Hereditary Breast and Ovarian Cancer (HBOC) Syndrome Testing Criteria*

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1 Breast Cancer Gene 1 and 2 (BRCA) Benefits t Change fr Texas Medicaid Effective July 1, 2015 Infrmatin psted May 15, 2015 Nte: This article applies t claims submitted t TMHP fr prcessing. Fr claims prcessed by a Medicaid managed care rganizatin (MCO), prviders must refer t the MCO fr infrmatin abut benefits, limitatins, prir authrizatin, and reimbursement. Effective fr dates f service n r after July 1, 2015, benefit criteria will change fr Breast Cancer Gene 1 and 2 (BRCA) Testing fr Texas Medicaid. BRCA1 and BRCA2 are human genes respnsible fr keeping breast cells frm grwing t rapidly r in an uncntrlled way. Specific inherited mutatins within these genes increase the risk f breast and varian cancer, have been linked t ther types f cancer such as pancreatic and prstate, and can be inherited frm a persn s mther r father. Nte: Cverage f BRCA1 and BRCA2 gene mutatin analysis testing, including BRCA large rearrangement gene mutatin analysis testing is based n the Natinal Cmprehensive Cancer Netwrk (NCCN) guidelines. BRCA gene mutatin analysis testing must be: Ordered nly if the test results will affect treatment decisins r prvide prgnstic infrmatin. Based n familial medical histry and the availability f previus familial gene mutatin analysis testing results. Fr unaffected male r females with a family histry f breast cancer, including diagnsis f carcinma in situ (DCIS): Clinical judgment shuld be used t determine if the client has a reasnable likelihd f a mutatin, cnsidering the client s current age and the age f the unaffected female relatives wh link the client with the affected relatives. Testing shuld nly be cnsidered when the apprpriate affected family member is unavailable fr testing. It is mandatry that a client wh is at risk fr BRCA1, BRCA2, r BRCA large rearrangement genetic mutatin receive genetic cunseling befre and after BRCA gene mutatin testing. Genetic cunseling must be prvided by a trained genetic cunselr, nurse specialist in genetics, r ther medical prvider pssessing expertise in genetic cunseling that is nt affiliated with the genetic testing labratry. Bth pre- and pst-test cunseling must prvide the depth f cntent and time fr the client t make an infrmed testing decisin. The genetic cunseling must be nndirective, and infrmatin abut the purpse and nature f the tests must be prvided t the client. Pre-test genetic cunseling must include: The risks and benefits f the specific genetic testing. The limitatins f the specific genetic testing t be perfrmed and the limitatins f interpreting test results fr an unaffected individual. BRCA large rearrangement gene mutatin analysis prcedure cde will be a benefit withut prir authrizatin fr services rendered in an independent labratry fr

2 independent lab/privately wned lab (n physician invlvement) and independent lab/privately wned lab (physician invlvement) withut age r gender restrictin nly after the client meets the criteria fr BRCA cmprehensive sequence gene mutatin analysis testing (prcedure cde 81211) and the test results are negative. Prcedure cde is limited t nce per lifetime. Additinal testing services may be cnsidered fr BRCA1 and BRCA2 cmprehensive sequencing gene mutatin analysis testing (prcedure cde 81211) n a case-by-case basis by a Medical Directr review with prir authrizatin if additinal gene mutatin analysis testing is supprted by medical necessity. Prcedure cde is limited t nce per lifetime, any prvider. Additinal BRCA large rearrangement gene mutatin analysis testing is nt a benefit f Texas Medicaid. Dcumentatin The fllwing gene mutatin analysis testing dcumentatin must be maintained in the client s medical recrd and is subject t retrspective review: The apprpriateness f the genetic testing The client s specific high-risk criteria The benefit f the specific genetic testing t be perfrmed Pre-testing genetic cunseling, including all f the fllwing: The date frmal pre-test cunseling was prvided with the name and qualificatins f the cunseling prfessinal The risks, benefits, and limitatins discussed with the client The client s ability t understand the risks, benefits, and limitatins and the client s infrmed chice t prceed with the specific gene mutatin analysis testing as evidenced by the client s signature n a cnsent frm specific t the genetic mutatin testing t be perfrmed. The client s BRCA1 and BRCA2 cmprehensive gene mutatin analysis testing results t supprt medical necessity fr BRCA large rearrangement gene mutatin analysis testing The client s BRCA large rearrangement gene mutatin analysis testing results Pst-testing genetic cunseling, including all the fllwing: The date frmal pst-test cunseling was prvided with the name and qualificatins f the cunseling prfessinal The client s ability t understand the results f the gene mutatin analysis testing and the apprpriate medical treatment resulting frm the test results. The client s treatment plan and any treatment plan changes based n interpretatin f the test results

