In the DME Proposed Rule CMS-1738-P released last month, CMS proposes a significant expansion of continuous glucose meter (CGM) coverage with two new classes of CGMs and fixed monthly payments for related supplies. The rule does not alter device pricing; it only addresses payment amounts for monthly supplies.
The proposal comes on the heels on legal actions challenging CMS’s limitation of coverage to those CGMs cleared by the FDA to fully replace glucometers. If finalized, CMS suggests changes take effect on April 1, 2021.
CMS-1738-P proposes the following CGM classifications and supply allowances:
Non-Adjunctive and Automatic
For those not already familiar with the term, adjunctive is an adjective to describe something that is “added to something else as a supplement rather than an essential part.” In this case, it describes the CGMs relationship to a blood glucose monitor. Non-adjunctive means the FDA has approved the CGM for use in making diabetes treatment decisions without a separate fingerstick.
Furthermore, this category of devices automatically checks glucose levels and sends patients alerts when levels are too high or too low.
Medicare currently covers these devices. Since Medicare does not have to reimburse for traditional glucometer supplies, the monthly supply allowance remains unchanged:
Non-Adjunctive and Manual
CGM devices categorized as non-adjunctive and manual also have FDA approval for accuracy, but they do not automatically transmit readings to the receiver or alert the patient of dangerous glucose readings until the patient manually checks their device. These devices are frequently used for overnight monitoring of glucose levels.
Based on readily available supplier pricing, CMS proposes the following monthly fee for disposable batteries and sensors used with non-adjunctive, manual CGMs:
Adjunctive and Automatic
Adjunctive devices do not have FDA approval to fully replace traditional glucometers, so Medicare will still have to pay for traditional glucometer supplies. As such, the monthly CGM supply allowance reflects a $34.35 payment reduction to permit separate billing of a glucometer and testing supplies. CMS proposes the following monthly fee for supplies used with these CGMs:
CMS may expand HCPCS for both the devices and the supplies, although the agency could direct contractors to utilize modifiers or claim narratives to differentiate between the types of supplies.
Interested parties can submit comments on any part of the proposal through January 4, 2021.
SOURCE LINKS
https://www.govinfo.gov/content/pkg/FR-2020-11-04/pdf/2020-24194.pdf
https://www.regulations.gov/comment?D=CMS-2020-0128-0001
The proposal comes on the heels on legal actions challenging CMS’s limitation of coverage to those CGMs cleared by the FDA to fully replace glucometers. If finalized, CMS suggests changes take effect on April 1, 2021.
CMS-1738-P proposes the following CGM classifications and supply allowances:
- Non-Adjunctive and Automatic.
- Non-Adjunctive and Manual.
- Adjunctive and Automatic.
Non-Adjunctive and Automatic
For those not already familiar with the term, adjunctive is an adjective to describe something that is “added to something else as a supplement rather than an essential part.” In this case, it describes the CGMs relationship to a blood glucose monitor. Non-adjunctive means the FDA has approved the CGM for use in making diabetes treatment decisions without a separate fingerstick.
Furthermore, this category of devices automatically checks glucose levels and sends patients alerts when levels are too high or too low.
Medicare currently covers these devices. Since Medicare does not have to reimburse for traditional glucometer supplies, the monthly supply allowance remains unchanged:
- $259.20 if used with a Class III device (e.g. Dexcom G5).
- $222.77 if used with a Class II device (e.g. Dexcom G6).
Non-Adjunctive and Manual
CGM devices categorized as non-adjunctive and manual also have FDA approval for accuracy, but they do not automatically transmit readings to the receiver or alert the patient of dangerous glucose readings until the patient manually checks their device. These devices are frequently used for overnight monitoring of glucose levels.
Based on readily available supplier pricing, CMS proposes the following monthly fee for disposable batteries and sensors used with non-adjunctive, manual CGMs:
- $52.01 if used with a Class III device (e.g. Freestyle Libre 1).
- $46.86 if used with a Class II device (e.g. Freestyle Libre 2).
Adjunctive and Automatic
Adjunctive devices do not have FDA approval to fully replace traditional glucometers, so Medicare will still have to pay for traditional glucometer supplies. As such, the monthly CGM supply allowance reflects a $34.35 payment reduction to permit separate billing of a glucometer and testing supplies. CMS proposes the following monthly fee for supplies used with these CGMs:
- $198.77 if used with a Class III device (e.g. Medtronic Minimed 770G).
- $172.62 if used with a Class II device.
CMS may expand HCPCS for both the devices and the supplies, although the agency could direct contractors to utilize modifiers or claim narratives to differentiate between the types of supplies.
Interested parties can submit comments on any part of the proposal through January 4, 2021.
SOURCE LINKS
https://www.govinfo.gov/content/pkg/FR-2020-11-04/pdf/2020-24194.pdf
https://www.regulations.gov/comment?D=CMS-2020-0128-0001
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