Medtronic announced February 8 FDA approval of the Revo MRI SureScan pacing system, described as “the first and only pacemaker in the U.S. specifically designed for use in an Magnetic Resonance Imaging (MRI) environment.” In describing the impact of the new device, Medtronic estimated that 200,000 patients annually had to forego otherwise clinically appropriate MRIs because of the presence of a pacemaker.
The power of HIT
The Centers for Medicare and Medicaid Services just announced that the selection of five organizations to participate in a demonstration project designed, under a 2008 Congressional mandate (PDF), to encourage more efficient utilization of advanced imaging technologies. In the demonstration, participating physicians will use advanced decision support information systems to receive instant feedback on whether their imaging referrals are consistent with practice standards promulgated by the relevant specialty societies.
Medicare value-based purchasing: Get ready for the new day
Health care newsletters and the policy blogosphere have been buzzing for a week or more over the Centers for Medicare and Medicaid Services publishing a proposed rule (PDF) for implementation of inpatient hospital value-based purchasing for discharges occurring on or after Oct. 1, 2012. And the buzz is justified.
MassDevice New Year’s Special | Ed Berger
Edward Berger
CEO, Larchmont Strategic Advisors
FDA-CMS parallel review: Charm offensive or meaningful change?
As regular readers of MassDevice.com already know, the Sept. 17, 2010, Federal Register contained a request for comments on a proposal to initiate parallel review of medical products by the Food & Drug Administration and the Centers for Medicare and Medicaid Services (PDF).
Four ways to control healthcare spending
Labor Day is swiftly receding in the rear view mirror, a potentially transformative (or at least disruptive) mid-year election is only eight weeks away, and Medicare payment regulations for FY 2011 start to go live (acute inpatient hospital) in less than a month — not a bad time to step back and assess some longer-term prospects for medical technology reimbursement and overall healthcare spending.
FDA-CMS data-sharing deal may mean less than meets the eye
The Food & Drug Administration and the Centers for Medicare and Medicaid Services signed a Memorandum of Understanding June 23 intended to promote data-sharing between the two agencies. Announcement of the MOU came from Center for Devices & Radiological Health director Dr. Jeffrey Shuren at a June 24 public workshop on device innovation. The MOU, Shuren said, “will allow for the first time routine and timely sharing of information and expertise between our two agencies to strengthen our ability to achieve our respective missions.
Pouring gasoline on the healthcare policy fire
As reported on this website, the U. S. House of Representatives has signed on to an additional six month "fix" for the unacceptable 21 percent reduction in Medicare physician reimbursements required under current law. So ends yet another sad and frustrating chapter in an extended epic of Congressional dithering on healthcare policy. For years, the perceived political cost has dissuaded Congress from any frontal effort to revise the wrong-headed and obviously ineffective 10-year-old sustainable growth rate (PDF) formula for limiting growth in Medicare spending or physicians’ services.
VCs: Healthcare reform won’t impede med-tech investment
Readers of this website, and this blog, are likely to have a special interest in the business impacts of healthcare legislative and regulatory initiatives. But when those initiatives are complex, with major societal implications and long implementation timelines, the likely effects on business operations, profitability and/or viability may not be obvious. When that is the case — as it most certainly is with this year’s healthcare reform legislation — it is often necessary to evaluate diverse perspectives and attempt to determine which among conflicting projections are more likely to be accurate. My personal prejudice? Be skeptical of those who are directly impacted; follow the people who follow — or supply — the money.
A sneak peak at proposed changes to Medicare
Medicare’s Notice of Proposed Rulemaking for changes to the Hospital Inpatient Prospective Payment System for the year beginning October 1, 2010 (fiscal 2011) will be published in the Federal Register May 4, but was made available for inspection on the CMS website April 19. Masochists who can’t wait to digest every detail of the 1,296-page proposal can download it here (PDF). The political fur will fly once stakeholders dig into the mind-numbing details of CMS’s assumptions and calculations and analyze the expected direct financial impact of various payment adjustments, during the public comment period (which ends June 18). In the meantime, I can offer a few highly selected observations.
Berwick’s appointment a boon for medical device makers?
If you’ve been studying the contents of the recently passed healthcare reform legislation, and you’ve looked in vain for the elements that emphatically implement systemic cost control and improvements in quality of care, President Barack Obama’s nomination of Dr. Donald Berwick as administrator of the Centers for Medicare and Medicaid Services comes as very good news indeed. With this nomination, the president has demonstrated that he fully understands that insurance reform alone — important as it may be — won’t fix the ills besetting U.S.
