Happy New Year, to my very special and amazing T1D community! While 2020 has been a terrible struggle in so many ways (some worldwide, some very personal), I am constantly filled with gratitude for our friendships and sharing of knowledge to make our lives better while living with T1 diabetes.
As a reminder, some of us celebrate the first day of the New Year as Change Your Lancet Day!!! Why? Because, a lot of us (maybe most of us) do not change lancets every time we do a finger stick.
The history of lancet changes? Probably goes back to development of the lancing device. You just would stick a lancet in … kind of forget about it … set the pricker and let it stick your finger. Mostly, you’d get a nice little drop of blood for testing. Didn’t seem really important to change it each time.
In fact, mostly only changed it when it became duller … the point at which my husband calls it The Club!
Lancets improved, pricking devices improved, CGM no longer required twice daily calibrations. We use the lancet fewer times a year. And we all have grown a large supply of lancets (yup, boxes of them!).
- It could be considered wise advice to change your lancet at least once a year … just sayin’! And why not January 1?!?!?
- Want to know what to do with spare lancets? You could do an art project. Or you could donate them to Insulin4Life, which sends supplies around the world. And they also take meters, lancers, unexpired strips, even unexpired insulin … a great organization.
Listen/watch Dr. Anne Peters of USC Westside Diabetes Center in Beverly Hills, CA discuss Type 1 diabetes and what you should know about the Covid-19 vaccines, 23 December 2020. She’s always so informative … great talk … amazing endocrinologist … extraordinary human!
CMS Proposes that All Continuous Glucose Monitors Would Be Considered Durable Medical Equipment was reported by Deborah Samenow for JDSupra.com, 23 November 2020. 
On November 4, 2020, CMS proposed that all continuous glucose monitors (CGMs) would be considered durable medical equipment (DME), replacing a prior policy set forth in CMS Ruling 1682-R (effective January 12, 2017) that concluded only certain types of CGMs would meet this benefit category definition. 85 Fed. Reg. 70358 (Nov. 4, 2020). Comments to the proposed rule must be received by January 4, 2021.
CGMs Will Meet Definition of DME: In this proposed rule, CMS now concludes that all CGMs meet these elements: (1) the ability to withstand repeated use; (2) expected life of at least three years; (3) primarily and customarily used to serve a medical purpose; (4) generally not useful to a person in the absence of an illness or injury; and (5) appropriate for use in the home. However, CMS is clear that while CGMs may now meet the definition of DME, the CGM prescribed for a particular beneficiary must still be reasonable and necessary for the treatment of that beneficiary’s illness or injury or to improve the functioning of a malformed body member per section 1862(a)(1)(A) of the Act.
This new proposal changes CMS prior policy regarding whether adjunctive CGMs are primarily and customarily used to serve a medical purpose. Specifically, CMS proposes that CGM systems that have not been approved by the FDA for use in making diabetes treatment decisions without the use of a separate blood glucose monitor, but could be used to alert the patient about potentially dangerous glucose levels while they sleep, are primarily and customarily used to serve a medical purpose. CMS believes that because adjunctive CGMs can provide information about potential changes in glucose levels while a beneficiary is sleeping and is not using a separate blood glucose monitor, these CGMs are primarily and customarily used to serve a medical purpose. CMS recognizes that these CGMs serve a medical purpose because they help patients avoid potential episodes of hypoglycemia or hyperglycemia, despite the fact that fingerstick blood glucose verification is still required for use in making diabetes treatment decisions. For these reasons, CMS proposes that all CGMs (adjunctive and non-adjunctive) would be considered DME, effective April 1, 2021. 85 Fed. Reg. at 70401.
Further, CMS is proposing that both therapeutic and non-therapeutic CGMs, when used in conjunction with a smartphone, satisfy the definition of DME because the durable receiver, used as a backup, is not generally useful to a person in the absence of an illness or injury. However, the smartphone must be used in conjunction with the non-disposable component of the CGM:
Medicare does not cover or provide payment for smartphones under the DME benefit. . . .If a Medicare beneficiary is using durable CGM equipment that meets the Medicare definition of DME, but also uses a smartphone or other non-DME device to display their glucose readings in conjunction with the covered DME item as described previously, Medicare will cover the disposable items since the beneficiary is primarily using their covered DME item to display their glucose readings. However, if the beneficiary is exclusively using a non-DME item like a smartphone to display glucose readings from disposable sensors, transmitters or other disposable CGM supplies, these disposable supplies cannot be covered since there is no covered item of DME in this scenario.
Read more: CMS Proposes that All Continuous Glucose Monitors Be Considered Durable Medical
I asked for a clearer definition of “adjunctive” from the Diabetes Patient Advocacy Coalition: The term “adjunctive” in the CMS context refers to CGMs that cannot be used for insulin dosing and are therefore “adjunctive” to therapy. The proposed rule splits the current single therapeutic CGM category (which contains Dexcom and Libre) into three categories – Therapeutic Automatic (Dexcom); Therapeutic Manual (Libre); and Adjunctive (Medtronic). The newly created Therapeutic Manual category will have a reimbursement rate that is 80% less than the current single category. A cut that large threatens to disrupt care for the more than 100,000 seniors using Libre (and more coming into system).
Click here for the DPAC official response
I doubt they could have written the CMS rule any less clear had they tired. I studied government, spent a good potion of my life reading federal rules and commenting about those rules for various organizations. I still have not figured this darn thing out completely. Except I know as a Medtronic user I was not going to completely like the outcome.
Well I figured out I was correct. The good news for Libre’ users is that with certain pumps the new Libre’ will be in the higher category. The people who are really fouled are those who use a CGM like Libre’ and not a pump.
I am hopeful someone will understand that CGM’s really are the most innovative part of having diabetes in 2021 regardless the method under which it is delivered.
rick,
Oh and Happy New Year !!!!!!