SERVICES AGREEMENT
This Agreement is effective this 1 day of February, 1996, (the "Effective
Date") between -Disease State Management, Inc., 00 Xxxxxx Xxxxxx, Xxxxxxxxx, Xxx
Xxxx 00000 ("Vendor") and Xxxxxxx-Xxxxx Squibb U.S. Pharmaceuticals, a division
of Xxxxxxx-Xxxxx Squibb Company, X.X. Xxx 0000, Xxxxxxxxx, Xxx Xxxxxx 00000-0000
(hereinafter called "BMSUSP"). Vendor agrees to provide services to BMSUSP
under the terms set forth below.
A. SERVICES
Vendor will provide the product(s) or service(s) set forth, and to the
specifications set forth in the proposal incorporated herein as Attachment
A.
The product and all elements as set forth on Attachment A are subject to
prior approval by BMSUSP, such approval not to be unreasonably withheld.
B. COMPENSATION
BMSUSP will pay Vendor according to the terms or payment schedule set forth
in Attachment A hereto.
In the event that BMSUSP shall request any changes in the concept,
specifications or scope of the product(s) or service(s) described on
Attachment A hereto, Vendor will notify BMSUSP of the cost of such
revisions and will not proceed without prior written approval.
If the compensation provision on Attachment A hereto is other than a flat
fee amount per element or for the entire project, Vendor will provide such
documentation in support of all xxxxxxxx as BMSUSP may reasonably require.
C. CONFIDENTIALITY
Vendor shall treat as confidential and secret any and all BMSUSP
Confidential Information. "BMSUSP Confidential Information" shall include,
but not be limited to, information relating to BMSUSP's past, present and
future marketing and research and development activities that may be
disclosed to Vendor by BMSUSP and/or BMSUSPs parent, subsidiary or
affiliate companies and which are identified in writing by BMSUSP as
confidential. BMSUSP Confidential information shall not include (i)
information known by Vendor prior to disclosure from BMSUSP. (ii)
information which is or becomes publicly known through no wrongful act of
Vendor, (iii) information that is independently developed by Vendor,
without use of information that otherwise constitutes BMSUSP Confidential
Information, or (iv) information disclosed pursuant to law, rule,
regulation or pursuant to a court order, provided that BMSUSP is given 10
days prior notice of such disclosure. Vendor expressly agrees that any
information it discovers or develops under this Agreement for the benefit
of BMSUSP shall not be used by Vendor or disclosed by Vendor to any third
party, nor shall Vendor show this Agreement or disclose the existence,
nature or subject matter of this
1
Agreement to any third. party without the prior written consent of BMSUSP.
Vendors obligations not to disclose BMSUSP Confidential Information to
third parties and not to otherwise use BMSUSP Confidential Information
shall survive the termination of this Agreement for a period of five years.
Vendor shall not duplicate any material containing BMSUSP Confidential
Information, except in the direct performance of its services under this
Agreement. Vendor shall return all copies of materials containing BMSUSP
Confidential Information upon Vendor's completion of services under this
Agreement or upon any earlier termination of this Agreement for any reason
whatsoever.
BMSUSP shall treat as confidential and secret any and all Vendor
Confidential Information. 'Vendor Confidential Information" shall include,
but not be limited to, information relating to Vendor's past, present and
future systems development activities that may be disclosed to BMSUSP
and/or BMSUSP's parent, subsidiary or affiliate companies and which are
identified in writing by Vendor as confidential, except that in no event
shall Vendor Confidential Information include information relating to
Vendor deliverables under this agreement. Vendor Confidential information
shall not include (i) information known by BMSUSP prior to disclosure from
Vendor, (ii) information which is or becomes publicly known through no
wrongful act of BMSUSP, (iii) information that is independently developed
by BMSUSP, without use of information that otherwise constitutes Vendor
Confidential Information, or (iv) information disclosed pursuant to law,
rule, regulation or pursuant to a court order, provided that Vendor is
given 10 days prior notice of such disclosure. BMSUSP expressly agrees
that any Confidential Information it discovers under this Agreement shall
not be disclosed by BMSUSP to any third party without the prior written
consent of Vendor. BMSUSP's obligations not to disclose Vendor
Confidential Information shall survive the termination of this Agreement
for a period of five years.
D. INDEMNIFICATION
Each party shall indemnify and hold the other party harmless from and
against all liability, damages, penalties, losses, costs or expenses,
including attorneys' fees, arising from or in any way related to its
willful or negligent actions or omissions in performing the
responsibilities as described in this Agreement, or for any willful or
negligent breach of this Agreement.
E. PROFESSIONAL STANDARDS
Vendor represents that it has facilities, personnel, experience and
expertise sufficient in quality and quantity to perform all such
assignments and projects given it by BMSUSP hereunder and agrees that it
will perform all such assignments and projects in a manner commensurate
with professional standards generally applicable to its industry.
2
F. OWNERSHIP OF MATERIALS
Any and all reports, information, data or other works created by Vendor for
BMSUSP in connection with this Agreement (with the exception of
customization of the Vendor's basic software and systems for BMSUSP as well
as the Vendor's basic software and systems themselves) shall be the sole
and exclusive property of BMSUSP. BMSUSP may use such work wherever and
whenever it chooses. This Agreement shall be deemed a transfer of
copyright and any copyrightable subject matter created by Vendor in such
works. Vendor shall execute any and all documents necessary to demonstrate
or perfect such transfer. Vendor shall not at any time in any manner
during or after this Agreement, under any circumstances, be entitled to or
claim any right, title or interest herein or any commission, fee or other
direct or indirect benefit from BMSUSP or BMSUSP's parent, subsidiary or
affiliate companies, in respect of such reports, data, information or other
works created by Vendor hereunder. Vendor agrees to execute or cause its
agents and/or employees to execute any documents necessary or desirable to
secure or perfect BMSUSP's legal rights and worldwide ownership in such
works, including, but not limited to documents relating to patent,
trademark and copyright applications.
