Obtain authorization and ensure medical necessity

Services must meet authorization and medical necessity guidelines; coverage does not guarantee reimbursement and is subject to member benefit details and state residence. Providers are responsible for submission of accurate documentation of services performed and coding according to industry standard coding guidelines; failure to follow guidelines may result in denial or recoupment.

• Coverage is contingent on meeting authorization and medical necessity for the procedure, diagnosis, and member's state of residence.
• Claims may be denied or recouped if coding/billing guidelines or current reimbursement policies are not followed.

Specify proprietary NIPS test and indication on the order

When ordering a proprietary NIPS/NIPT assay, document the specific test name and the clinical indication. Positive screening results must be followed by diagnostic confirmation (CVS or amniocentesis) per guidelines.

• Specify the proprietary test name (e.g., Harmony™, Panorama, MaterniT21™) on the order.
• Document indication for testing and plan for confirmatory diagnostic testing if screen-positive.

Prior authorization may be required for listed cfDNA CPT codes

Prior authorization may be required for molecular/cfDNA procedure codes listed in the policy; when applicable follow payer prior authorization processes for the enumerated CPT codes.

• Key cfDNA CPT codes listed include 81420, 81422, and 81507.
• Confirm payer prior authorization requirements for these codes before testing.

Follow payer prior-authorization procedures for listed prenatal codes

Prior authorization processes may apply to the broader set of prenatal screening and diagnostic CPT/HCPCS codes enumerated in the policy; follow payer-specific prior authorization workflows when ordering these services.

• Codes covered by prior auth processes include 81420, 81422, 81507 and additional biochemical and cytogenetic procedure codes (see policy code list).
• Verify prior authorization for amniocentesis/CVS and associated cytogenetic testing codes when applicable.

Step therapy: not applicable

No step therapy requirements are specified in this excerpt.

Follow-up actions for no-call or low fetal-fraction NIPS

If NIPS yields a no-call or is limited by low fetal fraction (e.g., early gestational age <10 weeks or high maternal BMI), consider alternative or additional screening or diagnostic options such as maternal serum AFP in the second trimester, repeat blood draw, or offer invasive diagnostic testing.

• Inform patient that no-call results are associated with increased aneuploidy risk and require additional investigation.
• Options include repeat cfDNA draw, maternal serum AFP (second trimester), comprehensive ultrasound, or CVS/amniocentesis for diagnostic confirmation.

Use a single prenatal screening approach and document choice

If a patient accepts screening, document and perform a single prenatal screening approach rather than multiple simultaneous screening tests per professional guidance.

• Do not perform parallel or simultaneous screening methodologies for the same pregnancy.
• Document the chosen screening approach in the medical record.

FDA advisory and remaining provider actions (reserved)

(Reserved) Consolidate any additional provider-action notes from source chunk 54 as applicable.

• Be aware of FDA communications noting NIPS are screening tests and not diagnostic; providers should not rely on NIPS alone to diagnose chromosomal abnormalities.

Submit accurate documentation and compliant coding

Providers must submit accurate clinical documentation and code claims according to industry-standard guidelines; failure to provide complete and accurate documentation and correct codes may result in claim denial or recoupment.

• Ensure coding follows CPT, ICD-10, HCPCS and payer-specific instructions when submitting claims.
• Maintain source clinical documentation to support medical necessity.

Document gestational age, maternal BMI, and fetal fraction when ordering/interpreting NIPS

When ordering or interpreting NIPS, document gestational age at blood draw, maternal BMI, and fetal fraction (when reported) and include any relevant prior ultrasound findings; note that positive NIPS results require follow-up diagnostic testing (CVS or amniocentesis) for confirmation.

• Record gestational age (cffDNA usually detectable by 6–7 weeks; fetal fraction typically ≥3–4% by 10 weeks).
• Record maternal BMI and any ultrasound findings that could affect interpretation.
• Document fetal fraction where provided by the lab and plan for confirmatory testing if positive.

Document counseling, informed consent, and genetic counseling offer

Document that prenatal genetic screening and diagnostic testing options were discussed with the patient and that informed consent and genetic counseling were offered when screening or diagnostic testing is performed.

• Record that counseling on available screening and diagnostic options occurred and whether the patient accepted or declined testing.
• Note if formal genetic counseling was provided or offered prior to testing.

Document counseling on NIPS benefits, risks, limitations, and results discussion

Document that the benefits, risks, and limitations of NIPS were discussed with the patient and that results were reviewed with a genetic counselor or other healthcare provider prior to making pregnancy management decisions.

• Specifically document discussion of NIPS limitations and FDA advisory that NIPS are screening tests and not diagnostic.
• Record that results and next-step recommendations (including need for diagnostic confirmation if positive) were discussed with the patient.

Risk of denial or recoupment for coding/documentation errors

Claims may be denied or recouped if coding/billing guidelines or current reimbursement policies are not followed or if documentation is inaccurate or incomplete.

• Ensure adherence to payer policies and timely submission of supporting clinical documentation to avoid denials or recoupment.

Manage and document no-call or insufficient fetal fraction results

Samples with insufficient fetal fraction (for example early gestational age <10 weeks or high maternal BMI) can yield test failure/no-call results; no-call outcomes are associated with increased aneuploidy risk and require additional investigation and documentation.

• Document the no-call and fetal fraction data in the chart and counsel the patient on increased aneuploidy risk.
• Offer follow-up options: repeat draw, maternal serum AFP, comprehensive ultrasound, or invasive diagnostic testing as appropriate.

Do not rely on NIPS alone for diagnostic decisions (FDA caution)

The FDA warns that NIPS are screening tests and can give false results; using NIPS results alone to make diagnostic determinations or to base definitive pregnancy decisions risks inappropriate care. Providers should counsel patients accordingly and document counseling and follow-up plans.

• Discuss FDA safety communication with patients and document that results are screening only.
• Do not use NIPS results alone to make definitive pregnancy management decisions without confirmatory diagnostic testing.

Offer and document confirmatory diagnostic testing for positive/equivocal NIPS

Use of NIPS results alone to diagnose chromosomal abnormalities is not appropriate; confirmatory diagnostic testing (CVS or amniocentesis with karyotype or microarray) should be offered for positive or equivocal NIPS results and this plan should be documented.

• Document the recommendation and patient decision regarding confirmatory invasive diagnostic testing following a positive NIPS.
• Record that reliance solely on NIPS for diagnosis is inappropriate and note any counseling provided.