`
`
`
`
`
`The flflflTlIlIllEll SUBSTANCE! Bflll'l'lllll SYSTEM [0805]
`
`A national, centralized system that creates new efficiencies
`in the delivery of prescriptive drugs.
`
`
`
`
`Presented by:
`
`CSCS Enterprises, Inc.
`Houston, TX 77077
`
`September 10, 2001
`
`0808 Confidential Document
`
`PAR1037
`
`IPR of US. Patent No. 7,668,730
`Page 1 of 19
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`IPR of U.S. Patent No. 7,668,730
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`CSCS Enterprises, Inc.
`
`The clIIITIInllEII SIIIISTIIIIGE collfltlll SYSTEM [0503]
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`The Healthcare industry is facing a number of challenges today unlike ever faced
`before. An educated, consuming public has ever increasing expectations for exponential
`improvement in Healthcare delivery, while at the same time, economic pressures are
`forcing tighter controls over cost, efficiency and quality.
`
`No member of the healthcare value chain is immune from this scrutiny. The
`industry has widely recognized a need for better efficiencies. Federal pressures such as
`the Healthcare Information Portability and Accountability Act (HlPAA) mandate making
`the exchange of information more ubiquitous, secure and efficient. Focus is also being
`placed on spiraling cost structures, with efforts to improve mitigation of risk, provide
`more
`efficient
`billing
`and business modeling,
`eliminate
`redundancy,
`improve
`informational flow and lessen system abuse.
`
`There is no one solution that will address these many challenges. Standards and
`guidelines such as those in HIPAA will help immensely with Informational Flow, and the
`Healthcare Informatics industry is focused on building support to address these needs
`into their products. This is driving both a new investment cycle into the Healthcare
`Industry, while at the same time creating a more complex set of needs that will need to
`be addressed in order to realize their true value of these efforts. HIPAA, while adding
`clear,
`important and necessary support and standards in the use of healthcare
`informatics, doesn’t provide vehicles that can substantially create entire new efficiencies
`within healthcare, but actually help enable them.
`
`the delivery of
`One area where there is substantial opportunity to impact
`healthcare is associated with prescription drugs. The DEA estimated that Rx drugs were
`sold for $25 billion in 1993 compared to an estimate of $31 billion spent on cocaine.
`Since that time prescriptions have risen over 50%, totaling close to 3 billion prescriptions
`annually. With soaring costs, the costs of prescription drugs is currently greater that $50
`billion annually, with limited ability to control or manage those costs.
`
`Over 4 million people a year in the U.S. misuse or abuse prescription drugs.
`According an August 1999 article in the Journal of the American Geriatrics Society,
`Older Americans (age 65 and older) currently account for 12.5% of the total US
`population, but consume 25% of all prescription medications.
`It is documented that 17%
`of the senior population misuses medications, accounting for approximately $2 billion
`loss annually. The AMA estimates that 5% of physicians are grossly negligent and 1-
`1.5% are dishonest in their prescribing. This would amount to a cost of $2.5 billion
`annually. 350,000 adverse medication errors (probably far greater not reported) occur
`each year among .5 million nursing home residents in the US. 1 employee in 10 has a
`problem with alcohol/drugs. Absenteeism is 66% higher among drug users. Health
`benefit utilization is 300% higher among drug users. Disciplinary actions are 90% higher
`among drug users. 47% of work-place accidents are drug related. Employee turnover is
`significantly higher among drug users.
`
`Confidential
`
`2
`
`PAR1037
`
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`Page 2 of 19
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`
`
`CSCS Enterprises, lnc.
`
`These estimates are for the cost of drugs themselves, and don't include many of
`the tangential costs associated with this abuse; additional healthcare required and costs
`associated with drug interactions, insurance fraud resulting from purchase of class drugs
`for resale on the street, dispensing of wrong prescriptions due to misread prescriptions,
`which are proportional greater.
`
`CSCS is a healthcare utility that can assist substantially in reducing these
`misused and abused prescriptions that can account for a savings of over $4 billion
`annually. CSCS enables major changes in the delivery of prescription drugs, with
`measurable social and economic impacts on spend within the healthcare value chain
`(less abuse-related healthcare costs, fewer erroneous prescriptions, more accountability,
`better tracking and management of prescriptions). CSCS creates a secure and private,
`independent, lnternet—based, centralized system for tracking and managing prescription
`information in aggregate, allowing electronic querying and real-time notification of
`patient’s prescription history at the time of prescription creation. This information is
`accessible within a controlled and appropriate context
`for use by healthcare
`professionals involved in the delivery of care to that patient.
`
`Consumers: The consuming patients get the most value out of CSCS. They
`will have a comfort knowing that their physician and other healthcare professionals
`involved in their care will have secure and private access to historical information about
`their active and inactive prescriptions that can create problems or interactions. CSCS
`will allow consumers and their physicians to better manage the patient’s prescriptive
`plan, lessening risk of misuse and counter-indications.
`
`Doctors: Physicians and other healthcare providers are at risk every time they
`prescribe a drug. These physicians, seeking to provide their patients the best possible
`healthcare possible, have not current vehicle for ensuring they have an accurate view of
`their patients’ use of prescription drugs.
`information about prescriptions from specialists
`or other referral services may not be communicated appropriately. Patients may not
`remember prescriptions they are taking, forgetting about them completely or not being
`able to pronounce them.
`Patients with regular prescription patterns can empower
`physicians to proactively deal with potential abuse problems.
`it can also provide audit
`information that helps protect the professional from lawsuits and other potential liabilities.
`
`Pharmacies: Pharmacies require a more precise method of monitoring the
`efficiency of the distribution of the over 3 billion prescriptions they fill each year. With the
`number .of chain pharmacies having now risen to 35,000 stores, their ability to provide
`the highest quality service is placing a strain on staffing and the delivery of rapid, timely
`and accurate product. Pharmacists are constantly challenged to circumvent duplication,
`abuse,
`fraud, and misuse of
`these medications while providing a cost effective
`medication delivery system.
`
`available
`expanding
`geographically
`a
`is
`complexity
`this
`to
`Adding
`pharmacopoeia, which exponentially raises the risks of negative drug interactions and its
`associated destructive medical outcome. CSCS can flag these issues in “real time”
`preventing or minimizing their occurrences.
`
`Confidential
`
`3
`
`PAR1037
`
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`Page 3 of 19
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`IPR of U.S. Patent No. 7,668,730
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`

