The inclusion of the Physician Payments Sunshine Act in the sweeping healthcare reform is not only a vehicle for transparency, but also for financing the overall cost of healthcare in the US. In my humble opinion, given the sufficient “advanced warning” provided – the bill passed on March 23, 2010, and physician payments tracking is required starting  January 1, 2012 – we are going to see the federal government hand out hefty fines for violations (up to $1M) on a regular basis.

Unfortunately for the Life Sciences industry, there is little sympathy given for large (or even small) payments – “transfers of value” as the government calls them – to doctors and other healthcare providers and organizations (known as HCPs and HCOs respectively). While it may be difficult to defend the clinical usefulness of sending a doctor to a conference in an exotic location, there is a true need for a healthy relationship between clinicians and Life Sciences organizations, and that need isn’t going away.

After all, doctors and other prescribers ultimately put new products to use when they come to market, and therefore represent a key customer segment. The industry also relies on clinician participation in current and future clinical trials of new medicines and medical devices. The challenge is how to maintain healthy interactions with HCPs and HCOs without creating a conflict of interest or the appearance of impropriety.

There are already a host of state regulations in place aimed at this problem; and more are on the way – making it increasingly difficult to navigate this delicate space and stay on the correct side of the law. Add to this the complexities of operating in and around major metropolitan areas that straddle state borders (New York, Boston, Chicago, Washington, D.C., Philadelphia), and the effort to identify and track every HCP’s state of licensure versus their state of residence and the problem of just knowing which provider is which quickly mushrooms.

Clearly a technology solution is needed.

For compliance, there are two main components required – data and process. While most large and even medium-sized Life Sciences companies have a customer master data solution in place, the quality of the data is a problem – “Garbage in, garbage out” – as the saying goes. In order to ensure quality data, the process by which said data is captured and entered into the master data solution is critical. Business Process Management (BPM) can solve this problem in two fundamental ways.

First, from the compliance standpoint, having standard processes that are controlled and enforced ensures that every payment has been approved following corporate compliance policies as well as all state and federal regulations. Furthermore, the flexibility that BPM provides allows companies to develop the processes required today knowing that these and the business rules that drive them can be easily adapted as the regulations and reporting requirements evolve.

Second, from a master data perspective these process controls also ensure that records of payment are added to the primary data source only after they have been officially approved. Each payment amount is confirmed and reconciled after the event takes place and an actual payment is made. This ensures that all of the data kept within the master source is accurate and was properly approved based on the rules at that point in time.

Taking a BPM approach addresses both sides of the compliance problem. It also provides the quality data and recorded approvals that, as part of the Physician Payments Sunshine Act, the US government now requires beginning January 1, 2012. The challenge and opportunity now becomes ensuring that the solution is in place in time to start tracking, and provide the organization an opportunity to review 2011 spending trends prior to compliance issues “going on your permanent record” with the Department of Health and Human Services in 2012.

This approach will allow the organization to ensure all compliance guidelines are being followed, HCPs/HCOs are not being overexposed for spend and provide time to modify compliance policies and the Aggregate Spend application itself before federal tracking begins. Additionally, to follow the new regulations, all Life Sciences manufactures whose products are reimbursed by any government program (Medicare, Medicaid, SCHIP) must have an Aggregate Spend Management solution rolled out and ready for use by the end of this year.

In order to roll it out by that time, you really should be starting to design and build it yesterday.

But fear not – Metastorm has already successfully deployed its Aggregate Spend Management solution for a number of our top Life Sciences clients, and our dedicated Life Sciences practice has the experience and tools to help your organization assess your process, data, applications, compliance and organization to quickly scope a solution. If you start now, end of year is completely feasible and your executives can rest easy knowing that their organization will be tracking all physician spend, will have the quality data available for review, and will still have time to make changes prior to the first federal reporting period.

For more information, please review Metastorm’s Aggregate Spend Management Solution brief or join us at any of our upcoming events. We’re here to help.

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Ethan Smith is the Director of Life Sciences Solutions at Metastorm where he oversees business and account development and solution creation for Metastorm’s global life sciences customers, partners and prospects.

Ethan has extensive experience in business process consulting in the life sciences industry. His areas of expertise include enterprise BPM strategies as well as the utilization of Metastorm BPM® and Metastorm ProVision® to establish Process Centers of Excellence. He has driven process initiatives across research and development, sales operations, incentive compensation, physician spend management and compliance functions. Prior to Metastorm, Ethan spent over 10 years in process consulting for the life sciences and insurance industries.

