Topic 43 – Use of Net Promoter Score Measures to Evaluate MSLs

A couple of my clients have discussed the use of the Net Promoter Score lately so I thought I would address it in my blog.

Quick background:

The concept of the Net Promoter Score was introduced in a Harvard Business Review article in 2003 by Fred Reichheld of Bain & Company. The net promoter score is measured by asking a single question: “How likely are you to recommend the company/product/service to a friend or colleague?” and is usually measured on a 0 to 10 basis. Scores of 9 and 10 are called Promoters, scores of 0 to 6 are Detractors and scores of 7 and 8 are called Passives. The Net Promoter Score is calculated by subtracting the percentage of customers that are Detractors from the percentage of customers that are Promoters.

People like the net promoter score because it is a simple measure of loyalty and when it is paired with an open ended question that asks why the particular score was given, it provides insight into what is important to the customer.

So, does the Net Promoter Score (NPS) provide value to MA? My research has not been able to find a single academic or metric-driven study on the use of NPS in MA specifically related to MSL activity. Common sense says this approach should be helpful but for now anyone using this approach is in experimental mode.

In MA the NPS question is often modified to be:

• "How likely are you to recommend engaging with [COMPANY X] Medical Science Liaisons to your colleagues or peers?” OR
• “How likely are you to recommend working with [MSL NAME] from [COMPANY X] to your colleagues?

PRO’s of Using NPS in MA:

• Brief nature of survey makes it suitable for rapid deployment immediately following MSL interaction to avoid the “blending” affect that occurs when HCPs are asked about MSL performance on a standard survey often weeks after their last interaction
• Relatively inexpensive to conduct compared to other market research
• NPS can help gather insights into what an HCP value in an MSL interaction, if open ended questions are employed as well

CONs of Using NPS in MA:

• Message vs Messenger: When an HCP recommends working or engaging with an MSL is that recommendation based on the quality of the content of the interaction or the interpersonal qualities of the MSL herself or himself?
• Not comparative: NPS does not give insight into whether HCPs recommend your MSLs any differently than they recommend competitor MSLs. Perhaps HCPs in a particular therapeutic area simply recommend all MSLs the similarly regardless of company.
• Not clearly actionable: If your NPS drops from one month to the next, what action should be taken? Some insight might be provided by the open ended questions but those responses are often only provided by the most dissatisfied

Given the inherent challenge, it is my opinion that the NPS is still a worthwhile measure, but it needs to be gathered as a part of a broader market research effort to give it the context that can help tease apart the reason for the scores.

The most effective NPS is gathered as soon as possible after the last interaction. In the case of MSLs, a system should be established to seek this guidance directly after a contact has been noted in the company’s contact management system. And, like all market research with HCPs, participation is highly impacted by compensation, so sufficient compensation must be offered to ensure enough participation to make the measure meaningful.

What is your experience with NPS? How do you frame the question? Share your experiences by clicking here.

Topic 42 – The Office-centric MSL

One of my readers asked me an interesting question:

“Are there examples of successful MSL roles that are primarily office-based (minimal travel)?”

Of course I could immediately think of some one-off type of examples like MSLs that focus on supporting other internal teams, like MSLs focused on training, or MSLs focused on providing a clinical development function technical leadership support. But, the simple answer is that I don’t know of any MSL groups that are primarily office-based. If you have experience with this, please leave a comment because my reader would really appreciate it.
Having failed to find a practical example, I nevertheless asked myself if I could imagine such a group existing in the future as a thought experiment. If we take as a given that the role of the MSL is to:

1. Establish relationships with stakeholders (usually thought leaders / key opinion leaders) in order to:

a. Provide the stakeholders with information and education on the disease state
b. Answer unprompted off-label questions about products / pipeline
c. Gather insights from stakeholders to share with the organization

2. Represent their organization in scientific settings like conferences
3. Facilitate efforts to work effectively with the research community
4. Support other scientific needs of the organization externally, like payers

I realize your mileage may vary on this definition, but if we accept it, than is there a future where most of that can be done from a desk?

I think it comes down to how acceptable the use of remote communications like FaceTime or Skype becomes. Today’s reality is that this is rarely done but I believe that this will grow much more common as this type of communication begins to be embedded in our daily interactions. I can imagine a future in 10 years or less where stakeholders express a preference for this type of communication – it is clearly more efficient for a stakeholder to sit at her or his desk and quickly interact with a number of different people than have to do the physical meet and greet with its inevitable open/closing loss of time. However, I think that this change will happen so gradually that we will come to realize that happened only by looking back on the differences.

And even in such a situation, there will still have to be travel for initial introductions which are much more impactful face to face and to conferences/meetings that have not gone virtual.

I just think the MSL job is too fundamentally about human contact to ever be exclusively office-based.

What do you think? Let me know by leaving a comment below.

Topic 35: Trends in Data Sciences for Medical Affairs

Data has always been the backbone of medical affairs.  Understanding the data that underlies the company’s products and the products of the competition and understanding the prevalence and treatment data available about the disease state has always been a requirement.  And, being able to summarize and explain the meaning of the data is one of the greatest values that MA brings to the organization.

But as a generator of data analysis and manager of data, most MA organizations have been passengers not drivers.  Most data sets are being generated by clinical development and analyzed by statistical staff within the clinical function.  Even after the product is on the market and the data generation turns from a clinical responsibility to a medical responsibility, most MA organizations still rely on these resources or the resources of outsourcers to define, manage and analyze their data.

