Notification



Notification Issue Date:



Medicare Advantage Policy

Title:Continuous Glucose Monitors and Artificial Pancreas Device Systems (APDS)
Policy #:MA00.002f

This policy is applicable to the Company’s Medicare Advantage products only. Policies that are applicable to the Company’s commercial products are accessible via a separate commercial policy database.


The Company makes decisions on coverage based on the Centers for Medicare and Medicaid Services (CMS) regulations and guidance, benefit plan documents and contracts, and the member’s medical history and condition. If CMS does not have a position addressing a service, the Company makes decisions based on Company Policy Bulletins. Benefits may vary based on contract, and individual member benefits must be verified. The Company determines medical necessity only if the benefit exists and no contract exclusions are applicable. Although the Medicare Advantage Policy Bulletin is consistent with Medicare’s regulations and guidance, the Company’s payment methodology may differ from Medicare.

When services can be administered in various settings, the Company reserves the right to reimburse only those services that are furnished in the most appropriate and cost-effective setting that is appropriate to the member’s medical needs and condition. This decision is based on the member’s current medical condition and any required monitoring or additional services that may coincide with the delivery of this service.


This Policy Bulletin document describes the status of CMS coverage, medical terminology, and/or benefit plan documents and contracts at the time the document was developed. This Policy Bulletin will be reviewed regularly and be updated as Medicare changes their regulations and guidance, scientific and medical literature becomes available, and/or the benefit plan documents and/or contracts are changed.



Policy

Coverage is subject to the terms, conditions, and limitations of the member's Evidence of Coverage.


Refer to the following News Article: Waiver of certain requirements during COVID-19 outbreak related to Durable Medical Equipment (DME), prosthetics, orthotics, and supplies for Medicare Advantage members (updated June 30, 2020)


MEDICALLY NECESSARY

SHORT-TERM INTERSTITIAL CONTINUOUS GLUCOSE MONITORING SYSTEM (CGMS)
When reported as a professional service, use of an FDA-approved short-term (i.e., 72-hour minimum) interstitial CGMS for detecting trends and patterns in glucose levels is considered medically necessary and, therefore, covered for individuals who meet one of the following criteria:
  • The individual is a pregnant female with type I or type II diabetes that requires insulin therapy.
  • The individual is a pregnant female who develops gestational diabetes, defined as any degree of glucose intolerance with onset or first recognition during pregnancy, which requires insulin therapy.
  • The individual has type I diabetes and requires determination of basal insulin level measurements prior to insulin pump initiation.
  • The individual has type I or type II diabetes and documentation of all of the following:
    • The individual has received diabetes self-management education and instruction from a health care professional with expertise in the management of diabetes.
    • The individual has a documented average of at least three glucose self-tests per day during the previous month.
    • The individual has a documented history of poorly controlled (i.e., severe ketosis or hypoglycemic episodes without experiencing warning and recognition of symptoms or hypoglycemic unawareness.
    • The individual is on an intensive insulin regimen, requiring two or more insulin injections per day, or utilizes an insulin pump.
      • The individual has one or more of the following while on an intensive insulin regimen:
        • Glycated hemoglobin (HbA1c) values less than four or greater than nine
        • Unexplained large fluctuations in daily glucose values before meals
        • Unexplained frequent hypoglycemic attacks
        • Episodes of ketoacidosis or hospitalizations for significantly elevated glucose levels

Short-term interstitial CGMS monitoring is intended only for periodic or occasional testing and to supplement, not replace, self-testing of blood glucose.

Short-term interstitial CGMS monitoring must be reported only once per monitoring period, regardless of the number of days involved. Continuous interstitial glucose monitoring must be performed for a minimum of 72 hours to show glucose trends effectively.

THERAPEUTIC (NON-ADJUNCTIVE) LONG-TERM INTERSTITIAL CGMS
A Food and Drug Administration (FDA) approved, therapeutic long-term CGMS is considered medically necessary and, therefore, covered as durable medical equipment (DME) when all of the following criteria are met:
  • The therapeutic long-term CGMS is prescribed by a professional provider.
  • The individual has insulin-dependent diabetes mellitus requiring multiple daily injections of insulin or a continuous subcutaneous insulin infusion pump.
  • The individual has been using a home blood glucose monitor and performs testing four or more times a day, and it is anticipated that the individual's insulin treatment regimen will continue to require frequent adjustments based on therapeutic CGMS testing results.
  • The CGMS is being used as a non-adjunctive device to replace a blood glucose monitor (i.e., Dexcom 5G Mobile CGMS).

