21st Century Cures Act
Latest action · Jul 13, 2015 Received in the Senate and Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
Progress
Where this bill reached, and when. A stage with no date was not reached; one that failed a vote and later carried shows the date it carried.
- IntroducedMay 19, 2015
- Passed HouseJul 10, 2015
- Passed SenateNot reached
- To the PresidentNot reached
- Became lawNot reached
Summary
21st Century Cures Act
(Sec. 2) The NIH and Cures Innovation Fund is established and funds are appropriated: (1) for biomedical research, including high-risk, high-reward research and research conducted by early stage investigators; (2) to develop and implement a strategic plan for biomedical research; and (3) to carry out specified provisions of this Act.
TITLE I--DISCOVERY
Subtitle A--National Institutes of Health Funding
(Sec. 1001) This bill amends the Public Health Service Act to reauthorize the National Institutes of Health (NIH) through FY2018.
(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.
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.
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.
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.
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.
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.
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.
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.
TITLE II--DEVELOPMENT
Subtitle A--Patient-Focused Drug Development
(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.
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.
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”).
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.Subtitle B--Other Reforms
(Sec. 4041) The Department of Energy must sell crude oil from the Strategic Petroleum Reserve.
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.Recorded votes 3
Newest first. Open one to see how every member voted.
| Roll call | Question | Result | Date |
|---|---|---|---|
| House 433 | On Passage | Passed344–77 | Jul 10, 2015 |
| House 432 | On Agreeing to the Amendment | Failed176–245 | Jul 10, 2015 |
| House 431 | On Agreeing to the Amendment | Failed141–281 | Jul 10, 2015 |
Cosponsors 230
Members who signed on, in the order they did. Signatures ran from May 19, 2015 to Jun 25, 2015; 4 are original cosponsors, there from the day it was introduced.
| Seat | Cosponsor | Signed on | |
|---|---|---|---|
| D-CO | Diana DeGette | Original | May 19, 2015 |
| D-NJ | Frank Pallone, Jr. | Original | May 19, 2015 |
| D-TX | Gene Green | Original | May 19, 2015 |
| R-PA | Joseph R. Pitts | Original | May 19, 2015 |
| R-MD | Andy Harris | May 22, 2015 | |
| D-CA | Anna G. Eshoo | May 22, 2015 | |
| R-VA | Barbara Comstock | May 22, 2015 | |
| R-MO | Billy Long | May 22, 2015 | |
| D-IL | Bobby L. Rush | May 22, 2015 | |
| R-KY | Brett Guthrie | May 22, 2015 | |
| R-WA | Cathy McMorris Rodgers | May 22, 2015 | |
| D-PA | Chaka Fattah | May 22, 2015 | |
| R-WV | David B. McKinley | May 22, 2015 | |
| D-IA | David Loebsack | May 22, 2015 | |
| D-GA | David Scott | May 22, 2015 |
Committees 3
Where it was sent and what each committee and subcommittee did with it, in order.
| Chamber | Committee | What it did |
|---|---|---|
| House | Energy and Commerce Committee | Referred May 19, 2015Markup May 21, 2015Reported Jul 7, 2015 |
| House | Ways and Means Committee | Referred May 19, 2015Discharged Jul 7, 2015 |
| Senate | Health, Education, Labor, and Pensions Committee | Referred Jul 13, 2015 |
Actions 37
Everything that happened, newest first.
- Jul 13, 2015Received in the Senate and Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
- Jul 10, 2015Considered as unfinished business. (consideration: CR H5035-5082)
- Jul 10, 2015The House resolved into Committee of the Whole House on the state of the Union for further consideration.
- Jul 10, 2015DEBATE - Pursuant to the provisions of H. Res. 350, the Committee of the Whole proceeded with 10 minutes of debate on the Brat amendment No. 1.
- Jul 10, 2015POSTPONED PROCEEDINGS - At the conclusion of debate on the Brat amendment, the Chair put the question on adoption of the amendment and by voice vote, announced that the noes had prevailed. Mr. Brat demanded a recorded vote and the Chair postponed further proceedings on the question of adoption of the amendment until a time to be announced.
In the Congressional Record 23
Days the Record’s own index lists this bill, newest first, with the pages and the members it names. Pages starting H are the House, S the Senate, E Extensions of Remarks.
| Where | In the Record | Members | Date |
|---|---|---|---|
| Senate | Debate and remarks S6508–S6510 | Elizabeth Warren D-MA | Nov 28, 2016 |
| House | Debate and remarks H6274 | Gus M. Bilirakis R-FL | Nov 17, 2016 |
| Senate | Debate and remarks S6324 | Ron Wyden D-OR | Nov 15, 2016 |
| House | Debate and remarks H5430 | Earl L. "Buddy" Carter R-GA | Sep 13, 2016 |
| Extensions | Debate and remarks E1133 | Michael T. McCaul R-TX | Jul 14, 2016 |
Research
What has been written about this bill: committee reports, cost estimates, the sponsor’s authority statement, printed hearings and the Congressional Research Service’s work.
