Discoveries in Health Policy: The NGS MAC and its Molecular Services LCD

Most is written about the MolDX molecular coverage program at CMS, and for several years, the Novitas contractor has had elaborate LCDs for both oncology and non oncology molecular tests.

Don't lose track of the fact that the NY/New England and Upper Midwest IL/MN/WI contractor "NGS" (originally standing for National Government Services) has produced its own elaborate molecular diagnostics LCD.

The LCD was released in draft form last fall. (Separately, the MAC has an LCD, effective April 1, 2016, for lung cancer genomic profiling, here, L36376. This attracts a lot of attention as this is the LCD for lung cancer genomic profiling in Massachusetts, where Foundation Medicine is located.) Details follow.

Original NGS MAC LCD for Molecular Testing
For historical purposes, the original 2015 draft LCD was still online at this website here. Since government websites change as LCDs move from draft to future-effective to final-effective, I have put a Word copy of the draft LCD in the cloud, here.

January-March 2016 Version
The LCD was in an effective version revised effective January 1, 2016, here.

April 2016 Future Effective Version
The most recent version is "Future Effective April 1, 2016" and is online here. A word version of the April 2016 future effective LCD is in the cloud, here.

Covered tests below the break, based on the "Future Effective" April 2016 version.

Special bonus: For readers who are overexcited by watching paint dry, and need to calm themselves down, I provide a redline of the October 2015 version to the April 2016 future effective version...in the cloud, here.

Note: Clippings below are from the FUTURE EFFECTIVE version for April 1, 2016.

TIER 1 AND TIER 2 INDICATIONS AND LIMITATIONS OF COVERAGE
TIER ONE:

CPT Code 81170
ABL1 (ABL proto-oncogene 1, non-receptor tyrosine kinase) (eg, acquired imatinib tyrosine kinase inhibitor resistance), gene analysis, variants in the kinase domain is considered medically necessary in patients with acute lymphoblasic leukemia (ALL) and chronic lymphoblastic leukemia (CLL) to guide therapeutic decision making.

CPT Codes 81206, 81207, and 81208
BCR/ABL is considered medically necessary in the evaluation of individuals with chronic myelogenous leukemia or BCR-ABL positive acute lymphoblastic leukemia to evaluate treated individuals who manifest suboptimal response to initial tyrosine kinase inhibitor therapy or loss of response to tyrosine kinase inhibitor therapy.

CPT Code 81210
BRAF gene analysis is considered medically necessary for patients who have malignant melanoma, non-small cell lung cancer, or hairy cell leukemia when needed to determine if a Medicare covered therapy is a reasonable option given the individual's specific clinical presentation.

CPT Codes 81162, 81211, 81212, 81213, 81214, 81215, 81216, 81217
BRCA1 and BRCA2 genetic testing is considered medically necessary for a beneficiary with a personal history of a cancer associated with the BRCA mutation who meets one or more of the criteria found in the most recent version of the NCCN guidelines for Genetic/Familial High-Risk Assessment: Breast and Ovarian or other evidence based guideline addressing genetic testing.

CPT Code 81218
CEBPA (CCAAT/enhancer binding protein [C/EBP], alpha) (eg, acute myeloid leukemia), full gene sequence is considered medically necessary in patients with Acute Myelogenous Leukemia (AML) to guide therapeutic decision making.

CPT Code 81219
CALR (calreticulin) (eg, myeloproliferative disorders), gene analysis, common variants in exon 9 is not covered.

CPT Code 81225
CYP2C6 19-cytochrome P450 CYP2C6 19-cytochrome P450
Based on the FDA’s Black Box warning for clopidogrel, the effectiveness of clopidogrel is dependent on its activation to an active metabolite by the cytochrome P450 (CYP) system, principally CYP2C19.

CYP2C619 genotyping may be medically necessary once per lifetime to identify individuals:

Who are poor metabolizers of clopidogrel, so that alternative treatment or treatment strategies can be considered.

Who are poor metabolizers of clopidogrel with acute coronary syndrome or who are undergoing percutaneous coronary intervention.

CPT Code 81226
CYP2D6 (cytochrome P450, family 2, subfamily D polypeptide 6) (e.g., drug metabolism), gene analysis, is only considered medically necessary for individuals with Huntington’s disease for whom doses of tetrabenazine greater than 50 mg per day are being considered, and for testing prior to the initiation of Cerdelga^TM (eliglustat) for Gaucher’s disease.

CPT Code 81227 Use only G9143 CYP2C9 and/or VKORC1 Gene Testing for Warfarin Response
Pharmacogenomic Testing for Warfarin Response, gene testing on CYP2C9 and/or VKORC1 see NCD 90.1 for coverage information.

