The Carelon Clinical Appropriateness Guidelines (hereinafter “the Carelon Clinical Appropriateness Guidelines” or the “Guidelines”) are designed to assist providers in making the most appropriate treatment decision for a specific clinical condition for an individual. As used by Carelon, the Guidelines establish objective and evidence-based criteria for medical necessity determinations where possible. In the process, multiple functions are accomplished:

To establish criteria for when services are medically necessary (i.e., in general, shown to be effective in improving health outcomes and considered the most appropriate level of service)
To assist the practitioner as an educational tool
To encourage standardization of medical practice patterns
To curtail the performance of inappropriate and/or duplicate services
To advocate for patient safety concerns
To enhance the quality of health care
To promote the most efficient and cost-effective use of services

The Carelon guideline development process complies with applicable accreditation standards, including the requirement that the Guidelines be developed with involvement from appropriate providers with current clinical expertise relevant to the Guidelines under review and be based on the most up-to-date clinical principles and best practices. Relevant citations are included in the References section attached to each Guideline. Carelon reviews all of its Guidelines at least annually.

Carelon makes its Guidelines publicly available on its website twenty-four hours a day, seven days a week. Copies of the Carelon Clinical Appropriateness Guidelines are also available upon oral or written request. Although the Guidelines are publicly-available, Carelon considers the Guidelines to be important, proprietary information of Carelon, which cannot be sold, assigned, leased, licensed, reproduced or distributed without the written consent of Carelon.

Carelon applies objective and evidence-based criteria, and takes individual circumstances and the local delivery system into account when determining the medical appropriateness of health care services. The Carelon Guidelines are just guidelines for the provision of specialty health services. These criteria are designed to guide both providers and reviewers to the most appropriate services based on a patient’s unique circumstances. In all cases, clinical judgment consistent with the standards of good medical practice should be used when applying the Guidelines. Guideline determinations are made based on the information provided at the time of the request. It is expected that medical necessity decisions may change as new information is provided or based on unique aspects of the patient’s condition. The treating clinician has final authority and responsibility for treatment decisions regarding the care of the patient and for justifying and demonstrating the existence of medical necessity for the requested service. The Guidelines are not a substitute for the experience and judgment of a physician or other health care professionals. Any clinician seeking to apply or consult the Guidelines is expected to use independent medical judgment in the context of individual clinical circumstances to determine any patient’s care or treatment.

The Guidelines do not address coverage, benefit or other plan specific issues. Applicable federal and state coverage mandates take precedence over these clinical guidelines. If requested by a health plan, Carelon will review requests based on health plan medical policy/guidelines in lieu of the Carelon Guidelines. Pharmaceuticals, radiotracers, or medical devices used in any of the diagnostic or therapeutic interventions listed in the Guidelines must be FDA approved or conditionally approved for the intended use. However, use of an FDA approved or conditionally approved product does not constitute medical necessity or guarantee reimbursement by the respective health plan.

The Guidelines may also be used by the health plan or by Carelon for purposes of provider education, or to review the medical necessity of services by any provider who has been notified of the need for medical necessity review, due to billing practices or claims that are not consistent with other providers in terms of frequency or some other manner.

General Clinical Guideline

Clinical Appropriateness Framework

Critical to any finding of clinical appropriateness under the guidelines for a specific diagnostic or therapeutic intervention are the following elements:

Prior to any intervention, it is essential that the clinician confirm the diagnosis or establish its pretest likelihood based on a complete evaluation of the patient. This includes a history and physical examination and, where applicable, a review of relevant laboratory studies, diagnostic testing, and response to prior therapeutic intervention.
The anticipated benefit of the recommended intervention should outweigh any potential harms that may result (net benefit).
Current literature and/or standards of medical practice should support that the recommended intervention offers the greatest net benefit among competing alternatives.
Based on the clinical evaluation, current literature, and standards of medical practice, there exists a reasonable likelihood that the intervention will change management and/or lead to an improved outcome for the patient.

If these elements are not established with respect to a given request, the determination of appropriateness will most likely require a peer-to-peer conversation to understand the individual and unique facts that would supersede the requirements set forth above. During the peer-to-peer conversation, factors such as patient acuity and setting of service may also be taken into account.

Simultaneous Ordering of Multiple Diagnostic or Therapeutic Interventions

Requests for multiple diagnostic or therapeutic interventions at the same time will often require a peer-to-peer conversation to understand the individual circumstances that support the medical necessity of performing all interventions simultaneously. This is based on the fact that appropriateness of additional intervention is often dependent on the outcome of the initial intervention.

