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                                                                             EXECUTIVE SU...
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 THE CHALLENGES OF AGGREGATE SPEND COMPLIANCE

Apparently Simple; But Very Challenging


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    INTENSIVE RECORD KEEPING                                       the Head for a speak...
LIFE SCIENCES & HEALTHCARE FOCUS

    coming from a wide range of distant and pass soon and impose a compliance deadline o...
LIFE SCIENCES & HEALTHCARE FOCUS
                                                                    SOLUTION: APTSPEND

A...
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       Temple of 1147 Main Street, Edison, NJ regulations and nuances emerging from the ...
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   the most basic level, Master Data Management the transactions against all available M...
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   provides an API to access that data, or exposes FILE TRANSFER POTOCOL (FTP)
   its da...
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   identify new HCP information and pull them into Management and Sales personnel when a...
LIFE SCIENCES & HEALTHCARE FOCUS
                                     SUMMARY OF FEATURES AND BENEFITS




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                                                                   SAMPLE SCREEN SHOTS

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                                    AGGREGATE SPEND REPORT




   EXPLANATIONS:


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                                        HCP SPEND POSITION




   EXPLANATIONS


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

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

  1. 1. 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
  2. 2. LIFE SCIENCES & HEALTHCARE FOCUS 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
  3. 3. LIFE SCIENCES & HEALTHCARE FOCUS 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. Solutions! Not just technology. PAGE 3 OF 14
  4. 4. LIFE SCIENCES & HEALTHCARE FOCUS 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 Solutions! Not just technology. PAGE 4 OF 14
  5. 5. LIFE SCIENCES & HEALTHCARE FOCUS 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 Solutions! Not just technology. PAGE 5 OF 14
  6. 6. LIFE SCIENCES & HEALTHCARE FOCUS 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 Solutions! Not just technology. PAGE 6 OF 14
  7. 7. LIFE SCIENCES & HEALTHCARE FOCUS 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 Solutions! Not just technology. PAGE 7 OF 14
  8. 8. LIFE SCIENCES & HEALTHCARE FOCUS 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 Solutions! Not just technology. PAGE 8 OF 14
  9. 9. LIFE SCIENCES & HEALTHCARE FOCUS 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 Solutions! Not just technology. PAGE 9 OF 14
  10. 10. LIFE SCIENCES & HEALTHCARE FOCUS 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 Solutions! Not just technology. PAGE 10 OF 14
  11. 11. LIFE SCIENCES & HEALTHCARE FOCUS 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 Solutions! Not just technology. PAGE 11 OF 14
  12. 12. LIFE SCIENCES & HEALTHCARE FOCUS 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. Solutions! Not just technology. PAGE 12 OF 14
  13. 13. LIFE SCIENCES & HEALTHCARE FOCUS 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. Solutions! Not just technology. PAGE 13 OF 14
  14. 14. LIFE SCIENCES & HEALTHCARE FOCUS 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 14 OF 14
  15. 15. LIFE SCIENCES & HEALTHCARE FOCUS 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 Solutions! Not just technology. PAGE 15 OF 14

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