Coverage and Coding
On Target Laboratories is committed to supporting patient access to CYTALUXⓇ by reducing barriers to reimbursement.
Here you will find information about coverage and coding for CYTALUX (pafolaclanine) injection and have access to a variety of resources including reimbursement guides, coding quick reference guides, and NTAP information.
CYTALUX has been granted the NTAP, or “New Technology Add-On Payment” designation by CMS.
NTAP, which is part of the CMS Inpatient Prospective Payment System (IPPS), was set up to support the adoption of cutting-edge technologies that have demonstrated substantial clinical improvement and ensure early availability to Medicare patients.
CYTALUX was 1 of only 8 new technologies to be granted the NTAP in 2023.
to learn more and understand how to code for add-on payment, visit the NTAP Provider Education.
See below for coverage information specific to Medicare, Medicaid, and Private Payers.
Medicare is a federally funded health insurance program that was established as part of the Social Security Act of 1965, which provides coverage to 49 million beneficiaries, and is administered through the following 4 benefit categories:
BECAUSE CYTALUX IS A HOSPITAL-ADMINISTERED PRODUCT, IT IS COVERED UNDER MEDICARE PART A.
Form CMS-1450, also known as the UB-04, is the standard claim form to bill Medicare Administrative Contractors (MACs).
Most states have direct administration of the program and also contract with managed care organizations to administer the program. Medicaid programs and their MCOs may follow Medicare’s coverage policies, while others may create their own coverage guidelines.
Each private payer plan administers its own benefits and determines specific coverage and payment policies. Some private payers may follow Medicare’s coverage policies, while other private payers may have more restrictive or less restrictive benefits. Private payers will consider covering CYTALUX when used for its FDA-approved indication. They may implement restrictions, such as requiring prior authorization and/or other utilization controls. Reimbursement may also vary significantly by the specific contracts that are negotiated between the hospitals and private payers.
ICD-10-PCS Procedure Coding System
Effective 10/1/2023, the Centers for Medicare & Medicaid Services (CMS) created 5 new PCS codes that capture the PCS method value “Fluorescence Guided Procedure” and the PCS qualifier value “Pafolacianine” and applies them to the fourth character body region values and applicable approaches. These changes enable the capture of additional detail for fluorescence-guided procedures that use Pafolacianine.
ICD-10-CM Clinical Modification Diagnosis Codes
The ICD-10-CM is used to classify diagnoses and reasons for visits in all health care settings. Always check with the payers guidelines to verify ICD-10-CM requirements, for individual rules may vary. There are a range of potential ICD-10-CM diagnosis codes that may be related to a diagnosis within CYTALUX approved label.
Medicare Severity Diagnosis Related Group (MS-DRG)
MS-DRG means Medicare severity-diagnosis-related group. It’s a system of classifying patient hospital stays. Within the system, Medicare classifies groups to facilitate service payments. CYTALUX is an inpatient drug and will be bundled by payers into hospital payment rates (MS-DRGs), all patient refined (APR DRGs), or other DRGs specific to the individual payer’s internal methodology. The DRG assignment depends on the diagnosis and the procedure with which CYTALUX will be bundled. There are 3 MS-DRGs that represent the procedures involving CYTALUX and available in the link below.
Professional Current Procedural Terminology (CPT) Codes
In addition to facility inpatient reimbursement, some hospitals also bill out professional physician fees separate from the inpatient procedure. The list of codes (linked below) is meant to serve as a guide of commonly used professional fees; it is not exhaustive, and individual circumstances and payer rules will determine coding.
National Drug Code (NDC)
The NDC, or National Drug Code, is a unique 10-digit (drug packaging) or 11-digit (claim filing), 3-segment number, and a universal product identifier for drugs in the United States. The 3 segments of the NDC identify: the labeler, the product, and the commercial package size.
There may be times when a payer may require our NDC number to be on the inpatient claim therefore it is important that you confirm the NDC billing instructions with each payer, as their requirements may vary. Proper billing of an NDC requires the 11-digit number in a 5-4-2 format.
Healthcare Common Procedure Coding System (HCPCS) is a standardized code system necessary for medical providers to submit healthcare claims to Medicare and other health insurances in a consistent and orderly manner.
Revenue codes may also be used to report services and supplies that are utilized during treatment.
CYTALUX Reimbursement Guide for Lung
CYTALUX Coding & Payment Quick Reference Guide for Lung
CYTALUX NTAP Provider Education for Lung
CYTALUX Coding & Payment Quick Reference Guide for Ovarian
CYTALUX NTAP Provider Education for Ovarian
CYTALUX 3-Day Payment Window Billing FAQs
The CYTALUX Reimbursement Support Line assists hospitals, healthcare providers and patients and is composed of a comprehensive reimbursement support program that is available to provide support for CYTALUX reimbursement and access issues.
Phone: 1 (765) 269–4419