AptSpend - Physicians sunshine act solution - aggregate spend solution - v3 - 2010-03

Call
888.453.0014
LIFE SCIENCES & HEALTHCARE FOCUS

Solutions! Not just technology.

Call
888.369.7634

Informational Primer

AptSPEND

Aggregate Spend
Management
—
Sunshine Act

www.apthealthusa.comAGE 1 OF 14
Solutions! Not just technology. P
379 THORNALL STREET, WEST TOWER - 7TH FL, METROPARK, NJ 08837

EXECUTIVE SUMMARY

T
he Physicians Payment Sunshine Act price. Ongoing data scrubbing is also offered as
aims to limit aggregate spend per an outsourced service.
physician, and mandates statutory
reports every quarter. Aggregate APTSPEND
Spend is the total amount spent by healthcare
AptSPEND is complete aggregate spend
manufacturers (pharmaceutical, biotechnology
compliance. It detects instances of violation;
and medical device organizations) on individual
proactively prevents non-compliance through
Healthcare Professionals and Organizations
timely alerts; produces all mandated and
(HCP/O) through payments, gifts, honoraria,
necessary reports; delivers the statutory reports
travel and other means.
electronically to the government agencies; and
provides a search engine for investigation and
LEGISLATION STATUS analysis of the spend data. Our mobile
The Federal Bill is expected to pass in computing interface pushes alerts to Blackberry,
2010, but several States have already enacted iPhone and Google Android devices, and reports
their own Sunshine Law, including California, are also accessible from any smart phone or
Massachusetts, Minnesota, Maine, District of PDA with an Internet browser.
Columbia, West Virginia, Vermont and Nevada, Our team includes legal counsel to help
with the earliest reports mandated from March you interpret nuances of the law.
31, 2011.
The proposed penalties range from IMPORTANT BENEFITS
$10,000 to $100,000 for each violation.
 Always fixed price. No surprises. No cost
overrun.
DATA DISCREPANCY CHALLENGE  Bolts on to and extracts data from ALL your
This regulatory compliance requirement existing applications, be they SAP, Oracle
is especially challenged by data discrepancies Apps or any custom built software.
across diverse sources of record, State to State  End-to-end turnkey solution. We implement
variations of the law, and the sheer volume of your aggregate spend compliance. Period.
data that must be aggregated, cleansed,  Proactively alerts user on individual HCP
processed and filed. cap.
While several companies are offering  Integrates with Blackberry, iPhone, Google
Sunshine Compliance as a consulting service, Android and Windows mobile devices.
we are offering a software that can bolt on to your  Automatically updates changes in regulation
existing information assets, backed by end-to- from a central server.
end service that includes configuration,
customization and implementation against a fixed

Solutions! Not just technology. PAGE 2 OF 14

THE CHALLENGES OF AGGREGATE SPEND COMPLIANCE

Apparently Simple; But Very Challenging

L
ife sciences organizations have long provided at less than market value, participation
contended with the challenge of in medical conferences, and so on. The report is
physician spend disclosure. Now also required to have all details of the medical
voluntary initiatives like the PhRMA practitioners and/or agents e.g. name, address,
Code and the OIG Compliance Program are registration number, etc.
being superseded by mandatory government Non disclosure of such items will attract
regulations, with a Federal mandate looming in severe penalties on the manufacturer.
the near future.

COMPLIANCE: A DAUNTING TASK
AGGREGATE SPEND REGULATIONS All spend management endeavor in the
The Physician Payment Sunshine Act medical space is daunting due to the sheer
was first proposed by US Senator Charles volume of physicians: over 850,000 of them. 94%
Grassley in 2007 as S-2029 - an amendment to of all physicians have a
the Social Security Act. The 2010 reincarnation relationship with pharmaceutical Volume of Data is a
Big Challenge
of the proposed Act is an attempt to provide and medical device companies;
transparency – by way of spending caps and 83% of them receive food & Over 850,000
Physicians
statutory reports – in the relationship between beverage in their workspace from nationwide
physicians and manufacturer of drugs, devices or the life sciences industry; 35%
medical supplies. receive cash reimbursement of
Under the provision of this Act, on the expenses for continuing education or meeting/
first day of each fiscal year quarter, each conference attendance; 28% receive payment for
manufacturer of a covered drug, device or speaking engagements.
medical supplies will be The Sunshine Act compliance challenge
Regulations Cap required to submit report in is especially intimidating primarily because of the
Aggregate Spend
by HCP/O electronic form to the multiple data related challenges.
and mandate government authorities with
Quarterly Statutory
Reports the details of transactions STATE TO STATE VARIATIONS
made with the physicians
Regulations vary from State to State.
directly or indirectly through
These have to be tracked as and when they
an agent, subsidiary or any other third party. The
occur. Impacted physicians’ records may have to
report is expected to have details on the value
be processed differently even in the middle of a
and description of the nature of payment made in
monthly cycle. Proper audit trails of all these
the form of compensation, food, entertainment,
regulatory changes need to be preserved for
gifts, trips and travel, product or other items
posterity for resolving investigative scrutiny.



