The 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. 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. 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.
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PHYSICIAN PAYMENT SUNSHINE PROVISION OF PPACA 2010
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Informational Primer
Aggregate Spend
Compliance
—
Sunshine Law
PPACA 2010
AptSPEND
Updated April 27, 2011
www.apthealthusa.comAGE 1 OF 25
Solutions! Not just technology. P
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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
followed
lations ha ve swiftly
State regu ipated.
A ho st of many mo re are antic
the Fede ral law, and It is difficult to
navigate this
Solutions! Not just technology.
sensitive space -
PAGE 2 OF 25
and stay compliant.
3. PHYSICIAN PAYMENT SUNSHINE PROVISION OF PPACA 2010
Quite obviously
technology
a
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.
Solutions! Not just technology. PAGE 3 OF 25
4. PHYSICIAN PAYMENT SUNSHINE PROVISION OF PPACA 2010
EXECUTIVE SUMMARY
T
he Physicians Payment Sunshine of record; (b) STATE TO STATE VARIATIONS of
initiative is a growing body of Federal the law; and, (c) the sheer VOLUME OF DATA
and State legislations that collectively that must be aggregated, cleansed, processed
addresses all or some of the following and filed.
goals: (a) Provide transparency with regard to
who, in the life sciences industry, is contributing APTSPEND
what benefits to which physician; (b) Mandate
AptSPEND is complete aggregate spend
statutory reports at least once a year; and, (c)
compliance solution that (a) detects instances of
Limit spend per physician. ―Aggregate Spend‖ is
violation; (b) proactively prevents non-
the total, collective, cumulative amount spent by
compliance through timely alerts; (c) produces all
healthcare manufacturers (pharmaceutical,
mandated and necessary reports; (d) delivers the
biotechnology and medical device organizations)
statutory reports electronically to the government
on individual Healthcare Professionals and
agencies; and, (e) provides a search engine for
Organizations (HCP/O) through payments, gifts,
investigation and analysis of the spend data. Our
honoraria, travel and other means.
mobile computing interface pushes alerts to
Blackberry, iPhone and Google Android devices,
LEGISLATION STATUS and reports are also accessible from any smart
The Federal Bill passed in March 2010 phone or PDA with an Internet browser.
as a provision under the Patient Protection and Our team includes legal counsel to help
Affordable Care (PPAC) Act, and several States you interpret nuances of the law.
— including, but not limited to, California,
Massachusetts, Minnesota, Maine, District of IMPORTANT BENEFITS
Columbia, West Virginia, Vermont and Nevada —
Always fixed price. No surprises. No cost
have already passed their versions of the
overrun.
Sunshine Law. The Federal Law goes into effect
Bolts on to, and extracts data from, ALL your
from January 1, 2012, with the earliest reports
existing applications, be they SAP, Oracle
(covering Jan-Dec 2012) mandated on or before
Apps, Siebel, Concur, or any custom built
March 31, 2013. The penalties range from
software.
$10,000 to $100,000 for each violation, and can
End-to-end turnkey solution. We implement
go up to $1 million.
your aggregate spend compliance. Period.
Alerts user on individual HCP cap.
IMPLEMENTATION CHALLENGES Integrates with Blackberry, iPhone, Google
This regulatory compliance requirement Android and Windows mobile devices.
is especially challenging because of the (a) Automatically updates changes in regulation
DATA DISCREPANCIES across diverse sources from a central server.
