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PROJECT PROPOSAL:

INNOVATIVE TECHNOLOGY APPLICATION PROJECT

(ITAP)

THE PURPOSE of the Innovative Technology Application Project is the

introduction of new technology to improve residents’ quality of life.

CMP FUNDING PROPOSAL FOR ITAP

(FOR THE PREDICTION, PREVENTION & TREATMENT

OF PRESSURE ULCERS)

LTC Research Foundation

Contact Information:

Mary Meldrum

(248) 225-2685 Phone

(248) 642-0766 Fax

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TABLE OF CONTENTS

Purpose 3

Introduction 3

Executive Summary 4

Making Technology Cost-Effective 5

The Great Need for Relief & F-Tag Initiatives 6

Assessment Changes 7

MDS 3.0 Section M Revision 8

Program Proposal/Program Design 9

New Technologies 10

Successful Results of ITAP 11

Conclusion 12

Budget 13

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THE PURPOSE of the Innovative Technology Application Project is the

introduction of new technology to improve residents’ quality of life.

INTRODUCTION

The LTC Research Foundation is a non-profit organization committed to

multiple aspects of long term care practice, including resident evaluation,

nursing care, facility administration, education, cost savings strategies,

advancement and implementation of new technology, treatments and

medical care.

As professionals in the long term care industry, we have seen how

important it is to recognize and prevent pressure ulcers early in their

development. We have seen the complications, the pain, and the

needless deaths and have experienced the frustration and heartbreak

first-hand.

Additionally, LTC Research Foundation is very familiar with the juggling

of remedies and funds to cover the costs of treatment. Pressure ulcers

are one of the top four deficiencies identified by CMS that haunt the long

term care industry and drain resources. Add in the penalties and legal

costs associated with this problem, and the numbers are staggering.

Long term care facilities tend not to employ new technologies due to the

fear of budgetary constraints and the cost of risk of trying something

new. However, new technology does exist that can detect, prevent and

promote early healing of pressure ulcers and bring early treatment to the

resident prior to eruption of the sore, and substantially abbreviate the

severity and length of time a sore might exist.

The LTC Research Foundation has recently put together an innovative

idea designed to target pressure ulcer prediction, prevention and

treatment with new technology systems. Essentially this is an

investigative program designed to demonstrate the effective use of new

technologies in the early identification and intervention of pressure ulcers

in long term care facilities. We seek to investigate solutions for bringing

these technologies into common use in a cost-effective and perhaps even

cost-saving way, in order to profoundly and positively impact the quality

of life of long term care residents.

In addition, other simple technology exists which provides seamless

continuity of care and the ability to treat wound care patients within a

facility by electronically transmitting the diagnostic information to a

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wound care clinic in order to get expert medical diagnosis, interpretation

and advice without the patient ever leaving the facility.

A coalition of health care professionals has been assembled and the LTC

Research Foundation has already secured in-kind contributions of certain

equipment for investigative purposes for a one-year pilot project, and the

cooperation of more than 20 nursing home facilities who have agreed to

participate in the pilot project.

In submitting this proposal for CMP funding, it is our hope to gain your

confidence and support for the Innovative Technology Application

Project. This investigation – and other projects like it –have the potential

to directly and positively benefit long term care residents and bring relief

to all those who have to deal with pressure ulcers.

EXECUTIVE SUMMARY

Nursing home quality continues to be a major policy concern for both

State and Federal policymakers. In response to this concern, and

specifically in response to the government’s F-Tag 314/Pressure Ulcer

Initiatives, LTC Research Foundation seeks to provide some resolution of

pressure ulcer deficiencies through investigation of the use of new

technology in long term care facilities. The Innovative Technology

Application Project (ITAP) is designed to positively influence the quality of

care and improve the resident’s outcome related to pressure ulcers.

The purpose of this proposal is to present to the Ohio Department of

Health, the Center for Medicare/Medicaid Services, and the Ohio TAP

Program, a multi-disciplinary project that seeks to deliver genuinely

impactful improvements in wound care in Ohio’s long term care industry.

