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Biomedical innovation legislation, Cures 2.0 Act, unveiled

The long-awaited Cures 2.0 Act (H.R. 6000) from Reps. Fred Upton, R-MI, and Diana DeGette, D-CO, was recently introduced in the House of Representatives, with provisions that impact GI.
Forensic medicine, science or criminalistics legal investigation or medical practice - malpractice justice concept with judge gavel in hands of lab scientist or doctor for criminal and civil laws
Forensic medicine, science or criminalistics legal investigation or medical practice - malpractice justice concept with judge gavel in hands of lab scientist or doctor for criminal and civil laws

This legislation is the sequel to the 21st Century Cures Act, which was signed into law in 2016 and focused on streamlining the drug and device approval process, increasing biomedical research and precision medicine, and developing targeted drugs for rare diseases.

Cures 2.0 aims to continue this effort by including policy changes to accelerate the discovery, development and delivery of 21st century cures, and advance the development of and access to innovative treatments.

Here are several important provisions included in Cures 2.0 that would impact GI:

Telehealth

Increases access to telehealth services for Medicare and Medicaid patients, including those covered under CHIP. This policy would:

  • Remove Medicare’s geographic and originating site restrictions.
  • Allow the Secretary of HHS to permanently expand the types of health care providers that can offer telehealth services and the types of services that can be reimbursed under Medicare.

FDA

Encourages innovative antimicrobial drug development.

Medicare coverage

Transforms how Medicare covers innovative new treatments and technologies to make those new discoveries available to patients sooner.

Claims data

Expands access to federal health plan claims data for research purposes to improve quality and cost-efficiency by linking the data with clinical data in registries.

Research

Requires more diversity in clinical trials to ensure any new drugs and treatments approved for use in the U.S. are both safe and effective for a greater ā€” and more representative ā€” portion of the population.

Authorizes $6.5 billion to create ARPA-H within NIH.

Patient education

Provides patients more information about the illness they face and the treatment options available to them to make them a more integral part of the decision-making process.

COVID-19

Requires studies into the implications of long COVID, including health disparities.

Includes the RISE Act, which provides $25 billion to federally backed researchers impacted by the COVID-19 pandemic.

AGA has endorsed this robust legislation and plans to advocate for additional congressional support to advance it through the legislative process in 2022.
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