aggregate spend / physician spend sunshine law compliance

Solutions! Not just technology. PAGE 1 OF 25

PHYSICIAN PAYMENT SUNSHINE PROVISION OF PPACA 2010

www.apthealthusa.com 379 THORNALL STREET, WEST TOWER - 8TH FL, METROPARK, NJ 08837

Call 888.369.7634

Call 888.453.0014

AptSPEND

Aggregate Spend Compliance

— Sunshine Law PPACA 2010

Solutions! Not just technology.

Informational Primer

Updated April 27, 2011



Table of Contents

Executive Summary … 4 History … 5 The Legislation … 6 Later Developments … 8 Implementation Challenges … 10 Solution … 14 Summary of Features … 19 Sample Screenshots … 21 About AptHEALTH … 24 The AptHEALTH Credo … 25

The Physician Payments

Sunshine provision in the comprehensive

healthcare reform bill of 2010 introduces a set

of complex issues and threats that need

resolution.

The demand for

transparency that shook the

financial sector is now gyrating

towards pharmaceutical, biotech and

Regulatory

investig

ation is

at an all t

ime hig

h.

A host of State regulations have swiftly followed

the Federal law, and many more are anticipated.

It is difficult to navigate this sensitive space - and stay compliant.



Quite obviously

a technology solution is required.

This paper serves as a Primer for anyone interested in learning about Aggregate

Spend (Physician Spend Sunshine Law) compliance.

It also presents a technology solution afterwards.



T he Physicians Payment Sunshine

initiative is a growing body of Federal

and State legislations that collectively

addresses all or some of the following

goals: (a) Provide transparency with regard to

who, in the life sciences industry, is contributing

what benefits to which physician; (b) Mandate

statutory reports at least once a year; and, (c)

Limit spend per physician. ―Aggregate Spend‖ is

the total, collective, cumulative amount spent by

healthcare manufacturers (pharmaceutical,

biotechnology and medical device organizations)

on individual Healthcare Professionals and

Organizations (HCP/O) through payments, gifts,

honoraria, travel and other means.

LEGISLATION STATUS

The Federal Bill passed in March 2010

as a provision under the Patient Protection and

Affordable Care (PPAC) Act, and several States

— including, but not limited to, California,

Massachusetts, Minnesota, Maine, District of

Columbia, West Virginia, Vermont and Nevada —

have already passed their versions of the

Sunshine Law. The Federal Law goes into effect

from January 1, 2012, with the earliest reports

(covering Jan-Dec 2012) mandated on or before

March 31, 2013. The penalties range from

$10,000 to $100,000 for each violation, and can

go up to $1 million.

IMPLEMENTATION CHALLENGES

This regulatory compliance requirement

is especially challenging because of the (a)

DATA DISCREPANCIES across diverse sources

of record; (b) STATE TO STATE VARIATIONS of

the law; and, (c) the sheer VOLUME OF DATA

that must be aggregated, cleansed, processed

and filed.

APTSPEND

AptSPEND is complete aggregate spend

compliance solution that (a) detects instances of

violation; (b) proactively prevents non-

compliance through timely alerts; (c) produces all

mandated and necessary reports; (d) delivers the

statutory reports electronically to the government

agencies; and, (e) provides a search engine for

investigation and analysis of the spend data. Our

mobile computing interface pushes alerts to

Blackberry, iPhone and Google Android devices,

and reports are also accessible from any smart

phone or PDA with an Internet browser.

Our team includes legal counsel to help

you interpret nuances of the law.

IMPORTANT BENEFITS

Always fixed price. No surprises. No cost

overrun.

Bolts on to, and extracts data from, ALL your

existing applications, be they SAP, Oracle

Apps, Siebel, Concur, or any custom built

software.

End-to-end turnkey solution. We implement

your aggregate spend compliance. Period.

Alerts user on individual HCP cap.

Integrates with Blackberry, iPhone, Google

Android and Windows mobile devices.

Automatically updates changes in regulation

from a central server.

EXECUTIVE SUMMARYEXECUTIVE SUMMARYEXECUTIVE SUMMARY



O n September 6, 2007, the original

Physician Payments Sunshine Act

of 2007 (S.2029) was introduced in

the Senate by Senator Chuck

Grassley (R-Iowa). Rep. Peter DeFazio (D-

Oregon) and Rep. Pete Stark (D-California)

introduced a similar bill (H.R. 5605) in the House

of Representatives in March 2008. Subsequently,

the Physician Payments Sunshine Act of 2009

was re-introduced in both Houses as S. 301 and

H.R. 3138 respectively, by Senator Chuck

Grassley (in the Senate) and by Rep. Baron Hill

(in the House of Representatives). The goal of

these bills was to create a single law at the

Federal level, common to all 50 states, to replace

various independent initiatives at the State level.

