340B PRICING AND PROCUREMENT340B PRICING AND PROCUREMENTELIGIBILITY, ENROLLMENT, AND ELIGIBILITY, ENROLLMENT, AND

REQUIREMENTSREQUIREMENTS

Virtual Health Center’s eHealthUniversity

Dr. Erica C. Watkins, PharmD, RPh

August 28, 2014

Learning ObjectivesLearning Objectives

340B Pricing DeterminationEntity eligibilityEntity Enrollment ProceduresRequirements and ProhibitionsDrug Procurement

Pricing DeterminationPricing Determination

The 340B PriceThe 340B Price

340B pricing program = 25 –50% of AWPDrug Manufacturers = offer sub-ceiling

pricesCalculated quarterly

100%100

%90%80%70%60%50%40%30%20%10%0%

66%

64% 53

%51%

49%

Adapted from a slide by Safety Net Hospitals for Pharmaceutical AccessSource: Data derived from Prices for Brand-Name Drugs Under Selected Federal Programs, Congressional Budget Office (June

2005)

Private Sector Pricing79%

58%

42%

Relative PricingRelative Pricing

EligibilityEligibility

Eligible EntitiesEligible Entities

Federal Grantees Comprehensive Hemophilia

Treatment Centers Federally Qualified Health

Centers Urban/638 Health Center Ryan White Programs Sexually Transmitted

Disease/Tuberculosis Title X Family Planning

Hospital Types Disproportionate Share

Hospitals Critical Access Hospitals Rural Referral Centers Sole Community Hospitals Children’s Hospitals Free Standing Cancer

Hospitals

Community Health Community Health Center EligibilityCenter Eligibility

Section 340B (a)(4)(A)“A Federally-qualified health center (as defined in section 1905(1)(2)(B) of the Social Security Act).”

EnrollmentEnrollment

• New entities, entity sites, contract pharmacies,Medicaid information

– 2 week registration periods, quarterly updates made to OPA Database

• Change requests: changes to existing information,rolling basis

Update Official October 1 January 1 April 1 July 1

Registration Period July 1 – 15 October 1 -15 January 1 – 15 April 1 - 15

340B Enrollment340B Enrollment

1. Determine Eligibility

2. Complete Appropriate Forms

3. OPA verifies scope of grantRegistration information MUST match the EHBs

4. Await Decision From OPA

340B Enrollment Steps340B Enrollment Steps

340B Enrollment340B Enrollment

Once enrolled, the newly participating entity must:

Set up an account with wholesaler using 340B ID

Determine if contract pharmacy services are appropriate

Contact HRSA’s Pharmacy Services Support Center (PSSC) for assistance with any/all technical issues

Contact the 340B Prime Vendor Program (PVP) to discuss participation in their added services.

Contract PharmaciesContract Pharmacies

340B Program allows entities to have multiple contract pharmacies for increased patient access to cost effective pharmaceuticals

The Covered Entity purchases the drug, but “ship to - bill to” procedure may be used

The Covered Entity retains legal title to all drugs purchased under 340B. The Covered Entity must pay for all 340B drugs.

340B Database340B Database Entities are not eligible for the program unless listed

in the 340B database Wholesalers will not ship discounted drugs unless it

is an exact match to the 340B database Information is updated daily Includes the Medicaid Exclusion File Online registration available for all applicants http://opanet.hrsa.gov/opa/default.aspx

RecertificationRecertification

– Required by Statute– Ensure program integrity, compliance,

transparency and accountability– Ensure accuracy of covered entity

information in the 340B database– It is the covered entity’s responsibility to ensure

the accuracy of the information in the 340B database

15

• Entities are required to recertify informationin the HRSA 340B database annually

• HRSA sends a notification email toAuthorizing Official and Primary Contact

• The Authorizing Official performs the recertification online

Recertification ImplementationRecertification Implementation

CurrentFQHC grant eligibilityDSH percentage quarterlyOwnership status quarterly

Began phased implementation of annual recertification Ryan White Programs, STD/TB – completed Family Planning - completed Hospitals – completed FQHC – anticipated January 2013

340B Recertification Steps340B Recertification Steps

1. Ensure all information in 340B Database is accurate and prepared for recertification via change request form

2. Only Entities that have been in the system at least 12 months will be required to recertify

3. Email with user name and Password will be mailed to the Authorizing Official and primary contact listed for the parent covered entity

4. Authorizing Official for Parent will be required to recertify for Parent and all Outpatient Facilities/satellite sites/sub-grantees/sub-contractors and contract pharmacies associated with the covered entity

Recertification steps cont.Recertification steps cont. 5. Authorizing Official will be required to certify and update any

information that is not complete. As the database has progressed throughout time, more requirements have been added and additional information may be required to be entered by Authorizing Official

6. Once Authorizing Official has completed any additional program updates they will “Certify” that their information is true, accurate, and that the covered entity will be in compliance with all program requirements.

7. HRSA/OPA will review certifications and verify-ALL INFORMATION MUST MATCH THE EHBs

8. HRSA/OPA will Recertify or Decertify the Covered Entity

340B Recertification Steps340B Recertification Steps

Keys to successful recertification?Verify contact information is up to date in the

340B Program databaseUpdate all information in EHBsSubmit 340B Program change form to update

entity informationMonitor 340B Program webpage and your email

prior to recertificationDo not mistake change form for recertification

Requirement and ProhibitionsRequirement and Prohibitions

1.

2.

3.

Duplicate Discount Prohibition*

No Diversion (Patient

Definition)* Certain Hospitals

Only–

–

Group Purchasing Organization (GPO) Prohibition*

Orphan Drug Exclusion

Major 340B Compliance Areas

MedicaidRebate340B

Price

• Records of individual’s care

• Health care services, health care professional

– Employed by, under contractual or other arrangements(referral)

• Entity has responsibility for care

• Service received is consistent with funding or designation status (hospitals exempt)

• Services must be more than dispensing

• Aids Drug Assistance Program (ADAP) exception

Patient DefinitionPatient Definition

• Applies to:

– Disproportionate Share

– Children’s Hospitals

– Free Standing Cancer Hospitals

• Such hospitals:

“...will not participate in a group purchasing organization or group purchasing arrangement for covered outpatient

drugs as of the date of this listing on the OPAwebsite.”

OPA GPO Certification Form

GPO ProhibitionsGPO Prohibitions

ProcurementProcurement

340B Prime Vendor Program

Apexus MissionApexus Mission

Apexus leverages its unique purchasing power and expertise to deliver value which helps eligible health care and public service organizations to access unmatched saving and optimize performance

ApexusApexus

The Prime Vendor serves participants in three distinct areas:– Negotiating sub-340B pricing– Establishment of distribution solutions and

networks to improve medication access

Benefits of ApexusBenefits of Apexus

No cost or risk to participateNo change of distributor requiredMaximized value delivered through a single

programLonger term contracts Price transparency

Vaccines

OutpatientPrescription

DrugsInpatient drugs Over-the-counter

drugs(with a prescription)Drug not

directlyreimbursed

Clinic administered

drugsFDA doesn’trequire NDC

BiologicsInsulin

http://www.ssa.gov/OP_Home/ssact/title19/1927.htm

Non-covered and Covered Non-covered and Covered drugsdrugs