10.4 Open Payments, EFPIA Codes & Publication-Related Transfers of Value
Key Takeaways
US Open Payments requires applicable manufacturers and group purchasing organizations to report specified payments or transfers of value to covered recipients under federal rules.
Covered recipients include physicians, teaching hospitals, physician assistants, nurse practitioners, clinical nurse specialists, certified registered nurse anesthetists and anesthesiologist assistants, and certified nurse-midwives.
CMS states that medical research writing or publication activities are included in a research payment when they are in the written research agreement or protocol and paid as part of that research payment.
Reasonable compensation for legitimate publication work is not automatically unethical under GPP 2022, but payment for a byline or influence is unacceptable and all legal, institutional, contractual, and disclosure rules apply.
EFPIA and other national frameworks differ from US Open Payments, so classification, consent or privacy, recipient, timing, and publication rules must be checked locally.
Open Payments, EFPIA Codes & Publication-Related Transfers of Value
Note
Financial transparency rules vary by jurisdiction and by the facts of the arrangement. A publication professional should identify the payer, recipient, activity, agreement, payment pathway, and applicable reporting framework before classifying a transfer.
US Open Payments
The US Physician Payments Sunshine Act created the Open Payments program administered by the Centers for Medicare & Medicaid Services (CMS). Applicable manufacturers and applicable group purchasing organizations report specified payments and other transfers of value involving covered recipients. CMS publishes the data and provides a review-and-dispute process.
Open Payments reporting is the reporting entity's legal responsibility, but publication professionals affect the underlying facts when they plan steering committees, author meetings, writing support, travel, research agreements, and consulting work. Accurate contracts, attendance records, invoices, and recipient data are therefore important.
Covered Recipients
Current covered-recipient categories include:
- physicians in the categories defined by the program;
- teaching hospitals;
- physician assistants;
- nurse practitioners;
- clinical nurse specialists;
- certified registered nurse anesthetists and anesthesiologist assistants;
- certified nurse-midwives.
The expanded nonphysician-practitioner categories apply to data collected from 2021 onward. A person's job title or doctorate alone is not enough to classify them. Confirm the professional category and the program definition. Certain payments involving principal investigators may also be reported in the research-payment context even when money flows through an institution.
Payment Categories
Open Payments distinguishes three broad records:
- General payments not made in connection with a research agreement or protocol;
- Research payments connected to a written research agreement or research protocol;
- Ownership or investment interests.
General-payment nature categories can include consulting, honoraria, food and beverage, travel and lodging, education, grants, royalties, gifts, or other defined categories. The correct category depends on the purpose and documentation, not on what the team informally calls the expense.
Research-payment reporting can capture a total payment to an institution and associated principal investigators. Do not assume that routing funds through a university removes the activity from Open Payments.
Medical Writing and Publication Activities
The key CMS point is narrower and more factual than a blanket rule. CMS's Open Payments FAQ states that medical research writing and publication activities are included in a research payment when the activity is included in the written research agreement or research protocol and paid as part of the research payment.
That means the following statement is unsafe: “Sponsor-provided medical writing assistance is never a reportable transfer of value because no cash went directly to the author.” The agreement, activity, recipient relationship, payment structure, and CMS reporting rules must be reviewed.
Likewise, it is unsafe to say every agency invoice is a physician payment. An agency may provide services to a sponsor or author group under arrangements that require fact-specific classification. Send uncertain cases to the reporting organization's Open Payments, legal, or compliance specialists rather than creating a publication-team exemption.
Compensation and Publication Ethics
Open Payments reporting and ethical authorship answer different questions:
| Question | Governing concern |
|---|---|
| Must a payment be reported? | Open Payments law and CMS rules |
| Is compensation permissible? | Law, institution, contract, company policy, GPP, venue requirements |
| Does the person qualify as an author? | Applicable authorship criteria |
| Must the relationship be disclosed in the publication? | Journal or conference policy, ICMJE, GPP, other rules |
GPP 2022 does not categorically prohibit reasonable compensation for legitimate work such as steering-committee participation, data analysis, manuscript review, or patient-partner contributions. It does reject paying someone merely to lend a name to a byline or influence an opinion. Compensation must be reasonable, transparently handled, and permitted by applicable law, institutional policy, contracts, corporate-integrity obligations, and venue disclosure rules.
