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  • Liquid Biopsy: Lung Cancer Screening Needs Help  [View instapost]
    Palmetto also published a clarification on billing for hotspot
    panels versus comprehensive genomic profiling suggesting labs bill targeted panels
    using CPT codes 81445, 81450, and 81455. For comprehensive genomic profiling,
    which includes testing for SNVs, small and large insertions and deletions, CNVS, and
    rearrangements/translo... however, Palmetto indicates labs should
    bill using CPT code 81479 (unlisted molecular pathology procedure). In our view,
    Palmetto distinguishing between hotspot (5 to 50 genes panels which detect SNVs
    and small insertions/deletions) and comprehensive genomic profiling is a positive

    MolDX Home / Covered Tests / Next Generation Sequencing Coding and Billing Guidelines (M00127, V1)
    MolDX
    Next Generation Sequencing Coding and Billing Guidelines (M00127, V1)

    Next Generation Sequencing (NGS)
    NGS testing platforms allow identification of somatic and/or germline alterations in multiple genes at the same time. This guideline focuses on two main types of somatic, tumor tissue-based, testing panels. Germline panels will be addressed in another article as needed.

    Targeted (aka Hot Spot) Tumor Panels
    Targeted NGS panels identify somatic alterations known to occur in certain areas (i.e., 'hotspots') in specific genes of interest. Generally, these NGS panels can detect single nucleotide variants (SNVs or point mutations) and small (typically ≤10 bp) insertions or deletions. These alterations typically represent genomic targets with corresponding targeted cancer therapies. Identification of a genomic target guides use of the corresponding targeted therapy.

    To bill for targeted NGS services, select CPT codes 81445, 81450 and 81455 according to the number of genes in your laboratory’s NGS panel for solid tumor and hematolymphoid neoplasms. The UOS for the NGS panel is one.

    Note: Individual gene tests performed in the NGS panel should NOT be registered and reported with multiple CPT Tier 1 and/or Tier II codes.

    Comprehensive Genomic Profile (CGP) Testing
    CGP refers to NGS-based testing that has been optimized to identify all types of molecular alterations (i.e., SNVs, small and large insertions and deletions, CNVs, and rearrangements/translo... in cancer-related genes in a single test using complex proprietary bioinformatics.

    Because CGP includes SNVs, small (≤ 10 bp) and large (> 10 bp) insertions and deletions, CNVs, AND rearrangements (i.e., translocations/fusions), CPT codes 81445, 81450, and 81455 do NOT describe a CGP service. Therefore, to report a CGP service, test providers should use CPT code 81479 - Unlisted molecular pathology procedure.

    For dates of service on and after

    ****January 1, 2016*****,

    MolDX covers tests reported with CPT Tier 1 codes; (81161-81393), Tier 2 codes, (81400-81408), Genomic Sequencing and other Molecular Multianalyte Assays (MAA), (81410-81471), MAA with Algorithmic Analyses, (0001M-0010M) HCPCS professional interpretation code, (G0452), microdissection codes (88380-88381) and not otherwise classified codes (NOC), (81479, 84999, 81599, 85999, 86849, 87999, 88199, 88299, 88399, and 89398.

    Unique Test Identifiers
    In order to establish appropriate coverage and reimbursement for MolDX claims, Palmetto GBA requires additional information on each MolDX test. The online registration process offered by the McKesson Diagnostic Exchange™, collects the required test information so providers ONLY have to submit test information one time. Upon completion of the registration process, a Z-Code Identifier is assigned for each registered test. Test providers enter this identifier in the SV101-7 claim field adjacent to every CPT code used to report the test. During claims processing, the MolDX staff matches the identifier to the test information in the registry and determines coverage for claims payment. To facilitate MolDX claims adjudication, Palmetto GBA has developed a MolDX Master Edit File to automate MolDX claims payment. (MolDx Registration)

    Technology Assessments (TA)
    MolDX tests in a prelaunch status will be evaluated to determine analytical and clinical validity and clinical utility. Palmetto GBA uses subject matter experts to evaluate the scientific data for each test. Once completed, Palmetto GBA will make and publish a coverage determination based on the final assessment.

    All registered tests are reviewed to validate that each test meets the Medicare criteria for coverage. During the registration and application review process, Palmetto GBA may request additional documentation to clarify or determine coverage on any test reported to Medicare for reimbursement.
    (Technical Assessment)

    Reimbursement Determination
    Based on the information provided for the TA, Palmetto GBA will apply multiple methodologies appropriate to the specific test to determine an equitable value for each submitted test. (Technical Assessment)

    MolDX Details
    What: The program will affect diagnostic services reported with the following CPT/HCPCS codes:
    Code Category/Description 2016 MolDx Code Range
    Tier 1 81161-81383
    Tier 2 81400-81408
    Genomic Sequencing and other Molecular Multianalyte Assays (MAA) 81410-81471
    Molecular Multianalyte Assays (MAA) 81490-81595
    MAA Proprietary Codes 0001M-0010M
    HCPCS: Molecular pathology procedure; physician interpretation and report G0452
    NOC 81479, 81599, 84999, 85999, 86849, 87999, 88199, 88299, 88399, 89398
    Dec 22, 2015. 10:36 AM | 1 Like Like |Link to Comment
  • Sequenom: Will Liquid Biopsy Replace The Dreaded Colonoscopy?  [View instapost]
    the eric topol clinical trial with SQNM
    http://1.usa.gov/1T4rYV6
    Dec 17, 2015. 03:04 PM | 1 Like Like |Link to Comment
  • What Does Shkreli's Arrest Mean For KaloBios' Share Price?  [View article]
    could Martin now close his short positions in the stocks he bashed if any held? say CYCC or MCUR ?
    Dec 17, 2015. 09:08 AM | 2 Likes Like |Link to Comment
  • At Current Prices, Someone Is Going To Buy Sequenom  [View article]
    someones putting pressure on them as they dont want to pull the poison pill and be bought for say 500M
    these suppressed pps are not fundamental driven but takeout driven
    80M in cash 130m marketcap 140m 2016 sales ip pool cash from illumina rising (but only lagging due to ivd validation process and illumina reporting to sequenom lag of 90-180 days)
    1 year from here we will be over this years highs of 4.80 imo
    sequenom sayd tageting 500M by 2020

