Transcript Safety Net Hospitals from National Rural Health Association

Getting Started in the
340B Program
Safety Net Hospitals for Pharmaceutical Access
William von Oehsen
President/General Counsel
[email protected]
(202) 872-6765
National Rural Health Association
June 17, 2010
© 2010 Safety Net Hospitals for Pharmaceutical Access
Overview
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SNHPA
(202) 552-5850
About SNHPA
340B provisions in health reform
Contract pharmacy opportunities
Patient definition
340B-1 proposal
SNHPA’s programs and services
Upcoming 340B /SNHPA events
SNHPA Rural Hospital Advisory Committee
Q &A
Bill von Oehsen
www.snhpa.org
Who is SNHPA?
SNHPA
(202) 552-5850
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Non-profit organization representing and supporting
500+ hospitals and health systems in 340B – including
rural hospitals
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Board Chair is CEO of network of rural hospitals
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Took lead role in including hospitals in the 340B law –
including rural hospitals
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Advocates on federal legislative and regulatory issues
related to drug pricing and other pharmacy matters
affecting safety-net providers
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Educates members on 340B policy developments in
Bill von Oehsen
Congress and regulatory agencies
www.snhpa.org
Health Reform and 340B
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SNHPA
(202) 552-5850
Most significant changes since 1992
Impacts all 340B stakeholders
Both positive and negative implications
Bill von Oehsen
www.snhpa.org
Expansion to New Entities
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SNHPA
(202) 552-5850
Now eligible:
◦ Free-standing children’s hospitals
◦ Some free-standing cancer hospitals
◦ Critical access hospitals
◦ Sole community hospitals and rural referral centers
with 8%+ Medicare DSH adjustment
All new covered entities must either be publicly owned
or be a private nonprofit contracting with a state or
local government to provide indigent care
Bill von Oehsen
www.snhpa.org
Key Issues for Rural Hospitals
● Application forms not available yet but start
getting prepared!
● SNHPA can assist with meeting state or local
government contracting requirement
● Requirement to withdraw from GPO does
not apply to CAHs, SCHs or RRCs between
8-11.75%
● Unclear about hospitals above 11.75%
SNHPA
(202) 552-5850
Bill von Oehsen
www.snhpa.org
Contract Pharmacy
Opportunities/Challenges
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SNHPA
(202) 552-5850
“Ship to/bill to arrangement”
Multiple contract pharmacy guidelines went into
effect on April 5
Particularly helpful for rural hospitals lacking an
outpatient pharmacy
Significant opportunity to expand Rx access and
increase revenue
New compliance challenges, including an
“expectation of” annual independent audits
Bill von Oehsen
www.snhpa.org
Inpatient Discounts
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SNHPA
(202) 552-5850
Hospitals currently pay 25-50% more for
inpatient drug products
Goal: Extend 340B to inpatient setting
Stand-alone bills pending: H.R. 444 and S. 1239
340B inpatient provisions passed Senate as part
of health care reform
Became law for 7 days
Removed in reconciliation bill
SNHPA continuing to push for passage
Bill von Oehsen
www.snhpa.org
Orphan Drug Exemption
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SNHPA
(202) 552-5850
“Orphan drugs” excluded from 340B for newlyeligible entities
◦ Won’t impact DSH hospitals but highly
problematic for rural and other new
providers
◦ Over 300 such drugs, many for multiple uses
◦ SNHPA, NRHA and others challenging
exclusion
◦ Children’s hospitals fix in House jobs/tax bill
◦ Need your help!
Bill von Oehsen
www.snhpa.org
Larger 340B Discounts
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Increased Medicaid rebate % likely to
yield steeper 340B discounts:
◦ Brand name drugs: 15.1% to 23.1%
◦ Clotting factor and pediatric drugs:
15.1% to 17.1%
◦ Generic drugs: 11% to 13%
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SNHPA
(202) 552-5850
Change in AMP formula will likely shrink
discount
Bill von Oehsen
www.snhpa.org
Medicaid and
Medicare Changes
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Drugs prescribed through Medicaid managed
care plans now eligible for rebates
◦ 340B providers exempt
◦ Preserves 340B savings on managed care drugs
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Medicare Part D coverage gap or “donut hole”
fixed
◦ Seniors will get 75% discount for “donut hole” drugs
◦ Seniors in “donut hole” will receive $250 towards
Part D drugs in 2010
SNHPA
(202) 552-5850
Bill von Oehsen
www.snhpa.org
New Integrity Provisions:
Impact on Drug Industry
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SNHPA
(202) 552-5850
OPA and HHS must make 340B ceiling prices
available
HHS must:
◦ Develop a system to ensure accurate drug
pricing, including spot checks and inquiries into
pricing changes
◦ Establish process for manufacturers to issue
refunds including for routine adjustments to
AMP and best price
Stronger sanctions against manufacturers
Bill von Oehsen
www.snhpa.org
New Integrity Provisions
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SNHPA
(202) 552-5850
HHS must issue regulations by 10/2010 to
establish formal dispute resolution process
◦ Should improve process for resolving disputes
◦ Hospitals must use this process to recover
alleged overcharges by manufacturers
◦ Manufacturers must use this process to
address diversion claims
Bill von Oehsen
www.snhpa.org
New Integrity Provisions:
Impact on Covered Entities
Annual recertification of OPA database
information
 Fines for intentional violations
 HHS must issue new detailed guidance on
Medicaid billing requirements
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SNHPA
(202) 552-5850
Bill von Oehsen
www.snhpa.org
GAO Report
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Government Accountability Office (GAO)
to prepare report for Congress by 9/2011
on 340B program:
◦ Should the program be expanded given that
millions of uninsured patients will gain
coverage?
◦ Does it hinder access at non-340B facilities?
