Health data as reflected in a patient's Explanation of Benefits (EOB) statements, typically derived from claims and other administrative data.

Data Element
National Drug Code
Description

National Drug Code (NDC), or if the prescription is a compound, the value 'Compound'
Submitted By: Mark Roberts / Leavitt Partners
Data Element Information
Use Case Description(s)
Use Case Description Administrative and financial transactions are a critical part of health care provisioning and management. There is a need for health care consumers to get access this health data to be able to make better care decisions and manage their health care journey. Making Explanation of Benefit data available to consumers will enable them to have greater visibility into the costs associated with their health care, identify potential errors, and enable them to plan for their future health care needs taking financial costs into account.
Consumer-directed exchange occurs when a consumer or an authorized caregiver invokes their HIPAA Individual Right of Access (45 CFR 164.524) and requests their digital health information (adjudicated claims and encounter data) from a HIPAA covered entity (CE) – health insurance company or payers via an application or other third-party data steward.
Estimate the breadth of applicability of the use case(s) for this data element All health care insurers (>1,800), third-party application developers, and all consumers of the health care system (>320M)
Link to use case project page http://hl7.org/fhir/us/carin-bb/
Healthcare Aims
  • Improving patient experience of care (quality and/or satisfaction)
  • Reducing the cost of care
  • Improving provider experience of care
Maturity of Use and Technical Specifications for Data Element
Applicable Standard(s) NUBC, CPT, HCPCS, HIPPS, ICD-9, ICD-10, DRGs, NDC, POS, NCPDP codes, and X12 codes.
http://hl7.org/fhir/us/carin-bb/artifacts.html#5
Additional Specifications HL7® FHIR® US Core Implementation Guide v3.1.1 based on FHIR R4
Current Use Extensively used in production environments
Supporting Artifacts This was part of the CMS Patient Access and Interoperability Rules, which went into effect July 1, 2021. CMS has suggested that industry consider using the CARIN for Blue Button Implementation Guide for the Patient Access API.
https://www.cms.gov/about-cms/health-informatics-and-interoperability-group/faqs
Extent of exchange 5 or more. This data element has been tested at scale between multiple different production environments to support the majority of anticipated stakeholders.
Supporting Artifacts While it is not known how many consumers have requested this data electronically, this information is communicated broadly today through other forms. This data is now being required to be communicated electronically through the CMS Patient Access API for which the regulation has suggested that industry consider using the CARIN for Blue Button Implementation Guide for the Patient Access API, we expect this data will be exchanged broadly throughout the health care sector.
https://www.cms.gov/about-cms/health-informatics-and-interoperability-group/faqs
Potential Challenges
Restrictions on Standardization (e.g. proprietary code) Some codes, but not all, are linked to proprietary code standards that may require a license.

Restrictions on Use (e.g. licensing, user fees) Licensed Industry Standard Code Systems

This IG includes value set bindings to code systems that reference industry standard codes which require implementers to purchase a license before the coded concepts can be used. The following information summarizes the set of licensed Code Systems required by this IG and provides links to the information about where to go to obtain a license:

• AMA CPT: The CPT procedure and modifier codes are owned by the American Medical Association.
• X12: CARC (Claim Adjustment Reason Codes are owned by X12..
• NUBC: The NUBC secretariat is the American Hospital Association..
• NUCC: National Uniform Claim Committee (NUCC) is presently maintaining the Taxonomy code set. The codes are free and publically available for download and use. If the use however is “For commercial use, including sales or licensing, a license must be obtained”. It would be appropriate for an app developer to file the license form just like they would for any other code set; however, there is no fee.
• NCPDP: Retail Pharmacy data standards are defined by the NCPDP .
• 3M APR-DRG: AP-DRGs and APR-DRGs are owned by 3M. Use of AP-DRGs and APR-DRGs require a license.

Code Systems Not Requiring Licenses

This IG includes value set bindings to code systems that are industry standard codes available for use without licenses. The following information summarizes the set of Code Systems required by this IG that are available for use:

• ICD-CM Diagnosis Codes (ICD-10-CM): International Statistical Classification of Diseases and Related Health Problems (ICD). This IG will use version 10. The ICD-10-CM code set is maintained by the National Center for Health Statistics (NCHS) of the Centers for Disease Control and Prevention (CDC) for use in the United States. It is based on ICD-10, which was developed by the World Health Organization (WHO) and is used internationally a medical classification.
• ICD-Procedure Codes (ICD-PCS): The ICD-10-PCS code set is owned by CMS..
• DRGs.:MS-DRGs are owned by CMS. MS-DRGs are used for the Medicare population.
• HCPCS Level II Procedure and Modifier Codes: Primarily include non-physician products, supplies, and procedures not included in CPT. They are owned by CMS and are available for use.
• NDC (National Drug Codes): The US Federal Drug Administration (FDA) Data Standards Council assigns the first 5 digits of the 11 digit code..
• RARCCodes: The RARC codes are owned by CMS.
Privacy and Security Concerns This data, like any patient data should be exchanged securely. Current processes exist, governed by CMS and ONC, to securely transfer this data.
Estimate of Overall Burden The data elements in this class are already held by health care payers, anticipated burden of collection of data would be negligible. The CMS rule and Patient Access API already require CMS covered payers to share this data electronically. Many payers covered by the CMS rule have or are already considering making this data available in the same fashion for other lines of business.
ONC Evaluation Details
Each submitted Data Element has been evaluated based on the following criteria. The overall Level classification is a composite of the maturity based on these individual criteria. This information can be used to identify areas that require additional work to raise the overall classification level and consideration for inclusion in future versions of USCDI
Criterion #1
Maturity - Current Standards		 Level 2 - Data element is represented by a terminology standard or SDO-balloted technical specification or implementation guide.
Criterion #2
Maturity - Current Use 		Level 2 - Data element is captured, stored, or accessed in multiple production EHRs or other HIT modules from more than one developer.
Criterion #3
Maturity - Current Exchange		 Level 2 - Data element is electronically exchanged between more than two production EHRs or other HIT modules of different developers using available interoperability standards.
Criterion #4
Use Case(s) - Breadth of Applicability		 Level 0 - Use cases apply to a limited number of care settings or specialties, or data element represents a specialization of other, more general data elements.

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