12/13/2020
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R31
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LCD posted for notice on 10/29/2020. LCD becomes effective for dates of service on and after 12/13/2020.
10/31/2019 DL35396 Draft LCD posted for comment.
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- Creation of Uniform LCDs With Other MAC Jurisdiction
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07/01/2020
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R30
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LCD revised and published on 06/25/2020 effective for dates of service on and after 07/01/2020, as a non-discretionary update to remove limitations 1 and 3, these services will now be covered when medically reasonable and necessary and performed within the indications of the LCD consistent with CMS direction. Minor formatting changes have been made.
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- Other (revised in response to CMS direction)
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11/14/2019
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R29
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LCD revised and published on 11/14/2019. Consistent with CMS Change Request 10901, the entire coding section has been removed from the LCD and placed into the related Billing and Coding Article, A52986. All CPT codes and coding information within the text of the LCD has been placed in the Billing and Coding Article.
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- Other (CMS Change Request 10901)
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06/13/2019
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R28
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LCD revised and published on 06/27/2019. Per current LCD format, the 'Coding Information' statement has been placed after the Analysis of Evidence section. There has been no change in coverage with this LCD revision.
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06/13/2019
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R27
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LCD revised and published on 06/13/2019. Effective for dates of service on and after 03/27/2019 the following coding changes have been made in the related Billing and Coding Article (A52986); CPT code 81450 has been removed from CPT/HCPCS Code Group 2 and added to CPT/HCPCS Code Group 1 with no diagnosis to procedure code restrictions at this time. This coding change is a clarification, in response to an inquiry, since the LCD provides coverage for at least 5 of the biomarkers included in the service represented by 81450. Consistent with Change Request (CR) 10901 all CPT and ICD-10 codes have been removed from the LCD and placed in the related Billing and Coding Article, A52986. Language has been added in place of removed codes in Limitation #3. IOM citations for related NCDs have been added and the references have been moved to the Bibliography section. There has been no change in coverage with this LCD revision.
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- Other (Change in LCD process per CMS CR 10901; Inquiry)
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04/04/2019
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R26
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LCD revised and published on 04/04/2019 effective for dates of service on and after 03/16/2018 to remove references to next generation sequencing due to implementation of NCD 90.2. Revised Molecular Test Indication related to Oncomine DX to refer to NCD 90.2. Removed CPT code 0022U from CPT/HCPCS Code Group 1, ICD-10 Group 2 Paragraph and Utilization Guidelines. NCD 90.2 listed as a Related National Coverage Document.
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01/01/2019
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R25
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LCD revised and published on 02/14/2019 effective for dates of service on and after 01/01/2019 to reflect the annual CPT/HCPCS code updates. The following CPT/HCPCS code(s) have been added to Group 1 Codes: 81233, 81236, 81237, 81305, 81320, and 81345. For the following CPT/HCPCS codes either the short description and/or the long description was changed. Depending on which description is used in this LCD, there may not be any change in how the code displays in the document: 81287, 81327, 81400, 81401, 81403, 81404, 81405, and 81407.
Covered Indications for Molecular Tests (#5) updated to include biomarker TERT for brain molecular biomarkers. ICD-10 Code Group #5 has been updated to include TERT reported with CPT code 81345. Utilization Guidelines have been updated to include the test for Brain Molecular Biomarkers (CPT code 81345) once per lifetime per beneficiary.
Covered Indications for Molecular Tests (#13) includes biomarker EZH2 for Myeloproliferative diseases. ICD-10 Code Groups #12, #16, and #22 have been updated to report EZH2 with CPT code 81236 or CPT code 81327.
Covered Indications for Molecular Tests (#13) updated to include biomarkers BTK and PLCG2 for Chronic lymphoid leukemia (CLL). ICD-10 Code Group #18 for CLL has been updated to include BTK reported with CPT code 81233 and PLCG2 reported with CPT code 81320.
Covered Indications for Molecular Tests (#13) updated to include biomarker MYD88 for Waldenstrom’s/Lymphoplasmacytic Lymphoma. New ICD-10 Code Group #28 for Waldenstrom’s/Lymphoplasmacytic Lymphoma has been added to include MYD88 reported with CPT code 81305. The following ICD-10 Code has been added for MYD88 reported with CPT code 81305 to ICD-10 Code Group 28: C88.0
CMS IOM language has been removed from the LCD per Change Request 10901.
