1. Introduction

Learning how to reduce the effects of arthritis or avoid surgery is important to a rapidly growing population of individuals. The Center for Disease Control estimates that between 2013 and 2015, an estimated 54.4 million US adults (22.7%) annually were diagnosed with some form of arthritis, with the diagnosis rate increasing to 43.5% by age 65. In another study on total knee replacement (a procedure often undertaken for severe arthritis), it was determined that nearly half of patients had significant pain from the knee that improved minimally in comparison to before they had the surgery. Treatment of arthritis is a major cost to Medicare with total knee replacement surgery alone for Medicare patients costing $11 billion during 2000-2010. With expected increases in cost as the population grows older, finding ways to cut these costs and provide effective treatment is very important. (Fallon, 2023)

The introduction of any paper provides an overview of the topic being discussed and the thesis of the paper, to be discussed in detail later. In this case, the topic is a relatively new medical procedure known as “Coolief” and an assessment of whether or not it is covered by Medicare. Coolief is a new non-invasive surgical procedure designed to reduce pain in patients with chronic arthritis. The procedure involves targeting the affected area and cooling the nerves before going on to create lesions that will then disrupt the nerves from transmitting pain signals to the brain. This is done through radiofrequency which is minimally invasive and results in less pain and shorter recovery time than traditional surgery. The benefits of this procedure have the potential to save large amounts of money by avoiding more costly invasive surgery and reducing the costs of ongoing pain management. However, the cost of the procedure is currently relatively high and is largely paid out of pocket by the patient. In this paper, we will explore the options available to patients using Medicare to manage cost and gain access to this procedure.

1.1. What is Coolief?

Radiofrequency can be a good strategy for decreasing ache that emanates from the facet joint. Coolief is a type of radiofrequency. Traditional radiofrequency sends a current to heat the nerve in question. The thought is that the nerve sends a scary sign to the brain. Heating the nerve causes harm to the surrounding tissue. This in turn causes irritation. Because the nerve tries to heal itself, the tissue builds up and finally the scary sign returns. This is why the impact of traditional radiofrequency is temporary. The nerve takes about 6-9 months to heal itself, so reduction of the targeted ache should last this long before the pain returns. This process can be carried out a number of times. Recurrence of the ache is not necessarily a bad thing. Regrowth of the nerve is slower and healthier than the original nerve. It has been said the maximum time period of effectiveness from regrowth to regrowth is about 2.5-3 years. At this point, if one can achieve the same period of reduction, he/she might consider the radiofrequency successful. Coolief boasts that the slow healing of the nerve and the increase in scar tissue can provide much more lasting relief. With traditional radiofrequency, the nerve is healed without scar tissue and the surrounding tissue returns to normal. This makes identification of the nerve and future procedures harder for the patient.

1.2. Importance of Medicare coverage

There is no doubt that the current medical management of chronic pain in elderly patients is far from adequate. These patients are largely steered away from more invasive and higher-risk procedures such as surgery due to their co-morbid conditions and fragility and are typically forced to rely on steroid injections and pain medications. Physical therapy is also beneficial for many of these patients, but access is limited due to functional limitations, transportation problems, and insurance coverage restrictions. RF procedures can be a highly effective way to manage pain for these patients, but the nature of the traditional procedures can make them too painful and risky. If there is a less painful outpatient procedure that can provide lasting relief for osteoarthritis and chronic pain patients, Medicare patients are exactly the population that will benefit the most. With the increased utilization of joint replacement procedures for osteoarthritis in elderly patients, a Medicare-covered Coolief procedure has strong potential to actually save the government money by helping patients avoid joint replacement and the multitude of associated costs and complications. (Kallas et al.2022)

Medicare plays an essential role in the healthcare of America’s elderly population, with over 46 million people receiving coverage. There has been much debate over recent years over the best way to provide the affordable and high-quality care that these patients need, but the consensus is that Medicare provides the best route to achieve this goal. The American Society of Anesthesiologists has been lobbying to get Cooled RF covered under the current Medicare program. It is important to show that this is a much better long-term solution for chronic pain patients and has the potential to save a lot of money in the long run for the government due to the lower re-treatment costs and potential to eliminate the need for opioid pain medications.

2. Medicare Coverage for Coolief

In regards to the 2012 report, the first category, which involves treatment to specific areas or nerves, directly correlates to the standard non-radiofrequency procedures. This aspect of Coolief should be covered in a similar fashion to other treatments through Medicare. However, it is the second category which may lead to some disappointment, as procedures or treatment which involve the systemic application of radiofrequency do not receive any specific mention. This is the act of applying radiofrequency to soften or damage a nerve, which is what the radiofrequency Coolief procedure attempts to do. Finally, the third category, which involves monitoring the nerve, is indirectly related to Coolief, with the possible exception of monitor-assisted medial branch blocks.

