Medical Device Daily Washington Editor

The Centers for Medicare & Medicaid Services reported last week that it is reopening its national coverage decision of April regarding initial staging of cervical cancer by positron-emission tomography with fluorodeoxyglucose (FDG) because of a letter from two physicians who make the case that the language of the NCD rules out many instances of vital staging.

The agency had reviewed the matter at the beginning of the year (Medical Device Daily, Jan. 8, 2009) and formally announced it will generally cover PET for staging for a variety of cancers (MDD, April 8, 2009). However, that NCD process did not go off without a hitch, according to Perry Grigsby, MD, and Barry Siegel, MD, both of the Washington University School of Medicine (St. Louis) who penned an April 14 letter that makes the case that the language of the NCD covers PET for initial staging only when conventional imaging is negative for extrapelvic metastases.

Writing on behalf of the National Oncology PET Registry working group, the two physicians state that they are of the view that the intent of the original NCD was "primarily to exclude the use of PET for cervical cancer under clinical circumstances where it would not be expected to guide patient management" and that given a substantial body of data provided to CMS on the topic, the exclusion of PET staging for cervical cancer when extrapelvic masses are seen in conventional imaging "was likely unintentional."

Grigsby and Siegel bolster their case for the procedure for patients who present with an extrapelvic mass by pointing out that "the existing literature and the University of Alberta (Alberta, Canada) technology assessment" make clear that physicians who are treating patients with the extrapelvic returns will need more information to properly stage the patient.

The letter states further that the Centers for Disease Control and Prevention published a data set in 2004 which included an estimate that more than 37% of those diagnosed with cervical cancer were 65 years of age or older and that the American Cancer Society (Washington) estimated in 2008 that more than 11,000 new cases are diagnosed annually, giving CMS responsibility for coverage decisions for more than 4,000 cases a year. Grigsby and Siegel also state that staging via PET will cut down on MRI use in this patient population. CMS is accepting comments until Sept. 12 and expects to make a final announcement by Nov. 11.

MedCAC to review RF ablation for AF

CMS also announced last week that the Medicare Coverage and Evidence Development Advisory Committee (MedCAC) will meet Oct. 21 to go over "the adequacy of the available evidence" for radio-frequency catheter ablation for treatment of atrial fibrillation.

The meeting announcement comes on the heels of the unsealing of an indictment of several device firms via a whistleblower lawsuit in Houston federal court (Medical Device Daily, July 17, 2009). The suit, filed by a former employee of Boston Scientific (Natick, Massachusetts), names the plaintiff's former employer as well as Medtronic (Minneapolis), St. Jude Medical (St. Paul, Minnesota), Atri-Cure (Westchester, Ohio), Endoscopic Technologies (San Ramon, California), and St. Jude subsidiary Epicor Medical (Sunnyvale, California) and alleges that the firms engaged in unlawful promotions of ablation devices to treat atrial fibrillation. The condition is thought to affect more than 1 million living in the U.S.

Medtronic recently reported that it had completed enrollment in a trial for its Frontiers RF ablation system for the AF indication. As of February 6, only two catheters had been approved by FDA for atrial fibrillation, the NaviStar ThermoCool and the EZ Steer ThermoCool Nav, both made by Biosense Webster (Diamond Bar, California).

FDA warns docs of glucose monitoring

FDA penned an Aug. 14 letter to physicians warning them against the use of glucose monitoring technology for patients with diabetes who are taking therapeutic products containing non-glucose sugars.

According to the FDA statement, some of the therapeutic products in question, "such as peritoneal dialysis solutions and certain immunoglobulins, can falsely elevate glucose results, which may prompt excessive insulin administration." The public health notice states further that glucose test strips that contain glucose dehydrogenase pyrroloquinoline quinone (GDH-PQQ) are subject to false high readings and that most such technology is used in healthcare settings outside the home.

Kappos sworn in at PTO

David Kappos was sworn in as the director of the Patent and Trademark Office last week and as expected, promised some changes at the beleaguered agency. In his Aug. 13 address to PTO employees, Kappos said he understands "both the importance and the difficulty of the work done by USPTO employees," and that many employees "are concerned about the time your managers are able to spend helping you learn the refinements of the patent laws." He promised that under his leadership, "we're going to address those issues too."

Kappos said that one of his priorities will be to reduce "the backlog of unexamined patent applications," said to number more than 750,000 by some counts, and to reduce pendancy from the current average of about 36 months. On the other hand, Kappos also remarked that while 2009 "has been a very tough year for the USPTO financially," next year "is also likely to be difficult; it certainly will start that way." However, he promised "to make a very high priority of moving the USPTO to more sustainable footing both in the short term ... and in the longer term."

Mark McCarty, 703-268-5690;