Spring 2009 IDN Summit Getting Our Arms Around “Never Events”: Do the Solutions Lie With New Medical Technologies Winifred S. Hayes, PhD President & CEO

Spring 2009 IDN SummitGetting Our Arms Around “Never Events”:

Do the Solutions Lie With

New Medical Technologies

Winifred S. Hayes, PhD

President & CEO

Hayes, Inc.

Disclaimer

Hayes, Inc., including its employees and contractors, have received no financial support, contributions, or remuneration of any kind from device manufacturers, pharmaceutical companies, biotech firms, or other organizations with a material or financial interest in medical technologies, including the products/technologies that will be discussed in the presentation that follows.

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Learning Objectives1. Review the current federal and state payers’ and commercial insurers’

positions on “never events,” listing current and potential future events that are excluded or likely to be excluded from coverage and reimbursement.

2. Review those health technologies promoted as effective preventive strategies relevant to “never events,” noting the quality of supporting scientific evidence and the case for cost-effectiveness.

3. Using catheter-associated urinary tract infections (CAUTIs), a “never event,” as a case study, explore an evidence-based approach to determining the cost-effectiveness of silver-coated urinary catheters as a potential solution to this problem.

4. Discuss systems and approaches that participants and their teammates can use to prevent “never events,” including the cost-effective use of medical technologies.

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Who We Are

• Founded and incorporated in 1989 by President and CEO Winifred S. Hayes, PhD

• An independent health technology research and consulting organization providing evidence-based, clinically focused information on health technologies

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What We Do• Track new and emerging health technologies likely

to have significant impact on the cost, utilization, and quality of healthcare

• Evaluate best available evidence and provide in-depth, rigorous analysis of relevant clinical trial data

• Provide assessments of safety, efficacy, and potential health benefit and operational/financial impact of a wide variety of health technologies

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Our Information Is

• Independent – no affiliation with any companies or manufacturers in the healthcare field

• Evidence-based – assessments rely on the best available scientific data from formal studies and clinical trials, not on expert opinion or user surveys

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• Tens of thousands of lives lost or negatively impacted each year.– More deaths than those caused by car accidents, breast

cancer, or AIDS.1

• Eighteen (18) types of medical errors account for 2.4 million extra hospital days and $9.36 billion in excess charges each year.2

• Since the 1999 IOM report, To Err Is Human, estimates indicate patient safety is only improving at about 1% each year.3

• Many of these events can be eliminated – they should “never” happen!

The High Cost of Medical Mistakes and Preventable, Unintended Events

1IOM, To Err Is Human: Building a Safer Health System; Washington, DC, National Academy Press; 1999

2JAMA, Excess Length of Stay, Charges, and Mortality Attributable to Medical Injuries During Hospitalization; 2003

3National Healthcare Quality Report AHQR; 2007

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Never Events: A History1999 Institute of Medicine (IOM) releases To Err is Human. Report

estimates that medical errors in U.S. hospitals cause 44,000 to 98,000 deaths annually.

National Quality Forum (NQF) releases Serious Reportable Events in Healthcare. Report includes 27 “never events,” defined as events that could have been anticipated and prepared for, but occur because of an error or other system failure.

President signs Deficit Reduction Act (DRA) of 2005, requiring the Secretary of Health and Human Services to identify by October 2007 at least two conditions that are:

• High cost or high volume or both • Result in a DRG that has a higher

payment • Could have been reasonably

prevented through the application of evidence-based guidelines

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2006

2000

National Quality Forum (NQF)’s Serious Reportable Events (SREs)

• Based on a consensus among representatives of all parts of the healthcare system

• Very serious, largely preventable• Twenty-eight (28) events• Classified as 1 of the following 6 categories:

surgical, product of device, patient protection, care management, environment, or criminal

Twenty five (25) states (and growing) require licensed healthcare facilities to report SREs in full or in part.

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On October 1, 2008, the Centers for Medicare & Medicaid Services (CMS) reduced payment associated with costs to treat a list of complications (the MS-DRG rate) CMS deems preventable with good care – events that should “never” happen.

Many of these hospital-acquired conditions (HAC), or never events, overlap with NQF’s SREs.

CMS’s “never event” list continues to grow.

