Medicare Coverage for Radiofrequency Ablation

1. Introduction

Medicare coverage concerns the current status of this treatment in the Medicare system. This is a rapidly changing area, with both regional differences and pending or recent national decisions by Medicare affecting coverage. Generally, radiofrequency ablations have been covered if a patient is a candidate for a previous diagnostic or therapeutic procedure for the same pain. An example can be facet joint injections, which are given for both diagnostic and therapeutic purposes for pain thought to originate from the facet joints. If the injections provide significant relief but the pain returns, then a radiofrequency ablation of the targeted medial branch nerves would be considered a treatment for that same pain and is expected to provide greater and more long-term relief. Due to recent changes, coverage is now expected to require some form of evidence that this form of treatment is improving the long-term outcome and function of a health condition, and new or continuing national coverage decisions are expected to affect the coverage of these procedures. (Lee et al.2021)(Cohen et al.2020)(Palmetto & Director, 2023)(Spears et al.2020)(Loveless et al., 2020)(Kettler & Noel, 2020)(Schaening-Perez & Schaening-Perez, 2020)(Schafer, 2020)(Lawrence & Moynihan, 2020)

Radiofrequency ablation (RFA) involves the use of a radio wave to create an electrical current and is used to treat some medical conditions. There are many different methods of generating radio waves, including monopolar and bipolar techniques and newer, potentially more efficient methods such as Elsman and cooled RF. In most cases, the radio waves are delivered to the target tissue via an electrode, with imaging guidance such as X-ray, CT, or ultrasound. Sufficiently high levels of radiofrequency current can create an ablation (or a small area of destruction), with minimal effects on surrounding healthy tissue. Ablation can be a treatment (or part of a treatment) for specific hip, back, neck, or shoulder pain, and in some cases partial relief is used to identify if a particular structure is the pain generator.

1.1 Definition of Radiofrequency Ablation

In the early days, the mean temperature achieved was around 60-70°C. However, with engineering progress, this has been increased to 90-100°C. This is important because if the temperature is too low, then the lesion will not be effectively destroyed. Conversely, if the temperature is too high, this can cause boiling of tissue fluids resulting in the formation of a layer of desiccated tissue around the electrode. This has high electrical resistance which may quench the ablation and limit the size of the treatment. Heating tissues to the correct temperature is a fine skill; excessive heating also increases the risk of complications and damage to normal tissues. (Nakagawa et al.2021)(Mayer et al.2021)(Lanka et al.2021)(Kautzner et al.2021)(Yavin et al.2021)(Deng et al.2022)(Zaltieri et al., 2021)(Reddy et al.2020)(Irastorza et al.2021)

Radiofrequency ablation (RFA) is a minimally invasive treatment for cancer. It is a procedure that uses electrical energy to destroy cancer cells. A needle electrode is positioned in the centre of the cancer under X-ray guidance. High frequency electrical energy is passed down the electrode into the cancer. This causes heat around the electrode which results in destruction of the cancer cells. A ‘grounding’ pad is attached to the patient and this allows the electrical circuit to be completed. RFA is sometimes referred to as radiofrequency (RF) therapy.

1.2 Importance of Medicare Coverage

Medicare is a health insurance program for people age 65 or older, people under age 65 with certain disabilities, and people of all ages with End-Stage Renal Disease (permanent kidney failure). The fiscal year (FY) 2002 Medicare prospective payment system (PPS) rate for malignant neoplasm of liver (ICD-9-CM codes 155.0-155.2) treated with percutaneous tumor ablation is $5,872. This PPS rate includes payment for all necessary services and care provided in the treatment of the illness. It is expected that in many cases the cost of RFA will be less than the PPS rate, so the hospital will retain any difference in payment between the cost of the RFA and the PPS rate. If the RFA cost is equal to the PPS rate, the hospital will retain typical Medicare inpatient reimbursement rate is based on the Diagnosis Related Group (DRG) for the primary diagnosis plus or minus additional payment depending on the presence of complicating or comorbid conditions or specific effective treatments. While data is currently not available to determine final DRG assignment of RFA cases, the cost of RFA is expected to be lower than the FY 2002 PPS rate for liver tumors, so RFA cases should be more profitable than the typical inpatient case. Since 1995, percutaneous tumor ablation has been performed on the inpatient and outpatient basis, with payment depending on the site of service. Services provided in the hospital outpatient setting are reimbursed under the Outpatient Prospective Payment System (OPPS). OPPS payment rates are established for groupings of Ambulatory Payment Classifications (APCs) of similar services. Since RFA is a relatively new technology, it is considered an unclassified service, and payment will be determined by the hospital and later reviewed by a Medicare fiscal intermediary. An interim payment will be made using the hospital’s estimate of RFA cost. While the details of current and future outpatient ablation payment are still unclear, it is anticipated that current RFA payment will be at least equal to the APC rate for more invasive organ or tissue destruction. The ability to retain payment will depend on a favorable APC rate for RFA or future changes to OPPS reimbursement of unclassified services.

