On July 18, the Centers for Medicare & Medicaid Services (CMS) and the Durable Medical Equipment Medicare Administrative Contractor (DME MAC) medical directors released the much-anticipated final Local Coverage Determination (LCD), Lower Limb Prostheses (L-33787). They also published an updated Lower Limb Prostheses – Policy Article that offers additional details on the new coverage including significant new examples and details on beneficiaries who qualify as K2 and K3 ambulators. In fact, there are examples offered that should help prescribers and practitioners identify more accurately which beneficiaries should be assigned a particular functional level. Notably, the DME MAC medical directors posted on their respective websites a response to the commenters who submitted statements earlier this year on the draft LCD. These comments, taken as a whole, are very supportive of the expertise necessary to provide prosthetic care and the clinical prosthetists who perform these services.
The final LCD expands the coverage criteria for microprocessor-controlled prosthetic knees (MPKs)—including fluid and pneumatic knees—for Medicare Functional Classification Level-2 (MFCL-2) beneficiaries (commonly known as K2), who are considered limited community ambulators and require a prosthetic knee based on the best available evidence. The LCD states that MPKs may be a viable therapeutic option for some limited community ambulating Medicare beneficiaries with lower-limb amputations. Specifically, the final LCD states, “Therefore, the criteria in the Lower Limb Prostheses Local Coverage Determination will be expanded to allow coverage of fluid, pneumatic, or electronic/microprocessor control additions for prosthetic knees in MFCL-2 beneficiaries when supporting documentation in the medical record outlines the rationale for selection of the higher-level knee.” The effective date for this final LCD was September 1.
The LCD also addresses complementary prosthetic foot options for Medicare beneficiaries who qualify under the new coverage policy. The policy states, “Criteria of higher-level foot systems will also be expanded to include MFCL-2 beneficiaries who meet the new coverage criteria for a fluid, pneumatic, or electronic/microprocessor control addition for a prosthetic knee, and who will require a compatible foot.”
The final LCD closely mirrors the proposed coverage policy but makes two important modifications: (1) The final LCD removes the word “all” from the requirement to consider and rule out other non-MPK lower-level knee systems (e.g., knee systems which exclude use of fluid, pneumatic, or microprocessors). This is a much more reasonable standard for coverage of MPK systems and will help practitioners serve beneficiaries in need without undue burdens to prove that all alternative lower-limb knee systems would not meet patients’ needs, as the draft LCD proposed. (2) The final LCD also clarifies that Healthcare Common Procedure Coding System (HCPCS) code L-5841 (addition, endoskeletal knee-shin system, polycentric, pneumatic swing, and stance phase control) is covered under the category of fluid and pneumatic knees for K2 beneficiaries. This L-Code was omitted from the draft LCD.
The policy article also explicitly includes reference to the statute that the national O&P organizations, including the National Association for the Advancement of Orthotics and Prosthetics (NAAOP) and the O&P Alliance organizations, worked to have enacted several years ago, as follows:
“Based on Social Security Act §1834(h)(5), for purposes of determining the reasonableness and medical necessity of orthotics and prosthetics, documentation created by an orthotist or prosthetist shall be considered part of the individual’s medical record to support documentation created by the treating practitioner.”
This is just another example of how favorably the new policy respects the clinical expertise of the treating prosthetist. In fact, in response to public comments, the DME MAC medical directors explicitly rejected one commenter’s recommendation that prosthetists should have no role in determining the functional level of the patient.
Context for This Advance in Prosthetic Coverage
This significant change in policy continues to signal a trend in how CMS addresses coverage of new technologies, including devices and components that were invented years ago but have not been widely covered under Medicare and private insurance plans. Fears of fraud and abuse in the durable medical equipment, prosthetics, orthotics, and supplies (DMEPOS) benefit contributed to years of pent-up demand for advanced Medicare coverage of emerging technologies. The O&P organizations have long advocated to increase investments and advocacy for research and building the O&P scientific evidence base to bolster the case for improved coverage policies.
Recent government focus on health equity and removal of health disparities has forced a comprehensive review of government policies that impact people with disabilities, a group that was recently designated by the federal government as a health disparity population. Finally, creation within CMS of the Technology Coding and Pricing Group (TCPG) and improvements in the HCPCS coding and pricing processes have recently helped accelerate reconsideration of numerous coverage, coding, and payment policies under the DMEPOS benefit. Years of coordinated joint advocacy to pressure the administration and Congress into action is clearly producing results.
