Notification



Notification Issue Date:



Medicare Advantage Policy

Title:Molecular Diagnostics
Policy #:MA06.017r

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


The Company makes decisions on coverage based on the Centers for Medicare and Medicaid Services (CMS) regulations and guidance, benefit plan documents and contracts, and the member’s medical history and condition. If CMS does not have a position addressing a service, the Company makes decisions based on Company Policy Bulletins. Benefits may vary based on contract, and individual member benefits must be verified. The Company determines medical necessity only if the benefit exists and no contract exclusions are applicable. Although the Medicare Advantage Policy Bulletin is consistent with Medicare’s regulations and guidance, the Company’s payment methodology may differ from Medicare.

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.


This Policy Bulletin document describes the status of CMS coverage, medical terminology, and/or benefit plan documents and contracts at the time the document was developed. This Policy Bulletin will be reviewed regularly and be updated as Medicare changes their regulations and guidance, scientific and medical literature becomes available, and/or the benefit plan documents and/or contracts are changed.



Policy

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

MEDICALLY NECESSARY

Refer to Attachment A for a list of codes and services that may represent medically necessary molecular diagnostic testing and may be covered when all of the general molecular diagnostic testing criteria listed below are met.

Refer to Attachment B for a list of codes and services that may represent medically necessary molecular diagnostic testing and may be covered when all of the general molecular diagnostic testing criteria listed below are met and the test-specific criteria outlined in the attachment are met.

GENERAL MOLECULAR DIAGNOSTIC TESTING CRITERIA TO ESTABLISH MEDICAL NECESSITY
  • The testing is used for individuals at risk by pedigree for a specific hereditary disease among other physiological and environmental factors, and when this testing is intended for screening, diagnosis, prognosis, predictive testing (pharmacogenomic), or risk assessment.
  • The analytical (technical) validity of the test has been confirmed (e.g., reliability and repeatability of the test are established through standard protocols).
  • Biological and clinical validity, (i.e., genotype to phenotype correlation; e.g., for genetic testing), of the test have been established through the peer-reviewed literature.
  • Peer-reviewed support and data establish the objective effect(s) of the test results on direct management and care of the individual for all applicable indications and clinical situations to verify clinical utility of the test.
  • When applicable, the individual displays clinical features, or is at direct risk of inheriting the mutation in question (pre-symptomatic).
  • When applicable, after history, physical examination, pedigree analysis, appropriate counseling, and completion of conventional diagnostic studies, a definitive diagnosis remains uncertain.

EXPERIMENTAL/INVESTIGATIONAL

Refer to Attachment C for a list of codes and services related to molecular diagnostic testing that are considered experimental/investigational and, therefore, not covered because the peer-reviewed literature does not support at least one of the following for the testing:
  • The analytical validity
  • The clinical validity
  • The test result will not have a direct effect on the management and clinical care of the individual being tested (i.e., clinical utility).

NOT COVERED

Refer to Attachment D for a list of codes and services related to molecular diagnostic testing that are not covered by the Company because these services are not covered by Medicare, as these tests are generally one of the following:
  • Tests considered screening in the absence of clinical signs and symptoms of disease that are not specifically identified as covered
  • Tests that confirm a diagnosis or known information
  • Tests to determine risk for developing a disease or condition in absence of an appropriate clinical history
  • Tests performed to measure the quality of a process
  • Tests without diagnosis-specific indications

Genetic testing of tissue samples from other family members (e.g., possible/probable carriers) is not covered by the Company because this service is not covered by Medicare. Therefore, it is not eligible for reimbursement consideration.

COVERAGE WITH EVIDENCE DEVELOPMENT

Refer to Attachment E for services that are coverable via Coverage with Evidence Development (CED), registry-based approach, or other properly designed methods of investigation.

REQUIRED DOCUMENTATION

The individual's medical record must reflect the medical necessity for the care provided. These medical records may include, but are not limited to: records from the professional provider's office, hospital, nursing home, home health agencies, therapies, and test reports.

The Company may conduct reviews and audits of services to our members, regardless of the participation status of the provider. All documentation is to be available to the Company upon request. Failure to produce the requested information may result in a denial for the service.
Policy Guidelines

This policy is consistent with Medicare’s coverage determinations where Medicare has published policy positions for the services that are addressed in this policy.

