What
Annual RxDC reporting of premiums, prescription drug spend, rebates/fees, and total health plan spending using CMS templates submitted through the HIOS portal.
Who
All group health plans and health insurers, including self-funded ERISA plans and fully-insured plans of any size. Excepted benefits (stand-alone dental/vision, most EAPs) are generally out of scope.
When
Due each June 1 for the prior calendar year (the "reference year"). Example: 2025 data is due June 1, 2026.
Who is legally responsible
Fully-insured (any size): the carrier is the responsible reporting entity; the employer provides premium contribution data by the carrier's deadline. Self-funded/level-funded: the plan sponsor (employer) is responsible, even if a TPA or PBM agrees to file. Risk: no separate RxDC penalty schedule exists; noncompliance can trigger IRC Section 4980D ($100 per day per affected individual).
June 1
CMS deadline
Annual RxDC submission for the prior calendar year's data.
Prior yr
Reference year
Each filing covers the prior calendar year. June 1, 2026 covers 2025 data.
Earlier
Carrier cutoff
Carriers/vendors set internal cutoffs months before June 1; miss it and you may have to file directly.
| Trigger | Timing | Who Sends | Notes |
|---|---|---|---|
| Annual RxDC submission (reference year data) | June 1 each year | Plan sponsor or insurer (may use vendor) | 2025 data is due June 1, 2026. This is the CMS deadline; carriers/vendors set earlier internal cutoffs. |
| Carrier/TPA request for employer premium contribution data | Commonly March to May (varies by carrier) | Employer to Carrier / TPA / PBM | Important: If you miss the carrier's cutoff, the carrier may file without your premium data or may exclude your plan, potentially requiring you to file directly in HIOS. |
Trigger: Annual RxDC submission (reference year data)
Timing: June 1 each year
Notes: 2025 data due June 1, 2026. Carriers/vendors set earlier internal cutoffs.
Trigger: Carrier/TPA request for employer premium data
Timing: Commonly March to May (varies by carrier)
Notes: Miss the cutoff and the carrier may exclude your plan, pushing you to direct HIOS filing.
- Employer/employee premium contributions: Average monthly dollar amounts by tier (single, EE+SP, EE+CH, family) for the reference year. This is the data element most carriers request from employers directly.
- Enrollment counts: Average monthly enrolled members by market segment.
- Medical claim totals: Inpatient, outpatient, professional, and other medical spend (usually from carrier/TPA). Self-funded plans must compile these themselves.
- Pharmacy data: Total Rx spend, rebates/price concessions, administrative fees, and top drugs by spend and by utilization (from PBM or carrier).
- CMS RxDC file structure: Plan list P2; data files D1 through D8 (plan and reporting info, spending, premiums, enrollment, Rx totals, top drugs, rebates, etc.); and narrative N1 when required.
- Contacts and access: HIOS account (if filing directly), carrier/TPA/PBM contacts, and any vendor portal credentials.
1
Confirm who is submitting and what they need from you
- Fully-insured: Ask your carrier if they will submit RxDC. If yes, request their employer data request form and deadline. Confirm whether you need a written agreement assigning them the filing obligation (most carriers have this in their standard contract, but verify).
- Self-funded / level-funded: Confirm your TPA/PBM or RxDC vendor's role. The plan sponsor remains legally responsible for the filing regardless of delegation.
2
Collect and provide employer-side data promptlyRespond to the carrier's or vendor's data request before their cutoff. Premium contribution amounts by tier are the most common employer-supplied data element.
3
Coordinate file ownershipDetermine who is submitting each of P2 and D1 through D8. Multiple submitters are permitted, but every file for a plan must be covered. Gaps, especially between carrier and carve-out PBM, are a common problem.
4
Review drafts for reasonablenessVerify enrollment counts align across P2, D1, and D2; check that premium contribution shares are correct; confirm the top-drug lists look plausible.
5
Submit via CMS HIOS (if filing directly)Load templates, attach the narrative (N1) if required, validate, and submit by June 1. Save the submission confirmation.
6
Document the filingKeep the final files, carrier or vendor attestation confirming what they submitted and for which plan IDs, and your internal premium contribution worksheet.
- Primary method: CMS Health Insurance Oversight System (HIOS) portal at portal.cms.gov.
- Carrier/TPA submissions: Most fully-insured carriers (especially small group) submit RxDC on the employer's behalf if they receive the employer's premium contribution data by their internal deadline.
