1. Proposal To Address Medications, Allergies And Laboratory 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

2. Purpose 1.Address key ambiguities 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.

3. Problems Found In Allergies #1 Consolidated CDA standards for allergies to medications are at the wrong term types in RxNorm: Fact: Most EHRs document allergies at the medication ingredient, medication class or brand name level but not at the SCD level. Problem: The standard does not state a “shall” for RxNorm ingredients level for medications. 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).

4. 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. 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

6. 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.

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 SCD and GPCK levels but at the corresponding SBD and BPCK levels. Additionally, during patient interview as well as in the inpatient setting meds are frequently documented at more general levels such as SCDF, SBDF and even BN or ingredients (but rarely at the SCDC level especially for multi ingredient drugs). Problem: Consolidated CDA references a dynamic value set that is only at the SCD and GPCK levels which make it very difficult (in many cases impossible) to translate med list entries that are at the more abstract levels (e.g., SCDF, SBDF, BN, ingredients) because of the one- to-many relationships seen in translating in that direction. Propose Solution Summary: Expand TTYs that can be use in the standard.

8. 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)

9. 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

10. Problems Found In CQM Value Sets For Medications NQF CQMs reference RxNorm based value sets that are too restrictive for practical and accurate reporting. Fact: 1.Most certified commerical 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: Reporting entities that know how to use the advanced services/features of their drug vendor products to identify patients that meet the intent of the quality measure but will be penalized for submitting QRDA reports that reference RXNORM codes that are not stated in the intentional value set definitions. Examples: Proprietary drug databases (NLM sanctioned sources) have enhanced drug classifications that can identify drug concepts intended for specific therapeutic uses and thereby potentially not only identify drugs missed in RxNorm based extensional value sets but also suppress reporting on patients that are on same ingredient drugs that do not meet the therapeutic intent (such as heparin flushes for anticoagulation therapy).

11. 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.

12. 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.

13. 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.

14. 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

15. 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.