Review of CMS Meaningful Use NPRM and ONC Standards and Certification IFR: Implications for Public Health

1. Review of CMS Meaningful Use NPRM and ONC Standards and Certification IFR: Implications for Public Health Call # 2 - February 8, 2010 Presenter: Steven C. Macdonald, PhD, MPH Washington State Department of Health Council of State and Territorial Epidemiologists (CSTE) Facilitators: Walter Suarez, MD, MPH, Kaiser Permanente and PHDSC Bill Brand, MPH, CPHIE, PHII Vicki Hohner, MA, Fox Systems Anna Orlova, PhD, PHDSC

2. Review and Comment Strategy • Webinar 1 – Friday, February 5 • Overview of CMS NPRM and IFR Special attention: public health topics/issues • Open discussion to identify NPRM and IFR areas/topics for comment • Webinar 2 - Today • Review of perspectives and comments on the NPRM and IFR from the Council of State and Territorial Epidemiologists (CSTE) • Discussion on standards, certification criteria and meaningful use requirements related to reporting Immunization data, lab data, and disease surveillance data to public health

3. Review and Comment Strategy • Webinar 3 Tuesday, February 23, 2010 – 2:00 to 4:00 pm ET • Continue discussion on topics of interest to public health identified during previous calls • Webinar 4Monday, March 1, 2010 – 12:00 to 2:00 pm ET • Conclude discussion on remaining topics of interest to public health • Review summary of comments gathered through previous calls • Concluding comments and next steps

4. Summary of Call 1 • Public health issues go beyond the three main items identified in the NPRM (immunizations, lab, disease surveillance) • Additional topics to comment on included: • Under Goal 1 (improving quality, safety, efficiency, and reducing health disparities) – expand on other areas besides demographics, smoking status, including electronic birth and death records data • Under Goal 2 (Engage patients and families in their care) – emphasize the importance of public health in engaging patients and families

5. Summary of Call 1 • Under Goal 3 (improve care coordination) – also comment on the importance of public health data exchanges in meeting care coordination goals • Under Goal 4 (improve population and public health) – additional elements to consider within immunizations data reporting, lab reporting and disease surveillance; also other possible topics to consider reporting beyond these three items • Under Goal 5 (improve adequate privacy and security protections for personal health information) – any topics relevant to public health to comment on?

6. Summary of Call 1 • Other NPRM topics: • Quality reporting and public health (looking at each of the various quality metrics and how they relate to public health / population health) • Eligibility of public health providers for the incentives • Other areas?

7. Summary of Call 1 • IFR Topics • Certification criteria for three public health areas (immunizations, labs, disease surveillance) • Other certification criteria in other areas that relate to public health • Standards defined for three public health areas • Standards defined for other areas that relate to public health

8. CSTE 60-day comment on CMS NPRM, ONC IFR Steven C Macdonald PhD, MPH Washington State Department of Health, Environmental Epidemiology

9. CSTE concerns • Actual submission in Stage 1 • immunization information • electronic laboratory reporting (ELR) • Methods • capability testing • performance testing • role of public health agencies in verification • Drop: opt-out clauses • Add: requirements for standardized vocabularies in ELR

10. State modifications • CMS NPRM language • will “allow States to add additional objectives to the definition of meaningful use or modify how the existing objectives are measured” • when those are “CMS-approved additional meaningful use requirements”

11. Medicaid program • ARRA-HITECH Act language • Medicaid EP or eligible hospital must demonstrate meaningful use through a “means that is approved by the State and acceptable to the [DHHS] Secretary” • CMS NPRM language • “More stringent requirements may be established for hospitals under the Medicaid program in States where [public health agency capacity to receive] exists”

12. State Medicaid HIT Plan • ARRA-HITECH Act language • “a State must demonstrate to the satisfaction of the [DHHS] Secretary that the State is conducting adequate oversight, including the routine tracking of meaningful use attestations and reporting mechanisms.” • CMS NPRM language: SMHP is expected to include • “routine tracking of meaningful use attestations” • “a description of the methodology in place used to verify such information”

