Why do oncology denials cost hospitals so much?
Oncology denials are costly because high-value items are concentrated in few claims. So every authorization, dosing or documentation error in a chemotherapy cycle weighs more on results than the same error in a routine claim.
In Brazil's private health system, the payer is the health plan (operadora), regulated by the Agência Nacional de Saúde Suplementar (ANS), the national supplementary health agency. A denial (claim denial) is a full or partial refusal by the health plan to pay a claim the hospital has already submitted.
Industry data show how much drugs weigh. At member hospitals of the Associação Nacional de Hospitais Privados (Anahp), Brazil's national association of private hospitals, drugs accounted for 21.34% of gross revenue in 2024, the largest share among supplies. Together with supplies and implants (OPME, órteses, próteses e materiais especiais), they reached 43.26% [1]. In the same group, the initial denial rate was 15.93% of amounts receivable from health plans in 2025, and the accepted denial rate (final loss) was 1.72% of gross health plan revenue [2].
The general logic of denials, the types and what RN 503/2022 requires contracts to include are in the Hospital claim denials guide. This guide covers what is specific to oncology.
Coverage refusal and denial are different problems
A coverage refusal happens before treatment, when the health plan declines the authorization. A denial happens afterwards, when the health plan does not pay, in full or in part, a claim already submitted. In oncology, the two overlap because treatment is delivered in cycles: each cycle has its own authorization and its own claim.
The distinction changes the path. A refusal is handled through review, a physician report or, in a technical disagreement, a medical board. A denial is handled through an appeal under the TISS standard and documentary evidence. The steps for refusals are in the Authorization denial guide, and the steps for appeals are in the Denial appeals guide.
What does the law require health plans to cover in oncology?
Law 9,656/1998 (Lei dos Planos de Saúde, the health plans law) sets three fronts of oncology coverage, depending on the plan's coverage segment [3]:
| Setting | Legal basis | Care timeframe | What the hospital must watch |
|---|---|---|---|
| Chemotherapy and radiotherapy during an inpatient stay | Art. 12, II, “d” | During the stay | Billed on the inpatient summary and the other expenses attachment |
| Outpatient and home oral antineoplastics, radiotherapy and blood therapy, as continuation of an inpatient stay | Art. 12, II, “g” (Law 12,880/2013) | 10 business days (RN 566/2022, art. 3, XVI) [4] | Link to the original inpatient stay |
| Home oral antineoplastics, including drugs for adverse effects and adjuvants | Art. 12, I, “c” (Law 12,880/2013) | Within 10 days of the prescription (art. 12, § 5) [3]; 10 business days (RN 566/2022, art. 3, XV) [4] | Prescription, report and compliance with the utilization guideline |
The law also requires coverage under items “c” and “g” to follow clinical protocols and therapeutic guidelines reviewed periodically, after hearing the specialty medical societies (art. 12, § 4) [3]. Under § 5, oral antineoplastics may be delivered in fractions by cycle, with proof that the patient received guidance on use, storage and disposal [3].
The full timeframes are in the ANS maximum care timeframes guide.
The Rol, the DUT and treatment outside the list
The ANS Rol de Procedimentos e Eventos em Saúde (procedures list, RN 465/2021) sets minimum coverage. Its Annex II contains the Diretrizes de Utilização (DUT, utilization guidelines), which tie coverage of some items to clinical criteria. The current Annex II, updated by RN 681/2026, has 176 numbered DUTs [8]. They include DUT 54 (drugs to control adverse effects and adjuvants of antineoplastic treatment), DUT 60 (oncology PET-CT) and DUT 64 (oral antineoplastic therapy for cancer) [8]. The criteria of each one are in the Annex II text.
Some biomarker DUTs tie test coverage to the drug label. DUTs 9 (BRAF), 21 (EGFR) and 30 (HER-2) cover mutation testing when the label requires it before treatment starts [8]. In practice, the test claim must show which drug prompted the order.
Adding oral antineoplastics to the Rol follows a priority track: 120 days, extendable by 60 calendar days, versus 180 + 90 days for other requests (Law 9,656/1998, art. 10, §§ 7 and 8) [3].
For treatment outside the Rol, Law 14,454/2022 must be read together with the STF decision in ADI 7265 (September 18, 2025), which set five cumulative criteria [7]:
- prescription by a licensed physician or dentist;
- no express rejection by ANS and no pending review to update the Rol;
- no therapeutic alternative in the Rol;
- efficacy and safety proven by evidence-based medicine;
- registration with Anvisa, Brazil's health regulatory agency.
Off-label use is a frequent point of friction in oncology. RN 424/2017 excludes off-label use from the medical board procedure [9]. Details are in the ANS procedures list, Utilization guidelines (DUT) and ANS medical board guides.
What are the most common chemotherapy denial reasons?
