Medical Aesthetics & Medspa

Account accountability under a medical director model

If your medspa uses a medical director model, decide whether biologics purchasing routes through that physician's NPI-verified account, and keep that verification current.

Have the practice document who may order under its verified account in writing. Clinical-use decisions remain with the physician regardless of who places an order.

• Decide how biologics purchasing routes through the medical director's account
• Keep the account holder's NPI verification current
• Document in writing who may place orders under the verified account
• Document the medical director's review of each new product category

Verifying supervision and delegation requirements

Supervision, delegation, and scope-of-practice rules for non-physician staff vary by state and change over time. Verify current requirements with the state medical board and your own counsel rather than relying on a vendor's claims.

Confirm staff roles and applicable supervision requirements with the practice's counsel, and revisit that confirmation if staffing or state rules change.

• Confirm current supervision rules with the state medical board, not the vendor
• Review delegation rules with counsel
• Re-verify requirements when state rules or staffing roles change
• Keep a written record of supervision policy for inspection readiness

Documentation standards under heightened scrutiny

This category has drawn FDA warning letters over disease and treatment claims made by distributors and clinics, so the documentation a vendor provides, and how it is stored and presented internally, carries real weight independent of any marketing claims the practice itself avoids making.

FDA states there are no FDA-approved exosome products. Exosome products are generally regulated as biologic drugs under section 351, and purchase and clinical-use decisions for any product belong to the physician and their own regulatory counsel.

These products are not FDA approved or licensed for any disease or condition. Information here is for licensed healthcare professionals and is not medical or legal advice.

• Keep complete lot documentation on file, independent of marketing materials
• Avoid relying on vendor marketing language in practice-facing materials
• Store documentation where it can be produced quickly on request
• Review intended use and marketing language with counsel periodically

Account verification and ordering access

Account verification requires an NPI number. Confirm account authorization arrangements, including who else at the practice may request or receive inventory, before ordering.

Ask what information is required for an authorized practice representative to manage a verified account, so the internal process for requesting and receiving inventory is clear to everyone involved.

• Confirm what NPI information the vendor requires for account verification
• Document the internal process for requesting and receiving inventory
• Confirm whether the vendor re-checks account verification periodically
• Decide who controls account credentials internally