CurrentBlue Cross Blue Shield - Rhode IslandPolicy N/A

Medical Coverage Policy Expanded Molecular Panel Testing of Cancers to Identify Targeted Therapies

Defines medical necessity criteria for next-generation sequencing (NGS) expanded molecular panel testing of cancers to identify targeted therapies for BlueCHiP for Medicare and states that the use of expanded panels is not medically necessary for commercial products. Includes coding guidance and prior authorization requirement for Medicare product.

Policy Summary

PayerBlue Cross Blue Shield - Rhode Island

PolicyMedical Coverage Policy Expanded Molecular Panel Testing of Cancers to Identify Targeted Therapies

Policy CodePolicy N/A

Change Typeclarified

Effective DateApr 1, 2018

Next Review Date

Key ActionPrior authorization is required for BlueCHiP for Medicare for the CPT codes listed (e.g., 0036U, 0037U) and for NGS testing to be considered medically necessary the listed clinical criteria must be met.

SourceLink

POLICY UPDATE CHANGES

CMS national coverage determination that NGS is reasonable and necessary when performed in a CLIA-certified laboratory, ordered by a treating physician, and criteria are met is noted and applied to BlueCHiP for Medicare.

2Product stances (Medicare vs Commercial)

2New CPT codes effective 2018-04-01 listed

Coverage Summary

Overview: Defines medical necessity criteria for next-generation sequencing (NGS) expanded molecular panel testing of cancers to identify targeted therapies for BlueCHiP for Medicare. Effective date: 2018-04-01. Last review: 2018-04-03.

Medical-Necessity Criteria

Medically necessary criteria for NGS expanded molecular panel testing (BlueCHiP for Medicare)

Next Generation Sequencing may be considered medically necessary when performed in a CLIA-certified laboratory, ordered by a treating physician, and ALL of the following are met:

ALL of the following

Test is performed in a CLIA-certified laboratory
Test is ordered by the treating physician
Clinical status
- Patient has recurrent, relapsed, refractory, metastatic, or advanced stage III or IV cancer
- Patient has decided to seek further cancer treatment (e.g., therapeutic chemotherapy)
Prior testing status
- Patient has not been previously tested with the same NGS test for the same primary diagnosis of cancer
- Repeat testing with the same NGS test is allowed only when a new primary cancer diagnosis is made
Test characteristics and reporting
- The diagnostic laboratory test (NGS) must have an FDA approved or cleared indication for use in that patient's cancer
- FDA approval or clearance as a companion in vitro diagnostic
- Results are provided to the treating physician for management and the report template specifies treatment options for the patient
Prior authorization is required for BlueCHiP for Medicare for the listed CPT codes when applicable
Medical record must document CLIA lab performance and treating physician order

Coverage for Commercial Products

Expanded cancer molecular panels for selecting targeted cancer treatment:

Use of expanded cancer molecular panels for selecting targeted cancer treatment is considered not medically necessary for Commercial products

The evidence is insufficient to determine the effects of the technology on health outcomes for Commercial products.

Coding

Assigned CPT / Proprietary codes referencedCPT

0036U	Exome (ie, somatic mutations), formalin-fixed paraffin-embedded tumor tissue and normal specimen, sequence analyses (EXaCT-1 Whole Exome Testing) (New Code effective 4/1/2018)
0037U	Targeted genomic sequence analysis, solid organ neoplasm, DNA analysis of 324 genes, interrogation for sequence variants, gene copy number amplifications, gene rearrangements, microsatellite instability and tumor mutational burden (FoundationOne CDx) (New Code effective 4/1/2018)

Filing instruction for other expanded panelsCPT

unspecified

Most available expanded cancer molecular panels have not been assigned CPT codes and should be filed with an appropriate genetic testing code

Provider Actions

Prior Authorization

Prior authorization for BlueCHiP for Medicare

Prior authorization is required for BlueCHiP for Medicare for the listed CPT/proprietary codes. To be considered medically necessary, the NGS test must meet the clinical criteria in the policy (performed in a CLIA-certified lab, ordered by the treating physician, and other specified clinical requirements).

Affected codes: 0036U, 0037U
Prior authorization (PA) is required for BlueCHiP for Medicare
Clinical criteria in the policy must be met for NGS testing to be considered medically necessary

Documentation Required

Documentation of clinical status and intent to treat

Medical records must document that testing was performed in a CLIA-certified laboratory and ordered by the treating physician. Documentation must include cancer stage/status (recurrent, relapsed, refractory, metastatic, or stage III/IV), intent to seek further cancer treatment, prior testing history (including whether the same NGS test was previously done for the same primary diagnosis), and that the diagnostic laboratory test is FDA approved/cleared as a companion in vitro diagnostic with the report specifying treatment options.

CLIA-certified laboratory performance
Treating physician order
Cancer stage/status (recurrent/relapsed/refractory/metastatic or stage III/IV)
Intent to seek further cancer treatment
Prior testing history (no prior same NGS test for same primary diagnosis except when new primary cancer)
FDA approval/clearance as a companion in vitro diagnostic and report specifying treatment options

Billing Rule

Filing unspecified panels

Most expanded cancer molecular panels have not been assigned specific CPT codes. Per the coding guidance in the policy, these panels should be filed using an appropriate genetic testing code.

Most available expanded panels lack assigned CPT codes
File unspecified/expanded panels using an appropriate genetic testing code per coding guidance

Background, Evidence, and Definitions

Background: Expanded molecular panels test numerous genetic markers across cancers to identify potential targeted therapies, offering a comprehensive genomic profile with NGS technology. Evidence for clinical validity and utility across diverse cancer types is limited because most panels test many variants without established benefit for specific cancers. While some individual markers have demonstrated utility and are outside the scope of this review, the broad use of expanded panels has limited evidence of improving health outcomes and carries a potential for harm if ineffective therapies are selected based on panel results.

Evidence	Finding
High prevalence of alterations in expanded panels	96% (420/439) patients had ≥1 molecular alteration; median 3 alterations; 85% had ≥2 alterations (Schwaederle et al. 2015)

Definitions:

- Expanded panels: Panels that test a wide variety of genetic markers in cancers without regard for whether specific targeted treatment has demonstrated benefit for that cancer.

- Companion in vitro diagnostic: An FDA approved or cleared diagnostic test essential for the safe and effective use of a corresponding therapeutic product.

Medicare Determinations

Name	Number	Type	Effective Date
Next Generation Sequencing (NGS) for Medicare Beneficiaries with Advanced Cancer	CAG-00450N	NCD

Changes: Reflects CMS decision memo CAG-00450N referenced; policy states Medicare coverage when criteria met. CMS determined NGS is reasonable and necessary and covered nationally when performed in a CLIA-certified laboratory, ordered by a treating physician, and the policy criteria are met; this policy applies to BlueCHiP for Medicare accordingly.

Revision History

2018-04-01policy_effective

Policy effective date for 'Expanded Molecular Panel Testing of Cancers to Identify Targeted Therapies' (BlueCHiP for Medicare criteria and coding updates effective).

2018-04-03policy_review

Policy last updated/reviewed.

guidance_reference

References CMS Decision Memo CAG-00450N: CMS determined that Next Generation Sequencing (NGS) is reasonable and necessary and is covered nationally when performed in a CLIA-certified laboratory, ordered by a treating physician, and the specified criteria are met; this CMS determination is noted and applied to BlueCHiP for Medicare for coverage when criteria are met.