Disclosing payments between industry and health professionals
Payment-transparency requirements make financial relationships between healthcare companies, professionals and organisations public. Laws and industry codes differ in who reports, which transfers count and how publication support is valued.
US legislation and its timetable
The US Physician Payment Sunshine Act, formally the National Physician Payment Transparency Program: Open Payments, was enacted in March 2010 within the Affordable Care Act and administered by the Centers for Medicare and Medicaid Services (CMS). It arose from anti-kickback enforcement, on the premise that public financial information would aid enforcement and curb inappropriate activity. Its purposes included discouraging inappropriate influence on research, education, guidelines and clinical decisions, reducing conflicts that could harm care or increase costs, and potentially helping patients choose practitioners.
The timetable changed during implementation.
| Position at the time | Collection and reporting | Public release |
|---|---|---|
| 2010 legislation account | Collection from 2012; first manufacturer report due 31 March 2013 | Not specified |
| Proposed rule released 14 December 2011, described January 2012 | Collection expected during 2012, exact start dependent on final regulations; first report due 31 March 2013, then full calendar years | Expected from 30 September 2013 |
| February 2013 implementation rules | Collection from 1 August 2013; 1 August–31 December data due 31 March 2014 | By September 2014, then annually |
The first financial data were released on 30 September 2014. The 2007 bill had proposed reporting payments above $500, before reintroduction within the 2010 legislation.
Who reports and who is covered
The 2013 implementation rules covered manufacturers of drugs, devices, biologics and medical supplies reimbursable under Medicare, Medicaid or the Children's Health Insurance Program, including foreign manufacturers operating or selling in the US regardless of manufacturing location. Over-the-counter products were excluded, and devices and supplies were limited to those requiring FDA premarket approval or notification. In joint ventures or co-promotions, the manufacturer making the payment reported it once unless the parties agreed otherwise.
In 2016, applicable manufacturers and group purchasing organisations had reporting obligations concerning covered recipients and teaching hospitals. Covered physicians held US licences in medicine, osteopathy, dentistry, optometry, podiatry or chiropractic; teaching hospitals received direct or indirect Medicare graduate-medical-education payments, with CMS publishing an annual list. Group purchasing organisations used large purchasing volumes to negotiate discounts for healthcare providers. Manufacturer-employed physicians were exempt.
The 2012 proposed rules also covered entities receiving funds at a covered recipient's request, such as institutional grants or charitable contributions, while excluding other licensed clinical professionals such as PhDs, registered or practical nurses and physician assistants. Contemporary advice was to consider tracking products not yet federally reimbursed in case later eligibility made retrospective reconstruction necessary. The 2012 interpretation of pre-emption left more restrictive state reporting laws applicable.
By 2013, some companies were already tracking promotional-meeting payments to other health professionals in anticipation of wider rules, including scanning nurses' badges or recording attendance. October 2015 Senate proposals would extend coverage to physician assistants, nurse practitioners and other prescribing advanced-practice nurses, with reporting from 2017 if passed.
Payments, reporting fields and exclusions
The early accounts used a $10 payment threshold, with smaller payments reportable once their annual recipient total exceeded $100. Manufacturers reported; physicians did not, although registering with CMS enabled notifications and disputes about inaccurate information. Direct and indirect transfers included consulting, honoraria, research or education compensation, grants, charitable contributions, royalties, ownership or investment interests, gifts, entertainment, travel, lodging, food and beverages.
The proposed rule described in 2012 required six fields.
- Recipient name, address and national provider identifier.
- Payment amount.
- Payment date; multi-date payments could be totalled on the first date or reported as separate entries.
- Associated covered drug, device, biologic or supply where reasonably connected to the payment.
- Payment form: cash or equivalent; in-kind items or services; stock, options, ownership, dividends or investment returns; or other.
- Payment nature: consulting; other services; honoraria; gifts; entertainment; food; travel with destinations; education; research; charity; royalties or licences; ownership or investment; medical-education faculty or speaker compensation; grants; or other.
Each transfer needed one form and one nature, so separable consulting fees, meals and travel required three entries, each with its own component amount. The proposed exclusions were as follows.
- Payments below $10 unless annual payments to the recipient exceeded $100.
- Product samples and educational materials benefiting patients.
- Covered-device loans for trial periods of 90 days or less.
- In-kind charity-care items.
- Warranty items or services.
- Discounts and rebates.
- Publicly traded securities' or mutual funds' dividends, profit distributions, ownership or investment interests.
- Employee healthcare under a manufacturer's self-insured plan.
- Payments solely for a recipient's licensed non-medical professional services.
- Payments solely for physician services in civil, criminal or administrative proceedings.
- Indirect transfers where the manufacturer did not know the recipient's identity.
The 2013 rules retained exclusions including unidentified indirect recipients, sub-threshold payments, product samples and educational items directly benefiting patients. The proposed database was to be searchable, understandable, downloadable and readily aggregated, including relationship information, physician and immediate-family ownership interests, and enforcement actions.
