88235
HCPCS/CPT
Prior Authorization
No Prior Auth Required
Code is covered without prior authorization (high confidence)
Medicare Pricing
Work RVU
0.00
Facility
N/A
Non-Facility
N/A
Documentation Required
- No documentation requirements for coverage are specified because the tests are considered experimental/investigational and not covered.
- The policy and cited guideline language recommend that participation in clinical trials evaluating these technologies remains a priority; therefore, documentation supporting enrollment in an IRB-approved clinical trial may be required when tests are used in that research context (policy: "Because the in-vitro analytic strategy has potential importance, participation in clinical trials evaluating these technologies remains a priority").
- Clinical documentation confirming type of pregnancy loss (miscarriage, IUFD, stillbirth) and medical indication for genetic testing.
- Documentation of specimen source and availability (POC, amniotic fluid, CVS, PUBS) and confirmation that fresh tissue was submitted when applicable.
Key Coverage Criteria
- Explicit technologies/procedures designated investigational (no covered indications listed): ChemoFx assay; differential staining cytotoxicity (DiSC) assay; fluorescence (Cytoprint) assay; human tumor cloning assay (HTCA); human tumor stem cell assay; methyl thiazolyl-diphenyl-tetrazolium bromide (MTT) assay; microculture kinetic (MiCK) apoptosis assay (also known as CorrectChemo); NexGen Cancer Cytotoxicity Assay; 3D Predict Glioma (Kiyatec Inc.); Reverse Phase Protein Array (Theralink).
- None. (No indications for which chemosensitivity assays are considered covered are stated in this policy.)
- Prenatal diagnostic evaluation for suspected Noonan spectrum disorders / RASopathies (as referenced).
- Prenatal diagnostic testing to identify genetic conditions in fetuses at increased risk based on abnormal prenatal screening results.
- Prenatal diagnostic testing for women who elect diagnostic testing due to other risk factors (e.g., abnormal ultrasound findings).
- Prenatal diagnostic testing for women with a history of a previous pregnancy affected by aneuploidy.
2 Active Policies
AMBETTER-CG-Prenatl-Diag-via-Amn-etc.-Preg-Loss-2025.1 — Concert Genetic Testing: Prenatal Diagnosis (via Amniocentesis, CVS, or PUBS) and Pregnancy Loss
AETNA-CPB-0245 — Tumor Chemosensitivity Assays
Related Codes
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