HCPCS code J7682 – Tobramycin inhalation solution (per 300 mg)

Key takeaways

HCPCS code J7682 bills FDA-approved, non-compounded tobramycin inhalation solution in unit dose form, given through a DME nebulizer.

One unit equals 300 mg, so each TOBI, Bethkis or generic ampule is one unit, and a 56-ampule box is 56 units.

Medicare covers J7682 for cystic fibrosis or bronchiectasis under LCD L33370, with the six diagnosis codes in Policy Article A52466 Group 10.

A J7682 line carries KO, plus KX when the LCD criteria are met, and JZ when no drug is discarded.

Compounded tobramycin goes to J7685, which Medicare denies, and TOBI Podhaler capsules never go on a J7682 line.

What HCPCS code J7682 covers

HCPCS code J7682 covers tobramycin inhalation solution that is an FDA-approved final product, non-compounded, in unit dose form and administered through DME. It bills per 300 milligrams. The descriptor comes from the CMS HCPCS quarterly file.

Tobramycin is an inhaled aminoglycoside antibiotic. Patients with cystic fibrosis use it to suppress Pseudomonas aeruginosa in the airways, and some patients with bronchiectasis use it too. A DME supplier dispenses the ampules and bills Medicare Part B under the nebulizer benefit.

J7682 is not a tiotropium code

J7682 is a tobramycin code and has no link to tiotropium. Tiotropium (Spiriva) has no nebulizer-solution HCPCS code in the CMS file. It is sold as handheld inhalers, which fall outside the DME nebulizer benefit.

If the order is for a nebulized long-acting antimuscarinic, the code with its own entry is J7677, revefenacin, billed per microgram. LCD L33370 covers revefenacin for obstructive pulmonary disease, not for cystic fibrosis.

J7682 vs J7685 and other nearby inhalation codes

Like the rest of the HCPCS Level II code set, the J76xx codes split each drug by product type and dose form. For tobramycin, the choice comes down to the product the pharmacy dispensed. The table lists the codes a J7682 biller is most likely to meet.

Patients with cystic fibrosis often use tobramycin, dornase alfa and hypertonic saline in the same month. Each drug gets its own line, its own code and its own units, so the saline goes on a separate J7131 line. Never fold them into one J7682 line.

Which ICD-10 codes support J7682?

Six ICD-10-CM codes support J7682, listed in Group 10 of Policy Article A52466. They cover cystic fibrosis with lung involvement, bronchiectasis and tuberculosis of lung.

Only E84.0 appears from the cystic fibrosis category. A claim coded to another E84 code, such as E84.9, falls outside Group 10. The policy article also warns that a listed code does not guarantee coverage by itself.

How to calculate J7682 units

Bill one unit for every 300 mg dispensed. Every product on the CMS crosswalk is a 300 mg ampule, so units equal ampules. The fill volume does not change the count: Bethkis and some generics come in 4 mL, while TOBI comes in 5 mL.

The labeled regimen is one 300 mg ampule twice a day for 28 days, then 28 days off. One treatment cycle is therefore 56 units. That matches the 56-ampule box, which the CMS crosswalk lists at 56 billable units.

• One 28-day on-cycle: 2 ampules × 28 days = 56 units.
• A 30-ampule package: 30 units.
• Supply limit: LCD L33370 caps any delivery at a three-month quantity, whatever the utilization.

Which modifiers belong on a J7682 line?

A covered J7682 line carries KO, KX and JZ. Policy Article A52466 sets each one, and a line missing a required modifier is rejected or denied before anyone reviews the records.

Medicare coverage rules for J7682

LCD L33370 treats tobramycin as reasonable and necessary for a beneficiary with cystic fibrosis or bronchiectasis. Coverage also depends on the equipment and on who bills the claim.

• Nebulizer: A small volume nebulizer (A7003, A7004 or A7005) and compressor (E0570) are considered for coverage when tobramycin is the covered drug.
• Who bills: Only the entity that dispenses the drug, licensed to dispense in the state where it is located.
• Practitioner billing: A practitioner may bill only if enrolled as a DMEPOS supplier, dispensing the drug and authorized by the state to dispense.
• Dispensing fee: Bill G0333 once for the first 30-day supply, then Q0513 for 30 days or Q0514 for 90 days. The fee goes on the same claim as the drug.
• Compounded product: Compounded tobramycin is J7685, and Medicare denies it under the same LCD.

A beneficiary whose tobramycin does not meet the Part B criteria may have coverage under a Part D plan instead. Check that route before you issue an ABN.

