Pharmacy Access: The 340B Program

June 24, 2008

Ann Ferrero & Bhavani PattabiramanPublic Health Analysts

U.S. Department of Health and Human ServicesHealth Resources and Services AdministrationHealthcare Systems BureauOffice of Pharmacy Affairs

Health Resources and Services Administration

2008 Primary Health Care All-Grantee Meeting

Office of Pharmacy Affairs Mission

Mission: Promote access to clinically and cost effective pharmacy services

Maximize the value of participation in 340B

Develop innovative pharmacy services

Serve as a Federal resource for pharmacy practice

Program Administration

Three Legs of the 340B Program Federal Team (OPA)

Pharmacy Services Support Center

(PSSC)

340B Prime VendorProgram (PVP)

OPA/340B Program

PSSC

PVP

FEDS

Pharmacy Services Support Center (PSSC) American Pharmacists Association (APhA) Services to OPA and 340B covered entities

Information and analysis Relationships and networking Program development/Free Technical Assistance Partner with schools of pharmacy to encourage students

to develop projects in 340B Safety-net organizations that promote access to clinically and cost effective pharmacy services.

Prime Vendor Program (PVP) No cost to participate/voluntary Drug price negotiation services

> 3000 drug items average 10% below 340B ceiling price

> $2 billion in purchase volume

Multiple wholesale distributor agreements All national and most regional wholesalers Favorable distribution costs

Other value added products/services

What is the 340B Drug Pricing Program? Section 340B of the Public Health Service

Act Provides discounts on outpatient drugs to

certain safety-net covered entities Covered drugs are only for covered entity

patients Manufacturers that participate in Medicaid

must also participate in the 340B program

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 (Pending)

HRSA Grant Award and Participation in 340B Drug Pricing Program “…If your organization is eligible to be a

covered entity under Section 340B of the PHSA and the assessment shows that participating in the 340B Drug Pricing Program and its Prime Vendor Program is the most economical and reasonable manner of purchasing or reimbursing for covered outpatient drugs (as defined in section 340B), failure to participate may result in a negative audit finding, cost disallowance or grant funding offset.”

Program Benefits Average savings of 25-50% on outpatient

drug purchases for 340B covered entities

Savings may be used to: Reduce price of pharmaceuticals for patients Expand drug formularies Expand services offered to patients

Program Prohibitions Diversion

Drug provided to a non-patient Drug dispensed in an area of a larger facility that is not

included in the defined covered entity Non-covered services

Duplicate Discounts 340B Discount + Medicaid Rebate on same drug Covered Entities must report Medicaid billing status For more information:

http://www.hrsa.gov/opa/medicaidexclusion.htm

OPA Website: http://www.hrsa.gov/opa

OPA Website: http://www.hrsa.gov/opa/legalresources.htm

OPA Database: http://opanet.hrsa.gov/opa/Login/MainMenu.aspx

OPA Database: http://opanet.hrsa.gov/opa/CE/CEExtract.aspx

OPA Database: http://opanet.hrsa.gov/opa/CP/CPExtract.aspx

Growth of 340B Drug Pricing Program

Growth of 340B Program by Covered Entity Type

Growth of HRSA Grantee and FQHC Look-alike 340B Covered Entity Sites

Growth in 340B Contract Pharmacy Arrangements

Participation in 340B Prime Vendor Program

Alternative Methods Demonstration Projects (AMDP) – December 2001-May 2008

38 Alternative Method Demonstration Project

Proposals

25 approved(13 CHCs)

7 currently under review

19 multiple contract pharmacy

5 Networks 1 Voluntarily Withdrawn

6 not approved

3 failed established criteria 3 voluntarily withdrawn

6 multiple contract pharmacy 1 networks

Proposed Guidance

Definition of PatientDefinition of Patient (72 FR 1543) (72 FR 1543) Clarifies previous FR Notice of October 1996Clarifies previous FR Notice of October 1996 Provides specific guidance and examples Provides specific guidance and examples A clear and enforceable definition to help A clear and enforceable definition to help

ensure against diversion and support 340B ensure against diversion and support 340B program integrityprogram integrity

Status Comment Period 1/12/07 – 03/13/07Comment Period 1/12/07 – 03/13/07 Comments being reviewed and final Comments being reviewed and final

publication being developedpublication being developed

Proposed Guidance Contract Pharmacy (Contract Pharmacy (72 FR 1540)72 FR 1540)

Updates previous FR Notice of August 1996Updates previous FR Notice of August 1996 Builds upon experience with Demonstration Builds upon experience with Demonstration

ProjectsProjects Incorporates Multiple Pharmacies as standard Incorporates Multiple Pharmacies as standard

optionoption Status

Comment Period 1/12/07 – 03/13/07Comment Period 1/12/07 – 03/13/07 Comments being reviewed and final Comments being reviewed and final

publication being developedpublication being developed

Proposed Guidance Children’s Hospitals

Clarifies children’s hospitals responsibilities as 340B covered entities

Describes application procedures Reaffirms drug manufacturers’ responsibility to

furnish 340B discounts under Pharmaceutical Pricing Agreement (PPA)

Status Comment period 7/9/07 – 9/7/07 Comments being reviewed and final publication

being developed

Grants to Establish or Expand Comprehensive Pharmacy Services

Purpose: To increase access to pharmacy services for CHC by establishing or expanding pharmacy services

Approximately 40 awards up to $150,000 per year, for two years

Anticipated Award Date: Sept 1, 2008

Grants Concepts to Establish or Expand Pharmacy Services

Onsite or contract pharmacy services 340B and the Prime Vendor Participation Effective risk management practices Clinical pharmacy services including MTM Partnership with school or college of pharmacy Pharmacy “best practices” Patient Safety & Clinical Pharmacy

Collaborative

Patient Safety Clinical Pharmacy Services Collaborative (PSPC)

Patient Safety Problem: IOM reports medication errors injure 1.5 Million people and

cost billions annually. Pharmacy services in HRSA programs & safety-net

partners growing rapidly. HRSA desires these programs to be the best and safest in the United States.

Solution: Work with internal and external stakeholders Identify safety-net best practice models of patient safety/

clinical pharmacy services. Use technical assistance and “collaborative care model” to

transfer best practices to other safety-net providers

PSPC Performance Goals More High Quality, Cost-Effective Clinical

Pharmacy Services

Enhanced Patient Safety

Effective Health Outcomes

PSPC Timelines 34 Site Visits completed = Leading Practices

Expert Panel = Change Package + Faculty

Enroll teams – May and June 2008. Enrollment deadline July 1, 2008.

First Learning Session - August 13 - 15, 2008

Fourth and Final Learning Session in Fall 2009

Patient Safety Clinical Pharmacy Services Collaborative For more information:

http://www.hrsa.gov/patientsafety http://www.healthdisparities.net

Contact: Phone: 1-800-628-6297 Email: patientsafety@hrsa.gov

Questions?

Contact InformationOffice of Pharmacy Affairs (OPA)

Phone: 301-594-4353 or 1-800-628-6297Web: http://www.hrsa.gov/opa

Pharmacy Services Support Center (PSSC)Phone: 1-800-628-6297Web: http://pssc.aphanet.org

Prime Vendor Program (PVP)Phone: 1-888-340-2787Web: http://www.340bpvp.com