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Aggregate Spend / Physician Spend Sunshine Law Compliance
Aggregate Spend / Physician Spend Sunshine Law Compliance
Aggregate Spend / Physician Spend Sunshine Law Compliance
Aggregate Spend / Physician Spend Sunshine Law Compliance
Aggregate Spend / Physician Spend Sunshine Law Compliance
Aggregate Spend / Physician Spend Sunshine Law Compliance
Aggregate Spend / Physician Spend Sunshine Law Compliance
Aggregate Spend / Physician Spend Sunshine Law Compliance
Aggregate Spend / Physician Spend Sunshine Law Compliance
Aggregate Spend / Physician Spend Sunshine Law Compliance
Aggregate Spend / Physician Spend Sunshine Law Compliance
Aggregate Spend / Physician Spend Sunshine Law Compliance
Aggregate Spend / Physician Spend Sunshine Law Compliance
Aggregate Spend / Physician Spend Sunshine Law Compliance
Aggregate Spend / Physician Spend Sunshine Law Compliance
Aggregate Spend / Physician Spend Sunshine Law Compliance
Aggregate Spend / Physician Spend Sunshine Law Compliance
Aggregate Spend / Physician Spend Sunshine Law Compliance
Aggregate Spend / Physician Spend Sunshine Law Compliance
Aggregate Spend / Physician Spend Sunshine Law Compliance
Aggregate Spend / Physician Spend Sunshine Law Compliance
Aggregate Spend / Physician Spend Sunshine Law Compliance
Aggregate Spend / Physician Spend Sunshine Law Compliance
Aggregate Spend / Physician Spend Sunshine Law Compliance
Aggregate Spend / Physician Spend Sunshine Law Compliance
Aggregate Spend / Physician Spend Sunshine Law Compliance
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Aggregate Spend / Physician Spend Sunshine Law Compliance

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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 …

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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  • @vivacidade Thanks for the information.
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  • This is what the EU is planning in terms of phrama transparency. As opposed to the US sunsihne law, it is not a EU wide law, but a self-regulation by the European pharma association EFPIA. http://de.slideshare.net/medtrustadvisory/efpia-pharma-transparency-code
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  • 1. Call 888.453.0014 LIFE SCIENCES & HEALTHCARE FOCUS Solutions! Not just technology. Call 888.369.7634 Functional Brief AptSPEND Aggregate Spend Management — Sunshine Act www.apthealthusa.comAGE 1 OF 16 Solutions! Not just technology. P 379 THORNALL STREET, WEST TOWER - 7TH FL, METROPARK, NJ 08837
  • 2. LIFE SCIENCES & HEALTHCARE FOCUS EXECUTIVE SUMMARY The Physicians Payment Sunshine Act aims to limit aggregate spend per physician, and mandates statutory reports every quarter. Aggregate Spend is the total 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 is expected to pass in 2010, but several States have already enacted their own Sunshine Law, including California, Massachusetts, Minnesota, Maine, District of Columbia, West Virginia, Vermont and Nevada, with the earliest reports mandated from March 31, 2011. The proposed penalties range from $10,000 to $100,000 for each violation. This regulatory compliance requirement is especially challenged by data discrepancies across diverse sources of record, State to State variations of the law, and the sheer volume of data that must be aggregated, cleansed, processed and filed. While several companies are offering Sunshine Compliance as a consulting service, we are offering a software that can bolt on to your existing information assets, backed by end-to-end service that includes configuration, customization and implementation against a fixed price. Ongoing data scrubbing is also offered as an outsourced service. AptSPEND is complete aggregate spend compliance. It detects instances of violation; proactively prevents non-compliance through timely alerts; produces all mandated and necessary reports; delivers the statutory reports electronically to the government agencies; and provides a search engine for investigation and analysis of the spend data. Our mobile computing interface pushes alerts to the Blackberry, iPhone and Google Android devices, and reports are also accessible from any smart phone or PDA with an Internet browser. Our team includes legal counsel to help you interpret nuances of the law. Important benefits  Always fixed price. No surprises. No cost overrun.  Bolts on to and extracts data from ALL your existing applications, be they SAP, Oracle Apps or any custom built software.  End-to-end turnkey solution. We implement your aggregate spend compliance.  Proactively alerts user on individual HCP cap  Integrates with Blackberry, iPhone, Google Android and Windows mobile devices.  Automatically updates changes in regulation from a central server. Solutions! Not just technology. PAGE 2 OF 16