CPT Code 81235
EGFR (epidermal growth factor receptor) (eg, non-small cell lung cancer) gene analysis, common variants (eg, exon 19 LREA deletion, L858R, T790M, G719A, G719S, L861Q) [when specified as EGFR mutation analysis testing]

EGFR testing is considered medically necessary as a technique to predict treatment response for individuals with non-small cell, non-squamous cell lung cancer undergoing treatment with EGFR tyrosine kinase inhibitor (TKI) therapy (for example, erlotinib [Tarceva® ], gefitinib [Iressa® ], or afatinib [Gilotrif® ]).

CPT Code 81240 and 81241
F2 gene (prothrombin coagulation factor II) and F5 gene (coagulation factor V)

The F2 and F5 genetic tests are not considered to be clinically efficacious; therefore, testing is not medically necessary.

CPT Codes 81245, 81246
The FLT3 is considered medically necessary in patients with acute myeloid leukemia (AML) to guide therapeutic decision making.

CPT code 81256
The HFE (hemochromatosis)(hereditary hemochrosis) gene analysis, common variants (e.g. C282Y, H63D) is considered medically necessary in patients with iron overload of uncertain etiology (e.g. when the test is used to avoid liver biopsy in someone when the ferritin and the transferrin saturation are elevated greater than 45%). The genotyping of patients with iron overload of uncertain etiology is allowed only once per lifetime.

CPT codes 81261-81264
The IGH@ (Immunoglobulin heavy chain locus) is considered medically necessary for acute myeloid leukemia (AML) and lymphoma, B-cell to guide therapeutic decision making.

CPT codes 81265-81268
Chimerism analysis to identify appropriate donors and monitor engraftment success or disease reoccurrence is considered medically necessary.

CPT code 81265 includes donor and recipient testing and should be reported with one unit of service. Except in rare cases, this service would only be performed once per lifetime.

CPT code 81266 describes a service that may be used for two different reasons: additional births and bone marrow transplant. When used in bone marrow transplants to report an additional double-cord blood sample, it is a covered service. Since its use to report multiple births would be atypical for the Medicare population, it would not be a covered service.

CPT code 81267 is considered medically necessary in patients with diagnoses of leukemia and lymphomas and should be used post transplantation to confirm successful engraftment or disease reoccurrence. Although the original donor specimen may be referenced, an additional 81265 should not be submitted in addition to the 81267 service. For labs that hold the pre-transplant specimen (81265 and/or 81266) until after the transplant occurs, use 81267 plus 81265 and 81266 if necessary.

CPT code 81267 may be reported for the findings of the pre and post-transplant comparison.

CPT code 81268 may be used to report chimerism using a buccal or other germline tissue specimen from the recipient post-transplantation. For laboratories that hold the pre-transplant specimen (81265 and/or 81266) until after the transplant occurs, use 81267 plus 81265 and 81266 if necessary.

National Government Services would not expect to see a claim for 81265 pre-transplant and an additional 81265 and 81267 post-transplant or a claim for CPT codes 81265 pre-transplant and an additional claim for 81268.

Note: Although the initial chimerism testing, CPT code 81265, for engraftment is usually limited to once in a lifetime, National Government Services recognizes special circumstances may require an additional service and will consider approval on a case-by-case basis through the appeal process.

CPT Code 81270
JAK2 genotyping is considered medically necessary in patients who have myeloproliferative disease (MDS), or for whom MDS is a strong consideration to guide therapeutic decision making.

CPT Codes 81272, 81273
CPT Code 81272 KIT (v-kit Hardy-Zuckerman 4 feline sarcoma viral oncogene homolog) (eg, gastrointestinal stromal tumor [GIST], acute myeloid leukemia, melanoma), gene analysis, targeted sequence analysis (eg, exons 8, 11, 13, 17, 18) is considered medically necessary in patients who have GIST, acute myeloid leukemia (AML) or melanoma to guide therapeutic decision making.

CPT Code 81273 KIT (v-kit Hardy-Zuckerman 4 feline sarcoma viral oncogene homolog) (eg, mastocytosis), gene analysis, D816 variant(s) is considered medically necessary in patients who have mastocytosis to guide therapeutic decision making.

CPT Code 81275
KRAS gene analysis, variants in codons 12 and 13, is considered medically necessary in patients with colorectal cancer or non-small cell lung cancer when needed to determine if a Medicare covered therapy is a reasonable option given the individual's specific clinical presentation.

CPT Code 81276
KRAS (Kirsten rat sarcoma viral oncogene homolog) (e.g., carcinoma) gene analysis; additional variant(s) (e.g., codon 61, codon 146) is considered medically necessary in patients with colorectal cancer or non-small cell lung cancer when needed to determine if a Medicare covered therapy is a reasonable option given the individual's specific clinical presentation.

CPT Code 81287
MGMT (O-6-methylguanine-DNA methyltransferase) (e.g., glioblastoma multiforme), methylation analysis) is considered medically necessary in patients with glioblastoma to guide therapeutic decision making.

CPT Code 81301
Microsatellite instability analysis (e.g., hereditary non-polyposis colorectal cancer, Lynch syndrome) of markers for mismatch repair deficiency (e.g. BAT25, BAT26), includes comparison of neoplastic and normal tissue, if performed may be considered medically necessary in patients with colon cancer to guide therapeutic decision-making.

