Under Bibliography revised the broken hyperlinks for the second and sixth references. Formatting and typographical errors were corrected throughout the LCD.
- Provider Education/Guidance
Under Coverage Indications, Limitation and/or Medical Necessity deleted verbiage “The ICD-10-CM codes for test frequencies exceeding once every 3 months are listed below” from the fourth paragraph. Under Associated Information subheading Utilization Guidelines deleted verbiage “(Group 1)” from letter A. and “(Group 3)” from letter B. Under Bibliography added hyperlink to source #6 and changes were made to citations to reflect AMA citation guidelines. Formatting, punctuation and typographical errors were corrected throughout the LCD.
At this time 21st Century Cures Act will apply to new and revised LCDs that restrict coverage which requires comment and notice. This revision is not a restriction to the coverage determination; and, therefore not all the fields included on the LCD are applicable as noted in this policy.
- Provider Education/Guidance
This LCD is being revised in order to adhere to CMS requirements per chapter 13, section 13.5.1 of the Program Integrity Manual, to remove all coding from LCDs. There has been no change in coverage with this LCD revision. Regulations regarding billing and coding were removed from the CMS National Coverage Policy section of this LCD and placed in the related Billing and Coding: HbA1c A56686 article.
At this time 21st Century Cures Act will apply to new and revised LCDs that restrict coverage which requires comment and notice. This revision is not a restriction to the coverage determination; and, therefore not all the fields included on the LCD are applicable as noted in this policy.
- Provider Education/Guidance
All coding located in the Coding Information section has been moved into the related Billing and Coding: HbA1c A56686 article and removed from the LCD.
At this time 21st Century Cures Act will apply to new and revised LCDs that restrict coverage which requires comment and notice. This revision is not a restriction to the coverage determination; and, therefore not all the fields included on the LCD are applicable as noted in this policy.
- Provider Education/Guidance
Under Reason(s) for change the selection was changed to “Request for Coverage by a Practitioner (Part B)” as “Reconsideration Request” was inadvertently selected.
At this time 21st Century Cures Act will apply to new and revised LCDs that restrict coverage which requires comment and notice. This revision is not a restriction to the coverage determination; and, therefore not all the fields included on the LCD are applicable as noted in this policy.
- Request for Coverage by a Practitioner (Part B)
Under Coverage Indications, Limitations and/or Medical Necessity changed verbiage from “90 days” to “3 months” in the last paragraph. Under ICD-10 Codes that Support Medical Necessity Group 1: Paragraph changed verbiage from “90 days” to “3 months” in the first sentence. Under Group 1: Codes added ICD-10 codes E11.9 and E11.22. This revision has a retroactive effective date of 2/26/2018.
At this time 21st Century Cures Act will apply to new and revised LCDs that restrict coverage which requires comment and notice. This revision is not a restriction to the coverage determination; and, therefore not all the fields included on the LCD are applicable as noted in this policy.
- Reconsideration Request
Under CMS National Coverage Policy removed the last two sentences in the first regulation that contained verbiage related to the NCD and LCD review process. Under ICD-10 Codes that Support Medical Necessity Group 2: Codes added ICD-10 Code E11.638 Type 2 Diabetes Mellitus with other Oral Complications. Under Bibliography changes were made to citations to reflect AMA citation guidelines. The date 2012 was added at the end of the first sentence, the italics were removed from the second sentence, and the city, state, and the words “various pages” was removed from the third sentence in the third reference.
At this time 21st Century Cures Act will apply to new and revised LCDs that restrict coverage which requires comment and notice. This revision is not a restriction to the coverage determination; and, therefore not all the fields included on the LCD are applicable as noted in this policy.
- Revisions Due To ICD-10-CM Code Changes
- Change in Affiliated Contract Numbers
Under ICD-Codes that Support Medical Necessity Group 1: Codes deleted E11.10 and E11.11 due to the Clinical Laboratory National Coverage Determination non-coverage.
At this time 21st CenturyCures Act will apply to new and revised LCDs that restrict coverage which requires comment and notice. This revision is not a restriction to the coverage determination; and, therefore not all the fields included on the LCD are applicable as noted in this policy.
