DPC Services That Are Not Covered


This page summarizes DPC services not covered by the plan due to:

  • Lack of FDA approval
  • Classification as experimental/investigational
  • Absence from the plan’s Summary Plan Description (SPD)

A service must be listed or clearly defined in the SPD to be covered. If it is not FDA approved or not included in the SPD, it is typically excluded.

Why FDA Approval Matters

FDA approval ensures:

  • Safety and efficacy
  • Clinical validation
  • Standardized dosing/formulation

Services, drugs, or devices without FDA approval are considered experimental, and the plan excludes them unless specifically added to the SPD.

Why Services Must Be in the SPD

  • ERISA compliance: Plans must follow written terms.
  • Consistency: Ensures fair administration for all members.
  • Cost predictability: Prevents unplanned benefit expansion.
  • Clinical appropriateness: Aligns coverage with evidence-based care.

If a service is not in the SPD, it is not covered.

Common DPC Services Not Covered or Limited Due to FDA Status

Below is a streamlined list of services often offered by DPCs that may lack FDA approval or may be excluded unless included in the SPD.

Not FDA Approved (Fully Excluded)

  • Compounded medications (including compounded hormones and compounded GLP-1s)
  • PRP injections (Platelet-Rich Plasma)
  • Seed cycling
  • IV nutritional therapy (for wellness, energy, immune boosting)
  • Shock Wave Therapy for non–FDA-approved indications
  • SoftWave Therapy is not FDA-approved for musculoskeletal repair, chronic pain treatment, erectile dysfunction, neuropathy, or regenerative claims
  • Food allergy Oral Immunotherapy (OIT) outside FDA-approved products

FDA-Approved in Narrow Circumstances (Other uses excluded)

  • Hyperbaric Oxygen Therapy (HBOT) — approved only for:
    • Gas embolism, CO poisoning, decompression sickness
    • Gas gangrene, crush injuries, radiation tissue damage
    • Severe anemia (when transfusion not possible)

    • Certain skin grafts/flaps and thermal burns

      Shock Wave Therapy (ESWT) — approved for:

    • Chronic plantar fasciitis
    • Limited approvals for lateral epicondylitis

  • Allergy therapies: Only FDA‑approved SLIT tablets (ragweed, dust mite, etc.) are covered. Protocol‑based OIT is not.

    SoftWave Therapy (Extracorporeal Shockwave Device – unfocused acoustic wave therapy) - approved for:

    • improving local blood circulation
    • reducing minor aches/pains
    • activating connective tissue

Mixed FDA Status (Coverage varies by SPD)

  • Bioidentical Hormone Replacement Therapy (BHRT):
    • FDA‑approved hormones exist

    • Compounded BHRT is not FDA approved → excluded

      Infertility services:

    • FDA‑approved medications exist but are not covered by the plan

    • Procedures (IVF, IUI, monitoring) are not regulated by FDA → excluded

      Medical weight loss programs:

    • FDA‑approved medications exist (e.g., GLP‑1s) must go through the PBM and follow the regular PA requirements
    • Peptides, compounded GLP‑1s, and supplement protocols → not FDA approved

Summary

Any service or therapy that is not FDA approved, considered experimental, or not included in the plan’s SPD is not covered. FDA approval sets the minimum standard for safety and efficacy, and the SPD defines what benefits the plan can pay for.

If a service is not FDA approved or not written into the SPD, it should be considered non‑covered by default.