Comments to Proposed LCD for Knee Orthoses

Prefabricated Knee Orthoses:

Codes L1800 – L1832, L1836, L1843, L1845, L1847, and L1850 describe prefabricated orthoses (see definition of prefabricated in Policy Article).

Codes L1831, L1836 and L1847 are covered for patients with flexion contractures of the knee (ICD-9 diagnosis code 718.46) with extension on passive range of motion testing of at least 10 degrees (i.e., a nonfixed contracture).

If a L1831, L1836 or L1847 is provided but the criterion above is not met, the orthosis will be denied as not medically necessary.

Response: We do not believe that it is appropriate to assign specific diagnoses to particular L-codes. Rather, we believe that it is appropriate for the physician to determine whether a particular orthosis is medically necessary. We recognize that the purpose of local coverage determinations is to provide guidance in determining when Medicare benefits are medically necessary. However, limiting orthoses to particular diagnosis codes unduly limits the professional discretion of physicians to decide when a particular orthosis is medically necessary. Furthermore, it fails to recognize that prescribing and furnishing orthoses often involves highly individualized determinations that cannot be reasonably encompassed in a local coverage determination.

Additionally, we believe that the above policy is not supported by current clinical standards. For example, the orthoses described by the above codes are routinely used to treat conditions that do not satisfy the above criteria, such as post-operative positioning, and post-injury support. Furthermore, the orthoses described by these codes do not include the features that are required to effectively treat contractures, e.g., dynamic extension/flexion assist.

Finally, this proposed coverage policy ignores the existence of extension contractures (i.e., a contracture of a joint that limits functional range-of-motion towards flexion), which are seen after some traumatic injuries and surgical interventions. A common clinical example of this is in Total Knee Arthroplasty, where both flexion and extension contractures can be present, along with quadriceps weakness.

There is no proven clinical benefit to the inflatable air bladder incorporated into the design of code L1847; therefore, payment will be based on the allowance for the least costly medically appropriate alternative, code L1831.

Response: First, we disagree with the statement that inflatable air bladders do not provide a clinical benefit. Air bladders are commonly used to restrict displacement of the patella and also to increase the medial and lateral stability of the knee during activities of daily living. Further illustration of these benefits can be viewed atwww.physsportsmed.com/issues/1999/08_99/paluska.htm.

Additionally, L1831 is not a “medically appropriate alternative” to L1847. L1847 incorporates free motion knee joints, while L1831 incorporates locking knee joints. The devices described by these codes are not comparable.

Code L1843 is covered for ambulatory patients who require valgus or varus bracing to alleviate pressure on the medial or lateral compartment of the knee. Code L1843 is covered for the following indications only:

  1. Moderate to severe unicompartmental osteoarthritis (ICD-9 diagnosis codes 715.09, 715.16, 715.26, 715.36, 715.89, 715.96)
  2. Meniscal cartilage derangement (717.0 – 717.5)
  3. Knee ligamentous disruption (717.81 – 717.9)
  4. Failed total knee arthroplasty (996.4, 996.66, 996.77, V43.65)
  5. Aseptic necrosis of tibia/fibula (733.49)
  6. Tibial plateau fracture (733.16, 733.93, 823.00, 823.02, 823.10, 823.12).

Response: Limiting the use of L1843 to the above criteria will preclude patient access to medically necessary care. There are a number of other diagnoses, including certain congenital and acquired musculoskeletal deformities and anomalies, for which it is clinically appropriate to use a knee orthosis with varus/valgus control.

Codes L1830, L1832, L1845, and L1850 are covered if either of the following criteria are met:

  1. The patient has had recent surgical intervention on the ligaments of the knee requiring range of motion limitations; or,
  2. The patient is ambulatory and has knee instability due to ligament insufficiency/deficiency or reconstruction.

If code L1830, L1832, L1843, L1845, or L1850 is provided but the patient does not meet the criteria for coverage, the orthosis will be denied as not medically necessary.

Response: While the above diagnoses are certainly reasonable circumstances that require fitting of orthoses described by L1830, L1832, L1845 and L1850, such orthoses may also be reasonable for other diagnoses, such as fractures, status post knee replacement with associated loosening of prosthesis or pain, cartilage or meniscal damage, skin grafting, soft tissue or connective tissue shortening, vascular repair, knee hyperextension, other general surgery or trauma. Accordingly, the above policy will improperly restrict the furnishing of medically necessary care.

