Greetings!
My name is Amanda Hubbard and I am an uninsured patient with an Implantable Cardioverter Defibrillator manufactured by Medtronic. I will have had my ICD for 2 years as of November 18, 2012, and have been uninsured for about 20 months. The ICD was placed for primary prevention of Sudden Cardiac Arrest due to congenital Long-QT Syndrome.
My ICD came with a CareLink monitor, which is a bedside monitor that downloads information from my device and sends it to Medtronic at regular intervals. Medtronic then takes my data, summarizes it, and forwards it to my doctor's office via an online portal. This allows my clinic to monitor me remotely, see the status of my device, look for lead problems and rhythm abnormalities, etc.
My clinic has a policy of removing patients from their arrhythmia registries if they do not keep regular appointments, and I was uninsured and could not pay, so I subsequently failed to keep my appointment schedule. For more than a year I simply assumed that my device was no longer monitored and hoped that the internal device-checks on my ICD would be enough to let me know if there was a problem with my device.
But in early August 2012 I started wondering what happened to my device data if there was no clinic to receive it, and if my device was indeed functioning properly, and so I performed a manual interrogation of my device with my CareLink monitor and then sent this email to Medtronic via the contact form on their website:
-----Original Message-----
From: Amanda S. Hubbard
Subject: Medtronic Form Submission
Product: Defibrillators (Implanted) Category: Patient, Friend or Family Member Question/Comment: Dear Medtronic,
I have a Medtronic Secura DR Cardioverter Defibrillator implanted for primary prevention of SCA.
I have a CareLink monitor, which continues to send transmissions. However, I am not currently under the care of a cardiologist because I am uninsured, and so I cannot ask my provider for my CareLink transmissions.
I am aware that HIPAA guarantees my right to access my health information, and would like to request copies of all the device interrogation data collected by Medtronic over CareLink since November 17, 2010.
Thank you for your attention,
Amanda S. Hubbard
Their response was this:
Dear Amanda Hubbard,
When you transmit via CareLink, the results of the transmission go directly to your doctor s office and are not sent to Medtronic. For this reason, you will need to contact your physician s office that you were previously at for the results.
If you are not sure which office to contact, please email again or contact Medtronic CareLink Patient Services at (800) 929-4043 and press option 2 for assistance. Our staff is available to take your call Monday through Friday from 8:00 a.m. to 5:00 p.m. Central Time.
Regards,
Michael-CareLink Patient Services Medtronic, Inc.
I found this response blatantly misleading, and so shortly thereafter I sent this email to Medtronic:
From: Amanda S. Hubbard Date: Sun, Sep 9, 2012 at 9:20 PM Subject: ICD patient concerns To: Jaimie A. Mattson Cc: Darrell E. Johnson
Dear Ms. Mattson and Mr. Johnson,
I received your email addresses from Hugo Campos, to whom I reached out with questions about access to my ICD interrogation information.
I received my Medtronic ICD in November 2010 for primary prevention of SCA due to Congenital Long-QT Syndrome. About 4 months after my ICD was placed, my insurance expired and I was unable to find coverage due to my pre-existing condition. As a result, I did not go to my clinic, did not have an in-office interrogation, and did not see my EP for more than a year. However, I continued to keep my CareLink monitor connected, and assumed that my device was still monitored, performing its checks, and sending the information to Medtronic. I expected that I would be notified if there was a problem with my device.
On August 1, 2012, in an attempt to receive copies of my interrogation information, I sent a manual transmission through via Carelink and then followed up with an email to Medtronic Customer Services via the contact button on your website. Please scroll to the bottom of this email for a copy of that communication, as well as Medtronic's response to my inquiries.
I found Medtronic's "official" response unsatisfactory for several reasons. First, the CareLink remote monitoring unit, which is labeled "Property of Medtronic," is the device responsible for collecting my patient data. The telephone number my CareLink monitor uses to transmit my interrogations is a Medtronic number, and not that of my clinic. Ergo, the interrogations go through Medtronic servers and are available at Medtronic, not directly to my clinic as your CSA suggested. So, I'd like an explanation for Medtronic's misleading response.
Second, I asked as a patient who does not have access to a clinician. I asked,* "*If I do not have access to a clinic, how can I get my data?" Medtronic's response did not address my question. Again, if I do not have access to a clinic, how can I get my interrogation information?