In the past two years, CMS has created a billing code for bone-anchored prostheses, paving the way for access to osseointegrated prostheses for Medicare beneficiaries who do not respond well to traditional socket technology. Last year, CMS determined that orthoses that employ the use of powered features are considered under the orthotic benefit category, leading to coverage of exoskeletons that assist beneficiaries with paralysis to stand and ambulate. This decision also established coverage of powered orthoses that assist beneficiaries with stroke and other conditions to perform upper-limb activities of daily living.
In addition, the DME MACs retired coding guidance for upper-limb prostheses that was having the effect of creating access challenges for beneficiaries with partial hand or finger amputations. The O&P national organizations are pursuing comprehensive coding reforms to the upper-limb prosthetic benefit to build on this initial success. Finally, for beneficiaries with limb loss who require the use of a power wheelchair in their homes, CMS granted coverage of seat elevation in power wheelchairs to improve the ability of beneficiaries to reach for objects and perform mobility related activities of daily living in the home. The MPK coverage expansion is the latest improvement to the Medicare benefit package in this area and will likely have a ripple effect in how private healthcare plans and other insurance programs cover these benefits in the future.
Details of the MPK Coverage Policy
LCDs analyze the evidence base and summarize the medical and functional information that must be demonstrated to establish that a particular item or service is reasonable and necessary under the Medicare program, commonly referred to as “medical necessity.” Medicare coverage will be provided when an item or service: 1) is eligible for coverage under a defined Medicare benefit category, 2) is reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member, and 3) meets all other applicable Medicare statutory and regulatory requirements. In addition to the “reasonable and necessary” criteria contained in this LCD, there are other payment rules that are discussed in the following documents that must also be met prior to Medicare reimbursement, including the LCD-related policy article, the Supplier Manual, and additional bulletin articles and other publications related to this LCD published on the DME MAC websites.
The LCD’s Summary of Evidence
The final LCD summarizes the evidence the DME MAC medical directors considered in connection with the LCD. The evidence focuses on the use of MPKs with limited community ambulators, classified as K2, who are described as having the ability or potential for ambulation with the ability to traverse low-level environmental barriers such as curbs, stairs, or uneven surfaces. The analysis concentrates specifically on the rate of falls, risk of falling, fear of falling, and gait performance with MPKs with integrated technology that allows the knee to detect when the user trips or stumbles and can automatically adjust to stabilize the knee unit compared to non-MPKs. The LCD is based on studies, clinical trials, and impact analyses that comprise the evidence base.
Conclusions Reached in the Final LCD
The DME MAC medical directors concluded that MPKs improve stability when the user is standing and walking and fall prevention with the addition of technology that can automatically increase resistance in the knee unit to provide support when a stumble is detected. The final LCD also states that the use of an MPK compared to a non-MPK may reduce the rate of falling, risk of falling, and fear of falling, as well as improve gait performance inK2 ambulators.
Finally, the medical directors confirmed that MPKs may be a viable therapeutic option for some limited community ambulating Medicare beneficiaries with lower-limb amputations. Therefore, the criteria in the Lower Limb Prostheses LCD were expanded to allow coverage of fluid, pneumatic, or MPK control additions for prosthetic knees in K2 beneficiaries when supporting documentation in the medical record outlines the rationale for selection of the higher-level knee.
Documentation Required to Demonstrate Medical Necessity
The LCD requires sufficient documentation in the clinical file for the Medicare program to cover an MPK for a K2 beneficiary. A summary of these documentation requirements include:
- How the selected knee will improve the beneficiary’s functional health outcomes
- How the selected knew will help the beneficiary accomplish their activities of daily living
- That lower-level knee options have been considered and ruled out based on the beneficiary’s individual • The MPK provided must be indicated for K2 individuals and include integrated technology that allows the knee to detect when the user stumbles, automatically increases resistance in the knee to provide support for recovery, and potentially prevents a fall.
Furthermore, the LCD stipulates that the beneficiary must be able to make use of a product that requires daily charging and can understand and respond to alerts/alarms, which may indicate knee dysfunction.
This documentation must be reflected in the standard written order and the patient’s medical record. In addition, each claim must be correctly coded for billing purposes and proof of delivery must be on file. The medical directors set forth additional documentation requirements to demonstrate medical necessity in a related policy article. The first requirement is consistent with the existing instructions for • When submitting a prosthetic claim, the billed code for knee, foot, ankle and hip, components must be submitted with modifiers K0–K4, indicating the expected beneficiary functional level. This expectation of functional ability information must be clearly documented and retained in the prosthetist’s records. The simple entry of a K modifier in those records is not sufficient. There must be information about the beneficiary’s history and current condition that supports the designation of the functional level by the prosthetist.
