Whenever the topic of healthcare and Congress comes up, you have to cringe a little and wonder what kind of rhetoric-filled squabble is about to ensue.
Happily, that may not be the case with a new piece of comprehensive legislation called the 21st Century Cures Act, which as its name implies, is all about creating better treatments and even cures for all kinds of diseases -- including diabetes.
Hey, it's not even being described as "bi-partisan" but is supposedly "non-partisan," according to the legislative leaders behind it.
Sure, this bill that's been in the works for over a year now is already nearly 400 pages long, and it's not even all written yet. But the word from those who've studied the language and delved into its nitty-gritty is that the potential for diabetes is huge.
To strenghten that further, some Diabetes Advocates have been calling on the D-Community to contact legislators about inserting more diabetes-specific language into the legislation, in particular about continuous glucose monitor (CGM) coverage by Medicare. That's been a huge issue for our community of late, and this may be the perfect opportunity to piggyback on this promising bill, as it moves through committee hearings and works its way through the congressional pipeline by the end of the year.
The influential House Energy and Commerce Committee in the U.S. House of Representatives takes up the 21st Century Cures Act during a hearing on April 30, and its backers have been actively promoting it on Twitter (!) using the hashtags #Cures2015 and #Path2Cures.
So what exactly is the 21st Century Cures Act?
The bill is the product of a bipartisan process known as the 21st Century Cures Initiative. Since its launch in April 2014, the initiative has held more than a dozen roundtables, eight congressional hearings and released five whitepapers—all focused on ways in which Congress might transform the way new treatments are approved and marketed in the US.
The massive, 393-page bill, known as the 21st Century Cures Act, is split up into five separate sections:
- Title I—Putting Patients First By Incorporating Their Perspectives Into The Regulatory Process And Addressing Unmet Needs
- Title II—Building The Foundation For 21st Century Medicine, Including Helping Young Scientists
- Title III—Modernizing Clinical Trials
- Title IV—Accelerating The Discovery, Development, And Delivery Cycle And Continuing 21st Century Innovation At NIH, FDA, CDC, And CMS
- Title V—Modernizing Medical Product Regulation
This whole thing materialized in April 2014, with the 21st Century Cures Intiative that focused on ways Congress could transform how new treatments are approved and marketed in the U.S. They traveled D.C. and the country, holding a dozen roundtables, eight congressional hearings and writing five whitepapers on the efforts to be made. A initial draft bill was introduced in January 2015 by Michigan Rep. Fred Upton and Colorado Rep. Diana DeGette, and this 4-minute video gives a basic overview of what it's all about.
Essentially, there are 5 major tenets:
- Putting Patients First By Incorporating Their Perspectives Into The Regulatory Process And Addressing Unmet Needs
- Building The Foundation For 21st Century Medicine, Including Helping Young Scientists
- Modernizing Clinical Trials
- Accelerating The Discovery, Development, And Delivery Cycle And Continuing 21st Century Innovation At NIH, FDA, CDC, And CMS
- Modernizing Medical Product Regulation
Uh huh, sounds good, doesn't it? But how?
The Regulatory Affairs Professional Society (RAPS) has a handy breakdown with a bit more detail on each section.
What does it mean for diabetes?
Taking a read-through, you can find some jewels showing how this would be a major help for people with diabetes (and other conditions, of course). Take these, for example:
Patient Voices: "The bill would require FDA to establish a structured framework for the meaningful incorporation of patient experience data into the regulatory decision-making process, including the assessment of desired benefits and tolerable risks associated with new treatments." Can you say, YES!!??
Less Focus on A1C as an Endpoint in Clinical Trials: We've been saying "Look beyond A1C!" for a long time in the patient community for drug and device development. This bill embraces that, with an emphasis on "surrogate endpoints" that might allow for data on efficiency to be used earlier in the process, so there might be a focus on more immediate glucose trend improvement rather than the A1C result months down the road.
Diabetes Company Marketing and Social Media: What companies can talk about before regulatory review, during that process and after market launch is always a tricky topic. But social media has changed that game, with many patients turning into the online world for answers and to share feedback. The bill would revamp the guidelines on how Pharma and other companies can talk about their products at each stage.
More Research Funding for Younger Scientists: We just touched on this topic earlier this week while covering the non-profit Diabetes Research Connection org -- younger scientists aren't getting the grant money or exposure, and they're leaving the field. This legislation would create incentives to support young scientists and also open up more transparency to allow scientists to better share their research.
Interoperability, Diabetes Data-Sharing, and Mobile Software: These are all big terms scattered throughout a few areas of the 21st Century Cures Act, referring to how the FDA regulates mobile apps and allows for data-sharing. Of course, there isn't much detail right now, so it's not exactly clear how changes will occur, but they will support progress.
Focus on Chronic Diseases... Within this bill, a proposed "21st Century Chronic Disease Initiative Act" would be established, as a "longitudinal study on outcomes of patients with chronic disease" in the hopes of improving outcomes for those people. The goal would be to "identify potential targets for preventative or therapeutic intervention." No more detail is laid out yet, but space is being held for future language; same goes for future language on precision medicine.
From the advocacy and pharma worlds, both JDRF and Medtronic offered some thoughts on how this 21st Century Cures Act might intersect with diabetes.
JDRF spokesperson Christopher Rucas says: "While the legislation is still in development, early drafts included a number of proposals that would help advance the discovery, development, and delivery of new therapies to patients. JDRF is pleased that the initiative includes proposals to help better incorporate patient perspectives into the regulatory process, improve processes for qualifying surrogate endpoints, and create a breakthrough regulatory pathway for devices."
Naomi Kingery Ruperto, a fellow D-advocate who works as Social Community Manager for Medtronic Diabetes, tells us: "Inclusion in this bill is a bit of a long shot, but it’s important to explore every avenue available. Our team has worked through the bill and they were also involved in shaping the draft language. The 'breakthrough device' language is still being reviewed and it could be an opportunity for future Artificial Pancreas technologies, but we will need to wait until the final language emerges to fully understand the impact."
She adds, "The situation is very fluid right now. We know there are a number of other diabetes-related bills that have been introduced and reintroduced, but it’s not clear which ones may survive. As we receive more updates, we will be sure to share them so the community knows how to get involved."
Like everything in Congress, details are hard to come by for this 21st Century Cures Act right now. That's why it's so critical for our Diabetes Community to raise our voice on this now, and let Congress know what's important to us.
Diabetes Call To Action
In early April, the push began from the Diabetes Advocates network to start encouraging the Energy and Commerce Committee to include language about CGM access for PWDs on Medicare.
Yes, there's already a different bill introduced, and that one happens to be stuck in the same committee! So, we're trying to get this tacked on to the 21st Century Cures Act -- or at least make lawmakers more aware that this matters to us.
Right now, we want to focus on contacting just the Energy and Commerce Committee members who are crafting this Cures legislation.
Writing letters or emails or even calling these Congress-folks would be great! And you can send a Tweet just by clicking “CGM in 21st Century Cures” after your representative member’s name. (If you don’t know which one is your Congress member, you can easily check on this link by simply entering your zip code.)
The E&C committee meeting is happening April 30, so let's make the next week count and reach out to these decision-makers who can help make diabetes a priority in this evolving 21st Century Cures Act!
Let's raise our voices, D-peeps!