The complex, intertwined role of patients in research and care

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Session 3: The complex, intertwined role of patients in research and care Joseph Chin, MD, MS, Acting Deputy Director, Coverage and Analysis Group, Centers for Medicare & Medicaid Services

The complex, intertwined role of patients in research and care Shared Decision Making in Medicare Joseph Chin, MD, MS ECRI 22nd Annual Meeting November 17, 2015 Disclaimer: Views and comments in this presentation are those of the presenter and do not represent the official positions and views of the Centers for Medicare and Medicaid Services.

Medicare population Age 65 years Disabled individuals Patients with end stage renal disease 60 50 40 Million 30 20 Aged Disabled 10 0 1990 1995 2000 2005 2010 2012 2014 year 3

Medicare Construct Established by the Social Security Act of 1965, Title XVIII 1862(a)(1) Notwithstanding any other provision of this title, no payment may be made under part A or part B for any expenses incurred for items or services (A) which, except for items and services described in a succeeding subparagraph or additional preventive services (as described in section 1395x(ddd)(1)of this title), are not reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member (E) in the case of research conducted pursuant to 1142, which is not reasonable and necessary Defined benefit program Benefit category Beneficiaries Providers Settings 4

Value in health care 01/26/2015 Sylvia Mathews Burwell, HHS Secretary Better Care, Smarter Spending, Healthier People http://www.hhs.gov/blog/2015/01/26/progress towards better caresmarter spending healthier people.html Burwell SM. Setting value based payment goals HHS efforts to improve U.S. health care. N Engl J Med. 2015 Mar 5;372(10):897 9. PMID: 25622024 5

What is Shared decision making? Model of decision making Important characteristics (Charles, Gafni, Whelan, 1997): at least two participants physician and patient; both parties share information; both parties take steps to build a consensus about the preferred treatment (or screening); and an agreement is reached to implement. Evidence based decision aid or tool Charles C, Gafni A, Whelan T. Shared decision making in the medical encounter: what does it mean? (or it takes at least two to tango). Soc Sci Med. 1997 Mar;44(5):681 92. PMID: 9032835 6

Why is SDM important? New technologies and multiple treatment options for important conditions in older adults Better Care Outcomes that important to beneficiaries Patient involvement and satisfaction Cancer screening Asymptomatic individuals Expanded consideration of benefits and harms 7

lung and bronchus cancer New Cases of Lung and Bronchus Cancer Deaths from Lung and Bronchus Cancer Median Age At Diagnosis 70 years Median Age At Death 72 years Lung and bronchus cancer is most frequently diagnosed among people aged 65 74. The percent of lung and bronchus cancer deaths is highest among people aged 65 74. Source: http://seer.cancer.gov/statfacts/html/lungb.html 8

Lung cancer screening with ldct Based on the National Lung Screening Trial (NLST), CMS added Medicare coverage of lung cancer screening with low dose CT (LDCT) for eligible beneficiary performed at specified radiology centers with data collection. Beneficiary eligibility: Asymptomatic, age 55 77 years;; Tobacco smoking history of at least 30 pack years; Current smoker or one who has quit smoking within the last 15 years. Requirement for initial shared decision making visit. 9

SDM visit Furnished by a physician or qualified non physician practitioner and includes: Determination of beneficiary eligibility; Shared decision making, including the use of one or more evidence based decision aids or tools; Counseling on adherence, impact of comorbidities and ability or willingness to undergo diagnosis and treatment; Counseling on cigarette smoking abstinence if former smoker or the importance of smoking cessation if current smoker. 10

Importance of sdm & data collection Narrow window of evidence NLST (positive defined high risk population) 2 other trials were negative DANTE; n = 2472 CTx5 vs no screening DLSCT; n = 4104 CTx5 vs no screening NLST; n = 53454 CTx3 vs CXR Age (inclusion criterion) mean age = 64.6; (60 74 years) 91% 50 64 years; (50 70 years) 73% 55 64 years; (55 74 years) Smoking history (inclusion criterion) mean = 47 pack years; ( 20 pack years) mean = 36 pack years; ( 20 pack years) mean = 56 pack years; ( 30 pack years) Expansive recommendations (age, duration) Coverage with Evidence Development (CED) Access to important services Data collection to demonstrate results in population screening Positive result LDCT (false positive rate) non calcified nodule 10 mm, etc; (291/351, 83%) nodule 5 mm; (542/611, 89%) non calcified nodule 4 mm; (17497/18146, 96 %) 11

Shared decision making in Medicare New formal concept for Medicare coverage Recognizes and emphasizes the role of the patient Monitor, evaluate and refine structure and implementation Complex screening, diagnosis and treatment considerations 12

Thank you 13