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

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

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 4 Monday, 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 Review and Comment Strategy

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 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? 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? 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 Summary of Call 1

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

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

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”

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”

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”

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”

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

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

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

Capability Test: HL7 conformance Standard protocols and software are available –NIST HL7 Conformance Testing with Message Maker –HL7 Messaging Workbench

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

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

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

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

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

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

Add: Requirements for standardized vocabularies in ELR LOINC SNOMED

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

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

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 HL for Immunization Registries –expectations regarding electronic birth registration –expectations for public health case reporting