Unlocking Intracept: Is This Procedure Covered by Medicare?

What is the Intracept Procedure for Chronic Low Back Pain?

Chronic low back pain can significantly impact daily life. For many, finding effective, long-term relief is a constant challenge. The Intracept procedure has emerged as a promising, minimally invasive option for chronic low back pain that originates from the vertebral endplates.

If you’re a Medicare beneficiary considering this treatment, a critical question quickly arises: does Medicare cover the Intracept procedure? Navigating healthcare coverage can be complex, especially for newer treatments.

This guide will provide a clear overview of Medicare’s approach to the Intracept procedure. We’ll explain the specific criteria required for coverage, the relevant billing codes, and potential limitations. We will also compare Medicare coverage to private insurance policies, shedding light on what patients can expect. For example, understanding how Medicare handles Intracept coverage in specific regions like Fairmont Intracept Medicare can be crucial for local patients.

Chronic low back pain is a pervasive issue, affecting millions globally. While many sources of back pain exist, a significant portion originates from the vertebral endplates, the top and bottom surfaces of the vertebrae. This specific type of pain is known as vertebrogenic pain. For individuals suffering from this condition, the Intracept procedure offers a targeted approach to relief.

The Intracept procedure is a minimally invasive treatment designed to alleviate chronic low back pain by addressing the basivertebral nerve (BVN), which transmits pain signals from the vertebral endplates. The procedure involves radiofrequency ablation, a technique that uses heat generated by radio waves to create a small lesion on the nerve, effectively disrupting its ability to send pain signals.

This innovative approach has shown promising results in clinical studies. For instance, data published in Orthopedic Design & Technology indicates that patients reported significant and lasting pain relief and functional improvement. Unlike traditional open surgeries, Intracept is performed through a small incision, typically as an outpatient procedure, allowing for faster recovery times.

The Science Behind Intracept

The Intracept Intraosseous Nerve Ablation System has garnered FDA approval as the first and only procedure approved explicitly for chronic vertebrogenic low back pain. This approval underscores the rigorous testing and evidence supporting its safety and efficacy.

The mechanism of action is precise: a small cannula is advanced into the vertebral body under fluoroscopic guidance. Once positioned correctly, a specialized probe is inserted through the cannula. Radiofrequency energy is then delivered through this probe, generating heat that ablates the basivertebral nerve. This nerve, located within the vertebral body, innervates the vertebral endplates. The Intracept procedure aims to interrupt the pain pathway at its source by targeting these specific nerves.

A key advantage of Intracept is that it does not involve spinal implants or the removal of bone or tissue. This preserves the natural anatomy of the spine and does not preclude future treatment options should they be needed. Clinical studies have demonstrated continued pain relief and functional improvement for several years post-procedure, highlighting its long-term benefits. The procedure explicitly addresses pain associated with Modic changes, which are inflammatory or degenerative in the vertebral endplates visible on an MRI.

Who is a Candidate for Intracept?

Patient selection is crucial for the success of the Intracept procedure. Healthcare providers carefully evaluate potential candidates to ensure they meet specific criteria. Generally, ideal candidates for Intracept are individuals who:

• Have chronic low back pain for at least six months:This means the pain has persisted for an extended period, indicating it’s not an acute, temporary issue.
• Have not found sufficient relief from at least six months of conservative care:This includes a range of non-surgical treatments such as physical therapy, medications (including narcotics and non-narcotics), chiropractic manipulation, and injection therapies. Given that approximately 80% of people will experience low back pain at some point in their lives, and a significant portion develop chronic pain, many individuals will have exhausted these conventional options.
• Have MRI findings consistent with vertebrogenic pain:An MRI must show Type 1 or Type 2 Modic changes in the vertebral endplates between the L3 and S1 vertebrae. These changes indicate inflammation or degenerative processes within the bone that are believed to be the source of the pain.
• Have lower back pain as their dominant symptom:The procedure is designed for pain originating from the vertebrae, not primarily from other spinal issues like disc herniation with radiculopathy (nerve pain radiating down the leg).

The journey to finding relief from chronic back pain can be long and frustrating, as television host Carson Daly shared in a story on the Today show, detailing his struggle and eventual positive experience with Intracept. This highlights the importance of thorough evaluation and appropriate patient selection to ensure the procedure suits an individual’s condition.

