Syncardia Systems LLC, of Tucson, Ariz., has petitioned the Centers for Medicare and Medicaid Services (CMS) to drop the coverage with evidence development (CED) mandate for artificial hearts, stating that multiple studies have demonstrated that artificial hearts meet the reasonable and necessary standard. Syncardia said its temporary Total Artificial Heart (TAH-t) should thus be available “unencumbered by the existing requirement for evidence development,” a change that could modestly bolster utilization and sales of these devices.

CMS issued a national coverage determination (NCD) for artificial hearts in 2008 for bridge-to-transplant (BTT), at which point the agency had decreed that patients be enrolled in the Intermacs registry. The NCD for artificial hearts under Section 20.9 of the Medicare coverage manual cites artificial hearts and related devices, while the policy specific to ventricular assist devices (VADs) appears in the coverage manual under section 20.9.1. The coverage policies received distinct review indices from the Coverage and Analysis Group, with artificial hearts under CAG-11453 while VADs appear under CAG-00432.

CMS lists the petitioners as both Syncardia and “Abbott,” the latter of which acquired the Heartmate series of VADs in its acquisition of St. Jude Medical in 2017. St. Jude in turn had acquired Thoratec, the originator of the Heartmate device, in 2015.

Request harkens to June 2018 meeting

Judy Skroback, Syncardia’s director of clinical research, said in the April 29, 2019, request that the petition was a follow-up to a meeting that took place in June 2018. The petition seeks an end to the CED requirement for the company’s 70 cc artificial heart when used to bridge the patient to transplant. Skroback cited in particular a study appearing in the Journal of Heart and Lung Transplantation (JHLT) said to cover Intermacs patients aged 19 and older over a period of 11 years. She said this population covers nearly four in five of all U.S. patients receiving the TAH-t over that same term, adding that two thirds of the patients in that cohort who were “facing certain death” had survived to a year. She noted further that the demand for heart transplant continues to exceed the supply by significant margins.

Skroback also pointed out that the only alternatives to total artificial hearts are ventricular assist devices (VADs), and that the only FDA-approved pulsatile biventricular VADs were discontinued in 2016. The remaining continuous-flow VADs are approved by the FDA for only one ventricle and hence their biventricular usage is off-label. Intermacs data from 2017 suggest that biventricular VAD usage carries a mortality rate of 49% at a year compared to the 35% death rate for artificial hearts. One patient has survived five years on the TAH-t and is currently aged 65 years.

The FDA in 2015 granted Syncardia an investigational device exemption for the 70 cc model of the TAH-t as destination therapy, three years after FDA approval as a humanitarian use device (HUD). The 50 cc model was approved in 2013 as a HUD device for destination therapy, while the portable drive unit, the Freedom driver, was approved in June 2014.

While VADs can be used for patients with biventricular heart failure, Skroback said this is typically done only for patients who cannot enroll in a study for the TAH-t. CMS has designated 65 centers for implant of the artificial heart.

CMS, FDA wary of large enrollment at single site

Skroback told BioWorld that the CED requirement was in large part a reflection of the FDA post-approval study (PAS) requirement. The FDA’s questions about the device revolved largely around the fact that 85% of the enrollees in the pivotal study for the TAH-t were enrolled at a single site, and thus both agencies were concerned about whether the results of those studies could be reliably extrapolated to other clinical sites.

The JHLT study provided CMS with the data the agency was looking for regarding the registry requirement, Skroback said, adding, “at that time, CMS indicated they were backlogged” with national coverage requests and were prioritizing such requests.

“We are anticipating [FDA] approval for our 50 cc Total Artificial Heart very soon” for BTT, Skroback said, which would make the device commercially available for two underserved populations, women and children. This version of the TAH-t is commercially available in the European Union and Canada, although Skroback noted that the company must jump through the same hoops as other device makers when it comes to reestablishing certification in the U.K.

While the removal of the CED requirement might not boost sales volumes by large margins, Skroback said, “I think we’ll have an uptick in volume in children’s hospitals” for the 70 cc model. “We historically have had the issue that most of our centers will enroll only one or two patients over the life of the study,” she said, adding that there may be a few centers that find it more economical to practice the device should the CMS opt to pull the CED mandate.

Mary Norine Walsh, past president of the American College of Cardiology, told BioWorld that the CED requirement does not affect most hospitals much. She added, however, that there are fewer centers accredited for implant of the TAH-t than are accredited for VAD devices. Walsh said the availability of hearts for transplant spiked significantly as the opioid crisis crested, but that demand for hearts for transplant nonetheless exceeded availability.

Walsh also said that while advances in the technology have been a tremendous benefit for patients, the field is probably a decade from a truly independent mechanical artificial heart due in large part to the battery problem.

Walsh observed that CED requirements are common stock in the world of cardiology even if CMS has dropped this requirement in a few instances. “I can’t predict what CMS will do, but I wouldn’t think they’d be in in hurry to change” its mind in this instance, based on past experiences. She said that most cardiology centers continue to forward patient data to the related registries even after the CMS drops the underlying CED requirement.

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