Receiving compensation neither automatically qualifies nor disqualifies someone as an author. The person must still meet the authorship criteria for the work.
Practical Classification Questions
For any publication-related value transfer, document:
- Who is the legal payer?
- Who receives cash or in-kind value?
- Is the recipient covered by the relevant framework?
- What service or expense is involved?
- Is it part of a written research agreement or protocol?
- Is payment direct or indirect?
- Which nature or research category applies?
- Are there exclusions, thresholds, delayed-publication rules, or special recipient rules?
- What journal, conference, institutional, or conflict-of-interest disclosure is also required?
Threshold amounts can be adjusted and rules can change. Check the current CMS program materials for the relevant data year rather than memorizing an approximate dollar value from an older guide.
Review and Dispute
Covered recipients can review attributed Open Payments records during the CMS review period and initiate disputes. A dispute does not necessarily prevent publication of the record; follow the current CMS process. Publication teams should preserve contracts, meeting dates, purpose, attendee roles, invoices, travel details, and research-agreement links so the reporting group can classify transactions accurately and investigate questions.
EFPIA and Europe
The EFPIA Code is an industry self-regulatory framework implemented through member associations and companies, alongside national laws and codes. It addresses transfers of value to healthcare professionals, healthcare organizations, and certain patient-organization relationships. Categories and public-disclosure mechanisms differ from the US system.
Data-protection and lawful-basis questions must be assessed under the applicable national implementation and current privacy law. Do not assume that affirmative consent is always required across every EFPIA country or that refusal always produces the same aggregate treatment. Some jurisdictions have statutory disclosure systems; others rely heavily on code-based processes. Local rules control.
Common areas requiring classification include:
- registration fees and sponsorship;
- travel and accommodation;
- service and consultancy fees;
- related expenses;
- grants and donations;
- research and development transfers, often disclosed in aggregate under code rules.
The UK, France, Portugal, Denmark, Australia, Japan, and other markets have distinct laws, codes, databases, or company-publication mechanisms. “The European rule” is not a sufficient compliance analysis.
Scenario
A manufacturer funds a clinical trial through a written research agreement with a university. The budget includes investigator work and medical research writing and publication activity. The team should not strip the writing amount out as categorically nonreportable. CMS says such activities are included when they are in the written research agreement or protocol and paid as part of the research payment. The reporting entity determines the exact submission using the agreement, recipients, and current CMS rules.
In a different project, an agency is paid to edit a publication for a sponsor, with no covered recipient receiving or directing a personal benefit. That does not automatically establish either reporting or exemption. The compliance team must evaluate the facts and payment pathway.
Important
Never use “no cash to the author” as the complete Open Payments test. Never use “reportable” as a synonym for “unethical.” Classification, permissibility, authorship, and publication disclosure are related but separate analyses.
A written clinical research agreement includes medical research writing and publication work paid as part of the research payment. How does CMS say the activity is treated?
It is always excluded because writing is editorial
It is included in the research payment
It is automatically a gift to every author
It can never appear in Open Payments if an agency performs the work
Which statement best reflects GPP 2022 on compensation?
Any compensated person is barred from authorship
All authors must receive the same honorarium
Reasonable compensation for legitimate publication work may be permissible, but payment for a byline or influence is unacceptable and applicable rules must be followed
Open Payments reporting automatically proves an ethical violation
Why should a global publication team not apply the US Open Payments workflow unchanged to every European country?
EFPIA prohibits all disclosure
European frameworks are identical but use a different currency
EFPIA implementation, national law, privacy basis, categories, and disclosure mechanisms vary by jurisdiction
Only journals may report transfers of value in Europe
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