Solutions! Not just technology. PAGE 4 OF 25
5. PHYSICIAN PAYMENT SUNSHINE PROVISION OF PPACA 2010
HISTORY
O
n September 6, 2007, the original program or seminar, or remuneration for
Physician Payments Sunshine Act promoting or participating in such a conference
of 2007 (S.2029) was introduced in or educational or informational program or
the Senate by Senator Chuck seminar", "product rebates or discounts",
Grassley (R-Iowa). Rep. Peter DeFazio (D- "consulting fees or honoraria" or "any other
Oregon) and Rep. Pete Stark (D-California) economic benefit")
introduced a similar bill (H.R. 5605) in the House
of Representatives in March 2008. Subsequently, PENALTIES
the Physician Payments Sunshine Act of 2009
To punish violations of the proposed law,
was re-introduced in both Houses as S. 301 and
the bills proposed penalties that were "not less
H.R. 3138 respectively, by Senator Chuck
than $10,000, but not more than $100,000, for
Grassley (in the Senate) and by Rep. Baron Hill
each such failure.‖
(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
INDUSTRY REACTION
various independent initiatives at the State level. The Pharmaceutical Research and
Manufacturers of America (PhRMA), which
represents the country‘s leading pharmaceutical
TRANSPARENCY
research and biotechnology companies, came
The bills aimed "to provide for
out with a statement in May 2008, supporting a
transparency in the relationship between
revised version of the bill, contingent upon "the
physicians and manufacturers of drugs, devices,
continued inclusion of the provision that
or medical supplies for which payment is made
preempts state law". PhRMA President Billy
under Medicare, Medicaid, or SCHIP." The
Tauzin said in a statement: "PhRMA believes that
control proposed was a quarterly report that
preempting local and state marketing reporting or
disclosed all payments over $25 in value
disclosure laws that have been enacted or are
disbursed "to a physician, or to an entity that a
pending avoids a confusing myriad of local, state
physician is employed by, has tenure with, or has
and federal requirements that confuse patients
an ownership interest in," along with details such
accessing the information and are overly
as date and nature of the payment (whether it
burdensome and costly for those required to
was for "food, entertainment, or gifts", "trips or
report."
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
Solutions! Not just technology. PAGE 5 OF 25
6. PHYSICIAN PAYMENT SUNSHINE PROVISION OF PPACA 2010
THE LEGISLATION
T
he Patient Protection and Affordable Direct compensation for serving as faculty or
Care Act (PPACA) - derisively referred as a speaker for a medical education
to, by opponents, as ―Obamacare‖ - program;
passed the Senate on Dec 24, 2009,
Compensation for services other than
and the House of Representatives on March 21,
consulting or faculty;
2010. It was signed into law by President Barack
Honoraria;
Obama on March 23, 2010. Section 6002 of the
PPACA implements the physician payment Gifts;
sunshine provision. Entertainment;
Food;
WHO ARE COVERED? Travel (including the destinations in
The legislation covers all drug, medical question);
device, biological or medical supply Education grant;
manufacturers and distributors, with the
Research grant;
exception of those that deal exclusively in OTC
Royalty or license;
(over the counter) items.
Current or prospective ownership interest;
REPORTING REQUIREMENTS Charitable contributions; and
All covered parties are required to Any other payment or transfer of value,
disclose to the Secretary of the U.S. Department except those covered under limitations
of Health and Human Services (HHS Secretary) (below).
all direct payments or transfers of value
exceeding $10 or more per transaction, or LIMITATIONS
totaling over $100 in a calendar year, to There are some significant limitations, as
physicians and teaching hospitals. The provision well, such as the following:
also requires those manufacturers to disclose 1. Payments through third parties, where the
any non-public ownership or investment interests covered party does not know the identity of
of physicians and their immediate family the ultimate beneficiary, are excluded.
members in the manufacturers. Therefore, the typical survey and marketing
research will not be covered.
COVERED TRANSACTIONS 2. Certain kinds of value transfers — such as,
Under these sunshine provisions, the loan of medical devices for under 90
payments that must be reported include, but are days, product samples intended for patient
not limited to, the following: use, and discounts (including rebates) — are
not covered.
Consulting fees;
Solutions! Not just technology. PAGE 6 OF 25
7. PHYSICIAN PAYMENT SUNSHINE PROVISION OF PPACA 2010
3. In the case of payments made towards product EFFECTIVE DATE
research or new development in connection
The reporting requirements go into effect
with a clinical investigation, the manufacturer
on March 31, 2013 when the report for January-
may delay reporting the payment for either four
December 2012 will be due; and, the information
years or until the drug, device or technology is
will be made available to the public online.
approved by the FDA.
4. Product samples that are not intended to be
sold and are intended for patient use.
PENALTIES
5. Educational materials that directly benefit The Federal law stipulates the following
patients or are intended for patient use. penalties.
6. Items or services provided under a contractual 1. Fines between $1,000 to $10,000 for each
warranty, including the replacement of a transaction or ownership interest that was not
covered device, where the terms of the reported in a timely manner; and, up to
warranty are set forth in the purchase or lease $150,000 for each annual submission that is
agreement for the covered device. late.