However, as MA groups grow more sophisticated in their use of data, and as real world data sets available for analysis continue to increase in size and importance, it may become in the best interest of MA to begin developing some data science capability of their own.

MA Stats

Some MA organization already have their own stats staff or stats staff assigned to them but working in clinical, but in my experience this is still the exception not the rule.  Instead, most organization rely on stats people internally who are not primarily focused on MA or on outsourced stats resources.  There are a number of challenges with this environment.  First, for the internally loaned people, most of them are not that familiar with what MA does and they are also usually not familiar with using real world data sets.  Leveraging them requires bringing them up the learning curve, sometimes at the expense of time and effectiveness of the analysis. 

Relying on to a large degree on outside statistical help is also very problematic.  In these outsourcing situations, the cost can be high and the learning curve that you are paying for becomes the property of the outsourcer to resell to your competition.  Additionally, when a non-stats person hires and manages a stats outsourcer, it is very difficult for them to understand if they are getting the best thinking out of the outsourcer and suggest other alternate directions if they feel the outsourcer is taking a less than optimal path.  It is this very difficulty that led many clinical organizations, even virtual clinical organizations, to realize that they always needed some stats capability in-house, even if it was simply to manage the outsourcers.  Finally, working with outsourcers makes it very difficult to answer quick, smaller “what if” questions that always seem to come up after the main analysis is complete.

Given the importance of these analysis for MA and the need to be flexible, I believe that more and more MA organizations will realize that they need their own stats capability on the MA team – focused full time on the data sets and analyses that are most relevant to the post-marketing world.

MA Data Managers

While some MA organizations already have stats, I have yet to see one that has their own data management function.  Nevertheless, I am going to suggest that this will be less rare in the future.  Data managers are responsible for the “care and feeding” of the databases that the stats team analyzes.  A common function on clinical. 

As medical affairs becomes more data sophisticated and as cutting edge groups decide to build huge repositories of real world data to perform ongoing analysis, the need for professional MA focused data managers will grow.  These data managers will be more focused on the collating and cleaning of external data then their clinical counterparts and that is why I think the need for an MA specialist group will take hold.

What do you think?  Does your MA team have its own stats function today?  Is data sciences in the plans for the future? If you would like to leavea comment, click here and scroll down.

Topic 32: Big Data in MA – Revisited

Overview

A couple of years ago I wrote a post (check it out here) on the emergence of big data for Medical Affairs. Given the rapid evolution of big data, two years is a long time ago so it’s worth revisiting this topic.

Let’s recap what we mean by “big data.” It is a broad concept, but for our discussion today we will be using big data to refer to the new capability to pull together huge quantities of data that were not directly generated for the purpose they are now being applied. Biopharma has excelled at generating proprietary data sets for a specific purpose, but big data take advantage of non-proprietary data that was generated for a different purpose by applying it in a new way.
These external data sources range in structure, format and value. The real trick to big data is pulling the data from disparate sources, efficiently cleaning it and standardizing it to allow it to be cross-referenced, then finding novel ways to use it.

Example of Big Data in MA

In the last couple of years we have seen examples of companies set up to provide big data services to MA. I will single out one here as an example, but this is not intended as an endorsement. I have no relationship with this company or practical experience with their products.

The company, Med’meme, is a case study of big data in MA. Based on their website, Med’meme takes large, public data sets – in this case lists of scientific presentations from medical meetings and peer-reviewed journals and clinical trial information at least – and in their backroom they apparently standardize it to make all those data cross referenceable. How well they do this, how complete and how accurate the data is, I can’t say. But, when you think about that data source as an MA professional I am sure you are jumping to a bunch of potential uses - like the ability to rank KOLs, to identify new KOLs, to track TA trends in publishing, to identify potential investigators, to be alerted to new publication identification, etc.

And that is the beauty of big data – there does not appear to be anything in their data set that has not been available (with some costs) to biopharma for years. Their service is finding a way to scrape it all together, standardize it and allow it to be searched effectively.

Buy v Build in Big Data

When I first published the article about big data I had a number of “buy vs. build” questions. The reality of big data in its current form is about re-using publically available data in novel ways, so building it internally is unlikely to produce proprietary value. However, combining these data sets with proprietary data, or asking interesting and unique questions of the data is something that can remain proprietary – so some hybrid solutions may be valuable.

If big data is not a part of the MA information technology planning it should be.  This capability represents an opportunity for strategic advantage in the short-term until it is widely adopted.

Conclusion

Big data is a new reality. A huge new data set, the Sunshine Act database, has just come on-line, and other data sources are increasingly making their data available for these types of analysis. Expect to see major development in this area in the coming couple of years.

What has been your experience with big data in MA? Leave a comment.

Topic 31: Changing Relationship between Medical Affairs and Access and Reimbursement

Note: This is a revised and extended version of a post I first published two years ago. This issue continues to evolve and be an area of focus for many MA Leaders.

Introduction

I received a question about what an optimal relationship should be between MA and Access & Reimbursement in the US. Access & Reimbursement (AR) is the function in pharma that is primarily responsible for negotiating the relationship between the company and the major payers and/or providers. In some organizations this group is known as Managed Markets, Market Access, Payer Relationship, or Contracting. Their primary goal is ensuring that the company’s drugs are listed as advantageously as possible on the formulary of the payer.

