SUPERSEDED LCD Reference Article Billing and Coding Article

Billing and Coding: Esketamine

A59249

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Draft Articles are works in progress and not necessarily a reflection of the current billing and coding practices. Revisions to codes are carefully and thoroughly reviewed and are not intended to change the original intent of the LCD.
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NOT AN LCD REFERENCE ARTICLE
This article is not in direct support of an LCD.

Document Note

Posted: 10/3/2024
Please note: Effective 10/18/2023 the following changes have been made to reflect the updated FDA label instructions for use.

Under FDA label for SPRAVATO™ (esketamine) nasal spray, CIII:

Effective 10/18/2023 the first bullet point has been changed to:
Risk for sedation, dissociation, and respiratory depression after administration. Monitor patients for at least two hours after administration.

Effective 10/18/2023, the paragraph under the fourth bullet point should read:
SPRAVATO™ is a non-competitive N-methyl D-aspartate (NMDA) receptor antagonist indicated, in conjunction with an oral antidepressant, for the treatment of treatment-resistant depression (TRD) in adults and depressive symptoms in adults with major depressive disorder (MDD) with suicidal thoughts or actions.

This change was formally made to the version of this article updated on 9/13/2024 with the revision effective date of 09/19/2024.

Note History

Contractor Information

Article Information

General Information

Source Article ID
N/A
Article ID
A59249
Original ICD-9 Article ID
Not Applicable
Article Title
Billing and Coding: Esketamine
Article Type
Billing and Coding
Original Effective Date
11/14/2022
Revision Effective Date
N/A
Revision Ending Date
09/18/2024
Retirement Date
N/A

CPT codes, descriptions, and other data only are copyright 2023 American Medical Association. All Rights Reserved. Applicable FARS/HHSARS apply.

Fee schedules, relative value units, conversion factors and/or related components are not assigned by the AMA, are not part of CPT, and the AMA is not recommending their use. The AMA does not directly or indirectly practice medicine or dispense medical services. The AMA assumes no liability for data contained or not contained herein.

Current Dental Terminology © 2023 American Dental Association. All rights reserved.

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CMS National Coverage Policy

Social Security Act (Title XVIII) Standard References:

  • Title XVIII of the Social Security Act, Section 1861(t)(1) states that the term “drugs” and the term “biologicals”, except for purposes of subsection (m)(5) and paragraph (2), include only such drugs (including contrast agents) and biologicals, respectively, as are included (or approved for inclusion) in the United States Pharmacopoeia, the National Formulary, or the United States Homeopathic Pharmacopoeia, or in New Drugs or Accepted Dental Remedies (except for any drugs and biologicals unfavorably evaluated therein), or as are approved by the pharmacy and drug therapeutics committee (or equivalent committee) of the medical staff of the hospital furnishing such drugs and biologicals for use in such hospital.
  • Title XVIII of the Social Security Act, Section 1861(t)(2)(A)
  • Title XVIII of the Social Security Act, Section 1861(t)(2)(B)
  • Title XVIII of the Social Security Act, Section 1833(e) states that no payment shall be made to any provider of services or other person under this part unless there has been furnished such information as may be necessary in order to determine the amounts due such provider or other person under this part for the period with respect to which the amounts are being paid or for any prior period.

Federal Register References:

  • Code of Federal Regulations (CFR), Title 42, Chapter IV, Subchapter B, Part 424, Section 424.535 Revocation of enrollment in the Medicare program.

Article Guidance

Article Text

This Billing and Coding Article provides billing and coding guidance for the drug SPRAVATO™ (esketamine) when administered at healthcare sites enrolled in the Food and Drug Administration (FDA) risk evaluation and mitigation strategies (REMS) program. Consistent with Title XVIII of the Social Security Act, Section 1861(t)( 2)(B) the term “medically accepted indication”, with respect to the use of a drug, includes any use which has been approved by the FDA for the drug, and includes another use of the drug if such use is supported by one or more citations which are included (or approved for inclusion) in one or more of the following compendia: the American Hospital Formulary Service-Drug Information, the American Medical Association Drug Evaluations, the United States Pharmacopoeia-Drug Information, and other authoritative compendia as identified by the Secretary.

Prescribing medications for indications that are not approved by the FDA or are not supported in one of the compendia listed above may lead to revocation from the Medicare program consistent with CFR, Title 42, Chapter IV, Subchapter B, Part 424, Section 424.535.

This instruction focuses on coding and billing for esketamine. Nothing stated in this instruction implies or infers coverage.

Coding Guidance

Notice: It is not appropriate to bill Medicare for services that are not covered as if they are covered. When billing for non-covered services, use the appropriate modifier.

Diagnosis code selection is based on the FDA approved label indication treatment of treatment-resistant depression (TRD) in adults. At this time, no other use of the drug is supported by one or more CMS approved compendium.

FDA label for SPRAVATO™ (esketamine) nasal spray, CIII:

WARNING: SEDATION; DISSOCIATION; ABUSE AND MISUSE; and SUICIDAL
THOUGHTS AND BEHAVIORS

See full prescribing information for complete boxed warning.