BENEFIT APPLICATION

Subject to the terms and conditions of the applicable Evidence of Coverage, molecular diagnostic testing is covered under the medical benefits of the Company’s Medicare Advantage products when the medical necessity criteria listed in this medical policy are met.

However, services that are experimental/investigational, non-covered, or not medically necessary are not eligible for coverage or reimbursement under the medical benefits of the Company’s Medicare Advantage plans.

For services in which there is no Medicare coverage determination addressing the services in this policy, the Company policy is applicable.

US FOOD AND DRUG ADMINISTRATION STATUS

There are a number of products related to molecular diagnostics approved by the FDA for a range of indications.

Genetic testing is a laboratory procedure and is historically not regulated by the US Food and Drug Administration (FDA). Clinical Laboratory Improvement Amendments (CLIA) establishes quality standards for all laboratory testing. However, recently, the FDA is reported to be involved in the evaluation of the service of genetic testing.

Description

The emergence of personalized laboratory medicine has been characterized by a multitude of testing options which can more precisely pinpoint management needs of individual patients. As a result, the growing compendium of so-called biomarkers requires a more careful evaluation by both clinicians and laboratorians as to what testing configurations can more optimally realize the promises of personalized medicine. There are a plethora of burgeoning tools, including both gene-based (genomic) and protein-based (proteomic) assay formats, in tandem with more conventional (longstanding) flow cytometric, cytogenetic, etc. biomarkers. Classified somewhat differently, there are highly diverse approaches ranging from single mutation biomarkers to multiple biomarker platforms, the latter of which often depend upon sophisticated biomathematical interpretative algorithms.

Coverage of such biomarkers must be predicated upon two fundamental principles:

First, there must be an appreciation of evidence-in-transition, where new biomarkers should be brought on-line in harmonization with their proven clinical validity/utility (CVU). Although analytical validity is an equally important metric, it remains more outside of a payer's purview to conduct such detailed evaluations. Therefore, in the absence of a standard CVU referee process (e.g., although FDA labeling of biomarkers can be a helpful adjunct, it may not always be relevant), the key imperative is for medical necessity to be reflected by the clear articulation of a particular biomarker niche.

Second, there must be a recognized decision impact of such biomarkers by the clinical community. In other words, there must be acceptance/uptake of specific testing into patient management.

MOLECULAR DIAGNOSTIC TEST (MDT) DEFINITIONS FOR THIS POLICY

An MDT is any test that involves the detection or identification of nucleic acid(s) (DNA/RNA), proteins, chromosomes, enzymes, cancer chemotherapy sensitivity, and/or other metabolite(s). The test may or may not include multiple components, may consist of a single mutation analysis/identification, and/or may or may not rely upon an algorithm or other form of data evaluation/derivation.

A laboratory-developed tests (LDT) is any test developed by a laboratory without FDA approval or clearance.

APPLICABLE TESTS/ASSAYS
In addition to the MDT definition, this coverage policy applies to all tests that meet at least one of the following descriptions:
  • All non-FDA--approved/cleared laboratory-developed tests (LDT)
  • All modified FDA-approved/cleared kits/tests/assays

GENETIC TESTING

Genetic testing identifies changes in chromosomes, genes, or proteins. The term "genetic testing" covers an array of techniques, including analysis of deoxyribonucleic acid (DNA), ribonucleic acid (RNA), genes, or gene products (e.g., enzymes and other types of protein).

The Centers for Disease Control and Prevention (CDC) Office of Public Health Genomics helped to establish and support the ACCE Model Project, which has become the standard for evaluating scientific data on new genetic tests. The ACCE Model System* for Collecting, Analyzing and Disseminating Information on Genetic Tests provides an evaluation framework that is applicable to a variety of genetic tests. The Evaluation of Genomic Applications in Practice and Prevention (EGAPP) used the ACCE framework and established this process as a way of evaluating an evidence-based method for assessing genetic tests and other types of genomic technology as it has transitioned from the research arena to the practice arena. The ACCE evaluation framework examines:
  • Analytical validity: Measures the specific genotypic test performance characteristics and whether the test accurately and reliably detects the gene marker(s) of interest. This refers to how well a test performs in the laboratory and how well the test measures the property or characteristic it is intended to measure. If the test does what its makers claim, it must produce the same results repeatedly and in different laboratories given the same set of procedures.
  • Clinical validity: Refers to the associations of the test result(s) with patient outcomes of interest, and may be expressed as clinical sensitivity, specificity, and predictive value for the outcome. Evidence is usually retrospective. This component refers to the accuracy with which a test predicts the presence or absence of a clinical condition or predisposition. Initially, the test has to be conducted on individuals who are known to have the condition (as well as those who do not) to determine its success rate.
  • Clinical utility: Clinical utility determines whether the use of genetic testing to modify medical management decisions improves patient outcomes. Best evidence is prospective, from randomized clinical trials of standard management procedures to genetic test--directed management. Evidence may also be derived using banked samples from already completed clinical trials, or by constructing an indirect chain of evidence linking test results to clinical outcome. If a test has utility, it means that the result (positive or negative) provides information that can be used in the formulation of an effective treatment or preventive strategy.
  • Ethical, Legal, and Social Implications: Determines what, if any, ethical, legal, or social implications may arise from the use of this test and its results.

