Medical research and drug approval legislation making its way through Congress

December 5, 2016

Bipartisan legislation that seeks to expand our nation’s ability to undertake more research into the causes and cures for disease and, where possible, bring treatments to market more quickly, has passed the House of Representatives with overwhelming bi-partisan support.

After a vote of 392 Yeas and only 26 Nays, the 21st Century Cures Act moves to the Senate for final debate and a scheduled vote the week of Dec. 5. If, as expected, the Senate approves the House-passed version, the bill will go to the President who has indicated he would sign the bill into law.

The main purpose of the 21st Century Cures bill is to boost funding for the National Institutes of Health (NIH) and to streamline the Food and Drug Administration’s (FDA) approval process for new drugs, devices and other therapies. The bill authorizes $6.3 billion in new spending for NIH and the FDA with the bulk of that money going to cutting edge NIH research such as the NIH Precision Medicine Initiative, the NIH Cancer Moonshot Initiative and the NIH Brain Research through Advancing Innovative Neurotechnologies Initiative.

Some of the new money is allocated to the FDA to support streamlining FDA data collection for patient experiences with new drugs and an expedited approval pathway to bring “breakthrough” drugs and devices to market sooner. The bill would also boost FDA hiring authority for researchers and product reviewers to help speed the approval process.

As is often the case, this “fast moving” bill became a legislative vehicle to which some non- “cures” initiatives could be attached, including some Medicare changes which had become stalled in the normal legislative process. These include:

Improving transparency of Medicare local coverage determinations

The bill would require Medicare Administrative Contractors (MAC) to post Local Coverage Decisions on the MACs website at least 45 days prior to the effective date. The posting must include a summary of the evidence and rationale that was considered in the making of the determination as well as hyperlinks to the proposed determinations and the comments received by the MACS.

EHR improvements

The bill establishes a formal definition of “interoperability” of Electronic Health Records (EHR) as “health information technology that is able to seamlessly function in concert with other health information technology”. Further, the bill defines “information blocking” as a practice that is likely to interfere with or prevent access and exchange of electronic health information. Information blocking includes any technology that impedes innovation or is likely to lead to fraud, waste, and abuse. Moving forward, in order for EHRs to be certified, they must be “Interoperable” and cannot have functions that lead to “information blocking.”

The bill also requires HHS to develop a strategy for reducing the documentation burdens of EHRs on health care providers. And, it would create a grant program to develop a stakeholder reporting system to collect information on EHR usability, interoperability and security to help providers choose an EHR product.

Update the Welcome to Medicare package

Finally, the bill requires CMS to update the Welcome to Medicare package it supplies to soon-to-be eligible Medicare enrollees. CMS would be required to request recommendations from stakeholders on information that should be included in the package within six months of the bill’s passage.

Senator Elizabeth Warren (D-MA) has recently expressed some opposition to the bill, particularly the FDA approval process acceleration arguing that it represents a windfall for the pharmaceutical industry. At this time, there does not appear to be significant support for her position.

As of the writing of this article, it still appears likely that the bill will pass the Senate prior to ending the current Congress and go to the President for his promised signature.

Read the more detailed article.