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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First of all, the revenue leakage problem is purely an operational issue – the drugs have already been discovered, approved, marketed and sold so most of the ‘hard part’ has been done. Unfortunately, in this space pricing is not simple. Almost all healthcare products are ultimately paid for by someone other than the end customer – the patient. This of course results in a complex web of regulations, government pricing, managed care formularies and tiers and wholesale distributors – just to name a few.

To that end, Metastorm has experience working with and developing process solutions for all of the players involved (including the United States government), and can help your organization too. Our technology has the ability to solve your organization’s revenue leakage problem, and more importantly, the fundamental issue plaguing the industry as a whole.

According to IDC, 4.4% of all pharma revenue, which equates to $11 billion annually, is lost to revenue leakage. This is a staggering figure considering that only the top 15 companies in the entire life sciences space generate that level of total revenue. Just think of what that number is relative to your company’s business!

To eliminate this unnecessary cost burden, pharma manufacturers need to automate the processes by which they communicate pricing information to their wholesaler trading partners. While many companies have an electronic data interchange (EDI) solution in place to address the issue, the IDC numbers tell a different story.

Most companies have found clever ways to use statistics to make it appear that the revenue leakage problem doesn’t exist in their organization. For example, many commercial contracting departments cite 98-99% success/accuracy rates for pricing. While those are impressive numbers, and should be commended, the flipside tells a different story – one of unnecessary profit loss in need of a solution.

Consider the same statistic another way: a 99% accuracy rate means that minimally 1% of total revenue is in dispute (i.e. chargebacks), or written off because of other operational and reconciliation issues. Any manager/director would love to lead a project that could reasonably promise to deliver 1% of existing revenue back to the bottom line. For any company with over $1 billion in total revenue, that’s a minimum return of $10,000,000 per year!

Sound too good to be true? It isn’t, and Metastorm has the experience and customer successes to prove it.

Our business process management (BPM) suite of software tools has been used by multiple companies in the space to deliver these types of results to their organizations. With Metastorm BPM you can automate these processes to submit and update pricing between a manufacturer and wholesalers, then provide both trading partners with a combined audit trail to ensure that pricing information is sent immediately, and that both parties have complete visibility (at a line item level) into every price and pricing/eligibility change.

These capabilities first ensure prices are updated prior to the contract effective date (eliminating chargebacks related to the timeliness of information), and second that when discrepancies do occur that both companies’ representatives have the same view of the same information for each transaction (minimizing the time required to resolve the issue). Both of these benefits seriously increase your bottom line by eliminating dollars going out the door unnecessarily while also providing the added benefit of reduced processing time, which frees up resources for more value-adding activities.

But don’t just take my word for it. I invite you to review our customer testimonials and other solution information to see for yourself how Metastorm has, and can solve the pharmaceutical revenue leakage problem and can improve the financial health of your organization.

Want to know more? Check out our life sciences solution page, and read this article about how Metastorm helped two major pharma’s collaborate on chargeback management. 

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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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