Edward Berger's blog

Medicare: Best practices don't ensure coverage for Medtronic's new pacemaker

March 23, 2011 by Edward Berger

Medicare coverage for Medtronic Inc.'s MRI-safe Revo pacemaker: Why doing everything right doesn't insure a perfect outcome.

CMS, FDA

Is Medicare unsafe for Medtronic's MRI-safe pacemaker?

March 8, 2011 by Edward Berger

Um, no. Contrary to popular belief, the Centers for Medicare and Medicaid Services Medicare never decided not to fund MRIs for people with Medtronic's new MRI-safe pacemaker.

Contrary to popular belief, the Centers for Medicare and Medicaid Services Medic

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

February 7, 2011 by Edward Berger

It's evident in the recognition across the political spectrum that health information technology is a key strut for healthcare reform, but don't expect HIT to bear fruit anytime soon.

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

January 20, 2011 by Edward Berger

There's a lot of buzz over new Centers for Medicare and Medicaid Services proposals for value-based purchasing — with good reason. Get ready for CMS to begin considering quality of care in 2012.

Medicare value-based purchasing

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.

It's the data, stupid

October 29, 2010 by Edward Berger

When it comes to Medicare coverage decisions, it's more important to have valid clinical data than a robust lobbying or advocacy campaign.

It's the data, stupid

In May 2009, following a year-long National Coverage Determination process, Medicare decided that it would not extend coverage to CT colonography, also known as virtual colonoscopy, for colorectal cancer screening. Advocates of CTC seem to have been shocked by the decision. CTC is non-invasive; it does not have the procedural risks associated with optical colonoscopy; it is thought to be more acceptable to patients; and it seems about as good as OC at identifying polyps of moderate or larger size — the ones that standard protocols recommend be removed and tested.

FDA-CMS parallel review: Charm offensive or meaningful change?

September 24, 2010 by Edward Berger

Actually, it's a little of both.

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

September 9, 2010 by Edward Berger

There are four ways to control healthcare spending, but not all of them are actual options in the U.S.

There are four ways to control healthcare spending, but not all of them are actu

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.

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