How to bill OPME: authorization, invoice and traceability

What does billing OPME mean?

Billing OPME means charging the health plan (operadora) for implants and special devices used in a procedure, with the authorization, the supplier invoice and the traceability record that prove the authorized device was the device implanted. It is part of hospital billing, with its own form, code and document rules.

Three things set OPME apart from an ordinary supply. It is requested on a specific annex before the procedure. It is posted with a TUSS table 19 code (supplies and OPME), which originates from Anvisa (Brazil's health regulatory agency) records ^[1]. And it needs physical proof: the sales invoice and the manufacturer's labels attached to the medical record ^[2].

Because each item is expensive, a form or code error weighs on the whole claim. At Anahp hospitals, OPME accounted for 7.61% of gross revenue and 7.30% of total expenses in 2024, with 119 reporting hospitals ^[4].

OPME billing has six steps

Each step leaves a document, and the claim only closes when all of them show the same device, the same lot and the same quantity.

Step 1: how do you request OPME authorization in TISS?

The request uses the OPME Request Annex, which the TISS Organizational Component defines as the annex for requesting authorization of orthoses, prostheses and special materials ^[1]. It never stands alone: field 3, “Referenced form number”, carries the number of the inpatient admission request or the SP/SADT form (the outpatient services and diagnostics form) it is linked to ^[1]. OPME is not requested on the Other Expenses Annex; OPME, chemotherapy and radiotherapy requests use their own annexes ^[1].

Three habits at this step save work later:

• Table 19 code from the start. The same code goes on the request annex and later on the billing annex ^[1].
• Item-by-item response. The health plan's response must list every requested item, including those not authorized ^[1]. Billing should learn about a refusal before surgery, not from the denial.
• Electronic submission. The annex batch is one of the transactions TISS requires to be electronic ^[1].

Brand options, clinical justification and arbitration are covered in the OPME authorization guide. For billing, note that in urgent or emergency cases CFM Resolution 2,318/2022 allows arbitration after surgery ^[2]; the claim should then include the report documenting the urgency.

Step 2: what to check on the supplier invoice

The supplier's sales invoice (nota fiscal) identifies the device and its value. When OPME arrives, the supply team checks three things against the authorization:

1. Device and code. Is it the authorized brand and item?
2. Lot. The annex to CFM Resolution 2,318/2022 ties the lot number to device traceability ^[2].
3. Labels. The supplier must deliver five numbered labels for each implantable device or component ^[2].

In private health plans, label 3 goes on the sales invoice ^[2]. TUSS table 38 has messages for a missing invoice: 3255 “ITEM ASSISTENCIAL SEM NOTA FISCAL DO FORNECEDOR” (care item without supplier invoice) and 1738 “DOCUMENTO FISCAL NÃO ENVIADO” (tax document not sent) ^[3]. When the contract ties the billed value to the invoice value, a mismatch triggers 3310 “VALOR DA NOTA FISCAL DIVERGENTE” (invoice value mismatch), in force since 12/01/2025 ^[3].

Step 3: recording traceability in the medical record

Traceability closes in the operating room. Under the annex to CFM Resolution 2,318/2022, the five labels have fixed destinations ^[2]:

Article 7 makes the labels, with full manufacturing data and the distributor's declaration of origin, a mandatory part of the medical record ^[2]. Article 1 makes the hospital's technical director responsible for the use of implants ^[2].

In practice, the OR team attaches label 1 during the procedure and records in the operative report what was implanted, how many units and, if anything was swapped or added, why. Since 12/01/2025, table 38 includes 3263 “NECESSÁRIO ENVIO DE ETIQUETAS DO IMPLANTE INSTALADO” (labels of the installed implant required) ^[3]: the health plan may require scanned labels with the claim.

CFM Resolution 1,956/2010, which still appears in some OPME articles, was revoked by Resolution 2,318/2022 (article 10) ^[2].

Step 4: which form is OPME billed on?

