Access & Reimbursement Guide - Information to Support the Access & Reimbursement Process for SPRAVATO - SPRAVATO HCP
←
→
Page content transcription
If your browser does not render page correctly, please read the page content below
Access & Reimbursement Guide
Information to Support the Access & Reimbursement Process
for SPRAVATO®
Indications:
SPRAVATO® (esketamine) CIII Nasal Spray is indicated, in conjunction with an oral antidepressant, for the treatment of:
• Treatment-resistant depression (TRD) in adults.
• Depressive symptoms in adults with major depressive disorder (MDD) with acute suicidal ideation or behavior.
Limitations of Use:
• The effectiveness of SPRAVATO® in preventing suicide or in reducing suicidal ideation or behavior has not been
demonstrated. Use of SPRAVATO® does not preclude the need for hospitalization if clinically warranted, even if patients
experience improvement after an initial dose of SPRAVATO®.
• SPRAVATO® is not approved as an anesthetic agent. The safety and effectiveness of SPRAVATO® as an anesthetic agent
have not been established.
Important Safety Information
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 (5.1, 5.2).
• Potential for abuse and misuse. Consider the risks and benefits of using SPRAVATO® prior to use in patients
at higher risk of abuse. Monitor for signs and symptoms of abuse and misuse (5.3).
• SPRAVATO® is only available through a restricted program called the SPRAVATO® REMS (5.4).
• 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 (5.5).
Please seeImportant
Please see Important Safety
Safety Information,
Information, including
including Boxed
Boxed WARNINGS,
WARNINGS, on pages
on pages 47-51. 46-49.
Pleasesee
Please seefull
fullPrescribing
Prescribing Information,
Information, including
including Boxed
Boxed WARNINGS,
WARNINGS, and Medication
and Medication Guide
Guide for for SPRAVATO®.
SPRAVATO®.
Provide theMedication
Provide the Medication Guide
Guide to your
to your patients
patients and and encourage
encourage discussion.
discussion.
12
Table of Contents
How to Use This Guide.......................................................................................................................... Pages 3-5
Introduction
Procurement Pathways
SPRAVATO® Coverage Considerations.............................................................................................. Pages 6-7
SPRAVATO® REMS ........................................................................................................................................ Page 8
Available Procurement Pathways for SPRAVATO®......................................................................Pages 9-16
The Buy-and-Bill Pathway
The REMS-Certified Specialty Pharmacy Pathway
Coding for SPRAVATO®...................................................................................................................... Pages 17-28
Coding for Observation and Monitoring of SPRAVATO® Administration Under HCP
Supervision Consistent With REMS Requirements
Other Coding Considerations
Filing Healthcare Claims.................................................................................................................. Pages 29-42
SPRAVATO® Dosage and Administration..................................................................................... Pages 43-45
Janssen CarePath ..................................................................................................................................... Page 46
Indications and Important Safety Information........................................................................ Pages 47-51
Appendices........................................................................................................................................... Pages 52-54
References................................................................................................................................................... Page 55
Please seeImportant
Please see Important Safety
Safety Information,
Information, including
including Boxed
Boxed WARNINGS,
WARNINGS, on pages
on pages 47-51. 46-49.
Pleasesee
Please seefull
fullPrescribing
Prescribing Information,
Information, including
including Boxed
Boxed WARNINGS,
WARNINGS, and Medication
and Medication Guide
Guide for for SPRAVATO®.
SPRAVATO®.
Provide theMedication
Provide the Medication Guide
Guide to your
to your patients
patients and and encourage
encourage discussion.
discussion.
23
How to Use This Guide
HOW TO USE
THIS GUIDE
Introduction
Introduction
This Access & Reimbursement Guide contains important information about SPRAVATO®, including its Procurement Pathways
uses and Important Safety Information, the Risk Evaluation & Mitigation Strategy (REMS), information
about how to identify authorized distributors, and guidance on access and reimbursement. SPRAVATO®
COVERAGE
This document is presented for informational purposes only and is not intended to provide CONSIDERATIONS
reimbursement or legal advice, nor does it promise or guarantee coverage, levels of reimbursement,
payment, or charge. Similarly, all CPT® and HCPCS codes are supplied for informational purposes only SPRAVATO®
and represent no statement, promise, or guarantee by Janssen Pharmaceuticals, Inc., that these codes REMS
will be appropriate or that reimbursement will be made. It is not intended to increase or maximize
AVAILABLE
reimbursement by any payer. Laws, regulations, and policies concerning reimbursement are complex PROCUREMENT
and are updated frequently. While we have made an effort to be current as of the issue date of this PATHWAYS
document, the information may not be as current or comprehensive when you view it. We strongly
recommend you consult the payer organization for its reimbursement policies. CODING
FILING HEALTHCARE
CLAIMS
SPRAVATO®
DOSAGE AND
ADMINISTRATION
JANSSEN CAREPATH
INDICATIONS AND
IMPORTANT
SAFETY INFO
APPENDICES
REFERENCES
CPT® - Current Procedural Terminology. CPT® is a registered trademark of the American Medical Association.
Please see Important Safety Information, including Boxed WARNINGS, on pages 47-51.
Please see full Prescribing Information, including Boxed WARNINGS, and Medication Guide for SPRAVATO®.
Provide the Medication Guide to your patients and encourage discussion.4
How to Use This Guide (continued)
HOW TO USE
1 Introductory Material THIS GUIDE
This introductory information provides an overview of SPRAVATO® usage, indications Introduction
and procurement options, as well as a summary of the REMS requirements for all uses of Procurement Pathways
SPRAVATO®. General coverage considerations are also presented, including a review of medical
necessity and a summary of SPRAVATO® coverage by site of care and payer. SPRAVATO®
COVERAGE
CONSIDERATIONS
2 Select the Applicable Procurement Pathway SPRAVATO®
REMS
SPRAVATO® may be covered under pharmaceutical benefit or medical benefit. This sets up
the “pathway” which will determine how a treatment center might procure SPRAVATO® and, AVAILABLE
in turn, determine the reimbursement process. To simplify use of this SPRAVATO® Access & PROCUREMENT
PATHWAYS
Reimbursement Guide, SPRAVATO® procurement pathways are separated into 2 sections:
CODING
The
Buy-and-Bill Pathway, which splits off into Medicare and Non-Medicare
The REMS-Certified Specialty Pharmacy Pathway
FILING HEALTHCARE
CLAIMS
From there you can navigate to relevant information on general coding for SPRAVATO®, coding
for observation and monitoring of SPRAVATO® administration, and other coding considerations.
