Transcript CMS and PET Where are we headed?

The Latest Federal Initiatives
in Evidence-Based Medicine
Barry M. Straube, M.D.
Centers for Medicare & Medicaid Services
Citizen’s Council on Health Care
November 10, 2005
Centers for Medicare & Medicaid
Services (CMS)
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Provides health benefits for over 76 million
Americans
Medicare
 Medicaid
 State Children's Health Insurance Program
(SCHIP)
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Spends over $600 billion annually for health
care services in CMS programs
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Centers for Medicare & Medicaid
Services (CMS)
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Healthcare Benefits Administration
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Establish payment methodology for providers
Conduct research on financing, treatment & management
Assure that contractors & state agencies run CMS programs
correctly
Identify fraud & abuse, take appropriate action
Beneficiary Focused Activities
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Benefits and health education
Healthcare data for choice
Advocacy: Appeals, Grievances, patient rights
Preventive services
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Centers for Medicare & Medicaid
Services (CMS)
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Quality-Focused Activities
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Laboratory Testing (CLIA)
Survey & Certification of Health Care Facilities (LTC, SNF,
HHA, Hospitals)
End-Stage Renal Disease Networks
Organ Procurement Organizations
Quality Improvement Organizations
Multiple Demonstration Projects
Health Information Technology promotion/adoption
Pay-for-Performance, Paying for Quality, Value-Based Purchasing
Healthcare data, public reporting
Evidence-Based Medicine, Technology & Innovation
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A Variation Problem
Dartmouth Atlas of Healthcare
CMS Quality Roadmap
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VISION: The right care for every person
every time
 Make
care:
 Safe
 Effective
 Efficient
 Patient-centered
 Timely
 Equitable
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CMS Quality Roadmap:
Strategies
1.
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Work through partnerships to achieve specific
quality goals
Publish quality measurements and information
as a basis for supporting more effective quality
improvement efforts
Pay in a way that expresses our commitment to
quality, and that helps providers and patients to
take steps to improve health and avoid
unnecessary costs
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CMS Quality Roadmap:
Strategies for QI
4.
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Assist practitioners in making care more
effective and less costly, especially by
promoting the adoption of HIT
Bring effective new treatments to patients
more rapidly and help develop better
evidence so that doctors and patients can
use medical technologies and treatments
more effectively
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Centers for Medicare & Medicaid Services
(CMS)
CMS as a Public Health Agency
 Using
CMS influence and financial leverage to
transform American healthcare system
 Quality, Value, Efficiency, Cost-effectiveness
 Assisting patients and providers in receiving
evidence-based, technologically-advanced care
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Evidence-Based Medicine
“Evidence-based medicine is
the conscientious, explicit,
and judicious use of current
best evidence in making
decisions about the care of
individual patients.”
D.L. Sackett et al: BMJ 312, no.7023
(1996):71-72
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Evidence-Based Medicine
“The practice of evidence-based
medicine means integrating
individual clinical expertise
with the best available external
clinical evidence from
systematic research and our
patient’s unique value and
circumstances.”
D.L. Sacket et al, BMJ 312, no.7023
(1996): 71-72
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Evidence-Based Medicine
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Evidence-Based Guidelines (EBGs)
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Different methods for designing guidelines
Global subjective judgment
 Consensus-based
 Evidence-based
 Outcomes-based
 Preference-based
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Guidelines should be based on evidence, not subjective
judgment or opinion
 “Evidence-based”: coverage, performance measures,
medical necessity, benefit design, disease management,
quality improvement, regulations, & public policies
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Features of EBGs
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Work of analyzing evidence and developing a
guideline or policy is done by a small group of
experts, usually sponsored by an organization
Utilization of an explicit, rigorous process
End “product” is generic, applying to a class or
group of patients, not individual patients
Effects on care are indirect
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Enable, motivate or (sometimes) force providers to
deliver certain types of care to groups of people,
NOT to a particular patient
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Evidence-Based Medicine
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Evidence-Based Individual Decision Making (EBID)
 Focus on educating clinicians to help them bring more
research and evidence into individual decisions about
individual patients
Integrating EBGs with EBID
 EBM should not just focus on individual physicians and
their decisions
 EBM is a set of principles and methods intended to
ensure that to the greatest extent possible, medical
decisions, guidelines, and other types of policies are
based on and consistent with good evidence of
effectiveness and benefit.
