The 21st Century Cures Act: five things to know

Approved in a show of bipartisan cooperation uncharacteristic in recent times, the 21^st Century Cures Act (H.R. 6) is moving to the Senate for further consideration. There is a lot that can be said of the bill, and a lot more will be said, pro and con, as it progresses through deliberations that could result in sweeping new high-tech health policy.

Key aspects of the bill, which the Senate is not expected to vote on until 2016, include steps to streamline clinical trials; advance personalized medicine by encouraging greater use of drug development tools, such as biomarkers; and creating incentives for developing drugs for uncommon but deadly diseases. The bill also calls for an additional $1.75 billion per year in funding to the National Institutes of Health, and $550 million in additional funding to FDA.

Here are five of key things managed healthcare executives should know about the act:

1. It passed the House of Representatives on July 10, 2015, but that doesn't make it a shoo-in for law.

David Nexon, senior executive vice president of the Advanced Medical Technology Association (AdvaMed) says the act likely will meet up on the Senate side with “multiple pieces of legislation” geared toward addressing some of the same issues within the act itself and other initiatives focused on additional health policy goals. Nexon doesn't foresee gridlock, instead he believes the Senate will take up the debate “by creating its own version of the bill” incorporating “additional elements” he believes will also be targeted toward keeping the U.S. number one in the world of healthcare technology.

Next: The second thing to know.

2. A key aim of the bill is to guarantee, and smooth out the funding stream for the National Institutes of Health (NIH).

The NIH, which also performs major roles in training biomedical researchers and disseminating health information, has, in a climate of austerity, struggled to keep pace with inflation and has recently seen its budget fall behind inflation in purchasing power. In addition, observers say research funding for the NIH and its labs has seesawed over recent years, depending on political climates, creating a discouraging atmosphere for researchers in a field in which it can take many years to amass sufficient data to form a basis for developing treatments and cures.

The 21^st Century Cures Act would establish in the U.S. Treasury an NIH and Cures Innovation Fund endowed with $1.86 billion in mandatory funds per year for FY2016 through FY2020 to be disbursed across the following initiatives: biomedical research, cures development, an accelerating advancement program, high-risk high-payoff research, and special funding support for early career researchers. The fund offers encouragement to researchers seeking assurance that lack of money will not represent a prominent roadblock to advancement of their lines of inquiry.

The 21^st Century Cures Act authorizes annual increases in NIH's overall budget from $3.1 billion in 2016 to $3.4 billion by 2018, while directing the agency to target resources, through a “strategic plan," which it is directed to develop to broaden its mission beyond its stronghold in crucial biomedical research and identify contributions to improving U.S. public health through biomedical research.

Next: The third thing to know

3. The bill modernizes and streamlines FDA drug and device approval processes.

It accepts alternatives to multiphase clinical trials in certain circumstances, and permits accelerated approval pathways for certain classes of drugs such as novel antibiotics. Under the new criteria the agency may consider not only randomized clinical trial data, but also, observational studies, registries and therapeutic use as evidence of efficacy for drug and device approvals.

Streamlining FDA approval in this manner has engendered some controversy. Jerry Avorn, MD, and Aaron S. Kesselheim, MD, JD, MPH, commented in an June 2015 op-ed in the New England Journal of Medicine that while they agree that many ideas in the 21st Century Cures Act “could streamline the development and evaluation of new drugs and devices;” such streamlining “could lead to the approval of drugs and devices that are less safe or effective than existing criteria would permit.”

Nexon, however, believes that speeding the pathway to approval in the case of advanced medical devices offers a valuable route to bringing clinically successful devices and treatments to patients more quickly. From his perspective, “None of the provisions of the act lower the FDA's regulatory scrutiny, but rather, they improve the predictability of the approval processes.” He says that, accompanied by modernizations of the payment system (an area the bill does not address) to allow Medicare to react more quickly to demonstrated clinical success, streamlining FDA approvals “will provide the managed care world with more the rapid availability of treatments.” 

Next: The fourth thing to know

4. The act promotes extensive use of patient data through support for the development of a nationwide health information technology infrastructure for the exchange of electronic health information.

In addition to directing the National Institutes of Standards and Technology to test health IT interoperability standards as they are developed or emerge, provisions of this subsection of the act would impose penalties for inappropriate blocking of patient data exchange between authorized legitimate senders and recipients.

5. The act instructs the government to sell millions of barrels of oil from the strategic petroleum reserve.

This idea emerged as an alternative to depriving existing vital programs of resources while directing funding to equally vital innovative health technology initiatives.

David Richardson is a writer based in Baltimore.