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NQF Serious Reportable EventsSurgical Events:

• Surgery performed on the wrong body part

• Surgery performed on the wrong patient

• Wrong surgical procedure on a patient

• Retention of a foreign object in a patient after surgery or other procedure

• Intraoperative or immediately postoperative death in a normal health patient (defined as ASA Class 1 patient)

Product or Device Events:• Patient death or serious disability associated with the use of contaminated drugs,

devices, or biologics provided by the healthcare facility

• Patient death or serious disability associated with the use or function of a device in patient care in which the device is used or functions other than as intended

• Patient death or serious disability associated with intravascular air embolism that occurs while being cared for in a healthcare facility

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NQF Serious Reportable EventsPatient Protection Events:• Infant discharged to the wrong person

• Patient death or serious disability associated with patient elopement (disappearance) for more than 4 hours

• Patient suicide, or attempted suicide resulting in serious disability, while being cared for in a healthcare facility

Criminal Events:• Any instance of care ordered by or provided by someone impersonating a physician,

nurse, pharmacist, or other licensed healthcare provider

• Abduction of a patient of any age

• Sexual assault on a patient within or on the grounds of a healthcare facility

• Death or significant injury of a patient or staff member resulting from a physical assault (i.e., battery) that occurs within or on the grounds of a healthcare facility

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NQF Serious Reportable EventsCare Management Events:• Patient death or serious disability associated with a medication error (e.g., error

involving the wrong drug, wrong dose, wrong patient, wrong time, wrong rate, wrong preparation, or wrong route of administration)

• Patient death or serious disability associated with a hemolytic reaction due to the administration of ABO-incompatible blood or blood products

• Maternal death or serious disability associated with labor or delivery on a low-risk pregnancy while being cared for in a healthcare facility

• Patient death or serious disability associated with hypoglycemia, the onset of which occurs while the patient is being cared for in a healthcare facility

• Death or serious disability (kernicterus) associated with failure to identify and treat hyperbilirubinemia in neonates

• Stage 3 or 4 pressure ulcers acquired after admission to a healthcare facility

• Patient death or serious disability due to spinal manipulative therapy

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NQF Serious Reportable EventsEnvironmental Events:• Patient death or serious disability associated with an electric shock while being

cared for in a healthcare facility

• Any incident in which a line designated for oxygen or other gas to be delivered to a patient contains the wrong gas or is contaminated by toxic substances

• Patient death or serious disability associated with a burn incurred from any source while being cared for in a healthcare facility

• Patient death associated with a fall while being cared for in a healthcare facility

• Patient death or serious disability associated with the use of restraints or bedrails while being cared for in a healthcare facility

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AHRQ is also weighing in with its Patient Safety Indicators (PSIs)

Many of these overlap with NQF’s SREs and CMS’s “never events,” but there are some new events as well, including:

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• Postoperative physiologic and metabolic derangements

• Postoperative hemorrhage or hematoma

• Iatrogenic pneumothorax

• Obstetric trauma

• Birth trauma – injury to neonate

• Etc.

CMS HACsAs of October 2008

1. Foreign object retained after surgery

2. Air embolism3. Blood incompatibility4. Stage 3 and 4 pressure

ulcers5. Falls and trauma6. Catheter-associated UTI7. Vascular catheter-associated

infections8. Surgical site infection (SSI) or

mediastinitis after CABG

For 20091. Surgical site infections following

certain elective procedures, including certain orthopedic surgeries, and bariatric surgery for obesity

2. Certain manifestations of poor control of blood sugar levels

3. Deep vein thrombosis and/or pulmonary embolism following total knee replacement and hip replacement procedures

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CMS will no longer pay the higher MS-DRG rate for the 11 Hospital-Acquired Conditions

(HAC) under the Medicare Inpatient Prospective Payment System, unless the condition was present upon admission.

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Also . . .

Under a 2009 National Coverage Determination (NCD) process, Medicare will not pay for 3 additional “never events”:

• Surgery on wrong body part

• Surgery on wrong patient

• Performing the wrong surgery on a patient

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Hospital-Acquired Conditions: Future

• Many other payers and states are following suit• The list is expected to grow significantly each

year• Significant step toward Value-Based Purchasing

– Major shift in paying for outcomes versus activities– HCAHPS performance is also an important part of this

change

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HACs

Foreign object retained after surgery

Air embolism

Blood incompatibility

Falls and trauma

PPSs

• Radiofrequency identification (RFID) tagging sponges ClearCount SmartSponge®

• Individually bar-coded surgical sponges: SurgiCount's Safety-Sponge™ System

• Connectors (i.e., Luer lock) between catheter and tubing• Pumps with an in-line air detector