Nothing in the preceding paragraph shall preclude Vendor from referring to
the general results of the project performed pursuant to this Agreement in
making marketing presentations to other potential customers. In addition,
BMSUSP agrees to provide Vendor with reasonable access to data generated by
the project performed pursuant to this Agreement for the sole purpose of
supplementing or supporting marketing presentations to other potential
customers, provided, however, that all such supplemental or supporting
presentations, insofar as they disclose data from the project, must be pre-
approved by BMSUSP. Such approval shall not be unreasonably withheld.
G. RELEASES
Any materials furnished hereunder which have not been created for BMSUSP
and are subject to the rights of third parties shall be specifically
identified to BMSUSP in writing. Vendor shall obtain (and deliver upon
request to BMSUSP) releases for all names, photographs, illustrations,
testimonials, and any and all other materials used in works which Vendor
prepares or uses. All such releases shall run to BMSUSP, its agents and
employees where appropriate and customary. Vendor's failure to obtain such
releases or the obtaining of such releases by Vendor shall in no way
relieve Vendor of its obligations in Paragraph F above except where the
releases have been obtained directly by BMSUSP. Except for works that have
been secured by permission, Vendor warrants and covenants that all works
provided by Vendor shall be original and shall not infringe any copyright
or violate any rights of any persons or entities whatsoever.
3
H. DURATION OF AGREEMENT
1. Term
This Agreement is effective as of the Effective Date and shall continue
in full force and effect until the earlier of (i) completion of the
project assigned hereunder, (ii) terminated by at least thirty (30)
days written notice by either party to the other, sent by registered
mail to the address for each party first set forth above, or to such
other address which a party may designate for its receipt of notices
hereunder.
2. Payment on Termination
Upon termination of this Agreement BMSUSP is to pay for all authorized
work in process, and BMSUSP shall assume Vendor's liability under and
indemnify Vendor with respect to all outstanding contracts made on
BMSUSP's behalf. Upon written notice of termination Vendor shall take
all steps necessary to wind up the work under this Agreement and to
mitigate BMSUSP's liability therefore.
3. Transfer Upon Termination
Vendor shall transfer, assign and make available to BMSUSP or BMSUSP's
representative all property and materials in Vendor's possession or
control belonging to and paid for by BMSUSP, and all information
regarding BMSUSP's project(s) covered by this Agreement, as set forth
in Paragraph C herein. Vendor also agrees to give all reasonable
cooperation toward transferring with approval of third parties in
interest all contracts and arrangements, if any, properly entered into
by Vendor in the performance of this Agreement, and all rights and
claims thereto and therein, upon being duly released from the
obligation thereof.
I. INDEPENDENT CONTRACTORS
The parties to this Agreement are independent contractors and nothing
contained in this Agreement shall be construed to place the parties in the
relationship of employer and employee, partners, principal and agent, or
joint ventures. Neither party shall have the power to bind or obligate the
other party nor shall either party hold itself out as having such authority.
J. THIRD PARTY OBLIGATIONS
In connection with this Agreement, Vendor shall make no commitments or
disbursements, incur no obligations nor place any advertising, public
relations or promotional material for BMSUSP's parent, subsidiary or
affiliate companies, nor disseminate any material of any kind using the
name of BMSUSP and/or BMSUSP's parent, subsidiary or affiliate companies or
using their trademarks, without the prior written approval of BMSUSP.
4
K. GOVERNING LAW
This Agreement is entered into in the State of New Jersey and shall be
constructed and governed under and in accordance with the laws of that
State.
L. MISCELLANEOUS
1) The terms of this Agreement shall be binding upon BMSUSP and
Vendor and their respective successors and permitted assigns.
Notwithstanding the foregoing, this Agreement is not assignable in whole or
in part by Vendor without the prior written consent of BMSUSP. Factoring
of accounts receivable is not permitted.
2) The failure of either party to take action as a result of a
breach of this Agreement by the other party shall constitute neither a
waiver of the particular breach involved nor a waiver of either party's
right to enforce any or all provisions of this Agreement through any remedy
granted by law or this Agreement.
3) BMSUSP is an Equal Opportunity Employer and does not discriminate
against any person because of race, color, creed, age, sex, or national
origin. Vendor represents that it has the same policy of Equal Opportunity
Employment.
4) The policy of BMSUSP is to protect the health, safety and quality
of life of its employees and the public, and to exercise responsible
stewardship of natural resources that may be impacted by its activities.
To realize this, BMSUSP is committed to maintaining programs and procedures
for the environmentally responsible management of facilities, materials,
production processes, products and packaging, transportation and
distribution, waste and ft minimization, energy, general business
operations and contracted goods and services. Vendor agrees with this
policy and further acknowledges that its performance under this Agreement
shall be in strict compliance with all applicable governmental laws and
regulations and in accordance with and in furtherance of this policy.
5) This Agreement contains the entire understanding of the parties
with respect to the subject matter contained herein, supersedes any prior
written or oral communications and may be modified in writing subject to
mutual agreement of the parties hereto.
