21st Century Cures Act passed overwhelmingly by House, major health reform bill moves to Senate

By Steve Brachmann
December 4, 2016

National Institutes of Health - Clinical Center (building #10) south entrance. Bethesda, Maryland USA. Photo by Christopher Ziemnowicz.

National Institutes of Health – Clinical Center (building #10) south entrance. Bethesda, Maryland USA. Photo by Christopher Ziemnowicz.

On Wednesday, November 29th, the U.S. House of Representatives voted to pass H.R.6, the 21st Century Cures Act, which will likely be voted on by members of the U.S. Senate in early December. The act’s purpose is to accelerate the discovery, development and delivery of new medicines. Media reports indicate that the bill would set in motion a $6.3 billion initiative in an effort to not only fund research in development in many medical fields but also increase consumer access to various treatments. By some measures, this bill is reportedly the largest reform of the U.S. health sector since 2010’s Affordable Care Act.

If enacted, the 21st Century Cures Act would establish a U.S. Treasury fund called the NIH and Cures Innovation Fund. That fund would receive $1.86 billion per year over four fiscal years up to 2020. Each year, $1.75 billion of those funds would be reserved for biomedical research of the National Institutes of Health (NIH), including basic, translational and clinical research. At least $500 million of these NIH funds would be used for an Accelerating Advancement Program to partner with national research institutes and national centers to accomplish biomedical research objectives. Of the remaining $1.25 billion or less, at least 35 percent will be allocated to early stage investigators which have earned at most one NIH competitive grant; at least 20 percent allocated for “high-risk, high-reward research”; and at most 10 percent reserved for intramural research. The other $110 million left in the yearly budget will be allocated to a cures development program and will fund drug manufacturing studies, health software and obtaining data on disease history.

Most of the bill is spread out among three titles, the first of them being discovery. This section instructs the NIH to establish an Innovation Prizes Program to fund areas of biomedical research “that could realize significant enhancements or improve health outcomes.” It also enables the NIH to offer support in later phases of clinical trials, calls for more collaboration with the U.S. Food and Drug Administration (FDA) to “implement a system that allows further research on clinical trial data” and establishes a nonprofit organization, Council for 21st Century Cures, which will focus on efforts to accelerate medicine discovery, development and delivery.

Title II of the 21st Century Cures Act focuses on the development aspects of the proposed bill and heaps no small amount of responsibility on the FDA. It amends the Federal Food, Drug, and Cosmetic Act (FD&C Act) to require the FDA to “establish processes under which patient experience data may be considered in the risk-benefit assessment of a new drug.” The FDA must also identify “precision” drugs which can treat serious or rare diseases and expedite their development, establish a program for priority review of breakthrough medical devices and train FDA employees on the “least burdensome appropriate means” concept in their review of medical devices. At the same time that the proposed bill would take away FDA authority in certain regards, such as requiring the agency to rely on third party certification of the safety and effectiveness of medical devices as meeting FDA criteria, it also authorizes additional hiring authority for the FDA for scientific, technical and professional positions within agency centers.

Title III deals with the delivery of innovative treatments and is perhaps the most tech-heavy section of the 21st Century Cures Act. This section would establish requirements for the interoperability and certification of health information technology, requires Medicare and Medicaid authorities to provide telehealth information to Congress and directs those same authorities to pay home health agencies for certain disposable medical devices made for individuals receiving home health services through Medicare. It also gives Medicare prescription drug plan sponsors the ability to limit drug access to certain beneficiaries for frequently abused drugs and appoints an ombudsman to respond to manufacturer complaints regarding Medicare coverage of their products.

Finally, Title IV of the act is directed towards Medicare and Medicaid reforms. It limits aggregate Medicaid payments to states for durable medical equipment and excludes certain generic drugs from the calculation of average manufacturer price when determining Medicaid rebates. This section also reduces Medicare payments for x-ray imaging technologies which use film or an imaging plate instead of a digital sensor and revises Medicare payments for infusion drugs and biologicals furnished through durable medical equipment. The U.S. Department of Health and Human Services (HHS) would also be directed to increase its support of Lyme disease and tick-borne diseases through strategic research. Interestingly, this section of the proposed bill also includes a rider provision which would direct the U.S. Department of Energy (DOE) to sell 80 million gallons of crude oil from the Strategic Petroleum Reserve through fiscal year 2025; it’s possible that this provision was added in order to fund new research required by this act.