Additionally, either of the following may apply:

Current literature and/or standards of medical practice support that one of the requested diagnostic or therapeutic interventions is more appropriate in the clinical situation presented; or
One of the diagnostic or therapeutic interventions requested is more likely to improve patient outcomes based on current literature and/or standards of medical practice.

Repeat Diagnostic Intervention

In general, repeated testing of the same anatomic location for the same indication should be limited to evaluation following an intervention, or when there is a change in clinical status such that additional testing is required to determine next steps in management. At times, it may be necessary to repeat a test using different techniques or protocols to clarify a finding or result of the original study.

Repeated testing for the same indication using the same or similar technology may be subject to additional review or require peer-to-peer conversation in the following scenarios:

Repeated diagnostic testing at the same facility due to technical issues
Repeated diagnostic testing requested at a different facility due to provider preference or quality concerns
Repeated diagnostic testing of the same anatomic area based on persistent symptoms with no clinical change, treatment, or intervention since the previous study
Repeated diagnostic testing of the same anatomic area by different providers for the same member over a short period of time

Repeat Therapeutic Intervention

In general, repeated therapeutic intervention in the same anatomic area is considered appropriate when the prior intervention proved effective or beneficial and the expected duration of relief has lapsed. A repeat intervention requested prior to the expected duration of relief is not appropriate unless it can be confirmed that the prior intervention was never administered.

Cell-free DNA Testing (Liquid Biopsy) for the Management of Cancer

Clinical Indications

General Requirements

Repeated testing of the same individual for the same indication should be limited to evaluation following an intervention, or when there is a change in clinical status such that additional testing is required to determine next steps in management. At times, it may be necessary to repeat a test using different techniques or protocols to clarify a finding or result of the original study.

Repeated testing for the same indication using the same or similar technology may be subject to additional review or require peer-to-peer conversation in the following scenarios:

Repeated diagnostic testing of the same tumor site with no clinical change, treatment, or intervention since the previous study
Repeated diagnostic testing of the same individual and the same tumor by different providers over a short period of time

Cell-free DNA (ctDNA, Liquid Biopsy) Testing

Individuals with invasive malignancy for whom liquid biopsy is a companion diagnostic test

Liquid (ctDNA) based testing is considered medically necessary for individuals with invasive malignancy for whom the liquid biopsy test is a companion diagnostic test described by the U.S. Food and Drug Administration (FDA) as necessary for patient selection, and BOTH of the following criteria are met:

Specific cancer treatment is being considered to correspond with the FDA companion diagnostic indication
Other somatic tumor testing results do not already provide support for the specific cancer therapy being considered that corresponds to the FDA companion diagnostic indication

Individuals with locally advanced (stage IIIb), recurrent, or metastatic non-small cell lung cancer

Liquid (ctDNA) based testing is considered medically necessary for individuals with pathologically confirmed locally advanced (stage IIIb), recurrent, or metastatic non-small cell lung cancer (NSCLC), and ALL of the following criteria are met:

There is insufficient tumor tissue available for NGS-based somatic profiling or for whom tissue biopsy is considered contraindicated due to the individual’s clinical condition
No prior NGS-based somatic profiling test has previously been performed for this pathological diagnosis of NSCLC
The test is being used to provide genetic information related to the current set of actionable mutations recognized by ASCO guidelines to inform management at diagnosis or treatment progression on or after chemotherapy or immunotherapy

Individuals with metastatic breast cancer who may benefit from PIK3CA or ESR1-targeted therapy

Liquid (ctDNA) based testing with PIK3CA or ESR1 somatic tumor testing is considered medically necessary to identify individuals who may benefit from the use of alpelisib or elacestrant, respectively (or other FDA-approved targeted agent) when ALL of the following criteria are met:

The individual is either an adult man OR postmenopausal woman
The individual has ER-positive and HER2-negative metastatic breast cancer
The individual is a candidate for an applicable FDA-approved targeted agent
The individual has not had prior testing for the targeted gene of interest in the metastatic setting
There is insufficient tumor tissue available for NGS-based somatic profiling or tissue biopsy is considered contraindicated due to the individual’s clinical condition

Individuals with metastatic adenocarcinoma of the prostate who may benefit from a PARP inhibitor or PD-1 inhibitor

Liquid (ctDNA) based testing is considered medically necessary for individuals with metastatic adenocarcinoma when ALL of the following criteria are met:

