Academy Responds to DMERC's Draft Local Coverage Policy on Knee Orthoses

The Academy sent a strong response to the DMERCs regarding their draft Local Determination and Policy on Knee Orthoses, objecting to several provisions as detrimental to patient access and quality of care.

The Academy faulted the L-CODE system for not having kept pace with advances in orthoses. The need for the use of addition codes in knee orthoses is warranted by CMS’ failure to create new base codes that reflect the current standard of care. The Academy also responded that there must be a distinction between suppliers and providers within the policy. The letter identified CERTIFIED orthotists and prosthetists as the only providers of O&P care, identifying all others as suppliers.

The 12-page response is as follows:

The American Academy of Orthotists and Prosthetists wishes to respond to the proposed changes presented in the DMERC’s Local Coverage Determination and Policy for Knee Orthoses. As the sole professional organization representing the individual clinical orthotist and prosthetist, and thus by extension, the patients we serve, we are compelled to object to certain provisions on the basis of their detrimental effect to the provision of timely and quality care for beneficiaries of CMS.

The policies proposed in the LCD reflect an undeveloped perspective on the L-code system. This system was conceived and largely created in the 1970s. Although codes are periodically added and deleted to reflect changes in practices and technology, these changes have not kept pace with the advances and changes inherent in a developing medical field. The result is a system that often does not maintain accurate descriptions for devices that represent the norm for care in orthotics and prosthetics.

The proliferation of prefabricated devices, coupled with an equal proliferation of DME suppliers for these items have changed the nature of providing patient care, increased utilization and subsequently, costs, at an alarming rate. The Academy realizes the need for cost containment, but we strongly oppose efforts that use the proposed narrow medical necessity policy to do so. Constraining the medical necessity guidelines for Knee Orthoses and adding burdensome prescription requirements to qualified providers adversely affects our profession economically and presents unnecessary barriers to patients seeking appropriate care from qualified individuals. We believe there is a way to provide quality care in an environment of fiscal control.

That process begins with a realistic look at the L-code system and how non-qualified suppliers utilize it. The distinction between “suppliers” and “providers” is inherent in the coding system’s descriptions of prefabricated and custom-fabricated devices. To “fabricate” a device requires a facility or laboratory to do so. To fit a patient with a custom-fabricated device requires a brick and mortar facility from which to provide the service essential in the delivery of that item. Orthotic and Prosthetic professionals have years of training in biomechanical and technical sciences; they possess knowledge of materials and clinical practice to prepare them for evaluation, measurement, fabrication, fitting and initial instruction in the use of orthotic and prosthetic devices, as well as the ability to modify and maintain such devices during follow-up care.

These skills require access to specialized clinical care settings and facilities. Other suppliers lack the specific training and education to perform these precise duties, and often work and practice from medical offices and storefronts that lack the specialized machinery to fabricate, adjust and service these devices. These suppliers augment shrinking reimbursements by supplying prefabricated and custom outsourced devices opportunistically to patients that may be served more efficiently and comprehensively with care from orthotists and prosthetists. The result is often increased utilization by suppliers who view the L-code system as a limitless economic treasure. The only “providers” of orthotic and prosthetic care are the certified orthotic and prosthetic practitioners credentialed by the American Board for Certification in Orthotics and Prosthetics (ABC) and the Board of Certification (BOC). The remaining DME vendors should be classified as “suppliers.”

With this perspective, limitations and constraints, when applied to suppliers, protect the integrity of the program and insure that devices are supplied as needed under the direction of a physician. However, these same constraints, when applied to practicing Orthotists and Prosthetists cause increased economic expense in an already capitated reimbursement environment and actually decrease a patient’s ability to access timely and qualified care. We feel the DMERCs should explore ways to distinguish certified providers from non-certified providers and regulate them accordingly.

With respect to the LCD draft policy article for Knee Orthoses the Academy offers a point-by-point commentary on the effect of these proposals on the provision of orthotic care to Medicare beneficiaries:

1. The position stating, “that certain L-code additions are included in the base procedure code for prefabricated knee orthoses” creates the assumption that all orthoses covered under a specific code are comprised of equal components or features. This assumption is inaccurate; it amounts to 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 legal description. For example: RCAI manufactures a post-operative knee orthosis (Model 77POP) that should be coded as L1832 according to the SADMERC’s O&P Classification List updated in July 2004. Yet eight of the eleven L codes (L2435, L2750, L2755, L2795, L2800, L2810, L2820 and L2830) considered as “included” under this policy are not found on this particular orthosis.

