CVRx has announced that it's BAROSTIM NEO implantable device has received the Centers for Medicare & Medicaid Services (CMS) inpatient New Technology Add-On Payment (NTAP).
FREMONT, CA: CVRx, a developer of the world's first FDA-approved neuromodulation device that is used for treating chronic heart failure (HF), has announced that its BAROSTIM NEO implantable device has received the Centers for Medicare & Medicaid Services (CMS) inpatient New Technology Add-On Payment (NTAP). CMS even proposed the national coverage determination (NCD) for Breakthrough designation treatments such as BAROSTIM NEO.
Operative from October 1, 2020, and for a three-year duration, Medicare will offer an add-on payment for BAROSTIM NEO of up to 65 percent of the device cost when the maximum amount allowed is $22,750 in addition to the Medicare Severity-Diagnosis Related Group (MS-DRG) payment for the implant process. The entire procedure compensation is estimated to be in the range of $39,895 - $44,170, as per the Medicare National Rate for Medicare patients in the inpatient setting.
BAROSTIM NEO achieved the highly sought-after Breakthrough Designation position by the FDA in 2016, which is only offered to drugs and devices that establish the potential to become a more efficient treatment for a life-threatening or debilitating illness. To reduce barriers to innovation, CMS introduced an alternative streamlined pathway for FDA Breakthrough devices that can qualify for NTAPs. By following this pathway, CMS awarded the NTAP for BAROSTIM NEO due to the tools FDA Breakthrough Therapy designation.
The NTAP program offer supports to get access to novel therapies that can provide considerable clinical advantages over current treatment options. The add-on payment refers to the delay between the market introduction of technology and the MS-DRG recalibration that shows the added expense of the technology. The NTAP connects the postponement with a temporary payment in addition to the MS-DRG payment generally made to the hospital.
Medicare planned a national Medicare Coverage of Innovative Technology (MCIT) rule for Breakthrough implantable technologies on August 31, 2020. BAROSTIM NEO is already widely compensated on a claim-by-claim settlement basis. NCD will eliminate the requirement for any adjudication in the claim-by-claim procedure.