• Preoperative autologous blood donation (PABD) for elective hip surgery

• Intraoperative blood recovery and filtration systems

• Tai Chi (martial art)

FY 2009CMS Hospital-Acquired Conditions (HAC) and

Proposed Product Solutions (PPS)

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HACs

Pressure ulcers stages III-IV

Catheter-associated urinary tract infection

Vascular catheter-associated infection

PPSs

• Support surfaces for prevention of pressure ulcers (i.e., pressure-relief mattresses, integrated bed systems, mattress overlay)

– Silkair® Low Air Loss Therapy System (Hill-Rom Inc.)– Tempur-Pedic Swedish Mattress™ (Tempur-Pedic International Inc.)– TheraPulse® ATP™ (Kinetic Concepts Inc.)

• Silver-coated urinary catheters (Bardex® I.C.; Kendall DOVER Silver Foley)

• BIOPATCH® Antimicrobial Dressing (Integra LifeSciences Corp.; Ethicon Inc., Div. of J&J Medical Ltd.)

• StatLock® Stabilization Devices (Bard® Medical/Venetec International Inc.)

• Antimicrobial central venous catheters (i.e., 2nd generation) Chlorhexidine-Silver Sulfadiazine (ARROWg+ard Blue PLUS® -Arrow), Minocycline-Rifampin (Glide Spectrum® - Cook Medical), Silver-Platinum-Carbon (Vantex® - Edwards Lifesciences), 5-FU (Angiotech) Benzalkonium/heparin (AMC Thromboshield - Edwards Lifesciences)

Continued HACs & PPSs

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HACs

Surgical site infection, mediastinitis, following CABG

Surgical site infections follow certain orthopedic procedures

PPSs

• Antibacterial Sutures (MONOCRYL™ Plus, Vicryl™ Plus, PDS™ Plus; Ethicon Inc., Div. of J&J Medical Ltd.)

• Covidien AMD™ Antimicrobial Dressings (Kendall, Covidien-Covidien)


• ChloraPrep® for skin antisepsis (Cardinal Health Inc.)






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HACs

Surgical site infection following bariatric surgery for obesity

Deep vein thrombosis and pulmonary embolism following certain orthopedic procedures

PPSs





• ActiveCare+SFT® Medical Compression Systems, DBN Ltd. • Sequential Compression Devices, or SCD’s (also known as

Lymphodema pumps) • A-V Impulse System® Foot Pump (Orthofix/Novamedix Ltd.)• Pradaxa® (dabigatran etexilate), Boehringer Ingelheim GmbH• Rivaroxaban (Xarelto®), Bayer Health Care & Ortho-McNeil

Pharm. Inc. (J&J)


The list of proposed product solutions (PPSs) continues to grow – after all, our medical industry is inventive if not innovative!

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So the questions we all are asking are: • Do these products live up to the vendors’ claims? • Do they prevent “never events?”• To what degree are these PPSs effective?• Are they cost-effective?

How should these questions be answered?

Are there “models” that we can use to ensure that our decisions yield

measurable clinical benefits using the most cost-effective methods?

YES!

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Evidence-Based Technology Acquisition (EBTA)

• Embedded as part of Value Analysis

• Core process within a New Product or Health Technology Assessment Committee

• Core element within a Capital Equipment Committee

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CEO’s Top Issues Confronting Hospitals

1In 2008, this issue was composed of both patient safety and quality. In prior years, they were two unique issues.2In 2008, this issue was broadened and changed from “biodisaster” to “disaster” preparedness.

American College of Healthcare Executives, 2008, Annual CEO Survey of Top Issues Confronting Hospitals

http://www.ache.org/Pubs/Releases/2009/CEOTopIssues_2008.pdf 27

Issue 2008 2007 2006Financial challenges 77% 70% 72%

Patient safety and quality1 43% NA NA

Care for the uninsured 41% 38% 37%

Physician-hospital relations 32% 35% 40%

Personnel shortages 30% 30% 30%

Governmental mandates 26% 22% 23%

Patient satisfaction 22% 17% 16%

Capacity 16% 11% 11%

Technology 9% 8% 8%

Issues about not-for-profit status 2% 4% 3%

Malpractice insurance 2% 2% 3%

Disaster preparedness2 1% 1% 1%

Patient safety NA 29% 27%

Quality NA 33% 29%

7%

24%

40%

40%

41%

43%

47%

57%

60%

66%

66%

Patient Safety and Quality

American College of Healthcare Executives, 2008, Annual CEO Survey of Top Issues Confronting Hospitals

http://www.ache.org/Pubs/Releases/2009/CEOTopIssues_2008.pdf

Redesigning care processes

Medication errors

Nonpayment for “never events”

