Coverage and Coding of Continuous Glucose Monitors Length: 15:43 Date Recorded: 3.15.17 Hello and welcome to another edition of Medicare Minute MD. I m Dr. Robert Hoover, medical director at CGS Administrators, the Jurisdiction C DME MAC. Today I m going to talk about a recent decision by the Centers for Medicare and Medicaid Services or CMS, that changed the Medicare Program s coverage of continuous glucose monitor systems. This change was effective January 12, 2017. What is a continuous glucose monitor system? A typical CGM system has three components a sensor that is inserted under the skin and measures glucose levels; some way to transmit that measurement; and, some way to display those measurements. With most CGM systems on the market today, the sensor and transmitter are replaced on a regular basis. I mentioned January 12 and that s a key date here. To understand what CMS did you have to go back about a month before the January 12 Ruling to an action taken by the Food and Drug Administration in December 2016. And to understand the FDA action, you need to understand two terms Adjunctive and non-adjunctive as they relate to CGM systems. Adjunctive means supplementary or in addition to. Non-adjunctive means that it can stand alone. So when the FDA talked about CGM systems prior to December 2016, they were all considered by the FDA to be adjunctive. So you might ask Adjunctive to what? Prior to December 2016, the FDA did not consider a CGM system as accurate enough to be the primary device for making therapy decisions about glucose levels. You had to make those decisions with a standard home glucose monitor. Several manufacturers of CGM systems have approached the FDA about changing their position on adjunctive use. In December, the FDA did that for one CGM system - the
Dexcom G5 Mobile CGM system. It was the first CGM system that the FDA allowed to be marketed as a non-adjunctive CGM system, meaning it could serve as the primary device to make therapy decisions. In other words, the FDA did not require a standard blood glucose monitor to make decisions about blood glucose level treatment. That decision triggered action at CMS to reconsider the benefit category for CGM system. Because of the adjunctive designation for CGM systems by the FDA, CMS did not cover CGM systems as durable medical equipment. They were considered precautionary or backup equipment because they were not the primary device used to make therapeutic decisions about diabetes treatment. With the change by the FDA for the Dexcom system, CMS had to reconsider coverage. On January 12, 2017 CMS issued Ruling 1682R. CMS Rulings are official pronouncements of the Agency by the Administrator and are binding on all contactors and Administrative Law Judges. Ruling 1682R made a benefit category decision about CGM systems. On your screen now you ll see the Conclusion from the CMS ruling. I ve highlighted the important points which I ll summarize: There s a lot of words here but I think the easiest way to remember this is that CGMs are covered for beneficiaries who have diabetes and require: 1. Frequent testing 2. Frequent dosing of insulin 3. Frequent adjustment of diet and insulin The CMS Ruling used two terms to classify CGM systems: Therapeutic CGM and Non-Therapeutic CGM. The CMS Ruling declared that therapeutic CGM systems are covered under the DME benefit because they re used to make therapeutic decisions about blood glucose treatment. And as of the date of this video, there is only one CGM system that meets this CMS benefit category definition the Dexcom G5 Mobile CGM system. Now let s dig a little deeper into this CMS decision and what make this DME. Recall I opened this segment talking about the components of a CGM system the sensor, the transmitter and the display device, sometimes called a receiver. The CMS Ruling determined that the Dexcom G5 receiver was considered the durable component meeting the defintion of DME. With that designation as DME, the disposable sensor and transmitter
get covered as supplies to the covered DME. Now let s shift gears to claim submission. How do claims for CGM systems get billed to the DME MAC? First, you have to determine if the device that you re billing is a Dexcom G5 Mobile CGM system. Dexcom has several different models and it s only the G5 version that qualifies as DME. And it s only the Dexcom G5 that, at the time of this video production, qualifies as DME. This means that devices from other manufacturers DO NOT meet the definition of DME. Turning to billing now, I ll first discuss the billing of everything BUT the G5 system first because that s the easiest to discuss. CMS established HCPCS codes several years ago to describe the components of a CGM system. On your screen now you ll see those codes. These are the codes that have been used to bill CGM systems to Medicare and should continue to be used to bill for Non-Therapeutic CGM systems. They are non-covered for Medicare because non-therpeutic CGM systems are not considered DME. What about billing for the Dexcom G5 system? The Ruling outlines therapeutic CGM as comprising two elements: (1) a DME component and, (2) an all-inclusive supply allowance. The DME component for the Dexcom G5 Mobile CGM system is the receiver. The receiver must be billed using HCPCS code E1399 - DURABLE MEDICAL EQUIP- MENT, MISCELLANEOUS When billing this code, suppliers must enter Dexcom G5 Receiver in the narrative field of the claim. The supply allowance for supplies used with the Dexcom G5 Mobile CGM System encompasses all items necessary for the use of the device and includes, but is not limited to: CGM sensor, CGM transmitter, home blood glucose monitor and related BGM supplies (test strips, lancets, lancing device, and calibration solutions) and all batteries. The supply allowance must be billed using HCPCS code A9999 DURABLE MEDICAL EQUIPMENT, MISCELLANEOUS SUPPLY Claims for A9999 must be billed as one (1) unit of service per month. When billing this
