On October 12, 2010, a conference call was held with Wendy Morgan, Chief Public Protection Division, Office of Vermont Attorney General on the 2011 Guide to Vermont's Law on Disclosure of Samples of Prescribed Products and Draft Sample Disclosure Form.  The following are notes from the call:

Reporting Rule of Thumb:

If an item arguably could fall into either of two categories requiring disclosure, one of which is an allowable expenditure or permitted gift, and the other a sample, the manufacturer must report the item as the expenditure or gift, NOT as a sample. For example, though a manufacturer may refer to the distribution of an evaluation or demonstration unit of a medical device as a “sample,” the distribution must be reported as a permitted gift, not as a sample.

Patient Assistance Programs:

Products provided to HCPs under a Patient Assistance Program are not reportable under the sample disclosure law.  However, these are reportable as gifts to a HCP.  Products given directly to patients are exempt from reporting.

Definitions:

1. The definition of a prescribed product under federal law is too broad.  The AG is looking for proposals from industry for a narrower definition. 
2. It doesn’t matter what terms you use internally.  If your products fall under the definitions supplied by Vermont for product samples, vouchers, or other, those items must be reported as such.
3. Vouchers provided directly to a patient are exempt from reporting.
4. OTC products provided to HCPs are not reportable as samples, however, they must be reported as gifts.
5. Further clarification on definitions can be found in the Guide To Vermont’s Prescribed Products Gift Ban And Disclosure Law For FY11 Disclosures - 08/13/2010.

Kits:

1. If a kit contains sample product and other reportable items (not identified as gifts – see Rule of Thumb above), such as coupons and vouchers, the kit is reportable as a product sample.
2. Packs or kits that do not include a prescribed product, and include only such items as educational material or other aids for the patient to use the prescribed product, are not “samples.” Such kits must be reported as permitted gifts; for Nature of Expenditure use “other.” Examples: a kit with educational materials and a pedometer, a timer, over the counter drugs or creams, or a pill container divided for days of the week.
3. There will be further guidance on kits containing multiple items.

Sample Disclosure Form:

1. Vermont will be modifying the form to allow for reporting multiple products or therapeutic class
2. Discount field is free text.  Use it to accurately describe the discount provided.  E.g. – up to $20 off.