- Welcome
- Azurity is committed to supporting patient access by helping to reduce barriers to reimbursement. The Reimbursement Support section of this website was designed to provide healthcare professionals with information related to the insurance reimbursement environment for GLIADEL Wafer.
Quick Links
- Coverage
- Medicare ▶
- Medicaid ▶
- Commercial Payers ▶
- Product Information
- Product information, including indications and prescribing information is provided for your reference. For product inquiries or to report an adverse event, please use the following contact information:
- Product Information | Please E-mail or phone for medical information requests:
- E-mail: medical.information@azurity.com
- Phone: 1-800-461-7449
- Adverse Events | Please E-mail or phone to report an adverse event:
- E-mail: aereports@azurity.com
- Phone: 1-800-461-7449
- Or to report to FDA:
- www.FDA.gov/medwatch or 1-800-FDA-1088.
- INDICATIONS
- GLIADEL Wafer is indicated in patients with newly diagnosed high-grade malignant glioma as an adjunct to surgery and radiation. GLIADEL Wafer is also indicated in patients with recurrent glioblastoma multiforme as an adjunct to surgery.
- Coding & Billing
- Correct coding is the responsibility of the provider submitting a claim for the item or service. Here we provide general billing and coding information for GLIADEL Wafer and related services. Please check with the payer to verify coding or special billing requirements.
- Arbor Pharmaceuticals cannot guarantee payment of any claim. Coding, coverage, and reimbursement may vary significantly by payer, plan, patient, and setting of care. Actual coverage and reimbursement decisions are made by individual payers following the receipt of claims. For additional information, customers should consult with their payers for all relevant coding, reimbursement, and coverage requirements. It is the sole responsibility of the provider to select the proper code and ensure the accuracy of all claims used in seeking reimbursement. All services must be medically appropriate and properly supported in the patient medical record.
Coding & Pricing
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- ICD-10-CM Diagnosis Codes
- International Classification of Diseases 10th Revision Clinical Modification (ICD-10-CM) Diagnosis Code
- Hospitals should use current ICD-10-CM codes to report a patient's diagnosis on claim submissions. Correct coding is the responsibility of the hospital submitting a claim for the item or service. Please check with the payer to verify coding or special billing requirements. Below is a range of ICD-10-CM diagnosis codes that may be reasonably related to a diagnosis within the product's approved label.
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- ICD-10-CM DIAGNOSIS CODE
- C71.0-C71.9
- DESCRIPTION
- Malignant Neoplasm of the Brain
- We recommend verifying a health plan's coding policies. Reimbursement Support can provide information to patients and healthcare professionals relating to payer-specific policies and can address other questions by:
- Phone: (877) 438-9759
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- ICD-10-PCS Procedure Codes
- Hospitals should report an appropriate ICD-10-PCS procedure code to describe implantation of GLIADEL® Wafer (carmustine implant). Correct coding is the responsibility of the hospital submitting a claim for item or service. Please check with the payer to verify coding or special billing requirements.
- Below is an ICD-10-PCS procedure implantation code that may be reasonable to report for GLIADEL Wafer. For additional information, please consult the current ICD-10-PCS code set/ manual. Please see the CMS website to download current and past ICD-10 code sets.
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- ICD-10-PCS PROCEDURE CODE1
- 3E0Q005
- DESCRIPTION
- Administration, Physiological Systems and Anatomical Regions, Introduction*, Cranial Cavity and Brain, Open, Antineoplastic, Other Antineoplastic
- *Introduction definition: Putting in or on a therapeutic, diagnostic, nutritional, physiological, or prophylactic substance except blood or blood product.
- 1. Please see the CMS website to download current and past ICD-10 code sets.
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- Medicare Severity Diagnosis Related Group
- Medicare Severity-Diagnosis Related Groups (MS-DRGs) are utilized by payers to group inpatient services into a global payment amount for the hospital stay, based in part on the patient's diagnoses at discharge. Hospitals should report the proper ICD-10-CM diagnosis code on the CMS-1450 (UB-04) claim form. Correct coding is the responsibility of the hospital submitting a claim for the item or service. Please check with the payer to verify coding or special billing requirements.
- The following MS-DRG may be appropriate to report to Medicare for GLIADEL® Wafer (carmustine implant) cases when implantation is medically reasonable and necessary.1 Other payers may assign different DRGs for GLIADEL Wafer implantation.
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- MS-DRG
- 023
- DESCRIPTION
- Craniotomy with major device implantation or acute complex central nervous system principal diagnosis with major complication/comorbidity or chemotherapy implant or epilepsy with neurostimulator.
