The Centers for Medicare and Medicaid Services have proposed new policy that could expand the use of transcatheter aortic valve replacement procedures, touting that it may provide more flexibility for starting and maintaining TAVR programs.
The original National Coverage Determination for TAVR procedures was cleared in 2012, when the technology and associated procedure was still new. The new policy from CMS looks to update requirements based on new information about the safety and viability of the procedures.
The new proposal, released yesterday, would reduce the number of cardiac surgeons required to independently examine and evaluate patient suitability for open aortic valve replacement surgery or TAVR from two to one.
“We believe this modification is appropriate given the advancements and progress made since 2012 as TAVR becomes more widely performed,” CMS wrote in its proposal.
Volume requirements for existing TAVR programs at hospitals looking to receive CMS reimbursement were raised slightly, according to the new proposal. Previously, hospitals were only required to perform 20 aortic valve replacements per year or 40 per two years – that requirement has been more than doubled to either 50 AVRs per year or 100 AVRs per two years.
For new programs looking to begin TAVR programs, the volume requirements stayed mostly the same, but language was shifted from 50 total AVRs per year to 50 open heart surgeries in the year prior to the program launch and at least 20 aortic valve related procedures in the two years prior to launch.
“When reassessing this requirement, CMS endeavored to balance ensuring hospitals have the experience and capabilities to handle complex structural heart disease cases while limiting the burden and barriers unnecessary requirements may have on both hospitals and patients flexibility. Therefore CMS proposes to maintain the annual volume of cases (≥ 50) in the previous year prior to TAVR but have provided flexibility on how that is met,” CMS wrote in its proposal.
In a press release, CMS said it met with “numerous stakeholders” as it sought new requirements for providers to perform a certain volume of heart procedures. The agency said that the volume procedures are included “given the link between heart procedure volume and patient outcomes in the medical literature and the risks from receiving care in low-volume settings.”
CMS added that it believes the new decisions will provide “more flexibility” in how providers meet those requirements, and that it reflects the “latest evidence on volume and outcomes.”
“CMS must continually refine our policies and requirements in light of emerging evidence. Today’s decision updates the requirements for hospitals and physicians to perform TAVR to ensure these requirements are in line with the latest research on patient outcomes, in order to broaden access to care while safeguarding quality and safety for Medicare beneficiaries,” CMS Administrator Seema Verma said in a press release.
The agency also said it is looking to gather more information about metrics other than volume that could be used to asses quality and safety, and said it is “specifically proposing a question regarding the relationship between other metrics and patient health outcomes, which could inform a future change to replace the volume criteria with a different metric.”
Earlier this month, results from trials of both Medtronic‘s (NYSE:MDT) and Edwards Lifesciences‘ (NYSE:EW) TAVR systems exploring their use in low-risk patients indicated that the devices were as safe as open surgery, paving the way for possible new indications for TAVR technology.