1. 340B PRICING AND PROCUREMENT ELIGIBILITY, ENROLLMENT, AND REQUIREMENTS Virtual Health Center’s eHealthUniversity Dr. Erica C. Watkins, PharmD, RPh August 28, 2014

2. Learning Objectives 340B Pricing Determination Entity eligibility Entity Enrollment Procedures Requirements and Prohibitions Drug Procurement

3. Pricing Determination

4. The 340B Price 340B pricing program = 25 –50% of AWP Drug Manufacturers = offer sub-ceiling prices Calculated quarterly

5. 100% 90% 80% 70% 60% 50% 40% 30% 20% 10% 0% 66% 64% 53% 51% 49% Adapted froma slide by Safety Net Hospitals for Pharmaceutical Access Source: Data derived from Prices for Brand-Name Drugs Under Selected Federal Programs, Congressional Budget Office (June 2005) Private Sector Pricing 79% 58% 42% Relative Pricing

6. Eligibility

7. Eligible 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

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

9. Enrollment

10. 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 OfficialOctober 1January 1April 1July 1 Registration PeriodJuly 1 – 15October 1 -15January 1 – 15April 1 - 15 340B Enrollment

11. 1.Determine Eligibility 2.Complete Appropriate Forms 3.OPA verifies scope of grant Registration information MUST match the EHBs 4.Await Decision From OPA 340B Enrollment Steps

12. 340B 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.

13. Contract 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.

14. 340B 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

15. Recertification – 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

16. Entities are required to recertify information in the HRSA 340B database annually HRSA sends a notification email to Authorizing Official and Primary Contact The Authorizing Official performs the recertification online

17. Recertification Implementation Current  FQHC grant eligibility  DSH percentage quarterly  Ownership status quarterly Began phased implementation of annual recertification  Ryan White Programs, STD/TB – completed  Family Planning - completed  Hospitals – completed  FQHC – anticipated January 2013

18. 340B 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

19. 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

20. 340B Recertification Steps Keys to successful recertification?  Verify contact information is up to date in the 340B Program database  Update all information in EHBs  Submit 340B Program change form to update entity information  Monitor 340B Program webpage and your email prior to recertification  Do not mistake change form for recertification

21. Requirement and Prohibitions

22. 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

23. Medicaid Rebate 340B Price

24. 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 Definition

25. 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 OPA website. ” OPA GPO Certification Form GPO Prohibitions

26. Procurement 340B Prime Vendor Program

27. Apexus 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

28. Apexus The Prime Vendor serves participants in three distinct areas: – Negotiating sub-340B pricing – Establishment of distribution solutions and networks to improve medication access

29. Benefits of Apexus No cost or risk to participate No change of distributor required Maximized value delivered through a single program Longer term contracts Price transparency

30. Vaccines Outpatient Prescription Drugs Inpatient drugs Over-the-counter drugs (with a prescription) Drug not directly reimbursed Clinic administered drugs FDA doesn’t require NDC Biologics Insulin http://www.ssa.gov/OP_Home/ssact/title19/1927.htm Non-covered and Covered drugs