Advancing Health Policy

KEY POINTS

• Our mission at Medtronic is to alleviate pain, restore health, and extend life. Our government interaction and lobbying efforts are not only consistent with that mission, but they advance it in important ways that help patients.
• To accomplish our goals of advancing patient health, Medtronic must maintain a constructive dialogue with government officials who have a significant impact on healthcare policy.
• Medtronic supports policies that improve patients’ access to life saving and life enhancing technology, healthcare system efficiency, and sustainability in the treatment of patients with our therapies.
• One example of Medtronic’s work with regulators and legislators is the Humanitarian Device Exemption (HDE), which Medtronic believes is critical for ensuring that life-saving medical devices are available to patients suffering from serious but rare diseases.
• Medtronic adheres to all federal and state laws, including requirements related to disclosure of government interaction and lobbying. Over the past 10 years, Medtronic’s activities related to government interaction and lobbying have remained relatively static, even though the company has nearly doubled in size over that same time period.

Overview

1. Government Interaction as Part of Our Mission to Help Patients
   
   

   Our mission at Medtronic is to alleviate pain, restore health, and extend life. Our government interaction and lobbying efforts are not only consistent with that mission, but they advance it in important ways that help patients.

2. Need for a Healthy Dialogue with Government Officials
   
   

   To accomplish our goals of advancing patient health, Medtronic must maintain a constructive dialogue with government officials who have a significant impact on healthcare policy. Many of these efforts have been directed at developing value-based payment and delivery system initiatives that are intended to improve healthcare outcomes while reducing costs to patients and payors. In pursuing these goals, Medtronic adheres to all federal and state laws, including requirements related to disclosure of these activities.

3. Humanitarian Device Exemption Example
   
   

   One example of Medtronic’s work with regulators and legislators is the Humanitarian Device Exemption (HDE), which provides an alternative approval method for devices intended to treat a rare disease or condition. This important regulatory pathway can make life saving and life enhancing technology available to small populations of patients who may otherwise lack treatment options. The HDE regulatory requirements are designed to take into account the small patient population and need for treatment options while still ensuring safety.

   Medtronic believes that the HDE is critical in ensuring that life-saving medical devices are available to patients suffering from serious but rare diseases, for which treatments may not otherwise be commercially viable. Examples of conditions treated by Medtronic therapies and devices under an HDE include chronic, intractable nausea and vomiting secondary to gastroparesis in diabetic patients or of idiopathic etiology; chronic intractable (drug refractory) primary dystonia; and chronic, severe, treatment-resistant obsessive compulsive disorder in certain adult patients.

4. Adherence to Disclosure Laws, No Significant Increase in Lobbying-Related Activities
   
   

   Medtronic adheres to all federal and state laws, including requirements related to disclosure of government interaction and lobbying. Over the past 10 years, Medtronic’s activities related to government interaction and lobbying have remained relatively static, even though the company has nearly doubled in size over that same period of time.

See also:

• Compliance and Responsible Promotion
• Medical Device Regulations
• Value-Based Healthcare
• Integrated Health Solutions