The 21st Century Cures Act

The Cures Act: the Act that Seeks to Cure the Opioid Crisis and Address Mental Health

We present a summary of each provision in the 21st Century Cures Act which aims to tackle mental health, addiction issues including the opioid crisis, and more.

The Cures Act Passes Congress

Congress just passed the 21st Century Cures Act to tackle mental health, addiction issues including the opioid crisis, and more.

With a vote of 94-5 in the Senate (and equally large margins in the House), the bill now heads to President Barack Obama, who has said he will sign it immediately. It has taken nearly three years to pass the act, and even the critics see the passage of this bill that has been in the works since 2015 as a win.

The new healthcare act is poised to do a lot of good, but it comes with a price tag of $3.5 billion over 10 years, redirects dollars spent on prevention, and includes what some criticize has “hand-outs” for medical device makers and “Big Pharma.”

Something to remember while legislators fight over how and if TrumpCare should repeal and replace ObamaCare is that, in the background, Congress is still working and passing legislation although, as you’ll learn below, that isn’t always a move in a useful direction.

HANDOUT OR WIN FOR PROGRESSIVES? First, The 21st Century Cures Act passes, potentially turning the FDA into a puppet of the pharmaceutical industry. Second, the Senate Passes Sweeping 21st Century Cures Act Funding Medicine. Third, Some Win, Some Lose From Medical Funding Bill. Fourth, Lobbyists Had A Big Say in Cures Bill. This bill has many hands on it, and that is both a positive and a negative influence. Who put the K Street language in here and is it valid? You find the answers to those questions and then you’ll learn something. We help by presenting a full summary of the Cures Act below.

FACT: The 21st Century Cures Act, which spans 25 separate sections touching on subjects as diverse as drug research and foster care, runs to nearly 1,000 pages. It isn’t the Patient Protection and Affordable Care Act, which also spans 1,000 pages. It is a bipartisan-passed Act for the care and protection of patients. You might ask yourself why this is OK and ObamaCare isn’t? The answer may be tax credits, Medicaid expansion, and the mandates. However, the GOP Better Way plan includes tax credits and a mandate-like provision, Is Medicaid the only point of contention?

The Good Provisions in the 21st Century Cures Act – What the Cures Act Gets Right

The major benefits of the Cures Act include, but aren’t limited to:

• Billions in funding to NIH and funding to the FDA.
• $1 billion in funding over two years to address the opioid crisis.
• Reauthorizing funding to mental health and suicide prevention programs.
• The fund also serves as a resource for programs that enable self-management among those living with chronic disease, improve tracking of hospital-acquired infections, address racial health disparities, increase immunization, and promote breastfeeding, among other concerns such as  funding Joe Biden’s Cancer Moonshot. See: Biden’s farewell gift: Cancer moonshot helps pass $6.3 billion research bill.

As positive as that sounds and is, there are some concerning provisions of the Cures Act buried in the bill next to unremarkable provisions like the one that “creates an assistant secretary for mental health.” We can call these problem areas “compromises” and be polite, or we can be more critical like Senator Sanders and Senator Warren. The 21st Century Cures Act merits close examination.

See the videos below for an overview, or see our full summary of the 21st Century Cures Act below.

See articles on the 21st Century Cures Act.

FACT: The Cures Act isn’t part of the Affordable Care Act, and thus isn’t on the chopping block if the ACA is repealed in 2017.

FACT: The Prevention and Public Health Fund has been the target of cuts by lawmakers in the past. In 2012, Congress cut the prevention fund by more than $6 billion over nine years to avoid Medicare physician payment reductions.

TWO SIDES TO EVERY STORY: We can spin this bill several ways. Fred Upton (R-MI), the chief sponsor of the bill, has called it “an innovative game-changer and a truly once-in-a-generation opportunity to bring our healthcare system light years ahead of where it is today.” By contrast, Vermont Senator Bernie Sanders complained that the bill “provides absolutely no relief for soaring drug prices” and amounts to a gift to the pharmaceuticals industry. “The greed of the pharmaceutical industry has no limit, and this bill includes numerous corporate giveaways that will make drug companies even richer … It’s time for Congress to stand up to the world’s biggest pharmaceutical companies, not give them more handouts.” Learn more: A massive healthcare bill includes a provision that could fast-track cancer research — but not everyone is on board.

