On March 4, 2011, the Vermont Attorney General’s office issued an update to its FY ’11 Guide to Vermont’s Prescribed Product Gift Ban and Disclosure Law. Through this update, the AGs office provided further clarification on issues raised in its 2/14/11 conference call.
The full update may be viewed on the Vermont Attorney General's website.
The following is a brief summary, in Q & A format, of the issues addressed:
Questions related to manufacturers:
Questions related to recipients:
- Q. Are specialty pharmacies that operate under the direction of one or more manufacturers to fill orders for the manufacturer “health care providers” under the statute?
- Q. In the Disclosure Form, the “Type of Recipient” must be reported. How should the various prescribers be reported on the form based on the set fields. Click here to download a sample FY 11 form to view the available fields.
Questions related to reporting
- Q. Can or should a wholesaler or marketer report its activities in the name of a manufacturer?
- Q. What if a distributor is independent of the manufacturer?
- Q. How can we submit data for non-licensed recipients or recipients without an ID number?
- Q. Are medical devices provided for demonstration or evaluation reported differently from medical devices that are loans or samples?
Questions related to clinical trials/samples
Questions related to nonprescription product:
Questions related to other Samples Reporting
- Q. Do samples – whether product, vouchers, or other items –distributed out-of-state to out-of-state recipients need to be reported?
- Q. For reporting purposes, who is the recipient of samples? The individual who requested the samples or the individual who signs for the samples?
- Q. Are vouchers created at a pharmacy considered the same as other vouchers?
- Q. Do samples that go directly to patients have to be reported?
- Q. How is product to be reported when it’s provided to an HCP for purposes of conducting an independent study that is neither a bona fide clinical trial nor a research project as such terms are defined in the Vt. Statute?
- Q. What if the number of vouchers or percent discount associated with a voucher is variable?
- Q. What if the reporting form is not clear how or where to report information I need to report?
If the non-profit is a subsidiary of the manufacturer, than any distributions made must be reported, whether or not the distributions are to indigent patient populations.
If distributions are made through a non-profit foundation that is a separate legal entity with a separate board of directors, that entity is not a manufacturer under the statute.
If the manufacturer has a marketing agreement with a company that is not a subsidiary, either the manufacturer or the company can report the expenditures. Regardless of who reports the expenditures, they must be reported under the manufacturer’s name.
No, even if the specialty pharmacy is licensed in VT, it is not a health care provider. Any reportable expenditures made by the pharmacy are reportable by either the manufacturer or the pharmacy, but not both.
|License Prefix||License Description||Type of Recipient|
|015||Dental Hygienist||Other Health Care Provider|
|025||Licensed Practical Nurse||Other Health Care Provider|
|026||Registered Nurse||Other Health Care Provider|
|047||Psychologist-Master||Other Health Care Provider|
|048||Psychologist – Doctorate||Other Health Care Provider|
|049||Nuclear Medicine Technologist||Other Health Care Provider|
|055||Physician Assistant||Other Prescriber|
|075||Licensed Nursing Assistant||Other Health Care Provider|
|089||Clinical Social Worker||Other Health Care Provider|
|101||RN with APRN Endorsement||Other Prescriber|
If a wholesaler or marketer (who would otherwise have to report) is acting at the direction of the manufacturer, either it or the manufacturer can report its activities in the name of the manufacturer, but both should not report.
If the distributor is independent of the manufacturer, it must report in its own name.
Over the next several months, the State of Vermont will assign ID numbers to institutional recipients and recipient organizations.
Until then, you can submit data using a non-licensed recipient’s Taxpayer ID; however, if you wish to do so, you must email each non-licensed recipient’s name and federal ID number as soon as possible to email@example.com, with “Federal ID” in the subject line.
A demonstration or evaluation unit provided to a health care provider must be reported at fair market value. Loans and samples of medical devices may be reported at $0 value.
Items, whether product or vouchers, that would otherwise constitute “samples,” but which are distributed through a clinical trial or research project, are properly reported as allowable expenditures rather than samples and Vermont will accept a $0 reported value for them.
[On the report form, choose “Other.” For “Nature,” indicate the type of sample (e.g., product or voucher). For “Purpose,” indicate “bona fide clinical trial” or “research project.” Then enter $0 for value.
At this time, the Attorney General will allow the reporting of nonprescription product or vouchers for nonprescription product that are properly categorized as permitted gifts to be reported as samples. However, the report must include the name of the prescription product with which the expenditure is associated, if any.
Yes, but only for those recipients who regularly practice in Vermont.
The recipient of product samples is the person who requested the samples, not the person who signed for them as is indicated as an alternative in the 12/27/10 Samples Guide.
Similarly, vouchers or other samples, other than product samples, should be reported as received by the ultimate intended recipient, even if left with front office staff a non-prescribing nurse.
Vouchers which are not created until the patient fills a prescription shall be reported as a voucher in the samples database; unlike the reporting of other vouchers, all such vouchers will have been redeemed.
No. Samples that go directly to patients do not have to be reported.
In such cases, if the independent study neither a bona fide clinical trial nor a research project as defined in the statute, the product shall be reported in the samples database.
In such cases, you are required to report the maximum amount or discount.
Use your best judgement. Vt. understands that the 2011 Samples Disclosure Form will not always easily or obviously accommodate the information you are trying to provide. If, through your reporting, it becomes clearer what categories would accommodate a greater variety of the samples being distributed, Vt. will change the form in the future.