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     PHYSICIAN PAYMENT SUNSHINE PROVISION OF PPACA 2010



                       Solutions! Not just technology.


Call
888.369.7634

                                                                       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
                                              379 THORNALL STREET, WEST TOWER - 8TH FL, METROPARK, NJ 08837
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       PHYSICIAN PAYMENT SUNSHINE PROVISION OF PPACA 2010

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       la                        arma                    The Phy              nsive
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                                    Su nshine prov        bill of 201 0 introduce
                                    health  care reform        threats tha
                                                                            t need
                                                  issues and
                                     of complex
                                     resolution.




                                      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.
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
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
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
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
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
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
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
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
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
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
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
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
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
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

Solutions! Not just technology.                                                                    PAGE 16 OF 25
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-



Solutions! Not just technology.                                                                       PAGE 17 OF 25
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.


Solutions! Not just technology.                                                                       PAGE 18 OF 25
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


Solutions! Not just technology.                                                                    PAGE 19 OF 25
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
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.



Solutions! Not just technology.                                                            PAGE 21 OF 25
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.




Solutions! Not just technology.                                                                    PAGE 22 OF 25
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
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.




Solutions! Not just technology.                                                             PAGE 24 OF 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
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

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Aggregate Spend / Physician Spend Sunshine Law Compliance

  • 1. Call 888.453.0014 PHYSICIAN PAYMENT SUNSHINE PROVISION OF PPACA 2010 Solutions! Not just technology. Call 888.369.7634 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 379 THORNALL STREET, WEST TOWER - 8TH FL, METROPARK, NJ 08837
  • 2. h. e hig im PHYSICIAN PAYMENT SUNSHINE PROVISION OF PPACA 2010 a ll t n a ta s for ni e mand ook the a tio The d that sh tig cy g s ns paren ow gyratin e tra sn nd inv ctor i , biotech a y ial se al ents t or f inanc ceutic sician Paym la arma The Phy nsive e gu ar ds ph e comprehe R tow ision in th s a set Su nshine prov bill of 201 0 introduce health care reform threats tha t need issues and of complex resolution. 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 Solutions! Not just technology. PAGE 16 OF 25
  • 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- Solutions! Not just technology. PAGE 17 OF 25
  • 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. Solutions! Not just technology. PAGE 18 OF 25
  • 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 Solutions! Not just technology. PAGE 19 OF 25
  • 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. Solutions! Not just technology. PAGE 21 OF 25
  • 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. Solutions! Not just technology. PAGE 22 OF 25
  • 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. Solutions! Not just technology. PAGE 24 OF 25
  • 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