Networking Health Information Technology at AHRQ

1. Networking Health Information Technologyat AHRQ GSA: Federal Health IT Initiatives--Enabling Collaboration J. Michael Fitzmaurice, Ph.D. Agency for Healthcare Research and Quality U.S. Department of Health and Human Services April 18, 2006

2. AHRQ’s Mission Improve the quality, safety, efficiency, and effectiveness of health care for all Americans.

3. AGENDA • AHRQ and patient safety • Investments in HIT for HC • Data Standards Program

4. Health Issues • Costs continue to rise • NHE is $1.9 trillion in 2004, growing at 7.9% • CPI grew at 3.3 percent in 2004; GDP deflator at 2.6%, • NHE/GDP is 16 %, up from 15.9% (2003); 9.1% (1980) Smith, C, et. al., “National Health Spending in 2004…,” Health Affairs (Jan-Feb, 2006) • Quality of health care is not optimal • Doctors provide appropriate health care only about half the time for 30 acute and chronic conditions. Beth McGlynn, et al., N Engl J Med, June 26, 2003 • 44 core national quality measures grew at 2.8 percent in 2004 and 2005.2005 National Healthcare Quality Report, AHRQ, December 2005

5. Health Issues • Access improves and diminishes • “Overall, more racial disparities in quality of care were narrowing than were widening, and most racial disparities in access to care were narrowing (affecting blacks, Asians and American Indians/Alaska Natives). But for Hispanics, the majority of disparities for both quality and access were growing wider.” 2005 National Disparities Report, AHRQ, December 2005 http://www.ahrq.gov/news/press/pr2006/nhqrdrpr.htm • Largest problems • lack of health insurance, lack of a primary care provider • Patient Safety costs lives and resources • Between 44,000 and 98,000 people die in hospitals annually due to medical error. IOM, To Err is Human, 2000. • Often preventable hospital injuries and complications lead to • More than 32,000 deaths, 2.4M extra days of care, and • Costs exceeding $9B annually in US. C. Zhan & Miller (AHRQ), Excess Length of Stay, Charges, and Mortality Attributable to Medical Injuries During Hospitalization, JAMA, October 8, 2003

6. Commonwealth Fund Survey on Medical Errors

7. Commonwealth Fund Survey on Medical Errors • In US, 34 percent of surveyed patients with health care problems reported at least one of four types of errors: • Experienced a medical mistake in treatment or care • Received the wrong medication or dose • Received incorrect results for a test • Experienced delays in notification about abnormal test results. • In US, 48 percent of surveyed patients who saw at least 4 doctors in the past two years reported at least one of these errors

8. National Coordinator for Health Information Technology: David Brailer, MD, PhD • Appointed National Coordinator for HIT on May 6, 2004 • Produced Framework for Strategic Action on July 21, 2004 • Reported on Responses to ONCHIT’s RFI— June 3, 2005 • Secretary created AHIC – his federal advisory committee • Developed/coordinated 4 NHIII contracts by November 2005 • Standards Harmonization—ANSI/HIMSS $3.3M • Privacy and Security (AHRQ)—RTI 11.5M • Compliance Certification-CCHIT 2.7M • NHIN Architecture—Accenture, CSC, IBM, Northrop Grumman 18.6M

9. AHRQ HIT Program Funding

10. One of 4 NHII Contracts • Privacy and Security (AHRQ-ONCHIT) • Research Triangle Institute for $11.5 M • National Governor’s Association, a partner • To identify privacy and security barriers, restrictions, and enablers to the development of interoperable systems at the state and regional levels • Focus on state privacy laws and business practices

11. Medicare Modernization Act Requires eRx Pilots • 4 awards totaling $6M, January 17, 2006, Administrated by AHRQ & CMS • Test eRx systems of data standards for how efficiently and effectively eRx information can be transmitted to and from providers and pharmacies • To reduce adverse drug events and improve appropriate use of medications • To enable providers to obtain formulary information and medication history • To test new ways of naming clinical drugs and their ingredients, and providing patient instructions • To assess workflow changes for pharmacies and physicians’ offices. • Initial standards + 3 eRx foundation standards Do they work together? • Contractors and site locations Report due to Congress: April 2007 • Rand Corporation-- New Jersey • Brigham and Women’s Hospital-- Boston • SureScripts— Florida, Mass., Nevada, New Jersey, Tenn. • Achieve Healthcare Information Technology-- Minnesota

12. AHRQ GrantsTransforming Healthcare Quality • AHRQ Planning Grants • $7M for 35 new grants; $5M for 28 grants to rural and small communities • For HC systems and partners to plan to implement HIT to promote patient safety and quality of care • AHRQ Implementation Grants • $19M for 40 new grants’ $12M for 25 grants rural and small hospitals • To evaluate the measurable and sustainable effects of HIT on improving PS & QC. • 50% cost sharing; Maximum 20% of federal funds for software and hardware • AHRQ Demonstrating the Value of HIT Grants • $12M for 24 new grants; $2M for 4 rural grants • To increase the knowledge and understanding of the value of HIT • Clinical, safety, quality, financial, organizational, effectiveness, efficiency • 6 State Contracts • Identify and support statewide data sharing and interoperability activities. • $1M/yr for 5 years—each: IN, UT, TN, CO, RI, DE (2005) • National Resource Center for HIT • NORC for $18.4 M over 5 years to support AHRQ HIT grantees and contractors

13. AHRQ • 16 grants for implementation of HIT projects awarded in November 2005 • 11 in rural areas $22.3 M over 3 years • Result of 35 planning grants awarded in FY 2004 • They “will seed and nourish the work already under way in regions and communities across the nation to improve the safety, quality and efficiency of health care.” (Janet Marchibroda, November 14, 2005)