SUPPLIES AND EQUIPMENT FOR A THERAPEUTIC LONG-TERM CGMS
Supplies (e.g., sensors and transmitters) for therapeutic long-term CGMS are considered medically necessary and, therefore, covered, once monthly while the individual is utilizing a therapeutic long-term CGMS and must be reordered by the treating professional provider on a yearly basis. One unit equals a one-month supply.

A receiver (monitor) is considered medically necessary and, therefore, covered, up to the manufacturer's useful lifetime limit of the device.

NOT COVERED

SHORT-TERM INTERSTITIAL CGMS
For short-term interstitial CGMS devices, a monitoring period of less than 72 hours is considered not medically necessary and, therefore, not covered.

All other uses for a short-term interstitial CGMS are considered experimental/investigational and, therefore, not covered because their safety and/or effectiveness cannot be established by review of the available published peer-reviewed literature.

NON-THERAPEUTIC LONG-TERM INTERSTITIAL CGMS
A long-term CGMS approved by the FDA for use as adjunctive devices (i.e., blood glucose monitor with traditional finger-stick testing) and not used as the sole device for making diabetes treatment decisions, is not covered by the Company, because it is considered a non-therapeutic item, and not covered by Medicare. Therefore, it is not eligible for reimbursement consideration.

REMOTE GLUCOSE MONITORS
Remote glucose monitors (e.g., mySentry™), to measure glucose levels via a subcutaneously implanted sensor, do not meet Medicare's definition of durable medical equipment (DME) because they are considered precautionary. Therefore, remote glucose monitors are not covered.

ARTIFICIAL PANCREAS DEVICE SYSTEMS
Artificial pancreas device systems (i.e., the threshold suspend device system, control-to-range and control-to-target systems, do not meet Medicare's definition of durable medical equipment (DME) because they contain components that are not covered by Medicare. Therefore, the artificial pancreas device systems are considered not covered.

ACCESSORIES AND SUPPLIES
Associated accessories for CGMS devices, such as shower covers and belt clips, are considered not medically necessary and, therefore, not covered.

Any additional software or hardware required for downloading CGMS data to a computer is considered not medically necessary and, therefore, not covered.

Smart devices (e.g., smart phones, tablets, personal computers) are not covered by the Company because they are not covered by Medicare. These items do not meet Medicare's definition of durable medical equipment because they are non-medical items. Therefore, smart devices are not eligible for reimbursement consideration.

REQUIRED DOCUMENTATION

The Company may conduct reviews and audits of services to our members regardless of the participation status of the provider. Medical record documentation must be maintained on file to reflect the medical necessity of the care and services provided. These medical records may include but are not limited to: records from the professional provider’s office, hospital, nursing home, home health agencies, therapies, and test reports.

PRESCRIPTION (ORDER) REQUIREMENTS
Before submitting a claim to the Company, the supplier must have on file a timely, appropriate, and complete order for each item billed that is signed and dated by the professional provider who is treating the member. Requesting a provider to sign a retrospective order at the time of an audit or after an audit for submission as an original order, reorder, or updated order will not satisfy the requirement to maintain a timely professional provider order on file.

PROOF OF DELIVERY
Medical record documentation must include a contemporaneously prepared delivery confirmation or member’s receipt of supplies and equipment. The medical record documentation must include a copy of delivery confirmation if delivered by a commercial carrier and a signed copy of delivery confirmation by member/caregiver if delivered by the DME supplier/provider. All documentation is to be prepared contemporaneous with delivery and be available to the Company upon request.

CONSUMABLE SUPPLIES (WHEN APPLICABLE)
The durable medical equipment (DME) supplier must monitor the quantity of accessories and supplies an individual is actually using. Contacting the individual regarding replenishment of supplies should not be done earlier than approximately seven days prior to the delivery/shipping date. Dated documentation of this contact with the individual is required in the individual’s medical record. Delivery of the supplies should not be done earlier than approximately five days before the individual would exhaust their on-hand supply.

