|
Title XVIII of the
Social Security Act, Section 1862 (a)(1)(A). This section excludes coverage
of items or services that are not reasonable and necessary for the
diagnosis or treatment of illness or injury or to improve the functioning
of a malformed body member.
Title XVIII of the Social Security Act, Section 1862 (a)(7). This section
prohibits Medicare payment for any expenses on items and services incurred
for routine physical examinations.
Title XVIII of the Social Security Act, Section 1833 (e). This section
prohibits Medicare payment for any claim that lacks the necessary
information to process the claim.
CMS Pub 100-2, 15, §50, 17-§10
Medicare Carriers Manual, Section 2050.5(A)
|
|
Botulinum toxin is a
complex protein produced by the anaerobic bacterium Clostridium. Botulinum
Toxin Type A injections are used to treat various focal muscle spastic
disorders and excessive muscle contractions such as dystonias, spasms,
twitches, etc. They produce a presynaptic neuromuscular blockade by
preventing the release of acetylcholine from the nerve endings. The
resulting chemical-denervation of muscle produces local paresis or
paralysis and allows individual muscles to be weakened selectively. It has
the advantage of being a potent neuromuscular blocking agent with good
selectivity, duration of action, with the smallest antigenicity, and fewest
side effects.
Before consideration of coverage may be made, it should be established that
the patient(s) has been unresponsive to conventional methods of treatments
such as medication, physical therapy and other appropriate methods used to
control and/or treat spastic conditions.
Coverage of Botulinum Toxin Type A for certain spastic conditions (e.g.,
cerebral palsy, stroke, head trauma, spinal cord injuries, and multiple
sclerosis), will be limited to those conditions listed in the Covered ICD-9
section of this policy. All other uses in the treatment of other types of
spasm, including smooth muscle types, will be considered as investigational
and therefore, noncovered by Medicare.
Botulinum Toxin Type A can be used to reduce spasticity or excessive
muscular contractions to relieve pain; to assist in posturing and walking;
to allow better range of motion; to permit better physical therapy; to
reduce severe spasm in order to provide adequate perineal hygiene.
Due to the uncommonness of organic writer’s cramp, Medicare would not
expect to see the treatment of this condition to be billed frequently.
There may be patients who require electromyography in order to determine
the proper injection site (s). The electromyography procedure codes
specified in the HCPCS section of this policy may be covered if the
physician has difficulty in determining the proper injection site.
The patient who has a spastic or excessive muscular contraction condition
is usually started with a low dose of Botulinum Toxin A (10 units) and the
accepted maximum dosage per site is about 25 units. Other spastic or
muscular contraction conditions, such as, eye muscle disorders, (e.g.,
blepharospasm) may require lesser amounts such as only 1-2 units. For
larger muscle groups, it is generally agreed that once a maximum of 25
units per site has been reached and there is no response, the treatment is
discontinued. The treatments may be resumed at a later date. With response,
the effect of the injections generally lasts for 3 months at which time the
patient may need repeat injections to control the spastic or excessive
muscular condition. It is usually considered not medically necessary to
give Botulinum Toxin Type A injections for spastic or excess muscular
contraction conditions more frequently than every 90 days, unless
acceptable justification is documented for more frequent use in the initial
therapy.
Coverage of treatments provided may be continued unless any two treatments
in a row, utilizing an appropriate or maximum dose of Botulinum Toxin Type
A failed to produce satisfactory clinical response. Providers must also
document the results of and the response to these injections after every
third session.
Requests may be considered for continued treatment during a treatment
period or for resumption at a later date if satisfactory results have not
been obtained, if compelling clinical evidence of medical necessity is
presented.
Medicare will allow payment for one injection per site regardless of the
number of injections made into the site. A site is defined as including
muscles of a single contiguous body part, such as, a single limb, eyelid,
face, neck etc,
Medicare will allow payment for the treatment of achalasia when dilatation
and/or myotomy is specifically contraindicated.
Irritable colon, biliary dyskinesia or any treatment of other spastic
conditions not listed as covered in this policy are considered to be
cosmetic, investigational (including the treatment of smooth muscle spasm),
not safe and effective, and are not accepted as the standard of practice
within the medical community.
Treatment of severe primary axillary hyperhidrosis. For purposes of this
policy, severe primary hyperhidrosis is defined as a condition involving
focal, visible and severe sweating of at least 6 months duration without
apparent cause that has at least 2 of the following characteristics: (1)
sweating is bilateral and relatively symmetric, (2) impairs daily
activities, (3) episodes occur at least once per week, (4) the age of onset
was less than 25 years, (5) there is a positive family history, and (6)
focal sweating stops during sleep. Treatment of severe primary axillary
hyperhidrosis will be considered as medically reasonable and necessary only
for patients in whom the axillary hyperhidrosis is barely tolerable or
intolerable and frequently or always interferes with daily activities in
spite of optimal treatment with topical agents, such as
prescription-strength aluminum chloride, or who could not tolerate these
agents.
Treatment of medically significant sialorrhea. Limited coverage exists for
medically significant sialorrhea. Injection into salivary glands will be
covered when there is documentation that:
1. A medically significant condition of sialorrhea exists, either on a
primary (overproduction) basis or due to conditions (e.g. Parkinson's
Disease) that interfere with normal swallowing mechanisms. The medical
record must show that the condition is medically significant, i.e. that
adverse health outcomes such as recurrent perioral skin breakdown or
recurrent aspiration pneumonia are caused by or significantly worsened by
the presence of the sialorrhea. The existence of drooling as a social or
caretaker concern does not qualify as medically significant.
2. The patient has failed to respond to a reasonable trial of less invasive
means, including pharmacotherapy (unless contraindicated) and at least one
other approach such as speech therapy, behavioral therapy or other
non-pharmacologic means.
Dosages are expected to conform to recommended levels for the threatment of
this conditon; greater than 100 U (cumulatively across all glands at a
single session) will not be considered medically necessary. The medical
record is expected to show documented evidence of improvement beyond the
subjective assessment that drooling has decreased.
|