`

`
`
`
`CSCS Enterprises, inc.
`
`Hospitals: Hospital therapeutics requires administration of medications on an
`acute and sub-acute basis with little or no knowledge of patient’s outpatient medication
`profile. The CSCS System provides this vital data in a manner that will change the
`hospital medication delivery system in a dramatic fashion. This immediately reduces
`costs, adverse drug reactions, and eliminates the risks of facilitating drug abuse and
`misuse.
`
`The CSCS system reduces or eliminates reliance on poorly trained pharmacy
`technicians or assistants in ensuring compliance with the regulatory agency demands in
`the accurate delivery of pharmaceuticals.
`
`Pharmaceutical Providers: The Pharmaceutical industry is in a constant race
`to provide the public with pharmacological
`formulations that are compatible with
`constantly evolving therapeutic formulations, and whose availability is being accelerated
`by the rapid expansion of effective clinical trials and research protocols.
`
`The industries ability to respond effectively to the competitive as well as
`regulatory demands is challenging because of the difficulty in realizing real or near term
`information access and tracking information. This responsibility requires an ongoing
`current database of pharmaceutical demands,
`immediate identification of adverse
`reactions, and recognition of the costly development of redundant pharmaceutical
`products.
`
`CSCS provides the Pharmaceutical industry with a vehicle to help them track and
`access appropriate information about prescriptive drugs.
`it provides the Industry with
`services which will assist in better planning, real time assessment and forecasting of
`regional pharmaceutical demands, helping to prevent essential medication shortages or
`unavailability. As well as timely recalls can be affected when focused Adverse Drug
`Reactions occur.
`
`Insurance
`Insurance CompaniesZGovernmenf: Government Agencies,
`Companies, Veterans Administration Medical System, Workers’ Compensation
`Providers, Private Third Party Payers, and Health Maintenance Organizations will find
`new efficiencies by utilizing CSCS. Even the pending new Medicare Programs, which
`include Pharmaceutical programs, can be brought
`to public availability with the
`comprehensive management support that is lacking today. CSCS removes many of the
`management
`limitations that affect such efficiencies and will help control costs of
`program delivery.
`All of
`these entities can have immediate access to potential
`medication abuse by identification of needless prescription duplications, potential drug
`interactions, and multi-source interstate prescription abuse. CSCS likewise recognizes
`fraudulent prescriptions as well as immediately documenting the most cost effective form
`of a prescribed medication.
`
`in addition, the significant reduction in adverse outcomes due to pharmaceutical
`drug interactions and misuse reduces the medical costs necessitated in providing the
`resulting therapies.
`
`industry standard XML interfaces, and,
`Healthcare Informatics Providers:
`potentially, secure access applets, will allow informatics providers to integrate their
`products and services and "include” CSCS access and use in a seamless fashion. The
`
`Confidential
`
`4
`
`PAR1037
`
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`

`

`CSCS Enterprises, Inc.
`
`intent of 0808 is not to dis-intermediate software or service providers in the market, but
`create an independent utility service that adds value to their products while achieving
`public good.
`
`UTILITY STRUCTURE
`
`0808 is an independent information utility that acts as the central service center
`for the management of Prescription drugs. By allowing ready access to appropriate
`information at various points within the prescription process, 0808 helps to protect the
`patient from a variety of potential risks associated with the prescription of drugs, creates
`an audit capability that can help protect the healthcare professional, while eliminating
`significant financial overspend due to information gaps and misuse.
`
`While operated as a for-profit entity, the CSCS Utility will expect a representative
`group from the various healthcare value chain members to act as an oversight
`organization to ensure acceptable levels of information security, access and protection.
`0808 creates an independent, non-affiliated entity to act as the information liaison
`between all members of the healthcare community.
`
`
`
`
`
`Figure 1: 0808 is an informational liaison to the healthcare community.
`
`it consists of a data store that is
`CSCS provides its services through technology.
`Access to the appropriate
`maintained within a specific informational schema.
`information takes place through a variety of secure interactions between C803 and
`various healthcare applications
`(or via the World Wide Web).
`0803 system
`components will all meet or exceed HIPAA guidelines.
`
`
`
`Confidential
`
`5
`
`PAR1037
`
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`Page 5 of 19
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`

