1. Medicare Preventive Services Marcel Salive, MD, MPH, FACPM Coverage and Analysis Group, OCSQ Director, Division of Medical and Surgical Services

2. Overview of talk Medicare preventive services –MMA and earlier –MIPPA National Coverage Determination process HIV Screening national coverage analysis

3. Medicare Preventive Services “Welcome to Medicare” initial preventive physical exam Abdominal aortic aneurysm screening Bone mass measurement Cardiovascular disease screening blood tests Colorectal cancer screening Diabetes screening, services, and supplies Glaucoma screening Medical nutrition therapy Pap test and pelvic exam with clinical breast exam Prostate cancer screening Screening mammogram Smoking cessation counseling Vaccinations

4. New Preventive Services (2005) MMA sections 611-613 Initial Preventive Physical Examination –Commonly “Welcome to Medicare” visit Cardiovascular Screening Blood Tests Diabetes Screening Benefits

5. “Welcome to Medicare” Physical Exam for New Enrollees One-time preventive physical exam within 12 months of a beneficiary's initial Part B enrollment Includes screening, education & counseling, and referral Coordinates the preventive services already covered by Medicare like cancer screenings, bone mass measurements and vaccinations

6. Preventive Examination Overview Medical History Social History Depression Screening Review of Functional Ability Review of Home Safety Physical Examination Written plan or checklist provided to patient for obtaining age appropriate screening tests

7. Components for Functional Ability/Level of Safety Screening for Hearing Impairment –The US Preventive Services Task Force Recommends questioning older adults about their hearing and making referrals for further evaluation when appropriate. Activities of Daily Living Discussion about Falls Risk –The US Preventive Services Task Force Recommends counseling elderly patients on specific measures to prevent falls Discussion about Home Safety –The US Preventive Services Task Force Recommends counseling adults about preventing household and recreational injuries

8. Physical Examination Height, Weight, Blood Pressure, EKG –Required by statute –New for 2009: EKG optional; BMI added Visual Acuity Screening –The US Preventive Services Task Force recommends screening elderly persons for diminished visual acuity using the Snellen Eye Chart –CMS does not specify instrument/test Other physical examination measures as appropriate

9. Examination Conclusion End of life planning (added 2009) Patients should receive appropriate follow-up based on any needs identified during the preventive examination Patients should also receive a written plan or checklist –Outlining Medicare covered screening and preventive services for which they are eligible

10. MIPPA, section 101 (2008) Gives the Secretary authority to extend Medicare coverage to additional preventive services that are Reasonable and necessary for the prevention or early detection of an illness or disability based on the national coverage determination process; “Strongly recommended” (A) or “recommended” (B) by the United States Preventive Services Task Force; and Appropriate for Medicare beneficiaries.

11. Coverage

12. Social Security Act 1862(a)(1)(A-B) “…no payment may be made…for items or services - which, except for items and services described in a succeeding subparagraph, are not reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member,… which are not reasonable and necessary for the prevention of illness,” Reasonable & Necessary

13. How Do We Apply R&N Today? Sufficient level of confidence that evidence is adequate to conclude that the item or service: –improves health outcomes –generalizable to the Medicare population Evidence assessed using standard principles of evidence-based medicine (EBM)

14. Internal Technology Assessment Draft Decision Memorandum Posted National Coverage Request Medicare Coverage Advisory Committee External Technology Assessment 6 months Reconsideration Staff Review Public Comments Final Decision Memorandum and Implementation Instructions 30 days 60 days 9 months Preliminary Discussions Benefit Category Department Appeals Board CMS National Coverage Decision (NCD) Process

15. What prompts NCDs? Internal or external request e.g., technological advance, new study, inappropriate use May reconsider non-coverage May address variation in local coverage policies

16. What decisions are made? National Coverage National Noncoverage National Coverage with restrictions –Specific populations –Specific providers/facilities –Evidence development

17. NCD Guidance Documents Factors CMS considers in: Opening an NCD review Referring an NCD to: -- Advisory committee (MEDCAC) -- External technology assessment

18. HIV screening Analysis opened: March 13, 2009 Proposed Decision released: Sept 9 –Annual voluntary HIV screening of Medicare beneficiaries at increased risk for HIV infection per USPSTF guidelines –Voluntary HIV screening of pregnant Medicare beneficiaries

19. USPSTF Recommendations: HIV screening All adolescents and adults at increased risk for HIV infection. Rating: ‘A’ routine screening adolescents and Adults who are not at increased risk for HIV infection. Rating: ‘C’ All pregnant women for HIV. Rating: ‘A’

20. Screening test analytic framework Simplicity Acceptability Accuracy Cost Precision Sensitivity/Specificity

21. Consideration of cost: HIV Screening Sanders, et al. (2008) published cost-effectiveness analysis reported that screening costs $50,000- $100,000 per QALY gained where HIV prevalence is between 0.1% and 0.5%. One published study places HIV prevalence in this range for persons age 65-74 years. (Owens et al. 2007) Not a major consideration in the decision for HIV screening, but helped develop capacity for this type of analysis.

22. Limitation CMS believes that statute and regulations only permit expanded coverage of additional preventive services that identify medical conditions or risk factors for individuals, such as voluntary HIV screening, which have been recommended with a grade of A or B by the USPSTF.

23. Possible prevention NCDs Tobacco cessation counseling Alcohol Misuse Screening and Behavioral Counseling Interventions Breast Cancer, Chemoprevention counseling Breast and Ovarian Cancer Susceptibility, Genetic Risk Assessment and BRCA Mutation Testing Chlamydial Infection, Screening Depression, Screening Diet, Behavioral Counseling in Primary Care to Promote a Healthy Diet Gonorrhea, Screening Hepatitis B Virus Infection, Screening Obesity in Adults, Screening & counseling Syphilis Infection, Screening Aspirin to prevent CVD

24. Further Information http://www.cms.hhs.gov:http://www.cms.hhs.gov Marcel Salive, MD, MPH –410/786-0297 –Marcel.Salive@cms.hhs.govMarcel.Salive@cms.hhs.gov