2. Medicare Coverage Criteria for Radiofrequency Ablation

Medicare provides coverage for radiofrequency ablation when it is considered medically necessary. However, the definitions and conditions of medical necessity can vary across payers. Medicare defines medically necessity as an item or service that is reasonable and necessary for the diagnosis or treatment of an illness or injury, affects a change in a patient’s diagnosis or treatment plan, and is considered safe and effective based on proven medical evidence. There must also be services available that are needed, such as physician supervision or interpretation of a diagnostic test. It should also be noted that the fact that a physician may make a profit from a specific service does not render it unreasonable and unnecessary in the Medicare program. Before a procedure can be performed, a physician should know whether or not the service is a covered benefit under Medicare. In the instance of radiofrequency ablation, there is no national coverage determination. Therefore, the decision to cover the service is left to the local Medicare carrier who is responsible for making a local coverage determination. (Manchikanti et al.2020)(Loveless et al., 2020)(Schafer, 2020)(Kettler & Noel, 2020)

2.1 Medical Necessity Requirements

As of June 1st, 2020, RFA for the treatment of chronic pain due to knee osteoarthritis will be considered for a 12-month mixed methods (cht and/or medication) trial of treatment, provided there is a documented history of pain lasting more than 6 months and radiographic evidence of osteoarthritis at the affected knee.

B. RFA of medial branches for the treatment of chronic post-thoracotomy pain is considered reasonable and necessary, provided the pain: 1. Is localized in the anterior thorax. 2. Has been present for at least four weeks. 3. Is confirmed to be of non-malignant origin.

A. RFA of spinal nerves is considered medically reasonable and necessary for the treatment of chronic low back pain, provided the following criteria are met: 1. Pain has failed to improve following one or more discectomy or surgical stabilization procedures. 2. Pain has been present for at least 6 months. 3. Pain is proven to be of discogenic origin. The diagnosis must be confirmed by controlled diagnostic blocks at the level to be treated. 4. Treatment is not being performed for the purposes of claim suppression or opioid dose reduction.

2.2 Documentation and Coding Guidelines

Documentation is vital for establishing medical necessity of RFA in patient medical records. Medicare policy has established specific guidelines regarding necessary documentation to substantiate claims for RFA services. When these services are not clearly reflected in the medical record, the claim will be denied. Information pertinent to the patient’s RFA procedure should be documented in various areas of the medical record: History and Physical, Progress Notes, Procedure Report, and Diagnostic Tests. Medicare guidelines specify that RF Ablation procedures must be reported using CPT codes 3299, 76000, or 76005. When these codes are submitted, the primary ICD-9 diagnosis code should be the symptom or condition that is local to the RFA. For instance, SI joint pain is the local diagnosis for a patient whose symptom is buttock or lower extremity pain. When the primary diagnosis is not local to the RFA procedure, the claim will be denied. If Medicare has established an LCD for the specific procedure, the diagnosis code must be consistent with the approved policy.

2.3 Coverage for Specific Conditions

A comparison of the new 2003 Medicare coverage policy and coverage policies of selected private insurers was performed using the Medicare national coverage policy on RF ablation as a benchmark. Coverage policies of private insurers were updated in October 2003 using data from the 2002 Medicare policy. Updates to the Medicare policy were analyzed to evaluate potential impact on convergence between Medicare and private insurers. Decision trees describing coverage and noncoverage of RF ablation were created for Medicare and representative private insurers. Depth and extent of private insurer coverage policies were measured by the percentage of agreement with corresponding Medicare policy items. Increasing resemblance of decision trees between private insurers and Medicare policy was noted. Percentage agreement with Medicare policy increased from 67% in 2002 to 76% in 2003. Decision trees displayed a 96% degree of similarity between Medicare and private insurers. The 2003 Medicare national coverage policy on RF ablation is the most current statement of Medicare coverage policy on the procedure as of September 2008. Private insurer coverage policies used as surrogates for Medigap policies may differ from those of the Medicare program. However, RF ablation coverage decisions of private insurers in 2003 showed a convergence towards the Medicare policy. With increasing Medicare policy endorsement of the procedure, the availability of RF ablation to Medicare beneficiaries has improved relative to past years and to what is expected for the future. High national adherence of optimal cardiac care to Medicare coverage guidelines for RF ablation may confer considerable clinical and patient care quality benefits for elderly patients with eligible conditions. (Henry-Lines, 2021)(Manchikanti et al.2023)(Kakish et al.2024)(Manchikanti et al.2020)(Tettelbach et al.2024)(Cohen et al.2020)(Dickow et al.2022)(Madrigal et al.2022)

3. Process of Obtaining Medicare Coverage for Radiofrequency Ablation

The process begins with an initial consultation visit. During the visit, the patient’s symptoms and medical history are reviewed to determine if he or she is a candidate for RFA. The oversight physician discusses the treatment options with the patient and may decide to schedule a subsequent visit for the pre-RFA appointment. During the initial consultation or at the pre-RFA visit, the oversight physician may determine that an imaging study (e.g., MRI) is needed to further evaluate the patient’s condition before a treatment option can be recommended. If it is determined that the patient is a candidate for RFA and it is the preferred treatment option, the oversight physician must document the medical necessity of the procedure in the patient’s medical record. The next step is to obtain preauthorization or prior authorization from Medicare for the RFA procedure. Preauthorization and prior authorization are processes of requesting approval from Medicare for payment of the RFA procedure before the procedure is done. Preauthorization is requested by the oversight physician before an office-based procedure is scheduled. Prior authorization is requested by the oversight physician or facility when the RFA procedure is scheduled in a facility setting to begin the process of follow up of office-based preauthorization for payment.