SPRAVATO®
DOSAGE AND
The chart on the next page will help guide you to the applicable pathway. ADMINISTRATION
If you purchase and bill for SPRAVATO®, payer policy will dictate how the drug and
JANSSEN CAREPATH
associated services are coded
If you acquire SPRAVATO® through a REMS-certified pharmacy, the pharmacy will bill the INDICATIONS AND
IMPORTANT
drug and the payer policy will dictate appropriate service codes SAFETY INFO
APPENDICES
3 Check the Appendices for Helpful Tools
For information on product ordering and sample letters for medical necessity and formulary REFERENCES
exception requests, please see Appendix A and Appendix B. This information is provided as a
general example only. The information needed to fill out these forms will vary based on the
prescriber’s clinical assessment of the patient’s specific circumstances and condition.
Please see Important Safety Information, including Boxed WARNINGS, on pages 47-51.
Please see full Prescribing Information, including Boxed WARNINGS, and Medication Guide for SPRAVATO®.
Provide the Medication Guide to your patients and encourage discussion.5
How to Use This Guide (continued)
HOW TO USE
Select the Applicable Coding Section THIS GUIDE
Introduction
If You Buy and Bill for SPRAVATO® Procurement Pathways
Use Combination Drug and Service G Codes for Use Drug HCPCS and Consider Using
SPRAVATO®
Medicare
(required) Service CPT® Codes for COVERAGE
CONSIDERATIONS
Non-Medicare
payers that do not require
Non-Medicare
payers that require G Codes
or accept the G Codes
SPRAVATO®
REMS
56-mg dose 56-mg dose
2 devices G2082 1 unit 2 devices S0013* 56 units
AVAILABLE
PROCUREMENT
PATHWAYS
84-mg dose 84-mg dose
3 devices
G2083 1 unit 3 devices S0013* 84 units
CODING
Evaluation & Management
FILING HEALTHCARE
(E/M) codes CLAIMS
FOR CODING INFORMATION, PLEASE SEE:
The Buy-and-Bill Pathway SPRAVATO®
• Medicare (pages 10-11)
DOSAGE AND
ADMINISTRATION
• Non-Medicare (pages 12-13) FOR CODING INFORMATION, PLEASE SEE:
The Buy-and-Bill Pathway
• Non-Medicare (pages 14-15) JANSSEN CAREPATH
The REMS-Certified Specialty Pharmacy
Pathway (page 16)
INDICATIONS AND
*S0013 – Esketamine, nasal spray, 1 mg. IMPORTANT
Payers that do not accept the G or S Codes may continue to SAFETY INFO
require J3490 (Unclassified drugs).
APPENDICES
If You Acquire SPRAVATO® Through a REMS-certified Pharmacy
Consider Using Service CPT® Codes for: REFERENCES
Medicare
and non-Medicare payers
Service:
Evaluation & Management
(E/M) codes
The fact that a drug, device, procedure or service is assigned an HCPCS code and a payment rate does not imply
coverage by the Medicare and/or Medicaid program, but indicates only how the product, procedure, or service may be
paid if covered by the program. Fiscal Intermediaries (FIs)/Medicare Administrative Contractors (MACs) and/or state
Medicaid administration determine whether a drug, device, procedure, or other service meets all program requirements
for coverage.It is important to note that payer requirements for SPRAVATO® administration coding may vary.
Please contact your payers for specific coding policies.
CPT® - Current Procedural Terminology. CPT® is a registered trademark of the American Medical Association.
Please see Important Safety Information, including Boxed WARNINGS, on pages 47-51.
Please see full Prescribing Information, including Boxed WARNINGS, and Medication Guide for SPRAVATO®.
Provide the Medication Guide to your patients and encourage discussion.6
SPRAVATO® Coverage Considerations
HOW TO USE
Factors That Influence Coverage THIS GUIDE
Third-party payers (eg, commercial insurers, Medicare, Medicaid) may cover drugs that require HCP SPRAVATO®
management for their approved U.S. Food and Drug Administration (FDA) indications, and the associated COVERAGE
CONSIDERATIONS
administration services. However, benefits may vary depending on the payer and the specific plan in
which a patient is enrolled. Factors That
Influence Coverage
Medical Necessity Coverage for SPRAVATO®
When third-party payers review drug claims, they will first determine if the type of service provided is
SPRAVATO®
covered under their policies. Next, payers will look for evidence supporting the medical necessity of the REMS
therapy. This evidence may include:
AVAILABLE
Information about the patient’s medical condition and history
PROCUREMENT
PATHWAYS
A physician’s statement or letter of medical necessity
Supporting literature (eg, peer-reviewed studies and compendia monographs)
CODING
Prescribing information
Availability of other treatment alternatives FILING HEALTHCARE
CLAIMS
Medical necessity refers to health care services or supplies needed to diagnose or treat an illness,
injury, condition, disease, or its symptoms, and that meet accepted standards of medicine. Generally, SPRAVATO®
health insurance companies provide coverage only for health-related services that they define or DOSAGE AND
ADMINISTRATION
determine to be medically necessary. Commercial insurers, Medicaid program coverage policies,
Medicare National Coverage Determinations, and Medicare Administrative Contractors’ Local Coverage JANSSEN
Determinations define medical necessity requirements. These documents contain guidance on covered CAREPATH
diagnoses, required documentation, and limitations of coverage for specific medical services or items.
INDICATIONS
Reimbursement policies and guidelines may vary by payer. AND IMPORTANT
SAFETY INFO
Administrative Considerations
Table 1: Other Considerations Potentially Involved in a Payer’s Decision to Cover a Product or Service APPENDICES
• Does the payer contract specifically indicate the sites of care that may bill for the drug and its
administration? REFERENCES
Site of Care • Payers may have site-specific coverage rules. For example, does the plan require that the drug
be administered only in a physician practice setting and restrict coverage if provided in a hospital
outpatient setting?
• Is the billing provider a “participating” member of, or “in-network” provider for, that specific plan?
Participating • Payers contract with providers to deliver services to the plan’s members. Providers are thus participating
Providers within that plan’s network, requiring them to abide by the contract charge structure when providing
care for that plan’s members. Services provided by non-participating providers may not be covered in
the absence of an approved exception request or other pre-approval from a health plan
• If required by the plan, has the appropriate referral or prior authorization been obtained?
• Many plans require that nonemergency services be pre-approved or that a primary care physician make
Prior the referral for specialty care. Some plans may require that certain products or services be prescribed
Authorization only by specific specialists. Failing to obtain appropriate referrals or pre-authorization can result in
nonpayment by the plan
Please see Important Safety Information, including Boxed WARNINGS, on pages 47-51.
Please see full Prescribing Information, including Boxed WARNINGS, and Medication Guide for SPRAVATO®.