TRANSPARENCY

The bills aimed "to provide for

transparency in the relationship between

physicians and manufacturers of drugs, devices,

or medical supplies for which payment is made

under Medicare, Medicaid, or SCHIP." The

control proposed was a quarterly report that

disclosed all payments over $25 in value

disbursed "to a physician, or to an entity that a

physician is employed by, has tenure with, or has

an ownership interest in," along with details such

as date and nature of the payment (whether it

was for "food, entertainment, or gifts", "trips or

travel", "a product or other item provided for less

than market value", "participation in a medical

conference, continuing medical education, or

other educational or informational program or

seminar, provision of materials related to such a

conference or educational or informational

program or seminar, or remuneration for

promoting or participating in such a conference

or educational or informational program or

seminar", "product rebates or discounts",

"consulting fees or honoraria" or "any other

economic benefit")

PENALTIES

To punish violations of the proposed law,

the bills proposed penalties that were "not less

than $10,000, but not more than $100,000, for

each such failure.‖

INDUSTRY REACTION

The Pharmaceutical Research and

Manufacturers of America (PhRMA), which

represents the country‘s leading pharmaceutical

research and biotechnology companies, came

out with a statement in May 2008, supporting a

revised version of the bill, contingent upon "the

continued inclusion of the provision that

preempts state law". PhRMA President Billy

Tauzin said in a statement: "PhRMA believes that

preempting local and state marketing reporting or

disclosure laws that have been enacted or are

pending avoids a confusing myriad of local, state

and federal requirements that confuse patients

accessing the information and are overly

burdensome and costly for those required to

report."

HISTORYHISTORYHISTORY



T he Patient Protection and Affordable

Care Act (PPACA) - derisively referred

to, by opponents, as ―Obamacare‖ -

passed the Senate on Dec 24, 2009,

and the House of Representatives on March 21,

2010. It was signed into law by President Barack

Obama on March 23, 2010. Section 6002 of the

PPACA implements the physician payment

sunshine provision.

WHO ARE COVERED?

The legislation covers all drug, medical

device, biological or medical supply

manufacturers and distributors, with the

exception of those that deal exclusively in OTC

(over the counter) items.

REPORTING REQUIREMENTS

All covered parties are required to

disclose to the Secretary of the U.S. Department

of Health and Human Services (HHS Secretary)

all direct payments or transfers of value

exceeding $10 or more per transaction, or

totaling over $100 in a calendar year, to

physicians and teaching hospitals. The provision

also requires those manufacturers to disclose

any non-public ownership or investment interests

of physicians and their immediate family

members in the manufacturers.

COVERED TRANSACTIONS

Under these sunshine provisions,

payments that must be reported include, but are

not limited to, the following:

Consulting fees;

Direct compensation for serving as faculty or

as a speaker for a medical education

program;

Compensation for services other than

consulting or faculty;

Honoraria;

Gifts;

Entertainment;

Food;

Travel (including the destinations in

question);

Education grant;

Research grant;

Royalty or license;

Current or prospective ownership interest;

Charitable contributions; and

Any other payment or transfer of value,

except those covered under limitations

(below).

LIMITATIONS

There are some significant limitations, as

well, such as the following:

1. Payments through third parties, where the

covered party does not know the identity of

the ultimate beneficiary, are excluded.

Therefore, the typical survey and marketing

research will not be covered.

2. Certain kinds of value transfers — such as,

the loan of medical devices for under 90

days, product samples intended for patient

use, and discounts (including rebates) — are

not covered.

THE LEGISLATIONTHE LEGISLATIONTHE LEGISLATION



3. In the case of payments made towards product

research or new development in connection

with a clinical investigation, the manufacturer

may delay reporting the payment for either four

years or until the drug, device or technology is

approved by the FDA.

4. Product samples that are not intended to be

sold and are intended for patient use.

5. Educational materials that directly benefit

patients or are intended for patient use.

6. Items or services provided under a contractual

warranty, including the replacement of a

covered device, where the terms of the

warranty are set forth in the purchase or lease

agreement for the covered device.

7. A transfer of anything of value to a covered

recipient when the covered recipient is a

patient and not acting in the professional

capacity of a covered recipient.

8. Discounts (including rebates).

9. In-kind items used for the provision of charity

care.

However, even with these limitations, the

mandated need for transparency is quite

significant.

FEDERAL LAW PREEMPTS STATE

LAWS, BUT...

The federal government included a clause

in the Sunshine Act to indicate that federal laws

preempt individual state laws to the extent that they

require the reporting of the same information. But

since current state laws require the reporting of

different items on a broader audience, they escape

federal preemption.

EFFECTIVE DATE

The reporting requirements go into effect

on March 31, 2013 when the report for January-

December 2012 will be due; and, the information

will be made available to the public online.

