Program Brief
The Centers for Education & Research in Therapeutics (CERTs) program seeks to increase awareness of the benefits and risks of new, existing, or combined uses of therapeutics. This will improve the effectiveness and safety of the use of the therapeutics. Several CERTs projects have been conducted in Medicare populations and even more have generated results applicable to those groups.
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Background
CERTs and Medicare
Quality Improvement Initiative
Prescription Drugs
Medical Devices
Long-term Care
Home Health
Mental Health
Looking to the Future
For More Information
References
Background
The goal of the Centers for Education & Research on Therapeutics CERTs) program is to conduct
research and provide education that will
advance the best use of therapeutics
(drugs, medical devices, and biological
products). The CERTs seek to increase
awareness of the benefits and risks of
new, existing, and combined uses of
therapeutics, thereby improving the
effectiveness and safety of their use.
The program is administered as a
cooperative agreement by the Agency
for Healthcare Research and Quality
(AHRQ), in cooperation with the U.S.
Food and Drug Administration. The
CERTs receive funds from both public
and private sources, with AHRQ
providing core financial support. The
CERTs comprise seven centers (select for a list of CERTs program centers), a Coordinating Center, a Steering
Committee, and numerous partnerships
with public and private organizations.
Collectively, the CERTs have more than
40 unique data sources and serve as a
national resource of experienced researchers. CERTs data, which
represent more than 64 million people,
can be used for large population-based
studies. Thus, CERTs research results
can be useful to the Medicare program
when evaluating policy options and
assessing the effects of policy decisions.
The recently passed Medicare
Prescription Drug, Improvement, and Modernization Act of 2003 (MMA)
will provide additional prescription
drug benefits for Medicare beneficiaries.
The new Medicare prescription drug
benefit presents a number of new
choices for beneficiaries, providers, and
policymakers.
CERTs Program Centers
Each center focuses its educational and research efforts on therapies in a particular population or therapeutic area:
- Duke University—Therapies for disorders of the heart and blood vessels.
- HMO Research Network—Drug
use, safety, and effectiveness in
health maintenance organization
populations.
- University of Alabama at Birmingham (UAB)—Therapies for
musculoskeletal disorders.
- University of Arizona Health Sciences
Center—Drug interactions that
result in harm.
- University of North Carolina at Chapel Hill (UNC)—Therapies for children.
- University of Pennsylvania School of
Medicine—Therapies for infection; antibiotic drug resistance.
- Vanderbilt University Medical
Center—Prescription drug use in a Medicaid population.
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CERTs and Medicare
Since the inception of the CERTs
program in September 1999, the
centers have developed a portfolio of
more than 200 completed and ongoing
studies with results that address
important issues regarding the best use
of therapeutics. Several of these projects
have been conducted within the elderly
population. The following examples
show how CERTs studies are relevant to
Medicare and the care of elderly
patients.
Quality Improvement Initiative
A number of the CERTs centers work
with Quality Improvement
Organizations (QIOs). QIOs constitute
the quality-assurance program for the
Centers for Medicare & Medicaid
Services (CMS), which currently pays
for medical care for 74 million
beneficiaries in the United States (38
million in Medicare, 36 million in
Medicaid). Both the CERTs and QIOs
share the mission of improving the
quality of health care for people covered
by Medicaid and Medicare.
CMS chooses the clinical topics to be
addressed, and the QIOs use a variety
of methods to improve care. The
current scope of work includes quality
improvement in inpatient hospitals, in
outpatient care (diabetes care, cancer
screening, adult immunizations), in
nursing homes, and in home health.
The Vanderbilt center and the
Tennessee QIO jointly completed a
project on beta-blocker compliance (for details, go to
Beta-blocker therapy for acute myocardial infarction). They have
plans for three additional joint projects:
- Patient compliance with prescribed angiotensin-converting enzyme (ACE) inhibitor therapy in heart failure (similar to the beta-blocker project).
- An intervention addressing inpatient care using a computerized provider order entry program.
- Collaboration and consultation to improve nursing home quality.
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Prescription Drugs
Drug-drug interactions
Exposure to
potential drug-drug interactions has
been a focus of investigators at the
Arizona center. In particular, their
research has found that people age 50
and older are at the greatest risk for
drug-drug interactions. This
information is consistent with the
results of other studies concluding that
older Americans have greater exposure
to prescription drugs than younger
people do and are more likely to take
many medications.
Beta-blocker therapy for acute
myocardial infarction1
The Vanderbilt
center conducted a study using data
from the Tennessee QIO. The
researchers found that more than 15
percent of patients who receive a
prescription for beta-blockers when
they are discharged from the hospital
do not have them filled. Because studies
have shown that beta-blockers can
improve health outcomes and reduce
costs, the investigators suggest that organizations work to improve patient
adherence to prescriptions.