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CMS Evidence-Based Initiatives
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National Coverage Decisions
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Medicare Benefit Categories and specific benefits
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Preventive Care Services
Technology & Innovation Assessments
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Coverage with Evidence Development
Medical Devices
Therapeutics
Diagnostics
Health Information Technology
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Data collection via EHRs, registries, eprescribing, etc.
Clinical Decision Support
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CMS Evidence-Based Initiatives
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Quality & Efficiency Measure development
 Quality Alliances
 National Quality Forum
 Constant reassessment
Drug Formulary for Medicare Prescription Drug Benefit
Pay-for-Performance Initiatives
 Hospital
 Physician
 Home Health, Skilled Nursing Facilities, ESRD
facilities
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CMS EBM Initiatives
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QIO and ESRD Network Quality Improvement
Activities
CMS Breakthrough Initiatives
Fistula First
 Surgical Care Improvement Program (SCIP)
 Nursing Home Initiatives
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Restraint reduction
 Pressure ulcers reduction
 Pain control
 Staff turnover rate reduction
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Steps to Coverage
Determination and Payment
Outside of CMS:
Congress determines benefit categories
 FDA approves drugs/devices for market
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Within CMS:
Benefit Category Determination
 Coverage Decision
 Coding Assignment
 Payment Determination
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National Coverage Determinations
(NCDs)
Evidence-based decisions on whether to add or
revise coverage for an item or service under
Medicare Part A or B
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Must meet statutory “reasonable and necessary”
standard
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Juxtaposed to FDA “safe and effective” standards
Binding on all contractors (supersedes any local
coverage policies)
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Most Coverage is Local
National
10%
Local
National
Local
90%
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What prompts NCDs?
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Internal (20%) or external (80%) requests
May involve:
New technology or treatment not addressed in
past
 Reconsideration of a prior non-coverage (or
limited coverage) decision
 Response to significant variation in local coverage
policies
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Key Factors Considered in National
Coverage Determinations
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Must be potentially a benefit of Medicare
Evidence of improved health outcomes
Appropriate for Medicare population
Replicable in provider community
Costs not a primary factor historically
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Recent NCD Guidance Documents
CMS requested public comment on factors to consider
in:
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Evidence development methods
Process for study design and implementation
 Registries
 Clinical trials
 Other methods
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Coverage with Evidence
Development (CED)
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Used for promising innovations with insufficient
evidence for individual patients or the Medicare
population
Also used when conclusive evidence is not
available, but existing evidence strongly suggests
probable benefit
Offers prompt coverage linked with more
evidence development
Speeds access, safeguards patients, improves
evidence for better decisions
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Coverage With Evidence Development =
an alternative to non-coverage
Coverage
Yes
Is existing
evidence
sufficient
to support
Medicare
coverage?
