COVID-19 Novel Coronavirus Pandemic

NCPDP Comments

1. NCPDP recommends adding reference to the NCPDP Emergency Preparedness Guidance document under the first bullet point in “Limitations, Dependencies, and Preconditions for Consideration”.
   1. NCPDP Emergency Preparedness Guidance document – NCPDP created guidance in response to the COVID-19 pandemic. This document provides guidance to the pharmacy industry for resources available during the pandemic. The intended audience is healthcare providers who would need resource information for assisting patients in accessing products and services provided by pharmacies during the pandemic. This information can be found in section 10 of the document and will be updated as new information is available.
   2. For details, refer to the NCPDP EMERGENCY PREPAREDNESS GUIDANCE document on the Resources page of the NCPDP website.

Adoption Level for HL7 2.5.1 IG

We believe the adoption level for the HL7 2.5.1 Implementation Guide for Immunization Messaging, Release 1.5 to be at a 5 for high or widespread adoption, given there are over 120,000 active HL7 interfaces exchanging immunization data using this standard (CDC 2020 IIS Annual Report). 

IG on Vocabulary Page

Given this page is focused on vocabulary, we recommend removing the HL7 IG 2.5.1 reference. If it stays, however, we believe it should reference the same HL7 IG 2.5.1 guide referenced on the ISA content page: www.healthit.gov/isa/exchanging-immunization-data-immunization-registries. 

Inclusion of IGs in the vocabulary list

It seems odd to include IG references in the list of vocabulary resources. After discussion with the HL7 Public Health Work Group, we recommend moving the IG references to the Content/Structure section (not that the immunization IG is already in that section).

SANER FHIR IG is an interoperability specification

We're not sure why the SANER FHIR IG is listed under terminology.  It's not a terminology IG but makes use of other terminology sets.  I would likely be better to be placed under Services/Exchange under Public Health.

WA State Department of Health SANER Comments

Washington State Department of Health fully supports the listing of the emerging standard Situational Awareness for Novel Epidemic Response (SANER). It is vital to ensuring public health and others can effectively monitor supplies, patient capacity and counts of patient’s being cared for during an outbreak or pandemic.

ACLA request to update content

Please revise both hyperlinks for Logica (https://covid-19-ig.logicahealth.org/index.html) to reference the official HL7 Logica webpage: http://hl7.org/standards/hsp-marketplace/index.html. The current ISA LOGICA hyperlink is to a non-HL7 website; HL7 projects must be hosted on an HL7 website per HL7 policy.

• Justification statement: We believe HL7 will maintain their website supporting HL7 standards perpetually so an HL7.org hyperlink is preferable.

  The SANER specification was published by HL7. Please update the hyperlink to the published version at: HL7 FHIR® Implementation Guide: Situational Awareness for Novel Epidemic Response (SANER) STU 1: http://hl7.org/fhir/uv/saner/STU1/ The current hyperlink is to HL7 FHIR’s ‘build’ environment which is preparatory to balloting and publication. (build.fhir.org/ig/HL7/fhir-saner/)

• Justification statement: We believe HL7 will maintain their website supporting HL7 standards perpetually so an HL7.org hyperlink is preferable.

  Please remove the June 4, 2020 date from the following reference: it has been updated twice since original publication: CARES Act Section 18115 require laboratories to report results of SARS-CoV2 or COVID-19 testing to the Secretary of HHS in the form and manner outlined in this memo "COVID-19 Pandemic Response, Laboratory Data Reporting: CARES Act Section 18115 June 4, 2020"    

WA State Department of Health SANER Comments

Washington State Department of Health fully supports the listing of the emerging standard Situational Awareness for Novel Epidemic Response (SANER). It is vital to ensuring public health and others can effectively monitor supplies, patient capacity and counts of patient’s being cared for during an outbreak or pandemic.

NCPDP Comments

1. Request ONC to add NDC as a value where NDC is used.
2. Add the following:

Type-Standard Standard Implementation/Specification- National Drug Code (NDC) Standards Process Maturity – Final Implementation Maturity- Production Adoption Level – 5 Federally Required – Yes Cost – $ Test Tool Availability – N/A

3. NCPDP Emergency Preparedness Guidance document - Declared emergencies, such as weather-related events (e.g., hurricanes, fires, floods, etc.), natural disasters (e.g., earthquakes) or pandemics (e.g., H1N1, COVID-19), have led NCPDP to create this document. This document provides guidance to the pharmacy industry for resources available during a declared emergency. The intended audience is healthcare providers who would need resource information for assisting patients in accessing their products and services provided by pharmacies during declared emergencies. This document will be updated as new information is available.

  Additionally, this document addresses certain emergency preparedness processes and procedures that could be established as daily occurrences to be invoked at a moment’s notice, mitigating urgent training for emergency situations. For example:

1. 1. 1. 1. Payers/pharmacy benefit managers should have declared emergency criteria established within standard plan benefit templates.
         2. Pharmacy systems should support declared emergency plan billing rules and claim routing information as part of their normal procedures.
         3. Enrollment files and product history are routinely updated and should be accessible during a declared emergency.

  For details, refer to the NCPDP EMERGENCY PREPAREDNESS GUIDANCE document on the Resources page of the NCPDP website.

Opportunity to Better Highlight the Specialty Care and Settings

HIMSS appreciates the addition of the new “Specialty Care and Settings” section of ISA, which includes information about COVID-19 needs.  However, it may be beneficial to find other approaches to highlight this section as an opportunity to help address the pandemic.  For example, when you click on the ISA Content tab, it does not include this new section.  We ask ONC to create a new tab for the “Interoperability for COVID-19 Novel Coronavirus Pandemic” Section that makes it more visible to ISA users.  Given the importance of federal guidance to respond to the pandemic, it seems like a missed opportunity to not highlight critical public health interoperability needs on COVID-19 in an easily accessible way.  As an initial step, ONC should also include an overview of this section and link on the main ISA webpage to enhance its overall visibility.  We also ask that ONC consider “Telehealth/Remote Patient Monitoring” an additional specialty care/setting for inclusion in this section.  There is a growing need to consider data exchange for home settings and considerations around device interoperability.  There are a number of applications in use and this setting requires work across a number of systems (emergency medical services, hospital electronic health records, telemedicine system (synchronous and asynchronous) and, remote patient monitoring and device management).  ISA should provide guidance on specific standards to assist in exchange with this setting.  In addition, HIMSS asks ONC to describe what the process is to determine inclusion in the Specialty Care and Setting section, including certain criteria that must be met.  A better overview of this section and how additional inclusions are determined would be beneficial and further highlight the information included there.