Extend Key Regulatory Flexibilities and Leverage New Technologies During Pandemic and Beyond

January 6, 2021

The Association for Clinical Oncology (ASCO) responded to two requests for information from the Department of Health and Human Services. One Request for Information (RFI) sought stakeholder feedback and recommendations on which of the temporary regulatory flexibilities instituted during the COVID-19 Public Health Emergency (PHE) should be extended beyond the PHE. The other asked for information on leveraging novel technologies to manage chronic diseases in aging populations living in underserved areas.

ASCO’s responses to both RFIs are summarized below.

COVID-19 Regulatory Relief

ASCO’s comments assert that prior to the COVID-19 PHE, certain longstanding policies, care delivery practices, and research procedures posed barriers to the efficient delivery of care and effective clinical research. During the pandemic, HHS offered temporary regulatory flexibilities on some of those same policies and practices to enable the nation’s health care system to continue to operate safely and efficiently during the crisis. HHS is now assessing which of these flexibilities should remain temporary, and which should become permanent or permanent with modification.

ASCO’s recommendations are informed by the American Society of Clinical Oncology’s Road to Recovery report and support cancer care delivery through permanent and broad use of telemedicine and flexibilities that promote transparency in the drug supply chain to prevent drug shortages. Other recommendations support policies to help ensure that the clinical trials system is more resilient, flexible, and accessible to patients.

Read the full RFI and ASCO’s comments.

Using New Technologies to Manage Chronic Diseases in Aging, Underserved Populations

ASCO recommends that HHS prioritize aging cancer populations living in rural areas as it assesses the extent to which technology can influence patient access to care, timeliness of care, and the quality of treatment and preventive services.

ASCO’s comments highlight how individuals living in underserved areas are at an increased risk of illness and reduced access to care during the COVID-19 pandemic and that adults over the age of 65 represent a majority of individuals diagnosed with cancer in the United States. The Association also points to the barriers and opportunities for bringing technology-driven solutions to both groups, which include unreliable access to technology, medication adherence, and remote patient monitoring.

Read the full RFI and ASCO’s comments.

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