clarifying the regulatory framework of off-label usage institute for international research...
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Clarifying the Regulatory Framework of Off-Label UsageInstitute for International ResearchWashington, DCJuly 17, 2002
Reimbursement for Off-Label Uses
Overview
Shifting gears from enforcement
What enables off-label reimbursement?
Reimbursement planning checklist
Additional information
Shifting Gears from Enforcement to Reimbursement
Payer decisions are independent of FDA enforcement for same product
Unlike labeling and advertising, no legal limitations on off-label reimbursement But there are some helpful mandates
What Enables Off-Label Reimbursement?
Use not matched to label Cost neutral Pressure from 6 Ps Published evidence Legal mandates Technology assessment
Use Not Matched To Label
If there is no PA and the use is not “far off” enough to trigger software recognition E.g. SSRIs; oral antibiotics; some
cancer agents
Cost Neutral
Off-label reimbursement is almost always an economic issue Even when couched in clinical terms
If off-label use is drug cost neutral, reimbursement typically happens
Pressure From 6 Ps
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
Compendia First source for most payers AHFS DI USP DI
Peer-reviewed journals Influential with larger, national payers
Legal Mandates
Medicare – cancer
Medicaid – all rebate drugs
State laws – primarily cancer, AIDS
Medicare “Anticancer chemotherapeutic
regimen”
“Medically accepted indication” means that the off-label use Is included or approved for inclusion in
compendia, or Carrier determines based on “supportive
clinical evidence” in peer- reviewed pubs
Medicaid
Rebate law requires coverage of off-label use if included or approved for inclusion in compendia
Not limited to cancer
No consideration of peer-reviewed pubs
State Laws
39 states (1999)
Typically cancer or HIV/AIDS
N/A to ERISA regulated plans
Off-Label Tech Assessments
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
National coverage (or non-coverage) decision – binding on contractors
OR
Contractor (Carriers, FIs, DMERCS) decisions at local level
National Process is Slow But Transparent
1. Request for coverage policy2. MCAC recommendation (sometimes)3. CAG staff decision4. Publication www.cms.hhs.gov/coverage
5. Reconsideration (?!) -- See Ocular Photodynamic Therapy With Verteporfin 4/12/00 – 3/28/02 on website
Contractor Process Can Be Mysterious LMRPs are published www.lmrp.net
See e.g. Noridian Neupogen/Leukine Policy effective 6/01/02
But informal, equally conclusive decisions are not published Notice via claim denials
Contradictory outcomes for no apparent reason are common
BCBSA TEC
Triggered by request from member plan
Advisory, not binding
Non-BCBS insurers subscribe
www.bcbs.com/healthprofessionals/tec.html
Devices
Closer scrutiny than drugs
Mfgr should expect that: Routine claims processing will identify
unlabeled uses All will be rejected unless supported
by solid published data
Reimbursement Planning Checklist 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
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