Provide the Medication Guide to your patients and encourage discussion.7
SPRAVATO® Coverage Considerations (continued)
HOW TO USE
Coverage for SPRAVATO® THIS GUIDE
Coverage for SPRAVATO® will vary by payer, individual contracts, and treatment setting. When SPRAVATO®
provided under the supervision of an HCP in an authorized site of care, the drug will often be covered COVERAGE
CONSIDERATIONS
under the payer’s medical benefit. Alternatively, the drug may be covered under the pharmacy benefit
and delivery to the site of care will be through a REMS-certified pharmacy distributor. Factors That
Influence Coverage
Table 2: SPRAVATO® Coverage Summary Coverage for SPRAVATO®
Medicare Medicare Medicare SPRAVATO®
Site of Caree Commercial Insurance
Part A Part B Part D REMS
• IPPS • Payer reimbursement policies AVAILABLE
Inpatient PROCUREMENT
Hospital • Covered within N/A N/A • Typically covered within the DRG PATHWAYS
(Acute Care) the MS-DRG*
CODING
Inpatient • IPF-PPS • Payer reimbursement policies
Psychiatric • Covered within N/A N/A • Typically covered within the DRG
Facility the MS-DRG FILING HEALTHCARE
CLAIMS
• OPPS • PDP • Payer reimbursement policies
SPRAVATO®
•D
rug and •M
ay be covered •M
ay be covered as a medical DOSAGE AND
management under pharmacy benefit, separately or in ADMINISTRATION
Hospital covered together benefit combination
Outpatient as a single service •R
EMS-certified with service
N/A (ie, G Code)
JANSSEN
Department pharmacy •M
ay be covered as a pharmacy CAREPATH
(HOPD) • L ocal Coverage distribution benefit, with REMS-certified
Determinations •P
ayer pharmacy distribution INDICATIONS
may apply management AND IMPORTANT
•P
ayer management tools†
SAFETY INFO
tools† may apply may apply
• PFS • PDP • Payer reimbursement policies APPENDICES
• Drug
and •M
ay be covered •M
ay be covered as a medical
management under pharmacy benefit, separately or in
covered together benefit combination REFERENCES
Physician as a single service •R
EMS-certified with service
N/A (ie, G Code)
Practice pharmacy •M
ay be covered as a pharmacy
• L ocal Coverage distribution benefit, with REMS-certified
Determinations •P
ayer pharmacy distribution
may apply management •P
ayer management tools†
tools† may apply may apply
*May be eligible for a New Technology Add-on Payment (NTAP).
† Prior authorization, step therapy, quantity limits, etc.
IPPS=Inpatient Prospective Payment System; IPF-PPS=Inpatient Psychiatric Facility Prospective Payment System; MS-DRG=Medicare
Severity Diagnosis-Related Group; OPPS=Outpatient Prospective Payment System; PDP=Prescription Drug Plan; PFS=Physician
Fee Schedule.
Please see Important Safety Information, including Boxed WARNINGS, on pages 47-51.
Please see full Prescribing Information, including Boxed WARNINGS, and Medication Guide for SPRAVATO®.
Provide the Medication Guide to your patients and encourage discussion.8
SPRAVATO® REMS
HOW TO USE
REMS Manages Known or Potential Risks Associated With a Drug and Is Required by the THIS GUIDE
U.S. FDA to Ensure that the Benefits of the Drug Outweigh its Risks SPRAVATO®
COVERAGE
SPRAVATO® is available only through a restricted distribution program called the SPRAVATO® REMS CONSIDERATIONS
because of the risks of serious adverse outcomes resulting from sedation and dissociation caused by
SPRAVATO®
SPRAVATO® administration, and abuse and misuse of SPRAVATO®. SPRAVATO® is intended for use only REMS
in a certified healthcare setting.
AVAILABLE
SPRAVATO® is intended for patient administration under the direct observation of healthcare PROCUREMENT
provider, and patients are required to be monitored by a healthcare provider for at least 2 hours. PATHWAYS
SPRAVATO® must never be dispensed directly to a patient for home use.
CODING
What are the REMS requirements?
FILING
Healthcare setting Pharmacy certification Patient enrollment HEALTHCARE
1 certification
2 All pharmacies must be
3 Patients in an outpatient
CLAIMS
All healthcare settings must certified in the REMS setting must be enrolled SPRAVATO®
be certified in the REMS in in order to receive and in the REMS with their DOSAGE AND
order to receive, dispense, dispense SPRAVATO®. prescriber in order to receive ADMINISTRATION
and/or treat patients with SPRAVATO® treatment.
JANSSEN
SPRAVATO®. CAREPATH
Healthcare Settings Type* INDICATIONS
AND IMPORTANT
SAFETY INFO
All REMS-certified Inpatient and Outpatient Healthcare Settings must have a healthcare provider
counsel patients on the safety risk of SPRAVATO® and monitor patients post-dose.
APPENDICES
Inpatient healthcare settings Outpatient healthcare settings
Covers inpatient units, inpatient Covers outpatient medical offices REFERENCES
pharmacy, and emergency departments and clinics
Before prescribing SPRAVATO® Before prescribing SPRAVATO®
treatment, complete and submit treatment, complete and submit
the inpatient healthcare setting the outpatient healthcare setting
enrollment form enrollment form
Before starting SPRAVATO® treatment, Before starting SPRAVATO® treatment,
inpatient settings are not required enroll the patient by completing and
to enroll the patient in the submitting the patient enrollment
SPRAVATO® REMS form to the SPRAVATO® REMS
During SPRAVATO® treatment, inpatient During SPRAVATO® treatment, submit
settings do not require the patient the patient monitoring form and
monitoring form. Report all suspected report all suspected adverse events to
adverse events to the SPRAVATO® REMS the SPRAVATO® REMS
*To get started, find more information on how to certify as a healthcare setting and/or pharmacy, and view all REMS
requirements and attestations by type of REMS stakeholder, visit www.SPRAVATOrems.com or call 1-855-382-6022
(8:00 AM to 8:00 PM ET).
Please see Important Safety Information, including Boxed WARNINGS, on pages 47-51.
Please see full Prescribing Information, including Boxed WARNINGS, and Medication Guide for SPRAVATO®.