Often new technologies that are proven and available are under-utilized

in long term care facilities generally due to the perception of high cost

barriers, fear of technological complexity and fear of general change of

established routines of care. This general dismissal and under-use of

potentially life-saving technology could profoundly affect the quality of

care and lives of long term care residents, and may indeed be costing

facilities more in the end.

In requesting CMP funding for ITAP, it is our desire to adhere to the Social

Security Act (Section 1919(h)(2)(A)(ii)), which provides that CMP funds

collected by a state from nursing homes must be applied to the

protection of the health or property of residents of nursing facilities that

the state finds to be deficient. CMS has given states flexibility in

determining the appropriate uses of CMP funds as long as those funds

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are used "in accordance with the law and in a consistent manner."

(Source: August 8, 2002 Memorandum from Steve Pelovitz, Director of

CMS Survey and Certification Group, to State Survey Agency Directors.)

Making Technology Cost-Effective

Twenty years ago, nursing home patients with bedsores were taped to the

bed rail, painted with Maalox and positioned under a heat lamp.

Today, there is a better medical understanding of bedsores and many

new methods and technologies available for treating them. Because of a

perception of the high cost of implementation and use of some of these

technologies, many facilities choose to stay with traditional methods of

care. In fact, raising the quality of care has proved to be a cost-effective

method in the past for other long term care issues. Adaptation of new

technology could follow this same pathway.

Due to the high introductory cost barrier of initiating and incorporating

some new technologies into tried and true routines, the long term care

industry has not yet fully embraced some of these advancements.

Traditional assessment and treatment methods are generally favored over

new technology in the perception of cost savings. In fact, prolonged use

of traditional dressings and other low-cost methods in wound care often

means extended treatment, complications and pain, and ultimately higher

costs for the complete treatment of a wound.

Where the use of new technology may appear to be a costly and

complicated, it may well be that it will ultimately result in a shorter

treatment time resulting in less pain and suffering, improved quality of

care, lower overall cost and better outcomes. In other words, it may be

costing long term facilities more to not make the leap to the use of new

technologies and methods in order to reap the rewards down the line. It

is not as simple as comparing the line-item costs of dressings versus new

technologies and what is directly reimbursable. There is a powerful need

for a longer term, more comprehensive look at outcomes and overall

costs versus savings.

The Innovative Technology Application Project’s mission is not only to

support medically viable ways to detect and treat bedsores early and

effectively, but to bring these effective technological solutions to the

nursing home industry in an affordable way in order to make it available

to those who need it the most.

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The Great Need for Relief & F-Tag Initiatives

Pressure Ulcer Statistics:

More than 1 million patients in the United States still suffer from

bedsores

More than 65,000 quietly die from related complications each year.

An estimated 11.6 – 28% of long term care residents are plagued

with pressure ulcers.

Taking into consideration all direct, indirect and peripheral costs,

over $25 billion total is spent annually on wound care in the United

States.

Each year the government spends an average of $3 billion on

wound treatment and care for pressure sores and bedsores.

Insurance companies pay out millions annually for this same

treatment.

Inflationary effects on these costs alone will push the amounts

spent annually even higher.

With the advent of the 78 million baby-boomers about to enter the

early stages of the disease process, we are faced with

overwhelming numbers of elderly people due to be warehoused in

long term facilities that need to be tended to by caregivers from a

smaller subsequent generation. This creates a supply/demand that

will significantly increase the cost of per patient care.

In elderly populations and in those who are institutionalized,

pressure ulcers are one of the most costly diseases to treat.

Pressure ulcers add an estimated burden of over $1 billion of

expenditures and an additional 2.2 million Medicare hospital days

to the United States health care system.

The cost of treatment is $2,000 - $40,000 per pressure ulcer.

Pressure ulcers can increase nursing time up to 50% and are very

costly in time and resources. Total cost of labor, resources and

time invested in treatment continues to rise dramatically.

The greatest cost of treating pressure ulcers in long term care is

borne by the facility because hospital stays have shortened due to

pressure from insurance companies to cut costs, placing higher

numbers of high-risk patients into nursing homes sooner.

