Understanding the Newest Rules for Showing
Clinical Utility of Molecular Tests and How They
Shape Payer Decisions
Jill Strassler
Douglas J. Moeller, MD
Executive War College
April 29, 2014
Agenda
•
Market Challenges
•
Advanced Diagnostics and implications of PAMA, Utility
•
How the Diagnostics Exchange supports this:
o What it is
o What it does
o What a Z-Code identifiers is
•
Z-Code Identifier Collaboration: CPT CodeBridgeTM , Palmetto GBA
•
Q&A
PROPRIETARY AND CONFIDENTIAL. Copyright © 2014 McKesson Corporation and/or one of its subsidiaries.
Challenges and Promise of Advanced Diagnostics
Nearly 30% of
Nearly
30% of
MDx claims
paid
1
MDxincorrectly
claims paid
incorrectly
Lack of test specificity and
identification
makes it difficult
Lack
of test specificity
and
to determine
coverage
or
identification
makes
it difficult
what
is being or
paid
to analyze
determine
coverage
analyze
whattype,
is being
paid
The number,
and complexity
MDx tests are growing rapidly
The of
MDx
market is exploding, over
10,0002 and counting
3000 MDx tests exist now
Molecular Diagnostics (MDx) are rapidly growing:
• Diagnostics have significant downstream cost impact
• Tests and their processes are complex and the science is progressing rapidly
Source: 1. Diagnostics Information System, www.diagnosticinformationsystem.com/learn.html, accessed Aug 28, 2013
2. GeneTests database, 2011, http://www.ncbi.nlm.nih.gov/projects/GeneTests/static/whatsnew/labdirgrowth.shtml.
3
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Need for Greater Granularity
Tier 1 Codes are gene specific but not test specific
 Example: 81257 is used for the following specific tests
•
•
•
•
•
Alpha thalassemia targeted mutation analysis of HBA1
Alpha thalassemia targeted mutation analysis of HBA2
Alpha thalassemia sequence analysis of HBA1
Alpha thalassemia sequence analysis of HBA2
Alpha thalassemia known family-specific mutation analysis
Tier 2 Codes are methodology specific but not test specific
 Example: 81401 (Level 2) is used for these disparate tests (germline & somatic)
•
•
•
•
4
Achondroplasia Mutation Analysis
ColoVantage® (methylated Septin 9)
Huntington Disease Mutation Analysis
Mantle Cell Lymphoma, bcl-1/JHt(11;14), Real-time PCR, Cell based
PROPRIETARY AND CONFIDENTIAL. Copyright © 2014 McKesson Corporation and/or one of its subsidiaries.
CPT Coding Reform Helps, but Not Test Specific
CPT 2013: KRAS
5
CPT Code
Code Description
Explanatory Text
81275
Tier 1
KRAS (v-Ki-ras2 Kirsten rat sarcoma viral
oncogene) (e.g., carcinoma) gene analysis,
variants in codons 12 and 13
81403
Tier 2
Molecular pathology procedure, Level 4
(e.g., analysis of single exon by DNA sequence
analysis, analysis of >10 amplicons using
multiplex PCR in 2 or more independent
reactions, mutation scanning or
duplication/deletion variants of 2-5 exons)
KRAS (v-Ki-ras2 Kirsten rat
sarcoma viral oncogene)
(e.g., carcinoma), gene
analysis, variant(s) in exon
3 (e.g., codon 61)
81405
Tier 2
Molecular pathology procedure, Level 6
(e.g., analysis of 6-10 exons by DNA sequence
analysis, mutation scanning or duplication/
deletion variants of 11-25 exons)
KRAS (v-Ki-ras2 Kirsten rat
sarcoma viral oncogene
homolog) (e.g., Noonan
syndrome), full gene
sequence
PROPRIETARY AND CONFIDENTIAL. Copyright © 2014 McKesson Corporation and/or one of its subsidiaries.
