BILLINGFOROFF-LABEL DRUGTHERAPY

If the contractor determines that the evidence, as supported by the criteria listed above, is supported, then off-label coverage will be outlined in an LCD or article ?

Consequently, we agree that claims for this treatment were billed incorrectly, and the payment from Medicare should be returned. Since Noridian (nor any other MACin the US) has not approved the off-label use of Ketamine to treat any mental health condition, it is non-covered

We are not surprised that the claims for this treatment were paid by Medicare. There is no HCPCSfor ketamine Consequently, the hospital?s claim may have reported an IVadministration code, such as 96365, and an unidentified drug listed under revenue code 0250 and/or some IV fluids like normal saline. There would be no way for Medicare to determine that the infusion therapy provided used ketamine for an off-label indication.

If the problem claims were submitted only within the last few months, perhaps the claims are available in DDEfor adjustment. The billers might be able to adjust the claim online by moving all the charges to the non-covered column (both for the drug and the administration of the drug) and appending modifier GZ to the HCPCS(non-covered, no ABN = Provider write off ) Another MAC, NGS, offers a slide deck that explains how to adjust or cancel a claim at the following link: https://www.ngsmedicare.com/documents/20124/121705/2364 0921 using fiss dde to adjust or cancel medicare 508 pdf/8745c2bb-2cd5-c482-5476-39c296f3c883?t= 1632163309367

In addition, we found an article published by the Journal of the American Academy of Psychiatry and the Law which recommends that the patient is offered a disclosure document explaining that the treatment they will receive is off label That article is available here: https://jaapl.org/content/early/2020/11/24/JAAPL.200049-20

Summing this information up, here are our recommendations:

- Adjust or cancel the claims submitted to Medicare or any other payor for infusions of Ketamine that were off-label use of that drug

- Consider submitting a request to the organization?s risk manager and/or medical staff to review the practice of offering ketamine infusions for off-label use

- If the organization decides to continue offering off-label ketamine infusions, provide the patient with an Advance Beneficiary Notice explaining that the cost will become the patient?s financial liability, and provide any patient receiving an off-label drug with an ?informed consent?notice prior to treatment.

Theprecedingmaterialsare for instructional purposesonly Theinformation ispresented "as-is"and to thebest of CorroHealth'sknowledgeisaccurateat the timeof distribution. However, dueto the ever-changinglegal/regulatory landscape, thisinformation issubject to modification asstatutes, laws, regulations, and/or other updatesbecome available. Nothingherein constitutes, isintended to constitute, or should berelied on aslegal advice. CorroHealth expressly disclaimsanyresponsibilityfor anydirect or consequential damagesrelated in anywayto anythingcontained in the materials, which are provided on an "as-is"basisand should beindependentlyverified beforebeingapplied. You expressly accept and agreeto thisabsoluteand unqualified disclaimer of liability Theinformation in thisdocument isconfidential and proprietaryto CorroHealth and isintended onlyfor thenamed recipient. No part of thisdocument maybereproduced or distributed without expresspermission. Permission to reproduceor transmit in anyform or byanymeanselectronicor mechanical, includingpresenting, photocopying, recordingand broadcasting, or byanyinformation storageand retrieval system must beobtained in writingfrom CorroHealth. Request for permission should bedirected to Info@Corrohealth.com

CPT® isa registered trademarkof theAmerican Medical Association

Medicarecodingforesketaminetreatment

In 2020, Medicare began covering the use of esketamine, a nasal spray, for treatment-resistant depression (TRD.) Although patient self-administers the nasal spray, the patient must be supervised for several hours post-administration in a monitored healthcare setting, as some patients experience significant adverse reactions. Medicare created two HCPCScodes, G2082 or G2083, to enable physicians and hospital outpatient clinics to report the cost of the drug and the subsequent monitoring of the patient:

G2082 - OFFICEOROTHEROUTPATIENT VISITFORTHEEVALUATION AND MANAGEMENTOF AN ESTABLISHED PATIENT THAT REQUIRESTHESUPERVISION OFA PHYSICIAN OROTHER QUALIFIED HEALTH CAREPROFESSIONAL AND PROVISION OFUPTO 56 MG OFESKETAMINE NASAL SELF-ADMINISTRATION, INCLUDES2 HOURSPOST-ADMINISTRATION OBSERVATION G2083 ? OFFICEOROTHEROUTPATIENT VISIT FORTHEEVALUATION AND MANAGEMENT OF AN ESTABLISHED PATIENT THAT REQUIRESTHESUPERVISION OFA PHYSICIAN OROTHER QUALIFIED HEALTH CAREPROFESSIONAL AND PROVISION OFGREATERTHAN 56 MG ESKETAMINENASAL SELF-ADMINISTRATION, INCLUDES2 HOURSPOST-ADMINISTRATION OBSERVATION Medicare reimbursement rates for 2023 are available in the PARA Dat a Edit or Calculat or t ab:

The cost of the esketamine nasal spray is the main consideration in Medicare payment levels. When the service is provided to a Medicare beneficiary in the outpatient facility setting, both the physician or qualified non-physician practitioner should report either G0282 or G0283 Pricing the service should take into consideration the cost of the drug, which is not separately reported because the G-codes includes the drug, with two dosage options available

Medicarecodingforesketaminetreatment

Janssen Neuroscience, the manufacturer of Spravato, offers a coding guide at https://www.spravatohcp.com/sites/www.spravatohcp-v1.com/files/cp133468v3 spravato coding overview brochure digital version pdf?v=14875 https://s3.amazonaws.com/public-inspection.federalregister.gov/2019-24086.pdf

The 2020 Medicare Physician Fee Schedule Final Rule discusses the added Medicare coverage for the treatment and the new codes; an excerpt is provided on the following pages.