Since there is no way to predict where the ulcer actually originated,

it is the facility that has possession of the patient at the time of

eruption that bears the burden of the cost of treatment and any

penalties.

Pressure ulcers represent one of the top four most common

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deficiencies found in long term care facilities.

The Center for Medicare, Medicaid Services (CMS) issued non-

compliance citations (with associated sanctions, including fines) to

over 45% of long term care facilities for pressure ulcers in 2002.

US Health and Human Services Department’s Healthy People 2010

initiative established a goal of reducing the proportion of nursing

home residents with pressure ulcers by 50% by 2010.

In 2005, US Centers for Medicare/Medicaid Services (CMS) issued

updated guidance for surveyors regarding F-Tag 314/Pressure

Ulcers. This initiative is due to be implemented in 2007:

F314 – 483.25(c) Pressure Sores: Based on a comprehensive

Assessment of a resident, the facility must ensure that –

(1) A resident who enters the facility without pressure sores does not

develop pressure sores unless the individual’s clinical condition

demonstrates that they were unavoidable; and

(2) A resident having pressure sores receives necessary treatment and

services to promote healing, prevent infection and prevent new

sores from developing.

Intent: (F314) 42 CFR 483.25(c) The intent of this requirement is that

the resident does not develop pressure ulcers unless clinically

unavoidable and that the facility provides care and services to:

Promote the prevention of pressure ulcer development;

Promote the healing of pressure ulcers that are present

(including prevention of infection to the extent possible); and

Prevent development of additional pressure

The timing of cost-effective and medically viable solutions to the

pressure ulcer dilemma is exquisite. LTC Research Foundation is poised

to address these devastating statistics and produce an effective method

of introducing new technologies for pressure ulcer detection, prevention

and treatment that will be sustainable, practical, cost-effective and can be

replicated in most if not all Ohio long term care facilities.

Assessment Changes

Since the recent advent of knowledge that pressure ulcers develop from

deep tissue injury and are present and progressing before they can be

clinically visualized and precede a visible stageable pressure ulcer,

medical professionals, CMS, insurance companies and healthcare

advocates are looking at the development of pressure ulcers in a

different light.

Recognition of deep tissue injury and the significance of its impact on

long term care policy and patient care is evident by the inclusion of a new

category (Section M, category “f”) in the forthcoming MDS version 3.0 in

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which provision is made for an unstageable deep tissue injury entry. This

wording is a “request” on the government’s part for long term care

facilities to recognize and identify deep tissue injury when they can.

Without the proper equipment, without the new technology, it simply

cannot be done.

This recognition of deep tissue injury as a precursor to pressure ulcer

development as reflected in the MDS 3.0 and coupled with the F-Tag

314/ Pressure Ulcer Initiative – both set forth by the government –

presents an opportunity for the long term care industry to explore

solutions using new technology to fulfill these benchmarks that the

government has set forth.

The capability to fulfill these goals will fall short until acceptance and

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implementation of new technological solutions replaces traditional

methods and standards of care. Use of new technology in the early

visualization and early medical intervention of pressure ulcers could

conceivably have an enormous impact on the percentages, severity and

actual numbers of pressure ulcers in long term care facilities.

Proposal for CMP Use

Program Design

Participating Facility Demographic Mix:

More than 15 Certified Medicare beds

Geographic accessibility

OSCAR data

30 Skilled nursing facilities

23 for-profit / 7 non-profit

5 Hospital-based

Facility Participation:

Voluntary participation

Can withdraw from project with no penalty

Facility recognition at end of year

Project will carry no less than 15 and no more than 30 facilities

Resident Participation:

Resident participation is voluntary

Resident and/or family members have the right to refuse the use of

new technology at any time without reason

No coercion will be used to influence resident participation in

project

No reprisal will be leveled as a result of refusal

Cost/Compensation:

