The Life Cycle of an NCPDP Standard

By Margaret Weiker, Vice President, Standards Development at NCPDP

One of the questions I often hear when talking about NCPDP standards is: How does a standard actually get created?

At NCPDP, standards development is a consensus-driven process that brings together stakeholders — members and non-members — from across the pharmacy and healthcare industries. It isn’t simply a matter of coming up with a new set of rules, writing a document, and publishing it. It involves identifying a business need, bringing the right people together, working through the details, reaching consensus, and taking the standard through a formal approval process.

So, what does it actually take to turn an idea into an NCPDP standard?

It starts with a business need

Every standard begins with a business need. That need might stem from a new or changing regulatory or legislative requirement; emerging technology, or the industry identifying a better way to exchange information.

Anyone — an organization or an individual, member or non-member — can submit a request to NCPDP for a new standard or a modification to an existing one. That request is submitted through a Data Element Request Form, or DERF.

A DERF can propose something entirely new or request a modification to an existing NCPDP standard or data element. There is also a specific type of DERF, known as a DERF/ECL, that requests an addition or modification to a value within an NCPDP External Code List (ECL).

The DERF review process

Once a request is submitted, NCPDP standards staff reviews it, assigns it an identification number, and recommends a Work Group (WG) assignment to the Standardization Committee and the Maintenance and Control (MC) and WG19 Co-Chairs.

This is where the real collaboration begins.

That collaboration matters because NCPDP standards are developed by the industry, for the industry. NCPDP members bring a wide range of different perspectives and experiences to the table — from pharmacies, payers, technology companies, prescribers, government and other healthcare stakeholders.

Once the DERF has been assigned to a Work Group, it is made available to members before the quarterly Work Group meeting, giving members the opportunity to review the request and come prepared to discuss it.

Whether the original submitter is a member or not, we strongly encourage them to attend the discussion. Why? Because Work Group members may have questions about how a proposed data element would be used, how it could affect existing transactions, or whether there are implications elsewhere in the standard.

The goal isn't simply to decide whether an idea sounds good. The goal is to understand the business need and determine the best way to address it through a consensus-driven standards process.

The Work Group gets to work

At the quarterly Work Group meeting, the DERF is discussed.

Members ask questions, identify potential challenges, suggest modifications and consider how the proposed change, or new standard, would work in the real world. Sometimes the group determines that additional information or work is needed, and the DERF is pended (held for further discussion). Other times, the request may be approved, approved with modifications, or denied with reasons provided.

That flexibility is an important part of standards development.

A request doesn't have to arrive as a perfect, finished solution. The Work Group process allows industry experts to collaborate and improve the proposal in real-time.

That’s the beauty of collaboration. What begins as one person's idea becomes something much stronger because of the expertise around the table.

Then comes the ballot

For DERFs that create a new NCPDP standard or modify an existing one, approval at the Work Group level is an important milestone — but it isn't the final step.

The approved DERF moves into NCPDP's formal ballot process.

NCPDP ballots are designed to ensure proposed standards have the support of the Consensus Group. New ballots are prepared following the February and August Work Group meetings, and each ballot period is open for 45 days.

During that time, Consensus Group members vote and may submit comments. And anyone outside the Consensus Group — member or non-member — may also submit comments. New ideas often bring disagreement, and that’s a healthy part of the process.

Comments and concerns are reviewed and adjudicated by the Work Groups. If substantial changes are needed, the ballot may be recirculated so the updated proposal can be reviewed again.

For a ballot to be considered valid and approved, it must receive votes from at least 60% of the NCPDP Consensus Group and achieve at least 75% approval.  The standard must then be approved by the NCPDP Board of Trustees.

Not every change takes the same path

Not every standards-related request follows the full ballot process.

ECLs contain the values associated with NCPDP data elements. When the industry needs to add or modify an ECL value, the request follows a different process and does not go through the standard ballot process. This list is updated and published up to four times per year.

Emergency and Expedited ECL processes are also available when a regulatory or legislative requirement requires a more accelerated response. This flexibility matters because healthcare does not always move on a predictable timeline.

The standards development process has pathways designed for both routine updates and urgent, time-sensitive needs.

Approval is not the end

After the Board’s approval, NCPDP standards and implementation guides are prepared for publication, along with associated materials such as updates to the Data Dictionary and ECL.

The standard is then published and made available to the industry.

But as we all know, healthcare continues to evolve. Regulations change. Technology changes. Organizations and operations change. New use cases emerge. That means NCPDP standards require ongoing maintenance.

In fact, this maintenance is one of the most important — and sometimes least visible — parts of standards development.

So, the next time you use an NCPDP standard, remember there is a whole formal process, and a community of industry stakeholders collaborating, behind it.