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Reimbursement News and Updates

Navigating the New Medicare LCD Changes: What CPOs Need to Know

On July 18th, 2024, Medicare released the future Lower Limb Prostheses Local Coverage Determination (LCD) and its accompanying Policy Article. These changes mark a significant advancement in prosthetic care, particularly for Certified Prosthetists and Orthotists (CPOs) who work with insurance providers to secure advanced prosthetic solutions for their patients. This post will outline the key updates and explain their significance for your practice, especially concerning Functional Level Characteristics.

These updates go into effect on September 1, so let’s talk about what to expect!

Key LCD Criteria Changes

The revised LCD introduces new pathways for some K2 transfemoral amputees to access K3 prosthetic feet and knees. The criteria for qualification are divided into two levels:

Initial Criteria:

• A clinician must assess and determine the patient’s functional level.
• The medical record must provide a clear rationale for selecting a K3 knee, detailing how it will improve the patient’s functional health outcomes and help them accomplish their activities of daily living (ADLs).
• The clinician must also document why less sophisticated K2 knees are unsuitable for the patient’s specific needs.

Additional Criteria for Microprocessor-Controlled Knees (MPKs):

• The MPK must be indicated for functional level (K2) patients.
• It must include stumble recovery functionality or comparable technology.
• The patient must be capable of understanding and responding to error alerts or alarms.
• The patient should be able to manage daily charging of the device.

Please note: If these criteria are met, a K2 patient may also qualify for a K3 foot, if it is required for the "safe and proper use" of the prosthetic knee.

Policy Article Updates

The updated Policy Article enhances clarity by providing detailed characteristics associated with each functional level (K-level). It emphasizes the need for specific documentation in the medical record, particularly regarding how a K3 knee will improve the patient’s ADLs. Additionally, prosthetists' and orthotists' notes are officially recognized as part of the medical record, underscoring the importance of thorough documentation.

Implications for CPOs

• Expanded Access to Advanced Prosthetics: The updated LCD allows you to offer K3 knees and feet to a broader range of K2 transfemoral Medicare patients. This expansion enables you to provide more personalized and effective prosthetic solutions that enhance patient mobility and stability.
• Importance of Detailed Documentation: To ensure compliance with the new guidelines, it's crucial that your clinical notes thoroughly address all relevant criteria. The DME MACs are expected to scrutinize these claims closely, so make sure your documentation is precise and comprehensive.
• Understanding Manufacturer Indications: The PDAC will not verify which MPKs are suitable for K2 patients; this responsibility falls to clinicians based on the manufacturer's indications. Therefore, it is vital to ensure that the MPK you select meets the necessary criteria.
• Preparing for Implementation: The updated LCD and Policy Article will take effect on September 1, 2024. Be sure to familiarize yourself with the new "Modifiers" section and incorporate these updates into all future prosthetic claims.

Reimbursement Resources to Support You:

Ottobock is here to equip you with the tools for a successful reimbursement journey for the Kenevo or C-Leg microprocessor knee. With these latest LCD changes by Medicare, these MPKs are more widely covered, but will require more thorough documentation in the reimbursement process. Our team is here and ready to help. Contact us if you have any questions or need support.

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Ottobock Leads the Charge in Expanding Access to Prosthetics for Underserved Patients

July 19, 2024 - Austin, TX - Medicare officially announces LCD changes that expand access to microprocessor-controlled knees (MPKs) for lower mobility users—a group that is often overlooked as users of this groundbreaking technology (view the changes here). Ottobock has been the driving force behind the expansion of Medicare coverage of MPKs for low-mobility patients, leading the way with two decades of research and advocacy. As the world’s largest prosthetics and orthotics manufacturer, Ottobock is proud to continue its unwavering commitment to improving access to advanced prosthetic technology for underserved patient communities.