6) The headings of each paragraph are for reference only and shall
not be construed as part of this Agreement.
5
7) Except for the obligation to pay money property due and owing,
either party shall be excused from any delay or failure in performance
hereunder caused by reason of any occurrence or contingency beyond its
reasonable control, including. but not limited to, failure of performance
by the other party, earthquake, labor disputes, riots, governmental
requirements, inability to secure materials on a timely basis, failure of
computer equipment, failures or delays of sources from which information or
data is obtained and transportation difficulties.
IN WITNESS WHEREOF, the parties hereto, each by a duly authorized officer, have
entered in to this Agreement this 1 day of February, 0000
Xxxxxxx-Xxxxx Xxxxxx Disease State Management, Inc..
U.S. Pharmaceuticals 00 Xxxxxx Xxxxxx
a division of Xxxxxxx-Xxxxx Xxxxxxxxx, Xxx Xxxx 00000
Squibb Company
By: /s/ Xxxxxx Xxxxx By: /s/ Xxxxxx X. Xxxxxxxx
--------------------------- -----------------------------------
Title: Vice President HealthCare Title: President & CEO
Management --------------------------------
-------------------------
6
Portions of this Exhibit have been omitted pursuant to a request for
confidential treatment. The omitted portions, marked by [****], have been
separately filed with the Commission.
PROGRAM OVERVIEW
NEEDS ASSESSMENT
DSMI-TM- will perform a comprehensive needs assessment to establish the
fundamental goals, objectives and data sets for the intervention protocol. The
needs assessment portion of the project development shall include:
1. Establishment of an Expert Consultation Panel. The panel will consist of a
board certified cardiologist, critical care/cvd rehabilitation nurse
specialist, a clinical dietitian, DSMI-TM- clinical expert, and a BMS
Disease Management Team member. Recruitment and contracting of the
clinical consultants shall be the responsibility of and at the discretion
of DSMI-TM-'s clinical department. DSMI-TM- will provide for review the
CVS/credentials of the expert consultants. Xxxxxxx-Xxxxx Squibb agrees to
review/accept advisory board recommendations. The panel will assist in the
development of the following:
a) Intervention protocol e) Baseline parameters
b) Program goals f) Inclusion/exclusion criteria
c) Data sets g) Appropriate DRG/ICD - 9 codes
d) Outcomes evaluation protocol
During Phase II of clinical development consulting experts will review
program materials, call algorithms and reports to insure that program
development goals are met.
Outcome measures and established data sets shall be reviewed by Xxxxxxx
XxXxxx, MD or other clinical expert at the discretion of DSMi-TM-.
DSMi-TM- will provide for BMS's disease state management team's review the
CVs of all outcome reviewers under consideration.
2. DSMI-TM- will conduct a comprehensive literature search in accordance
with procedures established by Dracup et al. (1994). The search will
involve a review of studies published in English between 1989 and
1995. Search terms will include treatment/pharmacologic compliance,
adherence, patient behavior modification programs and congestive heart
failure risk factors. Program content will reflect nationally
recognized guidelines (e.g., AHCPR) for the treatment of CHF. Where
data or published consensus statements are lacking, expert
consultation will be utilized.
3. DSMI-TM- will perform a review of preprinted published materials provide a
listing of available educational resources pertaining to CHF. DSMI shall
provide sample copies of available materials to BMS and the Expert Panel
for review.
4 DSMI-TM- will assist Xxxxxxx-Xxxxx Squibb Company in establishing target
accounts for program implementation. Such assistance will include:
a) Review of MEDLINE database to establish CHF incidence rates by age,
race, and sex. DSMI-TM- will provide a concise reference guide for use
by BMS consultants when meeting target accounts.
b) "Financial impact of CHF" overview sales presentation for BMS
consultants to utilize.
DSMI-TM- shall designate a minimum of one Senior Account Manager and
one Clinical taff Member to this project. Specific staff members will
be assigned to address project concerns as requested by BMS-TM-.
13
CONGESTIVE HEART FAILURE INTERVENTION
PROGRAM GOALS
1. Patient Intervention (Behavioral Goals):
a) Improve patient understanding and awareness with respect to:
-- Pharmacological Therapy
-- Self-monitoring of "critical" symptoms
-- Dietary needs and guidelines
-- Exercise regimen
-- Associated CHF risk factors
b) Enhance Patient Motivation and Confidence with respect to:
-- Pharmacological therapy
-- Self-monitoring of "critical" symptoms
-- Adherence to dietary recommendations
-- Exercise regimen
-- Modification of other risk factors contributing to progression of
CHF.
-- Enhance patient/provider communication making visits and
telephone interaction more efficient and effective.
c) Enhance Compliance with respect to:
-- Pharmacological therapy
-- Self-monitoring of "critical" symptoms
-- Dietary guidelines
-- Exercise regimen
-- Modifiable risk factors
d) Facilitate the appropriate use of referral resources with respect to:
-- Medical/treatment concerns
-- Cardiac rehabilitation, including exercise interventions
-- Dietary intervention, education and counseling
-- Modification of other risk factors contributing to the
progression of CHF. (e.g. , smoking cessation, weight loss
programs)
e) Facilitate appropriate and timely communication of critical CHF
symptoms to health care providers.
f) Facilitate early identification and referral for treatment of
depression and emotional distress.
g) Enhance communication of information between patient and health care
providers.