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- Revisions Due To CPT/HCPCS Code Changes
- Other (CMS Requirement)
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10/04/2018
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R24
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LCD revised and published on 10/04/2018 to update the policy in response to inquiry and reconsideration requests; all literature reviewed and added to policy. Non-coverage reaffirmed for CPT codes 0012M and 0013M for CxBladder. Non-coverage reaffirmed for CPT code 0002U for PolypDx™ Assay and Algorithm. Effective for dates of service on and after 05/15/2018 the following changes have been made to the policy:
Covered Indications for Molecular Tests updated to include a new group (#4) for Uveal Melanoma with biomarkers GNAQ and GNA11. GNAQ is reported with CPT code 81403 and currently does not have ICD-10 diagnosis code pairing. The following ICD-10 diagnosis codes have been added for GNA11 reported with CPT code 81479 to ICD-10 Code Group 4: C69.01, C69.02, C69.11, C69.12, C69.21, C69.22, C69.31, C69.32, C69.41, C69.42, C69.51, C69.52, C69.61, C69.62, C69.81, C69.82.
ThyroSeq has been added to the thyroid test group (new group #6). CPT Code 0026U has been added to CPT Group 1 Codes. ThyroSeq for CPT code 0026U has been added to ICD-10 Code Group 6 (new) and added to the asterisk note indicating ICD-10 diagnosis codes C73 and D44.2 should not be reported for this test. Utilization Guidelines have been updated to include the ThyroSeq test once per lifetime per beneficiary.
Covered Indications for Molecular Tests updated to include biomarker FGFR3 as covered under Urinary Tract (new #9). FGFR3 is reported with CPT code 81404 and currently does not have ICD-10 code pairing.
Covered Indications for Molecular Tests updated to include biomarkers PTEN, RB1 and TP53 to Prostate (new group #10). TP53 is reported with CPT code 81405 and currently does not have ICD-10 code pairing. ICD-10 Code Group 9 (new) has been updated to include PTEN for CPT codes 81321, 81322, 81323 and RB1 for CPT code 81479.
Covered Indications for Molecular Tests updated to include biomarkers MGMT, PTEN, RB1, TP53 and TSC2 for Neuroendocrine tumors (new group #17). TP53 is reported with CPT code 81405 and currently does not have ICD-10 diagnosis code pairing. ICD-10 Code Group for neuroendocrine tumors (new #25) has been updated to include MGMT reported with CPT code 81287, PTEN reported with CPT codes 81321, 81322, or 81323; and RB1 or TSC2 reported with CPT code 81479.
Covered Indications for Molecular Tests updated to include biomarker CTNNB1 to Desmoid Fibromatosis (new group #19). CTNNB1 is reported with CPT code 81403 and currently does not have ICD-10 diagnosis code pairing.
Covered Indications for Molecular Tests updated to include biomarker CTNNB1 to Hepatic Adenoma (new group #20). CTNNB1 is reported with CPT code 81403 and currently does not have ICD-10 diagnosis code pairing.
Covered Indications for Molecular Tests updated to include biomarkers CDKN2A, FGFR3, PIK3CA and TP53 for Bladder (new group #21). CDKN2A, FGFR3, PIK3CA and TP53 reported with CPT code 81404 or 81405 and currently does not have ICD-10 diagnosis code pairing. CPT codes 81321, 81322 and 81323 for biomarker PTEN and CPT code 81479 for biomarkers FGFR1, MTOR and RB1 added to new ICD-10 Diagnosis Code Group 27 for Bladder. The following ICD-10 diagnosis codes have been added to new ICD-10 Code Group 27: C67.0, C67.1, C67.2, C67.3, C67.4, C67.5, C67.6, C67.7, C67.8 and C67.9.
Effective for dates of service on and after 05/18/2018, CPT code 0022U added to CPT Group 1 Codes. Utilization Guidelines and ICD-10 Code Group 2 updated to reflect Oncomine DX CPT code changed from 81445 to 0022U.
