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

2. Purpose 1.Address key inconsistencies found in review of the Final rules for Stage 2 meaningful use and the referenced HL7 consolidated CDA standard. 2.Recommend a practical, low effort, late breaking solution to mitigate potential problems in CQM reporting. 3.Provide assistance if needed to help quickly resolve the prioritized ambiguities. 2

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. 1.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. 2.There is ambiguity in QDM vs. cCDA for non-drug allergies standards (SNOMED CT for QDM vs. UNII in cCDA). 3

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. 4

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. 5

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. 6

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. 7

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). 8

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: 1.Most certified commercial EMRs use vendor drug data from one of the 5 NLM sources (FDB, Medispan, Multum, Gold Standard, Micromedex 2.The value sets referenced for quality measure are frequently specified to be more detailed than their intended practical definition. Problem: 1.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. 2.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. 9

10. Proposed Solution For CQM Value Sets Recommended Value Sets for subsequent iterations of consolidation: Expand the RxNorm types 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. 10

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. 11

12. Summary Of Semantic Types Use In Real World Settings Use ContextsMedications Semantic TypesReasoning Med formulations level: SCD,SBD,GPC K,BPCK Routed Medication abstract level: SCDF, SBDF Ingredients level: IN,MIN,PIN Medication functional classifications: NDFRT Mechnism Of Action, Structural, Pharmacologic Effects Medication therapeutic classifications: (Not part of standards today) “Allergies”/intolerance s reporting/documentati on/decision support xxx xxx (really needs a valueset since not all classes are applicable in each axis) Generally documented at that higher level and not at the formulation level. Medlist documentationxxx Generally documented at the routed drug + dosing or the formulation level in EMRs. The latter commonly done during patient interview of med history. Medication orderingxxxxx Mostly at the formulation level for outpatient setting but in inpatient, commonly ordered as a routed medication with dose information as well, e.g., “captopril oral” + 50mg TID vs. “captopril 25mg oral tab” + 2 tabs TID. Quality measures inclusion criteria (indications) xxxx xxGenerally not drug strength specific but sometimes can be. Quality measures exclusion (contraindications) xxxx xGenerally similar to allergies and intolerances and rarely at the drug formulation level. The number of x’s reflects relative level of use for each context. 12

13. Appendix : Detailed discussion, examples and other issues 13

14. Examples Of Problems Found In Allergies Observed usage patterns for the documentation of medication allergens typically span therapeutically active ingredients (e.g., amoxicillin, codeine), brand names (e.g., LIPITOR, PERCOCET) and allergen groups (e.g., “Penicillins”)… named CDA Release 2.0 constraints for allergy observations are inconsistent with observed usage patterns… specifically: Table 117 references “Medication Brand Name” examples that are specific to the Semantic Brand Drug (TTY = SBD)… the “Brand Name” TTY would be more appropriate Table 118 references “Medication Clinical Drug” with examples specific to the Semantic Clinical Drug (TTY = SCD)… it is unusual to have allergens reported at this level. More commonly, “ingredient” (TTY = IN or PIN) would be observed for therapeutically active ingredient allergens Table 119 references “Medication Drug Class” examples that reference NDF-RT, this is correct, but would suggest that the RxNorm RXCUI for the “integrated” NDF-RT external code into RxNorm would be the constraint used Table 120 references “Ingredient Name Value Set” examples for FDA UNII; this is confusing… the more practical use would be RxNorm IN/PIN for therapeutically active ingredients and FDA UNII for “excipient” or “inactive” ingredients, using the RxNorm RXCUI for the “integrated” FDA UNII external code within RxNorm 14

15. Proposed Solution For Allergies For Problem #1 we propose inclusion of a dynamic value set for RxNorm ingredients in consolidated CDA to be added for medication allergies (TTY of IN, PIN and MIN). For Problem #2 we propose 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). This can be expanded over time. 15

16. Example Of Medication Documentation Standard Problem Frequently in the inpatient setting orders are specified at a broader level than what we see with prescriptions (outpatient setting): Inpatient OrderOutpatient Prescription Order Digoxin.375mg po dailyDigoxin.125mg tablet QTY: 90 Sig: 3 tablets po qd Zocor 30mg po qdZocor 10mg tablet QTY:90 Sig: 3 tablets po qd Broader RxNorm types: BN, ingredients More specific RxNorm types: SCD, SBD (note strenghts vs. dose in mg) 16

17. Proposed Solution For Medications Value Sets Expand the RxNorm TTYs for the dynamic value set to include SCDF, SCD, GPCK, SBDF, SBD, BPCK, BN, SCDG and SBDG. Can also include IN but generally that adds more noise than value. For the “shall” constraint for coded product name (generics) : SCDF, SCD, GPCK, SCDG,IN, PIN, MIN For the “may” constraint for brands: BN, BPCK, SBD, SBDF, SBDG 17

18. Proposed Solution For Medications Value Sets The Consolidated CDA use of dynamic value sets will certainly help but the problem still remains for reporting entities that wish to leverage enhanced attributes to identify drugs that meet the value set intent. Proposed solution is one of flexibility rather than major revision: 1.Publish additionally “in plain English” a intentional definition of the value set (e.g., anticoagulants including LMWH, heparins, oral aspirin excluding heparin flushes). The extensional value set can be used by reporters either as is or as a representative example of drugs to be used. 2.Allow the option to either use the specified value sets or alternatively report using RxNorm TTYs in (SCDF, SBDF, SCD, SBD, GPCK, BPCK). 3.Regardless of whether the reporter uses the referenced extensional value set or the broader RxNorm value set (#2) they would still need to submit the QRDA reports. 18

19. Justification For Proposed Medications Value Set Solution 1.We’re giving the reporting entities the option of doing more sophisticated /accurate reporting (because the vendor databases have more precise attributes for tuning to get back the right drugs that meet the intent of the value set stated in “English”). They’re not being penalized for discovering drugs that meet intent but were missed by the value set. 2.We’re still allowing the current NQF value sets to be used as per the original rule design for those reporting entities that just want to use the provided extensional value set because it’s easier for them. 3.CMS would now be able to easily analyze the QRDAs that were submitted but had new RxNorm concepts that were not in the original value sets to see what should be added vs. what was inappropriately reported during this field test period of MU 2. These reports can help identify what term types would be more appropriate for intentional definitions as well as what extensional value set gaps existed based on what was submitted vs. what was submitted that does not meet the intent. These statistics can be posted as evidence/guidance for adding more constraints but based on real world observations during that period. 4.Intentional value sets can then be stated citing observed evidence / statistics from #3 with more confidence to reporting entities. 19

20. Routes Problem HL7 CDA constraints reference FDA Medication Routes 2.16.840.1.113883.3.88.12.3221.8.7 Draft eMeasures referenced Snomed CT clinical routes Problem – expressed eMeasures and eMeasure value set inconsistent with HL7 constraint Problem – Drug Knowledge Base providers and 2014 CEHRT developers do not have clear direction on which route of administration code set to use within clinical information exchange and CQM applications Recommended Solution – eMeasure value sets should be constrained to FDA Routes 20

21. Future Lab orders and scope issue Comments for "Test Data for 170.314(e)(2)" document ONC definition of the Common MU Data set item (11) requires LOINC (170.207(c)(2)) for laboratory test results. It is our understanding that there is no requirement for lab orders to be coded in LOINC. In the Care Plan section (item L.b.ii, page 5 in the Test Data document), lab tests scheduled for the future would not need to be coded in LOINC since they are "orders" (have not been performed yet). Also, the code mentioned in the test data (30313-1) is to be used for a laboratory result of hemoglobin not for an order. 21