Proposal To Address Medications, Allergies Disparities In Final Rule MU Stage 2

1. Proposal To Address Medications, Allergies Disparities In Final Rule MU Stage 2 Co-presented by George Robinson, RPhFirstDataBank, Inc James Shalaby, Pharm.D. PSMI Consulting, Inc October 4th, 2012

2. Purpose • Address key inconsistencies found in review of the Final rules for Stage 2 meaningful use and the referenced HL7 consolidated CDA standard. • Recommend a practical, low effort, late breaking solution to mitigate potential problems in CQM reporting. • Provide assistance if needed to help quickly resolve the prioritized ambiguities.

3. Problems Found In Allergies #1 • Consolidated CDA standards for allergies to medications missing key term types in RxNorm: • Fact: Most EHRs document allergies mostly at the medication ingredient, medication class or brand name levels. • Problem: The standard is inconsistent with respect to which ingredient standard to use when the ingredient is a drug or excipient. • There is ambiguity in cCDA and ONC documentation with respect to ingredients in allergy documentation since it can be interpreted that any ingredient allergies can be documented using UNII or RxNorm. • There is ambiguity in QDM vs. cCDA for non-drug allergies standards (SNOMED CT for QDM vs. UNII in cCDA).

4. Problem #1 Solution Proposal Recommended Value Sets for subsequent iterations of consolidation: • Clarification in the future that only the use of RxNorm ingredients be used for drug ingredients and excipients. UNII ingredients only for non-drug substances. • Perhaps development of value sets for drugs vs. non-drug substances to eliminate any chance of ambiguity. Short-term solution for stage 2: • We’re not certain of any workarounds for this issue for the short-term. Process improvement recommendations: • Engaging expertise familiar with the major terminology vendor sources to help define the content of these value sets and their ability to support mappings to them in an unambiguous manner.

5. Problems Found In Allergies #2 • Consolidated CDA standards for allergies to medications are inclusive of too many NDFRT classes: • Fact: Most EHRs document allergy classes that span a very narrow subset of NDFRT classes: The industry uses one of the 5 major vendors supplying drug terminologies in the U.S. which collectively map to a very narrow subset of NDFRT. • Problem: The standard reference a dynamic value set (2.16.840.1.113883.3.88.12.80.18) which spans all NDFRT Chemical Structure, Physiologic Effect and Mechanism Of Action classes of which most do not map to any of the allergy classes that are found in EHRs today.

6. Problem #2 Solution Proposal Recommended Value Sets for subsequent iterations of consolidation: • adoption of a starter set of allergy NDFRT classes (an allergy classes value set) to what was recommended by NCPDP officially submitted on 5/24/2011 to the HITSC Vocabulary Task Force (attached) which was a result of an analysis of the most prevalent allergy classes used in the industry (38 in total). Short-term solution for stage 2: • Sending of null flavor allergy classes where there is no clear mapping to a correct NDFRT class. • White paper guidance • Brainstorming regarding what can be done now with nulls and new value sets and or other ideas to address these issues. Process improvement recommendations: • Specifically focus on allergy classes that have been validated as present in the 5 NLM sources (terminology vendors) as a start since it’s a much better representations of what gets documented for allergy classes today.

7. Problem Found In Standard For Medication Documentation • Consolidated CDA is too restrictive in value set definition for medications. • Fact: Patient medication lists in EHRs today are largely documented not only at the drug formulation level but also at more abstract levels that don’t involve strength and dose form. • Problem: Consolidated CDA references a dynamic value set that is only at formulation level.

8. Proposed Solution For Medications Documentation Value Set Recommended Value Sets for subsequent iterations of consolidation: • Expand the allowable types of RxNorm medications to extend beyond drug formulations to span commonly found types (routed medications with dose forms, routed medications , brand names, ingredients). Short-term solution for stage 2: • Use of null flavor • Creation of new, alternative value sets than can be recommended for use with nulls. • Whitepaper guidance. Process improvement recommendations: • Validation with EMR vendors on semantic types (see last slide).

9. Problems Found In CQM Value Sets For Medications • NQF CQMs reference RxNorm based value sets that are too restrictive for practical and accurate reporting (they’re at the drug formulation level). • Fact: • Most certified commercial EMRs use vendor drug data from one of the 5 NLM sources (FDB, Medispan, Multum, Gold Standard, Micromedex • The value sets referenced for quality measure are frequently specified to be more detailed than their intended practical definition. • Problem: • Value sets in CQM used for numerator criteria are at a drug formulation level (e.g., clinical drug). However, the intent of the value set is typically at a broader level such as a routed medication or therapeutic class level (no standard). Since patient medication can frequently be at more general levels than the drug formulation there is a issue with recognizing a valid drug in numerator reporting. • The same value sets are reused for the contraindication in a measure as for a numerator (indication) context. However, contraindications (typically allergies) are at a broader level than the clinical drug formulation in patient records. So patient reported contraindications would typically fail being recognized in QRDA reports because they’re not at that level.

10. Proposed Solution For CQM Value Sets Recommended Value Sets for subsequent iterations of consolidation: • Expand the RxNormtypes beyond drug formulations (clinical drugs) to include more abstract types such as routed medications with dose forms , brand names, ingredients or routed medications (all are supported in RxNorm). Short-term solution for stage 2: • Use of null flavors non-clinical drug higher level medications • Whitepaper guidance Process improvement recommendations: • Validation with EMR vendors on semantic types (see last slide). • There’s a need for a drug classification standard for therapeutic intent.

11. What are ways to deal with today’s issues for MU Stage 2? Generally the following solutions can be employed as discussed above (and perhaps there are more): • Null flavors • New value sets use with null flavor or should/may constraints • White paper • Brainstorming regarding what can be done now with nulls and new value sets and or other ideas to address these issues. • Interim final rule (last resort for real errors that have no solution). • Value sets changes in next version of MU.

12. Summary Of Semantic Types Use In Real World Settings The number of x’s reflects relative level of use for each context.

13. Appendix : Detailed discussion , examples and other issues