This Medical Policy is provided for informational purposes only.

If Members have any questions about the medical necessity of a service or procedure, they should discuss the question with their Network Provider or call a member of our Customer Service Team.

MEDICAL POLICY USE DISCLAIMER

  1. Medical Policy is used by Blue Cross & Blue Shield of Mississippi, A Mutual Insurance Company ("BCBSMS") as one set of guidelines (among other sets of guidelines) to assist BCBSMS in making benefit coverage decisions. BCBSMS utilizes Medical Policy adopted by our Medical Policy Advisory Committee ("MPAC") which is supported by the Blue Cross and Blue Shield Association Medical Policy, research and development. Medical Policies are the property of BCBSMS and any use of Medical Policy not agreed to by BCBSMS is strictly prohibited. The use of Medical Policy for purposes related to the health care of a BCBSMS plan member is permitted and is not a violation of the proprietary rights of BCBSMS.
  2. These Medical Policies are based on scientifically meritorious evidence provided through research for a particular medical technology. Medical Policy is also based on data from peer-reviewed scientific literature, from criteria developed by specialty societies and from guidelines adopted by other health care organizations.
  3. These Medical Policies apply to members/subscribers who have health insurance through BCBSMS. This Medical Policy also applies to Members of a self-insured group health plan for which Blue Cross & Blue Shield of Mississippi provides claims administration and persons covered by a Medicare Supplement policy offered by BCBSMS. This Medical Policy does not apply to any other individuals. Medical Policies may differ for Federal employees covered under the Federal Employees Health Benefits Plan.
  4. In the event of any conflict between this Medical Policy and any benefit plan, Summary Plan Description or other coverage document, the benefit plan, Summary Plan Description or other coverage document will govern.
  5. Medical technology is rapidly changing and these Medical Policies are subject to change without notice. Also, please be aware that as a result of ongoing changes being made to Medical Policy, BCBSMS cannot and does not guarantee that these Medical Policies are current.

BCBSMS Medical Policies are Subject to the Following Restrictions


This Medical Policy is provided for informational purposes only.

If Members have any questions about the medical necessity of a service or procedure, they should discuss the question with their Network Provider or call a member of our Customer Service Team.

MEDICAL POLICY USE DISCLAIMER

  1. Medical Policy is used by Blue Cross & Blue Shield of Mississippi, A Mutual Insurance Company ("BCBSMS") as one set of guidelines (among other sets of guidelines) to assist BCBSMS in making benefit coverage decisions. BCBSMS utilizes Medical Policy adopted by our Medical Policy Advisory Committee ("MPAC") which is supported by the Blue Cross and Blue Shield Association Medical Policy, research and development. Medical Policies are the property of BCBSMS and any use of Medical Policy not agreed to by BCBSMS is strictly prohibited. The use of Medical Policy for purposes related to the health care of a BCBSMS plan member is permitted and is not a violation of the proprietary rights of BCBSMS.
  2. These Medical Policies are based on scientifically meritorious evidence provided through research for a particular medical technology. Medical Policy is also based on data from peer-reviewed scientific literature, from criteria developed by specialty societies and from guidelines adopted by other health care organizations.
  3. These Medical Policies apply to members/subscribers who have health insurance through BCBSMS. This Medical Policy also applies to persons covered by the Mississippi Children's Health Insurance Program, Members of a self-insured group health plan for which Blue Cross & Blue Shield of Mississippi provides claims administration and persons covered by a Medicare Supplement policy offered by BCBSMS. This Medical Policy does not apply to any other individuals. Medical Policies may differ for Federal employees covered under the Federal Employees Health Benefits Plan.
  4. In the event of any conflict between this Medical Policy and any benefit plan, Summary Plan Description or other coverage document, the benefit plan, Summary Plan Description or other coverage document will govern.
  5. Medical technology is rapidly changing and these Medical Policies are subject to change without notice. Also, please be aware that as a result of ongoing changes being made to Medical Policy, BCBSMS cannot and does not guarantee that these Medical Policies are current.

BCBSMS Medical Policies are Subject to the Following Restrictions


This Medical Policy is provided for informational purposes only.

If Members have any questions about the medical necessity of a service or procedure, they should discuss the question with their Network Provider or call a member of our Customer Service Team.

