Open Payments and the Sunshine Act: marketing to clinicians

Every lunch a device representative brings to a practice, every honorarium for a talk and every flight to a training session can end up in a public federal database under the clinician’s name. The Physician Payments Sunshine Act, section 6002 of the Affordable Care Act, added section 1128G to the Social Security Act, codified at 42 U.S.C. 1320a-7h. CMS runs the reporting program under the name Open Payments and describes it as “a publicly accessible database of payments that reporting entities, including drug and medical device companies, make to covered recipients like physicians.”

This guide is for two readers: drug, device, biologic and medical supply companies that market to clinicians, and the practices whose clinicians are on the receiving end. It covers who reports, who is reported on, what counts as a payment, the categories in 42 CFR 403.904, the yearly review window, and what the HHS Office of Inspector General has said about speaker programs. The anti-kickback statute itself is covered in our guide to patient and physician referrals, and claims in device promotion are covered in our guide to medical device marketing claims. How a practice should describe manufacturer training, tier badges and paid roles in its own marketing is in our guide to promoting industry ties. Physician ownership of a hospital brings its own website and ad notices; see physician-owned hospital disclosure. Investigators who market their research site to sponsors will find claim rules in our guide to clinical research site marketing.

This is general information, not legal advice. Sources cited were checked on October 29, 2026: 42 U.S.C. 1320a-7h, 42 CFR 403.904 (current eCFR text), CMS Open Payments overview (page last modified June 30, 2026), Natures of Payment (June 5, 2026), Law and Policy (May 5, 2026), Data Overview (July 9, 2026), Covered Recipients and Reporting Entities (both September 2, 2026), 45 CFR 102.3, the OIG Special Fraud Alert on speaker programs (November 16, 2020) and 42 U.S.C. 1320a-7b(b). The reporting rules change through rulemaking, so check the current text before you rely on any detail.

Who reports and who is reported on

The statute puts the reporting duty on an “applicable manufacturer”, a manufacturer of a covered drug, device, biological or medical supply operating in the United States or a U.S. territory, possession or commonwealth, and on applicable group purchasing organizations. A covered product is one for which payment is available under Medicare, Medicaid or CHIP. CMS’s Reporting Entities page narrows that further: a covered drug or biological requires a prescription or a physician’s authorization to administer, and a covered device requires FDA premarket approval or premarket notification.

The statutory definition of a manufacturer reaches any entity engaged in the “production, preparation, propagation, compounding, or conversion” of a covered product, and also entities under common ownership that support its marketing, promotion, sale or distribution. CMS adds that distributors and wholesalers that hold title to a covered product are included. CMS lists exemptions, among them hospitals, hospital-based pharmacies and laboratories that make a covered product solely for their own use or their own patients. If you compound, read our guide to compounding pharmacy marketing alongside the CMS criteria.

Covered recipients are listed in 42 U.S.C. 1320a-7h(e)(6): physicians, teaching hospitals, physician assistants, nurse practitioners, clinical nurse specialists, certified registered nurse anesthetists and certified nurse-midwives. The non-physician practitioners were added by the SUPPORT for Patients and Communities Act of 2018 for information submitted on or after January 1, 2022. CMS also counts anesthesiologist assistants in this group, listing them next to certified registered nurse anesthetists in its Law and Policy page and in the CY 2022 Physician Fee Schedule final rule (86 FR 64996, November 19, 2021, checked October 29, 2026). Clinicians who are employees of the reporting manufacturer are excluded.

Physician ownership is reported too. Manufacturers and group purchasing organizations must report ownership and investment interests held by a physician or a physician’s immediate family member, other than publicly traded securities and mutual funds.

What counts as a payment or transfer of value

The statute defines a payment or other transfer of value as “a transfer of anything of value.” Under 42 CFR 403.904(a), the manufacturer reports direct and indirect payments to covered recipients, and payments made to a third party at the request of, or designated on behalf of, a covered recipient. A payment a clinician directs to a charity or a colleague is reported under the clinician’s name, with the name of the entity that received it.

