340B 101The Basics - LPHIlphi.org/CMSuploads/340B-101The-Basics-98128.pdf · What is 340B? 340...

The 340B Drug Pricing Program: The Basics

INTEGRITY ● ACCESS ● VALUE 1

Learning Objectives

Intent of the program

1

340B Pricing determination

2

Entity eligibility

3

4 5 6


Entity enrollment procedure

Program requirements

and prohibitions

Program guidanceand policy

Patient eligibility

determination

7

Drug delivery options

8

Available resources

9

What is 340B?

340 entities?

340 drugs on the formulary?

Year it was

340 pharmacies?

340 hospitals?

340 lawyers that got together


Year it was created?

got together

340 manufacturers

Creation of the 340B Program

DRUG PRICING PROGRAM

340B


$

Outpatient Drugs

Drug Manufacturers

Intent of the 340B Program

Safety net providers

SAVINGS

Improve financial stability


Patients340B Eligible Entities

stability

Stretch dollars to serve vulnerable patients

The 340B Price

The 340B price is actually a “ceiling” price

25-50%of the average wholesale price


340B


Drug Manufacturers


Can offer sub-ceiling prices

The 340B Price


25-50%of the average wholesale price


340B


Centers for Medicare and Medicaid Services

Drug Manufacturers


OFFICE OFPHARMACY AFFAIRS

340B Entity Eligibility

The eligibility to purchase at the 340B price belongs only to the entities


340B Entity Eligibility

Consolidated Health Centers

Federally Qualified Health Center, or FQHC look-alikes

Family planning (Title X)

Comprehensive hemophilia diagnostic treatment centers

Native Hawaiian health centers

Urban Indian organizations

Certified tuberculosis clinics


Ryan White Care Act (Parts A, B, C, D) grantees

Black lung clinics

Certified tuberculosis clinics

Certain disproportionate share hospitals (>11.75%)

Certified sexually transmitted disease clinics

340B Enrollment Procedure

ELIGIBLE ENTITIES MUST ENROLL

FORMS AND ENROLLMENT INFORMATION

Click on “Legal Resources”

http://www.hrsa.gov/opa


ADMISSION PROCESS

Submit completed form to OPA

OPA verifies eligibility

Participation begins next quarterly database update

340B Enrollment Procedure

FIND THE FORM

COMPLETE THE FORM

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

Click on “Introduction to 340B”


DEADLINES

�� participation begins 1 month after the enrollment deadline

340B Statute Requirements and Prohibitions

340B Legislation

Program Components


Program Components

Eligible Entities

Price Formula

Requirements & Prohibitions

340B Statute Requirements and Prohibitions


Audit Resell/Transfer

Prohibition

Duplicate Discount

Prohibition

Prime Vendor DisproportionateShare Hospital

GPO Exclusion

340B Regulation and Policy

Interpreting the legislation and

implementing the 340B Program

may at times be a challenge


Federal Register Notice publication

www.hrsa.gov/opa



Definition

entity has established relationship & maintains records of care

1

3 patient receives health care consistent with

2 patient receives health care services from health care professional employed/contracted with entity



www.hrsa.gov/opa/federalregister.htm


Definition of a Patient

3 patient receives health care consistent with range of services from the covered entity


Definition

If three requirements are not met, the person is not eligible for 340B drugs



www.hrsa.gov/opa/federalregister.htm


Definition of a Patient

340B Implementation Options

340B Eligible Entities

Entities expressed

interest in new ways

to increase access to


to increase access to

340B drugs

340B Implementation Options

340B Eligible Entities



Alternative Methods Demonstration Projects

www.hrsa.gov/opa/alternativemethods.htm

340B Program Resources:


Integrity Access Value

Integrity Resource:

Develops innovative pharmacy

service models

Serves as Federal resource for pharmacy

Administers 340B program

Office of Pharmacy Affairs (OPA)


Integrity

service models and supports technical assistance

for pharmacy practice

340B program

• Access to affordable drugs

• Application of “best practices”

• Efficient pharmacy management

• Systems to improve patient outcome

Importance of Comprehensive Pharmacy Services

Access Resource:

Helps eligible entities,

implement and

Providesinformation resources,

Pharmacy Services Support Center (PSSC)


implement and optimize the 340B program

resources,policy analysis &

education

Access

• Call Center

• Web Site

• Outreach Program

• Pharmacy Technical Assistance Program

Operates

Value Resource:

Offers value added products and services

Negotiates sub-ceiling prices

Helps with access to drug

Prime Vendor Program (PVP)


Offered at no cost to entity

Helps with access to drug distribution solutions

Value

Staying connected to the 340B World

ASHP meetings

June and December

APHA meeting

April

340B Coalition meetings

SNHPA http://www.safetynetrx.org

HRSA http://www.hrsa.gov/opa/

PSSC http://pssc.aphanet.org/


340B Coalition meetings

January and July

APhA Pharmacy Today

Access For All

Network at various entity specific meetings

(NACHC, NAPH, Primary Care Associations,etc.)

http://pssc.aphanet.org/

Prime Vendor Program http://340bpvp.com

The Monitor

List Serves

Others…

Contacts:

www.hrsa.gov/opa

1-800-628-6297


Pharmacy Services


pssc.aphanet.org

[email protected]

www.340bpvp.com

[email protected]

1-888-340-2787

Pharmacy Services Support Center

Prime Vendor Program

Thank You!


340B 101The Basics - LPHIlphi.org/CMSuploads/340B-101The-Basics-98128.pdf · What is 340B? 340...

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