21st Century Cures

The 21st Century Cures Act (P.L. 114-255) is landmark, bipartisan legislation that was signed into law on Dec. 13, 2016, and touches virtually all aspects of biomedical research, medical product development and the regulatory approval process. Read what FasterCures has said about 21st Century Cures over the years.

FasterCures worked closely with Congress, federal agencies and the advocacy community throughout the legislation’s journey to the president’s desk. In February 2017, we debuted the 21st Century Cures Tracker to track the implementation of the 100+ sections in Division A, which include the key provisions relevant to biomedical research and innovation. (Other divisions of the law pertain to mental health and Medicare; since those are not areas of focus for FasterCures, we will not be actively tracking them here.) Learn more about how to use the tracker with our FAQs page.

A few examples of the issues we will be tracking include the impact of changes to the National Institutes of Health’s administrative requirements for grantees, how the Food and Drug Administration implements new changes designed to enhance patient engagement and how the Department of Health and Human Services is using its new authorities to promote health information technology interoperability.

Many external factors will affect the progress of these initiatives, including policies related to hiring freezes and uncertain funding levels. This tracker is not meant to be a pass/fail report card, but rather a snapshot in time that can help explain impact and identify where progress is needed.

Please keep coming back, as we will be updating the information regularly. Use the button below to send us feedback on the value of the information we are presenting, and the usability of this new resource.

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FasterCures' 21st Century Cures Act Tracker (P.L. 114-255)

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Status Title Subtitle Section Tracked Deadlines and Requirements Update Date of Update Tags
fa fa-2x fa-long-arrow-right Title I — Innovation Projects and State Responses to Opioid Abuse - Sec. 1001. Beau Biden Cancer Moonshot and NIH innovation projects. Annual appropriation of funds into the NIH Innovation Account (FY17-26), and subsequent allocation to specific initiatives: PMI (FY17-26), BRAIN (FY17-26), Cancer Moonshot (FY17-23), and regenerative medicine (FY17-20).
In addition, requires NIH to submit a work plan to Congress by June 12, 2017 for the NIH Innovation Projects and to solicit input from the public prior to submitting the work plan.
Further directs NIH to submit an annual report to Congress by October 1st of each fiscal year 2018 – 2027 outlining the amount of money obligated as well as a description of the projects and how they are advancing.

On March 28, 2017, the Advisory Committee to the Director of NIH held a conference call to discuss the draft work plans outlined in this section. The meeting was announced in a federal register notice. It provided an overview of implementation and provided an update on work plans for each of the following: Cancer Moonshot Initiative, Regenerative Medicine, Precision Medicine Initiative, BRAIN Initiative

20170328 03/28/2017 Funding, NIH, Regenerative Medicine
fa fa-2x fa-long-arrow-right Title I — Innovation Projects and State Responses to Opioid Abuse - Sec. 1002. FDA innovation projects. Annual appropriation of funds into the FDA Innovation Account (FY17-25)
6/11/2017 - Requires submission of a work plan for the FDA Innovation Fund

April 24, 2017, The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Science Board to the FDA. The meeting will be held on May 9, 2017, from 2 p.m. to 5 p.m. The Science Board will provide recommendations on the Agency's Innovation Funds work plan.

20170424 04/24/2017 FDA, Funding, Regulatory Affairs
fa fa-2x fa-long-arrow-right Title I — Innovation Projects and State Responses to Opioid Abuse - Sec. 1003. Account for the state response to the opioid abuse crisis. Annual appropriations into the “Account for the State Response to the Opioid Abuse Crisis” (FY17-18) FasterCures will periodically assess this item as appropriate. 20161213 12/13/2016 Funding
fa fa-2x fa-check Title I — Innovation Projects and State Responses to Opioid Abuse - Sec. 1004. Budgetary treatment. Provision in effect upon enactment. Further tracking not required. Complete. 20161213 12/13/2016 FDA, Funding, NIH
fa fa-2x fa-long-arrow-right Title II — Discovery Subtitle A—National Institutes Of Health Reauthorization Sec. 2001. National Institutes of Health Reauthorization. Reauthorizes NIH funding for 2018, 2019, and 2020. FasterCures will periodically assess this item as appropriate. 20161213 12/13/2016 Funding, NIH
fa fa-2x fa-long-arrow-right Title II — Discovery Subtitle A—National Institutes Of Health Reauthorization Sec. 2002. EUREKA prize competitions. Requires NIH director support for prize competitions to advance biomedical science and improve health outcomes for diseases that are serious and represent a significant burden in the US.
The information reporting on prize program is included in triennial report.
FasterCures will periodically assess this item as appropriate. 20161213 12/13/2016 NIH, Rare Disease, Reports, Research
fa fa-2x fa-long-arrow-right Title II — Discovery Subtitle B—Advancing Precision Medicine Sec. 2011. Precision Medicine Initiative. 12/13/2017: requires HHS submission of a report on the relevant data access policies and procedures to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives. The report should include steps the HHS has taken to consult with experts or other heads of departments or agencies of the Federal Government in the development of such policies. FasterCures will periodically assess this item as appropriate. 20161213 12/13/2016 Data Sharing, Reports
fa fa-2x fa-long-arrow-right Title II — Discovery Subtitle B—Advancing Precision Medicine Sec. 2012. Privacy protection for human research subjects. Directs HHS to issue certificates of confidentiality to protect personal information of research participants from unauthorized disclosure.
6/11/2017: Updated policies go into effect.
FasterCures will periodically assess this item as appropriate. 20161213 12/13/2016 HHS, Privacy, Research
fa fa-2x fa-circle-thin Title II — Discovery Subtitle B—Advancing Precision Medicine Sec. 2013. Protection of identifiable and sensitive information. Enables HHS to exempt from disclosure, certain information that is or may be identifiable.

FasterCures does not plan on tracking the implementation of this provision at this time

