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John W. Hanna, MBA VP, Endocrinology Veracyte, Inc. [email protected] 650.243.6362 Influencing Payer Coverage
| Date post: | 08-Feb-2017 |
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John W. Hanna, MBA
VP, Endocrinology
Veracyte, Inc.
650.243.6362
Influencing Payer Coverage
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• Engage FDA on LDT Regulation
• Work to establish a pathway for coding, coverage and reimbursement
• Promote legislation supporting precision medicine
Coalition for 21st Century Medicine
www.twentyfirstcenturymedicine.org
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PAMA Act of 2014
Section 216 Authorizes CMS To Establish:
I. Market Based Rate Setting
II. Coding for Existing ADLTs & New ADLTs
III. Advisory Panel for Rate Setting
IV. Consolidate to four or less MAC contractors for labs
V. Report to Congress
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1Q 3Q 2Q
Start of Initial Period
1st quarter following LCD effective date
Initial Data Reporting
Period
Medicare Final LCD Effective
Date
Initial Commercial Offering of New Test
May take several years for
labs to generate clinical utility data sufficient for
LCD coverage
Draft LCD Published
Act
ivity
M
edic
are
Rat
e
No Medicare Payment
No Medicare Payment
Contractor Priced
Initial Data Collection
Period
Labs may report most recent 12 months of data
Actual List Charge (ALC) Payment for New ADLT
Medicare Rate Set at Weighted Median
Code & rate added to
CLFS and set until next ADLT reporting cycle
Lab Can Apply For ADLT Status and Be Assigned a Code Anytime Prior to Start of Initial Period
Hanna JW, Coalition for 21st Century Medicine Letter to CMS. January 18, 2016
New ADLT Designation, Coding & Payment
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About Veracyte, Inc.
• Founded in 2008 to address diagnostic ambiguity
• HQ and CLIA Molecular Lab in South San Francisco, CA
• Nearly 200 employees in South San Francisco & Austin, TX
• Two commercial products:
/ 3 / © 2015 Veracyte, Inc. All rights reserved.
Diagnostic Ambiguity: A Significant Healthcare Issue
$ BILLIONS
of Healthcare Dollars Wasted
HUNDREDS of THOUSANDS of Unnecessary,
Invasive Procedures
AMBIGUOUS DIAGNOSIS
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Veracyte Is Recognized in the Bay Area
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Evidence Driven Coverage for Afirma
Published Evidence Guidelines ~175 Million Lives Covered
Analytic Validation • Walsh PS, et al. JCEM 2012 Clinical Validation • Chudova D, et al. JCEM 2010 • Alexander E, et al. NEJM 2012 Clinical Utility • Duick D, et al. Thyroid, 2012 • Harrell M, et al. Endo Prac 2013 • Alexander E, et al. JCEM 2014 • Lastra E, et al. Cancer Cyto 2014 • McIver B, et al. JCEM 2014 • Sullivan, et al. Cancer Ctyo 2014 • Marti J, et al. Surg Onc 2015 • Angell TE, et al. JCEM 2015 • Witt RL, et al. Laryngoscope 2015 • Brauner E, et a.l Thyroid 2015 • Zhu Q, et al. A J Radiol 2015 • Yang S, et al. Cancer Cyto 2015 • Celik B, et al. Diagnos Cyto 2015 • Wu J, et al. Surgery 2015 • Sipos J, et al. Endo Prac 2016
NCCN Thyroid Carcinoma Guideline
2013–present
UpToDate Thyroid Nodule Management
2013-present
American Thyroid Association Thyroid Nodule
Management Guideline 2015-present
• Medicare ‘12 • UnitedHealthcare ‘13 • Aetna ‘13 • Cigna ‘13 • Humana ’13 • SelectHealth ‘13 • Emblem ‘14 • HealthNet ’14
• BS California ‘14 • Premera BCBS ‘14 • Horizon BCBS ‘14 • Highmark BCBS ‘14 • BCBS Louisiana ‘14 • WellMark BCBS ’14 • Hawaii MSA ’15 • Independence BC ‘15 • CareFirst ’15 • BCBS MASS ’15 • North Dakota ’15 • Excellus ’15 • HCSC ‘16 • Regence ’16 • BCBS South Carolina ‘16
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Constellation of Factors Impact Coverage Decision Making
Factor Effect Payer Comments
Patient and Provider Adoption
Patients and Providers ask for or use test and file claims, prompts closer test review
“There was demand and that did influence us”
Coverage by local Medicare contractor
Creates a status quo for others, may tip decision to cover
“We reviewed the studies of clinical utility and said, “there is clinical utility data, and Medicare covers”
Endorsement by medical societies
Inclusion in guidelines suggests a standard of care
“It wasn’t the new information that came out but rather a broadening sense of consensus”
Regulation Not FDA approved “FDA looks at safety and efficacy and not utility”
Trossman JR, et al. J Oncol Practice 2010:(6)5;238-42.