The individual has biopsy-proven adenocarcinoma of the prostate
The individual has not had prior NGS testing in the metastatic setting
The individual is a candidate for ONE of the following therapies:
- FDA-approved PARP inhibitor (olaparib, rucaparib, or other approved PARP inhibitor)
- FDA-approved PD-1 inhibitor (pembrolizumab, or other approved checkpoint inhibitor)
There is insufficient tumor tissue available for NGS-based somatic profiling or tissue biopsy is considered contraindicated due to the individual’s clinical condition

Examples of ctDNA panel tests include, but are not limited to:

Cancer Intercept®
CellMax-LBx
Circulogene Comprehensive Lung, Gastrointestinal and Liver and Pancreatic Cancer Panels; Hereditary Cancer Gene Panel
ClearID® Solid Tumor Cancer Panel
FoundationOne® Liquid CDx
Galleri™ Multi-Cancer Detection Test
GeneStrat®
Guardant360® CDx and Guardant360®
OncoGxOne™ NGS Solid Tumor Panel
OncoBEAM™ Lung2 Panel and OncoBEAM™ EGFR V2 Assay
PlasmaSELECT™ 64
Resolution ctDx Lung™
Target Selector™ Breast Cancer, Non-Small Cell Lung Cancer, Squamous Cell Lung Cancer and Prostate Cancer Profiles

Rationale

Liquid biopsy refers to diagnostic tests obtained from a blood sample used to inform the management of individuals with cancer. Given that intra-tumoral heterogeneity and tumor evolution contribute to treatment failure in patients with cancer, there has been interest in exploring liquid biopsy for use as an alternative to tissue biopsy in the diagnosis of cancer, for clinical response to targeted agents of cancer treatment, for early cancer detection (i.e., screening) and for cancer surveillance. Cell-free DNA (cfDNA) is defined as DNA that is circulating freely in body fluids, such as blood plasma, and is released from all types of cells. Circulating tumor DNA (ctDNA) refers to fragments of DNA that are released from a tumor and migrate into bodily fluids, such as blood plasma. A liquid biopsy panel is defined as five or more ctDNA genes or gene mutation variants being tested. There are more than a dozen commercially available liquid biopsy panel tests, and the turnaround time varies for this testing but is typically 7-10 days.

For liquid biopsy, preanalytical issues, such as the type of specimen analyzed, procedures of sample collection, handling, processing and storage, and certain patient factors.¹ Use of plasma (rather than serum) is preferred and the type of collection tubes, preservatives in those tubes, and temperature of those tubes for 3-7 days after specimen collection are also important. Moreover, liquid biopsy performance of liquid biopsy varies by patient setting. For example, ctDNA levels are often low or undetectable in patients with a low tumor burden, cancer at specific sites and specific histologies, or tumors that have low levels of proliferation, apoptosis and/or vascularization.² Of crucial importance to liquid biopsy is that clonal hematopoiesis of indeterminate potential (CHIP), a phenomenon associated with increasing age, can affect the interpretation of cfDNA results, particularly when low variant-associated fraction (VAF) ctDNAs are identified.² Overall, limited data are available regarding the effect of blood draw procedures and potentially confounding patient related factors that may contribute to the release of cell-free DNA.¹ Like other tests for clinical use, the stages of development for liquid biopsy tests include demonstration of analytical validity, clinical validity, and clinical utility. Importantly, clinical utility refers to evidence of clinically meaningful improvements in clinical outcomes (clinical efficacy or reduced toxicity) compared with standard testing methods used to direct patient management.

The most common clinical scenario where use of ctDNA analysis is pursued is for patients with advanced or metastatic non-small cell lung cancer. In the past, ctDNA analysis in advanced/metastatic NSCLC was reserved for the assessment of EGFR mutational status, either in treatment-naïve patients with insufficient tissue for tumor genotyping or after acquired resistance to 1st/2nd generation EGFR tyrosine-kinase inhibitor treatments. However, there is now evidence to support the clinical use of broad-based platform such as NGS in genotyping for multiple other actionable oncogene drivers (such as aberrations in EGFR, ALK, ROS1, RET, MET, HER2, KRAS, NTRK, and/or BRAF) in newly diagnosed patients with tumor tissue available for initial genotyping.^{3, 4} Prospective studies have shown that positive finding on plasma NGS testing are highly concordant with tissue-based NGS test findings, although negative findings in plasma requires further testing.^{5, 6} Some guidelines suggest that liquid biopsy can be used in certain clinical settings when tissue testing proves inadequate⁷, although the ASCO guidelines found that there is currently insufficient evidence to support the use of this test method routinely for the diagnosis of primary lung adenocarcinoma.³

