CMS Initiatives to Improve Evidence Based Prescribing

1. CMS Initiatives to Improve Evidence Based Prescribing Kelly Cronin Senior Advisor to the Administrator Centers for Medicare and Medicaid Services

2. Combining Part A, B, and D data for evidence development • MMA implementation provides unprecedented opportunity to study how drugs work in Seniors including • drug utilization patterns, safety profiles, effectiveness, quality of care, and cost of care • evidence created through analysis of integrated data combined with all other sources of evidence will enable prescribing decisions that will maximize the health outcomes of Medicare beneficiaries while minimizing their out of pocket costs

3. 5 Types of Studies with Integrated Medicare Data • Descriptive studies • quantify prescribing patterns by geographic area, frequency of under- and over-prescribing, rates of measurable adverse drug events, and rates of compliance • Epidemiologic studies • quantify an association between a drug and a health outcome • examine how a patients’ characteristics impact utilization and health outcomes • Economic impact studies • estimate the cost of treatment of a given condition or disease relative to the effectiveness of the drug of interest • Program evaluation • Estimate the impact of demonstration or pilot programs involving drug therapy in chronic care management

4. Strengths and Weaknesses of Integrated Medicare Data Analysis • Strengths: • Large, representative samples readily available for relatively low cost • Real world utilization and outcomes, more generalizable • Can link to private payers data to get total universe of care and younger age groups • Weaknesses: • Limited control of confounding variables (no randomization) • Measurement bias • Lack of adequate control group

5. Some Research Questions of Interest • Questions involving “off-label” uses of drugs (e.g., longer use, higher doses, or other clinical indications) • Questions about the value of newly approved drugs (e.g., do they reduce the cost of managing a given conditions or disease while improving longer-term health outcomes?) • Questions about differences in safety and effectiveness in particular subgroups of patients (e.g., seniors, patients with certain co-morbidities, patients from racial and ethnic minority groups)

6. Current Initiatives • Working with FDA on pilots for select drugs reimbursed under Part B • Identifying mechanisms to share integrated data with investigators outside CMS • Planning the infrastructure needed over the next several years to meet needs of multiple programs

7. Next Steps:Collaboration to Build Evidence Base • CMS can provide access to integrated data • AHRQ and FDA will be users • Researchers in academia and industry will also be key partners • Private sector alliance needed to agree on methods and coordinate collaboration to address key research questions • Build off of existing consensus on methods from ISPOR and ISPE • Consider a voluntary study registry to facilitate collaboration and avoid duplication

8. Acceleration of E-prescribing • Accelerate adoption of e-prescribing through MMA implementation • As of January 1, 2006 physicians who e-prescribe and plans will comply with foundation standards to enable electronic exchange of prescriptions and related info • Certification Commission addressing connectivity for EHRs in 2006 • Pilot additional standards in 2006 and test standards in long-term care setting

9. Reducing Barriers to Adoption • Proposed changes to Stark and Anti-kickback • 3 exceptions/safe harbors • E-prescribing technologies and services • EHRs before certification (more limited) • EHRs with certification • Open door forum November 9th • Public comments due in December

10. Questions? Kelly.Cronin@cms.hhs.gov