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
- All documentation must be maintained in the patient's medical record and made available to the contractor upon request.
- 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.
- 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.
