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.
The U.S. Centers for Medicare and Medicaid Services (CMS) has posted a draft rewrite of the coverage memo for next-generation sequencing (NGS), and while the draft rewrite fails to address a number of concerns, the agency eliminated references to advance-stage cancer, opening the door to considerably greater utilization.
A bipartisan group of 43 members of the U.S. House of Representatives has inked a letter to the U.S. Centers for Medicare and Medicaid Services (CMS), objecting to planned Medicare cuts for myocardial positron emission tomography (PET) imaging. The letter argues that the proposed rate cut of 72% would hamper access to a procedure that is typically provided in physician offices – and puts the onus on the CMS to justify the rate cut.
Medicare coverage of digital health is evolving, but there are those who have argued that the U.S. Centers for Medicare and Medicaid Services (CMS) is moving too slowly to capitalize on significant opportunities. The Advanced Medical Technology Association (Advamed) said in comments to the docket for the draft physician fee schedule that an advisory panel should be regularly convened in order to exploit the potential for digital health to "transform the delivery of care and improve patient care outcomes."
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