Allergies and Intolerances

CMS-CCSQ Sup. Criticality & Food Allergy Intolerance for USCDIv6

Data Elements: Criticality (Level 2) and Food Allergy Intolerance (Level 0)

1. Recommendation: Add the Criticality data element to Final USCDI v6. We further recommend that the Food Allergy Intolerance data element be advanced to Level 2 and included in the Final USCDI v6.
2. Rationale: The Food Allergy Intolerance data element is an essential data element which health care organizations need to record to provide safe provisions to patients over the course of rendered care. Furthermore, we also recommend adding the Criticality data element for observed allergy as an intolerance. The inclusion of Food Allergy Intolerance in USCDI v6 as a data standard for EHRs is supported by compelling evidence highlighting the prevalence, impact, and management challenges associated with food allergies. This integration is essential for improving patient safety, enhancing care coordination, and promoting better health outcomes. Firstly, the prevalence of food allergies is significant and increasing. In a systematic review and meta-analysis, (Clarke et al., 2020) found that food allergies affect approximately 6-8% of children in the United States. In addition, food allergies affect families and communities beyond the individual. Families with children suffering from food allergies report significant out-of-pocket expenses, averaging around $3,339 (USD) annually, which includes specialty foods and emergency response expenses. To reduce unnecessary costs and facilitate appropriate management, healthcare providers need accurate and accessible information about patients' food allergies. In addition, food allergies can lead to life-threatening anaphylactic reactions. According to a systematic review (Umasunthar et al., 2013), fatal food anaphylaxis is particularly common among children, with a reported incidence of 1.81 per million. To prevent adverse events, healthcare providers need to know about patients' food allergies. By integrating food allergy data into EHRs, healthcare professionals will be able to quickly access this information, ensuring appropriate precautions are taken during treatment and emergency situations. In addition, food allergies have a profound psychosocial impact. Children with food allergies and their caregivers can suffer from increased anxiety and reduced quality of life (Protudjer et al., 2021; Gupta et al., 2010). Documenting and sharing food allergy information in EHRs can help healthcare providers, patients, and families communicate better, leading to better management strategies and support. Food allergies also require significant educational needs. A lack of knowledge about food allergies can lead to mismanagement and increased allergy risk (Gupta et al., 2010). By standardizing food allergy information in EHRs, healthcare providers can ensure patients and their families receive consistent and accurate education about managing food allergies, including recognizing symptoms and understanding emergency protocols. The evidence strongly supports USCDI v6 including Food Allergy Intolerance as a data standard. The high prevalence of food allergies, the potential for severe reactions, the financial and psychosocial burdens on families, and the need for improved education all highlight the necessity of having comprehensive and accessible food allergy data in electronic health records. This integration would not only enhance patient safety but also improve the overall quality of care provided to individuals with food allergies. 

Non-medication Allergies

Will this data element include allergies to materials (e.g., metals)?  This should be included as well and if not already included in this scope we will need to submit a new submission.

Adverse Events as its own Data Class

We support the decoupling of Adverse Events (AE) from Allergies and Intolerances (A/I) as they are differentiated by context and temporal dimensions of clinical care.  Also, the inclusion of FDA regulated medical products will ensure that we address the entire scope of products - including medical devices in order to address the differences from these two classes (i.e., AE and A/I).  There is a case to include real world evidence and can only do so if these concepts are enabled through interoperability (i.e., USCDI).

Adverse Events / Allergies and Intolerances

Thanks for adding adverse events data elements. 

Please add a dedicated adverse events data class for FDA-regulated medical products.

An allergy is not always an adverse event.  We suggest having 2 classes:

1) Allergies/Intolerances

2) Adverse Events to FDA regulated medical products

Allergies and Intolerances - Drug Classes & Non-Drug Substances

Drug Classes. Although MED-RT was introduced in recent years (when it superseded NDF-RT), there may be some advantages for its use over SNOMED CT for representing allergies and intolerances to drug classes. First, SNOMED CT combines both drugs and drug classes within the same hierarchy and does not provide a way to easily differentiate between medication concepts and drug class concepts. MED-RT, on the other hand, has classes under the “Preparations by FDA Established Pharmacologic Class” (N0000189939) hierarchy and also has relationships to medication concepts in RxNorm which provides a clean separation between medication and drug class data elements. Second, while SNOMED CT is very comprehensive, it results in more clutter than MED-RT in that there are more concepts that are less clinically useful for the documentation of allergies and intolerances. For example, ancestors of interferon alfa (SNOMED CT 45754009) include Interferon (parent) and Immune enhancement agent (grandparent) which are less clinically useful because they are not drug classes but rather super-groupers that lack the specificity needed for the representation of allergies and intolerances. The MED-RT hierarchy, although not perfect, is less deeply nested with these kinds of super-groupers that can confound decision-making in patients who have these broad and vague allergies and intolerances in their medical records. Admittedly both SNOMED CT and MED-RT have their pros and cons. SNOMED CT is broader and more comprehensive, while MED-RT may be a more focused solution for this use case. It may be interesting to see how MED-RT evolves and whether other community members find it to be potentially useful for representing drug classes.

Non-Drug Substances. The ISA section for Allergies and Intolerances include recommendations to use SNOMED CT for the representation of food substances and environmental substances with adoption levels that are similar to or approaching that of the recommendation for the use of RxNorm for representing medications. Are we ready to add "Substance (Food)" and "Substance (Environmental)" as data elements to USCDI? I realize that there is a separate ONDEC submission process for new data elements. This is more of a general discussion to gauge readiness from implementers (I work for a health IT vendor).

Overall comments on allergies

Environmental and food allergies are tied to care. Each can inform potential medication allergies, and hospital precautions. For example, a walnut allergy can be indicative of latex allergies, and environmental allergies that bring on asthma can have serious and significant impacts in patient placement in the hospital and in treatment decisions. 

Food and environmental allergies are the original social determinant of health, as they are immediate and significant impacts on health. Additionally as patients gain access to records for self-management in apps, environmental and food allergies seem to be a logical area for app development and access needs. 

Please consider moving these to USCDI V2

Option to Tie Adverse Events to FDA-Regulated Medical Products

eHealth Exchange, the nation’s largest health information exchange network, agrees USCDI v2 should provide the option to tie Adverse Events to FDA regulated medical products when applicable.  Vendors should support an interoperable approach, though not necessarily require providers to use it.

To improve health of populatons, providers need the option to populate/derive the AdverseEvent resource based on data for already diagnosed/recognized in other resources (such as diagnoses or reactions noted in Condition or AllergyIntolerance, along with other supporting evidence for particular product exposures in MedAdmin, MedStatement, Procedure, or Immunization).