Facing a Skin Substitute Fraud Investigation? 6 Things You Should Know

By Barry Wax

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News

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Oct 20, 2026

Executive Summary: Federal investigators are actively examining Medicare billing involving skin substitutes and wound care, including cases in South Florida. If you receive a subpoena or learn that you are under investigation, understanding what investigators may be reviewing, your role in the case, and your legal options can help you make informed decisions before speaking with the government.

A federal healthcare fraud investigation does not always begin with an arrest. You may receive a subpoena. Federal agents may contact you. Someone you worked with may tell you investigators have been asking questions. Or Medicare billing that seemed routine at the time may suddenly be under review.

If the investigation involves skin substitutes or wound care, the amounts involved can be substantial. That can make the situation frightening, especially when you do not know what federal investigators are looking for or what happens next.

In South Florida, these investigations are already happening.

1. Why Are Skin Substitutes Getting So Much Attention?

Skin substitutes are biological or synthetic products used to help wounds heal. Medicare may cover them when they are reasonable and necessary for a patient’s condition.

Spending on these products has increased sharply. The HHS’s Office of Inspector General reported that Medicare Part B spending on skin substitutes surpassed $10 billion annually by the end of 2024.

Federal investigators have raised concerns about questionable billing and fraud involving these products. That does not mean every expensive claim is fraudulent. It does mean that certain billing patterns may get a closer look.

2. What Can Lead to a Skin Substitute Fraud Investigation?

Federal healthcare fraud cases can involve allegations that someone knowingly participated in a scheme to defraud Medicare or another healthcare benefit program.

In a skin substitute case, investigators may be looking for allegations involving:

• Billing for products that patients never received
• Using products that were not medically necessary
• Billing for more product than was actually used
• False wound measurements or medical records
• Billing under a provider who did not prescribe or provide the treatment
• Kickbacks connected to patients, referrals, or product orders

A high bill by itself does not prove fraud. Under 18 U.S.C. § 1347, the government must prove the required elements of healthcare fraud, including knowing and willful conduct.

3. Why Is This Relevant in Miami and South Florida?

South Florida has already been the focus of federal enforcement involving skin substitutes.

In the 2026 National Health Care Fraud Takedown, federal prosecutors announced charges in the Southern District of Florida stemming from schemes involving more than $4 billion in alleged fraudulent claims across several areas, including skin substitutes and wound care.

One case involved a Hialeah defendant accused of helping set up at least 11 South Florida clinics that allegedly billed Medicare more than $117 million for skin substitutes and wound-care products that were never provided. Medicare allegedly paid more than $55 million on those claims.

Those are allegations, not convictions. But the cases show that federal investigators are actively examining skin substitute billing in South Florida.

4. What Will Investigators Look At?

If you are under investigation, one of your first questions may be: What are they actually looking for?

The answer depends on the case. Investigators may review medical records, wound measurements, photographs, physician orders, billing codes, product quantities, patient histories, and Medicare claims.

They may also look at emails, text messages, financial records, referral arrangements, and communications with marketers or product companies.

The government may compare those records to determine who made treatment and billing decisions, whether the products were medically necessary, whether patients actually received them, and where the money went.

This does not mean every unusual record or billing decision proves criminal conduct. The full context behind those records can be important.

5. What Charges Could You Be Facing?

“Skin substitute fraud” is not one specific criminal charge. Depending on what investigators believe happened, a case could involve healthcare fraud, wire fraud, conspiracy, false statements, kickback allegations, or money laundering.

Some investigations may also involve civil claims under the False Claims Act.

What you could be facing depends heavily on your role. A physician who ordered treatment, a clinic owner who handled billing, and a marketer who arranged referrals may have very different involvement in the same investigation.

That is why it is important to understand exactly what the government believes you did before trying to explain or defend your actions.

6. What Happens If Federal Investigators Contact You?

Being contacted by federal agents or receiving a subpoena does not necessarily mean you have been charged with a crime.

You could be a witness, a subject of the investigation, or a target. Determining where you stand is one of the first things your attorney will want to understand.

If investigators contact you, do not alter or destroy records. Preserve emails, text messages, patient records, billing documents, and other relevant information. You should also avoid guessing or trying to explain complicated billing decisions on the spot.

Most importantly, consider speaking with a criminal defense attorney before giving investigators a statement. What you say early in an investigation can affect what happens later.

Barry Wax understands that a criminal investigation affects more than a case file. Your career, business, professional license, reputation, finances, employees, and family may all be affected. He takes the time to understand the person behind the allegation and explain what is happening in terms you can understand.

If you are facing a federal skin substitute or healthcare fraud investigation in Miami or South Florida, contact the Law Offices of Barry M. Wax to understand your options and make informed decisions about what comes next.

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