Together We Can Reduce CERT Errors...CGM devices that do not meet the definition of a therapeutic CGM and have not been approved by the PDAC will be denied as non-covered (no benefit)

Revised Feb 2020

DME CERT Outreach and Education Task ForceGlucose Monitors and Diabetic Testing Supplies

National Webinar – February 11, 20201

Together We Can Reduce CERT Errors

© 2020 Copyright, CGS Administrators, LLC.

Revised Feb 2020

Today’s DME CERT Task Force Panelists Cindy White, Michael Hanna

DME CERT Task Force Co-Coordinators

Jurisdictions A and D : Trina St. OursProvider Outreach & Education Consultant

Jurisdiction B and C: Michael HannaProvider Outreach and Education Consultant

2 © 2020 Copyright, CGS Administrators, LLC.

Revised Feb 2020

Agenda 2019 CERT Error Results

Trending CERT Errors

Blood Glucose Monitor Coverage Criteria

Documentation Requirements

Continuous Glucose Monitor Coverage Criteria

Resources and Questions


Revised Feb 2020

Comprehensive Error Rate Testing (CERT)• 2019 Improper Payment Rates and Projected Improper Payment

• CERT: https://www.cms.gov/files/document/2019-medicare-fee-service-supplemental-improper-payment-data.pdf

• The overall DMEPOS 2019 CERT Error Rate was 30.7%

• The 2019 CERT Error Rate for Glucose Monitors and related diabetic testing supplies was 32.8%

• 68.6% due to insufficient documentation and 18.4% for incorrect coding

• Projected improper payment of $74 million.


https://www.cms.gov/files/document/2019-medicare-fee-service-supplemental-improper-payment-data.pdf

Revised Feb 2020

Comprehensive Error Rate Testing (CERT)2019 Improper Payment DataCERT: https://www.cms.gov/research-statistics-data-and-systemsmonitoring-programsmedicare-ffs-compliance-programscertcert/2019-medicare-fee-service-supplemental-improper-payment-data

Service Type 2019 Improper Payment Rate 2019 Projected Improper Payment Amount

Overall 7.25% $28.91 B

Part A Providers (excluding Hospital Inpatient Prospective Payment System (IPPS))

8.07% $13.34 B

Part B Providers 8.64% $8.66 B

Hospital IPPS 3.57% $4.47 B

DMEPOS 30.70% $2.44 B

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https://www.cms.gov/research-statistics-data-and-systemsmonitoring-programsmedicare-ffs-compliance-programscertcert/2019-medicare-fee-service-supplemental-improper-payment-data

Revised Feb 2020

Insufficient Documentation Errors

Root Cause Description Line Count

Clinical disease management for DME is missing or inadequate.

2,303

A valid provider’s order is missing or inadequate. 1,681

Proof of delivery is missing or inadequate. 1,176

ACA 6407 requirement missing or inadequate. 367

Wound management documentation is missing or inadequate.

333

Documentation to support medical necessity of diabetic item(s) or supplies is missing or inadequate.

269


Revised Feb 2020

Appeal Rights from CERT Audits If the CERT contractor finds errors with the claim in question, the

supplier will receive an Overpayment Demand Letter and a revised Medicare Remittance Advice.

If the supplier does not agree with the outcome of the CERT review, they may either file an appeal to the Redeterminations department of their DME MAC (within 120 days of the date on the demand letter or Medicare Remittance Advice) or submit new additional documentation to the CERT contractor for their consideration.

• If a Redetermination is filed to the appropriate DME MAC within 30 days of the letter/MRA, all recoupment activities will cease until the redetermination decision is made.

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Revised Feb 2020

CERT Errors in Glucose Monitors and Testing Supplies


Revised Feb 2020

Glucose Monitors and Testing Supplies

Current CERT Error Trends

Medical RecordsOrders and NPIProof of DeliveryMisc. Billing


Revised Feb 2020

Blood Glucose Monitors and Related Testing Supplies -Coverage Criteria


Revised Feb 2020

Home Blood Glucose Monitors Blood Glucose Monitor (BGM) – E0607

• Basic Coverage Criteria:

1. Beneficiary must have diabetes.

2. Beneficiary must have sufficient training in using the device prescribed (evidence of training verified by orders for a blood glucose monitor and/or related testing supplies).


Revised Feb 2020

Home Blood Glucose Monitors Blood Glucose Monitor (BGM) with Special Features – E2100, E2101

• Basic coverage criteria met.

• Treating physician certifies that the beneficiary has severe visual impairment (20/200 or worse in both eyes).

