BlueCross BlueShield of Tennessee Medical Policy Manual

Laser Device for Obtaining Blood Sample

DESCRIPTION

Laser skin perforator devices are indicated for the perforation of skin to draw capillary blood for screening purposes. These devices are portable and battery operated. They produce a single pulse of laser light which ablates a small hole in an individualā€™s fingertip by vaporizing water in the skin. An example of a laser device is the LasetteĀ® Plus.

POLICY

IMPORTANT REMINDERS

ADDITIONAL INFORMATION

No randomized controlled studies were found in the published literature that would validate the efficacy of using laser devices to obtain blood samples.

SOURCES

CGS Administrators, LLC. (2019, January). Local coverage determination (LCD) glucose monitors (L33822). Retrieved August, 2019 from https://www.cms.gov. 

U. S. Food and Drug Administration. (1999, January). Center for Devices and Radiological Health. 510(k) Premarket Notification Database. K983673. Retrieved December 6, 2011 from http://www.accessdata.fda.gov.

U. S. Food and Drug Administration. (2003, December). Center for Devices and Radiological Health. 510(k) Premarket Notification Database. K033799. Retrieved February 17, 2016 from http://www.accessdata.fda.gov.

ORIGINAL EFFECTIVE DATE:  3/1/2002

MOST RECENT REVIEW DATE:  10/10/2019    

ID_BT

Policies included in the Medical Policy Manual are not intended to certify coverage availability. They are medical determinations about a particular technology, service, drug, etc. While a policy or technology may be medically necessary, it could be excluded in a member's benefit plan. Please check with the appropriate claims department to determine if the service in question is a covered service under a particular benefit plan. Use of the Medical Policy Manual is not intended to replace independent medical judgment for treatment of individuals. The content on this Web site is not intended to be a substitute for professional medical advice in any way. Always seek the advice of your physician or other qualified health care provider if you have questions regarding a medical condition or treatment.

This document has been classified as public information.