2015 - 340B & Prime Vendor Program Update - c.ymcdn.comc.ymcdn.com/sites/ · PDF...
Transcript of 2015 - 340B & Prime Vendor Program Update - c.ymcdn.comc.ymcdn.com/sites/ · PDF...
340B Sales by Entity Types
87%
13%
Percentage of Total Apexus Participant Sales
Hospital
Non-Hospital
0.40% 1.79% 3.29%
81.14%
0.00%
10.00%
20.00%
30.00%
40.00%
50.00%
60.00%
70.00%
80.00%
90.00%
Free-StandingCancer (CAN)
Children'sHospitals (PED)
Rural Hospitals(CAH/RRC/SCH)
DSH
% of Total Sales
Hospital
0.11% 0.56%
1.03%
5.83% 5.85%
0.00%
1.00%
2.00%
3.00%
4.00%
5.00%
6.00%
7.00%
HM STD/TB Title X (FP) Ryan White(HV)
FQHC
% of Total Sales
Non-Hospital
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GPO Prohibition
• Established in original 340B legislation in 1992 • Prevents GPO use for Covered Outpatient Drugs
• 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.”
• Release clarifying OPA Policy • February 23, 2013 – letter of GPO Prohibition enforcement by HRSA
• Hospitals must be compliant effective August 7, 2013
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GPO Prohibition Clarification –
Purchase Flow for Most Hospitals
Non-compliant State Compliant State
340B Registered
Hospital
All Other (Default to GPO)
Inpatient or
Non-Covered
Drugs (GPO)
340B
340B
All Other Out-
Patient Covered
Drugs (Default to Non-GPO
Account)
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©2014 Apexus. Reproduction without permission is prohibited.
How does the Medicaid Exclusion File work?
Medicaid
Exclusion
File
Manufacturer
State
Entity
340B
Discount
Medicaid
Rebate
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• Simple goal—prevent duplicate discounts
• Challenges for a solution—coordination of HRSA, states and CMS – Marketplace alternatives to the HRSA Medicaid Exclusion File
(ex. NCPDP standards, UD modifiers)
• State policy is variable and sometimes not informed – States refuse to use the Medicaid Exclusion File
– States require entities to share any 340B refund payments from manufacturers (from years ago)
– States require entities to self-audit for use of “non-covered outpatient drugs” in the past
• Apexus has contributed by providing education to states – 340B U for State Medicaid Pharmacy Directors (August 2014)
– Discussions regarding fair reimbursement models
Medicaid Update
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• Increase the number of audits
– Covered entity audits focus on diversion, duplicate discounts, and GPO prohibition (for DSH, CAN and PED)
– Manufacturer audits (OIG report pending)
• Publish
– Mega-guidance (summer 2015)
– Regulations
• Civil-monetary penalties
• Administrative dispute resolution
• Drug pricing
• Focus on Medicaid Exclusion File/policy (modernize)
• Continue working toward publishing 340B ceiling prices
HRSA Activity Expected in 2015
FY
2012
FY
2013
FY
2014
FY
2015* (As of
1/13/15)
Number of covered entities
audited
51 94 99 33
•Outpatient facilities/sub-grantees 410 718 1,476 698
•Contract pharmacies 860 1937 4,028 1688
Number of finalized reports 51 75 18 0
HRSA Audits by the Numbers
Orphan Drug Update
• Chaotic marketplace
• Wholesalers are at financial risk between the manufacturers and hospitals; some are more conservative and have decided to block all sales and manage the manufacturers’ products that agreed to sell as an exception
• HRSA wrote letters of inquiry to all companies for which complaints of not offering 340B prices on orphan drugs were received
– Of the 27 companies that had orphan drugs, 14 are offering 340B pricing and 13 are not
– Feb 4th - HRSA posted the names of the manufacturers not offering 340B pricing on their website
Apexus Programs Supporting HRSA
and 340B Stakeholders
Brand and Generic Rx
Pricing
Wholesaler Networks
Apexus Answers
Call Center
340B University™
& 340B OnDemand
CO
NT
RA
CT
ING
AS
SIS
TA
NC
E
ED
UC
AT
ION
Benefits of the 340B PVP to Covered
Entities
• Sub-340B and Sub-WAC pricing on outpatient
pharmaceuticals
• Discounts on value added products, services, and
supplies
• Apexus’ Manufacturer Refund Service
• Pricing transparency
• Distribution solutions
• 340B Education and compliance support
Benefits of 340B PVP to
Pharmaceutical Manufacturers
• Aggregator of outpatient purchasing in the
340B space
– Works closely with HRSA under an exclusive
agreement; successful track record (10 years)
– Understands government rules, drug pricing,
contracting, and the unique needs of both covered
entities and manufacturers
– Extend full price protections on all sales to
participating covered entities
– Provides a single point of entry into a complex
market for outpatient pharmaceuticals
Adapted from a slide by Safety Net Hospitals for Pharmaceutical Access
Source: Data derived from Prices for Brand-Name Drugs Under Selected Federal Programs, Congressional Budget Office
Prime Vendor Pricing Comparison
• Apexus team is working to identify and share
leading practices used by entities to minimize WAC
expense
– Large variances among participants
– Analyzing data by split-billing vendor
– Strategies: minimizing lost charges, determining a policy
for expired medications, evaluating Medicaid carve-out
status, and identifying GPO only areas
• Apexus contracting team has worked to provide
value by contracting for sub-WAC pricing, in 2014
– 7,508 products on non-GPO/WAC contracts
Minimizing WAC Expense
Look Familiar?
