On January 17, the Food and Drug Administration (FDA) outlined the criteria companies must meet to get a biologic deemed interchangeable with its branded counterpart in draft guidance. Interchangeable biosimilars are expected to offer greater savings to the health system than biosimilars that lack this designation.
ASCO in Action regularly provides the latest news and analysis related to cancer policy news; see the following online articles. These updates provide snapshots of ASCO’s ongoing advocacy efforts, as well as opportunities for ASCO members and guests to take action on critical issues affecting the cancer community.
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We commend the Food and Drug Administration (FDA) for establishing the Oncology Center of Excellence (OCE) with Dr. Richard Pazdur as its director. The FDA has provided not only regulatory guidance but also intellectual leadership in the development of oncology products and this new OCE will build on that past, creating a larger community of scientists and clinician experts within the agency. ASCO looks forward to working with the OCE and the new administration to help improve the lives of people living with cancer.
On January 18, 2017, the Department of Health and Human Services (HHS), along with more than a dozen other federal agencies, finalized updates to the Common Rule, which protects human subjects in biomedical research. This is the first time the Common Rule has been updated in nearly three decades, and the changes make major strides in modernizing protections for human subjects.
On January 16, Diagnosis: Cancer, featured a new blog post by ASCO Chief Medical Officer Richard L. Schilsky, MD, FASCO, FACP, “When Medical Records Can’t Be Shared, We All Lose,” looking at the persisting barriers that prevent the effective sharing of electronic patient records, also known as interoperability, across the healthcare system.
On January 11, representatives from ASCO participated in the final event in the Cancer Moonshot℠ “Making Health Care Better” series, which focused on community oncology, at the White House.
The World Health Organization and the National Cancer Institute released a report on January 10, that finds smoking and its side effects cost the world's economies more than $1 trillion and kill about 6 million people each year. The report also noted that this number is expected to rise by more than a third by 2030. ASCO issued the following statement from President Daniel F. Hayes, MD, FASCO, FACP.
ASCO has released, “ASCO Principles for Patient-Centered Healthcare Reform,” seven recommendations designed to ensure access to high-quality cancer care amid the changing U.S. healthcare delivery landscape. The principles aim to assist the new Congress and Administration, so, as they consider the critical underpinnings of any healthcare reform proposal, the needs of patients facing a cancer diagnosis are met.
As the leading medical professional oncology society committed to conquering cancer through research, education, prevention, and the delivery of high-quality patient care, ASCO is dedicated to working with policymakers and the entire cancer community to provide equal access to quality health care with special emphasis on reducing insurance and economic barriers to cancer care.
On January 3rd, the 115th Session of the U.S. Congress got underway. One of the first orders of business was appointing new leadership of Committees, including those with jurisdiction over issues of importance to cancer-related policy.
ASCO launched its 2017 Survey of Oncology Practice Operations (SOPO), an annual survey of business and operational issues in oncology practices. With this survey, the society aims to capture the current state of oncology management practices to help practices navigate the evolving cancer delivery system.
The Centers for Medicare and Medicaid Services (CMS) Electronic Health Record (EHR) Incentive Programs attestation system is now open. Eligible professionals and hospitals may attest for any 90-day continuous reporting period within the 2016 calendar year. Providers must attest by February 28, 2017 to avoid a 2018 payment adjustment.
CMS is accepting applications through January 30, 2017 for its new Clinical Practice Imrovement Activities (CPIA) study, which will look at the challenges of collecting and reporting quality data. Participants will receive full credit for the CPIA performance category through the Quality Payment Program under MACRA.
A new special series in the Journal of Clinical Oncology (JCO) arrives with the new year to share important knowledge, resources, and ways to encourage healthy lifestyle choices recognizing weight as an important cancer prevention measure.