7. A transfer of anything of value to a covered 2. For knowing violations, fines between $10,000
recipient when the covered recipient is a and $100,000 for each transaction not
patient and not acting in the professional reported, up to $1,000,000 for each annual
capacity of a covered recipient. submission.
8. Discounts (including rebates). Total annual penalties for a single manufacturer is
9. In-kind items used for the provision of charity capped at $1 million at this time.
care. State laws mandate their own penalties,
However, even with these limitations, the which are not covered in this document.
mandated need for transparency is quite
Some State Laws
significant. already in effect.
Federal Law
mandates data
FEDERAL LAW PREEMPTS STATE aggregation from
January 1, 2012.
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.
Solutions! Not just technology. PAGE 7 OF 25
8. PHYSICIAN PAYMENT SUNSHINE PROVISION OF PPACA 2010
LATER DEVLOPMENTS
H
HS has designated the Centers for information; and (f) Reporting of data.
Medicare and Medicaid Services
(CMS) as the agency responsible FORMS OF PAYMENT OR OTHER
for implementing the physician- TRANSFERS OF VALUE
payment disclosure (―sunshine‖) requirements in PPACA 2010 empowers the secretary to
PPACA. identify reportable ―forms of payment‖ beyond
On March 24, 2011 — a year and a day those prescribed by statute. In this regard,
after Congress enacted the Patient Protection stakeholders: (a) Encouraged CMS to clarify the
and Affordable Care Act (PPACA) — the Centers meaning of existing terms before it considers
for Medicare and Medicaid Services (CMS) scrutinizing additional forms of payment; and, (b)
hosted a special open-door forum to discuss with Stressed that the agency must first provide clarity
health care stakeholders PPACA-mandated on a number of definitional issues. The following
transparency provisions. The call was convened were cited as open issues subject to further
shortly after the long-awaited decision by the clarification: What does it mean to be an
secretary of the U.S. Department of Health and ―applicable manufacturer operating in the United
Human Services to give CMS the lead on States‖? Do the reporting provisions apply to pre-
implementing the payment disclosure commercial manufacturers with no approved or
requirements. In announcing the call, CMS said marketed products in the United States? Whether
it would be a listen-only participant, seeking payments are made by manufacturers to entities
comments on a series of key implementation other than ―covered recipients‖, and that entity
questions. The forum, according to CMS, was not makes further downstream payments to
intended to supplant the ordinary rulemaking physicians or teaching hospitals, whether those
process or to preview definitive policy statements payments considered reportable? The
of statutory interpretations. stakeholders also noted the need for guidance of
―covered recipients‖.
KEY CONCERNS RAISED
‗NATURE OF PAYMENT OR OTHER
Several key concerns were raised by
TRANSFERS OF VALUE‘
Stakeholders — represented mainly by industry
Feedback was sought by CMS on how to
associations such as AdvaMed, BIO and PhRMA
define the categories of ―natures of payment and
— in CMS‘s Special Open-Door Forum. They
transfer of value‖. Comments were focused on
mainly addressed six areas of particular interest
the adequacy of the existing categories, and the
to CMS: (a) Forms of payment and transfer of
need for narrowly tailored and highly granular
value; (b) Definitions of nature of payment or
definitions, citing the volume of data resulting
other transfer of value; (c) Additional categories
from preliminary collection efforts. Suggestions
of information to report; (d) Ownership or
from trade groups and stakeholders emphasized
investment interests; (e) Average consumer
Solutions! Not just technology. PAGE 8 OF 25
9. PHYSICIAN PAYMENT SUNSHINE PROVISION OF PPACA 2010
that mid-size manufacturers anticipated disclosing AVERAGE CONSUMER INFORMATION
more than one million value transfers done to CMS sought feedback on the types of
physicians in a year and the lack of guidance might information on industry-physician relationships and
implicate the risk of double or over-reporting. The on best-practice approaches to be included when
solution proposed is for CMS to establish clear publishing reported data to the consumers. One
reporting hierarchy — for example, if a payment industry representative mentioned that as a result
made for the purpose of research is, in part, for of the stigma associated with these relationships,
meals or travel, the value transfer should be he has observed an emerging reluctance on the
reported by the manufacturer once, as a payment part of physicians to engage in industry-physician
for research activities. endeavors, particularly research activities. A
surgeon in attendance emphasized that ―not all
ADDITIONAL CATEGORIES OF INFORMATION conflicts of interests make a person a scoundrel.‖
TO REPORT Stakeholders requested explanation on the
Responses on the feedback on categories benefits to consumers associated with these
of reportable information beyond the ―form‖ and relationships and also want CMS to ensure that the
―nature‖ of value transfers, mainly reiterated the information is presented in a consumer-friendly and
need for CMS to precisely and narrowly define accurate manner.
