Perspectives on national decision makers: The healthcare policy maker Osnat Luxenburg Director of Medical Technology Administration Ministry of Health, Israel
Health Policy
Constructing national policy regarding: (1) Screening programs involving radiation: currently- mammography Low dose CT for lung cancer screening? Virtual colonoscopy for colon cancer? cardiovascular imaging?
Generally accepted criteria for implementing screening program : The condition (1)Should be an important health problem (2)Epidemiology and natural history of the condition should be adequately understood and there should be a detectable risk factor, disease marker, latent period, or early symptomatic stage (3)All cost effective primary prevention interventions should have been implemented The test (4)A simple, safe, precise and validated screening test (5)Distribution of the test values should be known and a suitable cut off level agreed (6)The test should be acceptable to the population (7)Agreed policy on further diagnostic investigation of positive test results
Generally accepted criteria for implementing screening program : Treatment (8)Effective treatment or intervention; early treatment leading to better outcomes than late treatment (9)Evidence based policies on who should be offered treatment and the appropriate treatment (10)Clinical management of the condition optimized before introduction of screening The screening program (11)Evidence that the screening program is effective in reducing mortality and morbidity (12)Complete screening program (test, diagnostic procedures, treatment/intervention) must be clinically, socially, and ethically acceptable to health professionals and the public (13)Benefit should outweigh physical and psychological harm (14)Opportunity cost should be economically balanced in relation to expenditure on medical care as a whole (15)A plan for managing and monitoring the screening program and agreed quality assurance standards 16)Adequate staffing and facilities for testing, diagnostic treatment, and programm management
public health Do the medical staff and public know enough on radiation consequences? Is it tangible enough? Needs assessments as a tool? Constructing national policy regarding: (2) What is the right balance between : patient s empowerment involved in the decision making, taking responsibility on the treatment, educated.
Constructing national policy regarding: The right balance more dilemmas : Who can refer to CT exam asymptomatic patients? self referral? only physicians? National Leadership - when should we interfere as regulators? only in populations at risk (children..)?
Constructing national policy regarding: The right balance more dilemmas (2) : Which tools to use? legislation? directives? Recommendations? Referral guidelines? Facilitating education and training of the population and medical staff?
Constructing national policy regarding: (3) Economical constrains - Who should pay for the CT exam (and related tests)? Should there be a different policy regarding public reimbursement and private funding? How will it influence the infrastructure? number of CT devices, human resources, organizational infrastructure, CT-MRI relationship
Constructing national policy regarding: (4) Monitor the use and evaluate the clinical impact - utilization patters of CT exams over time identify populations at risk high dose imaging history as part of the E-medical files update regulations or recommendations according to the evidence and other imaging modalities
Israel : Israel s population - ~8 million people National Insurance Law 4 HMOs National coverage for approx. 4,500 medical services including: drugs, most imaging exams, interventional procedures, radiotherapy and nuclear medicine Imaging procedures referral by physicians Certificate of Needs (CON): CT, PET-CT, Lineacs, MRI etc.
MOH Policy: Strengthening the radiation protection of patients (RPoP) while implementing the following principles - Justification Optimization (ALARA) Quality Control Record of radiation exposure Focus on high radiation dose examinations CT Nuclear medicine Interventional procedures Attention to populations at risk: children, pregnant women National project of Mammography National project of Radiotherapy
RPoP - IMOH policy: RPoP directive published on Feb 2010 includes the following principles: Justification Optimization Quality Control Record of dose quantities Detailed guidelines were published: Neonatal and pediatric medical procedures involving radiation exposure Cardiac interventions and related exams
Data recording: Electronic medical files: o for all patient o hospitals and HMO s Certificate of Needs (CON): for CT, PET-CT, Lineacs, MRI and etc. MOH has national collective data regarding utilization patterns for all CON technologies and QC data. Patients doses on exam level at the HMO s and medical centers databases.
Israel Radiation emitting modalities : 65 CT 18 MRI 9 PET-CT 80 Gamma Cameras 24 Angiography 27 Linear Accelerators (2012 data) 1,038,000 CT exams 225,000 MRI exams 55,000 Cardiac Catheterization procedures 35,875 Angiography procedures 35,000 PET-CT exams 215,858 Radiotherapy treatments (to 15,675 patients)
CT - Utilization Pattern Rate devices according to the regulations (CON): 1:125,000 population At the end of 2014-65 CT devices operated Number of CT exams carried out at all institutes (hospitals and community) - 1,038,000 Exams per capita at the end of 2013 was 127.7 tests per 1,000 population
The rate of the CT tests (per 1,000 people) in Israel 1995-2013 140 120 100 80 60 40 20 0
Distribution of the CT tests by body parts (2013)
CT - Waiting times for testing (weeks) Waiting times >1 >1 >1 1 2 5 6 10 State Austria Switzerland Israel Belgium France Denmark UK Sweden * IHE Report CT and MRI services in Alberta: comparisons with other health care systems
Summary : First phase : construct your national policy adjusted to health coverage, characteristics of health care system and coherent with other health policy issues Second phase: evaluate the economical and infrastructure implications Third phase: implement using appropriate regulatory tools Fourth phase : Monitor the use and evaluate the clinical impact, update according
Thank you for you attention