Each record carries the recipient’s name as listed in the national provider enumeration system, primary business address, specialty, National Provider Identifier and at least one state license, plus the amount, the date, the form and the nature of the payment, and the marketed name of the related product. Since the 2018 amendment, NPIs are no longer withheld from the public data for information made available from 2022 onward.

Section 403.904(d) lists six forms: cash or cash equivalent; in-kind items or services; stock; stock option; any other ownership interest; and dividend, profit or other return on investment.

Section 403.904(e) lists eighteen natures, and the manufacturer picks the single one that best describes each payment:

Consulting fee
Compensation for services other than consulting, including serving as faculty or as a speaker at an event other than a continuing education program
Honoraria
Gift
Entertainment
Food and beverage
Travel and lodging (including the specified destinations)
Education
Research
Charitable contribution
Debt forgiveness
Royalty or license
Current or prospective ownership or investment interest
Compensation for serving as faculty or as a speaker for a medical education program
Long term medical supply or device loan
Grant
Space rental or facility fees (teaching hospital only)
Acquisitions

CMS’s Natures of Payment page gives examples for each. Two are directly about marketing: under Gift, “promotional items such as clocks or flash drives that have the company’s name printed on them”, and under Food and beverage, a salesperson who meets a physician for lunch to talk about a new drug and pays for the meal.

The meal in the break room

The in-office lunch is the payment a practice sees first hand, and the rule for it is specific. Under 42 CFR 403.904(g)(1), when a manufacturer provides food to a group and the cost of each person’s meal is not separately identifiable, “such as a platter provided to physicians in a group practice setting”, the manufacturer divides the total cost by everyone who ate, including office staff who are not covered recipients. It then reports that per-person value only for the covered recipients “who actually partook.”

Two consequences follow. Staff headcount lowers the per-person amount, so the manufacturer needs an honest count of who ate. And a clinician who did not eat should not be reported, which only works if someone records attendance. A sign-in sheet that records who actually ate protects both sides.

Under 403.904(g)(2), buffet meals, snacks, soft drinks or coffee made generally available to all participants of a large-scale conference or similar large-scale event do not need to be tracked or reported.

What is excluded

The statute and 42 CFR 403.904(h) exclude several categories from reporting. Among them:

Small payments below a threshold, unless the total to one recipient in the year passes an aggregate threshold. The original figures were set in the statute for 2013 and are adjusted by the consumer price index each year; under 403.904(h)(2)(ii), CMS publishes the values for each reporting year 90 days before it begins. Use the CMS figure for the year in question rather than a number from an older article.
Product samples, including coupons and vouchers for samples, not intended to be sold and intended for patient use.
Educational materials and items that directly benefit patients or are intended to be used by or with patients.
A short-term loan of a device or supply. The statute caps the trial period at 90 days, and CMS’s Law and Policy page says the exception applies for 90 total days in a calendar year, whether or not consecutive. A loan of 91 days or longer is reported as a long-term loan.
Discounts, including rebates.
In-kind items used for charity care.
Indirect payments through a third party where the manufacturer does not know the recipient’s identity.
Payments made solely in the context of a personal, non-business relationship.

A patient education brochure left in the waiting room is excluded. A branded gift for the clinician is not. The difference is who the item is for.

Speaker programs: what OIG warned about

On November 16, 2020, OIG issued a Special Fraud Alert on speaker programs, which it defined as company-sponsored events where a physician or other health care professional “makes a speech or presentation to other HCPs about a drug or device product or a disease state on behalf of the company.” Citing Open Payments data, OIG wrote that drug and device companies reported paying “nearly $2 billion” to health care professionals for speaker-related services in 2017 through 2019.