Does Medicare Cover the Intracept Procedure?

Understanding Medicare coverage for any medical procedure can be challenging, and the Intracept procedure is no exception. Medicare’s coverage decisions are primarily guided by the principle of “reasonable and necessary.” This means that for a service or item to be covered, it must be considered appropriate for the diagnosis or treatment of an illness or injury, and meet accepted standards of medical practice.

For the Intracept procedure, coverage is determined locally by Medicare Administrative Contractors (MACs) through what are known as Local Coverage Determinations (LCDs). These LCDs outline the specific medical necessity criteria that must be met for the procedure to be covered in a particular geographic region. For instance, the LCD – Intraosseous Basivertebral Nerve Ablation (L39644) – CMS provides detailed requirements that healthcare providers must follow to ensure their patients qualify for coverage. Providers and patients must consult the specific LCD applicable to their region.

Key Medicare Coverage Criteria

While specific details may vary slightly between MACs, the core criteria for Medicare coverage of the Intracept procedure are generally consistent and stringent. These requirements ensure the procedure is performed on patients most likely to benefit. We typically see the following prerequisites:

• Skeletally Mature Patient:The individual must be at least 18 years old.
• Chronic Lower Back Pain:The patient must have experienced chronic lower back pain for six months or more. This pain should be the dominant symptom and cause a functional deficit, which is often measured on pain or disability scales.
• Failure of Conservative Care:Crucially, the pain must not have responded adequately to at least six months of documented non-surgical management. This typically includes a combination of modalities, with most LCDs requiring evidence of failure from at least three of the following:
• Avoidance of activities that aggravate pain.
• A professionally directed course of physical therapy or therapeutic exercise program.
• Chiropractic manipulation.
• Cognitive therapy.
• Pharmacotherapy, including narcotic and non-narcotic analgesics, muscle relaxants, neuroleptics, and anti-inflammatories.
• Injection therapy targeting epidural or facet joint pain sources in the region of concern.
• MRI Demonstrating Modic Changes:As highlighted in the Thermal Destruction of the Intraosseous Basivertebral Nerve (BVN) for Vertebrogenic Lower Back Pain (L39420) document, a critical requirement is the presence of Type 1 or Type 2 Modic changes on an MRI of the L3 through S1 vertebrae.
• Absence of Other Pathology:There should be no additional vertebral pathology (such as fracture, tumor, infection, deformity, trauma, or post-surgical change) that could explain the patient’s symptoms or complicate the procedure.
• Physical and Psychological Assessment:A comprehensive assessment of the patient’s ability to tolerate and benefit from BVN ablation is often required.

Meeting these criteria is paramount for securing Medicare coverage. Thorough documentation by the treating physician is essential to support the procedure’s medical necessity.

The Importance of MRI and Modic Changes

The role of magnetic resonance imaging (MRI) and the presence of modifications are central to qualifying for Medicare coverage for the intracerebral procedure. Modic changes are specific alterations in the vertebral endplates and adjacent bone marrow visible on MRI scans. They are classified into three types, but for Intracept coverage, Type 1 and Type 2 are most relevant:

• Type 1 Modic Changes:These indicate bone marrow edema and inflammation. On MRI, they appear as areas of low signal intensity on T1-weighted images and high signal intensity on T2-weighted images. They are often associated with acute or subacute inflammatory processes and are thought to be a significant source of vertebrogenic pain.
• Type 2 Modic Changes:These represent fatty degeneration of the bone marrow. On MRI, they show high signal intensity on both T1- and T2-weighted images. While often considered a more chronic change, they can still be a source of persistent pain.

These Modic changes, specifically in the L3 to S1 vertebral bodies, serve as diagnostic proof that the patient’s chronic low back pain is likely of vertebrogenic origin, making them a suitable candidate for the Intracept procedure. Without clear MRI evidence of these changes, Medicare is unlikely to cover the procedure, as it targets pain stemming from this specific pathology.