20161213 12/13/2016 HHS, Privacy, Research
fa fa-2x fa-long-arrow-right Title II — Discovery Subtitle B—Advancing Precision Medicine Sec. 2014. Data sharing. Requires NIH grant recipients to share the data generated from NIH funded research. FasterCures will periodically assess this item as appropriate. 20161213 12/13/2016 Data Sharing, NIH, Research
fa fa-2x fa-long-arrow-right Title II — Discovery Subtitle C—Supporting Young Emerging Scientists Sec. 2021. Investing in the next generation of researchers. Establishes the "Next Generations of Researchers Initiative" in the NIH Office of the Director.
Requires submission of a report to Congress on any actions taken in response to the NAS comprehensive study on young researchers.
FasterCures will periodically assess this item as appropriate. 20161213 12/13/2016 NIH, Reports
fa fa-2x fa-long-arrow-right Title II — Discovery Subtitle C—Supporting Young Emerging Scientists Sec. 2022. Improvement of loan repayment program. Establishes a revised loan repayment program to support researchers in various high-need topic areas.
6/13/2018: requires the publication of GAO study on NIH efforts to attract, retain, and develop emerging scientists, including individuals from underrepresented groups.
FasterCures will periodically assess this item as appropriate. 20161213 12/13/2016 GAO, NIH, Reports, Workforce
fa fa-2x fa-long-arrow-right Title II — Discovery Subtitle D—National Institutes Of Health Planning And Administration Sec. 2031. National Institutes of Health strategic plan. 12/13/2018: requires development and publication of the NIH Strategic Plan. FasterCures will periodically assess this item as appropriate. 20161213 12/13/2016 NIH, Reports, Research
fa fa-2x fa-long-arrow-right Title II — Discovery Subtitle D—National Institutes Of Health Planning And Administration Sec. 2032. Triennial reports. Requires the development and publication by NIH of triennial reports to Congress on NIH activities. FasterCures will periodically assess this item as appropriate. 20161213 12/13/2016 NIH, Reports, Research
fa fa-2x fa-long-arrow-right Title II — Discovery Subtitle D—National Institutes Of Health Planning And Administration Sec. 2033. Increasing accountability at the National Institutes of Health. Provides for appointment of NIH Institute and Center Directors and implementation of term limits and reappointments.
12/13/2018: requires submission of report to Congress on efforts to prevent and eliminate duplicative biomedical research.
FasterCures will periodically assess this item as appropriate. 20161213 12/13/2016 NIH, Reports, Research
fa fa-2x fa-long-arrow-right Title II — Discovery Subtitle D—National Institutes Of Health Planning And Administration Sec. 2034. Reducing administrative burden for researchers. 12/13/2017: directs OMB to establish of the Research Policy Board.
12/13/2018: requires HHS review and revision of regulations and policies to reduce the administrative burden on researchers.
12/13/2018: requires HHS and USDA review and revision of regulations and policies for the care and use of laboratory animals to reduce administrative burden on researchers.
12/13/2018: requires submission of a Research Policy Board report to the White House and Congress containing formal recommendations on harmonization of policies to reduce administrative burden on researchers.
12/13/2020: requires publication of GAO report on the Research Policy Board's activities.
FasterCures will periodically assess this item as appropriate. 20161213 12/13/2016 FDA, GAO, HHS, NIH, Research
fa fa-2x fa-binoculars Title II — Discovery Subtitle D—National Institutes Of Health Planning And Administration Sec. 2035. Exemption for the National Institutes of Health from the Paperwork Reduction Act requirements. Exempts voluntary information collected during NIH research from current Paperwork Reduction Act requirements. Provision in effect upon enactment. FasterCures will periodically assess the status of implementation and impact on research activities. 20161213 12/13/2016 NIH, Research
fa fa-2x fa-long-arrow-right Title II — Discovery Subtitle D—National Institutes Of Health Planning And Administration Sec. 2036. High-risk, high-reward research. Provides NIH "other transactions authority" to carry out high risk, high reward research.
9/30/2020: requires NIH publication of report to Congress on activities outlined in this section.
FasterCures will periodically assess this item as appropriate, specifically noting NIH use of "other transactions authority" to carry out high risk, high reward research. 20161213 12/13/2016 Funding, NIH, Research
fa fa-2x fa-binoculars Title II — Discovery Subtitle D—National Institutes Of Health Planning And Administration Sec. 2037. National Center for Advancing Translational Sciences. Expands NCATS authority to fund clinical research and directs NCATS to include a complete list of all methods and tools it develops in its next biennial report. FasterCures will periodically assess the status of implementation and impact on research activities. 20161213 12/13/2016 NIH, Reports, Research
fa fa-2x fa-long-arrow-right Title II — Discovery Subtitle D—National Institutes Of Health Planning And Administration Sec. 2038. Collaboration and coordination to enhance research. 6/11/2017 (180 days): directs NIH to convene workshop of experts on pediatric and older populations to get input on appropriate age groups in research; 180 days after workshop (12/13/17) - NIH update to policies as appropriate.
12/13/2017: requires NIH to update guidelines to reflect the science regarding sex differences, and improve adherence to laws requiring inclusion of women and minorities.
12/13/2018: requires development and dissemination of appropriate measures related to reporting health information about sexual and gender minority populations.
Requires release of triennial report (as described above in section 2032) for inclusion of information regarding number of women and minorities included as research subjects.
FasterCures will periodically assess this item as appropriate. 20161213 12/13/2016 Diversity, NIH, Reports, Research
fa fa-2x fa-long-arrow-right Title II — Discovery Subtitle D—National Institutes Of Health Planning And Administration Sec. 2039. Enhancing the rigor and reproducibility of scientific research. 12/13/2017: requires convening of a working group to develop and issue recommendations to enhance rigor and reproducibility of NIH research.
6/13/2018: directs NIH Director to consider recommendations and develop or update policies as appropriate.
12/13/2018: directs NIH to issue a report to Congress regarding recommendations developed and any subsequent policy changes.
FasterCures will periodically assess this item as appropriate. 20161213 12/13/2016 NIH, Research
fa fa-2x fa-long-arrow-right Title II — Discovery Subtitle D—National Institutes Of Health Planning And Administration Sec. 2040. Improving medical rehabilitation research at the National Institutes of Health. Requires implementation of updates to Rehabilitation Research Plan, which must be revised and updated as appropriate, at least every five years. These updates will be reported to Congress.
Requires interagency coordination of medical rehabilitation research between NIH and other federal agencies.
FasterCures will periodically assess this item as appropriate. 20161213 12/13/2016 NIH, Reports, Research
fa fa-2x fa-long-arrow-right Title II — Discovery Subtitle D—National Institutes Of Health Planning And Administration Sec. 2041. Task force on research specific to pregnant women and lactating women. 3/13/2017 (90 days): requires establishment of a "Task Force on Research Specific to Pregnant Women and Lactating Women;" 18 months after establishment of task force (by 6/13/18 ) -- requires Task Force submission of a report to Congress.

12/13/2018: requires HHS to update regulations and guidance, as appropriate, regarding the inclusion of pregnant women and lactating women in clinical research.

April 18, 2017, the Federal Register published a meeting notice for the Task Force which will be August 21 & 22, 2017 and a second meeting will be November 6-7, 2017 

March 21, 2017, the NIH formally announced the establishment of the task force within the Eunice Kennedy Shriver National Institute of Child Health and Human Development. NICHD has reported to us that it is now in the process of compiling the slate of nominees to serve on the taskforce for the Secretary’s consideration.

January 18, 2017, The Secretary of HHS delegated authority to the NIH to establish this task force.