J7682 payment rate

Medicare’s payment limit for J7682 is $11.404 per 300 mg unit for October 1 to December 31, 2026. The beneficiary owes 20% coinsurance. The figure comes from the CMS ASP pricing files, which update every quarter.

At that rate, a 56-unit treatment cycle has a Medicare allowable of about $638.62 before coinsurance. CMS notes that a code’s presence in the payment file says nothing about coverage. The DME MAC still applies the LCD.

Medicare Advantage, Medicaid and commercial plans set their own rates. Check each contract rather than reusing the Medicare figure.

Prior authorization for tobramycin inhalation solution

Original Medicare does not require prior authorization for J7682. The LCD criteria and the KX attestation do that work instead. Medicare Advantage, Medicaid and commercial plans often require prior authorization for inhaled tobramycin.

As an example, Pennsylvania Health and Wellness clinical policy PA.CP.PHAR.211 asks for this evidence before it approves TOBI, Bethkis or Kitabis Pak:

• A documented cystic fibrosis diagnosis.
• Patient age of 6 years or older.
• Pseudomonas aeruginosa in at least one airway culture.
• No concurrent or alternating inhaled aztreonam (Cayston), unless records show an inadequate response to aztreonam alone.
• A dose no higher than 600 mg a day on a 28-days-on, 28-days-off cycle.

That policy approves the first request for 6 months. Renewals run 12 months and need evidence that the patient is responding, such as stable lung function or fewer hospital stays. Criteria differ by plan, so pull the payer’s own policy before you dispense.

Documentation to keep for a J7682 claim

A DME MAC reviewer checks the same file for every J7682 claim. Keep each item below before the first delivery, and keep it current for each refill.

• Standard written order: The supplier must receive it before submitting the claim, or the claim is denied as not reasonable and necessary.
• Medical records: Notes that support cystic fibrosis or bronchiectasis and the need for inhaled tobramycin.
• KX evidence: Proof that each LCD criterion is met, kept in the supplier’s file and available on request.
• Refill request: A documented contact and an affirmative response before each refill. Deliver no sooner than 10 calendar days before the current supply runs out.
• Proof of delivery: A delivery record for every shipment. Claims without one are denied.
• ABN: A properly executed notice for any GA line.

The 28-days-off weeks matter for refills. A refill shipped during an off-cycle, without a fresh affirmative response, looks like supply the patient did not need.

What J7682 does not cover

J7682 is limited to FDA-approved tobramycin nebulizer solution. These products and situations need a different code or end in a denial:

• Compounded tobramycin: Bill J7685. Medicare denies it under LCD L33370.
• TOBI Podhaler: A dry powder inhaler, not a nebulizer solution. The DME MAC correct-coding advisory says its capsules must not be billed with J7682.
• Tobramycin injection: Intravenous or intramuscular tobramycin is J3260, tobramycin sulfate, up to 80 mg.
• A diagnosis outside Group 10: Asthma or COPD alone does not support J7682. Bill GA with an ABN, or GZ without one.

The diagram below sorts each tobramycin product a supplier is likely to meet by the code it takes.

Common J7682 claim errors

Most J7682 rework traces back to units, modifiers or the dispensed product. The fixes below follow the wording of LCD L33370 and Policy Article A52466. Strong denial management workflows then catch any that slip through.

A clean claim for J7682 carries the code, units of ampules, KO, KX and JZ, a Group 10 diagnosis and the dispensing fee code.

How Pabau keeps tobramycin claims accurate

Errors on J7682 start when the order, the delivery record and the claim sit in different places. The biller then counts units from memory and picks modifiers without seeing the file.

Pabau, the practice management and billing platform we build, keeps the order, signed forms and the claim on the same patient record. The biller can see the product, the ampule count and the ABN before coding the line.

Claims management in Pabau prepares and tracks each claim from that record. When a remittance comes back, the denial reason sits next to the documents that answer it.

Get tobramycin claims right the first time

Pabau keeps the order, the ABN and the claim on one patient record. Your billing team can check units and modifiers before a J7682 claim goes out.

Book a demo

Conclusion

J7682 rewards a supplier who checks three facts before delivery. Those facts are the product, the diagnosis and the unit count. Confirm the ampules are FDA-approved tobramycin, not a compounded batch or Podhaler capsules.

Match the diagnosis to Group 10, and bill one unit per ampule. With KO, KX and JZ on the line, the claim passes the modifier edits in Policy Article A52466.

The cost of skipping those checks lands every 56 days, when the next cycle ships. Book a demo to see how Pabau keeps orders, ABNs and nebulizer drug claims in one place.

Continue your research

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