*From: Haddow JE, Palomaki GE. ACCE: A Model Process for Evaluating Data on Emerging Genetic Tests. In: Human Genome Epidemiology: A Scientific Foundation for Using Genetic Information to Improve Health and Prevent Disease. Khoury M, Little J, Burke W (eds.), Oxford University Press, pp. 217-233, 2003.
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Hayes, Inc. Hayes Genetic Test Evaluation (Synopsis). Cystic Fibrosis Transmembrane Regulator (CFTR) Testing for Cystic Fibrosis (CF). Lansdale, PA: Hayes, Inc.; August, 2011.

Hayes, Inc. Hayes Genetic Test Evaluation (Report). CYP2C19 Genotyping to Predict Response to Clopidogrel. Lansdale, PA: Hayes, Inc.; November, 2010.

Hayes, Inc. Hayes Genetic Test Evaluation (Report). CYP2D6 Genotyping for Dose Management of Tamoxifen. Lansdale, PA: Hayes, Inc.; September, 2008.

Hayes, Inc. Hayes Genetic Test Evaluation (Report). CYP2C9 and VKORC1 Variant Testing for Management of Warfarin Dose Initiation. Lansdale, PA: Hayes, Inc.; June, 2008.

Hayes, Inc. Hayes Genetic Test Evaluation (Report). Epidermal Growth Factor Receptor (EGFR) Sequence Variant Analysis for Predicting Response to Non-Small Cell Lung Cancer (NSCLC) Drug Therapy. Lansdale, PA: Hayes, Inc.; February, 2012.

Hayes, Inc. Hayes Genetic Test Evaluation (Report). Factor V Leiden (FVL) for Risk Assessment for Venous Thromboembolism (VTE) or Obstetric Complications. Lansdale, PA: Hayes, Inc.; October, 2008.

Hayes, Inc. Hayes Genetic Test Evaluation (Report). Fragile X Syndrome (FMR1). Lansdale, PA: Hayes, Inc.; August, 2008.

Hayes, Inc. Hayes Genetic Testing Evaluation (Report). Lansdale, PA: Hayes, Inc.;GJB2 (Connexin 26) and GJB6 (Connexin 30) Sequence Variant Analysis for Nonsyndromic Hearing Loss. June 2010.

Hayes, Inc. Hayes Genetic Test Evaluation (Report). Genetic Carrier Testing for Cystic Fibrosis. Lansdale, PA: Hayes, Inc.; June, 2004.

Hayes, Inc. Hayes Genetic Testing Evaluation (Report). Lansdale, PA: Hayes, Inc.; Genetic Testing for Lynch Syndrome (Hereditary Non-Polyposis Colorectal Cancer [HNPCC]). August 2009.

Hayes, Inc. Hayes Genetic Test Evaluation (Report). HFE-Associated Hereditary Hemochromatosis (HFE-HHC). Lansdale, PA: Hayes, Inc.; June, 2008.

Hayes, Inc. Hayes Genetic Testing Evaluation (Report). Lansdale, PA: Hayes, Inc.; HLA-B*5701 Screening for Abacavir (Ziagen®) Hypersensitivity in HIV Patients. November 2011.

Hayes, Inc. Hayes Genetic Test Evaluation (Synopsis). Immunoglobulin Heavy Variable Group (IgHV) Gene Testing in Chronic Lymphocytic Leukemia (CLL). Lansdale, PA: Hayes, Inc.; September, 2010.