Another area of keen interest in the application of ctDNA testing is in colorectal cancer where there is exploration of ctDNA in several potential applications to inform clinical decision-making. Prospective studies such as CIRCULATE, COBRA, Dynamic II/III, and ACT3 are underway in the MRD setting to further understand how ctDNA may be used.⁸ Data from the Dynamic study, a non-inferiority study featuring use of circulating tumor DNA (ctDNA) to guide adjuvant therapy for stage II colon cancer, have now been published.⁹ This is a phase II biomarker-driven multicenter trial that enrolled 455 patients in Australia and New Zealand who were randomly assigned to either ctDNA-guided chemotherapy or standard management, which was clinician-guided based on conventional criteria. The primary endpoint was recurrence-free survival (RFS) at 2 years with a non-inferiority design that involved a large 8.5% margin to still be considered non-inferior. Predictably, the relapse-free survival rate was low and non-inferior in both study arms. The putative advantage to the ctDNA guided therapy was that the proportion of patients who needed to be treated with adjuvant chemotherapy compared to standard management decreased (15.3% vs 27.9%). But the most striking caveat is that the risk of getting exposed to oxaliplatin-containing adjuvant chemotherapy (with its risk of chemotherapy-related peripheral neuropathy) tripled. There is a 2.7% risk of oxaliplatin exposure in the standard arm vs. 9.5% risk in the ctDNA arm. Thus, this innovation does not produce better cancer treatment outcomes and it increases the exposure to the drug most worthy of avoiding in this setting. The predictable early reaction of oncologists to this data was that ctDNA positive patients should be treated but that also ctDNA negative patients with T4 tumors who mismatch-repair proficient should also still be treated (consistent with ASCO guidelines Accounting for this likely set of actions, the net result of adding ctDNA testing for stage II colon cancer patients will be increased exposure to oxaliplatin-containing chemotherapy and little or no real world decrease in total use of adjuvant chemotherapy. Thus, it remains unclear whether use of ctDNA testing will produce net clinical benefit for this patient population.

Finally, there is also interest in the use of ctDNA testing for cancer screening. For example, use of the Galleri test (a type of circulating cell-free DNA test) has been studied in a prospective interventional trial called the PATHFINDER study.¹⁰ The premise is that a methylation assay applied to the cfDNA samples is highly informative as a signal for cancer detection and tissue of origin localization. The PATHFINDER study primary objectives are the per participant count of the number and types of diagnostic tests required to achieve diagnostic resolution following a “signal detected” multi-cancer early detection test result, and also the per participant time required to achieve diagnostic resolution following a “signal detected” multi-cancer early detection test result. These data have not yet been presented. The primary objectives of the PATHFINDER study are intermediate endpoints. Cancer screening studies require data to show that the benefits in terms of deaths avoided outweigh various harms of overdiagnosis and overtreatment that can occur based on the screening.¹¹

