Today, the Vermont Attorney General’s Office announced an offer to accept a limited penalty from medical device and biologic manufacturers to resolve failure to report expenses related to health care providers under Vermont’s Prescribed Products Gift Ban and Disclosure Law during any of the law’s reporting periods. This offer does not apply to other violations of Vermont’s law, such as gift ban violations. Unlike Vermont’s past offer of limited amnesty, this offer would require payment of a limited penalty to settle past – or anticipated – violations.

The state is offering to accept a payment in the amount of $10,000 per reporting period to settle failures to report, as well as any anticipated failure to report 2013 data.  It is possible that Vermont is reacting to the various delays in gathering and reporting data related to the federal Physician Payments Sunshine Act, as well as previously undisclosed activity that has come to light during the ramp-up process.  Although the announcement stated that Vermont is not seeking full disclosure for unreported activity, the state does expect to require disclosure – at a later, unspecified date – of some aggregate information related to unreported activities, as well as information about whether the manufacturer also gave gifts in violation of the state’s gift ban.

According to an email sent over the Vermont Attorney General’s listserv and posted to its website, reporting obligations under the Vermont law took effect on July 1, 2009, and applied to FY10 (7/1/09-6/30/10), FY11 (7/1/10-6/30/11), 2011 (7/1/11-12/31/11), 2012 (1/1/2012-12/31/2012), and 2013 (1/1/2013-12/31/2013).  Though the offer of limited penalties may encourage self-reporting, open questions remain.  For example, will companies that do not pay the limited penalties be subject to investigation and enforcement – particularly if they submit federal Sunshine Act reports that include addresses of Vermont physicians?  And what sort of “aggregate information related to the [previously unreported] activity” would manufacturers need to compile and submit at a later date?

To take advantage of the amnesty offer, manufacturers must email on or before May 1, 2014 with the following information:

  • Manufacturer name;
  • Reporting period(s) for which the manufacturer failed to report; and
  • Name, physical address, email address and phone number of person with whom the Office should communicate about the unreported activity.

More information about Vermont’s Prescribed Products Gift Ban and Disclosure Law is available here, and the official notice of limited financial penalties is available here.

Leave a Reply

Your email address will not be published. Required fields are marked *