Minnesota Administrative Rules

5620.0110 DEFINITIONS.

Subpart 1.

Scope.

As used in Minnesota Statutes, section 147.091, subdivision 1, paragraph (p), the following terms have the meanings given them.

Subp. 2.

Device.

"Device" means an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article including a component, part, or accessory, that as a completely assembled article exceeds $99 in cost and is:

A.

recognized in the official United States Pharmacopoeia and National Formulary and its supplements;

B.

intended for use in diagnosing disease or other conditions, or in curing, mitigating, treating, or preventing disease in a person;

C.

intended to affect the structure or function of the body of a person, and that does not achieve any of its principal intended purposes through chemical action within or on the body of a person and is not dependent upon being metabolized for the achievement of any of its principal intended purposes; or

D.

restricted under federal law to sale by or on the order of a licensed practitioner.

Nondurable medical equipment, meaning a supply or piece of equipment that is used to treat a health condition and cannot be reused, is excluded from this definition of device.

Subp. 3.

Drugs.

"Drugs" has the meaning in part 5600.0100, subpart 8.

Subp. 4.

Financial interest.

"Financial interest" means an asset that is directly owned or controlled by an individual or business and that has the potential to produce a monetary return.

Financial interest does not include the ownership of a building by a physician where space is leased to an individual or organization at the prevailing rate in a straight lease agreement or any interest held by a physician in a publicly traded stock.

Subp. 5.

Profit interest.

"Profit interest" means a financial amount received by the physician that exceeds the acquisition cost of a drug or device plus the cost of having the drug or device available.

Subp. 6.

Significant financial interest.

"Significant financial interest" means any financial interest as defined in subpart 4 that is equal to or greater than five percent of the whole or $5,000, whichever is the lesser amount.

Statutory Authority:

MS s 147.01

History:

14 SR 1774

Published Electronically:

June 11, 2008