relevant terms. Only one consumer advocacy
organization, requested CMS to expand the REPORTING OF DATA
definition of ―covered recipients‖ to include non- To ensure the accurate, efficient and cost-
physician prescribers, such as nurse practitioners effective reporting of data, CMS requested
and pharmacists. stakeholder input on the form of data reporting as
well as a mechanism for the correction of mistakes.
PHYSICIAN OWNERSHIP OR INVESTMENT It was suggested that individual-manufacturer-
INTERESTS related data be posted on a secured website for
CMS received one response on whether review and edit. This would enable the reporting
the agency should require additional information companies to review the accuracy of the data
regarding physician ownership or investment before it becomes available to consumers.
interests. AdvaMed requested consideration of the ―Covered recipients,‖ it was suggested, should
provisions under the legislation and to ascertain have a similar opportunity to correct incorrect
that the terms ―applicable manufacturers‖ and information.
―applicable [GPOs]‖ include the distribution model The physician-payment disclosure
of physician-owned companies. This would ensure requirement places a significant burden on
consistent treatment of the three business models manufacturers and GPOs, as it will require
(physician-owned manufacturers, GPOs and successful integration of policies, systems and
distributors) that present similar policy and legal technology. CMS believes that it has broad
risks. discretion to impose disclosure requirements
beyond those specifically set forth in the statute.
Solutions! Not just technology. PAGE 9 OF 25
10. PHYSICIAN PAYMENT SUNSHINE PROVISION OF PPACA 2010
IMPLEMENTATION CHALLENGES
L
ife sciences organizations have long The Sunshine compliance challenge is
contended with the challenge of especially intimidating primarily because of the
physician spend disclosure. Now data related challenges.
voluntary initiatives like the PhRMA
Code and the OIG Compliance Program are TOO MANY EXPENSE TYPES
being superseded by mandatory government
Companies need to track spend benefits
regulations, with a Federal mandate going into
for each healthcare provider (HCP) by expense
effect in 2012, for reporting in 2013.
type with reference to Federal as well as multiple
applicable State laws; control the spend on every
COMPLIANCE: A DAUNTING TASK HCP; and establish documentary proof that the
All spend management endeavor in the company is in compliance with all applicable
medical space is daunting due to the sheer Federal and State limits at any point in time. And
volume of physicians: over 954,000 of them. 94% all of these functions need to be exercised on a
of all physicians have a relationship with wide swatch of sensitive data, including but not
pharmaceutical and medical device companies; limited to, the following:
83% of them receive food & beverage in their Consulting fees;
workspace from the life sciences industry; 35%
Direct compensation for serving as faculty or
receive cash reimbursement of expenses for
as a speaker for a medical education
continuing education or meeting/conference
program;
attendance; 28% receive payment for speaking
Compensation for services other than
engagements.
consulting or faculty;
Solutions! Not just technology. PAGE 10 OF 25
11. PHYSICIAN PAYMENT SUNSHINE PROVISION OF PPACA 2010
Honoraria; San Francisco — sponsors Dr. McCollough for
a speaking engagement in SFO, and provides
Gifts;
a speaker‘s fee of $100.00. This is recorded in
Entertainment;
the SAP Sales & Distribution System.
Food; One of your event management companies
Travel (including the destinations in question); invites Dr. McCollough to attend an event in
Education grant; New York City, and this expenses is recorded
on a sign-in sheet. That is submitted manually
Research grant;
to your company.
Royalty or license;
These possibilities can go on and on.
Current or prospective ownership interest;
When will the company recognize the total spend
Charitable contributions; and on Dr. McCollough? How does one integrate these
Any other payment or transfer of value, except financial data from different sources within the
those covered under limitations (below). company, and accurately associate it with the right
physician?