Also, we believe that the above limitation is inconsistent with other guidance. Specifically, the Knee Orthosis – DRAFT Policy Article states that “L1850 describes a prefabricated orthosis…used to prevent hyperextension of the knee joint in ambulatory patients.” This statement demonstrates that the use of L1850 is significantly broader than only cases requiring range of motion limitations after surgery and instability due to ligament insufficiency/deficiency or reconstruction.

The following listing indicates the correct coding of base prefabricated orthosis codes and orthosis addition codes. Certain L-coded additions are considered included in the allowance for the base code (see below and accompanying Knee Orthoses Policy Article). All other L-coded additions not listed below as included with a specific base orthotic code are denied as not medically necessary.

Base Code Add-On Code(s) Included
L1800 None
L1810 L2385, L2390, L2425, L2435, L2750, L2755
L1815 L2795, L2800, L2810
L1820 L2385, L2390, L2425, L2435, L2750, L2755, L2795, L2800, L2810
L1825 L2795, L2800, L2810
L1830 None
L1831 L2385, L2390, L2425, L2435, L2750, L2755, L2795, L2800, L2810, L2820, L2830, Kxxx1
L1832 L2385, L2390, L2425, L2435, L2750, L2755, L2795, L2800, L2810, L2820, L2830, Kxxx1
L1836 L2820, L2830, Kxxx1
L1843 L2275, L2385, L2390, L2425, L2435, L2750, L2755, L2795, L2800, L2810, L2820, L2830, Kxxx1
L1845 L2275, L2385, L2390, L2425, L2435, L2750, L2755, L2795, L2800, L2810, L2820, L2830, Kxxx1
L1847 L2385, L2390, L2425, L2435, L2750, L2755, L2795, L2800, L2810, L2820, L2830, Kxxx1
L1850 L2275, L2385, L2390, L2425, L2435, L2750, L2755, L2795, L2800, L2810, L2820, L2830, Kxxx1

Response: We believe that this limitation is contrary to the basic structure of the add-on system of L-coding. This is essentially a redefinition of the base codes to include a host of features that may or may not be present in an orthosis that fits the actual legal description. Additionally, no mention is made regarding adjustment to the fee schedule to allow for the new “standard features.” Even if the fee schedule were adjusted upwards to assure beneficiary access to these orthoses, CMS would then overpay when those features were not part of the physicians order. This demonstrates the illogic and impracticability of this significant departure from historical administration of the L code system.

It is understandable that current technological advancements may give some the impression that all knee orthoses, under a given code, include certain “standard features” that are extraneously defined by add-on codes. However, this is not accurate and distorts the true acquisition cost of the orthosis. For example RCAI makes a postoperative knee (Model 77POP) that should be coded with L1832 according to the SADMERC’s July 2004 orthotics and prosthetics product classification list. Yet eight of the eleven L codes (L2435, L2750, L2755, L2795, L2800, L2810, L2820, & L2830) considered to be “included” under this policy are not found on this particular brace.

When a practitioner determines the brand or type of brace for a patient, “standard features” for any given brace are considered. The practitioner selects, modifies or designs an orthosis in light of its features to suit a particular patient’s needs. Simply because a given manufacturer determines to set one price for a brace with certain features and include those features as standard is no reason to assume that all orthoses described by the base codes have the same number of features.

In addition, some of the “included” addition codes are defined in such a way as to be disqualified from use on pre-fabricated braces. This would, for instance, include L2820, which is described as: “addition to lower extremity orthosis, soft interface for molded plastic, below knee section” (emphasis added). Similarly, L2830: “addition to lower extremity orthosis, soft interface for molded plastic, above knee section” (emphasis added). These codes were never intended to be included in the description of the base code and, by CMS’s own language, they are precluded from use in the very braces which they would now be considered as “standard equipment.”

The knee joint types that this provision limits are those that are generally used in custom fabricated orthoses. These additions are not included in the base codes. They are “usually inappropriate” to add to a prefabricated knee orthosis, but they are not included.