If required documentation is not available on file to support a claim at the time of an audit or record request, the durable medical equipment (DME) supplier may be required to reimburse the Company for overpayments.
Policy Guidelines

The use of a short-term interstitial continuous glucose monitoring system (CGMS) that is a provider-owned device loaned to an individual for a minimum of 72 hours is anticipated to be used no more than once every six months.

Interstitial CGMSs have been approved by the US Food and Drug Administration (FDA) for adult and pediatric individuals with diabetes.

BENEFIT APPLICATION

Subject to the terms and conditions of the applicable Evidence of Coverage, short-term continuous glucose monitoring (CGM) and therapeutic long-term CGMS are covered under the medical benefits of the Company’s Medicare Advantage products when the medical necessity criteria listed in this medical policy are met. However, services that are identified in this policy as not covered are not eligible for coverage or reimbursement by the Company.

Description

Developments in the ability to monitor interstitial fluid glucose at frequent intervals and to record them via a transmitter have provided the ability to monitor diabetic control in individuals who have proven refractory to conventional self-monitoring. These devices are of specific value in those individuals who have wide glycemic swings, frequent hospitalizations, and complications of their systemic illness.

SHORT-TERM INTERSTITIAL CONTINUAL GLUCOSE MONITORING SYSTEM

A short-term continuous glucose monitoring system (CGMS) is a health care provider--owned device that is loaned to an individual who wears it for a minimum of 72 hours. The individual calibrates the system at least twice a day by entering their glucose measurement obtained from a traditional blood glucose monitor.

The detailed glucose trend and pattern information is collected by the device and reviewed by a professional health care provider. Based on this information, adjustments may be made to the individual's medication, diet, or exercise regimen. Short-term interstitial CGMS are indicated for use in individuals with diabetes who demonstrate marked changes in status, as evidenced by unexplained glycemic fluctuations. These devices can also be used periodically to confirm the status of current diabetic therapy. They are intended only for occasional testing and to supplement, not replace, self-testing of blood glucose.

LONG-TERM CONTINUOUS GLUCOSE MONITORING SYSTEM

A long-term CGMS is indicated for use in individuals with diabetes who require insulin and need to be monitored for unexplained glycemic fluctuations and hypoglycemic unawareness. Hypoglycemic unawareness is the inability of an individual to notice and recognize symptoms of hypoglycemia while they are experiencing them. Complications of unaddressed hypoglycemia may include diabetic coma, brain damage, and seizures.

Most, long-term interstitial CGMS devices are FDA approved as an adjunct to traditional blood glucose monitoring. These devices allow individuals to track glucose levels and detect episodes of high and low blood sugar in real-time on an ongoing basis. The device consists of a disposable subcutaneous sensor, an external transmitter, and an external receiver (monitor), which can be a stand-alone device or built into an insulin pump. Sensors are worn as indicated by the device manufacturer in accordance with US Food and Drug Administration (FDA) labeling and are replaced on an ongoing basis.

NON-ADJUNCTIVE CGM
According to the FDA, on December 20, 2016, the Dexcom G5 Mobile Continuous Glucose Monitoring (GCM) System received supplemental approval, as the first device that can be used as a replacement for finger-stick testing in individuals 2 years of age and older for diabetes treatment decisions. Interpretation of the results of the device should be based on the glucose trends and several sequential readings over time. The product also aids in the detection of episodes of hyperglycemia and hypoglycemia, facilitating both acute and long-term therapy adjustments. Finger-sticks are required for calibration, at least once every 12 hours. More frequent calibrations may be required if symptoms do not match readings or when taking medications containing acetaminophen, which can falsely elevate the device's readings.

According to the Centers of Medicare and Medicaid (CMS), the Dexcom G5 Mobile Continuous Glucose Monitoring (GCM) System meets the requirements of a therapeutic CGM, by replacing the need for an adjunctive blood glucose monitor.

