scholarly journals Accelerating Advances in Cancer Care Research: A Lookback at the 21st Century Cures Act in 2020

2021 ◽  
Vol 19 (4) ◽  
pp. 378-384
Author(s):  
Leigh Gallo ◽  
Ronald S. Walters ◽  
Jeff Allen ◽  
Jenny Ahlstrom ◽  
Clay Alspach ◽  
...  

The 21st Century Cures Act (Cures Act), signed into law in 2016, was designed to advance new therapies by modernizing clinical trials, funding research initiatives, and accelerating the development and use of health information technology. To analyze the current issues in cancer care related to the implementation and impact of the Cures Act, NCCN convened a multistakeholder working group. Participants discussed the legislation’s impact on the oncology community since enactment and identified the remaining gaps and challenges as experienced by stakeholders. In June 2020, the policy recommendations of the working group were presented at the virtual NCCN Policy Summit: Accelerating Advances in Cancer Care Research: A Lookback at the 21st Century Cures Act in 2020. The summit consisted of informative discussions and a multistakeholder panel to explore the recommendations and the future of the Cures Act. This article explores identified policy recommendations from the NCCN Working Group and the NCCN Policy Summit, and analyzes opportunities to advance innovative cancer care and patient access to data.

2018 ◽  
Vol 25 (9) ◽  
pp. 1218-1220 ◽  
Author(s):  
Carolyn T Lye ◽  
Howard P Forman ◽  
Jodi G Daniel ◽  
Harlan M Krumholz

Abstract While federal regulation provides patients the right to access their electronic health records and promotes increased use of health information technology, patient access to electronic health records remains limited. The 21st Century Cures Act, signed into law over a year ago, has important provisions that could significantly improve access and availability of health data. Specifically, the provisions call for partnerships among health information exchange networks, educational and research initiatives, and health information technology certification requirements that encourage interoperability. The article reviews the potential benefits and concerns regarding implementation of these provisions, particularly the difficulty of aligning incentives and requirements for data sharing and the question of whether currently proposed rules and guidance will support the goal of improved patient access and health information exchange. Researchers, clinicians, and patients have the power to advocate for improved patient access and interoperability as policy development and implementation of the 21st Century Cures Act continues.


2021 ◽  
Author(s):  
Charlotte Blease ◽  
Liz Salmi ◽  
Maria Hagglund ◽  
Deborah Wachenheim ◽  
Catherine DesRoches

UNSTRUCTURED From April 5, 2021, as part of the 21st Century Cures Act, all providers in the US must offer patients access to the medical information housed in their electronic records. Via secure health portals, patients can login to access lab and test results, lists of prescribed medications, referral appointments, and the narrative reports written by clinicians (so-called ‘open notes’). As US providers implement this practice innovation, we describe six promising ways in which patient access to their notes might help address problems that either emerged with, or were exacerbated, by the COVID-19 pandemic


2017 ◽  
Vol 45 (S2) ◽  
pp. 39-41
Author(s):  
Nathan Cortez

The market can produce skewed information about investigational products awaiting FDA approval. But the FDA rarely steps in to correct such misleading information, despite statutory authority to do so. This article evaluates a recommendation by the FDA Transparency Working Group that FDA more clearly signal when and how it will correct misleading information about investigational products, and why such a recommendation is particularly important after the 21st Century Cures Act.


2019 ◽  
Vol 17 (5) ◽  
pp. 424-431
Author(s):  
Katy Winckworth-Prejsnar ◽  
James McCanney ◽  
Alyssa A. Schatz ◽  
Warren Smedley ◽  
Leonidas C. Platanias ◽  
...  

Multiple factors are forcing the healthcare delivery system to change. A movement toward value-based payment models is shifting these systems to team-based integration and coordination of care for better efficiencies and outcomes. Workforce shortages are stressing access and quality of care for patients with cancer and survivors, and their families and caregivers. Innovative therapies are expensive, forcing payers and employers to prioritize resources. Patients are advocating for care models centered on their needs rather than those of providers. In response, payment policies have recently focused on the promotion of alternative payment models that incentivize coordinated, high-quality care with consideration for value and controlling the increasing overall costs associated with cancer and its treatment. Given the multitude of factors confounding cancer care, NCCN convened a multistakeholder working group to examine the challenges and opportunities presented by changing paradigms in cancer care delivery. The group identified key challenges and developed policy recommendations to address 4 high-visibility topics in cancer care delivery. The findings and recommendations were then presented at the NCCN Policy Summit: Policy Challenges and Opportunities to Address Changing Paradigms in Cancer Care Delivery in September 2018, and multistakeholder roundtable panel discussions explored these findings and recommendations along with additional items. This article encapsulates the discussion from the NCCN Working Group meetings and the NCCN Policy Summit, including multistakeholder policy recommendations on delivery issues in cancer care designed to help inform national policies moving forward.


2021 ◽  
Vol 68 (2) ◽  
pp. 426-428
Author(s):  
Jennifer Carlson ◽  
Rachel Goldstein ◽  
Kim Hoover ◽  
Nichole Tyson

2003 ◽  
Vol 14 (2) ◽  
pp. 89-98 ◽  
Author(s):  
Angela J Robinson ◽  
Karen Rogstad

Genitourinary medicine services are expected to modernize in order to meet the needs of the NHS in the 21st century. Although increased funding is essential, there is a need for services to look at new ways of delivering care in order to deal with the increasing rate of sexually transmitted infections (STIs) including HIV in the community. This must include a review of skill-mix and roles. Some changes may appear to lower the quality of service. There must be auditing of changes to ensure that standards are not lowered. A short-lived working group was put together at the request of the RCP joint speciality committee for GUM consisting of representatives from diverse GUM clinics which have all been involved in extensive modernization of their service in order to meet demand. This report does not hold all the answers but provides suggestions for clinics wishing to initiate change. Changes must be appropriate to the local population and access pressures. More extreme measures may only be appropriate in the most severely stretched clinics and with consideration of measuring outcomes.


2016 ◽  
Vol 44 (2) ◽  
pp. 352-358 ◽  
Author(s):  
Mark A. Rothstein

The HIPAA Privacy Rule is notoriously weak because of its incomplete coverage, numerous exclusions and exemptions, and limited rights for individuals. The three areas in which it provides the most protection are fundraising, marketing, and research. Provisions of the 21st Century Cures Act, pending in Congress, and the Notice of Proposed Rulemaking to amend the federal research regulations (Common Rule), awaiting final regulatory action, would weaken the privacy protections for research. If these measures are adopted, the HIPAA Privacy Rule would have so little value that it might not be worth the aggravation and burden.


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