Responding to an OIG Subpoena in a Wound Care Investigation

An OIG subpoena reaching a wound care practice today rarely arrives alone. The Department of Health and Human Services Office of Inspector General is in the middle of a Medicare Part B review of skin substitute billing, Work Plan item OAS-25-09-005, examining 2020 through 2023 claims billed at $100 to more than $1,000 per square centimeter. A wound care provider or skin substitute supplier served with one of these subpoenas is already inside that review, or one like it, and the subpoena is the first formal signal of it.

OIG's Subpoena Authority

Under 5 U.S.C. Section 406, an Inspector General may subpoena the production of documents, records, and electronically stored information relevant to an investigation. The authority reaches private parties, including wound care practices and skin substitute distributors, but Congress barred its use against federal agencies themselves, and it reaches records only, not testimony. If the recipient refuses to comply, OIG's recourse is to ask a federal district court to enforce the subpoena; refusal alone is not contempt of court. This civil, document-focused authority is distinct from a DEA administrative subpoena, which a wound care practice that dispenses controlled substances might separately encounter.

Why Skin Substitute Billing Draws Scrutiny

Skin substitute billing is the category OIG is reviewing under Work Plan item OAS-25-09-005, announced in November 2024, because Medicare Part B payments for these products increased substantially across the 2020 through 2023 period the review covers. Coverage for a given skin substitute and wound type generally follows the local coverage determination, which generally covers diabetic foot ulcers and venous leg ulcers that have not responded to at least 4 weeks of standard wound care; other wound types have no national or local coverage requirement and are decided case by case. A practice's debridement and application coding has to match what that LCD allows before the product is applied. DOJ's $279,912,916 civil False Claims Act settlement with Apex Medical and Alexandra Gehrke, alongside a separate $30 million settlement from co-defendant Jeffrey King, announced by DOJ in December 2025, resolved allegations tied to more than $1.2 billion in false claims for unnecessary amniotic skin substitutes and reflects the same billing category OIG's Work Plan now targets.

Preserving Documents and Privilege

Once a subpoena arrives, the practice should issue a litigation hold covering emails, billing records, compliance logs, and clinical charts named in the request, not just the records already gathered for daily operations. Altering or destroying a record covered by the subpoena, including a signature log or an attestation created after the fact to patch a gap, risks exposure under 18 U.S.C. Section 1519, which punishes the knowing alteration or falsification of a record made with intent to obstruct a federal investigation, by up to 20 years. Keeping the investigation under counsel's direction, rather than letting compliance or billing staff run it independently, is what preserves attorney-client privilege and work product protection over interview notes and internal findings; an investigation begun before counsel is involved can lose that protection for the portion already done.

A subpoena naming a wound care practice's skin substitute billing is not a warning that a federal inquiry may follow. It means one has already started.

Scope Negotiation and Staff Communications

Counsel, not the practice, should be the point of contact with the OIG attorney or agent who issued the subpoena, negotiating the production timeline and narrowing requests that reach beyond the matters actually under review. Internal discussion of the subpoena should be limited to counsel and the designated compliance contact; staff whose wound care documentation or billing falls inside the request should be told the document pull or interview is occurring at counsel's direction, not instructed on what to say. The same exposure reaches a wound care practice's structure, not only its charts. See Wound Care Management Companies: MSO Structure and Fee Risk and Wound Care Nurse Practitioner Billing Compliance for how those arrangements draw separate scrutiny, and Wound Care LCD Compliance Across MAC Jurisdictions for the coverage rules behind the clinical chart itself.

Why Early Legal Counsel Is Critical

It is critical that wound care providers and skin substitute suppliers promptly retain experienced healthcare defense counsel upon receiving an OIG subpoena or other government inquiry. Early legal intervention can protect the provider's rights, narrow production to the matters actually under review, avoid inadvertent admissions in cover letters or staff interviews, and preserve attorney-client privilege and work product protection over the response. Delaying representation can shorten the time counsel has to negotiate scope and increase the exposure if the subpoena is the leading edge of a broader skin substitute billing inquiry.

How Health Law Alliance Can Help

Health Law Alliance has represented wound care practices and skin substitute suppliers navigating Medicare Part B billing reviews and the subpoenas that can follow them. Health Law Alliance's attorneys have overseen 2,000+ audits and handled 5,000+ matters, with 25+ years of experience. If your practice has received an OIG subpoena naming skin substitute, debridement, or other wound care billing, contact Health Law Alliance's wound care audit defense attorneys for a free, confidential consultation before any document is produced.