- Missed carrier deadline: If the employer does not supply data on time, the carrier may file without that data element or exclude the plan. At that point, the employer may need to register for HIOS and file a correction directly, more time-consuming than providing data up front.
- Multiple submitters allowed: Carriers, TPAs, and employers may each submit different files so long as all required files for the plan are covered and plan identifiers match across submissions.
- Copies of submitted RxDC filesP2, D1 through D8, and N1 if used, for each reference year.
- CMS HIOS submission receiptsAnd validation/error logs.
- Carrier/TPA/PBM attestationOr email confirming what they filed and for which plan IDs.
- Internal worksheetsSupporting premium contribution calculations and enrollment counts.
- RetentionRetain records at least 7 years, consistent with common audit lookback periods and ERISA document retention practices.
Common traps
Missing the carrier's internal data deadline: The June 1 CMS date is not the carrier's cutoff. Most carriers need employer data months earlier. Missing it can push the employer into direct HIOS filing.
Assuming the TPA "has it covered" for self-funded plans: The plan sponsor remains legally responsible even with a delegation agreement in place. Monitor the filing and keep confirmation on file.
Gaps between carrier and carve-out PBM: If Rx is carved out, the PBM may submit D6 through D8 while the carrier submits the medical and enrollment files. Coordinate early to ensure there are no missing files.
Mismatched plan identifiers: If multiple parties submit files for the same plan, the plan IDs must match across all submissions or CMS will flag the filing as incomplete.
FAQs
Does RxDC apply to small fully-insured employers?
Yes, the requirement applies to all group health plans regardless of size. For fully-insured plans, the carrier is the legally responsible reporting entity. The employer's obligation is to provide premium contribution data by the carrier's deadline so the carrier can complete the filing.
We're self-funded, can our TPA file?
Yes, but you remain the responsible party. Confirm who is submitting each file (P2 and D1 through D8), what data the TPA needs from you, and get written confirmation when they file. If the TPA fails, the plan sponsor is in violation.
What if multiple entities submit files for the same plan?
That's allowed; different parties may each submit different files. What matters is that all required files for the plan are covered and that plan identifiers match across every submission.
What is the "reference year"?
The prior calendar year. The June 1, 2026 deadline covers data for the 2025 reference year.
What if we miss June 1?
File as soon as possible and document good-faith efforts. CMS has the authority to enforce under IRC Section 4980D ($100/day per affected individual), though early RxDC filing cycles have generally focused on good-faith compliance rather than immediate penalties for late filers.
- CMS RxDC Overview Page: Summary of who must file, what's required, annual timing, and links to all REGTAP resources including instructions, templates, and the HIOS submission portal.
- REGTAP (CMS Registration for Technical Assistance Portal): Where the official RxDC reporting instructions, file templates, data dictionary, drug crosswalk, FAQs, and training materials are hosted. Create a free account to receive email alerts when resources are updated.
- CMS Enterprise Portal (HIOS submission): Where employers and carriers submit RxDC files directly to CMS.
- Federal Register: RxDC Final Rule (Nov. 23, 2021): The regulatory text implementing RxDC under the CAA 2021.
- 45 CFR Part 149: The codified regulation; RxDC requirements are in Subpart P.
- Fully-insured vs. self-funded: For fully-insured plans, carriers draft and submit RxDC; if the carrier fails under a written agreement, the carrier is in violation. For self-funded plans, the employer drafts and submits (typically via TPA/PBM), and the employer retains liability regardless of delegation.
- Level-funded plans: Treated as self-funded for RxDC purposes. The plan sponsor (employer) is the responsible party, not the stop-loss carrier or TPA.
- Mid-year carrier changes or multiple plans: If you switched carriers during the reference year, you may appear in multiple carrier files. Verify that all plan months are covered and that plan identifiers in P2/D1 align across submissions.
- Carve-out PBM: When Rx is carved out, the PBM typically submits the Rx files (D6 through D8) while the carrier or TPA submits the medical and enrollment files. Coordinate early; this split is a common source of missing files and mismatched counts.
- Excepted benefits and account-based plans: Stand-alone dental and vision, most EAPs, HRAs (other than ICHRAs that qualify as group health plans), and QSEHRAs are generally outside RxDC scope. Confirm applicability before excluding any arrangement.