CMS aims laser at diabetes

Thursday, January 31, 2002

ALBUQUERQUE, N.M. - CMS has granted a HCPCS code and an $870 allowable for a next-generation skin-piercing device that lets diabetics collect blood with a near painless method.

Cell Robotics Inter-national's Lasette Plus is a 9-oz., needle-free blood-sampling device that uses a battery-powered laser beam to puncture the fingertip. The user then squeezes a drop of blood from the fingertip, and tests the glucose level using strips and glucometer as usual.

With a doctor's prescription, every Medicare beneficiary with diabetes is eligible, according to CRI. "To my knowledge, there are no restrictions," said Paul Johnson, CRI's chief operating officer. "It should cover every diabetic."

The HCPCS code assigned to the cell phone-sized device is E0620. The allowable for all four DMERCS is $870.07, according to CRI. Medicare is also paying $12.69 for a disposable cartridge of film that protect the laser optics from the skin debris created when the laser is used. The film cartridge is good for about 120 uses.

The Lasette Plus would replace the steel lancet, for which Medicare pays about 10 cents a piece. The typical diabetic tests glucose levels once a day, although some insulin dependent diabetics check levels 10 and 15 times a day.

For years, technology companies have been working on non-invasive glucose sampling devices. Instead of piercing the skin, these devices would read glucose levels through the skin. None to date have hurdled the FDA and Medicare coding process.

CRI received 510k marketing clearance for the Lasette Plus in 1999, and the company began selling the device for a couple of thousand dollars. Today, the Lasette retails for less than $1,000.

The Medicare market for diabetes is enormous. The American Diabetes Association estimates that 18.6% of all Americans over the age of 65 have diabetes. The company believes that getting its own HCPCS and an allowable for the Lasette is a milestone on the way to penetration of the home use market.

Another milestone will be effective marketing, say diabetes providers. "It's one thing to get a HCPCS code, it's another thing to get a prescription," said Wade Thompson, director of diabetes management support services at MedExpress in West Columbia, South Carolina. "You can have all the HCPCS you want, but you've got to get that prescription."

A doctor's prescription, according to CRI, should simply read: "Lasette, use as directed."HME