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Local Coverage Determination (LCD)

HbA1c

L33431

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Proposed LCD
Proposed LCDs are works in progress that are available on the Medicare Coverage Database site for public review. Proposed LCDs are not necessarily a reflection of the current policies or practices of the contractor.

Document Note

Note History

Contractor Information

LCD Information

Document Information

Source LCD ID
N/A
LCD ID
L33431
Original ICD-9 LCD ID
Not Applicable
LCD Title
HbA1c
Proposed LCD in Comment Period
N/A
Source Proposed LCD
N/A
Original Effective Date
For services performed on or after 10/01/2015
Revision Effective Date
For services performed on or after 03/10/2022
Revision Ending Date
N/A
Retirement Date
N/A
Notice Period Start Date
N/A
Notice Period End Date
N/A

CPT codes, descriptions, and other data only are copyright 2023 American Medical Association. All Rights Reserved. Applicable FARS/HHSARS apply.

Fee schedules, relative value units, conversion factors and/or related components are not assigned by the AMA, are not part of CPT, and the AMA is not recommending their use. The AMA does not directly or indirectly practice medicine or dispense medical services. The AMA assumes no liability for data contained or not contained herein.

Current Dental Terminology © 2023 American Dental Association. All rights reserved.

Copyright © 2024, the American Hospital Association, Chicago, Illinois. Reproduced with permission. No portion of the AHA copyrighted materials contained within this publication may be copied without the express written consent of the AHA. AHA copyrighted materials including the UB‐04 codes and descriptions may not be removed, copied, or utilized within any software, product, service, solution, or derivative work without the written consent of the AHA. If an entity wishes to utilize any AHA materials, please contact the AHA at 312‐893‐6816.

Making copies or utilizing the content of the UB‐04 Manual, including the codes and/or descriptions, for internal purposes, resale and/or to be used in any product or publication; creating any modified or derivative work of the UB‐04 Manual and/or codes and descriptions; and/or making any commercial use of UB‐04 Manual or any portion thereof, including the codes and/or descriptions, is only authorized with an express license from the American Hospital Association. The American Hospital Association (the "AHA") has not reviewed, and is not responsible for, the completeness or accuracy of any information contained in this material, nor was the AHA or any of its affiliates, involved in the preparation of this material, or the analysis of information provided in the material. The views and/or positions presented in the material do not necessarily represent the views of the AHA. CMS and its products and services are not endorsed by the AHA or any of its affiliates.

Issue

Issue Description

This LCD outlines limited coverage for this service with specific details under Coverage Indications, Limitations and/or Medical Necessity.
Issue - Explanation of Change Between Proposed LCD and Final LCD

CMS National Coverage Policy


Title XVIII of the Social Security Act, §1862(a)(1)(A) allows coverage and payment for only those services that are considered to be reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member.

CMS Internet-Only Manual, Pub. 100-03, Medicare National Coverage Determinations (NCD) Manual, Chapter 1, Part 3, §190.21 Glycated Hemoglobin/Glycated Protein

Coverage Guidance

Coverage Indications, Limitations, and/or Medical Necessity

Hemoglobin A1c (HbA1c) refers to the major component of hemoglobin A1.

Performance of the HbA1c test at least 2 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 2 consecutive HbA1c results meeting the treatment goals) performing the HbA1c test at least 2 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). 

Palmetto GBA will allow 1 additional HbA1c test every 3 months for a total of 8 tests per year in patients with uncontrolled blood glucose levels. Additional tests beyond that frequency may be reimbursed on appeal with appropriate documentation of medical necessity.

HbA1c may be inaccurate in certain situations including anemia, transfusions, hemoglobinopathies and conditions of rapid red cell turnover. Other tests to assess diabetes, including glucose, glycated protein, or fructosamine levels, may be used and are described in the Lab National Coverage Determination 190.21 (NCD for Glycated Hemoglobin / Glycated Protein). This NCD lists the ICD-10 codes for HbA1c for frequencies up to once every 3 months.
Summary of Evidence

N/A
Analysis of Evidence (Rationale for Determination)