The orthotist evaluates a patient and determines the device that best meets their individual functional needs or satisfies the requirements of the prescription. Not all choices available to the orthotist meet the needs of each patient. When this occurs, the orthotist may have to select additional features, construction, joint configurations etc. These selections incur additional costs. This position effectively expands the base code procedure without adjustment to the schedule to allow for the new “standard features,” essentially lowering the reimbursement for an entire class of devices without proper consideration.

Even if the fee schedule were adjusted upwards to include these features, CMS would then overpay in instances when those items were not part of the physician’s order. There is no logic in this proposal; and it is a significant departure from historical administration of the L-code system. The L-code system, by design, is unbundled. To eliminate the ability to pass on optional expenses incurred by the provider to the recipient creates a bundled class of orthoses where bundled items do not exist at the wholesale level. This provision can result in a situation where the prescribed orthosis’ cost may actually exceed its allowable before evaluation, fitting and follow-up time are included. To expand the descriptor in this manner without changing the HCPCS verbiage is inappropriate. For these reasons the Academy recommends that the DMERC not eliminate add-on coding for prefabricated items.

2. The provision limiting the use of add-on code L-2755 (addition to lower extremity orthosis, high strength, lightweight material, all hybrid lamination/prepreg composite, per segment) to two criteria is an example of manipulating medical necessity policy to control costs. This result in decreased options for patients who might have other medical necessities that would benefit from the technology and increased the liability exposure for practitioners fabricating orthoses.

The criteria of: “Patient weight of greater than 250 lbs. and work environment requires a brace for high impact/high stress activities” ignore the inherent advantages of these lightweight/high strength materials to increase the functional potential of elderly patients without adding unnecessary weight and bulk. Medical conditions such as valgus of the opposite knee can preclude the use of a bulkier metal or thermo-plastic fabricated knee orthosis because it will interfere with swing phase of the opposite limb and potentially cause tissue breakdown and/or trauma. This restriction of the add-on code L-2755 would eliminate the use of a thinner, but equal strength material based on a restrictive medical necessity policy, denying the benefits of this technology to patients that would most certainly benefit from its use.

Most manufacturers design components (aluminum, stainless steel and composites) to ISO Standards. These standards require materials be used and recommended to provide patient safety. Most orthoses are designed for patients weighing up to 100KG or 220 lbs. Patients weighing over 200 lbs. may place considerable stresses on component locking mechanisms, uprights and plastics used in typical construction leading to failure of these parts and potential injury to the patient. The limitation of this add-on code is arbitrary and unsafe and poses a potential risk to CMS beneficiaries. The Academy must object to the restriction of legitimate technology to beneficiaries based on narrow medical necessity policy aimed at lowering costs through decreased utilization, and questions whether this policy will also indemnify suppliers and providers who follow these unsafe guidelines.

3. The positions that, “All other L-coded additions not listed below as allowed are not medically necessary” on prefabricated or custom fabricated knee orthoses reduces reimbursement outside the normal regulatory process in the same manner as number 2 above. Any addition code, by its very nature in an unbundled system, describes and represents a feature, construction option, or characteristic that is outside the base code descriptor. Addition codes, especially miscellaneous codes such as L-2999, cannot be assumed to be “not medically necessary” until they are considered under the established policy for the system. This amounts to regulating newly developed technologies and design considerations for specific medical necessities as “automatically rejected.” This provision represents a reduction in scope of an already inadequate descriptor system compared to the available technology. The Academy does not endorse a shrinking of the available options for orthotic treatment of patients requiring knee orthoses or the assertion that an add-on code not included on an arbitrary list is universally not medically necessary. CMS cannot presume to know that not one single beneficiary will require a feature not itemized on the list. We recommend that the current requirements of additional documentation for medical necessity be retained to keep these options available to patients requiring them. We refer the SADMERC to CMS’s own policy with regard to miscellaneous codes:

“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.”

4.The elimination of code L-2770 (Addition to lower extremity orthosis, any material, per bar or joint) for submission again represents a reduction of the coding system. The result is the elimination of construction options that may be medically necessary for patients that require additional structural stability. L-2770 and L-2755 are misunderstood in their application. While L-2755 refers to construction of laminated and cuffs and “shells,” L-2770 describes the material construction of uprights, joints and support bars and bands in an orthosis. These structures are distinct from each other.

