The CMS on Tuesday proposed giving hospitals and doctors more flexibility to meet requirements for Medicare and Medicaid coverage of a heart valve procedure.
Currently a doctor and hospital must perform a certain number of other cardiac procedures in order to get CMS reimbursement for transcatheter aortic valve replacements (TAVR).
For example, the current coverage determination requires that two cardiac surgeons independently examine patients and evaluate their suitability for the surgery, which is a less invasive surgical alternative to open-heart surgery for people with a condition called symptomatic aortic stenosis.
Now, the CMS is proposing that only one surgeon make the determination, which coincides with current consensus from the medical community. The agency decided not to forgo volume requirements for TAVR coverage altogether.
"We believe this modification is appropriate given the advancements and progress made since 2012 as TAVR becomes more widely performed," the proposal says.
The CMS approved coverage of TAVR surgeries in 2012 when the procedure was relatively new. Currently there are TAVR programs in more than 500 hospitals, according to the CMS.
To secure Medicare and Medicaid reimbursement for the procedure, the hospital previously had to perform at least 50 aortic valve replacements in the prior year and at least 1,000 catheterizations a year. The hospital also needed at least two physicians with cardiac surgery privileges.
Under the proposed changes, the 50 aortic valve replacements could include open heart surgeries.
"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," the proposal said.
The hospital still must have at least completed 20 aortic valve replacements within the prior two years, the CMS said.
The agency didn't change the catheterization and privilege requirements.
Doctors and experts have questioned the need for a volume requirement to get coverage.
A group of three cardiac doctors wrote to the CMS in October 2017 saying that procedure volume isn't an "absolute predictor of quality."
"Many research studies have examined the relationship of procedural volume and procedure quality outcome (for the same procedure not a fundamentally different procedure)," the letter said. "These studies show some correlation, however it is frequently weak."