OIG stated that it is “skeptical about the educational value of such programs” and that the companies paying and the clinicians who speak or attend can face liability under the anti-kickback statute, 42 U.S.C. 1320a-7b(b), when the remuneration is meant to induce or reward prescribing or ordering of products paid for by federal health care programs. The alert lists characteristics that, taken separately or together, potentially indicate a problem. Paraphrased:

Little or no substantive information is presented.
Alcohol is available or a meal exceeding modest value is provided, with the concern heightened when the alcohol is free.
The location is not conducive to exchanging educational information, such as restaurants or entertainment or sports venues.
The company sponsors a large number of programs on the same or substantially the same topic or product, especially without recent substantive change in the information.
A significant period has passed with no new medical or scientific information or new FDA-approved or cleared indication for the product.
Clinicians attend the same or substantially the same program more than once, including after speaking at it.
Attendees include people with no legitimate business reason to be there, such as friends, family, members of the speaker’s own practice or staff of facilities where the speaker is medical director.
Sales or marketing units influence speaker selection, or speakers and attendees are chosen based on past or expected revenue from their prescribing or ordering.
Speakers are paid more than fair market value, or pay takes into account the volume or value of business they generate.

OIG notes that the list is illustrative, that no single factor decides the question, and that the lawfulness of any arrangement depends on the facts, circumstances and intent of the parties. It also says clinicians can get the same information from package inserts, third-party conferences, journals and online resources without any payment, and that the alert is not meant to discourage meaningful training and education. Open Payments disclosure does not make a payment lawful. A speaker fee that is reported correctly can still be a kickback. How grants for accredited education and faculty fees are reported is covered in our guide to CME and sponsored symposia.

Clinicians as content creators

Device and drug marketing now reaches clinicians’ own social accounts, podcasts and websites. When a manufacturer pays a covered recipient to create or present content, that payment is a transfer of value, and 403.904(e)(2) requires the manufacturer to report it under the single nature that best describes it. Free products given to a clinician to feature are reported in the in-kind form, unless they fit an exclusion such as samples intended for patient use.

Reporting to CMS and disclosing to the audience are separate duties. A clinician who posts about a product they were paid or given something to promote also has to disclose that connection to viewers under the FTC’s endorsement rules, which we cover in our guide to healthcare influencer marketing.

The yearly cycle and the review window

CMS’s Open Payments overview lays out the annual cycle. Reporting entities collect data from January 1 through December 31, submit it to CMS between February 1 and March 31 of the following year, and CMS publishes the data on or by June 30. Before publication, covered recipients get 45 days, April 1 through May 15, to review and dispute records attributed to them, and reporting entities have a further correction period through May 30. The 45-day minimum comes from 42 U.S.C. 1320a-7h(c)(1)(C)(ix).

CMS states that review is voluntary, that “CMS does not mediate disputes” and that a covered recipient who disputes a record works directly with the reporting entity. CMS publishes the data “exactly as it is received” and refreshes it each January. Its Covered Recipients page tells clinicians to check their data every year, because reporting entities can submit data from previous years. Research payments tied to products not yet approved or cleared can be delayed, up to four calendar years after the payment, under 42 U.S.C. 1320a-7h(c)(1)(E).

For a practice, that makes April a date for the calendar. A clinician who has to register in the CMS system before reviewing should do it ahead of the window.

Why this matters for a practice’s reputation

Open Payments data is public and searchable by anyone, patients included. CMS says it “does not comment on what relationships may be beneficial or potential conflicts of interest” and that the data “is open to individual interpretation.” A practice cannot change what was reported, but it can make sure the record is accurate and that its own pages are consistent with it.

If a clinician’s bio says they consult for or speak on behalf of a company, the public record will show payments, and that is consistent. If a bio or a blog post praises a product without mentioning a paid relationship that appears in Open Payments, a patient can find the gap. Keep a short list of each clinician’s current industry relationships and check it against the pages that mention products.

Penalties

Section 1320a-7h(b) sets civil money penalties for each payment, transfer of value or ownership interest a manufacturer or group purchasing organization fails to report on time, with a higher range for a knowing failure, and annual caps for each. HHS adjusts these amounts for inflation each year in the table at 45 CFR 102.3, so read the current table rather than the figures in the statute. Penalties under this section fall on the reporting entity. Clinicians’ exposure for the underlying arrangement comes from the anti-kickback statute and related laws, as the OIG alert explains.

State rules can add to the federal ones

The federal statute preempts state laws that require manufacturers to report the same type of information about payments to covered recipients, but under 1320a-7h(d)(3)(B) it does not preempt state requirements for information not of that type, reporting by other kinds of entities, or reporting to government agencies for public health or oversight purposes. That leaves room for state rules of those kinds, so a company marketing in more than one state checks each state’s rules as well.

