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
7/2024). The CMN must
include
includes 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 other
than the skull or a vertebra;
(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,
Constraints and limitations.
(1)
Contraindications
Possible
contraindications to treatment include but are not limited to the
following non-exhaustive list of examples:
(f)(e) Fracture gap
greater than one centimeter or greater than one half of the diameter of the
bone;
(g)(f) Avascularity,
vascular insufficiency, or other vascular problems (e.g.,
thrombophlebitis);
(h)(g) Severe
osteoporosis;
(i)(h) The taking of
medication that may interfere with or alter bone metabolism and healing;
(k)(i) Paget's disease,
renal disease, or diabetes;
(l)(j) Sensory paralysis;
or
(m)(k) Synovial
pseudarthrosis.
(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;
(j) Infection or necrosis in the
bone;
(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.
Notes
Promulgated Under: 119.03
Statutory Authority: 5164.02
Rule Amplifies: 5164.02
Prior Effective Dates: 10/15/2006, 07/16/2018
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