On November 16, 2021, U.S. Home Representatives Diana DeGette (D-CO) and Fred Upton (R-MI) launched the extremely anticipated Cures 2.0 Act (H.R. 6000). Amongst different issues, this 173-page bipartisan invoice include provisions to speed up medical analysis, enhance affected person entry to novel therapeutics, and take away present boundaries to telehealth providers.
This invoice would additionally create a brand new company referred to as Superior Analysis Tasks Company for Well being (ARPA-H) inside the Nationwide Institutes of Well being (NIH). This company can be tasked with growing novel therapies to difficult ailments reminiscent of most cancers, diabetes, ALS, and Alzheimer’s. In a press release, DeGette and Upton stated, “By creating ARPA-H, we will be bringing together some of our nation’s greatest minds to help find cures to these devastating diseases. And we will – for the first time – be putting the full weight of the federal government behind the ongoing efforts to end these terrible illnesses as we know them – which is a mission that all of us should be able to get behind.” The invoice would offer $6.5 billion to ARPA-H via its first three years.
The Cures 2.0 invoice incorporates quite a few provisions that might impression the U.S. Meals and Drug Administration (FDA).
set up at the very least two extra intercenter institutes;
present grants for novel trial designs and different improvements in drug improvement;
submit a report back to Congress with respect to cell and gene therapies; and
challenge steerage on using real-world proof in evaluating the protection and effectiveness of breakthrough units and on the event and submission of chemistry, manufacturing, and controls data for merchandise topic to certainly one of FDA’s expedited regulatory pathways.
Moreover, the invoice would speed up the timeline for the designations of FDA’s breakthrough therapies and regenerative medication superior remedy (RMAT) therapies, permitting sponsors to request designations earlier than or after a brand new drug software (NDA) or biologics license software (BLA) is submitted. Below the Cures 2.0 Act, FDA would even be required to fulfill with sponsors, machine producers, scientific analysis organizations, the expertise neighborhood, and the affected person neighborhood to debate progressive approaches and incentives to undertake decentralized scientific trials.
Different provisions of this invoice embrace reforms to Medicare reimbursement and protection reminiscent of eradicating the situation that requires a affected person to reside in a rural space and to be in a doctor’s workplace with a view to qualify for telehealth providers. The Facilities for Medicare and Medicaid Providers (CMS) would be capable of grant larger flexibilities for healthcare suppliers to obtain reimbursement from Medicare for telehealth providers. One other key provision of this invoice would enable CMS to quickly cowl merchandise accepted or cleared by the FDA underneath the breakthrough remedy pathway for as much as 4 years. Lately, CMS issued a closing rule that rescinded expedited Medicare protection of breakthrough units for as much as 4 years as soon as the product had been accepted or cleared by the FDA. Moreover, this invoice would require the Authorities Accountability Workplace to submit a report back to Congress on suggestions to boost Medicare protection and reimbursement of progressive well being applied sciences.
The provisions of the Cures 2.0 Act have the potential to considerably impression public well being. By facilitating the investigation and improvement of novel therapies, we are able to count on that breakthroughs will outcome within the therapy of great and debilitating ailments. Sufferers dwelling in rural areas can be afforded larger entry to healthcare via telehealth providers. Lastly, sufferers will get elevated entry to merchandise which have acquired breakthrough designation as CMS can present reimbursement for these life-saving merchandise.
Whereas Representatives DeGette and Upton had hoped to introduce the Cures 2.0 laws earlier this yr, it was stalled as a consequence of competing calls for. At this level it’s extremely unlikely the laws can be thought of earlier than Congress adjourns this yr. Nonetheless, it’s anticipated to be a legislative precedence in 2022, given the broad bipartisan assist the primary Cures invoice loved. We are going to proceed to observe the progress of the Cures 2.0 Act because it strikes via Congress.