Notification



Notification Issue Date:



Claim Payment Policy


Title:GPS Cancer™ Testing by NantHealth

Policy #:06.02.50

This policy is applicable to the Company’s commercial products only. Policies that are applicable to the Company’s Medicare Advantage products are accessible via a separate Medicare Advantage policy database.

Application of Claim Payment Policy is determined by benefits and contracts. Benefits may vary based on product line, group or contract. Medical necessity determination applies only if the benefit exists and no contract exclusions are applicable. Individual member benefits must be verified.

In products where members are able to self-refer to providers for care and services, members are advised to use participating providers in order to receive the highest level of benefits.When services can be administered in various settings, the Company reserves the right to reimburse only those services that are furnished in the most appropriate and cost-effective setting that is appropriate to the member’s medical needs and condition. This decision is based on the member’s current medical condition and any required monitoring or additional services that may coincide with the delivery of this service.

For more information on how Claim Payment Policy Bulletins are developed, go to the About This Site section of this Medical Policy Web site.



Policy

Coverage is subject to the terms, conditions, and limitations of the member's contract.

GPS CANCER TESTING BY NANTHEALTH DESCRIBED IN THIS POLICY APPLIES TO MEMBERS ENROLLED IN PENNSYLVANIA'S COMMERCIAL PRODUCTS ONLY.

GPS Cancer testing by NantHealth will be covered and eligible for reimbursement consideration by the Company for any of the following conditions in an individual with documented performance status (PS) that identifies treatment of their condition as a viable option (e.g., ECOG Scale of Performance Status, Karnofsky Performance Status Scale):
  • Cancer of unknown primary
  • Rare cancers (i.e., less than one percent of cancers) with metastases for which there are only documented case reports and small series of treatment experience
  • Metastatic cancer that has progressed after treatment with a regimen of chemotherapy and for which additional chemotherapy is indicated
  • Primary brain cancer
  • Pediatric cancers
  • Triple negative breast cancer
  • Virally infected tumors
  • Metastatic non-small cell lung cancer that has progressed after treatment with two different regimens of chemotherapy and for which additional chemotherapy is indicated
  • Individuals eligible for cancer immunotherapy

Coverage for GPS Cancer testing by NantHealth may be withdrawn at any time for material failure to comply with any of the Company's requests for this information or upon the Company's evaluation and finding that demonstration of treatment effectiveness is absent or inadequate to support continued coverage.

All other coverage is subject to the terms and conditions of the members Benefit Plan.

BILLING REQUIREMENT

GPS Cancer testing by NantHealth must be reported with the unlisted Current Procedural Terminology [CPT] code 81479: Unlisted molecular pathology procedure. The unlisted Code 81479 must be reported with the following narrative: "GPS Cancer." Providers must not bill other procedure codes to represent GPS Cancer testing by NantHealth.

Inclusion of a code in this policy does not imply reimbursement. Eligibility, benefits, limitations, exclusions, precertification/referral requirements, provider contracts, and Company policies apply.
Guidelines

PERFORMANCE STATUS (PS)

Performance Status is widely used to quantify the functional status of cancer individuals, and is an important factor determining prognosis in a number of malignant conditions.

EASTERN COOPERATIVE ONCOLOGY GROUP (ECOG) PERFORMANCE STATUS (PS) SCALE
For healthcare professional providers to assess how an individual's disease is progressing, assess how the disease affects the daily living abilities of the individual, and determine appropriate treatment and prognosis.
GradeECOG
0Fully active, able to carry on all pre-disease performance without restriction
1Restricted in physically strenuous activity but ambulatory and able to carry our work of a light or sedentary nature, e.g., light house work, office work
2Ambulatory and capable of all selfcare but unable to carry out any work activities. Up and about more than 50 percent of waking hours
3 Capable of only limited selfcare, confined to bed or chair more than 50 percent of waking hours
4Completely disabled. Cannot carry on any selfcare. Totally confined to bed or chair
5Dead

KARNOFSKY PERFORMANCE STATUS (PS) SCALE DEFINITIONS RATING (%) CRITERIA
The Karnofsky Performance Scale Index allows individuals to be classified as to their functional impairment. This can be used to compare effectiveness of different therapies and to assess the prognosis in individuals. The lower the Karnofsky score, the worse the survival for most serious illnesses.
Able to carry on normal activity and to work; No special care needed
100
Normal no complaints; no evidence of disease
90
Able to carry on normal activity; Minor signs or symptoms of disease
80
Normal activity with effort; some signs or symptoms of disease
Unable to work; able to live at home and care for most personal needs; varying amount of assistance needed
70
Cares for self; unable to carry on normal activity or to do active work
60
Requires occasional assistance, but is able to care for most of personal needs
50
Requires considerable assistance and frequent medical care
Unable to care for self; Requires equivalent of institutional or hospital care; diseases may be progressing rapidly
40
Disabled; requires special care and assistance
30
Severely disabled; hospital admission is indicated although death is not imminent
20
Very sick; hospital admission necessary; Active supportive treatment necessary
10
Moribund; fatal processes progressing rapidly
0
Dead