An addition code describes a feature that is needed for a given patient’s particular needs as noted on a detailed physicians order. It has relevance, therefore, on a per patient basis. Each addition code should be reviewed individually and added by the prescribing physician who has evaluated the patient based on its merits in meeting a particular patient’s case needs.

For instance, L2999 should never be assumed as included in the base code since it is by nature not defined by an existing code. It is thus precluded from being part of the base code. In regard to miscellaneous codes, we would like to note CMS’s published policy:

National codes also include “miscellaneous/not otherwise classified” codes. These codes are used when a supplier is submitting a bill for an item or service and there is no existing national code that adequately describes the item or service being billed. The importance of miscellaneous codes is that they allow suppliers to begin billing immediately for a service or item as soon as it is allowed to be marketed by the Food and Drug Administration (FDA) even though there is no distinct code that describes the service or item. A miscellaneous code can be used during the period of time a request for a new code is being considered under the HCPCS review process. The use of miscellaneous codes also helps us to avoid the inefficiency of assigning distinct codes for items or services that are rarely furnished or for which we expect to receive few claims.

Because of miscellaneous codes, the absence of a specific code for a distinct category of products does not affect a supplier’s ability to submit claims to private or public insurers. Claims with miscellaneous codes are manually reviewed, the item or service being billed must be clearly described, and pricing information must be provided along with documentation to explain why the item or service is needed by the beneficiary.

In conclusion, we believe that furnishing orthoses often involves unique, individualized circumstances. We do not believe that Medicare can be reasonably certain that the above table anticipates the unique clinical circumstances surrounding every patient who will require an orthosis and features described by add-on codes.

Custom Fabricated Knee Orthoses:

Codes L1834, L1840, L1844, L1846 and L1855 – L1880 describe custom fabricated orthoses (also see Custom fabricated definition in Policy Article).
A custom fabricated orthosis is covered when there is a documented physical characteristic which requires the use of a custom fabricated orthosis in lieu of a prefabricated orthosis. Examples of situations which meet the criterion for a custom fabricated orthosis include, but are not limited to:

  1. Deformity of the leg or knee that precludes fitting with a prefabricated orthosis.
  2. Disproportionate size of thigh and calf.
  3. Minimal muscle mass upon which to suspend an orthosis.

Response: In addition to the above situations, we believe that custom fabrication should be allowed whenever it is expected that the orthosis will be needed for longer than six months. This should be explicitly recognized in Medicare policy. Prefabricated knee joints are usually made from relatively inexpensive materials that cannot reasonably be expected to withstand daily use for more than six months. Such a change is especially necessary in light of Medicare’s policy to deny replacement of an orthosis within its useful lifetime if it is worn out. Accordingly the above policy will give many beneficiaries no other option but to wear worn out orthoses.

Although these are examples of potential situations where a custom fabricated orthosis may be appropriate, suppliers must consider prefabricated alternatives such as pediatric knee orthoses in patients with small limbs, straps with additional length for large limbs, etc.

Response: We do not believe that it is appropriate for Medicare policy to require suppliers to consider alternatives to prescribed medical treatment. Such decisions rest with the physician, and Medicare should not place them with suppliers, nor hold suppliers accountable for such decisions.
Furthermore, manufactures routinely publish the size ranges of their products, e.g., DonJoy “Fource Point” extra small is sized to fit a thigh circumference, six inches above mid-patella, of 33-39 cm. Fitting of prefabricated knee orthoses require contouring of the knee joints to accommodate the shapes of the medial and lateral aspects of the knee, and manufactures generally will not accept returned items that have been altered. Finally, the proposed policy does not recognize the increased time or overhead required to “consider” alternative treatment.

If the medical necessity for a custom fabricated orthosis is not met, but the criteria for a prefabricated orthosis is met, payment will be based on the allowance for the least costly medically appropriate alternative, a prefabricated orthosis.

Written orders for custom fabricated orthoses must specifically state “Custom Fabricated” or specify a brand name and model that is only available as a custom fabricated product. If a claim for a custom fabricated orthoses is not supported by a written order specifying custom fabricated, payment will be based on the allowance for the least costly medically appropriate alternative, a prefabricated orthosis.

