--- title: "Physician Payments Sunshine Act, Definition | MedTech Terms" description: "U.S. law requiring disclosure of payments to physicians and teaching hospitals. Plain-English Commercialization definition for MedTech teams, with examples and" lang: en json-ld: | { "@context": "https://schema.org", "@graph": [ { "@type": "DefinedTerm", "@id": "https://medtechterms.com/terms/sunshine-act#term", "name": "Physician Payments Sunshine Act", "description": "The Sunshine Act (Open Payments program) requires manufacturers of drugs, devices, biologics, and medical supplies covered by Medicare/Medicaid/CHIP to report transfers of value to physicians, certain non-physician practitioners, and teaching hospitals.", "url": "https://medtechterms.com/terms/sunshine-act", "termCode": "sunshine-act", "inDefinedTermSet": { "@type": "DefinedTermSet", "name": "MedTech Terms", "url": "https://medtechterms.com/terms" } }, { "@type": "Article", "@id": "https://medtechterms.com/terms/sunshine-act#article", "headline": "Physician Payments Sunshine Act", "description": "U.S. law requiring disclosure of payments to physicians and teaching hospitals.", "url": "https://medtechterms.com/terms/sunshine-act", "mainEntityOfPage": { "@type": "WebPage", "@id": "https://medtechterms.com/terms/sunshine-act" }, "about": { "@id": "https://medtechterms.com/terms/sunshine-act#term" }, "articleSection": "Commercialization", "inLanguage": "en", "keywords": "Physician Payments Sunshine Act, Commercialization, medical device, MedTech", "author": { "@type": "Person", "name": "Christian Espinosa", "jobTitle": "Founder, Blue Goat Cyber", "url": "https://bluegoatcyber.com" }, "publisher": { "@type": "Organization", "name": "MedTech Terms", "url": "https://medtechterms.com" }, "isPartOf": { "@type": "WebSite", "name": "MedTech Terms", "url": "https://medtechterms.com" }, "datePublished": "2026-05-05", "dateModified": "2026-05-05", "citation": [ { "@type": "CreativeWork", "name": "CMS Open Payments", "url": "https://www.cms.gov/openpayments", "publisher": { "@type": "Organization", "name": "CMS" } }, { "@type": "CreativeWork", "name": "AdvaMed Code of Ethics", "url": "https://www.advamed.org/our-work/code-of-ethics/", "publisher": { "@type": "Organization", "name": "AdvaMed" } }, { "@type": "CreativeWork", "name": "AHRMM - Healthcare Supply Chain", "url": "https://www.ahrmm.org/", "publisher": { "@type": "Organization", "name": "AHRMM" } } ], "mentions": [ { "@type": "DefinedTerm", "@id": "https://medtechterms.com/terms/kol#term", "name": "Key Opinion Leader", "alternateName": "KOL", "url": "https://medtechterms.com/terms/kol" }, { "@type": "DefinedTerm", "@id": "https://medtechterms.com/terms/advisory-board#term", "name": "Advisory Board", "url": "https://medtechterms.com/terms/advisory-board" }, { "@type": "DefinedTerm", "@id": "https://medtechterms.com/terms/anti-kickback#term", "name": "Anti-Kickback Statute", "alternateName": "AKS", "url": "https://medtechterms.com/terms/anti-kickback" } ] }, { "@type": "BreadcrumbList", "itemListElement": [ { "@type": "ListItem", "position": 1, "name": "Home", "item": "https://medtechterms.com/" }, { "@type": "ListItem", "position": 2, "name": "Terms", "item": "https://medtechterms.com/terms" }, { "@type": "ListItem", "position": 3, "name": "Commercialization", "item": "https://medtechterms.com/terms?cat=Commercialization" }, { "@type": "ListItem", "position": 4, "name": "Physician Payments Sunshine Act", "item": "https://medtechterms.com/terms/sunshine-act" } ] }, { "@type": "FAQPage", "@id": "https://medtechterms.com/terms/sunshine-act#faq", "mainEntity": [ { "@type": "Question", "name": "What types of payments must be reported under the Sunshine Act?", "acceptedAnswer": { "@type": "Answer", "text": "Manufacturers must report a broad range of transfers of value, including consulting fees, research grants, meals, travel, educational items, and charitable contributions, if they exceed certain thresholds outlined by CMS." } }, { "@type": "Question", "name": "Who is considered an 'applicable manufacturer' under the Act?", "acceptedAnswer": { "@type": "Answer", "text": "An 'applicable manufacturer' is generally