14. AHRQ Patient Safety Health Care IT Data Standards Program • Funding: $10 Million in FY 04 to AHRQ, and in FY 2005 • Received advice from • Secretary of HHS -- HHS NHII Office • NCVHS -- CAHIT -- CHI -- IOM • Federal standards and program experts • Private sector (Markle Foundation, eHI, WEDI, AMIA, others) • Their recommendations include: • Drug terminologies -- SNOMED mapping • Patient safety event reporting • Meta-data registry -- Landscape • eRx -- NCVHS/CHI standards’ gaps • Knowledge representation -- Others • 70 percent went to standards to help reduce adverse drug events

15. AHRQ Patient Safety Data Standards Program • Drug Terminology Development and Mapping • FDA 4.600 M 4.000 M • NLM 1.150 M 1.150 M • Nomenclature and Mapping • NLM 2.100 M 2.400 M • Device Nomenclature • FDA .300 M .300 M • Patient Safety Reporting Standards • AHRQ .500 M .400 M • USHIK (Meta-data Registry) • CMS .300 M .300 M • Standards Landscape • NIST .300 M .300 M

16. Drug Safety

17. Health System Improvement: Case Study • Drug information takes too long, small print, hard to find • Drug labeling information • Submission in paper form to FDA • FDA Approval • Goes back to manufacturer, and back to FDA till approved • Public Awareness • Drug package insert of labeling information • Information location • Physicians Desk Reference • Access by information vendors • Frequent contact with manufacturers • National Drug Codes • Some re-used, compresses 11 digit code into 10 digits • Delayed receipt of drug codes by FDA from manufacturer • Re-labelers assign codes too

18. AHRQ-Funded PS Standard System • Electronic Product Listing System (ELIPS)—an inventory of drug products marketed in US • FDA adopted the HL7 standard for the exchange of product labeling information called Structured Product Labeling (SPL). • Used by the pharmaceutical companies for providing not only the content of labeling found in the package insert but also descriptive information on the medicinal product including: • Proprietary product name and code • Non proprietary name • Ingredient name(s) and Unique Ingredient Identifier(s) (UNII) and strength • Dosage form • Route of administration • Packaging configurations and codes • FDA will begin directly assigning National Drug Codes to new drugs

19. Improving Patient Safety AHRQ Data Standards Program DailyMed Web Site SPL-RxNorm NLM RxNorm Link Pharmaceutical Manufacturer FDA Approval SPL SPL Drug label Information ELIST HL7-SPL NDC SRS--UNII RxNorm Standards Contraindications Allergies

20. AHRQ-Funded PS Standard System • Substance Registration System • Develop SRS • Develop unique ingredient identifiers (UNII) • To identify active and inactive ingredients • To be used in ELIST and ELIPS • Product: Data Base for • NLM distribution via DailyMed • Health information suppliers • Public access

21. AHRQ-Funded PS Standard System • RxNorm--National Library of Medicine • Standard names for • US prescription drugs • OTC drugs with L.E. 3 active ingredients • Selected biologics (i.e., vaccines) • Linked to • Active ingredients • Strengths • Dose forms • Dose forms as administered • Related brand names • NDC’s • Available to the public on NLM’s DailyMed web site

22. AHRQ-Funded PS Standard System • Mapped to RxNorm from the terminology of • VA’s National Drug File • First DataBank • Medispan • Micromedix • Multim

23. End Result • AHRQ’s funding has paved the way to: • Accelerate development of terminology content • Provide for more frequent updates than quarterly • Expand RxNorm to cover • OTC drugs • Related products (e.g., vitamins) • More complete mapping: RxNorm and drug info vendors • Training and support mechanisms • Make this information publicly available

24. Interoperability Partnership • AHRQ • Patient Safety • Data Standards Program funding • FDA • System Specification and Development • HL7 SPL standard • Regulatory changes that are essential • NLM • Vocabulary expertise • Accurate drug information linking (RxNorm) • DailyMed web site

25. Patient Safety and Quality Improvement Act of 2005 (P.L. 109-41) • Signed into law: July 29, 2005 It encourages health care providers to contract with one or more HHS-accepted Patient Safety Organizations (PSOs) to • Collect and analyze data on patient safety events (including “near misses”, “close calls”, and “no-harm” events) • Develop and disseminate information to improve patient safety and to provide feedback and assistance to effectively minimize patient risk • Provides Federal privilege and confidentiality protections against disclosure of information that is collected or developed pursuant to a provider contract • Creates a network of patient safety databases • Accept, aggregate across the network, and analyze non-identifiable patient safety work product[s] voluntarily reported by patient safety organizations, providers, or other entities • Analyze national and regional statistics, including trends and patterns of health care errors • http://www.gpoaccess.gov/plaws/ ( “Public Law 109-41”)

26. How to Proceed? • How many states are collecting PSE data? • Who reports? • For what events is reporting mandatory? • What data are states collecting in their PSE reporting systems? • Are these elements standardized and categorized? • Are they analyzed? • When will PSO’s be designated? • What data standards are needed?

27. Patient Safety Improvements • More timely information to providers and consumers • More frequent updates of drug information • Faster dissemination of new drug information • More legible information to consumers • Reduced costs of supplying package inserts • Standardized, accurate, linkable information base for information vendors • Information source for decision support systems • Unique drug identifiers—NDC codes, RxNorm • National leadership in PS event reporting

28. Networking Health Information Technologyat AHRQ GSA: Federal Health IT Initiatives--Enabling Collaboration J. Michael Fitzmaurice, Ph.D. Agency for Healthcare Research and Quality U.S. Department of Health and Human Services April 18, 2006