Finally, I have discovered that I have had an RV lead problem for more than a year and will have to undergo lead revision or replacement. This lead problem did not trigger a care alert, but was evident upon examination of my r-wave and threshold values. I'm sure you would agree that if I had direct access to my CareLink remote transmissions, I could have caught this problem and sought remedy a year ago. Instead, I have been walking around with an potentially dangerous lead problem for more than a year simply because I am unable to get access to my own reports without going through a clinic. I hope you will take these concerns very seriously. Patients have the right to choose their device companies, and I chose Medtronic. I am only 35 years old, and will likely have an ICD for the rest of my life. And I will not hesitate in the future to choose whichever company will offer me safety, reliability, *and direct access to my interrogation s . * It's my data, my device, my body, and my future. Medtronic should not stand in the way of my ability to take care of myself.
Sincerely,
-- Amanda S. Hubbard
This exchange led to a phone conversation with Jaimie Mattson about the reasons Medtronic won't release interrogation information directly to patients. And after a number of weeks, she finally sent me an email outlining the supposed regulations which are prohibiting Medtronic from allowing me, the originator of the data, to get direct access to my own interrogation reports:
Hello Amanda,
I hope you are doing well. I wanted to follow-up with you since our phone call on September 14th. First, I hope you are healing and your lead revision surgery went well and was successful. I was very happy to hear that you sought medical care after learning from your physician that your R-waves and thresholds were not normal.
I wanted to clarify some of the information we spoke about in the phone. You wanted to know what statute number governed the process to distribute data. The FDA regulatory status of CareLink is one of a number of important reasons Medtronic does not provide CareLink device data directly to a patient. Medtronic's implantable cardiac devices and accompany data reports are currently designed, intended and approved for use only by licensed medical practitioners, not by patients. The FDA approved these prescription devices on the basis that physicians will be managing the patients, their disease, their device and their device data. The basis for that approval includes the understanding that the CareLink patient data is provided to a physician rather than directly to the patient. That premarket approval by FDA is mandated by the Title 21 Code of Federal Regulations Part 814 Premarket Approval.
*Title 21 Code of Federal Regulations (CFR) Part 814, Premarket Approval: * Premarket approval (PMA) is the FDA process of scientific and regulatory review to evaluate the safety and effectiveness of Class III medical devices. Class III devices are those that support or sustain human life, are of substantial importance in preventing impairment of human health, or which present a potential, unreasonable risk of illness or injury. Due to the level of risk associated with Class III devices, FDA has determined that general and special controls alone are insufficient to assure the safety and effectiveness of class III devices. Therefore, these devices require a premarket approval (PMA) application under section 515 of the FD&C Act in order to obtain marketing clearance.
Medtronic's compliance with the Health Insurance Portability and Accountability Act of 1996 (HIPAA) for CareLink supports the basis on which the FDA approved using CareLink to provide device data to physicians. The Protected Health Information about a patient in CareLink is considered part of the medical record maintained by the physician that is responsible for that CareLink patient.
Per HIPAA requirements, Medtronic has a business associate agreement (BAA) with physicians who use CareLink. This BAA is essentially a specialty confidentiality agreement that controls how Medtronic can use and disclose CareLink patient information. Consistent with the basis for FDA approval of CareLink, the BAA does not permit Medtronic to provide the patient data directly to the patient. As the legal owner of the medical record, the physician (or clinic) is the one to respond to a patient's request for access to the medical record, including CareLink data.
The above are the most important reasons why Medtronic consistently refers patients to their physicians to obtain their CareLink data. Medtronic is confident that all physicians will appropriately respond to their patient's request.
As we discussed, Medtronic is interested in looking at ways to work with patients and their clinicians to connect the patient with their data. We just launched an updated CareLink patient website that allows patients to see their appointments for scheduled transmissions. Clinicians have to opt-in for this service and it's our first step at exploring this journey.
Thank you for the phone call and for contacting me directly. I would be happy to continue our conversations and find ways to work together toward s our common goal.
Thank you, Jaimie Mattson
Obviously, I find this all incredibly frustrating and downright wrong. I want access to my own health data. I want the same level of access to my private health information as Medtronic is providing the clinics and providers. I want to be able to opt out of being data-mined by my own device company. I should not be treated like a lab-rat simply because I have a heart condition which requires medical intervention.
Medtronic is not interested in helping me get direct access to my private health information. They continue to tell me to "go through a clinic." But I see no reason that I should have to pay (or beg) a proxy to get access to data which originates from inside my body, is collected by a device I paid for and own, and which is integral to my life and death.
Right now I have no options.
I hope you can help.
Sincerely,
Amanda S. Hubbard