The January 2012 account described fines of $1,000–$100,000 per missing payment, capped at $1 million annually per company. The 2013 implemented-rule account specified $1,000–$10,000 per unintentionally unreported payment or interest, capped at $150,000 annually, with higher penalties for intentional failures.
Continuing education, books and reprints
In 2012, the Alliance for Continuing Education in the Health Professions sought changes recognising existing accreditation and commercial-support standards, while the CME Coalition encouraged comments before the 17 February deadline and supplied model responses. In 2013, physician faculty honoraria were exempt for activities accredited by the American Academy of Family Physicians, Accreditation Council for Continuing Medical Education, American Dental Association, American Medical Association or American Osteopathic Association. The exemption followed criticism of an earlier proposal lacking provision for accredited continuing medical education (CME).
By 2016, the speaker-payment exemption had been deleted. Indirect 2016 payments through continuing-education organisations had to be reported in 2017 if the manufacturer knew or learned physician attendees' or speakers' identities during the reporting year or by the following year's second-quarter end.
Books and reprints supplied to covered recipients were reportable under the implementation rules; 23 US representatives objected in November 2013, but CMS declined to change their classification. The House's July 2015 21st Century Cures Act proposal included exemptions for certified CME, medical texts and reprints, including non-promotional educational speaking or materials preparation. The Senate instead considered smaller bills, and whether these exemptions would be addressed remained uncertain in March 2016.
Laws and industry codes internationally
Laws impose governmental requirements; industry codes bind members of the relevant group. In 2013, legislative advocates argued for lower costs and corruption through mandated disclosure, while self-regulation advocates argued for cross-border uniformity and efficiency. A global system might improve compliance and reduce enforcement needs, but collecting and categorising large volumes of expenditure required time, staff and adaptable systems across changing national standards.
In 2013, reporting laws or self-regulatory measures existed in Australia, Denmark, France, Japan, Portugal, Slovakia, the Netherlands and the UK; US state legislation dated from 1993. Portugal, Slovakia and Estonia had less extensive requirements than France, while Denmark required identification of relationships without payment amounts and anticipated new legislation covering pharmaceutical and device companies, with primary financial-reporting responsibility assigned to professionals. In 2016, Danish companies still reported relationships rather than amounts, professionals reported financial support, and Portuguese companies reported support and sponsorship above €60.
By 2016, Slovakia's law and Japan's code dated to 2011, Australia's code to 2012, Portugal's law and the European Federation of Pharmaceutical Industries and Associations (EFPIA) code to 2013, Romanian, Danish and Greek laws to 2014, and Turkey's law and Australia's amended code to 2015. A 2019 European account listed Sunshine provisions in France, Portugal, Belgium, the UK, Denmark, Romania, Latvia, Turkey, Slovakia and Greece, and anti-corruption or transparency laws in Croatia, the Netherlands, Germany, Italy, Poland, Slovenia, Sweden and Spain, without a pan-EU payment-disclosure agreement.
France
France enacted its transparency law on 29 December 2011; the final implementing decree followed on 21 May 2013 and explanatory circular on 29 May. The 2013 rules required disclosure of agreements other than commercial goods-and-services sales, and benefits to these recipients.
- Healthcare professionals, excluding the reporting company's employees.
- Associations of professionals and professional students.
- Students in relevant occupations.
- Public or private health-system user associations.
- Health facilities.
- Health-sector foundations, learned societies and consulting organisations.
- Press, radio, television and online publishers.
- Prescription and dispensing software publishers.
- Legal entities contributing to initial professional training.
The publishing category deliberately included scientific, medical and specialist professional press, creating a possible direct impact on medical writers that could not yet be predicted in 2013. Agreement disclosures included the following.
- Parties' identities: professionals' names, addresses, qualifications, titles, specialties and registration numbers; students' names and institutions; legal entities' names, purposes and registered addresses.
- Signing date.
- Subject matter worded to protect confidential or trade-secret information.
- Promotional or scientific event programmes where applicable.
Direct or indirect cash or in-kind benefits of at least €10 including VAT required recipient details, amount, date, nature and reporting half-year. In-kind benefits included gifts, equipment donations, invitations, hospitality, trips, commissions, discounts, rebates and expense repayments. Agreements were reportable within 15 days; benefits for January–June by 1 August and July–December by 1 February. A planned French-language public site would retain information for five years, publishing first-half-year data by 1 October and second-half data by 1 April.
Before that site operated, the 2013 decree required 2012 data to professional councils by 1 June 2013 and first-half-2013 data by 1 August, with publication on company and council websites by 1 October; second-half data were due 1 February 2014. Whether foreign companies interacting with French professionals were covered remained unresolved in 2013. By 2016, reports used a government portal and public website; only an agreement's existence initially had to be reported, with an update to include payment amounts pending.