    heres the presentation for download http://bit.ly/1Z0y6S3

    liquid biopsy it THE big thing in cancer treatment and monitoring in 2016
    theres no valuation given yet this is the most undervalued stock in biotech richt now
    Dec 10, 2015. 03:29 AM | 4 Likes Like |Link to Comment
  • At Current Prices, Someone Is Going To Buy Sequenom  [View article]
    they will be break even soon ... no bleeding out my friend
    Dec 10, 2015. 03:17 AM | 2 Likes Like |Link to Comment
  • Cyclacel Pharmaceuticals' (CYCC) CEO Spiro Rombotis on Q2 2015 Results - Earnings Call Transcript  [View article]
    59 patients still alive nice
    Aug 12, 2015. 07:37 AM | Likes Like |Link to Comment
  • Sequenom June 2015 Results: Another Hit From Transition To Pool  [View instapost]
    William Blair ~ 6.00 PT

    Assuming the company can get to 2018 revenue of $200 million, and we use a comp-based revenue multiple of 3.5 times, we
    arrive at an enterprise value of about $700 million (versus about $300 million based on after-market trading). Further, with
    the recent Natera (NTRA $17.49) IPO placing a current market capitalization of $800 million on that business and the takeout
    amounts generated by Ariosa (up to $625 million) and Verinata ($450 million), Sequenom appears to be undervalued. Because
    we believe the company’s business model should hold up against these other companies, we believe the amount of the current
    discount is unwarranted even with the historical baggage and business model transition the company is going through.
    Aug 6, 2015. 09:15 AM | Likes Like |Link to Comment
  • Sequenom June 2015 Results: Another Hit From Transition To Pool  [View instapost]
    Thus, while this quarter was unequivocally a miss and was muddied by the lack of information provided by management on
    the call, we remain positive about the long-term opportunity here. We continue to believe that with the major IP issues largely
    put to bed, the cash position and path to profitability in strong positions, the average risk opportunity right in front of the
    company, and multiple new product and market opportunities likely to bear fruit in 2016 and beyond, the long-term outlook
    for Sequenom as a stand-alone company remains better than what the market will give credit for and we continue to view this
    as an attractive takeout candidate.
    So what happened on the second-quarter call? On the first-quarter call in May, management indicated it expected secondquarter
    volumes and revenue to be down sequentially. This was due to Quest (DGX $74.48; Market Perform) transitioning to
    its own noninvasive prenatal screening test and no longer using Sequenom as its send-out lab for these tests (but paying into
    the joint Illumina-Sequenom [ILMN $215.86; Outperform] patent pool). Management indicated that it expected this to cause a
    $3 million sequential decrease in revenue and a fall-off in test volumes, though the scope of volume fall-off was not specified at
    the time.
    The actual results showed volume did fall off by some 8,300 tests sequentially due to the Quest transition while the non-Quest
    related volumes were flat sequentially. However, revenue was down $5 million sequentially, with $3 million coming from the
    Quest transition (as expected) and an extra $2 million coming from delayed payments from out-of-network payers. The
    company believes these delays are due to some payers taking a more deliberate approach to payment in light of some of the
    noise caused in the market by competitors, which may be using very aggressive billing techniques.
    Aug 6, 2015. 09:14 AM | Likes Like |Link to Comment
  • Sequenom June 2015 Results: Another Hit From Transition To Pool  [View instapost]
    License Revenue
    License revenues are derived from direct license agreements with domestic and international customers to whom we have licensed our technology in certain countries. We also derive license revenues through a sharing of test fees under the Pooled Patents Agreement with Illumina. License revenue is recognized in the period reported by our partner or Illumina and in certain cases

    ****can result in a lag of revenue of up to one quarter from the period in which the test was performed.*****
    Aug 6, 2015. 06:53 AM | Likes Like |Link to Comment
  • Sequenom June 2015 Call Today: What To Watch For  [View instapost]
    all about SQNM NIPT and Liquid Biopsy
    http://bit.ly/1HKHJxB
    Aug 5, 2015. 03:13 PM | Likes Like |Link to Comment
  • NIPT: The Poster Child For Liquid Biopsy  [View article]
    now thats an argument lol
    Jul 15, 2015. 08:23 AM | Likes Like |Link to Comment
  • NIPT: The Poster Child For Liquid Biopsy  [View article]
    Deepest research on Sequenom SQNM here:
    http://bit.ly/1HKHJxB
    Jul 13, 2015. 12:56 PM | 2 Likes Like |Link to Comment
  • Natera - Successful IPO Raises Expectations As Recent Revenue Trends Are Worrying  [View article]
    all you need to know about NATERA NTRA and SQNM Sequenom here:
    http://bit.ly/1HKHJxB
    Jul 7, 2015. 10:31 AM | Likes Like |Link to Comment
  • ASCO 2015 Recap  [View instapost]
    SQNM liquid biopsy program
    http://bit.ly/1FWnH0N
    Jun 4, 2015. 11:58 AM | Likes Like |Link to Comment
  • Liquid Biopsy: What's In A Name?  [View instapost]
    much more on liquid biopsy here: http://bit.ly/1IKrrV4
    May 17, 2015. 05:11 PM | 1 Like Like |Link to Comment
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