13. Actual submission to public health • Language referring to Stage 2 points toward demonstration of actual submission as an appropriate state-specific more-stringent requirement in Stage 1 • “Measures that currently require the performance of a capability test (for example, capability to provide electronic syndromic surveillance data to public health agencies) will be revised to require the actual submission of that data” • State Health Agencies (SHAs) which are now capable of receiving submissions of immunization information and ELR will want to require such submissions to occur • “Examples of how States may consider adding to the Federal definition of meaningful use include requiring providers to participate in a health information exchange, and requiring that providers link to immunization, lead screening, or newborn screening registries”

14. Drop: Opt-out clauses in ELR, syndromic surveillance • CMS NPRM language • Provider needs to test sending capability “unless none of the public health agencies to which eligible hospital submits such information have the capacity to receive the information electronically” • Predictable stalemate • When public health attains ‘receive’ capability, the hospital/provider won’t have ‘send’ capability

15. Specification of capability test methods • Capability test options • Immunization registry precertification • HL7 conformance testing • Simulation • Verification of capability attestation

16. Capability Test: Immunization • Precertification: process of evaluating incoming data quality of new submitters before allowing them to regularly add data • Precertification review • format (whole file) • data field completeness (each record) • accuracy: data item coding, range, and format; cross-checks among data items • Pre-established rejection rate

17. Capability Test: HL7 conformance • Standard protocols and software are available • NIST HL7 Conformance Testing with Message Makerhttp://www.itl.nist.gov/div897/ctg/messagemaker/index.html • HL7 Messaging Workbenchhttp://www.hl7.org/Special/committees/ictc/index.cfm

18. Capability Test: ELR Simulation • Analogous to standard lab QA procedures • Fictional positive test results are inserted into a hospital lab LIS (flagged as “TEST”) • Transmitted from LIS to hospital EHR • Transmitted to the SHA public health unit • Test files examined for HL7 conformance, completeness and accuracy of data fields

19. Capability Test Verification • Hospitals and EPs can attest to ELR simulation testing or immunization registry precertification • Verification can be conducted as confirmation by consultation with SHA public health unit • CMS compliance review verification • state Medicaid verification

20. Verification of actual submission of immunization information • Immunization registry expectations • completeness, accuracy and timeliness • AIRA Data Quality Assurance for Incoming Data best practice guide • principles and business rules • Hospitals and EPs can attest to actual submission of immunization information • Verification can be conducted as confirmation by consultation with IIS

21. Performance testing of actual submission for ELR • State health agency data review • Performance audits

22. State health agency data review • Performance testing of actual submission • completeness • SHA public health unit documents proportion of results for reportable conditions that came from each individual hospital as ELR reports vs. paper reports • easy to conduct in SHAs which use the CDC-provided NEDSS Base System (NBS) • timeliness of reporting • accuracy of data fields • Verification of attestation • conducted as confirmation by consultation with SHA public health unit

23. Performance audits • Performance testing of actual submission • trained audit teams • select reportable results from lab records • search DOH database to see if complete results were received in a timely fashion • auditors can also examine code mapping tables (e.g., local code to LOINC) for accuracy • Verification of attestation • conducted as confirmation by consultation with SHA public health unit

24. Add: Requirements for standardized vocabularies in ELR • LOINC • SNOMED

25. LOINC codes • Hospital EHRs are required to be capable of receiving/using LOINC (v2.27) • Proposed rules do not require hospital labs to send messages to public health using the standardized LOINC vocabulary • For the small subset of lab data which comprise the reportable lab results, it is feasible and desirable for labs to use LOINC codes

26. SNOMED codes • Hospital EHRs are required to be capable of using either ICD-9-CM or SNOMED CT diagnosis codes in the problem list • SNOMED codes are included only as a Stage 2 Candidate Standard for ELR HIE • For the small subset of lab data which comprise the reportable lab results, it is feasible and desirable for hospital labs to use SNOMED codes

27. More detail on Stage 2 • If implementation of Stage 2 can start in October 2012, and if draft rules will not be issued until early 2012, gap is challengingly short for public health agency HIE capability development • More detail in the current rule language • expectations regarding cancer registry (such as pathology lab ELR) • expectation of required use of HL7 2.5.1 for Immunization Registries • expectations regarding electronic birth registration • expectations for public health case reporting