“Qualified Provider” DMERC Transmittal

The Centers for Medicare and Medicaid Services (“CMS”) recently announced new rules concerning “Payment to Providers/Suppliers Qualified to Bill Medicare for Prosthetics and Certain Custom-Fabricated Orthotics”. This transmittal, known as “Transmittal 329,” which will be effective on July 1, 2005, instructs Durable Medical Equipment Regional Carriers (“DMERCs”) to deny claims for prosthetics and certain custom-fabricated orthotics unless provided by a “qualified practitioner.” The transmittal also defines which individual codes they have included in the category of “Prosthetics and Certain Custom-Fabricated Orthotics”. Though it does not define specifically what constitutes a qualified practitioner, it does require that O&P practitioners be “certified,” whether billing independently or through a “medical supply company with a certified orthotist/prosthetist.”

BACKGROUND

Transmittal 329 is the latest effort by CMS to implement Section 423 of the Benefits Improvement and Protection Act of 2000 (“BIPA”). BIPA Section 423 requires CMS to define the term “qualified provider” in the context of orthotic and prosthetic services reimbursable by Medicare. As a result, CMS engaged members from the O&P community along with physical and occupational therapists to enter into a “Negotiated Rulemaking” process that would settle the issue of qualified provider as required under BIPA in addition to a large number of other issues that arose from the BIPA statute. The Negotiated Rulemaking process, however, failed to settle on a definition and parties did not reach consensus on significant issues. The Medicare Modernization Act of 2003 (“MMA”), Section 302(a), also requires CMS to define qualified practitioner, though not in as unequivocal a manner as BIPA.

Transmittal 329 specifies that unless a supplier has self-identified under one of the following categories during supplier enrollment and/or reenrollment, claims for certain O&P services will be denied:

  • Medical Supply Company with Certified Orthotist – Specialty code 51
  • Medical Supply Company with Certified Prosthetist – Specialty code 52
  • Medical Supply Company with Certified Orthotic and Prosthetist – Specialty code 53
  • Certified Orthotist – Specialty code 55
  • Certified Prosthetist – Specialty code 56
  • Certified Orthotist and Prosthetist – Specialty code 57

Aside from these categories and accompanying specialty codes, the transmittal does not define “qualified practitioner” in any explicit manner or by referencing BOC or ABC certification. Practitioners wishing to bill for prosthetics and/or custom-fabricated orthotics must re-enroll as Medicare suppliers before July 1, 2005, if their existing NSC applications did not designate their O&P certification.

ANALYSIS

Currently, DMERCs process and pay claims for prosthetics and custom orthotics without regard to the specialty that a supplier self-reports on the supplier number application form. On July 1, 2005, such O&P claims submitted by practitioners not specifying one of the above-mentioned specialties will be denied. In this respect, the key disagreement that arose in the Negotiated Rulemaking Committee between the O&P field and the therapy organizations has been largely resolved in the O&P field’s favor. CMS has essentially recognized the validity of the O&P community’s argument that ABC or BOC certification should be required in order to bill Medicare for O&P services, other than the portion of orthotics that is considered “off-the-shelf”. In addition, although additional analysis is required, the list of O&P codes that will require certification appears to be relatively expansive, which again cuts in favor of the O&P field.

The link to the announcement with the list of covered codes is:http://www.cms.hhs.gov/manuals/pm_trans/R329CP.pdf

November 18, 2004

  • Written by NAAOP

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

  • Written by NAAOP

Comments to Proposed Policy Article for Knee Orthoses

NON-MEDICAL NECESSITY COVERAGE AND PAYMENT RULES

For an item to be considered for coverage under the Brace benefit category, it must be a rigid or semi-rigid device which is used for the purpose of supporting a weak or deformed body member or restricting or eliminating motion in a diseased or injured part of the body. It must provide support and counterforce (i.e., a force in a defined direction of a magnitude at least as great as a rigid or semi-rigid support) on the limb or body part that it is being used to brace.

Items that do not meet the definition of a brace are noncovered. The following chart reflects the reasonable useful lifetime of prefabricated knee orthoses:L1800 – 6 months
L1810 – 6 months
L1815 – 6 months
L1820 – 6 months
L1825 – 6 months
L1830 – 6 months
L1831 – 2 years
L1832 – 2 years
L1836 – 3 years
L1843 – 3 years
L1845 – 3 years
L1847 – 2 years
L1850 – 2 years

The reasonable useful lifetime of custom fabricated orthoses is 3 years.

Response: As described below in this draft policy, L1832 describes a prefabricated knee orthosis that is “typically used for early rehabilitation following surgery.” This device is most often used for a few weeks to a few months following surgery and typically cannot withstand day to day usage for longer than 6 months. The Velcro closures and padding often wear-out during usage. Although the medial-lateral stability is provided by double metal uprights, the anterior-posterior control and medial-lateral containment is provided by soft materials that wear out much quicker than 2 years. Accordingly, the useful lifetime for L1832 should be 6 months. Similary, L1836 is also used frequently for post-operative positioning or post injury support. Because it is made using a soft interface material, it soils and wears easily. A three year lifetime is unreasonable. Rather, it should be six months, similar to L1830 (which also uses a soft interface material).

Replacement during the “reasonable useful lifetime,” is covered if the item is lost or irreparably damaged. Replacement for other reasons, including but not limited to irreparable wear, during the period of reasonable useful lifetime is denied as noncovered.

L-coded additions to knee orthoses (L2275 – L2830, Kxxx1) will be denied as noncovered when the base orthosis is noncovered.

Socks (L2840, L2850) or brace sleeves (A9270) used in conjunction with orthoses are noncovered because they are not used to support a weak or deformed body member or to restrict or eliminate motion in a diseased or injured part of the body (i.e., it does not meet the definition of a brace).

Repairs to a covered orthosis are covered when they are necessary to make the orthosis functional. The reason for the repair must be documented in the supplier’s record. If the expense for repairs exceeds the estimated expense of providing another entire orthosis, no payment will be made for the amount in excess.

CODING GUIDELINES

An orthosis (brace) is a rigid or semi-rigid device which is used for the purpose of supporting a weak or deformed body member or restricting or eliminating motion in a diseased or injured part of the body. It must provide support and counterforce (i.e., a force in a defined direction of a magnitude at least as great as a rigid or semi-rigid support) on the limb or body part that it is being used to brace. An orthosis can be either prefabricated or custom-fabricated.

Response: We believe that the above definition reference to “counterforce” is both confusing and inappropriate. The magnitude of the counterforce should never be “at least as great” as a rigid support. To do so would cause tissue injury. Furthermore, for the counterforce to be “at least as great” as a semi-rigid support would lead to fatigue stress of the materials and lead to early failure of the orthosis.

A prefabricated orthosis is one which is manufactured in quantity without a specific patient in mind. A prefabricated orthosis may be trimmed, bent, molded (with or without heat), or otherwise modified for use by a specific patient (i.e., custom fitted). An orthosis that is assembled from prefabricated components is considered prefabricated. Any orthosis that does not meet the definition of a custom-fabricated orthosis is considered prefabricated.

A custom-fabricated orthosis is one which is individually made for a specific patient starting with basic materials including, but not limited to, plastic, metal, leather, or cloth in the form of sheets, bars, etc. It involves substantial work such as cutting, bending, molding, sewing, etc. It may involve the incorporation of some prefabricated components. It involves more than trimming, bending, or making other modifications to a substantially prefabricated item.

A molded-to-patient-model orthosis is a particular type of custom-fabricated orthosis in which an impression of the specific body part is made (by means of a plaster cast, CAD-CAM technology, etc.) and this impression is then used to make a positive model (of plaster or other material) of the body part. The orthosis is then molded on this positive model.

Code L1800 describes a prefabricated knee orthosis constructed of latex, neoprene, spandex or other elastic material. There are flexible stays located medially and/or laterally. There are no condylar pads. There are no hinges or joints.

Code L1810 describes a prefabricated knee orthosis constructed of latex, neoprene, spandex or other elastic material. There are no condylar pads. There are hinges or joints.

Code L1815 describes a prefabricated knee orthosis constructed of latex, neoprene, spandex or other elastic material. There may be flexible stays located medially and/or laterally. There are also medial and lateral condylar pads. There are no hinges or joints.