Committee report
Congressional Budget Office cost estimates 2
- Jul 7, 2015H.R. 6, 21st Century Cures ActRules Committee Print 114-22
- Jun 23, 2015H.R. 6, 21st Century Cures ActAs ordered reported by the House Committee on Energy and Commerce on May 21, 2015
Constitutional authority
The sponsor’s statement, as printed in the Congressional Record, vol. 161, no. 77, May 19, 2015, page H3388.
Printed hearings 10
Hearings whose printed record names this bill, newest first: hearings on it, and wider hearings where it came up.
| Number | Hearing | Committee | Held |
|---|---|---|---|
| Serial No. 114-165 | EXAMINING LEGISLATION TO IMPROVE PUBLIC HEALTH181 pages | Energy and Commerce Committee | Sep 8, 2016 |
| S. Hrg. 114-680 | DEPARTMENTS OF LABOR, HEALTH AND HUMAN SERVICES, AND EDUCATION, AND RELATED AGENCIES APPROPRIATIONS FOR FISCAL YEAR 2017428 pages | Appropriations Committee | Jun 14, 2016 |
| Serial No. 114-137 | MEDICARE ACCESS AND CHIP REAUTHORIZATION ACT OF 2015: EXAMINING PHYSICIAN EFFORTS TO PREPARE FOR MEDICARE PAYMENT REFORMS177 pages | Energy and Commerce Committee | Apr 19, 2016 |
| S. Hrg. 114-529 | EXAMINING THE OPIOID EPIDEMIC: CHALLENGES AND OPPORTUNITIES123 pages | Finance Committee | Feb 23, 2016 |
| S. Hrg. 114-697 | ACHIEVING THE PROMISE OF HEALTH INFORMATION TECHNOLOGY: IMPROVING CARE THROUGH PATIENT ACCESS TO THEIR RECORDS50 pages | Health, Education, Labor, and Pensions Committee | Sep 16, 2015 |
CRS reports 5
Congressional Research Service work that CRS links to this bill or the law it became, newest first.
About this bill 3
Products that name it in their title: its number, its law number or one of its short titles.
| Product | Title | Kind | Published |
|---|---|---|---|
| R44720 | The 21st Century Cures Act (Division A of P.L. 114-255) Archived | Report | Dec 23, 2016 |
| R44502 | Senate Medical Innovation Bills: Overview and Comparison with the 21st Century Cures Act (H.R. 6) Archived | Report | May 17, 2016 |
| R44071 | H.R. 6: The 21st Century Cures Act Archived | Report | Aug 10, 2015 |
Also cite it 2
Products on other subjects that cite it, usually among other measures.
| Product | Title | Kind | Published |
|---|---|---|---|
| R44437 | Telehealth and Telemedicine: Description and Issues Archived | Report | Mar 29, 2016 |
| R44134 | Access to Unapproved Drugs: FDA Policies on Compassionate Use and Emergency Use Authorization Archived | Report | Aug 4, 2015 |
Amendments 8
Amendments offered to this bill.
Related bills 46
Companion bills and other measures the record links to this one.
Titles 4
Every title it has carried, official and short, at each stage.
- Official Title as Introduced
- To accelerate the discovery, development, and delivery of 21st century cures, and for other purposes.
- Short Titles as Introduced
- 21st Century Cures Act
- Short Titles as Reported to House
- 21st Century Cures Act
- Short Titles as Passed House
- 21st Century Cures Act
Subjects
Assigned by the Library of Congress. Policy area: Health.
- Administrative law and regulatory procedures
- Advisory bodies
- Budget deficits and national debt
- Child health
- Computers and information technology
- Congressional oversight
- Consumer affairs
- Department of Health and Human Services
- Drug safety, medical device, and laboratory regulation
- Drug therapy
- Drug trafficking and controlled substances
- Drug, alcohol, tobacco use
- Energy storage, supplies, demand
- Europe
- Executive agency funding and structure
- Food and Drug Administration (FDA)
- Fraud offenses and financial crimes
- Government studies and investigations
- Health
- Health care quality
- Health information and medical records
- Health personnel
- Health programs administration and funding
- Health promotion and preventive care
- Health technology, devices, supplies
- Home and outpatient care
- Hospital care
- Immunology and vaccination
- Infectious and parasitic diseases
- International organizations and cooperation
- Manufacturing
- Medicaid
- Medical education
- Medical research
- Medicare
- National Institutes of Health (NIH)
- Neurological disorders
- Oil and gas
- Prescription drugs
- Product safety and quality
- Public-private cooperation
- Research administration and funding
- Right of privacy
- Strategic materials and reserves
- Surgery and anesthesia
- User charges and fees
Text 4
Each version as it was printed, newest first.
- Jul 13, 2015Referred in Senate
- Jul 10, 2015Engrossed in House
- Jul 7, 2015Reported in House
- May 19, 2015Introduced in House
Everything here is as published by Congress: the summary is the Congressional Research Service's, the action wording is the clerks', and the subjects are the Library of Congress's. How far it got is read from the actions themselves, taking the most recent one of each kind, so a bill that failed a vote and later passed is shown as having passed. Records come from this bill on Congress.gov and govinfo.gov; cost estimates are the Congressional Budget Office's, and the hearings are the printed hearings GovInfo publishes, which can appear months after the hearing.
