Article - Billing and Coding: Esketamine (A59249)

CMS National Coverage PolicySocial 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 TextThis 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 GuidanceNotice: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 SUICIDALTHOUGHTS AND BEHAVIORSSee 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 isnot 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 weekWeeks 5 to 8:Administer once weeklyWeek 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 RequirementsAll 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.