CQM Value Set Challenges in MeaningfulUse Stage2

I cannot take credit for finding this issue.  One of the teams I work with discovered this particular challenge in working with the value sets for clinical quality measures.

It seems that several value sets in the Clinical Quality Measures have been used to identify appropriate medications for treatment, but have also been reused to identify patient allergies.

What is worry-some about this is how it impacts reporting.  Think this through:

• A  patient has been seen by a provider in the last year.  That makes them part of an initial population for a measure.
• They've been diagnosed with a particular disease.  That would make them appear in the denominator.  
• If they've been given a particular medication formulation, they also fall into the numerator.
• The measure makes allowances for patients who are allergic to the treatment regimen.  But in the implementation, the measure exclusion or exception criteria REUSES the medication value set as a value set describing a medication allergy.

This is where the problem shows up, and it has two consequences.

1. In the EHR, the substance that the patient is allergic to is recorded, not a specific medication formulation.  
2. In reporting exceptions / exclusions, the EHR would report the substance, but this wouldn't match what the conformance tools check for, so the EHR would need to implement a work-around.

Formulation vs. Allergen

You cannot go from medication formulations to allergens and still preserve the meaning of the value set.  Unfortunately, the value set for treatment only lists drug formulations.  It doesn't explain which ingredients are relevant for treatment in the quality measure.  

While it is quite possible to go from formulations to active ingredients in RxNORM, and also possible to match medication allergens encoded in RxNORM to drugs that contain that active ingredient, it doesn't help.  All that does is identify one or medications in the treatment value set as being one the patient shouldn't be given.  It doesn't necessarily tell you whether there are other acceptable alternatives, nor whether there is an intention to provide an exception or exclusion if those alternatives are available.

Some formulations have two (or more) active ingredients, one of which could be the reason it is included in a value set for treatment of a particular condition, yet the patient could be allergic to another of the ingredients.  So, you'd avoid that formulation for treatment, but it wouldn't excuse the provider from finding another formulation that did contain the necessary ingredient for treatment, but didn't contain the allergen.

In other cases, related drugs are similar enough that if a patient is intolerant of one, it is sufficient to rule out others (e.g., an allergy to penicillin might also rule out amoxicillin). 

Work-Arounds

There is a work-around, but it isn't pretty.  As I mentioned above, you can determine that a patient has an allergy to an active ingredient in a medication using RxNORM.  So if the treatment value set includes medications A and B, where A contains X, and B contains X + Y, you can make a list of ingredients: X, Y.  Then any patient who is allergic to X or Y can be identified as being allergic to at least one of the medications in the treatment value set.  You can even select an appropriate "proxy" medication, by ensuring that the medication you report an allergy to includes the ingredient that the patient is allergic to.  So if you have two patients, P1 allergic to X, you might report medication A, and P2 allergic to Y, you might report medication B, as being the best proxies for these allergies.

The failure here is that a provider should possibly have considered medication A for the patient, as that might have been an effective treatment.  While it's not possible to figure out what the allergen value sets must be via an algorithm, it is very easy to generate all possible solutions and have someone choose (using clinical judgement) which solution is appropriate in each of the affected cases.

What should be done?

I'm told that most of the data necessary to correct this issue is both readily available, and has been offered to the PTB (powers that be) to resolve this issue.  The challenge is that these value sets are based on measures which have been vetted by measure authorizing bodies (like NQF and Joint Commission), and changing the value sets (perhaps) changes the meanings of the measures (but not the intent).  So, while most technical folks would think (like I do), that the easy answer is to publish the correct value sets, there are some challenges to that solution that impact provenance of the measures.

I've heard a couple of solutions offered to resolve the issue.

1. Address the issue, publish a work-around (in detail), and provide folks with enough time and/or freedom to implement measures appropriately.  "Freedom" here might include loosening some of the validation criteria for conformance tests, so that the measures could be implemented using correct data.
2. Put a push on to fix the value sets in time for Stage 2 implementation.  This is the technically easy, but organizationally difficult solution.

Of course, I'd prefer to do it right the first time, so #2 is my preferred solution.  I've been on the other end of an ONC hurry-up to finish things.  I know it sucks to be on that end of things, and that it's also risky.  But is it better to fix it now, or spend a year gathering quality measure data that won't be comparable to anything else when we finally do fix the problem?

Either way it gets resolved, my hope is that it is fixed and the PTB let us know what the plans are to get a permanent fix together.

 -- Keith

P.S.  This isn't the only problem with value sets, just the most critical one to be solved.

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Update: December 2, 2012

Apparently, fixes are in the works.  This communication showed up in my inbox over the weekend.

CMS and ONC are working to release a public-facing tool to allow reporting and tracking of potential issues or bugs identified during the implementation process for the 2014 eCQMs released in October 2012. We encourage you to report these to the EHR Incentive Program Information Center at 1-888-734-6433 or email HIT_Quality_Measurement@cms.hhs.gov

Thank you to those who have reported issues to this point; CMS, ONC and NLM are working to resolve and will contact the reporter when a solution is agreed upon.

An update to the Value Set Authority Center (https://vsac.nlm.nih.gov) at NLM is anticipated in the near future which will include removal of the label “provisional” from value sets and codes that have been added to their respective terminologies since the measure release as well as correction of value sets related to medications and allergies. Please look to further communications from CMS, ONC, and NLM as to when this update will be released.