  • Risk for sedation and dissociation after administration. Monitor patients for at least two hours after administration.
  • Potential for abuse and misuse. Consider the risks and benefits of prescribing SPRAVATO prior to using in patients at higher risk of abuse. Monitor patients for signs and symptoms of abuse and misuse.
  • SPRAVATO is only available through a restricted program called the SPRAVATO REMS.
  • Increased risk of suicidal thoughts and behaviors in pediatric and young adult patients taking antidepressants. Closely monitor all antidepressant-treated patients for clinical worsening and emergence of suicidal thoughts and behaviors. SPRAVATO is not approved for use in pediatric patients.

SPRAVATO™ is a non-competitive N-methyl D-aspartate (NMDA) receptor antagonist indicated, in conjunction with an oral antidepressant, for the treatment of treatment-resistant depression (TRD) in adults.

Limitations of Use: SPRAVATO is not approved as an anesthetic agent. The safety and effectiveness of SPRAVATO as an anesthetic agent have not been established.

Utilization Parameters per the FDA label:

Weeks 1 to 4: Administer twice per week

Weeks 5 to 8: Administer once weekly

Week 9 and after: Administer every 2 weeks or once weekly. Dosing frequency should be individualized to the least frequent dosing to maintain remission/response.

Frequency of administration exceeding the FDA label may be subject to medical review (i.e., maximum of 8 administrations first month; maximum of 4 administrations second month; maximum 4 administrations third and subsequent months).

Documentation Requirements

  1. All documentation must be maintained in the patient's medical record and made available to the contractor upon request.
  2. Every page of the record must be legible and include appropriate patient identification information (e.g., complete name, dates of service[s]). The documentation must include the legible signature of the physician or non-physician practitioner responsible for and providing the care to the patient.
  3. The submitted medical record must support the use of the selected ICD-10-CM code(s). The submitted CPT/HCPCS code must describe the service performed.

Response To Comments

Number Comment Response
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Coding Information

Bill Type Codes

Code Description

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Revenue Codes

Code Description

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CPT/HCPCS Codes

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CPT/HCPCS Modifiers

Group 1

Group 1 Paragraph

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Group 1 Codes

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ICD-10-CM Codes that Support Medical Necessity

Group 1

(12 Codes)
Group 1 Paragraph

It is the provider’s responsibility to select codes carried out to the highest level of specificity and selected from the ICD-10-CM code book appropriate to the year in which the service is rendered for the claim(s) submitted.

The following ICD-10-CM codes support use per FDA approved indications HCPCS codes: G2082 and G2083

Group 1 Codes
Code Description
F32.0 Major depressive disorder, single episode, mild
F32.1 Major depressive disorder, single episode, moderate
F32.2 Major depressive disorder, single episode, severe without psychotic features
F32.4 Major depressive disorder, single episode, in partial remission
F32.5* Major depressive disorder, single episode, in full remission
F32.89 Other specified depressive episodes
F33.0 Major depressive disorder, recurrent, mild
F33.1 Major depressive disorder, recurrent, moderate
F33.2 Major depressive disorder, recurrent severe without psychotic features
F33.41 Major depressive disorder, recurrent, in partial remission
F33.42* Major depressive disorder, recurrent, in full remission
F33.8 Other recurrent depressive disorders
Group 1 Medical Necessity ICD-10-CM Codes Asterisk Explanation

* Note: Codes F32.5 and F33.42 for major depressive disorder in full remission would only be appropriate for Maintenance Phase of treatment and would not be appropriate for Induction Phase of treatment.

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ICD-10-CM Codes that DO NOT Support Medical Necessity

Group 1

Group 1 Paragraph

All ICD-10 Codes not listed under Group 1 of this article.

Group 1 Codes

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ICD-10-PCS Codes

Group 1

Group 1 Paragraph

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Group 1 Codes

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Additional ICD-10 Information

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Bill Type Codes

Contractors may specify Bill Types to help providers identify those Bill Types typically used to report this service. Absence of a Bill Type does not guarantee that the article does not apply to that Bill Type. Complete absence of all Bill Types indicates that coverage is not influenced by Bill Type and the article should be assumed to apply equally to all claims.

Code Description

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Revenue Codes

Contractors may specify Revenue Codes to help providers identify those Revenue Codes typically used to report this service. In most instances Revenue Codes are purely advisory. Unless specified in the article, services reported under other Revenue Codes are equally subject to this coverage determination. Complete absence of all Revenue Codes indicates that coverage is not influenced by Revenue Code and the article should be assumed to apply equally to all Revenue Codes.

Code Description

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Other Coding Information

Group 1

Group 1 Paragraph

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Group 1 Codes

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Coding Table Information

Excluded CPT/HCPCS Codes - Table Format
Code Descriptor Generic Name Descriptor Brand Name Exclusion Effective Date Exclusion End Date Reason for Exclusion
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Non-Excluded CPT/HCPCS Ended Codes - Table Format
Code Descriptor Generic Name Descriptor Brand Name Exclusion Effective Date Exclusion End Date Reason for Exclusion
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Revision History Information

Revision History Date Revision History Number Revision History Explanation
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Associated Documents

Medicare BPM Ch 15.50.2 SAD Determinations
Medicare BPM Ch 15.50.2
Related Local Coverage Documents
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Related National Coverage Documents
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SAD Process URL 1
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SAD Process URL 2
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Statutory Requirements URLs
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Rules and Regulations URLs
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CMS Manual Explanations URLs
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Other URLs
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Public Versions
Updated On Effective Dates Status
09/13/2024 09/19/2024 - N/A Currently in Effect View
09/23/2022 11/14/2022 - 09/18/2024 Superseded You are here

Keywords

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