Medical Device Daily Washington Editor

In a development that hardly catches medical societies and imaging providers flat-footed, the Centers for Medicare & Medicaid Services (CMS) has decided to use the coverage with evidence (CED) development rubric to reimburse for the use of a radioisotope of sodium fluoride for metastatic bone cancer.

CMS's Feb. 26 announcement states that CED coverage will be used to pay for the use of NaF-18 with PET scanning for both initial staging of the cancer and for ongoing staging after completion of initial treatments. Such studies must address at least one of four scenarios, including whether the patient's curative care is affected and whether palliative care is affected by the results of the scans. Quality of life and survival are the two other endpoints that can be covered in a study.

CMS had tackled this topic last year and issued a proposed decision memo Nov. 30, 2009 (Medical Device Daily, Dec. 2, 2009), and the agency said at the time that the rate of false positives was an issue. However, CMS acknowledged the ongoing shortage of technetium-99 (Tc-99) in the proposed decision memo. Though this predicament was not specifically cited as a source of impetus for the NaF-18 coverage analysis, there is widespread belief that the Tc-99 issue at least fed the NaF-18 review.

Robert Atcher, MD, past president of the Society for Nuclear Medicine (SNM; Reston, Virginia), told MDD in December that SNM had approached CMS on the issue, and that reimbursement for this application in the U.S. has lagged behind payment policy in Europe. Atcher also noted that SNM is interested in helping to bankroll a registry for NaF-18 when used with PET scanners.

The CMS announcement also states that a new drug application (NDA) for the radioactive sodium fluoride “has been filed [with FDA] by staff of the National Cancer Institute,“ the attainment of which is presumably necessary for coverage.

PTO and UK's IP agency to collaborate

To those not employed by a government, the phrase “Department of Redundancy Department“ is always funny. However, the U.S. Patent and Trademark Office (PTO) and the UK Intellectual Property Office (UKIPO) would like to eliminate redundant patent prosecution work if at all possible.

According to a March 10 PTO statement, the two IP agencies have declared their intent to “develop an action plan for reducing patent processing backlogs“ in both offices by “identify[ing] all areas of reutilization potential“ in the work done by the two. PTO's statement indicates that this analysis may be completed by year's end, at which point PTO and UKIPO “shall pursue measures designed to facilitate maximum reuse by building confidence in the work done by each office.“

The issue is not a paltry one for PTO, which is widely believed to have a backlog in excess of 700,000 patent applications, although the statement does not indicate what sort of backlog UKIPO faces. However, the statement includes remarks alluding to a substantial backlog at the UK office.

David Lammy, identified as the UK's Minister of State for higher education and intellectual property, is quoted as saying: “If we are serious about economic recovery, then we cannot sit back and watch good ideas go to waste.“ Lammy added that he seeks “an international system that works efficiently to provide innovative businesses with high quality patents in the timescales they need,“ the success of which he said would “secure our competitive advantage in innovative, high-growth sectors like advanced manufacturing, the life sciences, low-carbon and others.“

PTO chief David Kappos is quoted as characterizing legitimate but unapproved patents as being equal to “jobs not created,“ noting that clearing the PTO backlog is “our highest priority.“ Kappos states further that the agreement will enable the two agencies “rather than the applicants“ to “initiate the priority handling of applications.“

CMS updates facility certifications

The Centers for Medicare & Medicaid Services has announced the certification and re-certification of facilities for several procedures. For carotid artery stenting, CMS announces that Orange Park Medical Center (Orange Park, Florida) and Northside Hospital/Tampa Bay Heart Institute (St. Petersburg, Florida) have been certified or re-certified. CMS announced both on Feb. 26.

The University of Virginia Health System (Charlottesville, Virginia) has been re-certified as a facility for destination therapy for ventricular assist devices. According to CMS, UVA lost its certification in March 2009, but won the Joint Commission's nod on Feb. 13.

For bariatric surgery, CMS announced that three facilities were certified or re-certified Feb. 12. These include Robert Wood Johnson University Hospital (Hamilton, New Jersey), CentraState Medical Center (Freehold, New Jersey), and Bellevue Hospital (New York).

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