Our Future (Text Version)

AHRQ 2008 Annual Conference

Slide Presentation from the AHRQ 2008 Annual Conference

On September 9, 2008, this presentation was made at the 2008 Annual Conference. Select to access the PowerPoint® presentation (7.5 MB; Plugin Software Help).

Slide 1

Our Future

The slide shows a photograph of a shirtless boy riding a tall unicycle on a gravel road out in the desert.

Slide 2

Post-Market Registries

The slide shows a photograph of a man, dressed in camouflage, watching a dolphin, equipped with a small camera on one of its flippers, jump from the water.

Slide 3

Center for Medicare/Medicaid Prospective

The slide shows a photograph of Mark B. McClellan, M.D., Ph.D.

• Pay for performance.
• Centers for Medicare and Medicaid Services (CMS) National Coverage Determination (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.

Slide 4

Collaboration

• Government—Food and Drug Administration (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).

Slide 5

Industry Issues

• Access to data in a timely manner allowing for analysis and potential publications.
• Others having access to data which Industry does not.
• Data is incomplete with little compliance.
• INTERMACS does not meet FDA post market requirements.
• INTERMACS does not meet CMS requirements.

Slide 6

Industry Concerns

• Clarification as to who has access to data. If manufacturer does not have commercial pump they can not access data.
• Confidence that specific manufacturer data will not be provided to another manufacturer for pump to pump comparison.

Slide 7

Industry Request

• Industry participation on Steering Committees and involvement on Operations Committee.
• Creation of Publication Committee with Industry participation and review of articles which utilize data from their specific pump.
• Creation of formal review committee who reviews request for data and reasons for request.

Slide 8

Today.a Little Reward

The slide shows a photograph of a squirrel holding a Reese's peanut butter cup in its mouth.

• A database which is in compliance with CMS and FDA requirements and provides guidance to improve outcomes.
• Assurance of confidentiality regarding data.
• Access to data reports and individual reporting.
• Standardized registry clinical and device definitions including AE between FDA, NIH, industry & clinical.

Slide 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.

Slide 10

How INTERMACS Survive?

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Slide 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.

Slide 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.

• Total Non-Government—1,875,000.

Slide 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.

Slide 14

Potential Funding

• Societies (International Society for Heart and Lung Transplantation [ISHLT], Heart Failure Society of America [HFSA], Society of Thoracic Surgeons/ American Association for Thoracic Surgery [STS/AATS], American College of Cardiology [ACC]).
• Industry.
• Government (National Heart, Lung and Blood Institute [NHLBI], CMS).
• International government.

Slide 15

Tomorrow

The slide shows a photograph of a meerkat standing, sunny himself under a red heat lamp.

Slide 16

INTERMACS will feed

The slide shows a photograph of a mother and father Blue Jay feeding their four young babies.

• Those who govern.
  Those who treat.
  Those who create.

To improve the duration and quality of life of patients with advanced heart failure.