Medical Device Daily Washington Editor

Federal regulators who deal with medical technology rarely get credit for meeting their deadlines, but the Centers for Medicare & Medicaid Services (CMS) did just that with a recent decision on whether to expand reimbursement for home testing for prothrombin times.

The agency said late last year that it would revisit the question of reimbursement for home-based tests of prothrombin times in patients taking warfarin (Coumadin), which previously was reimbursed only for patients with mechanical heart valves (Medical Device Daily, Dec. 26, 2007). CMS said at the time it would publish its decision March 19.

CMS made its deadline with a March 19 decision memo stating, "After examining additional evidence, we are expanding Medicare coverage of home prothrombin monitoring to include chronic atrial fibrillation and venous thrombosis."

The agency did, however, attach several conditions. Among these is that Medicare will pay for such coverage so long as that the patient has been on anticoagulation therapy for at least three months and so long as the patient "has undergone a face-to-face education program on anticoagulation management" and has demonstrated the correct use of the test. This last condition formed one of the primary concerns CMS had in approving reimbursement.

The CMS decision memo noted that the medical literature on home self-monitoring has expanded since the 2001 decision for patients on mechanical heart valves, including one study conducted in 2002 that concluded that "no significant differences were found between self-testing and laboratory" tests of prothrombin times. An assessment conducted in 2005 also indicated no significant difference in test results, but also backed the notion that patients would use the test appropriately. Patients were also on record as consistently backing the idea of conducting the tests themselves.

Despite the favorable conclusions drawn from these and other studies, CMS acknowledged that it was concerned about low enrollment rates of "only 10-20% ... from the eligible population" for four of the studies used to support the additional coverage. The agency pointed out that a similar study was terminated "due to low enrollment." CMS described itself as "challenged to generalize the conclusions beyond patients who have demonstrated capability and motivation" to get through the necessary training and to keep up with the tests.

Despite those concerns, CMS has opted to cover such tests, with acting administrator Kerry Weems noting in the agency's accompanying statement that beneficiaries "will benefit greatly through the use of the home test."

Amy Murphy, associate director of media relations at the American College of Cardiology (ACC; Washington) told Medical Device Daily "generally, we are pleased that CMS has expanded coverage." The association has weighed in on several aspects of the proposed decision memo, including that it is concerned that out-of-specification results might require the test be done more than once a week, which is the maximum frequency CMS will reimburse.

SyntheMed gets warning for device trial

The conduct of clinical trials is no simple matter, but the recent FDA warning letter to biomaterials maker SyntheMed (Iselin, New Jersey) indicated that at least some of the clinical investigators hired by the company were not abreast of clinical trial requirements.

The Feb. 19 warning letter was redacted of any data indicating the nature of the study, but the only entry in the database for SyntheMed is for pediatric use of the Repel CV, an anti-adhesive used in cardiac surgeries. SyntheMed managed to persuade an advisory committee to recommend approval of the barrier last year (Medical Device Daily, Sept. 21, 2007), but there appears to have been no further action on FDA's part to date.

The warning letter stated that more than one of the clinical investigators (CIs) involved in the study performed assessments of the device despite the fact that those CIs were involved in the randomization and treatment of those patients. A similar set of events was discussed during the advisory committee hearings, but SyntheMed's position was that in at least some instances, the surgeon who performed the initial surgery, when the Repel was implanted, was the only surgeon available to perform the repeat surgery on that pediatric patient.

However, FDA also noted in the warning that such events were not reported to the sponsor or the institutional review board, and were not noted in monitoring documents. According to the warning letter, Eli Pines, PhD, responded in writing that the statistical rubric used to evaluate the trial data was tweaked to account for such incidents and that at least one of the CIs was "reminded ... that according to the protocol, the surgeon performing the surgery could not also perform the assessment." FDA said that this was inadequate due to lack of a written corrective action plan and called on the firm to provide such documentation along with deadlines for completion.

FDA also cited SyntheMed for lack of procedures for monitoring the investigational plan and for lack of a financial disclosure form for one of the CIs participating in the study.

At press time, SyntheMed had not returned calls for comment.

A Jan. 3 warning letter to ConnexMD (Seattle) suggested that the firm was unaware that the quality systems regulations applied to makers of software used with imaging equipment.

The lead citation was that Connex failed to establish procedures for quality audits, a conclusion the FDA investigator drew because the company "could not provide any documented quality audit procedures."

Connex also had difficulty coming up with documented procedures for management review procedures and for corrective and preventive action procedures. As for complaint procedures, the company managed to offer the unnamed investigator a "draft document ... that dealt with complaints," but this availed the firm of little because "it was not finalized."

FDA also noted that Connex did not have a "formally designated unit to maintain records of investigations" into device failures. While the company did offer the investigator "a list of the problems you have received ... there is no documentation of the actual investigation of these problems."