Illustration: a device company’s regional lunch program

Illustration only, not a real company. A company that makes a device requiring FDA premarket notification plans lunch-and-learn visits to group practices in its region. Representatives bring catered platters, present a short product overview and leave branded pens and notepads. The plan also includes an evening speaker dinner at a restaurant, where a local surgeon who uses the device presents, and the invitation list is drawn from the practices with the highest order volume.

Reviewed against the sources above, the lunches are food and beverage records, allocated per 403.904(g)(1) by dividing the platter cost by everyone who ate and reported only for covered recipients who ate, so the representative needs a dated sign-in that records who ate. The branded pens and notepads are gifts, not patient education materials. The speaker dinner matches several characteristics in the OIG alert: a restaurant venue, attendees chosen by order volume, and a speaker who is also a customer. The surgeon’s fee is reportable as compensation for services other than consulting, and reporting it does not resolve the anti-kickback question.

The revised plan keeps the in-office presentations with an attendance log for every visit, replaces branded gifts with patient education materials, and moves the speaker program to the practices’ own meeting rooms with substantive content. Speakers are selected by expertise and paid a documented fair market value, invitations are not based on order history, and counsel reviews the program before it starts.

Checklist

Confirm whether your company is an applicable manufacturer or group purchasing organization under the CMS criteria, including any common-ownership affiliates.
Record every payment and item of value to physicians, teaching hospitals and the listed non-physician practitioners, with recipient identifiers, amount, date, form and nature.
Allocate group meals by everyone who ate, staff included, and report only covered recipients who ate.
Use the CMS-published small-payment thresholds for the year in question.
Run speaker programs against every characteristic in the 2020 OIG alert, with fair market value documented.
Separate patient education materials from gifts to clinicians.
Pair any paid clinician content with FTC endorsement disclosure to the audience.
Practices: register in Open Payments and review records between April 1 and May 15 each year.
Practices: keep each clinician’s industry relationships on file and consistent with bios and product mentions on your site.
Check state gift and disclosure rules for each state where you market.

How we help

We build websites, local search and Google Ads for independent health care businesses, and we check clinician bios, product pages and sponsored content against the rules above before anything goes live. See our medical website design work. Our AI front desk is built with HIPAA in mind and answers questions about hours, locations and services from a list you approve. We confirm in writing what a BAA covers before any patient information flows through a tool, and if it is not covered, we do not route patient information through it. We do not sell lead lists and do not pay for referrals. For the wider set of rules we follow, see our healthcare marketing rules hub.

What is Open Payments?

Open Payments is the CMS program that carries out the Physician Payments Sunshine Act, 42 U.S.C. 1320a-7h. Drug, device, biologic and medical supply manufacturers and group purchasing organizations report payments and transfers of value to covered recipients, and CMS publishes the data each year on or by June 30.

Who are covered recipients?

Physicians, teaching hospitals, physician assistants, nurse practitioners, clinical nurse specialists, certified registered nurse anesthetists, anesthesiologist assistants and certified nurse-midwives. Clinicians employed by the reporting manufacturer are excluded.

Is a lunch brought to our office reported?

If the manufacturer is a reporting entity, yes. Under 42 CFR 403.904(g)(1) the cost of a shared meal is divided by everyone who ate, including staff, and the per-person value is reported for each covered recipient who ate.

Is there a minimum amount before a payment is reported?

Yes. Payments below a small-payment threshold are excluded unless the yearly total to one recipient passes an aggregate threshold. Both figures are adjusted each year, and CMS publishes them before each reporting year begins.

Can a clinician dispute a record?

Yes. Covered recipients can review and dispute records between April 1 and May 15 before publication. CMS does not mediate disputes; the clinician works with the reporting entity, which can correct records through May 30.

Does reporting a speaker fee make it legal?

No. Open Payments is a disclosure program. Whether a payment is lawful depends on the anti-kickback statute and related laws, and OIG’s 2020 Special Fraud Alert describes speaker program features that raise concern.

Sources

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