PENALTIES

The Federal law stipulates the following

penalties.

1. Fines between $1,000 to $10,000 for each

transaction or ownership interest that was not

reported in a timely manner; and, up to

$150,000 for each annual submission that is

late.

2. For knowing violations, fines between $10,000

and $100,000 for each transaction not

reported, up to $1,000,000 for each annual

submission.

Total annual penalties for a single manufacturer is

capped at $1 million at this time.

State laws mandate their own penalties,

which are not covered in this document.

Some State Laws already in effect.

Federal Law mandates data

aggregation from January 1, 2012.



H HS has designated the Centers for

Medicare and Medicaid Services

(CMS) as the agency responsible

for implementing the physician-

payment disclosure (―sunshine‖) requirements in

PPACA.

On March 24, 2011 — a year and a day

after Congress enacted the Patient Protection

and Affordable Care Act (PPACA) — the Centers

for Medicare and Medicaid Services (CMS)

hosted a special open-door forum to discuss with

health care stakeholders PPACA-mandated

transparency provisions. The call was convened

shortly after the long-awaited decision by the

secretary of the U.S. Department of Health and

Human Services to give CMS the lead on

implementing the payment disclosure

requirements. In announcing the call, CMS said

it would be a listen-only participant, seeking

comments on a series of key implementation

questions. The forum, according to CMS, was not

intended to supplant the ordinary rulemaking

process or to preview definitive policy statements

of statutory interpretations.

KEY CONCERNS RAISED

Several key concerns were raised by

Stakeholders — represented mainly by industry

associations such as AdvaMed, BIO and PhRMA

— in CMS‘s Special Open-Door Forum. They

mainly addressed six areas of particular interest

to CMS: (a) Forms of payment and transfer of

value; (b) Definitions of nature of payment or

other transfer of value; (c) Additional categories

of information to report; (d) Ownership or

investment interests; (e) Average consumer

information; and (f) Reporting of data.

FORMS OF PAYMENT OR OTHER

TRANSFERS OF VALUE

PPACA 2010 empowers the secretary to

identify reportable ―forms of payment‖ beyond

those prescribed by statute. In this regard,

stakeholders: (a) Encouraged CMS to clarify the

meaning of existing terms before it considers

scrutinizing additional forms of payment; and, (b)

Stressed that the agency must first provide clarity

on a number of definitional issues. The following

were cited as open issues subject to further

clarification: What does it mean to be an

―applicable manufacturer operating in the United

States‖? Do the reporting provisions apply to pre-

commercial manufacturers with no approved or

marketed products in the United States? Whether

payments are made by manufacturers to entities

other than ―covered recipients‖, and that entity

makes further downstream payments to

physicians or teaching hospitals, whether those

payments considered reportable? The

stakeholders also noted the need for guidance of

―covered recipients‖.

‗NATURE OF PAYMENT OR OTHER

TRANSFERS OF VALUE‘

Feedback was sought by CMS on how to

define the categories of ―natures of payment and

transfer of value‖. Comments were focused on

the adequacy of the existing categories, and the

need for narrowly tailored and highly granular

definitions, citing the volume of data resulting

from preliminary collection efforts. Suggestions

from trade groups and stakeholders emphasized

LATER DEVLOPMENTSLATER DEVLOPMENTSLATER DEVLOPMENTS



that mid-size manufacturers anticipated disclosing

more than one million value transfers done to

physicians in a year and the lack of guidance might

implicate the risk of double or over-reporting. The

solution proposed is for CMS to establish clear

reporting hierarchy — for example, if a payment

made for the purpose of research is, in part, for

meals or travel, the value transfer should be

reported by the manufacturer once, as a payment

for research activities.

ADDITIONAL CATEGORIES OF INFORMATION

TO REPORT

Responses on the feedback on categories

of reportable information beyond the ―form‖ and

―nature‖ of value transfers, mainly reiterated the

need for CMS to precisely and narrowly define

relevant terms. Only one consumer advocacy

organization, requested CMS to expand the

definition of ―covered recipients‖ to include non-

physician prescribers, such as nurse practitioners

and pharmacists.

PHYSICIAN OWNERSHIP OR INVESTMENT

INTERESTS

CMS received one response on whether

the agency should require additional information

regarding physician ownership or investment

interests. AdvaMed requested consideration of the

provisions under the legislation and to ascertain

that the terms ―applicable manufacturers‖ and

―applicable [GPOs]‖ include the distribution model

of physician-owned companies. This would ensure

consistent treatment of the three business models

(physician-owned manufacturers, GPOs and

distributors) that present similar policy and legal

risks.

