Negative Pressure Wound Therapy Billing: When the Billing File Tells a Different Story

Negative pressure wound therapy billing fraud can involve knowingly billing Medicare for a device sold under the wrong benefit category, pump use the treatment record cannot support, or supplies that never reached the patient. The wound-care team may see the treatment ending while the billing department sees another rental month. If you work with orders, delivery records or wound assessments, you may know exactly where those accounts part company.

Disposable System or DME Pump?

The difference between a negative pressure wound therapy disposable system and a DME pump starts with the product’s ability to withstand repeated use. The therapy’s name does not tell you whether the device belongs in the durable medical equipment benefit. The particular model and the way it was sold matter.

That was the issue in the Innovative Therapies and Cardinal Health case. In June 2017, the companies agreed to a $2,715,000 civil settlement. The whistleblower alleged that Innovative Therapies marketed certain Quantum wound-therapy devices as durable medical equipment despite knowing they lacked the expected life of durable medical equipment. After Cardinal’s acquisition, the line was renamed the PRO series.

The alleged problem reached back to the manufacturer’s description of the equipment. A biller could be working from a product category the manufacturer allegedly misrepresented. For someone inside the business, product specifications and sales instructions matter alongside the claim.

The code also has a product-specific requirement. Medicare pays the pump code, E2402, only for models its coding contractor has approved for it. That makes the model supplied and its coding designation part of the same inquiry as the invoice.

Pump Rental and Recurring Supplies

A wound pump claim has recurring components: the pump rental, dressing kits and canisters. E2402 identifies the pump, A6550 the dressing kits and A7000 the canisters in the 2024 payment data. The supplier bills for the equipment and the consumables used around it.

Medicare’s 2024 payment data for durable medical equipment and supplies put pump payments at $48.3 million and payments for the principal dressing-kit and canister codes at $22.1 million. The dressing creates a seal around the wound, while the canister collects drainage. The rental and the replaceable supplies each need to connect to the patient’s treatment.

Manufacturing and billing can also sit inside the same business. In the payment data, at least one manufacturer bills Medicare directly for negative pressure wound therapy. An insider may therefore work where the product description, delivery record and Medicare billing meet, rather than at a supplier buying equipment from an unrelated manufacturer.

Continued Use and the Four-Month Boundary

Continued pump billing depends on what happens to the wound after the original order. Wound measurements, assessments, dressing changes and evidence of actual use connect a rental month to care being provided during that month.

The policy reproduced in the HHS Office of Inspector General’s June 2007 report on pump payments shows how that connection worked for the 2004 claims it examined. A licensed medical professional had to assess the wound regularly, supervise or perform dressing changes, and document changes in the wound’s dimensions and characteristics at least monthly. The supplier had to obtain an assessment of healing progress based on measurements in the medical record.

Under that policy, coverage stopped when the pump was no longer used, the wound had healed enough to stop therapy, or it showed no measurable healing over the prior month. Coverage beyond four months required additional documentation, and time using the pump in the hospital counted toward that limit. An original order could not answer all those later questions.

The supply limits had their own evidence requirements. The policy allowed 15 dressing kits per wound per month and 10 canister sets per month, with documented exceptions for wound size and heavy drainage.

The treatment dates and wound measurements show what was happening when each rental or supply charge went to Medicare. A file showing why therapy began answers a different question from a file showing why Medicare was still being billed.

What Are the Documentation Guidelines for Durable Medical Equipment?

For a wound pump, the order, proof of delivery and clinical record need to tell a consistent story about the equipment and the treatment. The most revealing document may be the clinician’s chart behind the supplier’s completed form.

The Inspector General’s review of 2004 pump claims found that virtually all met supplier documentation requirements. The supplier generally had the signed order and delivery record. Yet the Inspector General estimated that 24% of pump claims failed Medicare coverage criteria. Having the documents in the supplier’s file and having clinical support for payment were very different results.

For 44% of claims with both a supplier-prepared statement and a medical record, reviewers found that the statement was not fully supported by the chart. The unsupported information included wound measurements, the type of wound, earlier treatments, whether the pump was being used and whether regular assessments occurred.

Some records actively disagreed. One supplier statement described a pressure ulcer while the chart described a nonhealing, infected wound after an amputation. In another example, the chart’s wound measurements were much smaller than those on the supplier statement, although the measurements were taken three days apart.

The report also described a claim for which the clinical account contradicted the entire premise of the rental:

The reviewers sought records from the prescribing physician and other providers involved in the patient’s care. The Inspector General recommended that Medicare review the medical record rather than rely only on supplier-prepared statements. The supplier’s own account of treatment was precisely what needed checking.

Lincare’s Respiratory Rentals Show Why Continued Use Matters

A respiratory-equipment case shows how taxpayers pay when a supplier knows use has stopped and keeps seeking rental payments. In its February 2024 civil settlement, Lincare agreed to pay $25.5 million and admitted that it sometimes sought monthly payments for non-invasive ventilators when it knew patients were not using them.

Lincare also admitted that staff frequently missed home visits required by its own protocols. In many instances, it continued seeking payments from federal health care programs when staff had not verified continued use or kept documentation showing it. The company had remote monitoring available for certain newer devices but did not use it to confirm that patients were using them as directed.

The parallel for wound-pump billing is the connection between the clinical staff’s knowledge and the next claim. A supplier’s visit record or use report can show what its billing process continued to charge for after the care team knew otherwise.

What an Insider Can Connect

The useful information connects the device, the wound, the claim and the people who knew what was happening. A product specialist may know why a model was sold as durable medical equipment. A clinician may know what the wound measurements actually showed. A billing employee may know why rental claims continued after the supplier learned that use had stopped.

The product matters too. Skin substitutes are not durable medical equipment or surgical dressings and are paid through physician and hospital outpatient systems. The same wound can appear in records for different products, each with its own payment category.

We work with that knowledge to connect the company’s records and decisions to the Medicare payments. A whistleblower case under the False Claims Act can pay 15% to 30% of what the government recovers.

When You Know Why the Claims Kept Coming

If you handle wound assessments, pump deliveries or recurring claims and know where the billing departed from the care, speak with our whistleblower experts about your wound-pump billing case. We build the case with you and bring in healthcare fraud whistleblower lawyers who understand equipment rentals and wound-care records. We stay beside you throughout the case, with your knowledge of the business at the center of the work.