Medicare Coverage Policy ~ Decisions
Augmentative and Alternative Communication (AAC) Devices
(#CAG-00055)
Decision Memorandum
To: |
File: Augmentative and Alternative Communication
Devices CAG - 00055, Reference CIM 60-9 Communicator |
From: |
Hugh F. Hill III, MD, JD Acting Director, Coverage and
Analysis Group
Lorrie Ballantine Health Insurance Specialist, Coverage
and Analysis Group
Madeline Ulrich, MD Medical Officer, Coverage and
Analysis Group |
Re: |
National Coverage Policy Request |
Date: |
April 26, 2000 |
Medicare is committed to having an open, understandable and
predictable coverage process for benefits provided by the program.
HCFA relies on medical and scientific evidence to make coverage
decisions, including medical literature and data, discussions with
medical experts and technology assessments. The agency is committed
to striking the appropriate balance between providing timely access
to medical advances and ensuring that new technologies and
treatments are effective and "reasonable and necessary."
We received a formal request for a national coverage
determination on Augmentative and Alternative Communication (AAC)
devices. The requestors asked that our current non-covered
determination on AACs found in the Coverage Issues Manual 60-9,
which is based on Section 1861(n) of the Social Security Act, the
definition of Durable Medical Equipment, be deleted and that AAC
devices be classified as durable medical equipment and be covered by
the Medicare program.
Before a coverage decision could be made, the Center for Health
Plans and Providers (CHPP) needed to make an initial determination
as to whether or not an item or service falls within a covered
benefit category. The decision that AAC devices were "convenience
items" and thus did not fit a benefit category had been made a
number of years ago. In response to the requestors, CHPP has
reversed this decision and has now decided that AAC devices are a
Medicare benefit in the category of durable medical equipment
(DME).
In order to make a national determination to cover AAC devices,
sufficient medical evidence to support such a decision must be
presented. Upon review of the supporting documentation presented by
the requester, we determined that we need more information to
support issuance of positive national coverage guidelines. Until we
receive and review additional information, we are reversing our
national non-coverage decision, and permitting carriers to make
local coverage decisions.
This means that, when this change has taken effect, carriers, as
required under Section 1862(a)(1)(A), will make coverage decisions
for claims for any AAC devices on either a case-by-case basis or
through a local policy. We expect to be able to issue a national
coverage decision with detailed coverage guidelines after review of
the additional information we are hereby requesting. Until we are
able to develop a national policy, local discretion prevails.
The material submitted in support of the request to cover AAC
devices is suggestive of the utility of these devices for those with
severe speech impairments, but did not offer sufficient medical
evidence to permit identification of those patients; outcomes data
supporting the beneficial long term effects of the devices; and
criteria for evaluation of patients that would assure that they
possess both the physical and cognitive ability to effectively use
an AAC device.
Of particular note in the supporting documentation, was a 1995
report detailing the recommendations of a workshop sponsored by the
National Institute on Deafness and Other Communications Disorders,
dealing with AAC research priorities. The recommendations included:
- Study of the influence of user variability on AAC use;
- Development of tools and strategies to validly and reliably
measure communicative, operational, linguistic, strategic and
social competence of children and adults who use AACs.
- Investigation of the effectiveness of AACs by user age,
etiology (of impairment) and social context "to determine those
factors that are related to success and failure of AAC use."
The results of the suggested research were not included in the
supporting material submitted. We recognize that these devices do
not lend themselves to randomized clinical trials, which are the
gold standard of scientific evidence, but we need more material
reporting results for multiple patients over extended periods in
order to develop specific coverage guidelines for AACs.
We are particularly desirous of receiving input from the
physician community treating patients whose disabling conditions
include severe speech impairment. We seek input from the entire
health care team likely to be providing services to a patient with a
severe speech impairment, including the attending physician,
specialists, such as neurologists, primary care givers, and other
therapists. The patient's attempts to make his or her needs for
medical care known to these involved parties is the essence of the
medical necessity for an AAC device.