Provide the Medication Guide to your patients and encourage discussion.9
Available Procurement Pathways for SPRAVATO®
HOW TO USE
How Is the Drug Procured? THIS GUIDE
SPRAVATO®
COVERAGE
Buy-and-Bill Coding Options CONSIDERATIONS
Drug and Service Drug and Service SPRAVATO®
Service Only
(bundled) (not bundled) REMS
S0013 J3490 AVAILABLE
G2082 (56 mg) PROCUREMENT
esketamine Unlisted drug
Appropriate PATHWAYS
OR + + E/M code(s)
The Buy-and-Bill Pathway
Procurement
Procurement Procurement
ProcurementG-2083 (84 mg) Appropriate Appropriate Procurement
Payer
Payer Payer Payer E/M code(s) E/M code(s) Payer
Pathway
Pathway Pathway Pathway Pathway The REMS-certified Specialty
Pharmacy Pathway
Medicare
Medicare ✓ Medicare
Medicare N/A N/A N/A Medicare
Buy-and-Bill
Buy-and-Bill Buy-and-Bill
Buy-and-Bill Buy-and-Bill CODING
Non-Medicare
Non-Medicare ✓Non-Medicare
Non-Medicare ✓ ✓ N/A Non-Medicare
FILING HEALTHCARE
CLAIMS
ViaVia
REMS-
REMS- Via REMS- Via REMS- Via REMS-
Certified
Certified Certified Certified N/A All payers N/A N/A Certified
✓ SPRAVATO®
All
Allpayers
payers All payers All payers
Specialty
Specialty Specialty Specialty Specialty DOSAGE AND
Pharmacy
Pharmacy Pharmacy Pharmacy Pharmacy ADMINISTRATION
JANSSEN
Via REMS-Certified CAREPATH
Specialty Pharmacy
INDICATIONS
AND IMPORTANT
SAFETY INFO
The fact that a drug, device, procedure, or service is assigned an HCPCS code and a payment rate,
APPENDICES
does not imply coverage by the Medicare and/or Medicaid program, but indicates only how the
product, procedure, or service may be paid if covered by the program. Fiscal Intermediaries
(Fls)/Medicare Administrative Contractors (MACs) and/or state Medicaid administration determine REFERENCES
whether a drug, device, procedure, or other service meets all program requirements for coverage.
It is important to note that payer requirements for SPRAVATO® administration coding may vary.
Please contact your payers for specific coding policies.
E/M=Evaluation and Management.
CPT® - Current Procedural Terminology. CPT® is a registered trademark of the American Medical Association.
Please see Important Safety Information, including Boxed WARNINGS, on pages 47-51.
Please see full Prescribing Information, including Boxed WARNINGS, and Medication Guide for SPRAVATO®.
Provide the Medication Guide to your patients and encourage discussion.10
The Buy-and-Bill Pathway
Medicare (G Code)
HOW TO USE
2021 Medicare G Codes for SPRAVATO® (esketamine) and Observation and Monitoring of THIS GUIDE
SPRAVATO® Administration Under HCP Supervision Consistent With REMS Requirements
SPRAVATO®
COVERAGE
In 2020, CMS established coding and payment rules for the evaluation and management, observation, CONSIDERATIONS
and provision of self-administered SPRAVATO® under Medicare Part B.1 The resulting HCPCS codes
(G2082 and G2083) incorporate both the provision of drug and professional services associated with SPRAVATO®
REMS
SPRAVATO® therapy. These codes are required for billing Medicare on both physician office (CMS-1500)
and hospital outpatient (CMS-1450) claims. Non-Medicare payers may choose to accept the G Codes but AVAILABLE
are not required to do so. PROCUREMENT
PATHWAYS
Because the G Codes describe both drug and service, SPRAVATO® is not coded separately on Medicare
The Buy-and-Bill Pathway
claims or on claims for non-Medicare payers that require G Codes. For payers that do not accept the G
Codes, providers will report separate codes for the drug and service. For more information, please see the The REMS-certified Specialty
Pharmacy Pathway
other section of this guide: “SPRAVATO® Coding With HCPCS and CPT® Codes.”
The following table describes the G Codes. Selection of the appropriate code is dose dependent. G2082 CODING
is used to report SPRAVATO® doses of 56 mg or less, and G2083 is used to report doses greater than 56
mg (ie, 84 mg, 3 devices).1 The 2-hour post-administration period is consistent with REMS requirements FILING HEALTHCARE
and remains the same for both doses. CLAIMS
SPRAVATO®
Table 3: G Codes to Report SPRAVATO® on Medicare Claims DOSAGE AND
ADMINISTRATION
HCPCS Code Descriptor JANSSEN
CAREPATH
Office or other outpatient visit for the evaluation and management of an established INDICATIONS
patient that requires the supervision of a physician or other qualified healthcare AND IMPORTANT
G2082 provider and provision of up to 56 mg of esketamine nasal self-administration, includes SAFETY INFO
2 hours post-administration observation.
APPENDICES
Office or other outpatient visit for the evaluation and management of an established
REFERENCES
patient that requires the supervision of a physician or other qualified healthcare
G2083 provider and provision of greater than 56 mg of esketamine nasal self-administration,
includes 2 hours post-administration observation.
The fact that a drug, device, procedure, or service is assigned an HCPCS code and a payment rate,
does not imply coverage by the Medicare and/or Medicaid program, but indicates only how the
product, procedure, or service may be paid if covered by the program. Fiscal Intermediaries (Fls)/
Medicare Administrative Contractors (MACs) and/or state Medicaid administration determine
whether a drug, device, procedure, or other service meets all program requirements for coverage.
CPT® - Current Procedural Terminology. CPT® is a registered trademark of the American Medical Association.
Please see Important Safety Information, including Boxed WARNINGS, on pages 47-51.
Please see full Prescribing Information, including Boxed WARNINGS, and Medication Guide for SPRAVATO®.
Provide the Medication Guide to your patients and encourage discussion.11
The Buy-and-Bill Pathway (continued)
Medicare (G Code)
HOW TO USE
Use the Links Below to Navigate Relevant Information For Medicare (G Code) THIS GUIDE
SPRAVATO®
Coding for SPRAVATO® COVERAGE
CONSIDERATIONS
• ICD-10-CM Diagnosis Codes
SPRAVATO®
REMS
• National Drug Code (NDC)
AVAILABLE
• NDC Units PROCUREMENT
PATHWAYS
The Buy-and-Bill Pathway
Other Coding Considerations The REMS-certified Specialty
Pharmacy Pathway
• POS Codes
CODING
• Code Modifiers
FILING HEALTHCARE
CLAIMS
Filing Healthcare Claims
SPRAVATO®
• Sample CMS-1500 Claim Form (G Codes) DOSAGE AND
ADMINISTRATION
• Sample CMS-1450 Claim Form (G Codes)
JANSSEN
CAREPATH
Appendices INDICATIONS
AND IMPORTANT
SAFETY INFO
• Sample Letter of Medical Necessity
• Sample Formulary Exception Request APPENDICES
• Ordering Information
REFERENCES
CPT® - Current Procedural Terminology. CPT® is a registered trademark of the American Medical Association.
Please see Important Safety Information, including Boxed WARNINGS, on pages 47-51.
Please see full Prescribing Information, including Boxed WARNINGS, and Medication Guide for SPRAVATO®.
