Medical Device Daily Washington Editor

FDA is often the bogeyman for companies trying to get a device to the U.S. market, but the safety/efficacy hurdle is only the first of two a company must climb over to recoup its developmental investment and become profitable. Once past FDA, another three-letter hydra awaits: CMS.

Thus, the makers of artificial hearts could take heart in last week's report by the Centers for Medicare and Medicaid Services that it will re-examine its reimbursement policy for artificial hearts, perhaps the most expensive of all implantable devices.

The CMS announcement, dated Aug. 1, stated that the agency "has a longstanding noncoverage policy regarding the use of artificial hearts" for both destination therapy (DT) and as a bridge to transplant (BTT). It said that part of the reason for the difference in coverage compared to ventricular assist devices (VADs), is that many patients on a VAD have some hope of recovering heart function.

The statement came in response to a petition filed by SynCardia (Tucson, Arizona), maker of the CardioWest temporary artificial heart.

Recent events seemed to augur such a development, but reading the tea leaves to predict government agency behavior is hazardous. Three years ago, CMS created a diagnostic-related group (DRG) into which artificial hearts could fit, DRG 103, but up to now the agency has not been persuaded as to necessity and appropriateness, the standards for issuance of a national coverage decision (NCD).

On the other hand, CMS's failure to approve such a decision doesn't keep local contractors from making local coverage decisions (LCDs) for a device. And at least one contractor, Blue Cross of California (Woodland Hills, California), reportedly has issued an LCD of medically necessity and reasonableness for the CardioWest TAH-t (Total Artificial Heart-temporary).

The CardioWest relies on externally provided pneumatic drivers to keep the pumping mechanism going, which limits patient mobility. FDA issued SynCardia a PMA for the device in 2004 with the BTT application, and the company is currently working on a portable pneumatic unit that can be toted on a two-wheel cart, similar to those used to haul briefcases and laptop computer cases.

Should the firm get a PMA from the agency for the portable pneumatic unit, it will have a substantial impact on patient mobility.

Another company, Abiomed (Danvers, Massachusetts), also participates in this game via its AbioCor artificial heart.

The first-generation AbioCor source that provides current via an external electromagnetic field that transfers charge to a coil implanted in the patient's body. Unlike the CardioWest, the AbioCor is not the subject of a PMA application. Potential implants depend on the continuation of the humanitarian device exemption (HDE) Abiomed won from FDA in 2006.

Any device sold under the HDE is restricted to sales of 4,000 units a year, the regulatory ceiling for the number of per-year diagnoses applicable to the device under the HDE protocol.

In its statement announcing review of its coverage policy, CMS said it is initiating its "national coverage analysis for the artificial heart when used for bridge to heart transplantation and for destination therapy" because CMS has the option of reimbursing for any device approved even as an HDE device, and both indications are the subject of at least an HDE.

Abiomed's president, Mike Minogue, recently told Medical Device Daily's sister publication, Cardiovascular Device Update, that Abiomed has no plan to pursue a PMA for the AbioCor, although the option is still open for its successor, the AbioCor II, which is in development, and roughly 30% smaller than its antecedent. The AbioCor II should fit into almost all men and half of the women in the U.S.

Neither the CardioWest heart nor the AbioCor is cheap.

The Cardio West's price tag runs to $106,000 while the AbioCor has a $250,000 price tag, numbers that may give even the most generous CMS reviewers a bad case of sticker shock. However, all the alternative therapies and interventions — including drug therapy — required to keep a patient alive in the face of total heart failure, run up a large tab, too.

CMS said that it is "interested in public comments that relate to" three areas of interest, including peer review literature on "artificial hearts when used for bridge to transplantation or destination therapy" and on hospital requirements, including staffing, equipment, experience, transplant status and so on.

CMS also is seeking input on surgeon and team training requirements, and will accept comments until Aug. 31. The agency said it expects to publish a proposed decision memo by Feb. 1, 2008, and to close the matter with a final decision by May 1.

Don Isaacs, media relations director at SynCardia, told Medical Device Daily that while $106,000 "is a lot of money," patients implanted with the CardioWest who eventually get transplants are typically on the device for less than three months, He said that this bridging will run up a smaller tab than all the other interventions that become necessary for patients with total heart failure, given the resources demanded by intensive-care units.

"Our device is probably the most economical way to save a patient's life," he said.

Isaacs cited an article appearing in the July 2006 edition of American Heart Journal that stated that the use of the CardioWest would be "significantly less expensive than the cost of a heart failure patient receiving medical therapy in the last year" of his or her life, though no specific numbers were given to back that claim.

"We are most keenly interested in a coverage decision as a bridge to transplant," Isaacs said, adding that SynCardia is not looking for a destination NCD from CMS for the CardioWest at this time.