20170418 04/18/2017 CDC, FDA, Guidances, NIH, Regulatory Affairs, Reports, Research
fa fa-2x fa-long-arrow-right Title II — Discovery Subtitle D—National Institutes Of Health Planning And Administration Sec. 2042. Streamlining National Institutes of Health reporting requirements. 12/13/2018: directs each national research institute or national center to submit a report on the amount of research that involves cross-center collaboration FasterCures will periodically assess this item as appropriate. 20161213 12/13/2016 NIH, Research
fa fa-2x fa-check Title II — Discovery Subtitle D—National Institutes Of Health Planning And Administration Sec. 2043. Reimbursement for research substances and living organisms. Further tracking not required. In effect upon enactment. Complete. 20161213 12/13/2016 NIH, Research
fa fa-2x fa-long-arrow-right Title II — Discovery Subtitle D—National Institutes Of Health Planning And Administration Sec. 2044. Sense of Congress on increased inclusion of underrepresented populations in clinical trials. Articulates a sense of Congress that National Institute on Minority Health and Health Disparities should increase representation of underrepresented populations in clinical trials. FasterCures will periodically assess whether the National Institute on Minority Health and Health disparities is taking action to increase representation of underrepresented populations in clinical trials. 20161213 12/13/2016 Diversity, NIH, Research
fa fa-2x fa-binoculars Title II — Discovery Subtitle E—Advancement Of The National Institutes Of Health Research And Data Access Sec. 2051. Technical updates to clinical trials database. Provides technical updates to clinical trials database. In effect upon enactment. FasterCures will periodically assess implementation; notably whether stipulated changes to the database have been made. 20161213 12/13/2016 Clinical Trials, Research
fa fa-2x fa-long-arrow-right Title II — Discovery Subtitle E—Advancement Of The National Institutes Of Health Research And Data Access Sec. 2052. Compliance activities reports. 12/13/2018: requires issuance of a Report On Activities To Encourage Compliance describing education and outreach, guidance, enforcement, and other activities undertaken to encourage compliance with section 402(j) of the Public Health Service Act (42 U.S.C. 282(j)).
Not later than 2 years after the final compliance date under the final rule implementing section 402(j) of the Public Health Service Act, and every 2 years thereafter for the next 4 years, issuance of a Report on Clinical Trials
FasterCures will periodically assess this item as appropriate. 20161213 12/13/2016 Clinical Trials, FDA, NIH, Reports, Research
fa fa-2x fa-binoculars Title II — Discovery Subtitle E—Advancement Of The National Institutes Of Health Research And Data Access Sec. 2053. Updates to policies to improve data. Updates policies to ensure reporting of data from valid analyses for certain clinical trials. Revised policies go into effect for all grant awards received 1 year after enactment. FasterCures will periodically assess this item as appropriate. 20161213 12/13/2016 Clinical Trials, Data Sharing, NIH, Research
fa fa-2x fa-long-arrow-right Title II — Discovery Subtitle E—Advancement Of The National Institutes Of Health Research And Data Access Sec. 2054. Consultation. 3/13/2017 (90 days): requires HHS to consult with relevant Federal agencies, including the Food and Drug Administration, the Office of the National Coordinator for Health Information Technology, and the National Institutes of Health, as well as other stakeholders (including patients, researchers, physicians, industry representatives, and developers of health information technology) to receive recommendations with respect to enhancements to the clinical trial registry data bank under section 402(j) of the Public Health Service Act (42 U.S.C. 282(j)), including with respect to usability, functionality, and search capability.

On February 28, 2017, the Secretary of HHS delegated the authority" to fulfill the requirements of this Section to the NIH.  In addition, on March 13, 2017 in a letter responding to several organizations who expressed interest in ensuring the requirements of this provision be fulfilled, the Director of the NIH highlighted a new partnership between NIH and technical experts at 18F to make enhancements to ClinicalTrials.gov. In addition, a new beta version of ClinicalTrials.gov was released on February 1, available here.