AVERAGE CONSUMER INFORMATION

CMS sought feedback on the types of

information on industry-physician relationships and

on best-practice approaches to be included when

publishing reported data to the consumers. One

industry representative mentioned that as a result

of the stigma associated with these relationships,

he has observed an emerging reluctance on the

part of physicians to engage in industry-physician

endeavors, particularly research activities. A

surgeon in attendance emphasized that ―not all

conflicts of interests make a person a scoundrel.‖

Stakeholders requested explanation on the

benefits to consumers associated with these

relationships and also want CMS to ensure that the

information is presented in a consumer-friendly and

accurate manner.

REPORTING OF DATA

To ensure the accurate, efficient and cost-

effective reporting of data, CMS requested

stakeholder input on the form of data reporting as

well as a mechanism for the correction of mistakes.

It was suggested that individual-manufacturer-

related data be posted on a secured website for

review and edit. This would enable the reporting

companies to review the accuracy of the data

before it becomes available to consumers.

―Covered recipients,‖ it was suggested, should

have a similar opportunity to correct incorrect

information.

The physician-payment disclosure

requirement places a significant burden on

manufacturers and GPOs, as it will require

successful integration of policies, systems and

technology. CMS believes that it has broad

discretion to impose disclosure requirements

beyond those specifically set forth in the statute.



L ife sciences organizations have long

contended with the challenge of

physician spend disclosure. Now

voluntary initiatives like the PhRMA

Code and the OIG Compliance Program are

being superseded by mandatory government

regulations, with a Federal mandate going into

effect in 2012, for reporting in 2013.

COMPLIANCE: A DAUNTING TASK

All spend management endeavor in the

medical space is daunting due to the sheer

volume of physicians: over 954,000 of them. 94%

of all physicians have a relationship with

pharmaceutical and medical device companies;

83% of them receive food & beverage in their

workspace from the life sciences industry; 35%

receive cash reimbursement of expenses for

continuing education or meeting/conference

attendance; 28% receive payment for speaking

engagements.

The Sunshine compliance challenge is

especially intimidating primarily because of the

data related challenges.

TOO MANY EXPENSE TYPES

Companies need to track spend benefits

for each healthcare provider (HCP) by expense

type with reference to Federal as well as multiple

applicable State laws; control the spend on every

HCP; and establish documentary proof that the

company is in compliance with all applicable

Federal and State limits at any point in time. And

all of these functions need to be exercised on a

wide swatch of sensitive data, including but not

limited to, the following:

Consulting fees;

Direct compensation for serving as faculty or

as a speaker for a medical education

program;

Compensation for services other than

consulting or faculty;

IMPLEMENTATION CHALLENGESIMPLEMENTATION CHALLENGESIMPLEMENTATION CHALLENGES



Honoraria;

Gifts;

Entertainment;

Food;

Travel (including the destinations in question);

Education grant;

Research grant;

Royalty or license;

Current or prospective ownership interest;

Charitable contributions; and

Any other payment or transfer of value, except

those covered under limitations (below).

TOO MANY SOURCES OF DATA

All these diverse types of expense are

incurred by a wide variety of far flung people within

the organization, and some of these accountable

entities are not even employees of the

organization, such as event management vendors.

Consider the following hypothetical scenario,

involving one Dr. Ethel McCollough, the

hypothetical Head of Radiology at a local hospital

in New Jersey:

Your Head of Sales for National Accounts out

of corporate office takes the hospital‘s

radiology department out for dinner; the total

bill is $156; the cost is recorded as an expense

reimbursement in your SAP Accounting

System, and value recorded per physician is

$52.00.

Your Local Sales Rep for the area whose beat

includes this particular hospital, provides a gift

bag to Dr. McCollough. The value is $15.00.

and this is recorded in the Siebel CRM System.

Your Marketing Department — working out of

San Francisco — sponsors Dr. McCollough for

a speaking engagement in SFO, and provides

a speaker‘s fee of $100.00. This is recorded in

the SAP Sales & Distribution System.

One of your event management companies

invites Dr. McCollough to attend an event in

New York City, and this expenses is recorded

on a sign-in sheet. That is submitted manually

to your company.

These possibilities can go on and on.

When will the company recognize the total spend

on Dr. McCollough? How does one integrate these

financial data from different sources within the

company, and accurately associate it with the right

physician?

TOO MANY SYSTEMS TO INTEGRATE

The example above shows how different

people create data in different information systems

of the company. The various ERP, CRM,

Salesforce Automation, Clinical Trials Management

and Accounting systems where data originates,

need to be tapped, the relevant information filtered

out, and integrated into one version of the truth so

that compliance, or lack thereof, can be detected.

SHEER VOLUME

The sheer volume of health care personnel

and the myriad transactions occurring with these

individuals through different avenues is quite

overwhelming. The combination of per-provider

spending caps and reporting provisions impose

steep record-keeping requirements.

