The Centers for Medicare & Medicaid Services (CMS) reported a decision last week to grant positive National Coverage Determination (NCD) status for artificial hearts. This landmark decision reportedly marks the first positive coverage position that CMS has taken since a non-coverage determination for artificial hearts was issued by the agency a little more than two decades ago.

According to CMS, there had previously not been enough evidence to offer up positive NCD for the devices, which are geared toward the more than 5 million heart failure patients in the U.S. More than 500,000 new cases are diagnosed each year, and more than 50,000 heart failure patients die from the disease every year.

Because the device requires a portion of the patient's own heart be removed, an artificial heart patient must be supported by his or her device through the end of life or until heart transplantation, CMS said, and that apparently was the basis of the agency's non-coverage policy to date.

"Our decision revises a long-standing non-coverage policy and allows beneficiary access to this advanced technology," said CMS Acting Administrator Kerry Weems. "Our decision also encourages the completion of FDA post-approval studies."

This controlled clinical environment is one of the protections afforded beneficiaries under the Coverage with Evidence Development (CED) framework. CED allows CMS to determine that a technology can be covered when it is provided within a research setting where there are added safety, patient protections, monitoring, and clinical expertise available to the beneficiary.

Ultimately, CMS said that this additional data will develop into new clinical evidence that can assist in the Medicare coverage process. An even more important outcome of this CED framework, however, is the production of evidence that will influence clinical practice and help Medicare beneficiaries and providers make the most appropriate diagnostic and therapeutic decisions.

CMS revealed its first signs of reversing the 1986 edict of non-coverage earlier this year (Medical Device Daily, Feb. 5, 2008).

Since the 1986 decision, only two manufacturers have conducted clinical trials studying the safety and health outcomes of using artificial hearts in patients. And now just two — Abiomed (Danvers, Massachusetts), maker of the AbioCor Total Replacement Heart, and SynCardia Systems (Tucson, Arizona), developer of the CardioWest artificial heart — are eligible under the national coverage decision.

"Quite honestly this is a decision we've been waiting 22 years for," Don Isaacs, a spokesman for SynCardia Systems, told Medical Device Daily. "But [we] had been petitioning CMS for a year now."

The company's version of an artificial heart can be described as a pulsating bi-ventricular device implanted into the chest to replace the patient's left and right ventricles, and it is sewn to the patient's remaining atria. By means of tubes through the patient's chest wall, each ventricle is connected to a drive console that provides pulsed pressurized air and enables device monitoring.

Isaacs said the company had three benchmarks it had hoped to obtain for this year and CMS' decision was one of those goals.

"It's not everything we wanted, but it's pretty darn close," he said of the CMS decision.

The CardioWest is covered by about half of insurers, including Aetna (Hartford, Connecticut) and BlueCross BlueShield (Chicago), according to SynCardia. With final CMS approval, most insurers are more likely to cover the device, the company said.

The CardioWest, a device which is not fully implanted in the body, costs around $100,000.

Originally designed as a permanent replacement heart, the CardioWest is approved as a bridge-to-transplant device for patients dying from end-stage biventricular failure (MDD, Oct. 19, 2004).

Abiomed also gave praise to the decision, stating in a press release that it was "advancement" for its AbioCor system. The company did not immediately return calls to MDD on Friday.

Currently, private insurance companies Cigna (Bloomfield, Connecticut) and Humana (Louisville, Kentucky) have coverage policies for the AbioCor, and HealthNet (Birmingham, Alabama) has a positive coverage decision for devices approved by FDA under a Humanitarian Device Exemption (HDE), which the AbioCor device received nearly two years ago. The device was initially rejected by an FDA circulatory system devices advisory panel in 2005.

The company said that AbioCor is the only artificial heart without wires piercing through the skin, reducing the chance of infection. Its remote diagnostics allow patients to return home, where they can resume normal activities, including bathing.

The AbioCor is able to pump blood through the body, simulating the rhythm of a heartbeat. The complete AbioCor system consists internally of a thoracic unit, a rechargeable battery, a miniaturized electronics package and a power receiver coil, and externally, a power transmitter coil, power and battery pack, hand-held alarm monitor and sophisticated computer console.

In addition to covering the devices, CMS previously recommended realigning the payment under msDRG 1 or 2 in a draft policy document. msDRG 1 is the highest-paying diagnosis-related group (DRG) in Medicare, and the final decision is expected in August.

The final coverage decision specifies the questions that studies must address and the standards those studies must meet for Medicare coverage. In developing this policy, CMS consulted with the Agency for Healthcare Research and Quality, and both agencies believe the questions and standards meet the requirements of the Medicare statute.

CMS said it will accept submissions from the research community about trials that may answer the agency's questions about artificial hearts. Clinical studies that are determined to meet CMS' requirements will be listed on the agency web site.