The Impact of Delayed Publication for Research Payments (42 CFR § 403.906(b))

Under 42 CFR 403.906(b), manufacturers may request delayed publication of certain research payments reported to CMS when disclosure could compromise product research or development or a clinical investigation. The data are still reported to CMS, but the public display is deferred until the earlier of (1) the related product’s FDA marketing authorization or (2) four calendar years after the date of payment. For small practices participating in industry-sponsored research, this delay means entries can surface on the public site years after services were rendered.

Because the record ultimately becomes public, clinics should track which engagements are flagged for delay, the triggering event that ends the delay, and the expected release cycle. Doing so allows the practice to prepare clinicians for public visibility, align documentation with the data elements published under 42 CFR 403.904(c), and use 42 CFR 403.908 for dispute/correction if details are wrong at publication.

Open Payments normally publishes transfers of value each program year. Research is different. To balance transparency with the confidentiality of ongoing development, 403.906(b) lets manufacturers report the payment to CMS while holding it from public view until a regulatory or time-based threshold is met. For a lean clinic, the operational question is simple: Which entries will appear later, and when? If you do not track this, you may be surprised by a multi-year-old study payment appearing beside a clinician’s name with product associations and dollar amounts the public will scrutinize.

This article turns the delayed publication rule into an operational routine. You will learn what qualifies, how the clock runs, what fields eventually publish, and how to organize your evidence, so disputes are quick if the posting is inaccurate once the delay ends.

Legal Framework & Scope Under 42 CFR 403.906(b)

What delayed publication is.
 Per 403.906(b), applicable manufacturers may designate certain research payments for delayed public display if they are made in connection with product research or development or a clinical investigation regarding a new drug, device, biological, or medical supply, or a new application of an existing product. The manufacturer reports the payment to CMS with the appropriate delay flag, but CMS does not publicly post the payment until the earlier of:

• the date the product (or new application) receives FDA marketing authorization, or

• four calendar years after the date of payment.

Scope limits and definitions.
 Definitions in 403.902 frame what counts as research and how covered products are identified. Not all activity labeled “research” qualifies for delay; the payment must meet the product research/clinical investigation conditions tied to a covered product pathway. Routine general support or education that is not product-development research is not eligible for this delay. The reporting and eventual publication data elements remain governed by 403.904(c), including identifiers, amount/date, nature of payment (research), and associated product information. Disagreement over details uses 403.908 procedures.

Practical meaning.
 The rule protects sensitive study work but does not erase the obligation to report; it only postpones public display. Clinics should therefore assume the data will become public and prepare evidence, summaries, and a calendar that anticipates the end of the delay.

Framework wrap-up: Properly classifying the payment as eligible research, setting the delay flag, and tracking the earlier-off endpoint reduces later administrative friction and reputational surprises under 403.906(b).

Administrator: CMS receives the reports, applies the delayed-publication logic in its systems, and posts the data when a delay expires.
 Clinic touchpoints: Clinics are not the filers but feel the downstream impact. Common triggers include:

• Manufacturer confirmations seeking site PI names, protocol identifiers, and product associations that flow to 403.904(c) elements when the entry goes public.
  

• Pre-publication notifications to clinicians to review records; if a delayed research payment is about to post, identity fields, date, amount, and product links should be confirmed.

• Public inquiries when the delay ends and an older study payment appears with a product association; the clinic may need a concise, evidence-based explanation.

When a posted entry is inaccurate, the clinic should use 403.908 to dispute with element-specific evidence.

Each control below is tied to 403.906(b) and, where relevant, to 403.904(c) and 403.908. The point is to run a light, predictable process without adding staff.

Control 1. Start a “Research Delay Tracker” at intake

How to implement. At study onboarding, create a row per engagement with fields: eligible for 403.906(b)? (yes/no), manufacturer’s delay attestation received?, covered product, anticipated FDA pathway, payment date(s), earlier-of date (FDA authorization vs +4 years), and expected CMS posting month.

 Evidence to retain. Contract excerpt stating product research/clinical investigation, protocol identifier, manufacturer’s written designation of delay, and any blinded naming conventions.

 Low-cost method. A protected spreadsheet with data validation, owned by the compliance lead.