Code L1820 describes a prefabricated knee orthosis with hinges or joints, constructed of latex, neoprene, spandex or other elastic material. There are medial and lateral condylar pads. There are hinges or joints.

Code L1825 describes a prefabricated knee orthosis constructed of latex, neoprene, spandex or other elastic material. A patellar buttress may be present. There are no stays, condylar pads, hinges or joints.

Code L1830 describes a prefabricated knee orthosis immobilizer, with rigid metal or plastic stays placed laterally and posteriorly. The interface material is constructed of canvas, closed cell foam or equal. The thigh and calf cuffs are one-piece construction held in place by velcro straps or equal. The orthosis immobilizes the knee joint and prevents flexion or extension. There are no hinges or joints.

Response: It is inappropriate to limit L1830 to only those orthoses that haveonly lateral and posterior stays, as many orthoses described by this code have medial and lateral as well as posterior.

Codes L1831 and L1847 describe prefabricated knee orthoses with joint(s) which lock the knee into a particular position. Code L1847 is distinguished from L1831 by the addition of an air bladder in the space behind the knee. These orthoses are designed for patients who are nonambulatory. They are typically used to treat a flexion contracture of the knee.

Response: The air bladder used in the space behind the knee is to provide comfortable immobilization. It is not typically used to treat knee flexion contractures because the counterforce would increase the amount of flexion, instead of reducing it. Also, these orthoses are not limited to non-ambulatory patients. Many times the patients are non, or partial, weight bearing; using crutches or other means for ambulatory assistance in situations involving post-operative positioning and post-injury support.

An adjustable flexion and extension joint is one which enables the practitioner to set limits on flexion and extension but allows the patient free motion of the knee within those limits. The increments of adjustability must be, at a minimum, 15 degrees. The joint may be either unicentric or polycentric.

Code L1832 describes a prefabricated knee orthosis that has double uprights and adjustable flexion and extension joints. Medial-lateral control of the knee is accomplished by way of the solid metal (or similar material) structure of the double uprights. It may have condylar pads. This orthosis is designed for a patient who can bear weight on the knee and is capable of ambulation. It is typically used for early rehabilitation following knee surgery.

Codes L1843 and L1844 describe prefabricated and custom fabricated (respectively) knee orthoses which are constructed of rigid thigh and calf cuffs and a single upright with an adjustable flexion and extension knee joint. It must have condylar pads. Through a series of straps/supports that cross over and around the knee joint, rotational control and varus or valgus force is exerted on the knee joint. These orthoses are designed to open the medial or lateral compartment of the knee to provide pain relief due to osteoarthritis. These orthoses are designed for patients who are fully ambulatory.

Response: It is excessively restrictive to limit the use of L1843 and L1844 to “fully ambulatory” patients. Many patients use these types of orthoses to facilitate limited ambulation, exercise therapy, and transfer activities.

Codes L1845 and L1846 describe prefabricated and custom fabricated (respectively) knee orthosis that have double uprights, condylar pads, and an adjustable flexion and extension joint and provides both medial-lateral and rotation control. Medial-lateral control of the knee is accomplished by the solid metal (or similar material) structure of the double uprights. Rotation control is accomplished by the combination of (1) solid metal (or similar material) in the anterior portion of the thigh and calf cuffs and (2) the condylar pads. These orthoses are designed for patients who are fully ambulatory.

Response: It is excessively restrictive to limit the use of L1845 and L1846 to “fully ambulatory” patients. Many patients use these types of orthoses to facilitate limited ambulation, exercise therapy, and transfer activities.

L1850 describes a prefabricated orthosis with double uprights and thigh and calf pads. It may or may not have joints. These orthoses are used to prevent hyperextension of the knee joint in ambulatory patients.L1860 describes a custom fabricated orthosis without joints, constructed of plastic or other similar material. These orthoses are used to prevent hyperextension of the knee joint in ambulatory patients.

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 specific base orthotic code. Claims for L-coded additions considered included in the base orthotic code are denied as not separately payable. See local coverage determination (LCD) for Knee Orthoses for L-coded additions considered 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

For all custom fabricated orthoses, codes L2320, L2330, L2335, L2340, L2750 and L2780 are considered included in the allowance for the base orthotic code. In addition for code L1858 only, code L2435 is also included in the allowance for the base orthotic code.

Claims for L-coded additions considered included in the base orthotic code are denied as not separately payable. See local coverage determination (LCD) for Knee Orthoses for L-coded additions considered not medically necessary.

Response: Please clarify that this policy applies only to all custom fabricated knee orthoses, instead of “all custom fabricated orthoses.”

Code Kxxx1 describes a removable soft interface for a knee orthosis. One unit of service includes all the components that are used at the same time on a single orthosis.

Either a nonremovable soft interface (L2820, L2830) or two (2) removable soft interfaces (Kxxx1) are included in the code for a prefabricated orthosis.

Codes L2320, L2330, L2335 and L2340 (non-molded and molded lacers, anterior swing band and pretibial shell, respectively) may only be billed as replacement items.

Response: If codes L2320, L2330, L2335 and L2340 (non-molded and molded lacers, anterior swing band and pretibial shell understood on non-molded/molded lacers) are only considered replacements, then this acknowledges that the base codes to which they would apply should contain them as descriptors (or they should be billable separately as additions). If this is the case, the fee schedule amounts for these base codes should be adjusted to include these components. They should be kept as separate add-on codes for both new orthoses and replacements, as originally intended when they were issued as new L codes.

Code L2755 (addition to lower extremity orthosis, high strength, lightweight material, all hybrid lamination/prepreg composite, per segment) describes the materials carbon graphite, composite carbon fiber, kevlar and titanium. These are the only materials considered high strength and light weight that may be billed using code L2755.

Code L2755 has a unit of service “per segment.” For the purposes of this policy, a segment is defined as above and below the knee. Therefore, for any knee orthosis, the maximum number of segments of code L2755 that may be reimbursed is two (2). Claims for additional units of service of code L2755 will be rejected or denied as incorrect coding.

Code L2770 (addition to lower extremity orthosis, any material, per bar or joint) is invalid for claim submission to the DMERC. Claims for code L2770 will be denied as an invalid code.

Response: This addition code is vital to accurately describe the material upgrade that may be needed to insure proper structural integrity of devices.

Currently, when a device is fabricated out of Stainless Steel, Titanium, Carbon Fiber/Epoxy, or significantly larger aluminum, this code is used to describe the added cost and effort to fabricate the clinically appropriate orthosis. This code is reserved for use with the uprights/sidebars, bands, and/or joints. L2770 should not be confused with L2755 (Addition to lower extremity orthosis, high strength, lightweight material, all hybrid lamination/prepreg composite, per segment), which is reserved for lamination type fabrication of the “shells” of a lower extremity orthosis. While ambiguity in the code description of L2770 has been a problem for sometime, the appropriate corrective action is revision of the HCPC code descriptor to “Addition to lower extremity orthosis, high strength, lightweight material, Stainless Steel, Carbon Fiber/Epoxy, Titanium or equal, per bar or joint.”

Code L2860 (addition to lower extremity joint, knee or ankle, concentric adjustable torsion style mechanism, each) is invalid for claim submission to the DMERC. Claims for code L2860 will be denied as an invalid code. Knee orthoses incorporating a concentric adjustable torsion style mechanism must be billed with code E1810 (dynamic adjustable knee extension/flexion device, includes soft interface material). Claims for knee orthoses incorporating a concentric adjustable torsion style mechanisms billed with code L2999 will be rejected or denied as incorrect coding.

Response: A concentric adjustable torsion style mechanism is a particular device which provides precise healing, stress/resistive strengthening (on a knee orthosis) to either the quadriceps or hamstring groups and to related musculature. They are incorporated into either custom-fitted (prefabricated) or molded-to-patient-model knee orthoses. On custom fitted models, substantial adjustments are made to the brace by qualified practitioners to meet the needs and/or unique shape of an individual patient. This includes fitting the body interface by permanently contouring metal uprights and sizing cuffs and straps for optimal positioning. Custom molded models are made for a specific patient. A patient model of the knee complex is made from a negative cast impression. The model is modified to accommodate anatomical trouble areas and for the proper distribution of force. Plastic and metal are formed to the patient model using exacting orthometric measurements to complete the brace.