code, suppliers must enter Supplies used with Dexcom G5 Receiver in the narrative field on the claim. You might ask What is this supply allowance? Recall that the Ruling declared that a CGM replaces the function of a standard home blood glucose monitor for beneficiaries with diabetes who have to monitor their blood glucose frequently in order to make therapeutic decisions about diet and insulin therapy. With the designation of the Dexcom G5 receiver as DME, there are supplies that are covered for the effective use of that DME. So CMS created a supply allowance, a monthly fee that s paid to the supplier for all supplies necessary for the use of the DME. It is not a set number of supplies. Like with the enteral nutrition supply allowance, the supply allowance for a CGM pays for everything needed for the CGM to function. So the sensors, transmitter, glucose monitor and supplies that are needed for the calibration of the CGM, batteries, etcetera. Anything that s needed. And with the supply allowance, you must not bill separately for anything related to the function of the CGM system. If you do, the claim lines for those items will be denied as unbundling. A couple of other important points before we move on to coverage. First, in today s technology-driven world, lots of folks use smart devices to monitor and track their health. Medicare does not pay for these types of technology. So for CGM systems, this has two important implications: First, Smart devices like tablet computers, laptops and smartphones are non-covered by Medicare because they do not meet the definition of DME. That is because they re not primarily and customarily used for a medical purpose, one of the tests for DME. If a suppliers chooses to bill Medicare for a beneficiary-owned smart device, it is billed using the non-covered HCPCS code A9270. Second, Medicare only covers items consided to be DME. And when the DME is covered, the supplies are covered. So coverage of the CGM system supply allowance 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.) as the display device, either separately or in combination with a receiver classified
as DME, the supply allowance is non-covered by Medicare. This is an important point so I ll repeat it. If a beneficiary uses a smart device to display their CGM data, Medicare will not pay for the supplies. It doesn t matter if they re using the receiver classified as DME in addition to the smart device. Use a smart device in any manner and the supplies are non-covered. Now let s move on to coverage. It s pretty simple. Recall the Ruling and that therapeutic CGM systems replace a standard home glucose monitor for beneficiaries that require frequent testing in order to make frequent therapeutic decisions about diet and insulin therapy. When you distill the Conclusion of the Ruling down to its basic elements, you get the coverage criteria displayed on your screen now: Recall earlier in this presentation I mentioned Frequent Testing, Frequent Dosing and Frequent Adjustment as the key concepts from the CMS Ruling. On your screen you re looking at those concepts converted to coverage statements. Let s take each one in turn: First, the beneficiary must have diabetes mellitus. The ruling doesn t make a distinction between type 1 and type 2 diabetes; however, it is clear from the Ruling that beneficiares who qualify for a CGM must be intensively managed because they must require frequent testing to make frequent adjustments to diet and insulin. Second, frequent testing. One of the cornerstones of intensive diabetes management is frequent glucose level testing 4 or more times per day. This is analagous to the beneficiaries in the home glucose monitor High Utilization category. Third, Frequent dosing The third bullet reflects the frequent dosing concept and allows coverage for beneficiares who are on multiple daily injections of insulin or MDI therapy. The medical literature generally uses this term to indicate patients that are taking 3 or more insulin injections per day. And it also includes the intensively managed patients on insulin pumps. Finally, frequent adjustment - rarely do patients with diabetes who are on oral agents, or even oral agents plus once or twice a day long-acting insulins, make frequent, that is multiple times per day, changes to the dosing of their medications. CGM systems are covered by Medicare for patients who must make multiple, daily adjustments to their diet and
insulin regimen. So to wrap this up and summarize. CMS issued Ruling R1682R on January 12, 2017 that classified CGM systems into two group Therapeutic and non-therapeutic. Therapeutic CGMs are covered by Medicare as DME, non-therapeutic CGM systems are not. As more devices come on the market that meet the therapeutic CGM definition, the Pricing, Data Analysis and Coding Contractor will update their web site. But as of the production of this video, only the Dexcom G5 Mobile CGM System meets this definition of a therapeutic CGM. In order to bill this Dexcom G5 system, you must use miscellaneous code E1399 for the receiver and A9999 for the supply allowance. The supply allowance covers all necessary supplies to maintain the CGM for a month. If you re billing any other system except the Dexcom G5, use the existing HCPCS codes A9276, A9277 and A9278. Coverage of a CGM system is for beneficiaries who frequently testing their blood glucose in order to make frequent adjustments and frequent dosing changes to their diabetes regimen. And one final note. The Glucose Monitors LCD and related Policy Article will be updated with this information in the near future. The effective date of coverage of therapeutic CGM systems will be for claims with dates of service on or after January 12, 2017. That does it for this edition of Medicare Minute MD. As with all of CGS educational offerings, this is only a summary of certain policy requirements. I encourage you to read the bulletin article titled Coverage and Coding Continuous Glucose Monitors that was published on the DME MAC web sites on March 23, 2017. Also keep an eye out for the revision to the Glucose Monitors LCD and related Policy Article for a complete description of the coverage, coding and documentation requirements. Thank you for watching and have a nice day.