AR has to make the case for reimbursement of their drug to a payer/providers Pharmacy and Technology Committee (P&T Committee) which is the body that ultimately makes the decision for the payer/provider. In the US, these P&T Committees consider the efficacy and safety of the treatment but they also consider the cost effectiveness of the treatment and its impact on total cost of care for a patient when deciding where to place the treatment on their formularies. The AR function has had to deal with a range of both government and private payers/providers, each with their own formularies.
The AR function in the US has grown in importance as the payers/providers have worked to limit their exposure to treatments they viewed as not cost effective through formulary placements that drive limitations like prior authorizations and co-payments for the patients. Even specialty areas like oncology, which used to have very few restrictions, are now seeing greater control exerted by the payers.

Defining a New Relationship

Just as the pressures on AR are forcing changes in the way they work with payers, those same pressures are changing the relationship between MA and AR. In the past, MA had a limited role to play in AR. For example, MA may have had a responsibility to train AR Account Managers on the scientific underpinnings of a new treatment, not dissimilarly to how MA may train sales staff. And AR might have occasionally asked an MA resource, typically Field Medical, to provide some scientific support for a formulary presentation. But, in general, these situations were ad hoc and limited.

However, now that AR’s success more directly drives the success of the pharma company and thus their importance has grown, the relationship between AR and MA is changing.

For a P&T Committee to control costs, they must be able to differentiate between treatments. This drives two major scientific needs:

1. The formulary committee needs a more robust scientific understanding of the drug’s properties, its known efficacy, its known risks and its place in the overall therapeutic area’s treatment options


2. The formulary committee is demanding more specialized data, specifically health economics and outcomes research (HEOR) data like cost effectiveness and total cost of care, and comparator data to allow them to understand the full impact of the drug’s use

Both of these ramped up requirements have direct impact on MA’s relationship with AR.

More Robust Scientific Understanding

MA’s role in terms of providing scientific support for P&T Committee presentations is growing from a part of the presentation to the core of the presentation. And with that growth comes the need for greater specialization by the presenters.
MA which develops and delivers the scientific elements of those presentations need to have a much more robust understanding of their P&T Committee audiences and how to effectively meet their scientific needs. This is leading to two trends in MA:

1. Much greater degree of training for Field Medical on the role of AR and P&T Committees
   OR


2. The identification and hiring of full time Field Medical-type roles specifically targeted at supporting AR

Given the importance of AR, supporting their needs can no longer be seen by MA as a side responsibility. Instead, it needs to be a core responsibility and an investment in training or personnel is needed to ensure that that Field Medical is prepared to adequately support this need. In addition to training, this will require new measures to be put in place to track Field Medical effectiveness, which I will discuss in a future blog post.

More Specialized Data

In many organizations, MA has taken the lead in developing data post-approval. And while HEOR has always been a part of generating that post-approval data, its importance has grown significantly. The increased demand for HEOR data has a number of implications:

• HEOR data should start being gathered in Phase 3B at least, and thus MA HEOR leaders need to engage with clinical development to ensure endpoints are included to begin the generation of HEOR data sets


• Post-Approval Data Generation Plans, which should be developed by MA to help drive the post-approval study efforts, must give greater consideration to the HEOR needs


• The priority given to Investigator Initiated Studies that cover HEO subjects may need to increase


• The need for specialized MA resources dedicated to developing and managing HEOR may need to increase, with new dedicated positions developed


• Processes for ensuring that the input of AR is gathered in the development of HEOR protocols should be re-examined to ensure that the results will meet the demands of the key formulary committees

In some companies have decided that HEOR is so important to AR that they have shifted the leadership of this research to the AR function itself. Whether the HEOR function reports to AR or is developed within MA, the need to ensure that the changing needs of P&T Committees are addressed has become a major priority for post-approval research.

Closing Thoughts

MA’s role as the owner of scientific education and communication for post-approval drugs is a critical element in today’s formulary-driven environment. MA needs to be an active partner to AR as it works to ensure patient access to the company’s drugs.

In your experience what has been the key to effective MA / AR partnership? Leave your comments below.

If you have a topic you would like me to cover, please email me from the link to the right.

Topic 30: Virtual MA Organizations – Leadership Implications

I have posted about outsourcing in MA in past posts here and here.

Today’s topic is focused on the virtual MA organization – an organization that outsources all or almost all of its key functions.  Given the capabilities of service providers, it is entirely feasible to outsource every sub-function within MA, including medical communications, grants management, medical information, standard and specialty field forces / MSL groups.

My goal today is not to discuss the pros and cons of a decision to form a virtual MA organization but instead to discuss some key aspects to making a virtual MA organization successful.  Although today’s post is looking at a fully virtual MA, the key points would be just as relevant for a mixed virtual and internal MA organization.

Reality of Virtual MA Organizations

Most organizations that decide to use virtual MA are organizations where very little MA infrastructure exists.  Either they are small organizations building their first MA function or they are mid-sized organizations that are going into a new TA.  Regardless of situation, the analysis that leads to a virtual MA organization is usually a buy vs. build decision.  When considering how to make virtual MA successful, we need to start at that point.

