INTERMACS Collaborators: • NHLBI: Sustainability – Are we there yet? • CMS: The blurred lines among DT, BTC, BTT • FDA: Benchmarks for next device approval • Industry: INTERMACS – The ultimate post market study • Hospitals: Utilizing the Quality Assurance Reports Sixth Annual Meeting, March 12, 2012 INTERMACS Annual Meeting March 2012
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INTERMACS Collaborators: NHLBI: Sustainability – Are we there yet?
Sixth Annual Meeting, March 12, 2012. INTERMACS Collaborators: NHLBI: Sustainability – Are we there yet? CMS: The blurred lines among DT, BTC, BTT FDA: Benchmarks for next device approval Industry: INTERMACS – The ultimate post market study - PowerPoint PPT Presentation
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INTERMACS Collaborators:
• NHLBI: Sustainability – Are we there yet?• CMS: The blurred lines among DT, BTC, BTT• FDA: Benchmarks for next device
approval• Industry: INTERMACS – The ultimate post
market study• Hospitals: Utilizing the Quality Assurance
Reports
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NHLBI: Sustainability–Are we there yet?
M Miller
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National Heart, Lung, and Blood Institute:
INTERMACS-Looking Forward to Full Sustainability
Marissa A. Miller, DVM, MPHProject Officer
Chief, Advanced Technologies and Surgery BranchNational Heart, Lung, and Blood Institute
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INTERMACS: From an Idea To…..
2005 0 patients/0 centers Complete NHLBI funding
No pre/post market studies 0 publications 0 citations 0 spin-offs
2012 6492 patients/131 centers Sustainable Public Private
Financial 131 hospitals engaged Device manufacturers integrated—sound business plan Longstanding NHLBI commitment
Scientific Where were we before the INTERMACS patient profiles,
INTERMACS survival curves, INTERMACS comparator data? Public Health Relevance
The trend toward rigorous registries—AHRQ publication, TVR Registry
Regulatory and reimbursement decisions being based on INTERMACS data
INTERMACS: Sustainability?
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Expand and Improve the Data MEDAMACS! & PEDIMACS! Augment collection of functional capacity & health status Streamline data fields New site monitoring paradigm Rigorous hospital standards
Strategically align with other programs PumpKIN REVIVE-IT International data collection efforts
Don’t get complacent!
INTERMACS What’s Left To Do To Assure Sustainability?
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Enhance as research tool and expand access De-identified data sets Semi-annual research fairs Web-based data requests
Formulate New Hypotheses Connect with transplant registry Link to CMS/reimbursement /insurance data Examine quality improvement/best practices
Ongoing Safety Surveillance (for the future) Link registry data to other data sources through UDI Implement automated safety surveillance tools to
prospectively monitor for failures and complications
INTERMACS What’s Left to Do To Assure Sustainability?
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INTERMACS Partnerships
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ResearchersPublic
International
Organizations
Industry
Hospitals Academia
CMS
FDA
NHLBI
The Next Frontier—Strategic Partners?
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CMS: View of INTERMACS
Jyme Schafer, MD
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Jyme Schafer, MDDirector, Division of Medical and Surgical
ServicesCoverage and Analysis Group
Medicare and INTERMACS:
Past, Present and Future
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Brief History of Medicare Coverage
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VAD Postcardiotomy – 1993 Bridge to transplant – 1996 Destination therapy with registry
requirement – 2003* INTERMACS was written into policy in 2007
Notwithstanding any other provision of this title, no payment may be made under part A or part B for any expenses incurred for items or services—
(A) which, except for items and services described in a succeeding subparagraph or additional preventive services (as described in section 1395x(ddd)(1) of this title), are not reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member
*** (E) in the case of research conducted pursuant to
section 1142, which is not reasonable and necessary to carry out the purposes of that section
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What is the definition of R&N?
Congress has not defined it in statute. For practical uses, CMS has operationalized the following definition:
Adequate evidence to conclude that the item or service improves clinically meaningful health outcomes for the Medicare population
Improved disease-specific survival without improved overall survival
Surrogate test result better
Image looks better Doctor feels confident
Historically, Medicare has stated publicly as a matter of policy that it does
not consider cost in making national coverage determinations.
