ASCO sent a letter to U.S. House of Representatives Speaker John Boehner [R-OH] and Minority Leader Nancy Pelosi [D-CA] encouraging the advancement of H.R. 6, the 21st Century Cures Act. The bill is the result of a yearlong effort by the House Energy & Commerce Committee to bring forward legislation that will accelerate the discovery, development, and delivery of promising new treatments to patients.
In the letter, ASCO commends the work of the House Energy and Commerce Committee and supports many of the provisions in the legislation.
ASCO is also encouraged that H.R. 6 will help foster big data advancements like ASCO’s CancerLinQ™, a cutting-edge health information technology (HIT) platform that will revolutionize how we care for people with cancer. However, the Society also noted in the letter that these advancements will be unable to reach their potential to improve patient care if the impediments of lack of interoperability of Electronic Health Records (EHRs) and information blocking are not quickly and adequately addressed. The legislation takes an important step inaddressing these issues, but concerns remain that as written, the legislation may place burdens on physician practices.
“It cannot be overstated that the current lack of interoperability is a major impediment to fully recognizing the potential of HIT,” wrote ASCO Chief Medical Officer Richard L. Schilsky, MD, FASCO. “Many oncologists have already expended significant resources in their existing EHR with the promise of interoperability. EHR vendors should not be allowed to pass the cost of new standards on to practices that may not be able to bear the additional outlay. ASCO encourages Congress to consider additional bill language or report language meet interoperability standards.”
ASCO also stated its support for the following provisions in particular:
- Providing mandatory funding for the NIH and FDA
- Investing in the future of biomedical research workforce through the Innovation Fund’s focus on young scientists.
- Furthering the development of precision medicine, shaping the future of treatment for cancer patients through the Innovation Fund.
- Requiring use of centralized IRBs to greatly accelerate the pace of clinical trials research in the United States.
- Easing restrictions on and burdensome paperwork of federal employee attendance at scientific meetings, which is vital to ensuring the most knowledgeable workforce at NIH and FDA.
- Encouraging data standardization, such as the requirements for ClinicalTrials.gov.
- Refining Sunshine Act provisions to ensure necessary access to Continuing Medical Education and peer-reviewed journals.
- Establishing patient-focused drug development that uses vital input from and experience data from patients to create a full risk-benefit analysis of any new treatment.
- Requiring transparency requirements for expanded access for drug companies to make public information about their expanded access plans after phase 2 and phase 3.
ASCO has weighed in heavily throughout the legislation’s development process and will continue to do so. Please visit ASCO in Action for the latest updates on this legislation.