Keys to Success

There are three keys to success to managing a virtual MA organization:

• Upfront Expectations


• Sufficient Internal Management Resources


• Structured System for Evaluations

Upfront Expectations
In order for the virtual MA organization to be successful, the vendors that provide the services need to have a clear understanding of what is expected of them and when so that they can develop the correct scope of the work for their pricing.  Defining what is expected of the vendor is easier in some cases, like for Medical Information defining expectations about call wait time and speed of fulfillment.  But, defining expectations is much harder in cases like an MSL group or a specialty education group.  This challenge is heightened by the fact that the reason some organization’s decided to go virtual is that they don’t have a lot of expertise in house.

Nevertheless, it is vital that a clear set of expectations and measures are agreed upon as a part of the vendor selection and contracting process.  There is no point in the process where the company has more control than at the point of contracting.  If clear expectations are set, both sides win because the vendor can appropriately staff and manage the group and the company can achieve their goals.  If not, the vendor may either need to increase the scope during the contract or simply fail to achieve some needed result and the company will face unexpected costs and missed expectations.

In order to set the right expectations a strategy for MA’s work for the next period must be developed in detail.  And this strategy should be developed before the vendor selection process occurs to ensure that the vendors are supporting the strategy not the strategy supporting the vendors.

WARNING: Some vendors in our industry will encourage buyers against doing this work in advance.  The vendors will tell the buyers that the vendor will develop these expectations after the contract is signed and/or after they are active.  Companies that take this approach usually end up spending much more than they expected and achieving less results than they expected.

Sufficient Internal Management Resources

Virtual does not mean management free.  While the vendors will definitely have their own managers, successful virtual MA organizations have learned that they need to closely manage the vendors to achieve expected results.

Given the situation that leads to a virtual MA organization as discussed above, it sometimes comes as a shock to those setting up one that they still need to hire.  And those hires need to be managerial-level staff.

A general rule of thumb is the greater the range of responsibilities and lack of clarity, the greater the need for management.  So, for example, outsourcing a MedInfo group, with clear metrics and expected volumes, might require only a ¼ Associate Director.  But managing an outsourced MSL group during launch, even if there is a clear expectations set up-front, would require a ½ time director to deal with the unexpected and new learnings from the healthcare community.

If the company is unwilling to invest in the resources needed to manage the virtual MA vendors, that is a sign that the value of MA is not really understood within the organization.  Unless that core issue is addressed it is unlikely that the virtual MA group will be successful.

Structured System for Evaluations

In addition to being actively managed, virtual MA vendors need to be on a half yearly or yearly structured evaluation process.  The structured process will force a review of the original goals and scope of the relationship and provide an opportunity to resolve ongoing issues.  Without a structured process for reviews, problems tend to fester and eventually result in a complete breakdown of the relationship.

Many companies entering into a virtual MA environment rely on the vendors to suggest the structures of these types of meeting.  I would recommend that the company own the process and set the agenda.  This will ensure that those issues most important to the company serve as the focus of the process as opposed to an add on.  It also avoids the “make the case for added scope” that many vendor-driven processes tend to become.

Do you have experience setting up or managing a wholly or partially virtual MA organization?  What would you recommend?  Please leave a comment or send me a message.

Topic 23: Key Implications for MA Leaders in the New Sunshine Act Rules

In previous posts this week I have broken down the key provisions of Sunshine Act rules.  Now I want to provide my thoughts on what this means for MA leaders and their teams.

Owning the Correction Process

Everyone who conveys something of value to a physician within biopharma will need to understand these rules and their part of tracking them.  This is a new administrative burden for many parts of biopharma.

BUT, there is one specific work activity that I want to address before I jump into implementation concerns.  When all this data is compiled and sent to CMS, the physicians will have a yearly chance to review it and offer corrections.  These corrections will need to be reviewed and discussed with the company.

So the big operational question is - Who is going to take point on that correction interaction?  Are we going to expect that the physician try to contact different functional areas within the company directly with their questions?  That may not be reasonable since the reported values will not make it clear who is responsible within the biropharma.

I am going to suggest that someone needs to take clear ownership of this responsibility and in the case of KOLs it should be MA.  MA should be responsible for serving as the point of contact for KOLs with these issues and driving the issues to resolution.  Non-KOL physicians should be handled by an administrative group in finance, but KOLs really need to handled carefully if we do not want to damage our relationships.

Overall Sunshine Implementation

To prepare for the Sunshine Act, MA needs to ensure the following:

1. Internal systems are being built to properly capture this information


2. MA personnel and specifically MSLs are receiving proper training to understand how and when to report this information


3. A physician education program is developed and MA’s role in executing the physician program is clearly defined

I will highlight each of these elements and discuss related key Sunshine Act rules.

1. Internal Systems Developed for Sunshine Reporting

This is one area that MA probably has the least control.  These should already be underway and hopefully MA has already had a fair amount of say.  If MA is part of the stakeholder group that is reviewing these systems, I would ask the following questions based on my reading of the Sunshine Act rules:

• Will the system cover all payments, even those related to OTC or other non-pharma products?


• Is the company going to report in a consolidated fashion or separately by subsidiary/JV?


• Is the organization going to add context statements to payments?  If so, which ones and when?


• How many products will be associated with each payment?  Rules allow up to 5


• Are we prepared to track corrections and resubmit within the 15 day window after corrections are due?

2. MA Personnel Training on Sunshine Reporting

There is a fair amount of nuance in the Sunshine Act reporting rules.  It is critical that training is developed that make the following clear to MA staff:

1. Overall Payments
   
   
   
   • If value is provided to a physician but not at the request of the physician, it still needs to be reported.
   