5
Traditional Payer programs require expensive,
manual resources and do not engage Providers
Traditional Silo Programs
Challenges
Utilization Mgmt
• Reluctantly comply to get permission and/or
reimbursement; necessary evil
Case & Care Mgmt
• Minimal Payer-Provider Adoption
• Asking for decision support, inside their
workflow
Network Direction
• Not informed, not actionable
Complex Benefit Coverage
• Struggling with administration,
transparency, consistency
Lack of Collaboration
6
•How do we get all parties to the table for
a better solution?
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Market Pressure/Reform Shifts Volume to Value Model
Reimbursement Reduction
Tiered Networks
Value Based Payment
CAGR 72%
Average Health System per Advisory Board
7
Mercer National Survey of Employer-Sponsored
Health Plans
Number of entities Pursing VBC
PROPRIETARY AND CONFIDENTIAL. Copyright © 2014 McKesson Corporation and/or one of its subsidiaries.
Payment driving delivery based on performance
Value-Based Care Model
8
ADMINISTER
MEASURE
Value-Based
Reimbursement
and Administration
Value-Based
Shared Metrics
DELIVER
Value-Based
Delivery
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Impacts of Protect Access to Medicare Act (PAMA)
• Shift to Market Based Payments
• Clinical Utility Assessments
• HCPCS, Unique Identifiers, CPT
9
PROPRIETARY AND CONFIDENTIAL. Copyright © 2014 McKesson Corporation and/or one of its subsidiaries.
Payers, Labs, Providers have the same problem…
How do
How
dowe
weensure
give
patients get the
patients the right
right care at the
care
without the
right cost without
administrative
administrative
burden?
burden?
Balancing Cost
Value
Balancing
&
Cost
& of
Quality
Quality
Care
of Care
… we need a new way to collaboratively work
together to solve it
10
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Strategy to Overcome Challenges
Measure
Understand
current variances
by provider, plan
product, member
Refine
Manage
Make policy changes
to enhance,
incentivize optimal
care quality and cost
and payment
Exception-based
approach to focus
care interventions
and resources
Shift in the way we understand, utilize diagnostics
11
PROPRIETARY AND CONFIDENTIAL. Copyright © 2014 McKesson Corporation and/or one of its subsidiaries.
McKesson Diagnostics Exchange™ - DEX
1. Marketplace
Lab, Payer,
Provider
Collaboration
2. Registry
4. InterQual®
MDx Clinical
Evidence
Summaries
McKesson
Diagnostics
Exchange
Test Catalog,
Registration and
Z-Code™
Identifier
Assignment
3. Assessment
Configurable
Evidence Support
& Coverage
Determination
Workflow
12
PROPRIETARY AND CONFIDENTIAL. Copyright © 2014 McKesson Corporation and/or one of its subsidiaries.
TM
McKesson Z-Code Identifiers
• Unique 5-character alpha-numeric identifier codes associated with each
specific advanced diagnostics test
• Generated when labs register tests in the McKesson Diagnostics Exchange
(DEX)
Test
Huntington
Disease Mutation
Analysis
Alpha Thalassemia
Z-Code Identifier ZBA44, ZBO84,
ZBE21
ZB896,ZB897,
ZBE43,ZBE42
CPT Code
81257
81401
They address test identification issues by:
• Identifying unique tests when used in conjunction with a CPT® code
• Enabling consistent identification across systems by labs, providers, payers
and policy makers
13
PROPRIETARY AND CONFIDENTIAL. Copyright © 2014 McKesson Corporation and/or one of its subsidiaries.
