What is the background of this issue? Why is this happening? Why am I just hearing about this?
In 2009, a “60 Minutes” report aired concerning fraud and abuse in Medicare relating to prosthetic devices. Subsequently, Congress commissioned a study through the Office of Inspector General (OIG) to determine the extent and impact of fraud and abuse with respect to prosthetic devices.
In 2011, the OIG published a report titled “Questionable Billing by Suppliers of Lower Limb Prostheses.” In the report, it claimed that fraud and abuse was a concern as it related to prosthetic devices, primarily around insufficient documentation to support the device that was delivered to the patient. If you’re interested in reading the 2011 OIG report, it can be found here.
After the OIG report was published, Medicare commissioned auditors (commonly referred to as RAC Audits), to audit past prosthetic claims to try to recoup any payments that were deemed to be inappropriate. These audits have been particularly aggressive and many prosthetic offices have had thousands of dollars taken back by Medicare for devices that have already been delivered to patients. Many of these audits are being overturned after review, but it is taking significant time and creating challenges for prosthetists throughout the country.
The proposal was just released by the Medicare Audit Contractors on July 16, 2015 and has a limited comment period open until August 31, 2015. This proposal is likely an effort by Medicare and their contractors to curb fraud and abuse in prosthetic care and device delivery, but the changes being proposed go significantly further than addressing fraudulent claims and would fundamentally alter the current path of amputee care, device delivery, and rehabilitation.
What are some of the biggest concerns with this drafted proposal?
While there are a significant number of concerns with the contents of this proposal and how it will impact people with limb loss, the Amputee Coalition has identified the following as major concerns to be aware of:
- Medicare will no longer consider your potential functional abilities with an appropriate device when determining your prosthetic needs. They completely redefine the functional “K-Levels” in this proposal.
- If you are using an assistive device such as a cane, crutch, or walker, you would be limited to less functional prosthetic devices. If you have a higher functional level, Medicare will not pay for you to have a wheelchair or any assistive device.
- Combining feet and ankles into a single code and limiting access to advanced technology would significantly harm your access to the feet and ankles that best meet your individual needs.
- You and your medical team may no longer be able to select the necessary socket systems or liner inserts to ensure the most appropriate fit for your needs. Elevated vacuum sockets would no longer be covered for anyone, and suction suspension systems would not be available for K1 level patients. Additionally custom fabricated (roll on) liners may not be covered for most patients, and cushioned liners would be unavailable for anyone who uses a molded distal cushion.
- You could be provided a less functional prosthesis or denied a device just because you may not be able to attain the “appearance of a natural gait,” or if your medical record references certain health complications.
- The Medicare proposal redefines the rehabilitation process for amputees and forces new amputees to rehab on out of date technology that they will not even use once they receive their permanent prosthetic device.
I’m not a Medicare patient, how does this impact me?
Even if you’re not currently a Medicare patient, it’s important to understand that often private insurance companies, the VA and others follow Medicare’s example. If this proposal were to move forward, there’s a likelihood that other payers would follow Medicare’s lead and these proposals could impact everyone.
What is the Amputee Coalition doing about this issue?
The Amputee Coalition is providing comments, requesting a meeting with Medicare and legislators, has a sample consumer letter available for amputees to submit their formal comments on the issue, and are asking for everyone to sign the online petition that’s been created. For more information and to see everything the Amputee Coalition is doing, check out our Medicare Issue Alert website.
How will the online petition to the White House help?
Once the online petition reaches 100,000 signatures, the White House is obligated to provide a formal response to the contents of the petition. This could help to elevate the issue into the national spotlight and highlight the major impacts and concerns we have with this drafted proposal, so make sure you sign it today and click the confirmation link you receive in your e-mail to make sure your signature counts!
How will writing letters and providing comments on the proposal help?
The more comments this draft proposal receives that raise concerns about the changes outlined within it, the more likely the drafters will make appropriate modifications to the proposal and will reconsider the harmful elements throughout the document before making any final changes to patient coverage and care.
Will my prosthetist be able to submit information into my medical record?
No. Your prosthetist’s notes are not necessarily considered part of the medical record currently, although their notes have been able to support your medical team’s decisions in determining your functional level. Under this proposal, your prosthetists notes would not be able to be considered at all, even if they were signed off on by a physician or licensed medical professional. The Amputee Coalition believes that you and your medical team should work together to ensure you receive the most appropriate prosthetic device for your needs at the time you need it. Your prosthetist is a vital part of your medical team and the Amputee Coalition believes their experience and knowledge of different prosthetic components can help the medical team determine the appropriate prosthetic component for each individual patient.
