What happens when the world’s biggest medical device maker becomes a “health services provider”?BMJ 2018; 363 doi: https://doi.org/10.1136/bmj.k4917 (Published 26 November 2018) Cite this as: BMJ 2018;363:k4917
All rapid responses
Medtronic was contacted several times by The BMJ and asked to respond to specific criticisms raised in this story. They chose not to respond directly to the questions. On October 19 I sent a series of questions to Medtronic in response to which I received a phone call from Fernando Vivanco, senior director, corporate communications at Medtronic. Mr Vivanco declined to answer any of the questions asked. On November 12 Medtronic responded to the International Consortium of Investigative Journalists, to which The BMJ is a partner on The Implant Files project. In this ICIJ response, Medtronic did not respond to my particular questions. The company also stated that it would not respond to any further questions. Neither I nor my editor Rebecca Coombes received an email from Medtronic on October 20.
When I referred to the “diabeter” device I meant the Medtronic MiniMed insulin pump device and the article will be corrected accordingly.
In its rapid response, Medtronic complains that I said they “controlled” clinical protocols. But I didn’t actually say this. Instead, I quoted accurately Alberto Quintanar Hernández, director general of the Red Cross in Tijuana, who said protocols were developed in conjunction with Medtronic. This was fact-checked at the time.
As for Medtronic’s claim that they do not donate staff as part of their agreements, three doctors I interviewed claimed otherwise. In addition, two former Medtronic employees have filed suit against Medtronic claiming that their donation of staff comprised a form of kickback - an accusation I put to Medtronic, but which they declined to answer.
Competing interests: No competing interests
Re: What happens when the world’s biggest medical device maker becomes a “health services provider”?
I write to correct several inaccuracies about Medtronic in the article “What Happens When the World’s Biggest Medical Device Maker Becomes a ‘Health Services Provider’?” by Jeanne Lenzer, Associate Editor, of the BMJ.
We are particularly disappointed, given our prior interactions with the author, by the article’s lack of balance and the omission of our input (outlined below) that rebuts several assertions and clarifies that Medtronic does not control clinical protocols or purchasing decisions and that Medtronic does not donate staff or offer staff free of charge as part of our Integrated Health Solutions (IHS)) business model. These gross omissions and lack of balance negatively mislead your readers about the actual execution of these business models in practice.
Medtronic’s positions are not included despite our numerous communications to BMJ and the International Consortium of Investigative Journalists (ICIJ) to set the record straight on the intent of our IHS services business, which is focused on improving healthcare delivery for patients. The article also does not reference the business practices we have in place to avoid the very issues of which we are wrongly being accused. As such, the article is misleading and is not befitting a peer-reviewed journal, irrespective of whether the piece was intended to be a feature article or anything else.
Specifically, because Ms. Lenzer indicated she was working with the ICIJ, she had full access to Medtronic’s responses to ICIJ, including two letters to ICIJ, dated October 24th and November 12th, that respectively stated:
“As a healthcare company, Medtronic is committed to improving healthcare delivery in the U.S. and across the globe. The company’s IHS business aims to enhance efficiency of care settings, such as cardiac catheterization labs and operating rooms, while also optimizing healthcare delivery from the time a patient is referred for treatment to the time he or she has fully recovered. To accomplish this, we leverage data to highlight variations in clinical decision-making, and we manage processes to enable more standardized and effective decision-making amongst healthcare providers. This leads to better patient outcomes at lower costs.
In response to your question, our IHS business does not “stifle competition” or “limit options for patients.” We do not control or direct healthcare professionals’ decision-making when it comes to patient care, the indications for procedures, the use of technology in patient care, or the selection of specific medical devices. Any decision to utilize a Medtronic device through a given procedure is a decision made solely by healthcare providers. Throughout our engagement and beyond, these healthcare providers and their health systems retain full autonomy to decide which procedures are indicated for which patients, and which medical devices they will use from which companies. This business also operates behind a firewall structure that functionally separates it from Medtronic’s medical device businesses.”
In addition to the ICIJ, Medtronic also provided a direct response to the author in an email dated October 20th, which reiterated these same points above regarding the IHS business model and which addressed other inaccuracies.