TOO MANY SOURCES OF DATA
All these diverse types of expense are TOO MANY SYSTEMS TO INTEGRATE
incurred by a wide variety of far flung people within The example above shows how different
the organization, and some of these accountable people create data in different information systems
entities are not even employees of the of the company. The various ERP, CRM,
organization, such as event management vendors. Salesforce Automation, Clinical Trials Management
Consider the following hypothetical scenario, and Accounting systems where data originates,
involving one Dr. Ethel McCollough, the need to be tapped, the relevant information filtered
hypothetical Head of Radiology at a local hospital out, and integrated into one version of the truth so
in New Jersey: that compliance, or lack thereof, can be detected.
Your Head of Sales for National Accounts out
of corporate office takes the hospital‘s SHEER VOLUME
radiology department out for dinner; the total The sheer volume of health care personnel
bill is $156; the cost is recorded as an expense and the myriad transactions occurring with these
reimbursement in your SAP Accounting individuals through different avenues is quite
System, and value recorded per physician is overwhelming. The combination of per-provider
$52.00. spending caps and reporting provisions impose
Your Local Sales Rep for the area whose beat steep record-keeping requirements.
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. DATA SCRUBBING CHALLENGE
Your Marketing Department — working out of All this data need to be cleansed before
Solutions! Not just technology. PAGE 11 OF 25
12. PHYSICIAN PAYMENT SUNSHINE PROVISION OF PPACA 2010
may be aggregated. The real and potential practices in multiple States. Data scrubbing
problems are humungous. represents a substantial challenge in aggregating
physician spend.
SPELLING
Is Dr. Ethel McCullough in one transaction, TOO MUCH DATA
the same is Dr. Ethel McCulough appearing on Sometimes the same transaction might
another transaction? The last name is spelled appear in two different applications within the
differently. Is it a genuine mistake, a slip of the company. Are they the same transaction, or are
hand, or a data entry error? they different transactions? There is no end to data
challenges.
IDENTIFICATION
The names are spelled identically, but the DATA DISCREPANCIES
National Provider Identifiers are different. Is that
The various disparate systems from which
authentic data or a mistake?
some of the data originates may not even have the
QUALIFIER
correct basic physician identifying information.
It is not uncommon to have a Dr. James
Family names of the doctors might be the same,
Carrigan, Sr.— the father — and a Dr. James
their practice address might be the same, they
Carrigan, Jr. — the son — practicing as
might me a husband-wife duo practicing from the
contemporaries. What if an event management
same clinic; how does one differentiate and identify
company or a data entry clerk misses the vital
the right HCP? Data duplication and conflicts are
suffix?
reality, and this poses the single biggest challenge
to timely and accurate compliance determination.
NO DATA.
All such data discrepancies, conflicts,
Sometimes a record might have the
duplicate records and missing information coming
National Provider Identifier missing. May be the
from a wide range of distant and sometimes
address of the clinic is missing, and the doctor
Solutions! Not just technology. PAGE 12 OF 25
13. PHYSICIAN PAYMENT SUNSHINE PROVISION OF PPACA 2010
discordant data sources must be continually an ―after the fact‖ reporting system.
resolved, cleansed and purged to arrive at the
correct information. TIME IS SHORT
It is a massive and ongoing data
The Federal bill requires data collection to
management challenge, in addition to the task of
begin from January 1, 2012 towards the first report
ensuring the proper convergence of business
due on March 31, 2013. Several States have
processes, technology, people and policies, and
already passed their respective versions of the
performing the triple duties of detection, prevention
Sunshine Act and reporting has already begun.