   
   • Waived fees – of a physician suggests it is donated to a charity on their behalf it will still be tracked, unless they truly waive their fee without obligation to the company
   
   
   • All payments need to be coded by category – training is needed on the definition and difference (eg. travel vs. meals)
   
   
   
   


2. Food
   
   
   
   • If a group meal is provided where the value is greater than $10 per person, each physician that actually partakes of the meal must be tracked
   
   
   • Unless the food provided at a large event, in which case it does not have to tracked
   
   
   
   


3. Indirect Payments
   
   
   
   • Value provided to a third party but expected to be delivered to a physician must be tracked under the physician’s name
   
   
   • Value provided to an institution with the intention that it will go to a physician even if that physician is unnamed must be tracked (eg. providing funding to a teaching hospital for research grants will have to be tracked to the recipient physician)
   
   
   • Blinded payments to physicians for market research do not need to be tracked
   
   
   
   


4. CME Programs
   
   
   
   • Accredited programs are exempt from reporting only if no names of speakers or even specific criteria for speaker selection is provided and the manufacturer does not pay the speakers directly
   
   
   • General subsidies for CME tuition does not have to be tracked
   
   
   
   


5. Patient Education
   
   
   
   • Patient education materials and items are excluded from being tracked
   
   
   
   

3. Educating Physicians and Especially KOLs

It is vital that our KOLs are aware of the rules so that we can avoid confusion and bad feelings.  Some key elements of the rules that I believe every physician/KOL should know:

1. General Rules of the Road
   
   
   
   • All value provided greater than $10 must now be reported, or multiple smaller transactions that add up to $100 in one year
   
   
   • All data is tracked and submitted yearly
   
   
   • Physician must register with CMS website to gain access to the data in their name
   
   
   • After registration, physician will receive notification when data is posted yearly about them
   
   
   • Physician will have 45 days after notifications to review data
   
   
   • Physician will go onto CMS website and enter any corrections they think are necessary
   
   
   • Manufacturer has 15 days to review the corrections submitted and accept or reject
   
   
   • If the manufacturer rejects the correction, the manufacturer and the physician are expected to negotiate and reach consensus
   
   
   • If consensus is not reached, the manufacturer value number is used but it is marked as “in dispute”
   
   
   
   


2. Nuance of Value Tracking
   
   
   
   • Value tracked will include OTC and other non-pharma products from the company
   
   
   • If value is provided to a physician but not at the request of the physician, it still needs to be reported.
   
   
   • Value contributed to charity in their name will still be reported – eg. primary research honoraria donated to a cause is still considered value provided and will not be coded as charity contribution but as primary research honoraria
   
   
   • Tracking pierces the outsourcing veil – if a manufacturer pays a CRO and the CRO pays the physician, it tracks as the manufacturer paying the physicians
   
   
   • Reporting on research payments and value may be delayed for up to 4 years or until FDA approval, so do not be surprised if some clinical trial payments do not show up on the yearly total.  Similarly don’t be surprised to see multiple year’s worth of payments show up in one year after FDA approval, but they will be labeled with the year actually worked.
   
   
   
   

Topic 22: We Read the Sunshine Act Rules So You Don’t Have To - Part 2

This is the second part of my review of the Sunshine Act rules.  You can read all of the exciting  282 pages  here.  The first part of this analysis is here.

There are a lot of these so I will break this into a couple of posts and conclude by highlighting the ones I think are the most challenging to address.

• Exclusions for Existing Personal Relationships (eg. husband [Pharma employee] give wife [physician] a string of pearls) will remain.  Pg. 111

• Exclusion for transfers of $10 or below assuming that such transfers do not add up to over $100 during the course of the year remains in effect and the $10 amount will not be raised until 2014. Pg. 112

• Small incidental items under $10 (eg. notepads, magnets) that are provided at large-scale conferences or events are exempt from tracking including for aggregate purposes. Pg. 114

• Items intended for patient education will be excluded, even when they hold some potential alternative value for the physician (eg. providing a thumb drive containing patient education material). Pg. 116

• Education materials that are targeted directly at a physician (eg. reference manual, text book) are not included in the patient education exception and thus their value must be tracked and reported. Pg. 117

• The exclusion for “in-kind” value provided to a physician supporting the physician’s ability to provide “no charge” services to patients who cannot afford them includes patients that cannot afford the co-pay as well as patients simply unable to pay. Pg. 119

• The exclusion allowing the short-term loan of a device has been clarified to be for only 90 days or less, even if the device is disposable and not used during the 90 days.  Additionally, the short-term loan is for a total of 90 days during a year, not a series of 90 day loans.  Pg. 122

• Physicians that receive value as subject in a clinical trial do not have to have that value reported since they receive that value in their role as patient not physician.  Pg. 123

• Indirect transfers of value or payments do not need to be tracked if the manufacturer is not aware of who the third-party they pay is providing value to.  If they are aware who the third party if providing value than they do need to report that value. Pg. 128

• Indirect payments do have to be tracked if the manufacturer provides it with instructions that would lead it to be given to a covered physician.  For example, if a manufacturer provides a payment to a teaching hospital specifically to provide grants for research, that manufacturer would need to report who received the grants even if they are not involved in deciding who will receive the money.  If they provided the money to the same teaching hospital but put no restrictions on that money and the hospital decided to use some for grants they would not have to report it.  Pg. 131

