House Passes the 21st Century Cures Act

Back in early May, I posted a blog article on the approved draft of the 21st Century Cures Act—a bill designed to streamline funding and hasten approvals for new biomedical research, cures, and medical treatments for rare, terminal, and chronic conditions.  In that article, I also promised that I would keep everyone up to speed as things developed.  Well… things are developing.

Don’t worry, though… it looks like mostly good things are happening, for once.

Oddly enough, the 21^st Century Cures Act seems to be the most bipartisan supported bill to emerge in years.  On Friday, it was brought to vote before the U.S. House of Representatives and passed in a landslide of 344 to 77.  Which is just mindboggling, to be honest with you.  Seriously… cooperative action is so out of character for this Congress that I suspect last week’s vote has led some people to worry they’d lost grip on reality.

We’re still only halfway there, of course. The 21^st Century Cures Act still has a bit to go before it becomes a law. So we’re not out of the woods just yet.

Next, the bill goes before the Senate for a final vote.  Of course, considering its overwhelming support in the House, it is unlikely the bill would hit any roadblocks there.  Once it is passed by the Senate, it will be forwarded to the appropriations committee so that it can be given actual funding.

Which is good… because this thing is going to need some serious funding.

Let’s take a quick look at the dollars and cents of it all, shall we?  Under the 21^st Century Cures Act, the National Institutes of Health (NIH) will be allotted a funding increase of $8.75 billion over a five year period.  Meanwhile, the Food and Drug Administration (FDA) will get a separate funding bonus of $550 million over the same five years.  This high price tag initially had certain folks rather concerned that it would add too heavily to the national deficit.  In order to deal with this issue, however, it was decided that funding would be bankrolled by a selloff of oil from the U.S. Strategic Petroleum Reserve.  The rest is supposed to be offset by Medicaid payment reforms and a delay in reinsurance payments for Medicare Part D standalone prescription drug plans (just how well that’s going to work in reality remains to be seen, of course).

All this new funding will go toward improving medical research, streamlining new drug approvals, and expanding available medical resources, an effort that will be spearheaded by federal agencies such as the NIH, FDA, and CDC.  For example, the 21^st Century Cures Act will allow medical researchers to screen patients in advance, before beginning clinical trials, in order to better ensure they are appropriate candidates.  There are reforms intended to encourage interoperability and data sharing between healthcare organizations and federal health agencies.  Other reforms will be put in place to streamline testing and approval processes for new drugs, cures, and other medical treatments.  Lastly, this act will provide rewards (such as market exclusivity and higher reimbursements to hospital) to drug companies that provide drugs for Medicare recipients.

Here is a list of just some of the key measures of the current 21st Century Cures Act:

• The NIH is authorized to require that scientific data be shared if that research is being fully funded by them
• The NIH and FDA will be required to implement a system allowing further research on clinical trial data 
• The CDC will be required to expand their surveillance of neurological diseases
• A special “Council for 21st Century Cures” will be established to accelerate the discovery, development, and delivery of new cures, treatments, and preventive measures
• The HHS will be required to monitor the use of antibacterial and antifungal drugs, as well as track resistances to these drugs
• Requirements will be established for interoperability and the certification of health information technology; discouragement or blocking of electronic health information exchange will be strictly prohibited
• Manufacturers and distributors of investigational drugs for serious conditions will be required to publish their policies on compassionate use requests
• The marketing exclusivity period will be extended by six months for any drug approved for a new indication that is a rare disease or condition
• The priority review voucher program for rare pediatric diseases will be revised and extended
• The Controlled Substances Import and Export Act will be amended to allow exported controlled substances to be re-exported within the European Economic Area
• Title XVIII (Medicare) of the Social Security Act will be amended to require the CMS to do the following:

1. Increase certain payments for new antimicrobial drugs
2. Establish a payment methodology for certain medical devices
3. Publish online estimated payments for certain outpatient items and services

• The Federal Food, Drug, and Cosmetic Act will be amended to reform drug approval processes by enacting the following measures:

1. Allow patient experience data to be considered in risk-benefit assessment of new drugs
2. Requires the FDA to qualify drug development tools
3. Allows the FDA to rely upon data that was previously submitted for a different purpose in order to expedite the development of certain drugs
4. A streamlined data review program will be established for the approval of a drug for an additional indication 

A handful of dissenters remain opposed to the bill, of course, mostly claiming it has the potential to cause dangerous or toxic drugs to be administered to patients because they have not been properly tested.  However, these opponents often fail to mention that the 21^st Century Cures Act will not eliminate any testing requirements, but instead will cut a ton of the bureaucratic red tape that slows down the availability of new cures and treatments that are desperately needed by patients with rare, terminal, or chronic conditions.  Besides, the current draft of the bill has an overwhelming amount of support from both Congress and the healthcare industry.

Long story short… the vast majority of people seem to think this bill is awesome.

The 21^st Century Cures Act is expected go to the Senate for a final vote in the coming weeks, and the chances are that it will pass.  There is always the possibility that the bill will be further amended or altered between now and then, of course, but no one really expects that to happen.  Then again, unexpected things have happened before.

Now if only we could get Congress to show this kind of bipartisan cooperation for everything else.  Sure, most would agree there is a snowball’s chance in Hades of that happening… but wouldn’t it be epically legendary if it did?

Stay tuned to the blog for updates.  We will post more articles as new developments occur.