Download Moldx update

MOLDX
UPDATE
Elaine K Jeter, MD
MolDX Program
• Established to address:
• Granular identification
• Coding to accommodate to growth of molecular testing
• Implement core clinical guidance for coverage
• Molecular Diagnostic Testing Policy:
• Labs must register their test & obtain unique ID
• Applies to all molecular codes – except micro
• Test ID is required claim element
• New test TA for coverage
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MolDX Registration Stats
Total FDA & LDT
6550
Tests with LCD applications
1032
Tests with NCD applications
147
Tests with Article applications
1089
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MolDX Coverage Stats
Tests Covered
Total FDA & LDT
FDA – unmodified
FDA – modified
2619
Tests Not
Covered
3302
219
154
19
17
*Tests determined to be either not a Medicare Benefit (i.e. statutorily
excluded) or not reasonable and necessary (R&N) by NCD or LCD. Medicare
does not cover tests that are screening in nature, confirmatory, or testing
absent any signs or symptoms of disease.
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Reasons for Non-coverage
• No benefit category
•
•
•
•
Screening
Confirmatory testing when dx is known
Quality measure
Test doesn’t apply to Medicare population
• SSA §(a)(1)(A) – “reasonable & necessary”
• Lack of or insufficient clinical utility physician
survey
• Lack of analytical validation
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MolDX TAs
Total TAs since inception
102
Non-covered
51
Tests with LCD
22
Tests with CDD LCD
4
Tests with educational article
16
Tests in process
3
Pre-submission
4
Incomplete
2
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Why so Many Policies?
• Over-utilization/abuse
• CYP testing
• Hypercoagulability/Thrombophilia
• Controlled Substance Monitoring and DOA Testing
• CV Risk Assessment
• Special stains and IHC
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Prostate CDD Policies
• Decipher (GenomeDx) – to determine which high-risk
patients after RP can be closely followed rather than
post-op XRT
• ConfirmMDx (MDxHealth) – to determine which biopsy
negative patients can avoid unnecessary repeat biopsies
• Prolaris (Myriad) – to determine which low risk by
biopsy prostate cancer patients can be managed by AS
• Oncotype Prostate (Genomic Health) – to determine
which low risk by biopsy prostate cancer patients can be
managed by AS
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MolDX Roll Out
• Operate under a JOA
•
•
•
•
JM (SC, NC, VA, WV)
JE (CA, NV, HI & Pacific islands)
JF (WA, OR, ID, UT, AZ, MT, WY, SD, ND, AK)
J15 (Oh, KY)
• Under discussion with other jurisdictions
• PAMA & Proposed Rule – silent on nat’l roll out
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Hospital Labs
• Incorrect info
• MolDX identifiers
• Does not apply to IP or OP labs billing Part A
• Applies to all hospital outreach labs that bill Part B
• CMS
• Current system can’t accommodate narrative field
• Developing work-around
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Next Generation Sequencing
• Technology that analyzes hundreds of genes
simultaneously
• Two major types
• Hot Spot Testing – looks at portions of genes and
only specific types of mutations – identify SNVs and
dup/dels
• Comprehensive Genomic Profiling – looks at entire
genes and all known mutations – identify SNVs,
dup/dels, CNVs and translocations
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Multi-gene “Hot Spot Testing
Missed
Missed
Found
Found
Missed
Hot Spot NGS panels identify:
• Pre-specified mutations occurring in very limited areas of genes of interest,
• Fail to detect all classes of genomic alterations
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Comprehensive Genomic Testing
Chromosome
Exon 1
Exon 2
Exon 3
Exon 4
Sequences coding regions of genes in
their entirety
Exon 3
Comprehensive NGS panels sequence all exomes and all classes of genomic alterations:
single nucleotide variants, dup/dels, copy number variants and translocations.