Hayes, Inc. Hayes Genetic Testing Evaluation (Report). Lansdale, PA: Hayes, Inc.; JAK2 Mutations for Chronic Myeloproliferative Disorders. February 2008.

Hayes, Inc. Hayes Genetic Testing Evaluation (Report). Lansdale, PA: Hayes, Inc.; KRAS Sequence Variant Analysis for Non-Small Cell Lung Cancer (NSCLC). October 2008.

Hayes, Inc. Hayes Genetic Testing Evaluation (Report). Lansdale, PA: Hayes, Inc.; KRAS Sequence Variant Analysis for Predicting Response to Colorectal Cancer Drug Therapy. November 2008.

Hayes, Inc. Hayes Genetic Testing Evaluation (Report). Lansdale, PA: Hayes, Inc.; MECP2 Testing for Rett Sydrome and Other Disorders. January 2011.

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Moskowitz SM, Chmiel JF, Sternen DL, et al. Clinical practice and genetic counseling for cystic fibrosis and CFTR-related disorders. Genet Med. 2008;10(12):851-868.

National Institute of Health Research Portfolio Online Reporting Tool (RePORT). Genetic Testing: How it is used for healthcare. [NIH website]. Available at: http://report.nih.gov/NIHfactsheets/ViewFactSheet.aspx?csid=43&key=G#Gc. Accessed July 31, 2013.

Online Mendelian Inheritance in Man (OMIM) [website]. 2009. Available at: http://www.ncbi.nlm.nih.gov/sites/entrez?db=omim. Accessed July 31, 2013.

Pane F, Intrieri M, Quintarelli C, et al. BCR/ABL genes and leukemic phenotype: from molecular mechanisms to clinical correlations. Oncogene. 2002;21(56):8652-8667.

Pfeifer JD, Zehnbauer B, Payton J. The changing spectrum of DNA-based specimen provenance testing in surgical pathology. Am J Clin Pathol. 2011;135(1):132-138.

Rachelefsky G, Hogarth DK. Issues in the diagnosis of alpha 1-antitrypsin deficiency. J Allergy Clin Immunol. 2008;121(4):833-838.

Rau R, Brown P. Nucleophosmin (NPM1) mutations in adult and childhood acute myeloid leukaemia: towards definition of a new leukaemia entity. Hematol Oncol. 2009;27(4):171-181.

Rezuke WN, Abernathy EC, Tsongalis GJ. Molecular diagnosis of B- and T-cell lymphomas: fundamental principles and clinical applications. Clin Chem. 1997;43(10):1814-1823.

Richards CS, Bradley LA, Amos J, et al. Standards and guidelines for CFTR mutation testing. Genet Med. 2002;4(5):379-391.

Roa BB, Savino CV, Richards CS. Ashkenazi Jewish population frequency of the bloom syndrome gene 2281 delta 6ins7 mutation. Genet Test. 1999;3(2):219-221.

Rocha V, Labopin M, Sanz G, et al. Transplants of umbilical-cord blood or bone marrow from unrelated donors in adults with acute leukemia. N Engl J Med. 2004;351(22):2276-2285.

Rodriguez-Revenga L, Mila M, Rosenberg C, et al. Structural variation in the human genome: the impact of copy number variants on clinical diagnosis. Genet Med. 2007;9(9):600-6.

Rohlfs EM, Zhou Z, Heim RA, et al. Cystic fibrosis carrier testing in an ethnically diverse US population. Clin Chem. 2011;57(6):841-848.

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Sanderson S, Emery J, Higgins J. CYP2C9 gene variants, drug dose, and bleeding risk in warfarin-treated patients: A HuGEnet systematic review and meta-analysis. Genet Med. 2005;7(2):97-104.

Schiffmann R, Slaugenhaupt SA, Smith J, Goldin E. GeneReviews. Mucolipidosis IV.

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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)

See Attachments A, B, C, D, and E


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)

See Attachment B


HCPCS Level II Code Number(s)

See Attachments A, B and C


Revenue Code Number(s)

N/A


Misc Code

N/A:

N/A


Coding and Billing Requirements

For molecular diagnostic test(s) being billed using CPT codes 81400-81408 or unlisted procedure codes, claims must be submitted with the name of the specific test.

