According to the American Orthotic and Prosthetic Association
(AOPA), the durable medical equipment regional carriers (DMERCs) have
determined that the useful lifetime of orthotic devices is five years. Medicare
will pay for a replacement during this five-year period only if the device is
lost, irreparably damaged or the patient’s medical condition changes such
that the device no longer meets the patients needs. Medicare coverage of
replacement due to irreparable wear during the period of the device’s
five-year useful lifetime is currently not covered. An AOPA government affairs
representative explained that the four DMERCs define wear as deterioration
sustained from day-to-day usage over time, where a specific event cannot be
identified that caused the deterioration.
While the Medicare five-year replacement rule has been on the
books for several years for durable medical equipment, prosthetics, orthotics
and supplies (DMEPOS), this policy has only been recently enforced for
orthotics. Why is this occurring? What kind of problems does this rule pose to
providers and patients and what can be done? To answer these questions,
O&P Business News interviewed experts in the O&P
Definition and Rationale
O&P Business News: What is the five-year
replacement rule? Why was it put into place?
Walter Gorski, director of legislative affairs, AOPA: The
issue of Medicare coverage for the replacement of orthotic devices that are
subject to irreparable wear was an issue that reared its head in the early
1990s. At that time, the Centers for Medicare and Medicaid Services (CMS)
officials had drafted regulations that said Medicare would not pay for the
replacement of an orthotic device if it was irreparably worn within five years
of the provision of the device. Those regulations have been on the books since
the early 1990s, however, only recently has Medicare been actively enforcing
Peggy Walker, RN, billing and reimbursement advisor for
the Orthotic Prosthetic Group of America (OPGA), US Rehab and the VGM Group:
This rule has been recently enforced because of a high increase of duplication
in billing for certain codes. In particular instances, certain providers were
billing inappropriately. For example, one patient was billed for four knee
braces within a four-month period. CMS sometimes reacts in a knee-jerk fashion.
They don’t understand that it is not necessary to apply such a sweeping
policy in order to stop the abuse by a few providers. It is confusing, however,
because the Medicare Carriers Manual states that if a patient needs a
replacement due to irreparable wear and tear it is supposed to be covered, even
without a physician’s order. It doesn’t say anything about a
John W. Michael, CPO, FAAOP, president of CPO Services
Inc, Portage, Ind.: The five-year replacement rule is another one of those
stray bullets that has hit O&P over the years. By that I mean this rule was
originally conceived and intended to apply to durable medical equipment such as
canes and walkers. CMS is now firing bullets at what they perceive as overuse
of non-custom devices such as made-to-template knee orthoses. In the process,
when they target the guy inappropriately providing non-custom devices, the
bullet hits the orthotist who is providing an intimately fitted, totally
custom-made KAFO. It is nothing personal — they didn’t even know the
orthotist and his patient were standing there.
As recently as January 2001, the local Medicare carriers assured
us in writing that this rule didn’t apply to O&P. It was intended to
protect program integrity. They wanted to make sure people weren’t getting
a new cane every few months — one for the car, one for the house, one for
the shopping center. This makes good sense. However, they have gradually
broadened the interpretation of the equipment rule to apply to custom orthoses.
The average lifespan of a custom orthoses is not five years. It is impossible
to make a blanket determination on how long all custom-made orthosis will last.
It depends on what type of device it is, how active the patient is and several
other factors. It is like saying, ‘what is the average lifespan after
surgery,’ without stating what kind of surgery was performed.
Damage Versus Wear
O&P Business News: What is the
difference between irreparable damage and irreparable wear?
Gorski: The DMERCs now distinguish between irreparable
damage and damage due to wear. But what is ironic is that Medicare will pay for
a device if it is irreparably damaged, such as being run over by a car or some
other unlikely scenario. In other words, Medicare will pay for a replacement
orthosis only if a specific event can be identified causing the device not to
function as it was originally intended.
Michael: That is the rub. Irreparable damage means they
will only replace the device within that five-year period if it is seriously
damaged, such as a walker being run over by a car in a nursing home parking
lot. But they won’t replace it if a patient is simply using it and it has
worn out due to normal use. This policy targets the more active individual who
is doing everything possible to live a normal life.
