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)

Status Section Tracked Deadlines and Requirements Update Date of Update Tags
fa fa-2x fa-long-arrow-right 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 CLIA waiver improvements. 12/13/2017: instructs CMS to issue draft guidance on CLIA waiver improvements, and issuance of final guidance within one year after comment period closes.

11/29/2017: FDA announced the availability of the draft guidance entitled “Select Updates for Recommendations for Clinical Laboratory Improvement Amendments of 1988 (CLIA) Waiver Applications for Manufacturers of In Vitro Diagnostic Devices.” Comments on the draft guidance must be submitted by 1/29/2018. .

20171129 11/29/2017 CMS, FDA, Guidances, Medical Devices, Regulatory Affairs
fa fa-2x fa-check Sec. 4010. Medicare pharmaceutical and technology ombudsman. 12/13/2017: requires HHS to establish a pharmaceutical and technology ombudsman.

2/12/2018: CMS announced James Bailey is currently serving as the new Medicare Pharmaceutical and Technology Ombudsman. 

20180212 02/12/2018 CMS, Health IT
fa fa-2x fa-check Sec. 4012. Telehealth services in Medicare. 12/13/2017: requires CMS to provide information to Congress on use of telehealth services by Medicare.

2/15/2018: Medicare published updated Medicare Learning Network (MLN) Booklet on Telehealth Services

2/9/2018: Congress passes the Bipartisan Budget Act including landmark support for telemedicine in Medicare. Specific sections on the topic: Sec. 50323. Increasing convenience for Medicare Advantage enrollees through telehealth.Sec. 50324. Providing accountable care organizations the ability to expand the use of telehealth., and; Sec. 50325. Expanding the use of telehealth for individuals with stroke.

11/15/2017: The Congressional Research Service published a report, "Telehealth Services Proposed for Medicare Part B Reimbursements, 2018: Fact Sheet"

6/15/2017: MedPac issued the June 2017 Report to the Congress: Medicare and the Health Care Delivery System. It includes some reference to telehealth.

Other resources relating to CMS telehealth services include:

20180215 02/15/2018 CMS, Health IT
fa fa-2x fa-long-arrow-right Sec. 4011. Medicare site-of-service price transparency. For 2018 and each year thereafter, requires HHS publishing data on a searchable Internet website related to Medicare payments made to ambulatory outpatient departments and outpatient surgical centers, and the liability of individual beneficiaries for those procedures.

7/31/2018: The Centers for Medicare and Medicaid announced that they will make available a website that provides comparison information between the OPPS and ASC payment and copayment rates.

7/20/2017: The Centers for Medicare and Medicaid announced their plan to establish the searchable Web site required by this section. CMS will provide details regarding the Web site will be issued through the subregulatory process and anticipates that the Web site will be made available in early CY 2018.

20180731 07/31/2018 CMS, HHS
fa fa-2x fa-long-arrow-right Sec. 4009. Improving Medicare local coverage determinations. 6/13/2017: requires Medicare Administrative Contractors (MACs) to publish a summary of evidence it considered when developing a local coverage determination (LCD).

FasterCures will periodically assess this item as appropriate.

20161213 12/13/2016 CMS
fa fa-2x fa-check Sec. 5012. Medicare coverage of home infusion therapy. Further tracking not required.

Complete.

20161213 12/13/2016 CMS
fa fa-2x fa-check Sec. 5004. Reducing overpayments of infusion drugs. Changes the payment methodology for DME infusion drugs.

7/21/2017: CMS provided detail on how it would implement the changes in payment methodology for DME infusion drugs required by this section.

20170721 07/21/2017 CMS
fa fa-2x fa-check Sec. 5003. Penalties for violations of grants, contracts, and other agreements. FasterCures will periodically assess this item as appropriate.

Further tracking not required. In effect upon enactment.

20161213 12/13/2016 CMS
fa fa-2x fa-check Sec. 5001. Savings in the Medicare Improvement Fund. Further tracking not required.

Complete.

20161213 12/13/2016 CMS
fa fa-2x fa-check 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 Sec. 5007. Fairness in Medicaid supplemental needs trusts. Further tracking not required.

Complete.

20161213 12/13/2016 CMS
fa fa-2x fa-binoculars Sec. 5006. Requiring publication of fee-for-service provider directory. FasterCures will periodically assess this item as appropriate.

Fee-for-service Provider Directory available here

20170101 01/01/2017 CMS
fa fa-2x fa-binoculars Sec. 5005. Increasing oversight of termination of Medicaid providers. FasterCures will periodically assess this item as appropriate.

FasterCures will periodically assess this item as appropriate. 

20161213 12/13/2016 CMS
fa fa-2x fa-check Sec. 5002. Medicaid reimbursement to States for durable medical equipment. Further tracking not required.

Complete.

20161213 12/13/2016 CMS

 

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