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.