MEDICAL POLICY USE DISCLAIMER

  1. Medical Policy is used by Blue Cross & Blue Shield of Mississippi, A Mutual Insurance Company ("BCBSMS") as one set of guidelines (among other sets of guidelines) to assist BCBSMS in making benefit coverage decisions. BCBSMS utilizes Medical Policy adopted by our Medical Policy Advisory Committee ("MPAC") which is supported by the Blue Cross and Blue Shield Association Medical Policy, research and development. Medical Policies are the property of BCBSMS and any use of Medical Policy not agreed to by BCBSMS is strictly prohibited. The use of Medical Policy for purposes related to the health care of a BCBSMS plan member is permitted and is not a violation of the proprietary rights of BCBSMS.
  2. These Medical Policies are based on scientifically meritorious evidence provided through research for a particular medical technology. Medical Policy is also based on data from peer-reviewed scientific literature, from criteria developed by specialty societies and from guidelines adopted by other health care organizations.
  3. These Medical Policies apply to members/subscribers who have health insurance through BCBSMS. This Medical Policy also applies to persons covered by the Mississippi Children's Health Insurance Program, Members of a self-insured group health plan for which Blue Cross & Blue Shield of Mississippi provides claims administration and persons covered by a Medicare Supplement policy offered by BCBSMS. This Medical Policy does not apply to any other individuals. Medical Policies may differ for Federal employees covered under the Federal Employees Health Benefits Plan.
  4. In the event of any conflict between this Medical Policy and any benefit plan, Summary Plan Description or other coverage document, the benefit plan, Summary Plan Description or other coverage document will govern.
  5. Medical technology is rapidly changing and these Medical Policies are subject to change without notice. Also, please be aware that as a result of ongoing changes being made to Medical Policy, BCBSMS cannot and does not guarantee that these Medical Policies are current.

BCBSMS Medical Policies are Subject to the Following Restrictions

Medical Policy Search
Printer Friendly Version Use of Common Genetic Variants to Predict Risk of Non-familial Breast Cancer

Use of Common Genetic Variants to Predict Risk of Non-familial Breast Cancer

 

DESCRIPTION

Several single nucleotide polymorphisms (SNPs), which are single base-pair variations in the DNA sequence of the genome, have been found to be associated with breast cancer and are common in the population, but confer only small increases in risk. Some commercially available assays test for several SNPs and combine results to predict an individual’s risk of breast cancer relative to the general population in order to identify those at increased risk who might benefit from more intensive surveillance.

Rare, single gene variants conferring a high risk of breast cancer have been linked to hereditary breast cancer syndromes. Examples are mutations in BRCA1 and BRCA2. These, and a few others, account for less than 25% of inherited breast cancer. Moderate risk alleles, such as variants in the CHEK2 gene, are also relatively rare and apparently explain very little more of the genetic risk.

In contrast, several common SNPs associated with breast cancer have been identified primarily through genome-wide association studies of very large case-control populations. The high-risk alleles occur with high frequency in the general population, although the increased breast cancer risk associated with each is very small relative to the general population risk. Some have suggested that these common risk SNPs could be combined to achieve an individualized risk prediction either alone or in combination with traditional predictors in order to personalize screening programs in which starting age and intensity would vary by risk. In particular, the American Cancer Society has recommended that women at high risk (greater than a 20% lifetime risk) should get breast magnetic resonance imaging (MRI) and a mammogram every year, while those at moderately increased risk (15% to 20% lifetime risk) should talk with their doctors about the benefits and limitations of adding MRI screening to their yearly mammogram.

Various companies now offer such SNP-derived risk estimates. For example, deCODE (Reykjavik, Iceland) offers the deCODE BreastCancer™ test, based on a panel of 7 SNPs identified primarily in genome-wide association studies. The website, 23andme.com, which offers direct-to-consumer (DTC) testing, includes 3 SNPs in known genes in their “Health Edition” test: 2 detect common polymorphisms in BRCA1 and BRCA2 genes associated with hereditary breast cancer in Ashkenazi Jewish populations, and one that detects a CHEK2 moderate risk variant. Navigenics (Foster City, CA) includes information on breast cancer risk in their overall DTC comprehensive genetic testing panel but does not appear to identify the individual SNPs used in their panel on their website. A comprehensive list of companies offering DTC genetic testing for various diseases including breast cancer is maintained and regularly updated by the Genetics and Public Policy Center.

Tests combining the results of SNPs to predict breast cancer risk are available either as a laboratory-developed service by physician order from a clinical laboratory licensed for high complexity testing under the Clinical Laboratory Improvement Amendments (CLIA); or as a DTC laboratory-developed service. In the latter case, it is not clear that the laboratory is necessarily CLIA-licensed although some states have chosen to regulate DTC laboratories in the same way as clinical laboratories (e.g., New York state). None of these tests have been cleared by the U.S. Food and Drug Administration.

As examples, but not inclusive of all available services, The deCODE BreastCancer™ test requires a physician order (however, the deCODEme Cancer Scan, which includes a breast cancer risk estimate, does not); 23andme and Navigenics accept direct consumer test orders; and all three companies either contract with or operate CLIA-licensed laboratories to do their genetic testing. The companies themselves mathematically combine single marker results into risk estimates and provide interpretations.