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Check out this webinar, Countdown to Life Sciences Aggregate Spend Compliance, to learn how Metastorm’s Aggregate Spend Solution can help Life Sciences organizations manage, track and report on all physician payments by:

• Setting active alerts for corporate compliance policy and regulatory requirement breeches
• Defining and approving payment of all physician budgets and operating plans
• Enforcing proper approvals dynamically based on business rules governing giving

Webinar Date: Tuesday, April 6, 2010
Session1: 6:00 am PT / 9:00 am ET / 1:00 pm GMT
Session 2: 10:00 am PT / 1:00 pm ET / 5:00 pm GMT

Register for 9:00 AM EST session.
Register for 1:00 PM EST session.

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According to the corresponding release this number is “the equivalent to total revenue for a top 20 pharma simply disappearing each year.”

The culprit? Revenue leakage.

According to the release, one of the major sources of revenue leakage, which costs pharmaceutical companies 4.4% of their overall revenue per year, is chargeback discrepancies. The release also states that “63% of manufacturers believe chargeback-related revenue leakage is a serious problem. This is up nearly 25% from a similar survey in 2006.”

With these staggering numbers it is very apparent that pharmaceutical companies have a huge problem on their hands. Fortunately, there are technologies available that can alleviate revenue leakage, and help these companies realize significant ROI along the way.

 For example—one of America’s largest pharmaceutical services companies, which ranks among the Fortune 25, has utilized the functionality of Metastorm BPM® to streamline and automate its contracts management and chargeback processes as well as over 175 other process across the enterprise, enabling it to:

• Establish more efficient and accurate tracking capabilities,
• Reduce chargeback disputes,
• Rapidly and efficiently  respond to changing market conditions, and
• Improve transaction transparency and supplier collaboration.

With the help of Metastorm BPM, these and many other benefits have been realized, enabling this company to achieve an exponential return on its investment, and helping it to avoid revenue leakage from poor process management.

Want to know more? Watch this customer video testimonial, and read this solution sheet.

You can also check out the Solutions for Life Sciences page on our website.

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The award recognizes organizations that have excelled in implementing innovative process improvement solutions to meet strategic business objectives.

AmerisourceBergen has certainly done exactly that—to date the organization has established a BPM Center of Excellence, deployed and optimized nearly 200 processes throughout the enterprise, and has approximately 3,000 users on the Metastorm software globally.

The AmerisourceBergen award entry highlights the company’s senior executive support for Metastorm BPM as an enterprise solution. It also outlines some of the key objectives that BPM software helps the company meet on an ongoing basis, including:

• maintaining high quality standards while managing growth,
• creating efficiencies,
• making better and faster decisions, and
• ensuring regulatory and legal compliance

“The pharmaceutical industry is extremely complex and competitive, and AmerisourceBergen has embraced the Metastorm BPM suite as an enabler to help effectively address market demands in a highly competitive environment,” stated Manoj Kumar, manager of Business Process Automation at AmerisourceBergen. “The results and return on investment have been significant.”

We congratulate AmerisourceBergen and Manoj Kumar, the company’s manager of Business Process Automation, for their dedication and hard work. Receiving this award is a great recognition of the broad scope and remarkable success of its BPM initiative.

To hear more comments from Manoj Kumar, listen to this audio clip

Watch the video below to learn more about how AmerisourceBergen leverages Metastorm BPM.

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“As we rolled out standard end-to-end business processes to users, BPM tools enabled users to see the big picture and put their role in context by understanding upstream and downstream process and data flows,” said an executive of the pharmaceutical company.

The article highlights how the company used BPM for various purposes from clinical trials to supply chain optimization. It started adopting BPM so much in fact; that it established a BPM Center of Excellence.

The article further discusses how BPM can be used for other purposes within the pharmaceutical industry such as integrating and managing communications between various manufacturing-related systems

Read the full article for more details on how the pharmaceutical company was able to fully adopt BPM throughout the company.

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Needing to coordinate clinical submissions with a global workforce while meeting FDA pharmaceutical guidelines, the company decided to use Metastorm BPM to create a 24 x 7 automated lifecycle of its clinical submissions. Deploying BPM, the company was able to generate metrics and reports quickly, increase employee productivity and decrease the standard turnaround time required to submit reports to the FDA while handling all document preparation offshore.

Below a senior systems analyst delves further into the advantages of using Metastorm BPM in his global clinical team.

Please visit Metastorm’s Web site to learn more about its solutions for pharmaceutical companies.

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