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
Solutions! Not just technology. PAGE 13 OF 25
14. PHYSICIAN PAYMENT SUNSHINE PROVISION OF PPACA 2010
SOLUTION
A
ptSPEND is a fully featured end-to- is that different from taking a packaged software
end aggregate spend compliance and configuring it for you? Typically, packaged
solution. It detects. It prevents. It products are parameter-driven, and with large
reports. It provides total compliance enough range of parameters you can change
with Federal and evolving State regulations. software behavior quite substantially, as we see
with enterprise applications like SAP. Ours is a
END-TO-END SOLUTION SOA (Service Oriented Architecture) approach,
where we have a wide range of software artifacts
AptSPEND is an end-to-end solution
that comprise our Aggregate Spend solution.
backed by service — it is not just software. In
Based on our analysis of your requirements, we
other words, we don‘t just provide a software
will mix-and-match the right set of artifacts, and
package. We conduct a full requirements
customize them to create your solution.
analysis, and then customize our software
Given the intricate relationship between
modules to create the right solution for you. How
life sciences companies and physicians, the
Figure-1
Solutions! Not just technology. PAGE 14 OF 25
15. PHYSICIAN PAYMENT SUNSHINE PROVISION OF PPACA 2010
complex nature of the regulations, and the available separately.
extensive data management challenges, an off-the- Once a source of master data has been
shelf packaged solution may not address the identified and configured into the system, the Data
multiple disclosure requirements and spending Scrubber deploys agents that will continually
limits. monitor those MDM resources to proactively
identify new HCP information and pull them into
DATA SCRUBBING AptSPEND to help validate future transactions.
As already alluded to above, obtaining
clean data is the biggest challenge in this REGULATIONS UPDATE
application. Here is an example: We keep track of the changing regulations
An entry from the SAP Sales & Distribution and nuances of the law emerging from the State
database identifies a certain Dr. Carolyn capitals as well as from the Federal government.
Temple of 1147 Main Street, Edison, NJ 08820 These are automatically updated into our central
as a participating HCP. Compliance Database, which synchronizes with
An entry from the Siebel CRM database your database periodically, at your discretion.
mentions a certain Caroline Temple, also of These updates are audit trailed, reported on the
1147 Main Street, Edison, NJ 08820, as a dashboard and included as Footnotes on important
participating HCP. reports.
An entry from the legacy Financial Accounting
system mentions a certain Mrs. Carolyn INTERPRETATION OF LAW
Temple of 114 Main Street, Edison, NJ 08820 We retain industry experts who help us
as the recipient of a payment. interpret the law. The answers to questions such
Without data scrubbing, an expense tracking as the following are not immediately clear without
system would identify three different individuals. legal counsel.
Only data scrubbing can correctly determine The participation of a physician in a clinical trial
whether these refer to the same individual, or two may stretch over years. What is the correct
different individuals or even three different method of pro-rating payments received across
individuals. multiple reporting periods?
Our Data Scrubber verifies and validates Can a research contract with two year validity
the transactions against all available Master Data be spread over reporting periods?
(MDM Resources) of the company, as well as If a New Jersey based doctor participates in an
(optionally) relies on manual data scrubbing Experts Panel in Michigan, need we report his
assistants who will investigate, search, call, verify speaking fees to both the New Jersey as well
and resolve all instances of doubt flagged by the as the Michigan authorities?
Data Scrubber. This manual data scrubbing We provide regulatory compliance experts at no
assistance can be provided by client personnel or charge to you to you to help ensure your
be executed by us as a BPO operation. Details compliance with the nuances of the law at all times.
Solutions! Not just technology. PAGE 15 OF 25
16. PHYSICIAN PAYMENT SUNSHINE PROVISION OF PPACA 2010
However, you must consult with your attorney operations, which can easily occur in large
before taking legally significant decisions. organizations.
We shall first initiate an MDM study in
FUNCTIONAL LANDSCAPE collaboration with your IT department to help
establish the solidity of the foundation on which the
The schematic in Figure-2 depicts the
entire compliance system rests. Anomalies
overall functional schematic of AptSPEND.
detected shall be corrected or temporarily
recognized as an integration issue while the
MASTER DATA MANAGEMENT rectification at source is in progress.
In order to ensure the quality and Our Data Scrubber verifies and validates
authenticity of transactional data, first the master the transactions against all available Master Data
data must be established as a clean, (MDM Resources) of the company. Agents will also
comprehensive and single version of the truth. At continually monitor those MDM resources to
the most basic level, Master Data Management proactively identify new HCP information and pull
(MDM) seeks to ensure that an organization does them into AptSPEND to help validate future
not use multiple (potentially inconsistent) versions transactions.
of the same master data in different parts of its
Figure-2
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17. PHYSICIAN PAYMENT SUNSHINE PROVISION OF PPACA 2010
TRANSACTIONAL DATA in RSS or Atom format, AptSPEND can tap into it.
