This piece supports our complete guide to adding cash pay regenerative and wellness services to an ortho or sports medicine practice.

What is regenerative medicine?

It's a broad term for products and approaches built around cells, tissues and related biologic materials. FDA's framework for regenerative medicine products covers areas such as cell therapies, therapeutic tissue engineering products, human cell and tissue products and combination products.

The term describes a category, not an approval. Two products described as regenerative can sit in very different regulatory positions, so every decision has to start with the specific product.

Is regenerative medicine FDA approved?

Some specific products are. Many products marketed as regenerative are not FDA approved for the claims made about them. FDA has issued a consumer alert about regenerative medicine products, including stem cells and exosomes, marketed with claims FDA hasn't approved.

So the honest answer for a practice is: check each product. Look for it on FDA's list of approved cellular and gene therapy products, read the consumer alert, and have your healthcare counsel confirm how the product is regulated and how you may describe it. Follow current FDA guidance, and recheck when it changes. Never call a product approved unless FDA has approved it for that use.

Step 1: Write down the regulatory scope

For each product or service on your list, record:

  • What it is and who makes it
  • Its current FDA status, with the source and the date you checked
  • How your counsel says it may be described publicly
  • Any state rules that apply

If a product's status is unclear, it's not ready.

Step 2: Name the clinical owner

Pick the licensed provider who owns the service line. In North Carolina, physicians are licensed by the NC Medical Board, and NPs and PAs practice within their own license and the supervision or collaboration rules that apply to them. Document each relationship. Every treatment should be prescribed and supervised by your licensed provider.

Step 3: Set up licensed supply

Verify each supplier's license yourself, through the NC Board of Pharmacy or FDA's lists where they apply. Expect the supplier to verify your clinic too. Require lot numbers and documentation with every shipment, store products according to labeling, and keep a receiving log.

Step 4: Build cash pay consent and posted fees

The new services are cash pay only. Post the cash fees in writing, add a service specific consent, and have patients sign a short financial policy before the visit. Our sibling piece on cash pay services in a sports medicine clinic covers the details.

Step 5: Set up systems and train the team

Add visit types, templates and consent forms to your EMR. Add separate cash pay items to your payment system. Train staff on a simple rule: staff handle logistics, fees and policies, and providers handle every clinical question.

Step 6: Soft open, then decide

Set a go or no go review before opening. Then see a small, capped group of invited patients, fix what breaks, and only then widen access. As RevMed puts it: "Marketing starts only after 30 days of real operation."

How should we talk about it?

Describe what the service is, who provides it and how to book a consult. Leave out results, timelines and patient stories about outcomes. Have counsel review every page and ad.

Where do we and RevMed fit?

We're an independent RevMed Group distribution partner based in Raleigh, so you have a local contact who knows your market. We'll get your RevMed account open and make introductions. Verification, ordering, fulfillment and launch support run through RevMed, and RevMed's launch team runs its Service Line Launch on a fixed 60 day calendar for established practices adding a peptide, wellness and longevity service line.

As RevMed puts it: "One login, one invoice, and reorders on your schedule instead of a dozen vendor portals." Once you're verified through RevMed, existing practices can be ordering within about 48 hours. RevMed also says ordering through one source means a lower cost per item. You'll see clinic pricing once you're verified.

Clinical decisions stay with your providers, and no revenue is guaranteed.

Next step

Planning a regenerative service line? Book a 15 minute intro, or open your clinic account through our Partner Link.