Limitations and Exclusions to Medicare Coverage

While Medicare does offer coverage for the Intracept procedure under specific conditions, it’s equally important to understand the limitations and exclusions that can impact eligibility. These restrictions ensure appropriate use of the procedure and prevent coverage for conditions that may not be practical or medically necessary.

Key limitations and exclusions include:

• Once-Per-Lifetime Limit Per Vertebra:Medicare generally covers the thermal destruction of the intraosseous basivertebral nerve only once per vertebral body (L3-S1) per lifetime. If a specific vertebral body has already been treated, it won’t be covered for re-treatment.
• Maximum of 4 Vertebrae:A lifetime maximum of four individual vertebral bodies can often be treated per beneficiary. This ensures that the procedure is applied judiciously.
• Retreatment is Not Covered:As detailed in the Billing and Coding: Intraosseous Basivertebral Nerve Ablation (A59466) article, prior BVN ablation of a named vertebral body precludes coverage for additional ablation at that specific level.
• Non-Covered Conditions:Certain patient conditions or diagnoses will typically result in non-coverage. These often include:
• Skeletally Immature Patients:Individuals under 18 years of age are generally excluded.
• Metabolic Bone Disease or Osteoporosis:These conditions can affect bone integrity and complicate the procedure or its outcomes.
• Active Infection:Any active systemic or local infection is a contraindication.
• Neurogenic Claudication or Radiculopathy as Primary Symptoms:The Intracept procedure is for vertebrogenic pain, not primarily for nerve compression symptoms radiating down the leg.
• Severe Cardiac/Pulmonary Compromise:Patients with significant heart or lung issues may not be suitable candidates due to procedural risks.
• Pregnancy:The procedure is contraindicated during pregnancy.
• Presence of Electronic Implants:Patients with pacemakers, defibrillators, or other electronic implants may be excluded or require specific precautions.
• Other Spinal Pathologies:Conditions such as significant spinal stenosis, spondylolisthesis, fracture, tumor, or severe deformity that are the primary cause of pain will typically lead to non-coverage, as the Intracept procedure is not designed to address these issues.

It’s crucial for both patients and providers to be fully aware of these limitations and exclusions to avoid unexpected coverage denials.

Navigating the Billing and Reimbursement Process

Once medical necessity is established and all coverage criteria are met, the next step involves the complex world of medical billing and reimbursement. The Intracept procedure means utilizing specific CPT (Current Procedural Terminology) codes and ICD-10 (International Classification of Diseases, 10th Revision) codes, and understanding how Medicare calculates payment.

Accurate coding and documentation are paramount to ensuring successful reimbursement. Providers must ensure that all services rendered are correctly coded and that the patient’s medical record thoroughly supports the medical necessity of the procedure, aligning with the requirements outlined in Medicare’s LCDs and billing articles. This also includes navigating prior authorization requirements, which vary depending on the specific Medicare plan.

CPT and Diagnosis Codes Medicare Recognizes

For the Intracept procedure, the following CPT codes are recognized:

• CPT Code 64628:This code is used for the thermal destruction of the intraosseous basivertebral nerve for the first two vertebral bodies (lumbar or sacral). This is the primary code for the procedure.
• CPT Code +64629:This add-on code is used for each additional vertebral body (lumbar or sacral) treated beyond the first two. This code is typically used if three or four vertebral bodies are treated in a single session.

Accurate ICD-10 diagnosis codes are equally important as they provide the medical justification for the procedure. While the specific code may vary based on the detailed diagnosis, a primary code commonly associated with vertebrogenic low back pain and the Intracept procedure is:

• ICD-10 Code M54.51:Vertebrogenic low back pain.

Other relevant ICD-10 codes that may support medical necessity, depending on the patient’s specific condition, could include codes related to spondylosis or disc degeneration that present with Modic changes. Providers must consult the most current billing guidelines, such as the Billing and Coding: Intraosseous Basivertebral Nerve Ablation (A59468) article, to ensure they use the correct and most specific diagnosis codes. Appropriate modifiers may also be necessary to describe the service and ensure proper reimbursement.

Understanding Medicare Payment Rates

Medicare reimbursement for the Intracept procedure varies significantly depending on the setting in which the procedure is performed: the physician’s office, a hospital outpatient department (HOPD), or an ambulatory surgical center (ASC). These rates are subject to national average payments and adjusted based on geographic location.