N/A

Proposed Process Information

Synopsis of Changes
Changes Fields Changed
N/A
Associated Information
Sources of Information
Bibliography
Open Meetings
Meeting Date Meeting States Meeting Information
N/A
Contractor Advisory Committee (CAC) Meetings
Meeting Date Meeting States Meeting Information
N/A
MAC Meeting Information URLs
N/A
Proposed LCD Posting Date
Comment Period Start Date
Comment Period End Date
Reason for Proposed LCD
Requestor Information
This request was MAC initiated.
Requestor Name Requestor Letter
View Letter
N/A
Contact for Comments on Proposed LCD

Coding Information

Bill Type Codes

Code Description

Please accept the License to see the codes.
N/A

Revenue Codes

Code Description

Please accept the License to see the codes.
N/A

CPT/HCPCS Codes

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Please accept the License to see the codes.

N/A

ICD-10-CM Codes that Support Medical Necessity

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Group 1

Group 1 Paragraph:

N/A

 Group 1 Codes:

N/A

N/A

ICD-10-CM Codes that DO NOT Support Medical Necessity

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Group 1

Group 1 Paragraph:

N/A

 Group 1 Codes:

N/A

N/A

Additional ICD-10 Information

General Information

Associated Information

Documentation Requirements

When the documentation does not meet the criteria for the service rendered or the documentation does not establish the medical necessity for the services, such services will be denied as not reasonable and necessary.

Utilization Guidelines

A. Up to 1 additional test per 3 month period for Diabetes Mellitus out of control.
B. Up to 1 monthly test for pregnant Type I diabetic patients.
Sources of Information
N/A
Bibliography

American Diabetes Association. Older Adults. Diabetes Care. 2016;39(Supp 1):S81-85.

American Diabetes Association. Prevention or Delay of Type 2 Diabetes. Diabetes Care. 2016;39(Supp 1):S36-38.

American Diabetes Association. Standards of medical care in diabetes-2013. Diabetes Care. 2013;36(Supp 1):S11-66.

Goldstein DE, Little RR, Lorenz RA, et al. Tests of glycemia in diabetes. Diabetes Care. 2004;27(7):1761-1773.

Sacks DB, Arnold M, Bakris GL, et al. Guidelines and recommendations for laboratory analysis in the diagnosis and management of diabetes mellitus. Clinical Chemistry. 2011;57(6):e1-e47.

Wisconsin diabetes mellitus essential care guidelines 2012. Wisconsin Diabetes Prevention and Control Program. 2012.

Revision History Information

Revision History Date Revision History Number Revision History Explanation Reasons for Change
03/10/2022 R19

Under Bibliography revised the broken hyperlinks for the second and sixth references. Formatting and typographical errors were corrected throughout the LCD.
  • Provider Education/Guidance
06/17/2021 R18

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
10/10/2019 R17

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
07/11/2019 R16

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
10/04/2018 R15

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)
09/27/2018 R14

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
06/07/2018 R13

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
02/26/2018 R12 The Jurisdiction "J" Part B Contracts for Alabama (10112), Georgia (10212) and Tennessee (10312) are now being serviced by Palmetto GBA. The notice period for this LCD begins on 12/14/17 and ends on 02/25/18. Effective 02/26/18, these three contract numbers are being added to this LCD. No coverage, coding or other substantive changes (beyond the addition of the 3 Part B contract numbers) have been completed in this revision.
  • Change in Affiliated Contract Numbers
10/01/2017 R11

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 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
10/01/2017 R10