More specific documentation requirements for beneficiaries whose functional level is K2 are established for the provision of MPKs, including fluid and pneumatic knees. The medical records must include all of the following:
- Documentation of a clinical evaluation of the beneficiary’s potential functional abilities by a treating practitioner or the prosthetist that designates a functional level of K2. (If completed by a prosthetist, the treating practitioner’s medical records must support the functional level assigned.)
- Discussion of the beneficiary’s overall medical health and the rationale for selection of a fluid, pneumatic, or electronic/microprocessor-control addition to a prosthetic knee system. Taking into consideration potential safety concerns of the advanced knee technology, the following must be included (at minimum):
■ Which functional health outcomes (e.g., fall reduction, injury prevention, lower energy expenditure) are expected to be improved with the selected knee, and
■ Specifically which activities of daily living (e.g., transferring, climbing stairs, grocery shopping, housekeeping, working) are expected to be improved with the use of the selected knee.
- Documentation to support that lower-level knee systems (e.g., knee systems which exclude use of fluid, pneumatic, or microprocessor) have been considered and ruled out, including the rationale for why a lower-level knee system would not be sufficient to meet the beneficiary’s specific functional and medical needs.
Additionally, for an electronic/MPK system for beneficiaries whose functional level is K2, the medical records must also include:
■ Documentation that the electronic/microprocessor knee is indicated for functional level K2 and has integrated technology that allows the knee to detect when the user trips or stumbles and can automatically adjust to stabilize the knee unit (e.g., stumble recovery), and
■ Documentation indicating the beneficiary can make use of a product that requires daily charging and has the capacity to understand and respond to error alerts and alarms indicating problems with the function of the unit.
KX, GA, GY, and GZ modifiers are also required for claims submission of fluid, pneumatic, and MPKs to facilitate claims processing and assist in the prevention of improper claims payments. The modifiers should be used in the following situations:
■ KX: The requirements specified in the medical policy have been met.
■ GA: The waiver of liability statement was issued as required by payer policy, individual case.
■ GY: The item or service is statutorily excluded or does not meet the definition of any Medicare benefit.
■ GZ: The item or service is expected to be denied as not reasonable and necessary.
Additional Guidance in Assessing K2 Beneficiaries
For the first time in many years, the medical directors offer additional details to the functional levels to assist physicians, physician extenders, therapists, and prosthetists in assessing which K-level to assign to an individual patient. This new guidance is published in the policy article related to the LCD and states the following:
Functional Level Characteristics for K2 Ambulators
- The individual has the ability or potential for ambulation with the ability to transverse low-level environments such as curbs, stairs, or uneven surfaces. This level is typical of the limited community ambulator.
- Can, with or without an assistive device, perform the following:
■ Perform K-level 1 tasks (safe ambulation within the home)
■ Ambulate on a flat, smooth surface (such as concrete, asphalt, porch, deck, patio garage, driveway)
■ Negotiate a curb
■ Access public or private transportation
■ Negotiate 1-2 stairs
■ Negotiate a ramp built to ADA specifications
- May require a wheelchair for distances that are beyond the perimeters of the yard/driveway, apartment building, etc.
- Is only able to increase their generally observed speed of walking for short distance or with great effort
- Generally is not capable of accomplishing most of the tasks at K3 level (or does so infrequently with great effort).
Conclusion
This finalized LCD is a major improvement in lower-limb prosthetic coverage for Medicare beneficiaries with limb loss. It comes after more than 20 years of clinical research, eight years after CMS stated that the Medicare program should consider coverage of MPKs for K2 ambulators, and major efforts by the national associations, manufacturers, and many others to improve Medicare coverage in this manner.
This LCD represents a significant advance forward in the treatment of individuals with lower-limb amputations to improve function and safety, specifically with respect to fall prevention. Together with other notable improvements to O&P coverage discussed earlier in this article, the Medicare benefit is becoming more responsive to the needs of beneficiaries with limb loss and limb difference. It will be critical for practitioners to carefully assess the functional levels of their patients, clearly and comprehensively document medical necessity for each patient they determine can benefit from an MPK, and self-police the profession to help ensure this new level of access continues well into the future.
Peter W. Thomas, JD, is general counsel to the National Association for the Advancement of Orthotics and Prosthetics and counsel to the O&P Alliance. Taylor Haines is the NAAOP Breece Fellow for 2024.
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