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OMNISENSE 7000S/8000S
Frequently Asked Questions
Following is a compiled list of questions frequently received from customers. You may find valuable information in our responses.
Who is eligible to have a bone density test under Medicare and
what is the average reimbursement amount?
As covered under the Bone Mass Measurement Act (1998), there are five groups of
qualified individuals that are covered by Medicare for bone strength testing if
ordered by a treating physician or qualified non-physician practitioner:
- An estrogen deficient woman at clinical risk for osteoporosis
- An individual with vertebral abnormalities
- An individual receiving long-term glucocorticoid therapy
- An individual with primary hyperparathyroidism
- An individual being monitored to assess the response to or efficacy of an FDA-approved osteoporosis drug therapy.
The average reimbursement for testing with Omnisense 7000S (Ultrasound, code 76977) was $33.00
How often can the test be repeated?
In general, bone strength assessment tests can be repeated and will be paid for
every two years, as long as the person falls into one of the above five groups and
the test is ordered by the beneficiary's treating physician or other treating
practitioner.
Do private insurance carriers cover bone strength
tests?
Reimbursement amounts and coverage criteria for bone strength assessment tests
offered through private employer-sponsored health plans are variable. There is
currently no federal law, as there is for Medicare, that standardizes coverage
criteria and reimbursement rates for bone density tests on the private side. Often
though, private health plans follow the Medicare rules.
How well can a measurement at the wrist predict the risk of
fracture of hip or spine?
A wealth of data and clinical studies support Omnisense' fracture prediction
abilities by measuring at the radius. Hip and spine are the traditional sites measured
by DXA. Omnisense' clinical studies demonstrate that by measuring the Radius,
Omnisense' fracture prediction ability is equal to that of DXA obtained at the hip
and spine.
Further, it is important to know that Omnisense measures a major fracture site--the wrist. This peripheral site is the earliest to fracture, often preceding hip and spine fractures by as much as 10 to 28 years.
What is being measured with
Omnisense?
Omnisense measures Speed of Sound (SOS) expressed as meters per second. SOS
is the most appropriate technology to measure bone strength since multiple bone
properties--microstructure, elasticity, cortical thickness, bone density--are
accounted for in the result.
DXA measurements are based on bone mineral density only, a limited predictor of bone strength and changes, over time.
What is Omnipath™ axial transmission technology?
Sunlight's patented axial transmission technology, Omnipath™--is based on the
measurement of the speed of ultrasonic waves (SOS) propagating along the
bone.
Omnipath™ enables measurement along the bone's maximal strength axis,
eliminating soft tissue effects and providing a more accurate measurement.
What advantage does a radius measurement offer over a heel
measurement?
The radius site, when measured by the Omnisense, enables a more accurate
measurement by allowing for a measurement along-the-bone, eliminating soft tissue
discrepancies. Heel ultrasound technologies, on the other hand, transmit signals
through the bone. When measuring through or 'across' the bone, soft tissue
discrepancies affecting measurement accuracy, are often a problem.
Is there a difference between weight bearing and non-weight
bearing bone in predicting the risk of fracture?
In predicting the risk of fracture it is important to keep in mind that osteoporosis is a
systemic disease that affects the entire skeleton. Ergo one bone can potentially
predict fracture risk as well as another. The key lies in the device's sensitivity to
bone change. In test after test, Onmisense has proven itself sensitive to bone changes
due to aging and in response to treatment.
How precise is
Omnisense?
Omnisense precision is 0.4% at the radius, one of the highest precision ratings in the
industry. Precision is important because it gives the system the ability to monitor
bone changes due to aging, treatment and other disorders.
Based on Omnisense's high precision levels, the FDA approved the Ornnisense indication for use in monitoring bone changes in the relevant age groups (50-65, peri & post-menopause).
Does Omnisense comply with WHO diagnosis criteria?
Yes, Omnisense is WHO compliant. The Omnisense reference database has the same
osteoporosis prevalence as Spine and Forearm DXA crossing the -2.5 diagnosis line
at approximately 75 years of age.
What should a physician do when there are different results
between Omnisense and DXA measurement results?
Each measurement is case dependent and the physician would need to take into
consideration all the clinical factors such as age, family history, ongoing treatment,
etc. to arrive at a diagnosis. It is very common to receive different results when
measuring both, at different sites as in the case of DXA or between two different
technologies like Onmisense and DXA.
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