Congress has been working in a bi-partisan way from 2015. They were working on an important medical innovation bill and the bill is intended to increase funding for the National Institutes of Health (NIH) while streamlining and reforming the Food and Drug Administration’s (FDA) approval process for the new devices and drugs. This bill is named the 21st Century Cures Act.
Congressional negotiators had announced an improved version of the 21st Century Cures Act earlier, and that version had bi-partisan support in both the Senate and House. Even though the House of Representatives passed a first version of the bill in early 2015, the Senate was not interested to take the bill as a single piece of legislation. Instead of that, they tried to negotiate a scaled down version of the bill.
The House Senate negotiations have led to the latest version of the bill. The Senate passed the 21st Century Cures Act on Dec 7 with a support by a vote of 95-4. The bill was already passed by the House of Representatives on Nov 30 by a vote of 392-26. It is reported that the bill will now go to President Obama for him to sign it into a law.
The bill offers 4.8 billion dollars to continue funding the important NIH programs like the NIH Precision Medicine Initiative, NIH Brain Research, and the NIH Cancer Moonshot Initiative via Advancing Innovative Neurotechnologies (BRAIN) program. There are changes that are made to the drug approval process, which includes streamlining data collection for the patient experiences with new medicines and expedited approval pathway. Experts believe that this is to bring breakthrough devices and drugs to the market soon.
The new bill will also enhance FDA hiring authority for product reviewers and researchers to speed up the approval process. In addition to that, many other provisions including one billion dollar to be offered as grants to various states to fight opiod addiction, mental health reforms, and many other notable provisions that are related to Medicare program will also be promoted.
One of the notable Medicare provisions is to improve transparency for local coverage decisions (LCD) that are made by the Medicare Administrative Contractors (MAC). As per the bill, MACs would need to post LCDs as a whole on a website at least forty-five days before the effective date. The posting should have data on when the particular determination was made public, as well as include the comments received by the MACs and hyperlinks to the proposed determinations.