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Access to Innovative Treatments Act of 2023
12/21/2024, 9:06 AM
Summary of Bill HR 2408
Bill 118 hr 2408, also known as the Access to Innovative Treatments Act of 2023, aims to improve access to cutting-edge medical treatments for patients in the United States. The bill focuses on streamlining the approval process for new medical technologies and treatments, with the goal of getting these innovations into the hands of patients more quickly.
One key aspect of the bill is the establishment of a new regulatory pathway for innovative treatments that have shown promise in early clinical trials. This pathway would allow these treatments to be approved for use in certain patients before completing the full FDA approval process, which can be lengthy and time-consuming. This would give patients with serious or life-threatening conditions access to potentially life-saving treatments sooner.
Additionally, the bill includes provisions to increase transparency and communication between the FDA, medical researchers, and patients. This would help ensure that patients are informed about the risks and benefits of new treatments, and that researchers have a clear understanding of the regulatory requirements for bringing their innovations to market. Overall, the Access to Innovative Treatments Act of 2023 seeks to strike a balance between promoting innovation in the medical field and protecting patient safety. By streamlining the approval process for new treatments and improving communication between stakeholders, the bill aims to ensure that patients have timely access to the latest medical advancements.
One key aspect of the bill is the establishment of a new regulatory pathway for innovative treatments that have shown promise in early clinical trials. This pathway would allow these treatments to be approved for use in certain patients before completing the full FDA approval process, which can be lengthy and time-consuming. This would give patients with serious or life-threatening conditions access to potentially life-saving treatments sooner.
Additionally, the bill includes provisions to increase transparency and communication between the FDA, medical researchers, and patients. This would help ensure that patients are informed about the risks and benefits of new treatments, and that researchers have a clear understanding of the regulatory requirements for bringing their innovations to market. Overall, the Access to Innovative Treatments Act of 2023 seeks to strike a balance between promoting innovation in the medical field and protecting patient safety. By streamlining the approval process for new treatments and improving communication between stakeholders, the bill aims to ensure that patients have timely access to the latest medical advancements.
Congressional Summary of HR 2408
Access to Innovative Treatments Act of 2023
This bill requires the Centers for Medicare & Medicaid Services (CMS) to review adverse national coverage determinations of drugs under Medicare within 30 days of receiving a request to do so. (Under the bill, adverse national coverage determinations are denials or limitations of coverage that are inconsistent with the drug's approval by the Food and Drug Administration.) The bill's requirements do not apply if the CMS already conducted such a review within a two-year period.
The bill also prohibits the CMS from applying prior coverage determinations that were made for drugs before they were approved by the FDA if such determinations are inconsistent with the drug's approval.
Read the Full Bill
Current Status of Bill HR 2408
Bill HR 2408 is currently in the status of Bill Introduced since March 30, 2023. Bill HR 2408 was introduced during Congress 118 and was introduced to the House on March 30, 2023. Bill HR 2408's most recent activity was Referred to the Subcommittee on Health. as of December 17, 2024
Bipartisan Support of Bill HR 2408
Total Number of Sponsors
2Democrat Sponsors
2Republican Sponsors
0Unaffiliated Sponsors
0Total Number of Cosponsors
2Democrat Cosponsors
0Republican Cosponsors
2Unaffiliated Cosponsors
0Policy Area and Potential Impact of Bill HR 2408
Primary Policy Focus
HealthAlternate Title(s) of Bill HR 2408
Access to Innovative Treatments Act of 2023
Access to Innovative Treatments Act of 2023
To amend title XVIII of the Social Security Act to provide a review process for adverse national coverage determinations with respect to drug coverage under the Medicare program.
Comments
Sponsors and Cosponsors of HR 2408
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