For code L1844 only, in addition to meeting the general criterion for a custom fabricated orthosis stated above, the patient must also meet the coverage criteria outlined for the prefabricated unloader brace L1843. If the patient does not meet the criteria above for a custom fabricated knee orthosis, payment will be based on the allowance for the least costly medically appropriate alternative, a prefabricated orthosis (code L1843).

For code L1846 only, in addition to meeting the general criterion for a custom fabricated orthosis stated above, the patient must also meet the coverage criteria outlined for the prefabricated brace L1845. If the patient does not meet the criteria above for a custom fabricated knee orthosis, payment will be based on the allowance for the least costly medically appropriate alternative, a prefabricated orthosis (code L1845).

Custom fabricated orthoses described by codes L1834, L1840, L1844, L1846 and L1855 – L1880 are not medically necessary in the treatment of knee contractures. If a custom fabricated knee orthosis is used in the treatment of a contracture, payment will be based on the allowance for the least costly medically appropriate alternative, a prefabricated orthosis (code L1831).

Response: Knee contractures should be subject to the same coverage criteria as all other conditions that require orthoses. If a patient meets all coverage criteria for knee contracture management, and also has conditions that make it medically necessary to use a custom brace, as stated elsewhere in this policy (e.g., “deformity of the leg or knee that precludes fitting with a prefabricated orthosis” or “disproportionate size of thigh or calf”), then a custom device for knee contractures should also be covered. Furthermore, many patients receive bracing for stability during sitting, standing and ambulation also have concomitant “contractures” that must be accommodated and treated to maintain their health status. This policy can be construed to preclude fitting such patients with a medically necessary custom orthosis. For example, this policy will have an adverse impact on stroke patients and geriatric patients that lose ambulatory status, since they have much greater rates of morbidity and mortality from, among other things, developing fixed contractures.
Codes such as L1846, L1855, L1870, L1880 are routinely used to custom fabricate a knee orthosis to treat knee contractures. The custom fabrication of an orthosis to manage a patient’s contracted joints should be the option of the healthcare team. The proposed ban on a valid treatment option will limit patient access to medically necessary care. The “least costly” orthosis should not replace the clinically appropriate one.

Custom fabricated L-coded orthoses are covered only if they are made by, or under the direct (i.e., on-site) supervision of an ABC (American Board for Certification in Prosthetics and Orthotics) certified orthotist, a BOC (Board for Orthotist Certification) certified orthotist, a registered occupational therapist or a licensed physical therapist. Claims for custom fabricated orthoses not made by, or under the direct supervision of, a qualified provider listed in this paragraph will be denied as not medically necessary.

Response: The proposed policy states that a device would be covered only if made (fabricated) by an ABC or BOC orthotist, or an OT or PT. Most OT’s and PT’s have no fabrication facilities, and certain ABC and BOC orthotists use central fabrication facilities for the actual making or fabrication of the devices. The two occurrences of “made” should be changed to “fitted and/or provided.” Accordingly, the policy would then read. “Custom fabricated L-coded orthoses are covered only if they are fitted and/or provided by…” and “Claims for a custom fabricated orthosis not fitted and/or provided by…”

The following listing indicates the correct coding of base custom fabricated orthosis codes and orthosis addition codes. Certain L-coded additions are considered included in the allowance for the base code (see accompanying Knee Orthoses Policy Article). All other L-coded additions not listed below as allowed for a specific base custom fabricated orthotic are denied as not medically necessary.