Blood Glucose Monitor (BGM) with Special Features – E2101 only

• Basic coverage criteria met.

• Treating physician certifies that the beneficiary has impairment of manual dexterity severe enough to use this special monitoring system (NOT dependent on visual impairment).


Revised Feb 2020

Diabetic Testing Supplies The following can be provided when a BGM is covered (or is owned

by the Medicare beneficiary):• Lancets (A4259)

• Blood glucose test reagent strips (A4253)

• Glucose control solution (A4256)

• Spring powered devices for lancets (A4258)

– More than one spring powered lancet device per six months is not medically necessary

Medical necessity for laser skin piercing devices (E0620) and related lens shield (A4257) has not been established, so any claims for these HCPCS codes will be denied as not reasonable and necessary


Revised Feb 2020

Diabetic Testing Supplies Utilization Guidelines:

• The quantity of test strips (A4253) and lancets (A4259) depends on the usual medical needs of the beneficiary, regardless of their diagnostic classification of Type 1 or Type 2 diabetes.

• Usual Utilization without Insulin

– Up to 100 strips and 100 lancets every three (3) months if the basic coverage criteria have been met.

• Usual Utilization with Insulin

– Up to 300 strips and 300 lancets every three (3) months if the basic coverage criteria have been met.


Revised Feb 2020

Diabetic Testing Supplies High Utilization Guidelines:

• More than 300 strips and 300 lancets every three (3) months if the following have been met:

– Basic coverage criteria 1 and 2 have been met.

– Within six (6) months prior to ordering quantities of strips and lancets that exceed the utilization guidelines, the treating practitioner has had an in-person visit with the beneficiary to evaluate their diabetes control and their need for the specific quantity of supplies that exceeds the usual utilization amounts.

– Every six (6) months, for continued dispensing of quantities of testing supplies that exceed the usual utilization amounts, the treating practitioner must verify adherence to the high utilization testing regimen.


Revised Feb 2020

Documentation Requirements


Revised Feb 2020

Medical Records The beneficiary’s medical record should support the need for the glucose

monitor and the supplies ordered by the treating practitioner.

The physician may collect test logs from the beneficiary and add them to the permanent medical record.

For overutilization, the medical record every six months should outline why it is medically necessary to test daily above Medicare standard guidelines.


Revised Feb 2020

Standard Written Order (SWO)For dates of service on and after January 1, 2020, an SWO must be communicated to the supplier prior to claim submission and must contain all of the following: Beneficiary's name or Medicare Beneficiary Identifier (MBI)

Order Date

General description of the item

• The description can be either a general description (e.g., wheelchair or hospital bed), a HCPCS code, a HCPCS code narrative, or a brand name/model number

• For equipment - In addition to the description of the base item, the SWO may include all concurrently ordered options, accessories or additional features that are separately billed or require an upgraded code (List each separately)

• For supplies – In addition to the description of the base item, the DMEPOS order/prescription may include all concurrently ordered supplies that are separately billed (List each separately)

Quantity to be dispensed, if applicable

Treating practitioner name or NPI

Treating practitioner's signature


Revised Feb 2020

Continuous Glucose Monitors (CGM)


Revised Feb 2020

Therapeutic Continuous Glucose Monitors (CGMs)Appropriate models

• Currently only certain FDA-approved devices with a non-adjunctive indication are applicable for billing.

– At present: Abbott Freestyle Libre, Dexcom G5, Dexcom G6

• Therapeutic CGMs are defined as glucose monitors used as a replacement for finger-stick blood glucose testing treatment decisions.

• CMS Ruling 1862R recognizes therapeutic CGMs are DME under section 1861(n) of the Act.

• DME suppliers should refer to Pricing, Data Analysis, and Coding contractor for verification of any devices that may qualify under this ruling.


Revised Feb 2020

Therapeutic Continuous Glucose Monitors (CGMs)

What’s not covered?• Other devices:

CGM devices that do not meet the definition of a therapeutic CGM and have not been approved by the PDAC will be denied as non-covered (no benefit).

• Tablets, phones, etc. instead of receiverCoverage of CGM supplies is limited to those therapeutic CGM systems where the beneficiary ONLY uses a receiver classified as DME to display glucose data. If a beneficiary uses a non-DME device (smart phone, tablet, etc.) instead of a receiver, Medicare will not pay for the device or the K0553 supply allowance.


