Medical Device Daily Washington Editor

Rumor has it that there is an ancient Chinese blessing (or curse) that states, "May you live in interesting times." Given the constant flux in medical device regulations and reimbursement, the industry probably thinks it lives in such a time.

A recent article in Food and Drug Law Journal examines the rapid state of change in clinical trial policy embodied in the FDA Amendments Act of 2007 (FDAAA) and recent attempts on the part of the Centers for Medicare & Medicaid Services to fine-tune device trial reimbursement.

According to authors Kirk Dobbins and Kay Scanlon, the net effect is more transparency but less certainty and a greater need for industry vigilance.

CMS undertook a review of its clinical trial reimbursement policy in 2000 to encourage beneficiary participation in trials, but uneven reimbursement of trial costs between local Medicare contractors created barriers for device makers and study sites. CMS tried to deal with this and other issues in a memo last April, but after scores of comments over five months and upon learning of the clinical trial provisions encoded in the FDA Amendments Act of 2007 (FDAAA) CMS chose to make no changes (Medical Device Daily, Oct. 19, 2007).

A requirement provided by FDAAA is the expansion of the data at the clinical trials database at clinicaltrials.gov, now requiring that ongoing device trials be listed (only voluntary before), and data on trial outcomes are also required.

The authors say that trial data must include "summary documents from advisory committee meetings, FDA assessment of trial results ... and safety/efficacy summaries for [PMA] medical devices."

FDAAA indemnifies the sponsor from any regulatory or legal responsibility for the submission of information regarding off-label use of the device at clinicaltrials.gov, an essential provision if FDA continues to require that some device trials examine off-label use, as recently recommended by an FDA advisory committee in its review of computer-assisted detection of various cancers (MDD, March 7, 2008).

Dobbins and Scanlan say that leaving clinical trial policy unchanged was, by CMS, "a decision to make no decision," understandable while the agency "decodes" FDAAA. Trials already underway are exempt from the new requirements, and the associated costs of those trials will be covered as they would normally be.

"In the interim," the authors write, "manufacturers must incorporate [into their studies] the seven desirable characteristics" listed by CMS during the guidance process last year. These include that the trial will "test whether the intervention potentially improves the participants' health outcomes" and "is well-supported by available scientific and medical information or it is intended to clarify or establish the health outcomes of interventions already in common clinical use." The trial should not "unjustifiably duplicate existing studies."

For devices yet to hit a pivotal trial, the authors recommend conducting a study that will satisfy both agencies. "Although the Medicare requirements ... may seem duplicative or burdensome," they write, "Medicare coverage and payment can have a positive influence on private coverage."

Some suspect that CED is a tool to fend off coverage, but the authors state that CMS can use CED "to provide conditional coverage, even when there is insufficient clinical evidence, rather than deny coverage."

Sponsors should CMS early in the developmental phase to establish "what clinical evidence CMS will need for favorable Medicare coverage," the article says, and that device makers can inquire into a parallel CMS/FDA review. But the two agencies have yet to formally publish any sort of guidance as to how this will be done.

Dobbins and Scanlan note that increased transparencies of the trials database "raise the stakes for manufacturers and clinical investigators when FDA regulatory review is unfavorable or clinical results are less than optimal." They recommend that stakeholders "plan to assist FDA and CMS to implement regulations and policy that are consistent with their statutory authority and Congressional intent."

DoD artificial limb research sets goals

With the carnage of war comes a need for artificial limbs, and the Department of Defense (DoD) is, for obvious reasons, the primary funder of medical devices for the federal government. Thus, the Defense Advanced Research Projects Agency (DARPA) recently reported its '09 objectives for artificial limbs.

According to a recent article in Force Health Protection and Readiness, DARPA's Revolutionizing Prosthetics initiative launched in 2005 to replicate the strength and dexterity of the natural limb.

Revolutionizing Prosthetics 2007, a two-year program, was aimed at developing a neural interface for a prosthetic arm, which "increased range of motion, strength, endurance and dexterity, and is easy to learn to use."

The successor program, Revolutionizing Prosthetics 2009, "will create a neurally controlled artificial limb that will restore full motor and sensory capability to upper extremity amputee patients," according to the article. The newer prosthesis "will be controlled, feel, look and perform like the native limb," and DARPA hopes that "at the end of the four-year program, the resulting prosthesis will be ready for human clinical trials."

Researchers hope to produce an artificial limb that "will be able to function as well as a normal human arm," and have the ability to "sense the position of the arm and hand relative to other parts of the body" and pick up signals for "touch, temperature and vibration."