Coolief is a relatively new procedure for the treatment of facet joint pain, which is now commonly recommended by specialists who deal with back and neck pain. Medicare has not typically covered 100% of the expenses for less invasive procedures such as Coolief, despite the substantial evidence showing that it is extremely cost effective. However, there are a few cases where forms of Coolief treatment may be covered, including the treatment of those with chronic disability and in some specific states where Medicare is administered by local or state agencies.

2.1. Eligibility criteria for Medicare coverage

Medicare coverage will end if a service is determined to be no longer reasonable and necessary for treatment after an LCD is reviewed and/or an NCD is changed. This is unlikely to occur at this stage without significant evidence that the procedure has been abused and is no longer providing benefit to patients.

As detailed in the quote below from the CMS website, Medicare will cover the approved category of services if it is reasonable and necessary for treatment, under the Social Security Act. Coverage is not restricted while an LCD or NCD is being reconsidered if the previous decision was that the procedure was reasonable and necessary. During the reconsideration, the previous decision will still be the active policy.

2. The procedure must be considered reasonable and necessary for treatment. The decision as to whether or not a procedure is reasonable and necessary is determined by the Local Coverage Determination (LCD) and/or National Coverage Determination (NCD) process. These are used to make decisions as to whether a service is covered on an item-by-item or service-specific basis. The process is detailed on the Centers for Medicare & Medicaid Services (CMS) website at [Link]

1. Be enrolled in a Medicare program that currently covers the services under consideration. Information about the local and national coverage of specific services is available at [Link] or by calling 1-800-MEDICARE.

In order to get Medicare coverage for Coolief*, patients must meet all of the following conditions:

Eligibility is restricted to individuals aged 65 or older. Smaller groups of people might also qualify for Medicare. These include individuals with disabilities, permanent kidney failure, and amyotrophic lateral sclerosis (Lou Gehrig’s Disease).

2.2. Types of Medicare plans that cover Coolief

Medicare coverage is a mixed bag. Understanding the types of plans available is the key to unlocking the puzzle. The most common form of Medicare coverage is Traditional Medicare. This is Medicare Part A and Part B. When you receive your Medicare card in the mail, you automatically get Traditional Medicare. Part A covers hospital stay, surgery, and hospice care. It does not cover doctor services. Part B covers doctor services, outpatient care, and some things Part A does not cover. This is the part where the patient is responsible for paying a monthly premium. In order for Traditional Medicare to pay any portion of Coolief treatment, the patient must have a referral from a Primary Care Physician or Orthopedic Surgeon to a Pain Management Physician. This is the first step and in many cases the most difficult step in obtaining Medicare coverage for Coolief. It can take a long time for a patient to successfully obtain a referral. Once the referral is obtained and a Pain Management Physician has evaluated the patient, Traditional Medicare will pay 80% of the Coolief treatment cost after the patient has met their yearly Part B deductible. At 20% cost to the patient, Coolief from a physician operating at an Inpatient hospital is a practical option for the patient’s minimally invasive treatment. (Kallas et al.2022)

2.3. Limitations and restrictions of Medicare coverage

Whether or not a session of cooled RF (Coolief) is covered by Medicare will depend on the local Medicare contractor and whether or not the procedure is being done in an inpatient or outpatient setting. RF ablation of any type is typically covered by Medicare if the procedure is being done in an inpatient setting and has been FDA approved for the particular indications. However, because Medicare determines which services are medically necessary for the treatment of a specific condition on a case-by-case basis, having the procedure covered by Medicare, even in an inpatient setting, is not a guarantee. An example would be if a patient had a 3rd degree knee sprain, pain from this condition is typically not chronic and would not need to be treated with an RF ablation procedure. Because the Medicare coverage policy is often decided in a local setting, it is best for a specific patient to discuss this issue with the physician who is recommending the procedure.

3. How to Apply for Medicare Coverage for Coolief

At this time, there is still a general consensus with insurance carriers about the coverage for Coolief. Most carriers will not cover the treatment as there is still an ongoing process with Medicare to validate the procedure. However, there are a select few who are already covering Coolief under the condition that Medicare has to approve it. Considering there are so many who suffer from knee and back pain that lasts for many years – to the point of considering surgical intervention – and who have several co-morbidities, the chances of trying to wait out the Medicare process for that long are not worthwhile. Consequently, patients may attempt to appeal Medicare for coverage, but this is a rigorous process with reconsideration taking up to 6 months. (Kallas et al.2022)

First and foremost, you will need to visit a doctor. In order to receive Medicare coverage, you must be a patient of a doctor who agrees to accept assignment, which is known as accepting a Medicare-approved amount as full payment for the services they provide. It is also important that your doctor be aware of the Medicare approval process for this treatment. And having already done this for several patients, Dr. Levin has already developed an understanding of how to get insurance companies to cover Coolief with Medicare.

