Pathways To Coverage Jim Almas, M.D. Coverage and Analysis Group (CAG) Centers for Medicare and Medicaid Services jim.almas@cms.hhs.gov

CMS IS HERE TO HELP SOLVE PROBLEMS

Medicare program integrity manual Chapter 13 13.1.1-National Coverage Determinations 13.1.3 Local Coverage Determinations National coverage determinations are made by request (from any party) The National coverage determination (NCD) process is accessible and defined

evidence-based Medicare Coverage Coverage determinations address whether the evidence is sufficient to conclude that the item or service improves clinically meaningful health outcomes for the Medicare population Age ≥ 65 years Disabled individuals Patients with end stage renal disease Million year

FDA-CMS Parallel review As discussed in the September 17, 2010, Federal Register notice (75 FR 57045), parallel review is intended to reduce the time between FDA marketing approval and CMS national coverage determinations, thereby improving the quality of patient health care by facilitating earlier access to innovative medical products for Medicare beneficiaries. Parallel review should be sponsor/requester initiated, voluntary, and include an option to opt out of a national coverage determination (NCD). http://www.gpo.gov/fdsys/pkg/FR-2011-10-11/pdf/2011-25907.pdf

Cologuard™ NCD timeline Formal Request Accepted: 08/11/2014 Proposed Decision Memo Released: 08/11/2014 Decision Memo Released: 10/09/2014

Appropriate study for crc screening Cross sectional study Large sample size (n = 9989) 90 centers in the US & Can Mean age = 64 years 6308 were 65 years and older In asymptomatic persons at average risk for colorectal cancer, multitarget stool DNA testing detected significantly more cancers than did FIT but had more false positive results. Imperiale TF, Ransohoff DF, Itzkowitz SH, Levin TR, Lavin P, Lidgard GP, Ahlquist DA, Berger BM. Multitarget Stool DNA Testing for Colorectal-Cancer Screening. N Engl J Med. 2014 Mar 19. PMID: 24645800.

Coverage of diagnostic tests Analytic Validity Clinical Validity Clinical Utility Technical performance Ability to accurately and reliably measure the analyte or genotype of interest Sensitivity Specificity Assay robustness Quality control Strength of clinical correlation Ability to accurately and reliably identify the disorder of interest Sensitivity Specificity Pos predictive value Neg predictive value Impact on health outcomes Likelihood that using the test to guide management will significantly improve health outcomes Benefits vs harms Efficacy Effectiveness Value FDA http://www.cdc.gov/genomics/gtesting/EGAPP/recommend/method.htm

NCD with CED (Coverage with evidence Development) Guidance Section 1142 of the Act Issued on November 20, 2014 Covers on the condition that they are furnished in the context of approved clinical studies or with the collection of additional evidence https://www.cms.gov/Medicare/Coverage/Coverage-with-Evidence-Development/ Agency for Healthcare Research and Quality (AHRQ) reviews all CED NCDs and indicates its support for clinical studies that CMS determines address the CED questions

In the absence of an NCD, the mac decides

Reimbursement is determined by the CLFS (PAMA) “What is missing that would be critical to reimbursement? Why is there so much concern about the cost of these tests?” A test can show excellent analytic validity and excellent clinical validity. The question facing Medicare is “What is the evidence that the use of this test improves the beneficiary’s outcome?” The grade of evidence and strength of recommendation will determine coverage. Reimbursement is determined by the CLFS (PAMA)

ARE THERE GENOMIC TESTS CMS DOESN’T COVER?

Thank you Jim.almas@cms.hhs.gov