are also reusable for minimally invasive procedures, so again, no rescan is necessary;
iv. Xoran’s MiniCAT on-site follow-up scan (after surgery or other treatment) has an even lower dose.

Xoran has helped reduce the overall population radiation dose, which is a growing concern. By scanning more than 2.5 million patients using MiniCAT CBCT systems instead of MDCT, the overall dose to those patients was lowered drastically.

b. Access to care—It is imperative that each patient has access to the best quality of care. Point-of-care CT makes superior diagnostic capabilities available to patients in remote areas and to low-mobility or disabled patients. Patients can be diagnosed on the premises of their physician’s offices, often during their exam, and the correct treatment plan can be initiated immediately.10,11

Access to care also has a time component. Timely and correct diagnosis leads to an accurate treatment plan. Doctors should have access to the best diagnostic tools to provide the best healthcare. Not only is accurate treatment imperative, it is also more cost-effective than presuming a diagnosis based on symptoms alone.12

Point-of-care CT leads to faster diagnosis, treatment, recovery, faster return to work, and lower rates of absenteeism. In the point-of-care CT model, patients lose approximately one-day of productivity per year, whereas without it, patients lose approximately 1.5 days. Considering that chronic rhinosinusitis is estimated to affect three-to-four million Americans per year, this amounts to 1.5-2 million productivity days lost. Note that this calculation does not take into consideration the extra time needed for a separate CT visit at a remotely located hospital or imaging center and the second return visit required at the ENT office.13,14

c. Reduction of unnecessary antibiotics—By determining the correct diagnosis, ENT and Allergy physicians can reduce the incorrect use of large spectrum antibiotics, and therefore hedge against the population’s resistance to antibiotics.5 Expedited treatment with the right medication is better for patients.

d. Improvement in patient compliance with the treatment plan—Patients undergoing point-of-care diagnosis with CBCT were 100% compliant, whereas patients referred to off-site imaging centers for diagnostic CT scans were only 50% compliant with their doctors’ recommendations. With this increased compliance, unnecessary antibiotic prescriptions were reduced by 60%.15

3. Same reimbursement for the same procedure.5
Should a doctor who uses a golden stethoscope get more for a patient exam?
Why reimburse for equipment (MDCT) that is designed for much more complex imaging procedures (yet still used for simpler ones), when less expensive, equally effective, and more efficient equipment (CBCT) is available? Why establish preferential treatment for reimbursing scans performed on higher priced equipment that generate the same or lesser quality results? Who benefits from that? Radiologists? Lobbyists? Insurance companies? Definitely not patients.

Instead, why not honor the letter and intent of Code of Federal Regulations (10 CFR 20.1003), which expressly requires consideration of “the state of technology” and “…the economics of improvements in relation to benefits to the public health and safety…”.5 CBCT scanners are less expensive systems that generate the same (or better) quality diagnostic images as MDCT systems for ENT and Allergy needs. The same concept also applies to hospitals as well as doctors’ offices—CBCT should be used in hospitals for the simpler, low-dose scans required for ENT and Allergy diagnostics, freeing up the large, expensive MDCT scanners for the more complex imaging tasks. Why not make patients’ experience better instead of protecting the sacred walls erected by radiologists to protect their market from erosion in the face of simpler, easier-to-use technologies?

“Same reimbursement for same procedure” drives innovation, lowering the cost of equipment for the same procedure.

4. CMS is embracing in-office, point-of-care CT.1,5,16
By promulgating regulations through IAC accreditation and XR-29 conformance requirements, Medicare has demonstrated that they are embracing in-office, point-of-care CBCT. CMS is ensuring that practices are providing high-quality procedures in their offices by relying on field experts and organizations for guidance, including NEMA, CMS, FDA5, IAC, and AAO-HNS1.

In addition, CMS is implementing quality measures, such as MACRA, which incentivize physicians to perform timely care and avoid unnecessary radiation exposure.16

CMS is not randomly penalizing non-hospital imaging procedures, rather, CMS looks to expert opinions and non-anecdotal data to form their reimbursement policies.

5. Medical-grade CBCT is different from dental CBCT.17,18
Medical-grade CBCT, as defined by FDA classification code JAK.17, is not the same as dental CBCT, FDA classification code, OAS.18

Medical-grade CBCT must conform to the same regulatory standards as MDCT. Dental CBCT, however, does not have to do so.

6. The true role of insurance companies.19
Insurance companies, by means of unilaterally dominating certain geographical markets, have enjoyed unchecked and under-scrutinized power. They have exerted pressure tactics on doctors, patients, medical device manufacturers, and others, into using certain products and procedures while neglecting others—without providing objective data or reasonable explanation to support the appropriateness and efficacy of their decisions. When providers in these areas depend on insurance reimbursement to support their medical practices, they are prevented from exercising their own medical judgment for their patients and are, instead, bullied into using unsubstantiated insurance-approved procedures which may not be the most appropriate and effective for their patients. In the process, they are increasing the cost of healthcare and passing it onto patients, while keeping their profits the same or higher.

What’s more, when radiology benefit managers (RBMs) are used by private payers to manage the utilization of imaging services through prior authorization, the reduction in cost was either inconclusive, or significant costs were simply shifted to physicians.19

Reimbursement for CBCT and MDCT imaging procedures for ENT and Allergy should be treated equally.

Politics, turf wars, vested interests, and insurance companies dictating how medical specialists diagnose their patients is the old way.

The new way is progressive, office-based, point-of-care imaging and procedures.

The new way is safety, quality, dose control, XR-29 conformance, and improved patient experience and outcome.

The new way is access to modern quality care and lower radiation dose procedures.

The new way is recognition that physicians deserve to be reimbursed for the diagnostic scans they perform on their own patients in their own office.

The new way is CBCT.

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