Local Coverage Determination (LCD)

Home Health Plans of Care: Monitoring Glucose Control in the Medicare Home Health Population with Type II Diabetes Mellitus

L35132

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Contractor Information

Contractor Name	Contract Type	Contract Number	Jurisdiction	States
Palmetto GBA	A and B and HHH MAC	11004 - HHH MAC	J - M	Alabama Arkansas Florida Georgia Illinois Indiana Kentucky Louisiana Mississippi New Mexico North Carolina Ohio Oklahoma South Carolina Tennessee Texas

LCD Information

Document Information

LCD ID
L35132

LCD Title
Home Health Plans of Care: Monitoring Glucose Control in the Medicare Home Health Population with Type II Diabetes Mellitus

Proposed LCD in Comment Period
N/A

Source Proposed LCD
DL35132

Original Effective Date
For services performed on or after 10/01/2015

Revision Effective Date
For services performed on or after 09/30/2021

Revision Ending Date
N/A

Retirement Date
N/A

Notice Period Start Date
11/14/2014

Notice Period End Date
12/29/2014

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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.

Title XVIII of the Social Security Act, §1814(a)(2)(C) Requirement of requests and certifications

42 CFR §409.42 Beneficiary qualifications for coverage of services

42 CFR §409.43 Plan of care requirements

42 CFR §424.22 Requirements for Home Health Services

CMS Internet-Only Manual, Pub. 100-02, Medicare Benefit Policy Manual, Chapter 7, §§20.2, 30.2.1, 40.1.2.4, 40.1.3

CMS Internet-Only Manual, Pub. 100-08, Medicare Program Integrity Manual, Chapter 6, §§6.2.1, 6.2.1.1, 6.2.2, 6.2.2.1, 6.2.3, 6.2.5, 6.2.6

Coverage Guidance

Coverage Indications, Limitations, and/or Medical Necessity

The goal of this Local Coverage Determination (LCD) is to ensure that evidence-based medicine addressing the risks of acute and chronic complications of diabetes mellitus (DM) are integrated into the delivery of home health (HH) services for Medicare beneficiaries with Type II DM. Initial treatment of individuals diagnosed with DM must take into account many factors, including the level of hyperglycemia/hypoglycemia and comorbidities. Physicians often recommend diet, exercise and medications alone or in combination to help reduce long-term risks of hyperglycemia.

Skilled nurse visits are permitted for the administration of daily insulin injections for the population of Medicare beneficiaries that are “either physically or mentally unable to self-inject insulin” and there is no other person who is able and willing to inject the beneficiary. Reasonable and necessary plans of care must contain sufficient information concerning the identified functional limitations to explain why an individual is physically or mentally unable to self-inject insulin. In the absence of another skilled service, failure to include the specific structural or functional impairments, together with the related activity limitations to support the determination that the individual beneficiary is either physically or mentally unable to self-inject insulin will result in a claim denial.

Evidence-based medicine supports ascertaining glucose control and the risk of secondary conditions known to occur in individuals with DM by monitoring glucose and hemoglobin A1c (HbA1c) levels in individuals with DM. This information and its communication between the physician and HH agency caring for a given beneficiary helps ensure that a HH plan of care (POC) is not only patient-centered, but also addresses prognosis - as required by the Medicare Benefit Policy Manual. Performing the HbA1c test quarterly in patients whose therapy has changed or who are not meeting glycemic goals is supported by the American Diabetes Association Standards of Medical Care in Diabetes - 2016 (ADA Standards). Based on Palmetto GBA’s claims data and the increased risk of emergency department (ED) encounters and acute inpatient admissions related to hypoglycemia in this population, physicians and HH agencies should consider the inclusion of HbA1c testing in the HH POC.

For other beneficiaries with stable glycemic control (defined as 2 consecutive HbA1c results meeting the treatment goals specified in the POC) performing the HbA1c test at least 2 times a year may be considered. The Americans with Disabilities Act (ADA) framework for considering treatment goals recognizes that “patient characteristics/health status” are important factors when considering glycemic goals. Beneficiaries eligible for the Medicare HH benefit 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 ED visits and acute inpatient hospitalization).