E1810 is intended for rental to multiple users (it is a capped rental item). Such a policy cannot be justified for a brace with a concentric torsion mechanism, since each such brace, prefabricated or custom molded, is designed for one and only one patient. The devices incorporating concentric adjustable torsion style mechanisms fit perfectly into the definition of orthosis that is set forth above in this Policy Article. The addition of one component (concentric torsion mechanism) should not change the Medicare benefit category for the device. These devices are orthoses and should therefore be coded with L codes. Many knee orthoses are provided to Medicare beneficiaries to assure stability in sitting, standing and ambulation, with the base orthoses and components prescribed by a physician in a detailed physician order. By adding a modular and removable L2860 component to this design, one orthosis can address concomitant quadriceps weakness for gait assist and address contracture so that ambulatory status is maintained. This is much less expensive than providing one custom brace for stability and one DME rental for contracture. Furthermore, a single device makes is much easier for the patient, thereby improving compliance with the proper use of the device.

The four DMERC medical directors previously recognized that a concentric adjustable torsion style mechanism is appropriately coded as an L code: “[i]f a concentric adjustable torsion style mechanism in the knee or ankle joint is being used for a custom fabricated Orthosis to provide an assist function to joint motion during ambulation, it should be coded as L2999.” Accordingly, L2860 should be a valid code that is covered by Medicare.

The allowance for the labor involved in replacing/repairing an orthotic component that is coded with a specific L code is included in the allowance for that component. The allowance for the labor (L4205) involved in replacing/repairing an orthotic component that is coded with the miscellaneous code L4210 is separately payable in addition to the allowance for that component.

The right (RT) and/or left (LT) modifiers must be used when billing for orthosis base codes, additions and replacement parts. When the same code for bilateral items (left and right) is billed on the same date of service, bill for both items on the same claim line using the RTLT modifiers and 2 units of service. Claims billed without modifiers RT and/or LT will denied or rejected as incorrect coding.

Code L2999 (lower extremity orthosis, not otherwise specified) should be used only when billing for item(s) that do not meet the definition of an existing code(s).

Code L4205 (Repair of orthotic device, labor component, per 15 minutes) may only be billed for time involved with the actual repair of an orthosis or for medically necessary adjustments made more than 90 days after delivery. Code L4205 must not be used to bill for time involved with other professional services including, but not limited to:

  • Evaluating the patient
  • Taking measurements, making a cast, making a model, use of CAD/CAM
  • Making modifications to a prefabricated item to fit it to the individual patient
  • Follow-up visits
  • Making adjustments at the time of or within 90 days after delivery

Response: We believe that code L4205 should include professional time in evaluating a patient for repairs, adjustments or modifications to an orthosis.

This is important because, in some instances, considerable time is spent evaluating the patient for the problems they have encountered. In some situations, for example, an excessive pressure area may be the result of a change in the patient’s physical or medical condition, progress in the rehabilitation phase of recovery, altered environmental conditions and/or the progressive nature of a chronic medical condition. Once the initial adjustments and modifications have been completed their efficacy must be evaluated before the patient is released. Many times, secondary and tertiary adjustments and/or modifications are required to completely resolve the problems that patients encounter.

Reimbursement for these services is included in the allowance for the HCPCS codes which describe the orthosis.

Similarly, code L4210 (Repair of orthotic device, repair or replace minor parts) must not be used for casting supplies or other materials used in the fitting or fabrication of an orthosis.

Should a supplier wish to submit a claim for services/items that are included in the allowance for the orthosis, code L9900 (Orthotic and prosthetic supply, accessory and/or service component of another HCPCS L code) must be used. Code L9900 is denied as not separately payable.

Suppliers should contact the Statistical Analysis Durable Medical Equipment Regional Carrier (SADMERC) for guidance on the correct coding of these items.

  • Written by NAAOP

Re: Comments to Draft Medicare Knee Orthoses Medical Policy

VIA ELECTRONIC MAIL AND FACSIMILE
Paul J. Hughes, MD

Medical Director

DMERC Region A

TriCenturion, LLC

P.O. Box 100282

Mail Code ZA-190

Columbia, SC 29202-3282

Adrian Oleck, MD

Medical Director

DMERC Region B

Adminastar Federal

8115 Knue Road

Mail Point AF10

Indianapolis, IN 46250

Stacey V. Brennan, MD

Medical Director

DMERC Region C

Palmetto GBA

P.O. Box 100141

Mail Code AG-250

Columbia, SC 29202

Robert D. Hoover, Jr., MD

Medical Director

DMERC Region D

CIGNA HealthCare

Metro Exchange Building

2 Vantage Way

Nashville, TN 37228

Dear DMERC Medical Directors:

These comments are sent in response to the four Durable Medical Equipment Regional Carriers’ (DMERCs) coordinated publication in draft form of the new medical policy for knee orthoses covered by the Medicare program.

Let us begin by thanking you for your decision in January 2004 to rescind the “policy clarification” that attempted to prohibit the use of add-on HCPCS codes in conjunction with base codes for orthoses that are described as “prefabricated.” NAAOP strongly disagreed with this policy clarification and submitted comments to that effect to the SADMERC and all four DMERC Medical Directors. NAAOP is grateful for your willingness to consider our views and to take steps to accommodate our concerns accordingly.

It is for this reason that NAAOP was so disappointed to read the new draft DMERC medical policy on knee orthoses. Not only is the same inappropriate and unsupported add-on code issue being proposed again, but a number of other very troubling proposals have been included in this draft in which NAAOP is forced, once again, to take exception. This new policy, if finalized in current form, will adversely impact practitioners and the Medicare program, and will deprive patients of necessary options that enhance the comfort, stability, and, most-importantly, function of knee orthoses. As we witnessed with the policy clarification in December 2003, this new policy is contrary to the history and fundamental nature of the L Code system and, we believe, should not be implemented without substantial revision.

There are a number of trends that concern NAAOP greatly with respect to the provision of Medicare-covered orthoses. First, The SADMERC and DMERC Medical Directors appear to be willing to grant orthotic practitioners less and less deference and recognition as health care professionals. Instead, they are more likely to view those who provide orthoses to Medicare beneficiaries as suppliers akin to salemen of off-the-shelf items, despite the complexity and wide range of orthoses provided to Medicare patients today. This approach devalues the high accreditation standards in the orthotic profession and undermines the importance of the thorough education and residency requirements necessary to become certified. This, in turn, opens the practice up to opportunistic behavior from other providers and suppliers, as well as non-professional “salespeople,” who boldly assert that they are just as qualified to provide comprehensive orthotic care as the orthotists who have devoted their lives and livelihoods to the orthotic profession. The ultimate result is a diminution in the quality of patient care.

Second, the first trend seems to emanate almost entirely from often legitimate concerns about overutilization and fraud and abuse generally. But as we have just suggested, the lack of recognition for professional orthotic care is, in part, responsible for the increasing number of providers and suppliers-who lack sufficient training and experience in orthotic care-billing an ever-increasing number of orthoses to patients. In our view, the answer to many of the controversial issues raised by the draft knee orthosis medical policy lies in treating orthotics as truly separate and distinct from durable medical equipment and developing medical policy that recognizes that quality orthotic care is as much a professional, clinical service as it is the provision of an orthoses.

This recognition is most effectively accomplished through certification of orthotists and accreditation of orthotic facilities. There are professional orthotic and prosthetic credentialing organizations and educational accreditation programs in place to provide guidance to CMS and the DMERCs as to whom should be considered a qualified supplier of orthotic and prosthetic care. CMS should accept the education and training criteria embraced by the American Medical Association in 1992 to be declarative of orthotics and prosthetics being allied health professions. In addition, standards have been established by the American Board for Certification in Orthotics and Prosthetics (ABC) and the Board for Orthotist/Prosthetist Certification (BOC) which currently administer psychometrically sound credentialing examinations for both orthotics and prosthetics.

NAAOP strongly supports the government’s efforts to tackle fraud and abuse and the DMERC’s use of post-payment audits is certainly one avenue to achieve results. But the Medicare program must also recognize the demographics of the Medicare population and the increased prevalence of conditions such as diabetes, obesity, and other chronic diseases and disabilities that will continue to build demand for orthotic intervention.