Now that you know Coolief is covered by Medicare, you can now find out how to apply for Medicare coverage for Coolief. To complete the application process, there are a number of steps that need to be taken:

3.1. Steps to apply for Medicare coverage

The most important part of the process lies in the fact that the doctor must get an Advanced Beneficiary Notice (ABN) signed by the patient. The ABN is a waiver signed by the patient, saying that if Medicare does not cover the claim requested, the patient is responsible for the remaining cost. If this form is not filled out and the claim is denied, the Arthrocare Corporation has reported that in many instances it is very difficult to challenge Medicare and win. Usually in these cases, the patient is responsible for the full fee, or the doctor’s office is left to accept a willing fee from Medicare which is often not enough to cover costs. Once the ABN is acquired, doctors should be able to confidently send the claim or fill it out online and get the treatment covered.

Question to ask is whether the patient has Medicare Part B. If the answer is yes, then he likely will have to fill out all forms necessary for a claim, signifying that he himself is getting the treatment. If the patient has another insurance carrier secondary to Medicare, there is a form that is required to claim that the treatment is covered by Medicare so that the secondary insurance will cover the rest of the cost. It is important when considering any of these forms to call the Medicare help line, as the actual Medicare employee is likely the only person capable of answering the question whether this is actually a necessary form.

3.2. Required documentation for the application

In order to apply for coverage for an outpatient or physician-administered treatment provided as part of a clinical trial, patients must submit a written request for a National Coverage Determination (NCD) by the Centers for Medicare & Medicaid Services. This determination is based on an assessment of available evidence of the efficacy of the procedure and includes a review of published literature and a formal opportunity for public participation. Your physician may help you to obtain evidence of the clinical trial’s Coolief treatment method, provided that evidence is necessary to satisfy the NCD request. If the NCD request is unsuccessful, patients may submit a coverage request to the local Medicare contractor to ask for a special payment for a procedure or item of DME. Pricing and coding information for this process can be found on the Medicare Coverage Database. If Medicare coverage is denied, patients have the right to an appeal, and your physician can provide guidance regarding the Medicare appeals process. Appeals processes for Medicare coverage determinations and for Medicare prescription drug coverage are outlined on the Medicare website. Patient appeal is a multi-step process that may involve several levels of appeal so long as each preceding level is unsuccessfully completed.

3.3. Tips for a successful application

Contacting your local Medicare carrier for advice on how to structure your application can be helpful. Outline the specifics of your condition and its impact on your everyday life. Stress the money that can be saved and the potential for greater, lasting efficacy compared to alternative and often more costly treatments. If you have private insurance that covers thermal radiofrequency procedures, obtaining a letter of proof that states your coverage for the particular type of RF ablation can greatly bolster your case. A statement confirming that Coolief would be a substitute using the same method of treatment can be effective. Finally, including any further medical literature regarding the continuous RF system as a necessary step forward for patients wanting longer-lasting relief of pain can add depth to the overall quality of the application. Be sure to attach these additional documents with references in coordination with both the primary and secondary insurance claim forms and all materials from your physician.

Due to the nature of Coolief being a minimally-invasive procedure that has only recently been approved by the FDA and Medicare, the chance of the application being denied on the first attempt is high. Don’t be discouraged, it’s quite a common occurrence given the circumstances. It may take more than one attempt to secure coverage for the procedure. However, you can follow the suggestions below to better your chances of approval on the first attempt. If denied, these same tactics should be applied to filing an appeal to overturn the decision.

4. Alternative Options for Coverage

Even though Medicare currently does not cover Coolief, there are alternative options for coverage and receiving the treatment at a lower cost. Both variants of the Coolief treatment can be covered by private insurance, so those eligible for Medicare can still receive the treatment at a lower cost assuming their insurance provider will cover the treatment. A study of privately insured patients with charges to a health maintenance organization found that the cost of cooled RF procedure was on average $2,740, which is a small increase from the $2,400 Medicare fee for standard RF procedure. Additionally, as long as the consumer has insurance that involves cost-sharing provisions, costs to the consumer are lower than those of standard RF. Private insurance coverage eliminates the need to ever use standard RF for Medicare beneficiaries, and the ability to obtain a better treatment at a lower cost is in the best interest of the patients and their providers to manage chronic pain in the aging Medicare population. This same concept applies to consumers who have private insurance and are considering the treatment as a future option. Create legal defense of the legislation by suggesting that costlier, more invasive procedures covered by Medicare have cheaper alternative treatments that are covered by Medicare and are of equivalent effectiveness. This fact provides a compelling defense of the policy change for any Medicare recipient considering Coolief, given that they would be forced to pay the full cost of the procedure. (Kallas et al.2022)

