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 individual’s fingertip by vaporizing water in the skin. An example of a laser device is the Lasette® Plus.
The use of a laser device for obtaining a blood sample is considered investigational.
Any specific products referenced in this policy are just examples and are intended for illustrative purposes only. It is not intended to be a recommendation of one product over another, and is not intended to represent a complete listing of all products available. These examples are contained in the parenthetical e.g. statement.
We develop Medical Policies to provide guidance to Members and Providers. This Medical Policy relates only to the services or supplies described in it. The existence of a Medical Policy is not an authorization, certification, explanation of benefits or a contract for the service (or supply) that is referenced in the Medical Policy. For a determination of the benefits that a Member is entitled to receive under his or her health plan, the Member's health plan must be reviewed. If there is a conflict between the Medical Policy and a health plan, the express terms of the health plan will govern.
No randomized controlled studies were found in the published literature that would validate the efficacy of using laser devices to obtain blood samples.
CGS Administrators, LLC. (2017, January). Local coverage determination (LCD) glucose monitors (L33822). Retrieved October 5, 2017 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: 11/8/2018
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.