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Evidence Relied Upon to Assess Reimbursement of MDx – 2008 Survey
Faulkner E, et al. J Managed Care Med. 2009;12(4)42-55.
/ 10 / Chambers JD, et al. Health Affairs 2015
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Would Uniform Coverage Decisions be Ethical?
Chambers JD, et al. Health Affairs 2015
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Agreement by Clinical Categories
Chambers JD, et al. Health Affairs 2015
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National Association of Managed Care Physicians – 2013 Survey
• 56 Medical Directors
• 73% Surveys Completed
• 70% Commercial
• 30% Health Systems
• Aetna, Cigna, Anthem and UnitedHealthcare
• >100 Million Lives
Faulkner E, et al. J Managed Care Med. 2015;18(1)5-13.
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77% of Medical Directors Accurately Defined Clinical Utility of MDx
Faulkner E, et al. J Managed Care Med. 2015;18(1)5-13.
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Evidence Most Likely to Inform Coverage Decisions for MDx
Top 3 answers selected, proportion of all respondents
Faulkner E, et al. J Managed Care Med. 2015;18(1)5-13.
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2009 EGAAP
1997 NIH Task Force
1998 SCGT
2002 Burke et al.
2006 AACE
Direct or indirect improvement in health outcomes
Definition of Utility for Molecular Testing
“Data must be collected to demonstrate the benefits and risks that accrue from both positive and negative tests”
“The benefits and risks to be considered include psychological, social and economic consequences of testing as well as the implications for health outcomes”
“Clinical utility refers to the likelihood that the test will lead to an improved health outcome”
Firmly associated clinical utility with health benefits, defined in terms of clinical endpoints, and distinguished from ELSI
Grosse SD, et al. Genetics In Medicine. 2006 Teutsch SM, et al. Genetics In Medicine. 2009
/ 17 / Jeter EK, South Carolina Association of Health Plans Meeting. Dec 4, 2015
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Freuh & Quinn – Contextual HTA Evaluation
Frueh FW, Quinn B. Expert Rev Mol Diagn 2014:14(7)777-86 Trusheim et al. Pharmacogenomics 2013;14:325-334
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Freuh & Quinn – Accepted Outcomes Measures
Frueh FW, Quinn B. Expert Rev Mol Diagn 2014:14(7)777-86
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Why Is The Claim Being Denied?
• WPC + Policy Reporter + FindACode
• Denial reason or med policy specific appeals
• Identify administrative errors
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Appeals Are Like Ice Cream Cones
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Commercial Appeals Process
Patients reach a claim resolution quicker, and have greater appeals rights.
Customer service claim review for processing errors
Were all plan benefits provided to the patient?
External Review
Legal Action
Was the claim adjudicated correctly based on Med Policy?
Was the procedure medically necessary?
Specialty matched review board
External Review
Provider Process Patient Process
Level 1
Level 2
Level 3
Level 4
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Appeals Communication
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ACA Appeal and Review Mandate
• Sec. 1001 of the Affordable Care Act (ACA) requires an internal and an external review process
• External reviews follow a state process or a federal process
• State external review process: 1. Default process with minimum standards
2. If process fails to meet standards, may bring legal action
• Federal external review process: 1. Accredited Independent Review Organization (IRO); or
2. The HHS-Administered External Review Process administered by MAXIMUS
• ERISA Plans • Follows similar Federal requirements for IRO review
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Who Conducts External Reviews?
Segment External Review Organization
Commercial MCI International, Maximus, MCMC, iMedecs
Blue Cross iMedecs, MCMC, AMR, AllMed, ProPEER, Permedion, IMX, Ipro, MPRO, Maximus, MCS, MES, NMR, MMRO, HHC
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Closing Thoughts
• Coverage decisions are multi-factorial
• Comprehension of MDx clinical utility is growing
• Communicate test evidence with every claim
• Know state laws and administrative processes
• Maintain a consistent and clear message
