The%20Latest%20Federal%20Initiatives%20in%20Evidence-Based%20Medicine

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The Latest Federal Initiatives in Evidence-Based
Medicine

• Barry M. Straube, M.D.
• Centers for Medicare Medicaid Services
• Citizens Council on Health Care
• November 10, 2005

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Centers for Medicare Medicaid Services (CMS)

• Provides health benefits for over 76 million
  Americans
• Medicare
• Medicaid
• State Children's Health Insurance Program (SCHIP)
• Spends over 600 billion annually for health care
  services in CMS programs

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Centers for Medicare Medicaid Services (CMS)

• Healthcare Benefits Administration
• 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
• 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)

• Quality-Focused Activities
• 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
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CMS Quality Roadmap

• 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. Work through partnerships to achieve specific
   quality goals
2. Publish quality measurements and information as a
   basis for supporting more effective quality
   improvement efforts
3. 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

1. Assist practitioners in making care more
   effective and less costly, especially by
   promoting the adoption of HIT
2. 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.

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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 patients unique
  value and circumstances.

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Evidence-Based Medicine

• Evidence-Based Guidelines (EBGs)
• Different methods for designing guidelines
• Global subjective judgment
• Consensus-based
• Evidence-based
• Outcomes-based
• Preference-based
• 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

• 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
• 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

• 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

• National Coverage Decisions
• Coverage with Evidence Development
• Medicare Benefit Categories and specific benefits
• Preventive Care Services
• Technology Innovation Assessments
• Medical Devices
• Therapeutics
• Diagnostics
• Health Information Technology
• Data collection via EHRs, registries,
  eprescribing, etc.
• Clinical Decision Support

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CMS Evidence-Based Initiatives

• 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

• QIO and ESRD Network Quality Improvement
  Activities
• CMS Breakthrough Initiatives
• Fistula First
• Surgical Care Improvement Program (SCIP)
• Nursing Home Initiatives
• 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
• 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
• Must meet statutory reasonable and necessary
  standard
• 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
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Local
National
Local
90
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What prompts NCDs?

• 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

• 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
• Evidence development methods
• Process for study design and implementation
• Registries
• Clinical trials
• Other methods

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Coverage with Evidence Development (CED)

• 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 ProcessesExamples

• 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 ProcessesExamples

• 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
• 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)

• 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)

• Components
• Identifying prioritizing technologies for
  assessment
• Collecting analyzing data
• Synthesizing grading evidence
• Disseminating findings recommendations
• 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

• Medicare Coverage Advisory Committee
• External TA
• AHRQ
• Evidence-Based Practice Center (EPC)
• Other qualified entity
• For more information
• www.cms.hhs.gov/coverage

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FDA Parallel Review

• 2005 HHS Medical Innovation Task Force report
  Moving Medical Innovations ForwardNew
  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

• CMS FDA currently discussing simultaneous
  evaluation of FDA-regulated medical products when
  the product sponsor and both CMS FDA agree to
  such parallel review
• Federal Register notice expected soon for public
  comment
• Pilot project being defined
• Several post-marketing surveillance projects in
  development
• 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

• Evidence-Based Practice Centers (EPCs)
• 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

• Effective Health Care Program
• 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

• 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

• National Guideline Clearinghouse
• Partnership between AHRQ, AMA, AHIP
• Guidelines compendium, comparison, syntheses
• Partnering with CMS, NIH, FDA and other federal
  agencies to utilize EBM principles in quality and
  research activities
• NIH
• Translational and applied research
• HRSA
• 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 Barry.Straube_at_cms.hhs.gov
• Phone [phone]