Pursuing the laudable goal of decreasing inappropriate utilization should not translate into the implementation of medical policy that fundamentally changes the quality of orthotic care available to Medicare beneficiaries. The risk of overutilization of orthoses can clearly be addressed without sacrificing access to, and the safety of, professional orthotic clinical care and related orthotic technology.

Unfortunately, the current draft knee orthoses medical policy implicitly rejects a more focused response to the risk of overutilization and, instead, proposes sweeping changes to the entire L code system that, in our view, are inappropriate and potentially harmful to patients. The current draft seems to be less a medical policy based on clinical studies and sound medical practice and more a rationing policy that employs a “least common denominator’ approach, all with the intention of limiting Medicare expenditures for orthoses with little recognition of the impact on patient care.

Attached please find NAAOP’s specific comments to various sections of the draft Local Coverage Determination as well as comments to the draft “Policy Article.” Our comments are inserted directly into the existing draft medical policy and policy article for ease of review. But our overall concerns can be summarized into six basic points, five substantive and one procedural in nature.

1. Replacement of the Term “Custom Fitted” with the Term “Prefabricated”

The draft knee orthoses medical review policy continues the alarming trend that began several years ago where the SADMERC and DMERCs have been systematically phasing out the term “custom fitted” from the L-code descriptors and medical policies for orthoses, and replacing this term with the word “prefabricated.” The end result of this approach is that a whole sector of relatively complex orthotic treatments have been relegated to being viewed as “off-the-shelf” orthoses that require minimal professional training to provide to patients.

This inappropriate designation simply does not reflect the level of professional knowledge and skill that is often required to adequately assess the patient and provide appropriate orthotic care. This policy trend has set the stage for the Medicare program to treat these orthoses like durable medical equipment is treated. Some examples include periodic rebasing of reimbursement rates for groups of these devices (seemingly without legal authority to do so), the requirement to first provide prefabricated orthoses before providing custom orthotic treatment, and application to competitive bidding.

2. Requiring Fitting of a Prefabricated Orthosis First

The requirement in this draft policy-which has also appeared in prior DMERC orthotic medical policies-that orthotists must first attempt to fit the patient with a prefabricated orthosis before designing, fabricating and fitting a custom orthosis continues to potentially place Medicare beneficiaries in harm’s way. This policy again underscores the DMERC’s lack of recognition for the professional, clinical service that is integral to quality orthotic care. The standard that should determine whether a prefabricated orthosis or custom fabricated orthosis will address the unique circumstances of the patient is medical necessity.

The preference for prefabricated orthoses-rather than relying on the physician and orthotist to determine the optimal treatment plan-that the DMERCs are building into the Medicare orthotic benefit invites minimally trained and largely unqualified suppliers to attempt to meet the needs of Medicare patients through trial and error. For these reasons, NAAOP strongly urges the DMERCs to eliminate this blanket policy from this draft and all other orthotic policies that employ this preference for prefabricated orthoses and work together to develop an alternative that better meets the needs of the government, beneficiaries and the orthotists who serve them.

3. Prohibiting Practitioners from Billing Add-on Codes with Prefabricated Codes

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. There is simply insufficient support for the prohibition on the use of add-on codes in conjunction with base codes for orthoses that are described as “prefabricated.” However, in instances where a particular add-on code is clearly inappropriate to be billed with a base orthotic code, the DMERC claims process should and, in fact, does edit these codes out for denial of payment.

Notwithstanding instances where inappropriate add-on codes are edited out of Medicare claims, there are a number of examples in clinical practice where orthoses described as “prefabricated” require the addition of appropriate add-on codes for individual patient needs. The point of the L code system’s add-on codes is to not deconstruct braces for additional payment, but to assure that a physician and orthotist can uniquely tailor the care that is needed. It is impossible to know ahead of time what care (and add-ons) may be necessary for the unique needs of the patient. A special removable silicone liner(s) for burn patients or a special knee cap for comfortable 3-point leverage for a patient with a dislocated patella are examples of this important point.

The draft knee orthosis policy 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:

  1. force practitioners to rely more often on more costly custom-fabricated orthoses, even when a prefabricated orthosis with add-on features could be used;
  2. cause practitioners to provide prefabricated orthoses without making medically appropriate additions to the orthoses, because such additions are no longer reimbursable; or
  3. 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.

4. Add-on Codes Should Not Be “Folded” into Existing Base Codes

NAAOP opposes the draft policy that seeks to incorporate certain features represented by separate add-on codes into a base code, without a corresponding rebasing of the reimbursement level for the base code. This proposal apparently stems from data that suggests that with certain base codes, a similar set of add-on codes are often simultaneously billed to the Medicare program. This new policy would set a precedent that fundamentally alters the very nature of the orthotic billing code system and, in our view, the DMERCs do not have this authority. It would also create a circumstance where the Medicare program would be paying for a set of features (formerly represented by separate add-on codes) that the patient may not require or receive due medical contraindications or other reasons.

5. Restricting Base Codes for Specific Diagnoses

The draft knee orthosis policy also proposes to restrict certain base codes to patients with specific diagnoses. To our knowledge, this is an unprecedented proposal. NAAOP strongly opposes this portion of the draft policy and urges the DMERCs to reconsider it because it artificially restricts physicians and orthotists in their orthotic treatment options. Again, the test should not be whether a particular course of orthotic treatment meets a preconceived notion of what it is capable of achieving. The test should be whether the particular treatment chosen by the physician and qualified orthotist is medically necessary for the patient in question.

6. The Draft Medical Policy on Knee Orthoses Represents a Substantive Change to National Policy and, Therefore, Requires Notice-And-Comment Rulemaking Pursuant to the Administrative Procedure Act.

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) and (c). The SADMERC and DMERCs, acting in concert by issuing this draft policy at the exact same time and in the same form from one DMERC to another are, in effect, taking the place of CMS and are creating de facto national policy. This essentially circumvents the APA’s “notice-and-comment” requirement that calls for publication of the draft policy in the Federal Register. 5 U.S.C. § 553(b). Accordingly, we believe that the SADMERC and DMERCs are not permitted to make the kind of substantive changes that are proposed in the knee orthoses medical policy 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 should not be applicable to this draft policy. 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’ draft knee orthoses medical 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 and a whole host of other orthotic treatments that are routinely covered today after consultation between the physician, orthotist and patient determines the medical necessity of a particular course of orthotic care. Accordingly, the change in medical policy is a substantive rule, not an interpretation of existing policy. It should, therefore, be subject to the APA’s notice-and-comment requirements and the failure to satisfy these requirements leaves it open to challenge.

For the reasons discussed above, we believe that the draft knee orthoses medical policy should be substantially revised before being implemented. Again, we appreciate the opportunity to offer our views and thank you for your willingness to consider them. If you would like to discuss these issues directly, please call me at (432) 683-3788.

Sincerely,
Michael J. Allen, CPO, FAAOP
President, NAAOP.

  • Written by NAAOP

NAAOP Submits Written Comments to Face-to-Face Physician Visit Proposed Rule

On Friday, September 24, 2004, NAAOP hand delivered public comments to Mark McClellan, M.D., Ph.D., Administrator of the Centers for Medicare and Medicaid Services, regarding the face-to-face physician visit requirement of the Medicare Modernization Act. CMS proposed to expand Section 302(a)(2)-which currently regulates clinical conditions for coverage of only Durable Medical Equipment (“DME”)-to cover all orthotics, prosthetics and supplies (commonly referred to as “DMEPOS”), thereby disregarding the limits set forth in the statute. If Section 302(a)(2) is expanded to include orthotics and prosthetics (“O&P”), a face-to-face examination of the patient by a physician or other practitioner would be required in order for Medicare to cover and reimburse the O&P treatment.

NAAOP stated in its formal comments that the proposed expansion of Section 302(a)(2) is inconsistent with the statute. Based on the law, a face-to-face physician visit is required when the Secretary has determined that significant and continuous cases of fraud and abuse have occurred in a particular benefit category. There is very little evidence, if any, that this is the case with O&P.

In the few instances where fraud and abuse has been examined by the Office of Inspector General, the reason for the fraudulent activity involved non-certified suppliers who inappropriately
used the O&P billing codes. The high standard of demonstrating repeated fraud and abuse established in the MMA has simply not been met in the case of O&P, NAAOP asserted.