CPT Code 81310
NPM1 (nucleophosmin) is considered medically necessary in patients with acute myeloid leukemia (AML) to guide therapeutic decision making.

CPT Code 81311
NRAS (neuroblastoma RAS viral [v-ras] oncogene homolog) (e.g., colorectal carcinoma), gene analysis, variants in exon 2 (e.g., codons 12 and 13) and exon 3 (e.g., codon 61) is considered medically necessary in patients with colorectal cancer when needed to determine if a Medicare covered therapy is a reasonable option given the individual's specific clinical presentation.

CPT Code 81313
PCA3 testing is considered medically necessary in patients ONLY when all biopsies in previous encounter(s) are negative for prostatic cancer, the subsequent prostate specific antigen (PSA) is rising, and when the patient or physician wants to avoid repeat biopsy (“watchful waiting”).

When the physician plans to biopsy the prostate, NGS will consider a PCA3 test as not medically necessary, and thus, not a covered Medicare benefit. NGS considers all other indications for PCA3 not reasonable and necessary.

Medical record documentation must indicate the rationale to perform a PCA3 assay.

CPT Code 81314
PDGFRA (platelet-derived growth factor receptor, alpha polypeptide) (e.g., gastrointestinal stromal tumor [GIST]), gene analysis, targeted sequence analysis (eg, exons 12, 18) is considered medically necessary in patients with PDGFRA-associated chronic eosinophilic leukemia or GIST caused by mutations in the PDGFRA gene to guide therapeutic decision making.

CPT Codes 81370- 81383
HLA Class I or II typing is considered medically necessary when one of the following indications is met:

Transplantation:

Standard of care determination of HLA matching for solid organ transplant (donor/recipient). – Solid organ transplant registries include both serological HLA testing (e.g., crossmatch) and genomic molecular DNA typing. Family members, or unrelated living donors or cadaveric donors who donate bone marrow or a solid organ are HLA tested pre-transplant to determine compatibility with the potential recipients.
Standard of care identification of determination of HLA matching for hematopoietic stem cell/bone marrow transplantation -allele-level typing will provide clinical guidance for the HLA-A,B,C Class I and DRB1, DQB1,DPB1, and DQA1 Class II loci in the average transplant program because it is well established that mismatches at certain HLA loci between donor-recipients are closely linked to the risk of graft versus host disease. Potential marrow donors may enroll with a national registry such as the United States National Marrow Donor Program or the Canadian Blood Services registry.

Disease Association:

Standard of care testing to diagnose certain HLA related diseases/conditions when the testing is supported by the clinical literature and is informative for the direct management of a patient bearing a certain allele(s). It is not expected that more than one test would be required in a given beneficiary’s lifetime. Possible covered indications when standard laboratory testing (tissue typing) not adequate:
HLA-B*27 for the diagnosis of certain cases of symptomatic patients with presumed ankylosing spondylitis or related inflammatory disease. HLA-B*27 is covered for ankylosing spondylitis in cases where other methods of diagnosis would not be appropriate or have yielded inconclusive results (NCD 190.1).
In the work-up of certain patients with an unclear diagnosis of celiac disease and gluten hypersensitivity usually related to ambiguous standard laboratory results and/or inconsistent biopsy results (e.g., HLA-DQ2 by HLA-DQB1*02 and of DQ8 by HLA-DQB1*0302).

Pharmacogenetics:

Standard of care testing to diagnose certain HLA related drug hypersensitivity reactions when the testing is supported by the clinical literature and is informative for the direct management of a patient bearing a certain allele(s) associated to fatal skin drug reactions (Stevens-Johnson syndrome and toxic epidermal necrolysis). It is not expected that more than one test would be required in a given beneficiary’s lifetime. Possible covered indications:
HLA –B*5701 when testing performed prior to the initiation of an abacavir-containing regime in the treatment of HIV Infection.
HLA-B*1502 when genotyping may be useful for risk stratification when the testing is performed prior to the initiation of carbamazepine therapy in the treatment of patients at high risk of having this allele. HLA-B*1502 occurs almost exclusively in patients with ancestry across broad areas of Asia, including South Asian Indians.

Identification of HLA compatible platelets for transfusion when standard typing is not adequate.

CPT Code 81401

CPT code 81404, and 81405

CPT code 81479

TIER 1 COVERED MOLECULAR PATHOLOGY PROCEDURES

TIER 2 COVERED MOLECULAR PATHOLOGY PROCEDURES

NON COVERED TESTS

TIER 2 NON-COVERED MOLECULAR PATHOLOGY PROCEDURES

NON-COVERED GENOMIC SEQUENCING PROCEDURES
Genomic sequencing procedures, referenced in CPT/HCPCS Code sections (Groups 5 and 6) will be denied automatically as not medically necessar

Monday, February 22, 2016

The NGS MAC and its Molecular Services LCD