Residents will not be compensated for participation in project

There will be no additional costs charged to the patient by the

facility for the use of new technology

Resident will not be billed by any other company for the use of new

technology

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Participating facilities will not be charged for the use of new

technology equipment

Initial 2-Day Training & Education:

Based on AHCPR guidelines for clinical practice on wound care

Evaluation of current practices and procedures

Overview of wound care best practice

Hands-on training on new technology

Integration of new technology with current practice

Open house educational program for family members explaining

ITAP as well as general education on pressure ulcers

Evaluation of education

Ongoing support, adjustment, education and feedback throughout

length of project

Weekly Compliance Monitor:

Monitor will contact each facility weekly

Record of compliance will be kept

Report log regarding equipment use will be maintained

Report log regarding policy & procedure will be maintained

On Call Resource:

24-hour resource regarding policy & procedure

24-hour tech support will be provided for equipment

Screening & Assessment Method:

New technology will be interfaced with admission screening

methods.

All technology is non-invasive and will not be used as an alternative

or replacement of any plan of care

New Technologies:

Many new technologies and treatments can be integrated into the

assessment and care plans of long term care residents.

The LTC Research Foundation has secured pledges of commitment from

technology companies to provide the equipment and the training

necessary to the selected facility sites for one year for the Innovative

Technology Implementation Project. Their contributions of time and

equipment to this project demonstrate a desire to seek solutions to the

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pressure ulcer problem as well as the cost barrier difficulties they

experience in the long term care industry.

These are new technologies that have been through clinical trials and are

proven and being used in some long term care facilities, but are still

under-utilized in the long term care community:

1. Ultrasound imaging technology:

A unique high resolution image

Has been clinically demonstrated to visualize deep tissue injury

FDA approved, non-invasive

Images can be forwarded for interpretation and evaluation

2. Palm Pilot:

Point of care alternative to paper forms

Allows clinicians to efficiently enter data. Users enter information at

the bedside

Return the Palm Pilot to its base station, and synchronize the new

data to a database

Reduces need for paper and transcription errors.

3. Digital Infrared Thermal Imaging (DITI):

Produces instant easily visualized thermal images

No contact with resident/patient

FDA approved, non-invasive

Used in detecting and monitoring deep tissue injury.

Images stored on a computer, which can quickly forward them for

interpretation and evaluation.

These and/or similar technologies will be implemented in the long term

facilities participating in ITAP.

Successful Results:

Our one-year ITAP will provide a 12 month period in which selected

facilities will explore new technologies with solid tech support, without

the fear of penalty or high cost of new equipment.

It is the goal of ITAP in collaboration with in-kind support of technology

companies and assistance from CMP funding to demonstrate some of the

following outcomes:

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To provide an understanding how new technology affects the

quality of life of long term care residents.

Promote the use of new technology in long term care facilities.

Promote education of patients and families on how new technology

can improve their care and quality of life.

To provide education of best practice standards of wound care to

staff and residents according to AHCPR guidelines.

Provide education to direct care workers how the use of new

technology can affect the care and outcome of long term care

residents.

Identify barriers that inhibit the use of new technology through the

direct care staff.

To identify obstacles of new technology use and extract solutions

to overcome these obstacles so that new technology can prosper

and improve the quality of care in long term care.

Demonstrate a better understanding of how facility administration

and technology companies can bridge the cost barriers while

providing the highest level of care.

To increase the knowledge of technology companies and the long

term care industry on how to work within the budget constraints to

increase use of new technology.

Provide a better understanding of how the use of new technology

can promote “best practice at best pricing”.

ITAP is designed to act as a portal where the possibilities of a long term

relationship can be explored that can mutually assist both new

technology companies and long term care facilities and promote quality

of life for residents.

Conclusion:

Following the one-year pilot of ITAP for wound care, review and

evaluation of its goals and results by ODH, CMS, TAPS and Ohio’s

Ombudsmen will be initiated by the LTC Research Foundation.

LTC Research Foundation will seek to expand its Innovative Technology

Application Project in the future to include more of Ohio’s long term care

facilities, and to encompass other areas of long term care deficiencies

recommended by ODH.