References

Merker JD, Oxnard GR, Compton C, et al. Circulating Tumor DNA Analysis in Patients With Cancer: American Society of Clinical Oncology and College of American Pathologists Joint Review. J Clin Oncol. 2018;36(16):1631-41. Epub 2018/03/06. PMID: 29504847
Ignatiadis M, Sledge GW, Jeffrey SS. Liquid biopsy enters the clinic – implementation issues and future challenges. Nat Rev Clin Oncol. 2021;18(5):297-312. Epub 2021/01/22. PMID: 33473219
Kalemkerian GP, Narula N, Kennedy EB, et al. Molecular Testing Guideline for the Selection of Patients With Lung Cancer for Treatment With Targeted Tyrosine Kinase Inhibitors: American Society of Clinical Oncology Endorsement of the College of American Pathologists/International Association for the Study of Lung Cancer/Association for Molecular Pathology Clinical Practice Guideline Update. J Clin Oncol. 2018;36(9):911-9. Epub 2018/02/06. PMID: 29401004
Tan AC, Tan DSW. Targeted Therapies for Lung Cancer Patients With Oncogenic Driver Molecular Alterations. J Clin Oncol. 2022;40(6):611-25. Epub 2022/01/06. PMID: 34985916
Sabari JK, Offin M, Stephens D, et al. A Prospective Study of Circulating Tumor DNA to Guide Matched Targeted Therapy in Lung Cancers. J Natl Cancer Inst. 2019;111(6):575-83. Epub 2018/11/30. PMID: 30496436
Sacher AG, Paweletz C, Dahlberg SE, et al. Prospective Validation of Rapid Plasma Genotyping for the Detection of EGFR and KRAS Mutations in Advanced Lung Cancer. JAMA Oncol. 2016;2(8):1014-22. Epub 2016/04/08. PMID: 27055085
Rolfo C, Mack P, Scagliotti GV, et al. Liquid Biopsy for Advanced NSCLC: A Consensus Statement From the International Association for the Study of Lung Cancer. J Thorac Oncol. 2021;16(10):1647-62. Epub 2021/07/12. PMID: 34246791
Malla M, Loree JM, Kasi PM, et al. Using Circulating Tumor DNA in Colorectal Cancer: Current and Evolving Practices. J Clin Oncol. 2022:Jco2102615. Epub 2022/07/16. PMID: 35839443
Tie J, Cohen JD, Lahouel K, et al. Circulating Tumor DNA Analysis Guiding Adjuvant Therapy in Stage II Colon Cancer. N Engl J Med. 2022;386(24):2261-72. Epub 2022/06/04. PMID: 35657320
Nadauld LD, McDonnell CH, 3rd, Beer TM, et al. The PATHFINDER Study: Assessment of the Implementation of an Investigational Multi-Cancer Early Detection Test into Clinical Practice. Cancers. 2021;13(14). Epub 2021/07/25. PMID: 34298717
Welch HG, Black WC. Overdiagnosis in cancer. J Natl Cancer Inst. 2010;102(9):605-13. Epub 2010/04/24. PMID: 20413742

Codes

The following code list is not meant to be all-inclusive. Authorization requirements will vary by health plan. Please consult the applicable health plan for guidance on specific procedure codes.

Specific CPT codes for services should be used when available. Nonspecific or not otherwise classified codes may be subject to additional documentation requirements and review.

CPT/HCPCS

CPT® (Current Procedural Terminology) is a registered trademark of the American Medical Association (AMA). CPT® five-digit codes, nomenclature and other data are copyright by the American Medical Association. All Rights Reserved. AMA does not directly or indirectly practice medicine or dispense medical services. AMA assumes no liability for the data contained herein or not contained herein.

May Be Medically Necessary When Criteria are Met

81462	Solid organ neoplasm, genomic sequence analysis panel, cell-free nucleic acid (eg, plasma), interrogation for sequence variants; DNA analysis or combined DNA and RNA analysis, copy number variants and rearrangements
81463	Solid organ neoplasm, genomic sequence analysis panel, cell-free nucleic acid (eg, plasma), interrogation for sequence variants; DNA analysis, copy number variants, and microsatellite instability
81464	Solid organ neoplasm, genomic sequence analysis panel, cell-free nucleic acid (eg, plasma), interrogation for sequence variants; DNA analysis or combined DNA and RNA analysis, copy number variants, microsatellite instability, tumor mutation burden, and rearrangements
81479	Unlisted molecular pathology procedure
0179U	Oncology (non-small cell lung cancer), cell-free DNA, targeted sequence analysis of 23 genes (single nucleotide variations, insertions and deletions, fusions without prior knowledge of partner/breakpoint, copy number variations), with report of significant mutation(s)
0239U	Targeted genomic sequence analysis panel, solid organ neoplasm, cell-free DNA, analysis of 311 or more genes, interrogation for sequence variants, including substitutions, insertions, deletions, select rearrangements, and copy number variations
0242U	Targeted genomic sequence analysis panel, solid organ neoplasm, cell-free circulating DNA analysis of 55-74 genes, interrogation for sequence variants, gene copy number amplifications, and gene rearrangements
0397U	Oncology (non-small cell lung cancer), cell-free DNA from plasma, targeted sequence analysis of at least 109 genes, including sequence variants, substitutions, insertions, deletions, select rearrangements, and copy number variations. Test uses a next–generation sequencing (NGS) targeted sequence analysis panel to evaluate cell–free DNA (cfDNA) from a plasma specimen for 109 genes associated with non–small cell lung cancer (NSCLC) to provide a profile of mutations that may impact treatment options.