3.1 Initial Consultation and Referral

Initial consultation and referral require the patient to identify the pain management physician as the specialist who is best able to perform the RFA procedure and manage their chronic pain. At this time, the patient and primary care physician will need to gather and forward all office notes, imaging reports, and other documentation of chronic pain to the pain specialist. This is essential in order to confirm the diagnosis of a painful spinal condition and to establish medical necessity for RFA, should the patient decide to proceed with the procedure. Office notes and other documentation from the referring physician may help to establish medical necessity for RFA and establish that conservative treatments have been tried and have failed. If records are incomplete or insufficient in establishing medical necessity for RFA, the pain specialist may ask the patient to set up an appointment with the referring physician to request and gather additional documentation. This, of course, results in a delay in the process of care for the patient with chronic pain who is seeking RFA as a means to a quicker return to normal functional status.

3.2 Pre-authorization and Prior Authorization

Under Medicare Fee-for-Service, patients with traditional Medicare are not required to complete the pre-authorization process. The RF specialist or provider will verify if the patient is eligible for Medicare and then submit a requisition for the RFA procedure. Written details of the approved request will be sent to both the patient and the RF specialist, although it is important to realize that it may not necessarily mean Medicare coverage for the procedure.

The patient may have discomfort, redness, or swelling at the puncture site. These symptoms will often disappear in a couple of days. If they do not, are prolonged, or become worse, the patient should contact their referring physician. In some occasions, it may be necessary to consult the RF specialist or the interventional radiologist who performed the procedure. If necessary, the patient will then ask their physician or specialist to submit an explanation and further details of the RFA treatment on a Medicare Part B pre-authorization request form. The patient should be well informed and understand the details of the authorization process and what is required from them and their physician. Written details of the approved request will be sent to both the patient and the RF specialist, usually taking between 10-14 days. Keep in mind that a lack of pre-authorization confirmation is not uncommon with the Medicare managed care plans but will always ensure that the payment responsibility lies with the health plan. (Taylor et al.2021)(Ladds et al.2020)(Snapiri et al.2020)(Herrera et al.2021)(Buttery et al.2021)

Now that the RFA treatment has been scheduled, the next step is to obtain authorization for this outpatient procedure. Pre-authorization or prior authorization is a requirement for some Medicare beneficiaries, particularly those enrolled in Medicare+Choice, with the check made as to whether the patient is still a candidate of Less Invasive Surgery. In this situation, the referring physician or provider initiating the RFA request would have received the completed RFA medical necessity form from the RF specialist.

3.3 Billing and Reimbursement

There are two CPT codes for radiofrequency ablation of the liver (CPT 47370) or lung (CPT 32994). Appropriate use of these codes is dependent on effective communication. Currently, there is no distinct DRG for this service, so reimbursement is calculated based on hospital costs of similar cases. This is a further justification to remain educated about coding for this service, as it is possible that a distinct RF ablation DRG may be created in the future. Finally, with the exception of Medicare patients, billing for RF ablation of lung or liver tumors is done using an evaluation and management code (typically the same one used during biopsy of the lesion) as well as a modifier for the specific procedure. Global fees for these procedures should not be accepted, as they are split into two distinct components: the evaluation and management service and the ablation itself. Complete understanding of appropriate coding and billing for these services will ensure maximal working knowledge of RF ablation in the field of interventional oncology.

3.4 Appeals and Reconsideration

Solis goes on to highlight the process of appealing and its importance. There is a distinction between reopening a denied claim and formally appealing it. The former is easier and usually involves resubmitting the claim with a brief note, and it is recommended that this should be done first. Incurring a 10% reduced payment and being limited to $500 per claim in terms of reimbursement. Full appeals involve a written request to the fiscal intermediary, including the specific reasons for disagreement, and can involve the presentation of the case in person. Solis points out that there is a high success rate with appeals and encourages it despite it being a time-consuming process. He also explains that under the new regulations, Medicare’s gain-sharing laws are being put on hold during the appeal process. This is important as previously, even if a hospital won an appeal and was granted full reimbursement, the associated physician groups would be responsible for returning any money that they had received in excess of the Medicare payment, and this would come out of the hospital’s reimbursement. This has been cited as a major disincentive for physician participation in the appeals process. The final method of seeking reconsideration is taking legal action, although this is not advised unless all other reconsideration methods have been exhausted because of the cost and time consumption. However, if a physician opts for legal action and wins his case, legal actions will result in Medicare having to pay the prevailing party interest and the direct costs of litigation and attorney’s fees as these fees are now to be covered under Medicare sanction.

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