New Local Coverage Determination ‘Most Important Topic’ to Affect O&P Profession in Decades, Experts Say

The recently published draft policy for Local Coverage Determination for Lower Limb Prosthetics has the potential to completely change professions in the profession of orthotics and prosthetics, according to representatives of the National Association for the Advancement of Orthotics and Prosthetics.

“This is fundamentally reshaping how prosthetic care, coverage and coding works,” David McGill, JD, president of the National Association for the Advancement of Orthotics and Prosthetics (NAAOP) and vice president of legal affairs and reimbursement for Össur, said during a webinar co-hosted by Össur and NAAOP. The webinar’s other featured speaker was Peter W. Thomas, JD, general counsel for the NAAOP, who said the Local Coverage Determination (LCD) for Lower Limb Prosthetics is “probably the most important topic that is before the industry over the past 2 decades.”

While the draft policy is a proposal, Thomas warned O&P stakeholders not to underestimate its potential impact. It would cover the entire United States because all four Durable Medical Equipment Medicare Administrative Contractors (DME MACs) have released it and would serve as a model for other payers.

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“This does not just impact Medicare. This impacts all private payers and VA [Department of Veterans Affairs] and everyone else,” he said. “Where Medicare goes, so often the private payers go as well. And they make many changes to the uniform code set, which all payers are obligated to follow.”

The deadline for comment on the LCD was set for Aug. 31.

Clinical changes affect K levels, rehab and assessments

The new LCD would redefine the use of K levels to determine function, Thomas said. In the past, prosthetists were able to incorporate a patient’s potential function into the assessment of K level. This will no longer be the case in the new, simplified policy.

“Essentially what they are doing is writing ‘potential’ out of the policy. That is a fundamental change in how prosthetic care is prescribed in this country, and it will have a very deleterious impact on patient access to all kinds of prostheses and prosthetic components … that really form, at this point, the standard of care in this country,” Thomas said.

According to the draft, patients who use a walker or crutches with a prosthesis will be defined as K1 amputees and patients who use a cane with a prosthesis will be defined as K2, while K3 and K4 amputees will not be allowed to use an assistive device. Thomas said the new determinations assume a patient’s level of function is completely static with no account for volume fluctuations or changes in the patient’s body or the prosthetic socket.

“It is going to drive patients into lower K levels and lower technology,” Thomas said. In a statement, the NAAOP has claimed this change is “sending amputees back to the 1970s.”

The LCD also has created a defined rehabilitation program that patients must participate in to receive a prosthesis, McGill and Thomas noted. The draft states that for a preparatory prosthesis, patients must be scheduled to undergo the program; for a definitive prosthesis, patients must show they have completed the program. To show successful completion of the program, according to the new LCD the patient must be able to don and doff the prosthesis without assistance; must be able to transfer without assistance, even when the prosthesis is off; must have “sufficient wear tolerance for a normal day”; and must “attain sufficient balance and stability to ambulate with ease of movement and energy efficiency with preparatory prosthesis after limb volume stabilization.”

McGill said the LCD provides no definitions for the above terms in quotation marks and measures such as “sufficient wear tolerance for a normal day” are difficult to define. Beyond the vague nature of the policy, he said, its overall impact is one that creates barriers in front of patients in need of a prosthesis.

“The bottom line is, it [will be] harder for patients to get a limb,” McGill said. He said the physical and psychological effects of barriers to receiving a limb “can have a really profound impact” on patients.

David McGill
Peter W. Thomas

Another clinical change embedded in the proposed LCD is a requirement for functional assessment to receive a definitive prosthesis. The requirements for the assessment are extensive, Thomas said, and may prove too burdensome for some amputees.

“I have no doubt that there will be some amputees who will give up on this process,” Thomas said.

While some of the assessment requirements are reasonable, Thomas said, they are interspersed with “major hoops” for patients to jump through. For example, Thomas said, the functional assessment requires proof that the patient has “sufficient trunk control, good upper body strength, adequate knee stability with good quad strength and control, good static and dynamic balance or Tinetti score of greater than 24 and adequate posture.” This neglects abnormalities, trauma, comorbidities and other complicating factors that affect many amputees, he said.

“If this constitutes a checklist that beneficiaries have to demonstrate before they are even eligible for a prosthesis, this is a major problem,” Thomas said.

He added the functional assessment also requires proof that a prosthesis provides “appearance of natural gait,” which he said is not only offensive to patients but is not an indicator of the effectiveness of prosthetic care.

“We are going to fight tooth and nail to have that removed,” Thomas said.

According to the draft, the functional assessment requirements also call for an in-person independent medical examination (IME) which must take place before a prosthesis can be ordered and which cannot be conducted by a prosthetist. Thomas said the policy is moving care away from the use of prosthetists, which he said DME MACs believe are financially incentivized to diagnose patients and should not have a role in the functional assessment process.