OPME is billed on the Other Expenses Annex, used for gases, drugs, supplies, OPME, fees, rentals and daily rates ^[1]. It has no number of its own: field 2, “Referenced form number”, carries the main form's number ^[1].

On each line, three fields decide whether OPME is recognized:

• Table 19 code. The same as on the request. OPME posted as an ordinary supply may get 3192 “COBRANÇA DE ITEM ASSISTENCIAL EM TIPO DE DESPESA INVÁLIDA” (care item billed under an invalid expense type) ^[3].
• Expense code. TUSS table 25 classifies the expense; code 08 is OPME and 03 is supplies ^[5].
• Quantity and value. Quantity follows the operative report; value follows the contract. If OPME is part of a bundle, it is not billed separately (code 3211 covers an item billed despite being in the negotiated bundle) ^[3].

Details of each form and annex are in the TISS claim forms guide; code lookup is in the TUSS code table guide.

Step 5: the review before submission

Before closing the batch, billing compares four points: what was authorized, delivered, implanted and billed. The logic and denial codes are in the OPME denials guide; here is the claim checklist:

• the authorization covers the device, code and quantity billed;
• the invoice shows the same device, lot and value;
• labels in the record match the invoice and the operative report;
• the billed quantity matches surgery, and any excess has a supplementary authorization;
• the Other Expenses Annex points to the right main form;
• OPME carries its table 19 code and the OPME expense code, not an ordinary-supply code;
• the value follows the contract and nothing in a bundle is billed separately.

Step 6: submitting a claim with OPME

Submission follows the TISS electronic batch, in the current version. The OPME claim goes out with the full dossier: authorization, invoice, scanned labels and operative report, in the attachment format agreed with the health plan. File structure errors are covered in the TISS XML errors guide. If a denial comes back, the appeal answers the specific code; see OPME denials.

What we see in operations

At Accrua, OPME (implants and special devices) claims are checked through the same steps as this guide, before they leave the hospital. Accrua OS reads the authorized request, the Other Expenses Annex, the TUSS table 19 code, the supplier invoice and the label records in the medical record, and checks all of it against the contract and that health plan's denial history for that device.

What we look for is a mismatch between documents: a device used that differs from the one authorized, an invoice with no matching label, a quantity that does not match the operative report. Each mismatch becomes a task for whoever can solve it, with the source shown. When a device swap in the operating room requires a supplementary authorization, the team learns about it before submission, not after the denial.

In our managed operation, auditors with nursing backgrounds check whether the medical record supports the use. Changing an item that affects the value of a claim is always a person's decision, and every action is logged in an audit trail.

Where to start

1. Map the OPME path from the authorization desk to billing and name an owner for each step.
2. Standardize the table 19 code used on the request, in the item master and on the claim.
3. Close receiving with lot, invoice and five-label checks before the device reaches the OR.
4. Agree with the OR team on attaching label 1 during surgery and recording any swap.
5. Apply the step 5 checklist before every submission and track claims returned for missing documents.

OPME billing FAQ

Which TISS form is OPME billed on? On the Other Expenses Annex, linked to the inpatient summary or to the SP/SADT form through the “Referenced form number” field.

What is the difference between the OPME Request Annex and the Other Expenses Annex? The first requests authorization and links to the admission request or SP/SADT form. The second bills the OPME used and links to the inpatient summary or SP/SADT form. The table 19 code is the same on both.

How many labels does OPME need? Five per implantable device or component under CFM Resolution 2,318/2022: medical record (mandatory), patient report, sales invoice, supplier and surgeon.

Where does the invoice label go? In private health plans, label 3 goes on the sales invoice, according to the manual attached to CFM Resolution 2,318/2022.

Is CFM Resolution 1,956/2010 still in force? No. It was revoked by CFM Resolution 2,318/2022, which now covers labels, the three brand options and arbitration.

What if the surgeon uses more OPME than authorized? Record the reason in the operative report, request a supplementary authorization before submission and attach labels for every unit. Otherwise the excess tends to be denied (3190).