defined as an entity that operates in the United States and is engaged in the production, preparation, propagation, compounding, or conversion of a covered drug, device, biological, or medical supply for sale or distribution." } }, { "@type": "Question", "name": "Who are 'covered recipients' for reporting purposes?", "acceptedAnswer": { "@type": "Answer", "text": "'Covered recipients' include physicians (medical doctors, osteopathic doctors, dentists, optometrists, podiatrists, and chiropractors), certain non-physician practitioners (physician assistants, nurse practitioners, clinical nurse specialists, certified registered nurse anesthetists, and certified nurse midwives), and teaching hospitals." } }, { "@type": "Question", "name": "What are the penalties for non-compliance with the Sunshine Act?", "acceptedAnswer": { "@type": "Answer", "text": "Non-compliance can result in significant civil monetary penalties, both for failing to report and for knowingly submitting false information, as stipulated in the Social Security Act, Section 1128G." } } ] } ] } --- [ MedTech Terms The authoritative reference ](/) Browse Learn [Latest](/latest) About 1. [Home](/) 2. / 3. [Terms](/terms) 4. / 5. [Commercialization](/terms?cat=Commercialization) 6. / 7. Physician Payments Sunshine Act [All terms](/terms) Commercialization [Hospital Buyer & Reimbursement](/ecosystems/hospital-buyer) # Physician Payments Sunshine Act U.S. law requiring disclosure of payments to physicians and teaching hospitals. Reviewed by [Christian Espinosa, Founder, Blue Goat Cyber](/authors/christian-espinosa) Last reviewed May 5, 2026 ## Definition The Sunshine Act (Open Payments program) requires manufacturers of drugs, devices, biologics, and medical supplies covered by Medicare/Medicaid/CHIP to report transfers of value to physicians, certain non-physician practitioners, and teaching hospitals. What the regulation says The Physician Payments Sunshine Act, also known as the Open Payments program, mandates that applicable manufacturers report payments and other transfers of value made to covered recipients to the Centers for Medicare & Medicaid Services (CMS), as detailed in 42 CFR Part 403, Subpart I. This regulation aims to increase transparency regarding financial relationships between the healthcare industry and healthcare providers, aligning with broader transparency initiatives from bodies like the FDA regarding medical device marketing practices. ## What this means in practice Reported annually by CMS and publicly searchable. Mis-reporting creates reputational and enforcement risk; [KOL](/terms/kol) agreements must be FMV and well-documented. ## Examples - A medical device company pays a surgeon a consulting fee for their expertise in developing a new surgical tool, requiring this payment to be reported to CMS. - A pharmaceutical manufacturer sponsors a physician's travel and accommodation to attend an educational conference where their drug is discussed, necessitating disclosure under the Open Payments program. - A MedTech company provides a research grant to a teaching hospital for a study involving their diagnostic equipment, which then must be reported to CMS. Common pitfalls - • Failing to accurately categorize transfers of value can lead to misreporting and penalties. - • Inadequate documentation of fair market value for key opinion leader (KOL) agreements can result in non-compliance. - • Overlooking indirect payments or transfers of value made through third parties can lead to enforcement actions. - • Not understanding the specific definitions of "applicable manufacturer" and "covered recipient" can lead to reporting errors. ## Frequently asked questions What types of payments must be reported under the Sunshine Act? Manufacturers must report a broad range of transfers of value, including consulting fees, research grants, meals, travel, educational items, and charitable contributions, if they exceed certain thresholds outlined by CMS. Who is considered an 'applicable manufacturer' under the Act? Who are 'covered recipients' for reporting purposes? What are the penalties for non-compliance with the Sunshine Act? ## Related terms