INTENSIVE RECORD KEEPING the Head for a speaking engagement in NYC
and provides a speaker’s fee of $50.00. This
The sheer volume of health care
is recorded in the SAP Sales & Distribution
personnel and the myriad transactions occurring
System.
with these individuals through different avenues
 When will the company realize that the total
is quite overwhelming. The combination of per-
spend on Head of Radiology has exceeded
provider spending caps and reporting provisions
the State spending limit of $100 for the year?
impose steep record-keeping requirements.
How does one integrate this financial
data from different sources within the company
TOO MANY MOVING ELEMENTS and accurately associate it with the right
Companies need to track spend benefits physicians?
for each healthcare provider (HCP) by expense
type with reference to the multiple State laws (if
TOO MANY SYSTEMS TO INTEGRATE
applicable); control the spend on every HCP; and
The example above shows how different
establish documentary proof that the company is
people create data in different information
in compliance with all applicable Federal and
systems of the company. The various ERP,
State limits at any point in time.
CRM, Salesforce Automation, Clinical Trials
Management and Accounting systems where
TOO MANY SOURCES OF DATA data originates, need to be tapped, the relevant
Companies must track physician spend information filtered out, and integrated into one
information across diverse and disparate version of the truth so that compliance, or lack
transactional payment systems such
as thereof, can be detected.
reimbursement, gift, grants, incentive, accounts
payable, etc. For instance:
DATA DISCREPANCIES
 Your Regional Sales Manager takes a
The various disparate systems from
hospital’s radiology department out for
which some of the data originates may not even
dinner; the total bill is $156;
Too Many Sources have the correct basic physician identifying
of Data the cost is recorded as an
information. Family names of the doctors might
expense reimbursement in the
Too Many be the same, their practice address might be the
Information Systems legacy Accounting System,
to Integrate same, they might me a husband-wife duo
and per-physician values are
practicing from the same clinic; how does one
allocated as $52.00.
differentiate and identify the right HCP? Data
 Your Local Sales Rep provides a gift bag to
duplication and conflicts are reality, and this
the head of radiology in the same hospital.
poses the single biggest challenge to timely and
The value of $15.00 and this is recorded in
accurate compliance determination.
the Siebel CRM System.
All such data discrepancies, conflicts,
 Your marketing department later sponsors
duplicate records and missing information



coming from a wide range of distant and pass soon and impose a compliance deadline of
sometimes discordant data sources must be 2013.
continually resolved, cleansed and purged to
arrive at the correct information.
It is a massive and ongoing data
management challenge, in
Data Management
is the Big Challenge addition to the task of
ensuring the proper
Diverse Data Feeds
need to be convergence of business
aggregated and processes, technology, people
cleansed
and policies, and performing
the triple duties of detection,
prevention and reporting.

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
At least eight States have already
passed their respective versions of the Sunshine
Act and compliance is mandated from as early as
March 31, 2011. The Federal bill is expected to


SOLUTION: APTSPEND

AptSPEND “is” Aggregate Spend Compliance

A
ptSPEND is a fully featured end-to- the-shelf IT solution will not address the multiple
end aggregate spend compliance disclosure requirements and spending limits.
solution. It detects. It prevents. It But we don’t just hand over software. We
reports. It provides total compliance use the tool to craft the custom solution you
with State and pending Federal regulations. need, and then we run it – for as long as you want
us to.

END-TO-END SOLUTION
DATA SCRUBBING
AptSPEND is an end-to-end solution
As already alluded to above, obtaining
backed by service — it is not just software.
clean data is the biggest challenge in this
Given the intricate relationship between
application. Here is an example:
life sciences companies and physicians, the
 An entry from the SAP Sales & Distribution
complex nature of the regulations, and the
database identifies a certain Dr. Carolyn
extensive data management challenges, an off-

