Is Orthobiologics Covered by Insurance? Full Coverage Guide

Insurance Coverage for Orthobiologics Explained

Understanding Why Insurance Hesitates to Cover Orthobiologics

Orthobiologics—biological products used to support healing in bones, joints, tendons, and ligaments—have become increasingly common in non-surgical care. They include options like Platelet-Rich Plasma (PRP), stem cell-based injections, and hyaluronic acid (HA) treatments. These therapies are often offered in orthopedics, pain management, and sports medicine clinics as alternatives to steroid injections or surgery.

Yet despite their growing use, many patients are surprised to learn that most orthobiologic treatments are not covered by insurance. Whether you’re a patient hoping to avoid surgery or a caregiver researching options, understanding why insurers hesitate is essential for planning both care and costs.

If you’re unfamiliar with the basics of these therapies, start by reading A Complete Guide to Orthobiologics in Regenerative Medicine for an overview of what they are and how they work.

What Are Orthobiologics and How Are They Used?

Orthobiologics refer to substances made from the body (or biocompatible sources) that can support the healing of musculoskeletal tissues. Common examples include:

• PRP (Platelet-Rich Plasma): Prepared from a patient’s own blood to concentrate growth factors that support tissue repair.
  

• Stem cell-based products: Typically derived from bone marrow aspirate or adipose tissue; used to support regeneration in cartilage or soft tissues.
  

• Hyaluronic acid (HA): A lubricating substance often injected into arthritic joints to improve mobility and reduce discomfort.
  

Clinicians use these treatments to help patients with early arthritis, chronic tendon injuries, and joint pain who want to delay or avoid surgery. To see how these therapies are applied in real clinical settings, read our companion guide on Practical Uses of Orthobiologics in Modern Medicine.

Why Most Insurers Don’t Cover Orthobiologics

While orthobiologics have shown potential benefits, insurance companies typically label them as “experimental” or “investigational.” This classification is the primary reason claims are denied.

1. Lack of Long-Term Standardized Evidence

Insurers often require large, multi-year clinical trials proving consistent safety and effectiveness before covering a treatment. PRP, for example, has many small studies showing short-term symptom relief, especially for osteoarthritis, but there’s still variation in:

• How PRP is prepared (single vs. double spin, leukocyte-rich vs. poor)
  

• How many injections are given
  

• Which conditions respond best
  

Without clear, uniform protocols, insurers argue the data is not strong enough to warrant broad coverage.

2. Regulatory Definitions Limit Coverage

Many orthobiologic procedures fall outside traditional FDA approval pathways. For example, PRP is regulated under the “practice of medicine” and blood handling rules rather than as an FDA-approved drug. This regulatory gray area gives insurers grounds to reject claims as non-standard.

3. Cost-Containment Priorities

Even when evidence shows potential, insurers weigh the cost of adding a new therapy. Orthobiologics can range from $500–$3,000 per session, and many require multiple sessions. Until coverage policies change, payers often prefer lower-cost, established treatments like corticosteroid injections or physical therapy.

Why Are PRP Injections Not Covered by Insurance?

Patients frequently ask, “Why is PRP not covered by insurance?” The short answer is that PRP is still labeled investigational.

Insurers argue that the benefit depends heavily on preparation method, provider skill, and patient biology—making it difficult to guarantee predictable outcomes. In addition, PRP is not a manufactured drug with FDA approval, so insurers are not required to include it in standard benefits.

Some private plans allow partial coverage if PRP is used during surgery (such as tendon repair), but standalone PRP injections for arthritis or sports injuries are almost always self-pay.

Why Is Regenerative Medicine Not Covered by Insurance?

Orthobiologics fall under the broader category of regenerative medicine, which focuses on supporting the body’s natural repair processes. Because this field is still developing, most regenerative procedures are excluded from insurance coverage.

Insurers say they need:

• Clear FDA approval or device clearance
  

• Clinical guidelines from specialty societies
  

• Long-term data from large randomized controlled trials
  

Until these elements are in place, regenerative techniques—including PRP, stem cells, and microfat grafting—remain classified as elective.

For context on how these therapies fit within musculoskeletal care, see our explainer Biologics in Orthopedics Explained.

Are There Any Exceptions?

While rare, there are a few situations where insurance may cover parts of an orthobiologic procedure:

• During surgery: Some plans cover PRP or bone graft substitutes used intraoperatively in spine or joint repair.
  

• Worker’s compensation cases: Occasionally approved if deemed necessary for returning to work.
  

• Clinical trials: Patients enrolled in approved research studies may have costs covered.
  

• Medicare: Generally does not cover orthobiologics but may cover certain FDA-approved bone graft substitutes. See our full guide on Medicare Coverage for Orthobiologics.
  

Always check with your insurer and get prior authorization when possible.

What Patients Should Expect to Pay

Because most orthobiologic treatments are considered elective, clinics typically require out-of-pocket payment.
Typical price ranges:

Patients should also plan for:

• Multiple sessions (especially with PRP or stem cells)
  

• No reimbursement from insurance or HSAs unless used intraoperatively
  

• No retroactive coverage even if results are positive
  

Clinics should provide clear written estimates and payment plans before starting care.

Key Misconceptions About Coverage

Talking to Your Insurer: Questions to Ask

If you are exploring orthobiologic therapies, contact your insurance provider and ask:

• Is this therapy listed as investigational or experimental?
  

• Are any components covered if used during surgery?
  

• Does my plan allow out-of-network reimbursement for elective care?
  

• Will I need prior authorization or supporting documentation from my physician?
  

• Are payment plans available through the clinic if not covered?
  

Document every conversation and ask for written responses whenever possible.

The Bottom Line

Insurance companies are cautious about covering orthobiologics—not because they’re unsafe, but because the field is still developing and lacks standardized long-term data. Until coverage expands, patients considering these therapies should be prepared for self-pay costs and should base their decision on clear medical advice, not insurance expectations.

By understanding the reasons behind non-coverage, patients and caregivers can make informed choices about whether orthobiologics fit into their care plan—and budget.

About Me

I’m Oscar Tellez, I’ve spent the past 10 years working in regenerative medicine. My focus is on advancing safe, evidence-based applications of PRP, fat, bone marrow, birth tissues such as Wharton’s Jelly, exosomes, and cell factors.I share insights designed to help clinicians responsibly integrate regenerative care into their practice while staying compliant with FDA, FTC, and DEA guidelines.

You can connect with me directly on [Website], [LinkedIn] and [Facebook].

DISCLAIMER:
This content is for educational purposes only and is not intended as medical or legal advice. Regenerative medicine products and therapies are subject to FDA, FTC, and DEA regulations. Clinicians should verify compliance and consult with qualified professionals before offering these treatments.