--- title: "340B, 340B Drug Pricing Program | MedTech Terms" description: "Federal program providing discounted drugs to safety-net providers. Plain-English Reimbursement definition for MedTech teams, with examples and related terms." lang: en json-ld: | { "@context": "https://schema.org", "@graph": [ { "@type": "DefinedTerm", "@id": "https://medtechterms.com/terms/340b#term", "name": "340B Drug Pricing Program", "alternateName": "340B", "description": "340B requires drug manufacturers to offer outpatient drugs at discounted prices to covered entities including disproportionate-share hospitals, FQHCs, and other safety-net providers. Primarily a drug program, it intersects with combination products and physician-administered drug-device pairs.", "url": "https://medtechterms.com/terms/340b", "termCode": "340b", "inDefinedTermSet": { "@type": "DefinedTermSet", "name": "MedTech Terms", "url": "https://medtechterms.com/terms" } }, { "@type": "Article", "@id": "https://medtechterms.com/terms/340b#article", "headline": "340B, 340B Drug Pricing Program", "description": "Federal program providing discounted drugs to safety-net providers.", "url": "https://medtechterms.com/terms/340b", "mainEntityOfPage": { "@type": "WebPage", "@id": "https://medtechterms.com/terms/340b" }, "about": { "@id": "https://medtechterms.com/terms/340b#term" }, "articleSection": "Reimbursement", "inLanguage": "en", "keywords": "340B Drug Pricing Program, 340B, Reimbursement, 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": "HRSA 340B", "url": "https://www.hrsa.gov/opa", "publisher": { "@type": "Organization", "name": "HRSA" } }, { "@type": "CreativeWork", "name": "AdvaMed - Payment & Coverage", "url": "https://www.advamed.org/our-work/", "publisher": { "@type": "Organization", "name": "AdvaMed" } }, { "@type": "CreativeWork", "name": "AMA CPT Resources", "url": "https://www.ama-assn.org/practice-management/cpt", "publisher": { "@type": "Organization", "name": "AMA" } } ], "mentions": [ { "@type": "DefinedTerm", "@id": "https://medtechterms.com/terms/combination-product#term", "name": "Combination Product", "url": "https://medtechterms.com/terms/combination-product" } ] }, { "@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": "Reimbursement", "item": "https://medtechterms.com/terms?cat=Reimbursement" }, { "@type": "ListItem", "position": 4, "name": "340B Drug Pricing Program", "item": "https://medtechterms.com/terms/340b" } ] }, { "@type": "FAQPage", "@id": "https://medtechterms.com/terms/340b#faq", "mainEntity": [ { "@type": "Question", "name": "What is the primary goal of the 340B program?", "acceptedAnswer": { "@type": "Answer", "text": "The primary goal is to enable eligible healthcare providers, known as 'covered entities,' to purchase outpatient drugs at discounted prices, thereby stretching federal resources and providing more comprehensive services to their communities." } }, { "@type": "Question", "name": "How does 340B impact MedTech manufacturers?", "acceptedAnswer": { "@type": "Answer", "text": "MedTech manufacturers, particularly those producing combination products or physician-administered drug-device pairs, must assess if their products contain a drug component subject to 340B pricing requirements, which can affect their market strategy and pricing models." } }, { "@type": "Question", "name": "What are the compliance risks for covered entities?", "acceptedAnswer": { "@type": "Answer", "text": "Covered entities face risks such as drug diversion, duplicate discounts (where both 340B and Medicaid rebates are claimed), and non-compliance with patient eligibility criteria, all of which can lead to sanctions or repayment obligations." } } ] } ] } --- [ MedTech Terms The authoritative reference ](/) Browse Learn [Latest](/latest) About 1. [Home](/) 2. / 3. [Terms](/terms) 4. / 5. [Reimbursement](/terms?cat=Reimbursement) 6. / 7. 340B Drug Pricing Program [All terms](/terms) Reimbursement [Hospital Buyer & Reimbursement](/ecosystems/hospital-buyer)[Startup Lifecycle](/ecosystems/startup-lifecycle)340B # 340B Drug Pricing Program Federal program providing discounted drugs to safety-net providers. Reviewed by [Christian Espinosa, Founder, Blue Goat Cyber](/authors/christian-espinosa) Last reviewed May 5, 2026 ## Definition 340B requires drug manufacturers to offer outpatient drugs at discounted prices to covered entities including disproportionate-share hospitals, FQHCs, and other safety-net providers. Primarily a drug program, it intersects with combination products and physician-administered drug-device pairs. What the regulation says The 340B Drug Pricing Program is authorized by Section 340B of the Public Health Service Act. The Health Resources and Services Administration (HRSA) is responsible for administering the program, including oversight of covered entities and manufacturers to ensure compliance with 340B requirements. HRSA