Covered Indications for Molecular Tests (#1) updated to include ColonSeq® for Colorectal Cancer and (#2) LungSeq® for Non-Small Cell Lung Cancer. ICD-10 Code Group 1 updated to add ColonSeq® for CPT code 81445. ICD-10 Code Group 2 updated to add LungSeq® for CPT code 81445.
In response to the annual ICD-10 code update, effective for dates of service 10/1/2018 and after the following ICD-10 codes have been deleted from ICD-10 code group 3: C43.11, C43.12, D03.11 and D03.12 and the following ICD-10 codes have been added to ICD-10 code group 3: C43.111, C43.112, C43.121, C43.122, D03.111, D03.112, D03.121, D03.122.
At this time 21st Century Cures Act will apply to new and revised LCDs that restrict coverage which requires comment and notice. This revision is not a restriction to the coverage determination; therefore, not all the fields included on the LCD are applicable as noted in this policy.
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- Revisions Due To ICD-10-CM Code Changes
- Reconsideration Request
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07/26/2018
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R23
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LCD revised and published on 07/26/2018. The following revisions have been made in the covered indications section of the policy:
ThyGenX represented by CPT code 81445 has been added under Molecular Tests for Thyroid, ICD-10 Code Group Paragraph 5 and Utilization Guidelines effective for dates of service on and after 04/09/2018.
RosettaGX Reveal Thyroid miRNA has been added as a covered service under Molecular Tests for Thyroid, ICD-10 Code Group Paragraph 5 and Utilization Guidelines effective for dates of service on and after 04/09/2018. Literature submitted has been reviewed and added to the policy.
FLT3 D836 has been revised to FLT3 D835 under Molecular Tests for AML, CML/CMML and MDS covered indication sections. FLT3 D835 has also been removed from the following ICD-10 Code Group Paragraphs; Group 11, Group 16 and the newly numbered Group 21 (formerly group 22 before renumbering with this revision) since CPT 81246 does not have any diagnosis restrictions effective for dates of service 01/01/2015 and after.
Biomarker ATM listed under Molecular Tests for CLL covered indications has been removed from the LCD. This biomarker has also been removed from ICD-10 Code Group Paragraph 17 as there are no coverage restrictions for ATM at this time.
The CPT codes listed with IGH/BCL2 under Molecular Tests in the Follicular lymphoma section have been changed to 81401 and 81402. ICD-10 diagnosis code Group 18 has been deleted as 81401 and 81402 do not have any diagnosis limitations effective for dates of service on and after 01/01/2016. In response to removing Group 18 the ICD-10 code groups have been renumbered.
A clarifying statement has been added under the CPT Code Group 1 Paragraph to explain that these CPT codes do not have diagnosis limitations and providers should refer to the covered indications of the LCD for reasonable and necessary guidelines for biomarkers included in these CPT codes.
PIK3CA has been removed from the following ICD-10 Code Group Paragraphs list of biomarkers; Group 1, Group 4, Group 5 and Group 6 effective for dates of service on and after 01/01/2015.
Diagnosis codes C21.0, C21.2 and C21.8 have been added to ICD-10 Code Group 1 as covered diagnoses effective for dates of service on or after 12/01/2016.
Diagnosis code C55 has been added to ICD-10 Code Group 6 as a covered diagnosis effective for dates of service on or after 12/01/2016.
A typographical error was made during the ICD-9 to ICD-10 translation resulting in ICD-10 code C92.02 being placed in ICD-10 Code Group 10 instead of the correct ICD-10 code, C91.02. C92.02 is being deleted from ICD-10 Code Group 10 and C91.02 is being added effective for dates of service 12/01/2016 and after.
Diagnosis codes C93.10, C93.11 and C93.12 have been added to ICD-10 Code Group 16 as covered diagnoses effective for dates of service 12/01/2016 and after.
Diagnosis codes C91.60, C91.61 and C91.62 have been added to newly numbered ICD-10 Code Group 20 (formerly group 21 before renumbering with this revision) as covered diagnoses for T-cell leukemia effective for dates of service on or after 12/01/2016.
