Ohio Admin. Code 5160-10-28 - DMEPOS: osteogenesis stimulators
(A)
Coverage.
(1)
Payment may be
made for the purchase only of a noninvasive osteogenesis
stimulator.
(2)
The default certificate of medical necessity (CMN) form
is the ODM 07134, "Certificate of Medical Necessity: Osteogenesis Stimulators"
(rev. 7/2018). The CMN must include an attestation that appropriate coverage
criteria are met.
(3)
Payment may be made for a spinal electrical
osteogenesis stimulator only if at least one of the following criteria is
met:
(a)
The
individual has undergone multilevel spinal fusion surgery;
(b)
The individual
has undergone spinal fusion surgery that has failed, and at least nine months
have elapsed since the most recent operation; or
(c)
The individual
has undergone spinal fusion surgery, and previous attempts at spinal fusion at
the same site have failed.
(4)
Payment may be
made for a non-spinal electrical osteogenesis stimulator only if at least one
of the following criteria is met:
(a)
The fracture is in a long bone and has failed to unite
for at least three months, which the provider substantiates with the following
documentation:
(i)
At least two sets of images including multiple views of
the fracture site, the first and last of which were taken at least ninety days
apart; and
(ii)
A written statement by a qualified interpreting
practitioner that there has been no clinically significant evidence of fracture
healing during the period when the images were taken.
(b)
The
individual has congenital pseudarthrosis; or
(c)
The individual
has undergone joint fusion surgery that has failed, and at least nine months
have elapsed since the most recent operation.
(5)
Payment may be
made for an ultrasonic osteogenesis stimulator only if all of the following
criteria are met:
(a)
The fracture is in a long bone;
(b)
The fracture is
not tumor-related; and
(c)
The fracture has failed to unite for at least three
months, which the provider substantiates with the following
documentation:
(i)
At least two sets of images including multiple views of
the fracture site, the first and last of which were taken at least ninety days
apart; and
(ii)
A written statement by a qualified interpreting
practitioner that there has been no clinically significant evidence of fracture
healing during the period when the images were taken.
(6)
Payment may be made for either an electrical or an
ultrasonic osteogenesis stimulator for an individual who is younger than
twenty-one years of age only if all of the following additional criteria are
also met:
(a)
There is radiological documentation that skeletal maturity
has been attained;
(b)
The fracture gap is not greater than one half of the
diameter of the bone to be treated; and
(c)
The fracture does
not involve a vertebra.
(B)
Requirements,
constraints, and limitations.
(1)
Contraindications to treatment include but are not
limited to the following examples:
(a)
Fracture of a short bone, a flat bone, or an
epiphysis;
(b)
Fracture that results from cancer;
(c)
Fracture that
needs additional reduction or is comminuted;
(d)
Fracture with
post-reduction displacement of greater than fifty per cent;
(e)
Fracture with
internal or external fixation;
(f)
Fracture gap
greater than one centimeter or greater than one half of the diameter of the
bone;
(g)
Avascularity, vascular insufficiency, or other vascular
problems (e.g., thrombophlebitis);
(h)
Severe
osteoporosis;
(i)
The taking of medication that may interfere with or
alter bone metabolism and healing;
(j)
Infection or
necrosis in the bone;
(k)
Paget's disease, renal disease, or
diabetes;
(l)
Sensory paralysis; or
(m)
Synovial
pseudarthrosis.
(2)
Payment will not knowingly be made for an electrical
osteogenesis stimulator used in proximity to vital equipment, such as a
pacemaker, that may be adversely affected by changes in electromagnetic
fields.
(3)
Separate payment will not be made for the concurrent
use of more than one osteogenesis stimulator on the same fracture site.
Replaces: 5160-10-28
Notes
Promulgated Under: 119.03
Statutory Authority: 5164.02
Rule Amplifies: 5164.02
Prior Effective Dates: 10/15/2006
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