Does this affect everyone who uses a prosthetic device?
Not everyone. Currently the focus of these audits and this proposal is for all lower limb prosthetic devices. However, there is always a possibility that upper limb prosthetics could go through similar reviews in the future if this proposal is finalized. Medicare and the Auditors have primarily focused on claims where patients have been classified between the K2 and K3 functional levels. The reason for this is because of the increase in technology (and therefore cost) associated with the transition from a patient who is designated as a K2 functional level to a patient that is designated as a K3 functional level.
Does this proposal limit the number of prosthetic devices I can be provided throughout my life?
No. There is nothing within this proposal that would limit patients to a certain number of devices throughout their lifetime. While some private insurance companies have used clauses that include restrictions like “one limb per limb per lifetime,” Medicare has never made any such a proposal.
What are the current K-Levels defined by Medicare?
K-Levels are a functional assessment scale used by Medicare to indicate person’s rehabilitation potential. The scale indicates a person’s potential to use and get around using an appropriate prosthetic device for their needs. The current K-Level definitions are as follows:
| K0 | The patient does not have the ability or potential to ambulate or transfer safely with or without assistance and a prosthesis does not enhance their quality of life or mobility. This level does not warrant a prescription for a prosthesis. |
| K1 | The patient has the ability or potential to use a prosthesis for transfers or ambulation on level surfaces at a fixed cadence. This is typical of a household ambulatory or a person who only walks about in their own home. |
| K2 | The patient has the ability or potential for ambulation with the ability to traverse low-level environmental barriers such as curbs, stairs or uneven surfaces. This is typical of the limited community ambulator. |
| K3 | The patient has the ability or potential for ambulation with variable cadence. A person at level 3 is typically a community ambulatory who also has the ability to traverse most environmental barriers and may have vocational, therapeutic or exercise activity that demands prosthetic use beyond simple locomotion. |
| K4 | The patient has the ability or potential for prosthetic ambulation that exceeds basic ambulation skills, exhibiting high impact stress or energy levels. This is typical of the prosthetic demands of an active child or adult, or athlete. |
What are the proposed changes to these K-Level definitions under the drafted proposal?
Under the drafted proposal, many patients would be forced into a lower K-Level because of their use of assistive devices and because these new proposed definitions eliminate the patient’s potential when considering their functional level:
| K0 | Does not have the ability to ambulate or transfer safely with or without assistance and a prosthesis does not enhance their quality of life or mobility. |
| K1 | Has demonstrated the ability to use a prosthesis for transfers or ambulation on level surfaces at a fixed cadence. Typical of the household ambulator. Who can walk for distances that are considered reasonable for walking inside the home but limited for walking in the community because of endurance, strength, or safety concerns.
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| K2 | Has demonstrated the ability for ambulation to traverse low-level environmental barriers such as curbs, stairs or uneven surfaces. Typical of the limited community ambulator who can ambulate without assistance and is able to function physically and psychologically within the community independently.
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| K3 | Has demonstrated sufficient and adequate lower extremity function for personal independence during ambulation with variable cadence. Typical of the unlimited community ambulator who has the ability to traverse most environmental barriers without physical or safety concerns and has vocational, therapeutic or exercise activity that demands prosthetic utilization beyond typical environmental barriers.
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| K4 | Has demonstrated sufficient and adequate strength, endurance, range of motion, and coordination for personal independence during ambulation. Exhibiting recreational demands, high impact activities, or elevated energy levels, typical of the prosthetic utilization for the energetic child, active adult, or athlete. An “active community ambulator” who not only can walk distances with no difficulty but also run on even ground with little difficulty.
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If Medicare is taking back money from my prosthetist with these audits, will they ever take back my prosthetic device?
Medicare will not take back your prosthetic device, but you may need additional documentation by your doctor to continue receiving repairs to your device and to ensure you receive the same level of device that you currently have when you need a replacement.
Does this have anything to do with the Affordable Care Act (“Obamacare”)?
This proposal does not have anything to do with the Affordable Care Act. Private payers and government programs have always looked to find ways to reduce costs while attempting to maintain or improve patient care. These types of audits have occurred in other professions and industries for years before healthcare reform as a way for Medicare to ensure they are paying for appropriate services.
Did the Amputee Coalition contribute to these proposed changes in any way?
Absolutely not. The Amputee Coalition was not involved with any aspect of this proposal and we are doing everything we can to ensure that the concerns we have with the contents of the proposal are addressed and corrected before any changes are made. The Amputee Coalition further recommends in our formal comments that Medicare and their auditors convene an appropriate group of professionals, patients, and advocacy organizations to determine the best practices in patient care are upheld before any changes are made.