 Authority. 42 CFR 403.906(b) (delayed publication conditions).

Control 2. Compute the “earlier-of” date on day one

How to implement. Ask the sponsor for the target FDA milestone and record it; if unknown, calculate payment date + 4 calendar years. The posting occurs no later than the first public refresh after whichever event happens first.

 Evidence to retain. Sponsor communication on anticipated authorization and your calculation notes.

 Low-cost method. A formula column that chooses the earlier date automatically.

 Authority. 42 CFR 403.906(b) (earlier of authorization or four years).

Control 3. Map eventual public fields to clinic records

How to implement. For each delayed payment, pre-stage the 403.904(c) elements: recipient identifiers (name, NPI, license/state), amount/date, nature (research), associated product, and any required study descriptors. Ensure your internal files contain exact spellings and identifiers to avoid disputes later.

 Evidence to retain. Credentialing snapshots; sponsor remittances; study documents.

 Low-cost method. Add a mini “Field Map” section to the Tracker with hyperlinks to each artifact.

 Authority. 42 CFR 403.904(c) (published data elements for research).

Control 4. Get the delay attestation in writing

How to implement. Request a short sponsor statement confirming the delay designation and eligibility basis (product research/clinical investigation). File it under the Tracker row.

 Evidence to retain. Email confirming the 403.906(b) designation and the covered product.

 Low-cost method. A standard one-paragraph email template sent at contract signature.

 Authority. 42 CFR 403.906(b) (manufacturer’s designation drives CMS handling).

Control 5. Create two alert streams: sponsor-milestone and CMS-window

How to implement. Put calendar reminders 1) quarterly to ask the sponsor if FDA authorization has occurred, and 2) 30 days before the next CMS review window to verify identity fields and amounts in anticipation of posting.

 Evidence to retain. Dated outreach emails and sponsor replies; internal pre-publication checklists.

 Low-cost method. Shared calendar plus a two-line checklist for each alert.

 Authority. 42 CFR 403.906(b) (timing), 42 CFR 403.908 (pre-publication review/dispute procedure).

Control 6. Prepare a one-page public explainer per study

How to implement. Draft a neutral statement explaining that research payments were reported to CMS, but public display was delayed under 403.906(b) until [authorization date or four-year point]. Keep it internal until needed.

 Evidence to retain. The signed statement, with the Tracker row ID and exhibits list.

 Low-cost method. A text template with mail-merge fields (product, dates, role).

 Authority. 42 CFR 403.906(b); aligns with 403.904(c) publication.

Control 7. Dispute by element if the record is wrong

How to implement. When a delayed entry goes public and contains errors, file a 403.908 dispute that names the precise 403.904(c) element(s) (e.g., associated product, amount, date) and attaches labeled exhibits.

 Evidence to retain. Cover letter keyed to elements, exhibits (A, B, C), and final CMS screenshot post-correction.

 Low-cost method. A re-usable dispute packet template with checkboxes for elements.

 Authority. 42 CFR 403.908 (review, dispute, correction), referencing 403.904(c).

Playbook wrap-up: These controls ensure that when a delayed entry finally posts, your clinic can verify it quickly and respond confidently, all within the guardrails of 403.906(b).

Case Study

Scenario (de-identified): A community oncology practice participates in a manufacturer-sponsored Phase II trial for a new indication of an existing biologic. The sponsor marks site payments for delayed publication under 403.906(b). Three years later, the FDA approves the new indication. During the next CMS cycle, a two-year-old payment appears publicly, with the practice’s PI listed and the product association shown.

Clinic posture and actions:

• Because the practice maintained a Research Delay Tracker, staff had already logged the earlier-of event as “FDA approval” rather than the four-year sunset. They expected publication.

• The compliance lead ran a 403.904(c) field check: PI name/NPI, date, amount, nature (research), and product association all matched the contract and remittances.

• The clinic released its one-page public explainer, noting that the payment had been reported at the time, but public display was deferred under 403.906(b) until approval.

• A local journalist asked whether the payment influenced prescribing. The clinic pointed to the study protocol, the research nature category, and independent oversight. No dispute was necessary.