DATA SCRUBBING CHALLENGE

All this data need to be cleansed before



may be aggregated. The real and potential

problems are humungous.

SPELLING

Is Dr. Ethel McCullough in one transaction,

the same is Dr. Ethel McCulough appearing on

another transaction? The last name is spelled

differently. Is it a genuine mistake, a slip of the

hand, or a data entry error?

IDENTIFICATION

The names are spelled identically, but the

National Provider Identifiers are different. Is that

authentic data or a mistake?

QUALIFIER

It is not uncommon to have a Dr. James

Carrigan, Sr.— the father — and a Dr. James

Carrigan, Jr. — the son — practicing as

contemporaries. What if an event management

company or a data entry clerk misses the vital

suffix?

NO DATA.

Sometimes a record might have the

National Provider Identifier missing. May be the

address of the clinic is missing, and the doctor

practices in multiple States. Data scrubbing

represents a substantial challenge in aggregating

physician spend.

TOO MUCH DATA

Sometimes the same transaction might

appear in two different applications within the

company. Are they the same transaction, or are

they different transactions? There is no end to data

challenges.

DATA DISCREPANCIES

The various disparate systems from which

some of the data originates may not even have the

correct basic physician identifying information.

Family names of the doctors might be the same,

their practice address might be the same, they

might me a husband-wife duo practicing from the

same clinic; how does one differentiate and identify

the right HCP? Data duplication and conflicts are

reality, and this poses the single biggest challenge

to timely and accurate compliance determination.

All such data discrepancies, conflicts,

duplicate records and missing information coming

from a wide range of distant and sometimes



discordant data sources must be continually

resolved, cleansed and purged to arrive at the

correct information.

It is a massive and ongoing data

management challenge, in addition to the task of

ensuring the proper convergence of business

processes, technology, people and policies, and

performing the triple duties of detection, prevention

and reporting.

STATE TO STATE VARIATIONS

On top of all the data scrubbing

challenges, companies must deal with the fact that

regulations vary from state to state. One state

allows medical samples, another does not. Such

variations have to be tracked as and when they

occur. Impacted physicians‘ records may have to

be processed differently even in the middle of a

monthly cycle. Proper audit trails of all these

regulatory changes need to be preserved for

posterity for resolving investigative scrutiny.

HCP’s NOT PERSONALLY LIABLE

The physicians themselves are not under

any compulsion or threat of penalty to make

special efforts to ensure that life sciences

companies and event managers have the correct

data as to their proper ID, the organizations they

are associated with, the various States they

practice in, and so on.

ALERTS NEED MORE INFORMATION

The system must even track sales territory

segmentation and know which sales rep is dealing

with which HCP, so that they can be proactively

alerted when limits are approached; this cannot be

an ―after the fact‖ reporting system.

TIME IS SHORT

The Federal bill requires data collection to

begin from January 1, 2012 towards the first report

due on March 31, 2013. Several States have

already passed their respective versions of the

Sunshine Act and reporting has already begun.



SOLUTIONSOLUTIONSOLUTION

Figure-1

A ptSPEND is a fully featured end-to-

end aggregate spend compliance

solution. It detects. It prevents. It

reports. It provides total compliance

with Federal and evolving State regulations.

END-TO-END SOLUTION

AptSPEND is an end-to-end solution

backed by service — it is not just software. In

other words, we don‘t just provide a software

package. We conduct a full requirements

analysis, and then customize our software

modules to create the right solution for you. How

is that different from taking a packaged software

and configuring it for you? Typically, packaged

products are parameter-driven, and with large

enough range of parameters you can change

software behavior quite substantially, as we see

with enterprise applications like SAP. Ours is a

SOA (Service Oriented Architecture) approach,

where we have a wide range of software artifacts

that comprise our Aggregate Spend solution.

Based on our analysis of your requirements, we

will mix-and-match the right set of artifacts, and

customize them to create your solution.

Given the intricate relationship between

life sciences companies and physicians, the



complex nature of the regulations, and the

extensive data management challenges, an off-the-

shelf packaged solution may not address the

multiple disclosure requirements and spending

limits.

DATA SCRUBBING

As already alluded to above, obtaining

clean data is the biggest challenge in this

application. Here is an example:

An entry from the SAP Sales & Distribution

database identifies a certain Dr. Carolyn

Temple of 1147 Main Street, Edison, NJ 08820

as a participating HCP.

An entry from the Siebel CRM database

mentions a certain Caroline Temple, also of

1147 Main Street, Edison, NJ 08820, as a

participating HCP.

An entry from the legacy Financial Accounting

system mentions a certain Mrs. Carolyn

Temple of 114 Main Street, Edison, NJ 08820

as the recipient of a payment.

Without data scrubbing, an expense tracking

system would identify three different individuals.