20170327 03/27/2017 Clinical Trials, Data Sharing, FDA, NIH, ONC, Research
fa fa-2x fa-long-arrow-right Title II — Discovery Subtitle F—Facilitating Collaborative Research Sec. 2061. National neurological conditions surveillance system. Directs CDC to establish integrated surveillance system to be called the "National Neurological Conditions Surveillance System".
Authorizes appropriation of funds to support the system: $5M per year (FY18-22).
12/13/2017: requires CDC submission of a report to Congress "regarding aggregate information collected" by the system. This report will be made public and will be updated biennially.
12/13/2020: requires HHS submission of a report to congress describing implementation of this system.
FasterCures will periodically assess this item as appropriate. 20161213 12/13/2016 CDC, Funding, Reports
fa fa-2x fa-long-arrow-right Title II — Discovery Subtitle F—Facilitating Collaborative Research Sec. 2062. Tick-borne diseases. Requires HHS to establish the "Tick-Borne Disease Working Group." (And subsequent sun-setting of the working group 6 years after enactment of the act.)
12/13/2018 (and every 2 years thereafter): delivery of a summary of tick-born disease research, treatment, and epidemiological studies.
FasterCures will periodically assess this item as appropriate. 20161213 12/13/2016 CDC, FDA, HHS, NIH, Reports, Research
fa fa-2x fa-long-arrow-right Title II — Discovery Subtitle F—Facilitating Collaborative Research Sec. 2063. Accessing, sharing, and using health data for research purposes. 12/13/2017: requires HHS issuance of guidance clarifying that remote access of health data by researchers (under appropriate circumstances) is not forbidden by regulation.
12/13/2017: requires HHS issuance of guidance clarifying requirements for the authorized disclosure of protected health information for research.
12/13/2017: requires HHS establishment of a "Working Group on Protected Health Information for Research" to study and, within 1 year of establishment, report on whether the uses and disclosures of protected health information for research purposes should be modified.
12/13/2017: requires submission of a report to the HHS Secretary
FasterCures will periodically assess this item as appropriate. 20161213 12/13/2016 CDC, Data Sharing, FDA, Guidances, HHS, NIH, Regulatory Affairs, Reports, Research
fa fa-2x fa-check Title II — Discovery Subtitle G—Promoting Pediatric Research Sec. 2071. National pediatric research network. Requires NIH to continue to support the National Pediatric Research Network. Complete 20161213 12/13/2016 NIH, Research
fa fa-2x fa-long-arrow-right Title II — Discovery Subtitle G—Promoting Pediatric Research Sec. 2072. Global pediatric clinical study network. Encourages NIH to support a global clinical study network and engage with authorities in the European Union to establish and operationalize such a network. FasterCures will periodically assess this item as appropriate. 20161213 12/13/2016 NIH, Research
fa fa-2x fa-long-arrow-right Title III — Development Subtitle A—Patient-Focused Drug Development Sec. 3001. Patient experience data. Requires FDA to include a statement regarding any patient experience data that was used at the time a drug is approved. FasterCures will periodically assess this item as appropriate. 20161213 12/13/2016 FDA, Patient Engagement, Regulatory Affairs
fa fa-2x fa-long-arrow-right Title III — Development Subtitle A—Patient-Focused Drug Development Sec. 3002. Patient-focused drug development guidance. 6/11/2017 (180 days): instructs FDA to develop a plan to issue draft and final versions of guidance documents regarding the collection of patient experience data, and the use of such data in drug development.
6/13/2018: requires FDA to issue a draft version of at least one such guidance identified in plan and within 18 months from close of public comment period, issue a final/ revised guidance.
12/13/2021: requires FDA to issued patient experience guidance documents
FasterCures will periodically assess this item as appropriate. 20161213 12/13/2016 FDA, Guidances, Patient Engagement, Regulatory Affairs
fa fa-2x fa-check Title III — Development Subtitle A—Patient-Focused Drug Development Sec. 3003. Streamlining patient input. Exempts FDA from going through the Paperwork Reduction Act clearance process when requesting information from patients regarding their disease or treatments. Complete. 20161213 12/13/2016 FDA, Patient Engagement
fa fa-2x fa-long-arrow-right Title III — Development Subtitle A—Patient-Focused Drug Development Sec. 3004. Report on patient experience drug development. Requires FDA to periodically issue a report on FDA's use of patient experience data in regulatory decision-making, in particular with respect to the review of patient experience data and information on patient-focused drug development tools as part of approved applications. FasterCures will periodically assess this item as appropriate. 20161213 12/13/2016 FDA, Patient Engagement, Regulatory Affairs, Reports
fa fa-2x fa-long-arrow-right Title III — Development Subtitle B—Advancing New Drug Therapies Sec. 3011. Qualification of drug development tools. 12/13/2018: instructs FDA to convene a public meeting to solicit input on a new qualification process for biomarkers and other drug development tools.
12/13/2018: requires FDA to publish taxonomy on drug development tools for public comment. 1 year after close of comment period taxonomy must be finanlized.
12/13/2019: directs FDA to issue draft guidance on this qualification process.
12/13/2021: directs FDA to release a report which describes the use of, and success of, this new qualification process.
FasterCures will periodically assess this item as appropriate. 20161213 12/13/2016 FDA, Guidances, Medical Product Development, Regulatory Affairs, Reports
fa fa-2x fa-binoculars Title III — Development Subtitle B—Advancing New Drug Therapies Sec. 3012. Targeted drugs for rare diseases. Permits FDA to allow the sponsor of a drug or biologic application for a genetically targeted drug or variant protein targeted drug to rely on data for the same or similar technology from previously approved applications developed by the same sponsor. FasterCures will periodically assess this item as appropriate. 20161213 12/13/2016 FDA, Rare Disease, Regulatory Affairs
fa fa-2x fa-binoculars Title III — Development Subtitle B—Advancing New Drug Therapies Sec. 3013. Reauthorization of program to encourage treatments for rare pediatric diseases. Reauthorizes the pediatric rare disease priority review voucher program until 2020. FasterCures will periodically update based on the implementation and use of the voucher program. 20161213 12/13/2016 FDA, Medical Product Development, Rare Disease, Regulatory Affairs
fa fa-2x fa-long-arrow-right Title III — Development Subtitle B—Advancing New Drug Therapies Sec. 3014. GAO study of priority review voucher programs. 12/31/2020: requires GAO to issue report evaluating the three Priority Review Voucher (PRV) programs: Neglected Tropical Disease, Rare Pediatric Disease, and Medical Countermeasure. FasterCures will periodically assess this item as appropriate. 20161213 12/13/2016 FDA, GAO, Medical Countermeasures, Medical Product Development, Rare Disease, Regulatory Affairs
fa fa-2x fa-binoculars Title III — Development Subtitle B—Advancing New Drug Therapies Sec. 3015. Amendments to the Orphan Drug grants. Updates the Orphan Drug grant program to clarify that grants may be used for observational studies and other analyses to assist in the understanding of the natural history of a rare disease or condition. FasterCures will periodically assess this item as appropriate. 20161213 12/13/2016 Funding, HHS, Rare Disease
fa fa-2x fa-check Title III — Development Subtitle B—Advancing New Drug Therapies Sec. 3016. Grants for studying continuous drug manufacturing. Allows the FDA to issue grants to further the study of continuous manufacturing for drugs. Complete. 20161213 12/13/2016 FDA, Funding, Medical Product Development
fa fa-2x fa-long-arrow-right Title III — Development Subtitle C—Modern Trial Design And Evidence Development Sec. 3021. Novel clinical trial designs. 6/13/2018: directs FDA to host a public meeting to discuss the incorporation of complex adaptive and other novel trial designs into clinical protocols and new drug applications.

12/13/2019: requires FDA to issue draft guidance addressing the use of complex adaptive and other novel trial design in the development of new drugs or biologicals; within 1 year after the public comment period closes, FDA finalization of such guidance.
FasterCures will periodically assess this item as appropriate. 20161213 12/13/2016 Clinical Trials, FDA, Guidances, Medical Product Development, Regulatory Affairs
fa fa-2x fa-long-arrow-right Title III — Development Subtitle C—Modern Trial Design And Evidence Development Sec. 3022. Real world evidence. 12/13/2018: requires FDA to develop and begin to implement, a framework to evaluate the use of real world evidence to help support the approval a new indication for a for a previously approved drug, or to support post-approval study requirements.

12/13/2021: requires FDA to issue draft guidance based on implementation and use of RWE framework which describes circumstances where RWE may be relied upon and appropriate standards and methodologies for collection and analysis of RWE; by 18 months after the above comment period closes finalization of guidance.
FasterCures will periodically assess this item as appropriate. 20161213 12/13/2016 FDA, Guidances, Medical Product Development, Regulatory Affairs
fa fa-2x fa-long-arrow-right Title III — Development Subtitle C—Modern Trial Design And Evidence Development Sec. 3023. Protection of human research subjects. 12/13/2018: requires HHS to submit a report to Congress describing progress being made to harmonize differences between the human subject regulations under the Common Rule and the Federal Food Drug and Cosmetic Act.

12/13/2019: requires harmonization of these rules is to be completed.
FasterCures will periodically assess this item as appropriate. 20161213 12/13/2016 Clinical Trials, FDA, Health Citizenship, HHS, NIH, Research
fa fa-2x fa-binoculars Title III — Development Subtitle C—Modern Trial Design And Evidence Development Sec. 3024. Informed consent waiver or alteration for clinical investigations. Gives FDA the flexibility to waive or alter informed consent requirements for clinical trials with minimal risk. FasterCures will periodically assess this item as appropriate. 20161213 12/13/2016 Clinical Trials, FDA, Research
fa fa-2x fa-binoculars Title III — Development Subtitle D—Patient Access To Therapies And Information Sec. 3031. Summary level review. Permits FDA to rely upon qualified data summaries to support the approval of a supplemental application for a new indication of an already approved drug.
FasterCures will periodically assess the status of implementation and impact on research activities. 20161213 12/13/2016 -
fa fa-2x fa-binoculars Title III — Development Subtitle D—Patient Access To Therapies And Information Sec. 3032. Expanded access policy. 2/11/2017: Requires manufacturers with one or more investigational drugs for treatment of serious disease or conditions, to have publically accessible expanded access policies for these investigational drugs (60 days after enactment, or upon initiation of Phase 2/3 study).