Revised Feb 2020

Therapeutic Continuous Glucose Monitors (CGMs) – Basic Coverage Criteria

1. Diabetes mellitus diagnosis; and,

2. Frequent home testing (four or more times per day) with home blood glucose monitor (BGM); and,

3. Multiple (three or more) daily injections of insulin or a continuous subcutaneous insulin infusion (CSII) pump; and,

4. Insulin regime requires frequent adjustment based on BGM or CGM testing results; and,

5. In-person encounter with physician within six months prior to ordering CGM to evaluate diabetes control and to determine that criteria 1-4 above are met; and,

6. In-person encounter with physician every six months to assess adherence to CGM regimen and diabetes treatment plan.


Revised Feb 2020

Therapeutic Continuous Glucose Monitors (CGMs) When a therapeutic CGM (K0554) is covered, the related

supply allowance (K0553) is also covered:

• This supply allowance includes all items necessary for the use of the device (sensors, transmitter, strips, lancets, etc.).

Replaces standard home blood glucose monitor and supplies.

Claims for a BGM and related supplies billed in addition to an approved CGM device and associated supply allowance will be denied as not reasonable and necessary.


Revised Feb 2020

CGM FAQs Can the beneficiary use a smartphone in addition to an FDA-

approved receiver?

Yes, that is acceptable. A secondary device such as a smartphone or tablet can be used along with an approved receiver. This may be necessary due to the visual impairments of the beneficiary or they have a caregiver that also needs to monitor the data provided by the receiver.


Revised Feb 2020

CGM FAQs Why are claims for strips and lancets denying after the

beneficiary changes to a CGM? Per the CMS Ruling 1682R, a standard blood glucose monitor

and test strips are viewed as equivalent, or “same or similar” to a CGM. Consequently, once CGS billing commences, edits are established to deny future billing of glucose monitors and the associated testing supplies. The DME supplier should no longer bill individual testing supplies (i.e., A4253, A4259) after the beneficiary receives the CGM. They should bill using HCPCS code, K0553, which covers all supplies required for the CGM. The supplier should bill one unit of service per month of the K0553.


Revised Feb 2020

CGM FAQs What if a beneficiary gets a continuous glucose monitor then decides

they don’t like it or the co-pay is too high? Can they go back to a regular blood glucose monitor?

The supplier, beneficiary and physician/non-physician practitioner should be aware that moving to the CGM replaces the BGM and it should be medically necessary for them to do so – all six coverage criteria must be met . If there are medical contraindications to the use of the CGM, there must be documented reasons in the medical record why the CGM is no longer medically necessary and the physician is now ordering a BGM to replace the CGM. The supplier’s first BGM/testing supply claim must go through Redeterminations to ascertain the need for the BGM as edits are in place to deny any BGM and supplies claims after the switch to a CGM is made.


Revised Feb 2020

Resources


Revised Feb 2020

Resources Jurisdiction DME MAC Websites:

• Jurisdiction A – https://med.noridianmedicare.com/web/jadme/

• Jurisdiction B – https://www.cgsmedicare.com/jb

• Jurisdiction C – https://www.cgsmedicare.com/jc

• Jurisdiction D – https://med.noridianmedicare.com/web/jddme/


https://med.noridianmedicare.com/web/jadme/

https://www.cgsmedicare.com/jb

https://www.cgsmedicare.com/jc

https://med.noridianmedicare.com/web/jddme/

Revised Feb 2020

Questions?


Revised Feb 2020

DisclaimerThe DME MAC CERT Outreach and Education Task Force consists of representatives from each of the DME MACs and is independent from the CMS CERT Team and CERT Contractors, who are responsible for the calculation of the Medicare Fee-for-Service Improper Payment Rate.

The DME MAC CERT Outreach and Education Task Force has produced this material as an informational reference for providers furnishing services in our contract jurisdictions. The CERT Task Force employees, agents, and staff make no representation, warranty, or guarantee that this compilation of Medicare information is error-free and will bear no responsibility or liability for the results or consequences of the use of this material. Although every reasonable effort has been made to assure the accuracy of the information within these pages at the time of publication, the Medicare program is constantly changing, and it is the responsibility of each provider to remain abreast of the Medicare program requirements. Any regulations, policies and/or guidelines cited in this publication are subject to change without further notice. Current Medicare regulations can be found on the Centers for Medicare & Medicaid Services (CMS) website at http://www.cms.gov.


http://www.cms.gov/

Documents

Together We Can Reduce CERT Errors...CGM devices that do not meet the definition of a therapeutic CGM and have not been approved by the PDAC will be denied as non-covered (no benefit)