The arsenal of retina drugs and biosimilars is growing, and with that comes increasing complexity in ensuring the diagnosis code for the drug is not only on-label from the US Food and Drug Administration (FDA) but also for individual payers. Usually, it comes as a surprise when a payer denies a drug, indicating the diagnosis is “experimental.” The most common reason for this is that the payer did not include the particular diagnosis on their list of approved indications or diagnoses for that drug. This month’s column answers some common questions.
Q. According to the FDA or other regulatory authorities, what are the approved indications for an injectable drug?
A. The drug’s package insert contains a great deal of information, including indications and usage, dosage and administration, and complete prescribing information. For example, many of the current retina drugs are indicated for neovascular (wet) age-related macular degeneration (AMD), macular edema following retinal vein occlusion (RVO), diabetic macular edema (DME), and/or diabetic retinopathy (DR).
Q. Which ICD-10 diagnosis codes correspond to the drug’s approved indications?
A. Typically, the manufacturer creates a Coding and Billing Guide to distribute to practices with a list of corresponding FDA-approved diagnoses based on the coverage indications. These guides can be downloaded from the manufacturer’s website. Using these guides as a reference tool, so the physician knows which diagnoses are approved, is an essential first step.
Q. Do payers require specific diagnosis codes to reimburse for an injectable drug?
A. Medicare Advantage (Part C) and commercial payers typically have policies for each retina drug or group of drugs, such as anti-VEGF agents, that will include their coverage indications, step-therapy criteria, preauthorization criteria, and the diagnoses they will cover for each drug. Remember, the payer may provide a preauthorization, but the fine print usually states that preauthorization does not guarantee payment. Associating the FDA-approved indications with their corresponding diagnoses and what the payer deems “covered” is imperative to ensure payment for the administered drugs.
Q. What are the consequences of submitting a claim with a diagnosis code that is not on-label?
A. If the practice does not follow the payer rules for diagnoses, step-therapy, and preauthorization, it risks denial of the claim and lack of payment to cover the drug’s costs. The result is having to pay a drug invoice without receiving reimbursement for the drug used, which can rarely be billed to the patient due to the contract with the payer. If this situation occurs frequently, it can create a substantial financial issue that can potentially negatively affect the practice’s cash flow and ability to remain in business.
Q. How can coders verify that diagnosis codes match the payer’s requirements for a drug?
A. The first step is to sign up for email alerts and newsletters for all payers. The next step is assigning a point person to review the policies for changes, additions, and deletions. Communication between the various people and departments, such as the preauthorization coordinator, the physician, and billing, is imperative to ensure no issues with improper or off-label diagnosis codes. The feedback loop is critical to stop denials before they occur and before the drug is injected.
Conclusion
As new treatment options are developed for retinal diseases, knowing and following the rules for payers is imperative to ensure payment for the services rendered. The process to ensure on-label diagnoses for each drug remains critical to the success of the practice. Otherwise, there is a risk of paying for injectable drugs for which the practice has not received reimbursement. RP