Having established the authenticity of the
CSV, EXCEL AND FLAT FILES
MDM, we poll all applicable sources of
Comma delimited files, Excel files and the
transactional data, and aggregate information from
common Flat file are three of the commonest data
all. Towards this task, we provide a wide variety of
interchange formats today and we readily support
data collection interfaces.
these kinds of data feeds.
USER EXITS
FILE TRANSFER POTOCOL (FTP)
When an application where data exists,
AptSPEND can pick up a data feed from
provides an API to access that data, or exposes its
an FTP server.
database schema so that we can perform direct
database access, we write custom code within
DIRECT ENTRY
AptSPEND to set up this feed. Our solution
Although AptSPEND does not expect any
provides these integration points into the system
of the spend data to be entered directly into
that can be utilized for a wide variety of uses.
AptSPEND, we do provide a user interface for
doing just that.
WEB SERVICES INTERFACE
Web services are now becoming an
increasingly common and convenient data DATA SCRUBBER
interchange technology. Many modern software Veracity of data being the most challenging
provide a web services interface to external piece of the aggregate spend compliance puzzle,
applications desirous of using its data. In such the Data Scrubber is vital to our success. All data
cases, we shall write custom code within feeds are stored in a staging area where the data
AptSPEND to interact with the relevant web scrubber goes to work, verifying, validating and
services to pick up the data. cleaning the data before it is migrated to the clean
transactions database for compliance processing.
WEB FEEDS The Data Scrubber verifies and validates the
Web feeds are commonly utilized to transactions against all available Master Data
publish frequently updated data in a web (MDM Resources) of the company, as well as
compatible format. The most common of these is relies on manual data scrubbing assistants who will
RSS, which is commonly understood to stand for investigate, search, call, verify and resolve all
"Really Simple Syndication." Atom is yet another instances of doubt flagged by the Data Scrubber.
standard that has garnered serious industry The process may include substantial
support, including Google‘s, and is technically human intervention depending on the dirtiness of
superior to RSS. the data. We provide a data scrubbing outsourced
If a source data object within your service that employs manual methods involving
corporate information systems provides web feeds investigation, searching, calling, verifying, cross-
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18. PHYSICIAN PAYMENT SUNSHINE PROVISION OF PPACA 2010
checking and establishing the accuracy of data. PROACTVE PRE-VIOLATION ALERTS
Once a source of master data has been It also proactively alerts relevant
identified and configured into the system, the Data Management and Sales personnel when an HCP
Scrubber deploys agents that will continually assigned to their department and/or personal
monitor those MDM resources to proactively account approaches the mandated limit. These
identify new HCP information and pull them into alerts can be configured with the desired triggers,
AptSPEND to help validate future transactions. timings and delivery methods. AptSPEND is
capable of mobile computing and will deliver alerts
VENDOR PORTAL into any smart phone or other kind of portable
device.
We provide a portal for vendors to login
and upload their data that is typically collected at
REPORTING INSTRUCTIONS
industry events sponsored by the company. The
It generates all reporting instructions to the
portal allows data entry as well as file uploads. All
Reports Engine, which then produces the reports
such data goes into the staging area that is input to
and delivers them as advised. The reporting
the data scrubber.
instructions include data, format, delivery
mechanism to be employed, and target recipient
COMPLIANCE ENGINE list.
The Compliance Engine is the center-piece
of AptSPEND.
REPORTS ENGINE
The Reports Engine is the ultimate value
STAYING CURRENT WITH REGULATIONS
we deliver to you.
It manages the Compliance Rules
It stores all the report formats, templates and
Database pertaining to Federal and State-by-State
delivery interface configuration information.
regulations. New regulations and alterations are
It receives ―delivery ready‖ data from the
entered into this module and is stored in the
Compliance Engine.
Compliance Rules Database.
If you subscribe to our Live Compliance It applies the relevant template and report
Update service, your Compliance Rules Database format to create the output, be it a PDF, Excel,
will be automatically synchronized with our central web feed, data stream, or any other format.
Compliance Rules Database periodically. It delivers the information to the target recipient
through the interface of choice.