- 1. Federal Register, Vol. 83, No 160, August 17, 2018, Medicare Program; Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals and the Long-Term Care Hospital Prospective Payment System and Policy Changes and Fiscal Year 2019 Rates; Quality Reporting Requirements for Specific Providers; Medicare and Medicaid Electronic Health Record (EHR) Incentive Programs (Promoting Interoperability Programs) Requirements for Eligible Hospitals, Critical Access Hospitals, and Eligible Professionals; Medicare Cost Reporting Requirements; and Physician Certification and Recertification of Claims Table 5 – List of Medicare Severity Diagnosis Related Groups (MS-DRGs), Relative Weighting Factors, and Geometric and Arithmetic Mean Length of Stay . CMS Website. Available at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/AcuteInpatientPPS/FY2019-IPPS-Final-Rule-Home-Page-Items/FY2019-IPPS-Final-Rule-Tables.html
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- CPT Drug Administration Code
- Current Procedural Terminology (CPT) Code
- CPT codes are 5-digit numeric codes established by the American Medical Association (AMA) that describe medical procedures and services. Payers may offer to reimburse physicians for the following CPT codes when GLIADEL® Wafer (carmustine implant) implantation is medically appropriate:
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- CPT CODE
- 61510
- 61517
- 61518
- DESCRIPTION
- Craniectomy, trephination, bone flap craniotomy; for excision of brain tumor, supratentorial, except meningioma
- Implantation of brain intracavitary chemotherapy agent Note: 61517 is an add-on code; report 61517 in conjunction with 61510 or 61518
- Craniectomy for excision of brain tumor, infratentorial or posterior fossa; except meningioma, cerebellopontine angle tumor, or midline tumor at base of skull
- Payers may require physicians to report a different CPT code for Gliadel® Wafer implantation. We recommend verifying a health plan's coding policies. Reimbursement Support can provide information to patients and healthcare professionals relating to payer-specific policies and can address other questions by:
- Phone: (866) 516-4950, Option 4
- E-mail: reimbursement@arborpharma.com
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- National Drug Codes
- National Drug Codes (NDCs)
- NDCs identify a drug's manufacturer, the specific drug formulation, and the product's package size. NDCs are generally expressed in a 10-digit number. Some payers require hospitals to report 11-digit NDCs when reporting a drug on a claim form. The 10-digit and corresponding 11-digit NDC numbers for GLIADEL® Wafer (carmustine implant) are listed below.
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- GLIADEL WAFER 10-DIGIT NDC
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24338-050-08
- GLIADEL WAFER 11-DIGIT NDC WITH LEADING ZERO
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24338-0050-08
- Payers may require hospitals to indicate the number of units of GLIADEL Wafer implanted in a patient on the CMS-1450 (UB-04) claim form. Up to eight (8) GLIADEL Wafers may be implanted in a patient if medically appropriate.
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- Revenue Codes
- Revenue codes capture hospital cost data by department, which the facility uses for cost reporting purposes. Some payers request that hospitals report revenue codes on claim forms.
- Below are revenue codes that may be appropriate to report for GLIADEL® Wafer (carmustine implant).
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- REVENUE CODE
- 0250
- 0280
- 0636
- DESCRIPTION
- General pharmacy
- Oncology
- Drugs requiring detailed coding
- Coverage Policy
GLIADEL Wafer is administered in an in-patient setting. For information tailored to Medicare, Medicaid or Commercial Payers, please select the appropriate tab below. Coding, coverage and reimbursement may vary significantly by payer, plan and patient. Click here for GLIADEL Wafer Indication and Important Safety Information.
Coverage
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- Medicare
- Medicare Part A
- Medicare does not cover GLIADEL® Wafer or most other drugs separately in the hospital inpatient setting. Medicare recognizes MS-DRG 023 for coverage when medically reasonable and necessary according to accepted standards of medical practice. The Centers for Medicare and Medicaid Services (CMS) has not issued a National Coverage Determination (NCD) describing the medically reasonable and necessary use of GLIADEL Wafer. Local Medicare contractors (Fiscal Intermediaries, Carriers or Part A/B Medicare Administrative Contractors (MACs)) may make jurisdiction-specific coverage decisions that relate to GLIADEL Wafer; however, contractors have not published local coverage determinations (LCDs) or other coverage instructions through articles and bulletins as of publication of this guide.
- Medicare Part B
- Physician services are generally covered under Medicare Part B if they are medically reasonable and necessary for the diagnosis or treatment of an illness or injury according to accepted standards of medical practice. CMS has not issued an NCD describing physician services as they may relate to the implantation of GLIADEL Wafer. Local Medicare contractors may make jurisdiction-specific coverage decisions that relate to GLIADEL Wafer; however, contractors have not published LCDs or other coverage instructions through articles and bulletins as of publication of this guide.
- For more information on Medicare reimbursement for GLIADEL Wafer, contact Reimbursement Support at (866) 516-4950, Option 4.
