JOIN US AT THE ASH ANNUAL MEETING FOR A PRESENTATION ON ENJAYMO  |  MONDAY 12/12 @ 8 am

Not an official event of the 64th ASH Annual Meeting and Exposition. This presentation is not sponsored or endorsed by ASH. Not CME-accredited. MAT-US-2208046-v1.0-11/2022

VISIT US AT ASH  |  DECEMBER 10-13  |  BOOTH #643

Not an official event of the 64th ASH Annual Meeting and Exposition. This presentation is not sponsored or endorsed by ASH. Not CME-accredited. MAT-US-2208046-v1.0-11/2022

ENJAYMO coverage and
reimbursement

Sanofi is committed to helping ensure all patients with Cold
Agglutinin Disease (CAD) have access to treatment with ENJAYMO

Information about coverage and reimbursement will help guide you in obtaining coverage for your patients.*

*The codes referenced in this document may be used to communicate services rendered when filing claims for ENJAYMO. These codes are being provided for informational purposes only and should be verified, as codes may change. The provision of billing codes does not constitute reimbursement or legal advice. Providers are solely responsible for ensuring the accuracy of billing submissions to any payer.

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Diagnosis

The ICD-10-CM diagnosis code for cold autoimmune hemolytic anemia (CAD) is D59.12.1

ICD-10-CM Code
D55-D59 Hemolytic anemias
D59 Acquired hemolytic anemias
D59.1 Other autoimmune hemolytic anemias
D59.12 Cold autoimmune hemolytic anemia

ICD-10 code D59.12 can also be referred to as chronic cold hemagglutinin disease, Cold Agglutinin Disease, cold agglutinin hemoglobinuria, Cold type (primary) (secondary) (symptomatic) autoimmune hemolytic anemia, and cold type autoimmune hemolytic disease.

National Drug Code (NDC)

ENJAYMO has a 10-digit NDC code displayed on its packaging. In most cases, this should be converted to an 11-digit NDC code for billing purposes.2,3 Below are both NDC codes for ENJAYMO.

10-digit NDC NDC 80203-347-01
11-digit NDC NDC 80203-0347-01
How supplied One 1100 mg/22 mL (50 mg/mL) single dose vial per carton

Payer requirements for NDC use and format may vary. Please contact each payer for specific coding policies.

CPT® code

CPT® codes are used to describe the procedures that may be performed on a patient and/or how a drug or supply being billed was administered.4 CPT® codes commonly associated with the administration of IV-infused monoclonal antibodies such as ENJAYMO are listed below. Confirm preferred coding policy with payer prior to administration whenever possible.

Primary
96365 Intravenous infusion, for therapy, prophylaxis, or diagnosis (specify substance or drug); initial; up to 1 hour
96366 Each additional hour (list separately in addition to code for primary procedure; report 96366 for infusion intervals of greater than 30 minutes beyond 1-hour increments)

Per CMS guidelines, if the incremental amount of infusion time is 30 minutes or less, the time is not to be billed separately. Note that some payers may require reporting the actual number of minutes on the claim.

CPT® is a registered trademark of the American Medical Association.

HCPCS procedure codes

HCPCS codes are assigned by CMS and are used by Medicare and most private payers to describe products administered in a physician's office or hospital setting.5 As part of the standardized Level II HCPCS coding system, ENJAYMO has been issued a permanent J code, which went into effect October 1, 2022, and is listed below. All claims made October 1 should utilize the permanent J code to facilitate reimbursement.

Note that utilization of the permanent J code does not impact the ability of ENJAYMO to maintain transitional pass-through payment status under the Medicare Hospital Outpatient Prospective Payment System (OPPS). As always, the coding system is not a methodology for making coverage or payment determinations. The existence of HCPCS codes does not imply coverage; it implies only that the product may be reimbursed if covered. Coding should be verified with each patient's health plan prior to submitting a claim.

Permanent J Code Description
J1302 Intravenous injection, sutimlimab-jome, 10 mg

The permanent J code replaces all temporary codes and should be used for both inpatient and outpatient billing as of October 1, 2022.

JW modifier: Providers and suppliers are required to report the JW modifier on Part B drug claims for discarded drugs and biologicals. Also, providers and suppliers must document the amount of discarded drugs or biologicals in Medicare beneficiaries’ medical records.6

Place of service codes

Because ENJAYMO can be administered in various settings (infusion center, physician's office, patient's home if deemed clinically appropriate by the prescribing physician), it is important to populate a claim with the appropriate 2-digit place-of-service (POS) code.7 Always verify the preferred POS codes for your patients' health plan before submitting a claim.

Reimbursement considerations

ENJAYMO is designed to be prepared and administered by a healthcare provider. The drug costs are expected to be covered under the Medicare Part B benefit. Please refer to the individual patient’s plan to determine any applicable coverage requirements. The specifics of coverage may vary by payer.