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NGS is Here
• May replace several individual tests & provide
potential healthcare cost savings
• Decrease number biopsies
• Decrease aggregate cost
• Possible decrease ‘shot gun’ use of chemotherapy
• May possibly improve patient outcomes
• Identify patients for targeted therapy missed by
Companion Dx or LDT
• Identify patients for clinical trials & investigational
therapies
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NGS High Points
• No standardization or cross validation of platforms
• Generally more sensitive than companion dx
methodologies – unclear if better outcomes
• Less tissue required for analysis
• Pressure to cover this technology
• Academic centers
• Industry – vocal high profile companies & political ears
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Non-standardized Testing
• Three components
• Pre-analytical
• Sequencing
• Data interpretation using complex algorithms
• No comparison between labs or platforms, and
disagree on methods to determine components
• 80% concordance – simplest DNA alterations
• 20% concordance – complicated alterations
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Low Allele Frequency
• NGS – high assay sensitivity & tumor
heterogeneity
• Detect alterations in very small number of cells
• Report positive alteration – directly guide tx
• 100% therapeutic response to cells, but the vast
majority of tumor remains untreated and the
patient experiences a poor outcome
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False Results
• High false positives
• ~50% of reported alterations are erroneous
• Driver mutations vs passenger mutations
• Many patients will receive tx they will not respond to
• Patients will be shunted from other treatments they
could have received while chasing the erroneous result
• False negatives
• Most “hotspot” labs must perform FISH testing to rule
out false negatives
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Lack Data Collection
• NGS panels place patients in harms way by
allowing patients to:
• Receive testing & tx that compete with existing trials
• Receive ineffective treatments
• Miss publication of key toxicities that lead to better
understanding of disease
• Potentially hamper, rather than advance science, by
use of off-label drugs without a body of literature
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Solutions to NGS Pitfalls
• Standardize Testing
• CAP/AMP developing standards
• FDA assessment of LDTs
• Compare testing with existing literature
established with targeted therapy – does it
improve outcomes
• Attach high quality testing as inclusion criteria in
current and future clinical trials
• Collect outcomes and aggregate nationally
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Example of Problem
• NSCLC NCCN Guidelines – Version 7.2015
• ALK and EGFR – adequate literature for
coverage
• Adenocarcinoma – test all patients
• Squamous histology – if never smokers, small bx
used in testing, or mixed histology
• ROS1 – adequate literature for coverage after
NCCN review
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Limited Published Info
Emerging Targeted Agents for NSCLC Patients with Genetic Alterations
Genetic Alterations (Driver event)
Available Targeted Agent with Activity against
Driver Event in Lung Cancer
BRAF V600E mutation
Vermurafenib¹, Dabrafenib²
MET amplification
Crizotinib³,⁴
ROS1 rearrangements
Crizotinib⁵
HER2 mutations
Trastuzumab⁶ (cat 2B), Afatinib⁷ (cat 2B)
RET
Cabozantinib⁸ (cat 2B)
Case report
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Emerging Targeted Agents
• Evidence is inadequate – case reports,
abstracts, small trials
• Multiple ongoing trials waiting final reporting
on these agents
• Insufficient evidence to allow wholesale
coverage
• Unclear where to include these other agents in
biologic pathways
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Coverage & Coding Issues
• Genes in NGS panels must meet R&N
determination
• AMA acknowledges error to “unbundle” –
currently correcting their error
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NGS in MolDX
• NGS panel must submit new DEX registration
• End date prior test registrations
• Must include genes in NGS panel
• Coverage remains the same – based on R&N
• Reimbursement will change
• Working with AMA
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ICD-10
• Unspecified codes were intentionally removed
from 9 to 10 crosswalk – specificity is the
purpose of ICD-10
• LCDs back to CAC to remove ICD-10s that were
erroneously included
• Request addition of specific ICD-10s where
needed with reasoning – add as needed
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CSM & DOA Policy Goals
• For pain & substance use disorder patients:
• Define appropriate indications
• Testing frequency for prescribed substances
• Define documentation requirements
• Tests ordered & medical indication for specific test
selection
• Provide education-testing methods & limitations
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10000 20000 30000 40000
Assay of cocaine
0
# of claims
82520
Jul
Jan Jul Jan Jul Jan Jul Jan Jul Jan
2011
2012
2013
2014
2015
41 / 174 Providers
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10000 15000 20000
Assay of dihydrocodeinone
0
5000
# of claims
82646
Jul
Jan Jul Jan Jul Jan Jul Jan Jul Jan
2011
2012
2013
2014
2015
66 / 114 Providers
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83805
15000
0 5000
# of claims
25000
Assay of meprobamate
Jul Jan Jul Jan Jul Jan Jul Jan Jul Jan
2011
2012
2013
2014
2015
55 / 133 Providers
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83840
30000
0
10000
# of claims
Assay of methadone
Jul Jan Jul Jan Jul Jan Jul Jan Jul Jan
2011
2012
2013
2014
2015
44 / 177 Providers
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Drug Testing Claims Data
• Utilization spikes
•
Physician owned labs (POLs) – self-referral
•
Billing semi-quant testing with Quantitative codes
•
Using methodology codes (83542 – LC-MS) to bill for
opioid metabolites; 83925 – opiate(s), drug & metabolites
• Billing schemes to induce referrals
•
Labs charges physician below market flat fee, physician
marks up to private payers
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Testing for Substance Use
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UDT Testing for Pain
Risk Group
Baseline
Frequency of Testing
Low Risk
Prior to initiation of COT
Random testing – 1-2x/yr for prescribed meds,
non-prescribed meds that pose a safety risk if
taken with prescribed meds, and illicit substances
based on patient hx, clinical presentation, and/or
community usage
Moderate Risk Prior to Initiation of COT
Random testing – 1-2x/6 mo for prescribed meds,
non-prescribed meds that pose a safety risk if
taken with prescribed meds, and illicit substances
based on patient hx, clinical presentation, and/or
community usage
High Risk
Random testing – 1-3x/3 mo for prescribed meds,
non-prescribed meds that pose a safety risk if
taken with prescribed meds, and illicit substances
based on patient hx, clinical presentation, and/or
community usage
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Prior to Initiation of COT
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UDT Coding/Billing Claim
• One drug per claim line
• Each drug must use short string text in SV101-7
field of claim
• Up to 7 drugs reimbursed per CPT
• Tiered panel reimbursement:
• 8-15
• 16-34
• >35
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Questions?
[email protected]
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