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- Typographical Error
- Other (Recon, Inquiry)
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03/08/2018
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R22
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LCD revised and published on 03/08/2018 effective for dates of service on and after 12/22/2017 to add limited coverage for Oncomine DX test reported with CPT code 81445 for Non-Small Cell Lung Cancer (NSCLC). Language has been added to #2 under Molecular Tests in the Covered Indications area and CPT code 81445 has been added to ICD-10 Group 2 Paragraph for NSCLC. Utilization guidelines have been added for the Oncomine DX test when reported with CPT code 81445. References received with a reconsideration request for the Oncomine DX test have been reviewed and added to the policy. Link to L36715-BRCA1 and BRCA2 Genetic Testing and L35062-Biomarkers Overview added to the Related Local Coverage Documents section. For provider education/guidance, per Annual Review, removed Bill Types 18x and 21x as those Bill Types are not for inpatient services claims; update to CFR listing per template.
At this time 21st Century Cures Act will apply to new and revised LCDs that restrict coverage which requires comment and notice. This revision is not a restriction to the coverage determination; therefore, not all the fields included on the LCD are applicable as noted in this policy.
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- Reconsideration Request
- Other (Annual Review)
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01/01/2018
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R21
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LCD revised and published on 01/25/2018 effective for dates of service on and after 01/01/2018 to reflect the annual CPT/HCPCS code updates. For the following CPT/HCPCS codes either the short description and/or the long description was changed: 81400, 81401, 81403, 81404, 81405, 81406. Depending on which description is used in this LCD there may not be any change in how the code displays in the document. The following CPT/HCPCS codes have been added to CPT/HCPCS Code Group 1: 81120, 81121, 81175, 81176, 81334, 81520. The following CPT/HCPCS code has been deleted from CPT code group 1: 0008M. To clarify coverage for the new CPT/HCPCS code additions, ICD-10 Group Code Paragraphs have been updated as follows: Group 4: IDH1 (81120) and IDH2 (81121); Group 10: RUNX1 (81334); Group 11: ASXL1 (81175, 81176), IDH1 (81120), IDH2 (81121) and RUNX1 (81334); Group 15: ASXL1 (81175, 81176); Group 22: ASXL1 (81175, 81176), IDH1 (81120) and IDH2 (81121); and Group 24: 81520 has been added and 0008M has been deleted.
At this time 21st Century Cures Act will apply to new and revised LCDs that restrict coverage which requires comment and notice. This revision is not a restriction to the coverage determination; therefore, not all the fields included on the LCD are applicable as noted in this policy.
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- Revisions Due To CPT/HCPCS Code Changes
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11/09/2017
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R20
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LCD revised and published on 11/09/2017 effective for dates of service on and after 08/01/2017 to add the following new CPT/HCPCS codes for Proprietary Laboratory Analyses (PLA) to Group 2 CPT/HCPCS Codes as non-covered: 0009U, 0013U, 0014U, 0016U, and 0017U. LCD revised with effective dates of service on and after 10/02/2017 to reflect the 4Q17 CPT/HCPCS code updates. For the following CPT/HCPCS code(s) either the short description and/or the long description was changed: 81405 and 0002U. Depending on which description is used in this LCD, there may not be any change in how the code displays in the document.
At this time 21st Century Cures Act will apply to new and revised LCDs that restrict coverage which requires comment and notice. This revision is not a restriction to the coverage determination; therefore, not all the fields included on the LCD are applicable as noted in this policy.
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- Revisions Due To CPT/HCPCS Code Changes
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10/01/2017
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R19
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LCD revised and published on 10/05/2017 effective for dates of service on and after 10/01/2017 to reflect the ICD-10 Annual Code Updates. The following ICD-10 code has been deleted from Group 20 codes: C96.2. The following ICD-10 codes have been added to Group 20 codes: C96.20, C96.22, C96.29.
At this time 21st Century Cures Act will apply to new and revised LCDs that restrict coverage which requires comment and notice. This revision is not a restriction to the coverage determination; therefore, not all the fields included on the LCD are applicable as noted in this policy.
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- Revisions Due To ICD-10-CM Code Changes
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08/10/2017
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R18
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LCD revised and published on 08/10/2017 effective for dates of service on and after 05/01/2017 to add the following CPT code as non-covered to Group 2 Codes: 0005U.
