Eshoo, Guthrie, DelBene, Wenstrup Urge CMS to Provide Seniors Access to Innovative Medical Devices

December 16, 2022
Press Release

WASHINGTON, D.C.Congresswoman Anna G. Eshoo (CA-18) along with Representatives Brett Guthrie (KY-02), Suzan DelBene (WA-01), and Brad Wenstrup (OH-02) urged Centers for Medicare & Medicaid Services (CMS) Administrator Chiquita Brooks-LaSure to issue a proposed rule to streamline Medicare beneficiaries' access to innovative medical devices before the end of the year.

After CMS formerly repealed a rule to better facilitate Medicare coverage of FDA-approved medical devices in 2021, Reps. Eshoo and Guthrie led a letter urging CMS to reconsider its repeal and if not, to propose policies in its place to achieve the bipartisan goal of providing Medicare beneficiaries access to innovative medical devices. Over a year later, CMS has not issued a new rule.

The Members wrote:

“Medicare beneficiaries suffering from life-threatening diseases, disabilities, injuries, and chronic illnesses should have timely and equitable access to innovative technologies. Unfortunately, far too many Medicare patients today face challenges accessing the technologies and treatments they need due to unnecessary delays in establishing consistent Medicare coverage policies for new medical devices and diagnostics.

We firmly believe a successful implementation of a TCET rule should include an independent transitional coverage pathway for breakthrough devices that have been proven safe and effective by the FDA.”

The full text of the letter is below and PDF of the letter can be found HERE.

Dear Administrator Brooks-LaSure,

We are writing to encourage the Centers for Medicare & Medicaid Services (CMS) to issue the Transitional Coverage for Emerging Technologies (TCET) proposed rule by the end of 2022.  Following repeal of the Medicare Coverage for Innovative Technology (MCIT) rule last year, CMS has expressed repeated commitment for establishing a pathway to facilitate Medicare beneficiary access to innovative and emerging medical technologies. While we remain concerned that the repeal of MCIT may hinder patient access to U.S. Food and Drug Administration (FDA) approved breakthrough treatments, we commend the agency for its continued commitment to this important policy goal and appreciate inclusion of this rule in the 2023 Unified Regulatory Agenda. 

Medicare beneficiaries suffering from life-threatening diseases, disabilities, injuries, and chronic illnesses should have timely and equitable access to innovative technologies. Unfortunately, far too many Medicare patients today face challenges accessing the technologies and treatments they need due to unnecessary delays in establishing consistent Medicare coverage policies for new medical devices and diagnostics.

We firmly believe a successful implementation of a TCET rule should include an independent transitional coverage pathway for breakthrough devices that have been proven safe and effective by the FDA. Such a process will meaningfully improve the Medicare coverage process for emerging technologies and will ensure that Medicare beneficiaries, especially those in rural and medically underserved communities, can access the innovative treatments they need once they become available.  To that end, we respectfully urge you to move quickly to help improve the lives of the many Medicare beneficiaries who stand to gain from timely access to emerging and innovative technologies by issuing the TCET proposed rule by the end of 2022.

We thank you for your consideration of this request, and appreciate your continued commitment to Medicare beneficiary access to innovative medical devices and diagnostics.

Sincerely,

 

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