  • 3. LIFE SCIENCES & HEALTHCARE FOCUS AptSPEND is Aggregate Spend Compliance AGGREGATE SPEND REGULATIONS Life sciences organizations have long contended with the challenge of physician spend disclosure. Now voluntary initiatives like the PhRMA Code and the OIG Compliance Program are being superseded by mandatory government regulations, with a Federal mandate looming in the near future. The Physician Payment Sunshine Act was first proposed by US Senator Charles Grassley in 2007 as S-2029 - an amendment to the Social Security Act. The 2010 reincarnation of the proposed Act is an attempt to provide transparency – by way of spending caps and statutory reports – in the relationship between physicians and manufacturer of drugs, devices or medical supplies. Under the provision of this Act, on the first day of each fiscal year quarter, each manufacturer of a covered drug, device or medical supplies will be required to submit report in electronic form to the government authorities with the details of transactions made with the physicians directly or indirectly through an agent, subsidiary or any other third party. The report is expected to have details on the value and description of the nature of payment made in the form of compensation, food, entertainment, gifts, trips and travel, product or other items provided at less than market value, participation in medical conferences, and so on. The report is also required to have all details of the medical practitioners and/or agents e.g. name, address, registration number, etc. Non disclosure of such items will attract severe penalties on the manufacturer. COMPLIANCE: A DAUNTING TASK All spend management endeavor in the medical space is daunting due to the sheer volume of physicians: over 850,000 of them. 94% of all physicians have a relationship with pharmaceutical and medical device companies; 83% of them receive food & beverage in their workspace from the life sciences industry; 35% receive cash reimbursement of expenses for continuing education or meeting/conference attendance; 28% receive payment for speaking engagements. The Sunshine Act compliance challenge is especially intimidating primarily because of the multiple data related challenges. STATE TO STATE VARIATIONS Regulations vary from State to State. These have to be tracked as and when they occur. Solutions! Not just technology. PAGE 3 OF 16
  • 4. LIFE SCIENCES & HEALTHCARE FOCUS 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. INTENSIVE RECORD KEEPING The sheer volume of health care personnel and the myriad transactions occurring with these individuals through different avenues is quite overwhelming. The combination of per-provider spending caps and reporting provisions impose steep record-keeping requirements. TOO MANY MOVING ELEMENTS TO TRACK Companies need to track spend benefits for each healthcare provider (HCP) by expense type with reference to the multiple State laws (if applicable); control the spend on every HCP; and establish documentary proof that the company is in compliance with all applicable Federal and State limits at any point in time. TOO MANY SOURCES OF DATA Companies must track physician spend information across diverse and disparate transactional payment systems such as reimbursement, gift, grants, incentive, accounts payable, etc. For instance:  Your Regional Sales Manager takes a hospital’s radiology department out for dinner; the total bill is $156; the cost is recorded as an expense reimbursement in the legacy Accounting System, and per-physician values are allocated as $52.00.  Your Local Sales Rep provides a gift bag to the head of radiology in the same hospital. The value of $15.00 and this is recorded in the Siebel CRM System.  Your marketing department later sponsors the Head for a speaking engagement in NYC and provides a speaker’s fee of $50.00. This is recorded in the SAP Sales & Distribution System.  When will the company realize that the total spend on Head of Radiology has exceeded the State spending limit of $100 for the year? How does one integrate this financial data from different sources within the company and accurately associate it with the right physicians? TOO MANY INFORMATION SYSTEMS TO INTEGRATE The example above shows how different people create data in different information systems of Solutions! Not just technology. PAGE 4 OF 16