Pay for performance

Public reporting of outcomes data

Surgical mistakes

Other

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Redesigning work environment to reduce errors

Compliance with accrediting organizations (i.e., Joint Commission)

Nosocomial infections

Leapfrog demands (i.e., computerized physician order entry; ICU staffing by

trained intensivists; and evidence-based hospital referral)

What does it mean to be “evidence-based?”

• Evidence derived from formed scientific research/clinical trials

• Synthesizes and critiques all the best available research

• Not based on opinion, survey data, or usual clinical practices

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• What is EBTA?

• How does EBTA work?

• What benefits are derived from EBTA?

• What role does health technology assessment play in EBTA?

• What role does health technology assessment play in value analysis?

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Definition of Key Concepts

• Evidence-Based Medicine (EBM)

• Health Technology Assessment (HTA)

• Value Analysis and Evidence-Based Value Analysis (VA & EBVA)

• Evidence-Based Technology Acquisition (EBTA)

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Evidence-Based Medicine

EBM is the conscientious, explicit, and judicious use of current best evidence in

making decisions about the care of individual patients.

Integrates clinical expertise with thebest available external clinical

evidence from systematic research.

Adapted from Sackett DL, et al. Evidence based medicine: what it is and what it isn’t. BMJ. 1996;312(7023):71-72.

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What is Health Technology Assessment?

Health Technology Assessment is the systematic, evidence-based evaluation of the properties, effects, and/or other impacts of health care technologies.

David Hailey, Alberta Heritage Foundation for Medical Research, 2003

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Health Technology Assessment (HTA)

• Systematic literature search

• Critical appraisal of the evidence

• Analysis of the body of evidence

• Conclusions about safety, efficacy, clinical effectiveness

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What is Value Analysis?

“A creative analytical study and evaluation of a product, service or technology’s function, with the objective being to determine the lowest cost approach to providing an equivalent or better performance of a required function”

(Adapted from the HCP Group, LTD Certified Value Analysis Workbook, @ 2002)

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Why use a systematic, objective, evidence-based approach?

1. Acquire health technologies that yield high-quality care at a sustainable cost.

2. Avoid acquiring ineffective or unsafe technology.

Goal: Improved patient care and financial viability

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Why should we link VA and HTA?• To improve patient safety and clinical outcomes• To promote efficient utilization of resources • To support strategic technology planning and

reduce conflict• To guide the appropriate implementation of

health technologies• To maximize cost-effectiveness

Transforming Healthcare with Evidence

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Where would HTA fit? Product

Users

Finance

VAT’s&

HTA

Purchasing

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EBTA

EBTA is a health technology acquisition decision that begins with a comprehensive assessment of the best available scientific evidence.

Value Analysis Process

1. Information Phase

2. Function Analysis Phase

3. Creative Phase

4. Evaluation/ Analytical Phase (HTA is used here)

5. Development Phase

5. Presentation Phase

7. Implementation Phase

8. Re-evaluation Phase

Orr, T. A Value Analysis Approach to Healthcare Revenue Improvement.

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CASE STUDY: A value analysis opportunity

When urinary catheterization is necessary, what is the most cost-effective approach to achieving this function while preventing ‘unintended adverse outcomes,’ including catheter-acquired urinary tract infections (CAUTI)?

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Step One: Information Phase

“Gather data regarding current process/product and context of use.”

