Huuuuge news in the Diabetes Community!!!
In a surprise move late last week, the Centers for Medicare and Medicaid Services (CMS) issued a policy decision allowing for certain continuous glucose monitors (CGM) to be covered under Medicare!
This important 16-page ruling on Jan. 12 came after business hours on the East Coast, and it was the JDRF -- one of the organizations that's led advocacy efforts on this issue for several years -- that put the word out right away among the D-Community.
There are several reasons why this is a really big deal:
- CGM is a powerful therapy tool, one that can in particular save lives of people who experience hypoglycemia unawareness, or have dramatic highs and lows. SO naturally, it should be covered by insurance
- With Medicare refusing to cover it, patients using CGM who hit Medicare age were suddenly losing access to this important tool, which is nonsensical and frankly, unethical
- Classifying CGM as core therapy rather than "supplemental" paves the way not only for broader coverage of CGM across the board, but also for Artificial Pancreas systems on the near horizon
What Exactly Has Changed: Up until now, CMS has considered CGM technology to be "precautionary," meaning it was classified as a supplemental type of device that wasn't medically necessary. CGM also didn't fall under the "Durable Medical Equipment" category that covers other diabetes devices and supplies, therefore it wasn't eligible for Medicare coverage. That now changes.
A critical step that led to this CMS decision was the FDA's ruling in December that the Dexcom G5 specifically is accurate enough to be used for insulin dosing and treatment decisions. Thanks to that landmark FDA decision, the Medicare and Medicaid agency could now consider CGM "therapeutic" and classify it as Durable Medical Equipment -- officially qualifying it for coverage by Medicare and roughly 20 state Medicaid programs that haven't allowed coverage to date.
Even though many of us in the patient community have been using Dexcom data for treatment decisions for a long time, and many of us advocated for that dosing claim last year, it took the FDA's expanded designation to really push CMS to change its coverage status.
Only Dexcom: For now, this CMS coverage decision only applies to the Dexcom G5, because that's the only model that FDA has determined is "non-adjunctive," or good enough to replace fingersticks. That FDA designation has not been granted to Medtronic's competing CGM product as of now.
No Guarantees: No, this new CMS decision does not guarantee you access to a CGM if you're on Medicare. It is not a nationwide coverage policy determination, meaning it's not a blanket approval across the board. Rather, CMS has paved the way for case-by-case decisions, that you would have to apply for along with your healthcare provider. It does call for coverage of the receiver, transmitter, four sensors, and glucose test strips for calibrating twice a day.
Everyone with Diabetes: The good news is that it doesn't matter if you have type 1 or type 2, this ruling applies to you. The wording of the CMS ruling specifically refers to both types of diabetes, and the agency's press office confirms it applies to all D types. But it is important to note that this CGM Access for Medicare has been established as of Jan. 12 (the date of the decision), meaning it's not retroactive and doesn't apply to those who've already had their CGMs or tried to get Medicare coverage in the past. Dexcom plans to work with the agency in coming months to finalize details on coverage policy.
Even with all those caveats, can we get a 'Woot' here, people? This is a major step in the right direction!!
Our Diabetes Community has been pushing for this change for years, with the #MedicareCoverCGM initiative, and this is a great step toward making it a reality for all of those on Medicare and Medicaid. Obviously, Dexcom was on top of the world after hearing about this CMS decision, reflected in a news release issued on Thursday, following by a stock surge of 26% when the market opened the following day.
Congressional Reps Tom Reed and Diana DeGette, co-chairs of the House Diabetes Caucus, praised the CMS decision; they were also the main sponsors on multi-year legislation pushing for the Medicare CGM Access Act, which had 274 sponsors on both sides of the aisle before the last Congressional session ended.
Ironically, this Medicare decision came just as the Republican-led Congress was working to start the repeal process on the Affordable Care Act (one that ensures protections for those of us with pre-existing conditions)... so it's almost like the healthcare universe was trying to balance itself out.
As noted, this is currently a limited decision allowing for Medicare coverage on a case-by-case basis. That means anyone who wants to get a CGM covered under Medicare must get prior approval, working with their healthcare provider to make that happen. Of course, that process isn't mapped out anywhere, so it's probably going to be the same kind of struggle we're all familiar with when trying to get your insurance provider to approve anything for diabetes.
The next step is working to get this implemented across the board, so individual patients don't have to go through that prolonged approval process one by one. Our community will continue to advocate for CMS to create a national policy determination that applies to everyone.
No doubt, this is a blow for Medtronic, maker of the other CGM here in the States.
We reached out their reaction, but the company didn't respond to a request for comment. In the past, when we've asked the company about their plans to pursue a dosing claim as Dexcom has done, Medtronic basically told us they weren't spending their energy on that effort, but instead working directly in support the legislative push in Congress to get Medicare coverage for CGM.
Now it seems that bypassing the push a for an FDA accuracy designation was a bad idea on Medtronic's part. CMS has made its initial coverage decision specific to Dexcom, which quite obviously puts Medtronic at a disadvantage.
It's TBD whether FDA will determine the newest Medtronic CGM sensor, the Guardian 3, to be good enough for a dosing designation as well. Clinical research data shows that the Guardian 3 is not as good as the Dexcom G5, but since that product hasn't hit market yet (as the company isn't planning to launch its new Minimed 670G hybrid closed loop with Guardian 3 until Spring 2017), we just don't know what real-world use will show on accuracy.
Does This Put Our Test Strips in Danger?
Some folks have expressed worry that if CGM is now considered the gold standard of glucose monitoring, it will become even harder to get insurance coverage for test strips for the ubiquitous fingerstick meters that almost all of us still use.
Quite simply, there could be a danger here.
Obviously, just because the Dexcom G5 has a dosing designation, it doesn't mean you don't have to do fingersticks anymore. You still need to calibrate the CGM at least twice a day, for the G5. And many of us will still keep testing our blood sugars by finger, as a complement to CGM. These new rulings should not make CGM use a requirement, when thousands of patients will want to stick with traditional fingerstick testing.
While there's no direct indication that this change will lead Medicare or private insurers to start limiting test strips, some government and policy folk have already pushed for limitations on test strips in the past. And Medicare-covered PWDs are no strangers to limits being placed on the number of strips they can obtain. So yes, those decision-makers could very well see this new FDA designation and CMS ruling as fodder for more cutbacks on traditional supplies.
Also, towards the end of this new CMS document, there's this passage that could be interpreted dangerously by those deciding on coverage:
So we all need to be diligent, to make sure this CGM coverage decision doesn't result in an either-or situation in which patients can only get access to one type of meter and supplies or the other.
All our advocacy efforts and conversations with Medicare leaders should emphasize that traditional glucose test strips are still basic necessities alongside a CGM, and they shouldn't be taken away.
Again, this is a huge milestone and we're excited to see it finally happening. We send a giant heap of thanks to everyone who's been a part of the efforts -- from grassroots patient advocates, to the big orgs like JDRF and the American Association of Clinical Endos (AACE), to the folks at Dexcom and lawmakers who've been supporting this change for a long time.
Together, you all helped push for an important breakthrough. This is how advocacy is supposed to happen!