  • 5. LIFE SCIENCES & HEALTHCARE FOCUS the company. The various ERP, CRM, Salesforce Automation, Clinical Trials Management and Accounting systems where data originates, need to be tapped, the relevant information filtered out, and integrated into one version of the truth so that compliance, or lack thereof, can be detected. DATA DISCREPANCIES The various disparate systems from which some of the data originates may not even have the correct basic physician identifying information. Family names of the doctors might be the same, their practice address might be the same, they might me a husband-wife duo practicing from the same clinic; how does one differentiate and identify the right HCP? Data duplication and conflicts are reality, and this poses the single biggest challenge to timely and accurate compliance determination. All such data discrepancies, conflicts, duplicate records and missing information coming from a wide range of distant and sometimes discordant data sources must be continually resolved, cleansed and purged to arrive at the correct information. It is a massive and ongoing data management challenge, in addition to the task of ensuring the proper convergence of business processes, technology, people and policies, and performing the triple duties of detection, prevention and reporting. PHYSICIANS 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. TIMELY ALERT NEEDS EVEN 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 pass Solutions! Not just technology. PAGE 5 OF 16
  • 6. LIFE SCIENCES & HEALTHCARE FOCUS soon and impose a compliance deadline of 2013. SOLUTION: AptSPEND AptSPEND is “aggregate spend compliance”. It detects. It prevents. It reports. It provides total compliance with State and pending Federal regulations. AN END-TO-END SOLUTION SUPPORTED BY SERVICE – NOT JUST SOFTWARE Given the intricate relationship between life sciences companies and physicians, the complex nature of the regulations, and the extensive data management challenges, an off-the-shelf IT solution will not address the multiple disclosure requirements and spending limits. But we don’t just hand over software. We use the tool to craft the custom solution you need, and then we run it – for as long as you want us to. Solutions! Not just technology. PAGE 6 OF 16
  • 7. LIFE SCIENCES & HEALTHCARE FOCUS DATA SCRUBBING As already alluded to above, obtaining clean data is the biggest challenge in this application. Here is an example:  An entry from the SAP Sales & Distribution database identifies a certain Dr. Carolyn Temple of 1147 Main Street, Edison, NJ 08820 as a participating HCP.  An entry from the Siebel CRM database mentions a certain Caroline Temple, also of 1147 Main Street, Edison, NJ 08820, as a participating HCP.  An entry from the legacy Financial Accounting system mentions a certain Mrs. Carolyn Temple of 114 Main Street, Edison, NJ 08820 as the recipient of a payment. Without data scrubbing, an expense tracking system would identify three different individuals. Only data scrubbing can correctly identify whether these refer to the same individual, or two different individuals or even three different individuals. Our Data Scrubber verifies and validates the transactions against all available Master Data (MDM Resources) of the company, as well as relies on manual data scrubbing assistants who will investigate, search, call, verify and resolve all instances of doubt flagged by the Data Scrubber. This manual data scrubbing assistance can be provided by client personnel or be executed by us as a BPO operation. Details available separately. Once a source of master data has been identified and configured into the system, the Data Scrubber deploys agents that will continually monitor those MDM resources to proactively identify new HCP information and pull them into AptSPEND to help validate future transactions. REGULATIONS UPDATE We keep track of the changing regulations and nuances emerging from the State capitals as well as from the Federal government. These are automatically updated into our central Compliance Database, which synchronizes with your database periodically, at your discretion. These updates are audit trailed, reported on the dashboard and included as Footnotes on important reports. INTERPRETATION OF LAW AND BUSINESS RULES UPDATE We retain industry experts who help us interpret the law. The answers to questions such as the Solutions! Not just technology. PAGE 7 OF 16