14
CONGESTIVE HEART FAILURE INTERVENTION
PROGRAM GOALS
2. Business Goals
a) MCO Goals
-- Enhance CHF patient management
-- Strengthen patient/provider relationship
-- Encourage adherence to recognized treatment guidelines via pre-printed
provider mailing.
-- Improve competitive position
-- Position MCO as innovative technological leader in competitive market
place
-- Link providers, nursing services, case management and patients
-- Improve pharmacy services awareness of treatment compliance statistics
through reporting services outlined under "Reports" in this document.
-- Reduce risk factors associated with costly:
-- Unscheduled physician visits
-- Emergency room intervention
-- Hospitalizations
-- Provide expanding database for critical pathways development
b) Xxxxxxx-Xxxxx Squibb Company
-- Enhance competitive position
-- Encourage drug compliance/secure adherence to ACE inhibition therapy
-- Strengthen customer commitment to BMS partnership
-- Provide powerful customer driven selling tool
-- Develop business alliance with major home health care providers
-- Provide a unique opportunity for Xxxxxxx-Xxxxx Squibb
Company to partner with home care market leaders and enhance
MCO relationships
-- Provide widespread introduction into previously inaccessible
markets
15
PROGRAM SCHEDULE
See the "Program Intervention Description" section for details about each of the
interventions. This protocol would be delivered to patients during their first
year of involvement in the program. Note that the term "provider" is used to
denote a case manager or another health care provider designated to receive
communications regarding the patient.
STANDARD PROTOCOL ( Enrollment Call plus 12 follow up interventions to be
delivered to all enrollees)
-- MONTH 1
Business Reply Card (BRC) + program description
Enrollment call to patient
Personalized patient report
Personalized provider summary report
These are fully demand published reports to highlight
baseline parameters.
-- MONTHS 2-13
One follow-up call/month
One personalized patient report/month
One personalized provider update/month
16
PROGRAM INTERVENTION DESCRIPTION
See the "Program Schedule" (page 10) section for an outline of the protocol for
delivering these program components. Note that the term "provider" is used to
refer to a case manager or another health care provider designated to receive
communications regarding the patient.
STANDARD PROTOCOL
Business Reply Card (BRC)/Program Description
-- Pre-printed card designed for distribution by providers to patients
and return via postage paid mail response by patient to DSMI-TM-
-- Brief assessment for identifying patient data (e.g., name, phone
number, best time to contact) necessary for DSMI-TM- to initiate
enrollment call to patient
-- Program description attachment for patient to tear off and keep for
future reference
ENROLLMENT TELEPHONE CALL
-- Call to enroll patients in the program as per receipt of Business
Reply Card
-- Call placed by operator according to patient's preferred contact times
as per Business Reply Card
-- Cost-efficient interface: operator-initiated contact to identify
patient and transfer to automated, voice response system
-- Option to reconnect with operator during or after voice response
interaction
-- High appeal voice response system using a recorded human voice versus
computer synthesized speech
-- Patient responds in normal speaking voice versus pushing touch tone
buttons
-- Self-reported assessment of relevant medical and behavioral factors:
disease status, prescribed treatment including diet, exercise,
medications, patient motivation, treatment barriers, patient knowledge
indicators regarding symptom identification and disease self-
management
-- Patient receives personalized questions and clinically appropriate
feedback driven by expert system to promote patients' awareness of
their condition and adherence to their treatment regimen
-- Creates foundation for expanding patient data file which drives the
personalized, interactive program services
17
PATIENT REPORT
-- Laser printed, on-demand published report and program description
including text that is personalized based upon enrollment
questionnaire responses and graphics that are personalized to
patient's gender
-- Mailed to patient within a week after completion of enrollment
telephone call
-- Personalized and pre-printed materials reinforce awareness and
knowledge regarding their condition and promote treatment adherence
and proper self-management skills
-- Referral information fosters appropriate use of health care resources
by patient
PROVIDER SUMMARY REPORT
-- Laser printed, on-demand published report summarizing a patient's
enrollment survey data not to exceed one page in length
-- Mailed to patient's provider within a week after enrollment telephone
call
-- "At-a-glance" format provides efficient documentation of critical
patient data, ready for insertion into the medical record not to
exceed one page in length
-- Facilitates identification of patient education needs and hard-to-
manage patients, appropriate allocation of health care resources, and
timely modification of treatment regimens
-- Enhances patient provider communication
FOLLOW-UP CALLS
-- Telephone calls placed by operator to patients according to patient's
preferred contact times and the program intervention schedule
-- Cost-efficient interface: operator-initiated contact to identify
patient and transfer to automated, voice response system
-- Option to reconnect with operator during or after voice response
interaction
-- Option to be connected to provider or other health care resource by
follow-up call operator
-- High appeal voice response system using a recorded human voice versus
computer synthesized speech
-- Patient responds in normal speaking voice versus pushing touch tone
buttons
-- Self-report follow-up assessment of relevant medical and behavioral
factors: update on disease status, prescribed treatment including
diet, exercise, and medications, patient motivation, treatment
barriers, patient knowledge indicators regarding symptom
identification and disease self-management
-- Patient receives personalized questions and clinically appropriate
feedback driven by expert system to promote patients' awareness of
their condition and adherence to their treatment regimen
-- Allows identification of patient concerns and appropriate referral
-- Adds vital progress information to the longitudinal patient database,
over time
PATIENT UPDATES
-- Laser printed, on-demand published report including text that is
personalized based upon enrollment questionnaire responses, and
graphics that are personalized to patient's gender
-- Mailed to patient within three days of telephone intervention to
insure timely receipt by patient
-- Personalized and pre-printed materials reinforce patient awareness and
knowledge regarding their condition and promote treatment adherence
-- Referral information fosters appropriate use of health care resources
by patient
18
PROVIDER UPDATES
-- Laser printed, on-demand published report integrating patient's
follow-up and enrollment data
-- Mailed to patient's provider within a week after each patient follow-
up call
-- "At-a-glance" format provides efficient documentation of critical
patient data, ready for insertion into the medical record
-- Facilitates identification of patient education needs and hard-to-
manage patients, appropriate allocation of health care resources, and
timely modification of treatment regimens
-- Enhances patient-provider communication
ORGANIZATIONAL DATA REPORTS
-- Comprehensive data sets will be determined by expert consultation.