When filing a claim

It is recommended that ENJAYMO coverage be confirmed with all payers prior to patient administration, as patient benefits vary among payers and by plans.


Some payers also have policies that may affect coverage for ENJAYMO. These include:

  • Site of care: Some payers may have coverage rules that restrict certain providers from delivering infusion therapies
  • Network providers: Some payers have exclusive contracts with in-network or participating providers to provide infusion therapies. These may include contracts for coverage in physician offices and outpatient settings or to specialty pharmacies that provide drugs and biologics to the provider
  • Prior authorization: Many plans may require providers to obtain prior authorization (eg, medical necessity) to begin a course of treatment. Check with the payer to determine their process, requirements, and method for requesting authorization.

Documenting necessity

As a new medication used to treat a rare disease, some insurers may not be familiar with ENJAYMO. These insurers may require additional documentation to process either a prior authorization or a claim upon receipt.

Documentation that may be required includes:

ENJAYMO prescription

Statement of medical necessity from the attending physician

See example here
Prescribing Information

ENJAYMO full Prescribing Information

Download here
FDA approval

Documentation of ENJAYMO FDA approval

Find proof of approval here
Patient case

Details on the patient’s case history, previous therapy, and clinical course

Resources for your practice

ENJAYMO Billing and Coding Guide for Reimbursement

download-icon

ENJAYMO Letter of Medical Necessity

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ENJAYMO Appeal Checklist

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CARDINAL Pivotal Trial Reprint

download-icon

IMPORTANT SAFETY INFORMATION AND INDICATION

CONTRAINDICATIONS

ENJAYMO is contraindicated in patients with known hypersensitivity to sutimlimab-jome or any of the inactive ingredients.

WARNINGS AND PRECAUTIONS

Serious Infections

  • ENJAYMO may increase susceptibility to serious infections, including infections caused by encapsulated bacteria such as Neisseria meningitides (any serogroup), Streptococcus pneumoniae, and Haemophilus influenzae.
  • Serious infections (bacterial and viral) were reported in 17% (4/24) of patients receiving ENJAYMO in a single-arm open-label clinical trial.
  • Vaccinate patients for encapsulated bacteria according to the most current ACIP recommendations for patients with persistent complement deficiencies. Revaccinate patients in accordance with ACIP recommendations.
  • Immunize patients without a history of vaccination against encapsulated bacteria at least 2 weeks prior to receiving the first dose of ENJAYMO. If urgent ENJAYMO therapy is indicated in an unvaccinated patient, administer vaccine(s) as soon as possible.
  • If ENJAYMO treatment is administered to patients with active systemic infections, monitor closely for signs and symptoms of worsening infection. Some infections may become rapidly life-threatening or fatal if not recognized and treated promptly. Inform patients of these signs and symptoms and steps to be taken to seek immediate medical care.
    • Consider interruption of ENJAYMO treatment in patients who are undergoing treatment for serious infection.
    • Consider patients’ immune status when initiating treatment with ENJAYMO.

Infusion-Related Reactions

  • Administration of ENJAYMO may result in infusion-related reactions. In the CARDINAL study, 8% (2/24) of patients treated with ENJAYMO experienced infusion-related reactions.
  • Monitor patients for infusion-related reactions and interrupt if a reaction occurs.
  • Discontinue ENJAYMO infusion and institute appropriate supportive measures if signs of hypersensitivity reactions, such as cardiovascular instability or respiratory compromise, occur.

Risk of Autoimmune Disease

  • Based on its mechanism of action, ENJAYMO may potentially increase the risk for developing autoimmune diseases such as systemic lupus erythematosus (SLE). Development of SLE has been associated with inherited classical complement deficiency.
  • Monitor patients being treated with ENJAYMO for signs and symptoms and manage medically.

Recurrent Hemolysis After ENJAYMO Discontinuation

  • If treatment with ENJAYMO is interrupted, closely monitor patients for signs and symptoms of recurrent hemolysis, e.g., elevated levels of total bilirubin or lactate dehydrogenase (LDH) accompanied by a decrease in hemoglobin, or reappearance of symptoms such as fatigue, dyspnea, palpitations, or hemoglobinuria. Consider restarting ENJAYMO if signs and symptoms of hemolysis occur after discontinuation.

ADVERSE REACTIONS

  • The most common adverse reactions (10%) with ENJAYMO were respiratory tract infection, viral infection, diarrhea, dyspepsia, cough, arthralgia, arthritis, and peripheral edema.

INDICATION

ENJAYMO (sutimlimab-jome) is indicated to decrease the need for red blood cell (RBC) transfusion due to hemolysis in adults with cold agglutinin disease (CAD).


Please see full Prescribing Information.

See the full Medication Guide.

Learn more about Sanofi’s commitment to fighting counterfeit drugs.