This requirement to post compassionate use policies may explain a two-fold increase between September 2016 and March 2017, in the number of companies with posted policies as reported by Avalere Health. Full report available here.

20170327 03/27/2017 -
fa fa-2x fa-binoculars Title III — Development Subtitle D—Patient Access To Therapies And Information Sec. 3033. Accelerated approval for regenerative advanced therapies. Authorizes FDA to designate certain products as Regenerative Medicine Advanced Therapies, making them eligible for increased and earlier interactions with FDA.

FDA has articulated the eligibility criteria for a drug to receive RMAT designation and the process to submit a request. For more, please see this March 21, 2017 FDA voice blog post.

CBER Director reflects on how RMAT designation will speed approval at the May 2017, Food & Drug Law Institute Annual Conference. (See more here

 

20170508 05/08/2017 Regenerative Medicine
fa fa-2x fa-long-arrow-right Title III — Development Subtitle D—Patient Access To Therapies And Information Sec. 3034. Guidance regarding devices used in the recovery, isolation, or delivery of regenerative advanced therapies. 12/13/2017: requires issuance of draft guidance clarifying how, in the context of regenerative advanced therapies, the Secretary will evaluate devices used in the recovery, isolation, or delivery of regenerative advanced therapies.

FasterCures will periodically assess this item as appropriate.

20161213 12/13/2016 Regenerative Medicine
fa fa-2x fa-long-arrow-right Title III — Development Subtitle D—Patient Access To Therapies And Information Sec. 3035. Report on regenerative advanced therapies. 3/1/2017 (and every year thereafter): requires HHS to submit a report to Congress on the number and type of applications for regenerative advanced therapies.
FasterCures will periodically assess this item as appropriate. 20161213 12/13/2016 FDA, Regenerative Medicine, Regulatory Affairs
fa fa-2x fa-long-arrow-right Title III — Development Subtitle D—Patient Access To Therapies And Information Sec. 3036. Standards for regenerative medicine and regenerative advanced therapies. 12/13/2017: instructs HHS to review regulations and guidance relevant to regenerative advanced therapies; and, through a public process, update such regulations and guidance as the Secretary determines appropriate.
FasterCures will periodically assess this item as appropriate. 20161213 12/13/2016 FDA, Guidances, Regenerative Medicine, Regulatory Affairs
fa fa-2x fa-binoculars Title III — Development Subtitle D—Patient Access To Therapies And Information Sec. 3037. Health care economic information. Clarifies the scope of permissible manufacturer communications regarding health care economic information to certain entities.
FasterCures will periodically assess this item as appropriate. 20161213 12/13/2016 FDA
fa fa-2x fa-long-arrow-right Title III — Development Subtitle D—Patient Access To Therapies And Information Sec. 3038. Combination product innovation. Contains a number of elements designed to improve the regulation and review of combination products, including issuing guidance by 12/13/2020 that describes the process for managing pre-submission interactions, best practices for ensuring that feedback represents FDA's best advice, and information on meetings between the sponsor and FDA. FasterCures will periodically assess this item as appropriate. 20161213 12/13/2016 FDA, Guidances, Regulatory Affairs
fa fa-2x fa-long-arrow-right Title III — Development Subtitle E—Antimicrobial Innovation And Stewardship Sec. 3041. Antimicrobial resistance monitoring. 12/13/2017, and annually thereafter: requires FDA and CDC to issue reports addressing national trends in antimicrobial use and resistance to those drugs.
FasterCures will periodically assess this item as appropriate. 20161213 12/13/2016 CDC, FDA, HHS, Infectious Disease, Reports
fa fa-2x fa-long-arrow-right Title III — Development Subtitle E—Antimicrobial Innovation And Stewardship Sec. 3042. Limited population pathway. Creates a new pathway for FDA to approve antibacterial and antifungal drugs based for limited populations, using a benefit-risk profile specific to that population.
6/13/2018: requires FDA to issue draft guidance describing this pathway and related processes.
At least every 2 years, FDA must report to Congress on the applications and approvals under this program.
12/31/2021: requires GAO issuance of a report on this program.
FasterCures will periodically assess this item as appropriate. 20161213 12/13/2016 FDA, GAO, Infectious Disease, Regulatory Affairs, Reports
fa fa-2x fa-check Title III — Development Subtitle E—Antimicrobial Innovation And Stewardship Sec. 3043. Prescribing authority. Clarifies that nothing in this section restricts the authority of healthcare providers to prescribe antimicrobial drugs or products. In effect upon enactment.
Complete. 20161213 12/13/2016 FDA, Infectious Disease
fa fa-2x fa-long-arrow-right Title III — Development Subtitle E—Antimicrobial Innovation And Stewardship Sec. 3044. Susceptibility test interpretive criteria for microorganisms; antimicrobial susceptibility testing devices. 12/13/2017: instructs FDA to establish and regularly maintain a website that lists appropriate interpretive criteria standards for antimicrobial drug susceptibility assays.
12/13/2018: requires FDA to submit a report to Congress on implementation of this provision.


FasterCures will periodically assess this item as appropriate. 20161213 12/13/2016 FDA, Infectious Disease, Regulatory Affairs, Reports
fa fa-2x fa-long-arrow-right Title III — Development Subtitle F—Medical Device Innovations Sec. 3051. Breakthrough devices. 12/13/2017: requires FDA to issue guidance on the implementation of the medical device review pathway established by this provision.
1/1/2019: requires FDA to issue a report to Congress on the new medical device review pathway and opportunities for improvement.
FasterCures will periodically assess this item as appropriate. 20161213 12/13/2016 FDA, Medical Devices, Regulatory Affairs
fa fa-2x fa-long-arrow-right Title III — Development Subtitle F—Medical Device Innovations Sec. 3052. Humanitarian device exemption. 6/13/2018: requires FDA to issue a guidance document define "probable benefit" in the context of the humanitarian device exemption.
FasterCures will periodically assess this item as appropriate. 20161213 12/13/2016 FDA, Guidances, Medical Devices, Regulatory Affairs
fa fa-2x fa-long-arrow-right Title III — Development Subtitle F—Medical Device Innovations Sec. 3053. Recognition of standards. Instructs FDA to review and update its guidance on submission and evaluation of independent standards for medical device review.
FasterCures will periodically assess this item as appropriate. 20161213 12/13/2016 FDA, Guidances, Medical Devices, Regulatory Affairs
fa fa-2x fa-long-arrow-right Title III — Development Subtitle F—Medical Device Innovations Sec. 3054. Certain class I and class II devices. 3/13/2017 (and every 5 years thereafter), instructs FDA to publish in the Federal Register a notice that contains Class II devices exempt from reporting requirements due to low risk; followed by 60 day public comment period. Final list published 7/11/2017.
4/12/2017 (and every 5 years thereafter): instructs FDA to provide a list of Class I devices exempt from reporting requirements due to low risk.

