Every year, when ICD-10, CPT, and HCPCS Level II codes are updated, NCDs (and Local Coverage Determinations) must also be updated

Food & Drug Administration (FDA) FDA grants accelerated approval to elamipretide (Forzinity) as first treatment for Barth syndrome (2025) Journal of the American College of Cardiology (JACC) PROGRESSHF trial: safety and tolerability of elamipretide in heart failure patients Neurology (AAN Journals) MMPOWER2 trial: elamipretide in primary mitochondrial myopathy Genetics in Medicine (Nature) TAZPOWER trial: efficacy and safety of elamipretide in Barth syndrome Biochimica et Biophysica Acta (BBA) Bioenergetics Cardiolipin remodeling and cristae structure: role in mitochondrial function Journal of Cardiovascular Pharmacology (PMC) SS31 reduces oxidative stress and improves mitochondrial bioenergetics Alzheimers Drug Discovery Foundation Cognitive Vitality Report: SS31 (elamipretide) preclinical and clinical overview Orphanet Journal of Rare Diseases (PMC) Barth syndrome: clinical presentation, diagnosis, and emerging therapies Centers for Disease Control and Prevention (CDC) Vaccine administration: subcutaneous injection technique (angle, site selection, no aspiration) Johns Hopkins Arthritis Center Patient guide: how to give a subcutaneous injection (stepbystep instructions) NCBI Bookshelf (StatPearls) Best practices for injection: aseptic technique, preparation, and administration Pharmacologic Considerations of Subcutaneous Drug Administration (PMC) Site rotation, absorption kinetics, and prevention of lipohypertrophy Related research, protocols, and guides Explore the available research context, protocol variants or comparisons, and practical guides

Pick up from the Hotel
At 90 days, the treatment group demonstrated a higher mean HRQoL score, particularly in the pain domain
Maintenance doses are then tailored to keep those levels topped up, and their duration of effect is directly tied to the prescribed frequency (e.g., a shot every 12 weeks for many)