CD&D

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

According to CMS, there previously had not been enough evidence to offer up a positive NCD for the devices, used to extend the lives of the more than 5 million heart failure patients in the U.S. A key roadblock to coverage has been the need to remove the patient's native heart to use the artificial one.

Kerry Weems, CMS acting administrator, said that the decision "revises a long-standing non-coverage policy and allows beneficiary access to this advanced technology .... [and] encourages the completion of FDA post-approval studies."

This, the agency said, provides a "controlled clinical environment" to protect beneficiaries under the Coverage with Evidence Development (CED) framework, so "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 ...."

Ultimately, CMS said that this additional data developed in these trials will provide the clinical evidence needed to 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.

Since the 1986 decision, only two manufacturers — Abiomed (Danvers, Massachusetts), maker of the AbioCor Total Replacement Heart, and SynCardia Systems (Tucson, Arizona), developer of the CardioWest artificial heart — have conducted clinical trials studying the use of artificial hearts. No those two are eligible for coverage under the NCD.

"Quite honestly, this is a decision we've been waiting 22 years for," Don Isaacs, a spokesman for SynCardia Systems, told Cardiovascular Devices & Drugs. "[W]e had been petitioning CMS for a year now."

The company's artificial heart is a bi-ventricular device used to replace the patient's left and right ventricles and sewn to the remaining atria. It is not entirely implanted in the chest but employs tubes through the patient's chest wall, each ventricle connected to a drive console that provides pulsed pressurized air and enables device monitoring.

Isaacs said the CMS decision was one key benchmark for the company. "It's not everything we wanted, but it's pretty darn close."

Costing around $100,000, the CardioWest was originally designed as a permanent replacement heart but is now used as a bridge-to-transplant device for patients suffering end-stage biventricular failure and is FDA-approved for that application.

The company says that the CardioWest is covered by about half of the country's insurers, including Aetna (Hartford, Connecticut) and BlueCross BlueShield (Chicago). With final CMS approval, most insurers are more likely to cover the device, Cardio-West said.

Abiomed also welcomed the CMS decision, saying in a statement that it offered "advancement" for its AbioCor technology.

Currently, private insurance companies Cigna (Bloomfield, Connecticut) and Humana (Louisville, Kentucky) have existing 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 AbioCor is implanted totally within the body, its action simulating the rhythm of a heartbeat. It does not have wires or tubes piercing through the skin, a feature thus reducing the chance of infection. Its remote diagnostics allow patients to return home, where they can resume normal activities, even bathing.

The complete AbioCor system consists, internally, of a thoracic unit, a rechargeable battery, a miniaturized electronics package and a power receiver coil; and, externally, of a power transmitter coil, power and battery pack, hand-held alarm monitor and computer console.

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

The final coverage decision specifies the questions that clinical studies must address and the standards those studies must meet. 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 website.