Not Medically Necessary

81327	SEPT9 (Septin9) (eg, colorectal cancer) promoter methylation analysis
0007M	Oncology (gastrointestinal neuroendocrine tumors), real-time PCR expression analysis of 51 genes, utilizing whole peripheral blood, algorithm reported as a nomogram of tumor disease index
0229U	BCAT1 (Branched chain amino acid transaminase 1) and IKZF1 (IKAROS family zinc finger 1) (eg, colorectal cancer) promoter methylation analysis
0285U	Oncology, response to radiation, cell-free DNA, quantitative branched chain DNA amplification, plasma, reported as a radiation toxicity score – RadTox™ cfDNA test
0306U	Oncology (minimal residual disease [MRD]), next-generation targeted sequencing analysis, cell-free DNA, initial (baseline) assessment to determine a patient-specific panel for future comparisons to evaluate for MRD
0307U	Oncology (minimal residual disease [MRD]), next-generation targeted sequencing analysis of a patient-specific panel, cell-free DNA, subsequent assessment with comparison to previously analyzed patient specimens to evaluate for MRD
0326U	Targeted genomic sequence analysis panel, solid organ neoplasm, cell-free circulating DNA analysis of 83 or more genes, interrogation for sequence variants, gene copy number amplifications, gene rearrangements, microsatellite instability and tumor mutational burden
0333U	Oncology (liver), surveillance for hepatocellular carcinoma (HCC) in high-risk patients, analysis of methylation patterns on circulating cell-free DNA (cfDNA) plus measurement of serum of AFP/AFP-L3 and oncoprotein des-gammacarboxy-prothrombin (DCP), algorithm reported as normal or abnormal result
0340U	Oncology (pan-cancer), analysis of minimal residual disease (MRD) from plasma, with assays personalized to each patient based on prior next-generation sequencing of the patient’s tumor and germline DNA, reported as absence or presence of MRD, with disease-burden correlation, if appropriate
0388U	Oncology (non-small cell lung cancer), next-generation sequencing with identification of single nucleotide variants, copy number variants, insertions and deletions, and structural variants in 37 cancer-related genes, plasma, with report for alteration detection.
0405U	Oncology (pancreatic), 59 methylation haplotype block markers, next-generation sequencing, plasma, reported as cancer signal detected or not detected
0409U	Oncology (solid tumor), DNA (80 genes) and RNA (36 genes), by next-generation sequencing from plasma, including single nucleotide variants, insertions/deletions, copy number alterations, microsatellite instability, and fusions, report showing identified mutations with clinical actionability
0410U	Oncology (pancreatic), DNA, whole genome sequencing with 5-hydroxymethylcytosine enrichment, whole blood or plasma, algorithm reported as cancer detected or not detected
0422U	Oncology (pan-solid tumor), analysis of DNA biomarker response to anti-cancer therapy using cell-free circulating DNA, biomarker comparison to a previous baseline pre-treatment cell-free circulating DNA analysis using next-generation sequencing, algorithm reported as a quantitative change from baseline, including specific alterations, if appropriate
0428U	Oncology (breast), targeted hybrid-capture genomic sequence analysis panel, circulating tumor DNA (ctDNA) analysis of 56 or more genes, interrogation for sequence variants, gene copy number amplifications, gene rearrangements, microsatellite instability, and tumor mutation burden

ICD-10 Diagnosis

Refer to the ICD-10 CM manual

History

Status	Review Date	Effective Date	Action
Updated	n/a	01/01/2024	Annual CPT code update: Added 81462, 81463, and 81464. NMN codes: Added 0422U, 0428U; Removed 0011M, 0356U, 0368U.
Revised	04/12/2023	11/05/2023	Independent Multispecialty Physician Panel (IMPP) review. Metastatic breast cancer – expanded testing to include ESR1 ctDNA per FDA. Metastatic prostate adenocarcinoma – specified FDA approved PARP and PD-1 inhibitors. Additional edits for clarity. Split CPT code list into those considered medically necessary and not medically necessary. Added CPT 0397U (MN) and 0388U (NMN).
Updated	n/a	10/01/2023	Added new CPT codes 0368U, 0405U, 0409U, and 0410U. Added CPT codes 81327, 0007M, 0011M, 0229U, 0285U, 0333U, 0340U (moved from Somatic Tumor Testing guidelines).
Created	09/21/2022	02/12/2023	IMPP review. Original effective date.

Carelon Archives

ARCHIVED Cell-free DNA Testing for the Management of Cancer 2024-01-01 to 03-16

Table of Contents

Description and Application of the Guidelines