Reducing Hypoglycemia-related ED visits/Inpatient Hospitalizations among Beneficiaries with DM

Hypoglycemia-related ED visits and acute inpatient hospitalizations among elderly patients with DM are recognized as potentially preventable adverse drug events (ADE). The United States (U.S.) Department of Health and Human Services (HHS) Healthy People 2020, a decade-long work plan for improving the health of the U.S. population, contains a specific Medical Product Safety (MPS) objective [MPS-5.2 reduce ED visits for overdose from injectable antidiabetic agents] aimed at reducing the baseline rate by 10% by 2020. Insulin-related hypoglycemia and errors (IHEs) are especially prevalent in individuals with advanced age, limited life expectancy and frailty. This LCD seeks to help reduce these adverse events by promoting evidence-based HH plans of care.

Summary of Evidence

N/A

Analysis of Evidence (Rationale for Determination)

N/A

General Information

Associated Information

Documentation Requirements

In order for HH patients to be eligible to receive services under the Medicare HH benefit the following must be documented for certification/recertification:

a) Patient is under a physician care
b) Homebound status-with documentation of confinement to home in medical records
c) Established POC-must be signed and dated by the certifying physician
d) Face-to-Face-no more than 90 days prior or 30 days after start of home health care
e) Skilled need-services must be medically necessary and documentation of the skilled need should be in the patients medical records

If the requirements for certification are not met then claims for subsequent episodes of care, which require a recertification, will not be covered- even if the requirements for recertifications are met. Recertifications are needed at least every 60 days when there is a need for continuing home care.

1. Documentation should show that the patient is either physically or mentally unable to self-inject insulin and there is no other person who is able and willing to inject the patient.

2. Documentation must be legible, relevant and sufficient to justify the services billed. This documentation must be made available to the A/B MAC upon request.

Sources of Information
N/A

Bibliography

American Diabetes Association. Standards of medical care in diabetes: Older adults. Diabetes Care. 2016;39(Suppl 1):S81-S85.

American Diabetes Association. Standards of medical care in diabetes. Diabetes Care. 2016;39(Suppl 1):S1-S112.

Geller AI, Shehab N, Lovegrove MC, et al. National estimates of insulin-related hypoglycemia and errors leading to emergency department visits and hospitalizations. JAMA Intern Med. 2014;174(5):678-686.

Koller EA, Chin JS, Conway PH. Diabetes prevention and the role of risk factor reduction in the Medicare population. Am J Prev Med. 2013;44(4S4):S307-S316.

Nathan DM, Buse JB, Davidson MB, et al. Medical management of hyperglycemia in type 2 diabetes: A consensus algorithm for the initiation and adjustment of therapy. Diabetes Care. 2009;32(1):193-203.

Office of Disease Prevention and Health Promotion. Healthy People 2020 Objective MPS-5.2 Reduce Emergency Department (ED) Visits for Overdoses From Injectable Antidiabetic Agents. Accessed August 24, 2021.

U.S. National Library of Medicine National Institutes of Health. National Estimates of Insulin-related Hypoglycemia and Errors Leading to Emergency Department Visits and Hospitalizations. Accessed August 24, 2021.