Base Code Add-On Code(s) Allowed
L1834 Kxxx1, L2275, L2300, L2310, L2755, L2760, L2768, L2795, L2800, L2810, L2820, L2830, L2999
L1840 Kxxx1, L2385, L2435, L2760, L2770, L2785, L2810, L2820, L2830, L2999
L1844 Kxxx1, L2385, L2390, L2395, L2405, L2415, L2425, L2430, L2435, L2492, L2755, L2768, L2785, L2795, L2810, L2820, L2830, L2999
L1846 Kxxx1, L2300, L2385, L2390, L2395, L2405, L2415, L2435, L2492, L2795, L2768, L2785, L2810, L2820, L2830, L2999
L1855 Kxxx1, L2275, L2300, L2385, L2390, L2395, L2397, L2405, L2415, L2425, L2430, L2435, L2492, L2755, L2760, L2768, L2795, L2820, L2785, L2800, L2810, L2820, L2830, L2999
L1858 Kxxx1, L2275, L2397, L2405, L2415, L2425, L2492, L2755, L2785, L2795, L2810, L2820, L2830, L2999
L1860 Kxxx1, L2820, L2830
L1870 Kxxx1, L2300, L2310, L2385, L2390, L2395, L2397, L2405, L2415, L2425, L2430, L2435, L2492, L2760, L2768, L2785, L2795, L2800, L2810, L2820, L2830, L2999
L1880 Kxxx1, L2300, L2310, L2385, L2390, L2395, L2397, L2405, L2415, L2425, L2430, L2435, L2492, L2755, L2760, L2768, L2785, L2795, L2800, L2810, L2820, L2830, L2999

Response: As discussed above with respect to the table for prefabricated orthoses, we believe that the restrictions set forth in the above table are contrary to the very nature of the L code add-on system and represent a significant departure from the historical administration of the L code system. While we appreciate this attempt to provide coding guidance to providers and suppliers, the practical result will be to restrict a health care practitioner’s ability to practice sound medical care.

Miscellaneous

L-coded additions to knee orthoses (L2275 – L2830, Kxxx1) will be denied as not medically necessary if either the base orthosis is not medically necessary or the specific addition is not medically necessary.

Claims for add-on code L2755 (Addition to lower extremity orthosis, high strength, lightweight material, all hybrid lamination/prepreg composite, per segment) are covered for patients in whom either criterion 1 or 2 are met:

  1. Work environment requires a brace designed for high impact/high stress activities; or,
  2. Patient weight is greater than 250 lbs. If criterion 1 or 2 is not met, claims for code L2755 will be denied as not medically necessary.

If criterion 1 or 2 is not met, claims for code L2755 will be denied as not medically necessary.

Response: Most manufactures design components and bars (stainless steel, aircraft aluminum and composites) to ISO standards. These standards require particular materials to be used in order to provide patient safety. Most orthoses are designed for patients up to 100 kilograms or 220 pounds in order to meet the strength required by ISO manufacturing design specifications and the patient’s height, weight and activity level. Therefore, prescribing physicians, in consultation with their orthotists, select joints and materials to assure safe functional use of the complete knee orthoses by the patient. This selection must pay particular attention to the activity level and height of the patient, as longer length bars and thigh and cuff sections create longer levers with higher stress on plastic thigh and calf sections, bars and component locks. A restriction of 250 pounds is excessive for most component locks, bar stocks, and plastics that are used in typical thigh and calf sections and is arbitrary and unsafe to Medicare beneficiaries. Furthermore, it is the supplier who will be held liable for patient injuries that result from this unsafe medical policy.

Additionally, L2755 is appropriate in situations requiring rigid rotational control. Accordingly, the above-mentioned policy should be amended to reflect the Medicare beneficiary’s need for support during their activities of daily living, not just during work or if they are overweight. Finally, the code’s definition includes the term “lightweight,” which often is inappropriate for high impact/high stress environments or for individuals over 250 pounds.

Coverage of a removable interface (Kxxx1) is limited to a maximum of two (2) per year beginning one (1) year after the date of service for initial issuance of the orthosis. Additional interfaces will be denied as not medically necessary.

ICD-9 Codes that Support Medical Necessity

The presence of an ICD-9 code listed in this section is not sufficient by itself to assure coverage. Refer to the section on “Indications and Limitations of Coverage and/or Medical Necessity” for other coverage criteria and payment information.

