Medical Device Daily Washington Editor
FDA has issued a formal guidance on clinical studies and trials for neurothrombectomy devices, but at least one industry insider sees the guidance as less about news and more about a formal statement of the informal policy the agency has used for the past few years.
The guidance, dated June 18, states that eight hours is still the expected window for the onset of treatment after the ischemic stroke event, and recommends that manufacturers should establish “whether your device causes the formation of smaller clots, either during or after its use.”
FDA stated that it is “aware of the difficulty in recruiting subjects for stroke treatment studies” and will “consider various study designs if they are scientifically sound” and include “randomized comparisons to other legally marketed devices or therapies, or concurrent controls” who get the current standard of care.
Follow-up assessment recommendations include the use of angiography immediately following the procedure “to assess the extent of restoration of flow.” The guidance also details the agency’s expectations regarding other neurological imaging assessments as well as evaluations of neurological function, which would come immediately following the procedure, 24 hours after the procedure, seven to 10 days following discharge, and at 30 and 90 days.
Among the recommended safety endpoints are distal thrombus formation and “re-occlusion or stroke in other territories not previously involved.” Recommended efficacy endpoints include measurement of neurological function by any one of several means, including the Barthel Index and the Glasgow Outcomes Scale. Measures of success, interestingly enough, may include “a significantly increased number of subjects having a good outcome compared to untreated controls or equivalent outcome compared to treatment with other efficacious devices or therapies.”
Andrew Weiss, president/CEO of CoAxia (Minneapolis), told Medical Device Daily that he was not sure “what prompted them to issue this guidance,” but that the document reaffirms the agency’s interest in randomized, controlled trials as well as some of the “rational, intelligent things” that devices should be tested for, including “whether flow has been re-established.”
Weiss said “I think this is quite a complete statement,” but “from our standpoint, this is nothing really new.” He added that one could argue that “they should have done this a few years ago, and my guess is that they’ve got a lot of input from their advisers,” which may have helped prompt the agency to make a formal statement.
Still, it won’t change anything at CoAxia. “This is essentially what we’ve been doing the past few years,” Weiss said.
FDA to go e-registration
FDA announced last month that it will postpone the medical device registration requirements pending roll-out of its electronic registration program.
According to the June 19 announcement, the program is contingent upon “new legislation that may affect registration and listing,” presumably a reference to the FDA reauthorization bills now wending their ways through the House and Senate. Establishments that are already registered for 2007 are in the clear until Dec. 31, and the agency will continue to take in paper registrations for 2007 for the balance of the year or until the electronic registration program goes into effect.
The agency stated that electronic registration will be more accurate “because error-checking is built in,” and the new system is accompanied by a change to the required period of review of registration, making that review an annual event instead of a twice-a-year task. This latter feature is also awaiting Congressional approval.
The e-registration system will allow 24/7 access and will allow a company to enter “more than one proprietary name for a given product,” according to FDA. The agency stated that a company’s marketing efforts would be augmented because “your listing data will be more useful to hospitals, healthcare professionals, and others who are trying to find sources for particular types of devices.”
CMS proposes quality incentives to offset SGR
The Centers for Medicare & Medicaid Services issued a proposed payment policy yesterday for doctors under Medicare Part B that maintains the negative payment update required by the sustainable growth rate (SGR) mechanism. However, the agency intends to use a nest egg of $1.35 billion to offset those cuts.
Acting CMS administrator Leslie Norwalk said in a prepared statement yesterday that “for the past five years, Congress has intervened to prevent the implementation of the negative updates resulting from this formula.” She said that appropriate physician compensation is important, but that “how the program pays also matters,” describing the Physician Quality Reporting Initiative (PQRI) as a way to “promote better quality and better care.”
The proposed rule would include an update for anesthesia work, boosting such payments by 32%, which was proposed by the Relative Value Update Committee (RUC) of the American Medical Association (Washington). The statement also noted that CMS has adopted “the recommendations of the RUC with regard to more than 50 procedures which were included in the 2007 five-year review of work, but for which a decision was deferred until the 2008 proposed rule.”
The agency is also proposing to “revise the methodology for determining the average sales price for Part B drugs by defining bundled arrangements” and requiring drug makers to “allocate bundled price concessions proportionately to the dollar value of units of each drug sold under the bundled arrangement.”
CMS said it will update the geographic practice guidelines “to reflect more recent data,” which will presumably increase payments to doctors in at least some regions. As for the SGR cuts, CMS indicated that they would reduce payments by 9.9% because the scheduled cuts of roughly 5% for each of the past two years were overridden by Congress without a permanent fix. The $1.35 billion that would help offset the SGR cut is from the Physician Assistance and Quality Initiative Fund, which is under the control of the Secretary of Health and Human Services. According to the CMS press release, this fund will be used “to extend voluntary quality reporting bonus payments into 2008.”