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Translating Evidence into Policy: Crossing the Policy Chasm

Translating Evidence into Policy: Crossing the Policy Chasm. Andy Schneider January 5, 2012. Two Whose Research Crossed the Chasm. Steve Nissen , Cleveland Clinic Meta-analysis of cardiovascular risk of rosiglitazone maleate (Avandia) (NEJM 5/21/2007) Peter Pronovost , Johns Hopkins

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Translating Evidence into Policy: Crossing the Policy Chasm

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  1. Translating Evidence into Policy: Crossing the Policy Chasm Andy Schneider January 5, 2012

  2. Two Whose Research Crossed the Chasm • Steve Nissen, Cleveland Clinic • Meta-analysis of cardiovascular risk of rosiglitazone maleate (Avandia) (NEJM 5/21/2007) • Peter Pronovost, Johns Hopkins • Practice guidelines to reduce CRBI infections in ICU patients (NEJM 12/28/2006; New Yorker 2/10/2007)

  3. Two Whose Research Crossed the Chasm • Different research • Different bridges across the chasm • Same achievement: Changing policy and practice to reduce patient harm

  4. Avandia, Clinical Trials, and Post-Marketing Requirements Today • FDA restrictions on access to Avandia (9/22/2010) • “Boxed warning” added to Avandia label • CHF and Myocardial Infarction (modified 5/18/2011) • FDA Amendments Act of 2007 (FDAAA) • Section 801 mandates submission of clinical trials data and expansion of www.ClinicalTrials.govto include results • Section 901 authorizes the FDA to require postmarketing studies and clinical trials for prescription drugs (Guidance for Industry April 2011), http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM172001.pdf

  5. CRBIs Today: Fewer CLABSIs, Greater Transparency • According to CDC, CLABSIs in ICUs dropped an estimated 58% from 2001 to 2009 • January 2011 – CMS Hospital Inpatient Quality Reporting (IQR) program requires hospitals that elect to participate to use the CDC’s National Healthcare Safety Network to report CLABSI data from all adult, pediatric, and neonatal ICUs • Hospital Compare will be reporting facility-specific information on central line infections from the CDC’s National Healthcare Safety Network beginning in January 2012

  6. The Federal Policy Process:Three Institutional Silos • Legislative Branch (Congress) • Legislation (spending, taxing, regulating) • Oversight (hearings, investigations) • Executive Branch (Department of Health and Human Services) • Implement legislation (regulations, grantmaking) • Judicial Branch (Federal courts) • Enforce compliance by Executive Branch with Congressional intent • Enforce compliance by Congress with Constitution

  7. Congress • House of Representatives (434 Members) • Senate (100 Senators) • Committees (Authorizing, Appropriations, Oversight) • Support agencies • Congressional Budget Office (CB0) • Government Accountability Office (GAO) • Medicare Payment Advisory Commission (MedPAC) • Medicaid and CHIP Payment and Access Commission (MACPAC)

  8. Department of Health and Human Services (HHS) • Centers for Medicare & Medicaid Services (CMS) (FY 2010 spending in billions: $731.1) • National Institutes of Health (NIH) ($30.8) • Centers for Disease Control and Prevention ($6.5) • Food and Drug Administration (FDA) ($3.3) • Agency for Healthcare Research and Quality (AHRQ)($0.4)

  9. The Nissen Path • 2006: DREAM and ADOPT published • 5/25/2007 NEJM publishes meta-analysis • 6/6/2007 House Oversight hearing • 9/27/2007 FDAAA enacted • 11/14/2007 FDA requires “Boxed Warning” • 2/20/10 Senate Finance Committee report • 9/22/10 FDA restricts marketing of Avandia • 5/18/2011 FDA expands “Boxed Warning”

  10. Senate Finance Committee StaffOversight Report (January 2010) “The totality of evidence suggests that GSK was aware of the possible cardiac risks associated with Avandia years before such evidence became public….GSK had a duty to sufficiently warn patients and the FDA of its concerns in a timely manner. Instead, GSK executives intimidated independent physicians, focused on strategies to minimize findings that Avandia may increase cardiovascular risk, and sought ways to downplay findings that the rival drug ACTOS (pioglitazone) might reduce cardiovascular risk.” http://finance.senate.gov/newsroom/chairman/release/?id=bc56b552-efc5-4706-968d-f7032d5cd2e4, p. 15

  11. The Pronovost Path • 8/9/2002- CDC Guidelines for Prevention of Intravascular Catheter-Related Infections • Sept. 2003 - AHRQ funds “Keystone Project” in Michigan ($455,000) • 12/28/2006 – NEJM publishes results • 2/1/2007 – Atul Gawandi article in New Yorker • 4/16/2008 – House Oversight Committee hearing on Healthcare-Associated Infections

  12. The Pronovost Path (cont.) • September 2008 – AHRQ funds continuation of Keystone Project to test strategy for reducing CLABSIs in 100 hospital ICUs from 10 States over a 3-year period($3 million) • February 2009 – Recovery Act (ARRA) includes $40 million for State Health Depts for prevention or reduction of HAIs • June 2009 – HHS Action Plan to Prevent HAIs (2013 National Prevention Target: 50% reduction in CLABSI in ICU and ward-located patients or 0.50 Standardized Infection Ratio (SIR)) • April 2011 – CDC issues Guidelines for the Prevention of Intravascular Catheter-Related Infections • January 2012 – www.hospitalcompare.hhs.gov will be reporting hospital-specific information on CLABSIs from the CDC's National Healthcare Safety Network

  13. CLABSI Infections 2001 - 2009 “In 2009 alone, an estimated 25,000 fewer CLABSIs occurred in U.S. ICUs than in 2001, a 58% reduction. This represents up to 6,000 lives saved and $414 million in potential excess health-care costs in 2009 and approximately $1.8 billion in cumulative excess health-care costs since 2001. A substantial number of CLABSIs continue to occur, especially in outpatient hemodialysis centers and inpatient wards.” MMWR (March 4, 2011)

  14. Policy Tools • Performance Goals (e.g., FDA restricted access program, HHS Action Plan) • Diffusion Grants (e.g., AHRQ) • Transparency (e.g., Clinical Trials.gov, Hospitalcompare.hhs.gov, Whynotthebest.org) • Regulatory requirements (e.g. FDA post-marketing guidance) • Payment incentives (e.g., Medicare IQR)

  15. Lessons Learned • Research is critical to improving public health policy and reducing patient harm • Not all pharmaceutical manufacturers will police themselves • Not all medical professionals or hospitals will police themselves • There are many paths across the policy chasm

  16. Lessons Learned (cont.) Crossing the chasm takes: • Research that is methodologically sound • Research that either • meshes with pre-existing policymaker agendas or • is so ground-breaking that it starts a policy conversation • Time • Tenacity • Luck

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