Update on 340B Drug Pricing Program LCDR Joshua E. Hardin MBA, RN/BSN, MLT Donna Murray Office of Pharmacy Affairs U.S. Department of Health and Human Services Health Resources and Services Administration Healthcare Systems Bureau
Principal Covered Topics What is the mission of OPA and the programs it leads What is the Intent of 340B Program and Eligible Entities Recent Legislation and its affects on HRSA/OPA Program Integrity and Recertification Patient Safety and Clinical Pharmacy Services Collaborative (PSPC)
Office of Pharmacy Affairs Mission: Promote access to clinically and cost effective pharmacy services 340B Drug Pricing Program Patient Safety and Clinical Pharmacy Services Collaborative
Program Administration Three Legs of the OPA Federal Team Pharmacy Services Support Center (PSSC/PharmTA) 340B Prime Vendor Program (PVP) OPA/340B Program FEDS
Intent of 340B Permit covered entities to stretch scarce Federal resources as far as possible, reaching more eligible patients and providing more comprehensive services. H.R. Rep. No. 102-384(II), at 12 (1992)
340B Eligible Entities Federally Qualified Health Centers (FQHC) Comprehensive Hemophilia Treatment Centers Ryan White Programs (Parts A, B, C, D) Sexually Transmitted Disease/Tuberculosis Programs (STD/TB) Title X Family Planning Clinics Urban / 638 Tribal Programs Federally Qualified Health Center Look-Alikes (FQHC-LA) Disproportionate Share Hospitals (DSH) Children s Hospitals Free Standing Cancer Hospitals Critical Access Hospitals Sole Community Hospitals Rural Referral Centers
Why Definition of Patient? Statute does not define patient Necessary to provide clarity on who is and is not a patient for the purposes of 340B Ensures against diversion and supports 340B program integrity 1996 FR Notice is current guidance New Guidance Under Development Clarifies previous FR Notices of 1996 and 2007
Growth of 340B Covered Entity Sites
Growth of 340B Contract Pharmacies
What s Keeping Us Busy? Affordable Care Act Section 7101 allowed for the expansion of the program to 5 New Entity Types Section 7102 allowed for greater integrity of the 340B program Annual Recertification for all entities Pricing transparency Civil Monetary Penalties Administrative Dispute Resolution Section 7103 GAO study on improvements
Recent Program Legislation Health Care and Education Reconciliation Act Section 2302 Orphan Drug Exclusion for new covered entity types Critical Access Hospitals Free Standing Cancer Hospitals Rural Referral Centers Sole Community Hospitals Medicaid and Medicare Extenders Act 2010 Children s Hospitals exempt from Orphan Drug Exclusion
GAO Findings The 340B program allows certain providers within the U.S. health care safety net to stretch federal resources to reach more eligible patients and provide more comprehensive services. Covered entities interviewed reported using it for these purposes. Distribution of drugs at 340B prices generally did not affect providers access to drugs.
GAO Findings cont. Oversight of the 340B program is inadequate to provide reasonable assurance that covered entities and drug manufacturers are in compliance with program requirements. 340B program has increasingly been used in settings, such as hospitals, where the risk of improper purchase of 340B drugs is greater.
Recent OIG Study State Medicaid Policies and Oversight Activities Related to 340B-Purchased Drugs June 2011 OIG recommendations : CMS direct States to create written 340B policies CMS inform States about tools they can use to identify claims for 340B-purchased drugs HRSA share 340B ceiling prices with States. (HRSA will need to seek legislative authority to implement) HRSA, in conjunction with CMS, improve the accuracy of the Medicaid Exclusion File
Program Integrity Other activities Non-discrimination policy Audits Authority Guidelines Plans
Program Integrity and Recertification Current: FQHC grant eligibility quarterly DSH percentage quarterly Ownership status quarterly Began phased implementation of annual recertification starting 8/1/2011 Ryan White Programs completed October 2011 STD/TB-currently in process IHS/Family Planning -January 2012 Continue with other entities as online systems are developed
Patient Safety and Clinical Pharmacy Services Collaborative (PSPC) Quality Improvement Collaborative aimed at improving health outcomes and patient safety for high-risk patients Enhance care coordination Foster multidisciplinary, team based care Strengthen patient centered medical home Integrate medication management
Who is involved in the PSPC? Community based teams across the country Organizations include safety net provider and hospitals, public health departments, and HIV clinics Partners include colleges of pharmacy, primary care associations, and Quality Improvement Organizations, Multidisciplinary care teams delivering patient centered services to improve medication safety and health outcomes
PSPC Aim Patient-centered, integrated care teams, armed with cost-effective clinical pharmacy services to improve the health outcomes and safety for high medication risk patient populations in alignment with national quality standards. PSPC s vision: By 2015 3,000 communities have an integrated delivery system that assure optimal health outcomes and patient safety
How to get involved in PSPC 4.0 1.Step 1 Read PSPC Info Packet 2.Step 2 Complete PSPC Participation Package (online) Share contact information for team/partners 3.Step 3 HRSA will review information and send a welcome email to the team lead Website: http://www.hrsa.gov/patientsafety 20
Contact Information Office of Pharmacy Affairs (OPA) Web: www.hrsa.gov/opa www.hrsa.gov/patientsafety Pharmacy Services Support Center (PSSC) Phone: 1-800-628-6297 Web: http://pssc.aphanet.org 340B Prime Vendor Program (PVP) Phone: 1-888-340-2787 Web: http://www.340bpvp.com
340B Prime Vendor Program NASTAD Presentation Mary Ellen England Dir. Marketing and Education
340B Program Administration HRSA s Office of Pharmacy Affairs 340B PVP Prime Vendor Program (Apexus Inc.) Pharmacy Services Support Center (PSSC/PharmTA)
Apexus Mission Apexus leverages its unique purchasing power and expertise to deliver value which helps eligible health care and public service organizations to access unmatched savings and optimize performance
Apexus, the 340B PVP Negotiates Sub 340B pricing on Pharmaceuticals Distribution Solutions Establishes solutions and networks that provide access to affordable medications Value Added Provides other value added products and services.
