Medicare Coverage for Ketamine

1. Introduction

We are in the midst of an opioid epidemic, and opioid-associated deaths have been on the rise. Patients with chronic pain throughout the United States are limited in their options when it comes to receiving pain relief through the Medicare system. In fact, there is no specific guideline in Medicare’s National Coverage Determination to address the use of opioids for chronic non-cancer pain. This issue came to a head in 2018 when the Centers for Disease Control and Prevention (CDC) released guidelines for prescribing opioids. These guidelines stated that opioids should not be the first-line therapy for chronic non-cancer pain. With the increasing limitations placed on prescribing opioids for chronic non-cancer pain, patients and providers need to consider other options. Unfortunately, with the limitations in place for acupuncture and massage therapy, there are few non-opioid treatment options that can be covered by Medicare. Pursuing relief for pain, it is important that safe and effective options for treatment are available to Medicare beneficiaries. So where does that leave patients that are suffering from chronic non-cancer pain and the providers that are looking to help them? One safe and effective treatment that will remain an option for Medicare patients is the intravenous infusion of ketamine. An important thing to remember is that in the field of anesthesiology, ketamine is considered to be an essential medicine by the World Health Organization. It is a safe and cost-effective anesthetic agent that has been used in medical and surgical settings throughout the world for over 50 years. And more importantly, the use of ketamine as an infusion for pain relief is not the use of anesthesia for patients with chronic non-cancer pain. Rather, it is the utilization of a sub-anesthetic dose that has a different mechanism of action to provide analgesic effects. Due to these factors, there is a strong argument to be made for ketamine infusion therapy being a safe and effective treatment for chronic non-cancer pain in Medicare patients. With the opioid epidemic, the limitations on other non-opioid therapies, and the need to provide an effective and safe treatment for pain, ketamine infusion therapy can be a viable treatment option for patients who suffer from chronic non-cancer pain. Given these reasons, there is a need to explore whether patients have access to Medicare coverage for this treatment, and if not, what can be done to get it covered. (Brendle et al., 2022)(Aguilar et al.2024)(Hull et al.2022)(Derakhshanian et al.2021)

2. Understanding Ketamine

Ketamine comes in two forms: esketamine and racemic ketamine; both can be taken intravenously, intramuscularly, by injection, or by nasal spray depending on the patient and the condition being treated. Esketamine is the S-enantiomer of racemic ketamine and was approved by the FDA in March 2019 and is to be used for treatment-resistant depression and major depressive disorder with acute suicidal ideation or behavior. Because this form of treatment is new, it is important for the patient and provider to fully understand the risks, benefits, and alternative forms of treatment with the help of a pharmaceutical company’s risk evaluation and mitigation strategy.

When it comes to administering ketamine to treat mental health disorders, this is still a new and evolving form of treatment. Its use in treating mental health disorders is considered to be an off-label form of prescribing. In legal terms, “off label” means that it has not received approval from the Food and Drug Administration (FDA) for use in psychiatry, however it is still considered to be a legal and ethical practice. In the medical field, many medications and forms of treatment are used and found to be effective for purposes different from which they were originally intended, and this is an example of one of those situations. Ketamine has a well-established role in medical and surgical anesthesia over the past 50 years. It is also commonly used in emergency rooms for painful procedures and has a very safe and effective track record. In addition to this, it has also been used to treat chronic pain, however, this is also considered to be an off-label form of treatment.

3. Medicare Coverage for Ketamine

Since Medicare Advantage does not cover ketamine infusions, it is unlikely that there will ever be a way to get ketamine infusion treatments covered at any outpatient clinics. Because of this, ketamine coverage will be focused exclusively on the relatively new option of receiving “Take-Home Ketamine”. This is typically a compounded medication through a retail or mail order pharmacy.

Be aware that the coverage determination must be done before the patient has the prescription filled at a pharmacy. If a patient seeks coverage for medication costs after obtaining the prescription, Medicare has no way to cover the cost of medications obtained from a pharmacy. This is because almost all Part D medications are now dispensed through Medicare Advantage plans, and due to factors related to billing and reimbursement, Part D plans are not able to pay pharmacies directly for medications.

To find out what Medicare will cover for a specific medication, patients can ask their providers to request what is called a “coverage determination” from the patient’s Part D plan. This process requires that the provider submit a statement explaining the medical necessity of the medication, and may require additional documentation from the patient’s medical record. In the case that a coverage determination is denied, there is an appeals process that can be utilized, and many patients have had the denial overturned with the help of their providers.