In 2005, Ottobock initiated the first clinical study involving patients in a low-mobility user group utilizing MPKs, leading to two pivotal publications. Despite the early evidence, it wasn't until 2014 when Dr. Andreas Kannenberg published the first systematic review of five MPK studies involving patients with limited mobility. However, this was still insufficient to sway Medicare at that time. Undeterred, Ottobock continued to fund more than 80% of subsequent studies, reinforcing its dedication to this critical research.

By 2021, the cumulative efforts paid off when Dr. Kannenberg and Dr. Andreas Hahn, VP of Clinical Research & Services at Ottobock published another comprehensive systematic review, encompassing 704 patients across 15 publications and 13 clinical trials. This rigorous scientific groundwork culminated in Ottobock filing the LCD Reconsideration Request in March 2022. This request has led to the current revision of the LCD for Lower Limb Prostheses, which, upon this finalization, expand Medicare coverage of MPKs to a whole new demographic of patients who meet specified conditions.

"The journey to expanding Medicare coverage for microprocessor knees to this group of patients has been long and challenging, but immensely rewarding. Our extensive research and clinical trials have consistently shown the profound impact that advanced prosthetic technology can have on individuals with limited mobility,” stated Dr. Andreas Kannenberg, the Executive Medical Director of Ottobock North America. “This expansion is not just a testament to the hard work and dedication of our team at Ottobock; it also underscores the importance of innovation and evidence-based practice in transforming healthcare and enhancing patient outcomes. We look forward to continuing our efforts to ensure that every patient, regardless of their mobility level, has access to the best possible care."

What do the LCD changes mean?

These changes by CMS to Medicare coverage are effective September 1, 2024. The new guidelines expand access to advanced prosthetic knees for more patients, ensuring better technology is available. Changes also include specific requirements for claim processing to improve accuracy and enhance patient care by providing access to state-of-the-art prosthetics and streamlining the claims process. There were no relevant changes compared to the proposed LCD, the coverage criteria are unchanged. However, in the connected Policy Article, the DME MACs have adopted a clarification in the criteria for the K-levels that was proposed by an Interagency Workgroup back in 2017. Overall, it will be easier for prosthetists to qualify patients with accepted and published clinical criteria.

Kenevo: The Only MPK Designed Specifically for Low-Mobility Users

In alignment with Ottobock’s mission to help people maintain and regain their freedom of movement, the global manufacturer saw the need to support the growing population of lower-mobility patients. Ottobock developed the first and only MPK that is designed specifically for this patient group. With a sharp focus on safety, stability, and providing confidence, the Kenevo is unlike any other knee joint on the market today. With this Medicare decision, more patients than ever will have access to the groundbreaking product.

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Ottobock Advocates for Expanded Access to Proven Prosthetic Technologies Under New Proposed LCD Changes

Our mission at Ottobock is to help people maintain and regain their freedom of movement. Our commitment includes advocacy that those with limb loss or limb difference have access to the safest and most appropriate prostheses as recommended by their clinician.

As a testimony to this commitment, we are pleased to share some exciting news. On January 18th, the DME MACs announced proposed changes to the Medicare Local Coverage Determination (LCD) for Lower Limb Prosthetics, including MPK coverage for K2 patients. This is the direct result of a LCD Reconsideration Request filed by Ottobock to the DME MACs on 03/31/2022 (read the application HERE). We started working on this policy change in 2005 with the initiation of the very first MPK study in K2 patients. Over the years, Ottobock has commissioned and supported a total of 11 clinical studies; resulting in 13 peer-reviewed publications, two peer-reviewed systematic reviews - including one meta-analysis of the study results of 704 patients that have all proved the benefits of MPK technology for K2 patients. Without this body of evidence built by Ottobock, this positive policy change would not have been possible.

CLICK HERE TO READ THE FULL ANNOUNCEMENT AND SUPPORTING DETAILS

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New Documentation and Clinician Checklists for Upper Limb Orthoses

Noridian has created a Documentation Checklist and a Clinician Checklist for upper limb orthoses. The checklists were created to help suppliers and clinicians understand the requirements necessary for upper limb orthoses when providing and billing. Although there is not an Upper Limb Orthosis Local Coverage Determination (LCD) Guidance suppliers are reminded to still abide by the Standard Documentation Requirements for All Claims Submitted to DME MACs Local Coverage Article criteria when documenting medical necessity for their patients.