The reasons fall into five groups: cycle authorization, dose and fractioning, price, administration fees and documentation. The table links each reason to the message in table 38 of the TUSS (Terminologia Unificada da Saúde Suplementar, Brazil's unified health plan terminology) that usually comes with it, and to the document that prevents it [6].
| Reason | Table 38 message (code) [6] | Document that prevents it |
|---|---|---|
| Cycle given on a date other than the approved one | 1732 — chemotherapy with an event date different from the approved one | Request a new date from the health plan before infusion; record the delay and its clinical reason in the chart |
| Full vial billed when the health plan pays the fractioned dose | 3312 — amount paid according to fractioning | Fractioning and leftover rule in the contract; record of the prepared dose and the discard |
| Quantity above the authorized amount | 3292 — quantity above the authorized amount | Recalculate the dose by weight or body surface area and get a new authorization before the cycle |
| Quantity incompatible with the procedure | 3190 — quantity incompatible with the procedure | Prescription with dose, route and regimen; pharmacy check |
| Amount above the contract price | 1705 — amount billed above the agreed value | Contract price table set up for each health plan |
| Administration fee billed improperly | 3216 — item billed improperly for drug administration | Contract rule for room and administration fees by route |
| Missing clinical justification | 3217 — no justification or insufficient justification | Physician report with staging, line of therapy and protocol |
Codes 3190, 3216, 3217, 3292 and 3312 have been in effect since December 1, 2025, with implementation by June 30, 2026; code 1705 since November 16, 2006 [6]. Code 1732 appears on the ANS platform and in the official version 202607 spreadsheet with an effective date of December 1, 2025 and an implementation end date of August 31, 2014, an inconsistency in the database itself [6]. The meaning of each message is in the TISS denial codes guide.
See the steps as a table
| Step | Document that prevents the denial |
|---|---|
| 1. Prescription | Physician report with staging, protocol and calculated dose |
| 2. Authorization | Chemotherapy attachment, with authorization code and approved cycle date |
| 3. Pre-cycle check | Date, dose, weight and protocol match the authorization |
| 4. Preparation and infusion | Pharmacy record (lot and leftover) and nursing record (dose, route, times) |
| 5. Billing | Contract price and unit, fractioning rule and fees |
| 6. Statement and appeal | Table 38 code, documentary evidence and contract deadline |
Authorization is per cycle, not per treatment
In chemotherapy, authorization follows the treatment plan, but the health plan checks each cycle against what it approved. Under the TISS standard (Troca de Informações na Saúde Suplementar, Brazil's mandatory health plan data exchange standard), a chemotherapy request can only be sent on its own request attachment. It cannot go only on the inpatient or outpatient services (SP/SADT) form [5]. The same rule applies to OPME and radiotherapy [5].
Three situations often lead to denials here. The first is a cycle delayed for toxicity or an abnormal test result, without notice to the health plan: the date given no longer matches the approved date. The second is a change of protocol or line of therapy without a new request. The third is a change in the patient's weight, which changes the calculated dose and, with it, the authorized quantity.
The authorization flow, timeframes and handling of refusals are in the Prior authorization guide.
Dose, fractioning and price: where the claim loses value
In a chemotherapy claim, value tends to concentrate in the drugs, and that is where calculation disagreements weigh most. A vial rarely matches the patient's exact dose. If the contract does not say what happens to the leftover, the health plan may pay only the fractioned dose, with message 3312 [6].
Price is the second front. Law 10,742/2003 created the CMED (Câmara de Regulação do Mercado de Medicamentos, Brazil's drug market regulation chamber) and the country's drug price cap system [10]. In the contract between hospital and health plan, however, the negotiated reference applies: a price guide, a proprietary table or acquisition cost plus margin. The comparison of these references is in the Supplies and drugs denials guide.
| Claim item | What to check before submission |
|---|---|
| Prescribed dose | Weight, height and body surface area updated for the cycle |
| Prepared dose | Pharmacy record with lot, quantity and leftover |
| Billed unit | Same unit as TUSS table 20 and the contract |
| Price | Reference and edition set in the health plan contract |
| Fees | Room and administration fees by route and contract rule |
| Supportive drugs | Antiemetics and premedication with a prescription and a coverage basis |
Administration record: what the chart must show
The claim only holds up on appeal if the medical record proves what was given. For each drug, the nursing record should show dose, route, start and end times, and any adverse events. The pharmacy should keep the preparation record, with lot and leftover.
In audits, a missing administration check often leads to denial of the whole item, even when the drug was dispensed. What must be recorded is detailed in the Medical record audit guide.
What we see in operations
At Accrua, an oncology claim is read cycle by cycle. Accrua OS matches the authorization for each cycle against the prescription, the calculated dose, the administration record and the drug charged, and checks all of it against that health plan's rules on vial splitting, wastage and pricing, loaded together with the contract and the denial history by item.
When the charged dose does not match the prescribed dose, the authorization does not cover the cycle, or the drug was billed as a full vial where the contract calls for splitting, the alert goes to an auditor with nursing training, with the source of each mismatch. Changing the item is that auditor's decision; the system prepares the case and logs who decided and on what basis.
The fix we look for is at the source: setting the splitting and wastage rule per health plan in the item master, so pharmacy and billing work from the same criteria. What we learn in each oncology drug appeal goes back into the review of the next cycle.
Where to start
- Pull the oncology denials from the last 6 months by health plan, table 38 code and amount.
- Review each health plan contract: fractioning rule, price reference, administration fee and appeal deadline.
- Create a pre-cycle check that compares date, dose, protocol and weight with the current authorization.
- Standardize the physician report with staging, line of therapy, protocol and justification for each drug.
- Audit every chemotherapy claim before submission, with rules for each health plan.