Cross References

Attachment A: Molecular Diagnostics
Description: Services that are Considered Medically Necessary

Attachment B: Molecular Diagnostics
Description: Services that are Considered Medically Necessary with Criteria

Attachment C: Molecular Diagnostics
Description: Services that are Considered Experimental/Investigational

Attachment D: Molecular Diagnostics
Description: Services that are Considered Exclusions

Attachment E : Molecular Diagnostics
Description: Services that are coverable via Coverage with Evidence Development (CED), registry-based approach, or other properly-designed designs







Policy History

Revisions from MA06.017r:
01/01/2020This version of the policy will become effective on 01/01/2020 due to coding updates & other changes, including language for 0009M from Attachment B.

The following codes are being deleted from the policy:

0081U, 0009M

Narratives for the following procedure codes are being revised:

81350
0011M
81404
81406
81407

The following codes are being added to the policy:

0140U
0141U
0142U
0151U
0152U
0153U
0154U
0155U
0156U
0157U
0158U
0159U
0160U
0161U
0162U
81277
81307
81308
81309
81522
81542
81552
87563


Additionally, procedure code 0005U is being moved from Attachment C to Attachment B.

Revisions from MA06.017q:
11/06/2019This policy has been reissued in accordance with the Company's annual review process.
10/01/2019This version of the policy went through a code update process effective 10/01/2019:
  • Procedure code 0104U was deleted from this policy.
  • Procedure codes 0109U, 0111U, 0112U, 0113U, 0114U, 0115U, 0118U, 0120U, 0129U, 0130U, 0131U, 0132U, 0133U, 0134U, 0135U, 0136U, 0137U, and 0138U were added to Attachment C of this policy.

Revisions from MA06.017p:
07/01/2019This version of the policy went through a code update process effective 07/01/2019:
  • Procedure code 0057U was deleted from this policy.
  • Procedure codes 0084U, 0090U, 0096U and 0098U were added to Attachment B of this policy.
  • Procedure codes 0086U, 0087U, 0088U, 0089U, 0094U, 0097U, 0099U, 0100U, 00101U, 00102U, 00103U and 00104U were added to Attachment C of this policy.

Revisions from MA06.017o:
01/01/2019Effective 01/01/2019, the following CPT codes have been added to Attachment B for this policy due to coding updates. The services represented by these procedure codes are considered medically necessary only when criteria are met:

81163
81164
81165
81166
81167
81171
81172
81173
81174
81177
81178
81179
81180
81181
81182
81183
81184
81185
81186
81187
81188
81189
81190
81204
81233
81234
81236
81237
81239
81271
81274
81284
81285
81286
81289
81305
81306
81312
81320
81329
81333
81336
81337
81343
81344
81345
81443
81518
0081U

Effective 01/01/2019, the following CPT code has been added to Attachment C for this policy due to coding updates. The service represented by this procedure code is considered experimental/investigational:

0080U

Effective 01/01/2019, narratives for the following CPT codes have been revised in Attachment B for this policy due to coding updates. The services represented by these procedure codes are considered medically necessary only when criteria are met:

81162, 81212, 81215, 81216, 81217, 81287

Effective 01/01/2019, narratives for the following CPT codes have been revised in Attachment D for this policy due to coding updates. The services represented by these procedure codes are considered exclusions:

81244, 81327

Effective 01/01/2019, the following CPT codes have been deleted from Attachment B for this policy due to coding updates:

81211, 81213, 81214

Revisions from MA06.017n:
11/21/2018This policy has been reissued in accordance with the Company's annual review process.
10/01/2018Effective 10/01/2018, the following ICD-10 codes have been deleted from this policy as a result of code updates:
    C43.11, C43.12, D03.11, D03.12, E78.4

Effective 10/01/2018, the following ICD-10 codes have been added to this policy as a result of code updates:
    C43.111, C43.112, C43.121, C43.122, D03.111, D03.112, D03.121, D03.122, E78.41, E78.49

Effective 10/01/2018, the following CPT codes have been added to Attachment B for this policy due to coding updates. The services represented by these procedure codes are considered medically necessary only when criteria are met:
    0070U, 0071U, 0072U, 0073U, 0074U, 0075U, 0076U

Effective 10/01/2018, the following CPT codes have been added to Attachment C for this policy due to coding updates. The services represented by these procedure codes are considered experimental investigational:
    0067U, 0068U, 0069U, 0078U, 0079U

Effective 10/01/2018, the following CPT code has been deleted from this policy due to coding updates:
    0028U
The following procedure code has been deleted from this policy as well:
    G0464

Revisions from MA06.017m:
07/01/2018This version of the policy is effective as of 07/01/2018.

