BAROSTIM NEO received the extremely sought-after Breakthrough Designation position by the FDA in 2016, which is only given to devices and drugs that prove the potential to become a more effective treatment for a debilitating or life-threatening condition.
FREMONT, CA: CVRx, a developer of FDA-approved neuromodulation equipment to treat chronic Heart Failure (HF), announces that its BAROSTIM NEO implantable device has received the Centers for Medicare & Medicaid Services (CMS) inpatient New Technology Add-On Payment (NTAP). Furthermore, CMS proposed National Coverage Determination (NCD) for Breakthrough Designation treatments similar to BAROSTIM NEO.
Operative 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 price (the maximum amount allowed $22,750) in addition to the Medicare Severity-Diagnosis Related Group (MS-DRG) compensation for the implant procedure. The complete procedure reimbursement is projected to be in the range of $39,895 - $44,170, according to the Medicare National Rate for Medicare patients in the inpatient setting.
BAROSTIM NEO received the extremely sought-after Breakthrough Designation position by the FDA in 2016, which is only given to devices and drugs that prove the potential to become a more effective treatment for a debilitating or life-threatening condition. To eliminate barriers to the invention, CMS established alternate streamlined paths for FDA Breakthrough equipment to be suitable for NTAPs. Ensuing this pathway, CMS rewarded the NTAP for BAROSTIM NEO due to the devices’ FDA Breakthrough Therapy designation.
The NTAP program provisions access to novel treatments that provide substantial clinical benefits over current treatment options. The add-on expense addresses the delay between the market outline of technology and the MS-DRG recalibration that replicates the technology’s added price. The NTAP links the postponement with a temporary payment along with the MS-DRG payment usually made to the hospital.
On August 31, 2020, Medicare anticipated a national Medicare Coverage of Innovative Technology (MCIT) rule for Breakthrough implantable technologies. BAROSTIM NEO is already broadly reimbursed on a claim-by-claim adjudication basis; yet, the NCD will eradicate the need for any settlement in the claim-by-claim process.