Clinical guidelines put forth by medical associations are usually intended to guide treatment decisions, but just how much influence do guidelines have over the adoption and reimbursement of new technologies?
This question recently sparked a debate among a group of experts during a virtual panel organized to discuss updated guidelines released late last year for the management of U.S. patients with ventricular arrhythmias and the prevention of sudden cardiac death. The discussion focused, in particular, on the inclusion of subcutaneous implantable cardioverter-defibrillator (S-ICD) therapy.
Most commercial payers look to peer-reviewed literature when developing coverage decisions for new medical devices, according to Jim Cross, MD, the former head of national medical policy and operations who is now a private consultant.
"When the literature is not all that defining in a particular question of who should get the device, then they do look at the appropriate professional societies to guide them along," Cross said.
For example, the guidelines published in October 2017 by the American Heart Association (AHA), American College of Cardiology (ACC), and the Heart Rhythm Society (HRS) included the use of Boston Scientific's Emblem S-ICD as it was the first time the guidelines had been updated since FDA approved that device back in 2012. The European Society of Cardiology beat its U.S. counterparts to the punch in 2015 by including the S-ICD in its guidelines that year.
According to Cross, most of the major private payers lump all ICDs into the same coverage policy, with S-ICDs being a subset with more or less the same criteria as for the transvenous ICDs. Good in theory, but that certainly does not seem to be the reality for physicians who have come to consider S-ICDs to be an important treatment option for a lot of their patients.
"I've run into too many situations where the payers are denying coverage for something that's been FDA approved for six years and being deemed investigational," countered Bradley Knight, MD, medical director of cardiac electrophysiology at Northwestern Memorial Hospital.
If the patient is going to get an implantable defibrillator either way and the costs of a subcutaneous ICD is comparable to the cost of a transvenous ICD system, Knight said, what difference does it make to the payer which device the physician and patient decides is best?
"For devices, the level of evidence that is typically needed for FDA approval is not at the level of evidence required for a drug," Cross said. While a pre-market application approval is based on more rigorous data than a 510(k) clearance, even devices approved through the PMA process tend to fall short of payer expectations in terms of developing a clinical policy, he said.
"So the payers are all going to look for additional peer-reviewed evidence that supports that technology, and if it is not all level I evidence and much of it is level II prospective evidence then they're going to look to the societies," Cross said.
The problem with that process, pointed out Joshua Cooper, MD, director of cardiac electrophysiology at Temple University Health System, is that peer-reviewed literature doesn't cover complications that have a zero occurrence rate.
"This whole discussion really revolves around the lead," Cooper said, meaning that one of the primary benefits of subcutaneous ICD systems is that there is no lead in the bloodstream as there is with the more conventional ICD systems, and leads are the weakest part of transvenous ICDs.
"The various ways that the lead can be problematic for transvenous systems are, for the most part, absent for subcutaneous ICDs," Cooper said. "The risk of infection is lower if the lead is not in the blood space. The risk for thrombus is zero if the lead is not in the blood space. The risk of scaring or narrowing vessels is zero if the lead is not in the blood space."
"In the medical literature we often see reports of things that happen and there is a much lower incidence of people reporting things that don't happen," he added. So if insurance companies are basing coverage decisions on what they see in the published literature, they, of course, will not find as much evidence around S-ICDs as there is for ICDs.
Both Knight and Cooper were early adopters of the S-ICD and both doctors agreed that there are several types of patients who are better suited for the subcutaneous approach than the transvenous approach.
"Patients who have no veinous access, previous infections, the need for their vascular space for other reasons like chemotherapy ports and dialysis, and patients with many years ahead of them would be the low-hanging fruit patients I would consider an S-ICD," Cooper said.
He explained that young patients, in particular, may benefit from an S-ICD rather than an ICD because the leads used in conventional ICDs pose a greater risk the longer they sit in the bloodstream.
"As we move forward to getting more experience with the S-ICD option, and see how it works in different populations and the incidence of new arrhythmias in patients who have never had one before, my personal practice has been to shift to considering a subcutaneous ICD after having a long discussion with the patient about the pros and cons of a transvenous lead versus a purely subcutaneous system," Cooper said.
Knight agreed and said that for patients who need an implantable defibrillator, he actually considers the subcutaneous option first unless there are reasons the individual patient should not get an S-ICD.
Stephen Hammill, MD, a member of the AHA/ACC/HRS guideline writing committee, a former HRS president, and a professor of medicine at the Mayo Clinic, explained that the guidelines are updated about once every six to 10 years and the writing committee includes 19 members who have no relationships with industry to avoid conflicts of interest.
After the committee writes the guidelines they are sent out to 36 official reviewers from each of the participating societies and then refined based on reviewer input.
"For this go around with the subcutaneous sudden cardiac death guidelines there were over 1,000 comments that had to be individually reviewed and addressed and the guidelines were then altered based on that input," Hammill said.