CAD=Cold Agglutinin Disease; CPT®=Current Procedural Terminology; CMS=Centers for Medicare & Medicaid Services; HCPCS=Healthcare Common Procedure Code System; ICD-10-CM=International Classification of Diseases, Tenth Revision, Clinical Modification; IV=intravenous; NDC=national drug code; OPPS=Outpatient Prospective Payment System.
References:
  1. Centers for Disease Control and Prevention (CDC). ICD-10-CM Tabular List of Diseases and Injuries. 2020. Accessed September 8, 2022. https://www.cdc.gov/nchs/icd/icd-10-cm.htm
  2. Blue Cross Blue Shield of Illinois. National Drug Code (NDC) Billing Guidelines. February 2019.
  3. ENJAYMO. Prescribing information. Genzyme Corporation.
  4. Rouse M. Current Procedural Terminology (CPT) code. SearchHealthIT. 2020. Accessed April 21, 2022. https://searchhealthit.techtarget.com/definition/Current-Procedural-Terminology-CPT
  5. HCPCS.codes. 2019 HCPCS NOC Codes. Accessed April 21, 2022. https://hcpcs.codes/noc-codes/2019/
  6. Centers for Medicare & Medicaid Services. Medicare Uniform Instructional Provider Bill and Supporting Regulations 42 CFR 424. July 2019. Accessed September 8, 2022. https://www.cms.gov/Regulations-and-Guidance/Legislation/PaperworkReductionActof1995/PRA-listing-items/CMS-1450
  7. Centers for Medicare & Medicaid Services. Place of Service Codes for Professional Claims. September 2021. Accessed September 26, 2022. https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/Downloads/Website-POS-database.pdf
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IMPORTANT SAFETY INFORMATION AND INDICATION

CONTRAINDICATIONS

ENJAYMO is contraindicated in patients with known hypersensitivity to sutimlimab-jome or any of the inactive ingredients.

WARNINGS AND PRECAUTIONS

Serious Infections

  • ENJAYMO may increase susceptibility to serious infections, including infections caused by encapsulated bacteria such as Neisseria meningitides (any serogroup), Streptococcus pneumoniae, and Haemophilus influenzae.
  • Serious infections (bacterial and viral) were reported in 17% (4/24) of patients receiving ENJAYMO in a single-arm open-label clinical trial.
  • Vaccinate patients for encapsulated bacteria according to the most current ACIP recommendations for patients with persistent complement deficiencies. Revaccinate patients in accordance with ACIP recommendations.
  • Immunize patients without a history of vaccination against encapsulated bacteria at least 2 weeks prior to receiving the first dose of ENJAYMO. If urgent ENJAYMO therapy is indicated in an unvaccinated patient, administer vaccine(s) as soon as possible.
  • If ENJAYMO treatment is administered to patients with active systemic infections, monitor closely for signs and symptoms of worsening infection. Some infections may become rapidly life-threatening or fatal if not recognized and treated promptly. Inform patients of these signs and symptoms and steps to be taken to seek immediate medical care.
    • Consider interruption of ENJAYMO treatment in patients who are undergoing treatment for serious infection.
    • Consider patients’ immune status when initiating treatment with ENJAYMO.

Infusion-Related Reactions

  • Administration of ENJAYMO may result in infusion-related reactions. In the CARDINAL study, 8% (2/24) of patients treated with ENJAYMO experienced infusion-related reactions.
  • Monitor patients for infusion-related reactions and interrupt if a reaction occurs.
  • Discontinue ENJAYMO infusion and institute appropriate supportive measures if signs of hypersensitivity reactions, such as cardiovascular instability or respiratory compromise, occur.

Risk of Autoimmune Disease

  • Based on its mechanism of action, ENJAYMO may potentially increase the risk for developing autoimmune diseases such as systemic lupus erythematosus (SLE). Development of SLE has been associated with inherited classical complement deficiency.
  • Monitor patients being treated with ENJAYMO for signs and symptoms and manage medically.

Recurrent Hemolysis After ENJAYMO Discontinuation

  • If treatment with ENJAYMO is interrupted, closely monitor patients for signs and symptoms of recurrent hemolysis, e.g., elevated levels of total bilirubin or lactate dehydrogenase (LDH) accompanied by a decrease in hemoglobin, or reappearance of symptoms such as fatigue, dyspnea, palpitations, or hemoglobinuria. Consider restarting ENJAYMO if signs and symptoms of hemolysis occur after discontinuation.

ADVERSE REACTIONS

  • The most common adverse reactions (10%) with ENJAYMO were respiratory tract infection, viral infection, diarrhea, dyspepsia, cough, arthralgia, arthritis, and peripheral edema.

INDICATION

ENJAYMO (sutimlimab-jome) is indicated to decrease the need for red blood cell (RBC) transfusion due to hemolysis in adults with cold agglutinin disease (CAD).


Please see full Prescribing Information.

See the full Medication Guide.

Learn more about Sanofi’s commitment to fighting counterfeit drugs.