At this time 21st Century Cures Act will apply to new and revised LCDs that restrict coverage which requires comment and notice. This revision is not a restriction to the coverage determination; and, therefore not all the fields included on the LCD are applicable as noted in this policy.
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- Revisions Due To CPT/HCPCS Code Changes
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02/01/2017
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R17
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LCD revised and published on 07/13/2017 to add references received with a reconsideration request for CxBladder coverage. After review of the submitted literature it has been determined that non-coverage of CxBladder will remain. No substantial changes are being made to the LCD at this time.
At this time 21st Century Cures Act will apply to new and revised LCDs that restrict coverage which requires comment and notice. This revision is not a restriction to the coverage determination; and, therefore not all the fields included on the LCD are applicable as noted in this policy.
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02/01/2017
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R16
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LCD revised and published on 05/11/2017 effective for dates of service on and after 02/01/2017 to add the following CPT codes as non-covered to Group 2 Codes: 0002U and 0003U. An explanation of non-coverage for these codes has been added to the Limitation section of the policy.
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- Revisions Due To CPT/HCPCS Code Changes
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01/01/2017
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R15
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LCD revised and published on 01/12/2017 effective for dates of service on and after 01/01/2017 to reflect the annual CPT/HCPCS code updates. For the following CPT/HCPCS codes either the short description and/or the long description was changed. Depending on which description is used in this LCD, there may not be any change in how the code displays in the document: 81402 and 81407. The following CPT/HCPCS code 81327 has been added to group 1 CPT codes and Group 1 Paragraph for ICD-10 codes of the LCD.
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- Revisions Due To CPT/HCPCS Code Changes
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12/01/2016
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R14
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LCD posted for notice on 10/13/2016. LCD becomes effective for dates of service and after 12/01/2016.
05/19/2016 DL35396 Draft LCD posted for comment.
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- Automated Edits to Enforce Reasonable & Necessary Requirements
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10/01/2016
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R13
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LCD revised and published on 09/29/2016 effective for dates of service on and after 10/01/2016 to reflect the ICD-10 Annual Code Updates. The following ICD-10 codes have been added to the list of Group 8 diagnosis codes: N42.31, N42.32 and N42.39. The following ICD-10 codes have been added to Group 9 diagnosis codes: C49.A0, C49.A1, C49.A2, C49.A3, C49.A4, C49.A5 and C49.A9. The following Group 8 ICD-10 codes have undergone a descriptor change: N40.0 and N40.1.
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- Revisions Due To ICD-10-CM Code Changes
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01/22/2016
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R12
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LCD revised and published on 05/12/2016 to correct source for Starczynowski.
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01/22/2016
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R11
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LCD revised and published on 04/14/2016, effective for dates of service 01/22/2016, to add limited coverage for Prosigna upon additional reconsideration request. A new Group for CPT/HCPCS code 0008M was created for the following ICD-10 codes for 0008M: C50.011, C50.012, C50.019, C50.111, C50.112, C50.119, C50.211, C50.212, C50.219, C50.311, C50.312, C50.319, C50.411, C50.412, C50.419, C50.511, C50.512, C50.519, C50.611, C50.612, C50.619, C50.811, C50.812, C50.819, C50.911, C50.912, C50.919. Submitted sources have been added to the LCD. Please note: The content of this LCD version remains the same as the prior version (R10) except that additional codes have been added to the Revision History for this version to accurately reflect all the code additions.
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01/22/2016
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R10
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LCD revised and published on 04/14/2016, effective for dates of service on and after 01/22/2016, to add limited coverage for Prosigna upon additional reconsideration request. A new Group for CPT/HCPCS code 0008M was created for the following ICD-10 codes for 0008M: C50.011, C50.012, C50.111, C50.112, C50.211, C50.212, C50.311, C50.312, C50.411, C50.412, C50.511, C50.512, C50.611, C50.612, C50.811, C50.812, C50.911, C50.912. Submitted sources have been added to the LCD.
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01/01/2016
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R9
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LCD revised and published on 02/11/2016, effective for dates of service 12/14/2015 and after, to add coverage for ThyraMIR services reported with CPT code 81479. The following ICD-10 codes have been added to Group 5 for ThyraMIR: E01.0, E01.2, E04.0, E04.8, E04.9.