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What is an NCD?
National Coverage Determination (NCD) Policy for the Medicare FFS program Continuity in coverage across the country May include clinical indication, patient
population, centers of excellence, provider qualifications, etc.
NCD Manual Section 20.9, Artificial Hearts and Related Deviceshttp://www.cms.gov/manuals/downloads/
ncd103c1_Part1.pdf17
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Artificial Hearts and Related Devices (20.9)
Each VAD indication has different coverage criteria
Postcardiotomy (1993): limited to FDA device label
Bridge to transplant (1996): patient approved and listed for transplant, transplant center (some exceptions)
Destination therapy (last updated 2010):
detailed patient selection (NYHA, OMM, LVEF,
peak VO2); facility criteria (procedure volume, third party certification, INTERMACS, focus on informed consent for procedure)
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Staff Review
ProposedDecision
Memorand
um Posted
National Coverage Request
MEDCAC
External
Technology
Assessment
Reconsideration
Staff Review
Public
Comment
Final DecisionMemorandum
andImplementati
on Instructions
Benefit Category
Departmental Appeals
Board
MEDICARE NATIONAL COVERAGE PROCESSMEDICARE NATIONAL COVERAGE PROCESS
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Preliminary
Discussions
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Medicare and INTERMACS
Past Supported registry innovation and data
collection Present
Continuous communication with UAB Information sharing, status updates Monitoring of participation NCD requires registry participation Consider INTERMACS an example for others
Industry: INTERMACS – The ultimate post market study
D Naftel
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Device Manufacturers
• What services do the device manufacturers receive for their fee?
I. Registry Data• Data contained in the Registry that relate only to MCSD’s
manufactured by the Company• Information is de-identified• Dataset includes all pre-implant medical conditions,
implant details, re-hospitalizations, adverse events, quality of life information, neurocognitive assessments and transplant and survival status
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Device Manufacturers (Continued)
• What services do the device manufacturers receive for their fee?
II. Standard Reports• Provided as an aggregate basis and are de-identified • Reports include pre-implant medical conditions, implant
details, re-hospitalizations, adverse events, quality of life information, neurocognitive assessments and transplant, recovery and survival status
• Allows device manufacturers to benchmark its MCSDs against the national data for comparison purposes
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Device Manufacturers (Continued)
• What services do the device manufacturers receive for their fee?
III. Company MCSD Reports• Provided as an aggregate basis and are de-identified• Report contains summaries of outcome events including
actuarial depictions and competing outcome analyses and will include all pre-implant medical conditions, implant details, adverse events, re-hospitalizations, quality of life information, neurocognitive assessments, and transplant and survival status
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Device Manufacturers (Continued)
• What services do the device manufacturers receive for their fee?
IV. Device Malfunction Notifications: Upon Occurrence• Company will be notified within 72 hours if a device
malfunction occurs with respect to a MCSD manufactured by the Company
• A complete report will be sent within 45 days of the event to the Company providing full details, sufficient to enable the Company to fulfill its CFR reporting requirements to the US Food and Drug Administration.
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Hospitals: Utilizing the Quality Assurance Reports
D Schmuhl
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DARLENE SCHMUHL, RNDARLENE SCHMUHL, RN
CLEVELAND CLINICCLEVELAND CLINIC
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UTILIZING THE QUALITY UTILIZING THE QUALITY ASSURANCE REPORTSASSURANCE REPORTS
MD’S,NURSE MANAGER
PI REVIEWS ALL DATA
SITE ADMINISTRATORREVIEWS AND ANSWERS TO
DISCREPANCIES AND COMPLIANCE
DCC SENDS REPORTFEEDBACK TO DCC WITH
COMMENTS, QUESTIONS, SUGGESTIONS
PRESENTATION AND DISCUSSION OF REPORT AT MCS MEETING
ADDITIONAL DATA COLLECTIONAND ANALYSIS OF NON-CONSENTED