Drug-coated balloon (DCB) angioplasty devices have been categorised by the US Centers for Medicare and Medicaid Services (CMS) into the same billing code as plain balloon angioplasty, following the expiration of the technology’s transitional pass-through and new technology add-on payments on the 1st of January 2018. The decision not to create a separate reimbursement code for DCBs comes to the surprise and disappointment of a wide range of stakeholders and advocates, from industry to public advocacy groups.
The conflation of the two technologies into the same ambulatory payment classification has caused protests from scientists, physicians, societies, public advocacy groups and industry alike, who argue that the decision will indirectly discourage DCB use despite evidence of superiority compared to plain angioplasty.
A recent viewpoint article published in the Journal of the American College of Cardiology (JACC): Cardiovascular Interventions calls the ruling “arbitrary” and “disappointing”, urging “all who advocate for patients with peripheral artery disease” to engage on CMS decisions regarding payment.
Vascular News spoke to Mehdi Shishehbor (Case Western Reserve University School of Medicine, University Hospitals, Cleveland, USA), first author of the article, who finds the decision both puzzling and alarming. “There is Level 1 evidence from three randomised controlled trials with three different devices, showing clearly that drug-coated balloons compared to angioplasty alone is superior”, he says. “We [Shishehbor and colleagues] are puzzled as to why the CMS would treat DCBs as being the same as angioplasty, because by not giving it a new billing code, the CMS is implying that DCBs and angioplasty are the same. We are just dumbfounded. I have no idea why they believe that.”
Although DCB treatment costs are significantly higher than angioplasty use per-treatment, Shishehbor points to higher long-term costs of reintervention rates and continued care stemming from the lower patency rates of plain angioplasty. Grouping the two under one APC billing code, the fear is that patients who are uninsured or relying on Medicare and Medicaid will not receive DCB treatment, as hospitals pay out of pocket for the higher costs of the device.
The CMS can allow innovative device technologies that are too novel to be included in regular coverage, to instead be covered over a short-term period under the transitional pass-through add-on payment and new technology add-on payment categories. This ensures patients gain access to beneficial new treatments while the CMS gather data to make a decision on its long-term ambulatory payment classification (APC), or billing code. The pass-through phase usually lasts for up to two years, and Shishehbor notes that this period is rarely extended. In the JACC article, Shishehbor et al write that the CMS “should be applauded for approving additional DCB coverage through [add-on payments], recognising the incremental clinical benefits afforded by DCB compared with traditional uncoated angioplasty for patients with peripheral artery disease.”
As the pass-through and new technology add-on payment phase came to an end, however, the decision was made to package DCB device treatment costs into an existing category for angioplasty—surprising professional societies, physicians, public policy organisations and medical centres who argued against the idea “out of concern over unintended patient consequences”, write Shishehbor et al. What should have been done, they argue, was to create a new APC category or assign the device to a “more appropriate APC category”.
The unintended consequences
In the long-term, Shishehbor et al argue that elderly and disadvantaged patients who rely on Medicare and Medicaid will be assigned to suboptimal treatment with plain angioplasty.
“This policy in the USA affects everyone over the age of 65”, Shishehbor told Vascular News, “because the majority of these patients—male or female and regardless of race—get their insurance through the Medicare system. So every single patient over the age of 65 who relies heavily on Medicare as their insurance, which is a majority of the population, may be affected by this. It also affects those who do not have insurance, or rely on Medicaid as insurance.”
“For these patients it is very unlikely that they would receive treatment with a technology that costs 5–6 times more than the other technology, as the hospital would have to pay out of their own pocket in order to use it”, Shishehbor said. He added that in 2018, the uncoated balloon alternative, which physicians are likely to fall back on for these patients, “is not something that is clinically appropriate in most cases—if not all”.
Chairman of the NCVH, Craig Walker, voiced his opposition on the change when it was proposed in 2017, and encouraged physicians to submit public comments. He said at the time that the proposed payment structure (now implemented) “would not adequately reflect the added costs of DCB and could adversely impact access for Medicare beneficiaries given the difference in costs between a plain balloon and DCB. The clinical benefits and cost effectiveness of DCB angioplasty have been well-established through randomised controlled trials and large-scale, population based observational studies. CMS’ approval of both inpatient and outpatient temporary add-on payments for DCB was in recognition that DCBs represent a significant clinical improvement in the treatment of PAD relative to plain balloon angioplasty catheters when compared to drug coated balloon therapy.”
“I believe an appropriate payment structure after the expiration of these add-on payments is important to avoid patient access barriers to a technology that reduces repeat interventions for patients and health care costs to Medicare.”
A fee-for-service system of care
Describing the disconnect described between the evidence of DCB superiority and the failure to designate it to a new APC category, Shishehbor explained it is due to the guidelines which inform CMS’ decisions. “The bigger issue comes down to the fact that this is really not the CMS’ fault. These are rules that are set by Congress and by the government.”
“When CMS wants to give something a pass-through code, the rules say they need to look whether clinically, that technology offers something superior. But for the regular billing code in the second phase, there is no rule that says the CMS need to look at efficacy. They only need to look at cost.”
The CMS responded to the request that a new reimbursement code be created for DCBs, explaining that their decision is based on “a prospective payment system that relies on the principles of averaging, with some cases in an APC being more costly than others (and some being less costly)”.
These principles however, as Shishehbor maintains, are problematic. “What they [the CMS] say is they believe in the concept of averaging”, Shishehbor told Vascular News. “The idea is, sometimes physicians use angioplasty and sometimes physicians use DCBs, and over time the cost kind of averages out. That would be true if DCB and plain balloons were the same, but they are not the same. A drug-coated balloon is much more superior—not only from the standpoint of patency, but also from the standpoint of patient quality of life and even long-term cost, because as patients come back for reinterventions due to their lower patency plain angioplasty, this affects cost to the healthcare system.”
“This principle is outlined by Congress and by the law, and that rule fundamentally is what we need to change if we want to move towards a value-based system rather than a fee-for-service system.”
The role of industry
Not alone in voicing disagreement with the reimbursement code decision for DCB devices, Sheshehbor et al’s call to action is joined by industry actors and stakeholders. Mark Pacyna, VP and GM of the Peripheral business in Medtronic’s Cardiac and Vascular Group, recently released a statement in response to Shishehbor et al, referring directly to the article. “As discussed in the JACC article”, Pacyna says, “DCBs serve as a cost-effective solution to safely and effectively treat femoropopliteal disease, while also reducing rates of reintervention. While the expiration of CMS’ transitional pass-through add-on payment for DCBs was anticipated, data has proven that drug coated balloons offer economic and clinical value.” He concluded, “Medtronic and our collaborating partners will continue to pursue appropriate reimbursement for DCB procedures and ensure access to this proven therapy that improves outcomes and delivers long-term savings to health systems and payers.”
Shishehbor hopes that through collaborative engagements between societies, public advocacy groups and scientists, their concerns can be communicated to the CMS and influence the upcoming reevaluation of DCB reimbursement.
Regarding the role of industry partners in this collaborative response, Shishehbor comments he is aware that industry is engaging CMS on their own, “because they also believe that something has to be done”. To his knowledge however, there is no direct collaboration between industry and people like Shishehbor, “who are advocating on behalf of my patients and on behalf of my profession” rather than for financial reasons. However, he says, “They are fighting on the right side of the isle, fighting for something that I believe as a scientist and as a physician, is the right thing to do. […] Industry obviously wants these devices to be paid for by the government, and we do too.” In this sense, he says, they are aligned.