A new legislative biennium in Vermont means further changes to the Vermont Gift Ban (18 V.S.A. §4631a) as well as the aggregate spend reporting requirements (18 V.S.A.§4632). On May 6, 2011, the Vermont House and Senate approved Senate Bill 104 which is currently awaiting the signature of Governor Shumlin. See the MediSpend Legislative Watch for a summary of how the revised legislation will affect Pharmaceutical and Medical Device Manufacturers.
The legislation, a copy of which is available here, will change the reporting dates from a fiscal year to a calendar year. Commencing in 2012, the Vermont aggregate spend disclosure form will be due on or before April 1st. Additional changes include:
- The definition of a "Manufacturer" - now exempts from the gift ban and reporting requirements a manufacturer whose only prescribed products are classified as Class I by the FDA, are exempt from pre-market notification under Section 510(k) of the federal Food, Drug and Cosmetic Act, and are sold over-the-counter without a prescription;
- Market Research and Surveys – bans payments for market research or surveys, other than a bona fide clinical trial or "systematic investigation";
- Patient Assistance Programs – prescribed products distributed pursuant to a Patient Assistance Program are now permitted gifts and not subject to reporting;
- Payments in conjunction with clinical trials – payments must be reported after the earlier of FDA approval or clearance or 4 calendar years from payment (used to be 2 years);
- Loans of medical devices – the allowable trial period is extended from 90 days to 120 days;
- Over the counter drugs and medical devices provided to health care providers for distribution to patients must be reported.
Stay tuned for a conference call on June 16th at 1pm EST. with the Vermont Attorney General's Office to discuss the draft 2011 Guide which should be issued in early June.