Barostim is an implantable pulse generator that electrically stimulates baroreceptors in the carotid artery to rebalance the nervous system and improve heart failure symptoms. The new policy covers the implant for patients with heart failure and patients in CVRx’s BENEFIT-HR trial, which is evaluating the device in an expanded patient population.
“We are pleased that Devoted Health, one of the fastest-growing Medicare Advantage plans in the U.S., has issued a policy covering Barostim,” said CVRx President and CEO Kevin Hykes. “Together, the Devoted Health and Humana coverage policies represent approximately 21 percent of Medicare Advantage enrollment and mark continued progress toward broader, more consistent coverage for Barostim and greater access to the therapy for patients living with heart failure.”
Devoted Health has the eighth-largest Medicare Advantage enrollment in the US among national health insurance companies, providing coverage for 466,000 Medicare Advantage members across 29 states, CVRx said.
Related: CVRx enrolls first patient in BENEFIT-HR study
Barostim received FDA premarket approval (PMA) in 2023 and has since received various reimbursement options. Devoted Health’s new coverage policy builds on this year’s reimbursement developments for the device.
In January, the Centers for Medicare and Medicaid Services (CMS) approved Category B Investigational Device exemption (IDE) coverage for patients enrolled in the BENEFIT-HR trial and Category I CPT codes went into effect for Barostim’s implant procedure. Humana issued a policy covering Barostim for its Medicare Advantage members in May.
In October 2024, CMS assigned Barostim a new payment classification and reassigned the implant to a higher-paying Medicare Severity Diagnosis Related group (MS-DRG) for inpatient procedures.
In 2024, Hykes applauded the actions of CMS, saying it “ appropriately recognizes the resource requirements associated with the Barostim implant procedure in the outpatient setting.”