DETECTING COMPLIANCE VIOLATION
It processes the cleansed data emerging DATA MINING & SEARCH ENGINE
from the Data Scrubber against the applicable Ad hoc searches for any kind of
regulations and detects compliance violation, investigation into the database, whether it relates
approaching violation and positive compliance. to regulatory laws, clean transactional data, reports
& alerts produces or the audit trail.
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19. PHYSICIAN PAYMENT SUNSHINE PROVISION OF PPACA 2010
SUMMARY OF FEATURES
A
dvanced features abound. Mobile Windows mobile devices. It is architected from
computing, Web Services, RSS/ ground-up on the mobile platform.
Atom web feeds, statistical
inference, predictive d a t a DATA FEED AGGREGATION METHODS
discrepancy resolution, et al. The data feed aggregation engine
provides diverse methods for collecting data,
AptSPEND COMPONENTS including web services, RSS/Atom feeds, FTP
interface, CVS or Excel files, and User Exists that
Figure-3 on the next page summarizes
require a little bit of custom code (which we
the functional components of the system.
provide) to tap on to your internal resources,
AptSPEND is not a parameter-driven software
wherever they may reside.
package, but a library of components and
services that can be reused to quickly compose
VENDOR PORTAL
the right solution for any aggregate spend
A vendor portal is another major source
requirement. So it has the quick delivery of a
of data, where your vendors, especially event
prebuilt package, but the performance of a
organizers, may independently upload data into
custom application.
AptSPEND through file upload and/or data entry.
INTEROPERABILITY DATA SCRUBBER
The software bolts on to all your existing All data is scrubbed prior to aggregation.
software application, be they SAP, Oracle Data is the most challenging piece of this
Applications, or custom built applications, using a compliance puzzle. So a lot of activities and effort
diverse range of data feed aggregation methods occurs in this module. All raw feeds are
ranging from user exits and the ubiquitous file exhaustively validated against available MDM
transfer to web services and more esoteric Atom resources; errors are flagged; human intervention
web feeds. is required for resolving issues. We also have
agents checking continually against all known
TURNKEY SOLUTION MDM resources to proactively identify new HCPs
We don‘t just deliver software; we deliver against future transactions.
and implement you complete aggregate spend Data scrubbing service is optionally
solution: end-to-end on a turnkey basis. available as an outsourced service.
MOBILE PLATFORM COMPLIANCE ENGINE
AptSPEND works with your Blackberry, The heart of the system which (a)
iPhone, Google Android smart phone and manages the Compliance Rules Database
pertaining to Federal and State-by-State
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20. PHYSICIAN PAYMENT SUNSHINE PROVISION OF PPACA 2010
regulations; and (b) processes the cleansed data pushes it out to the target recipient through the
emerging from the Data Scrubber against the interface of choice, which could be any of the
applicable regulations and instructs the Report following:
Engine what information is to be delivered to whom 1. PDF (most commonly)
at what time through what interface. 2. Excel file
3. Web service (custom data stream)
DATA MINING / SEARCH ENGINE 4. FTP upload/download
Investigations and any kind of searches 5. RSS or Atom feed
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
Figure-3
Solutions! Not just technology. PAGE 20 OF 25
21. PHYSICIAN PAYMENT SUNSHINE PROVISION OF PPACA 2010
SAMPLE 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.
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22. PHYSICIAN PAYMENT SUNSHINE PROVISION OF PPACA 2010
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.
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23. PHYSICIAN PAYMENT SUNSHINE PROVISION OF PPACA 2010
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.
Solutions! Not just technology. PAGE 23 OF 25
24. PHYSICIAN PAYMENT SUNSHINE PROVISION OF PPACA 2010
ABOUT APTHEALTH
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.
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25. PHYSICIAN PAYMENT SUNSHINE PROVISION OF PPACA 2010
THE APTHEALTH CREDO
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
Solutions! Not just technology. PAGE 25 OF 25
26. PHYSICIAN PAYMENT SUNSHINE PROVISION OF PPACA 2010
Call
888.369.7634 AptSPEND is Aggregate Spend
Call
888.453.0014
Solutions! Not just technology.
www.apthealthusa.com
379 THORNALL STREET, WEST TOWER - 8TH FL, METROPARK, NJ 08837
Solutions! Not just technology. PAGE 26 OF 25