BALTIMORE--Certain respiratory assist devices, including some continuous positive airway pressure devices, are being reclassified as capped-rental items, CMS announced last week.

Effective April 1, RADs with bi-level capability and a backup rate--what used to be known as "intermittent assist devices with continuous positive airway pressure devices"--will no longer be considered DME requiring "frequent and substantial servicing for payment purposes," the agency said in a statement on Thursday.

Instead, monthly rental payments from Medicare will decrease at the fourth month of rental, and after 13 months of rental, title will transfer to the beneficiary and payments will stop altogether. Medicare will continue to pay 80 percent, and beneficiaries 20 percent, of the Medicare allowed payment amount for maintenance for the equipment after the rental payments end.

But in a response issued late Friday, the American Association for Homecare said it is "dismayed" at the rule and disagrees with CMS' assumption that patients who need this type of equipment would be able to determine when maintenance or repairs would be required and to arrange for these services.

According to the association, "These patients suffer from progressive terminal conditions that affect their ability to fill their lungs. Their conditions can vary from stable to rapidly regressive and can change from stable to rapid regression in short periods of time. They are at high risk for respiratory failure. To maintain their safety and health status, these patients require frequent monitoring, adjustment and service that would not be available under the capped rental payment category."

Cynthia Gray, RRT, vice president of respiratory and HME for Oklahoma City-based CV Medical Solutions, said that with the change, she is concerned about patient safety, especially because the agency doesn't explain how it will pay for emergency calls and repair of equipment. "They say they're going to do it, but there is no provision made to take care of it," she explained.

Gray said a portion of CPAP patients--3 percent at CV Medical Solutions--are on CPAPs with the backup feature, which will breathe for them if they stop breathing on their own. Such patients range from those who only use the machine at night to those who use it 12 or more hours a day.

Although she doesn't think the rule will affect the average user, it is a serious concern for those with special needs, such as neuromuscular patients or those with a tracheostomy, Gray said. "Unless CMS makes a provision that they will pay for clinical follow-up of these patients, you're going to have an increased number of [emergency room] and hospital visits," she said.

The CPAP also needs to be serviced every year, she continued. "Either the patient pays for it or they don't," she said. "If it's not done, there could be subsequent death."

Since 1992, RADs with a backup rate feature have been paid by Medicare on a continuous monthly rental basis. The change is being made in an attempt to save millions of dollars after an HHS Office of Inspector General report found that the RADs do not require frequent servicing. The OIG reported that supplier services consist mainly of routine maintenance and patient monitoring. "While other types of RADs have been paid correctly as capped-rental devices, the RADs with a timed backup feature were incorrectly categorized," CMS said in its announcement.

According to CMS, beneficiaries will pay less out of pocket as a result of the changes. They are now paying up to $128 a month in coinsurance, but that rate will drop to $96 starting in the fourth month of the rental and be eliminated altogether after the 13th month when patients assume ownership of the device.

The rule only applies to RADs and not ventilators, CMS noted.

To view the rule, published in the Jan. 27 Federal Register, click here.