[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"detail-sidebar-cat-1-en-105":3,"doc-seo-168725-105":53,"doc-detail-168725-en":127},{"code":4,"msg":5,"data":6},0,"success",[7,14,19,24,29,34,39,44,49],{"id":8,"doc_module":9,"doc_module_name":10,"category_name":11,"show_sort_weight":12,"slug":13},11,1,"Template","Presentations",90,"presentations",{"id":15,"doc_module":9,"doc_module_name":10,"category_name":16,"show_sort_weight":17,"slug":18},12,"Resumes",80,"resumes",{"id":20,"doc_module":9,"doc_module_name":10,"category_name":21,"show_sort_weight":22,"slug":23},14,"Invoices",70,"invoices",{"id":25,"doc_module":9,"doc_module_name":10,"category_name":26,"show_sort_weight":27,"slug":28},15,"Posters",60,"posters",{"id":30,"doc_module":9,"doc_module_name":10,"category_name":31,"show_sort_weight":32,"slug":33},16,"Social Media",50,"social-media",{"id":35,"doc_module":9,"doc_module_name":10,"category_name":36,"show_sort_weight":37,"slug":38},17,"Forms",40,"forms",{"id":40,"doc_module":9,"doc_module_name":10,"category_name":41,"show_sort_weight":42,"slug":43},18,"Letters",30,"letters",{"id":45,"doc_module":9,"doc_module_name":10,"category_name":46,"show_sort_weight":47,"slug":48},21,"Paper Templates",5,"papers-templates",{"id":50,"doc_module":9,"doc_module_name":10,"category_name":51,"show_sort_weight":4,"slug":52},158,"General","general-158",{"code":4,"msg":54,"data":55},"ok",{"site_id":56,"language":57,"slug":58,"title":59,"keywords":60,"description":61,"schema_data":62,"social_meta":120,"head_meta":122,"extra_data":124,"updated_unix":126},105,"en","self-disclosure-template-for-hrsa-opa-and-manufacturers-340b-noncompliance","Self-Disclosure Template for HRSA OPA and Manufacturers - 340B Noncompliance","","Comprehensive self-disclosure template for covered entities reporting 340B noncompliance to the Health Resources and Services Administration (HRSA) Office of Pharmacy Affairs (OPA) and, when needed, pharmaceutical manufacturers. It outlines responsibilities to correct noncompliance, distinguishes material vs. non-material breaches, and includes procedures for contacting HRSA and communicating with manufacturers. The template provides a sample HRSA OPA disclosure letter with sections for entity background, noncompliance summary, affected parties, internal and external corrective action plans, and a request for OPA action, emphasizing full transparency and good-faith remediation.",{"@graph":63,"@context":119},[64,80,102],{"@type":65,"itemListElement":66},"BreadcrumbList",[67,71,74,77],{"item":68,"name":69,"@type":70,"position":9},"https://docshare.wps.com","Home","ListItem",{"item":72,"name":10,"@type":70,"position":73},"https://docshare.wps.com/template/",2,{"item":75,"name":41,"@type":70,"position":76},"https://docshare.wps.com/template/letters/",3,{"item":78,"name":59,"@type":70,"position":79},"https://docshare.wps.com/template/self-disclosure-template-for-hrsa-opa-and-manufacturers-340b-noncompliance/168725/",4,{"url":78,"name":59,"@type":81,"image":82,"author":87,"headline":59,"publisher":90,"fileFormat":93,"inLanguage":57,"description":61,"dateModified":94,"datePublished":95,"encodingFormat":93,"isAccessibleForFree":96,"interactionStatistic":97},"DigitalDocument",{"url":83,"@type":84,"width":85,"height":86},"https://docshare.wps.com/thumbnails/self-disclosure-template-for-hrsa-opa-and-manufacturers-340b-noncompliance/168725.png","ImageObject",442,249,{"name":88,"@type":89},"Himbo","Person",{"url":68,"name":91,"@type":92},"DocShare","Organization","application/vnd.openxmlformats-officedocument.wordprocessingml.document","2026-09-26","2026-09-01",true,{"@type":98,"interactionType":99,"userInteractionCount":101},"InteractionCounter",{"@type":100},"ViewAction",6,{"@type":103,"mainEntity":104},"FAQPage",[105,111,115],{"name":106,"@type":107,"acceptedAnswer":108},"When is HRSA OPA self-disclosure required for 340B noncompliance?","Question",{"text":109,"@type":110},"Self-disclosure to HRSA is required for material breaches. For non-material breaches, work directly with the manufacturer(s) to resolve the issue.","Answer",{"name":112,"@type":107,"acceptedAnswer":113},"What information should be included in the noncompliance summary section?",{"text":114,"@type":110},"Include when the issue occurred (date range), the cause, how and when it was first identified, the scope, and details relevant to the issue type (e.g., eligibility timing, diversion/patient definition periods, affected sites, and involved vendors).",{"name":116,"@type":107,"acceptedAnswer":117},"What corrective actions should be addressed in the letter?",{"text":118,"@type":110},"Provide internal corrective actions with dates and planned steps, plus external corrective actions involving parties beyond the entity (including manufacturers and Medicaid when applicable). Best practice is to disclose the full extent of noncompliance and coordinate remediation with each manufacturer prior to corrective steps.","https://schema.org",{"og:url":78,"og:type":121,"og:title":59,"og:site_name":91,"og:description":61},"article",{"robots":123,"canonical":78},"index,follow",{"doc_id":125,"site_id":56},168725,1790298673,{"code":4,"msg":5,"data":128},{"doc_id":125,"user_id":129,"nickname":88,"user_avatar":130,"doc_module":9,"category_id":40,"category_name":41,"doc_title":59,"doc_description":61,"doc_content":131,"file_id":132,"file_url":133,"file_type":134,"file_size":135,"view_count":101,"is_deleted":4,"is_public":9,"is_downloadable":9,"audit_status":9,"page_count":136,"language":137,"language_code":57,"site_id":56,"html_lang":57,"table_of_contents":138,"faqs":139,"seo_title":140,"seo_description":61,"update_tm":141,"read_time":76},687197100911,"https://ap-avatar.wpscdn.com/avatar/a000239b6f1da00475?x-image-process=image/resize,m_fixed,w_180,h_180&k=1785132997149421697","Purpose: This tool provides a comprehensive template for entities self-reporting 340B noncompliance to the Health Resources and Services Administration’s (HRSA’s) Office of Pharmacy Affairs (OPA) and/or pharmaceutical manufacturers.