jill strassler douglas j. moeller, md executive war college april 29, 2014 understanding the newest...

Jill StrasslerDouglas J. Moeller, MD

Executive War College

April 29, 2014

Understanding the Newest Rules for Showing Clinical Utility of Molecular Tests and How They Shape Payer Decisions

PROPRIETARY AND CONFIDENTIAL. Copyright © 2014 McKesson Corporation and/or one of its subsidiaries.

• 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

Agenda


Challenges and Promise of Advanced Diagnostics

3

Nearly 30% of MDx claims paid

incorrectly

Lack of test specificity and identification makes it difficult

to determine coverage or analyze what is being paid

The MDx market is exploding, over 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

Nearly 30% of MDx claims paid

incorrectly1

Lack of test specificity and identification makes it difficult

to determine coverage or analyze what is being paid

The number, type, and complexity

of MDx tests are growing rapidly

10,0002 and counting

Impa

ct

Prob

lem

Cau

se

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.

http://www.diagnosticinformationsystem.com/learn.html

http://www.ncbi.nlm.nih.gov/projects/GeneTests/static/whatsnew/labdirgrowth.shtml


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)

• Achondroplasia Mutation Analysis • ColoVantage® (methylated Septin 9)• Huntington Disease Mutation Analysis• Mantle Cell Lymphoma, bcl-1/JHt(11;14), Real-time PCR, Cell based

Need for Greater Granularity

4

5PROPRIETARY AND CONFIDENTIAL. Copyright © 2014 McKesson Corporation and/or one of its subsidiaries.

CPT Code Code Description Explanatory Text

81275Tier 1

KRAS (v-Ki-ras2 Kirsten rat sarcoma viral oncogene) (e.g., carcinoma) gene analysis, variants in codons 12 and 13

81403Tier 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 independentreactions, 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)

81405Tier 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

CPT Coding Reform Helps, but Not Test Specific CPT 2013: KRAS

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 •How do we get all parties to the table for a better solution?

6


Market Pressure/Reform Shifts Volume to Value Model

Mercer National Survey of Employer-Sponsored Health Plans

Average Health System per Advisory Board

7

2011

65

99

164

2012

154

150

304

Q3 2013

250

233

483

Commercial

Government

Reimbursement Reduction Tiered Networks

CAGR 72%

Number of entities Pursing VBC

Value Based Payment

8

Value-Based Care Model

Value-BasedShared Metrics

Value-BasedDelivery

MEASURE DELIVER

Value-BasedReimbursement

and Administration

ADMINISTER

Payment driving delivery based on performance



Impacts of Protect Access to Medicare Act (PAMA)

9

• Shift to Market Based Payments

• HCPCS, Unique Identifiers, CPT

• Clinical Utility Assessments


Payers, Labs, Providers have the same problem…

10

Balancing Cost & Quality of Care

… we need a new way to collaboratively work together to solve it

Balancing Value Cost & Quality

of Care

How do we give patients the right care without the administrative

burden?

How do we ensure patients get the right care at the

right cost without administrative

burden?

Strategy to Overcome Challenges

11

Shift in the way we understand, utilize diagnosticsPROPRIETARY AND CONFIDENTIAL. Copyright © 2014 McKesson Corporation and/or one of its subsidiaries.


McKesson Diagnostics Exchange™ - DEX

12

2. Registry

Test Catalog, Registration and

Z-Code™ Identifier

Assignment

3. Assessment

Configurable Evidence Support

& Coverage Determination

Workflow

4. InterQual®

MDx Clinical Evidence

Summaries

1. MarketplaceLab, Payer,

Provider Collaboration

McKesson Diagnostics Exchange

McKesson Z-CodeTM Identifiers

13

• 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)

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


Test Huntington Disease Mutation Analysis

Alpha Thalassemia

Z-Code Identifier ZBA44, ZBO84, ZBE21

ZB896,ZB897, ZBE43,ZBE42

CPT Code 81401 81257

DEX Enables Unique Value

Evidence-driven

Benefits

• Unique Identification

• Able to clearly tie value to specific test

• Access to clinical evidence

• Evidence requirement clarity

Value

• Clear process to submit information needed to determine necessity, utility

• Test differentiation

• Reduced denials/appeals

• Improved clinical satisfaction/decision making


McKesson Diagnostics Exchange (DEX) Functionality

15

Transparently identify and

evaluate tests

Determine coverage

and reimbursement

• Labs register tests• Z-CodeTM Identifiers assigned

Registry Module

• Access to McKesson InterQual Evidence Summaries for education and support of policy decisions


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


McKesson Diagnostics Exchange (DEX): Test Measurement and Reimbursement Process

17

• 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

PROPRIETARY AND CONFIDENTIAL. Copyright © 2014 McKesson Corporation and/or one of its subsidiaries.18

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


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

AMA-McKesson Collaboration: CPT CodeBridgeTM

19


Lessons Learned: Palmetto GBA pilot

20

• 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

PROPRIETARY AND CONFIDENTIAL. Copyright © 2014 McKesson Corporation and/or one of its subsidiaries.22

• 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 byenabling 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

McKesson Diagnostics Exchange Helps

jill strassler douglas j. moeller, md executive war college april 29, 2014 understanding the newest...

Documents

carcinoma gene analysis

dna sequence analysis

molecular diagnostics

analysis of single exon

gene specific

complexity of mdx tests

specific example

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