Health Information Management

The week in Medicare updates

APCs Insider, December 5, 2014

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CMS releases directions on the off-label/modified use of waived blood glucose monitoring systems 
On November 24, CMS posted information regarding off-label use of blood glucose monitoring systems (BGMS). Off-label use applies whether the test is waived or non-waived and it means that the test is considered modified and therefore defaults to a high-complexity test under Clinical Laboratory Improvement Amendments (CLIA) regulations. This notice will require all laboratories using the device for an off-label use to meet all applicable CLIA high-complexity requirements. If any non-compliance is identified, a written statement of deficiencies (Form CMS-2567) will be issued and followed up using standard operating procedures and timeframes found in the applicable regulations and guidance documents.
View the survey and certification letter.
 
CMS updates NCCI Manual 
On November 24, CMS posted a notice that the 2015 version of the NCCI Manual is now available and will be effective January 1, 2015. All additions and revisions are in red italicized font. 
View the NCCI website.
 
CMS updates policies regarding screening for cervical cancer with HPV testing
On November 25, CMS posted a tracking sheet regarding national coverage analysis (NCA) of screening for cervical cancer with human papillomavirus (HPV) testing. The tracking sheet states CMS has accepted to initiate an NCA on this matter. 
View the document.



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