ADJUNCTIVE CGMS
CGM devices approved by the FDA for use as adjunctive devices, used with finger-stick testing, and not used solely for making diabetes treatment decisions, such as changing one's diet or insulin dosage based the readings of the CGM, are not considered therapeutic.

REMOTE GLUCOSE MONITORS

A remote glucose monitor (e.g., mySentry™) receives information transmitted from a CGM-enabled pump. The CGM-enabled pumps use glucose sensors that report glucose values every 5 minutes for up to 72 hours. These readings are used with fingerstick results to detect trends and patterns in glucose levels for individuals who have diabetes.

A remote glucose monitor (e.g., mySentry™) has two components: an alarm clock--sized monitor, in the form of a table-top viewing screen, and a small, companion “signal booster,” or data transmission device, called the Outpost. It allows a caregiver in another room to see the monitor’s color screen and all the key metrics of the linked pump; if the pump sets off an alarm, that alarm is relayed to the monitor.

The remote glucose monitor (e.g., mySentry™) captures data from a CGM-enabled pump and relays that information, along with blood sugar readings, up to 100 feet away. The CGM-enabled pump works in close proximity (i.e., within six feet) of either the monitor itself or the Outpost signal booster. The primary use of the remote glucose monitor (e.g., mySentry™) is for a caregiver to receive alerts and information from the CGM-enabled pumps during night-time monitoring.

ARTIFICIAL PANCREAS DEVICE SYSTEMS (APDS)

Despite the availability of increasingly effective treatment modalities, a substantial proportion of individuals with insulin-dependent diabetes cannot achieve adequate glycemic control.

One of the critical path initiatives of the US Food and Drug Administration (FDA) is to accelerate the development and availability of a safe and effective artificial pancreas for the treatment of diabetes mellitus. In partnership with the National Institutes of Health (NIH), the FDA has established a multi-disciplinary group of scientists and clinicians to address the clinical, scientific, and regulatory challenges related to the artificial pancreas device systems.
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US Food and Drug Administration (FDA). Medical Devices. The Artificial Pancreas Device System. FDA's Efforts to Advance Artificial Pancreas Device Systems. Last updated 2/2/2017. Available at: https://www.fda.gov/medicaldevices/productsandmedicalprocedures/homehealthandconsumer/consumerproducts/artificialpancreas/default.htm. Accessed March 20, 2018.

Vigersky RA, Fonda SJ, Chellappa M, et al. Short- and long-term effects of real-time continuous glucose monitoring in patients with type 2 diabetes. Diabetes Care. 2012;35(1):32-8.

Voormolen DN, Devries JH, Franx A, et al. Effectiveness of continuous glucose monitoring during diabetic pregnancy (GlucoMOMS trial); a randomised controlled trial. BMC Pregnancy Childbirth. 2012;12(1):164.

Wilson DM, Beck RW, Tamborlane WV, et al. The accuracy of the FreeStyle Navigator continuous glucose monitoring system in children with type 1 diabetes. Diabetes Care. 2007;30(1):59-64.

Wojciechowski P, Rys P, Lipowska A, et al. Efficacy and safety comparison of continuous glucose monitoring and self-monitoring of blood glucose in type 1 diabetes. Pol Arch Med Wewn. 2011;121(10):333-43.

Wolpert HA. The nuts and bolts of achieving end points with real-time continuous glucose monitoring. Diabetes Care. 2008;31(Suppl 2):S146-S149.

Yates K, Hasnat MA, Dear K, Ambler G. Continuous glucose monitoring-guided insulin adjustment in children and adolescents on near-physiological insulin regimens: a randomized controlled trial. Diabetes Care.2006;29(7):1512-1517.

Yogish C. Kudva, Rickey E. Carter, Claudio Cobelli, Rita Basu, and Ananda Basu. Closed-Loop Artificial Pancreas Systems: Physiological Input to Enhance Next-Generation Devices. Diabetes Care 2014;37: 1184–1190. Available at: http://care.diabetesjournals.org/content/37/5/1184.full.pdf. Accessed March 20, 2018.



Coding

Inclusion of a code in this table does not imply reimbursement. Eligibility, benefits, limitations, exclusions, precertification/referral requirements, provider contracts, and Company policies apply.