Provide the Medication Guide to your patients and encourage discussion.12
The Buy-and-Bill Pathway (continued)
Non-Medicare (G Code)
HOW TO USE
2021 G Codes for SPRAVATO® (esketamine) and Observation and Monitoring of THIS GUIDE
SPRAVATO® Administration Under HCP Supervision Consistent With REMS Requirements SPRAVATO®
COVERAGE
In 2020, CMS established coding and payment rules for the evaluation and management, observation, CONSIDERATIONS
and provision of self-administered SPRAVATO® under Medicare Part B.1 The resulting HCPCS codes (G2082
SPRAVATO®
and G2083) incorporate both the provision of drug and professional services associated with SPRAVATO® REMS
therapy. These codes are required for billing Medicare on both physician office (CMS-1500) and hospital
outpatient (CMS-1450) claims. Non-Medicare payers may choose to accept the G Codes but are not AVAILABLE
PROCUREMENT
required to do so. PATHWAYS
Because the G Codes describe both drug and service, SPRAVATO® is not coded separately on Medicare
The Buy-and-Bill Pathway
claims or on claims for non-Medicare payers that require G Codes. For payers that do not accept the G
Codes, providers will report separate codes for the drug and service. For more information, please see the The REMS-certified Specialty
Pharmacy Pathway
other section of this guide: “SPRAVATO® Coding With HCPCS and CPT® Codes.”
The following table describes the G Codes. Selection of the appropriate code is dose dependent. G2082 is CODING
used to report SPRAVATO® doses of 56 mg or less, and G2083 is used to report doses greater than 56 mg
(ie, 84 mg, 3 devices).1 The 2-hour post-administration period is consistent with REMS requirements and FILING HEALTHCARE
remains the same for both doses. CLAIMS
SPRAVATO®
Table 4: G Codes to Report SPRAVATO® on Non-Medicare Claims DOSAGE AND
ADMINISTRATION
HCPCS Code Descriptor JANSSEN
CAREPATH
Office or other outpatient visit for the evaluation and management of an established INDICATIONS
patient that requires the supervision of a physician or other qualified healthcare AND IMPORTANT
G2082 provider and provision of up to 56 mg of esketamine nasal self-administration, includes
SAFETY INFO
2 hours post-administration observation.
APPENDICES
Office or other outpatient visit for the evaluation and management of an established
REFERENCES
patient that requires the supervision of a physician or other qualified healthcare
G2083 provider and provision of greater than 56 mg of esketamine nasal self-administration,
includes 2 hours post-administration observation.
The fact that a drug, device, procedure, or service is assigned an HCPCS code and a payment rate,
does not imply coverage by the Medicare and/or Medicaid program, but indicates only how the
product, procedure, or service may be paid if covered by the program. Fiscal Intermediaries (Fls)/
Medicare Administrative Contractors (MACs) and/or state Medicaid administration determine
whether a drug, device, procedure, or other service meets all program requirements for coverage.
CPT® - Current Procedural Terminology. CPT® is a registered trademark of the American Medical Association.
Please see Important Safety Information, including Boxed WARNINGS, on pages 47-51.
Please see full Prescribing Information, including Boxed WARNINGS, and Medication Guide for SPRAVATO®.
Provide the Medication Guide to your patients and encourage discussion.13
The Buy-and-Bill Pathway (continued)
Non-Medicare (S Code and J Code)
HOW TO USE
New SPRAVATO® Drug Code for Non-Medicare Payers THIS GUIDE
Effective January 1, 2021, CMS has established a new HCPCS code to identify SPRAVATO®: SPRAVATO®
COVERAGE
S0013 – E
sketamine, nasal spray, 1 mg2 CONSIDERATIONS
This is a product-specific billing code, intended to facilitate commercial payer claims processing for SPRAVATO®
REMS
SPRAVATO®. Providers must continue to report the G codes on Medicare claims.
AVAILABLE
Table 5: S0013 Is Available to Separately Report SPRAVATO® to Non-Medicare Payers PROCUREMENT
PATHWAYS
Site of Care Payer Product-specific HCPCS Code The Buy-and-Bill Pathway
The REMS-certified Specialty
Physician Office Non-Medicare S0013 - Esketamine, nasal spray, 1 mg2 Pharmacy Pathway
CODING
Hospital Outpatient
Non-Medicare S0013 - Esketamine, nasal spray, 1 mg2
Department
FILING HEALTHCARE
CLAIMS
Each 28 mg spray device of SPRAVATO® represents 28 units of S0013. Inaccurate reporting of
drug HCPCS units is a common claims error and can result in denied or delayed payment. When
SPRAVATO®
coding for S0013, report the total number of 1 mg increments administered. Table 6 illustrates the DOSAGE AND
correlation among SPRAVATO® spray devices, milligrams, and HCPCS units used for billing. ADMINISTRATION
JANSSEN
Table 6: SPRAVATO® HCPCS Billing Units CAREPATH
Number of 28 mg Spray Number of Billing Units Based on S0013 INDICATIONS
Total Milligrams (mg) AND IMPORTANT
Devices of SPRAVATO® (1 mg SPRAVATO® per unit) SAFETY INFO
1 28 28
APPENDICES
2 56 56
REFERENCES
3 84 84
In lieu of S0013, payers may continue to require J3490 (Unclassified drugs). Use of this
miscellaneous code will require submission of supporting information. Because requirements may
vary by payer, it is advisable to check local requirements before submitting claims.
Unclassified codes are not drug-specific, thus always reported as 1 unit. Please see pages 39-42
for sample claim forms using J3490.
CPT® - Current Procedural Terminology. CPT® is a registered trademark of the American Medical Association.
Please see Important Safety Information, including Boxed WARNINGS, on pages 47-51.
Please see full Prescribing Information, including Boxed WARNINGS, and Medication Guide for SPRAVATO®.
Provide the Medication Guide to your patients and encourage discussion.14
The Buy-and-Bill Pathway (continued)
Non-Medicare (G Code, S Code and J Code)
HOW TO USE
Use the Links Below to Navigate Relevant Information for Non-Medicare THIS GUIDE
(G Code, S Code and J Code) SPRAVATO®
COVERAGE
Coding for SPRAVATO® CONSIDERATIONS
• ICD-10-CM Diagnosis Codes SPRAVATO®
REMS
• National Drug Code (NDC)
AVAILABLE
• NDC Units PROCUREMENT
PATHWAYS
Coding for Observation and Monitoring of SPRAVATO® Administration The Buy-and-Bill Pathway
Under HCP Supervision Consistent With REMS Requirements
The REMS-certified Specialty
Pharmacy Pathway
Evaluation and Management (E/M) Overview CODING
• SPRAVATO® Administration – E/M Code Considerations by Payer
FILING HEALTHCARE
• SPRAVATO® Administration – E/M Code Considerations by Patients CLAIMS
• Prolonged Clinical Staff Services With Physician Supervision SPRAVATO®
DOSAGE AND
• Prolonged Service With or Without Direct Patient Contact (physician time) ADMINISTRATION
Other Coding Considerations JANSSEN
CAREPATH
• POS Codes
INDICATIONS
• Code Modifiers AND IMPORTANT
SAFETY INFO
Filing Healthcare Claims
APPENDICES
• Sample CMS-1500 Claim Form (G Codes)
• Sample CMS-1450 Claim Form (G Codes) REFERENCES
• Sample CMS-1500 Claim Form (S Codes)
• Sample CMS-1450 Claim Form (S Codes)
• Sample CMS-1500 Claim Form (J Codes)
• Sample CMS-1450 Claim Form (J Codes)
Appendices
• Sample Letter of Medical Necessity
• Sample Formulary Exception Request
• Ordering Information
Please see Important Safety Information, including Boxed WARNINGS, on pages 47-51.