April 13, 2017, FDA issued a notice in the Federal Register identifying a list of class I devices that are now exempt from premarket notification requirements, subjects to certain eliminations. FDA's action will decrease regulatory burdens on the medical device industry and will eliminate private costs and expenditures required to comply with certain Federal regulation.

March 14, 2017, FDA issued a notice in the Federal Register identifying more than 1,000 medical class II devices it is proposing to exempt or partially exempt from the premarket review process. A 60-day comment period is now open, after which FDA may narrow or expand this list.

20170413 04/13/2017 FDA, Medical Devices, Regulatory Affairs
fa fa-2x fa-long-arrow-right Title III — Development Subtitle F—Medical Device Innovations Sec. 3055. Classification panels. Requires FDA to provide an annual opportunity for stakeholders to provide recommendations for individuals with appropriate expertise to fill voting member positions on medical device classification panels
FasterCures will periodically assess this item as appropriate. 20161213 12/13/2016 FDA, Medical Devices, Regulatory Affairs
fa fa-2x fa-check Title III — Development Subtitle F—Medical Device Innovations Sec. 3056. Institutional review board flexibility. Removes the requirement that a sponsor of medical device trial use a local institutional review board. In effect upon enactment.
Complete. 20161213 12/13/2016 FDA, Medical Devices, Regulatory Affairs
fa fa-2x fa-long-arrow-right Title III — Development Subtitle F—Medical Device Innovations Sec. 3057. CLIA waiver improvements. 12/13/2017: instructs CMS to issue draft guidance on CLIA waiver improvements, and issuance of final guidance within one year after comment period closes.
FasterCures will periodically assess this item as appropriate. 20161213 12/13/2016 CMS, FDA, Guidances, Medical Devices, Regulatory Affairs
fa fa-2x fa-long-arrow-right Title III — Development Subtitle F—Medical Device Innovations Sec. 3058. Least burdensome device review. 6/13/2018: requires FDA to conduct an audit on training and use of least burdensome requirements during review of medical devices.
FasterCures will periodically assess this item as appropriate. 20161213 12/13/2016 FDA, Medical Devices, Regulatory Affairs
fa fa-2x fa-long-arrow-right Title III — Development Subtitle F—Medical Device Innovations Sec. 3059. Cleaning instructions and validation data requirement. 6/11/2017: requires HHS to identify and publish of a list of reusable medical devices that require additional instruction on, and validation of, proper cleaning and disinfection procedures.
FasterCures will periodically assess this item as appropriate. 20161213 12/13/2016 FDA, Medical Devices, Regulatory Affairs
fa fa-2x fa-long-arrow-right Title III — Development Subtitle F—Medical Device Innovations Sec. 3060. Clarifying medical software regulation. 12/13/2018 (and every two years thereafter): requires HHS issuance of a report on the current state of health-related software and the regulation of those products.
FasterCures will periodically assess this item as appropriate. 20161213 12/13/2016 FDA, Health IT, Regulatory Affairs, Reports
fa fa-2x fa-long-arrow-right Title III — Development Subtitle G—Improving Scientific Expertise And Outreach At FDA Sec. 3071. Silvio O. Conte Senior Biomedical Research and Biomedical Product Assessment Service. 12/13/2020: requires GAO submission to Congress of a report on the effect of these amendments to HHS hiring authorities.

Plans to reduce the size of the Federal workforce may adversely impact FDA. Read our blog on FDA Workforce Issues 

20170314 03/14/2017 FDA, GAO, HHS, NIH, Reports, Workforce
fa fa-2x fa-long-arrow-right Title III — Development Subtitle G—Improving Scientific Expertise And Outreach At FDA Sec. 3072. Hiring authority for scientific, technical, and professional personnel. 6/13/2018: requires FDA submission to Congress of a report on workforce needs and planning.
1/1/2022: requires GAO issuance of a report on FDA progress to recruit and retain staff.

Plans to reduce the size of the Federal workforce may adversely impact FDA. Read our blog on FDA Workforce Issues 

20170314 03/14/2017 FDA, GAO, Reports, Workforce
fa fa-2x fa-long-arrow-right Title III — Development Subtitle G—Improving Scientific Expertise And Outreach At FDA Sec. 3073. Establishment of Food and Drug Administration Intercenter Institutes. 12/13/2017: requires FDA establishment of at least one Intercenter Institute.

On January 19, 2017, Commissioner Califf announced the formation of the Oncology Center of Excellence and named Richard Pazdur as its director.  The FDA allocated $3.6 million of existing agency funds to establish the OCE. However, a drafting error in sec. 1001(b)(3)(A) may prevent FDA from receiving an additional $75 million to fund the OCE. (Read more here and here).

20170119 01/19/2017 FDA, Regulatory Affairs
fa fa-2x fa-long-arrow-right Title III — Development Subtitle G—Improving Scientific Expertise And Outreach At FDA Sec. 3074. Scientific engagement. 12/29/2017: Improves NIH and FDA scientist's ability to attend scientific conferences to promote professional development. Not later than 90 days after the end of the fiscal year, each operating division of HHS is required to prepare, and post online, an annual report on scientific meeting attendance and related travel spending for each fiscal year.

FasterCures will periodically assess this item as appropriate. For more details on how we think this provision can positively impact FDA workforce, see our memo: “Strengthening FDA’s Workforce: Opportunities for Action.” 

20170310 03/10/2017 HHS, Workforce
fa fa-2x fa-long-arrow-right Title III — Development Subtitle G—Improving Scientific Expertise And Outreach At FDA Sec. 3075. Drug surveillance. Makes targeted edits to FDA Drug Surveillance program to allow FDA to focus on risk.
FasterCures will periodically assess this item as appropriate. 20161213 12/13/2016 FDA
fa fa-2x fa-binoculars Title III — Development Subtitle G—Improving Scientific Expertise And Outreach At FDA Sec. 3076. Reagan-Udall Foundation for the Food and Drug Administration. Makes key updates to Reagan-Udall Foundation.
FasterCures will periodically assess this item as appropriate. 20161213 12/13/2016 FDA
fa fa-2x fa-long-arrow-right Title III — Development Subtitle H—Medical Countermeasures Innovation Sec. 3081. Medical countermeasure guidelines. 3/1/2017 (and each year thereafter in which there is less that $1.5 billion available for procurement of medical countermeasures): requires HHS to deliver a report to Congress describing the impact this may have on national security needs.

