Corporate Compliance

This week in Medicare updates

Medicare Insider, December 2, 2014

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Directions on the off-label/modified use of waived blood glucose monitoring systems (BGMS)
 
On November 24, CMS posted information regarding off-label use of BCMS. “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 the 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. Included with this memorandum are Frequently Asked Questions (FAQs) prepared by CMS and FAQs prepared by the FDA, respectively.
 
View the survey and certification letter.
 
EMTALA requirements and implications related to Ebola virus disease (Ebola)
 
On November 24, CMS posted a memorandum conveying information useful in responding to inquiries from hospitals concerning implications of Ebola for their compliance with EMTALA. Every hospital or critical access hospital (CAH) with a dedicated emergency department (ED) is required to conduct an appropriate medical screening examination of all individuals who come to the ED. Every ED is expected to have the capability to apply appropriate Ebola screening criteria when applicable, to immediately isolate individuals who meet the screening criteria to be a potential Ebola case, to contact their state or local public health officials to determine if Ebola testing is needed, and, when a decision to test is made, to provide treatment to the individual, using appropriate isolation precautions, until a determination is made whether the individual has Ebola. In the case of individuals who have Ebola, hospitals and CAHs are expected to consider current guidance of public health officials in determining whether they have the capability to provide appropriate isolation required for stabilizing treatment and/or to accept appropriate transfers. In the event of any EMTALA complaints alleging inappropriate transfers or refusal to accept appropriate transfers, CMS will take into consideration the public health guidance in effect at the time.
 
View 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 National Correct Coding Initiative website.
 
Update regarding Hospital Appeals Settlement process
 
On November 25, CMS updated its Inpatient Hospital website regarding the Hospital Appeals Settlement process. It directed those organizations with questions about this process to the “Critical Steps for Providers on the Appeals Settlement Process” in the Downloads section on the website.
 
View the Inpatient Hospital website.
 
View the “Critical Steps for Providers on the Appeals Settlement Process” document.
 
Screening for cervical cancer with human papillomavirus (HPV) testing
 
On November 25, CMS posted a tracking sheet regarding national coverage analysis (NCA) of screening for cervical cancer with HPV testing. The tracking sheet states CMS has accepted to initiate an NCA on this matter.
 
View the document.



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