Comment

Medication route

C-CDA specifies medication routes from NCIT/FDA, with an SCT translation; FHIR US Core leaves route unspecified. I recommend including medication route in ISA to support coordination. I recommend avoiding terms that precoordinate other dimensions (IV bolus, IV drip), or, if they are to be included, clarifying the scope and use of the value set.  

NCPDP Comments

While RxNorm is useful for communication of clinical data for clinical care, the NDC is critical for specific product identification in research, dispensing and administrative workflows. The NDC is the key, unique, product identifier and is the standard of practice used throughout the pharmacy industry to identify the specific product. The industry heavily relies on the NDC in all aspects of its business, including, but not limited to, drug ordering, medication dispensing, reporting, billing, rebates, adverse event reporting and patient safety. RxNorm lacks the specificity required to uniquely identify a product.

Preserving Clinical Context

General Comments: USCDI specifies lots of clinical data classes and data elements

  • Resolving to myriad de-coupled fragments
  • With vanishingly little focus on:
    • Clinical context and vital inter-relationships, e.g., between problems, diagnoses, complaints, symptoms, encounters, history and physical findings, allergies, medications, vaccinations, assessments, goals/objectives, clinical decisions, orders, results, diagnostic procedures, interventions, observations, treatments/therapies, referrals, consults, protocols, care plans and status...
    • Elements and context + purpose of capture:  e.g., blood pressure, its measurement (systolic, diastolic), its unit of measure (mm/Hg), its reason for capture, its context of capture (sampling site, sampling method, patient position, at rest/during/post exercise...

It is crucial to consider, determine and resolve how clinical content and context are bound together and preserved in USCDI.  The ultimate end user (often a clinician) must be able to readily discern context and inter-relationships – otherwise USCDI places an undue (and often unresolvable) burden on this user.  Only the source EHR/HIT system can structure clinical content and context properly.  Once data is stuffed into the USCDI framework and related exchange artifact (e.g., FHIR resources) this opportunity is forever lost.

NCPDP Comment

  1. Please remove previous NCPDP comments from 2017, as they no longer apply.
  2. NDC Adoption level is 5 since it is mandated by HIPAA.

Compounded products will not…

Compounded products will not have an NDC code. Herbal products do... good point.

RxNorm is a good choice…

RxNorm is a good choice. Hadn't realized that NDC was federally required. Ideally there would not be a choice of sending either RxNorm OR NDC because that would break interoperability. If both are sent that would be OK.

UOM and VSAC

Medications category should include code system for unit of measure to be complete (UCUM).  A defined and limited value set of medication units of measure should be identified and available in VSAC

NCPDP - Comments - Not applicable to 2018 edition

The National Drug Code (NDC) should have an Adoption Level of 5 and Federally Required should be a Yes. It is mandated under HIPAA.

SNOMED is not currently used. NCPDP Standards would need to be modified to support SNOMED.

Medication Reference Terminology (MED-RT) is not currently used.  NCPDP Standards would need to be modified to support MED-RT.

NDC Federally Required and Adoption level

Thank you for your comments.  We acknowledge the federal requirement to include NDC on CMS 1500 claim form.  With respect to adoption level, we would appreciate  your comments on level of adoption and use of NDC within existing health IT systems.