Revision History Information

Revision History Date	Revision History Number	Revision History Explanation	Reasons for Change
09/30/2021	R15	Under *Bibliography* sources were added and changes were made to citations to reflect AMA citation guidelines. This revision is effective on 9/30/21.	Provider Education/Guidance
10/24/2019	R14	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: Home Health Plans of Care: Monitoring Glucose Control in the Medicare Home Health Population with Type II Diabetes Mellitus A56674 article. Typographical errors were corrected throughout the LCD. At this time 21^stCentury 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
07/04/2019	R13	All coding located in the *Coding Information* section has been moved into the related Billing and Coding: Home Health Plans of Care: Monitoring Glucose Control in the Medicare Home Health Population with Type II Diabetes Mellitus A56674 article and removed from the LCD. At this time 21^stCentury 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
06/20/2019	R12	Under *Sources of Information* sources were removed and placed under Bibliography. Under *Bibliography* sources were added and changes were made to citations to reflect AMA citation guidelines. Formatting, punctuation and typographical errors were corrected throughout the LCD. Acronyms were inserted and defined where appropriate throughout the LCD. At this time 21^stCentury 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
10/11/2018	R11	Under Coverage Indications, Limitations and/or Medical Necessity punctuation was corrected, acronyms were defined and words were capitalized or changed to lower case as appropriate. Under *Bibliography* changes were made to citations to reflect AMA citation guidelines. At this time 21^stCentury 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 Public Education/Guidance
10/19/2017	R10	Under *CMS National Coverage Policy* replaced change request 9189 citation with CMS Internet-Only Manual citation. DATE (10/6/17): 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 Other (Annual Validation)
01/01/2017	R9	Under *CPT/HCPCS Codes* the description was revised for HCPCS code G0300. This revision is due to the 2017 Annual CPT/HCPCS Code Update and becomes effective 1/1/17.	Provider Education/Guidance Revisions Due To CPT/HCPCS Code Changes
11/10/2016	R8	Under *CMS National Coverage Policy* corrected the title for Title XVIII of the Social Security Act, §1814(a)(2)(C) and corrected the section number cited for CMS Internet-Only Manual, Pub 100-02, Medicare Benefit Policy Manual, Chapter 7 to now read 40.1.3. Under *Sources of Information and Basis for Decision-Websites 3.* corrected the title.	Provider Education/Guidance Typographical Error
10/01/2016	R7	Under *ICD-10 Codes That Support Medical Necessity* 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 and deleted ICD-10 codes E11.321, E11.329, E11.331, E11.339, E11.341, E11.349, E11.351 and E11.359. This revision is due to the Annual ICD-10 Code Update and becomes effective 10/01/16.	Provider Education/Guidance Revisions Due To ICD-10-CM Code Changes
06/03/2016	R6	Under *Coverage Indications, Limitations and/or Medical Necessity* removed “When a daily medication is required the first-line agent is generally an oral medication like Metformin, unless there is a contraindication to its use. This policy establishes the expectation that for those Medicare beneficiaries requiring medications to achieve long-term control of glucose levels, Metformin shall be considered first-line therapy unless there is a specific contraindication to its use. Likewise Medicare beneficiaries who despite being maintained on daily insulin regimens are poorly controlled should be considered for treatment with Metformin.” Removed “Reasonable and necessary home health plans of care for Medicare beneficiaries with Type II diabetes must therefore include the monitoring and reporting of not only intermittent capillary blood/serum glucose levels but also quarterly (and no less often than 120 days) HbA1c levels.” Removed “Palmetto GBA will maintain the current quarterly (and no less often than 120 days) HbA1c frequency for the home health beneficiary population “whose therapy has changed or who are not meeting glycemic goals” and added “physicians and home health agencies should consider the inclusion of HbA1c testing in the Home Health Plan of Care.” Removed reasonable and necessary from the first sentence of the fourth paragraph. Under *Documentation Requirements* removed 2. The results of the most recent HbA1c. 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.	Reconsideration Request
