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¿La infusión de ketamina está cubierta por Medicare?

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1. Introduction

Ketamine, a drug first synthesized in 1962, has come a long way from its original use as a battlefield anesthesia during the Vietnam War. For a variety of reasons, it was not until 2000 that its efficacy in treating major depression and other mood disorders was explored and at this point its use was primarily off label and oral. Now, almost 20 years later, intravenous ketamine infusions have become a valuable treatment option for patients suffering from mood disorders such as major depression, post-partum depression, bipolar depression, and PTSD! This is in part because ketamine has been shown to rapidly decrease the suicidal ideation that can stem from these disorders. With the FDA approval of esketamine in 2019, this treatment modality’s popularity will only grow with time. Unfortunately, due to the fact that it is still a relatively new treatment, it can be quite costly and is not covered by all medical insurance providers. This is an issue as mood disorders can be quite debilitating and may affect one’s ability to work, thus making the cost of ketamine treatments out of reach for those who may need it most. This paper will discuss the need for Medicare to cover ketamine infusions and the reasons as to why it is vital for those who are of Medicare age or disabled to have this option for treatment. (Bloomfield et al.2024)

1.1 What is Ketamine Infusion?

The therapeutic use of ketamine as an anesthetic agent dates back to the 1960s, and it has been FDA approved as an anesthetic since that time. Sub-anesthetic doses of ketamine have been shown to have a rapid and sustained effect in some patients with severe depression and suicidality. These patients are often excluded from ECT and other neurostimulation treatments, or are unable to tolerate the common side effects associated with those treatments. There has been a large increase in public awareness, and hope from patients, for the use of ketamine to treat severe depression. The recent increase in development of ketamine clinics and increased media coverage has led to many patients seeking this treatment, often with much confusion as to its availability and how it can be accessed. The costs for IV ketamine can vary widely, from $25 to $100+ per treatment. This usually involves an office visit co-pay if covered by insurance, or the cost of the entire ER or office visit if administered in that setting. Since an initial treatment phase may involve 2-3 treatments per week, the costs can be prohibitive for many patients, especially if there is no coverage or reimbursement available. This being the case, some patients have pursued ketamine treatment in an ER setting, or as an inpatient, as this may be the only way to access the treatment despite the potential risks or lack of ideal monitoring in these settings. (Brendle et al., 2022)

1.2 Importance of Medicare Coverage

In recent years, research has shown that ketamine has a broad range of use in both depression and chronic pain with a remarkable decrease in symptoms. Ketamine first gained popularity for its fast-acting dissociative anesthetic effect, but medical professionals have discovered its efficacy in treating mood disorders and pain conditions. A patient may receive regular ketamine infusion treatments to combat chronic symptoms from these conditions. With the increasing popularity of ketamine infusion, the out-of-pocket cost has become a significant concern for many patients. It is typical that insurance coverage is desirable for any type of medical treatment due to the cost burden of self-pay. However, insurance coverage for ketamine infusion can vary significantly and can be quite complex. With some conditions, this leaves patients wondering whether insurance will cover a treatment in which there are no other comparable options. This is exactly the case with Medicare and is the motivation for this article. After conducting extensive research, I have constructed a comprehensive guide that explains the coverage of ketamine infusion for Medicare beneficiaries. (Komal & Kishor, 2024)

2. Medicare Coverage for Ketamine Infusion

2.2 Criteria for Medicare Coverage In order to determine Medicare coverage, the most important thing is for the patient to check if ketamine infusion is being considered a reasonable and necessary treatment for their specific condition. The treatment must have supporting evidence and an acceptance of the medical community in order for Medicare to cover it. This is a constant battle for newer treatments and medications, and criteria do vary between different states in America.

2.1 Overview of Medicare Coverage Ketamine is considered for coverage under Medicare, but is subject to the same limitations of coverage as any other service. Ketamine is not specifically mentioned in the Medicare National Coverage Determinations or Local Coverage Determinations, meaning that it is an off-label use of a medication. In situations such as these, the decision to cover the service is made by the independent contractors and carriers who implement Medicare, based on general acceptance in the medical community and supporting evidence. Even though ketamine is seen to be a relatively safe and cost-effective treatment for depression in comparison to Electroconvulsive Therapy, it is possible that some insurance companies will reject covering it or classify it as a non-essential service.

Ketamine infusion has been around for decades before getting mainstream coverage by news outlets. Primarily known as an anesthetic and party drug, it has since been linked with relief of depression and chronic pain. Two-thirds of patients who had little to no relief from other medications experienced fast-acting relief of depression symptoms, with 50% having a significant reduction in symptoms.