The 21st Century Cures Act has broad bipartisan support having been passed in the U.S. House by an overwhelming 344-77 roll call vote. It also has the backing of the White House; a statement release from the White House’s Office of the Press Secretary on November 30th calls the 21st Century Cures Act “critically important legislation” which increases funding to combat the American heroin epidemic, supports the “Cancer Moonshot” led by Vice President Joe Biden and takes meaningful steps towards improving mental health and Alzheimer’s disease outcomes.

There are those, however, who are quite critical of certain aspects of the 21st Century Cures Act, especially in regards to how the legislation would affect FDA regulatory activities. Some have pointed out that the changes to the FDA drug and device approval process favor speed in approval over accuracy and patient safety concerns. The worry is that the spirit of wanting to speed drug development to find cures to rare and serious diseases has led to the cutting of compliance regulations which could risk patient safety. Others have pointed to the fact that decentralization of FDA authority on what constitutes a “safe and effective” drug could lead to inconsistent application of those rules. The bill also has significant detractors in the U.S. Senate, with both Sens. Bernie Sanders (I,D-VT) and Elizabeth Warren (D-MA) have both openly come out as being against this legislation, with Sanders’ disapproval coming from a released statement while Warren voiced her concerns on the Senate floor in late November.

The Author

Steve Brachmann

Steve Brachmann is a writer located in Buffalo, New York. He has worked professionally as a freelancer for more than a decade. He has become a regular contributor to IPWatchdog.com, writing about technology, innovation and is the primary author of the Companies We Follow series. His work has been published by The Buffalo News, The Hamburg Sun, USAToday.com, Chron.com, Motley Fool and OpenLettersMonthly.com. Steve also provides website copy and documents for various business clients.

Warning & Disclaimer: The pages, articles and comments on IPWatchdog.com do not constitute legal advice, nor do they create any attorney-client relationship. The articles published express the personal opinion and views of the author and should not be attributed to the author’s employer, clients or the sponsors of IPWatchdog.com. Read more.

Discuss this

There are currently 18 Comments comments.

  1. Gene Emmons December 4, 2016 9:41 am

    Spend the money if you wish, but substantially decrease the responsibility of government. The FDA is infamous for its inefficiency. I voted against, not for, more government regulation. There must be a way to use this money to increase incentives and reward private companies for their production of innovative cures and treatments.

  2. Mira de Vries December 4, 2016 10:13 am

    $6.3 billion could do a lot more good if invested in humane, hands-on personal care for the sick and disabled. When will we stop wasting billions on looking for a pill for every ill?

  3. Lewis Lowden December 4, 2016 10:27 am

    At the moment it seems that the U.S. social and political mind-set/weltanschauung (World view), along with many other countries, are moving toward a weltanschauung as portrayed in Isaac Asimov’s Foundation series vs that of Rod Sterling’s more compassionate and rational weltanschauung as portrayed in his Star Trek series. Good, bad, right or wrong–for those of us who believe and know that we are our brother’s and sister’s keeper–we are in for a long and bumpy ride…let us pray.

  4. Lewis Lowden December 4, 2016 10:35 am

    Correction to my comment: Credit to Gene Roddenberry and not Rod Sterling for Star Trek.

  5. desertpat December 4, 2016 12:09 pm

    My concern is that this funds ONLY pharmaceutical research, and does nothing for promising, novel approaches to curing disease that are often simple, inexpensive and have no side effects.

  6. weredoomed December 4, 2016 2:09 pm

    /great I can pay for the research and sky high priced drug.

  7. chris December 4, 2016 2:23 pm

    Countries around the world have approved cures for many diseases. However, the FDA won’t approve them because they didn’t come from U.S. companies and they themselves haven’t tested them thoroughly. Let’s get real. Most of this has to do with money and who’s making it. They say there are 10,000 known diseases and only 500 with a cure. Less defense spending, less government and a reduction in profits.