4.1. Private insurance coverage for Coolief

One advantage of going with a liquid-cooled device is that it can be produced at a lower price than traditional Coolief. Although insurance coverage varies greatly, if a patient has private insurance, Medicare is not accessed unless there is a copay or if the patient’s specific benefits have run out, then the one under Medicare. Although all policies vary, private insurance coverage for the first radiofrequency ablation by a specialist should cover the procedure because it is cheaper than knee joint replacement and the effects can last up to 2 years. Even if first-time coverage cannot be obtained, once the procedure is performed to relieve knee pain, there is a possible pre-existing condition clause in the patient’s policy that fast arthritis relief can be obtained in a future attempt to treat knee pain. This is a key piece of information. Another important point is that different states have different regulations for what they consider to be the first radiofrequency ablation. Unfortunately, RF ablation is in a state of terminology transition between procedures involving electrometric testing to place the probe in the exact point of pain and RF lesioning of nervous tissue and older procedures of simple probe placement and general tissue heating. It is uncertain which one will be considered Coolief, and the position of the probe can be quite painful for the patient. Because Medicare has already determined the latter to be inconclusive in pain relief, coverage would only be sought to be partial and/or temporary in past treated areas for the latter that is now considered general RF ablation. Medicare has technically already denied coverage for knee joint replacement for arthritis pain. This is because trials proving efficacy of general traditional RF ablation on pain loci prior to joint replacement have generally underdosed the patients with local anesthetics, and it has been determined that the trial patients cannot be conclusively said to have had area-specific joint pain. Anyone looking to go through with general RF ablation should schedule a consultation with a local Medicare administrator for specific determination of coverage, noting again that different states have different interpretations of the procedure.

4.2. Other financial assistance programs

Coolief is a minimally-invasive procedure for chronic pain patients without the need for general anesthesia, incisions, or hospitalization. An outpatient procedure, Coolief allows patients to have a better quality of life, improve their function, and potentially decrease reliance on medications. These patients often have tried a variety of treatment options such as physical therapy, steroid injections, medications, ablative procedures, or even surgeries. Unfortunately, even those with the most disabling chronic pain may not meet medical necessity criteria for RF ablation procedures. This occurs all too frequently when insurance carriers have payment policies that are not in accord with the peer-reviewed medical literature or simply deny payment based on a patient’s specific diagnosis regardless of the literature. Oftentimes, these denials ignore the potential benefits of specific interventions to the patient as well as the long-term costs associated with medications or surgical treatments. When this is the case, RF ablation or Coolief has the potential to decrease systemic opioid use, which is a staggering and frequently addictive problem in chronic pain patients. There is ample evidence that with proper patient selection, chronic pain disease states including degenerative joint disease or post-laminectomy syndrome can be treated effectively with RF ablation or Coolief. In these circumstances, a patient’s appeal of an insurance denial can be a complex and stressful process and oftentimes require legal assistance. An excellent summary of general concepts to insurance appeals is provided on the American Medical Association website.

4.3. Discussing options with healthcare providers

While some Medicare policies may not cover Coolief procedures, others may provide an opportunity for discussion with healthcare providers. Since every case is unique, it is important to consult your healthcare provider openly and honestly about your continued pain after RFA and discuss if the symptoms negatively affect your quality of life. If your provider deems that your pain is still due to osteoarthritis or degeneration in the joint and the Coolief procedure is medically necessary, there is a chance you and your provider can appeal the decision of Medicare to request an alternative coverage option for the Coolief procedure. Although there is no guarantee of coverage, this route may provide the best chance for patients with chronic joint pain to gain access to the innovative Coolief procedure. Another opportunity may be the discussion of other treatments that are covered by Medicare, such as hyaluronic injections or opioid pain management. Though the efficacy of such treatments is questionable and the risk of complications may be high, it is important for patients to know fully what is and is not covered by Medicare in the treatment of chronic joint pain. At times, this can be a point of frustration for patients who feel their only option is a treatment that is temporary or has a significant risk of adverse effects. An open discussion of all treatment options available and their implications may reinforce the acceptance or denial of coverage for Coolief and bring clarity to the best course of action in managing chronic joint pain.

References:

Fallon, E. A., 2023. Prevalence of diagnosed arthritis—United States, 2019–2021. MMWR. Morbidity and mortality weekly report. cdc.gov

Kallas, O.N., Nezami, N., Singer, A.D., Wong, P., Kokabi, N., Bercu, Z.L., Umpierrez, M., Tran, A., Reimer, N.B., Oskouei, S.V. and Gonzalez, F.M., 2022. Cooled radiofrequency ablation for chronic joint pain secondary to hip and shoulder osteoarthritis. RadioGraphics, 42(2), pp.594-608. rsna.org