1.1 	A bill for an act
1.2 	relating to health; requiring manufacturers of certain recalled implantable 
1.3 	medical devices to be financially responsible for removal and replacement;
1.4 	proposing coding for new law in Minnesota Statutes, chapter 604.
1.5 	BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF MINNESOTA:

1.6 	Section 1. [604.111] RECALL OF IMPLANTABLE MEDICAL DEVICE.
1.7 		Subdivision 1.Definitions. For the purposes of this section, the following 
1.8 	definitions apply:
1.9 	(a) "Implantable device" means a medical device implanted in the human body, 
1.10 	including a pacemaker, defibrillator, heart valve, hearing device, or joint replacement.
1.11 	(b) "Manufacturer" means a manufacturer of an implantable medical device sold in 
1.12 	this state.
1.13 	(c) "Patient" means a resident of this state who has an implantable device removed 
1.14 	in the state due to a recall.
1.15 	(d) "Provider" means a hospital, health care facility, or health care provider 
1.16 	performing services for payment to remove and replace an implantable device due to a 
1.17 	recall.
1.18 	(e) "Recall" means a Class I or a Class II recall, as classified by the federal Food 
1.19 	and Drug Administration.
1.20 		Subd. 2.Costs; responsibility of manufacturer. The manufacturer of an 
1.21 	implantable device that is the subject of a recall shall be financially responsible for all 
1.22 	costs incurred by a patient having the recalled implantable device removed and replaced 
1.23 	including:
1.24 	(1) the cost of the replacement implantable device;
2.1 	(2) the cost of any procedures to remove, replace, and dispose of the implantable 
2.2 	device;
2.3 	(3) any other medical costs directly associated with the removal and replacement 
2.4 	of the device; and
2.5 	(4) costs associated with a health complication resulting from the removal and 
2.6 	replacement of the implantable device up to $100,000, such as costs incurred while treating 
2.7 	an infection acquired during the removal and replacement of the implantable device.
2.8 		Subd. 3.Payment; binding arbitration. (a) A provider shall submit a request 
2.9 	directly to the manufacturer for payment of the charges listed in subdivision 2. The 
2.10 	provider shall submit other costs not associated with the device recall to the patient or 
2.11 	the patient's health coverage program. The request for payment must reflect the rates that 
2.12 	would have been billed in the absence of this section, including any discounts offered 
2.13 	under Medicare, medical assistance, Veterans Administration programs, and other federal 
2.14 	and state health care programs, and any discounted rates received under the patient's 
2.15 	health coverage program. 
2.16 	(b) If the manufacturer and the provider cannot reach agreement on the financial 
2.17 	responsibility for replacing the implantable device, the manufacturer and the provider 
2.18 	shall submit the matter to binding arbitration. Within 60 days from the day the payment 
2.19 	request was submitted to the manufacturer: (1) the manufacturer must submit payment; or 
2.20 	(2) binding arbitration must occur between the manufacturer and the provider.

2.21 	EFFECTIVE DATE. This section is effective for recalled implantable device 
2.22 	removals and replacements performed on or after the day following final enactment.