`

`CSCS Enterprises, Inc.
`
`CSCS Components are integrated into a robust utility system.
`components include:
`
`These
`
`Central Data Store: At the core of 0808, the Central Data Store provides a
`scalable, robust data store that maintains all pertinent information about prescription
`activities. The Central Data Store has the ability to allow the Schemas to be changed
`without disruption of the system.
`
`Application Interfaces: Healthcare informatics and applications (such as
`physician practice management systems or Pharmacy systems) will be provided
`vehicles to securely access and interact with CSCS using industry standard XML and
`security tools. As appropriate, 0803 may provide secure applets that will make it easier
`to integrate CSCS interactions, as well as minimize the development costs associated
`with interlacing these applications.
`
`Report infrastructure: 0303 will provide appropriate levels of reporting to the
`Oversight Committee, as well as other healthcare members as appropriate and
`necessary.
`Such reporting/informational access can include up-to-date patient
`prescription information to their primary care physician or pharmacy, comparisons for
`potential drug interactions, or emergency information access.
`
`Hosting/management: Deployment of 0808 is via a secure, redundant, hosted
`environment. Operational and administrative personnel will need to pass rigorous
`screening processes, and will only have access to information as is contextually
`necessary.
`
`
`
`
`
`Confidential
`
`6
`
`PAR1037
`
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`Page 6 of 19
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`IPR of U.S. Patent No. 7,668,730
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`

`

`CSCS Enterprises, inc.
`
`uses Informational Elements
`
`CSCS maintains a specific set of data elements, security elements, and transaction
`elements within its data store and application sets. This information is used by 0808
`applications, as well as 3rd party and provider-developed applications. The information is
`delivered to authorized health care providers and other authorized participants as
`appropriate.
`
`
`
`
`
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`
`
`
`
`
`
`
`
`
`
`
`
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`
`
`L0 in Name
`L0 in Password
`Biometric Identifier o tionai
`Identit of User
`Authentication of User
`Authorized for Data Set access
`Authorized for Transaction
`
`
`
`Information log of access attempts — successful and non-successful
`Information log of transaction attempts — successful and non-successful
`Encr
`tion ke s
`Di
`ital Si natures
`A
`lication Pro rammin Interfaces as ossible
`
`Data elements»
`
`
`.
`Doctor Name
`Doctor DEA Number
`
`Patient Name
`Patient ID # e.-. SS# Passort#
`Patient Address Cit State Zi-
`
`Patient Phone Numer
`
`
`
`
`
`
`Dru- s urescribed
`Dosa-e
`
`
`
`
`_i
`
`
`
`Freguency
`Start/ End Date
`
`Duration
`
`
`
`Quantitx
`Number Refills
`Substitution allowed?
`Generic Allowed?
`
`Notes
`
`
`
`
`
`Aberrant Use Flag
`Date Prescri
`tion filled
`
`Place Prescription filled
`Pharmacist Name
`Pharmacist Phone Number
`Pharmacist DEA Number
`
`Application Programming Interfaces as possible
`
`Confidential
`
`7
`
`PAR1037
`
`IPR of US. Patent No. 7,668,730
`Page 7 of 19
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`IPR of U.S. Patent No. 7,668,730
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`

`CSCS Enterprises, lnc.
`
`Transaction types
`
`
`
`
`
`
`
`
`
`
`
`
`Dis-Ia Active Medication Histo
`
`
`Disla Inactive Medication Histo
`Dis-la Com-lete Medication Histo
`
`Disglay by Patient Identifier
`
`Disla b Patient Name
`
`Dis-Ia
`b Date 5
`
`Disglay by Drug Name
`Disglax by Prescriber
`Disglav by Pharmacy
`Ci
`Dis la
`b Geo ra h
`Dis la
`b Phone Number
`Dis la
`b Aberrant Use Fla
`Add New Record
`U date/Chan e Record
`Add Log EntEvg
`U date Lo- Ent
`
`
`
`Dis-la Lo- Entries
`
`
`Aggrove Prescrigtion
`
`Decline Prescri-tion
`
`
`
`State Zi Code
`
`
`
`
`
`
`
`Aberrant Use Flag — True
`Aberrant Use Fla- — False
`Accent Results
`
`Decline Results
`_.
`
`Lo on
`L0 off
`Time Out — Inactive
`Time Out — disconnected
`Encriétion
`Create Report
`
`Confidential
`
`3
`
`PAR1037
`
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`Page 8 of 19
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`IPR of U.S. Patent No. 7,668,730
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`IPR of U.S. Patent No. 7,668,730
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`IPR of U.S. Patent No. 7,668,730
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