issues guidance and maintains a public database for registered covered entities and participating manufacturers, as outlined in official program documents. ## What this means in practice Affects pricing strategy for combination products and physician-administered therapeutics distributed through 340B-eligible sites. ## Examples - A manufacturer of a pre-filled syringe (a combination product) containing an outpatient drug must evaluate if that drug component is subject to 340B pricing when sold to a covered entity. - A disproportionate-share hospital, as a 340B covered entity, purchases insulin pens at a discounted 340B price for its eligible outpatients. - A pharmaceutical company ensures its contract pharmacies adhere to 340B program rules for dispensing eligible drugs to covered entity patients. Common pitfalls - • A common pitfall is misinterpreting which specific drug-device combination products are subject to 340B discounts, leading to incorrect pricing or compliance issues. - • Failing to maintain accurate records of 340B eligible purchases and distributions can result in HRSA audits and potential sanctions. - • Manufacturers may incorrectly classify drugs, including those in combination products, as exempt from 340B discounts. - • Covered entities might not have robust systems to prevent diversion of 340B-purchased drugs to ineligible patients or for ineligible uses. - • Not staying updated on HRSA guidance and policy changes can lead to inadvertent non-compliance. ## Frequently asked questions What is the primary goal of the 340B program? The primary goal is to enable eligible healthcare providers, known as 'covered entities,' to purchase outpatient drugs at discounted prices, thereby stretching federal resources and providing more comprehensive services to their communities. How does 340B impact MedTech manufacturers? What are the compliance risks for covered entities? ## Related terms Grouped by theme ### Editor's picks · Hand-selected related concepts [ Regulatory Combination Product Product comprised of two or more regulated components - e.g., drug-device, biologic-device. ](/terms/combination-product) ### More in Reimbursement · Same category [ Reimbursement Ambulatory Payment Classification(APC) The Medicare grouping system that determines hospital outpatient payment amounts under OPPS, analogous to MS-DRGs for inpatient. ](/terms/apc)[ Reimbursement ASC Site-of-Service Shift Migration of procedures from hospitals to ambulatory surgery centers. ](/terms/asc-shift)[ Reimbursement Budget Impact Model(BIM) Financial model that estimates the total cost consequences of adopting a new technology to a payer's budget over a defined horizon. ](/terms/budget-impact-model)[ Reimbursement Bundled Payment Single payment that covers all services for an episode of care. ](/terms/bundled-payment) Cited by Where this term appears across MedTech Terms. Ecosystems (2) - [Hospital Buyer & Reimbursement](/ecosystems/hospital-buyer) - [Startup Lifecycle](/ecosystems/startup-lifecycle) ## Primary references 3 sources Link health: 3 verified · last checked 2026-06-20 HRSA· 1 AdvaMed· 1 AMA· 1 1. [1 HRSA 340B Verified HRSA · hrsa.gov ](https://www.hrsa.gov/opa) 2. [2 AdvaMed - Payment & Coverage Verified AdvaMed · advamed.org ](https://www.advamed.org/our-work/) 3. [3 AMA CPT Resources Verified AMA · ama-assn.org ](https://www.ama-assn.org/practice-management/cpt) Inline markers like \[1\] jump to the matching reference above. Sponsor note ### Need cybersecurity expertise on a connected-device launch? Blue Goat Cyber helps MedTech teams ship connected products that hospital security teams will actually procure. [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 Reimbursement Acronym 340B Sources 3 Updated 5/5/2026 [Compare with another term](/compare?a=340b) Learn in 60 seconds Card Lesson Quiz Federal program providing discounted drugs to safety-net providers. - · Affects pricing strategy for combination products and physician-administered therapeutics distributed through 340B-eligible sites. - · Primarily a drug program, it intersects with combination products and physician-administered drug-device pairs. Remember this Watch out: A common pitfall is misinterpreting which specific drug-device combination products are subject to 340B discounts, leading to incorrect pricing or compliance issues. Related terms - [Combination Product ](/terms/combination-product) You may also need Auto-suggested from Reimbursement and shared keywords. - [Physician Payments Sunshine Act ](/terms/sunshine-act) - [Emergency Use Authorization(EUA) ](/terms/eua) - [HIPAA(HIPAA) ](/terms/hipaa) - [HCPCS Codes(HCPCS) ](/terms/hcpcs) - [New Technology Add-On Payment(NTAP) ](/terms/ntap) - [Prior Authorization ](/terms/prior-authorization) [All Reimbursement terms](/terms?cat=Reimbursement) 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)