\nBackground/Instructions: Covered entities are responsible for correcting any instance of noncompliance with 340B Program requirements. Once an issue is identified, the entity should follow its material breach policy requiring self-disclosure to HRSA (see 340B PVP Education Tool: \u0013 HYPERLINK \"https://www.340bpvp.com/Documents/Public/340B%20Tools/establishing-material-breach-threshold.docx\" \u0014Establishing Material Breach Threshold\u0015); however, it is likely that the manufacturer will need to be contacted regardless of materiality for diversion and duplicate discount compliance issues:\nNon-material breach: work with manufacturer(s) directly to resolve issue\nMaterial breach: self-disclose to HRSA and work with manufacturer(s) to resolve. Covered entity should email letter to \u0013 HYPERLINK \"mailto:340bselfdisclosure@hrsa.gov\" \u0014340bselfdisclosure@hrsa.gov\u0015\nThis tool includes the following resources to support resolving noncompliance:\nSample letter for disclosure to HRSA OPA\nRecommendations for disclosing noncompliance to manufacturers\nNOTE: Transparency with all parties is critical. Best practice for covered entities is to disclose the full extent and duration of the breach of compliance. The covered entity is expected to work in good faith with any affected manufacturer to mutually agree on a plan to address all breaches of compliance and how restitutions should be made.\n\u000f\nSample Letter to HRSA OPA\n[Place letter on covered entity letterhead]\nDate: [Date]\nDirector, Office of Pharmacy Affairs\u000bHealth Resources and Services Administration\nRe: [Entity Name; 340B ID Number]\nDear [Director, HRSA OPA]:\nThe purpose of this letter is to disclose a 340B compliance issue regarding [issue such as duplicate discount, patient definition, GPO Prohibition] and describe a plan for corrective action.\n[Entity] ([340B ID Numbers]) discloses that the compliance issues presented in this letter occurred and that it is dedicated to achieving complete compliance with 340B requirements and prohibitions. [Entity] offers this letter to provide a summary of the circumstance and a transparent plan for corrective action.\nEntity and Partner Background\n[Entity] is a [340B Entity type] located in [City, State] and has participated in the 340B Program since [date]. (Include the following text if relevant: [Entity] contracts with [Vendor] to provide [describe services] at [Location(s) at issue].)\nSummary of Noncompliance\n[Brief description] occurred during [date range] and was caused by [description]. The issue was first identified on [date, method]. [Insert detailed description of the issue and scope] (Examples of the types of details to provide include: If the issue deals with eligibility, then when did the covered entity believe it became ineligible? How does this date compare to the date in 340B OPAIS? Or, if the issue relates to diversion or patient definition, what time period was involved? If the issue affected only some covered entity sites, which sites? If the issue involved a particular vendor or vendors, which ones and why?)\nExternal Affected Parties\n[Entity] has identified the following external parties that may have been affected: (e.g., manufacturers, contract pharmacies, wholesalers. List should reflect level of detail known at time of disclosure/update; covered entity may be unable to identify all categories of external parties at the time of initial disclosure).\n\u000f\nCorrective Action Plan\nInternal Corrective Action Plan (within entity/partners)\n[Entity] has taken corrective actions including: [description, including dates, such as evaluation/change of software/vendor, changes to policy and procedure manual, contact/action with partners such as vendors/Medicaid, changes to 340B OPAIS/Medicaid Exclusion File information]\u000b\u000b[Entity] ","cbCaijWCAJAip1oi","https://ap.wps.com/l/cbCaijWCAJAip1oi","docx",71628,7,"English","# Purpose and Background\n## Material vs. Non-Material Breach Guidance\n## HRSA OPA Self-Disclosure Email and Transparency Expectations\n# Sample Letter to HRSA OPA\n## Letter Header and Re: Topic\n## Entity and Partner Background\n## Summary of Noncompliance\n## External Affected Parties\n## Corrective Action Plan\n## Request for OPA Action","[{\"question\":\"When is HRSA OPA self-disclosure required for 340B noncompliance?\",\"answer\":\"Self-disclosure to HRSA is required for material breaches. For non-material breaches, work directly with the manufacturer(s) to resolve the issue.\"},{\"question\":\"What information should be included in the noncompliance summary section?\",\"answer\":\"Include when the issue occurred (date range), the cause, how and when it was first identified, the scope, and details relevant to the issue type (e.g., eligibility timing, diversion/patient definition periods, affected sites, and involved vendors).\"},{\"question\":\"What corrective actions should be addressed in the letter?\",\"answer\":\"Provide internal corrective actions with dates and planned steps, plus external corrective actions involving parties beyond the entity (including manufacturers and Medicaid when applicable). Best practice is to disclose the full extent of noncompliance and coordinate remediation with each manufacturer prior to corrective steps.\"}]","Self-Disclosure Template for HRSA OPA and Manufacturers - 340B Noncompliance | DOCX",1788236192]