1. HIT Policy Committee Health Information Exchange Workgroup Comments on Notice of Proposed Rule Making (NPRM) and Interim Final Rule (IFR) Deven McGraw, Chair Center for Democracy & Technology Micky Tripathi, Co-Chair Massachusetts eHealth Collaborative February 17, 2010

2. - 1 - BACKGROUND 1.EPs required to incorporate significant amount of structured data, but IFR and NPRM do not make it any easier for providers to accomplish that objective. No content exchange standard for EHR systems to receive structured data Hospitals deliver majority of labs across the country, but NPRM and IFR impose no requirements on hospitals to send structured data to EPs, and no standards if they do 2.Even where standards are specified, they are ambiguous and do not provide the amount of clarity needed to motivate vendor innovation and development. 3.Without significant strengthening of the lab portions of the NPRM and IFR, may need to consider weakening other NPRM Stage 1 objectives that rely on availability of structured lab data. 4.The federal government has a wide variety of levers it can use to reinforce the NPRM and IFR.

3. - 2 - RECOMMENDATIONS THAT DIRECTLY ADDRESS LABS EPHospitalStage 1 measure NPRM Incorporate clinical lab-test results into EHR as structured data Incorporate clinical lab test results into EHR as structured data At least 50% of all clinical lab tests ordered whose results are in a positive/negative or numerical format are incorporated in certified EHR technology as structured data na Capability to provide electronic submission of reportable lab results (as required by state or local law) to public health agencies and actual submission where it can be received Performed at least one test of the EHR system's capacity to provide electronic submission of reportable lab results to public health agencies IFR na Submission of lab results to public health agencies (content exchange) HL7 2.5.1 (Cx) LOINC when LOINC received from lab (V) na Submission to public health agencies for surveillance or reporting HL7 2.3.1 or 2.5.1 (Cx) Locally defined (V) na

4. - 3 - RECOMMENDATIONS THAT ARE INDIRECTLY AFFECTED BY RECOMMENDATIONS ON LABS EP or hospitalStage 1 measure NPRM Generate lists of patients by specific conditions to use for quality improvement, reduction of disparities, and Outreach Generate at least one report listing patients of the EP or eligible hospital with a specific condition. Report ambulatory quality measures to CMS or the States For 2011, provide aggregate numerator and denominator through attestation as discussed in section II(A)(3) of this proposed rule. For 2012, electronically submit the measures as discussed in section II(A)(3) of this proposed rule Implement 5 clinical decision support rules relevant to specialty or high clinical priority, including diagnostic test ordering, along with the ability to track compliance with those Rules Implement 5 clinical decision support rules relevant to the clinical quality metrics the EP/Eligible Hospital is responsible for as described further in section II(A)(3). Provide patients with an electronic copy of their health information (including diagnostic test results, problem list, medication lists, allergies), upon Request At least 80% of all patients who request an electronic copy of their health information are provided it within 48 Hours Provide patients with timely electronic access to their health information (including lab results, problem list, medication lists, allergies) within 96 hours of the information being available to the EP At least 10% of all unique patients seen by the EP are provided timely electronic access to their health Information

5. - 4 - RECOMMENDED CHANGES TO NPRM AND IFR Stage 1 - Labs Adopt the HL7 2.5.1 Implementation Guide, which specifies HL7 2.5.1 and LOINC specifications, as the definition of “structured data” for EHR lab results (NPRM) Extend the same HL7 2.5.1 certification criteria for hospital lab reporting to all lab result reporting (not just to public health reporting as currently specified) (IFR) Require hospitals to demonstrate this capability through at least one test (parallel with public health reporting requirement) (NPRM) Include HL7 2.5.1 content exchange standard in certification criteria for EP and hospital EHR technology (not just vocabulary standard as currently specified) (IFR) Reduce options for public health reporting content exchange and vocabulary standards, or at a minimum explain the circumstances in which each of the standards would be required (IFR & NPRM) Stage 1 - eRX eRX – refine eRX measure to account for markets in which 75% eRX may not be possible (for example, due to low pharmacy participation in Surescripts) (NPRM) Stage 2 - Labs IFR and NPRM: Signal requirements for ordering

6. - 5 - OTHER RECOMMENDED ONC ACTIONS The Office of the National Coordinator (ONC) should support efforts to release CLIA Survey and Cert Letter as soon as possible. CLIA is policy lever that can be used more aggressively to get labs more quickly into compliance ONC does not oversee CLIA but has worked closely on these rules with Centers for Medicare & Medicaid Services (CMS) ONC’s support of stronger CLIA guidance will bolster HHS’ efforts overall to promote lab result standardization State HIT Coordinator should be required or encouraged to work with state CLIA administrators to align state-level lab approach with national CLIA, standards, and certification requirements. Federal and state employee health programs could require contractors to use such standards.