2.1 Overview of Medicare Coverage

Ketamine has been used for mental health purposes since the early 1970s, and the discovery of its antidepressant properties has been well documented. Although ketamine is primarily used as an anesthesia, over the past 10-15 years, ketamine has become popularized as an off-label treatment for depression. While off-label use of ketamine for depression is currently not approved by the Food and Drug Administration (FDA), there are practitioners who still use the medication for this purpose. Patients who receive ketamine infusion for depression may have difficulty affording treatment due to high out of pocket costs, and it is for this reason that understanding Medicare coverage for ketamine infusion is important. (Walsh et al.2022)

Medicare is a program that provides health insurance to Americans aged 65 and older, as well as some who are disabled or have specific medical conditions. The purpose of the program is to provide insurance to individuals who might have difficulty purchasing insurance through the private market, and funds for the program are collected from payroll taxes and from the Social Security trust fund. As of 2012, there are roughly 50 million people who are currently receiving Medicare, and this number will likely grow as the baby boomer generation continues to reach 65 years of age. The estimated cost for Medicare in 2012 is $555.3 billion, with much of the funding coming from the general fund of the U.S. Treasury. Part D of Medicare is a prescription medication program that can help beneficiaries who currently have or are eligible for Medicare pay for medications.

2.2 Criteria for Medicare Coverage

Eligibility for Medicare coverage is determined by the Local Coverage Determination (LCD) for the administered treatment or the National Coverage Determination (NCD). No specific LCD exists for the use of ketamine for infusion therapy; however, in May 2012, the United States (US) Centers for Medicare and Medicaid Services (CMS) issued an NCD for the use of infusion therapy for the treatment of Chronic Depression. According to the decision memo for NCD 160.3, there are specific criteria that define eligibility for Medicare coverage of infusion therapy services for the treatment of Chronic Depression. Infusion therapy with ketamine for depression would likely fall into the category of treatment for mental health disorders. The Decision Memo for NCD 160.3 outlines the following criteria for Medicare coverage for infusion therapy services for the treatment of Chronic Depression: – Patient is currently diagnosed with Chronic Major Depression with a current episode that has persisted for 12 months or more. – Patient has tried four or more adequate antidepressant treatments of different pharmacologic classes without satisfactory improvement. – Patient has had at least 2 Inpatient psychiatric treatments, partial hospitalization, or Intensive Outpatient treatment encounters within the same episode of depression. The above-listed criteria provide specific parameters for Medicare coverage of infusion therapy services in the treatment of Chronic Depression. The intent of this NCD is to restrict the utilization of infusion therapy to those patients who have a course of illness marked by severe psychomotor and/or cognitive retardation. The criteria essentially dictate that the patient’s status be such that they are at high risk for hospitalization in a setting where they would likely require ECT or have already attempted ECT. According to the NCD, this confined category of patients is the only group for whom specific therapeutic benefit can be expected with infusion therapy. (Klein et al.2024)

2.3 Potential Limitations of Coverage

Ketamine has gained a reputation as an agent with a broad range of effectiveness for depression and other mood disorders. However, there are limitations. Potential limitations on ketamine infusion treatment are particularly relevant due to the out-of-pocket nature of this treatment in many settings (i.e. not being covered by insurance). Ketamine infusions are often administered for treatment-resistant depression. Although Medicare does cover treatments for mental health conditions, the varying map of local coverage decisions can determine whether ketamine infusions will be covered for TRD. An additional factor in coverage is the eventual FDA approval of esketamine, which was granted on March 5, 2019. The FDA’s approval of esketamine for TRD will likely step up the levels of evidence and regulation required for ketamine treatment coverage by third-party payers, which could be disadvantageous given that esketamine is a stereoisomer of ketamine and actually has higher costs related to staffing and required resources for administration. Finally, due to the current economic situation of the US, it is possible that ketamine infusion coverage will take a hit due to the economic concerns with such coverage post COVID-19. However, this is purely speculation.