3 Prir Authrizatin Prir authrizatin is nt required fr BRCA large rearrangement gene mutatin analysis testing (prcedure cde 81213) when submitted with a negative test result fr prcedure cde Prir authrizatin is required fr initial BRCA1 and BRCA2 gene testing (prcedure cdes 81211, 81212, 81214, 81215, 81216, and 81217). If the client s previusly btained BRCA1 and BRCA2 cmprehensive sequencing gene mutatin analysis testing (prcedure cde 81211) results are nt available, prir authrizatin fr additinal BRCA1 and BRCA2 cmprehensive sequencing gene mutatin analysis testing may be cnsidered n a case-by-case basis by Medical Directr review when the testing criteria fr these studies are met fr client s wh: Have previusly been tested fr BRCA1 and BRCA2 cmprehensive sequencing gene mutatin analysis testing and received negative results when all the fllwing criteria are met: Every reasnable effrt and dcumentatin f the specific effrts made t btain BRCA1 and BRCA2 cmprehensive sequencing gene mutatin analysis test results frm the client s genetic testing physician r the testing labratry. Dcumentatin f negative results fr BRCA1 and BRCA2 cmprehensive sequencing gene mutatin analysis testing are required fr medically necessary BRCA large rearrangement gene mutatin analysis testing. BRCA1 and BRCA2 cmprehensive sequencing r funder gene mutatin analysis testing was btained and interpreted befre BRCA large rearrangement gene mutatin analysis testing (prcedure cde 81213) was available. A cmpleted Hereditary Breast and Ovarian Cancer (HBOC) Genetic Testing Prir Authrizatin Request Frm that has been signed and dated by the referring prvider must be submitted. The physician s signature n a submitted dcument indicates that the physician certifies, t the best f the physician s knwledge, that the infrmatin in the dcument is true, accurate, and cmplete. All dcumentatin that is submitted with a handwritten physician s signature must have a handwritten date next t the signature and must be kept in the client s medical recrd. Stamped r digitalized signatures will nt be accepted. Fr cmprehensive sequencing, the physician must indicate ne f the fllwing n the prir authrizatin request frm: The client s familial genetic histry that supprts medical necessity fr the requested BRCA1 and BRCA2 cmprehensive sequencing, funder gene mutatin analysis, r knw familial variant gene mutatin analysis testing. Every reasnable effrt was made t btain the client s familial genetic histry and have been unable t btain BRCA1 and BRCA2 cmprehensive sequencing gene mutatin analysis testing results fr the affected family member(s). Additinally, dcumentatin f the specific effrts made t btain the client s familial genetic histry must be submitted with the request.

4 T facilitate a determinatin f medical necessity and avid unnecessary denials, the prvider must prvide crrect and cmplete infrmatin, including accurate medical necessity f the services requested. T cmplete the prir authrizatin request prcess, the prvider must mail f fax the request t the TMHP Special Medical Prir Authrizatin Unit and include dcumentatin f medical necessity. Medical dcumentatin submitted by the physician must verify the client s diagnsis r family histry. Requisitin frms frm the labratry are nt sufficient fr the establishment f a client s persnal and family histry. Fr all BRCA1 and BRCA2 cmprehensive gene mutatin analysis testing, the client must meet criterin specific t his r her persnal histry. The criteria fr each histry are listed belw. Dcumentatin f the client s persnal histry and the required criterin supprting medical necessity must be submitted with the prir authrizatin request. A clse relative is defined as: Bld relative frm the same side f the family. Male r female. First degree-parent r sibling. Secnd degree- aunt, uncle r grandparent. Third degree first cusin r great-grandparent. Hereditary Breast and Ovarian Cancer (HBOC) Syndrme Testing Criteria* Table A *Based n NCCN HBOC guidelines N ther criterin are required if the client is: Table B An individual (male r female) frm a family with a knwn deleterius BRCA1/BRCA2 mutatin A female with a persnal histry f breast cancer, including invasive r ductal carcinma in situ (DCIS), diagnsed at 45 years f age r yunger A female with a persnal histry f breast cancer, including DCIS, diagnsed at any age and f an ethnicity assciated with higher mutatin frequency, such as Ashkenazi Jewish, Icelandic, Swedish, r Hungarian descent A wman with a persnal histry f epithelial varian cancer, including fallpian tube and primary peritneal cancers, diagnsed at any age A man with a persnal breast cancer, including DCIS, diagnsed at any age

