Title: Quality,%20Performance%20Measures,%20and%20Practice%20Guidelines:%20What%20Technology%20Manufacturers%20Should%20Know
1Quality, Performance Measures, and Practice
Guidelines What Technology Manufacturers Should
Know
- Beth Kosiak, Ph.D.
- Associate Executive Director, Health Policy
- American Urological Association
2Overview
- Qualitythe big picture
- Performance measures
- Guidelines
- CMS and performance measures
- What all of this means to device companies
3What 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
4What 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)
5Why 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)
6Why 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)
7Why 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
8Percent Of Recommended Care ReceivedThe Quality
of Health Care Delivered to Adults in the United
States NEJM, June 26, 2003
9The Big Picture
- High cost
- Unexplained variation in care
- Higher cost not associated with higher quality
10What 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)
11What 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))
12What is the Purpose of Measurement?
- Establish clear baseline
- Monitor performance over time
- Internal quality improvement
- Accountability
- Information for choice (purchasers, consumers,
general public)
13Types 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)
14Types 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)
15Types 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
16Types 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
17What 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
18What 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.
19What 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.
20Guidelines and Measures
- Guidelines provide the evidence base for
development of a performance measure
21How 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
22BackgroundPerformance 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
23BackgroundPerformance Measurement
- Major employers (GTE, Digital) create HEDIS
measures and NCQA - Wanted valuequality/cost
24CMS 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
25CMS 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
26CMS and Performance Measures
- Health PlansHEDIS and CAHPS, 1998
- Dialysis Facilities2001
- Nursing Homes---2002
- Home Health Agencies2003
- Hospitals2005
- Physicians2008??
27From 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
28Relevance 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
29Relevance 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
30Relevance 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
31Relevance 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
32Relevance 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
33CMSEmphasizing 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
34What 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
35Questions? Comments?
- Bkosiak_at_auanet.org
- 410-689-3703
- THANK YOU!!