BENEFIT APPLICATION

Subject to the terms and conditions of the applicable benefit contract, GPS Cancer testing by NantHealth is covered under the medical benefits of the Company’s products.

Description

A proprietary test by the healthcare informational technology company, NantHealth called GPS Cancer is a Clinical Laboratory Improvement Amendment (CLIA)-certified diagnostic test that combines whole genome sequencing of tumor-normal specimens together with ribonucleic acid (RNA) sequencing and quantitative protein analysis to identify the protein pathways active in certain types of cancer. The potential for this comprehensive and critical molecular information is suggested to be particularly useful in oncology, where the heterogenous genetic character of malignant diseases has long presented challenges.

Through GPS Cancer testing by NantHealth, the professional provider can identify which of the multitude of molecular alterations that are present in cancer cells translate to abnormal proteins being produced and which are the key targets for many therapeutic cancer interventions. GPS Cancer™testing by NantHealth can potentially improve individual outcomes by providing information about risk or diagnosis of disease, by guiding clinical management decisions. GPS Cancer™ testing by NantHealth is intended to contribute to the evidence base that will influence clinical practice and help members and professional providers make the most appropriate diagnostic and therapeutic decisions.
References


American Cancer Society. Viruses that can lead to cancer. [American Cancer Society Web site]. 04/27/2015. Available at:http://www.cancer.org/cancer/cancercauses/othercarcinogens/infectiousagents/infectiousagentsandcancer/infectious-agents-and-cancer-viruses. Accessed January 04, 2016.

Dobbin KK, Beer DG, Meyerson M, et al. Interlaboratory comparability study of cancer gene expression analysis using oligonucleotide microarrays. Clin Cancer Res. 2005;11(2 Pt 1):565-572.

Dupuy A, Simon RM. Critical review of published microarray studies for cancer outcome and guidelines on statistical analysis and reporting. J Natl Cancer Inst. 2007;99(2): 147–157.

Helwick, Caroline. NCI-led scientists develop criteria for Omics tests used in clinical investigations. [American Society of Clinical Oncolog [ASCO]y Web site]. 12/15/2013. Available at:
http://www.ascopost.com/issues/december-15,-2013/nci-led-scientists-develop-criteria-for-omics-tests-used-in-clinical-investigations.aspx. Accessed January 04, 2016.

Hodson J. NANTOMICS Unveiled at J.P. Morgan 32nd Annual Healthcare Conference.[Nanthealth Web site]. 01/15/2014. Available at:
http://nanthealth.com/advancing-diagnostics/nantomics-unveiled-j-p-morgan-32nd-annual-healthcare-conference/. Accessed January 04, 2016.

Institute of Medicine (IOM). Evolution of Translational OMICS: Lessons Learned and the Path Forward. National Academies Press: Washington, DC; 2012.

Leek JT1, Scharpf RB, Bravo HC, eta al. Tackling the widespread and critical impact of batch effects in high-throughput data. Nat Rev Genet.2010;11(10):733-739.

McShane LM. Development of omics-based tests for clinical use: the challenge of achieving statistical robustness and clinical utility. [FDA Web site]. 06/13/2014. Available at:
http://www.fda.gov/downloads/MedicalDevices/NewsEvents/WorkshopsConferences/UCM401476.pdf. Accessed January 04, 2016.

McShane LM, Cavenagh MM, Lively TG, et al. Criteria for the use of omics-based predictors in clinical trials: explanation and elaboration. [Biomed Central Medicine Web site]. Available at: http://www.biomedcentral.com/1741-7015/11/220. Accessed January 04, 2016.

Moore MH, Kelly AB, Jewell SD, et al. Biospecimen reporting for improved study quality (BRISQ). Cancer Cytopath. 2011;119(2):92-101.

National Cancer Institute (NCI). NCI issues omic checklist for tests. Cancer Discov. 2014;4(2):OF6. doi: 10.1158/2159-8290.CD-NB2013-157.