05/05/2016	R5	Under *Coverage Indications, Limitations and/or Medical Necessity* section added the following verbiage to the end of the last paragraph: Performing the HbA1c test quarterly in patients whose therapy has changed or who are not meeting glycemic goals is supported by the American Diabetes Association Standards of Medical Care in Diabetes - 2016 (ADA Standards).¹ Based on Palmetto GBA’s claims data and the increased risk of emergency department (ED) encounters and acute inpatient admissions related to hypoglycemia in this population, Palmetto GBA will maintain the current quarterly (and no less often than 120 days) HbA1c frequency for the home health beneficiary population “whose therapy has changed or who are not meeting glycemic goals”. For other beneficiaries with stable glycemic control (defined as two consecutive HbA1c results meeting the treatment goals specified in the plan of care) 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. Beneficiaries eligible for the Medicare home health benefit 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). Reducing Hypoglycemia-related ED visits/Inpatient Hospitalizations among Beneficiaries with DM Hypoglycemia-related emergency department visits and acute inpatient hospitalizations among elderly patients with diabetes mellitus are recognized as potentially preventable adverse drug events (ADE).² The US Department of Health and Human Services (HHS) Healthy People 2020, a decade-long work plan for improving the health of the US population, contains a specific Medical Product Safety (MPS) objective [MPS-5.2 Reduce emergency department (ED) visits for overdose from injectable antidiabetic agents] aimed at reducing the baseline rate by 10% by 2020.³ Insulin-related hypoglycemia and errors (IHEs) are especially prevalent in individuals with advanced age, limited life expectancy and frailty. This LCD seeks to help reduce these adverse events by promoting evidence-based home health plans of care.⁴ Under *Sources of Information and Basis for Decision* section added the section titled *Websites* and the four URLs listed below: 1. Prevention or delay of type 2 diabetes; Standards of Medical Care in Diabetes - 2016 2. National Estimates of Insulin-Related Hypoglycemia and Errors Leading to Emergency Department Visits and Hospitalizations 3. Healthy People 2020 Objective MPS-5: Reduce emergency department (ED) visits for common, preventable adverse events from medications 4. Older adults; Standards of Medical Care in Diabetes - 2016	Provider Education/Guidance Reconsideration Request
01/01/2016	R4	Under CMS National Coverage Policy added reference to CMS Internet-Only Manual, Pub 100-04 Medicare Claims Processing Manual, Change Request 9369, Transmittal 3378 dated October 16, 2015. Under CPT/HCPCS Codes section removed G0154 and added HCPCS codes G0299 & G0300.	Provider Education/Guidance Public Education/Guidance Revisions Due To CPT/HCPCS Code Changes
11/13/2015	R3	Under CMS National Coverage Policy merged all references to CMS Internet-Only Manual, Pub 100-02, Chapter 7 into 1 source. Under Coverage Indications, Limitations and/or Medical Necessity in the first paragraph added “/hypoglycemia”. Punctuation corrections were made throughout. Under Sources of Information and Basis for Decision corrected all sources to AMA formatting; removed hyperlink to Nathan, Buse and Davidson reference, removed reference to CMS IOM 100-02, Chapter 7, section 30.2.1 as it is already properly referenced in CMS National Coverage Policy; and placed all sources in alphabetical order.	Provider Education/Guidance Public Education/Guidance Revisions Due To CPT/HCPCS Code Changes Typographical Error Other (Annual Validation; CR 9369 Transmittal 3378 )
10/01/2015	R2	Under *CMS National Coverage Policy* added the following: 42 CFR §424.22-Requirements for Home Health, 42 CFR §409.42-Beneficiary qualifications for coverage of services, §409.43 Plan of care requirements, Title XVIII of the Social Security Act, §1835 (a)(2)(A) Procedure for payment of claims of providers of services, Title XVIII of the Social Security Act, §1814 (a)(2)(C) Requirements of requests and certifications, CMS Internet-Only Manual, Pub 100-02, Medicare Benefit Policy Manual, Chapter 7, §30.2.1 and CMS Internet-Only Manual, Pub 100-08, Medicare Program Integrity Manual, Transmittal 603, dated July 21, 2015, Change Request 9189. Under *ICD-10 Codes That Support Medical Necessity* added “the” to the second sentence of the paragraph. Under *Associated Information-Documentation Requirements* added the requirements for certification/recertification and added “the” to statement #1.	Provider Education/Guidance Other (Change Request 9189, Transmittal 603)
10/01/2015	R1	Per CMS Internet-Only Manual, Pub 100-08, Medicare Program Integrity Manual, Chapter 13, §13.1.3 LCDs consist of only “reasonable and necessary” information. All bill type and revenue codes have been removed.	Other (Bill type and revenue code removal)

Associated Documents

Attachments
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Updated On	Effective Dates	Status
09/23/2021	09/30/2021 - N/A	Currently in Effect	You are here
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Keywords

Home Health
Diabetes
Insulin
Glucose Monitoring

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Home Health Plans of Care: Monitoring Glucose Control in the Medicare Home Health Population with Type II Diabetes Mellitus

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