The growing prevalence of obesity in our patient population demands that options for high strength and increased support remain viable component additions when the medical necessity for higher strength supportive structures in the construction of knee orthoses is indicated. The Academy recommends retaining L-2770 but changing the descriptor to: “Addition to lower extremity orthosis, high strength and/or lightweight material, stainless steel, heavy duty aluminum, titanium, carbon fiber or equal per bar, joint or band.”

5. The limitation for coverage of codes L-1830, L-1832, L-1845 and L-1850 to: a) recent surgical intervention on the ligaments of the knee requiring range of motion; or b) knee instability due to ligament insufficiency/deficiency or reconstruction is not justified.

First, the inclusion of L-1850, which commonly describes the Swedish Knee orthosis, is incorrect. This orthosis is specifically designed to prevent hyperextension or recurvatum of the knee. It is not appropriate for treatment following surgical repair of the medial or lateral ligaments of the knee, or for medial/lateral instability of the knee.

The restriction of the remaining codes to the diagnoses listed precludes their use for other appropriate diagnoses. For instance, L1830, L1832, L1843 and L1845 are appropriate and conservative treatment for a stable condylar fractures, post knee replacement immobilization, burn trauma, capsular adhesions, vascular repair, soft or connective tissue shortening and peripheral neuropathies. L1832 and L1845 in particular are commonly used as a post-operative orthoses for knee replacement, fracture management, condylar derangement, and a variety of soft tissue disorders, which do not require surgical intervention. Eliminating an entire range of application for these orthoses is unnecessary and unreasonable. These orthoses are indicated for any number of conditions in addition to those proposed. The physician’s prescription should determine the medical necessity of these orthoses. The Academy does not see the logic in this policy and does not recommend its implementation because it would restrict application of clinically accepted means of treatment for a variety of disorders conservatively and inexpensively.

6. The policy recommendation limiting the use of code L-1860: “as used to prevent hyperextension of the knee in ambulatory patients” is also incorrect and unnecessarily restrictive.

L-1860 can be used to prevent hyperextension, but this design is more frequently employed effectively to provide medial/lateral stability encompassing the joint axis of the knee by extending above the femoral condyles. In some cases this design may also be employed to prevent excessive knee flexion. Supracondylar designs are used in ambulatory and non-ambulatory patients alike. To restrict this design criterion to a patient that is already ambulating eliminates its use as a means to promote stable ambulation as part of the rehabilitation of a non-ambulatory patient. The Academy cannot see the logic in eliminating a proven and viable method of providing multi-plane support for patients who require this level of stability. We recommend the descriptor include: “used to provide multi-plane control of knee instability in ambulatory.”

7. The proposal to eliminate the use of addition codes L-2320 (non-molded lacer), L-2330 (lacer, molded to patient), L-2335 (anterior swing band) and L2340 (pre-tibial shell molded to patient model) for “use only as replacement items” again eliminates additional and medically necessary items for patients who require this level of support without adding them to the appropriate base codes. It is not logical to offer an item as a replacement item when it is not contained in any base code initially. If it is to be added to the base codes, then appropriate adjustments to the verbiage and the allowable are necessary.

Thigh lacers, molded and non-molded are added to base orthoses of several designs to provide circumferential support and stability for patients whose musculature cannot support their extremity in weightbearing. Anterior swing bands and molded anterior shells, added to base orthoses, provide sagittal plane stability to a wide range of persons with multiple, varied diagnoses from arthritis to fractures to diabetes related neuropathic disorders. Base codes do not include these descriptors. Each of these items requires significantly more materials, labor and time to fabricate and add to a base procedure. Patients for which these items are medically necessary cannot function effectively or safely without them. Because of their wide application in lower extremity orthoses, the elimination of these codes would require the creation of four additional base codes for each AFO, KO, KAFO, and HKAFO in the L-code system. The Academy sees no alternative but to continue to allow these items to be used as add-on codes for lower extremity base procedures when they are documented as medically necessary and prescribed by a physician.