National Institutes of Health (NIH). Genetic and rare diseases information center (GARD). Rare cancers. [NIH Web site]. Available at: https://rarediseases.info.nih.gov/gard/diseases-by-category/1/rare-cancers. Accessed 12/18/2015.

Oken MM, Creech RH, Tormey DC et al. Toxicity and response criteria of the eastern cooperative oncology group. Am J Clin Oncol. 1982;5(6):649-655.

Sedgewick AJ, Benz SC, Rabizadeh S , et al. Learning subgroup-specific regulatory interactions and regulator independence with PARADIGM. Bioinformatics. 2013;29(13):62-70.

Shi L, Reid LH, Jones WD, et al. The MicroArray Quality Control (MAQC) project shows inter- and intraplatform reproducibility of gene expression measurements. Nat Biotechnol.2006 ;24(9):1151-1161.

Sorensen JB, Klee M, Palshof T, et al. Performance status assessment in cancer patients. An inter-observer variability study. Br J Cancer.1993; 67(4): 773–775.

Vucic EA, Thu KL, Robison K, et al. Translating cancer “omics” to improved outcomes. Genome Research. 2012;22(2):188-195.




Coding

Inclusion of a code in this table does not imply reimbursement. Eligibility, benefits, limitations, exclusions, precertification/referral requirements, provider contracts, and Company policies apply.

The codes listed below are updated on a regular basis, in accordance with nationally accepted coding guidelines. Therefore, this policy applies to any and all future applicable coding changes, revisions, or updates.

In order to ensure optimal reimbursement, all health care services, devices, and pharmaceuticals should be reported using the billing codes and modifiers that most accurately represent the services rendered, unless otherwise directed by the Company.

The Coding Table lists any CPT, ICD-9, ICD-10, and HCPCS billing codes related only to the specific policy in which they appear.

CPT Procedure Code Number(s)

THE FOLLOWING CODE IS USED TO REPRESENT GPS CANCER TESTING BY NANTHEALTH:


81479



Professional and outpatient claims with a date of service on or before September 30, 2015, must be billed using ICD-9 codes. Professional and outpatient claims with a date of service on or after October 1, 2015, must be billed using ICD-10 codes.

Facility/Institutional inpatient claims with a date of discharge on or before September 30, 2015, must be billed with ICD-9 codes. Facility/Institutional inpatient claims with a date of discharge on or after October 1, 2015, must be billed with ICD-10 codes.


ICD-10 Procedure Code Number(s)

N/A


Professional and outpatient claims with a date of service on or before September 30, 2015, must be billed using ICD-9 codes. Professional and outpatient claims with a date of service on or after October 1, 2015, must be billed using ICD-10 codes.

Facility/Institutional inpatient claims with a date of discharge on or before September 30, 2015, must be billed with ICD-9 codes. Facility/Institutional inpatient claims with a date of discharge on or after October 1, 2015, must be billed with ICD-10 codes.


ICD-10 Diagnosis Code Number(s)

ICD-10 diagnoses must be in in accordance with the conditions/performance status as reflected in this Policy.


HCPCS Level II Code Number(s)

N/A


Revenue Code Number(s)

N/A

Coding and Billing Requirements


Cross References

 Policy: 06.02.14h:In Vitro Chemosensitivity and Chemoresistance Assays

 Policy: 06.02.06p:Genetic Testing for Inherited Breast Cancer 1 (BRCA1) and Breast Cancer 2 (BRCA2) Mutations (Independence Administrators)

 Policy: 06.02.10q:Genetic Testing for Inherited Susceptibility to Colon Cancer and Microsatellite Instability Testing (Familial Adenomatous Polyposis and Lynch Syndrome) (Independence Administrators)

 Policy: 06.02.27l:Assays of Genetic Expression in Tumor Tissue for Breast Cancer Prognosis (Independence Administrators)

 Policy: 06.02.30e:Pharmacogenetic Testing to Determine Drug Sensitivity (Independence Administrators)

 Policy: 06.02.32d:Multigene Expression Assays for Predicting Recurrence in Colon Cancer (Independence Administrators)

 Policy: 06.02.35t:Genetic Testing (Independence Administrators)


Policy History

Revisions from 06.02.50
08/29/2018The policy has been reviewed and reissued to communicate the Company’s continuing position on GPS Cancer™ Testing by NantHealth.


Effective 10/05/2017 this policy has been updated to the new policy template format.

Version Effective Date: 03/01/2016
Version Issued Date: 03/01/2016
Version Reissued Date: 08/29/2018

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Independence Blue Cross is an independent licensee of the Blue Cross and Blue Shield Association, serving the health insurance needs of Philadelphia and southeastern Pennsylvania.