For services performed in a facility setting (HOPD or ASC), CPT codes 64628 and +64629 are assigned to Ambulatory Payment Classification (APC) 5115. This APC groups similar outpatient services together for payment purposes. The Intracept procedure is considered device-intensive, meaning the cost of the device itself is a significant component of the overall payment.

Here’s a general comparison of approximate national average payment rates (subject to change and geographic adjustment, based on 2025 CMS/PFS Final Rule and 2025 CMS/OPPS/ASC Final Rule data):

• Physician Payment (CPT 64628):Approximately $399.16 (based on the 2025 conversion factor of $32.3465). This is the professional fee for the physician performing the procedure.
• Hospital Outpatient Department (HOPD) Payment (APC 5115):Approximately $12,867. This covers the facility costs, including the device, supplies, and staff.
• Ambulatory Surgical Center (ASC) Payment (APC 5115):Approximately $9,524. This also covers facility costs, often at a lower rate than HOPDs.

These are national averages; reimbursement can vary based on the specific MAC, local geographic adjustments, and other factors. For HOPDs, the procedure is designated as device-intensive, requiring particular reporting of the device cost (HCPCS code C1889 with revenue code 0278) to ensure proper payment. Providers should always verify the latest reimbursement schedules and guidelines with their respective MACs.

How Do Different Insurance Plans Cover Intracept?

Beyond original Medicare, patients often have Medicare Advantage or private insurance coverage. The coverage landscape for the Intracept procedure can differ significantly across these various plans, making it essential for patients and providers to understand the specific policies of each insurer.

While original Medicare sets a baseline for coverage through its LCDs, Medicare Advantage plans and private insurers may have unique criteria, prior authorization processes, and network requirements. This variability underscores the importance of thorough policy verification before proceeding with the Intracept procedure.

Does Medicare cover the Intracept procedure under Medicare Advantage Plans?

Yes, Medicare Advantage (MA) plans, also known as Medicare Part C, are legally required to cover at least the same services as Original Medicare (Parts A and B). If Original Medicare covers the Intracept procedure in your region, your Medicare Advantage plan should also cover it, provided you meet the medical necessity criteria outlined in the relevant LCDs.

However, MA plans often have their own specific administrative rules, which can include:

• Prior Authorization:Many Medicare Advantage plans require prior authorization for procedures like Intracept. This means the provider must obtain approval from the plan before the procedure is performed. The authorization process typically involves submitting detailed clinical documentation to demonstrate medical necessity.
• Network Limitations:MA plans often operate within specific provider networks. Patients may need to ensure their physician and the facility where the procedure is performed are in-network to receive the highest level of coverage and avoid higher out-of-pocket costs.
• Specific Coverage Criteria:While they must cover what Original Medicare covers, some MA plans may have additional internal guidelines or interpretations of the LCDs. For example, a Coverage Criteria Summary from Cohere (a Medicare Advantage plan) outlines detailed medical necessity requirements, including specific documentation of conservative care failure and Modic changes.

Patients and providers should always contact the specific Medicare Advantage plan directly to confirm coverage, understand any prior authorization requirements, and verify network participation.

How does Medicare cover the Intracept procedure compared to private insurance?

Coverage for the Intracept procedure under private insurance plans can be even more varied than with Medicare. While some private insurers have established favorable coverage policies, others may have more restrictive criteria or may still consider the procedure investigational in some contexts.

• Varying Private Payer Policies:Some major private insurers, such as Humana, have issued favorable coverage policies for the Intracept procedure, recognizing its clinical benefits for appropriate patients. For instance, Humana’s Coverage Policy for the Intracept Procedure details its specific criteria. However, other private insurers may have different approaches, ranging from full coverage to case-by-case review, or even denial based on their internal medical policies.
• Policy Verification is Key:Due to this variability, verifying coverage with each private insurance company is essential. This involves understanding their medical necessity criteria, prior authorization requirements, and exclusions.
• Influence of MACs:It’s also worth noting that coverage can be influenced by a region’s specific Medicare Administrative Contractor (MAC). This means the process for securing approval for Fairmont Intracept Medicare patients might differ slightly from other areas, even within the broader Medicare system, as MACs interpret national guidelines for their local jurisdictions.

