PIL02b2 – Publishing and Maintaining Externally Developed Implementation Guides

Background

X12 publishes implementation guides that define consistent use of one or more of X12’s transactions for a specific business purpose. At times, other organizations that represent the interests of specific industries and sub-industries need implementation guides that support their specific business activities and carry the weight and authority of X12's moniker.

Using X12’s primary development process as outlined in the ASC Standards Development Manual (ASC02) is the preferred method for developing implementation guides. However, in some cases, extenuating circumstances preclude the use of the ASC02 process. Examples include, but are not limited to, X12 not having member representatives who are subject matter experts on the specific business activity or X12 groups having a workload that does not support the timely development of the implementation guide. In these situations, having an established consensus-based process that supports X12 review of implementation guides developed outside of the Accredited Standards Committee is beneficial.

The ASC conducted a pilot of this new process in 2020 and is conducting this second pilot in 2021 to expand the conditions assessed under the pilot.

Proof of Concept

To further prove the concepts and processes of this pilot, external subject matter experts and X12 staff will cooperatively draft an implementation guide that supports the Good Faith Estimate requirements of the Price Transparency rule contained in the Consolidated Appropriations Act, 2021.

Publication of an implementation guide standardizing the data content and related requirements of these Good Faith Estimates per the Consolidated Appropriations Act, 2021 will ensure consistent, effective, and interoperable exchanges within the health care industry. The health care industry needs an accurate and efficient implementation guide based on X12’s well-established infrastructure published quickly as the requirements go into effect 1/1/2022.

X12’s technical report library does not currently include any implementation guides related to the submission of a Good Faith Estimate. Within X12, products that support the health care industry are generally the responsibility of X12N. X12N does not have a task group or work group with specific responsibility for work products related to Good Faith Estimates.

Pilot Evaluation

The pilot shall be deemed a success if it results in a Good Faith Estimate implementation guide published in the first quarter of 2022.

Pilot Policies

X12 establishes the following policies as governance for the pilot.

• The pilot is established as a committee-level pilot.
• The draft implementation guide will be developed using X12’s technical report development tools.
• The final implementation guide will be produced using X12’s standard publication processes, tools, style, and format.
• Approval to publish will be based on the pilot process described herein or in a subsequent revision.
• Progress shall be monitored by the PRB chair, with staff assistance as requested.
• Since the implementation guide is specific to the health care industry, X12N shall be assigned review responsibility. X12N does not have a task group or work group with specific responsibility for work products related to Good Faith Estimates so all review and balloting shall be conducted at the subcommittee level.
• ASC subcommittees shall not define additional procedural steps under this pilot. All procedural steps are defined herein or in a subsequent revision to this pilot.
• The pilot process assumes best-case results at each step. If there are setbacks that affect the best-case plan, the ASC chair, PRB chair, and X12N chair shall determine the appropriate procedural fallback based on the policies and procedures defined herein.
• The pilot process will be patterned after previous pilots and the ASC Standards Development Manual (ASC02) where possible.
• X12N shall establish majority approval via an electronic ballot before the proposed work is presented for an X12J technical review.
• Since this implementation guide is being developed to support federal requirements which are required in 2022, the X12J chair will expedite the technical review. Depending on the timing, the X12J chair may schedule an interim meeting to review the technical merits of the draft implementation guide timely.

X12 establishes the following process flow for the pilot:

• A maintenance request (MR) will be submitted to allow for due-process tracking and other record-keeping.
• The draft implementation guide shall be subject to a 30-day X12N subcommittee review period. During this review period, X12 constituents shall have online access to the draft implementation guide and may submit comments via an online form. This is the only opportunity X12N constituents have to provide feedback on the draft implementation guide.
• The developers of the proposed work shall consider all submitted comments before an X12N subcommittee ballot is initiated.
• The proposed work may be revised based on the comments submitted. Such revisions, whether substantive or non-substantive, do not require another review period.
• The ASC and X12N officers shall concur with the revisions on behalf of their respective stakeholders.
• X12N shall execute a 14-day electronic pass/fail stakeholder ballot on a motion to move the draft implementation guide forward to X12J for a technical review.
• Comments are accepted during the review period and shall not be accepted during balloting.
• X12J shall conduct a technical review following ASC02 Section 5.6 X12J Reviews Proposed Revisions.
• If any technical issues are identified, they shall be resolved by the external group that developed the draft.
• If no technical issues are identified or the technical issues are resolved, X12J shall recommend that PRB approve an electronic ASC stakeholder ballot.
• PRB shall evaluate due process based on this pilot process. If due process was achieved, PRB shall approve a 30-day electronic stakeholder ballot on a motion to publish the draft implementation guide.
• If the motion to publish is approved, staff publishes the implementation guide and expedites its availability in Glass, X12’s online viewer.

Document History