Recently, the SADMERC and most of the DMERCs (Regions B, C, and D) have
released a “coding clarification” for orthoses. This coding clarification
prohibits the use of add-on codes in conjunction with orthoses base codes
that include the word “prefabricated” in their descriptions. NAAOP believes
that this coding clarification represents a significant and unreasonable
limitation on the ability of orthotists to furnish patients with orthoses
that provide optimum functionality, fit, and comfort. Accordingly, NAAOP
has sent the following letter to the SADMERC and DMERCs, challenging this
new coding policy and requesting that they rescind the policy.
We encourage all organizations and practitioners who agree with NAAOP’s
position to submit to the SADMERC and DMERCs a letter stating their views on
this important issue.
December 23, 2003
Doran D. Edwards, MD
Medical Director
Statistical Analysis DME Regional Carrier
Palmetto GBA
2300 Springdale Drive, Building One
Mail Code: AG-370
Camden, SC 29020
Re: Use of Add-On Codes with Prefabricated Orthoses Base Codes
Dear Dr. Edwards:
We are writing in response to your recent ?coding clarification?
that states that suppliers of orthotic services may not use add-on L codes
in conjunction with ?prefabricated? orthoses. This new policy will
adversely impact practitioners and the Medicare program, and will deprive
patients of necessary options that enhance comfort, stability, and,
most-importantly, function of orthoses. This new policy is contrary to the
history and fundamental nature of the L Code system and, we believe, is
invalid. We, therefore, ask you to retract it immediately.
Coupled with the alarming trend of the SADMERC to systematically
delete references to the term ?custom fitted? in L code descriptions and to
replace this phrase with the term ?prefabricated,? we believe that
prohibiting practitioners from using add-on codes with prefabricated codes
constitutes a serious threat to the current practice of orthotics that must
be corrected.
We understand that this policy is in response to apparent abuses in the
system. We whole-heartedly share your interest in curtailing such abuses.
However, we feel that a more focused response is appropriate. A sweeping
change to the entire L code system, in our view, is not a reasonable
response to this perceived problem.
1. The ?Coding Clarification? Is Unreasonable
There is insufficient support for this prohibition on the use of add-on
codes in conjunction with base codes for orthoses that are described as
?prefabricated.? Frequently, a particular ?prefabricated? orthosis may not
fit within a single L code description, or it will be medically necessary to
add a component, material, or feature to a prefabricated orthosis in order
to provide medically necessary support and/or function.
Clinical orthotic care includes many examples where it is appropriate to use
an add-on code with a base code that includes the term ?prefabricated? in
its description. For example, fracture bracing is accepted as a viable
option to plaster and fiberglass casts for several types of fractures.
Prefabricated systems can be utilized in situations where, previously, the
entire orthosis had to be custom molded. Long leg, rigid, prefabricated
fracture braces have a base code of L2136 (KAFO fracture orthosis, femoral
fracture cast orthosis, rigid, prefabricated). However, not all fractures
would be appropriately treated with a KAFO utilizing free motion knee
joints. There may be ligament damage to the knee or fracture stabilization
issues, requiring immobilization of the patient?s knee using a drop lock or
requiring a limitation of knee motion with plans to allow a gradual increase
of motion over time. The HCPCS codes provide three viable options for these
different scenarios: L2182, drop lock knee joint; L2184, limited motion knee
joint; or L2186, adjustable motion knee joint. None of these control
options ? which would be clinically appropriate where medically necessary
and ordered by a physician ? are included in the base procedure. Instead,
these options are described using the add-on code adaptability of the L
coding system.
In the treatment of fractures, it may also be necessary to un-weight
the limb and transfer the body weight through the thigh section of the
fracture orthosis. One common method used to accomplish this is through the
use of a weight-bearing thigh component described by L2188 (addition to
lower extremity fracture orthosis, quadrilateral brim). In other instances,
most commonly when the fracture is high on the femur, the physician may
alternatively request increased rotational control of the limb and proximal
support between the limb and the trunk. In these situations, the orthotist
commonly uses hip control components, described by code L2192 (addition to
lower extremity fracture orthosis, hip joint, pelvic band, thigh flange, and
pelvic belt), to control the limb relative to the trunk and further
stabilize the fracture.
There are many other examples in common clinical practice where orthoses
described as ?prefabricated? require the addition of appropriate add-on
codes for individual patient need. The orthotic ?coding clarification?
restricts practitioners from providing necessary services, ultimately
depriving patients of proper medical treatment. This new policy will have
one of three impacts. It will either: (a) force practitioners to rely more
often on more costly custom-fabricated orthoses, even when a prefabricated
orthosis with add-on features could be used; (b) cause practitioners to
provide prefabricated orthoses without making medically appropriate
additions to the orthoses, because such additions are no longer
reimbursable; or (c) shift additional costs onto practitioners who will feel
compelled to provide the additional add-on features despite the lack of
additional reimbursement. Thus, this rule will be highly detrimental to
practitioners, the Medicare program generally, and the quality of patient
care.
