Quality,%20Performance%20Measures,%20and%20Practice%20Guidelines:%20What%20Technology%20Manufacturers%20Should%20Know

1
Quality, Performance Measures, and Practice
Guidelines What Technology Manufacturers Should
Know

• Beth Kosiak, Ph.D.
• Associate Executive Director, Health Policy
• American Urological Association

2
Overview

• Qualitythe big picture
• Performance measures
• Guidelines
• CMS and performance measures
• What all of this means to device companies

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What is Quality?

• IOM the degree to which health services for
  individuals and populations increase the
  likelihood of desired health outcomes and are
  consistent with current professional knowledge
• AHRQ doing the right thing, at the right time in
  the right way, for the right person with the best
  possible results

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What is Quality?

• Striking the right balance in the provision of
  health services, by avoiding overuse (e.g.,
  getting unnecessary tests, too many
  hysterectomies), underuse (e.g., not being
  screened for high blood pressure, low rates of
  hip replacement among Hispanics) and misuse
  (e.g., being prescribed drugs that have dangerous
  interactions, adverse events)

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Why Focus on it?

• US healthcare spending continues to rise at a
  rate many consider unacceptable (16 of GDP in
  2004)
• The United States continues to have the highest
  per capita health care spending among
  industrialized countries (OECD)
• But international quality data places the U.S. in
  the bottom quartile of industrialized countries
  (OECD)

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Why Focus on it?

• Unexplained geographic variation in healthcare
  practices (Wennberg)
• IOM 2001 Crossing the Quality Chasmthe gap
  between care we could have and care we actually
  get is a chasm
• Most recent Medicare information shows that cost
  and quality vary independently of one
  anotherhigh cost does not equal high quality
• Disparities in healthcare exist across regions
  and racial and ethnic groups (AHRQ
  Congressionally-mandated annual reports on
  National Healthcare Disparities National
  Healthcare Quality)

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Why Focus on it?

• McGlynn, et. al. 2003
• Doctors provide appropriate health care only
  about half the time
• Alcohol Dependence 11
• Hip Fracture 23
• Peptic Ulcer 33
• Diabetes 45
• Low back pain 69
• Prenatal care 73
• Breast Cancer 76
• Cataracts 79

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Percent Of Recommended Care ReceivedThe Quality
of Health Care Delivered to Adults in the United
States NEJM, June 26, 2003
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The Big Picture

• High cost
• Unexplained variation in care
• Higher cost not associated with higher quality

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What is a Performance Measure?

• Some number or rating that enables you to monitor
  and track performance over time
• Numerator/Denominator
• Denominatorthe entire population of interest
  (Medicare beneficiaries)
• Numeratorthose who received the care/process
  those who have the outcome (got a flu shot)

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What is a Performance Measure?

• Example DVT Prophylaxis for patient undergoing
  major urologic surgery
• NumeratorPatients who received DVT prophylaxis
• Denominatoreveryone who underwent applicable
  surgeries (complete cystectomy (51590)
  retropubic radical prostatectomy (55845) radical
  nephrectomy (50230))

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What is the Purpose of Measurement?

• Establish clear baseline
• Monitor performance over time
• Internal quality improvement
• Accountability
• Information for choice (purchasers, consumers,
  general public)

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Types of Measures

• Structurecapacity/ability to do certain things,
  provide services (number of hospital beds,
  nursing staff/patient ratio, Board certification,
  EMR system, facility accreditation, surgical
  volume)
• Process---a certain procedure or service provided
  (Mammogram performed, flu shot given, patient
  told treatment options, foot exam performed, beta
  blocker given after heart attack, script written)

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Types of Measures

• Outcome What happened? What was the result of
  the procedure or treatment course? Did the
  patient avoid hospitalization or
  re-hospitalization? Go into remission? Live
  longer than those who did not get the service?
  Experience fewer side effects? (mortality rate,
  re-hospitalization rate, patient quality of life)

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Types of Measures

• Patient experience of carequality from the
  patients perspective (Consumer Assessments of
  Health Providers and Systems (CAHPS) survey)
• Surveys are based on the latest science and have
  been thoroughly tested and include the following
  areas
• Health plans
• Hospitals
• Nursing homes
• Dialysis facilities
• Individual clinician survey

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Types of Measures

• Efficiency when a given level of output
  (quality of care) is achieved at the lowest total
  cost
• Cost of Care measure ratio of actual resource
  use to expected resource use, given equivalent
  high quality of care
• Comparative Effectiveness measures -Measures
  compare both clinical and cost effectiveness of
  medical procedures and services

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What is a Guideline?

• Systematically developed statements to guide
  practitioners and patient decisions about
  appropriate health care for specific
  circumstances. (Floyd and Lohr, 1990)
• The content of a guideline is based on a
  systematic review of clinical evidence - the main
  source for evidence-based care

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What is a Guideline?