  • 8. LIFE SCIENCES & HEALTHCARE FOCUS following are not immediately clear without legal counsel.  The participation of a physician in a clinical trial may stretch over years. What is the correct method of pro-rating payments received across multiple reporting periods?  Can a research contract with two year validity be spread over reporting periods?  If a New Jersey based doctor participates in an Experts Panel in Michigan, need we report his speaking fees to both the New Jersey as well as the Michigan authorities? We provide this service to you to help ensure your compliance with the nuances of the law at all times. FUNCTIONAL LANDSCAPE The following schematic depicts the overall functional schematic of AptSPEND. MASTER DATA MANAGEMENT (MDM) APPROACH In order to ensure the quality and authenticity of transactional data, first the master data must be established as a clean, comprehensive and single version of the truth. At the most basic level, Solutions! Not just technology. PAGE 8 OF 16
  • 9. LIFE SCIENCES & HEALTHCARE FOCUS MDM seeks to ensure that an organization does not use multiple (potentially inconsistent) versions of the same master data in different parts of its operations, which can easily occur in large organizations. We shall first initiate an MDM study in collaboration with your IT department to help establish the solidity of the foundation on which the entire compliance system rests. Anomalies detected shall be corrected or temporarily recognized as an integration issue while the rectification at source is in progress. Our Data Scrubber verifies and validates the transactions against all available Master Data (MDM Resources) of the company. Agents will also continually monitor those MDM resources to proactively identify new HCP information and pull them into AptSPEND to help validate future transactions. TRANSACTIONAL DATA AGGREGATION Having established the authenticity of the MDM, we poll all applicable sources of data and aggregate information from all. Towards this task, we provide a wide variety of data collection interfaces. USER EXITS When an application where data exists, provides an API to access that data, or exposes its database schema so that we can perform direct database access, we write custom code within AptSPEND to set up this feed. WEB SERVICES INTERFACE Web services are now becoming an increasingly common and convenient data interchange technology. Many modern software provide a web services interface to external applications desirous of using its data. In such cases, we shall write custom code within AptSPEND to interact with the relevant web services to pick up the data. WEB FEEDS Web feeds are commonly utilized to publish frequently updated data in a web compatible format. The most common of these is RSS, which is commonly understood to stand for "Really Simple Syndication." Atom is yet another standard that has garnered serious industry support, including Solutions! Not just technology. PAGE 9 OF 16
  • 10. LIFE SCIENCES & HEALTHCARE FOCUS Google’s, and is technically superior to RSS. If a source data object within your corporate information systems provides web feeds in RSS or Atom format, AptSPEND can tap into it. CSV, EXCEL AND FLAT FILES Comma delimited files, Excel files and the common Flat file are three of the commonest data interchange formats today and we readily support these kinds of data feeds. FILE TRANSFER POTOCOL (FTP) AptSPEND can pick up a data feed from an FTP server. DIRECT ENTRY Although AptSPEND does not expect any of the spend data to be entered directly into AptSPEND, we do provide a user interface for doing just that. DATA SCRUBBER Veracity of data being the most challenging piece of the aggregate spend compliance puzzle, the Data Scrubber is vital to our success. All data feeds are stored in a staging area where the data scrubber goes to work, verifying, validating and cleaning the data before it is migrated to the clean transactions database for compliance processing. The Data Scrubber verifies and validates the transactions against all available Master Data (MDM Resources) of the company, as well as relies on manual data scrubbing assistants who will investigate, search, call, verify and resolve all instances of doubt flagged by the Data Scrubber. The process may include substantial human intervention depending on the dirtiness of the data. We provide a data scrubbing outsourced service that employs manual methods involving investigation, searching, calling, verifying, cross-checking and establishing the accuracy of data. Once a source of master data has been identified and configured into the system, the Data Scrubber deploys agents that will continually monitor those MDM resources to proactively identify new HCP information and pull them into AptSPEND to help validate future transactions. Solutions! Not just technology. PAGE 10 OF 16
