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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