Only data scrubbing can correctly determine

whether these refer to the same individual, or two

different individuals or even three different

individuals.

Our Data Scrubber verifies and validates

the transactions against all available Master Data

(MDM Resources) of the company, as well as

(optionally) relies on manual data scrubbing

assistants who will investigate, search, call, verify

and resolve all instances of doubt flagged by the

Data Scrubber. This manual data scrubbing

assistance can be provided by client personnel or

be executed by us as a BPO operation. Details

available separately.

Once a source of master data has been

identified and configured into the system, the Data

Scrubber deploys agents that will continually

monitor those MDM resources to proactively

identify new HCP information and pull them into

AptSPEND to help validate future transactions.

REGULATIONS UPDATE

We keep track of the changing regulations

and nuances of the law emerging from the State

capitals as well as from the Federal government.

These are automatically updated into our central

Compliance Database, which synchronizes with

your database periodically, at your discretion.

These updates are audit trailed, reported on the

dashboard and included as Footnotes on important

reports.

INTERPRETATION OF LAW

We retain industry experts who help us

interpret the law. The answers to questions such

as the following are not immediately clear without

legal counsel.

The participation of a physician in a clinical trial

may stretch over years. What is the correct

method of pro-rating payments received across

multiple reporting periods?

Can a research contract with two year validity

be spread over reporting periods?

If a New Jersey based doctor participates in an

Experts Panel in Michigan, need we report his

speaking fees to both the New Jersey as well

as the Michigan authorities?

We provide regulatory compliance experts at no

charge to you to you to help ensure your

compliance with the nuances of the law at all times.



However, you must consult with your attorney

before taking legally significant decisions.

FUNCTIONAL LANDSCAPE

The schematic in Figure-2 depicts the

overall functional schematic of AptSPEND.

MASTER DATA MANAGEMENT

In order to ensure the quality and

authenticity of transactional data, first the master

data must be established as a clean,

comprehensive and single version of the truth. At

the most basic level, Master Data Management

(MDM) seeks to ensure that an organization does

not use multiple (potentially inconsistent) versions

of the same master data in different parts of its

operations, which can easily occur in large

organizations.

We shall first initiate an MDM study in

collaboration with your IT department to help

establish the solidity of the foundation on which the

entire compliance system rests. Anomalies

detected shall be corrected or temporarily

recognized as an integration issue while the

rectification at source is in progress.

Our Data Scrubber verifies and validates

the transactions against all available Master Data

(MDM Resources) of the company. Agents will also

continually monitor those MDM resources to

proactively identify new HCP information and pull

them into AptSPEND to help validate future

transactions.

Figure-2



TRANSACTIONAL DATA

Having established the authenticity of the

MDM, we poll all applicable sources of

transactional data, and aggregate information from

all. Towards this task, we provide a wide variety of

data collection interfaces.

USER EXITS

When an application where data exists,

provides an API to access that data, or exposes its

database schema so that we can perform direct

database access, we write custom code within

AptSPEND to set up this feed. Our solution

provides these integration points into the system

that can be utilized for a wide variety of uses.

WEB SERVICES INTERFACE

Web services are now becoming an

increasingly common and convenient data

interchange technology. Many modern software

provide a web services interface to external

applications desirous of using its data. In such

cases, we shall write custom code within

AptSPEND to interact with the relevant web

services to pick up the data.

WEB FEEDS

Web feeds are commonly utilized to

publish frequently updated data in a web

compatible format. The most common of these is

RSS, which is commonly understood to stand for

"Really Simple Syndication." Atom is yet another

standard that has garnered serious industry

support, including Google‘s, and is technically

superior to RSS.

If a source data object within your

corporate information systems provides web feeds

in RSS or Atom format, AptSPEND can tap into it.

CSV, EXCEL AND FLAT FILES

Comma delimited files, Excel files and the

common Flat file are three of the commonest data

interchange formats today and we readily support

these kinds of data feeds.

FILE TRANSFER POTOCOL (FTP)

AptSPEND can pick up a data feed from

an FTP server.

DIRECT ENTRY

Although AptSPEND does not expect any

of the spend data to be entered directly into

AptSPEND, we do provide a user interface for

doing just that.

DATA SCRUBBER

Veracity of data being the most challenging

piece of the aggregate spend compliance puzzle,

the Data Scrubber is vital to our success. All data

feeds are stored in a staging area where the data

scrubber goes to work, verifying, validating and

cleaning the data before it is migrated to the clean

transactions database for compliance processing.

The Data Scrubber verifies and validates the

transactions against all available Master Data

(MDM Resources) of the company, as well as

relies on manual data scrubbing assistants who will

investigate, search, call, verify and resolve all

instances of doubt flagged by the Data Scrubber.

