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 4th, 2012
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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.
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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).
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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 shortterm.
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.
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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.
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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.
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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.
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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).
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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.
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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.
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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.
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Summary Of Semantic Types Use In Real World Settings
Use Contexts
Medications Semantic Types
Med
Routed
Ingredients
formulations Medication
level:
level:
abstract IN,MIN,PIN
SCD,SBD,GPC
level:
K,BPCK
SCDF, SBDF
“Allergies”/intolerance
s
reporting/documentati
on/decision support
xxx
xxx
Medication functional
classifications: NDFRT
Mechnism Of Action,
Structural, Pharmacologic
Effects
Reasoning
Medication therapeutic
classifications: (Not part of
standards today)
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 documentation
xxx
xxx
Generally documented at
the routed drug + dosing or
the formulation level in
EMRs. The latter commonly
done during patient
interview of med history.
Medication ordering
xxx
xx
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)
x
xxx
Quality measures
exclusion
(contraindications)
x
xx
Generally not drug strength
specific but sometimes can
be.
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xxx
xxx
xxx
The number of x’s reflects relative level of use for each context.
x
Generally similar to allergies
and intolerances and rarely
at the drug formulation
level.
Appendix : Detailed discussion , examples and
other issues
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