Medical Affairs Focus

Thoughts on Global Medical Affairs

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!


2 responses to “Topic 22: We Read the Sunshine Act Rules So You Don’t Have To – Part 1

  1. Rachel Couchenour February 11, 2013 at 2:23 pm

    Impressive, thanks for shairng your learnings. I stopped reviewing regs last Monday after learning we have 180 days after approval to report since we have no approved products.

  2. Pingback: Topic 22: We Read the Sunshine Act Rules So You Don’t Have To – Part 2 « Medical Affairs Focus

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