1. Requested Information by CMS Team During April 30th Hearing

2. Proposal to CMS for National Coverage Determination of Coronary Artery Calcium Test
based on Latest National CVD Prevention Guidelines
Screening Test Based on Cholesterol, Blood Pressure and 7 Other Risk Well-Known Factor using ACC/AHA ASCVD Risk Calculator1
Step 1
10 yr Risk <5%
10 yr Risk 5% to 20%
10 yr Risk >20%
Intensive Drug Therapy Needed
No Drug Needed
Diagnostic Test
Using Non-Contrast CT Scan of the Chest to Measure Coronary Artery Calcium (CAC) Score
Step 2
CAC = 0
CAC = 1-99
& <75th %
CAC 100
or 75th %
Step 3
Consider Deferring Statin Therapy Specially in Medicare Population
Lifestyle Management
Consider pharmacologic lipid Rx
Intensive Therapy with lipid lowering drugs and aggressive life style changes
1 ASCVD (atherosclerotic cardiovascular disease) Risk Calculator described in the next slide. 2

3. Screening Test

4. Diagnostic Test

5. Diagnostic Test

6. Other Examples of CMS Approved Screening and Diagnostic Tests
Screening Tests
Office BP Measurement
Mammography
Prostate (PSA)
Cervical Cancer (HPV)
A subset undergoes
diagnostic tests
Diagnostic Tests
24-72 Hour Ambulatory BP Monitoring
Breast Sonography / Biopsy
Prostate Sonography / Biopsy
Cervical Cancer Biopsy
A subset undergoes
treatment
Treatment 6

7. Latest National Guidelines for Cholesterol Lowering and Atherosclerotic CVD (ASCVD) Prevention

8. 1) The 2018 Cholesterol Guidelines supported by the following 12 medical organizations:
AHA/ACC/AACVPR/AAPA/ABC/ACPM/ADA/AGS/APhA/ASPC/NLA/PCNA Guideline on the Management of Blood Cholesterol

9. The writing committee consisted of medical experts including cardiologists, internists, interventionalists, a nurse practitioner, pharmacists, a physician assistant, a pediatrician, a nephrologist, and a lay/patient representative. The writing committee included representatives from the American Heart Association (AHA), American College of Cardiology (ACC), American Association of Cardiovascular and Pulmonary Rehabilitation (AACVPR), American Association Academy of Physician Assistants (AAPA), Association of Black Cardiologists (ABC), American College of Preventive Medicine (ACPM), American Diabetes Association (ADA), American Geriatrics Society (AGS), American Pharmacists Association (APhA), American Society for Preventive Cardiology (ASPC), National Lipid Association (NLA), and Preventive Cardiovascular Nurses Association (PCNA).

10. 2) The 2019 Prevention Guidelines issued by American College of Cardiology and American Heart Association:
2019 ACC/AHA Guideline on the Primary Prevention of Cardiovascular Disease

11. MESA: The Largest Longitudinal Multi-Ethnic Study of Atherosclerosis– 6,814 Patients
Nonfatal MI & CHD Death
14.13
(7.91,25.22)
10.26
(5.62,18.71)
Numerous studies, most notably the largest multi-ethnic study of atherosclerosis (MESA) showed that CAC score over 100 is equivalent to “High Risk” which requires aggressive medical treatments to prevent a future CVD event such as heart attack or stroke.
4.47
(2.45,8.13)
Ref
Coronary Artery Calcium (CAC) Score

12. All Cause Mortality and CAC Scores:
Long Term Prognosis in 25,253 Patients
Time to Follow-up (Years)
CAC 0 (n=11,044)
1-10 (n=3,567)
(n=5,032)
(n=2,616)
(n=561)
(n=955)
(n=514)
1,000+ (n=964)
2=1363, p< for variable overall and for each category subset.
Cumulative Survival
0.0
2.0
4.0
6.0
8.0
10.0
12.0
0.70
0.75
0.80
0.85
0.90
0.95
1.00
10.4
Compelling longitudinal data from numerous cohorts across the world have shown that the higher the CAC the lower the survival rate.

13. The EISNER Trial

14. EISNER Trial

15. EISNER Trial 2137 eligible patients Randomized in 2:1 ratio
713 assigned to
no-scan group
1424 assigned to
CAC scan group
4 year
clinic evaluation
4 year
clinic evaluation

16. EISNER Trial – CAC Zero Group Compared to No Scan Group
P≤0.005 for both measures
Rozanski JACC 2011

17. EISNER Trial
CAC scan led to improved risk factors without increased cost
Compared with the no-scan group, the scan group showed a net favorable change in systolic blood pressure (p ≤ 0.02), low-density lipoprotein cholesterol (p ≤ 0.04), and waist circumference (p ≤ 0.01), and tendency to weight loss among overweight subjects (p ≤ 0.07), and improvement of Framingham Risk Score compared to no scan group

18. Conclusion:
Powerful, consistent evidence behind the recent guidelines creates a professional, ethical, and legal obligation for physicians to order CAC testing for their patients who meet indications for this diagnostic test.
CAC scoring identifies high-risk patients at risk of fatal events who should be treated with preventive interventions, and identifies low-risk individuals who can avoid unnecessary drug therapy and other diagnostic procedures.
Furthermore, now that healthcare media has educated millions of consumers with information about CAC, lack of coverage can deepen the healthcare disparity between the rich and the poor, the highly educated and the lay people. People who cannot afford paying out of pocket for CAC diagnostic test will most likely be harmed.

19. Therefore,
we respectfully request that CMS consider NCD for diagnostic Coronary Artery Calcium testing in primary prevention of ASCVD only in a clinically selected group of patients in the Intermediate Risk category based on shared decision making between the patient and the healthcare provider.