- Payer Reimbursement
- MS-DRG 023
- Medicare payment for MS-DRG 023 varies by hospital due to differences in area wages, indirect medical education, disproportionate share status, cost of living adjustments, outliers and other factors. DRG payments to hospitals are made under a prospective payment system and are intended to cover all facility costs associated with an inpatient hospital stay including costs for hospital outpatient services performed within 72 hours of admission. Payment to hospitals excludes payments for physician services.
- GLIADEL WAFER PHYSICIAN SERVICES
- Medicare reimbursement for physician services associated with GLIADEL Wafer implantation is based on the national fee schedule that is adjusted for geographic variations and updated annually. Medicare reimbursement is based on the lesser of the adjusted fee schedule amount or actual charges, as follows: physicians are reimbursed for 80% of the allowable amount and the patient or patient's secondary insurer is responsible for the remaining 20% coinsurance.
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- Documents
- Annotated CMS 1500 (08/05) Form ▶
- Sample Appeal Letter ▶
- Checklist for Claims Submission ▶
- Codes
- ICD-10-CM Diagnosis Codes ▶
- ICD-10-PCS Procedure Codes ▶
- CPT Drug Administration Code ▶
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- Medicaid
- Medicaid programs do not cover GLIADEL® Wafer (carmustine implant) or most other drugs separately in the hospital inpatient setting. Coverage for an inpatient stay as well as physician services associated with GLIADEL Wafer will vary from state to state as each Medicaid program establishes its own eligibility standards and determines the type, amount, duration, and scope of services. Reimbursement rates for services will also vary from state to state. In addition, state Medicaid programs may apply coverage and utilization restrictions such as prior authorization.
- For more information on Medicaid reimbursement for GLIADEL Wafer, contact Reimbursement Support at (866) 516-4950, Option 4.
- Payer Reimbursement
- Medicaid payer reimbursement for inpatient stays as well as physician services associated with GLIADEL Wafer varies by state. Some states may base hospital reimbursement on MS-DRGs, cost-to-charge ratios, per diem rates or other methodologies. In addition, payment varies from hospital to hospital due to various factors. Many states base physician reimbursement on a statewide fee schedule that may be updated on a quarterly or annual basis. Also, Medicaid is always the payer of last resort; therefore, it is secondary to Medicare or any third party that may be liable for medical payments or medical support on the beneficiary's behalf.
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- Documents
- Checklist for Claims Submission ▶
- Codes
- ICD-10-CM Diagnosis Codes ▶
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- Commercial Payers
- Most third-party payers, including HMO plans, managed care organizations, indemnity plans and others provide coverage for inpatient stays and physician services associated with GLIADEL® Wafer (carmustine implant). However, specific coverage requirements and restrictions depend on a patient's benefits and will vary based on plan type and hospital site of service. Payers may establish formal published policies that relate to GLIADEL® Wafer; however, the lack of a published policy from a particular payer does not mean that a diagnosis discharge codes associated with GLIADEL® Wafer is not covered by that payer. Some commercial insurers may apply coverage and utilization restrictions such as prior authorization.
- For more information on Commercial payer reimbursement for GLIADEL® Wafer, contact Reimbursement Support at (866) 516-4950, Option 4.
- Payer Reimbursement
- Many plans restrict patients to a select network of hospitals and have contractual arrangements with these “in-network” hospitals. Commercial payer reimbursement for inpatient stays as well as physician services associated with GLIADEL Wafer depends on network status, a patient's benefits and will vary based on plan type. Some payers may base hospital reimbursement on MS-DRGs, cost-to-charge ratios, per diem rates or other contracted methodologies. In addition, payment varies by hospital due to various contractual factors. Commercial payer reimbursement for physician services related to GLIADEL® Wafer implantation may be based on a common fee schedule similar to the Medicare reimbursement methodology for physician services or other contracted rates.
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- Documents
- Checklist for Claims Submission ▶
- Codes
- ICD-10-CM Diagnosis Codes ▶
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- Patient Assistance
- Azurity Pharmaceuticals offers Reimbursement Support to help you minimize payer access and coverage challenges.
- What to expect when you contact Reimbursement Support:
- • Understanding of coverage, coding and payment issues
- • General prior authorization information
- • Provide general guidance for appealing a denied claim
- • Payer policy information
- Azurity Pharmaceuticals offers a Patient Assistance Program (PAP) which provides Azurity medicines at no cost to financially needy patients who meet program eligibility criteria. Patients who meet the eligibility requirements and wish to be considered for participation must complete and submit a Patient Assistance Program (PAP) Application. To download an application, follow the link to GLIADEL PAP APPLICATION, also located below (under Forms). It is important that the patient complete all requested information and sign where indicated, as incomplete applications will delay the application process.
- If you require Reimbursement Support or if you have Patient Assistance Program related questions or inquiries, please contact us:
- Phone: (877) 438-9759
- Fax: (877) 438-9759
- Hours: Monday - Friday, 8:00 AM to 5:00 PM CST
- Forms
- Action
- Please submit completed applications via fax:
- Fax #: (877) 438-9759