We are very interested in a useable definition of "severe". We
have seen estimates that up to 4.5 million people in the United
States suffer from speech impairment, but we do not know how severe
these impairments are or which of them might benefit from an AAC. We
seek scientific proof or clinical rationale that might support the
use of AACs for an appropriate and clearly defined patient
population. The population might be defined by disease entity with
severity indices. We do not wish to cover these devices in
populations where they have no medical benefit or where there is no
evidence of improvement for a defined population. We need
information showing that these devices have a positive health
outcome.
Information which can support clinical inclusion characteristics
for approval of AAC devices might address the following points:
What are the specific chronic disease entities, including
variants within such entities, which result in complete, permanent
loss of meaningful oral communication, but which do not impair
cognitive and physical ability to use AAC equipment successfully?
Such impairments and variants should have defined diagnostic
criteria, which make a definite diagnosis possible, and such
criteria should be included in the response.
What are the specific symptomatic or functional deficits for
which AAC devices are useful? The original request was for a
population that had loss of speech, characterized as dysarthria,
apraxia or aphasia. We are concerned that this list is both too
inclusive and also exclusive of populations that could benefit, and
thus further specification and refinement are needed. For example,
patients who are aphonic on a long term basis due to laryngeal
disorders may be eligible for an AAC device, but are not discussed
in the supporting material received. On the other hand, we are not
convinced that all patients with aphasia could benefit from an AAC.
Language impairment could occur as a component manifestation of
several neurological disorders, which produce cognitive deficits.
This merits particular consideration because cognitive impairment
will impede learning and the ability to operate any device,
including an AAC.
We are interested in knowing if speech language pathologists or
physicians with whom they work have developed metrics that correlate
cognitive scales with outcomes after AAC use. If so, did the
outcomes positively trend at certain levels of cognition? Are there
any controlled studies comparing the outcomes and benefits of AACs
with other interventions which may foster language such as
additional care giver attention and provision of social support?
There was some material submitted by the requester indicating that
improved social support did foster communication, but no comparison
to AAC use was presented.
Similarly, while the information provided did describe five
stages of dysarthria and recommended coverage of the device
beginning at stage III, no objective and quantifiable means of
distinguishing between the five stages was presented. We would be
interested in knowing if objective testing exists, which would
permit such distinctions, and receiving descriptions of it, if
available.
Information that might support development of exclusion criteria
might address:
Whether patients with some or all types of aphasia should be
excluded from coverage of an AAC device. What types of chronic brain
diseases should be excluded? How severe does the chronic brain
disease have to be before a patient is incapable of use of these
devices? How would we measure or define the severity of chronic
brain failure or cognitive function? Should this be determined
through neuropsychiatric testing? If so, what test(s) would be
accurate, reliable and valid?
We believe that most of the disease entities for which coverage
of AAC devices might be appropriate will require an neurologist's
assessment of the etiology of the speech loss, the type of speech
loss, the severity of loss and the presence or absence of excluding
conditions before a specific recommendation for the equipment could
be made. Comments on specific tests, if any, which should be
included in that assessment to ensure that the patient has
sufficient cognitive and physical capacity to be able to effectively
use AAC equipment, are requested.
We would like recommendations as to the number of visits with a
speech language pathologist which are necessary for training of the
patient in the use of a particular AAC device and in customizing its
features to meet the patient's medical needs.
Can the speech language community develop valid and reliable
objective measures for assessing the benefits realized from an AAC
device in each patient at specified periods after the device has
been provided? We are interested in comments from speech language
pathologists, treating physicians and ancillary personnel on this
issue. This may be an ongoing process. We do not address duration of
use as a coverage criterion here, but this may be dealt with by
other components within HCFA as a condition of payment.
Implementation instructions to contractors will follow and the
effective date for this decision will be no later than January 1,
2001.
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