• Indirect payments where the manufacturer is not able to be aware of the payment recipient are excluded from reporting.  For example if a manufacturer hires a market research company to provide double-blind market research, they cannot know who received the value and as such they do not need to track the indirect payments. Pg. 134

• Indirect payments that result in reporting are to be tracked for two quarters beyond the payment year.  For example if a teach hospital is given money for grants in March of 2013, it must track that money through the end of Q2 2014.  Money dispersed after that point does not have to be tracked.  Pg. 136

• When industry funds CME, the speaker payments do not need to be tracked if the following is true 1) the CME events meets the ACCME, AMA or other major certification requirement, 2) the manufacturer does not provide suggested speaker names or even a list of suggested names/qualifications, 3) the manufacturer does not pay the speaker directly.  Pg. 140

• When industry pays to subsidize the accredited CME attendees tuition fees it is exempt from reporting. Pg. 140

• Payments make in connection with prescriber education beyond materials that is required by REMS must be reported like any other educational value provided. However, the value of “Dear Doctor” and other education materials is excluded.  Pg. 141

• There is quite a bit about the definitions of stock and option ownership and investment interest that I am not covering in detail because I don’t think it relates extensively to MA.

• While not required, the rules suggest that prior to report submission the individual physicans are provided with a report of what information is going to be sent in the report to provide them with an opportunity to make corrections.  Pg. 156

• Reports are due by the end of Q1 of the following year. Pg. 157

• Reports are to be accompanied by attestations of accuracy by the CEO or similar top company officer.  Pg. 164

• Physicians and teaching hospitals will be notified that a new report is available and open to be reviewed and corrected generally through web postings at CMS, and directly if they register with the CMS ahead of time. Pg. 171

• Physicians will be given 45 days after notification and before publication to go online and review the data about to be published and submit corrections. Pg. 172

• Manufacturers only have 15 days after the 45 day review period to correct their data and resubmit to CMS.  Pg. 173

• To receive the data for review, physicians will need to register and validate their identify. Pg. 174

• Physicians who dispute the data provided by a manufacturer in their name must resolve the issue directly with the manufacturer.  The physician will be able to enter their suggested correction in the CMS database and CMS will provide the suggested correction to the manufacturer but will not be engaged in issue resolution. Pg. 180

• If the physician and the manufacturer cannot come to an agreement within the 15 day correction period, the transaction will be marked as disputed but the manufacturer’s original data will be displayed.  Pg. 184

• The CMS will update the database at least once after the initial publication to reflect corrected data that arrives after the initial correction period. Pg. 185

• Reporting on payments made to support development of new drugs, devices, biologics or medical supplies can be delayed until FDA approval or 4 calendar years, whichever comes first. Pg. 194

• The delayed reporting is only applicable for new drugs, any development of new indications on existing approved drugs is not subject to the delay. However, new generics will be considered new drugs for reporting purposes. Pg. 196

• Reporting is required even for products that fail in development, after the 4 year time period has expired. Pg 198

• Delaying the report of value provided for new drug development is optional – the manufacturer still has to report the amount of value provided and then may choose to request that the reporting be delayed.  Pg. 199

• Information will be maintained on the CMS databases for 5 years after publication date. Pg. 206

• The new Federal rules will pre-empt state reporting rules after the Federal rules go into effect. Pg. 211

• Rest of report is Federal administrative analysis, not relevant in terms of rule execution.

I will analyze what this means for MA leaders and their team in a subsequent post.  Please leave your comments below.

Topic 22: We Read the Sunshine Act Rules So You Don’t Have To - Part 1

We have been discussing the Sunshine Act here on the MA Focus blog for awhile.  The much delayed rules of have finally been released – all 282 pages!  And, boy, are they exciting reading!

Biopharma is to begin collecting this data on August 1, 2013 with the first set of reports due to CMS on March 31, 2014.  So, to the degree your teams will need to be educated on what to capture and how to report, there is actually very little time to set up the systems you need.

As a result, even if these rules are not exciting reading, they are important.  I have reviewed them and identified some highlights that I think will be important to everyone in MA.  I summarize the highlights below along with page references if you want to read all the riveting detail.  There are a lot of these so I will break this into a couple of posts and conclude by highlighting the ones I think are the most challenging to address.

• Unrelated Products – the rule makes clear that you must track all payments (direct and indirect) made to a physician even if those payments are related to a product not covered by the act (eg. a product still in development, an OTC product)  pg. 19

• If a company is bringing its first covered product to market (meaning its first FDA approved drug or device) then after the approval it has 180 days before it is expected to begin reporting.  Pg.21

• If a company has subsidiaries or JVs as defined in the statute it has the option to provide its reporting either individually or in a consolidated fashion.  Pg. 27

• Companies do not need to report on non-physician prescribers, like Nurse Practioners, unless those non-physician prescribers pass the payment or value they receive through to a physician.  Pg. 37

• The “employee exemption” has been clarified to exclude physicians so an organization cannot claim that a physician is an employee and thus not report on that physician.  Pg. 39

• Payments to non-healthcare departments of universities affiliated with teaching hospitals are excluded from reporting. Pg. 41

• All physician information must include name (first, last, middle initial), address, specialty and NPI number.  Additionally, you must report state professional license numbers(s) for at least one state. Pg. 44

• Value provided that is transferred to another entity at the request of or the benefit of the physician must be reported under the physician’s name.  For example, a payment to a group practice at the request of physician is reported under the requesting physician’s name. Pg.51

