1 / 21

Overview

Clarifying the Regulatory Framework of Off-Label Usage Institute for International Research Washington, DC July 17, 2002 Reimbursement for Off-Label Uses. Overview. Shifting gears from enforcement What enables off-label reimbursement? Reimbursement planning checklist Additional information.

denise-carson
Télécharger la présentation

Overview

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript

  1. Clarifying the Regulatory Framework of Off-Label UsageInstitute for International ResearchWashington, DCJuly 17, 2002Reimbursement for Off-Label Uses

  2. Overview • Shifting gears from enforcement • What enables off-label reimbursement? • Reimbursement planning checklist • Additional information

  3. 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

  4. What Enables Off-Label Reimbursement? • Use not matched to label • Cost neutral • Pressure from 6 Ps • Published evidence • Legal mandates • Technology assessment

  5. 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

  6. 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

  7. Pressure From 6 Ps • Prescribers are the most influential • Pharmacists influence formulary drugs • Patientadvocates affect decisions • Plaintiffs trigger reconsideration • Politicians occasionally impact payers • Press coverage can help

  8. Published Evidence • Compendia • First source for most payers • AHFS DI • USP DI • Peer-reviewed journals • Influential with larger, national payers

  9. Legal Mandates • Medicare – cancer • Medicaid – all rebate drugs • State laws – primarily cancer, AIDS

  10. Medicare • “Anticancer chemotherapeutic regimen” • “Medically accepted indication” means that the off-label use • Is included orapproved for inclusion in compendia, or • Carrier determines based on “supportive clinical evidence” in peer- reviewed pubs

  11. 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

  12. State Laws • 39 states (1999) • Typically cancer or HIV/AIDS • N/A to ERISA regulated plans

  13. 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

  14. Medicare Coverage Process • National coverage (or non-coverage) decision – binding on contractors OR • Contractor (Carriers, FIs, DMERCS) decisions at local level

  15. National Process is Slow But Transparent • 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

  16. Contractor Process Can Be Mysterious • LMRPs are published www.lmrp.net • See e.g. Noridian Neupogen/Leukine Policyeffective 6/01/02 • But informal, equally conclusive decisions are not published • Notice via claim denials • Contradictory outcomes for no apparent reason are common

  17. BCBSA TEC • Triggered by request from member plan • Advisory, not binding • Non-BCBS insurers subscribe • www.bcbs.com/healthprofessionals/tec.html

  18. 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

  19. 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

  20. Additional Information • July 2002 Literature Search: TAGLAWDC@aol.com

  21. 1875 Eye St., N.W. - Suite 900 Washington, DC 20006 USA 202.785.3800 TAGLAWDC@aol.com www.tag-associates.com

More Related