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Elements of Risk:

• 80% of UTIs related to catheters

• Risk of UTI increases over time

• 13,000 deaths attributed to UTI in 2002

• Costs to treat range from $500-$5682

Kleevins (CDC-NNIS). Available at: http://www.cdc.gov/ncidod/dhqp/pdf/hicpac/infections_deaths.pdf

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Step One: Environmental factors that increase risk

• Poor basic hand and perineal hygiene

• Non-adherence to aseptic catheter insertion and catheter care

• Failure to remove catheters as soon as possible

• “High-risk” critical care units

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Step One: Patient factors that increase risk

“At-risk” patient populations:• Diabetics• Obesity• Immunocompromised• Urinary or fecal incontinence• Surgical wounds• Poor personal hygiene

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Step OneAdditional relevant information:

• Baseline CAUTI rates, overall and by subgroups (department, patient characteristics, nursing team/unit, catheter type)

• Current catheter usage (types and distribution)• Clinical impact of CAUTIs on costs (per case) –

nationally; hospital-specific• Clinical impact of CAUTIs on LOS• Clinical impact of CAUTIs on mortality (#, rates)• Achievable CAUTI benchmark rates• CMS CAUTI “never event” goal

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Step OneAdditional relevant information (cont.):

• Catheter insertion evidence-based (EB) practice protocol • Catheter care and handling EB practice protocol• EB patient indications for catheterizations• EB patient contraindications for catheterization• Rates of catheterization by patient category and clinical

department• Average number of indwelling catheter days prior to

removal• Comparable national catheterization rates by above

variables

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Step Two: Functional Analysis Phase

“Consider primary functions/processes/productsand discuss in detail.”

• Compliance with EB insertion protocol• Compliance with EB care and handling protocol• Compare catheterization rates with national

benchmarks• Compare CAUTI rates with “achievable” and

CMS benchmarks

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Step Two: Functional Analysis Phase (cont.)

• Correlation of types of catheter with CAUTI rates• Identification of unintended outcomes (and

frequency) in addition to CAUTI• Conclusions regarding factors contributing to

CAUTI occurrence• Basic functional requirements of urinary catheter

and closed urine collection system

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Step Two: Functional AnalysisPractices that impact infection control:

• Patient hygiene (preparation protocol prior to catheter insertion and with catheter insertion)

• Hand-washing protocols for staff• Standing orders for nurses to discontinue catheters• Flagging of patients that need to be considered for

catheter discontinuation• Catheter care protocols• Urinary collection systems and patient transfers

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Recent Changes

Have there been any internal process changes or material changes within your institution over the past year relevant to urinary catheter usage?

Any change that has been made could potentially have an impact on the infection rates that you are experiencing.

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Step Three: Creative Phase“Brainstorming to identify improvement alternatives.”

Brainstorming regarding methods of providing for necessary urinary catheterization without CAUTI or other unintended adverse outcomes:

• Hygiene and insertion process changes• Managing duration of use (tracking system)• Silicon versus latex• Silver hydrogel-coated catheters (SCC)• Etc.

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Silver-hydrogel Coated CatheterThe silver-hydrogel coated catheter (either latex or silicone) protects the urethra by creating an environment that microorganisms do not like to adhere to, thus minimizing biofilm formation.

• The silver-hydrogel coated catheter (either latex or silicone) protects the urethra by creating an environment that microorganisms do not like to adhere to, thus minimizing biofilm formation.

• Catheters eliminate the mechanical protection provided by micturation and create a conduit to the bladder on which pathogens can form a protective biofilm against both antibiotics and the host's immune system.

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Prior to making a decision -

Let’s look at the clinical studies of silver-hydrogel coated versus non-coated catheters for the reduction of CAUTIs.

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Value Analysis Process

Step 1: Information Phase + Step 2: Function Analysis Phase + Step 3: Creative Phase +

Step 4: Evaluation/Analytical Phase

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Step Four: Evaluation/Analytical Phase

Critically examine and weigh all the evidence and data. Alternative approaches/products are critically evaluated, modeled, and ranked for acceptability and clinical/financial impact.

• Product knowledge

• Problem

• Causes

• Actions taken to control UTIs

• Cost benefit with use of SCC using calculator

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5757

58

59

60

61

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What did we learn from our review and critique of the

evidence?

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Silver-Coated Urinary Catheters (SCC)

• Some proof that SCCs reduce the incidence of bacteriuria in patients with indwelling urinary catheters for > 3 days and < 30 days (or < 10 days)

• Rates of effectiveness vary greatly (50% to 0% reduction)

• Underlying base infection rates are critical to SCCs impact

• Most studies’ endpoints are bacteriuria, not symptomatic urinary tract infections

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Questions?

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Are SCCs cost-effective?

