On September 6, 2012, the Vermont Attorney General’s Office issued an official notice that it is offering a limited amnesty to manufacturers of medical devices and biologics whose obligation to comply with the state’s prescribed products gift ban and disclosure law began on or after July 1, 2009. On that date the gift ban and disclosure law, which had previously applied only to manufacturers of prescription drugs, was amended to cover manufacturers of devices and biologics who do business in Vermont as well.
The offer of amnesty is limited in several ways. First, although the Vermont law imposes both a ban on certain gifts and payments to health care providers and a requirement to report those payments that are permitted, the amnesty offer is limited to violations of the reporting requirement. In other words, a manufacturer that made a payment to a provider in violation of the state’s gift ban will not be protected under the amnesty from penalties for that violation.
Second, manufacturers must take advantage of the offer by October 1, 2012, by sending an email to firstname.lastname@example.org with the following information:
- Manufacturer’s name
- Reporting period(s) for which the manufacturer failed to report
- Name, physical address, email address and phone number of the person with whom the Office should communicate about unreported activity
Manufacturers will also be responsible for paying registration fees from prior years.
Third, the offer applies only to manufacturers of medical devices and biologics. Manufacturers of prescription drugs who did business in Vermont before July 1, 2009 cannot take advantage of the offer.
Finally, the Office may require further action from manufacturers who take advantage of the amnesty offer. In particular, the Office states that it plans to require disclosure at a later date of some aggregate information related to unreported activity. In addition, the Office states that it may seek to execute an Assurance of Discontinuance to secure future compliance with the law.