3. Benefits of Medicare Coverage for Ketamine Infusion

Enhanced quality of life The ultimate gauge of success for any medical treatment is improvement in the patient’s quality of life. Ketamine infusion has the potential to provide significant improvement of symptoms or remission for patients suffering from depression and chronic pain. With effective treatment, these patients can reclaim their lives and re-establish healthy and meaningful activities. Although traditional medical treatments can be effective, many patients continue to suffer with significant symptoms and impairment. Success of ketamine treatment for these patients would mean liberation from the burden of their illness. The ability to improve the lives of Medicare patients is especially important, as depression and chronic pain often lead to disability and progression to other serious medical conditions. (Clark, 2020)

Reduced financial burden The cost of ketamine infusions can be substantial, and often is not covered by private insurance companies. This is a significant barrier to many patients, especially those who are on fixed or limited incomes. Until now, obtaining treatment with ketamine has been financially out of reach for most patients. By making ketamine infusion a viable treatment option for Medicare patients, there is potential for relief of a significant financial burden experienced by patients and their families. As more psychiatric medications and therapies become available, there will be a trend of increased out-of-pocket costs for patients due to limited coverage by insurers. The high cost of ketamine and lack of coverage by private insurers is a familiar scenario for the growing number of Americans who are living with mental health disorders. Coverage of an effective treatment such as ketamine will set an important precedent for the future coverage of psychiatric treatments, ultimately benefiting all patients.

Improved access to treatment Patients who are covered by Medicare have improved access to a wide variety of medical services that are normally not covered by other insurance entities. The coverage of off-label medications helps patients with treatment-resistant mood disorders in particular. Many patients who suffer from treatment-resistant major depressive disorder have failed multiple trials of medications and therapy and so are labeled as «treatment resistant.» These patients are in desperate need of a new and innovative treatment such as ketamine. With Medicare coverage of ketamine infusion, these patients will have the opportunity to break out of the vicious cycle of depression and failed treatments, and ultimately reach remission of their depression. This has the potential to save many lives as depression is a significant cause of suicide and suicide attempts. At this time, the data supporting the use of ketamine for TRMD is limited, but this patient population stands to benefit the most. As more research is done, it is also likely that the indications for ketamine use will expand, further benefiting Medicare patients.

3.1 Improved Access to Treatment

The availability of ketamine treatments for many people suffering from severe depression can be the difference between living a functional life and not. This simple yet effective treatment can change the very core of someone’s life who has suffered for years from treatment-resistant depression. An example would be a 22-year-old female patient who has suffered from depression since she was a child and has tried a plethora of medications and therapies, all of which had some improvement but never enough. This resulted in multiple suicide attempts and not being able to complete her college education. A course of ketamine treatment pulled her out of her depressive state and stopped suicidal thoughts she had been having. She was then able to complete a course in nursing school and now is gainfully employed helping others. Without Medicare coverage, she would not have had access to this treatment and could have had a very different outcome. (Rodgers et al.2024)

Access to mental health treatment in the United States is challenging. Family physicians attend to 40% of patients with psychiatric disorders, yet many have limited time and reimbursement for managing mental health issues. Psychiatrists are in short supply and many do not accept insurance. This leaves patients to fend for themselves and suffer, and others may have access but the cost or the medication is a burden to them, leaving many patients with untreated mental health conditions.

3.2 Reduced Financial Burden

Discussion of the reduced financial burden provided by Medicare coverage for patients needing ketamine infusion therapy is an important and direct way to quantify the impact of improved access in terms of societal resources and patient well-being. Using the assumption that the same mental health diagnosis treated with ketamine infusion would be otherwise refractory and lead to higher medical expenses (i.e. hospital admissions, residential treatment, increased outpatient visits and medications) or the mental health condition would decrease the patient’s functional status (ability to work, go to school) and lead to an approval of social security or an increase in disability status. Then any treatment that reduces the frequency of these occurrences would reduce the financial burden of illness. This will be a tough analysis to truly quantify as many of the indirect cost impacts are difficult to measure. For example, how can one measure potential income if no or only a partial disability claim is filed? Also, it will be tough to determine if ketamine infusion for refractory mental health conditions would actually prevent an increase in disability status. Nonetheless, the potential cost savings may be substantial. This would be both for the patient in terms of potential improvement in functional status and for government and private insurance payers. Measuring any cost offset would require a longitudinal analysis of a large sample of patients with mental health conditions with a comparison of those who did and did not receive ketamine infusion therapy. Clearly, disorders that are chronic and severe and refractory to other treatments would be best suited for this type of analysis. A decrease in the economic burden of mental health conditions is a worthy goal and may provide an opportunity for ketamine infusion therapy to prove its value in the field of mental health treatment.