NAAOP’s comments also noted that there is a clear and distinct difference between O&P and DME. The hands-on training of orthotists and prosthetists requires years of clinical practice and biomechanical and technical skill. O&P practitioners require access to clinical care settings and technical laboratories, unlike DME suppliers who, until recently, were not required to be certified and often sell DME out of storefronts and pharmacies.

In the past, CMS has noted the differences between O&P and DME as separate and distinct and treated them as such. NAAOP encouraged CMS to remain consistent with the policy it set forth in 2002 when CMS declined to extend a statutory DME provision in BIPA 2000 to O&P because doing so would constitute an unauthorized expansion of Congressional authority. In addition, the MMA’s competitive bidding program exempts custom orthoses and all prostheses but DME is impacted by this statute. Clearly, there is precedent for treating DME and O&P as separate and distinct.

Should CMS not follow this precedent, however, NAAOP asked CMS to use “medical necessity” as the guiding principal for the application of the new regulatory rules. Under the proposed rule, CMS states that the “face-to-face examination should be for the purpose of evaluating and treating the patient’s medical condition and not for the sole purpose of obtaining the prescribing physician’s or practitioner’s order for the DMEPOS.” NAAOP does not believe that this proposal is unreasonable for initial orders of orthotics and prosthetics, as the patient has invariably had an acute episode of illness or injury that requires, as part of a treatment plan, orthotic or prosthetic intervention. However, for long term users of orthoses and prostheses, the proposed rule seems misplaced and out-of-step with current medical practice.

NAAOP stressed that CMS should make a distinction in the final rule between one-time, temporary users of orthoses and permanent, long term users of orthoses. NAAOP noted with respect to prosthesis users that all amputations are permanent and, therefore, all prosthesis (i.e., artificial limb) users have a long term need for prosthetic care. In these instances, a trained, professional orthotist and/or prosthetist, working with the seasoned patient, are in the best position to assess the continued orthotic and/or prosthetic needs of the individual, and make a recommendation to the physician for approval of the plan of care.

NAAOP explained to CMS in its comments that individuals with long term impairments or disabilities usually become very familiar with their O&P needs and establish close working relationships with their O&P practitioners. By subjecting these individuals to a requirement for a face-to-face physician examination that specifically prohibits a visit for “the sole purpose” of obtaining the physician’s order-when this is exactly what is needed from the physician-the proposed rule would do nothing more than cause delay in treatment, additional barriers to care, and unnecessary costs to the program.

The proposed rule suggests that CMS will “promulgate through contractor instructions other criteria required for payment, such as for prescription renewal requirements, repair, minor revisions and replacement.” [Emphasis added]. NAAOP strongly supports an exemption from the face-to-face physician requirement for those types of services. To impose such a requirement every time an orthotic or prosthetic user needs an adjustment, revision, repair, or component replacement would create a significant burden on physicians, raise significant barriers for patients and O&P practitioners to provide timely and appropriate care, and would yield no corresponding benefit to the Medicare program in terms of proliferation of use or quality of care.

NAAOP stressed that O&P practitioners clearly have the training and skills necessary to assess for themselves, in consultation with the O&P patient, whether that patient’s orthosis or prosthesis is in need of maintenance, repair or revision. The physician’s original prescription signifying the medical necessity of the orthosis or prosthesis in need of maintenance or repair should extend to the life of the device, as is currently the case under the Medicare O&P benefit. Absent medical complications involving the use of the orthosis or prosthesis, there is no reason for continued physician involvement during the course of routine use necessitating repair or maintenance of the orthosis or prosthesis.

These comments were hand delivered to the Centers of Medicare and Medicaid Services’ Washington, D.C. office. A decision on the final rule on Section 302(a)(2) should be released in the near future.

Peter W. Thomas, NAAOP General Counsel, and Nicole M. Yost drafted this article. For more information, please contact us at 800-662-6740 or by email atinfo@naaop.org.

  • Written by NAAOP

Knee Orthoses Policy Meetings Combined

The Centers for Medicare and Medicaid Services assigned to the Durable Medical Equipment Regional Carriers (DMERCs) the task of developing medical policies for the purpose of processing and reviewing Medicare claims for Durable Medical Equipment, Prostheses, Orthoses and Supplies (DMEPOS) and other selected items. The DMERCs have developed a draft local coverage determination (LCD) and policy article for Knee Orthoses.

We are soliciting comments from manufacturers, suppliers, physicians, and other professionals involved in the ordering, provision, or use of these items. We recommend that you send this draft medical policy to selected members of your organization for review and comment. If you disagree with any aspect of the policy, you should be very specific and, if possible, offer an alternative indication, guidelines, etc. You should provide a clinical rationale for your position. If comments relate to medical necessity criteria, you should include references from the published clinical literature (e.g., standard textbooks, peer-reviewed journals, etc.). We would also encourage a written response if you agree with the policy.

When comments on this policy have been received, they will be reviewed and revisions to the policy will be considered. The revised policy will be published in future DMERC Regional Bulletins and Supplier Manual updates, allowing for adequate notice, before the policy’s effective date.Please submit your comments to each DMERC medical director by mail at the addresses below no later than October 25, 2004. Comments may also be submitted via e-mail through each DMERC’s Web site. In addition, a public meeting will be held by each DMERC to receive comments. Information regarding this meeting may be obtained from each individual DMERC’s Web site.

Paul J. Hughes, M.D.
Medical Director, DMERC Region A
TriCenturion, LLC
7909 Parklane Road – Suite 190
Columbia, SC 29223
www.tricenturion.com

Adrian M. Oleck, M.D.
Medical Director, DMERC Region B
AdminaStar Federal
8115 Knue Road
Indianapolis, IN 46250
www.adminastar.com

Stacey V. Brennan, M.D.
Medical Director, DMERC Region C
Palmetto GBA
P.O. Box 100141 – MailStop AG-250
Columbia, SC 29223
www.palmettogba.com

Robert D. Hoover, Jr., M.D., M.P.H.
Medical Director, DMERC Region D
CIGNA Healthcare-Medicare Administration
2 Vantage Way
Nashville, TN 37228
www.cignamedicare.com

Thank you for your participation in our policy development process.

A public meeting will be held by the Region A DMERC PSC for the purpose of receiving comments from interested parties on a recently released draft Local Coverage Determination.

The comment period extends from September 10, 2004 through October 25, 2004.

The policy is: Knee Orthosis

The meeting will be held on November 2, 2004 (Tuesday) from 1:00 – 3:00 P.M., Conference Rooms F & G at:

DMERC A PSC offices
Tricenturion
7909 Parklane Road – Suite 190
Columbia, SC 29223

Anyone wishing to attend and present at this meeting must register no later than Monday October 25, 2004, with Ms. Connie Hawkins (803) 264-7780. Each speaker will be allowed from 10 – 15 minutes, depending on the number of registered presenters.

Should you desire to participate in this forum but are unable to attend in person contact Ms. Hawkins for arrangements. All comment materials must be delivered in writing at the time of the meeting. These written materials will constitute the official record of each presentation. The next Draft LCD Open Meeting will be held on Tuesday, October 19, 2004, from 1:00 PM – 3:00 PM, in the Board Room at:

AdminaStar Federal
8115 Knue Road
Indianapolis, IN 46250
for discussion of the following draft policy: Draft Policy Name Knee Orthoses

Requests to Present Information at the Draft LCD Open Meeting

Interested parties who wish to make presentations at this meeting must submit a written request that includes the following items:

  • Name
  • Address
  • Telephone Number
  • E-mail Address
  • Name and address of the organization represented (If Applicable)
  • Brief Description of the Information Planned for Presentation

Requests must be received by October 8, 2004 to:

Adrian Oleck, MD
Region B DMERC Medical Director
AdminaStar Federal
8115 Knue Rd. – Mail Point AF10
Indianapolis, IN 46250

All requests will be acknowledged by either confirming or denying the request to present at the meeting. All members of the public are invited to attend the open meeting as observers. If a person is physically unable to attend the meeting but is interested in teleconferencing into the meeting, please send e-mail to: draft_lmrp_comments_DMERC@anthem.com. Approximately seven (7) days prior to the meeting, teleconference, parties will be notified of the telephone number and access number to the Draft LCD Open Meeting.