The codes listed below are updated on a regular basis, in accordance with nationally accepted coding guidelines. Therefore, this policy applies to any and all future applicable coding changes, revisions, or updates.

In order to ensure optimal reimbursement, all health care services, devices, and pharmaceuticals should be reported using the billing codes and modifiers that most accurately represent the services rendered, unless otherwise directed by the Company.

The Coding Table lists any CPT, ICD-9, ICD-10, and HCPCS billing codes related only to the specific policy in which they appear.

CPT Procedure Code Number(s)

MEDICALLY NECESSARY
THE FOLLOWING CODES ARE USED TO REPRESENT SHORT-TERM INTERSTITIAL CONTINUOUS GLUCOSE MONITORING SYSTEMS:

95249, 95250, 95251


Professional and outpatient claims with a date of service on or before September 30, 2015, must be billed using ICD-9 codes. Professional and outpatient claims with a date of service on or after October 1, 2015, must be billed using ICD-10 codes.

Facility/Institutional inpatient claims with a date of discharge on or before September 30, 2015, must be billed with ICD-9 codes. Facility/Institutional inpatient claims with a date of discharge on or after October 1, 2015, must be billed with ICD-10 codes.


ICD - 10 Procedure Code Number(s)

N/A


Professional and outpatient claims with a date of service on or before September 30, 2015, must be billed using ICD-9 codes. Professional and outpatient claims with a date of service on or after October 1, 2015, must be billed using ICD-10 codes.

Facility/Institutional inpatient claims with a date of discharge on or before September 30, 2015, must be billed with ICD-9 codes. Facility/Institutional inpatient claims with a date of discharge on or after October 1, 2015, must be billed with ICD-10 codes.


ICD -10 Diagnosis Code Number(s)

SHORT-TERM INTERSTITIAL CGMS IS MEDICALLY NECESSARY WHEN REPORTED WITH THE DIAGNOSIS CODES IN ATTACHMENT A


THERAPEUTIC LONG-TERM INTERSTITIAL CGMS IS MEDICALLY NECESSARY WHEN REPORTED WITH THE DIAGNOSIS CODES IN ATTACHMENT B



HCPCS Level II Code Number(s)

MEDICALLY NECESSARY


K0553 Supply allowance for therapeutic continuous glucose monitor (CGM), includes all supplies and accessories, 1 month supply = 1 unit of service

K0554 Receiver (monitor), dedicated, for use with therapeutic glucose continuous monitor system

NOT COVERED

THE FOLLOWING CODES ARE USED TO REPRESENT NON-THERAPEUTIC LONG-TERM INTERSTITIAL CONTINUOUS GLUCOSE MONITORING SYSTEM:

A9276 Sensor; invasive (e.g., subcutaneous), disposable, for use with interstitial continuous glucose monitoring system, 1 unit = 1 day supply

A9277 Transmitter; external, for use with interstitial continuous glucose monitoring system

A9278 Receiver (monitor); external, for use with interstitial continuous glucose monitoring system

THE FOLLOWING CODE IS USED TO REPRESENT REMOTE CONTINUOUS GLUCOSE MONITORING SYSTEM (E.G., mySentry™):

A9999 Miscellaneous DME supply or accessory, not otherwise specified

THE FOLLOWING CODES ARE USED TO REPRESENT ARTIFICIAL PANCREAS DEVICE SYSTEM:

S1034 Artificial Pancreas Device System (eg, Low Glucose Suspend [LGS] Feature) Including Continuous Glucose Monitor, Blood Glucose Device, Insulin Pump And Computer Algorithm That Communicates With All Of The Devices

S1035 Sensor; Invasive (eg, Subcutaneous), Disposable, For Use With Artificial Pancreas Device System

S1036 Transmitter; External, For Use With Artificial Pancreas Device System

S1037 Receiver (Monitor); External, For Use With Artificial Pancreas Device System



Revenue Code Number(s)

N/A

Coding and Billing Requirements


Cross References

Attachment A: Continuous Glucose Monitors and Artificial Pancreas Device Systems (APDS)
Description: ICD-10: Short term CGM