EFPIA disclosure
EFPIA, with 40 corporate and 33 national-association members, adopted its Disclosure Code in June 2013 and amended it in 2014. In 2013, its earlier professional-interactions code encouraged publication of institutional donations and grants, while its patient-organisation code required reports on support beginning or continuing on 1 January 2012, first published by the first-quarter end of 2013. The codes applied to members, subsidiaries and affiliates and set minimum national standards.
The Disclosure Code required first reports in 2016 on 2015 data, annually within six months of year-end, on company websites or a central platform, in local languages with English encouraged. Its 2016 reporting categories and exclusions were as follows.
| Item | Scope |
|---|---|
| Donations and grants | Healthcare organisations only |
| Event costs | Registration, permissible travel and accommodation, and organisation sponsorship agreements with organisations or appointed event managers |
| Services and consultancy | Transfers could be summed per recipient and category rather than itemised individually |
| Exclusions | Transfers solely concerning over-the-counter medicines; unlisted transfers such as medical-utility items, meals, drinks and samples; ordinary medicine purchases and sales between companies and professionals or organisations |
Transfers included direct and indirect cash or in-kind benefits, and covered professionals in medicine, dentistry, pharmacy and nursing. Research-and-development support for nonclinical studies, clinical trials and qualifying non-interventional studies was aggregated, including studies collecting patient data from or on behalf of professionals specifically for the study. In 2016, aggregate reporting also applied where legal restrictions or lack of recipient consent prevented individual disclosure. For those legal restrictions, each category required total value, recipient numbers and their percentage of all recipients; research-and-development reporting instead used one jurisdiction-wide amount without accompanying detail.
Public disclosures were retained three years unless local law required less or consent was withdrawn; underlying records were retained at least five years unless local law required less. National associations had to incorporate requirements by 31 December 2013, with deviations allowed for national-law conflicts, including France, Denmark and Portugal. The Netherlands reported individual 2012 payments in 2013, whereas the UK's first reports aggregated 2012 relationships. By 2016 most associations used company sites, while Spain, the Netherlands and Belgium required unique country identifiers. Eucomed, representing devices, had not imposed reporting requirements in the 2013 and 2016 accounts.
Valuing medical writing and publication support
A 2010 account anticipated that practising physicians writing directly for industry might have their writing-service payments reported. Publication professionals interpreted manufacturer-funded writing support to physician authors in 2012 as a transfer of value, including support supplied through agencies or internal staff, and anticipated reporting data from publication professionals. No standard valuation model existed; objective market data, external valuation consultants or professional-society guidance could help manufacturers independently justify fair market value and develop data-capture systems with writers.
In 2013, the International Society for Medical Publication Professionals (ISMPP) considered publication support a transfer to covered authors, including contracted trial publications and other work such as reviews, covering intended journal submissions and professional-congress submissions or presentations. Manufacturer employees were not reportable; the society suggested this might extend to agency-employed or freelance writers paid by manufacturers. It offered two valuation approaches without a prescriptive algorithm.
- Divide actual project costs by all authors, including internal and non-US authors, then assign value only to external covered recipients.
- Estimate fair market value by publication type from average costs divided by average author numbers, using a manufacturer-selected representative sample.
By 2016, companies still interpreted writing-support reportability differently. Three positions were described.
- No: support benefits the manufacturer by meeting its ethical publication obligation, rather than benefiting the author.
- Yes: authors otherwise would have done the work or paid for it.
- Sometimes: clinical-study manuscript support is not a transfer, but requested support for investigator-initiated research is.
The argument against assigning value was that timely trial publication benefits manufacturers and that a reported transfer could be mistaken for payment for authorship, undermining authors, sponsors and results. Neither US rules nor EFPIA's code clearly resolved writing and editorial support; EFPIA's FAQs remained ambiguous. Companies had to publish methodological notes and could explain their writing-support decisions there, although that specific explanation was optional.
Reactions and payment data
In 2013, early reports described physicians unaware of publication-support reporting, concerned about individual allocations, requesting removal from sponsored papers or anticipating less participation as authors. Among 103 physicians in an Industry Standard Research study, 74% opposed sharing the data. Industry-communication representatives feared reporting errors and misuse by critics, the press or litigators, arguing that fair-market consulting, education and research payments could be misrepresented.
A 2014 commentary warned of confusion between research-drug donations and physician payments; trial funding including administration and drug costs might appear as one large payment to an investigator. In 2016, inconsistent company approaches were thought likely to confuse authors and potentially discourage investigator or author participation, losing clinical interpretation and possibly harming care. Such unintended effects, including delayed publications if clinicians declined writing support, remained possibilities rather than established outcomes in 2013.
Open Payments reportedly received eleven million hits in the first 24 hours after its September 2014 launch. On 1 October 2015, the BMJ published a feature covering payment types and the five largest paying companies, associated drugs and physician recipients. A 2017 report using 2015 data found that 48% of US physicians received industry-related payments totalling $2.4 billion, primarily general payments, with greater likelihood and value among surgical than primary-care specialties and men than women.