• If value is provided to a physician but not at the request of the physician, it still needs to be reported. Pg. 52

• Value provided directly to a group of physicians (eg. practice) that are not a covered entity (eg. teaching hospital) will need to be divided among all the physicians in the practice or following some “fair” approach determined by the manufacturer.  Pg.  53

• Value provided to one covered entity (eg. teaching hospital) but directed by the manufacturer to a physician within the hospital are to be reported against the physician, not covered entity. Pg. 54

• If a physician or covered entity waives their payment, they need to be clear whether they want it sent to a third party (eg. charity) “on their behalf.”  If so, it will be reported as value received by the physician.  If not, even if the manufacturer donates it, it should not be reported. Pg. 59

• Manufacturers may provide a brief context statement for each payment but it’s optional.  Pg. 66

• Manufacturers can report up to 5 products related to a payment or transfer of value using NDC numbers when available.  Pg. 70

• The nature of each payment needs to be coded into pre-set categories (eg. Consulting , honoraria, gift, education, meals, grant, travel) and when a payment crosses the approved categories it is up to the manufacturer to decided which one is most appropriate. However, if the payments for each category is discrete (eg. meal vs. plane ticket) the payments should be reported separately and coded individually. Pg. 75

• In the case where a physician requests their payment be made to a charity, the nature of the payment category is not “charitable contribution” but it is the category for the actual value provided (eg. consulting fee, grant) Pg. 82

• For Food/Beverage, if the manufacturer provided food at a group setting other than a conference, the manufacturer has to track the value of the per person cost (total meal cost divided by total number of people partaking) if it exceeds $10 but only for those physicians that partake in the meal (eg. drink the coffee, eat the sand which). Pg. 85

• Research payments are those associated with a broad definition of research including preclinical, P1-4 and IIS, and applies when there is a contract for research AND/OR a research protocol. Pg. 101

• The requirements pierce the outsourcing veil – meaning that a payment made by a manufacturer to a CRO, who pays SMO, who pays the physician – would be tracked as a payment by the manufacturer to the physician for the amount the physician receives. Pg. 101

• Research payments will be tracked by providing the name of the covered entity (eg. hospital) and the name of the principle investigators (PIs) associated with the research. Pg. 105

End of Part 1 - Only 177 Pages to Go!

Update: Caronia and Off Label Promotion - The Beat Goes On

At a recent CBI compliance conference in DC, Tom Abrams, director of the Office of Prescription Drug Promotion (OPDP) in the Center for Drug Evaluation and Research (CDER) basically said that as far as his agency was concerned nothing was going to change in their enforcement of off-label promotion.  His rationale is, in my non-legal opinion, in the vein of "it depends on what the definition of 'is' is".  I think OPDP has chosen to see what they want to see in the ruling, but regardless they are not changing their approach or tactics.

Take a look at his full statement below:

The government has determined not to seek further review of the Second Circuit’s decision in United States v. Caronia, No. 09-5006-cr (2d Cir.).  FDA does not believe that the Caronia decision will significantly affect the agency’s enforcement of the drug misbranding provisions of the Food, Drug, and Cosmetic Act (FD&C Act).

In 2009, Alfred Caronia was convicted of conspiring to distribute a misbranded drug in violation of the FD&C Act.  A divided panel of the Second Circuit held that the jury instructions erroneously permitted, and that the government’s argument encouraged, the jury to treat speech promoting unapproved (off-label) uses of an FDA-approved drug as a criminal offense in and of itself.  The court of appeals did not address the constitutionality of the theory of liability on which the government had defended the conviction:  namely, that the promotion of a drug for an unapproved use may be relied on as evidence that the unapproved use is an intended one, and a drug that lacks adequate directions for its intended uses is misbranded.

Because the court did not address the constitutionality of a prosecution resting on that theory, and because the court also acknowledged that the First Amendment does not preclude an enforcement action based on speech regarding unapproved uses that is false or misleading, the Second Circuit’s decision does not bar the government from continuing to enforce the misbranding provisions of the FD&C Act, including through criminal prosecution where appropriate, in cases involving off-label promotion.  More generally, the decision does not strike down any provision of the FD&C Act or its implementing regulations, nor does it find a conflict between the Act’s misbranding provisions and the First Amendment or call into question the validity of the Act’s drug approval framework.

Bottom line, they are sticking with the belief that while anyone has the "right" to promote off-label, doing so ultimately leads to misbranding which is in violation of the FD&C act.  How you square this with the Second Circuit's ruling that there is protection for promoting off-label as long as the information provided is true will be an argument that will, no doubt, end up back in court.  I'm not a lawyer but I thought my rights trump your laws.

But for now off-label promotion remains open to OPDP enforcement.

What are your thoughts?

h/t PharmaExec Blog

Update: Off Label Free Speech Ruling Left Unchallenged at Appeals Level

As I discussed here, a recent ruling by the Second Circuit Appeals Court provided a new legal foundation for off-label promotion on free-speech grounds.  As the law currently stands in the Second Circuit, as long as the speech is "truthful" it is protected by the First Amendment and thus open to anyone.  Sales reps and MSLs in Ney York, Conn. and Vermont have one less thing to worry about.

Many, myself included, assumed that the FDA would ask for a re-hearing in the Second Circuit, but that date has come and gone without such a request.  You can read about it here.

