**

B.       Determining Whether a CT Scan Is Reasonable and Necessary

**

Sufficient information must be provided with claims to differentiate CT scans
from other radiology services and to make coverage determinations. Carefully
review claims to ensure that a scan is reasonable and necessary for the
individual patient; i.e., the use must be found to be medically appropriate
considering the patients symptoms and preliminary diagnosis.

There is no general rule that requires other diagnostic tests to be tried
before CT scanning is used. However, in an individual case the Medicare
Administrative Contractor (MAC) medical staff may determine that use of a CT
scan as the initial diagnostic test was not reasonable and necessary because
it was not supported by the patients symptoms or complaints stated on the
claim form; e.g., periodic headaches."

Claims for CT scans are reviewed for evidence of abuse, which might include
the absence of reasonable indications for the scans, an excessive number of
scans, or unnecessarily expensive types of scans considering the facts in the
particular cases.

**

C.      Approved Models of CT Equipment

** **

1.      Criteria for Approval

**

In the absence of evidence to the contrary, the MAC may assume that a CT scan
for which payment is requested has been performed on equipment that meets the
following criteria:

  1. The model must be known to the Food and Drug Administration (FDA), and
  2. Must be in the full market release phase of development.

Should it be necessary to confirm that those criteria are met, ask the
manufacturer to submit the information in C.2. If manufacturers inquire about
obtaining Medicare approval for their equipment, inform them of the foregoing
criteria.

**

2.      Evidence of Approval

**

  1. The letter sent by the Bureau of Radiological Health, FDA, to the manufacturer acknowledging the FDAs receipt of information on the specific CT scanner system model submitted as required under Public Law 90-602, The Radiation Control for Health and Safety Act of 1968."
  2. A letter signed by the chief executive officer or other officer acting in a similar capacity for the manufacturer which: 
    1. Furnishes the CT scanner system model number, all names that hospitals and physicians offices may use to refer to the CT scanner system on claims, and the accession number assigned by FDA to the specific model;
    2. Specifies whether the scanner performs head scans only, body scans only (i.e., scans of parts of the body other than the head), or head and body scans;
    3. States that the company or corporation is satisfied with the results of the developmental stages that preceded the full market release phase of the equipment, that the equipment is in the full market release phase, and the date on which it was decided to put the product into the full market release phase.

**

D.      Mobile CT Equipment

**

CT scans performed on mobile units are subject to the same Medicare coverage
requirements applicable to scans performed on stationary units, as well as
certain health and safety requirements recommended by the Health Resources and
Services Administration. As with scans performed on stationary units, the
scans must be determined medically necessary for the individual patient. The
scans must be performed on types of CT scanning equipment that have been
approved for use as stationary units (see C above), and must be in compliance
with applicable State laws and regulations for control of radiation.

**

1.      Hospital Setting

**

The hospital must assume responsibility for the quality of the scan furnished
to inpatients and outpatients and must ensure that a radiologist or other
qualified physician is in charge of the procedure. The radiologist or other
physician (i.e., one who is with the mobile unit) who is responsible for the
procedure must be approved by the hospital for similar privileges.

**

2.      Ambulatory Setting

**

If mobile CT scan services are furnished at an ambulatory health care facility
other than a hospital-based facility, e.g., a freestanding physician-directed
clinic, the diagnostic procedure must be performed by, or under the direct
personal supervision of, a radiologist or other qualified physician. In
addition, the facility must maintain a record of the attending physicians
order for a scan performed on a mobile unit.

**

3.      Billing for Mobile CT Scans

**

Hospitals, hospital-associated radiologists, ambulatory health care
facilities, and physician owner/operators of mobile units may bill for mobile
scans as they would for scans performed on stationary equipment.

**

4.      Claims Review

**

Evidence of compliance with applicable State laws and regulations for control
of radiation should be requested from owners of mobile CT scan units upon
receipt of the first claims. All mobile scan claims should be reviewed very
carefully in accordance with instructions applicable to scans performed on
fixed units, with particular emphasis on the medical necessity for scans
performed in an ambulatory setting.

**

E.      Multi-Planar Diagnostic Imaging (MPDI)

**

In usual CT scanning procedures, a series of transverse or axial images are
reproduced. These transverse images are routinely translated into coronal
and/or sagittal views. MPDI is a process which further translates the data
produced by CT scanning by providing reconstructed oblique images which can
contribute to diagnostic information. MPDI, also known as planar image
reconstruction or reformatted imaging, is covered under Medicare when provided
as a service to an entity performing a covered CT scan.

**

F.      Computed Tomographic Angiography (CTA)

**

CTA is a general phrase used to describe a non-invasive method, using
intravenous contrast, to visualize the coronary arteries (or other vessels)
using high-resolution, high- speed CT.

After examining the medical evidence, the Centers for Medicare and Medicaid
Services has determined that no national coverage determination is appropriate
at this time (March 12, 2008). Section 1862(a)(1)(A) of the Social Security
Act decisions should be made by local MACs through a local coverage
determination process or case-by-case adjudication. See Heckler v. Ringer, 466
U.S. 602, 617 (1984) (Recognizing that the Secretary has discretion to either
establish a generally applicable rule or to allow individual adjudication.).
See also, 68 Fed. Reg. 63692, 63693 (November 7, 2003).