-- Standard data reports, aggregate information, to payor and
participating organizations, provided quarterly. Configuration of
standard reports to be determined upon completion of the Expert Panel
data set development. Nonstandard reports will be developed by DSMI-
TM-'s staff at the request of BMS and its client organizations. DSMI-
TM-/BMS will establish customary and reasonable developmental and
production fees for the aforementioned nonstandard reports.
-- To insure confidentiality and security of program database, reports to
Xxxxxxx-Xxxxx Squibb on program data to include aggregate patient
information only, as per format requested by Xxxxxxx-Xxxxx Squibb.
19
PROGRAM DEVELOPMENT
Program development will proceed in two stages. During the first stage, to be
completed within 45 days of contract signing, DSMI-TM- will establish and
convene a Congestive Heart Failure advisory panel meeting to determine:
intervention goals, protocol structure, required data sets, educational
requirements, high risk behaviors, available resources and modifiable behaviors.
DSMI-TM- will provide a panel summary report to BMS. Additionally, not later
than signature date plus 45 days, DSMI-TM- will deliver preliminary program
components to be used by Xxxxxxx-Xxxxx Squibb to market the program. These
components will include five (5) copies for each of the following prototypes of
the program: sample marketing brochure/sales aid, sample business reply
card/program description, sample personalized patient report (including partial
Greek text), and sample personalized provider report (including partial Greek
text). In addition, a voice response call-in telephone demonstration will be
accessible.
The second stage of program development will require an additional 150 days to
deliver a fully operational program, including the following components:
-- Business reply card/program description (design/layout, print
specifications and artwork in a form specified by BMS)
-- Personalized patient report and 12 patient updates
-- Personalized provider report and 12 standard protocol provider updates
-- Enrollment call and 12 standard protocol follow-up calls
-- Marketing brochure and sales presentation aid
The entire program development includes the following tasks:
PHASE I
-- Consultation with Xxxxxxx-Xxxxx Squibb Company to finalize program
specifications. Such consultation will establish: BMS disease
management team's program objectives, requested data sets, outcome
protocol overview to include goals/objectives and tentative design,
marketing and business goals. BMS will provide DSMI-TM- with an
overview in writing no later than contract signing date plus 45 days.
-- Development of and consultation with expert panel as described. Such
consultation will assist in the establishment of: primary CHF
treatment protocols and algorithms, documented intervention methods,
target data for outcomes evaluation, required database for
evaluation/reporting, patient educational requirements, national
resources for preprinted CHF educational materials, standardized
quality of life measures and incidence/economic overview of congestive
heart failure. Consultants will be recruited no later than 15 days
after contract signing.
-- BMS/DSMI-TM- will establish a formal developmental reporting and
review process. DSMI-TM- will provide BMS a comprehensive project
developmental overview annotating clinical development completion
dates for individual modules. Additionally, formal review conference
dates will be established no later than 45 days after contract
signing.
-- Integration of market research/client/clinical information to finalize
program content.
-- DSMI-TM- shall host a patient directed focus group session to solicit
input for program goals, design and print materials.
20
PHASE II
-- Design of graphic presentation for pre-print and on-demand published
materials
-- Coordination of personalized clinical copy with personalized graphics
-- Design of systems configuration
-- Systems programming for internal reporting for on-demand publishing,
interactive voice response, and outcomes analysis
-- Voice recording and training of the voice response system
-- Identification of appropriate educational brochures and materials
PHASE III
-- Testing of the operable program
-- Proof reading/editing pre-printed and on-demand published materials
PHASE IV: PILOT PROGRAM
DSMI-TM- shall conduct a pilot test, for a maximum of 100 participants,
recruited by BMS, to demonstrate the efficiency of the fulfillment process. The
test shall include the following interventions:
-- Mail BRCs to pilot program participants
-- Process all BRCs returned to DSMI-TM-
-- Conduct enrollment telephone call
-- Mail personalized patient report
-- Mail personalized provider summary report
-- Conduct follow-up telephone call at 2-weeks after enrollment
-- Mail personalized patient update
-- Mail personalized provider update
-- The test shall be conducted in a period not to exceed 90 days,
including recruitment of participants
To insure program validation, DSMI-TM- shall assist in the
development of an Intervention Program Outcomes Assessment as described in
this document. Additionally, at the discretion of DSMI-TM- and in
consultation with BMS-TM-, DSMI-TM- shall insure that program goals, targeted
behaviors, questions and strategies are valid through expert consultation.
Upon completion of the Pilot Program, DSMI-TM- shall begin patient
enrollment. Patients will receive program interventions described under
"Program Intervention Description" on page 14 of this document.
