The demise of the Medicare Coverage of Innovative Technologies (MCIT) rule may not be the end of the breakthrough devices coverage story, but Lee Fleisher of the U.S. Centers for Medicare & Medicaid Services (CMS) said the MCIT rule was riddled with deficiencies. Fleisher said CMS is of the view that expedited coverage of breakthrough medical devices would be better handled under existing statutory authorities, suggesting the agency sees no need for the MCIT-driven provisions of the Cures 2.0 legislation.

Physicians occasionally go over the line where Medicare services are concerned, but the U.S. Department of Justice announced Sept. 15 that a cardiologist in Orlando, Fla., went farther than the ordinary illicit billing.

The U.S. Centers for Medicare & Medicaid Services (CMS) has withdrawn the rule for the Medicare Coverage of Innovative Technologies (MCIT) program, an action that predates the agency’s self-imposed deadline of December 2021 by three months. The agency cited some previously discussed issues with the rule, but the move was blasted by industry as thwarting the support of the majority of stakeholders.

Medicare coverage does not necessarily mean appropriate reimbursement levels, a point pressed by Inspire Medical Systems Inc. at the Aug. 23 Medicare outpatient advisory panel hearing. The panel agreed that the company’s hypoglossal nerve stimulation (HNS) device for sleep apnea was subject to an inappropriate device offset figure, which could lead to a Medicare rate increase of more than $7,000 and a significant boost of sales of the company’s flagship Inspire HNS device.

The U.S. Centers for Medicare & Medicaid Services (CMS) has proposed to drop its national non-coverage policy for pulmonary embolectomy, a procedure for which multiple devices have been cleared or approved by the FDA. Several stakeholders, including more than one med-tech trade association, had requested such a change, and CMS indicated that much more evidence will be needed before it can forge a national coverage policy that would eliminate the impending geographically differentiated patient access.

The U.S. Centers for Medicare & Medicaid Services (CMS) had previously waded into a sea of opposition from device makers and medical societies alike in its proposal to eliminate the inpatient-only (IPO) list. The new administration at CMS has proposed to reverse that move and sustain the IPO, which should alleviate concerns that outpatient procedures will ding the reputations of these devices.

Regardless of the controversy swirling around the FDA’s accelerated approval of Biogen Inc.’s Alzheimer’s drug, Aduhelm, that U.S. approval is expected to open the door to more opportunities for Alzheimer’s treatments and diagnostics.

Regardless of the controversy swirling around the FDA’s accelerated approval of Biogen Inc.’s Alzheimer’s drug, Aduhelm, that U.S. approval is expected to open the door to more opportunities for Alzheimer’s treatments and diagnostics.

Medicare coverage of telehealth services in the U.S. received a boost during the COVID-19 pandemic, a change that stakeholders have argued should be made permanent. The Centers for Medicare & Medicaid Services (CMS) has proposed to extend coverage of some of these services throughout calendar year 2023 in the draft Medicare physician fee schedule, but some stakeholders are urging Congress to act before the end of the year to make these benefits permanent.

The Medicare inpatient draft for fiscal 2022 reflects the effects of the COVID-19 pandemic on claims data for a large number of devices, including those that received additional reimbursement under the new technology add-on payment (NTAP) program. Device makers are urging CMS to add a second year of extension to those NTAP payments, however, a proposal which if adopted would give the affected device makers additional time to recoup their investments.