Figure-1



Temple of 1147 Main Street, Edison, NJ regulations and nuances emerging from the State
08820 as a participating HCP. capitals as well as from the Federal government.
 An entry from the Siebel CRM database These are automatically updated into our
mentions a certain Caroline Temple, also of central Compliance Database, which
1147 Main Street, Edison, NJ 08820, as a synchronizes with your database periodically, at
participating HCP. your discretion. These updates are audit trailed,
 An entry from the legacy Financial Accounting reported on the dashboard and included as
system mentions a certain Mrs. Carolyn Footnotes on important reports.
Temple of 114 Main Street, Edison, NJ 08820
as the recipient of a payment. INTERPRETATION OF LAW
Without data scrubbing, an expense We retain industry experts who help us
tracking system would identify three different interpret the law. The answers to questions such
individuals. Only data scrubbing can correctly as the following are not immediately clear without
identify whether these refer to the same legal counsel.
individual, or two different individuals or even  The participation of a physician in a clinical
three different individuals. trial may stretch over years. What is the
Our Data Scrubber verifies and validates correct method of pro-rating payments
the transactions against all available Master Data received across multiple reporting periods?

Our DATA (MDM Resources) of the  Can a research contract with two year validity
SCRUBBER company, as well as relies on be spread over reporting periods?
Plays a Major Role manual data scrubbing  If a New Jersey based doctor participates in
To help ensure the assistants who will investigate, an Experts Panel in Michigan, need we report
authenticity of the
Data search, call, verify and resolve his speaking fees to both the New Jersey as
all instances of doubt flagged well as the Michigan authorities?
by the Data Scrubber. We provide this service to you to help
This manual data scrubbing assistance ensure your compliance with the nuances of the
can be provided by client personnel or be law at all times.
executed by us as a BPO operation. Details
available separately.
FUNCTIONAL LANDSCAPE
Once a source of master data has been
The schematic in Figure-2 depicts the
identified and configured into the system, the
overall functional schematic of AptSPEND.
Data Scrubber deploys agents that will continually
monitor those MDM resources to proactively
identify new HCP information and pull them into
MASTER DATA MANAGEMENT
AptSPEND to help validate future transactions. In order to ensure the quality and
authenticity of transactional data, first the master
REGULATIONS UPDATE data must be established as a clean,
We keep track of the changing comprehensive and single version of the truth. At



the most basic level, Master Data Management the transactions against all available Master Data
(MDM) seeks to ensure that an organization does (MDM Resources) of the company. Agents will
not use multiple (potentially inconsistent) versions also continually monitor those MDM resources to
of the same master data in different parts of its proactively identify new HCP information and pull
operations, which can easily occur in large them into AptSPEND to help validate future
organizations. transactions.
We shall first initiate an MDM study in
collaboration with your IT department to help TRANSACTIONAL DATA
establish the solidity of the
Master Data Having established the authenticity of the
Management foundation on which the entire
MDM, we poll all applicable sources of
is Key compliance system rests.
to achieving transactional data and aggregate information from
Aggregate Spend Anomalies detected shall be
all. Towards this task, we provide a wide variety
Accuracy corrected or temporarily
of data collection interfaces.
recognized as an integration
issue while the rectification at source is in
USER EXITS
progress.
When an application where data exists,
Our Data Scrubber verifies and validates

Figure-2



provides an API to access that data, or exposes FILE TRANSFER POTOCOL (FTP)
its database schema so that we can perform AptSPEND can pick up a data feed from
direct database access, we write custom code an FTP server.
within AptSPEND to set up this feed.
DIRECT ENTRY
WEB SERVICES INTERFACE Although AptSPEND does not expect any
Web services are now becoming an of the spend data to be entered directly into
increasingly common and convenient data AptSPEND, we do provide a user interface for
interchange technology. Many modern software doing just that.
provide a web services interface to external
applications desirous of using its data. In such DATA SCRUBBER
cases, we shall write custom code within
Veracity of data being the most
AptSPEND to interact with the relevant web
challenging piece of the aggregate spend
services to pick up the data.
compliance puzzle, the Data Scrubber is vital to
our success. All data feeds are stored in a staging
WEB FEEDS
area where the data scrubber goes to work,
Web feeds are commonly utilized to
verifying, validating and cleaning The Data Scrubbing
publish frequently updated data in a web
the data before it is migrated to Process
compatible format. may involve
the clean transactions database a lot of
The most common of these is RSS, which
for compliance processing. The Human
is commonly understood to Intervention
A Wide Variety of Data Scrubber verifies and
Data Interfaces stand for "Really Simple
validates the transactions against
make it a lot Easier Syndication." Atom is yet
to Tap into all available Master Data (MDM Resources) of the
Diverse Sources another standard that has
company, as well as relies on manual data
of Data garnered serious industry
scrubbing assistants who will investigate, search,
support, including Google’s,
call, verify and resolve all instances of doubt
and is technically superior to RSS.
flagged by the Data Scrubber.
If a source data object within your
The process may include substantial
corporate information systems provides web
human intervention depending on the dirtiness of
feeds in RSS or Atom format, AptSPEND can tap
the data. We provide a data scrubbing outsourced
into it.
service that employs manual methods involving
investigation, searching, calling, verifying, cross-
CSV, EXCEL AND FLAT FILES
checking and establishing the accuracy of data.
Comma delimited files, Excel files and the
Once a source of master data has been
common Flat file are three of the commonest data
identified and configured into the system, the
interchange formats today and we readily support
Data Scrubber deploys agents that will continually
these kinds of data feeds.
monitor those MDM resources to proactively