The process may include substantial

human intervention depending on the dirtiness of

the data. We provide a data scrubbing outsourced

service that employs manual methods involving

investigation, searching, calling, verifying, cross-



checking and establishing the accuracy of data.

Once a source of master data has been

identified and configured into the system, the Data

Scrubber deploys agents that will continually

monitor those MDM resources to proactively

identify new HCP information and pull them into

AptSPEND to help validate future transactions.

VENDOR PORTAL

We provide a portal for vendors to login

and upload their data that is typically collected at

industry events sponsored by the company. The

portal allows data entry as well as file uploads. All

such data goes into the staging area that is input to

the data scrubber.

COMPLIANCE ENGINE

The Compliance Engine is the center-piece

of AptSPEND.

STAYING CURRENT WITH REGULATIONS

It manages the Compliance Rules

Database pertaining to Federal and State-by-State

regulations. New regulations and alterations are

entered into this module and is stored in the

Compliance Rules Database.

If you subscribe to our Live Compliance

Update service, your Compliance Rules Database

will be automatically synchronized with our central

Compliance Rules Database periodically.

DETECTING COMPLIANCE VIOLATION

It processes the cleansed data emerging

from the Data Scrubber against the applicable

regulations and detects compliance violation,

approaching violation and positive compliance.

PROACTVE PRE-VIOLATION ALERTS

It also proactively alerts relevant

Management and Sales personnel when an HCP

assigned to their department and/or personal

account approaches the mandated limit. These

alerts can be configured with the desired triggers,

timings and delivery methods. AptSPEND is

capable of mobile computing and will deliver alerts

into any smart phone or other kind of portable

device.

REPORTING INSTRUCTIONS

It generates all reporting instructions to the

Reports Engine, which then produces the reports

and delivers them as advised. The reporting

instructions include data, format, delivery

mechanism to be employed, and target recipient

list.

REPORTS ENGINE

The Reports Engine is the ultimate value

we deliver to you.

It stores all the report formats, templates and

delivery interface configuration information.

It receives ―delivery ready‖ data from the

Compliance Engine.

It applies the relevant template and report

format to create the output, be it a PDF, Excel,

web feed, data stream, or any other format.

It delivers the information to the target recipient

through the interface of choice.

DATA MINING & SEARCH ENGINE

Ad hoc searches for any kind of

investigation into the database, whether it relates

to regulatory laws, clean transactional data, reports

& alerts produces or the audit trail.



A dvanced features abound. Mobile

computing, Web Services, RSS/

Atom web feeds, statistical

i n f e r e n c e , p r e d i c t i v e d a t a

discrepancy resolution, et al.

AptSPEND COMPONENTS

Figure-3 on the next page summarizes

the functional components of the system.

AptSPEND is not a parameter-driven software

package, but a library of components and

services that can be reused to quickly compose

the right solution for any aggregate spend

requirement. So it has the quick delivery of a

prebuilt package, but the performance of a

custom application.

INTEROPERABILITY

The software bolts on to all your existing

software application, be they SAP, Oracle

Applications, or custom built applications, using a

diverse range of data feed aggregation methods

ranging from user exits and the ubiquitous file

transfer to web services and more esoteric Atom

web feeds.

TURNKEY SOLUTION

We don‘t just deliver software; we deliver

and implement you complete aggregate spend

solution: end-to-end on a turnkey basis.

MOBILE PLATFORM

AptSPEND works with your Blackberry,

iPhone, Google Android smart phone and

Windows mobile devices. It is architected from

ground-up on the mobile platform.

DATA FEED AGGREGATION METHODS

The data feed aggregation engine

provides diverse methods for collecting data,

including web services, RSS/Atom feeds, FTP

interface, CVS or Excel files, and User Exists that

require a little bit of custom code (which we

provide) to tap on to your internal resources,

wherever they may reside.

VENDOR PORTAL

A vendor portal is another major source

of data, where your vendors, especially event

organizers, may independently upload data into

AptSPEND through file upload and/or data entry.

DATA SCRUBBER

All data is scrubbed prior to aggregation.

Data is the most challenging piece of this

compliance puzzle. So a lot of activities and effort

occurs in this module. All raw feeds are

exhaustively validated against available MDM

resources; errors are flagged; human intervention

is required for resolving issues. We also have

agents checking continually against all known

MDM resources to proactively identify new HCPs

against future transactions.

Data scrubbing service is optionally

available as an outsourced service.

COMPLIANCE ENGINE

The heart of the system which (a)

manages the Compliance Rules Database

pertaining to Federal and State-by-State

SUMMARY OF FEATURESSUMMARY OF FEATURESSUMMARY OF FEATURES



regulations; and (b) processes the cleansed data

emerging from the Data Scrubber against the

applicable regulations and instructs the Report

Engine what information is to be delivered to whom

at what time through what interface.