Please see full Prescribing Information, including Boxed WARNINGS, and Medication Guide for SPRAVATO®.
Provide the Medication Guide to your patients and encourage discussion.15
The REMS-Certified Specialty Pharmacy Pathway
Drugs Supplied at No Cost to Provider
HOW TO USE
Payers, including Medicare Part D, may cover a drug under the patient’s pharmacy benefit. Under this THIS GUIDE
model, SPRAVATO® may be delivered to the administering site via a REMS-certified pharmacy. When
SPRAVATO®
the drug is supplied by a REMS-certified pharmacy, it cannot be billed by the administering provider. COVERAGE
However, the HCP observation and monitoring of the drug’s administration is a billable service.3 CONSIDERATIONS
When reporting drug administration services associated with pharmacy-supplied drugs, consider SPRAVATO®
reporting the services with the relevant evaluation and management codes. Payer policies may vary. REMS
AVAILABLE
If You Acquire SPRAVATO® Through a REMS-certified Pharmacy PROCUREMENT
PATHWAYS
Consider Using Service CPT® Codes for The Buy-and-Bill Pathway
Medicare and non-Medicare payers*
The REMS-certified Specialty
Service: Consider using Pharmacy Pathway
Evaluation & Management
(E/M) Codes CODING
*Payer requirements for SPRAVATO® administration coding may vary. Please contact your payers for specific coding policies. FILING HEALTHCARE
CLAIMS
SPRAVATO®
DOSAGE AND
ADMINISTRATION
JANSSEN
CAREPATH
INDICATIONS
AND IMPORTANT
SAFETY INFO
APPENDICES
REFERENCES
CPT® - Current Procedural Terminology. CPT® is a registered trademark of the American Medical Association.
Please see Important Safety Information, including Boxed WARNINGS, on pages 47-51.
Please see full Prescribing Information, including Boxed WARNINGS, and Medication Guide for SPRAVATO®.
Provide the Medication Guide to your patients and encourage discussion.16
The REMS-Certified Specialty Pharmacy Pathway (continued)
HOW TO USE
Use the Links Below to Navigate Relevant Information for the THIS GUIDE
REMS-Certified Specialty Pharmacy Pathway SPRAVATO®
COVERAGE
CONSIDERATIONS
Coding for SPRAVATO®
SPRAVATO®
• ICD-10-CM Diagnosis Codes REMS
• National Drug Code (NDC) AVAILABLE
PROCUREMENT
• NDC Units PATHWAYS
The Buy-and-Bill Pathway
Coding for Observation and Monitoring of SPRAVATO® Administration
Under HCP Supervision Consistent With REMS Requirements The REMS-certified Specialty
Pharmacy Pathway
CODING
Evaluation and Management (E/M) Overview
FILING HEALTHCARE
• SPRAVATO® Administration – E/M Code Considerations by Payer CLAIMS
• SPRAVATO® Administration – E/M Code Considerations by Patients
SPRAVATO®
DOSAGE AND
• Prolonged Clinical Staff Services With Physician Supervision ADMINISTRATION
• Prolonged Service With or Without Direct Patient Contact (physician time) JANSSEN
CAREPATH
INDICATIONS
Other Coding Considerations AND IMPORTANT
SAFETY INFO
• POS Codes
APPENDICES
• Code Modifiers
REFERENCES
Appendices
• Sample Letter of Medical Necessity
• Sample Formulary Exception Request
• Ordering Information
Please see Important Safety Information, including Boxed WARNINGS, on pages 47-51.
Please see full Prescribing Information, including Boxed WARNINGS, and Medication Guide for SPRAVATO®.
Provide the Medication Guide to your patients and encourage discussion.17
Coding for SPRAVATO® (esketamine)
HOW TO USE
ICD-10-CM Diagnosis Codes THIS GUIDE
ICD-10-CM diagnosis codes use 3 to 7 alpha and numeric characters to achieve the greatest level of SPRAVATO®
specificity. Codes with 3 characters are included in ICD-10-CM as the heading of a category of codes that COVERAGE
CONSIDERATIONS
may be further subdivided by use of additional characters to provide greater detail. A 3-character code is
to be used only if it is not further subdivided. A code is invalid if it has not been coded to the full number SPRAVATO®
of characters required for that code, including the 7th character, if applicable.4 REMS
There is no ICD-10-CM code for treatment-resistant depression (TRD) or major depressive disorder (MDD) AVAILABLE
with acute suicidal ideation or behavior. Payer requirements for ICD-10-CM codes will vary. It is essential PROCUREMENT
PATHWAYS
to verify correct diagnosis coding with each payer. The codes below are provided for your consideration.
CODING
Table 7: ICD-10-CM Diagnosis Codes for Consideration* 5
ICD-10-CM Diagnosis Codes
National Drug Code (NDC)
Code Description
Under HCP Supervision
Code Considerations for Patients New to SPRAVATO®
E/M Code Considerations
F32.0 Major depressive disorder, single episode, mild
Prolonged Service
F32.1 Major depressive disorder, single episode, moderate Other Coding
Considerations
F32.2 Major depressive disorder, single episode, severe without psychotic features
FILING HEALTHCARE
CLAIMS
F32.9 Major depressive disorder, single episode, unspecified
F33.0 Major depressive disorder, recurrent, mild SPRAVATO®
DOSAGE AND
ADMINISTRATION
F33.1 Major depressive disorder, recurrent, moderate
JANSSEN
F33.2 Major depressive disorder, recurrent, severe without psychotic features CAREPATH
F33.9 Major depressive disorder, recurrent, unspecified
INDICATIONS
AND IMPORTANT
Code Considerations for Patients Already Receiving SPRAVATO® SAFETY INFO
F32.4 Major depressive disorder, single episode, in partial remission
APPENDICES
F32.5 Major depressive disorder, single episode, in full remission
F33.40 Major depressive disorder, recurrent, in remission, unspecified REFERENCES
F33.41 Major depressive disorder, recurrent, in partial remission
F33.42 Major depressive disorder, recurrent, in full remission
*These codes are not intended to be promotional or to encourage or suggest a use of drug that is inconsistent with FDA-approved use.
The codes provided are not exhaustive and additional codes may apply.
Please see Important Safety Information, including Boxed WARNINGS, on pages 47-51.
