Purpose: The purpose of this tool is to provide an example 340b program policy and procedure
Download 319.19 Kb.
|
- Navigate this page:
- Introduction
- Instructions
- Table of Contents
 Purpose: The purpose of this tool is to provide an example 340B Program policy and procedure (P&P) manual that exhibits high program integrity to assist participating disproportionate share hospital (DSH) leaders in the preparation of their own unique, site-specific P&P manual that supports placing compliant guidance/policy into practice.
Introduction: Policies and procedures (1) promote compliance with regulations and statute requirements; (2) reduce variation in practice; (3) standardize practice throughout the organization; and (4) serve as a resource for new team members. In addition, policies and procedures allow covered entities to establish and educate staff on key expectations for practice and procedures. There are typically three parts of a P&P manual: policies, purpose, and procedures.
a. When the activity or task is triggered b. What steps are performed c. Who performs each step d. When each step is performed e. How the steps are performed Each organization will have a different format for its policies and procedures. The key elements of a P&P manual include policies, purpose, procedures, definitions, references, subject/title, effective date, original date of issue, date last reviewed, and date last revised. In addition, appropriate policy approvals are evident and legible on the documented policy, including the date of the approval and the signature, title, and department of the responsible person. Instructions:
Table of Contents Purpose 4 This document contains the written policies and procedures that [Entity] uses to oversee 340B Program operations, provide oversight of contract pharmacies, and maintain a compliant 340B Program. 4 Background 4 Section 340B of the Public Health Service Act (1992) requires drug manufacturers participating in the Medicaid Drug Rebate Program to sign a pharmaceutical pricing agreement (PPA) with the Secretary of Health and Human Services. 4 The 340B Program is administered by the federal Health Resources and Services Administration (HRSA) in the Department of Health and Human Services (DHHS). 4 340B Policy Statements 4 [Entity] complies with all requirements and restrictions of Section 340B of the Public Health Service Act and any accompanying regulations or guidelines including, but not limited to, the prohibition against duplicate discounts/rebates under Medicaid, and the prohibition against transferring drugs purchased under 340B to anyone other than a patient of the entity. [REFERENCE: Public Law 102-585, Section 602, 340B Guidelines, 340B Policy Releases]. 4 [Entity] uses any savings generated from 340B in accordance with 340B Program intent. [Appendix: include reference to 340B intent from 340B University notes]. 4 [Entity] has systems/mechanisms and internal controls in place to reasonably ensure ongoing compliance with all 340B requirements. 4 [Entity] maintains auditable records demonstrating compliance with the 340B Program. 4 Definitions 5 Definitions of terms may be found in [Appendix: 340B Glossary of Terms, retrieved from the Apexus website //docs.340bpvp.com/documents/public/resourcecenter/glossary.pdf]. 5 References 5 Each section includes other references to P&Ps, 340B Glossary of Terms, HRSA website, etc. as applicable. 5 Policy Review, Updates, and Approval 5 These written policies and procedures will be updated and approved by [Entity] staff/committee whenever there is a clarification, or change, in the rules, regulations, or guidelines to the 340B Program requirements. Otherwise, the policy will be reviewed and approved annually. 5 Directory: documents -> public -> resourcecenter public -> Jcomm expert team on public -> World meteorological organization data buoy cooperation panel annual report for public -> O. P. Singh saarc meteorological Research Centre (smrc) public -> Acknowledgements resourcecenter -> Sample 340b policy & Procedures Manual Page resourcecenter -> Purpose: This document provides information on what to report to the Health Resources and Services Administration (hrsa) when a 340B price is unavailable for a covered outpatient drug. Instructions public -> Interagency Committee on the Health Effects of Non-ionising Fields: Report to Ministers 2015 public -> Main publications Download 319.19 Kb. Share with your friends:
|
