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.
On June 4-5, DeviceTalks is taking over the Twin Cities medtech industry with one of the most anticipated conferences of the spring, bringing you the best and brightest minds in the industry.
Heidi Dohse: Sr. Program Manager, Healthcare, Google, Founder, Tour de Heart Foundation, Acessa Health Inc. Michael J. Pederson: Senior Vice President, Cardiac Arrhythmias and Heart Failure Division, Abbott Hon. Melvin Carter: Mayor, Saint Paul Tim Philips: Compliance Officer, FDA’s Office of Medical Device and Radiological Health Operations Dr. Myriam J. Curet, MD, FACS: Chief Medical Officer, Intuitive Surgical
Take a look at our incredible line up of speakers and join us now.
Use the code "KEYNOTE" to save 15% on the cost of registration.