Overview

CMS is working in collaboration with the DHHS Office of the National Coordinator for Health IT (ONC) to develop an electronic template that will assist providers with data collection during the Lower Limb Prosthetic (LLP) Face-to-Face Examination. This template may also facilitate the electronic submission of medical documentation.

CMS has developed data elements that they believe would be useful in supporting the documentation requirements for coverage of LLP. Once finalized these proposed data elements will be delivered to ONC for consideration and/or inclusion in ONC's development process. This list of data elements in NOT intended to be a final data entry form (see CMS website for the complete list).

• Define progress notes for the Face-to-Face evaluation for a LLP
• Define orders for LLP
• Define required and supporting LCMP documentation
• Define required and supporting LLP Supplier documentation
• Specification of LLP equipment

Objectives

The pilots are designed to validate multiple methods of implementing eClinical Templates in production environments to enable the responsible providers, consulting providers, and service/equipment suppliers to create, share, and provide medical documentation to CMS for the determination of coverage (prior authorization, pre-payment review, and post-payment audit). The pilots will test, in limited production, the ability to:

• Effectively interact with the responsible providers
• Guide the collection of information for the specific use case (LLP in this case)
• Incorporate information from Licensed/Certified Medical Professionals (LCMPs) and LLPs
• Submit documentation via HIHs to CMS esMD Phase 1 gateway for CMS contractor review
  • Note: use of esMD Phase 1 is the preferred method of submission; however, other methods such as contractor portals, faxes, and paper submission will be considered

Pilot Streams

The eClinical Template Pilot Program will focus on three distinct "streams" intended to explore multiple methods of provider interaction, time to market, and incorporation of documentation into the medical record in the EHR. These streams are defined below, along with specific requirements for each:

Stream 1 – EHR Native eClinical Template

1. Test the ability to incorporate eClinical Templates into EHR technology using the vendor’s native template capability and store the resulting data in the EHR database.
2. Validate ability to generate eClinical Template medical documentation as PDF files to:
   • Send to LLP supplier
   • Submit via HIH using esMD Phase 1.

Participants:

1. EHR Vendor(s)
2. HIH(s)
3. Provider(s)
4. LLP Supplier(s)

Stream 2 – Structured Data Capture (SDC) eClinical Template

1. Test the ability to utilize SDC eClinical Templates in EHR technology to prepopulate the template with EHR data, capture missing information, and store new information in the EHR (or incorporate a PDF created from the SDC eClinical Template).
2. Validate ability to create the SDC eClinical Template medical documentation as PDF files to:
   • Send to LLP supplier
   • Submit via HIH using esMD Phase 1

Participants:

1. SDC eClinical Template Repository (link to)
2. EHR vendor(s)
3. HIH(s)
4. Provider(s)
5. LLP Supplier(s)

Stream 3 – Web based portal eClinical Template

1. Test the ability to a Web based portal eClinical Template to capture required and optional information, create a PDF representation and incorporate the resulting PDF result of the eClinical Template in the EHR.
2. Validate ability to:
   • Exchange the PDF between the Provider, LCMP and LLP supplier
   • Submit via HIH using esMD Phase 1

Pilot Participants:

1. eClinical Template Web Portal vendor/service
2. HIH(s)
3. Provider(s)
4. LLP supplier(s)

Participating LLP Pilot Organizations:

Reference Material