21
CONGESTIVE HEART FAILURE
INTERVENTION PROGRAM QOL ASSESSMENT
Recent research has indicated that the primary method of assessing the
success/failure of a Congestive Heart Failure Management Program is to recognize
its impact on the targeted patient's ability to perform daily tasks, participate
in productive activities, emotional status and ability to self-manage his/her
disease. Studies such as Guyatt et al's "Measurement of Health-Related Quality
of Life in Heart Failure" published in the Journal of the American College of
Cardiology and Wenger et al's "Quality of Life: Can it and should it be
assessed in Patients with Heart Failure?" published in Cardiology 76(5): 391-8,
1989 clearly demonstrate that these measures are a significant tool for
evaluating congestive heart failure patients' well being.
DSMI-TM- will establish a comprehensive quality of life assessment program to
assist in validating the operational intervention protocols. The nature of a
QOL assessment dictates that data be self-reported. As per the behavioral goals
of the program, positive changes in these variables would be utilized as
indicators of the efficacy of the intervention. In addition, the patient
satisfaction measure listed below will be examined as a performance indicator
for the program. Such measures will reflect HEDIS Guidelines and CHF TyPE
functional status codes. The QOL assessment protocol shall reflect the
recommendations of the Expert Advisory Panel.
BIANNUALLY
A report will be prepared biannually displaying summary statistics derived from
aggregate patient data for each of the measures shown below. Each measure will
be collected during the program telephone contacts at program entry, six month
post entry and at the conclusion of the program. Once repeated measures are
available, summary statistics for longitudinal changes in each variable from
baseline and from the preceding semester for each individual will also be
reported.
1. Patient awareness and understanding of:
a) Medication/prescription regimen
b) Critical CHF symptomology
c) Dietary intervention and recommendations
d) Exercise recommendations
e) Other risk factors contributing to progression of CHF
2. Motivation and confidence with respect to:
a) Adherence to medication/prescription regimen
b) Self-monitoring of CHF symptoms
c) Adherence to dietary recommendations
d) Adherence to exercise recommendations
e) Modification of other risk factors contributing to progression of CHF
3. Adherence with respect to:
a) Medication/prescription regimen
b) Ongoing self-monitoring of CHF symptoms
c) Dietary protocol
d) Exercise protocol
e) Modification of other risk factors contributing to progression of CHF
4. Use of health care services:
a) Unscheduled physician office visits
b) Emergency room services
c) Dietary counseling
22
d) Cardiac rehabilitation services
e) Hospitalizations
5. Quality of care measures
a) Selection of relevant HEDIS items on satisfaction with health care
b) Baseline quality of care assessment results as described under the
"annual" outcomes section below
6. Overall program satisfaction
ANNUAL
A baseline quality of life measure will be obtained through either written or
telephone administration within the first month of a patient's enrollment in the
program. As noted under the "biannual" outcomes section above, the results of
this baseline assessment will be reported in the semester reports as summary
statistics for aggregate patient data collected during the preceding semester.
The quality of life measure will be administered to each patient a second time
during the twelve month phone contact. As the follow-up quality-of-life data
become available, they will also be incorporated into the biannual reports.
23
CONGESTIVE HEART FAILURE
INTERVENTION PROGRAM OUTCOMES
ASSESSMENT PROGRAM
DSMI-TM- will assist Xxxxxxx-Xxxxx Squibb in the development of a study to
evaluate the effectiveness of the aforementioned intervention protocol. After
consultation with BMS/ and in conjunction with the Expert Consultation Panel,
DSMI-TM- will establish a comprehensive database reflecting the outcome measures
listed below. Additionally, DSMI-TM- shall assist BMS in establishing entry
criteria, exclusion criteria, goals, objectives and any additional controls
required to ensure comparative validity. Such information shall include:
-- Number of hospitalizations per patient
-- Number of unscheduled physician office visits/patient
-- Percentage of increase/decrease in reported symptoms
-- Number of emergency room interventions
-- Number of home nursing interventions required
Selection of a comparative data set shall be the responsibility of Xxxxxxx-Xxxxx
Squibb and its affiliated clients. The establishment of baseline measures shall
be conducted by BMS/ to insure appropriate comparisons may be drawn.
DSMI-TM- involvement/funding of an outcome evaluation extends only to the
aforementioned items. Further requirements regarding design, implementation,
publication of said study are the sole responsibility of BMS/ and its clients.
24
PROGRAM MARKETING AND TRAINING
DSMI-TM- will provide 4 full day training sessions to BMS staff or
representatives to assist in the marketing and training efforts for the program.
BMS will have access to additional services that may include any of the
following:
-- Development of marketing and/or training strategies and procedures
-- Coordination and/or presentations for meetings and seminars with
payors/sponsoring organizations
-- Individual phone and/or in-person consultation with payors/sponsoring
organizations
-- Written correspondence with payors/sponsoring organizations
-- Preparation of written materials and/or phone demonstrations for the
payors/sponsoring organizations
PROGRAM OPERATION
As DSMI-TM-'s program development team nears completion of the program, a
program operation team will be assembled to participate in testing the system.
This facilitates a smooth transition period for the shift from the development
to the operations staff. DSMI-TM- will maintain responsibility for managing its
in-house staff and its subcontractors who are involved in ongoing operations of
the program interventions. Quality assurance measures are included in the
interactive program interventions and DSMI-TM-'s internal reporting systems.