DEX Enables Unique Value
Evidence-driven
Benefits
Value
• Unique Identification
• Clear process to submit
information needed to
determine necessity, utility
• Able to clearly tie value to
specific test
• Access to clinical evidence
• Evidence requirement
clarity
• Test differentiation
• Reduced denials/appeals
• Improved clinical
satisfaction/decision making
McKesson Diagnostics Exchange (DEX)
Functionality
Registry
Module
• Labs register tests
• Z-CodeTM Identifiers assigned
Transparently
identify and
evaluate tests
• Access to McKesson InterQual
Evidence Summaries for education
and support of policy decisions
15
Determine
coverage
and
reimbursement
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Clinical Evidence Summary (CES)
16
•
128 CES families
covering 680+
molecular and genetic
tests
•
Represent much of the
molecular and genetic
test volume
•
Content updated
quarterly
•
Helps inform medical
policy
PROPRIETARY AND CONFIDENTIAL. Copyright © 2014 McKesson Corporation and/or one of its subsidiaries.
McKesson Diagnostics Exchange (DEX):
Test Measurement and Reimbursement Process
• Match the uniqueness of the test on the back end as you do on the front
end
• Test code for ordering the test; unique in the LIS
• Missing in BIS if only tracking by CPT code
• Request a Z-Code identifier (4-6 weeks with detailed submission)
• Z-Code identifiers can be:
• Used to run management reports from the BIS for tracking and measurement
• Included on claim submissions in the S101-7 comment field as support to the
CPT code in S101-2
17
PROPRIETARY AND CONFIDENTIAL. Copyright © 2014 McKesson Corporation and/or one of its subsidiaries.
McKesson Diagnostics Exchange (DEX) :
Simplifying the Coverage Determination Process
• Standardization and consistency of content needed/provided
• Convenient vehicle for communication
• One time preparation -> multi-payer review
18
PROPRIETARY AND CONFIDENTIAL. Copyright © 2014 McKesson Corporation and/or one of its subsidiaries.
AMA-McKesson Collaboration:
CPT CodeBridgeTM
Mapping Z-Code™ Identifiers to AMA CPT® codes will help to:
• Bring clarity, consistency, and transparency to MDx testing
• Allow greater specificity for use, identification, reporting and tracking of
MDx tests
• Connect clinical and financial data across claims systems, EHRs and
other healthcare systems
• Enable informed MDx test selection, coverage and payment decisions
• Support goal of improving health outcomes and
enabling broader adoption of personalized medicine
19
PROPRIETARY AND CONFIDENTIAL. Copyright © 2014 McKesson Corporation and/or one of its subsidiaries.
Lessons Learned: Palmetto GBA pilot
• What is it?
•Use of Z-Code identifiers for unique test identification and
•The Diagnostics Exchange for coverage decisions
•Launched as part of MolDx Program for 2011 in Jurisdiction 1/E, 11
•Unique identifiers improve the process
•Helps the payer better understand the test you performed
•Reduces the denial/rejection rate
•Reduces pend for review claims
•Labs that demonstrate clinical utility get paid
20
PROPRIETARY AND CONFIDENTIAL. Copyright © 2014 McKesson Corporation and/or one of its subsidiaries.
Strategy to Overcome Challenges
Measure
Understand
current variances
by provider, plan
product, member
Refine
Manage
Make policy changes
to enhance,
incentivize optimal
care quality and cost
and payment
Exception-based
approach to focus
care interventions
and resources
Shift in the way we understand, utilize diagnostics
21
PROPRIETARY AND CONFIDENTIAL. Copyright © 2014 McKesson Corporation and/or one of its subsidiaries.
McKesson Diagnostics Exchange Helps
• Bring unique identification to MDx where growth exceeds the
ability to keep up with traditional coding structures
• Provides the labs the ability to differentiate their tests and ensure
awareness of their utility
• Reduce medical costs for unnecessary or miscoded tests by
enabling precise matching of reimbursement to the exact test
performed
• Clearly adjudicate claims by eliminating variances in coding and
more easily make and manage coverage policies
• Develop a well-informed UM program by effectively measuring
utilization of diagnostics
22
PROPRIETARY AND CONFIDENTIAL. Copyright © 2014 McKesson Corporation and/or one of its subsidiaries.
Questions
23
PROPRIETARY AND CONFIDENTIAL. Copyright © 2014 McKesson Corporation and/or one of its subsidiaries.