Comments on Draft Policies

All members of the public are invited to offer comment on this draft policy via e-mail or by the U.S. Postal Service. The formal comment period in which to submit comments for this draft policy is September 10, 2004 through October 25, 2004. Comments may be sent via e-mail todraft comments, or by hardcopy mail to the address above.

Public Meeting for Draft DMERC Local Coverage Determination – Knee Orthosis

A public meeting will be held by the Region C DMERC for the purpose of receiving comments from interested parties on a recently released draft Local Coverage Determination. The comment period extends from September 10, 2004 through October 25, 2004. The policy is: Knee Orthosis

The meeting will be held on November 2, 2004 (Tuesday) from 1:00 – 3:00 P.M., Conference Rooms F & G at:

DMERC A PSC offices
Tricenturion
7909 Parklane Road – Suite 190
Columbia, SC 29223

Anyone wishing to attend and present at this meeting must register no later than Monday October 25, 2004, with Ms. Gwen Backman (803) 763-7492. Each speaker will be allowed from 10 – 15 minutes, depending on the number of registered presenters.

Should you desire to participate in this forum but are unable to attend in person contact Ms. Gwen Backman for arrangements. All comment materials must be delivered in writing at the time of the meeting. These written materials will constitute the official record of each presentation. A public meeting will be held for the purpose of soliciting comments on the following new draft medical policy: Knee Orthoses

When: Wednesday, October 13, 2004
Time: 1:00 – 3:00 PM (CDT)
Where: Centers for Medicare and Medicaid Services

Region VII Regional Office
Pioneer Room #260
601 East 12th Street
Kansas City , Missouri

This meeting is being held in a federal office building and security screening is required. Attendees are encouraged to allow enough time for security screening procedures. Picture identification is mandatory. Interested parties who cannot physically attend the meeting may participate via teleconference by dialing toll-free 866.495.8274 and entering conference code 601008.

Comments should be limited to scientific, evidence-based information and professional consensus opinions. If possible, offer alternative indications, guidelines or coverage criteria. Information received at this meeting will be considered with the written comments submitted during the comment period, which officially ends on October 25, 2004.

Persons interested in speaking must submit their request, in writing or by phone, by Friday, October 8, 2004. Time allotments will depend on the number of registered presenters; however, regardless of the number registered, times will not exceed 20 minutes per speaker. Written copies or transcripts of presentation material must be provided to the Medical Director. Speakers may provide this material at the meeting site.

Thank you for participating in our policy development process.

Robert D. Hoover, Jr., M.D., M.P.H.
Medical Director, DMERC Region D
CIGNA HealthCare-Medicare Administration

2 Vantage Way
Nashville, TN 37228
615.782.4500 ext. 28812

  • Written by NAAOP

NAAOP’S Formal Letter to CMS Administrator on Section 302(a)

Mark McClellan, M.D., PhD
c/o Ms. Karen Daily
Center for Medicare and Medicaid Services

Department of Health and Human Services
Attention: CMS-1429-P
P.O. Box 8012
Baltimore, MD 21244-8012

Dear Dr. McClellan:

This letter constitutes formal comments from the National Association for the Advancement of Orthotics and Prosthetics (“NAAOP”) to the Centers for Medicare and Medicaid Services (“CMS”) on Section 302(a)(2) of the Medicare Program Revisions to Payment Policies Under the Physician Fee Schedule for Calendar Year 2005 (69 Fed. Reg. 47488, August 5, 2004) addressing clinical conditions for coverage of Durable Medical Equipment (“DME”).

NAAOP is a national non-profit association representing the collective interests of certain specialized clinicians-as well as the rehabilitation and disability communities they serve-who are engaged in the provision of quality orthotic and prosthetic (“O&P”) healthcare. Specifically, NAAOP represents highly trained and educated clinicians who carefully evaluate both limb loss and limb or trunk dysfunction for the purpose of providing appropriate, custom-designed orthoses (orthopedic braces) and prostheses (artificial limbs). Quality O&P care assures a custom body interface to each patient’s unique shape and activity level in order to maximize function and minimize an individual’s disability. These clinical services often mean the difference between functional independence and long term disability for people with amputations, musculoskeletal conditions, neurological disorders, stroke, and large numbers of congenital and acquired physically disabling conditions.

NAAOP is responding to this proposed rule because CMS has proposed to extend Section 302(a)(2) of the Medicare Modernization Act from DME to all orthotics, prosthetics and supplies (commonly referred to as “DMEPOS”), without regard to the limits set forth in the statute as to the application of Section 302(a)(2).

The Expansion of Section 302(a)(2) of the MMA from DME to all DMEPOS is Inconsistent with the Statute and Fails to Recognize Significant Distinctions Between the Provision of DME Items and Professional Orthotic and Prosthetic Clinical Care and Related Custom Technology

Section 302(a)(2) of the MMA requires the Secretary of Health and Human Services to establish clinical conditions for payment of covered items of durable medical equipment. The law requires the Secretary to establish types or classes of covered items that require a face-to-face examination of the individual by a physician or practitioner and also requires a prescription for items of DME. However, the proposed rule seeks to expand this face-to-face physician visit requirement to orthotics, prosthetics and supplies. CMS reasons that this expansion is appropriate because it believes that orthotics, prosthetics and supplies require “the same level of medical intervention and skill as DME.” NAAOP strongly disagrees with this reasoning since professional O&P clinical care requires clinical judgment while DME is often drop shipped or supplied by lay sales representatives. Consequently, NAAOP objects to the expansion of the face-to-face physician visit requirement to orthotics and prosthetics. We have no position with respect to expansion of this requirement to “supplies” as NAAOP’s members do not generally supply these items.

Expanding the Face-to-Face Physician Requirement to Professional O&P Clinical Care is Inconsistent with the Statute:

The statutory language of the MMA is very clear with regard to which Medicare benefits CMS should apply the face-to-face physician visit requirement. The statute specifically states that “motorized or power wheelchairs” require a face-to-face examination of the individual by a physician or other practitioner as well as a written prescription for the item. MMA, Section 302(a)(2). The statute then directs the HHS Secretary to establish similar standards on a priority basis for which the Secretary determines there has been “a proliferation of use, consistent findings of charges for covered items that are not delivered, or consistent findings of falsification of documentation to provide for payment” of covered items.

There is very little evidence that the proliferation of use witnessed with some items of DME is present in the orthotic and prosthetic benefit. In the one report where the Office of Inspector General examined a spike in billings under a small number of orthotic billing codes, the principal reason for the problem was identified to be non-certified suppliers (e.g., DME suppliers) inappropriately utilizing the orthotic billing codes. See, Medicare Payments for Orthotics – Inappropriate Payments (OEI-02-99-00120), Office of Inspector General, (March 2000). To address this concern, the OIG recommended, and Congress later enacted in BIPA 2000, special payment provisions for the provision of orthotics and prosthetics.

NAAOP asserts that the rather stringent standard of demonstrable and repeated fraudulent and abusive conduct established by Section 302(a)(2) of the MMA statute has not been met in the case of orthotics and prosthetics and, therefore, the face-to-face physician requirement should not be expanded to these professions.

Expanding Section 302(a)(2) Fails to Recognize the Distinction Between the Provision of DME Items and Professional Orthotic and Prosthetic Clinical Care and Related Custom Technology:

Contrary to the proposed rule’s statement that “items of [prosthetics, orthotics and supplies] require the same level of medical intervention and skill as DME,” DME and orthotics and prosthetics are completely separate and distinct. While it is true that DME and O&P are both reimbursed under a fee schedule by the Durable Medical Equipment Regional Carriers (“DMERCs”), they each have separate statutory authority for coverage under the Medicare program. 42 U.S.C. 1395x(s)(6) and 42 U.S.C. 1395x(s)(9), respectively. Providing professional orthotic and prosthetic clinical care and related custom technology to Medicare patients is vastly different from the provision of DME items and supplies.

Certified orthotists and prosthetists must undergo specialty instruction, skills training, clinical residency and extensive testing specific to the care and management of the O&P patient. Such specialty education and training is unique to O&P, encompassing bodies of knowledge and skills not embraced by any other health care specialty. The provision of professional orthotic and prosthetic care is a unique mix of hands-on clinical practice and biomechanical and technical skill. In order to provide quality orthotic and prosthetic care, O&P practitioners must have access to clinical care settings and technical laboratories designed to provide customized clinical care and technical services.