Frequently Asked Questions about Intracept and Medicare

What is the process for appealing a Medicare denial for the Intracept procedure?

Receiving a denial for a medically necessary procedure can be disheartening, but you have the right to appeal. The Medicare appeals process typically involves several steps:

1. Review the Denial Letter:Carefully read the denial letter to understand the specific reason for the denial. This will guide your appeal strategy.
2. Internal Appeal (Redetermination):The first step is to request a “redetermination” from Medicare. Your doctor can help by providing a detailed letter of medical necessity, explaining your medical history, previous unsuccessful treatments, and why the Intracept procedure is the most appropriate and necessary treatment for your condition, supported by your MRI findings. Include any additional documentation that strengthens your case.
3. Reconsideration:If the redetermination is denied, you can request a “reconsideration” by a Qualified Independent Contractor (QIC). This is an independent review of your case.
4. Administrative Law Judge (ALJ) Hearing:If the QIC upholds the denial, you can request a hearing before an Administrative Law Judge.
5. Medicare Appeals Council Review:If the ALJ decision is unfavorable, you can request a review by the Medicare Appeals Council.
6. Federal Court Review:As a final step, if all previous appeals are unsuccessful, you may be able to pursue judicial review in a federal district court.

Throughout this process, meticulous documentation and persistence are key.

How many times will Medicare cover the Intracept procedure?

Medicare coverage for the Intracept procedure is subject to specific frequency limitations. Generally, Medicare will cover the thermal destruction of the intraosseous basivertebral nerve only once per vertebral body (L3-S1) per lifetime. This means that if you have the procedure performed on a specific vertebra (e.g., L4), that particular vertebra will not be covered for re-treatment in the future.

Furthermore, a lifetime limit of four total vertebral bodies can typically be treated per beneficiary (within the L3-S1 range). This ensures that the procedure is used appropriately and not excessively. Patients and providers must adhere to these limits to ensure continued coverage.

What should I do if I think I’m a candidate for Intracept?

If you are experiencing chronic low back pain and believe the Intracept procedure might be a suitable option for you, we recommend taking the following steps:

1. Consult a Spine Specialist or Pain Management Physician:Seek an evaluation from a healthcare provider specializing in spine care or Pain Management. They have the expertise to diagnose the specific cause of your pain and determine if Intracept is appropriate.
2. Discuss Your Pain History:Be prepared to provide a comprehensive history of your low back pain, including its duration, severity, and how it impacts your daily activities.
3. Undergo an MRI:If you haven’t recently had one, your specialist will likely order an MRI of your lumbar spine to check for Modic changes (Type 1 or Type 2) in the L3-S1 vertebral bodies. This is a critical diagnostic step for Intracept eligibility.
4. Review Conservative Treatment History:Document all non-surgical treatments you have tried, including duration and effectiveness. This evidence is crucial for demonstrating that conservative care has failed, a key Medicare requirement.
5. Discuss Coverage:Ask your provider about Medicare’s specific coverage criteria for Intracept in your region and what steps they take to ensure medical necessity and proper billing.

These proactive steps will help you and your healthcare team find potential relief from chronic vertebrogenic low back pain.

Conclusion

The Intracept procedure represents a significant advancement in treating chronic low back pain originating from the vertebral endplates. Understanding coverage nuances is key to accessing this innovative therapy for Medicare beneficiaries. While Medicare covers the Intracept procedure, it does so under stringent medical necessity conditions, emphasizing specific diagnostic criteria like Modic changes on MRI and a documented history of failed conservative care.

Navigating the landscape of LCDs, CPT codes, and reimbursement rates can be complex, and variations exist across Medicare Advantage plans and private insurers. However, patients can successfully pursue this treatment with thorough documentation, adherence to established criteria, and proactive communication with healthcare providers and insurance companies.

We encourage individuals with chronic vertebrogenic low back pain to consult their spine specialists. By working closely with your medical team and understanding the specific requirements, you can advocate for your health and potentially open up a path to long-term pain relief. The future of vertebrogenic pain treatment holds promise, and informed patient advocacy remains a powerful tool in accessing these beneficial advancements.