docThe 340B Drug Pricing Program: The Basics
download 
Report Transcription
The 340B Drug Pricing Program: The Basics
The 340B Drug Pricing Program: The Basics INTEGRITY ● ACCESS ● VALUE 1 Learning Objectives 1 2 3 Intent of the program 340B Pricing determination Entity eligibility 4 5 Program requirements and prohibitions 6 Entity enrollment procedure Program guidance and policy 7 8 9 Patient eligibility determination Drug delivery options Available resources INTEGRITY ● ACCESS ● VALUE 2 What is 340B? 340 entities? 340 drugs on the formulary? Year it was created? 340 pharmacies? 340 hospitals? 340 lawyers that got together 340 manufacturers INTEGRITY ● ACCESS ● VALUE 3 Creation of the 340B Program 340B DRUG PRICING PROGRAM $ Drug Manufacturers Outpatient Drugs INTEGRITY ● ACCESS ● VALUE 4 Intent of the 340B Program Safety net providers 340B Eligible Entities SAVINGS Improve financial stability Stretch dollars to serve vulnerable patients Patients INTEGRITY ● ACCESS ● VALUE 5 The 340B Price 340B DRUG PRICING PROGRAM 25-50% of the average wholesale price The 340B price is actually a “ceiling” price Can offer sub-ceiling prices Drug Manufacturers INTEGRITY ● ACCESS ● VALUE 6 The 340B Price 340B DRUG PRICING PROGRAM 25-50% of the average wholesale price The 340B price is actually a “ceiling” price OFFICE OF PHARMACY AFFAIRS Drug Manufacturers Centers for Medicare and Medicaid Services INTEGRITY ● ACCESS ● VALUE 7 340B Entity Eligibility The eligibility to purchase at the 340B price belongs only to the entities INTEGRITY ● ACCESS ● VALUE 8 340B Entity Eligibility Consolidated Health Centers Comprehensive hemophilia diagnostic treatment centers Federally Qualified Health Center, or FQHC look-alikes Native Hawaiian health centers Family planning (Title X) Urban Indian organizations Certified tuberculosis clinics Ryan White Care Act (Parts A, B, C, D) grantees Certain disproportionate share hospitals (>11.75%) Black lung clinics Certified sexually transmitted disease clinics INTEGRITY ● ACCESS ● VALUE 9 340B Enrollment Procedure ELIGIBLE ENTITIES MUST ENROLL FORMS AND ENROLLMENT INFORMATION http://www.hrsa.gov/opa Click on “Legal Resources” ADMISSION PROCESS Submit completed form to OPA OPA verifies eligibility Participation begins next quarterly database update INTEGRITY ● ACCESS ● VALUE 10 340B Enrollment Procedure FIND THE FORM http://www.hrsa.gov/opa/legalresources.htm COMPLETE THE FORM Click on “Introduction to 340B” DEADLINES participation begins 1 month after the enrollment deadline INTEGRITY ● ACCESS ● VALUE 11 340B Statute Requirements and Prohibitions 340B Legislation Program Components Price Formula Eligible Entities Requirements & Prohibitions INTEGRITY ● ACCESS ● VALUE 12 340B Statute Requirements and Prohibitions Prime Vendor Audit Resell/ Transfer Prohibition Duplicate Discount Prohibition Disproportionate Share Hospital GPO Exclusion INTEGRITY ● ACCESS ● VALUE 13 340B Regulation and Policy Interpreting the legislation and implementing the 340B Program may at times be a challenge OFFICE OF PHARMACY AFFAIRS Federal Register Notice publication www.hrsa.gov/opa INTEGRITY ● ACCESS ● VALUE 14 340B Regulation and Policy 1 entity has established relationship & maintains records of care 2 patient receives health care services from health care professional employed/contracted with entity Definition of a Patient OFFICE OF PHARMACY AFFAIRS 3 patient receives health care consistent with range of services from the covered entity Federal Register Notice publication www.hrsa.gov/opa/federalregister.htm INTEGRITY ● ACCESS ● VALUE 15 340B Regulation and Policy If three requirements are not met, the person is not eligible for 340B drugs Definition of a Patient OFFICE OF PHARMACY AFFAIRS Federal Register Notice publication www.hrsa.gov/opa/federalregister.htm INTEGRITY ● ACCESS ● VALUE 16 340B Implementation Options 340B Eligible Entities Entities expressed interest in new ways to increase access to 340B drugs INTEGRITY ● ACCESS ● VALUE 17 340B Implementation Options 340B Eligible Entities OFFICE OF PHARMACY AFFAIRS Alternative Methods Demonstration Projects www.hrsa.gov/opa/alternativemethods.htm INTEGRITY ● ACCESS ● VALUE 18 340B Program Resources: Integrity Access Value INTEGRITY ● ACCESS ● VALUE 19 Integrity Resource: Office of Pharmacy Affairs (OPA) Administers 340B program Develops innovative pharmacy service models and supports technical assistance Serves as Federal resource for pharmacy practice Integrity Importance of Comprehensive Pharmacy Services • Access to affordable drugs • Efficient pharmacy management • Application of “best practices” • Systems to improve patient outcome INTEGRITY ● ACCESS ● VALUE 20 Access Resource: Pharmacy Services Support Center (PSSC) Helps eligible entities, implement and optimize the 340B program Provides information resources, policy analysis & education Access Operates • Call Center • Outreach Program • Web Site • Pharmacy Technical Assistance Program INTEGRITY ● ACCESS ● VALUE 21 Value Resource: Prime Vendor Program (PVP) Negotiates subceiling prices Helps with access to drug distribution solutions Offers value added products and services Offered at no cost to entity Value INTEGRITY ● ACCESS ● VALUE 22 Staying connected to the 340B World ASHP meetings June and December APHA meeting April 340B Coalition meetings January and July APhA Pharmacy Today Access For All Network at various entity specific meetings (NACHC, NAPH, Primary Care Associations,etc.) SNHPA http://www.safetynetrx.org HRSA http://www.hrsa.gov/opa/ PSSC http://pssc.aphanet.org/ Prime Vendor Program http://340bpvp.com The Monitor List Serves Others… INTEGRITY ● ACCESS ● VALUE 23 Contacts: OFFICE OF PHARMACY AFFAIRS Pharmacy Services Support Center www.hrsa.gov/opa 1-800-628-6297 pssc@aphanet.org pssc.aphanet.org Prime Vendor Program 1-888-340-2787 340B_primevendor@340bpvp.com www.340bpvp.com INTEGRITY ● ACCESS ● VALUE 24 Thank You! INTEGRITY ● ACCESS ● VALUE 25