identify new HCP information and pull them into Management and Sales personnel when an HCP
AptSPEND to help validate future transactions. assigned to their department and/or personal
account approaches the mandated limit. These

VENDOR PORTAL alerts can be configured with the desired triggers,
timings and delivery methods. AptSPEND is
We provide a portal for vendors to login
capable of mobile computing and will deliver
and upload their data that is typically collected at
alerts into any smart phone or other kind of
industry events sponsored by the company. The
portable device.
portal allows data entry as well as file uploads. All
such data goes into the staging area that is input
REPORTING INSTRUCTIONS
to the data scrubber.
It generates all reporting instructions to
the Reports Engine, which then produces the
COMPLIANCE ENGINE reports and delivers them as advised. The
The Compliance Engine is the center- reporting instructions include data, format,
piece of AptSPEND. delivery mechanism to be employed, and target
recipient list.
STAYING CURRENT WITH REGULATIONS
It manages the Compliance Rules
REPORTS ENGINE
Database pertaining to Federal and State-by-
The Reports Engine is the ultimate value
State regulations. New regulations and alterations
we deliver to you.
are entered into this module
Our Live Update
 It stores all the report formats, templates and
Service and is stored in the
keeps you delivery interface configuration information.
Compliance Rules Database.
Up-to-date
 It receives ―delivery ready‖ data from the
on Current If you subscribe to our
Regulations Compliance Engine.
Live Compliance Update
service, your Compliance  It applies the relevant template and report

Rules Database will be automatically format to create the output, be it a PDF,

synchronized with our central Compliance Rules Excel, web feed, data stream, or any other

Database periodically. format.
 It delivers the information to the target

DETECTING COMPLIANCE VIOLATION recipient through the interface of choice.

It processes the cleansed data emerging
from the Data Scrubber against the applicable DATA MINING & SEARCH ENGINE
regulations and detects compliance violation, Ad hoc searches for any kind of
approaching violation and positive compliance. investigation into the database, whether it relates
to regulatory laws, clean transactional data,
PROACTVE PRE-VIOLATION ALERTS reports & alerts produces or the audit trail.
It also proactively alerts relevant


SUMMARY OF FEATURES AND BENEFITS

A
dvanced features abound. Mobile 3. The software bolts on to all your existing
computing, Web Services, RSS/ software application, be they SAP, Oracle
Atom web feeds, statistical Applications, or custom built applications,
inference, predictive data using a diverse range of data feed
discrepancy resolution, et all. aggregation methods ranging from user exits
and the ubiquitous file transfer to web

AptSPEND COMPONENTS services and more esoteric Atom web feeds.
4. We implement your compliance solution. End
Figure-3 summarizes the functional
-to-end turnkey solution provided.
components of the system.
5. AptSPEND works with your Blackberry,
iPhone, Google Android smart phone and
DIFFERENTIATING FACTORS Windows mobile device.
1. Fixed price solution. 6. Data scrubbing service is optionally available
2. AptSPEND is a software tool, not a time & as an outsourced service.
material consulting engagement.

Figure-3


SAMPLE SCREEN SHOTS

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.

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.



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.




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.




Call
888.369.7634 AptSPEND is Aggregate Spend Compliance

Call
888.453.0014

Solutions! Not just technology.

www.apthealthusa.com
379 THORNALL STREET, WEST TOWER - 7TH FL, METROPARK, NJ 08837


AptSpend - Physicians sunshine act solution - aggregate spend solution - v3 - 2010-03

Recommended

More Related Content

What's hot

What's hot (7)

Similar to AptSpend - Physicians sunshine act solution - aggregate spend solution - v3 - 2010-03

Similar to AptSpend - Physicians sunshine act solution - aggregate spend solution - v3 - 2010-03 (20)

Recently uploaded

Recently uploaded (20)

AptSpend - Physicians sunshine act solution - aggregate spend solution - v3 - 2010-03