[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"doc-seo-282211-105":3,"detail-sidebar-cat-1-en-105":81,"doc-detail-282211-en":127},{"code":4,"msg":5,"data":6},0,"ok",{"site_id":7,"language":8,"slug":9,"title":10,"keywords":11,"description":12,"schema_data":13,"social_meta":74,"head_meta":76,"extra_data":78,"updated_unix":80},105,"en","340b-policy-to-practice-guide-compliance","340B Policy to Practice Guide - Compliance","","340B Policy to Practice Guide provides sample, real-world approaches for implementing 340B requirements with compliance. It is designed for 340B entity leaders and focuses on the relationship between the covered entity and health care professionals, including the 340B Patient Definition and referrals to outside providers. The guide highlights auditable documentation practices, explains common operational challenges, and outlines actionable steps to build referral agreements and verification workflows that support pharmacy access and HRSA compliance 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responsibilities and communication, map a consistent process across medical record, provider, and pharmacy staff, maintain lists of contracted providers and NPI numbers, and implement verification workflows that exclude prescriptions lacking an approved referral agreement from 340B 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practices or that have recently been audited by HRSA with no adverse audit findings. This particular Policy to Practice Guide is intended for 340B entity leaders and provides information about referrals to outside health care professionals and the 340B Patient Definition.  \nInstructions: This guide is does not represent the only approach to applying this particular policy to practice. Entities are encouraged to consult their compliance and legal staff to determine how to best implement 340B policies into practice at their site. Endorsement of the content of This Guide by the Office of Pharmacy Affairs is not stated or implied.  \nPolicy: The 340B Patient Definition addresses the health care professional-entity relationship  \n( [http://www.hrsa.gov/opa/programrequirements/federalregisternotices/patientandentityeligibi](http://www.hrsa.gov/opa/programrequirements/federalregisternotices/patientandentityeligibi)[lity102496.pdf](lity102496.pdf)) . An excerpt of the 340B Patient Definition appears below:  \n“2. The individual receives health care services from a health care professional who is either employed by the covered entity or provides health care under contractual or other arrangements (e.g. referral for consultation) such that responsibility for the care provided remains with the covered entity…”  \nPractice: Entities report increased confidence that referral prescriptions are being documented in a compliant and auditable manner by including criteria below as part of their operational process:  \n• The 340B entity maintains documentation in the entity’s record of health care that justifies the 340B entity had responsibility for the health care resulting in the 340B prescription.  \n• Documentation of the both the request for referral, as well as a summary of the referral visit, is accessible in the patient’s medical record.  \n• Entities typically require that documentation or verification of referral and the resulting summary of referral visit be accessible to the pharmacy filling the prescription.  \n• Some entities do not have adequate systems in place to consistently document referrals, and have faced challenges in implementing referral prescriptions using 340B. Attributes that entities have discussed as contributing to these challenges include: large/complex health systems, high number of health care professionals used for referrals, lack of confidence that staff documents referrals consistently in the patient’s medical record, lack of pharmacy (or contract pharmacy) access to accurate information about referral care, etc. ) . These organizations often exclude referral prescriptions from 340B.  \nAction Steps: Entities report taking the following actions to establish systems to document referrals for 340B patients:  \n• Contact select priority health care professionals/groups that are important to the continuity of patient care to establish referral contracts.  \n• Meet with health care professional/group which the entity wants to establish a referral contract, to make sure they understand the entity’s responsibilities associated with the 340B Patient Definition.  \n• Create a referral agreement that explains the 340B entity’s responsibility for care and expected communication between organizations.  \n• Sketch out process (possibly including medical record’s staff, health care professional staff, and pharmacy staff) to make sure the covered entity can input and access required documentation consistently, be able to retrieve the documentation and/or view it, to demonstrate the patient referral from the entity health care professional.  \n• Ensure the covered entity pharmacy has an easily accessible list of health care professional names and NPI \\#’s for each contracted referral health care professional or grou","cbCaim1nde0WKLco","https://ap.wps.com/l/cbCaim1nde0WKLco","pdf",747227,"English","# Policy\n## 340B Patient Definition\n# Practice\n## Referral documentation requirements\n## Common implementation challenges\n# Action Steps\n## Referral contracts and agreements\n## Operational verification workflows\n## Contract pharmacy coordination","[{\"question\":\"What does the 340B Patient Definition require for referrals?\",\"answer\":\"It requires that the individual receives services from a health care professional either employed by the covered entity or providing care under contractual arrangements (including referrals for consultation) such that responsibility for the care remains with the covered entity.\"},{\"question\":\"How can entities ensure referral prescriptions are documented compliantly and audibly?\",\"answer\":\"Entities document responsibility for the care tied to the 340B prescription, keep both the referral request and referral-visit summary accessible in the patient’s medical record, and provide pharmacy access to the required referral documentation.\"},{\"question\":\"What actions help entities build systems to document 340B referrals?\",\"answer\":\"Entities establish referral contracts, create referral agreements defining responsibilities and communication, map a consistent process across medical record, provider, and pharmacy staff, maintain lists of contracted providers and NPI numbers, and implement verification workflows that exclude prescriptions lacking an approved referral agreement from 340B eligibility.\"}]","340B Policy to Practice Guide - Compliance | PDF"]