A Full Summary of the 21st Century Cures Act

The above highlights of the 21st Century Cures Act are impressive, and they aren’t the only parts included. No bill is ever going to be entirely beneficial to everyone, or even interesting. Below is a summary of the whole bill with problem sections highlighted and explained.

Specifically, we will explain “the pork” in the 21st Century Cures Act to show the way Congress is working for the people and to what extent they are working for K Street instead.

The full summary is presented below, but first a few points to give the bill context.

• Every provision in the bill requires funding to be approved by the budget process, and many rely on the repeal of the Affordable Care Act. Thus what seems like funding to a program like NIH could have a net effect of less than zero by the time the ACA is repealed, if it is.
• Some “downright bad” provisions have already been scrapped so some part of Congress is working for the people here. For example, a section related to Sunshine Act Revisions was removed before the bill passed. See: Congress to remove controversial payment reporting exemption in 21st Century Cures Act and See: Republicans reach deal to pass Cures Act by end of year, but Democrats pushing for changes.
• The bill does a lot to deregulate the drug and medical device industry but doesn’t do much to address price gouging. An argument can be made for deregulation, but a stronger argument can be made that price gouging is the core of our current healthcare crisis. Why pass a Cures bill aimed at drugs if drug costs aren’t going to be addressed?
• Some provisions below seem innocent, but in the context of other laws and industry practices, they end up being questionable. We will try to explain connections in each section.
• Congress put forth a beneficial bill, then they chopped out some sections that might have helped people and added in others. By the time the House and Senate passed it, there were provisions incorporated to please their corporate donors on K Street. They then gave it a positive name and hoped people don’t read the final law. Lobbyists need a seat at the table but Congress should not be their lap dogs. The most damaging provisions of the bill are buried in the later sections, and only a few people who dig through the technical bits and understand the full picture will ever be as angry as they should be. One critic includes the very vocal Elizabeth Warren.

“Why bother with a fig leaf in the Cures bill? Why pretend to give any money to NIH or opioids?”… “Because this funding is political cover for huge giveaways to giant drug companies [and medical device makers].” – Elizabeth Warren

SEE: 21st Century Cures Act: Pork Or Promise? Forbes provides more reading.

TIP: The summary below is a work in progress and uses the summary from Congress.gov as a starting point. Our NOTES are titled NOTES. All titles are summarized, more NOTES to be added. If you want another perspective or more detail on a provision, I strongly suggest using this 100-page guide to H.R. 6: The 21st Century Cures Act prepared by experts via the Congressional Research Service regarding the original bill published on Aug 10, 2015.

TITLE I–DISCOVERY

Subtitle A–National Institutes of Health Funding

NOTE: This section is mostly all beneficial to the public at large. It pulls some funds from other programs to fund NIH, but this section doesn’t contain much pork.

(Sec. 1001) This bill amends the Public Health Service Act to reauthorize the National Institutes of Health (NIH) through FY2018.

NOTE: Funding NIH is useful. A lot of the critics of the bill say it doesn’t fund enough, but NIH has been underfunded by falling victim to sequestration. Drawing billions over 5 years from “revenue generated from the sale of SPR [Strategic Petroleum Reserves] oil” might be a good start. However, this needs to be approved by a Republican Controlled Congress under Trump, which could lead to its defunding or falling victim to more sequestration.

(Sec. 1002) The NIH must establish an Innovation Prizes Program to fund areas of biomedical science that could realize significant advancements or improve health outcomes.

NOTE: What isn’t to love about competition spurring on biotech innovation? This popular provision is another star player. Bills tend to lead with the most popular provisions. This is smart tactics and was also true for the PPACA. Learn more about the sweet Prize program or see the actual provision.

