A Medical Device Daily

The Centers for Medicare & Medicaid Services reopened its coverage policy last year on the use of artificial hearts (Medical Device Daily, August 9, 2007), and recently said it has opted to allow limited reimbursement as part of an evidence development effort, known as coverage with evidence development (CED).

All the same, makers of artificial hearts have their work cut out for them.

In its proposed memo, CMS said the available evidence fails to make a conclusive argument about the reasonableness and necessity of an artificial heart for New York Heart Association class IV heart failure. However, CMS said that it found the evidence nonetheless “promising” and that the agency “supports additional research” on the question.

The conditions for reimbursement of such studies are several, including that a study should show whether there were any “unique circumstances, such as expertise available in a particular facility or an unusual combination of conditions in particular patients that affected their outcomes.” CMS also wants the sponsor to establish an average time to device failure when it is implanted in “a larger number of patients.”

One of the factors that will complicate study design, especially given the persistent problem with the difficulty of getting an artificial heart into smaller human bodies, is the requirement that the study protocol “explicitly address subpopulations ... particularly traditionally under-represented groups in clinical studies.”

CMS said that it had issued a non-coverage decision for artificial hearts in 1986, but the September 2006 approval of a humanitarian device exemption for the Abiocor, manufactured by Abiomed (Danvers, Massachusetts), prompted a second look at coverage for both destination and bridge-to-transplant (BTT) uses. CMS noted that FDA granted the HDE despite the fact that the circulatory systems advisory committee recommended no HDE.

The CMS announcement said that FDA approved the Abiocor for patients who aren’t candidates for transplantation, “who are near death from end-stage biventricular Class IV heart failure,” and whose other treatment options have run out. As the CED label suggests, any such study will have to produce evidence that could be used in any future decisions on the coverage question.

CMS said that one of its “major concerns is the relatively few implanting hospitals and uneven distribution of patient experience among those hospitals” that have participated in previous studies. CMS also said it was concerned about the relatively few patients enrolled in the destination arm for the Abiocor and the lack of recent data on BTT patients for the Cardio West artificial heart from Syncardia (Tucson, Arizona).

CMS concluded that the data from those studies “can[not] be extrapolated outside of the controlled, monitored” study conditions. The agency expects to complete its analysis May 1.

PTO seeks regulatory flexibility input

Of the controversies over recent patent reform legislation, one of the less conspicuous has been the ability of the U.S. Patent and Trademark Office to exercise regulatory discretion. PTO’s effort last year to cut down on complex language in patent applications (Medical Device Daily, Aug. 21, 2007) apparently has generated enough controversy that has responded with a notice in the Federal Register on the question.

In the FR notice PTO posted last year addressing patent language, the agency said that the proposal to tighten the requirements would help patent examiners more effectively examine “claims that contain more than one independent and distinct invention.”

“The current practice of listing multiple inventions in the alternative in a single claim” is “especially prevalent in the pharmaceutical, chemical, and biotechnology fields,” and the agency wants “more specificity” in patent claims.

The use of Markush language to describe patent claims is said to be the biggest source of patent congestion at PTO because such claims often include components present in existing products and because applicants more frequently employ Markush language “to claim multiple inventions and/or to recite hundreds, if not thousands, of alternative embodiments of a single invention in one claim.”

Regardless of how one sees the Markush language question, PTO now seeks comments on its regulatory flexibility analysis, despite the fact that it is of the opinion that such an analysis is not required for this change. PTO said it will accept input from stakeholders until April 9.

In the current FR notice, PTO reiterated its position that patent applications containing Markush claims “are confusing, difficult to understand and frequently border on being unmanageable” and “often consume a disproportionate amount of Office resources.” One possible outcome of its proposed change would be to “require that a claim ...be limited to a single invention,” which could force PTO to “apply a restriction requirement” on applications that define “multiple and distinct inventions.”

PTO indicated that healthcare product developers are likely to feel the effect of any Markush language restrictions because “an estimated 9,186 of the 21,187 small-entity applications in the biotechnology/chemical arts” employed the alternative language the use of which PTO seeks to tamp down.