3.3 Enhanced Quality of Life

Most patients with depression would tell you that the day to day experience of having depression is far more terrible than what is captured in these aggregate results. Ketamine treatment is unique in that within one infusion there are many patients who have a rapid and dramatic improvement in their depressive symptoms. Instead of waiting 4-6 weeks for an oral antidepressant to start working, and potentially going through several different medications which could take years, ketamine can rapidly improve your depressive symptoms. This does not mean that ketamine is a cure for depression, rather it is a very useful tool and buying time for the patient to do the necessary therapy work to get to the root causes of their depression. Imagine a person who has been severely depressed for a year, and has essentially put their life on hold waiting for the day when they will finally feel well enough to start living life again. This person would likely benefit a great deal from getting relief of their depressive symptoms. (Lengvenyte et al.2022)

4. How to Navigate Medicare Coverage for Ketamine Infusion

You can begin this process by determining eligibility and coverage for Ketamine Infusion services under Medicare before even receiving services. Asking Medicare directly is a good place for accurate general information. Even better is to contact each regional insurance carrier separately. The «Local Coverage Determination» (LCD) helps to specify all Medicare coverage parameters and again, it can vary by region. LCD policies can be googled and a search for «Ketamine Infusion LCD Medicare» can easily and quickly direct you to the proper LCD. Unfortunately, the LCD’s are many times difficult to interpret without some clarification from Medicare and/or the insurance carrier. These decisions have the possibility of affecting whether the Medicare beneficiary will receive coverage for services rendered. An affirmative LCD on a particular service is not a guarantee of medical necessity or payment. If the LCD or the Carrier indicate that it is indeed covered, but they still do not give a clear answer on the immediate necessity or a refusal is given and services are later denied, this can become a case for appeal. Now that we have established the possibility of coverage, the next step is to determine medical necessity and Medicare Guidelines can help to break down this description. Medical necessity can ultimately decide whether or not a procedure is deemed as a Medicare-coverable service. Medicare has said that it will not cover services that are not deemed as «medically necessary.» This means that the service is not only safe and effective, but also that the potential benefits outweigh the risks and that it will provide an adequate solution for the patient’s condition. If a patient has an issue of severe depression that has potential of great harm to themselves and has exhausted all other treatment options, they may be an excellent candidate for Ketamine Infusion. Especially if the other medications or ECT have proven ineffective. In these cases, the patient has a better chance of Medicare approval on the prior authorization. (All)

4.1 Understanding Medicare Guidelines

Medicare determines national coverage determinations (NCD) which specify whether a certain treatment is covered. If there is no NCD, then there will be a local coverage determination (LCD) which is specific to a state’s Medicare coverage details. These can be found on the Medicare website. Often times they are difficult to interpret and will give very little information as to whether a specific treatment will be covered. It is at this point where the patient or physician will contact the Medicare help line. This is where the process can vary significantly and become quite frustrating for the patient and physician.

Ketamine infusions are generally unapproved by Medicare, Medicare Advantage (MA), and most third-party insurers for psychiatric conditions. However, on occasion, ketamine will be recommended and prescribed by a patient’s psychiatrist or physician with the hopes of it being covered. This will typically take a specific process to show that the ketamine is being used to treat an approved condition and that there are no other viable treatment options. This process will often still be unsuccessful. In some instances, ketamine is recommended by a patient’s pain management physician or anesthesiologist. This is usually the result of a recommendation for a series of low-dose ketamine infusions to treat chronic pain conditions. Although this type of treatment has a higher likelihood of Medicare coverage, the steps to obtain that coverage are similar to that of psychiatric ketamine treatments.

Medicare coverage guidelines can be difficult to understand and vary significantly by state and region. There are some commonalities and a general step-by-step outline of how to go about understanding the Medicare guidelines for a specific treatment.

4.2 Seeking Prior Authorization

Given that Medicare is a federally run insurance program with a significant amount of uniformity in coverage throughout the country, all the information necessary to make a decision to seek prior authorization should be available. However, the reality is that the knowledge of Medicare policies of local carrier and its ability to apply that knowledge are often limited. There is a risk that the carrier will make a decision regarding coverage which is unfounded in Medicare policy. It is also important to prepare for the possibility that the carrier will deny the service and have a decision reversed on the basis of the true policy and/or undergo a successful appeal by the provider to a federal administrative law judge. Step one in seeking a favorable and binding decision on the coverage of a service would be to do some research on how similar services have been addressed by the Medicare program and secure any documentation of Medicare policy which is favorable. A provider may wish to efficiently retain an attorney of demonstrated experience in health law and Medicare law. A written opinion by an attorney specialized in Medicare law may be obtained depending on the resources of the provider. This and any other documentation should then be compiled and submitted to the carrier, and work should be done to ensure the correctness of the carrier’s initial decision. It is important to keep in mind that the more complex and time-consuming the process of seeking a coverage decision, the more likely a patient is to lose faith that the service will be covered. This is another argument for a quick response time on the part of the carrier. (Steffel, 2020)