Subtitle B–National Institutes of Health Planning and Administration

(Sec. 1022) Directors of national research institutes and national centers have five-year terms in office.

(Sec. 1023) The NIH must reduce the administrative burdens of researchers funded by the NIH.

(Sec. 1027) The support the National Center for Advancing Translational Sciences may provide to clinical trials is extended through a later clinical trial phase.

(Sec. 1028) Each national research institute must conduct or support high-risk, high-reward research.

NOTE: This section amends 42 USC 287: National Center for Advancing Translational Sciences and sets out terms for the sort of data that must be collected on the functioning of NIH for review in 2 years by Congress. This is a boring section that seems to be aimed at improving NIH. If there is something insidious in here, it is hiding.

Subtitle C–Supporting Young Emerging Scientists

(Sec. 1041) A loan repayment program is established for health professionals engaging in research. The maximum awards of other loan repayment programs are increased.

NOTE: This section amends 42 U.S.C. 288 et seq. to increases the loan repayments. So, it gives NIH more money to attract health professionals by upping the maximum they can pay toward loans.

Subtitle D–Capstone Grant Program

(Sec. 1061) Capstone Awards are established to support outstanding scientists in concluding research programs. Recipients cannot be principal investigators on subsequent NIH awards.

NOTE: This section allows for more “capstone rewards” for “young emerging scientists,” as the subtitles above and section title allude.

Subtitle E–Promoting Pediatric Research through the National Institutes of Health

(Sec. 1081) The Pediatric Research Initiative is revised to require establishment of a National Pediatric Research Network comprised of pediatric research consortia.

(Sec. 1083) The NIH must convene a workshop on appropriate age groupings and age exclusions in human research and must publish the number of children included in NIH research.

NOTE: This section funds The Pediatric Research Initiative. You can learn more about it here. Congress has been adding and removing funding from NIH, and it has posed some difficulty for The Pediatric Research Initiative, which seeks to assistance in the development of new diagnostics, treatments, and cures.

Subtitle F–Advancement of the National Institutes of Health Research and Data Access

(Sec. 1101) The NIH must standardize data in the clinical trial registry data bank.

NOTE: This is a section on transparency.

Subtitle G–Facilitating Collaborative Research

(Sec. 1121) The NIH and the Food and Drug Administration (FDA) must implement a system that allows further research on clinical trial data.

(Sec. 1122) The Centers for Disease Control and Prevention (CDC) must expand surveillance of neurological diseases.

(Sec. 1124) The Department of Health and Human Services (HHS) must revise health information privacy rules to allow: (1) use of protected information for research purposes to be treated as use for health care operations, (2) remote access to information by researchers, and (3) individuals to authorize future use of their information for research.

NOTE: This is a section on improvements and requirements for the FDA, CDC, and HHS (other health related agencies).

Subtitle H–Council for 21st Century Cures

(Sec. 1141) The Council for 21st Century Cures, a nonprofit corporation, is established to accelerate the discovery, development, and delivery of innovative cures, treatments, and preventive measures.

NOTE: A section on creating a non-profit board. Boards are useful.

TITLE II–DEVELOPMENT

Subtitle A–Patient-Focused Drug Development

NOTE: This section seems innocent enough, but it includes a provision that deregulates the FDA to allow “more cures” through. This sounds beneficial on paper. However, critics are skeptical. They feel that less regulation is only going to solve the corporate pharmaceutical problem of “how to make more money” now that Pharma stocks are slumping.”

(Sec. 2001) This bill amends the Federal Food, Drug, and Cosmetic 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.

NOTE: The idea of patient-focused drug development is praised widely. “Patient-focused drug development has the potential to become the most transformational piece of this bill” said Dr. Janet Woodcock, MD, Ph.D. the director of the U.S. FDA Center for Drug Evaluation and Research according to Forbes.

Subtitle B–Qualification and Use of Drug Development Tools

(Sec. 2021) The FDA must establish a process to qualify drug development tools (methods, materials, or measures that aid drug development and regulatory review) as reliable for use in supporting approval or investigational use of a drug.