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 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
  • Revisions Due To ICD-10-CM Code Changes
05/04/2017 R9 Under ICD-10 Codes that Support Medical Necessity - added codes to LCD to maintain compliance with NCD: 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, E13.37X9, Z79.84. These codes are effective as of 10/01/2016.
  • Provider Education/Guidance
04/07/2017 R8 Under CMS National Coverage Policy Removed duplicate SSA 1862(a)(1)(A). Added correct verbiage to SSA 1862(a)(1)(A) to read “allows coverage and payment for only those services that are considered to be reasonable and necessary for the diagnosis or treatment of illness or to improve the functioning of a malformed body member. Grammatical correction to remove the “s” from Internet-Only Manuals. Under Coverage Indications, Limitations and/or Medical Necessity- Revised verbiage to correct quotes taken from IOM Pub 100-03 Chapter 1 part 3 Section 190.21 Removed the word “diabetic” and added hyphen to “long-term” in sentence “HbA1c assesses glycemic control over a period of 4-8 weeks and appears to be the more appropriate test for monitoring a diabetic patient who is capable of maintaining long-term, stable control.” Removed “severe hypoglycemic or ketoacidosis” and “or other” from sentence “...(for example, post-major surgery, severe hypoglycemic or ketoacidosis, or as a result of glucocorticoid or other therapy.” In second paragraph removed verbiage “patients with” from sentence “HbA1c is widely accepted as medically necessary for the management and control of patients with diabetes.” In third paragraph, removed the second “type” from sentence “Testing for uncontrolled type one or type two diabetes mellitus…” Under ICD-10 Codes that Support Medical Necessity- Removed all “unspecified eye” codes:
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
10/01/2016 R7 Under ICD-10 Codes That Support Medical Necessity Group 2: Codes added ICD-10 codes E08.3211, E08.3212, E08.3213, E08.3219, E08.3291, E08.3292, E08.3293, E08.3299, E08.3311, E08.3312, E08.3313, E08.3319, E08.3391, E08.3392, E08.3393, E08.3399, E08.3411, E08.3412, E08.3413, E08.3419, E08.3491, E08.3492, E08.3493, E08.3499, E08.3511, E08.3512, E08.3513, E08.3519, E08.3521, E08.3522, E08.3523, E08.3529, E08.3531, E08.3532, E08.3533, E08.3539, E08.3541, E08.3542, E08.3543, E08.3549, E08.3551, E08.3552, E08.3553, E08.3559, E08.3591, E08.3592, E08.3593, E08.3599, E08.37X1, E08.37X2, E08.37X3, E08.37X9, E09.3211, E09.3212, E09.3213, E09.3219, E09.3291, E09.3292, E09.3293, E09.3299, E09.3311, E09.3312, E09.3313, E09.3319, E09.3391, E09.3392, E09.3393, E09.3399, E09.3411, E09.3412, E09.3413, E09.3419, E09.3491, E09.3492, E09.3493, E09.3499, E09.3511, E09.3512, E09.3513, E09.3519, E09.3521, E09.3522, E09.3523, E09.3529, E09.3531, E09.3532, E09.3533, E09.3539, E09.3541, E09.3542, E09.3543, E09.3549, E09.3551, E09.3552, E09.3553, E09.3559, E09.3591, E09.3592, E09.3593, E09.3599, E09.37X1, E09.37X2, E09.37X3, E09.37X9, E10.3211, E10.3212, E10.3213, E10.3219, E10.3291, E10.3292, E10.3293, E10.3299, E10.3311, E10.3312, E10.3313, E10.3319, E10.3391, E10.3392, E10.3393, E10.3399, E10.3411, E10.3412, E10.3413, E10.3419, E10.3491, E10.3492, E10.3493, E10.3499, E10.3511, E10.3512, E10.3513, E10.3519, E10.3521, E10.3522, E10.3523, E10.3529, E10.3531, E10.3532, E10.3533, E10.3539, E10.3541, E10.3542, E10.3543, E10.3549, E10.3551, E10.3552, E10.3553, E10.3559, E10.3591, E10.3592, E10.3593, E10.3599, E10.37X1, E10.37X2, E10.37X3, E10.37X9, E11.3211, E11.3212, E11.3213, E11.3219, E11.3291, E11.3292, E11.3293, E11.3299, E11.3311, E11.3312, E11.3313, E11.3319, E11.3391, E11.3392, E11.3393, E11.3399, E11.3411, E11.3412, E11.3413, E11.3419, E11.3491, E11.3492, E11.3493, E11.3499, E11.3511, E11.3512, E11.3513, E11.3519, E11.3521, E11.3522, E11.3523, E11.3529, E11.3531, E11.3532, E11.3533, E11.3539, E11.3541, E11.3542, E11.3543, E11.3549, E11.3551, E11.3552, E11.3553, E11.3559, E11.3591, E11.3592, E11.3593, E11.3599, E11.37X1, E11.37X2, E11.37X3, E11.37X9, E13.3211, E13.3212, E13.3213, E13.3219, E13.3291, E13.3292, E13.3293, E13.3299, E13.3311, E13.3312, E13.3313, E13.3319, E13.3391, E13.3392, E13.3393, E13.3399, E13.3411, E13.3412, E13.3413, E13.3419, E13.3491, E13.3492, E13.3493, E13.3499, E13.3511, E13.3512, E13.3513, E13.3519, E13.3521, E13.3522, E13.3523, E13.3529, E13.3531, E13.3532, E13.3533, E13.3539, E13.3541, E13.3542, E13.3543, E13.3549, E13.3551, E13.3552, E13.3553, E13.3559, E13.3591, E13.3592, E13.3593, E13.3599, E13.37X1, E13.37X2, E13.37X3 and E13.37X9. Under ICD-10 Codes That Support Medical Necessity Group 3: Codes added ICD-10 codes O24.415, O24.425 and O24.435 and the code descriptions were revised for O24.011, O24.012, O24.013, O24.019, O24.111, O24.112, O24.113, and O24.119. This revision is due to the Annual ICD-10 Code Update and becomes effective 10/1/16.
  • Provider Education/Guidance
  • Revisions Due To ICD-10-CM Code Changes
06/03/2016 R6 Under Sources of Information and Basis for Decision updated the URLs for Standards of Medical Care in Diabetes - 2016 for Prevention or delay of type 2 diabetes and Older adults.
  • Other (Updated URLs)
05/05/2016 R5 Under Coverage Indications, Limitations and/or Medical Necessity section added the following verbiage after the first sentence of the second paragraph:

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
03/10/2016 R4 Under ICD-10 Codes That Support Medical Necessity-Group 2-Secondary Dual Codes-diagnoses that must be used in conjunction with a Group 1 code that indicates a current state of uncontrolled diabetes (hyperglycemia) added E10.21 as it was inadvertently omitted from Group 2.
  • Other
03/10/2016 R3 Under CMS National Coverage Policy added the first statement. Under Coverage Indications, Limitations and/or Medical Necessity language quoted from the Centers for Medicare and Medicaid Services (CMS) National Coverage Determinations (NCDs) and coverage provisions in interpretive manuals was italicized. In the last paragraph revised “Decision” to read “Determination”. Under ICD-10 Codes That Support Medical Necessity added verbiage to the first sentence, deleted the heading and the paragraph under the heading-Primary Codes, the heading and two paragraphs under the heading-Secondary (Dual) Codes, and the Group 1: Asterisk Note. The ICD-10 codes were distributed into Group 1 (Primary Codes), Group 2 (Secondary (Dual) Codes) and Group 3 (codes related to pregnancy). ICD-10 codes E13.00, E13.01 and E13.10 were added to Group 1. Under Associated Information-Utilization Guidelines A. revised the sentence to state, “Up to one additional test per 3 month period for Diabetes Mellitus out of control (Group 1). Under Associated Information-Utilization Guidelines-B revised the Group cited to now read “3”.
  • Provider Education/Guidance
  • Other
10/01/2015 R2 Under ICD-10 Codes That Support Medical Necessity added ICD-10 codes inadvertently omitted from the LCD:
E15
E16.0
E16.1
E89.1
  • Other (ICD-10 Conversion)
10/01/2015 R1 Under CMS National Coverage Policy added “(NCD)” into title of Medicare National Coverage Determinations Manual. Under Coverage Indications, Limitations and/or Medical Necessity in third paragraph changed “We” to now read “Palmetto GBA”. Under Sources of Information and Basis for Decision revised citations to AMA format. Added authors and journal information for National Academy of Clinical Biochemistry source. Removed reference to NCD 190.21 and linked NCD to this policy in Related National Coverage Documents section.
  • Provider Education/Guidance
  • Other (Maintenance
    Annual Review)
N/A

Associated Documents

Attachments
N/A
Related National Coverage Documents
NCDs
190.21 - Glycated Hemoglobin/Glycated Protein
Public Versions
Updated On Effective Dates Status
03/03/2022 03/10/2022 - N/A Currently in Effect You are here
Some older versions have been archived. Please visit the MCD Archive Site to retrieve them.

Keywords

  • Hemoglobin A1c
  • HbA1c

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