Requested Information by CMS Team During April 30th Hearing

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 http://tools.cardiosource.org/ASCVD-Risk-Estimator/ described in the next slide. 2

Screening Test

Diagnostic Test

Diagnostic Test

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

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

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

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).

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

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

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) 11-100 (n=5,032) 101-299 (n=2,616) 300-399 (n=561) 400-699 (n=955) 700-999 (n=514) 1,000+ (n=964) 2=1363, p<0.0001 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.

The EISNER Trial

EISNER Trial

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

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

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

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.

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.