• Developed to support integrity
provisions
• Inaugurated September 2011
• 2014 Graduates: > 2,000
• Sessions in 2015: 10+
• Diversity of stakeholders
Assistance/Education
• Critical HRSA need
• Launched: October 1, 2012
• HRSA-approved answers
• Hours of operation: Mon-Fri
8:00 AM – 5:00 PM CST
• 888.340.2787
EDUCATION APEXUS ANSWERS
• Mega-guidance, summer 2015
• GPO Prohibition: Split-billing software
configuration/malfunction, minimizing WAC spend
• Defining material breach of non-compliance
• 340B Contract pharmacy attempting to manage
repayment/credits on behalf of entity (manufacturer
wonders “Why is this pharmacy mailing me a check?”)
• Instead of repayment or credit-rebill, some entities opt to
adjust future purchasing to correct past mistakes
• Interpretation of covered outpatient drugs
• Inquiries regarding orphan drugs
Apexus Answers: Hot Topics
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340B University: Top Compliance-
Focused Tools
1. 340B independent audit RFP checklist
(new)
2. Split-billing tool (new)
3. Self-disclosure tool
4. Sample self-audit guides
5. Sample SOPs
Tools: https://www.340bpvp.com/340b-university/tools-and-resources/
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Apexus Certificate Program -Curriculum Structure & Audience
Level 1
Open Course
Overview
of foundational 340B knowledge
Le
vel 2
Application Certificate
Application
in 340B operational
integrity
Level 3
Master Certificate
Policy
to practice compliance
interpretation
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• Grow sub-340B portfolio savings value
• Continue to build out portfolio of sub-WAC pricing to minimize WAC expenditures and support participants in optimizing
• Maintain high customer satisfaction and call center ratings
• Advance manufacturer refund program through strategic partnerships
• Implement specialty pharmacy solution to support participants’ access to product and 340B pricing
• Expand education offerings for advanced training and certification
Focus for 2015
• Manufacturers support opening 340B statute,
scrutinizing hospital eligibility criteria
• Republican control of Senate and retirement of
340B-supportive legislators change environment
for 340B
• Orphan drug lawsuit is expected to have final
briefs due in March 2015
• GAO and OIG have 340B reports underway
(Medicare)
• Reimbursement challenges with payers and
Medicaid will increase
340B Environmental Scan
340B Intent
To permit covered entities “to stretch scarce
Federal resources as far as possible, reaching
more eligible patients and providing more
comprehensive services.” H.R. Rep. No. 102-384(II), at 12 (1992)
Ongoing Points of Dispute
• Is the intent of 340B for the entity, the patient, or
both?
• Should hospital eligibility criteria (DSH %) be
revisited?
• Do contract pharmacies need to be limited in some
way?
• Should program be limited to the uninsured?
• What should be done to modernize the HRSA
Medicaid Exclusion File?
• Does HRSA have the authority to issue regulations?
Contact Information
Apexus Answers:
M-F 8:00-5:00 PM CT
Email: [email protected]
Website: www.340BPVP.com