Medical Device Daily Washington Editor

The Centers for Medicare & Medicaid Services has opened a review of national coverage for two issues in connection with the use of magnetic resonance angiography and as the saying goes, they have good news and bad news.

First, the bad news is that the agency is proposing no change to non-coverage of the use of MRI in patients with pacemakers or implanted defibrillators, even if the FDA-approved label says the device will not interact with the magnetic fields and radio frequency waves generated by MRI machines. CMS notes that the request precedes the existence of devices purported to avoid interactions – at least where FDA is concerned – and that it is in possession of no evidence of a benefit.

On a more positive note, CMS has opted to propose removing the phrase "blood flow measurement" from a portion of the National Coverage Determinations Manual that disallows coverage. The move would not provide a national coverage decision as such, but would leave the decision to regional payment entities. The agency notes that it has been reminded that there is "an apparent contradiction" between the non-coverage language under one portion of the manual and a second section that generally addresses MRI for angiography. CMS expects to finalize this review Sept. 28.

In reference to the pacemaker/ICD question, the agency's notice refers to a document published in 2007 by the American College of Radiology (ACR; Reston, Virginia) that offers guidelines in determining whether to subject a patient with an ICD or a pacemaker to an MRI field. That document states that physicians should see the presence of these two types of electrophysiology hardware as "a relative contraindication for MRI," and that any decision to proceed ought to be done "on a case-by-case and site-by-site basis, and only if the site is staffed with individuals" with some experience in such uses. The proposed decision memo notes that the request for this coverage came from Medtronic (Minneapolis), and that the Medicare Coverage and Evidence Development Advisory Committee had not met to discuss the idea.

As for removing the phrase "blood flow measurement" from the list of non-reimbursable procedures, CMS noted that it received unanimous support for the idea in the 86 public comments filed between Jan. 20 and Feb. 19, 2009.

The agency did its homework in addressing the question, reviewing more than 30 peer-reviewed studies dating as far back as 1988, examining the technology's capability in assessing blood flow from both the aortic and mitral valves as well as valve volumes. As a result, CMS states, the non-coverage of MRI for blood flow "is no longer supported by the available evidence," although none of the studies cited were conducted after 2007.

Anita McGlothlin, ACR's director of health policy, told Medical Device Daily that "ACR along with other societies had requested that CMS reopen the MRI coverage determination" and that ACR was the original requestor. She said that the association sees blood flow as "a medically warranted procedure that has always been an important exam" in dealing with conditions such as congestive heart failure.

India publishes regs for import and sale

The world's most populous democracy is not exactly at the forefront of medical device regulations, but India has published a June 3 draft guidance for the import and sale of medical devices.

The Central Licensing Approval Authority (CLAA) needed 82 pages in a pdf document to spell out the requirements, which include post-market surveillance. According to the document, manufacturers and their agents have 10 days to notify the authorities of any "immediate" adverse events, generally speaking. The document also states that in the event the device was used with other devices and/or drugs, "it should be assumed that the device was associated with the event." However, manufacturers have 48 hours to notify CLAA if there are questions as to whether the device was used appropriately and the adverse event is a fatality.

Firms making high-risk devices, which are taxonomically deemed class D devices, can go to market with an FDA approval or a CE mark so long as the plant undergoes an inspection by CLAA and another licensing authority. However, the manufacturer will have to cover the cost of such inspections. The document does not give a timeline for finalization of the draft.

Bone shavers subject of warning

FDA published a notice yesterday that it "has become aware of instances in which pieces of tissue have remained within certain arthroscopic shavers" despite adherence to recommended cleaning procedures.

According to the FDA posting, the agency has taken in reports that "the tissue retained was not evident to the naked eye" and that manufacturers have sent their customers an advisory to reinforce the message that thorough cleaning is essential. FDA states that its concern is over the potential impact on sterilization of the shavers and that the agency is also taking steps to prod administrators at hospitals and other provider settings to take measures to reinforce cleaning standards for the devices.