Effective 07/01/2018, the following CPT codes have been added to Attachment B for this policy due to coding updates. The services represented by these procedure codes are considered medically necessary only when criteria are met:

0046U, 0047U, 0048U, 0049U

Effective 07/01/2018, the following CPT codes have been added to Attachment C for this policy due to coding updates. The services represented by these procedure codes are considered experimental investigational:

0045U, 0050U, 0053U, 0055U, 0056U, 0057U, 0060U

Revisions from MA06.017l:
04/01/2018Effective 04/01/2018, the following CPT codes have been added to Attachment B for this policy due to coding updates. The services represented by these procedure codes are considered medically necessary only when criteria are met:

0037U, 0040U

Effective 04/01/2018, the following CPT codes have been added to Attachment C for this policy due to coding updates. The services represented by these procedure codes are considered experimental investigational:

0036U, 0012M, 0013M

The following CPT codes have been deleted from Attachment C for this policy because of their termination by AMA:

0004U, 0015U

Revisions from MA06.017k:
01/01/2018Effective 01/01/2018, the following CPT codes have been added to Attachment B for this policy due to coding updates. The services represented by these procedure codes are considered medically necessary only when criteria are met:

0500T, 81105, 81106, 81107, 81108, 81109, 81110, 81111, 81112, 81120, 81121, 81175, 81176, 81232, 81238, 81247, 81248, 81249, 81258, 81259, 81269, 81334, 81335, 81361, 81362, 81363, 81364, 81520, 81521, 81541, 81551, 87634, 87662, 0027U

Effective 01/01/2018, the following CPT codes have been added to Attachment C for this policy due ti coding updates. The services represented by these procedure codes are considered experimental investigational:

81230, 81231, 81283, 81328, 81346, 81448, 0026U, 0028U, 0029U, 0030U, 0031U, 0032U, 0033U, 0034U, 0011M

Effective 01/01/2018, the narratives for the following procedure codes have been revised due to coding updates:

81257, 81432, 81439

Revisions from MA06.017j
11/22/2017This policy has been reissued in accordance with the Company's annual review process.
10/01/2017This version of the policy is effective as of 10/01/2017.

The following CPT code has been added to Attachment A for this policy. The service represented by this procedure code is considered medically necessary with applicable criteria review: 0023U

The following CPT code has been added to Attachment B for this policy. The service represented by this procedure code is considered medically necessary only when criteria are met: 0018U, 0022U

The following CPT codes have been added to Attachment C for this policy. The services represented by these procedure codes are considered experimental investigational: 0019U,
0021U

Revisions from MA06.017i:
08/01/2017This version of the policy is effective as of 08/01/2017.

This policy has been identified for the CPT code update, effective 08/01/2017.

The following CPT codes have been added to Attachment B for this policy. The services represented by these procedure codes are considered medically necessary only when criteria are met:

0012U, 0016U, 0017U


The following CPT codes have been added to Attachment C for this policy. The services represented by these procedure codes are considered experimental investigational:

0008U, 0009U, 0010U, 0013U, 0014U, 0015U

Revisions from MA06.017h:
05/01/2017This policy has been identified for the CPT code update, effective 05/01/2017.

The following CPT codes have been added to Attachment C, (which represents experimental/investigational services), of this policy: 0004U, 0005U

Revisions from MA06.017g:
02/01/2017This version of the policy will become effective on 02/01/2017.
This policy has been identified for the CPT code update, effective 02/01/2017.

The following CPT codes have been added to this policy: 0001U, 0002U, 0003U

Revisions from MA06.017f:
01/01/2017This version of the policy will become effective on 01/01/2017.

The following CPT codes have been deleted from this policy: 81280, 81281, 81282

The following CPT codes have been added to this policy: 81327, 81413, 81414, 81422, 81439, 81539, 87483

Revisions from MA06.017e:
10/01/2016This version of the policy will become effective 10/01/2016.
This policy has been identified for the ICD-10 CM code update, effective 10/01/2016.

