E78.00 — Pure hypercholesterolemia, unspecified
ICD-10-CM
Prior Authorization
No Prior Auth Required
Code is covered without prior authorization (high confidence)
Documentation Required
- Medical records for each visit must clearly document the medical necessity for apheresis, including which pharmacologic agents were tried and the details of lifestyle changes attempted.
- If statin intolerance is claimed, the record must contain the actual findings and symptoms reported that support intolerance.
- Clinical notes supporting the need for apheresis must be signed by the treating provider and dated for the date of service.
- Claims may require submission of supporting documentation for pre- or post-payment review by Noridian or authorized Medicare auditors.
Key Coverage Criteria
- Plasma apheresis is covered for functional homozygotes with familial hypercholesterolemia who have an LDL cholesterol > 500 mg/dL and who remain refractory to appropriate lifestyle changes and maximal statin therapy with or without ezetimibe.
- Plasma apheresis is covered for functional heterozygotes with familial hypercholesterolemia who have no known cardiovascular disease and an LDL cholesterol > 300 mg/dL despite appropriate lifestyle changes and maximal statin therapy with or without ezetimibe.
- Plasma apheresis is covered for functional heterozygotes with familial hypercholesterolemia who have known cardiovascular disease and an LDL cholesterol > 200 mg/dL despite appropriate lifestyle changes and maximal statin therapy with or without ezetimibe.
- Plasma apheresis is covered for familial hypercholesterolemia during pregnancy when the treating physician documents that usual therapy is inadequate to assure uteroplacental perfusion.
- For tests that currently lack specific CPT codes (functional intracellular analysis and total antioxidant function), bill using CPT 84999 and add a note identifying which test was performed in the Remarks area for Part A claims and the Narrative area for Part B claims.
- Coverage and reasonable/necessary determinations for assays for vitamins and metabolic function are governed by LCD L34914 and claims must meet that LCD's requirements to be covered.
20 Active Policies
L40271 — MolDX: Biomarker Testing for Risk Stratification in Metabolic Dysfunction-Associated Steatotic Liver Disease and Metabolic Dysfunction-Associated Steatohepatitis
J05
A57559 — Billing and Coding: MolDX: Biomarkers in Cardiovascular Risk Assessment
J05
L36523 — MolDX: Biomarkers in Cardiovascular Risk Assessment
J05
A60305 — Billing and Coding: MolDX: Biomarker Testing for Risk Stratification in Metabolic Dysfunction-Associated Steatotic Liver Disease and Metabolic Dysfunction-Associated Steatohepatitis
J05
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