To ensure that we are very clear, the following is Medtronic’s position regarding five misleading elements of BMJ’s article.
1. Medtronic does not control clinical protocols or purchasing decisions.
Our Integrated Health Solutions business focuses on improving healthcare delivery for patients. Throughout our engagement and beyond, healthcare providers and their health systems retain full autonomy to decide which procedures are indicated for which patients, and which medical devices they will use from which companies. We do not control or direct healthcare professionals’ decision-making when it comes to patient care, the indications for procedures, the use of technology in patient care, or the selection of specific medical devices, nor do we stifle competition or limit options for patients. IHS operates within the Medtronic IHS managed service organization (MSO), which is a separate business enterprise that houses the Medtronic services and solutions business and is unrelated to the manufacture and sale of medical therapies and products. IHS has firewalls that are designed to prevent the inappropriate flow of information to Medtronic’s medical device businesses, such as protected patient data and sensitive clinical operations data (e.g., pricing information), and help maintain independence from the device company — so the healthcare provider retains full control over clinical decision-making.
2. Medtronic does not donate staff or offer staff free of charge.
Staff employed by Medtronic to perform non-clinical operations within the customer’s health system are compensated for by the customer as a service offered in the contract.
3. Medtronic may finance or underwrite the purchase of certain medical equipment used in the hospital setting, and when we do, that equipment is fully reimbursed and paid for by customers.
As part of Medtronic’s overall service contracts with health care providers, HCPs may contract for hospital equipment. This equipment is included in the overall price of the contract and is paid for over the length of the contract. This may be done through financing or lease arrangements, which are common arrangements and contracting models for purchasing capital equipment in health care and other industries. The equipment is not free or given away in exchange for market share.
4. Diabeter is not a medical device.
“Diabeter” is not a medical device as referred to in the article. Diabeter refers to Medtronic’s diabetes management clinics, which are an example of our commitment to improving healthcare delivery. These diabetes management clinics provide comprehensive, cutting-edge care — supported by dedicated healthcare professionals and specialists — for more than 1,500 children and adults who are living with type 1 diabetes. The Diabeter clinics, located in the Netherlands and operated by a subsidiary of Medtronic, offer patients an independent specialized center where diabetes is the only focus of attention. Patients have a choice of medical therapies and a host of professional support services from endocrinologists, nutritionists, and psychologists. Physicians at these clinics use their medical judgment in selecting appropriate treatment for their patients. Medtronic is not involved in the physicians’ medical decision-making process, nor are any incentives provided for using Medtronic products. While the Diabeter Clinics are in their early stages, the results are promising, with improved clinical outcomes (better blood glucose control) and reduced costs.
5. Medtronic provided $206.90 in food and beverage expenses over a period of four years to Dr. Andres Smith Favela, the president of the board of the Red Cross of Tijuana.
The article states that Medtronic provided “gifts and payments” to Dr. Smith. As reflected in our records and on CMS’s Open Payments Data website, in the period between 2013 and 2017, Dr. Smith received reimbursement from Medtronic for food and beverage expenses in the amount of $206.90.
Medtronic is extremely proud of our joint venture with the Red Cross—one of the most respected aid agencies in the world—to help the underserved population of Tijuana. The Red Cross Hospital in Tijuana is a non-profit charitable institution established in 1991 to provide disaster relief and to help care for underinsured people.
In 2017, Medtronic and Red Cross Tijuana entered into an agreement to work together to help improve cardiac care at the hospital. These joint efforts have resulted in a new cardiac suite, significantly expanded cardiac services, and an improved EMS system. While our partnership is still in its infancy, we have great hopes for the continued success of the program in improving access to quality cardiac care for the underserved population of Tijuana.
We believe that partnerships between industry and healthcare providers, such as the program in Tijuana, will be instrumental in reducing healthcare costs and improving quality of, and access to, healthcare. We are proud of our efforts and those of our partners to find innovative ways to tackle the cost, quality and access issues impacting healthcare systems around the world, and we will continue to advance these partnerships – with all of the appropriate conditions identified above – to advance patient care and improve patient outcomes.
1. See https://openpaymentsdata.cms.gov/physician/114887/payment-information (last visited November 29, 2018).
Competing interests: Employee of Medtronic