  • 11. LIFE SCIENCES & HEALTHCARE FOCUS VENDOR PORTAL We provide a portal for vendors to login and upload their data that is typically collected at industry events sponsored by the company. The portal allows data entry as well as file uploads. All such data goes into the staging area that is input to the data scrubber. COMPLIANCE ENGINE The Compliance Engine is the center-piece of AptSPEND. STAYING CURRENT WITH REGULATIONS It manages the Compliance Rules Database pertaining to Federal and State-by-State regulations. New regulations and alterations are entered into this module and is stored in the Compliance Rules Database. If you subscribe to our Live Compliance Update service, your Compliance Rules Database will be automatically synchronized with our central Compliance Rules Database periodically. DETECTING COMPLIANCE VIOLATION It processes the cleansed data emerging from the Data Scrubber against the applicable regulations and detects compliance violation, approaching violation and positive compliance. PROACTVE PRE-VIOLATION ALERTS It also proactively alerts relevant Management and Sales personnel when an HCP assigned to their department and/or personal account approaches the mandated limit. These alerts can be configured with the desired triggers, timings and delivery methods. AptSPEND is capable of mobile computing and will deliver alerts into any smart phone or other kind of portable device. REPORTING INSTRUCTIONS It generates all reporting instructions to the Reports Engine, which then produces the reports and delivers them as advised. The reporting instructions include data, format, delivery mechanism to be employed, and target recipient list. Solutions! Not just technology. PAGE 11 OF 16
  • 12. LIFE SCIENCES & HEALTHCARE FOCUS REPORTS ENGINE The Reports Engine is the ultimate value we deliver to you.  It stores all the report formats, templates and delivery interface configuration information.  It receives “delivery ready” data from the Compliance Engine.  It applies the relevant template and report format to create the output, be it a PDF, Excel, web feed, data stream, or any other format.  It delivers the information to the target recipient through the interface of choice. DATA MINING & SEARCH ENGINE Ad hoc searches for any kind of investigation into the database, whether it relates to regulatory laws, clean transactional data, reports & alerts produces or the audit trail. Solutions! Not just technology. PAGE 12 OF 16
  • 13. LIFE SCIENCES & HEALTHCARE FOCUS Summarizing the features and benefits AptSPEND FUNCTIONAL COMPONENTS The following schematic summarizes the functional components of the system. DIFFERENTIATING FACTORS 1. Fixed price solution. 2. AptSPEND is a software tool, not a time & material consulting engagement. 3. The software bolts on to all your existing software application, be they SAP, Oracle Applications, or custom built applications, using a diverse range of data feed aggregation methods ranging from user exits and the ubiquitous file transfer to web services and more esoteric Atom web feeds. 4. We implement your compliance solution. End-to-end turnkey solution provided. We do it all. 5. AptSPEND works with your Blackberry, iPhone, Google Android smart phone and Windows mobile device. 6. Data scrubbing service is optionally available as an ongoing outsourced engagement. Solutions! Not just technology. PAGE 13 OF 16
  • 14. LIFE SCIENCES & HEALTHCARE FOCUS Sample Screen Shots Dashboard  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. Solutions! Not just technology. PAGE 14 OF 16
  • 15. LIFE SCIENCES & HEALTHCARE FOCUS Aggregate Spend Report 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 exported the data to Excel or PDF format.  Provides quick access menus to jump to other reports. Solutions! Not just technology. PAGE 15 OF 16
  • 16. LIFE SCIENCES & HEALTHCARE FOCUS HCP Spend Position This screen allows shows the aggregate spend per HCP, which appropriately colored flags to communicate the limit compliance status at a glance. Solutions! Not just technology. PAGE 16 OF 16
  • 17. 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 17 OF 16

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