Coverage with
Evidence
Development
No
Non-coverage
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Flexible Coverage Processes
Examples
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Prophylactic implantable cardioverter
defibrillator (ICD)
 Data
submitted to national registries, at low cost
for participating hospitals all over the country
 Otherwise would have more limited coverage
 Expanded coverage to reach more patients
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Flexible Coverage Processes
Examples
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Additional off-label uses of cancer drugs
No FDA-approved results, and no studies covered in
medical references
 Previously would not have been nationally covered
 Evidence developed through clinical trials
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FDG-PET scanning
For dementia and neurodegenerative disorders
 For cancer diagnosis, staging, monitoring
 Evidence developed through clinical trials
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Coverage with Evidence
Development NCDs
PET for AD
Sep 04
CRC NCI Trials
Jan 05
ICDs
Jan 05
PET 6 Cancers
Jan 05
Cochlear Implant
Apr 05
US Fracture Healing
Apr 05
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Technical Assessments (TAs)
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Health tech assessment to meet policy or clinical
objectives
Technology performance characteristics assessed
Safety
 Efficacy
 Effectiveness
 Outcomes
 Appropriateness
 Economic impacts
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Technical Assessments (TAs)
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Components
Identifying & prioritizing technologies for assessment
 Collecting & analyzing data
 Synthesizing & grading evidence
 Disseminating findings & recommendations
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Criteria for commissioning a TA
Body of evidence extensive & timeframes in jeopardy
 Complexity of medical & scientific literature is great
 Significant differences of opinion exist
 Technical/clinical expertise or analytic methods great
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TA Options
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Medicare Coverage Advisory Committee
External TA
AHRQ
 Evidence-Based Practice Center (EPC)
 Other qualified entity
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For more information:
www.cms.hhs.gov/coverage
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FDA Parallel Review
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2005 HHS Medical Innovation Task Force
report: “Moving Medical Innovations
Forward—New Initiatives from HHS”
Recommended increased collaboration between
CMS and FDA in four areas
Parallel review
 Post-marketing surveillance
 Humanitarian Device Exemptions (HDEs)
 Summaries of safety and effectiveness (SSEs)
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FDA Parallel Review
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CMS & FDA currently discussing simultaneous
evaluation of FDA-regulated medical products when
the product sponsor and both CMS & FDA agree to
such parallel review
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Several post-marketing surveillance projects in
development
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Federal Register notice expected soon for public comment
Pilot project being defined
Provide FDA with access to claims data for monitoring safety
or effectiveness of Part B devices, drugs, biologicals
Part D expansion when data available
HDEs and SSEs not being discussed yet
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AHRQ EBM Activities
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Evidence-Based Practice Centers (EPCs)
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1997: AHRQ established 12 EPCs to promote EB practice in
everyday care
Review relevant scientific literature on clinical, behavioral, and
organization and financing topics to produce evidence reports &
technology assessments
Reports utilization:
 Informing and developing coverage decisions
 Quality measures
 Educational materials and tools
 Guidelines
 Research agendas
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AHRQ EBM Activities
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Effective Health Care Program
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Medicare Modernization Act (MMA) Section 1013
Authorizes AHRQ to support and conduct research with a focus on
outcomes, comparative clinical effectiveness, and appropriateness
of pharmaceuticals, devices and health care services
Research determined by needs of Medicare, Medicaid, and SCHIP
programs
Approaches
 Synthesize knowledge: EPCs
 Generate knowledge: DEcIDE Research Network
 Translate knowledge: Clinical Decisions & Communications
Science Center
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AHRQ Effective Health Care
Topics
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Arthritis and non-traumatic joint disorders
Cancer
Chronic obstructive pulmonary disease and asthma
Dementia including Alzheimer's disease
Depression and other mood disorders
Diabetes mellitus
Ischemic heart disease
Peptic ulcer disease and dyspepsia
Pneumonia
Stroke and hypertension
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AHRQ & NIH EBM Activities
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National Guideline Clearinghouse
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Partnering with CMS, NIH, FDA and other federal
agencies to utilize EBM principles in quality and research
activities
NIH
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Partnership between AHRQ, AMA, AHIP
Guidelines compendium, comparison, syntheses
Translational and applied research
HRSA
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Organ Donation Breakthrough Initiative
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Contact Information
Barry M. Straube, M.D.
Acting Chief Medical Officer
Acting Director, Office of Clinical Standards & Quality
Centers for Medicare & Medicaid Services
7500 Security Boulevard
Baltimore, MD 21244
Email: [email protected]
Phone: (410) 786-6841
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