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01/01/2016
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R8
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LCD revised and published on 01/28/2016 to reflect the annual CPT/HCPCS code updates. For the following CPT/HCPCS codes, either the short description or the long description was changed. Depending on which description is used in this LCD, there may not be any change in how the code displays in the document: 81210, 81275, 81402, 81435, 81436, 81445, 81450. The following code has been added to CPT group 2 as NON-COVERED; 81595 as the service represented by this code is currently non-covered per the LCD under the non-conventional methods of NGS limitation. CPT code 81170 has been added to groups 10 and 16 to replace 81403 for reporting ABL1. CPT code 81218 has been added to groups 11 and 23 to replace 81403 for CEBPA. CPT code 81272 has been added to groups 3 and 9 to replace 81404 for KIT. CPT 81273 has been added to groups 11, 16, 19, 21, and 23 to replace 81402 for KIT. CPT 81276 has been added to groups 1, 2, 5, 6, 11, 16, and 23. CPT code 81311 has been added to groups 1, 3, 5, 11, 16, and 23 to replace 81404 associated with NRAS. CPT code 81314 has been added to group 9 to replace 81404 associated with PDGFRA. CPT code 81538 has been added for VeriStrat® testing to group 2 diagnosis.
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- Revisions Due To CPT/HCPCS Code Changes
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10/01/2015
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R7
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LCD revised and published on 11/13/2015 to add ICD-10 diagnosis codes with higher specificity to Group 5 effective for dates of service on and after 10/01/2015. Diagnosis codes added to Group 5: D44.2, D44.9, E01.1. Sources from reconsideration requests have been reviewed and added to the LCD sources. No substantial changes have been made based on the reconsiderations.
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- Reconsideration Request
- Other (Clarification)
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10/01/2015
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R6
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LCD revised and published on 10/08/2015 to reflect that OVA1 should be reported with CPT 81503 rather than 84999 effective for dates of service on and after 10/01/2015.
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- Revisions Due To CPT/HCPCS Code Changes
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10/01/2015
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R5
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LCD revised and published on 08/13/2015 to add multiple sources submitted with several reconsideration requests regarding Prosigna, molecular kidney cancer testing and bladder cancer testing. All literature was reviewed. No changes to the policy were made based on these reconsideration requests.
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10/01/2015
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R4
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LCD revised and published on 01/23/2015 to reflect the annual CPT/HCPCS code updates For the following CPT/HCPCS code(s) either the short description and/or the long description was changed. Depending on which description is used in this LCD, there may not be any change in how the code displays in the document: 81245; 81402; 81403; 81404; 81405. The following codes have been added to CPT group 2 as NON-COVERED; 81445, 81450 and 81455.The following codes have been added to the LCD but will not have any diagnosis to procedure code editing at this time; 81246; 81435; and 81436.CPT code 81313 has been added to group 8 to replace 81479 for reporting PROGENSA® PCA3 Assay. Original and subsequent decisions to non-cover Prosigna are reaffirmed upon additional reconsideration request. Submitted sources have been added to the LCD.
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- Revisions Due To CPT/HCPCS Code Changes
- Reconsideration Request
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10/01/2015
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R3
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LCD revised and published on 10/09/2014, effective for dates of service on or after 10/01/2015. Non-coverage for Prosigna reaffirmed upon reconsideration request. LCD revised to add ICD-10-CM codes under group 5 for indeterminate malignancy, as well as presumed or documented malignancy of the thyroid gland per a reconsideration request. LCD also revised to add limited coverage for MyPRS multiple myeloma testing.
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10/01/2015
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R2
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10/01/2014 LCD revised and published on 08/14/2014 to provide clarifications to the statement regarding next generation sequencing methods in the limitations section and to the cancer of unknown primary testing area. Reference to Local Coverage Article A52986 was inserted into LCD.
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10/01/2015
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R1
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10/01/2014 LCD revised and published on 08/14/2014 to provide clarifications to the statement regarding next generation sequencing methods in the limitations section and to the cancer of unknown primary testing area. Reference to Local Coverag Article A52986 was inserted into LCD.
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