- Provider Education/Guidance
Under CMS National Coverage Policy added CMS Manual System, Pub 100-04, Medicare Claims Processing Manual, Change Request 10156, Transmittal 3797, Dated June 16, 2017,Changes to the Laboratory National Coverage Determination (NCD) Edit Software for October 2017. Under ICD-10 Codes That Support Medical Necessity Group 1: Codes added ICD-10 codes E11.10 and E11.11. These codes were added due to the 2017 Annual ICD-10 Updates. Under ICD-10 Codes That Support Medical Necessity Group 2: Codes deleted ICD-10 codes E08.3529, E08.3539, E08.3549, E08.3559, E08.37X9, E09.3529, E09.3539, E09.3549, E09.3559, E09.37X9, E10.3529, E10.3539, E10.3549, E10.3559, E10.37X9, E11.3529, E11.3539, E11.3549, E11.3559, E11.37X9, E13.3529, E13.3539, E13.3549, E13.3559 and E13.37X9. These codes were deleted due to CR 10156, Transmittal 3797.
At this time 21st CenturyCures Act will apply to new and revised LCDs that restrict coverage which requires comment and notice. This revision is not a restriction to the coverage determination; and, therefore not all the fields included on the LCD are applicable as noted in this policy.
- Provider Education/Guidance
- Revisions Due To ICD-10-CM Code Changes
- Provider Education/Guidance
E08.3219, E08.3299, E08.3319, E08.3399, E08.3419, E08.3499, E08.3519, E08.3529, E08.3539, E08.3549, E08.3559, E08.3599, E08.37X9, E09.3219, E09.3299, E09.3319, E09.3399, E09.3419, E09.3499, E09.3519, E09.3529, E09.3539, E09.3549, E09.3559, E09.3599, E09.37X9, E10.3219, E10.3299, E10.3319, E10.3399, E10.3419, E10.3499, E10.3519, E10.3529, E10.3539, E10.3549, E10.3559, E10.3599, E10.37X9, E11.3219, E11.3299, E11.3319, E11.3399, E11.3419, E11.3499, E11.3519, E11.3529, E11.3539, E11.3549, E11.3559, E11.3599, E11.37X9, E13.3219, E13.3299, E13.3319, E13.3399, E13.3419, E13.3499, E13.3519, E13.3529, E13.3539, E13.3549, E13.3559, E13.3599, E13.37X9
Under Sources of Information and Basis for Decision - Revise the reference listed to read: American Diabetes Association. Standards of medical care in Diabetes-2013. Diabetes Care. 2013;36(sup 1):S11-S66. Updated the reference: Wisconsin diabetes mellitus essential care guidelines to 2012 version from 2011.
- Provider Education/Guidance
- Typographical Error
- Provider Education/Guidance
- Revisions Due To ICD-10-CM Code Changes
- Other (Updated URLs)
Performance of the HbA1c test at least two times a year in patients who are meeting treatment goals and who have stable glycemic control is supported by the American Diabetes Association Standards of Medical Care in Diabetes - 2016 (ADA Standards)1. For beneficiaries with stable glycemic control (defined as two consecutive HbA1c results meeting the treatment goals) performing the HbA1c test at least two times a year may be considered reasonable and necessary. The ADA framework for considering treatment goals recognizes that “patient characteristics/health status” are important factors when considering glycemic goals.2 Beneficiaries eligible for the Medicare home health benefit, for example, often have multiple coexisting chronic illnesses that would support a higher target goal for the HbA1c (e.g., < 8.5%) in order to avoid adverse events (e.g., hypoglycemia-related emergency department visits and acute inpatient hospitalization).
Under Sources of Information and Basis for Decision section added the section titled Websites and the two URLs listed below:
1. Prevention or delay of type 2 diabetes; Standards of Medical Care in Diabetes - 2016
2. Older adults; Standards of Medical Care in Diabetes – 2016
- Provider Education/Guidance
- Other
- Provider Education/Guidance
- Other
E15
E16.0
E16.1
E89.1
- Other (ICD-10 Conversion)
- Provider Education/Guidance
- Other (Maintenance
Annual Review)