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
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)
Principal Covered Topics
Promote access to clinically and cost
effective pharmacy services
340B Drug
Pricing Program
Patient Safety
and Clinical
Pharmacy Services
Collaborative
Office of Pharmacy Affairs Mission:
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
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
What’s Keeping Us Busy?
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 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
20
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
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
Contact Information
340B Program Administration
HRSA’s Office of Pharmacy Affairs
340B PVP Prime Vendor
Program (Apexus Inc.)
Pharmacy Services
Support Center
(PSSC/PharmTA)
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 – Mission
• Sub 340B pricing on Pharmaceuticals Negotiates
• Establishes solutions and networks that provide access to affordable medications
Distribution
Solutions
• Provides other value added products and services.
Value Added
Apexus, the 340B PVP
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: [email protected]
Beverly Daniel - Membership Coordinator
Phone: 972-910-6616
Email: [email protected]
Customer Service Hotline
1-888-340-2787
INTEGRITY ● ACCESS ● VALUE 1
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 2
Describe the
purpose and
function of HRSA
PSSC
1
Describe the
valuable services
HRSA PSSC offers
2 List the
foundational
principles upon
which HRSA
PSSC operates
3
LEARNING
OBJECTIVES
INTEGRITY ● ACCESS ● VALUE 3
Information &
Assistance Optimize value
GOAL:
Serves as the primary access resource for 340B
Purpose
HRSA PSSC
INTEGRITY ● ACCESS ● VALUE 4
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 5
Clinically and Cost Effective Pharmacy Services
ACCESS
QUALITY
OUTCOMES
Clinically & Cost
Effective Pharmacy
Services OPERATIONS
INTEGRITY ● ACCESS ● VALUE 6
Value of HRSA PSSC
• Understanding
• Implementing
• Optimizing
ACCESS
• Timely
• Reflects Current Policy
• Meets High Quality Standards
HRSA PSSC
INTEGRITY ● ACCESS ● VALUE 7
Services
Relationships and
Networking
Program Development
Information Analysis and
Management
INTEGRITY ● ACCESS ● VALUE 8
Information Analysis and Management
Call Center 1-800-628-6297 [email protected] or
INTEGRITY ● ACCESS ● VALUE 9
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 10
Information Analysis and Management
PharmTA
Free technical assistance to
eligible entities
To request, call
1-800-628-6297
INTEGRITY ● ACCESS ● VALUE 12
Interactive Financial Analysis
pssc.aphanet.org/resources.htm
INTEGRITY ● ACCESS ● VALUE 13
Information Analysis and Management (cont.)
Policy Analysis
Monitors, analyzes, and communicates policy
developments within the scope of the 340B Program
INTEGRITY ● ACCESS ● VALUE 14
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
INTEGRITY ● ACCESS ● VALUE 15
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
INTEGRITY ● ACCESS ● VALUE 16
Education Programs
Inter-Agency Agreements
Continuing Education
Student Programs
Educational Tools and
Resources
INTEGRITY ● ACCESS ● VALUE 17
1
7
Contacts:
www.hrsa.gov/opa www.hrsa.gov/patientsafety
pssc.aphanet.org
1-800-628-6297
www.340bpvp.com
1-888-340-2787
Pharmacy Services
Support Center
Prime Vendor
Program
Healthcarecommunities.org