5 If the female individual has: Additinal criteria: Only ne criterin needs t be met A persnal histry f breast cancer, including DCIS, diagnsed at 50 years f age r yunger An additinal primary (tw primary sites, including bilateral r clearly separate ipsilateral) tumrs ccurring either synchrnusly r asynchrnusly At least ne clse bld relative with breast cancer at any age An unknwn r limited family histry Table C If the female individual has: Additinal criterin: A persnal histry f breast cancer, including DCIS, diagnsed at 60 years f age r yunger Triple negative breast cancer Table D If the female individual has: Additinal criteria: Only ne criterin needs t be met A persnal histry f breast cancer, including DCIS, diagnsed at any age At least ne clse bld relative with breast cancer diagnsed at 50 years f age r yunger At least tw clse bld relatives with breast cancer at any age At least ne clse bld relative with epithelial varian cancer, including fallpian tube and primary peritneal cancers At least tw clse bld relatives with pancreatic cancer r prstate cancer (Gleasn scre 7 r greater) at any age A clse male relative with breast cancer at any age Table E If the individual (male r female) has: Additinal criteria: A persnal histry f pancreatic cancer r prstate cancer (Gleasn scre 7 r greater) at any age regardless f ancestry At least tw clse bld relatives with ne f the fllwing: Breast cancer Ovarian cancer, including fallpian tube and primary

6 peritneal cancers Prstate cancer (Gleasn scre 7 r greater) Pancreatic cancer Table F If the individual (male r female) has: Additinal criterin: A persnal histry f pancreatic cancer at any age and f an ethnicity assciated with higher mutatin frequency, such as Ashkenazi Jewish, Icelandic, Swedish, r Hungarian descent One r mre clse bld relatives with pancreatic cancer Table G If the unaffected individual (male r female) has: Additinal criteria: A family histry f breast r varian cancer, including DCIS At least ne first r secnd degree bld relative meeting any f the criteria in Tables A thrugh F At least ne third degree bld relative wh has breast cancer, including DCIS, r varian cancer, including fallpian tube and primary peritneal cancers, and at least tw clse bld relatives with ne f the fllwing : Breast cancer, including DCIS, f which at least ne with breast cancer was diagnsed at 50 years f age r yunger: Ovarian cancer, including fallpian tube and primary peritneal cancers Retractive Authrizatin A request fr retractive authrizatin (RA) must be submitted n later than seven calendar days beginning the day after the lab draw is perfrmed. Requests received after the allwed seven calendar-day perid will be denied fr dates f service that ccurred befre the date the request was received.

7 Reimbursement BRCA1 and BRCA2 full sequence gene mutatin analysis testing variant gene mutatin analysis testing (prcedure cde ) labratry results must be submitted with the BRCA large rearrangement gene mutatin analysis testing (prcedure cde ) claim. Prcedure cde may be reimbursed when submitted with a negative test result fr prcedure cde Interpretatin f gene mutatin analysis results is nt separately reimbursable. Interpretatin is part f the physician evaluatin and management (E/M) service. Nte: All new and updated prcedure cdes and their assciated reimbursement rates are prpsed benefits pending a rate hearing and apprval expenditures. Prviders will be ntified when the rates and expenditures are apprved. Fr mre infrmatin, call the TMHP Cntact Center at

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