2011 Strategic Initiatives Improve Satisfaction and Engagement Increase the Value to PVP Participants Improve internal operations and systems Improve critical elements of the 340B PVP Meet the Evolving Needs of HRSA
Benefits of PVP to Covered Entities No cost to participate No change of distributor required Maximize value delivered through a single national program Access to 340B sub-ceiling prices for drugs and discounts on other products/services Longer term contracts to base formulary decisions Pricing transparency via secure website
PVP Portfolio/Contracting Over 4500 covered drugs at sub-ceiling pricing Average of One or two products within therapeutic drug class Best market pricing for non-covered drugs, vaccines, supplies and services Two to three year agreements where possible No rebates; but performance based contracting is permitted Participant advisory councils- DSH, FQHC, Title X, HTC to date
What Drugs Are Covered within the 340B program Covered drugs: Outpatient Prescription drugs Over-the-counter drugs (accompanied by prescription) Clinic administered drugs within eligible facilities Non-covered drugs: *Vaccines In-patient drugs
Other Outpatient Rx Products and Services Vaccines all Patient assistance program Software Auditing and overcharge recovery services Prescription vials/labels/printer cartridges Diabetic supplies meters, strips and syringes Outpatient Rx technology and automation ScriptPro, Automed, Innovation, VoiceTech, others Apothecary supplies Reverse distribution (pharmacy returns)
Contact Information Mary Ellen England, MS, RD/LD MBA Phone: 972-910-6638 Email: mengland@340bpvp.com Beverly Daniel - Membership Coordinator Phone: 972-910-6616 Email: bdaniel@340bpvp.com Customer Service Hotline 1-888-340-2787
HRSA Pharmacy Services Support Center: The 340B Access Resource Nick Chang Operations Manager, PSSC HRSA Pharmacy Services Support Center NASTAD Webinar 1/18/2012 INTEGRITY ACCESS VALUE 1
LEARNING OBJECTIVES 1 Describe the purpose and function of HRSA PSSC 2 Describe the valuable services HRSA PSSC offers 3 List the foundational principles upon which HRSA PSSC operates INTEGRITY ACCESS VALUE 2
Purpose HRSA PSSC Serves as the primary access resource for 340B Information & Assistance GOAL: Optimize value INTEGRITY ACCESS VALUE 3
Vision and Mission access to affordable, clinically, and cost effective pharmacy services provide information, education, and policy analysis optimize the value improve medication use and advance patient care INTEGRITY ACCESS VALUE 4
Clinically and Cost Effective Pharmacy Services ACCESS OPERATIONS Clinically & Cost Effective Pharmacy Services OUTCOMES QUALITY INTEGRITY ACCESS VALUE 5
Value of HRSA PSSC HRSA PSSC Timely Reflects Current Policy Meets High Quality Standards ACCESS Understanding Implementing Optimizing INTEGRITY ACCESS VALUE 6
Services Information Analysis and Management Relationships and Networking Program Development INTEGRITY ACCESS VALUE 7
Information Analysis and Management Call Center 1-800-628-6297 PSSC@aphanet.org or INTEGRITY ACCESS VALUE 8
Types of Services for Ryan White Clinics Recertification Registration Change Request Forms General questions related to the 340B Drug Pricing Program. Level II Expert Consultant Site Visit Limited due to funding Peer to Peer Webinars and Community Access INTEGRITY ACCESS VALUE 9
10 INTEGRITY ACCESS VALUE Information Analysis and Management PharmTA Free technical assistance to eligible entities To request, call 1-800-628-6297
11 INTEGRITY ACCESS VALUE Information Analysis and Management (cont.) Website pssc.aphanet.org
12 INTEGRITY ACCESS VALUE Interactive Financial Analysis pssc.aphanet.org/resources.htm
13 INTEGRITY ACCESS VALUE Information Analysis and Management (cont.) Policy Analysis Monitors, analyzes, and communicates policy developments within the scope of the 340B Program
14 INTEGRITY ACCESS VALUE Relationships and Networking Live Presentations Articles in journals and Pharmacy Today Interactive web-based learning opportunities Dialogue and collaboration with other safety net stakeholder organizations
15 INTEGRITY ACCESS VALUE 340B Peer-to-Peer: www.healthcarecommunities.org/ 340B Basics to Ensure Integrity 1/25 @ 2PM Systems for Maintaining Integrity 2/29 @ 2PM Medicaid Billing and Avoiding Duplicate Discounts 3/28 @ 2PM 340B Audits: Understanding the Process and Preparing Your Pharmacy 4/25 @ 2PM
Education Programs Inter-Agency Agreements Continuing Education Educational Tools and Resources Student Programs INTEGRITY ACCESS VALUE 16
17 INTEGRITY ACCESS VALUE 1 7 Contacts: www.hrsa.gov/opa www.hrsa.gov/patientsafety Pharmacy Services Support Center 1-800-628-6297 pssc@aphanet.org pssc.aphanet.org Healthcarecommunities.org Prime Vendor Program 1-888-340-2787 340B_primevendor@340bpvp.com www.340bpvp.com