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

Growth of 340B Covered Entity Sites

Growth of 340B Contract Pharmacies

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 – 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

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 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 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: mengland@340bpvp.com

Beverly Daniel - Membership Coordinator

Phone: 972-910-6616

Email: bdaniel@340bpvp.com

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 PSSC@aphanet.org 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 11

Information Analysis and Management (cont.)

pssc.aphanet.org Website

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

pssc@aphanet.org

1-800-628-6297

www.340bpvp.com

340B_primevendor@340bpvp.com

1-888-340-2787

Pharmacy Services

Support Center

Prime Vendor

Program

Healthcarecommunities.org