Compounding is defined by the FDA as combining, mixing, or altering ingredients to create a medication tailored to an individual patient's needs; to be covered a compounded prescription must contain at least one federal legend drug and the active medication component must be in therapeutic amounts with safety and effectiveness supported by scientific literature or national compendia.
The CFS diagnostic policy aligns with the 2015 IOM (IOM) diagnostic criteria and NIH consensus recommendations: exclusionary screening laboratory and imaging tests (e.g., ANA, CBC, chemistries, thyroid tests, Lyme serology, MRI when indicated, polysomnography) are covered, while many specialized/investigational tests (eg, gene expression profiling, evaluation of mitochondrial disorders, enteric dysbiosis, RNase L assays) are not covered.
Estradiol pellet implantation is not covered: there are no FDA-approved commercially available implantable estradiol pellet formulations in the US, published data show unpredictable and fluctuating serum concentrations and concerns about release rates, reversibility, bleeding, infection, and limited safety evidence.
IV antibiotic therapy for Lyme disease is appropriate only in limited, specific circumstances (for example Lyme arthritis after oral antibiotic failure, cardiac conduction disease with PR prolongation, or objective neurologic complications) and evidence does not support prolonged or repeat IV courses; prolonged or repeat courses (>4 weeks) are considered not medically necessary based on RCTs and guideline statements.