Influencing Payer Coverage for Advanced Genomic Testing
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The document outlines Veracyte, Inc.'s strategies in influencing payer coverage for molecular diagnostics, emphasizing engagement with regulatory bodies and the importance of establishing reimbursement pathways. It addresses the complexities of coverage decisions influenced by clinical utility data, patient and provider adoption, and endorsements by medical societies. Additionally, it discusses the appeals process for denied claims and highlights the growing comprehension of clinical utility in molecular testing.
Influencing Payer Coverage for Advanced Genomic Testing
- 1. John W. Hanna, MBA VP, Endocrinology Veracyte, Inc. john@veracyte.com 650.243.6362 Influencing Payer Coverage
- 2. / 2 / • 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
- 3. / 3 / 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
- 4. / 4 / 1Q 3Q2Q 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 Activity Medicare Rate 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
- 5. / 5 / 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
- 6. / 6 / Veracyte Is Recognized in the Bay Area
- 7. / 7 / 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
- 8. / 8 / 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.
- 9. / 9 / Evidence Relied Upon to Assess Reimbursement of MDx – 2008 Survey Faulkner E, et al. J Managed Care Med. 2009;12(4)42-55.
- 10. / 10 /Chambers JD, et al. Health Affairs 2015
- 11. / 11 / Would Uniform Coverage Decisions be Ethical? Chambers JD, et al. Health Affairs 2015
- 12. / 12 / Agreement by Clinical Categories Chambers JD, et al. Health Affairs 2015
- 13. / 13 / 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.
- 14. / 14 / 77% of Medical Directors Accurately Defined Clinical Utility of MDx Faulkner E, et al. J Managed Care Med. 2015;18(1)5-13.
- 15. / 15 / 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.
- 16. / 16 / 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. / 17 /Jeter EK, South Carolina Association of Health Plans Meeting. Dec 4, 2015
- 18. / 18 / 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
- 19. / 19 / Freuh & Quinn – Accepted Outcomes Measures Frueh FW, Quinn B. Expert Rev Mol Diagn 2014:14(7)777-86
- 20. / 20 / Why Is The Claim Being Denied? • WPC + Policy Reporter + FindACode • Denial reason or med policy specific appeals • Identify administrative errors
- 21. / 21 / Appeals Are Like Ice Cream Cones
- 22. / 22 / 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 ProcessPatient Process Level 1 Level 2 Level 3 Level 4
- 23. / 23 / Appeals Communication
- 24. / 24 / 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
- 25. / 25 / 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
- 26. / 26 / 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
- 27. Questions? John W. Hanna, MBA VP, Endocrinology Veracyte, Inc. john@veracyte.com 650.243.6362