8. The policy statement that: “Custom devices are never medically necessary in the treatment of knee contractures” separates knee contractures from all other conditions of the knee with respect to custom orthoses. If conditions are set forth to require documentation for custom orthoses for all other diagnoses and treatments with Knee Orthoses, contracture management should be no different. Knee contractures are not only caused by orthopedic conditions as implied in the Appendices. A patient that meets coverage criteria for contracture management, and meets conditions that necessitate custom bracing as described elsewhere in this policy (“ deformity of the leg or knee that precludes fitting with a prefabricated orthosis, disproportionate size of calf or thigh.”) should be eligible for a custom orthosis.

Contractures that have a neurologic origin, such as those caused by upper motor neuron disorders, (Cerebral Vascular accidents, Traumatic Brain Injuries, Spinal Cord Injuries and others) are not easily controlled, held or reversed by prefabricated orthoses. These contractures often require the greater strength, durability and intimate fit provided by custom fabricated orthoses to be successfully managed. This population represents some of the most vulnerable beneficiaries. When they lose ambulatory status, rates of morbidity and mortality increase from among other things, fixed contractures! Furthermore, many patients that receive custom bracing for stability during sitting, standing and ambulation also have concomitant contractures that must be accommodated. Is it the intention of CMS to deny these beneficiaries coverage?

Again, we point out that the prevalence of obesity in our population creates the very real possibility that patients will not be served by prefabricated devices due to size constraints. Contractures that progress unchecked, result in reduced function, greater disability, poor hygiene, increased care costs and the need for possible surgical intervention. The Academy feels strongly that limiting contracture management to prefabricated devices will have a detrimental and costly effect on patient care. We recommend that the criteria for custom devices in contracture management remain identical to that for other knee orthoses: “deformity of the leg or knee that precludes fitting with a prefabricated orthosis, disproportionate size of thigh or calf, or minimal muscle mass on which to suspend an orthosis.”

9. The draft policy describes a prefabricated orthosis as: “…typically used for early rehabilitation following surgery.” Certainly there are other uses for prefabricated orthoses as well, but this description describes a device that is typically used for a temporary amount of time, usually from 3 to 6 months.

These devices are designed for temporary use. As such, they are fabricated from materials with a useful lifetime of 3 to 6 months with daily use. Despite this acknowledgement, the policy guidelines for the reasonable lifetime of prefabricated devices L1831, L-1832, L1836, L1845, L-1847 and L-1850 is from 2 to 3 years. The simple fact is that most prefabricated orthoses that are used on a daily basis for up to 6 months are structurally worn, unhygienic and in need of replacement. This policy precludes the replacement of a device for normal wear and tear that is irreparable.

This replacement policy is inconsistent with the expected use of a these devices and results in increased costs. In situations where a less expensive, prefabricated orthosis is indicated for continual use, the replacement policy related to useful life discourages the use of the less expensive device and encourages the provider to fit the patient with a more expensive custom fabricated orthosis simply to provide greater durability. The Academy recommends establishing a useful lifetime for prefabricated devices of no more than 6 months.

10. Policy regarding L2860 (addition to lower extremity joint, knee or ankle concentric adjustable torsion style mechanism, each) making it invalid for claim submission to the DMERC eliminates a very important and medically necessary joint mechanism used for tissue lengthening and quadriceps assist during ambulation. Claims for this code will be denied as an invalid code and must be billed using E1810 (dynamic adjustable knee extension/flexion device, includes soft interface material).

This joint is incorporated into devices that are distinctly different than those devices described by E1810. A concentric adjustable torsion mechanism provides precise healing stress and resistive strengthening to a knee orthosis that applies these forces to the quadriceps or hamstring muscle groups. The joints are incorporated into custom or certain prefabricated orthoses. Substantial adjustments to this mechanism are required on a regular basis; and are performed by a qualified practitioner. This may include contouring uprights fitting body interfaces on a custom basis for an individual patient. Custom-made devices are made for a specific patient following the practices common for custom-made orthoses made from casts or molds of the patient’s extremity.

E (rental) codes are intended for multiple user DME items. These items are not designated as “each brace, prefabricated or custom molded, incorporating a concentric torsion mechanism designed for one and only one patient.” The devices incorporating concentric torsion style mechanisms fit perfectly into the above description. The DMERC has used the addition of a specific joint mechanism to change the classification of an entire device. These devices are orthoses and should be classified using L codes.

The efficacy of these mechanisms is well documented. Patients with upper motor neuron disorders, orthopedic related tissue shortening, static contractures and tone induced (spastic and hypertonic) deformities benefit from these devices immensely. The use of these devices can frequently eliminate more costly treatment, including surgical lengthening, decubitus treatment and long-term assistance care. These are long-term custom-fitted orthoses and mechanisms incorporated into custom-made orthoses that provide economic treatment options for beneficiaries.

