Code is covered without prior authorization (high confidence)
Medicare Pricing
Work RVU
0.52
Facility
$187.71
Non-Facility
$187.71
Documentation Required
Rigorous clinical evaluation should precede diagnostic molecular testing.
Disease-specific diagnostic criteria or clinical findings as listed throughout the policy must be documented (e.g., Amsterdam II or revised Bethesda for Lynch syndrome; Schwartz score for LQTS; clinical criteria for Marfan Syndrome [see Appendix]; clinical features lists for Angelman, Prader-Willi, CADASIL, etc.).
For general medical necessity: documentation that all of the following are met: The member displays clinical features, or is at direct risk of inheriting the mutation (pre-symptomatic); and The result of the test will directly impact the treatment being delivered to the member; and After history, physical examination, pedigree analysis, genetic counseling, and completion of conventional diagnostic studies, a definitive diagnosis remains uncertain and a suspected diagnosis is listed; and Disease-specific criteria met.
Key Coverage Criteria
Loeys-Dietz syndrome (TGFBR1, TGFBR2): Testing medically necessary when: asymptomatic individual has affected first-degree relative with known deleterious mutation (test for familial mutation); or to confirm diagnosis in individual with LDS characteristics (begin with TGFBR2 sequencing, then TGFBR1 if negative).
Ask Verity about documentation requirements, denial risks, or coverage in your state.
For whole exome sequencing: documentation that member and family history have been evaluated by a Board-Certified or Board-Eligible Medical Geneticist; member receives pre- and post-test counseling by an independent provider (e.g., ABMG or ABGC-certified Genetic Counselor or APGN credentialed by GNCC or ANCC); alternate etiologies considered and ruled out when possible; clinical presentation does not fit a well-described syndrome for which single-gene/panel testing is available; WES more efficient than separate single-gene tests/panels; diagnosis cannot be made by standard clinical work-up (excluding invasive procedures); documentation that WES is predicted to have impact on health outcomes (treatment, surveillance, palliative care, reduce diagnostic uncertainty, or inform reproductive counseling).
Testing strategies often require documentation of family testing/results: e.g., specific familial APC, DMD, MUTYH, VHL, and many other genes—where a familial mutation is known, documentation of that mutation and rationale for targeted testing must be provided; full sequencing often only when family-specific mutation cannot be identified first.
For Factor V Leiden and F2 testing: documentation of abnormal APC resistance assay result (for Factor V Leiden) and clinical/family history indications as listed (e.g., first unprovoked VTE, recurrent VTE, VTE associated with OCP/HRT, pregnancy-related VTE, family history of VTE <50 years, etc.).