Grouped by theme ### Editor's picks · Hand-selected related concepts [ Commercialization Advisory Board Convening of external experts to advise on strategy or product. ](/terms/advisory-board)[ Commercialization Anti-Kickback Statute(AKS) U.S. criminal statute prohibiting remuneration to induce federal healthcare business. ](/terms/anti-kickback)[ Commercialization Key Opinion Leader(KOL) Influential clinician who shapes peer practice and adoption. ](/terms/kol) ### More in Commercialization · Same category [ Commercialization AdvaMed Code of Ethics Industry code governing interactions between U.S. medical-device companies and healthcare professionals. ](/terms/advamed-code)[ Commercialization Bottom-Up Market Sizing Building market size from procedure volumes × price × penetration. ](/terms/bottom-up-sizing)[ Commercialization Distributor vs Direct Sales Choice between selling through third-party distributors or hiring a direct salesforce. ](/terms/distributor-direct)[ Commercialization Field Clinical Engineer(FCE) Manufacturer representative providing clinical and technical support in the OR or cath lab. ](/terms/field-clinical-engineer) Cited by Where this term appears across MedTech Terms. Ecosystems (1) - [Hospital Buyer & Reimbursement](/ecosystems/hospital-buyer) ## Primary references 3 sources Link health: 3 verified · last checked 2026-06-20 CMS· 1 AdvaMed· 1 AHRMM· 1 1. [1 CMS Open Payments Verified CMS · cms.gov ](https://www.cms.gov/openpayments) 2. [2 AdvaMed Code of Ethics Verified AdvaMed · advamed.org ](https://www.advamed.org/our-work/code-of-ethics/) 3. [3 AHRMM - Healthcare Supply Chain Verified AHRMM · ahrmm.org ](https://www.ahrmm.org/) Inline markers like \[1\] jump to the matching reference above. Sponsor note ### Selling a connected device into health systems? Hospital procurement increasingly requires MDS2, SBOM, and security questionnaires - we help your team answer them confidently. [Book a 30-minute discovery session](https://go.bluegoatcyber.com/meetings/blue-goat-cyber/discovery-session) - No obligation - Expert-led from minute one - NDA available on request MedTech Terms is a community resource sponsored by [Blue Goat Cyber](https://bluegoatcyber.com). Definitions are independent of any vendor. On this term Category Commercialization Sources 3 Updated 5/5/2026 [Compare with another term](/compare?a=sunshine-act) Learn in 60 seconds Card Lesson Quiz U.S. law requiring disclosure of payments to physicians and teaching hospitals. - · Reported annually by CMS and publicly searchable. - · Mis-reporting creates reputational and enforcement risk; KOL agreements must be FMV and well-documented. Remember this Watch out: Failing to accurately categorize transfers of value can lead to misreporting and penalties. Related terms - [Key Opinion Leader(KOL) ](/terms/kol) - [Advisory Board ](/terms/advisory-board) - [Anti-Kickback Statute(AKS) ](/terms/anti-kickback) You may also need Auto-suggested from Commercialization and shared keywords. - [Medicare Physician Fee Schedule(MPFS) ](/terms/physician-fee-schedule) - [340B Drug Pricing Program(340B) ](/terms/340b) - [Stark Law ](/terms/stark-law) - [AAMI TIR97(TIR97) ](/terms/aami-tir97) - [Medical Device Reporting (FDA)(MDR) ](/terms/mdr-reporting) - [Off-Label Use ](/terms/off-label-use) [All Commercialization terms](/terms?cat=Commercialization) MedTech Terms An authoritative, plain-language reference for the regulatory, quality, cybersecurity, and software terms that shape modern medical devices. Browse - [All terms](/terms) - [A–Z index](/a-z) - [Categories](/categories) - [Ecosystems](/ecosystems) - [Learning paths](/paths) - [Compare terms](/compare) - [Quiz](/quiz) Resources - [FDA Medical Devices](https://www.fda.gov/medical-devices) - [EU MDR](https://eur-lex.europa.eu/eli/reg/2017/745/oj) - [IMDRF](https://www.imdrf.org/) - [Methodology](/methodology) - [Changelog](/changelog) - [Editor: Christian Espinosa](/authors/christian-espinosa) - [About this site](/about) © 2026 MedTech Terms. Reference content for educational purposes - not regulatory advice. A community resource sponsored by [Blue Goat Cyber](https://bluegoatcyber.com)