Please see full Prescribing Information, including Boxed WARNINGS, and Medication Guide for SPRAVATO®.
Provide the Medication Guide to your patients and encourage discussion.18
Coding for SPRAVATO® (esketamine) (continued)
HOW TO USE
National Drug Code (NDC) THIS GUIDE
The NDC is a unique number that identifies a drug’s labeler, product, and trade package size. The NDC SPRAVATO®
is most often used on pharmacy claims, including drugs provided for home infusion. However, the COVERAGE
CONSIDERATIONS
NDC is also required on Medicare claims for dual-eligible beneficiaries (Medicaid cross-over claims),6
Medicaid fee-for service claims,6 and by some private payers.7 Although the FDA uses a 10-digit format SPRAVATO®
when registering NDCs, payers often require an 11-digit NDC format on claim forms for billing purposes. REMS
It is important to confirm with your payer if an NDC is needed and the format the payer requires. To
AVAILABLE
convert the 10-digit format to the 11-digit format, insert a leading zero into the middle sequence, PROCUREMENT
as illustrated below: PATHWAYS
CODING
ICD-10-CM Diagnosis Codes
Table 8: SPRAVATO® NDC8
National Drug Code (NDC)
FDA Specified 10-Digit NDC 11-Digit NDC
Description Under HCP Supervision
(5-3-2 format) (5-4-2 format)
E/M Code Considerations
56-mg Dose Kit: Unit-dose carton containing two 28-mg nasal
50458-028-02 50458-0028-02 Prolonged Service
spray devices (56-mg total dose)
Other Coding
Considerations
84-mg Dose Kit: Unit-dose carton containing three 28-mg nasal
50458-028-03 50458-0028-03
spray devices (84-mg total dose)
FILING HEALTHCARE
CLAIMS
Payer requirements for NDC use and format can vary widely. Please contact your payers for specific
coding policies and more information on correct billing and claims submission.
SPRAVATO®
DOSAGE AND
ADMINISTRATION
JANSSEN
CAREPATH
INDICATIONS
AND IMPORTANT
SAFETY INFO
APPENDICES
REFERENCES
Please see Important Safety Information, including Boxed WARNINGS, on pages 47-51.
Please see full Prescribing Information, including Boxed WARNINGS, and Medication Guide for SPRAVATO®.
Provide the Medication Guide to your patients and encourage discussion.19
Coding for SPRAVATO® (esketamine) (continued)
HOW TO USE
NDC Units THIS GUIDE
The NDC unit of measure is determined by how the drug is supplied. The number of NDC units dispensed SPRAVATO®
is based on the packaging and numeric quantity administered to the patient. Here are examples for 56-mg COVERAGE
CONSIDERATIONS
and 84-mg doses of SPRAVATO®:
SPRAVATO®
REMS
Table 9: SPRAVATO® NDC Units
AVAILABLE
Dose to Be Billed 11-Digit NDC Packaging NDC Unit of Measure NDC Units PROCUREMENT
PATHWAYS
56-mg 50458-0028-02 56-mg Dose Kit UN 2 CODING
ICD-10-CM Diagnosis Codes
84-mg 50458-0028-03 84-mg Dose Kit UN 3
National Drug Code (NDC)
Under HCP Supervision
Accurate NDC coding typically requires the following components7:
E/M Code Considerations
R
eporting the NDC with 11 digits in a 5-4-2 configuration (this may require converting a 10-digit NDC
to an 11-digit NDC) Prolonged Service
Reporting the correct NDC unit of measure Other Coding
Considerations
Reporting the number of NDC units dispensed
FILING HEALTHCARE
Reporting the qualifier, N4, in front of the NDC CLAIMS
For a 56-mg dose, use the 56-mg Dose Kit (NDC 50458-028-02) containing two 28-mg nasal spray SPRAVATO®
devices. This is how the NDC coding format* will appear: DOSAGE AND
ADMINISTRATION
N450458002802 UN2
For an 84-mg dose, use the 84-mg Dose Kit (NDC 50458-028-03) containing three 28-mg nasal spray JANSSEN
devices. This is how the NDC coding format* will appear: CAREPATH
N450458002803 UN3
INDICATIONS
AND IMPORTANT
SAFETY INFO
APPENDICES
REFERENCES
Please see Important Safety Information, including Boxed WARNINGS, on pages 47-51.
Please see full Prescribing Information, including Boxed WARNINGS, and Medication Guide for SPRAVATO®.
Provide the Medication Guide to your patients and encourage discussion.20
Coding for Observation and Monitoring of SPRAVATO®
Administration Under HCP Supervision Consistent With
REMS Requirements
HOW TO USE
THIS GUIDE
Evaluation and Management (E/M) Overview
SPRAVATO®
COVERAGE
CONSIDERATIONS
SPRAVATO®
REMS
SPRAVATO® Administration – E/M Code Considerations by Payer
AVAILABLE
PROCUREMENT
PATHWAYS
CODING
SPRAVATO® Administration – E/M Code Considerations by Patient ICD-10-CM Diagnosis Codes
National Drug Code (NDC)
Under HCP Supervision
E/M Code Considerations
Prolonged Clinical Staff Services With Physician Supervision Prolonged Service
Other Coding
Considerations
FILING HEALTHCARE
CLAIMS
Prolonged Service With or Without Direct Patient Contact (physician time)
SPRAVATO®
DOSAGE AND
ADMINISTRATION
JANSSEN
CAREPATH
INDICATIONS
AND IMPORTANT
SAFETY INFO
APPENDICES
REFERENCES
Please see Important Safety Information, including Boxed WARNINGS, on pages 47-51.
Please see full Prescribing Information, including Boxed WARNINGS, and Medication Guide for SPRAVATO®.
Provide the Medication Guide to your patients and encourage discussion.21
Coding for Observation and Monitoring of SPRAVATO®
Administration Under HCP Supervision Consistent With
REMS Requirements (continued)
HOW TO USE
Evaluation and Management (E/M) THIS GUIDE
Historically, the code levels for evaluation and management (E/M) services were based on complexity of SPRAVATO®
medical decision making (MDM). Within the code definitions, time was included as an adjunct, intended COVERAGE
CONSIDERATIONS
to assist selection of the most appropriate E/M level. Beginning in 2021, time alone may be used to select
the appropriate code level9 for office or other outpatient E/M service codes (99202-99205 and SPRAVATO®
99212-99215). REMS
When time is used for reporting E/M service codes, the time defined in the code descriptors is used for AVAILABLE
selecting the appropriate level of service. The E/M services to which these guidelines apply require a PROCUREMENT
PATHWAYS
face-to-face encounter with the physician or other qualified healthcare professional (HCP).9
For coding purposes, time for these services is the total time on the date of the encounter. It includes CODING
both face-to-face and non–face-to-face time personally spent by the physician and/or other HCP(s) on ICD-10-CM Diagnosis Codes
the day of the encounter but does not include time in activities normally performed by clinical staff.9
National Drug Code (NDC)
Physician/HCP time includes the following activities : 9
Under HCP Supervision
Preparing to see the patient (eg, review of tests) E/M Code Considerations
Obtaining and/or reviewing separately obtained history Prolonged Service
Performing a medically appropriate examination and/or evaluation Other Coding
Considerations
Counseling and educating the patient/family/caregiver
Ordering medications, tests, or procedures FILING HEALTHCARE
CLAIMS
Referring to and communicating with other healthcare professionals (when not separately reported)
Documenting clinical information in the electronic or other health record SPRAVATO®
DOSAGE AND
I ADMINISTRATION
ndependently interpreting results (not separately reported) and communicating results to the
patient/family/caregiver
JANSSEN
Care coordination (not separately reported) CAREPATH
INDICATIONS
AND IMPORTANT
SAFETY INFO
APPENDICES
REFERENCES
CPT® - Current Procedural Terminology. CPT® is a registered trademark of the American Medical Association.