• Contains systematically developed
  recommendations, strategies, or other information
  to assist health care decision making in specific
  clinical circumstances.
• Produced under the auspices of a relevant
  professional organization (e.g., medical
  specialty society, government agency, health care
  organization, or health plan).
• Included a verifiable, systematic literature
  search and review of existing evidence published
  in peer-reviewed journals.

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What is the Purpose of a Guideline?

• To describe appropriate care based on the best
  available scientific evidence and broad
  consensus
• To reduce inappropriate variation in practice
• To provide a more rational basis for referral
• To provide a focus for continuing education
• To promote efficient use of resources
• To act as focus for quality control, including
  audit
• To highlight shortcomings of existing literature
  and suggest appropriate future research.

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Guidelines and Measures

• Guidelines provide the evidence base for
  development of a performance measure

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How are Guidelines and Measures Different?

• Guideline establishes the standard of carewhat
  is the best care you should provide (ceiling)
• Guideline provides compilation of latest science
  and how it affects practice--gives guidance to
  practitioner and to patient
• Measure establishes the baseline for carewhat is
  the care everyone should get? (floor)
• Measure is for monitoring by others to show them
  how you do (grade). Rewards based on results

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BackgroundPerformance Measurement

• Late 80spurchasers move to managed care to save
  money in face of rising healthcare costs
• Healthy, employed populationfocus on preventive
  care
• Enrolled populationallowed for consistent data
  collection and plan accountability

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BackgroundPerformance Measurement

• Major employers (GTE, Digital) create HEDIS
  measures and NCQA
• Wanted valuequality/cost

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CMS and Performance Measurement

• In 1998, HCFA mandated HEDIS and CAHPS patient
  survey data from all Medicare managed care plans
• Provision of comparative information to support
  market model of health care, by fostering
  consumer and purchaser choice

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CMS and Performance Measures

• CMS continued development of quality measures
  with hospitals, nursing homes, home health, and
  dialysis facilities
• CMS, states, and private purchasers mandated
  public reporting at the individual
  facility/hospital/plan level

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CMS and Performance Measures

• Health PlansHEDIS and CAHPS, 1998
• Dialysis Facilities2001
• Nursing Homes---2002
• Home Health Agencies2003
• Hospitals2005
• Physicians2008??

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From Public Reporting to Pay for Performance

• Public reporting not enough to shift marketneed
  to align provider incentives to encourage change
• Shift from pay for service to payment for
  performance
• Hundreds of pay for performance initiatives
  across the country
• Dont yet have much evidence that they work

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Relevance to Medical Device Industry--Guidelines

• CPT and HCPCS codes enable payment for devices
  (FDA approval, performed in multiple locations,
  clinical efficacy documented, in use by
  healthcare professionals)
• However, level of evidence needed for code
  approval does not necessarily correspond to level
  of evidence needed for inclusion guideline
• Thus, procedure may be currently be paid for and
  in use, but not included in guideline because
  peer reviewed evidence may not be sufficient to
  justify it

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Relevance to Medical Device Industry--Guidelines

• Payers are becoming more aggressive, looking for
  justification of continued payment in guidelines
• Have denied payment for procedures because not in
  referenced in guideline
• Thus, you should have active interest in getting
  independent research conducted on procedures that
  include your class of product

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Relevance to Medical Device IndustryPerformance
Measures

• Guidelines are the foundation of measures
  therefore, measures include codes for procedures
  included in guidelines
• CMS and other payers are beginning to focus on
  payment for those who achieve high scores
  (relative or absolute) on certain measures
• Therefore, the payment focus will be on
  procedures included in those codesideally you
  have a device in those codes

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Relevance to Medical Device IndustryPerformance
Measures

• P4P is supposed to help foster value based
  purchasing valuequality/cost
• Interest is beginning to focus on high quality
  for the lowest cost
• Therefore, assuming equal effectiveness of
  devices, the cost of your device if you have one
  that corresponds to a procedure included in a
  performance measure will be increasingly
  important
• Comparative effectiveness measures

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Relevance to Medical Device Industry--Gainsharing

• CMS demonstration on gainsharing (DRA of 2005
  Section 5007 Medicare Hospital Gainsharing
  Demonstration)
• January 1, 2007-December 31, 2009
• This demonstration will examine the effects of
  gainsharing aimed at improving the quality of
  care in hospitals. It will determine if
  gainsharing is an effective means of aligning
  financial incentives to enhance quality and
  efficiency of care.
•  CMS funding 6 projects that propose multiple
  approaches to achieving savings that occur during
  the in-patient stay and immediately after
  discharge

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CMSEmphasizing Evidence

• Medicare Coverage Advisory Committee is now the
  Medicare Evidence Development and Coverage
  Advisory Committeedata collection as condition
  of coverage, even after initial marketing
• MEDCAC--Unbiased deliberation of current state of
  the art technology and science

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What You Can Do

• Jointly fund research fund projects with
  reputable institutions
• Let us know that you are doing this and if our
  doctors are involved
• Understand that youll be needing more post
  market evidence

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Questions? Comments?

• Bkosiak_at_auanet.org
• 410-689-3703
• THANK YOU!!