Economic impact of beta-blocker
therapy for heart failure2
The Duke
center evaluated the economic impact
of using beta-blockers to treat heart
failure. The impact was considered
from the perspectives of society,
physicians, hospitals, and Medicare.
From the perspectives of society and
Medicare, the use of these drugs would
reduce costs, primarily as a result of
fewer hospital admissions. Based on the
predictions, even if Medicare
completely reimbursed the cost of beta-blockers,
it would still reduce costs. The
Duke center has proposed the same
type of cost study for several other
cardiovascular medications. Similar cost
analyses could be applied to other
medications proven to save lives.
Partnership with the Coalition for
Affordable Quality Healthcare (CAQH)
CAQH is mounting a
national initiative in collaboration with
professional societies such as the
American Heart Association to promote
continued adherence to beta-blocker
therapy in patients who have suffered a
heart attack. The decision to focus on
beta-blocker therapy was based on
results of data generated by the Duke
center, which has provided consultation
in support of this initiative.
Adherence to guidelines for reducing
gastrointestinal complications3
Several strategies have been shown to
reduce gastrointestinal complications
for patients taking nonsteroidal antiinflammatory
drugs (NSAIDs). Various
groups have incorporated these
strategies into guidelines that health
care providers can consider when
treating patients. After finding that the
recommended strategies are not
commonly followed in patients age 50
and older in at least one Medicaid
program, researchers at the Vanderbilt
center are developing an intervention
using computerized provider order
entry to increase the use of
gastroprotective strategies in high-risk
patients taking NSAIDs. If successful,
this could be used as a model for
Medicare.
Tensions in antibiotic prescribing4
The use of newer antibiotics in cases
when older antibiotics would be equally
effective promotes the development of
resistance to these drugs. The
University of Pennsylvania center has
examined physician perspectives
regarding the tension between patient
and public health values in use of
antibiotics. A survey of physicians,
which was conducted to identify drug
choices for patients with community-acquired
pneumonia, revealed that both
generalists and infectious disease
specialists were more likely to prescribe
newer antibiotics than older ones.
Prescribing Safety Program
The
HMO Research Network center is
leading an ambitious drug safety
program that includes all seven CERTs
research centers. Until now, most work
on drug safety has focused on
inpatients, even though outpatients
receive far more prescriptions.
Identifying the most important errors
in this largely unexamined setting is a
necessary first step to developing
methods for preventing them. These
two aims—identification and
prevention—are the subjects of an
AHRQ-funded patient safety grant
awarded to the HMO Research
Network for the CERTs Prescribing
Safety Program.
The project will characterize the
frequency and severity of medication
errors, focusing on the most commonly
misused drugs, drugs with especially
strong warnings against misuse, and
medication errors in vulnerable
populations such as the elderly. Once
the frequency and severity of
medication errors have been
determined, investigators will test the
effectiveness of three interventions for
physicians. Two of the interventions are
experiments with electronic
prescription order entry, which is a
system designed to help reduce errors
by providing physicians with
information about therapies and
dosing. The third intervention is a
randomized trial that will assess the
effects of group physician education.
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Medical Devices
Economic impact of drug-coated
coronary stents on hospital systems
Recently, the development of stents
coated with antithrombotic or
antiproliferative drugs has increased the
potential benefits of coronary stenting,
and early clinical experiences appear
promising. The Duke center has
developed a model to evaluate the
economic impact of these stents on
hospitals based on proposed Medicare
reimbursements and how
reimbursement decisions may affect
practice.
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Long-term Care
Prevention of falls
A substantial
number of nursing facilities are funded
by Medicare, and one of the CMS
quality goals is to reduce falls among
patients in both intermediate care and
skilled nursing facilities. The Vanderbilt
center offers an established fall-prevention
program that is now being
used by the Alabama and Tennessee
QIOs. This program puts into practice
the results of previous research on the
effect of inappropriate use of
medications, such as sedatives and
tranquilizers, that increase the
probability of falls and fractures in the
elderly.
Secondary prevention of fractures in
patients with osteoporosis living in
long-term care facilities
A leading
detriment to elderly health is
osteoporosis, which results in bone
fragility and increases susceptibility to
fractures. Elderly people residing in
skilled nursing facilities who have
already had such a fracture are the most
susceptible to the devastating effects of
this disease. Several studies have
reported inadequate monitoring and
treatment of osteoporosis, despite
strong evidence for and guidelines on
effective prevention strategies.
