1. Pathways To Coverage Jim Almas, M.D. Coverage and Analysis Group (CAG)
Centers for Medicare and Medicaid Services

2. CMS IS HERE TO HELP SOLVE PROBLEMS

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

4. 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

5. 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).

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

7. 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 Mar 19. PMID:

8. 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

9. 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
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

10. In the absence of an NCD, the mac decides

11. 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)

12. ARE THERE GENOMIC TESTS CMS DOESN’T COVER?

13. Thank you