Outcome: The clinic avoided reputational turbulence by preparing for the delay’s expiration and verifying each published field in advance.

Checklist wrap-up: These six tasks operationalize the delayed-publication rule, ensuring your clinic can validate and explain entries when the delay ends.

Risk Traps & Fixes Under 42 CFR 403.906(b)

Delayed publication is straightforward in concept, but easy to mishandle operationally. The following traps link each error to its consequence and a control anchored in the regulation.

• Assuming “research” always qualifies for delay.
   Fix: Confirm that the payment is tied to product research or development or a clinical investigation of a covered product as contemplated by 403.906(b); general research support without a qualifying product pathway is not eligible.
   Consequence: Avoids expecting a delay, where CMS will publish promptly.

• Forgetting the “earlier-of” timing rule.
   Fix: Calculate the earlier of FDA authorization or four calendar years from payment date and record it in the Tracker; plan communications for the expected posting cycle under 403.906(b).
   Consequence: Prevents surprise postings and rushed explanations.

• Not pre-mapping 403.904(c) publication fields.
   Fix: Pre-stage identifiers, amount/date, nature = research, and associated product with exact spellings to match eventual publication per 403.904(c).
   Consequence: Reduces the likelihood of mis attribution or product mismatches at posting.

• No written delay designation from the sponsor.
   Fix: Capture a brief written statement that the manufacturer has flagged the payment for delay under 403.906(b) and file it with the study record.
   Consequence: Provides clear evidence of why the entry was not public earlier.

• Waiting to prepare a dispute until after public posting.
   Fix: Keep a ready 403.908 dispute packet template keyed to the publication elements so you can submit within days if an error appears.
   Consequence: Shortens correction cycles and limits reputational impact.

• Losing track of multi-year, multi-milestone payments.
   Fix: For installment or milestone-based payments, track each payment date and compute separate earlier-of dates; delays may expire at different times under 403.906(b).
   Consequence: Prevents piecemeal surprises as individual installments surface.

Wrap-up: Treat delayed publication as a dated commitment, not a blanket exemption. These fixes keep your clinic aligned with 403.906(b) and ready for precise, element-based corrections under 403.904(c) and 403.908.

Make delayed-publication management a routine, not a fire drill. Assign a single owner (compliance lead) for the Research Delay Tracker, and designate a backup. Train coordinators for 15 minutes each quarter on three items: (1) the eligibility test in 403.906(b), (2) the earlier-of timing, and (3) the specific 403.904(c) fields that will appear when the entry posts. Maintain a simple dashboard with two metrics: % of eligible studies with written delay attestation on file and % of delayed entries pre-validated before expected posting. These show a functioning control environment without adding headcount.

Delayed publication under 42 CFR 403.906(b) postpones, but does not eliminate, public display of qualifying research payments. For small practices, the key is to treat each delayed entry as inevitably public and prepare now: compute the earlier-of endpoint, collect proof of eligibility, pre-map the 403.904(c) publication fields, and keep a dispute kit aligned to 403.908. With a one-page Tracker and a few calendar nudges, your clinic can turn a complex, multi-year timeline into a predictable process.

Immediate next steps for a small clinic:

1. Stand up the Research Delay Tracker and populate it for all current studies, including eligibility, product, payment date(s), and earlier-of computation (403.906(b)).

2. Request and file a written delay designation from each sponsor where appropriate (403.906(b)).

3. Pre-map each delayed entry’s 403.904(c) fields to internal artifacts so you can verify instantly at posting.

4. Add quarterly sponsor-milestone checks and pre-window validations to your calendar (403.906(b); 403.908).

5. Adopt a one-page public explainer template and a 403.908 dispute packet keyed to specific publication elements for rapid response.

• 42 CFR 403.906 — Delayed publication of payment or other transfer of value for research
  

• 42 CFR 403.904 — Reports of payments or other transfers of value and of physician ownership or investment interests
  

• 42 CFR 403.902 — Definitions (Open Payments)
  

• 42 CFR 403.908 — Procedures for review, dispute resolution, and corrections

• 42 U.S.C. 1320a-7h — Transparency reports and reporting of physician ownership or investment interests