Medical Device Daily Washington Editor

CMS has the unenviable task of deciding which treatments and diagnostics it will reimburse, and the agency recently decided to decline a request to cover the use of positron-emission tomography (PET) using the radiotracer fluorodeoxyglucose (FDG-PET), to detect three conditions.

The original request, made in February, asked that CMS reimburse the use of FDG-PET to detect chronic osteomyelitis, infections associated with hip arthoplasty, and “fever of unknown origin.”

According to a May 18 letter to the agency written by Abass Alavi, MD, professor of radiology at the University of Pennsylvania (Philadelphia), the images acquired by this technology “are superior to those provided by conventional nuclear medicine techniques for assessment of infection,” including scintigraphy with 67~acitrate or technetium 99-labeled leukocytes.

Alavi also makes the case that FDG-PET images “allow direct comparison with corresponding structural imaging modalities, such as CT and MRI,” which gives clinicians the ability to “determine the precise location of the sites of infection or inflammation.”

A letter to the agency submitted by Michael Becker, general manager of global reimbursement at GE Healthcare (Waukesha, Wisconsin), said that peer reviewed published literature”supports expansion of coverage for PET to include the three indications under consideration.” Becker cited 17 articles from peer-reviewed journals in support of the claim.

Another supporter of the proposal, Shyam Srinivas, MD, associate staff physician at the Cleveland Clinic, weighed in as well, informing CMS in a June letter that “we are providing sub-standard care and subjecting our patients to a sub-standard test when we use gallium or indium as imaging agents when FDG-PET is available.”

Srinivas said that technetium “is not a sensitive test for chronic osteomyelitis but is good for acute processes, so it should remain as the first line test,” adding that “if there is a question of infection or inflammatory process, FDG-PET would be far better than any other technique we currently have.”

However, the agency was unmoved, stating in its Dec. 20 decision memo: “[w]e assign greater weight to evidence produced by randomized clinical trial [RCT] design” than to the findings offered by the “case series [that] were available,” and CMS described these case studies as “a weaker methodological design than RCTs.”

The decision memo also said “there are no consistent assessment criteria in the literature.”

CMS reopens prothrombin monitoring NCD

CMS is considering another proposed national coverage decision (NCD), this time for in-home prothrombin time (INR) monitoring, with the possibility that the agency will reimburse the use of INR for chronic atrial fibrillation (AF) and deep-vein thrombosis.

The statement at the CMS web site notes that at present, “coverage is limited to patients with mechanical heart valves,” but CMS is revisiting the NCD “[a]fter examining additional medical evidence.”

The conditions pertaining to such coverage include that the patient “requires chronic oral anticoagulation with warfarin for a mechanical heart valve, chronic atrial fibrillation, or deep venous thrombosis” and “has been anticoagulated for at least three months.” The test would be limited to once a week.

The request was filed in a June letter from the Prothrombin-Time Self-Testing Coalition and signed by Larry Cohen, president of International Technidyne (Edison, New Jersey), David Phillips VP for marketing at HemoSense (San Jose, California) and John Ridge, the director of reimbursement at Roche Diagnostics (Indianapolis).

The letter states that the literature on the subject “supports a conclusion that home PT/INR monitoring is at least as effective and safe as in-clinic monitoring in maintaining PT/INR levels within target range and reducing the incidence of major hemorrhagic and thromboembolic complications,” and that the test is not contraindicated for elderly patients.

CMS said it expects to complete its assessment on March 19.

FDAAA requirement commences Dec. 26

FDA recently reported that it will commence with enforcement of a new regulatory requirement for makers of biologics, devices and drugs the day after Christmas.

The requirement was part of the Food and Drug Administration Amendments Act of 2007 (FDAAA), which Congress passed just in time to avert the issuance of pink slips at the agency, a prospect communicated to Congress by FDA commissioner Andrew von Eschenbach, MD, in a letter to Congress in August (Medical Device Daily, Aug. 6).

A recent posting at the FDA web site reminds industry that the new provisions “require additional information to be submitted to the clinical trials data bank” at clinicaltrials.gov, “including expanded information on clinical trials and information on the results of clinical trials.”

This certification must accompany all PMAs, 510(k)s and humanitarian device exemptions. Sponsors also need to be aware of a provision of the FDAAA that allows the agency to impose civil money penalties for failure to file on time.

A copy of the certification form is available at the FDA web site as an editable pdf file. This file can be found at fda.gov/oc/initiatives/advance/fdaaa.html on the link titled “Certification of Compliance with Requirements of ClinicialTrials.gov Data Bank Form.”