The Centers for Medicare & Medicaid Services has canceled plans to create a new regulatory pathway that aimed to accelerate Medicare coverage for medical devices, according to a ModernHealthcare report.
The federal agency reportedly withdrew the proposition, known as Excite, from review at the White House’s Office of Management and Budget this month, nine months after it was submitted.
Details on why the proposition was pulled, and whether or not CMS has plans to pursue such a pathway in the future are unclear, according to the ModernHealthcare report.
The proposition was derived from an industry proposal known as the Provisional Accelerated Coverage to Encourage Research initiative, or Pacer, according to the report.
Pacer was submitted to CMS officials in late 2016, according to ModernHealthcare, and CMS sent their Excite rule to the OMB a few months later.
CMS officials had previously confirmed that they would seek to hasten access to medical devices for Medicare beneficiaries, but could not confirm how close the Excite proposal conformed to the earlier Pacer proposal, according to the report.
Under the earlier Pacer proposal, CMS would be allowed to grant provisional Medicare coverage to FDA-approved products while the maker of the devices had time to collect additional evidence currently required by CMS to obtain reimbursement, ModernHealthcare reports.
Earlier this month, CMS said it is thinking about extending coverage for magnetic resonance imaging scans to patients with cardiac rhythm management devices after reviewing studies showing that MRI scans are safe.
Early rates for DeviceTalks Boston end August 15th.
Don't miss the chance to save $100 and join top medtech innovators including leaders from Hologic, Google, Gray Matter, TransEnterix, NxStage Medical, Smith & Nephew, HeartFlow, Dynatronics, Johnson & Johnson, Allied Minds, and many more.
View Full Agenda
Register today to save. Use code LASTCALL to save an additional 10%.