Please see Important Safety Information, including Boxed WARNINGS, on pages 47-51.
Please see full Prescribing Information, including Boxed WARNINGS, and Medication Guide for SPRAVATO®.
Provide the Medication Guide to your patients and encourage discussion.22
SPRAVATO® Administration – E/M Code Considerations
HOW TO USE
There is currently no unique, designated code to describe the observation and monitoring of SPRAVATO® THIS GUIDE
administration as required by REMS. HCPs must consult with each patient’s payer since coverage will vary.
SPRAVATO®
Please note that healthcare providers are responsible for selecting appropriate codes for any particular COVERAGE
claim based on the patient’s condition, the items and services that are furnished, and any specific payer CONSIDERATIONS
requirements. It is advisable to contact your local payer with regard to local payment policies.
SPRAVATO®
REMS
Table 10: SPRAVATO® Administration – E/M Code9 Considerations by Payer*
AVAILABLE
Medicare E/M Code for the Outpatient Site of Care PROCUREMENT
PATHWAYS
G0463-Hospital outpatient clinic visit for assessment and management of a patient2
CODING
This code is used exclusively for coding E/M services provided to Medicare beneficiaries in the hospital outpatient setting.
ICD-10-CM Diagnosis Codes
It applies to all levels of E/M for both new and established patients.
National Drug Code (NDC)
*Payer requirements for SPRAVATO® administration coding may vary. Please contact your payers for specific coding policies.
Under HCP Supervision
E/M Code Considerations
Note that under Medicare, all levels of E/M services provided in the hospital outpatient department, for both Prolonged Service
new and established patients, are to be reported with a single HCPCS code (G0463). Other payer policies may Other Coding
vary. Table 10a summarizes E/M coding options by payer: Considerations
Table 10a: SPRAVATO® Administration – E/M Code Considerations by Payer† FILING HEALTHCARE
CLAIMS
Site of Care Medicare* Commercial Medicaid
SPRAVATO®
DOSAGE AND
CPT® 99202-99205 CPT® 99202-99205 CPT® 99202-99205 ADMINISTRATION
Physician Practice
CPT® 99212-99215 CPT® 99212-99215 CPT® 99212-99215
JANSSEN
CAREPATH
Hospital Outpatient CPT® 99202-99205 CPT® 99202-99205
G0463
Department CPT® 99212-99215 CPT® 99212-99215
INDICATIONS
AND IMPORTANT
SAFETY INFO
*The E/M Codes only apply to Medicare when SPRAVATO® is obtained via specialty pharmacy and the HCP provides the associated services.
†
If the drug is purchased and billed by the provider, Medicare requires the G Codes (combined drug and service).
APPENDICES
REFERENCES
The fact that a drug, device, procedure or service is assigned an HCPCS code, and a payment rate does
not imply coverage by the Medicare and/or Medicaid program, but indicates only how the product,
procedure, or service may be paid if covered by the program. Fiscal Intermediaries (FIs)/Medicare
Administrative Contractors (MACs) and/or state Medicaid administration determine whether a drug,
device, procedure, or other service meets all program requirements for coverage.
CPT® - Current Procedural Terminology. CPT® is a registered trademark of the American Medical Association.
Please see Important Safety Information, including Boxed WARNINGS, on pages 47-51.
Please see full Prescribing Information, including Boxed WARNINGS, and Medication Guide for SPRAVATO®.
Provide the Medication Guide to your patients and encourage discussion.23
SPRAVATO® Administration – E/M Code Considerations
HOW TO USE
The following table summarizes the E/M Codes to consider for SPRAVATO® administration: THIS GUIDE
Table 11: SPRAVATO® Administration – E/M Code9 Considerations by Patient* SPRAVATO®
COVERAGE
CONSIDERATIONS
Total Time Spent on Day of Encounter
E/M Code Descriptor (when using time for code selection)
SPRAVATO®
New Patients REMS
• M edically appropriate history and/or examination
99202 15-29 minutes AVAILABLE
• Straightforward medical decision making PROCUREMENT
PATHWAYS
• Medically appropriate history and/or examination
99203 30-44 minutes
• Low level of medical decision making CODING
ICD-10-CM Diagnosis Codes
• Medically appropriate history and/or examination
99204 45-59 minutes
• Moderate level of medical decision making
National Drug Code (NDC)
• Medically appropriate history and/or examination Under HCP Supervision
99205 60-74 minutes
• High level of medical decision making
E/M Code Considerations
Established Patients† Prolonged Service
• Medically appropriate history and/or examination Other Coding
99212 10-19 minutes Considerations
• Straightforward medical decision making
• Medically appropriate history and/or examination FILING HEALTHCARE
99213 20-29 minutes
• Low level of medical decision making CLAIMS
• Medically appropriate history and/or examination
99214 30-39 minutes SPRAVATO®
• Moderate level of medical decision making DOSAGE AND
ADMINISTRATION
• Medically appropriate history and/or examination
99215 40-54 minutes
• High level of medical decision making JANSSEN
CAREPATH
*Payer requirements for SPRAVATO® administration coding may vary. Please contact your payers for specific coding policies.
†
CPT® code 99211 (sometimes called a “nurse visit”) is not applicable to SPRAVATO® administration. INDICATIONS
AND IMPORTANT
This code does not require the presence of a physician or other qualified HCP, as presenting problems are usually minimal and services
SAFETY INFO
are typically performed in 5 minutes.9
APPENDICES
REFERENCES
CPT® - Current Procedural Terminology. CPT® is a registered trademark of the American Medical Association.
Please see Important Safety Information, including Boxed WARNINGS, on pages 47-51.
Please see full Prescribing Information, including Boxed WARNINGS, and Medication Guide for SPRAVATO®.
Provide the Medication Guide to your patients and encourage discussion.You can also read