For HCPCS codes L1831, L1836 and L1847:
718.46 CONTRACTURE OF LOWER LEG JOINT
For HCPCS codes L1843 and L1844:
715.09 OSTEOARTHROSIS GENERALIZED INVOLVING MULTIPLE SITES
715.16 OSTEOARTHROSIS LOCALIZED PRIMARY INVOLVING LOWER LEG
715.26 OSTEOARTHROSIS LOCALIZED SECONDARY INVOLVING LOWER LEG
715.36 OSTEOARTHROSIS LOCALIZED NOT SPECIFIED WHETHER PRIMARY OR SECONDARY INVOLVING LOWER LEG
715.89 OSTEOARTHROSIS INVOLVING OR WITH MULTIPLE SITES BUT NOT SPECIFIED AS GENERALIZED
715.96 OSTEOARTHROSIS UNSPECIFIED WHETHER GENERALIZED OR LOCALIZED INVOLVING LOWER LEG
717.0 – 717.5
717.81 – 717.9
733.16 PATHOLOGICAL FRACTURE OF TIBIA OR FIBULA
733.49 ASEPTIC NECROSIS OF OTHER BONE SITES
733.93 STRESS FRACTURE OF TIBIA OR FIBULA
823.00 CLOSED FRACTURE OF UPPER END OF TIBIA
823.02 CLOSED FRACTURE OF UPPER END OF FIBULA WITH TIBIA
823.10 OPEN FRACTURE OF UPPER END OF TIBIA
823.12 OPEN FRACTURE OF UPPER END OF FIBULA WITH TIBIA
996.4 MECHANICAL COMPLICATION OF INTERNAL ORTHOPEDIC DEVICE IMPLANT AND GRAFT
996.66 INFECTION AND INFLAMMATORY REACTION DUE TO INTERNAL JOINT PROSTHESIS
996.77 OTHER COMPLICATIONS DUE TO INTERNAL JOINT PROSTHESIS
V43.65 KNEE JOINT REPLACEMENT

Response: It is inappropriate to delineate the diagnoses that qualify a Medicare beneficiary to certain medical care. The listing appears incomplete because it does not recognize other acquired or congenital deformities or anomalies of the lower extremities. This narrow definition of medical necessity removes a health care practitioner’s ability to select appropriate care in certain instances.

Section 1833(e) of the Social Security Act precludes payment to any provider of services unless “there has been furnished such information as may be necessary in order to determine the amounts due such provider” (42 U.S.C. section 1395l(e)). It is expected that the patient’s medical records will reflect the need for the care provided. The patient’s medical records include the physician’s office records, hospital records, nursing home records, home health agency records, records from other healthcare professionals and test reports. This documentation must be available to the DMERC upon request.

An order for all items must be signed and dated by the treating physician, kept on file by the supplier, and made available to the DMERC upon request. Items billed to the DMERC before a signed and dated order has been received by the supplier must be submitted with an EY modifier added to each affected HCPCS code.
Orders must be sufficiently detailed including all options or additional features that will be separately billed. If the item is a custom fabricated orthosis, this must be specifically stated on the order.
The ICD-9 code that justifies the need for the item must be included on the claim.

Suppliers must add a KX modifier to knee orthoses codes only if all of the coverage criteria in the “Indications and Limitations of Coverage and or Medical Necessity” section of this policy have been met and evidence of such is retained in the supplier’s files and available to the DMERC upon request. If the requirements for the KX modifier are not met, the supplier may submit additional documentation with the claim to justify coverage, but the KX modifier must not be used.

Response: The requirements surrounding the KX modifier to retain such medical necessity evidence in the supplier’s record is heavy handed and unnecessary. Requiring the supplier to contact and request the appropriate records from the physician, hospital, therapist, nursing home, home health agency, or any other health care provider/supplier (and to obtain test results) simply to have them in the supplier’s record is excessive and unnecessary requirements. It should be recognized that the Medicare beneficiary’s medical record also includes the information obtained in the records of the supplier, maintained in the normal course of business.

For custom fabricated orthoses (L1834, L1840, L1844, L1846, L1855-L1880), there must be detailed documentation in the orthotist’s records to support the medical necessity of custom fabricated rather than a prefabricated orthosis. This information does not have to be routinely sent in with the claim, but must be available to the DMERC upon request.
When billing L2999, the following information should accompany the claim: manufacturer’s name; product name; justification of patient’s medical necessity for the item. In addition, if the item is custom fabricated, a complete and clear description of the item, including what makes this item unique, and a breakdown of charges (material and labor used in fabrication) must be included with the claim.

An order is not necessary for the repair of an orthosis; however, claims for code L4210 must be accompanied by a description of the part that is being repaired or replaced. This information should be entered into the narrative field on an electronic claim or attached to a paper claim.
Refer to the Supplier Manual for more information on documentation requirements

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