  8. Jerry Stapleton December 4, 2016 2:41 pm

    Hmm, now how much is being dedicated to identifying root causes and prevention? Wait for it…zippo! Just more money down the Big Pharma rat hole. This is shameful legislation that will do NOTHING to improve lives of Americans.

  9. Gene Quinn December 4, 2016 2:59 pm

    It is interesting how many here seem to want to focus on high drug prices rather than low drug prices. I mean I get it. It makes sense to want the latest and greatest drugs for free or practically free, but that is pretty unrealistic and extraordinarily naive. Of course, there are all kinds of drugs off patent and without any kind of protection that are extremely cheap. I wonder how those drugs came into existence and how they got so cheap? Oh… wait… I know… it is because they were patented once upon a time and then the patent ran out and after the patent ran out and the creator of the drug made money sufficient to warrant taking the extreme risk for that drug and the 90% percent of drugs that fail completely and lose money the generic manufacture started selling the drug for very little.

    95% of the essential drugs in the world are or were once protected by a patent. If you don’t want patent protection and other forms of rights that will incentivize drug development then you are in favor of no new drugs. It is that simple.

    See: http://www.ipwatchdog.com/2016/09/12/essential-medicines-off-patent/id=72542/

  10. desertpat December 4, 2016 3:36 pm

    According to the book The Truth About Pharmaceutical Companies, much of the R&D comes from publicly-funded universities; they get it free while taxes pay for it. But whatever. . . .this is our system. I’ve found to my great surprise that there are alternatives to just about any drug, and they do work. Some of our research dollars should absolutely go to looking at these novel approaches. Win-win, except for the drug companies. BTW, almost no drug cures a disease, except for a few antibiotics. They tamp down or suppress symptoms or body processes, and always have side effects–always.

  11. Mira de Vries December 4, 2016 3:41 pm

    We live in a society obsessed with drugs, egged on by the medical profession not to mention the pharmaceutical industry. Occasionally a physician refreshingly sees through the deceit. Seamus O’Mahony in his book *The Way We Die Now* speaks of “a deluded optimism about the benefits of medical treatment … disguised as ?giving hope’” and Henry Marsh in his book *Do No Harm* also states “The real utility of the drug is to give dying patients hope.“

  12. adavaas December 4, 2016 3:44 pm

    I find it amazing this was passed in the so-called “anti-science” Republican-held House and is set to pass the “anti-science” Republican-held Senate, meanwhile the bill’s biggest critics are Democrats whose complaint sums up as “but a company might PROFIT. We can’t have that!”

  13. Yaakov Watkins December 4, 2016 4:10 pm

    $1.83 billion isn’t enough to accomplish what the bill is supposed to.

  14. Mira de Vries December 4, 2016 5:17 pm

    Contributor adavaas (above) finds it amazing this was passed. Is it not inherent in our political systems that the wealthy can buy political favors?

  15. M Schneider December 4, 2016 6:11 pm

    Can you say “thalidomide,” boys and girls?

  16. Ampman December 5, 2016 3:04 am

    I’m totally against any grant to big corporations. $6.3B are a lot of money to give away to them for little predictable benefits for the mass. I recently paid attention to prices in a pharmacy and was startled at all the high prices for pills of disputable benefits, including vitamins and nutritional supplements. I certainly don’t want to pay for them. Luckily I can do without them as I took in NO PILLS for the last 20-30 years and longer. It’s because eating proper food dispenses all pills, and nature is quite good at healing us. There are also many natural (food-based) remedies that have no bad side effects.

  17. Anon December 5, 2016 6:12 am

    M Schneider,

    Can you explain your comment?

  18. Litster December 9, 2016 7:31 pm

    Perhaps one of the bigger criticisms of the 21st Century Cures Act is that it values getting new medical developments to the market faster, rather than more safely. But perhaps this isn’t ALL that bad. Yes, it’s bad, because consumers of medical technology have come to expect that if there is a commercially available medical device or drug, it has met certain standards for efficacy and safety. However, it takes a long time for medical technology to get that far. It’s ridiculous that Americans aren’t able to get treatments available elsewhere simply because of bureaucratic red tape or slow drug trials. Having an incompletely tested treatment may sometimes be better than no treatment at all? Yes, there are risks, but shouldn’t patients have the option to decide? It’s their life, isn’t it?