V Int erim Final Rule w it h Com m ent Period [CMS-1715-IFC]

A. Coding and Paym ent for Evaluat ion and Managem ent , Observat ion and Provision of Self-Adm inist ered Esket am ine (HCPCS codes G2082 and G2083)

On March 5, 2009, the U.S. Food and Drug Administration (FDA) approved Spravato? (esketamine) nasal spray, used in conjunction with an oral antidepressant, for treatment of depression in adults who have tried other antidepressant medicines but have not benefited from them (treatment-resistant depression (TRD)) Because of the risk of serious adverse outcomes resulting from sedation and dissociation caused by Spravato administration, and the potential for abuse and misuse of the product, it is only available through a restricted distribution system under a Risk Evaluation and Mitigation Strategy (REMS) A REMSis a drug safety program that the FDA can require for certain medications with serious safety concerns to help ensure the benefit of the medication outweigh its risks

Patients with major depression disorder who, despite trying at least two antidepressant treatments given at adequate doses for an adequate duration in the current episode, have not responded to treatment are considered to have TRD. TRD is especially relevant for Medicare beneficiaries.

Medicarecodingforesketaminetreatment

Depression in the elderly is associated with suicide more than at any other age; adults 65 or older constitute 16 percent of all suicide deaths. The decrease in average life expectancy for those with depressive illness, including Medicare beneficiaries, is 7 to 11 years. Depression is a major predictor of the onset of stroke, diabetes, and heart disease; it raises patients?risk of developing coronary heart disease and the risk of dying from a heart attack nearly threefold

There has also been a longstanding need for additional effective treatment for TRD, a serious and life-threatening condition A treatment session of esketamine consists of instructed nasal self-administration by the patient, followed by a period of post-administration observation of the patient under direct supervision of a health care professional

Esketamine is a non-competitive N-methyl Daspartate (NMDA) receptor antagonist It is a nasal spray supplied as an aqueous solution of esketamine hydrochloride in a vial with a nasal spray device. This is the first FDA approval of esketamine for any use. Each device delivers two sprays containing a total of 28 mg of esketamine.

Patients would require either two (2) devices (for a 56mg dose) or three (3) devices (for an 84 mg dose) per treatment. After reviewing the Spravato Prescribing Information, Medication Guide, and REMSrequirements, we have concluded that effective and appropriate treatment of TRD with esketamine requires discrete services of a medical professional, meaning those that may furnish and report E/M services under the PFS, both during an overall course of treatment and at the time the drug is administered

Because of the risk of serious adverse outcomes resulting from sedation and dissociation caused by Spravato administration, and the potential for abuse and misuse of the product: the product is only available through a restricted distribution system under a REMS; patients must be monitored by a health care provider for at least 2 hours after receiving their Spravato dose; the prescriber and patient must both sign a Patient Enrollment Form; and the product will only be administered in a certified medical office where the health care provider can monitor the patient

Further information regarding certification of medical offices is available at www SPRAVATOrems com or 1-855-382-6022

Because this newly available treatment regimen addresses a particular and urgent need for people with TRD, including Medicare beneficiaries, we recognize that it is in the public interest to ensure appropriate patients have access to this potentially life-saving treatment. We recognize, however, that the services and resources involved in furnishing this treatment are not adequately reflected in existing coding and payment under the PFS, or otherwise under Medicare Part B

Given the FDA approval conditions/requirements including that the drug is only available as an integral component of a physicians?service, the absence of existing HCPCScoding that would adequately describe the service with the provision of the product, and our understanding based on review of the Spravato Prescribing Information, Medication Guide, and REMSrequirements, we do not believe the Medicare beneficiaries in the greatest medical need of this treatment would be likely to have access to it until such time that Medicare coding and payment are updated

Medicare coding and payment policies are generally adopted through annual updates to the PFS Unless we adopt coding and payment changes for this treatment beginning January 1, 2020, we believe that the next practicable alternative would be either standalone rulemaking or PFS rulemaking for 2021. Both of these alternatives would risk the lives of Medicare beneficiaries with TRD for several months to over a year.

Therefore, to facilitate prompt beneficiary access to the new, potentially life-saving treatment for TRD using esketamine, we are creating two new HCPCSG codes, G2082 and G2083, effective January 1, 2020 on an interim final basis For CY2020, we are establishing RVUs for these services that reflect the relative resource costs associated with the evaluation and management (E/M), observation and provision of the self-administered esketamine product using HCPCSG codes.

We note that we have historically established coding and payment on an interim final basis for truly new services when it is in the public interest to do so. Like most other truly new services, we expect diffusion of this kind of treatment into the market will take place over several years, even though we expect some people to benefit immediately

Consequently, the expected impact on other PFSservices is negligible for 2020, and we will consider the public comments we receive on this interim final policy as we consider finalizing coding or payment rules for this treatment beginning in 2021 The HCPCSG-codes are described as follows: