NEWS & EVENTS

Clarification to Vermont’s Prescribed Product Gift Ban and Disclosure Law

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:

Answer:

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.

Answer:

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.

Answer:

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.

Answer:

Please see the following table for mapping purposes.
License Prefix License Description Type of Recipient
015 Dental Hygienist Other Health Care Provider
016 Dentist Other Prescriber
025 Licensed Practical Nurse Other Health Care Provider
026 Registered Nurse Other Health Care Provider
030 Optometrist Other Prescriber
031 Osteopathic Physician-Limited Doctor
032 Osteopathic Physician Doctor
033 Pharmacist Pharmacist
042 Physician Doctor
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
056 Podiatrist Other Prescriber
060 Physician-Limited Temp. Doctor
075 Licensed Nursing Assistant Other Health Care Provider
089 Clinical Social Worker Other Health Care Provider
101 RN with APRN Endorsement Other Prescriber

Answer:

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.

Answer:

If the distributor is independent of the manufacturer, it must report in its own name.

Answer:

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 prescribedproducts@atg.state.vt.us, with “Federal ID” in the subject line.

Answer:

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.

Answer:

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.

Answer:

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.

Answer:

Yes, but only for those recipients who regularly practice in Vermont.

Answer:

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.

Answer:

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.

Answer:

No. Samples that go directly to patients do not have to be reported.

Answer:

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.

Answer:

In such cases, you are required to report the maximum amount or discount.

Answer:

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.

Medispend Marketing


Posted on Mar 17, 2011, 10:31:09 AM

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