«Whatever the reason, should a Medicare beneficiary get infused ketamine and a bill is submitted for the services, it may be initially denied. Medicare has a process by which the provider can seek approval of coverage for the services prior to rendering them. In the case of a Part B service, the process is referred to as a Local Coverage Determination (LCD), and for Part A service, it is a National Coverage Determination (NCD). At its most basic, an LCD/NCD is a determination by the local or national Medicare contractor whether a particular item or service is covered on a regional or national basis. It is reasonable to assume that a given LCD/NCD for infusion of ketamine as a treatment for CRPS is unlikely to exist. Therefore, the next administrative step should be to seek a written preliminary decision by the Medicare carrier as to whether a proposed service is expected to meet the reasonable and necessary criteria for coverage. This would be accomplished for a Part B service by the filing of a pre-determination request, and a NCD covered Part A service would have a parallel process using a pre-ruling request. The Medicare carrier is required to issue a decision in a timely fashion, and a request for a quicker response time is certainly within reason given that any delay is likely to mean that the patient has already been treated or the provider has lost patient confidence that the service will be covered.»

4.3 Appeals and Reconsideration Process

If initial/gateway determinations yield unfavorable results, providers or patients can enter the Medicare appeals process. This can be done independently or simultaneously with the reconsideration process, with different processes and forms for parts A and B. During any appeals/reconsideration, it is crucial the MD and patient provide all clinical information requested, even if it seems repetitive, to promote the best chances at overturning a decision. If a patient’s appeal is denied, the specifics of the case will dictate whether continuing to the administrative law judge (ALJ) level is worth pursuing. Unfortunately, if a case is remanded through the ALJ or the courts with a decision requiring favorable NCD revision, success may solidify coverage of the treatment for future patients with the same condition, but it will likely not affect the appealing party directly. When considering if it is worth participating in the appeals process for a given case, the potential risks and benefits should be discussed by the patient and provider. An estimate of the probability of success is important when comparing the time and resources of appealing a denied claim vs. seeing other patients and potentially aiding their treatment. This will be easier to discern with the specifics of the highest level appeal change coming to pass, but still is an important consideration. (Anderson et al., 2022)

References:

Bloomfield, A., Chan, N., Fryml, L., Horace, R. and Pyati, S., 2024. Ketamine for chronic pain and mental health: regulations, legalities, and the growth of infusion clinics. Current Pain and Headache Reports, 27(10), pp.579-585. [HTML]

Brendle, M., Robison, R., & Malone, D. C., 2022. Cost-effectiveness of esketamine nasal spray compared to intravenous ketamine for patients with treatment-resistant depression in the US utilizing clinical trial efficacy …. Journal of Affective Disorders. researchgate.net

Komal, K. & Kishor, K., 2024. Ketamine: Recent application in administration of anesthesia, torment and medicare. AIP Conference Proceedings. [HTML]

Walsh, Z., Mollaahmetoglu, O.M., Rootman, J., Golsof, S., Keeler, J., Marsh, B., Nutt, D.J. and Morgan, C.J., 2022. Ketamine for the treatment of mental health and substance use disorders: comprehensive systematic review. BJPsych open, 8(1), p.e19. cambridge.org

Klein, E.G., Schroeder, K., Wessels, A., Phipps, A., Japha, M., Schilling, T. and Zimmer, J.A., 2024. How donanemab data address the coverage with evidence development questions. Alzheimer’s & Dementia. wiley.com

Clark, J. D., 2020. Ketamine for chronic pain: Old drug new trick?. Anesthesiology. [HTML]

Rodgers, A., Bahceci, D., Davey, C.G., Chatterton, M.L., Glozier, N., Hopwood, M. and Loo, C., 2024. Ensuring the affordable becomes accessible–lessons from ketamine, a new treatment for severe depression. Australian & New Zealand Journal of Psychiatry, 58(2), pp.109-116. [HTML]

Lengvenyte, A., Strumila, R., Olié, E. and Courtet, P., 2022. Ketamine and esketamine for crisis management in patients with depression: Why, whom, and how?. European Neuropsychopharmacology, 57, pp.88-104. sciencedirect.com

All, L. O. B., . Clinical Policy: Outpatient Testing for Drugs of Abuse. fideliscare.org. fideliscare.org

Steffel, J., 2020. End of Life Uncertainty: Terminal Illness, Medicare Hospice Reimbursement, and the Falsity of Physicians’ Clinical Judgments. U. Cin. L. Rev.. uc.edu

Anderson, K. E., Darden, M., & Jain, A., 2022. Improving prior authorization in Medicare Advantage. Jama. [HTML]

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