Transcript Reimbursement for Off-Label Uses

Clarifying the Regulatory Framework of Off-Label Usage
Institute for International Research
Washington, DC
July 17, 2002
Reimbursement for Off-Label Uses
Overview
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Shifting gears from enforcement
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What enables off-label reimbursement?
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Reimbursement planning checklist
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Additional information
Shifting Gears from
Enforcement to Reimbursement
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Payer decisions are independent of FDA
enforcement for same product
Unlike labeling and advertising, no legal
limitations on off-label reimbursement
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But there are some helpful mandates
What Enables Off-Label
Reimbursement?
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Use not matched to label
Cost neutral
Pressure from 6 Ps
Published evidence
Legal mandates
Technology assessment
Use Not Matched To Label
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If there is no PA and the use is not “far
off” enough to trigger software
recognition
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E.g. SSRIs; oral antibiotics; some cancer
agents
Cost Neutral
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Off-label reimbursement is almost
always an economic issue
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Even when couched in clinical terms
If off-label use is drug cost neutral,
reimbursement typically happens
Pressure From 6 Ps
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Prescribers are the most influential
Pharmacists influence formulary drugs
Patient advocates affect decisions
Plaintiffs trigger reconsideration
Politicians occasionally impact payers
Press coverage can help
Published Evidence
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Compendia
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First source for most payers
AHFS DI
USP DI
Peer-reviewed journals
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Influential with larger, national payers
Legal Mandates
 Medicare – cancer
 Medicaid – all rebate drugs
 State laws – primarily cancer, AIDS
Medicare
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“Anticancer chemotherapeutic regimen”
“Medically accepted indication” means
that the off-label use
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Is included or approved for inclusion in
compendia, or
Carrier determines based on “supportive
clinical evidence” in peer- reviewed pubs
Medicaid
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Rebate law requires coverage of offlabel use if included or approved for
inclusion in compendia
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Not limited to cancer
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No consideration of peer-reviewed pubs
State Laws
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39 states (1999)
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Typically cancer or HIV/AIDS
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N/A to ERISA regulated plans
Off-Label Tech Assessments
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All or nothing: Done once for product,
rather than case-by-case
Tend to be clinically driven with cost
undercurrent
E.g. - Medicare, BCBSA TEC
Medicare Coverage Process
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National coverage (or non-coverage)
decision – binding on contractors
OR
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Contractor (Carriers, FIs, DMERCS)
decisions at local level
National Process is Slow
But Transparent
1.
2.
3.
4.
5.
Request for coverage policy
MCAC recommendation (sometimes)
CAG staff decision
Publication www.cms.hhs.gov/coverage
Reconsideration (?!) -- See Ocular
Photodynamic Therapy With Verteporfin
4/12/00 – 3/28/02 on website
Contractor Process
Can Be Mysterious
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LMRPs are published www.lmrp.net
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See e.g. Noridian Neupogen/Leukine Policy
effective 6/01/02
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But informal, equally conclusive decisions are
not published
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Notice via claim denials
Contradictory outcomes for no apparent
reason are common
BCBSA TEC
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Triggered by request from member plan
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Advisory, not binding
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Non-BCBS insurers subscribe
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www.bcbs.com/healthprofessionals/tec.html
Devices
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Closer scrutiny than drugs
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Mfgr should expect that:
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Routine claims processing will identify
unlabeled uses
All will be rejected unless supported by
solid published data
Reimbursement
Planning Checklist
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Favored category (Ca; HIV/AIDS)
Payer mix
How far off (Dx; dose; route of admin.)
Treatment setting
Prior authorized; case managed
Formulary
Cost – product, Rx budget, overall
Additional Information
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July 2002 Literature Search:
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