DSMI-TM- will update/modify the intervention reports/calls when warranted at the
request of BMS or upon discovering effective program improvements at no charge
for 90 days following program introduction. Change request must be made in
writing. At the expiration of 90 days, DSMI-TM- will continue to update and
revise the system as necessary. Additional changes will be considered. such
changes will be funded in a manner to be approved by both DSMI-TM- and Xxxxxxx-
Xxxxx Squibb Company.
Algorithms within the expert systems directing the mail and phone interventions
allow for easy modification of program elements without interruption of service
delivery. The systems development staff are available as-needed to make any
necessary modifications. While DSMI-TM-'s clinical department will remain
responsible for any outcomes analyses evaluating the clinical impact of the
program, DSMI-TM-'s program operation team will monitor quality assurance
indicators (e.g. enrollment rate, participant satisfaction, follow-up completion
rate) on a continual basis to insure appropriate delivery of program services as
agreed upon by DSMI-TM- and Xxxxxxx-Xxxxx Squibb Company.
DATABASE DEVELOPMENT
The program database will be constructed and maintained using a standard
Relational Data Base Management System (DBMS). The primary record index will be
based upon patient identification. All information collected at enrollment and
during all subsequent interventions will be stored in the database. The record
schema(s) will be developed according to the specific question sets and data
required by the proposed program. Data may be imported or exported off-line
using a variety of industry standard formats, or on-line using DSMI-TM-'s SQL
Server interface. DSMI-TM- will use industry standard procedures for insuring
the confidentiality and security of the program database.
25
Portions of this Exhibit have been omitted pursuant to a request for
confidential treatment. The omitted portions, marked by [****], have been
separately filed with the Commission.
PRODUCT DEVELOPMENT FEES
The cost is [*****] to deliver the preliminary program components and the fully
operational program. Fee is payable according to the following schedule:
-- 40% upon contract signing
-- 20% upon delivery of preliminary materials
-- 20% at delivery of operational program
-- 20% upon completion of the pilot program
Developmental fees will cover:
-- Clinical
-- Expert Consultation: DSMi-TM- shall fund all travel, honorarium
and associated fees involved in the convening of the Expert
Advisory Panel Meeting described under "Program Overview" in this
document. DSMI-TM- shall provide all panel members with a
program synopsis, meeting agenda, targeted goals and any
additonal information as necessary to insure expert panel members
are fully prepared for the meeting. Additionally, DSMI-TM- will
provide a follow up mailing for all members to solicit additional
feedback and highlight the panel's recommendations. The panel's
recommendations , as well as, any additional feedback shall be
incorporated into the final intervention at the discretion of
DSMI-TM- and BMS-TM-. Any additional requirements for expert
consultation beyond the services of the "Expert Consultation
Panel" shall be at the sole expense of BMS.
-- Clinical Content
-- Intervention Algorithms
DSMi-TM- shall provide for review and revision all interventional
algorithms. Upon receipt of draft documents, BMS shall review
and return all documents for editing within 5 business days to
DSMi-TM-. DSMi-TM- shall incorporate suggested revisions within
5 business days. Upon receipt of "Second Draft" BMS shall have
the right to an additional edit/revision. BMS shall return
"Second Draft" documents within 5 business days for editing by
DSMi-TM-. Upon completion of final editing by DSMi, BMS shall
make final comments and provide signature approval of all
documents within 5 business days. BMS agrees that all reviews/
revisions shall be concluded in accordance with the formal
developmental reporting/review process under " Program
Development" in this document and in accordance with established
time lines. All documents sent to BMS shall include a cover
sheet indicating due dates for return to DSMI-TM-, a comments
section and a signature authorization.
-- Testing and Debugging
-- Systems
-- Database Development
DSMI-TM- will provide a time and events calendar for database
development to BMS-TM- for review. The program database model
will reflect agreed program parameters.
-- On-Demand Publishing
-- Voice Training (IVR)
-- Call Center Integration
-- Graphics/ Communication
-- Logo Design
-- Layout (preprinted and on-demand materials)
-- Illustration Development
26
* Voice Recording/Studio
* Primary Marketing Materials
* Print Materials
* Operational Voice Demonstration
* Sales Materials
Printing fees for all pre-printed materials (e.g., marketing/sales aids,
BRC/program description) will be the responsibility of Xxxxxxx-Xxxxx Squibb.
At Xxxxxxx-Xxxxx Squibb's request, and at no additional cost, DSMI-TM-
will incorporate a managed care organization's logo or other identifying
graphic element on all camera ready art/disk, when provided with camera ready
disk version/disk version or graphic standards manual from the designated
managed care organization.
DSMI-TM- will furnish estimates for printing costs upon determination
of volumes and final specifications.
27
Portions of this Exhibit have been omitted pursuant to a request for
confidential treatment. The omitted portions, marked by [****], have been
separately filed with the Commission.
PROGRAM OPERATION FEES
The per patient program cost is $[*****] per patient for the 12-month
standard protocol, payable at the time of patient enrollment. In the event of
a patient withdrawal from the intervention program, DSMI-TM- will prorate the
remaining expenses. For operator services and telephone time utilized during
a conversion between a patient and another health care resource which is
initiated by the follow-up call operator, there will be a charge of $ per
minute. This $ per minute fee covers all charges for operator, staff and
telephone time which may occur in the event that DSMI-TM- initiates the
described contact.
The following schedule demonstrates the amortization of the operational fees
based upon the intervention model being proposed. This schedule shall form
the basis for proration of fees due to patients' attrition from the program.
