Are Orthobiologics Covered by Medicare? Coverage Explained

Orthobiologics and Medicare: What’s Covered and What’s Not

Understanding Medicare’s Stance on Orthobiologics

Orthobiologics—like platelet-rich plasma (PRP), stem cell-based injections, and hyaluronic acid—are increasingly offered in orthopedic and sports medicine clinics to support joint, tendon, and ligament healing. Many older adults see them as a possible alternative to surgery or long-term steroid use.

But one of the most common questions caregivers and patients ask is: are orthobiologics covered by Medicare?

The short answer is no, and this often causes confusion for seniors trying to plan their care and costs. If you want to understand the broader reasons insurers are hesitant, see our full guide on Insurance Coverage for Orthobiologics Explained.

What Are Orthobiologics and How Are They Used?

Orthobiologics are biologically based substances used to support the body’s natural repair processes. They’re most often used in musculoskeletal care for:

• Early arthritis and joint degeneration
  

• Chronic tendon or ligament injuries
  

• Pain that hasn’t improved with physical therapy or steroids
  

Common orthobiologics:

• PRP (Platelet-Rich Plasma): Concentrated platelets from your blood, rich in growth factors that support tissue recovery.
  

• Stem Cell-Based Therapies: Prepared from bone marrow or adipose (fat) tissue, sometimes used for cartilage and tendon support.
  

• Hyaluronic Acid (HA): A joint lubricant that can improve mobility in osteoarthritis.
  

These therapies are usually performed in outpatient clinics as an alternative to surgery.

Are Orthobiologics Covered by Medicare?

Currently, orthobiologics are not covered by Medicare.

Medicare labels these procedures as “investigational” or “experimental.” The Centers for Medicare & Medicaid Services (CMS) only reimburse treatments that are considered medically necessary and supported by strong, standardized clinical evidence.

Because orthobiologics lack long-term, large-scale trial data and have significant variability in preparation methods, CMS does not include them in standard benefits.

So if your clinic submits a claim, Medicare is likely to deny it—even if your doctor recommends the treatment.

Does Medicare Cover Biologics at All?

This is where much of the confusion begins. Many people assume that because Medicare covers some biologic drugs, it must also cover orthobiologics.

So, does Medicare cover biologics? Yes—but only certain FDA-approved biologic medications, not orthobiologics used in orthopedics.

Biologic drugs like Humira, Enbrel, and Remicade (used for rheumatoid arthritis or Crohn’s disease) are covered under:

• Medicare Part B if given in a clinic
  

• Medicare Part D if taken at home
  

However, these drugs are completely different from PRP, stem cell-based therapies, or HA injections. Medicare does not classify those as biologic drugs, so they are not covered.

Does Medicare Pay for PRP Treatments?

No, Medicare does not pay for PRP treatments for orthopedic use.

In 2019, CMS reviewed PRP and issued a decision memo:

• PRP may be covered for non-healing diabetic or venous wounds in limited pilot programs
  

• PRP is not covered for joint pain, arthritis, or sports injuries
  

So if you are asking “does Medicare pay for PRP?” or “does Medicare pay for PRP treatments?”, the answer is no—unless it is used for chronic wounds under strict conditions.

In all other orthopedic cases, PRP is considered elective and must be self-funded.

To understand the broader coverage gap, see Why Regenerative Medicine Isn’t Covered by Insurance.

Why Medicare Does Not Cover Most Orthobiologics

Medicare applies strict evidence and cost standards. Orthobiologics have not met these for several reasons:

• Lack of large clinical trials: There are promising small studies, but few long-term randomized trials with standardized protocols.
  

• No FDA drug approval: PRP and stem cells are processed at the point of care and are not FDA-approved medications.
  

• Variability in preparation: Different clinics prepare and inject these therapies in different ways, making results hard to predict.
  

• High elective cost: Because these treatments are expensive and considered optional, Medicare excludes them to control costs.
  

Rare Exceptions and Special Situations

While standard Medicare coverage excludes orthobiologics, a few rare exceptions exist:

• During surgery: If PRP or bone graft substitutes are used during spinal fusion or orthopedic surgery, they may be covered as part of the surgical materials.
  

• In clinical trials: Patients enrolled in CMS-approved research trials may receive partial coverage.
  

• Through Medicare Advantage: Some private Medicare Advantage plans may include regenerative services as supplemental benefits, but this is uncommon and varies by plan.
  

If you are planning treatment and want to estimate costs, see Cost of Orthobiologic Injections: What Patients Need to Know.

How to Confirm Coverage Before Starting Treatment

Because coverage is unlikely, it’s important to verify everything in writing before scheduling:

• Call 1-800-MEDICARE or your plan’s member services
  

• Ask your provider for the CPT/HCPCS billing code they will use
  

• Request a pre-determination of coverage from your plan
  

• Have your doctor submit a letter of medical necessity (this may be needed for an appeal later)
  

• Get an itemized cash-pay estimate from your clinic for comparison
  

If you’re comparing other regenerative therapies, see Prolotherapy and Insurance: A Patient’s Guide and Regenerative Injection Therapy Costs Explained.

What This Means for Seniors and Caregivers

Because orthobiologics are not covered by Medicare, seniors should:

• Expect to pay out of pocket
  

• Confirm if their Medicare Advantage plan offers any special coverage
  

• Ask clinics about payment plans or package pricing
  

• Avoid assuming that “FDA-cleared equipment” means Medicare approval
  

• Consider covered treatments like physical therapy or corticosteroids first if cost is a barrier
  

These treatments can be valuable, but must be seen as self-funded options for now.

Key Takeaways

• Are orthobiologics covered by Medicare? → No, not for orthopedic conditions
  

• Does Medicare cover biologics? → Only FDA-approved biologic drugs, not PRP or stem cells
  

• Does Medicare pay for PRP treatments? → Only in rare wound-care trials, not for arthritis or joint pain
  

• Medicare rarely covers regenerative therapies due to limited evidence and high cost
  

• Always verify in writing and prepare for self-pay costs
  

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.