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Minnesota Legislature

Office of the Revisor of Statutes

SF 3266

as introduced - 84th Legislature (2005 - 2006) Posted on 12/15/2009 12:00am

KEY: stricken = removed, old language.
underscored = added, new language.

Current Version - as introduced

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A bill for an act
relating to health; requiring manufacturers of certain recalled implantable
medical devices to be financially responsible for removal and replacement;
proposing coding for new law in Minnesota Statutes, chapter 604.

BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF MINNESOTA:

Section 1.

new text begin [604.111] RECALL OF IMPLANTABLE MEDICAL DEVICE.
new text end

new text begin new text end

new text begin Subdivision 1. new text end

new text begin Definitions. new text end

new text begin For the purposes of this section, the following
definitions apply:
new text end

new text begin (a) "Implantable device" means a medical device implanted in the human body,
including a pacemaker, defibrillator, heart valve, hearing device, or joint replacement.
new text end

new text begin (b) "Manufacturer" means a manufacturer of an implantable medical device sold in
this state.
new text end

new text begin (c) "Patient" means a resident of this state who has an implantable device removed
in the state due to a recall.
new text end

new text begin (d) "Provider" means a hospital, health care facility, or health care provider
performing services for payment to remove and replace an implantable device due to a
recall.
new text end

new text begin (e) "Recall" means a Class I or a Class II recall, as classified by the federal Food
and Drug Administration.
new text end

new text begin Subd. 2. new text end

new text begin Costs; responsibility of manufacturer. new text end

new text begin The manufacturer of an
implantable device that is the subject of a recall shall be financially responsible for all
costs incurred by a patient having the recalled implantable device removed and replaced
including:
new text end

new text begin (1) the cost of the replacement implantable device;
new text end

new text begin (2) the cost of any procedures to remove, replace, and dispose of the implantable
device;
new text end

new text begin (3) any other medical costs directly associated with the removal and replacement
of the device; and
new text end

new text begin (4) costs associated with a health complication resulting from the removal and
replacement of the implantable device up to $100,000, such as costs incurred while treating
an infection acquired during the removal and replacement of the implantable device.
new text end

new text begin Subd. 3. new text end

new text begin Payment; binding arbitration. new text end

new text begin (a) A provider shall submit a request
directly to the manufacturer for payment of the charges listed in subdivision 2. The
provider shall submit other costs not associated with the device recall to the patient or
the patient's health coverage program. The request for payment must reflect the rates that
would have been billed in the absence of this section, including any discounts offered
under Medicare, medical assistance, Veterans Administration programs, and other federal
and state health care programs, and any discounted rates received under the patient's
health coverage program.
new text end

new text begin (b) If the manufacturer and the provider cannot reach agreement on the financial
responsibility for replacing the implantable device, the manufacturer and the provider
shall submit the matter to binding arbitration. Within 60 days from the day the payment
request was submitted to the manufacturer: (1) the manufacturer must submit payment; or
(2) binding arbitration must occur between the manufacturer and the provider.
new text end

new text begin EFFECTIVE DATE. new text end

new text begin This section is effective for recalled implantable device
removals and replacements performed on or after the day following final enactment.
new text end