MONTH ACCRUED OPERATIONAL FEES MONTH ACCRUED OPERATIONAL FEES
----- ------------------------ ----- ------------------------
Enrollment [*****] 7 [*****]
1 [*****] 8 [*****]
2 [*****] 9 [*****]
3 [*****] 10 [*****]
4 [*****] 11 [*****]
5 [*****] 12 [*****]
6 [*****]
28
EXCLUSIVITY
Xxxxxxx-Xxxxx Squibb agrees to provide enrollment of a minimum of 3000 patients
within 24 months of the delivery of an operational program. For a period
beginning with the date this Agreement is signed and ending 24 months from date
DSMI-TM- completes Phase IV of the program (the "Exclusivity Period"), DSMI-TM-
agrees not to engage or participate in any other project involving the
development or implementation of an interactive program in the treatment of
diagnosed primary congestive heart failure. At the conclusion of the
Exclusivity Period, provided at least 3,000 patients are enrolled in the
program, Xxxxxxx-Xxxxx Squibb shall have the right, but not the obligation, to
negotiate an exclusive arrangement for an interactive program in the treatment
of diagnosed congestive heart failure. In the event such negotiations are
unsuccessful, Xxxxxxx-Xxxxx Squibb shall have the right to match any bona fide
offer made to DSMI-TM- for an interactive program in the treatment of diagnosed
congestive heart failure. This right of first refusal shall endure for a period
of twelve months from the conclusion of the Exclusivity Period.
CONSULTING
A per diem fee plus direct expenses is required for consultation services
performed by DSMI-TM- or its consultants. Such fees would be required for
activities performed for parties outside Xxxxxxx-Xxxxx Squibb on behalf of the
program and/or activities beyond the program development/marketing and training
operations functions outlined in this proposal.
CUSTOMIZATION
Any customization other than incorporation of MCO logo or other identifying
graphic element will constitute a revision to the intervention protocol (i.e.,
additional patient and/or physician reports and/or variations in on-demand or IV
content). DSMI-TM- shall furnish estimates for development and delivery to
Xxxxxxx-Xxxxx Squibb prior to undertaking any revision. Additionally, DSMi-TM-
shall provide upon request estimated development and production fees for
additional reporting.
29
Portions of this Exhibit have been omitted pursuant to a request for
confidential treatment. The omitted portions, marked by [****], have been
separately filed with the Commission.
OPTIONAL INTENSIVE INTERVENTION PROTOCOL
DSMI-TM- will provide Xxxxxxx-Xxxxx Squibb with the opportunity to enhance the
Standard Protocol by offering an intensive intervention program which can be
integrated into the program at the request of Xxxxxxx-Xxxxx Squibb. Patients
reporting symptoms indicating they are at increased risk of hospitalization,
emergency room evaluation, or requiring additional support can be enrolled in
the intensive protocol. The development and implementation of this module is
independent of the standard protocol and may be initiated by Xxxxxxx-Xxxxx
Squibb at any time. Development fees and operational costs are independent of
the standard intervention program. The protocol and fees are outlined below:
INTENSIVE PROTOCOL DEVELOPMENT
PROGRAM DEVELOPMENT FEES
The fee for the development of the intensive intervention protocol shall be
$[*****]. This fee supports the development of three additional telephone
interventions and corresponding reports.
PROGRAM OPERATIONAL FEES
An additional per patient fee of $[*****] will be charged each time a patient
receives the three-week intensive protocol, payable at the time that the patient
receives the first follow-up call included within this protocol. OPERATIONAL
FEES SHALL BE PRORATED AT $[*****] PER CALL FOR PATIENTS WHO DO NOT RECEIVE THE
FULL INTENSIVE INTERVENTION PROTOCOL.
INTENSIVE PROTOCOL
This module may be instituted in addition to the standard protocol after any
standard follow-up call at which critical indicators are found, such as
significant weight gain. If the patient has no critical indicators at the next
scheduled standard follow-up, he or she will continue to receive the standard
protocol unless such indicators arise at subsequent follow-up calls. Any
standard follow-up call which yields these critical indicators will
automatically trigger the intensive protocol regardless of what month it occurs
during the standard protocol. Criteria for the critical indicators are to be
determined.
WEEKLY INTERVENTIONS:
-- One follow-up call/week for three consecutive weeks
-- One personalized patient update/week for three consecutive weeks
-- One personalized provider update/week for three consecutive weeks
DSMI-TM- SHALL PROVIDE FAX CAPABILITY FOR PROVIDER REPORTS DURING THE
INTENSIVE INTERVENTION PHASE.
SAMPLE PATIENT SCENARIO
-- Patient is enrolled on January 1 and receives 1 month interventions.
-- During the month 2 follow-up call in February, patient reports critical
data (e.g., significant weight gain) which triggers the intensive protocol
of three weekly interventions subsequent to patient's month 2 standard
follow-up call.
-- Patient's standard month 3 (March) follow-up call occurs after the
intensive protocol. No critical indicators are reported for this call or
for the standard calls in months 4-7 (April - July).
-- In month 8 (August) patient reports critical data (e.g., difficulty
breathing when lying flat) which triggers the intensive protocol of three
weekly interventions subsequent to their month 8 standard follow-up call.
-- After the intensive protocol of three weekly interventions subsequent to
patient's month 8 standard follow-up call.
30
-- After the intensive protocol the patient's month 9 standard follow-up call
in September yields no critical indicators. Patient continues to have no
critical indicators during the remainder of the year 1 standard protocol
including (i.e., through months 10 - 12 or October - December).
31
