Firm Gets Medicare Coverage for Portable Osteoporosis Diagnostic Device

CMS recently approved Medicare coverage for a portable, pocket-sized diagnostic device for osteoporosis when used in ambulatory surgical centers (ASC) and outpatient hospital settings.

Finnish medical device company Bone Index said its Bindex device has a National Coverage Determination and that it is still trying to get the device covered for payment in physicians’ offices. The company said its device can detect osteoporosis with 90% sensitivity and specificity.

CMS recently approved Medicare coverage for a portable, pocket-sized diagnostic device for osteoporosis when used in ambulatory surgical centers (ASC) and outpatient hospital settings.

Read more about bone health.

Bindex is a pulse-echo ultrasound transducer and measures cortical bone thickness at the upper shaft of the tibia. The transducer collects the sound waves reflected from the bone and transmits the signal to a connected computer equipped with company software. With an algorithm, it calculates a density index from this measure along with other clinical risk factors or patient characteristics, such as age, weight, and height, to estimate the probability of osteoporosis.

Many people will not know they have osteoporosis, a skeletal disorder characterized by loss of bone mass, deterioration of bone tissue, and decline in bone quality, until they have a fracture. In some cases, fractures can lead to disability, chronic pain, loss of independence, lower quality of life, and even death. About 21% to 30% of patients who experience a hip fracture die within 1 year.

By 2020, approximately 12.3 million individuals in the United States older than 50 years are expected to have osteoporosis.

The most commonly used screening test is the central dual-energy x-ray absorptiometry (DXA) of the hip and lumbar spine. A DXA also gives a measurement of bone mineral density. A central DXA is commonly used to define osteoporosis according to some treatment guidelines and is used as the threshold for when to begin preventive drug therapies.

Bone Index said its device is aimed at avoiding the radiation from a DXA, and at lower cost.