No public information on this provision is available on the website of the HHS Assistant Secretary for Preparedness and Response. FasterCures is reaching out to HHS and Congressional stakeholders to determine if there is any information on this report to Congress that can be made available to the public

20170314 03/14/2017 Funding, HHS, Medical Countermeasures, Reports
fa fa-2x fa-binoculars Title III — Development Subtitle H—Medical Countermeasures Innovation Sec. 3082. Clarifying BARDA contracting authority. Clarifies that the contracting authority for procurement of medical countermeasures using the "special reserve fund" resides within BARDA. In effect upon enactment.
FasterCures will periodically assess this item as appropriate. 20161213 12/13/2016 BARDA, HHS, Medical Countermeasures
fa fa-2x fa-long-arrow-right Title III — Development Subtitle H—Medical Countermeasures Innovation Sec. 3083. Countermeasure budget plan. 3/14/2017, and every year thereafter: requires HHS to deliver to Congress of a coordinated 5-year budget plan for medical countermeasure development and procurement; and be made publicly available in a manner that does not compromise national security.

A new 5-year budget plan is not publicly available on the website of the HHS Assistant Secretary for Preparedness and Response (ASPR). ASPR’s FY17 “Budget in Brief” document is available, but is likely out of date. FasterCures is reaching out to HHS and Congressional stakeholders to determine if there is any information that can be made available to the public.

20170314 03/14/2017 HHS, Medical Countermeasures
fa fa-2x fa-long-arrow-right Title III — Development Subtitle H—Medical Countermeasures Innovation Sec. 3084. Medical countermeasures innovation. 12/13/2020: requires GAO publication of a review of medical countermeasure innovation program established by this provision. The program will sunset on 9/30/2022.
FasterCures will periodically assess this item as appropriate. 20161213 12/13/2016 BARDA, GAO, HHS, Medical Countermeasures, Medical Product Development, Reports
fa fa-2x fa-check Title III — Development Subtitle H—Medical Countermeasures Innovation Sec. 3085. Streamlining Project BioShield procurement. Further tracking not required. In effect upon enactment.
Complete. 20161213 12/13/2016 BARDA, HHS
fa fa-2x fa-long-arrow-right Title III — Development Subtitle H—Medical Countermeasures Innovation Sec. 3086. Encouraging treatments for agents that present a national security threat. Establishes a Priority Review Voucher program at FDA to incentivize the development of medical countermeasures; sunsets 10/1/2023.

FasterCures will periodically assess this item as appropriate. 20161213 12/13/2016 FDA, Medical Countermeasures, Regulatory Affairs
fa fa-2x fa-check Title III — Development Subtitle H—Medical Countermeasures Innovation Sec. 3087. Paperwork Reduction Act waiver during a public health emergency. Waives Paperwork Reduction Act during a public health emergency.
Complete. 20161213 12/13/2016 HHS
fa fa-2x fa-check Title III — Development Subtitle H—Medical Countermeasures Innovation Sec. 3088. Clarifying Food and Drug Administration emergency use authorization. Clarifies Food and Drug Administration emergency use authorization.
Complete. 20161213 12/13/2016 FDA, Medical Countermeasures, Regulatory Affairs
fa fa-2x fa-binoculars Title III — Development Subtitle I—Vaccine Access, Certainty, And Innovation Sec. 3091. Predictable review timelines of vaccines by the Advisory Committee on Immunization Practices. Provides predictable review timelines of vaccines by the Advisory Committee on Immunization Practices. FasterCures will periodically assess this item as appropriate. 20161213 12/13/2016 CDC, Infectious Disease, Vaccines
fa fa-2x fa-long-arrow-right Title III — Development Subtitle I—Vaccine Access, Certainty, And Innovation Sec. 3092. Review of processes and consistency of Advisory Committee on Immunization Practices recommendations. 6/13/2018: requires CDC submission to Congress of a report on decision-making processes used by the Advisory Committee on Immunization Practices and opportunities for improvement. FasterCures will periodically assess this item as appropriate. 20161213 12/13/2016 CDC, Infectious Disease, Reports
fa fa-2x fa-long-arrow-right Title III — Development Subtitle I—Vaccine Access, Certainty, And Innovation Sec. 3093. Encouraging vaccine innovation. 12/13/2017: requires HHS to submit a report to Congress on promoting innovation in infectious disease vaccine development.

The National Vaccine Advisory Committee 2017 meeting on June 6 and June 7 with include an update on the the Secretary of the Department of Health and Human Services' report on vaccine innovation required by this section and other themes related to encouraging vaccine innovation. Information on the final meeting agenda will be posted prior to the meeting on the NVAC website.

20170417 04/17/2017 BARDA, CDC, FDA, HHS, Infectious Disease, NIH, Reports, Vaccines
fa fa-2x fa-check Title III — Development Subtitle J—Technical Corrections Sec. 3101. Technical corrections. Further tracking not required. In effect upon enactment. Complete. 20161213 12/13/2016 FDA
fa fa-2x fa-check Title III — Development Subtitle J—Technical Corrections Sec. 3102. Completed studies. Strikes studies from the law that have been completed. Complete. 20161213 12/13/2016 FDA
fa fa-2x fa-long-arrow-right Title IV — Delivery - Sec. 4001. Assisting doctors and hospitals in improving quality of care for patients. 6/13/2017: requires ONC issuance of a report on the Medicare and Medicaid EHR Meaningful Use Incentive program.
6/13/2018: requires ONC issuance of recommendation for a voluntary certification program for health IT use in pediatric settings.
12/13/2018: requires ONC adoption of certification criteria for a voluntary certification program for health IT use in pediatric settings.
12/13/2018: requires HHS issuance of a strategy and recommendations for improving patient care and reducing the administrative burden of electronic health record use by medical professionals.
FasterCures will periodically assess this item as appropriate. 20161213 12/13/2016 Health IT, HHS, ONC, Reports
fa fa-2x fa-long-arrow-right Title IV — Delivery - Sec. 4002. Transparent reporting on usability, security, and functionality. 12/13/2017: requires ONC promulgation of a rule updating the health IT certification program to include new requirements for interoperability.
12/13/2017: requires HHS awarding of grants, contracts, or agreements to independent entities on a competitive basis to support the convening of stakeholders as described in subsection (a)(2), collect the information required to be reported in accordance with the criteria established as described subsection (a)(3), and develop and implement a process in accordance with paragraph (5) and report such information to the Secretary.
FasterCures will periodically assess this item as appropriate. 20161213 12/13/2016 Health IT, Interoperability, ONC, Regulatory Affairs
fa fa-2x fa-long-arrow-right Title IV — Delivery - Sec. 4003. Interoperability. 6/13/2017: requires ONC to convene appropriate public and private stakeholders to develop or support a trusted exchange framework for trust policies and practices and for a common agreement for exchange between health information networks.
6/13/2018: requires ONC publication of health IT trusted exchange framework and common agreement.
6/13/2019: requires ONC publication of health IT networks that have adopted the trusted exchange framework common agreement. To be updated annually thereafter.
6/13/2019: requires HHS, directly or through a partnership with a private entity, to establish a provider digital contact information index to provide digital contact information for health professionals and health facilities.
Not later than 30 days after the date on which the Health IT (HIT) Advisory Committee first meets, the committee will establish and publish a schedule for assessing relevant health IT issues. The schedule will be updated annually. (The HIT Advisory Committee consolidates the pre-existing HIT Policy Committee and the HIT Standards Committee.)

