Medical Device Daily Washington Editor

The Centers for Medicare & Medicaid Services has announced a national coverage determination for the use of collagen scaffolds for patients who have had a partial removal of the meniscus, which might suggest good news for ReGen Biologics (Hackensack, New Jersey), maker of the Menaflex collagen scaffold for use in patients who have had a partial removal of the meniscus.

CMS's announcement states that the request was internally generated and a company spokeswoman told Medical Device Daily that as best as ReGen can tell, "no claims have been filed for Medicare reimbursement."

ReGen won an informal consensus of approvability for a 510(k) application for its Menaflex in an advisory committee hearing last year (Medical Device Daily, Nov. 18, 2009), which FDA gave its formal nod to the following month. The decision has proved to be highly unpopular, though, with the new management at FDA vowing to conduct an investigation into the clearance.

Such an investigation would have to range much farther than just the halls of FDA. ReGen recruited several members of the New Jersey congressional delegation to aid in its cause at FDA, including Rep. Frank Pallone (D-New Jersey), who is rumored to be drafting legislation that would curtail the 510(k) program.

The fact that the request for review was generated internally at CMS raises the question of why the agency would take up the matter if the sponsor is not trying to obtain reimbursement. While FDA and CMS are long rumored to have overlapping considerations, the interests of the two do not always mesh, including off-label use of medical devices. The idea that CMS would take up a matter in response to a situation that FDA is seen as having bungled would ordinarily seem odd, but a CMS non-coverage decision would virtually ensure that private payers refuse coverage as well, an outcome that would let a number of public officials off the hook, including Pallone.

Another factor that lends to speculation is that ReGen wrangled a concession from FDA on the membership of the panel, persuading FDA to appoint temporary voting members who, by and large, were sports orthopedists. Needless to say, this group does not typically deal with Medicare patients.

In an unattributed e-mailed statement, ReGen told Medical Device Daily that it "did not make the coverage determination request" and that "we do not believe that Medicare-covered patients will constitute any significant portion of Menaflex patients." The company expressed surprise "that CMS would take this up when, to our knowledge, no claims have been made for Medicare reimbursement."

CMS is accepting comments until Sept. 26 and expects to publish a proposed decision memo by Feb. 26, 2010. The final decision, CMS indicates, will be made public May 28, 2010.

FDA, Air Force, sign MOU for nanotox

FDA and the Air Force have signed a memorandum of understanding by which the two will share resources in research designed to establish a better base of science for nanotoxicology.

Among the points of emphasis in this collaboration are an effort to reduce redundancy in their respective areas of research and a better understanding of what kinds of materials are liable to pass through the blood brain barrier. The effort will seek to exploit "global expression profiling by microarray and proteomics methods" that are capable of simultaneously identifying genes and proteins.

The collaboration will also entail joint efforts to identify biosignatures of exposure to nanoscale materials and to jointly publish findings in peer-reviewed journals.

MCAC to review ablation for atrial fibrillation

The Medicare Coverage and Evidence Development Advisory Committee reported it will hold a meeting on Oct. 21 to review data in support of the use of ablation technology to treat atrial fibrillation.

CMS has listed the subject as a possible item for consideration for some time, and the move heralds in a potentially lucrative market for the firms who have managed to get catheter ablation devices through the FDA gauntlet. Both radio frequency and thermal ablation procedures would presumably be candidates for the CMS coverage discussion, assuming the failure to mention one or the other in the CMS announcement is deliberate.

FDA reopens transparency docket

FDA has announced that it is reopening the public comment period regarding the agency's transparency initiative. The agency reported earlier this month that it will take comments on transparency until Nov. 6.

The agency had reported earlier this year that it would review comments until Aug. 6, but FDA intends to hold a second public meeting "in the fall of 2009," presumably the reason for the reopening of the docket.

FDA announces workshop

FDA has reported it will hold a 510(k) workshop for computer software used in blood bank operations.

According to the announcement in Friday's edition of the Federal Register, the workshop will include "presentations and panel discussions" led by FDAers and other experts in the field on blood establishment computer systems, or BECSs. These systems were the subject of a 2007 guidance on BECS system validation, but computer systems have been under fairly regular scrutiny since the late 1990s, when the agency published Part 11 requirements.

Mark McCarty, 703-268-5690; mark.mccarty@ahcmedia.com