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CAUTI CalculatorIMPACT OF USING SILVER/HYDROGEL-COATED CATHETERS ON CATHETER

ASSOCIATED URINARY TRACT INFECTIONS

0

0.00%

0

$0

$0

Estimated Savings Resulting from Silver/Hydrogel-Coated Catheters (SCCs)

0.00%

0

$0

0

$0.00

$0

$0

Base Annual Cost of Catheter Associated Urinary Tract Infections (CAUTIs)

Average Cost per CAUTI

Base Number of CAUTI Cases

Base CAUTI Rate

Enter Estimated Annual Number of Catheterizations

Annual Savings Related to SCCs

Number of Reduced Cases Expected with SCCs

Expected Reduction in CAUTI Cases

Base Annual Cost of CAUTI Cases

USER INPUT DATA HERE

Default is based on average of the data from Table 1 below.

Annual catheterizations times the base CAUTI rate.


Estimated number of CAUTIs times average CAUTI cost.

Annual Additional Cost of SHCs

Cost of Catheters

Annual Number of Catheterizations

ANNUAL COSTS AVERTED/INCURRED FROM USING SILVER/HYDROGEL-COATED CATHETERS


Estimated number of CAUTIs times the expected reduction.

Estimated number of reduced CAUTI cases times average CAUTI cost.

User data from above.


Number of catheterizations times additional cost of SCCs.

Savings related to using SCCs minus the additional cost of using SCCs.

Additional Cost of SCCs

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Note: User must enter data in the orange cell. User may enter data in the pink cells, or use the default data provided. Yellow and green cells should not be changed.

Model Overview and Instructions:

This model estimates the cost-effectiveness of using SCCs for short-term catheter use. The model calculates the annual cost of CAUTI at an institution, the projected savings resulting from reduced CAUTIs as a result of the use of SCCs, the estimated additional cost of using SCCs, and the overall net savings to the facility of using SCCs for short-term catheter use. This model is based on estimated cost savings from a review of seven published reports. The table below summarizes the data included in those reports.

The cost-effectiveness of SCCs depends on a number of factors: background prevalence of CAUTIs at an institution, anticipated reduction in CAUTI after the introduction of SCCs, likelihood of complications (symptomatic CAUTI or bacteremia) among patient population, cost of treating complications, and the cost difference between SCCs and standard catheters. While defaults are provided in the model, the user can alter any of these variables and get very different estimates of cost-effectiveness.

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Default Data

Source Base CAUTI Rate

Expected Reduction

% CAUTIs Incurring Costs

Cost per CAUTI

Extra Cost per Catheter

Projected Savings

Bologna et al (1999) Blind, prospective MCT

8.1% (ICU)

40% 100% $2,471 $5.00 $98,021 for 108 ICU beds/yr

Karchmer et al. (2000) RC Crossover Trial

1.36% (ICU & step-down units)

19% 100% $839-$4,693 $107,225/yr $14,456-$573,293/yr for a 600 bed hospital

Saint (2000) Lit. Review with Economic Analysis

3% (5 studies- Unit type unknown)

47% 24% for SNUTI; 4% for BSI

SNUTI=$74 to $402; BSI=$2,041

$5.30 $4.09 per patient

Maki and Tambyah (2001) Meta-Analysis with Cost Analysis

26% ( 8

Prospective studies)

42% 65% diagnosed and treated

$1,000 $5.00 $6.05/100 catheters

Plowman et al. (2001) Lit Review and Economic Model

7.3% (Medical / Surgical )

11.4% surgical;

14.6% medical

Assumes 100% 3.6 additional HDs

$13.00 Break even; any higher reduction in CAUTI rate expected to result in savings

Kwan (2002) Prospective Case Series (Single Institution Study)

4.9% (Tertiary care

including ICUs)

45% Assumes 100% mean $1,214; median $613

$8.00 Median cost of $12,563/yr; Mean cost of $142,314/yr for 350-bed tertiary hospital

Rupp et al. (2004) Prospective Surveillance Study (with cost analysis)

6.3% (10 Units-Adult and pediatric

ICUs)

57% Assumes 100% $700 - $5,682 $4.86 $5,811-$535,452/yr for ICUs in a 600-bed tertiary hospital

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Table 1. Estimates of Cost Savings from the Use of Silver/Hydrogel-Coated Catheters (SHCs)



5,000

8.14%

407

$2,113

$859,991


37.57%

153

$323,099

5,000

$6.86

$34,300

$288,799




Base CAUTI Rate












Cost of Catheters











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5,000

2.00%

100

$2,113

$211,300


15.00%

15

$31,695

5,000

$7.50

$37,500

-$5,805








Cost of Catheters

















Base CAUTI Rate


71



1,300

8.14%

106

$2,113

$223,598


2.50%

3

$5,590

1,300

$6.86

$8,918

-$3,328








Cost of Catheters

















Base CAUTI Rate


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What is the appropriate protocol for the use of SCCs in XYZ Hospital?