The provision of DME, in contrast, has little in common with the provision of orthotic and prosthetic patient care. DME suppliers have not been certified for many years and are only now, as a result of the MMA, being required to obtain certification. Clinical patient settings and laboratories are not needed to provide DME, which is usually sold in storefronts and in pharmacies across the country. Indeed, the field of DME requires far less “medical intervention and skill” than the provision of professional O&P clinical care and related custom technology.

As such, the safeguard of requiring a face-to-face physician visit in order for orthotic and prosthetic care to be reimbursed is completely unnecessary and burdensome to Medicare beneficiaries, the practitioners who provide these services, and physicians who prescribe these services. The education, training, and skill level that O&P practitioners have should accord them some degree of deference from CMS to act as partners with physicians in recommending an appropriate course of treatment to O&P patients. As such, the risk of inappropriate proliferation of use of professional O&P clinical care and related custom technology is far less likely than in the field of DME.

CMS Should Remain Consistent with Its Prior Treatment of DME and O&P

There are at least two recent examples where CMS has separately treated DME from orthotics and prosthetics that should serve as strong evidence that CMS should continue to treat these two distinct fields separately. First, in Section 531 of the Beneficiary Improvement and Protection Act of 2000 (“BIPA 2000”), Congress included a provision that permitted DME billing code applications to receive an in-person meeting between the manufacturer requesting a new billing code and the CMS coding panel. In response to the proposed rule implementing this provision of BIPA 2000 (66 Fed. Reg. 58743 (Nov. 23, 2001)), NAAOP requested that orthotic and prosthetic billing code applications receive the same treatment under this new law and submitted comments to that effect.

CMS did not publish a final rule but in telephone conversations with CMS staff, CMS confirmed that they declined to extend this statutory provision impacting DME to orthotics and prosthetics based on the premise that to do so would be an unauthorized expansion of Congressional authority. If this reasoning was valid in the year 2002-when NAAOP confirmed CMS’ position-this same interpretation should apply in 2004.

Similarly, in Section 302(b) of the MMA, Congress created a competitive acquisition program under Medicare for DME but specifically exempted all custom orthotics and all prosthetics. This constitutes that vast bulk of professional orthotic and prosthetic clinical care and related technology except for what the MMA defined as “off the shelf” orthotics. Congress’ reasoning behind this exclusion was that customized devices and services do not lend themselves well to a competitive bidding framework and that professional orthotic and prosthetic services were significantly different (as well as separate and distinct legally) from the provision of DME. This separate treatment of DME and O&P should not be inconsistently applied absent a clear directive from Congress, which clearly does not exist in this instance.

As a practical matter, it should be noted that virtually every orthosis and prosthesis that is reimbursed by the Medicare program must be accompanied by a written physician’s order detailing the O&P treatment required. Therefore, application of this face-to-face physician visit requirement to orthotics and prosthetics will provide CMS with little, if any, additional control over utilization of these services. However, application to orthotics and prosthetics of a number of provisions in the proposed rule could cause delays in treatment of O&P patients, potential compromising the functional outcomes and medical status of beneficiaries with amputations and other orthopedic impairments. Application of Section 302(a)(2) to professional O&P clinical care and related custom technology could erect unnecessary barriers to care, without any significant corresponding benefit to the Medicare program.

If the Secretary Chooses to Expand Section 302(a)(2) to Orthotics and Prosthetics, Medical Necessity Should be the Guiding Principal for Application of the Regulations to Professional O&P Clinical Care and Related Custom Technology

If the HHS Secretary insists on expanding Section 302(a)(2) beyond what the statute clearly seems to authorize, then NAAOP suggests that the final regulations should rely on the concept of “medical necessity” as the guiding principal when determining how the provisions of the rule will apply to professional O&P care.

The Physician’s Order Should Depend on the Medical Necessity of the Professional O&P Care Needed, Not Whether the Physician Designed an Overall Treatment Plan

The proposed rule states that the “face-to-face examination should be for the purpose of evaluating and treating the patient’s medical condition and not for the sole purpose of obtaining the prescribing physician’s or practitioner’s order for the DMEPOS.” The proposed rule continues by stating that the physician is expected to “conduct a sufficient examination of the patient’s medical condition to ascertain the appropriate overall treatment plan and to order the DMEPOS as only one aspect of that treatment plan.” NAAOP believes that for initial orders of orthotics and prosthetics, this proposal is not unreasonable, as the patient has invariably had an acute episode of illness or injury that requires, as part of a treatment plan, orthotic or prosthetic intervention. However, for long term users of orthoses and prostheses, this proposed rule seems misplaced and out-of-step with current medical practice.

NAAOP believes that CMS should make a distinction in the final rule between one-time, temporary users of orthoses (i.e., those who have a need for support of an injured body part following an acute episode until such time as routine healing and rehabilitation restore function to that body part) and permanent, long term users of orthoses. Many people with orthopedic impairments who require orthotic treatment are permanent users of orthotic devices and, therefore, have a long term need.

Similarly, all amputations are permanent and, therefore, all prosthesis (i.e., artificial limb) users have a long term need for prosthetic care. Except for a new amputee’s first prosthesis in which the physician has significant involvement, long term prosthesis users do not require, and routinely do not have, a close relationship with their physician for their prosthetic needs (absent ongoing medical complications). In these instances, the trained, professional orthotist and/or prosthetist, working with the seasoned patient, are in the best position to assess the continued orthotic and/or prosthetic needs of the individual, and make a recommendation to the physician for approval of the plan of care.

Other than chronic or progressive conditions and instances where medical complications are at issue, most individuals who have long term orthotic and/or prosthetic needs do not have an active “medical condition,” but rather, have long term impairments or disabilities. These individuals usually become very familiar with their O&P needs and establish close working relationships with their O&P practitioners. These practitioners are highly trained to provide ongoing professional services to O&P patients with limited involvement from the physician, in most instances.

Again, other than chronic or progressive disorders, it would be rare that an individual who has lived with an amputation or orthopedic impairment for a significant period of time would require an ongoing plan of treatment designed by a physician, unless other complications are in play. To subject these individuals to a requirement for a face-to-face physician examination that specifically prohibits such a visit for “the sole purpose” of obtaining the physician’s order-when this is exactly what is needed from the physician-appears to be an unnecessary barrier that is out-of-step with current medical practice and will lead to nothing more than a delay in treatment, additional barriers to care, and unnecessary costs to the program.

In these instances, the physician’s role should be to assess and, if appropriate, approve themedical necessity of the recommended orthotic or prosthetic treatment, whether or not a face-to-face examination with the physician has occurred and whether or not a plan of treatment has been developed by the physician. Indeed, for long term O&P users, there is usually no other treatment that would be appropriately prescribed other than the professional O&P clinical care and related custom technology itself. To require physicians to develop a plan of treatment for these patients where the O&P care is “only one aspect of that treatment plan” could prompt physicians to unnecessarily prescribe other services such as physical or occupational therapy or other services, just to ensure the physician is in compliance with this rule and is ultimately reimbursed for the face-to-face visit. This has the potential to add unnecessary costs to the Medicare program without any corresponding benefit.

The Physician’s Prescription Should be Effective for the Life of the O&P Device, including Repairs, Maintenance, Minor Revisions and Replacement of Component Parts

The proposed rule suggests that CMS would “promulgate through contractor instructions othercriteria required for payment, such as for prescription renewal requirements, repair, minor revisions and replacement.” [Emphasis added]. NAAOP strongly supports an exemption from the face-to-face physician requirement for these types of services. To impose such a requirement every time an orthotic or prosthetic user needed an adjustment, revision, repair, or component replacement would create a significant burden on physicians, raise significant barriers for patients and O&P practitioners to provide timely and appropriate care, and would yield no corresponding benefit to the Medicare program in terms of proliferation of use or quality of care.

O&P practitioners clearly have the training and skills necessary to assess for themselves, in consultation with the O&P patient, whether that patient’s orthosis or prosthesis is in need of maintenance, repair or revision. The physician’s original prescription signifying the medical necessity of the orthosis or prosthesis in need of maintenance or repair should extend to the life of the device, as is currently the case under the Medicare O&P benefit. Absent medical complications involving the use of the orthosis or prosthesis, there is no reason for continued physician involvement during the course of routine use necessitating repair or maintenance of the orthosis or prosthesis.