Attachment B: Continuous Glucose Monitors and Artificial Pancreas Device Systems (APDS)
Description: THERAPEUTIC LONG-TERM INTERSTITIAL CGMS







Policy History

MA02.002f
04/25/2018The policy has been reviewed and reissued to communicate the Company’s continuing position on Interstitial Continuous Glucose Monitoring Systems (CGMSs) and Artificial Pancreas Device Systems (APDS).
01/01/2018This version of the policy will become effective 01/01/2018.
    The following CPT code has been added to this policy: 95249
    The following CPT codes have been revised, in this policy: 95250, 95251

MA00.002e
11/03/2017This policy has been updated to include the Medicare Coding for the therapeutic non-adjunctive continuous glucose monitors (CGM) and supplies.

The following codes were added to the policy
    K0553 Supply allowance for therapeutic continuous glucose monitor (CGM), includes all supplies and accessories, 1 month supply = 1 unit of service

    K0554 Receiver (monitor), dedicated, for use with therapeutic glucose continuous monitor system

The Following codes were removed from the policy
    THE FOLLOWING CODE IS USED TO REPRESENT THE THERAPEUTIC LONG-TERM INTERSTITIAL CGMS (RECEIVER/MONITOR):

    E1399 Durable medical equipment, miscellaneous

    THE FOLLOWING CODE IS USED TO REPRESENT THERAPEUTIC LONG-TERM INTERSTITIAL CONTINUOUS GLUCOSE MONITORING SYSTEM SUPPLIES (e.g., SENSORS AND TRANSMITTERS):

    A9999 Miscellaneous DME supply or accessory, not otherwise specified
Codes removed from Attachment A
    E08.00 E08.01 E08.10 E08.11 E08.21 E08.22 E08.29 E08.311 E08.319 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 E08.36 E08.37X1 E08.37X2 E08.37X3 E08.37X9 E08.39 E08.40 E08.41 E08.42 E08.43 E08.44 E08.49 E08.51 E08.52 E08.59 E08.610 E08.618 E08.620 E08.621 E08.622 E08.628 E08.630 E08.638 E08.641 E08.649 E08.65 E08.69 E08.8 E08.9
    E13.00 E13.01 E13.10 E13.11 E13.21 E13.22 E13.29 E13.311 E13.319 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 E13.36 E13.37X1 E13.37X2 E13.37X3 E13.37X9 E13.39 E13.40 E13.41 E13.42 E13.43 E13.44 E13.49 E13.51 E13.52 E13.59 E13.610 E13.618 E13.620 E13.621 E13.622 E13.628 E13.630 E13.638 E13.641 E13.649 E13.65 E13.69 E13.8 E13.9
    O24.311 O24.312 O24.313 O24.319 O24.33 O24.811 O24.812 O24.813 O24.819 O24.83 O24.911 O24.912 O24.913 O24.919 O24.93 O99.810 O99.815

Codes Added Attachment A
    O24.02 Pre-existing type 1 diabetes mellitus, in childbirth
    O24.12 Pre-existing type 2 diabetes mellitus, in childbirth
    O24.424 Gestational diabetes mellitus in childbirth, insulin controlled
    O24.429 Gestational diabetes mellitus in childbirth, unspecified control

Codes Added to Attachment B
    E09.00 E09.01 E09.10 E09.11 E09.21 E09.22 E09.29 E09.311 E09.319 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 E09.36 E09.37X1 E09.37X2 E09.37X3 E09.37X9 E09.39 E09.40 E09.41 E09.42 E09.43 E09.44 E09.49 E09.51 E09.52 E09.59 E09.610 E09.618 E09.620 E09.621 E09.622 E09.628 E09.630 E09.638 E09.641 E09.649 E09.65 E09.69 E09.8 E09.9 O24.02 O24.12 O24.32 O24.82 O24.92

MA00.002d
10/01/2017This policy has been identified for the ICD-10 CM code update, effective 10/01/2017.

The following ICD-10 CM codes have been added to this policy: In Attachments A and B
    E11.10 Type 2 diabetes mellitus with ketoacidosis without coma
    E11.11 Type 2 diabetes mellitus with ketoacidosis with coma

MA00.002c
01/12/2017This policy has been updated to include the Medicare Coding and Coverage position for the therapeutic continuous glucose monitors (CGM).

