In today’s Life Sciences world everything is becoming increasingly more difficult – all of the “easy” drugs have been discovered, the human genome has been mapped and parts even patented (albeit with much dispute), the blockbuster model has crumbled, cost pressures are intensifying and regulatory scrutiny is at an all time high. The cries for transparency that have rocked the financial sector are now being turned toward pharmaceutical, biotech and medical device companies.

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.

===========================

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.

Related posts:

1. Webinar: Countdown to Life Sciences Aggregate Spend Compliance Attention Life Sciences organizations! Check out this webinar, Countdown to...
2. Financial compliance at the process level In the new presidential administration, it is intended that new...
3. Solving pharma’s 11 billion dollar revenue leakage problem In lieu of the recent eye-opening study from IDC regarding...
4. Managed File Transfer helps NY financial aid agency with compliance and SOA It was a record breaking year for college admissions and...
5. IDC: serious problem for pharmaceuticals – revenue leakage A recent study from IDC shows that pharmaceutical manufacturers will...

Related posts brought to you by Yet Another Related Posts Plugin.