Syncardia Systems LLC, of Tucson, Ariz., has petitioned the Centers for Medicare and Medicaid Services (CMS) to drop the coverage with evidence development (CED) mandate for artificial hearts, stating that multiple studies have demonstrated that artificial hearts meet the reasonable and necessary standard. Syncardia said its temporary Total Artificial Heart (TAH-t) should thus be available “unencumbered by the existing requirement for evidence development,” a change that could modestly bolster utilization and sales of these devices.
The U.S. Centers for Medicare and Medicaid Services (CMS) has significantly relaxed the national restrictions on coverage of next-generation sequencing for cancer, affirming that early-stage breast and ovarian cancer patients will be covered. However, Medicare administrative contractors can cover tests that have not been reviewed by the FDA, a move that should also significantly boost utilization for makers of next-generation sequencing systems in clinical labs.
Jenavalve Technology Inc., of Irvine, Calif., has won an FDA breakthrough device designation for its namesake transcatheter aortic valve replacement device, but Jenavalve said it will file for a humanitarian device exemption in the second half of 2020, suggesting that the device won’t be commercially available for at least another year.
The draft rules for the Stark and Anti-Kickback statutes (AKS) seem to have excluded makers of devices, but Meena Datta of Sidley Austin told BioWorld MedTech that while these agencies have plenty of reasons to rethink that notion, the final rules are unlikely to emerge in 2020 simply because of the complexity of the undertaking. While the final rules may reverse the drafts’ exclusion of makers of devices and diagnostics, device makers were upbeat at the prospect that they could engage in value-based payment arrangements with providers.
The exclusion of makers of devices and drugs from a proposed overhaul of the Anti-Kickback Statute (AKS) probably took many in industry by surprise, but Premier Inc., of Charlotte, N.C., argued that this approach fails to capitalize on an opportunity to hold manufacturers accountable for clinical outcomes in value-based arrangements.
Pq Bypass Inc., of Milpitas, Calif., said that the Centers for Medicare and Medicaid Services (CMS) has agreed to cover its TORUS 2 investigational device exemption (IDE) clinical trial, which is evaluating the Torus stent graft in the treatment of peripheral artery disease (PAD) in the superficial femoral artery (SFA).
While the U.S. Centers for Medicare and Medicaid Services (CMS) revisits its coverage policy for transcatheter mitral valve repair devices, several physician societies have drafted recommendations for operator and institutional volume requirements that could restrict the number of centers authorized to practice devices such as Abbott Park, Ill.-based Abbott Laboratories’ Mitraclip.
Policymakers are often as sensitive to overall health care spending as they are to increases in Medicare spending, and the latest report on both brought some good news and some bad news. The good news is that overall health care spending was essentially flat as a share of gross domestic product (GDP) in 2018, but the bad news is that Medicare spending jumped 6.4%, thus renewing the troublesome historical trend of outpacing typical GDP growth.
Patient engagement has become more than a buzzword for the FDA and drug and device developers. But for payers, not so much. When valuing new drugs and devices, payers often undervalue or ignore what they may consider convenience updates, giving little to no consideration to the difference a seemingly minor improvement could make to patients debilitated by fatigue, pain, the burden of treatment and the burden of a disease itself.
The U.S. Centers for Medicare and Medicaid Services (CMS) has decided against a series of rate cuts for PET imaging in the Medicare physician fee schedule for 2020, a move lauded by physicians who were facing a rate cut of as much as 80% for nuclear medicine and molecular imaging procedures.
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