The DMERC policy on this mechanism previously dictated that code L2999 be used: “If a concentric adjustable torsion style mechanism in the knee or ankle joint is being used for a custom fabricated orthosis to provide assist function to joint motion during ambulation, it should be coded as L2999.” (Supplier Manual, July 1999) The Academy recommends that code L2860 be reinstated as an add-on code or that the concentric adjustable torsion style mechanism be billed using L2999 following the guidelines referenced above for medical necessity.

11. Several areas in the draft policy promote confusion, appear inconsistent with other policies and raise questions as to the intent of the policy. For instance:

A) The requirement for documentation of “physical characteristics which require the use of custom fabricated orthosis” is mandated, however, not specific as to where in the documentation, or whose documentation has to include it.

The DMERCs, through probe audits, frequently request documentation from the physician records that support the use of specific orthoses and prostheses. The Academy is concerned that this policy makes it incumbent on the orthotist to have in his/her records, physician documentation that specifically mentions a device, specifies a custom device or even provides the rationale for certain addition codes, beyond the actual prescription for this device. This is not reasonable, and bases payment for services provided in good faith by providers, on the quality of individual physician’s record keeping. Despite this unfairness, denials for orthotic and prosthetic devices have occurred for lack of physician documentation, despite prescriptions that call for custom devices etc.

A clarification that allows a prescription, signed by the referring physician that specifies a custom device, and/or specific add-on codes, along with an appropriate diagnosis is sufficient documentation to support the use of these devices is both fair and prudent. Significant administrative costs, inconvenience and frustration result from audits that compel orthotic and prosthetic practitioners to request documentation from busy physician offices before payment, without reimbursement for time and administrative costs. This fosters resentment towards the providers and reduces referrals from physicians who see this as an unnecessary intrusion to their practice.

B) The restriction on billing code L4205 (repair of an orthotic device, labor component, per 15 minutes) 90 days after delivery effects the ability of the provider to bill for repairs within the warrantee period that are a result of medical changes, damage or breakage not related to product construction, abuse or damage caused by trauma, falls or other incidental insults (i.e., damage outside the control or responsibility of the provider). Clarification of this rule is necessary.

C) Reference to the Kellgren-Lawrence Scale for describing the severity of degenerative changes in articular cartilage associated with osteoarthritis is confusing. Not all physicians utilize this measurement tool. Rarely is this type of information provided to the orthotist with an order for a knee orthosis. If this is to be a documentation requirement, whose record must contain it? What happens in the event of a clinical diagnosis where no radiograph is taken to identify the presence or absence of osteophytes?

D) The policy refers to “qualified providers as responsible for fabrication or direct supervision of fabrication of custom devices.” How is this policy to be enforced when fabrication of custom made devices after measurement by a qualified provider can occur out of state and at central fabrication facilities, perhaps not under the direct supervision of a “qualified provider?” The Academy is concerned that enforcement of this provision is not feasible and not necessary. We wholeheartedly support the qualified provider distinction and suggest if: “the measurement and final fitting of a custom device were performed directly by a qualified provider, the requirement for reimbursement of custom made devices would be met,”

The Academy supports initiatives to control spiraling costs in the Medicare Program but encourages the DMERCs and CMS to do so by adopting strategies that identify non-certified and unscrupulous suppliers, strengthening the definition and of qualified providers and developing policies that prevent non-certified and unqualified suppliers from utilizing the L-code system in abusive and fraudulent manners.

In instances where the Office of Inspector General has investigated fraud and abuse, evidence clearly points to the inappropriate utilization of L-codes by non-certified O&P suppliers. There is little, if any, evidence of fraud and abuse by certified O&P providers. The use of the L-code system by a variety of suppliers yields questionable utilization and billing practices. This administrative commingling of O&P and DME blurs the delineation between qualified providers and non-qualified suppliers. Attempts to include O&P providers under the regulatory control of DME suppliers is not supported by OIG data, and severely impacts the provision of quality care to the beneficiaries of the Medicare Program. The DMERCs should not adopt policies that control costs through the manipulation of the medical necessity provisions in the L-code system, but should look to distinguish certified providers from non-certified providers and regulate them accordingly. The Academy is dedicated to the provision of quality care by continually educated professionals.