“We strongly disagree,” he said. “Taking out the very person who has the most intricate knowledge of prosthetics from the determination of what that person’s functional level is and what their functional potential is, is a major problem.”


Changes to current coverage

The LCD also makes changes to coverage of items including elevated vacuum systems; mechanical plantar and dorsiflexing ankles; and add-on components.

The LCD draft states that “insufficient published clinical evidence” exists for continued coverage of elevated vacuum systems, but Thomas said no references or citations are provided to back this claim. In fact, he said, a plethora of peer-reviewed scientific evidence exists in support of elevated vacuum systems.

“There are a lot of alarming provisions in this [draft]; this is unbelievable,” Thomas said. “The impact of this is that you are going to have elevated vacuum systems that are simply not payable by Medicare. … You can expect that there will be a ripple effect of this policy [to other payers] if in fact it is maintained.”

McGill added the “vast majority” of major private payers do currently provide coverage for elevated vacuum systems, but this change would make it easier for them to drop that coverage.

The current LCD does not have a K level restriction on code L5968 (mechanical ankle), according to McGill, but the new LCD draft restricts the code to patients who are K3 or higher. No references support this change, McGill said. Many K2 amputees use this technology, so McGill said the change is another attempt to limit access to needed technology.

Another change is in the area of add-on codes, the speakers said. The draft LCD states no add-on codes will be allowed for immediate, preparatory and definitive prostheses.

“We do think that there is an error in the draft. They could not possibly mean that there are no add-on codes for definitive prostheses. That would eviscerate the entire code set and all it would do is allow the billing of the base code,” Thomas said. He added the LCD contains numerous references that indicate the add-on codes will continue for definitive prostheses. However, McGill and Thomas believe the plan to remove add-on codes relating to preparatory and immediate prostheses is accurate.

Thomas said this change is an attempt for DME MACs to save money, with patients taking the hit.

“The impact is a dramatic limitation in components for new amputees; certainly, from a provider perspective, a dramatic limitation in the ability to bill for and to provide the correct and functionally appropriate technology and components to an amputee; and it also just completely ignores current Medicare practices and the current standard of care,” he said.

Coding changes

The draft LCD also includes a number of coding changes. For prosthetic feet, it discontinues codes L5971, L5975, L5976 and L5979. It collapses L5980, L5981 and L5987 into a new L code and collapses codes L5982, L5984, L5986 into a new K code. It contains just three foot add-on codes.

The bottom line regarding foot codes is the current segmentation would be removed, according to McGill.

“You would now have much broader code categories and broader descriptions,” McGill said, adding this will cause industry companies to streamline their product lines. Because the current segmentation allows manufacturers to offer a variety of products at a variety of prices, this leads to a narrowing of choices for patients.

Changes to liner codes are confusing, McGill said, and additional guidance is needed regarding codes L5673 and L5679. The goal of the changes may be to push custom-fabricated liners into a code that applies to prefabricated codes, which would have a negative impact on patients and practitioners.

“It is hard to tell what is going on with the liners, but it is cause for enormous concern,” he said.

Code changes in the LCD also apply to sockets, McGill said: the draft restricts the use of codes L5629 and L5631- both acrylic resin lamination codes – as well as total contact codes L5637 and L5650.

McGill said this change is another attempt to limit the options available to patients. He also drew attention to a few miscellaneous coding changes: more guidance is needed for ultra-light material codes, L5940-L5960; the draft restricts the use of alignable system codes, L5910 and L5920; and it deems protective outer surface codes, L5962, L5964 and L5966 “rarely necessary.”

Response and next steps

Thomas said the O&P community has been blindsided by many of these changes.

“We are not really sure where this is coming from. This is such a tour de force of bad Medicare policy,” he said, referring to the draft as “a full assault on the prosthetics field and lower limb amputees across the country.”

This demands a powerful response, according to Thomas and McGill.

“We need to fight back and push back in a big way,” Thomas said.

NAAOP has initiated a petition to the White House calling for the Medicare policy to be rescinded. For the White House to respond formally to a petition, 100,000 signatures are needed and at press time, the petition had reached this goal with more than 102,000 signatures. The deadline for the NAAOP petition is Aug. 30, 2015 and additional signatures can be collected until that date.

“We are making an all-points bulletin for you to do all you can,” Thomas said, urging practitioners to have their coworkers, friends, family and patients to sign the petition. NAAOP also had a comprehensive, line-by-line review of the LCD in the works. Sample letters are posted on the NAAOP website for patients and practitioners to submit comments on the formal LCD process. Thomas also encouraged practitioners to use the draft letters available at He noted a response is needed for people who work in rehabilitation and other aspects of O&P patient care. Additionally, patient voices are needed.

“It is important that we reach out as a community to all those who have a role and a stake in the future of prosthetic care in this country,” he said. – by Amanda Alexander

Disclosures: McGill and Thomas report no relevant financial disclosures.

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