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Industry Prospective

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Industry Prospective

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    1. Industry Prospective Robin Bostic, Thoratec VP Health Policy and Health Economics INTERMACS Industry Sub-Committee Representative I was really delighted to be asked to share with you an industry prospective on registries. Being from Thoratec, a company who manufactures ventricular assist devices, my insights come more from the device side of things. I was really delighted to be asked to share with you an industry prospective on registries. Being from Thoratec, a company who manufactures ventricular assist devices, my insights come more from the device side of things.

    2. Post-Market Registries I believe registries provide a very unique and sometimes needed perspective. Even after a NIH trial reporting clear benefit, a somewhat innovative technology such as VADs used to provide end of life heart support known as Destination Therapy can face slow acceptance and very narrow indications. A registries can provide additional data which can drive standardization of care and even expanded indications for use. I believe registries provide a very unique and sometimes needed perspective. Even after a NIH trial reporting clear benefit, a somewhat innovative technology such as VADs used to provide end of life heart support known as Destination Therapy can face slow acceptance and very narrow indications. A registries can provide additional data which can drive standardization of care and even expanded indications for use.

    3. Center for Medicare/Medicaid Prospective Pay for performance CMS NCD requires CMS Destination Therapy centers report outcomes to a national data base Better quality and more efficiency Better evidence after market Access risk and cost Initially this initiative was driven by a concept embraced by Mark McClellan the head of CMS at the time. CMS completed an National coverage decision expanding coverage to include Destination Therapy. In this NCD, they required CMS VAD Centers to meet specific criteria, one was to report to a national data base in order to show better quality and more efficiency, better after market evidence and access to risk and cost. Initially this initiative was driven by a concept embraced by Mark McClellan the head of CMS at the time. CMS completed an National coverage decision expanding coverage to include Destination Therapy. In this NCD, they required CMS VAD Centers to meet specific criteria, one was to report to a national data base in order to show better quality and more efficiency, better after market evidence and access to risk and cost.

    4. Collaboration Government - FDA, National Institute of Health (NIH), CMS (regulating, researching, reimbursing ventricular assist devices (VADs)) DCC (data clinical coordinating center) Hospitals and clinicians (providing care) Industry (manufacturing VADs) Societies (overseeing standards of care of patients with the VADs) Not only did they mandate registry reporting, but fostered collaboration not only with NHLBI who provided funding for the registry, but also collaboration with governing bodies, data clinical coordinating centers, providers and yes, even manufacturers. Several subcommittees were formed to support Intermacs, one being an Industry committee. I’m going to share with you some of our early concerns.Not only did they mandate registry reporting, but fostered collaboration not only with NHLBI who provided funding for the registry, but also collaboration with governing bodies, data clinical coordinating centers, providers and yes, even manufacturers. Several subcommittees were formed to support Intermacs, one being an Industry committee. I’m going to share with you some of our early concerns.

    5. Industry Issues

    6. Industry Concerns

    7. Industry Request

    8. Today…a Little Reward So what do we have…. A data base that is compliant with cms and fda requirements, some assurance of confidentiality regarding data. An added benefit is the standarization of Adverse event definitions. So what do we have…. A data base that is compliant with cms and fda requirements, some assurance of confidentiality regarding data. An added benefit is the standarization of Adverse event definitions.

    9. Outstanding Issues FDA utilization of INTERMACS to meet all post-marketing requirements. Reconciliation of INTERMACS data. What has been reported and number of pumps provided by center. Method in transferring clinical trial data needs to be outlined. Publication and data access policies need to be open and transparent.

    10. How INTERMACS Survive?

    11. INTERMACS Resource Analysis 1) 1000 new patients per year while maintaining the existing database. 2) Partial compensation for clinical site coordinators. 3) Quality assurance for the database. Thus 6 auditors and 3 clinical coordinators at the Data Coordinating Center. 4) Business development person to secure funding for the Center.

    12. INTERMACS Resource Analysis Personnel (direct +Indirect) 1,200,000 Materials 25,000 Equipment 50,000 Travel 2x1.0Kx 100 sites 100,000 Other Direct 100,000 Clinical Coordinators 300,000 Consultants 100,000

    13. Potential Revenue Drivers Today Data access Data reports Post market registries Future Provide data collection and analysis for Manufacturer pre-market studies NHLBI expanded studies Establish subset of International registries

    14. Potential Funding

    15. Tomorrow

    16. INTERMACS will feed

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