Resources:
https://www.cms.gov/medicare-coverage-database/view/article.aspx?articleid=55426

https://med.noridianmedicare.com/documents/2230715/26734435/Documentation+Checklist+-+Upper+Limb+Orthoses

https://med.noridianmedicare.com/documents/2230703/16619307/Clinician+Checklist+Upper+Limb+Orthoses

PDAC Verified: Prosthetics

Items Requiring Coding Verification Reviews

Many items require coding verification review by the PDAC contractor. As indicated in Local Coverage Determinations (LCDs) and related Policy Articles containing such HCPCS codes, claims will be denied if the products requiring coding verification review are not listed on the PDAC Product Classification List.

View the current list of HCPCS codes that require coding verification review, the applicable LCD or Advisory Article for each code, and the code requirement effective date (i.e., claims with dates of service on/after).

A full list of Durable Medical Equipment and applicable coding can be found on the PDAC Classification List.

Prior Authorization Webinar Resources

 

Noridian Lower Limb Prostheses (LLP): Physician and Prosthetist Records Webinar

The supplier's notes are only part of the whole medical record and are considered in the context of documentation made by the referring provider and other healthcare practitioners to provide additional details to demonstrate that the prosthetic arm or leg billed to Medicare was reasonable and necessary. In other words, the supplier's notes are expected to corroborate and provide details consistent with the physician/practitioner records. In the event of a conflict between the physician/practitioner notes and the supplier's record, the DME MAC would likely deny payment. Similarly, payment may not be provided solely based on the supplier’s documentation. Therefore, in the absence of physician/practitioner documentation, the DME MACs may deny payment for the prosthetic component. VIDEO

 

 

Noridian Prior Authorization: Lower Limb Prosthetics Webinar

As of December 1, 2020, prior authorization through Medicare is required for codes L5856, L5857, L5858, L5973, L5980, and L5987 in all states and territories. Prior authorization helps Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) suppliers ensure that applicable Medicare coverage, payment, and coding rules are met before DMEPOS items are delivered. The prior authorization program helps to protect the Medicare Trust Fund from improper payments while ensuring that beneficiaries can receive the DMEPOS items they need in a timely manner. Prior authorization requirements are subject to the supplier’s region and guidelines. VIDEO

 

 

Noridian Orthotics Same or Similar Webinar

Claims for Orthotic braces with dates of service within the reasonable useful lifetime from the date of service of a previously paid same or similar Orthotic Brace (similar or identical HCPCS code) for the same beneficiary, for the same anatomical site, will be denied as the reasonable useful lifetime requirement has not been met.

Reasonable Useful Lifetime (RUL) is the period of time, after which Medicare payment can be made for replacement of DME that is lost, stolen, or irreparably damaged. Computation of the RUL is based on when the equipment is delivered to the beneficiary, not the age of the equipment. The RUL is used to determine how often it is reasonable to pay for the replacement of DME under the Medicare program and is not explicitly set forth as a minimum lifetime standard. When it comes to RUL, one must consider "irreparable damage" and "irreparable wear". Damage refers to unexpected events, such as loss or theft, and are covered under RUL. Wear is the deterioration sustained from day-to-day usage over time that cannot be traced to a specific event. Wear is not covered by Medicare and does not meet the requirement of RUL.

To replace a same or similar Orthotic brace before the useful lifetime has expired, there must be a documented reason why the current device no longer meets the patient’s functional needs. There are a few tips you can use when checking same or similar equipment. Noridian and CGS have developed the following Medicare resources:

• Noridian Same or Similar Chart
• CGS Same/Similar Code Lookup
• Lower Limb Prostheses Replacements

 

Suggested HCPCS Codes - U.S. only

Suggested L-Codes for Prosthetics:

• Prosthetics Suggested Coding

Suggested L-Codes for Orthotics:

• Orthotics Suggested Coding

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