Furthermore, since the inception of the L Code system, the fee schedule
amounts for L codes are based on the assumption that base codes will be
submitted in conjunction with appropriate add-on codes. Accordingly, the
reimbursement for a base code is often set lower than if the item were to be
furnished on a stand-alone basis. By prohibiting the combination of
prefabricated orthoses codes and add-on codes, this policy will result in
inappropriately low reimbursement for many orthoses, inadequately
reimbursing practitioners for the cost of furnishing orthotic care.
2. The ?Coding Clarification? Represents a Substantive Change to
Existing Policy and Therefore Requires Notice-And-Comment Rulemaking
Pursuant to the Administrative Procedure Act.
We believe that the ?coding clarification? represents a substantial
departure from prior policy that, at a minimum, requires notice and comment
rulemaking. Unlike most HCPCS codes, in which a single code is meant to
globally cover an entire procedure or item, L codes have always been divided
into ?base? codes and ?add-on? codes that a practitioner combines, when
appropriate, in order to represent the unique functionality and components
of a prosthesis or orthosis. There is no precedent for introducing a third
category of L codes: base codes that cannot be used in conjunction with
add-on codes.
In fact, this ?coding clarification? conflicts with the SADMERC?s
coding advice for certain ?prefabricated? orthoses. For example, in August
2000, the SADMERC classified two products as ?L4360 + L2200.? The
description for L4360 is ?Pneumatic ankle foot orthosis, with or without
joints, prefabricated, included fitting and adjustment.? The description
for L2200 is ?Addition to lower extremity, limited ankle motion, each
joint.? This coding recommendation cannot be reconciled with the new
?coding clarification? for orthoses, demonstrating that the policy is a
departure from prior policy.
Furthermore, at least one HCPCS coding publication includes a
statement immediately below the header of ?Orthotic Devices ? Upper Limb?
stating that ?the procedures in this section are considered as ?base? or
?basic procedures? and may be modified by listing procedures from the
?additions? sections and adding them to the base procedure.? See 2003 HCPCS
Level II (Ingenix, Inc. 2002). This sentence is immediately followed by
codes for shoulder orthoses, which are all described as ?prefabricated.?
The only reasonable interpretation of this sentence is that the codes that
follow are prefabricated base codes that can be modified by add-on codes
when necessary and appropriate.
The Administrative Procedure Act (APA) requires all federal agencies
to publish proposed rules in the Federal Register in order to provide the
public with notice and an opportunity to comment. 5 U.S.C. ? 553(b), (c).
The SADMERC and DMERCs, acting in the place of CMS to create de facto
national policy, may not circumvent this ?notice-and-comment? requirement.
Accordingly, we believe that the SADMERC and DMERCs are not permitted to
completely revise the L code system without adhering to the requirements of
the APA.
While there is an exception to the APA notice-and-comment
requirement for ?interpretive rules,? 5 U.S.C. ?553(b)(3)(A), this exception
is not applicable to the DMERCs? coding ?clarification.? Though the line
between substantive rules and interpretative rules is not always clear,
?[i]f a rule creates rights, assigns duties, or imposes obligations, the
basic tenor of which is not already outlined in the law itself, then it is
substantive.? La Casa Del Convaleciente v. Sullivan, 965 F.2d 1175, 1178
(1st Cir. 1992). The DMERCs? new orthoses coding policy represents a
fundamental and substantive change to the L code system. It will result in
the denial of coverage of add-on orthotic features that previously were
covered by Medicare when used in conjunction with a prefabricated orthosis
and when medically necessary. Accordingly, the change in coding policy is a
substantive rule, not an interpretation of existing policy. It is,
therefore, subject to the APA?s notice-and-comment requirements and the
failure to satisfy these requirements renders the policy invalid.
* * * * *
For the reasons discussed above, we believe that the ?coding clarification?
for orthotics is invalid and should be retracted immediately. If you would
like to discuss this issue directly, please call me at (432) 683-3788.
Sincerely,
Michael J. Allen, C.P.O., FAAOP
President, NAAOP
cc: Paul Hughes, MD, Medical Director for Region A
Adrian Oleck, MD, Medical Director for Region B
Doran Edwards, MD, Medical Director for Region C
Robert Hoover, MD, Medical Director for Region D
Peter W. Thomas, General Counsel, NAAOP
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