What is an OPME denial?
An OPME denial is a denial, full or partial, of the amount billed for implants and special materials on a hospital claim. The health plan (operadora) refuses payment when it finds the item was not authorized, not proven, not covered, billed in a different quantity or value, or already included in a package.
It is a specific case of hospital claim denials, with two practical differences. The first is value: plates, screws, stents and joint prostheses are among the most expensive claim items. At Anahp hospitals, OPME was 7.61% of gross revenue in 2024, with 119 reporting hospitals [5]. The second is proof: OPME has its own documents (authorization with brand and quantity, supplier invoice and manufacturer labels), and missing any one of them is enough for a denial.
What are the most common causes of OPME denials?
The causes repeat, and almost every one has its own code in table 38 of TUSS (Brazil's Unified Supplementary Health Terminology) [2]. It is the message table health plans use in authorization and billing responses under the TISS standard, the national data-exchange standard set by the ANS, Brazil's health plan regulator [3]. Descriptions below are quoted from TUSS version 202607 (official ANS spreadsheet), with an English gloss.
| Code | Table 38 description (gloss) | Usual cause | Document that answers it |
|---|---|---|---|
| 2505 | O CÓDIGO COBRADO É DIFERENTE DO CÓDIGO AUTORIZADO (billed code differs from authorized code) | Brand swapped or item different from the authorized one | Authorization with brand and code; urgency report |
| 3190 | COBRANÇA DE ITEM ASSISTENCIAL EM QUANTIDADE INCOMPATÍVEL COM O PROCEDIMENTO (quantity incompatible with procedure) | More screws or components than authorized | Operative note justifying quantity; labels |
| 3197 | COBRANÇA DE ITEM ASSISTENCIAL NÃO UTILIZADO (item not used) | Item billed with no implant record | Labels in the record; operative note; OR sheet |
| 3255 | ITEM ASSISTENCIAL SEM NOTA FISCAL DO FORNECEDOR (no supplier invoice) | Invoice missing or item not identified | Sales invoice (nota fiscal) with label 3 |
| 3212 | COBRANÇA DE PROCEDIMENTO/ITEM ASSISTENCIAL INCOMPATÍVEL COM RELATÓRIO TÉCNICO (inconsistent with technical report) | Billed item differs from physician's description | Consistent medical report and operative note |
| 3211 | COBRANÇA DE PROCEDIMENTO/ITEM ASSISTENCIAL INCLUSO NO PACOTE NEGOCIADO (included in negotiated package) | Separate billing of item already in package price | Contract annex with package contents |
| 3254 | ITEM ASSISTENCIAL PAGO A FORNECEDOR TERCEIRIZADO (paid to third-party supplier) | Item bought and paid directly by the health plan | Contract and authorization naming the supplier |
| 3192 | COBRANÇA DE ITEM ASSISTENCIAL EM TIPO DE DESPESA INVÁLIDA (invalid expense type) | OPME billed as a regular supply | Recode in TUSS table 19 |
| 3287 | PROCEDIMENTO/ITEM ASSISTENCIAL NÃO POSSUI COBERTURA PELO PLANO DO BENEFICIÁRIO (not covered by the plan) | Item outside plan coverage | Medical report; coverage rules |
| 3251 | ITEM ASSISTENCIAL EM DESACORDO COM OS CRITÉRIOS TÉCNICOS ADOTADOS PELA OPERADORA (inconsistent with plan's technical criteria) | Technical disagreement | Clinical justification; panel or arbitration record |
| 3263 | NECESSÁRIO ENVIO DE ETIQUETAS DO IMPLANTE INSTALADO (implant labels required) | Claim sent without labels | Scanned labels attached |
| 3310 | VALOR DA NOTA FISCAL DIVERGENTE (invoice value mismatch) | Billed value differs from invoice | Invoice and contract pricing rule |
The 3200-series codes in the table and 3310 took effect on 12/01/2025, with implementation by 06/30/2026; 2505 has been in force since 11/16/2006 [2]. The old OPME-specific 2200 series is not in TUSS version 202607 [2]; remittances for older claims may still show it, so check which code the remittance shows. The meaning of each message is in the guide TISS denial codes.
OPME is billed with TUSS table 19 codes (supplies and OPME), not as a regular supply [3]; billing it under the wrong item can trigger 3192 (invalid expense type).
Four documents prove OPME use
The health plan pays for OPME only when the claim shows, with no gaps, that the authorized item was the one delivered, implanted and billed. Four documents make that proof.
- Authorization. The approval code with brand, table 19 code and quantity. It is the reference for everything that follows. How to obtain it, including the three-brand rule and arbitration, is covered in the guide OPME authorization.