Also, see the Genetic Testing for Hereditary Breast and/or Ovarian Cancer medical policy.

 

POLICY

Testing for one or more single nucleotide polymorphisms (SNPs) to predict an individual’s risk of breast cancer is considered investigational.

 

POLICY EXCEPTIONS

None 

 

POLICY GUIDELINES

Investigative service is defined as the use of any treatment procedure, facility, equipment, drug, device, or supply not yet recognized by certifying boards and/or approving or licensing agencies or published peer review criteria as standard, effective medical practice for the treatment of the condition being treated and as such therefore is not considered medically necessary.

The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.

 

POLICY HISTORY

07/22/2010: Approved by Medical Policy Advisory Committee

07/29/2011: Policy reviewed; no changes.

07/13/2012: Policy reviewed; no changes.

01/14/2013:  Added the following new 2013 CPT code to the Code Reference section: 81479.

 

SOURCE(S)

Blue Cross Blue Shield Association policy # 2.04.63

 

CODE REFERENCE

Non-Covered Codes

This is not an all-inclusive list of non-covered procedure codes.

All codes billed for this procedure are considered investigational and not eligible for coverage. 

Code Number

Description

CPT

81479Unlisted molecular pathology procedure (New 01-01-2013) 

83890

Molecular diagnostics; molecular isolation or extraction, each nucleic acid type (ie, DNA or RNA) (Deleted 12-31-2012)

83891Molecular diagnostics; isolation or extraction of highly purified nucleic acid, each nucleic acid type (ie, DNA or RNA) (Deleted 12-31-2012)
83892Molecular diagnostics; enzymatic digestion, each enzyme treatment (Deleted 12-31-2012)
83893Molecular diagnostics; dot/slot blot production, each nucleic acid preparation (Deleted 12-31-2012)
83894Molecular diagnostics; separation by gel electrophoresis (eg, agarose, polyacrylamide), each nucleic acid preparation (Deleted 12-31-2012)
83896Molecular diagnostics; nucleic acid probe, each (Deleted 12-31-2012)
83897Molecular diagnostics; nucleic acid transfer (eg, Southern, Northern), each nucleic acid preparation (Deleted 12-31-2012)
83898Molecular diagnostics; amplification, target, each nucleic acid sequence (Deleted 12-31-2012)
83900Molecular diagnostics; amplification, target, multiplex, first 2 nucleic acid sequences (Deleted 12-31-2012)
83901Molecular diagnostics; amplification, target, multiplex, each additional nucleic acid sequence beyond 2 (List separately in addition to code for primary procedure) (Deleted 12-31-2012)
83902Molecular diagnostics; reverse transcription (Deleted 12-31-2012)
83903Molecular diagnostics; mutation scanning, by physical properties (eg, single strand conformational polymorphisms [SSCP], heteroduplex, denaturing gradient gel electrophoresis [DGGE], RNA'ase A), single segment, each (Deleted 12-31-2012)
83904Molecular diagnostics; mutation identification by sequencing, single segment, each segment (Deleted 12-31-2012)
83905Molecular diagnostics; mutation identification by allele specific transcription, single segment, each segment (Deleted 12-31-2012)
83906Molecular diagnostics; mutation identification by allele specific translation, single segment, each segment (Deleted 12-31-2012)
83907Molecular diagnostics; lysis of cells prior to nucleic acid extraction (eg, stool specimens, paraffin embedded tissue), each specimen (Deleted 12-31-2012)
83908Molecular diagnostics; amplification, signal, each nucleic acid sequence (Deleted 12-31-2012)
83909Molecular diagnostics; separation and identification by high resolution technique (eg, capillary electrophoresis), each nucleic acid preparation (Deleted 12-31-2012)
83912Molecular diagnostics; interpretation and report (Deleted 12-31-2012)
83913Molecular diagnostics; RNA stabilization (Deleted 12-31-2012)
83914Mutation identification by enzymatic ligation or primer extension, single segment, each segment (eg, oligonucleotide ligation assay [OLA], single base chain extension [SBCE], or allele-specific primer extension [ASPE]) (Deleted 12-31-2012)
84999Unlisted chemistry procedure
88384Array-based evaluation of multiple molecular probes; 11 through 50 probes (Deleted 12-31-2012)
88385Array-based evaluation of multiple molecular probes; 51 through 250 probes (Deleted 12-31-2012)
88386Array-based evaluation of multiple molecular probes; 251 through 500 probes (Deleted 12-31-2012)
  

ICD-9 Procedure

 

 

ICD-9 Diagnosis

 

 

HCPCS

 

 

 

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