(Sec. 2022) The sponsor of a drug for a serious condition may request that the FDA agree to an accelerated approval development plan. The plan must include the design of the drug study.

NOTE: This is a significant section on transparency and on the accelerated approval of drugs under section the Federal Food, Drug, and Cosmetic Act Chapter 5 Part A (a section on drugs and devices and fast track programs).

Subtitle C–FDA Advancement of Precision Medicine

(Sec. 2041) The FDA must define “precision” drugs and the evidence needed to support their use in a subset of patients. To expedite clinical development of precision drugs for the treatment of serious or rare conditions, the FDA may rely upon data previously submitted for a different approved drug or indication.

Subtitle D–Modern Trial Design and Evidence Development

(Sec. 2061) The FDA must issue guidance that addresses using alternative statistical methods in clinical trials and in the development and review of drugs.

(Sec. 2062) To support approval of a drug for a new indication, the FDA must evaluate the use of evidence from clinical experience (in place of evidence from clinical trials) and establish a streamlined data review program.

Subtitle E–Expediting Patient Access

(Sec. 2082) Manufacturers and distributors of investigational drugs for serious conditions must publish their policies on expanded access (also known as “compassionate use”).

NOTE: Expanded access (also known as “compassionate use”) is part of this bill that allows drugs and devices to be used without putting them through the FDA approval processes. It is, like the other provisions related to this, a mixed bag. Cancer Patients Deserve Faster Access to Life-Saving Drugs. This has been true for some time but has to be weighted against related loopholes which allow for drugs to be used for conditions they aren’t proven to affect.

Subtitle F–Facilitating Responsible Manufacturer Communications

(Sec. 2101) The definition of, and requirements for, health care economic information that is provided to entities selecting drugs for coverage or reimbursement are revised.

Subtitle G–Antibiotic Drug Development

(Sec. 2121) At the request of the sponsor of an antibacterial or antifungal drug for treatment of a serious infection, the FDA may agree on a process for developing data to support approval of the drug for use in a limited population of patients.

HHS must monitor the use of antibacterial and antifungal drugs and resistance to these drugs.

(Sec. 2122) The FDA must identify and publish susceptibility test interpretive criteria for antimicrobial drugs. (These criteria characterize the drug resistance of microbes.) The FDA may allow marketing of devices that use these criteria without premarket approval.

(Sec. 2123) This bill amends title XVIII (Medicare) of the Social Security Act (SSAct) to require the Centers for Medicare & Medicaid Services (CMS) to provide an additional payment to certain hospitals for providing certain new antimicrobial drugs (DISARM drugs) to inpatients. Total additional payments cannot exceed 0.02% of total payments to hospitals.

NOTE: This section requires public programs to help support past DISARM acts. See Antibiotic Resistance Targeted in 21st Century Cures Act.

Subtitle H–Vaccine Access, Certainty, and Innovation

(Sec. 2141) The Advisory Committee on Immunization Practices must expedite review of certain vaccines. The CDC must provide a vaccine developer, upon request, with information on public health needs and priorities and certain epidemiological analyses or data.

Subtitle I–Orphan Product Extensions Now; Incentives for Certain Products for Limited Populations

(Sec. 2151) The marketing exclusivity period of a drug approved for a new indication that is a rare disease or condition is extended by six months.

(Sec. 2152) The priority review voucher program for rare pediatric diseases is extended through 2018 and revised to apply only to serious diseases.

NOTE: This section is a mixed bag, giving longer exclusive use to life-saving drugs can lead to price gouging such as the Mylan Epipen scandal. It can also provide incentives to drug makers to focus on finding cures for rare diseases. Some of our altruistic Congresspeople probably see this as “dangerous,” and others think that “deregulating may help free-market innovation.”

Subtitle J–Domestic Manufacturing and Export Efficiencies

(2162) This bill amends the Controlled Substances Import and Export Act to allow unimpeded re-exportation of certain exported controlled substances within the European Economic Area.