DATA MINING / SEARCH ENGINE

Investigations and any kind of searches

may be performed on the data through a search

engine for instant end-user computing reports.

REPORTS ENGINE

The Reports Engine receives ―delivery

ready‖ data from the Compliance Engine and

pushes it out to the target recipient through the

interface of choice, which could be any of the

following:

1. PDF (most commonly)

2. Excel file

3. Web service (custom data stream)

4. FTP upload/download

5. RSS or Atom feed

Figure-3



SAMPLE SCREENSHOTSSAMPLE SCREENSHOTSSAMPLE SCREENSHOTS

DASHBOARD

EXPLANATIONS

This is a dashboard providing some high level summaries at a glance.

Amongst other things, it provides:

Vital statistics of various marketing programs and HCP expense status.

Early warnings to management on possible instances of noncompliance.

Monitoring of promotional programs from the sunshine perspective.

The facility to drill down to the lowest level details supported by charts and tables for

quick assimilation, with quick access menus for navigating across the application from

the dashboard.



AGGREGATE SPEND REPORT

EXPLANATIONS:

This screen:

Provides an information panel for aggregate spend amount that was transferred to recipient HCPs.

Provides facilities for selecting date ranges for periods, type of recipients, state etc.

Provides the facility to export the data to Excel or PDF format.

Provides quick access menus to jump to other reports.

DISCLAIMER: The data shown on these sample screens has been sanitized to protect any proprietary

information. So the data is really only representative and not real.



HCP SPEND POSITION

EXPLANATIONS

This screen allows shows the aggregate spend per HCP, with appropriately colored flags to

communicate the limit compliance status at a glance.

DISCLAIMER: The data shown on these sample screens has been sanitized to protect any

proprietary information. So the data is really only representative and not real.



A value-driven, customer-proactive and service-oriented technology-company whose

quintessential drive is growth, APTHEALTH seeks to provide excellent value - consistently - to

clients, partners and business associates. With group companies, subsidiaries and alliance partners

in USA, India, United Kingdom, Germany, Netherlands, France, Belgium, Switzerland, Sweden,

Scandinavia, Canada, Singapore and China, APTHEALTH addresses the North American

marketplace from its U.S. headquarters at Metropark in the Greater New York area.

Led by professionals steeped in decades of healthcare experience with front-ranking

American/European companies, the joint-venture between Artilligence, Inc. and Aptsource Software

brings together organizations with diverse skills spanning hospitals, pharmaceuticals, medical

informatics, information technology and outsourced services. This joining of strengths allow us to

leverage each other's technical and management skills, economies of scale, agile cost models and

thereby results in a business organization which is greater than the sum of its parts.

Committed to providing clients with consistently superior value and believing that high value

need not mean high price, APTHEALTH brings to the table a value proposition that is also cost

effective and sometimes innovatively priced.

We count amongst our strengths:

The solid domain expertise provided by our highly experienced Subject Matter Experts

(SMEs) in the healthcare space.

Our solutions for life sciences and healthcare providers that have emerged over the

years.

Our close association with the Object Management Group that allows us access to

some of the latest standards applicable to software engineering and the healthcare

domain.

The incorporation of quality assurance in the core process and not merely as an

independent verification & validation add-on.

The wide variety of our services that cover some of today's hottest topics such as EHR,

some of the latest compliance issues such as FDAAA, as well as bread-and-butter solid

value propositions in Tele-Radiology.

The time-tested delivery methodologies that have served hundreds of clients.

Our wide global reach that enables us to service multinational corporations across

geographically disparate locations.

ABOUT APTHEALTHABOUT APTHEALTHABOUT APTHEALTH



We choose not to be just another company.

It is our "right" to be uncommon – if we can.

We seek opportunity – not security.

We want to take the calculated risk;

To dream and to build,

To fail and to succeed

We take pride in our work,

For that‘s what separates excellence from mediocrity.

We attack our work with fervor & passion,

For nothing great was ever achieved without enthusiasm

We value talent, education and genius.

But we believe in persistence and determination above all else.

While others dream of success,

We stay awake and work hard at it.

We believe in thinking BIG,

For success is limited only by one‘s imagination.

We choose to stand erect, proud and unafraid,

To enjoy the benefits of our creations.

That is what AptHEALTH is all about.

We choose not to be just another company.

Inspired by the "Official Credo" of American Entrepreneurs Association (c) 1961

THE APTHEALTH CREDOTHE APTHEALTH CREDOTHE APTHEALTH CREDO



AptSPEND is Aggregate Spend Call 888.369.7634

www.apthealthusa.com 379 THORNALL STREET, WEST TOWER - 8TH FL, METROPARK, NJ 08837

Call 888.453.0014

Solutions! Not just technology.

aggregate spend / physician spend sunshine law compliance

Health & Medicine