Sunshine Act / CMS Rules Released

1. Name of the covered recipient.
2. Address of the covered recipient.
3. Identifiers for physician covered recipients: Specialty, National Provider Identifier (NPI), State professional license number(s), and the State(s) in which the license is held.
4. Amount of payment or other transfer of value.
5. Date of payment or transfer of value.
6. Form of payment or transfer of value.
7. Nature of payment or transfer of value.
8. Related covered drug, device, biological or medical supply.  See detailed rules on pages 263-264.
9. Eligibility for delayed publication. See 403.910 (pages 280-282) …reserved for “payments made under product research or development agreements and clinical investigations.”
10. Payments to third parties.
11. Payments or transfers of value to physician owners or investors.
12. Additional information or context for payment or transfer of value including the category. See full rules on pages 264-265. Those most applicable to Travel & Entertainment:
    1. Gift.
    2. Entertainment.
    3. Food and beverage. **
    4. Travel and lodging (including the specified destinations).

**-Special rules for reporting food and beverage.

1)     When allocating the cost of food and beverage among covered recipients in a group setting where the cost of each individual covered recipient’s meal is not separately identifiable, such as a platter provided to physicians in a group practice setting, applicable manufacturers must calculate the value per person by dividing the entire cost of the food or beverage by the total number of individuals who partook in the meal (including both covered recipients and non-covered recipients, such as office staff). The per person value of the meal must be reported as a payment or other transfer of value only for covered recipients who actually partook in the food or beverage.

2)     Applicable manufacturers are not required to report or track buffet meals, snacks, soft drinks, or coffee made generally available to all participants of a large-scale conference or similar large-scale event.

Pending Issues:

1)      Submission File Format:  CMS agreed to “provide applicable manufacturers and applicable GPOs with reporting templates and more details on reporting.” In other words, this is pending, but expected to be published no later than 90 days prior to the reporting date…so stay tuned.

2)      Teaching Hospitals: CMS will publish the list once annually and make it available publicly and for download at least 90 days before the beginning of the reporting year. In the case of 2013, which will be a partial reporting year, the teaching hospital list will be published by May 3, 2013; for 2014 reporting, by October 3, 2013.

Full release available here.

PDF of CMS release here.