At this point the FDA can go two ways - they can ignore the ruling and let it stand for the Second Circuit, which may result in a set of haphazard interpretations over time as different Circuit Counts rule differently, or it can appeal the ruling the Supreme Count.  Assuming the Supreme Court would agree to hear the case, appealing it to them could result in a ruling that the Second Circuit ruling should be the law of the land.

So the FDA is left with a choice - take what it has and accept that the off-label promotion rules may gradually crumble or risk those rules completely by appealing to the Supremes.  They have until mid-March (or until mid-May if they wish to extend their timeline) to make that decision.  I will continue to fill you in when I learn more - watch this space!!

Topic 21: ISS and the Web

I was speaking with a long time friend about this subject the other day and thought it would be an interesting blog post.

Investigator Initiated Studies (IIS) supported by biopharma grants is a significant element of MA responsibilities for some companies.  We will not be jumping into the strategic and scientific value of IIS studies with this post.  Instead, I will focus on the operational aspects, and specifically how I would think technology would make the process much more efficient.

Grant Application Process

Technology to manage the grant application process is widely available.  Transparency in this process is critical.  One of the goals of MA is to build positive working relationships with the scientific community and it is that same community of physicians and scientists applying for grants. So it is critical to ensure that the grant application process is just another element of the overall positive relationship.  That’s not to say all grant requests are supported, but the requesting process needs to be clear and efficient.  A good example of this can be seen at Celegene’s grant application webiste which includes an online application process and portal to allow the grant requestor visibility into the grant making process.

Not everyone can afford to build their own portal, but there are plenty of other solutions available over the web that require little in the way of investment and can meet the basic requirements, including here, here and here.

Depending on your interpretation of regulations, you may or may not be able to use these same systems to convey to the grant applicants that the organization’s research priorities are and grant resources are, to ensure that they have reasonable expectations.  See this example on the Genzyme page where they offer a direct link from the grant page to their research focus pages.

Study Execution Process

The use of the technology after the grant has been made varies widely among companies.  In the past, many organizations made the grant decisions, provided the product or funding, and then left the investigator alone.  After a period of time results either would or would not come out but the company had little involvement.  The problem with this approach is the situation where the IIS produced no results.  Without results, it calls into question the ethics of the funding.

So today, most organizations stay engaged in the IIS process but how they stay engaged varies widely.  I would like to suggest that one efficient way to stay engaged is to offer as part of the grant support the use of an electronic data capture (EDC) system.  While small scale studies like IIS don’t have to use systems like EDC since the data is limited, by providing such a service to the IIS it ensure that the study is capturing data in a structure manner, that the data is being managed and that the study will have something to show for the grant.  All these systems work over the web so there is no need for the IIS to manage the software themselves.

What has been your experience using technology to support IIS?  Leave a comment.

Topic20: MSL Organization Structure and Staffing Overview

I have had a number of posts about MSLs, including posts about MSLs driving value, posts about MSL team leadership and posts about MSLs vs. sales.  However, I have not discussed MSL organization structure and staffing.

When thinking about MSL organization, it’s important to start with MSL to management ratios.  Typically, the type of manager to staff ratios that work best in an MSL group is about 8 MSLs to 1 manager.  There are all sorts of reasons why this could be scaled up to 12 to 1, including a fairly static therapeutic areas, MSLs that work extensively with other functions like Clinical or Managed Markets, or a team of all veteran MSLs that need little coaching.  And there are all sorts of reasons you might want to scale back to 6 to 1 or even 5 to 1, if it’s a new therapeutic area for the company or inexperienced MSLs or a challenging KOL environment.  But, those extremes 5 to 1 on one end and 12 to 1 on the other are the practical end limits.  Much more than 12 people and it is not feasible for the manager to have a clear understanding of what their team is doing.  Less than 5 to 1 and there is not enough work to occupy a full time manager and you know I feel that is important (see post here).

Given those ratios, how should the teams be formed?  MSLs are inherently regional and that would lend themselves into regional organization structures, but they are also specialists often focused on a single therapeutic area or set of therapeutic areas.  If the MSL group is large enough, you can do both – separate MSL groups by therapeutic area then by region within those groups.  In reality, however, few organizations are large enough to organize that way.  As a result, most groups mix or combine therapeutic responsibilities and build regional teams.  To the degree that MSLs need therapeutic coaching, it can be provided through cross-team therapeutically aligned training and development.

Determining how many MSLs are needed starts with a clear definition of MSL responsibilities.  MSLs have such a potentially broad remit in today’s environment (they could theoretically be focused on activities in support of Clinical or Market Access activities as well as MA and scientific outreach) that without a clear definition scaling can’t be done.  Sometimes it’s a purely practical matter to determine this question – who is paying for the MSLs?  That often clarifies what types of activities they will perform.  But in many organizations MSLs routinely do work in support of functions other than the budget owner and so it really needs to be well defined.

Once the remit of the MSLs is understood, the next questions that help determine staffing are environmental.  Key factors include:

• New or existing therapeutic area for the company


• Complexity of the therapeutic area


• Degree of competition for access to scientific experts


• Expected changes in the therapeutic area in the next three years

Once the role of the MSL is understood and the environmental factors are clear, a good estimate of the work load can be developed and from there an estimated staffing level.

On another post I will discuss the challenge of starting up an MSL group from scratch and the buy or build decision.

What has been your experience in this area?  What ratios do you follow?