Thank you for your consideration of our comments to this very important issue. If you have any questions or need additional information, please do not hesitate to contact me or our Washington counsel, Peter W. Thomas, Esq., at 202-466-6550.

Sincerely,
Michael J. Allen, CPO, FAAOP President
cc: NAAOP Board of Directors

  • Written by NAAOP

CMS Proposes New Coverage Criteria for DMEPOS

In the proposed physician fee schedule for federal fiscal year 2005, the Centers for Medicare and Medicaid Services (CMS) published proposed coverage criteria for durable medical equipment, prosthetics, orthotics, and supplies (DMEPOS). If finalized in their current form, these coverage criteria will impose additional requirements on Medicare coverage of orthotic and prosthetic services.

The proposed regulations are in response to the Medicare Modernization Act (MMA) that was enacted at the end of last year. As part of an effort to improve quality and reduce fraud, section 302(a)(2) of the MMA requires CMS to establish regulatory standards governing the coverage of durable medical equipment. Of note, the statutory language does not instruct CMS to create these standards for orthotic or prosthetic services. Additionally, the MMA states that CMS’s standards should specify the “types or classes” of DME that require a face-to-face examination with a physician (or certain other practitioners) and that CMS should first establish standards for types of DME where there has been “a proliferation of use, consistent findings of charges for covered items that are not delivered, or consistent findings of falsification of documentation.”

Despite the language of the MMA, CMS proposes to apply these regulations to all DMEPOS, not just DME. Additionally, the agency has chosen not to prioritize the restrictions based on which services have been associated with past fraud and abuse.

Furthermore, the preamble expresses the agency’s view that orthotic and prosthetic services are equivalent to DME. CMS states that “we believe items of [prosthetics, orthotics, and supplies] require the same level of medical intervention and skill as DME.” Obviously, many orthotists and prosthetists believe that orthotic and prosthetic care requires far greater skill and training than DME and would, therefore, disagree with this statement.

Face-to-Face Visits. The most significant change to the regulations is the proposed requirement for a face-to-face visit with a physician, physician assistant (PA), clinical nurse specialist (CNS), or nurse practitioner (NP). (Note: This language would prohibit a physical therapist from prescribing DMEPOS, but not necessarily from providing orthotic and prosthetic services.) Currently, an orthotist or prosthetist may furnish an item to a beneficiary based on a physician’s written order, regardless of whether the beneficiary has recently had a face-to-face visit with a physician.

For example, currently, if a patient needs to replace a lower limb prosthesis, the prosthetist can communicate with the treating physician, request a written prescription, and then furnish the new prosthesis. Under the proposed regulations, the patient would have to first have a face-to-face visit with a physician, PA, CNS, or NP. While this is consistent with current practice in many instances, the proposed regulation may lead to a delay in some patients’ treatment.

Furthermore, the preamble states that “the face-to-face examination should be for the purpose of evaluating and treating the patient’s medical condition and not for the sole purpose of obtaining the prescribing physician’s or practitioner’s order for the DMEPOS.” The text of the proposed regulation states that Medicare will not pay for a face-to-face examination that is solely for the beneficiary to obtain a prescription.

How these statements apply to orthotic and prosthetic care is unclear. For example, if a patient needs a new upper limb prosthesis, the preamble to the regulation indicates that the patient must go to the physician so that the physician can evaluate and treat the patient’s medical condition, not solely so that the physician can prescribe a new artificial limb. Exactly what the physician is expected to do, in addition to prescribing the limb, is unclear. What is clear is that Medicare will not reimburse the physician for his time if the visit is solely so that the patient can obtain a prescription for a new prosthesis. This is obviously a major potential problem for the orthotics and prosthetics field.

Order Required Before Delivery. Currently, most items of DMEPOS may be delivered based on a verbal physician order. Only seven types of DME items currently require a written order prior to delivery: pressure reducing pads; mattress overlays; mattresses; beds; seat lift mechanisms; TENS units; and power operated vehicles. All DMEPOS items, however, require a written physician order prior to the supplier billing Medicare.

Under the proposed regulations, a supplier must have a signed written order prior to delivery of any DMEPOS item. While this will be a major problem for the DME field, it may be less of an issue for orthotists and prosthetists. Nevertheless, this is a change from the current documentation requirements, and the orthotics and prosthetics field will need to analyze this change’s effects and comment to CMS, if necessary.

Order Must Be Signed Within 30 Days of Visit. The proposed rule will also require that the physician’s written order is signed and dated within thirty days of the face-to-face visit. While in the past there have been time limits requiring delivery within thirty days of the written order, there has not been a requirement that the written order must be within thirty days of a face-to-face physician visit.

This requirement ignores the unique clinical circumstances surrounding orthotic and prosthetic care. For example, with respect to highly complex prostheses, it may take a number of patient visits before a prosthetist determines exactly what prosthetic components are appropriate. The written order should be sufficiently detailed to reflect each component for which the prosthetist bills Medicare. Often, thirty days from the patient’s visit with the physician will represent a very small window for the prosthetist to finalize the prosthesis design and obtain a sufficiently detailed written physician order.

Commenting on the Rule. CMS is accepting comments on the proposed rule through September 24, 2004. The preamble and text of the proposed rule can be found at www.cms.hhs.gov(PDF). It is of critical importance that orthotists, prosthetists, and others who are concerned with this proposal express their concerns to CMS (electronic comments can be submitted at www.cms.hhs.gov and should refer to CMS-1429-P). As part of this effort, the National Association for the Advancement of Orthotics and Prosthetics (NAAOP) will be submitting comments to CMS on these important issues.

Also, a more in-depth discussion of these and other Medicare documentation requirements will be included at the Third Annual Meeting: Protecting & Expanding Your Practice, to be held in Las Vegas on November 19th and 20th.

For more information, please visit oandpbiznews.com.

Adam H. Greene is a health care attorney with Powers Pyles Sutter & Verville, P.C. and frequently works with the National Association for the Advancement of Orthotics and Prosthetics. You may contact Mr. Greene at (202) 466-6550.

  • Written by NAAOP

Region B Knee Orthoses Policy Meeting

To: NAAOP Members

A Region B public hearing will be held for the purposes of soliciting comments on Knee Orthoses policy. You are encouraged to participate in person or through written comments.

Region B Public Hearing
When: Tuesday, October 19, 2004
Time: 1:00 to 3:00 PM (CDT)
Where: Board Room at AdminaStar Federal
8115 Knue Road
Indianapolis, IN 46250

Requests to Present Information at the Open Meeting

Interested parties who wish to make presentations at this meeting must submit a written request that includes the following items:

  • Name
  • Address
  • Telephone Number
  • E-mail Address
  • Name and address of the organization represented (If Applicable)
  • Brief Description of the Information Planned for Presentation

Requests must be received by October 8, 2004 to:

Adrian Oleck, MD
Region B DMERC Medical Director
AdminaStar Federal
8115 Knue Rd.
Mail Point AF10
Indianapolis, IN 46250

All requests will be acknowledged by either confirming or denying the request to present at the meeting.

All members of the public are invited to attend the open meeting as observers. If a person is physically unable to attend the meeting but is interested in teleconferencing into the meeting, please send e-mail todraft_lmrp_comments_DMERC@naaop.com. Approximately seven (7) days prior to the meeting, teleconference, parties will be notified of the telephone number and access number to the Open Meeting.

Comments on Draft Policies

All members of the public are invited to offer comment on this draft policy via e-mail or by the U.S. Postal Service. The formal comment period in which to submit comments for this draft policy is through October 25, 2004. Comments may be sent via e-mail by to draft_lmrp_comments_DMERC@naaop.com, or by hardcopy mail to the address above.

  • Written by NAAOP

Region D Knee Orthoses Policy Meeting

To: NAAOP Members

A public hearing will be held for the purposes of soliciting comments on Knee Orthoses policy. You are encouraged to participate in person or through written comments.

Region D Public Hearing
When: Wednesday, October 13, 2004
Time: 1:00 to 3:00 PM (CDT)
Where: Centers for Medicare and Medicaid Services
Region VII Regional Office
Pioneer Room #260
601 East 12th Street
Kansas City, Missouri

For other information: CIGNA Medicare

Thank you for your participation in this important process.

  • Written by NAAOP