MA00.002b
10/01//2016This policy has been identified for the ICD-10 CM code update, effective 10/01/2016.
  • The following ICD-10 CM codes have been revised in this policy:

FROM: O24.011 Pre-existing diabetes mellitus, type 1, in pregnancy, first trimester
TO: O24.011 Pre-existing type 1 diabetes mellitus, in pregnancy, first trimester

FROM: O24.012 Pre-existing diabetes mellitus, type 1, in pregnancy, second trimester
TO: O24.012 Pre-existing type 1 diabetes mellitus, in pregnancy, second trimester

FROM; 24.013 Pre-existing diabetes mellitus, type 1, in pregnancy, third trimester
TO; O24.013 Pre-existing type 1 diabetes mellitus, in pregnancy, third trimester

TO; O24.019 Pre-existing diabetes mellitus, type 1, in pregnancy, unspecified trimester
FROM; O24.019 Pre-existing type 1 diabetes mellitus, in pregnancy, unspecified trimester

FROM; O24.03 Pre-existing diabetes mellitus, type 1, in the puerperium
TO; O24.03 Pre-existing type 1 diabetes mellitus, in the puerperium

FROM; O24.111 Pre-existing diabetes mellitus, type 2, in pregnancy, first trimester
TO; O24.111 Pre-existing type 2 diabetes mellitus, in pregnancy, first trimester

FROM; O24.112 Pre-existing diabetes mellitus, type 2, in pregnancy, second trimester
TO; O24.112 Pre-existing type 2 diabetes mellitus, in pregnancy, second trimester

FROM; O24.113 Pre-existing diabetes mellitus, type 2, in pregnancy, third trimester
TO; O24.113 Pre-existing type 2 diabetes mellitus, in pregnancy, third trimester

FROM; O24.119 Pre-existing diabetes mellitus, type 2, in pregnancy, unspecified trimester
TO; O24.119 Pre-existing type 2 diabetes mellitus, in pregnancy, unspecified trimester

FROM: O24.13 Pre-existing diabetes mellitus, type 2, in the puerperium
TO: O24.13 Pre-existing type 2 diabetes mellitus, in the puerperium

  • The following ICD-10 CM codes have been deleted from this policy:

E08.321, E08.329, E08.331, E08.339, E08.341, E08.349, E08.351, E08.359, E10.321, E10.329, E10.331 E10.339, E10.341, E10.349 E10.351, E10.359, E11.321, E11.329, E11.331, E11.339, E11.341, E11.349, E11.351, E11.359, E13.321, E13.329, E13.331, E13.339, E13.341, E13.349, E13.351, E13.359
  • The following ICD-10 CM codes have been added to this policy:

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, 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, 13.3319, 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, E13.37X9, O24.415, O24.425, O24.435.

MA00.002a
05/11/2016The policy has been reviewed and reissued to communicate the Company’s continuing position on Interstitial Continuous Glucose Monitoring Systems (CGMSs) and Artificial Pancreas Device Systems (APDS).
02/11/2015The following requirements have been added to this policy:

ARTIFICIAL PANCREAS DEVICE SYSTEMS

Artificial pancreas device systems (i.e. the Threshold Suspend Device System, Control to Range [CTR] and Control to Target [CTT], does not meet Medicare's definition of durable medical equipment (DME) because they contain components that are not covered by Medicare. Therefore, the artificial pancreas device systems are considered not covered.
  • The following policy statement has been deleted from this policy:

ARTIFICIAL PANCREAS DEVICE SYSTEM

The artificial pancreas device system is considered experimental/investigational and, therefore, not covered because the safety and/or effectiveness of this service cannot be established by review of the available published peer-reviewed literature.
  • The Description has been updated.
  • The following ICD-9 codes has been removed:
      251.1 Other specified hypoglycemia
      V45.85 Insulin pump status

MA00.002
01/01/2015This is a new policy.




Version Effective Date: 01/01/2018
Version Issued Date: 12/29/2017
Version Reissued Date: 04/25/2018