NOTE: I do not know why we can now send controlled substances to Europe. Someone put this provision in the bill. If anyone who knows who benefits from this, please comment below.

Subtitle K–Enhancing Combination Products Review

(Sec. 2181) The FDA must describe the responsibilities of each agency center charged with reviewing drugs, medical devices, or biological products when reviewing a product that is a combination of drug, medical device, or biological product.

Subtitle L–Priority Review for Breakthrough Devices

(Sec. 2201) The FDA must establish a program for priority review of breakthrough medical devices.

NOTE: The Comptroller General of the United States shall conduct a study on the effectiveness of awarding priority review vouchers under section 529 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360ff). This re-authorizes a program which allows those device makers who are trying to cure rare pediatric diseases get sent to the front of the approval line via a voucher.

Subtitle M–Medical Device Regulatory Process Improvements

(Sec. 2221) The FDA must accredit third parties to certify device manufactures’ quality systems as meeting FDA criteria. The FDA must rely on this certification when determining the safety and effectiveness of certain changes to medical devices.

(Sec. 2222) “Valid scientific evidence” is defined for purposes of the FDA determining the effectiveness of a medical device without clinical investigations.

(Sec. 2223) FDA employees that review premarket submissions of medical devices must receive training regarding the “least burdensome appropriate means” concept.

(Sec. 2225) The FDA must identify types of medical devices that do not require submission of a report prior to commercial marketing.

(Sec. 2227) The FDA may exempt from effectiveness requirements certain medical devices intended to benefit fewer than 8,000 individuals.

NOTE: This section deregulates the FDA and places less quality assurance restrictions on medical device makers. It provides a handout to medical device makers, but is not unreasonable.

Subtitle N–Sensible Oversight for Technology Which Advances Regulatory Efficiency

(Sec. 2241) “Health software” is defined and, with specified exceptions, exempted from FDA regulation.

Subtitle O–Streamlining Clinical Trials

(Sec. 2262) Institutional Review Boards responsible for reviewing plans for clinical testing of a medical device no longer need to be local.

(Sec. 2263) Clinical testing of medical devices or drugs no longer requires the informed consent of the subjects if the testing poses no more than minimal risk and includes safeguards.

NOTE: Who benefits from Sec. 2263? It is probably not the public. Why would that provision be needed? This seems like the start of a slippery slope.

Subtitle P–Improving Scientific Expertise and Outreach at FDA

(Sec. 2281) The Silvio O. Conte Senior Biomedical Research Service is revised to remove the limit on the number of members and make other changes.

(Sec. 2283) Changes are made to the Reagan-Udall Foundation for the Food and Drug Administration to revise Board of Directors membership, Executive Director compensation, and accounting.

(Sec. 2285) The FDA is granted additional hiring authority for scientific, technical, or professional positions within certain centers.

Subtitle Q–Exempting from Sequestration Certain User Fees

(Sec. 2301) This bill amends the Balanced Budget and Emergency Deficit Control Act of 1985 to exempt from sequestration FDA administrative expenses funded through certain user fees.

Subtitle R–Other Provisions

(Sec. 2321) This bill expresses the sense of Congress that recording unique medical device identifiers in electronic health records could enhance medical surveillance.

NOTE: I am tempted to say “not this again.” Yet here it is.

TITLE III–DELIVERY

Subtitle A–Interoperability

(Sec. 3001) Requirements are established for interoperability and certification of health information technology. Practices that discourage the exchange of electronic health information are prohibited.

Subtitle B–Telehealth

(Sec. 3021) The CMS and Medicare Payment Advisory Commission must provide information to Congress regarding telehealth.

NOTE: Telehealth is a pretty cool concept. It is about using telecommunications (like the internet) to provide healthcare advice. See What is Telehealth?.

Subtitle C–Encouraging Continuing Medical Education for Physicians

(Sec. 3041) Part A (General Provisions) of title XI of the SSAct is amended to remove the requirement that manufacturers of medical products report payments to physicians for certain educational activities.