• Clinical application– Patient population– Projected decrease in CAUTI rates– Training of staff

• Financial– Cost– Savings

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Summary“Evidence-based Value Analysis Process” includes the incorporation of Health Technology Assessment to maximize both clinical and financial benefits.•Acquire health technologies that yield high-quality care at a sustainable cost.•Avoid acquiring ineffective or unsafe technology.•Minimize overall costs associated with UTI “never events” and SCC usage.

Patient safety, treatment effectiveness, and long-term financial viability should be the “Goal” of each decision.

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ReferencesCutler DM, McClellan M. Is technological change in medicine worth it? Health

Aff (Millwood). 2001; 20(5):11-29.

Hayes Inc. Hayes Medical Technology Directory. Silver-Coated Urinary Catheters for the Prevention of Urinary Tract Infections. Lansdale, PA: Hayes, Inc.; December 16, 2008.

Eden J, Wheatly B, McNeil B, Sox H, eds. Knowing What Works in Healthcare: A Roadmap for the Nation. Institute of Medicine (IOM). 2008. National Academies Press. Available at: http://www.nap.edu/catalog/12038.html.

Johnson JR, Kuskowski MA, Wilt TJ. Systematic review: antimicrobial urinary catheters to prevent catheter-associated urinary tract infection in hospitalized patients. Ann Intern Med. 2006;144 (2):116-126. Available at: http://www.annals.org/. http://www.annals.org....

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http://www.nap.edu/catalog/12038.html

References cont.Kaiser Family Foundation (KFF) [website]. Snapshots: How Changes in

Medical Technology Affect Health Care Costs. March 8, 2007. Available at: http://www.kff.org/insurance/snapshot/chcm030807oth.cfm.

Keefe S. Ahead of the Curve. Advance for Nurses [website]. 2008;10(14):19. Available at: www.advanceweb.com/nurses.

Kleinpell RM, Munro CL, Giuliano KK. Targeting Health Care-Associated Infections: Evidence-Based Strategies. Chapter 42. Patient Safety and Quality: An Evidence-Based Handbook for Nurses; 2006.

Klevens RM, Edwards JR, Richards CL, et al. Estimating health care-associated infections and deaths in U.S. Hospitals, 2002. Public Health Rep. 2007;122(2): 160-166. Available at: http://www.cdc.gov/ncidod/dhqp/pdf/hicpac/infections_deaths.pdf.

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http://www.kff.org/insurance/snapshot/chcm030807oth.cfm

http://www.advanceweb.com/nurses

http://www.cdc.gov/ncidod/dhqp/pdf/hicpac/infections_deaths.pdf

References cont.Lo E, Nicolle L, Classen D, et al. Strategies to prevent catheter-associated urinary

tract infections in acute care hospitals. Infect Control Hosp Epidemiol. 2008;29(Suppl 1):S41-S50.

Redberg RF. Evidence, appropriateness, and technology assessment in cardiology: a case study of computed tomography. Health Aff (Millwood). 2007;26(1):86-95.

Reed SD, Shea AM, Schulman KA. Economic implications of potential changes to regulatory and reimbursement policies for medical devices. J Gen Intern Med. 2007;23(1):50-56.

Rothenberg BM. Medical Technology as a Driver of Healthcare Costs: Diagnostic Imaging. BlueCross and BlueShield Association [website] October 2003. Available at: http://www.bcbscom/blueresources/cost/diagnostic-imaging.html?templateName=templat.

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http://www.bcbscom/blueresources/cost/diagnostic-imaging.html?templateName=templat

http://www.bcbscom/blueresources/cost/diagnostic-imaging.html?templateName=templat

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Spring 2009 IDN Summit Getting Our Arms Around “Never Events”: Do the Solutions Lie With New Medical Technologies Winifred S. Hayes, PhD President & CEO