The Medicare device coverage gap delays life-saving treatment for seniors
Imagine dying of thirst with a glass of water just out of reach. The analogy is extreme, but that is how helpless some patients feel when they can't access therapies approved to treat their deadly disease.
That vulnerability is particularly acute for people aged 65 and older whose lives depend on access to advanced medical devices. This is due to the Centers for Medicare and Medicaid Services' current reimbursement policies that delay Medicare coverage of these groundbreaking therapies because they are administered by a device, not a pill or a syringe.
Over the last decade, there has been a welcomed emergence of cutting-edge medical devices that treat a wide range of chronic diseases — including glioblastoma, a deadly brain cancer with a significantly poor prognosis. These groundbreaking technologies put patients in control of their care by providing them with the freedom to receive the treatments they need from the comfort and convenience of their homes.In many cases, the Food and Drug Administration has recognized the importance of these therapies by approving them for patient use. However, CMS' reimbursement policies for medical devices continue to prevent many of these same patients from gaining timely access to those treatments.
As it stands, there is a nearly five-year gap between when a new medical device receives FDA approval and is subsequently covered by Medicare.
This is time that many patients diagnosed with hard-to-treat cancers do not have. Modernizing the reimbursement framework for new FDA-approved medical devices would provide patients access to game-changing treatments that can improve their overall quality of life and give them more time with their friends and family.
Nothing can prepare you for the heartbreaking news that you or a loved one has been diagnosed with a primary or metastatic brain tumor. Yet, this is the reality for the 1.3 million Americans living with this devastating disease.
Throughout my own battle with cancer, I was blessed to have friends and family by my side as I underwent treatment. Their support was critical to my survival, and that experience continues to inspire my commitment to patients who deserve unrestricted access to innovative therapies that can extend and improve their lives.
Washington leaders are broadly in agreement over the need to close this gap in coverage. The previous administration tried to fix it by releasing the long-awaited Transitional Coverage for Emerging Technologies pathway last year.
Unfortunately, it fell well short of patients' expectations. Among other things, it forced most devices through the National Coverage Determination pathway, which does not guarantee a faster review. It also capped the number of devices eligible for expedited Medicare coverage to five annually.
A bipartisan group of lawmakers likewise attempted to solve the problem. They introduced common-sense legislation that would have eliminated the five-product maximum under Transitional Coverage for Emerging Technologies and ensured that all new FDA-approved medical devices are instantly covered by Medicare.
It garnered robust support in both chambers, passing out of the House Ways and Means Committee before running out of time to advance in the Senate.
Thankfully, Sens. Todd Young (R-Ind.) and Alex Padilla (D-Calif.) have recently teamed up in the 119th Congress to introduce the bipartisan Ensuring Patient Access to Critical Breakthrough Products Act of 2025, which seeks to streamline Medicare's regulatory process, cutting red tape and strengthening access to proven therapies for seniors.
Far too many seniors are being told to wait, not because the necessary treatments don't exist but because Medicare's reimbursement policies have overlooked the critical treatment timeline and failed to keep pace with innovation.
Looking ahead, Congress must prioritize the passage of this pivotal legislation so that patients have unobstructed access to innovative treatment options that the FDA has deemed safe and effective.
In the fight against cancer, patients should have access to every approved therapy. Refusing to cover groundbreaking treatments is like putting hope just out of reach.
Kelly Sitkin is the president and chief executive officer of the American Brain Tumor Association, the first national advocacy organization dedicated solely to brain tumors. ABTA is an advocacy partner of Novocure, the maker of the Tumor Treating Fields therapy.
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My full commitment is behind advancing Telomir-1 toward human studies in the most responsible and rigorous way. The potential here is too significant to ignore.' 'This is one of the most comprehensive rejuvenation profiles we've seen in a vertebrate aging model,' added Dr. Itzchak Angel, Chief Scientific Advisor. 'The ability to reverse both genomic and epigenetic instability while improving survival supports the growing potential of Telomir-1 as a foundational therapy for aging-related diseases.' Cautionary Note Regarding Forward-Looking Statements This press release, statements of Telomir's management or advisors related thereto, and the statements contained in the news story linked in this release contain 'forward-looking statements,' which are statements other than historical facts made pursuant to the safe harbor provisions of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These risks and uncertainties include, but are not limited to, the potential use of the data from our studies, our ability to develop and commercialize Telomir-1 for specific indications, and the safety of Telomir-1. Any forward-looking statements in this press release are based on Telomir's current expectations, estimates and projections only as of the date of this release. These risks and uncertainties include, but are not limited to, the potential use of the data from our studies, our ability to develop and commercialize Telomir-1 for specific indications and safety of Telomir-1. These and other risks concerning Telomir's programs and operations are described in additional detail in its Annual Report on Form 10-K for the fiscal year ended December 31, 2024, which is on file with the SEC. Telomir explicitly disclaims any obligation to update any forward-looking statements except to the extent required by law. Contact Information SOURCE: Telomir Pharmaceuticals, Inc View the original press release on ACCESS Newswire
