Universe Reference · Part of the CMS Program Audit Guide
The FA Universe: Tables, Tests, and Failure Modes
FA (Formulary Administration) is the Part D protocol that asks whether the plan administers the formulary at the pharmacy counter the way the CMS-approved formulary says it should. The data lives almost entirely inside the PBM, which shapes both the risk and the preparation.
What FA Tests
1. Formulary match
Point-of-sale adjudication must be consistent with the CMS-approved formulary: covered drugs cover, and off-formulary drugs are handled the required way.
2. UM edit authorization
Prior authorization, step therapy, and quantity limit edits applied at the counter must actually exist on the approved formulary for that drug. Unauthorized edits are immediate findings.
3. Transition and notice
New enrollees and LTC residents who hit a formulary issue must get the required transition supply and the required written notice on time.
FA and CDAG are tightly linked: FA records what the plan's point-of-sale logic did automatically, CDAG records what happened after a human looked at the case. The same prescription can appear in both protocols, and the universes have to tell consistent stories.
The Routinely Submitted FA Tables
RCFA
Rejected Claims (Formulary Administration)Pharmacy point-of-sale claims rejected for formulary or utilization management reasons during the review period. The single most-audited piece of FA, and the record of what members were told at the counter.
RCT
Rejected Claims (Transition)Transition fills provided to new enrollees and long-term care residents who hit a formulary issue during their transition window.
NE
New EnrolleesThe roster of members who became eligible during the period. CMS cross-references NE against RCT to confirm transition obligations were met for the right people.
A note on PDE. The record layout also defines a Prescription Drug Event table, but per the CMS Audit Submission Checklist it is not a routine submission. Sponsors provide PDE data only when CMS instructs them to. Do not treat it as part of the standard FA package.
The Deadlines That Matter
| Obligation | Standard |
|---|---|
| Universe submission | 15 business days from the engagement letter |
| Transition window (new enrollees) | First 90 days of enrollment; LTC residents get a longer period |
| Transition notice | Written notice within 3 business days of the transition fill adjudication |
| Mid-year formulary change notice | At least 30 days in advance under most circumstances |
Where FA Universes Fail
- •Reject codes that contradict the approved formulary. A PA rejection with no PA edit on file, or a not-covered rejection for an on-formulary drug. CMS reconciles the universe against the approved formulary, so the mismatch is visible immediately.
- •NDC formatting damage. NDC is an 11-character numeric field, and Excel transformations strip leading zeros. Length-10 NDCs in a first submission are one of the most common format findings.
- •Transition logic gaps. New enrollees who hit rejections in their first weeks with no transition fill offered, days' supply below the minimum, LTC status misclassified from stale enrollment data, and transition-flagged claims well past the window.
- •Notification shortfalls. More transition fills than transition notices, notices generated in the system but never mailed, and modified templates where CMS-standardized notices were required.
- •The unvalidated PBM hand-off. FA is the universe most exclusively produced by the PBM, and plans that submit the PBM's file as-is are accepting its data quality as their own. Specialty pharmacy and limited-distribution claims adjudicated in separate systems are a recurring completeness gap.
Go Deeper
- •The full FA universe guide walks through reject codes, transition rules, notifications, and the PBM delegation reality in detail.
- •The CDAG universe reference covers the coverage determination side that FA rejections feed into.
- •The free Universe Header Check tool validates your FA file headers against the current CMS spec in your browser.
Frequently Asked Questions
What are the FA universe tables?
Three tables are routinely submitted: RCFA (rejected claims for formulary administration reasons), RCT (rejected claims transition, covering transition fills), and NE (new enrollees). A fourth table in the record layout, PDE (Prescription Drug Event data), is not routinely collected; sponsors submit it only when CMS instructs them to.
What does the FA protocol actually test?
Three connected questions: whether point-of-sale adjudication matches the CMS-approved formulary, whether prior authorization, step therapy, and quantity limit edits applied at the counter actually exist on the approved formulary, and whether transition fills and required member notices happened on time for new enrollees and long-term care residents.
What is a transition fill?
A one-time supply a plan must provide when a new enrollee, within the first 90 days of enrollment, tries to fill a Part D drug that is off-formulary or carries a UM restriction the member cannot immediately meet. It buys the member time to switch to a covered alternative or request a coverage determination. Long-term care residents get a longer transition period with different supply requirements, and a written transition notice is due within three business days of the fill.
Why do reject reason codes matter so much in FA?
The NCPDP reject code tells CMS what the pharmacy saw when a claim was rejected, and CMS reconciles those codes against the approved formulary. A claim rejected as prior-authorization-required for a drug with no PA edit on the approved formulary is a direct finding, as is a not-covered rejection for a drug that is on the formulary. Codes must be reported exactly as the adjudication system returned them.
Validate Your FA Universe Before CMS Does
The CMS Universe Scrubber checks FA files against the CMS record layouts: reject code formatting, NDC validity, transition fill rules, and cross-universe consistency with CDAG.