◦ Are providers using savings “to further
program objectives?”
SNHPA
(202) 552-5850
Bill von Oehsen
www.snhpa.org
Patient Definition
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Significant restrictions proposed in 2007
guidance:
◦ Would end use of 340B medicines to fill
prescriptions written outside hospital walls
◦ Imposes major burden on pharmacists to
research multiple eligibility criteria for
assessing patient status
SNHPA
(202) 552-5850
Bill von Oehsen
www.snhpa.org
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Patient Definition
SNHPA has worked with broader 340B
Coalition to block proposal
 Key members of Congress have
communicated their concerns to HRSA
 340B Coalition has offered an alternative
to HRSA that all covered entity groups
support
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SNHPA
(202) 552-5850
Bill von Oehsen
www.snhpa.org
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340B-1Proposal
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A proposed, limited inpatient discount program included in tax
extender bill
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Would apply to only 1/3 of 340B-eligible hospitals with ≥ 20.2%
DSH adjustment
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All CAHs, SCHs & RRCs would be eligible
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Extends inpatient discounts for drugs:
◦ Administered or dispensed to uninsured patients, and
◦ For which hospitals collect no reimbursement
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HRSA must implement program by January 2011
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Represents compromise between congressional leadership and
drug industry
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SNHPA
(202) 552-5850
Hospital groups cut out of discussions until the very end
Bill von Oehsen
www.snhpa.org
340B-1 Proposal
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Several troubling provisions:
◦ HRSA must implement entire program by regulation, including
definition of “patient” and duplicate discount provisions
◦ Mandatory OIG inspection of all qualifying hospitals, whether
enrolled or not
◦ OIG inspection to focus on diversion and duplicate discounts
◦ Stiff penalties – fines, automatic recoupment, easier termination
◦ Easier to be audited by manufacturers
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Could give HHS discretion to combine 340B and
340B-1
SNHPA
(202) 552-5850
Bill von Oehsen
www.snhpa.org
How You Can Help!
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SNHPA
(202) 552-5850
Contact your lawmakers how the extension
about importance of extending 340B
Urge them to expand 340B to inpatient setting
Emphasize considerable savings for you hospital
and for Medicaid (over $1 billion)
Highlight the substantial administrative burden
of dual inventories
Ask for co-sponsorship of H.R. 444 and S. 1239
Attend SNHPA Legislative Day (7/22/10)
Bill von Oehsen
www.snhpa.org
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Membership Benefits
Free technical assistance calls with
attorneys and other professionals with
decades of 340B experience
 Inventory management guidance
 Comprehensive comparison tools
 Pricing clearinghouse
 Identify and recover overcharges
 Free regional roundtables
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SNHPA
(202) 552-5850
Bill von Oehsen
www.snhpa.org
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Membership Options
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Small Hospital membership: $975
◦ For hospitals w/25 or fewer beds
◦ Three (3) technical assistance calls
Membership dues range from $5,500$7,500
 Affiliate membership: $500
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◦ For hospitals not yet enrolled in 340B
SNHPA
(202) 552-5850
Bill von Oehsen
www.snhpa.org
SNHPA Membership Benefits
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SNHPA
(202) 552-5850
Biweekly electronic bulletin
Free subscription to The Drug Discount Monitor
Best practice tools
“Survival Kit”
State and federal policy tracking tools
Patient assistance programs information
Medicare Part D Resources Center
Members-only listserv
Significant discounts on membership for small
hospitals
Bill von Oehsen
www.snhpa.org
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Upcoming Events
14th Annual 340B Coalition Conference
Co-hosted by Apexus
July 19-21, 2010
Washington, DC
www.340bcoalition.org
*Special breakout sessions for rural providers
SNHPA Legislative Day
July 22, 2010
Contact Jaimie Vickery at (202) 552-5855 or
[email protected]
SNHPA
(202) 552-5850
Bill von Oehsen
www.snhpa.org
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Upcoming Events
Complimentary Webinar
“340B for Newly Eligible Hospitals”
July 7, 2010
1:00-2:30 PM (Eastern)
http://www.snhpa.org/app/webinars/7-7-10/
Questions? Contact Anna Mangum
[email protected] or (202) 552-5863
SNHPA
(202) 552-5850
Bill von Oehsen
www.snhpa.org
SNHPA Rural Hospital
Advisory Committee
Open to rural hospital members
 Meets every other month via telecon to
provide input into new programs for rural
hospitals
 Co-chairs (SNHPA Board members):
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◦ Dr. Charles Hart, CEO, Regional Health, Inc. (SD)
◦ Brad Atherton, Director of Pharmacy, John D.
Archbold Memorial Hospital (GA)
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SNHPA
(202) 552-5850
To join, contact Anna Mangum at
[email protected] or (202) 552-5863
Bill von Oehsen
www.snhpa.org
SNHPA Resources
SNHPA
1501 M Street, NW, 7th Floor
Washington, DC 20005
Phone: 202-552-5850
Fax: 202-552-5868
www.snhpa.org
SNHPA Newsletter
Drug Discount Monitor
www.drugdiscountmonitor.com
(free for members)
340B Career Resource
www.rxjobsolutions.com
(member discounts)
SNHPA
(202) 552-5850
Bill von Oehsen
www.snhpa.org
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Contact Information
SNHPA
(202) 552-5850
Bill von Oehsen
President/General Counsel
(202) 872-6765
william.vonoehsen@
snhpa.org
Anna Mangum
Director, Programs and
Membership
(202) 552-5863
[email protected]
Ted Slafsky
Executive Director
(202) 552-5860
[email protected]
Rob Recklaus
Director of Government
Relations
(202) 552-5852
[email protected]
Bill von Oehsen
www.snhpa.org