- Supplier invoice. The sales invoice (nota fiscal) identifies the item, lot and value. Under the annex to CFM Resolution 2,318/2022, label 3 goes on the sales invoice in private health care [1].
- Identification labels. The supplier provides five labels numbered 1 to 5 for each implantable item or component: label 1 must go in the medical record; 2 in the patient's report; 3 on the invoice; 4 for supplier control; 5 for the lead surgeon [1]. Labels, with full manufacturing data and the distributor's declaration of origin, are a mandatory part of the record (art. 7) [1].
- Operative record. The operative note and OR sheet state what was implanted, how many and why. This is the document that explains a larger quantity than authorized or a change of item during surgery.
Traceability comes from the lot number, checked on receipt, according to the CFM annex [1]. When all four documents show the same item, lot and quantity, a denial for lack of proof loses its basis.
How to prevent OPME denials before submission?
The best defense is to check before billing. The check compares four points, and each mismatch matches a known denial.
| Point | Question | Typical denial if it fails |
|---|---|---|
| Authorized vs. delivered | Did the supplier deliver the authorized brand and code? | 2505 |
| Delivered vs. implanted | Do labels in the record match the invoice and operative note? | 3197, 3263 |
| Implanted vs. billed | Is the billed quantity the one recorded in surgery? | 3190 |
| Billed vs. contracted | Do value and billing follow the contract and package? | 3310, 3211 |
Three routines support the check:
- Labels in the operating room. OR staff attach the labels to the record during surgery, not later. A lost label is the hardest failure to fix.
- Changes recorded on the spot. If the surgeon uses a different item or more units, the operative note records the reason, and the authorization team requests a supplement before the claim goes out.
- Billing with the full file. The OPME claim goes out with the approval, the invoice, the scanned labels and the operative note. What the record must contain is covered in the guide Medical record audit.
How to appeal an OPME denial
When a denial arrives, the appeal answers the code given, not the denial in general. The TISS standard has specific messages for denial appeals (appeal, receipt, status request and response) [3].
- Read the code and justification. RN 503/2022 bars health plans from blocking access to denial justifications and audit routines. It also bars them from blocking appeals, provided billing follows the current TISS version [4].
- Attach the document that answers the code: invoice for 3255, labels for 3263, authorization or urgency report for 2505, operative note for 3190.
- Meet the contract deadline. RN 503/2022 requires contracts to set appeal, response and post-reversal payment deadlines. The appeal deadline must equal the response deadline [4]. The rule sets no number of days; the contract does.
- Log the outcome by code and health plan, to fix the cause in the next check.
In emergencies, CFM Resolution 2,318/2022 allows arbitration after surgery [1]. The appeal should include the physician's report on the urgency and the labels of the material used.
On denials of authorized procedures, there are two points to watch. The Anahp contracting manual (2025) suggests a clause under which the plan does not deny what it authorized, except in exceptional, well-founded cases [6]. And CFM Resolution 2,448/2025, which bars auditors from denying authorized and proven procedures, has articles marked as suspended by court order in the text published by the CFM, accessed on October 17, 2026 [7]. The full step by step is in the guides Denial appeal and Appeal deadlines.
Who does what in the proof of use
An OPME denial is rarely the fault of a single area. CFM Resolution 2,318/2022 makes the hospital's technical director responsible for implant use [1], and the routine depends on four teams.
| Area | Responsibility |
|---|---|
| Authorization team | Approval with brand, code and quantity; supplement when an item changes |
| Supply chain and OPME | Receipt with lot, invoice and five-label check |
| Operating room | Labels in the record during surgery; complete operative note |
| Billing | Four-point check; full file attached; appeal by code |
What we see in operations
At Accrua, OPME (implants and devices) is checked claim by claim before submission, together with the medical record, prescriptions, items and bundle. For each device, Accrua OS checks whether the proofs of use described in this guide are present and consistent with each other, and matches the item against the authorization: a device swapped during surgery without an authorization update shows up before the claim goes out.
In the hospital's history, we split OPME denials by code and by health plan and compare appeal outcomes when the file was complete and when a proof was missing. That reading shows where the fix has to happen: in the operating room, in the authorization team or in billing.
In our managed operation, auditors with nursing training build the file, and the agent drafts the appeal with the evidence the health plan asks for under that code. Accepting the denial or dropping the appeal is a person's decision, and every step is logged in an audit trail.
Where to start
- Pull recent OPME denials by table 38 code and health plan.
- Create the four-point checklist (authorized, delivered, implanted, billed) and apply it before every submission.
- Agree with the OR on labeling during surgery and recording any swap of material.
- Check the contract for who supplies the OPME, what the package includes and the appeal deadlines.
- Build appeals by code, with the document that answers each message.