The following ICD-10 CM codes have been deleted from this policy:
    D49.5, E78.0, R31.2, R97.2

The following ICD-10 CM codes have been added to this policy:
    D49.511: Neoplasm of unspecified behavior of right kidney
    D49.512: Neoplasm of unspecified behavior of left kidney
    D49.519: Neoplasm of unspecified behavior of unspecified kidney
    D49.59: Neoplasm of unspecified behavior of other genitourinary organ
    E78.00: Pure hypercholesterolemia, unspecified
    E78.01: Familial hypercholesterolemia
    R31.21: Asymptomatic microscopic hematuria
    R31.29: Other microscopic hematuria
    R97.20: Elevated prostate specific antigen [PSA]
    R97.21: Rising PSA following treatment for malignant neoplasm of prostate

The following ICD-10 CM code narrative been revised in this policy:
    N40.0
    FROM: Enlarged prostate without lower urinary tract symptoms
    TO: Benign prostatic hyperplasia without lower urinary tract symptoms

Revisions from MA06.017d:
07/01/2016This version of the policy will become effective 7/01/2016.

The following HCPCS code has been added to the applicable attachments of this policy (Attachment B (which is for services that are medically necessary with criteria) for MAMMAPRINT® & in Attachment C (which is for experimental/investigational services) for Mammostrat® Breast Cancer Test, the Breast Cancer IndexSM, BreastOncPx™, NexCourse® Breast IHC4, BreastPRS™, and EndoPredict™):

S3854

CPT Code 81226 for CYP2D6 is moving from Attachment C (which is for experimental/investigational services) to Attachment B (which is for services that are medically necessary with criteria); since this testing is now medically necessary for certain FDA-approved drugs.

CPT Code 0008M for Prosigna Breast Cancer Prognostic Gene Signature Assay is moving from Attachment C (which is for experimental/investigational services) to Attachment B (which is for services that are medically necessary with criteria); since this testing is now medically necessary with specific criteria.

Revisions from MA06.017c:
01/01/2016This policy has been identified for the CPT and HCPCS code updates, effective 01/01/2016.

The following CPT and HCPCS codes have been added to the applicable attachments of this policy:

81162, 81170, 81218, 81219, 81272, 81273, 81276, 81311, 81314, 81412, 81432, 81433, 81434, 81437, 81438, 81442, 81490, 81493, 81525, 81528, 81538, 81540, 81545, 81595, G0476

The narratives for the following CPT codes have been revised in the applicable attachments of this policy:

81210, 81275, 81355, 81401, 81402, 81403, 81404, 81405, 81406, 81435, 81436, 81445, 81450, 81455

Revisions from MA06.017b:
10/01/2015ICD-10 codes have been added to the policy.

Revisions from MA06.017a:
07/01/15This policy has been identified for the CPT code update, effective 07/01/2015.

The following CPT code has been added to Attachment B of this policy: 0009M

Within the Attachment B of this policy, it is already stated, among other criteria for this sort of testing, that nucleic acid sequencing-based testing of maternal plasma for fetal aneuploidy is considered not medically necessary and, therefore, not covered in women with low- or average-risk singleton pregnancies. The following language is being added after this statement: 0009M represents the test called VisibiliT™, which is intended for usage in pregnancies that are not high-risk singleton pregnancies. Thus, procedure code 0009M is considered not medically necessary and, therefore, not covered.

The following CPT code has been added to Attachment C, (Services that are Considered Experimental/ Investigational), of this policy: 0010M

Additional genetic tests have been added to the existing list of genetic tests represented by the following nonspecific CPT codes: 81401, 81406

Revisions from MA06.017:
01/01/2015This is a new policy.

Note: This policy has been identified for the CPT and HCPCS code updates, effective 01/01/2015.

The following CPT and HCPCS codes have been added to this policy:

81246, 81288, 81313, 81410, 81411, 81415, 81416, 81417, 81420, 81425, 81426, 81427, 81430, 81431, 81435, 81436, 81440, 81445, 81450, 81455, 81460, 81465, 81470, 81471, 81519, 83006, 87505, 87506, 87507, 87623, 87624, 87625, 87806, 88364, 88366, G0464

The following CPT narratives have been revised in this policy:

81245, 87631, 87632, 87633, 88365

The following HCPCS code has been deleted from this policy:

S3855




Version Effective Date: 01/01/2020
Version Issued Date: 01/03/2020
Version Reissued Date: N/A