The Centers for Medicare and Medicaid Services (CMS) said today it wants to give Medicare patients better access to cutting-edge medical devices, and that it’s willing to pay more for them beginning in fiscal year 2020.
In its proposed rule, CMS said it might pay more for “certain transformative new devices” for inpatients through a new technology add-on payment and raise payments for those devices from 50% of the device cost to 65%.
Covered devices approved or cleared through the FDA’s Breakthrough Devices Program might qualify for the higher payments even if they don’t meet CMS’s existing “substantial clinical improvement” criterion.
Medtech manufacturers currently have to demonstrate that their devices offer a substantial clinical improvement over existing technologies and that, absent an add-on payment, they would be inadequately paid for under the regular Medicare payment.
In the proposed rule, CMS acknowledged that these new devices may not have had time to demonstrate “fully developed” substantial clinical improvement. These devices could qualify for higher payments solely on the basis of their cost, the agency said. This change would apply to applications for fiscal year 2021.
CMS also wants public comments on the substantial clinical improvement criterion it uses to evaluate applications for both inpatient and outpatient new technology add-on payments for devices.
The agency also detailed seven new or renewed medtech applications it is considering for new technology add-on payments for FY 2020. Renewed applications include:
- Respicardia’s Remedē transvenous implantable neurostimulation system designed to treat patients with central sleep apnea.
- Claret Medical’s Sentinel Cerebral Protection System. Boston Scientific (NYSE:BSX) bought Claret Medical in 2018.
- Procept BioRobotics’ Aquabeam ablation system, which uses a robotically controlled waterjet to ablate prostate tissue without needing heat.
New applications include:
- CivaTech Oncology’s CivaSheet, a flexible, implantable device that emits targeted, low-dose Palladium-103 to cancerous tissue.
- Johnson & Johnson’s (NYSE:JNJ) Spravato (esketamine) nasal spray designed for treatment-resistant depression.
- GT Medical Technologies’ GammaTile brachytherapy designed to treat brain tumors, co-developed with IsoRay (NYSE:ISR).
- TherOx’s Supersaturated Oxygen (SSO2) Therapy, an acute myocardial infarction treatment designed to improve microvascular flow and reduce infarct size following primary coronary intervention with stenting. Zoll acquired TherOx in June.