Investigators from the University of
Alabama at Birmingham (UAB) center
and the Duke center have collaborated
with the Claude D. Pepper Older
Americans Independence Center and
the Health Services Advisory Group,
Inc., to develop an intervention study
to improve care for such patients in
Arizona and North Carolina.
The patterns and predictors of
compliance with osteoporosis treatment
guidelines by health care providers are
not well understood. The purpose of
the collaboration between UAB and
Duke is twofold:
- To identify barriers to compliance with current osteoporosis guidelines among skilled nursing facilities in Arizona and North Carolina.
- To implement and evaluate a randomized, controlled intervention to improve compliance.
The investigators are interested
primarily in the prescribing patterns of
physicians in skilled nursing facilities
for drugs such as Fosamax (alendronate
sodium) and Actonel (risendronate
sodium), which can prevent fractures.
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Home Health
Improving medication use in home
health patients5
The Vanderbilt center
has published papers that define,
quantify, and suggest ways to improve
medication use in patients of home
health agencies. Medications are often
duplicated in home health patients, and
researchers find that medication
improvement programs are especially
helpful for this common problem and
also in increasing adherence to
cardiovascular medications. Study
results can apply to efforts of home
health agencies to meet Medicare
requirements.
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Mental Health
Effect of changing managed care
delivery on the continuity of care6
Medicare includes drug benefits that
may involve managed mental health
care programs. A recently published
study from the Vanderbilt center
suggests that changes made to reduce
costs in managed mental health care
programs can adversely affect the
continuity and quality of care provided
to patients. These results suggest that
changes in mental health care delivery
should be designed with safeguards to
keep patient care constant.
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Looking to the Future
The CERTs continue to conduct
research and develop educational
projects that study and report the
effects, safety, use, and cost-effectiveness
of various medical therapies. The
centers also continue to study current
and potential approaches that Medicare
and other third-party payers institute to
improve quality and address cost
concerns. The results of completed and
future projects can be used to make
coverage and other policy decisions for
Medicare beneficiaries and to help
provide the highest quality, most cost-effective
care possible.
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For More Information
More information on the CERTs program is available from:
Anne Trontell, M.D., M.P.H.
Program Director, Centers for Education and Research in Therapeutics
Center for Outcomes and Effectiveness Research, AHRQ
Phone: (301) 427-1607
Fax: (301) 427-1640
E-mail: Anne.Trontell@ahrq.hhs.gov
Carmen Kelly, Pharm.D.
Project Officer, CERTs Coordinating Center
Center for Outcomes and Effectiveness Research, AHRQ
Phone: (301) 427-1513
E-mail: Carmen.Kelly@ahrq.hhs.gov
In addition, the CERTs program welcomes input about the types of research and education that Medicaid programs need to better address costs, effectiveness, and safety issues related to the use of therapeutics. Comments may be sent to CERTs program staff at AHRQ, or to:
Judy Donald
Project Manager
CERTs Coordinating Center
Kaiser Foundation Center for Health Research
E-mail: Judy.L.Donald@kpchr.org
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References
1. Butler J, Arbogast PG, BeLue R, et
al. Outpatient adherence to betablocker
therapy after acute
myocardial infarction. J Am Coll
Cardiol 2002;40:1589-95.
2. Cowper PA, DeLong ER, Whellan
DJ, et al. Economic effects of betablocker
therapy in patients with
heart failure. Am J Med
2004;116:1040-111.
3. Smalley W, Stein CM, Arbogast PG,
et al. Underutilization of
gastroprotective measures in patients
receiving nonsteroidal antiinflammatory
drugs. Arthritis
Rheum 2002;46:2195-200.
4. Metlay JP, Shea JA, Asch DA.
Antibiotic prescribing decisions of
generalists and infectious disease
specialists: thresholds for adopting
new drug therapies. Med Decis
Making 2002;22:498-505.
5. Meredith S, Feldman P, Frey D, et
al. Improving medication use in
newly admitted home healthcare
patients: a randomized controlled
trial. J Am Geriatr Soc
2002;50:1484-91.
6. Ray WA, Daugherty JR, Meador
KG. Effect of a mental health
"carve-out" program on the
continuity of antipsychotic therapy.
N Engl J Med 2003;348:1885-94.
AHRQ Publication No. 05-P010
Current as of March 2005
Internet Citation:
Medicare Uses of Research from CERTs. AHRQ Publication No. 05-P010, March 2005. Agency for Healthcare Research and Quality, Rockville, MD. http://www.ahrq.gov/clinic/certmedicare.htm
540 Gaither Road Rockville, MD 20850