The Government and Accountability Office (GAO) is accepting nominations for the new Health Information Technology Advisory Committee. GAO is responsible for 14 of the 25 seats, with the responsability for the remaining falling to other parts of the government. 

20170323 03/23/2017 Health IT, Interoperability, ONC
fa fa-2x fa-binoculars Title IV — Delivery - Sec. 4004. Information blocking. HHS is directed, through rule-making, to determine activities that do not constitute information blocking, and therefore are not subject to penalties established by this section. (No date provided in law.) FasterCures will periodically assess this item as appropriate. 20161213 12/13/2016 Health IT, HHS, Interoperability, ONC, Regulatory Affairs
fa fa-2x fa-long-arrow-right Title IV — Delivery - Sec. 4005. Leveraging electronic health records to improve patient care. 12/13/2020: requires HHS submission to Congress, a report concerning best practices of patient safety organizations to improve the integration of health information technology into clinical practice. FasterCures will periodically assess this item as appropriate. 20161213 12/13/2016 Health IT, ONC, Reports
fa fa-2x fa-long-arrow-right Title IV — Delivery - Sec. 4006. Empowering patients and improving patient access to their electronic health information. Requires HHS issuance of guidance to health information exchanges on best practices to ensure that patient data is private, secure, accurate, and able to be shared when appropriate. FasterCures will periodically assess this item as appropriate. 20161213 12/13/2016 Guidances, Health IT, HHS, Interoperability, ONC
fa fa-2x fa-long-arrow-right Title IV — Delivery - Sec. 4007. GAO study on patient matching. 12/13/2017: requires GAO issue a study on matching patient identities to their health information - and protection of their privacy - by electronic health records and other health IT products. FasterCures will periodically assess this item as appropriate. 20161213 12/13/2016 GAO, Health IT, ONC, Reports
fa fa-2x fa-long-arrow-right Title IV — Delivery - Sec. 4008. GAO study on patient access to health information. 6/13/2018: requires GAO submission of a report to Congress on the findings of the study conducted  FasterCures will periodically assess this item as appropriate. 20161213 12/13/2016 GAO, Health IT, Reports
fa fa-2x fa-long-arrow-right Title IV — Delivery - Sec. 4009. Improving Medicare local coverage determinations. 6/13/2017: requires each Medicare administrative contractor must start publishing their local coverage determinations with explanations. FasterCures will periodically assess this item as appropriate. 20161213 12/13/2016 CMS
fa fa-2x fa-long-arrow-right Title IV — Delivery - Sec. 4010. Medicare pharmaceutical and technology ombudsman. 12/13/2017: requires HHS to establish a pharmaceutical and technology ombudsman.

FasterCures will periodically assess this item as appropriate.

20161213 12/13/2016 CMS, Health IT
fa fa-2x fa-long-arrow-right Title IV — Delivery - Sec. 4011. Medicare site-of-service price transparency. For 2018 and each year thereafter, requires HHS publishing data on Medicare payments made to ambulatory outpatient departments and outpatient surgical centers, and the liability of individual beneficiaries for those procedures. FasterCures will periodically assess this item as appropriate. 20161213 12/13/2016 CMS, HHS
fa fa-2x fa-long-arrow-right Title IV — Delivery - Sec. 4012. Telehealth services in Medicare. 12/13/2017: requires CMS to provide information to Congress on use of telehealth services by Medicare. FasterCures will periodically assess this item as appropriate. 20161213 12/13/2016 CMS, Health IT
fa fa-2x fa-check Title V — Savings - Sec. 5001. Savings in the Medicare Improvement Fund. Further tracking not required. Complete. 20161213 12/13/2016 CMS
fa fa-2x fa-check Title V — Savings - Sec. 5002. Medicaid reimbursement to States for durable medical equipment. Further tracking not required. Complete. 20161213 12/13/2016 CMS
fa fa-2x fa-circle-thin Title V — Savings - Sec. 5003. Penalties for violations of grants, contracts, and other agreements. FasterCures does not plan on tracking the implementation of this provision at this time. FasterCures does not plan on tracking the implementation of this provision at this time. 20161213 12/13/2016 CMS
fa fa-2x fa-circle-thin Title V — Savings - Sec. 5004. Reducing overpayments of infusion drugs. FasterCures does not plan on tracking the implementation of this provision at this time. FasterCures does not plan on tracking the implementation of this provision at this time. 20161213 12/13/2016 CMS
fa fa-2x fa-circle-thin Title V — Savings - Sec. 5005. Increasing oversight of termination of Medicaid providers. FasterCures does not plan on tracking the implementation of this provision at this time. FasterCures does not plan on tracking the implementation of this provision at this time. 20161213 12/13/2016 CMS
fa fa-2x fa-circle-thin Title V — Savings - Sec. 5006. Requiring publication of fee-for-service provider directory. FasterCures does not plan on tracking the implementation of this provision at this time. FasterCures does not plan on tracking the implementation of this provision at this time. 20161213 12/13/2016 CMS
fa fa-2x fa-check Title V — Savings - Sec. 5007. Fairness in Medicaid supplemental needs trusts. Further tracking not required. Complete. 20161213 12/13/2016 CMS
fa fa-2x fa-check Title V — Savings - Sec. 5008. Eliminating Federal financial participation with respect to expenditures under Medicaid for agents used for cosmetic purposes or hair growth. Further tracking not required. Complete. 20161213 12/13/2016 CMS
fa fa-2x fa-check Title V — Savings - Sec. 5009. Amendment to the Prevention and Public Health Fund. Further tracking not required. Complete. 20161213 12/13/2016 -
fa fa-2x fa-check Title V — Savings - Sec. 5010. Strategic Petroleum Reserve drawdown. Further tracking not required. Complete. 20161213 12/13/2016 -
fa fa-2x fa-check Title V — Savings - Sec. 5011. Rescission of portion of ACA territory funding. Further tracking not required. Complete. 20161213 12/13/2016 -
fa fa-2x fa-check Title V — Savings - Sec. 5012. Medicare coverage of home infusion therapy. Further tracking not required. Complete. 20161213 12/13/2016 CMS