340B Drug Pricing Program Assessment Supplement – Training

for BPHC Consultants

October 21, 2014

Michelle Herzog U.S. Department of Health and Human Services Health Resources and Services Administration

Healthcare Systems Bureau Office of Pharmacy Affairs

Covered Entity Compliance

• Registration • Recertification • Diversion • Duplicate Discounts

Registration

• Currently 22 entity types eligible to participate from Federal grantees to hospitals

• Requirements for eligibility are listed on the HRSA OPA website at http://www.hrsa.gov/opa/eligibilityandregistration/index.html

• Initial “Certification” (Registration) is required and HRSA reviews and validates eligibility

• Once listed on 340B database, covered entity can purchase 340B drugs using their 340B ID

Initial Certification

• Eligibility Verification • EHB • Pending verification status

• Attestation language • Meet eligibility requirements • Systems for compliance • Self report of changes/violations

Annual 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

Diversion

• Diversion means: 340B drug is…. Provided to an individual who is not a patient of that

entity Dispensed in an area of a larger facility that is not

eligible (e.g. an inpatient service, a non-covered clinic) Entities should enroll all eligible offsite outpatient or satellite

sites

• Required to follow patient definition guidelines - 61 Fed. Reg. 55156 (October 24, 1996)

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Duplicate Discounts

• Duplicate Discount = Accessing the 340B Discount and Medicaid Rebate on same drug

• Safety-net providers required to inform HRSA • HRSA maintains this list known as the Medicaid

Exclusion File on HRSA’s public website • HRSA provides guidance to covered entities and states “Clarification on Use of the Medicaid Exclusion File”

(http://www.hrsa.gov/opa/programrequirements/policyreleases/medicaidexclusionclarification020713.pdf)

• Final Notice, Duplicate Discounts and Rebates on Drug Purchases published at 58 Fed. Reg. 34058 (June 23, 1993).

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Program Integrity Guiding Principles: • Maximize oversight reach • Manage compliance risk Strategy

• Initial certification • Annual

recertification • Program audits • Site visits

Resources • Systems • Staff

Program Integrity (continued)

Areas of Focus • Eligibility • Duplicate Discount • Diversion • Group Purchasing Organization

HRSA Audits

• All covered entity types considered for risk-based audit selection • Risk-based factors – length in program, number of outpatient

facilities, number of contract pharmacies, complexity of program, volume of purchase

• Target audits – focus on specific allegation • Conducted by HRSA regional staff • Further information on the audit process is available at

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

Site Visit Supplement

• Verify the existence of appropriate documents • Consultants not expected to review patient

records or conduct any other type of sampling • The clinical consultant will be responsible to

address/ask the 340B questions. • The Team Lead will be responsible for ensuring

that the 340B questions have been answered electronically.

• The site visit report will not be able to be submitted until the 340B responses have been entered.

Question 1 & 2

1. Does the Health Center participate in the 340B drug pricing Program? YES/NO (if NO, completion of this supplement is not required)

2. Does the health center have written 340B policies, procedures, or other related documents? YES/NO (if No, Proceed to Question 4.)

Question 3

3. If Yes to #2, do the policies, procedures, or other related documents address the following areas: a. Assure that the individuals provided access to 340B drugs purchased by the health Center meet all of the following areas:

Question 3.a.i.

3.a.i The health center has an established relationship with the individual, as documented by the health center maintaining records of the individuals health care? YES/NO

Question 3.a.ii

3.a.ii The individual receives health care services from a health care professional who is either employed by the health center or under contractual or other arrangements (e.g., referral for consultation) such that responsibility for care provided remains with the health center; i.e., 340B prescriptions are only made available that receive services that are either provided directly by the health center (Form 5A Column I and/or II) and/or through formal written referral arrangements (Form 5A Column III) consistent with the approved scope of project YES/NO

Question 3.b

3.b. The prevention of Duplicate Discounts for patients covered under Medicaid? YES/NO

Question 4

4. Does the health center dispense 340B drugs to patients through a contract pharmacy services model? YES/NO (If NO is selected, click submit) If yes, please verify the following:

• Does a written contract exist between the health center and contract pharmacy(ies)? YES/NO

• Does the health center have within its contract or in written policies and procedures how the contract pharmacy will ensure against diversion? YES/NO

• Does the health center have, within its contract or in its written policies and procedures, a process that reflects how the contract pharmacy will ensure against duplicate discounts? YES/NO

Question 5

5. Does the health center attest that it provides oversight (e.g., annual audit or other mechanism) of the 340B drugs dispensed by the contract pharmacy? YES/NO Example Community Health Center (CHC) Comprehensive Policy and Procedure Manual can be found at: https://docs.340bpvp.com/documents/public/resourcecenter/340B_Tool_Guide.pdf

FY 2015 – looking forward

• Enhanced Program Integrity Strategy

• Communications strategy • Regulations

• Civil Monetary Penalties • Administrative Dispute Resolution

• Ceiling Price Database

340B Resources

HRSA Prime Vendor Program (PVP) • Contract with Apexus • No cost to participate • http://www.340bpvp.com • ApexusAnswers@340bpvp.com • 340B University – educational opportunity • Drug price negotiation services • Multiple wholesale distributor agreements • Favorable discounts on other pharmacy

related products/service

Peer to Peer Program

• Showcases high performing 340B entities in order to provide practical examples of excellence in 340B integrity and quality

• Serves as a resource for other entities wishing to raise the standard of their 340B practices.

• All 340B entity types are encouraged to apply. • Qualified applications are evaluated on a rolling basis (limited spots are

available). • Applicants will be evaluated on 5 key areas:

o 340B program integrity o Providing access to affordable medications o Efficient business practices o Outcomes-driven clinical programs o Quality assurance programs

• Selected sites that will receive benefits such as off-site training, APhA association membership and access to other 340B events.

To apply, visit http://www.hrsa.gov/opa, click on the "Peer to Peer" tab on the right side of the screen and select "340B Peer to Peer Application.”

Contact Information

Office of Pharmacy Affairs (OPA) Phone: 301-594-4353 Web: http://www.hrsa.gov/opa 340Bdatacollection@hrsa.gov Apexus Answers (primary resource for 340B consultation) Prime Vendor Program Phone: 1-888-340-2787 ApexusAnswers@340bpvp.com Web: http://www.340bpvp.com