For example, if you have polio and your leg is paralyzed and
deformed as a result, it may be that the only way you can walk at all is to use
a custom KAFO, stressing the brace with each step from dawn until bedtime in
the course of your full-time active employment and your responsibilities as a
parent and spouse. Consequently, the stresses of supporting your paralyzed and
deformed leg wear out the orthosis after three years. The current irreparable
wear policy expects you to stop walking for a few years until your eligibility
is restored, which might mean you lose your job, become wheelchair-dependent
and stop living independently. That can’t be good public policy.
Gorski: Many orthotic devices simply do not last five
years. There is an intimate fit with the body and due to general wear on the
device, fluctuating body fluids and frequent washings, devices have a tendency
to not function as they were originally intended after a period of time, many
times short of that five-year period. We understand where this policy came from
— unscrupulous providers billing Medicare frequently for the same device.
However, it seems to be an incongruous policy that is shortsighted.
O&P Business News: What is AOPA doing to
amend this rule?
Michael: About two years ago, AOPA was successful in
convincing CMS to rescind the interpretation related to prostheses, but they
were not successful in extending the legislation to cover orthotic devices at
Gorski: About eight months ago, AOPA met with senior
officials from CMS and recommended that they revise the policy and apply the
same policy that governs prosthetic devices to orthotic devices. The
recommendations to CMS on the replacement of orthotics are that payment shall
be made for the replacement of orthotic devices or the replacement of any part
of such devices without regard to continuous use or useful lifetime
restrictions if an ordering physician determines that the provision of a
replacement device, or a replacement part of such device, is necessary because
of any of the following:
- A change in the physiological condition of the patient
- An irreparable change in the condition of the device, or in
part of the device
- The condition of the device or part of the device requires
repairs and the cost of such repairs would be more than 60 percent of the cost
of a replacement device, or as the case may be, of the part being replaced
If a physician determines that a replacement device, or
replacement part, is necessary: 1) such determination shall be controlling;
and, 2) such replacement device or part shall be deemed to be reasonable and
necessary; except that if the device, or part, being replaced is less than
three years old (calculated from the date on which the beneficiary began to use
the device or part), the secretary may also require confirmation of the
necessity of the replacement device or replacement part.
Our intention was to adopt a universal policy that mimicked the
prosthetic policy that is on the books. However, we were told DME providers
would take full advantage of this and would also want specific policies related
to DME. Consequently, CMS rejected our policy. So now we are working with them
to see if we can find a more targeted approach.
CMS sometimes takes a broad look at fraud and abuse policies.
Instead of applying targeted fraud and abuse provisions, they tend to take a
sledgehammer approach and issue a blanket policy that, while addressing the
fraud and abuse concern, has unintended effects on access and quality to many
services covered by the Medicare program.
What Can Be Done?
O&P Business News: What can the O&P
industry and providers do to ensure patients receive the devices they need?
Walker: It’s always a reaction — you push me,
I’ll push you back. We need to work together as an industry and show CMS
that depending on the device, an orthosis might have a six-month or one or
two-year manufacturer warranty on it. If it’s past the warranty and truly
worn out, it should be replaced. Some orthoses will last five years, others
Providers will automatically get denied on all orthoses billed
within that five-year period, regardless of whether the claim is done correctly
or not. After they get denied, they need to send in additional documentation
for review. Pictures help. The review process generally takes about 45 days. If
everything is in place, in most instances, the device will be replaced. It
would be more efficient if they would allow practitioners to send that
additional information with the first claim.
Gorski: We are hoping CMS will revise the policy in order
for Medicare patients to receive timely orthotic treatment and for
practitioners to be paid appropriately for these services. Our goal is to work
with Medicare officials without seeking congressional intervention to change
the policy. For the time being, AOPA recommends that when practitioners see
patients who require orthotic device replacements, practitioners should fully
document the medical necessity for the replacement. While we cannot guarantee
that Medicare will cover the replacement of the device, the practitioner’s
case will be much stronger if he or she precisely describes in the medical
record why the device no longer functions as originally intended. If
practitioners receive denial notices, we recommend they make an appeal. Having
detailed information in the patient’s medical record should help
practitioners receive proper payment from Medicare.