Ketamine is a generic drug available at many compounding pharmacies for a relatively low cost. This is good news for the large number of patients in the US who are Medicare eligible. They may be aware, however, that Medicare has imposed some restrictions on coverage for compounded medications, and may be curious what the out of pocket cost will be for ketamine treatments.

4. Benefits of Medicare Coverage for Ketamine

It is the third section in our month-long series on Medicare coverage for ketamine infusions. You can find the previous two weeks here: Introduction and Background to Ketamine and The Role of Ketamine in Modern Medicine. Also, remember that this series is not intended to be individual advice. I am providing general information to infuse some clarity into a murky topic. It is important to find out how these issues specifically apply to your individual situation, and my hope is that this information will be a springboard for informed questions. With a clearer understanding of ketamine’s role and the existing coverage landscape (both of which are still works in progress), we can now delve into the potential benefits that would stem from expanded Medicare coverage for ketamine. While our current series is focusing on Medicare, the potential benefits that would accompany improved access to care would be relevant to patients of all ages. In general, we will define “benefits” as improved access to and/or quality of care, and we will break down the potential benefits into five main categories. (Aguilar et al.2024)(Havlik et al.2023)(Thornton et al.2024)(Agboola et al.2020)(Hull et al.2022)

5. Conclusion

To facilitate patient access to this novel treatment and ensure healthcare equity, it is recommended that Medicaid clarify coverage policy details for ketamine treatment in a manner that will be more readily understood by patients and providers. With a clearer understanding of whether a given patient is covered for the treatment and what specific criteria need to be met for coverage, patients can avoid a potentially futile treatment course and providers can avoid treatment initiation prior to fulfillment of coverage requirements. More specific policy detail will also facilitate advocacy efforts by patients and providers to appeal adverse coverage decisions. High-level policy clarification will also make it easier for enrollment brokers and managed care organizations to make the required coverage determinations. Finally, one additional approach to facilitate access would be to increase the rate of coverage, although policymaker consideration of this approach would need to weigh potential cost to the Medicaid program against the potential public health benefits.

Ketamine therapy is an exciting and evolving health technology. Given its expanding evidence base, key opinion leader support, and rapid adoption in clinical practice, consideration of insurance coverage is a crucial step to facilitate treatment access. This health policy analysis examines Medicaid coverage for IV ketamine infusions for mood disorder treatment in 2019. Key findings included that Medicaid programs in only 22 states have a public-facing policy regarding ketamine coverage, rate of coverage is highly variable by state, and policies were often difficult to access, interpret, and apply to specific patient cases.

References:

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

Aguilar, A.G., Beauregard, B.A., Conroy, C.P., Khatiwoda, Y.T., Horsford, S.M., Nichols, S.D. and Piper, B.J., 2024. Pronounced regional variation in esketamine and ketamine prescribing to US Medicaid patients. Journal of Psychoactive Drugs, 56(1), pp.33-39. medrxiv.org

Hull, T.D., Malgaroli, M., Gazzaley, A., Akiki, T.J., Madan, A., Vando, L., Arden, K., Swain, J., Klotz, M. and Paleos, C., 2022. At-home, sublingual ketamine telehealth is a safe and effective treatment for moderate to severe anxiety and depression: findings from a large, prospective, open-label effectiveness trial. Journal of Affective Disorders, 314, pp.59-67. sciencedirect.com

Derakhshanian, S., Zhou, M., Rath, A., Barlow, R., Bertrand, S., DeGraw, C., Lee, C., Hasoon, J. and Kaye, A.D., 2021. Role of ketamine in the treatment of psychiatric disorders. Health psychology research, 9(1). nih.gov

Havlik, J.L., Murphy, M.J., Gong, N., Tang, D. and Krystal, J.H., 2023. Characteristics of esketamine prescribers among medicare beneficiaries in the United States, 2019-2020. JAMA Network Open, 6(4), pp.e2311250-e2311250. jamanetwork.com

Thornton, N.L., Wright, D.J. and Glozier, N., 2024. Implementation of a ketamine programme for treatment-resistant depression in the public health system: Lessons from the first Australian public hospital clinic. Australian & New Zealand Journal of Psychiatry, p.00048674241237094. sagepub.com

Agboola, F., Atlas, S.J., Touchette, D.R., Fazioli, K. and Pearson, S.D., 2020. The effectiveness and value of esketamine for the management of treatment-resistant depression: a summary from the Institute for Clinical and Economic Review’s Midwest Comparative Effectiveness Public Advisory Council. Journal of managed care & specialty pharmacy, 26(1), pp.16-20. jmcp.org