Subtitle D–Disposable Medical Technologies

The CMS must pay home health agencies for certain disposable medical devices furnished to individuals receiving home health services under Medicare.

NOTE: I do not fully understand the implications of this, but it seems to help device makers. It updates 42 USC 1395m: Special payment rules for particular items and services. See: Home health services Medicare.Gov.

Subtitle E–Local Coverage Decision Reforms

(Sec. 3081) Medicare administrative contractors must publish local coverage determinations.

Subtitle F–Medicare Pharmaceutical and Technology Ombudsman

(Sec. 3101) A pharmaceutical and technology ombudsman within the CMS must receive and respond to complaints from manufacturers of medical products regarding Medicare coverage of their products.

Subtitle G–Medicare Site-of-Service Price Transparency

(Sec. 3121) The CMS must publish estimated Medicare beneficiary prices for items and services provided by hospital outpatient departments or ambulatory surgical centers.

Subtitle H–Medicare Part D Patient Safety and Drug Abuse Prevention

(Sec. 3141) Medicare prescription drug plan sponsors may limit the access of certain beneficiaries to frequently abused drugs.

NOTE: It is useful to limit the government’s footing the bill for drugs that lead to addiction. However, we are missing any section dealing with the negotiation of drug prices. SEE: Negotiating for Lower Drug Costs in Medicare Part D and The Politics Of Medicare And Drug-Price Negotiation (Updated).

TITLE IV–MEDICAID, MEDICARE, AND OTHER REFORMS

Subtitle A–Medicaid and Medicare Reforms

(Sec. 4001) Aggregate Medicaid payments to states for durable medical equipment are limited to the amount that would be paid under Medicare, effective January 1, 2020.

(Sec. 4002) Generic drugs authorized by the brand name drug manufacturer are excluded from the calculation of average manufacturer price when determining rebates under Medicaid.

(Sec. 4003) Medicare payments are reduced for x-ray imaging that uses film or an imaging plate (instead of a digital sensor). After 2016, a multiple procedure payment reduction policy cannot be applied to a physician’s imaging services until the CMS publishes an analysis of any efficiencies that may exist when more than one study is performed on the same patient on the same day.

(Sec. 4004) Medicare payments for infusion drugs and biologicals furnished through durable medical equipment are revised.

(Sec. 4005) CMS must expand and extend through August 31, 2018, the Prior Authorization of Power Mobility Devices Demonstration.

(Sec. 4006) For HHS grants, contracts, or other agreements, monetary penalties are established for fraudulent claims, fraudulent statements, and failure to provide timely access to the Inspector General of HHS.

NOTE: This section seems to cut Medicaid, but I am still unclear of its impact. See H.R. 6: The 21st Century Cures Act review by Congressional Research Services for detailed reviews of each provision in this section. Keep in mind H.R. 6 describes the bill as of 2015, not the final passed bit of legislation.

Subtitle B–Other Reforms

(Sec. 4041) The Department of Energy must sell crude oil from the Strategic Petroleum Reserve.

NOTE: Here is the section about crude oil sales funding this program.

Subtitle C–Miscellaneous

(Sec. 4061) HHS must: (1) conduct or support research on Lyme disease and other tick-borne diseases, (2) establish the Interagency Lyme and Tick-Borne Disease Working Group, and (3) submit a strategic plan for tick-borne disease research.

NOTE: This is the section about tick-borne diseases. It is needed.

TIP: For more information see H.R. 6, the 21st Century Cures Act: Frequently Asked Questions from House.Gov. They answer questions like What does the Strategic Petroleum Reserve have to do with health innovation funding? And How will the 21st Century Cures Act change clinical trials and drug approvals?.

TIP: See Regulatory Explainer: The (Updated) 21st Century Cures Act for another summary of the effects of these provisions. Also see H.R. 6: The 21st Century Cures Act review by Congressional Research Services for a detailed examination of the original bill by health experts who explain the background of each provision in the original bill.