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Biden Set to Nominate Califf to Again Lead FDA

The White House is reportedly in the process of vetting former Food and Drug Administration Commissioner (FDA) Dr. Robert Califf to become the agency's leader once again. Califf had previously headed the agency in the last year of the Obama administration. President Biden has struggled to find a candidate who is both qualified and could win Senate confirmation. The White House ruled out the current acting commissioner, Dr. Janet Woodcock, after it became clear she would face opposition from a group of senators. By law, Woodcock can no longer serve as acting commissioner after November 15, unless a permanent commissioner has been nominated.

Califf's potential nomination points to the White House's desire for a steady hand to calm recent internal turmoil at the agency. Last month, the top two officials of the FDA's vaccine office, Marion Gruber and Phil Krause, announced that they are leaving the agency this fall, reportedly over frustration with the Centers for Disease Control and Prevention (CDC) and its Advisory Committee on Immunization Practices involvement in COVID-19 vaccine decisions that they think should be left to the FDA. 

During his time at FDA, Califf was instrumental in expanding the agency's activities in leveraging real-world evidence (RWE) to monitor post-market safety and adverse events and to make regulatory decisions. He has continued to be involved in thought leadership in this area since leaving FDA, as well as keynoted the AMIA Health Informatics Policy Forum in 2019.

Administration

ONC Announces USCDI+ to Improve Federal Dataset Interoperability

The Office of the National Coordinator for Health Information Technology (ONC) announced a new initiative last week that seeks to standardize the health care data sets of federal agencies that are not being addressed by the current baseline. Dubbed USCDI+, the initiative builds on the U.S. Core Data for Interoperability (USCDI), the first version of which was adopted as part of the ONC's 21st Century Cures Act Final Rule implementation. This new process will support federal partners “who have a need to establish, harmonize and advance the use of interoperable datasets that extend beyond the core data in the USCDI in order to meet agency-specific programmatic requirements,” ONC wrote in blog post announcing the new initiative.

ONC said it is in the early stages of this initiative with both the Centers for Medicare & Medicaid Services (CMS) and the CDC. Additional federal agencies will also participate “once we've gotten the program more firmly established.” According to ONC, the USCDI+ process will build on the USCDI by adding:

  • A discovery process and charter;
  • Identification of use cases, data specifications, and agency programmatic incentives/requirements for use of any specific USCDI+ dataset;
  • Evaluation of data classes/elements according to objective criteria, such as industry priority and readiness, level of standards maturity, and identified agency need.

The deadline for developers of certified health IT products to support USCDI version one is December 31, 2022. A second version that incorporates new standards surrounding sexual orientation, gender identity and social determinants of health data was finalized this past July.

AHRQ Releases Draft Review of Rural Telehealth-Guided Provider-to-Provider Communication

Last week, the Agency for Healthcare Research and Quality (AHRQ) released a systematic review on ways to improve rural health through telehealth-guided provider-to-provider communication. The report assessed the use, effectiveness, and implementation of telehealth supported provider-to-provider communication and collaboration for providing telehealth services to rural populations.

The report revealed, perhaps unsurprisingly, that telehealth for provider-to-provider communication is used to different extents across specific clinical care uses such as psychiatry, emergency, and stroke care. It also noted that use was increasing even prior to the COVID-19 pandemic. As to clinical effectiveness, the review found that telehealth to support direct patient care may provide benefits for inpatient care, for neonates in rural hospitals, for outpatient management of depression and diabetes, and emergency care for stroke/heart attack/chest pain as well as trauma. Notably, no studies in the review reported harms or unexpected negative outcomes for provider-to-provider telehealth. Finally, the review cited inadequate provider time, technology, and other resources, as well lack of understanding of the rural context and long-term commitments to telehealth as barriers to broader implementation of provider-to-provider telehealth in rural settings.

Legislation & Politics

Bipartisan House Bill Seeks to Create a Rural Telehealth Access Task Force

Representatives Greg Pence (R-IN) and Angie Craig (D-MN) have introduced the Rural Telehealth Access Task Force Act (HR 5506), which aims to create a federal task force to study how telehealth is used in rural parts of the country, what barriers it faces in adoption and expansion, and how federal programs to expand broadband connectivity are fostering telehealth growth. The bill would bring together several federal departments that have been instrumental in advancing connected health initiatives. The task force would include representatives from the Federal Communications Commission (FCC) which oversees, among other things, the COVID-19 Telehealth Program and Connected Care Pilot Program; the Department of Health and Human Services (HHS); the Department of Veterans Affairs, which administers the largest telehealth program in the country; and the National Telecommunications and Information Administration.

Last September, the FCC, HHS, and Department of Agriculture signed a Memorandum of Understanding to launch an interagency Rural Telehealth Task Force to advance then-President Trump's Executive Order on Improving Rural and Telehealth Access. While telehealth adoption and use exploded during the coronavirus pandemic, some of that growth has subsided as some patients have returned to in-person care. The industry is currently awaiting guidance at the state and federal levels on long-term telehealth policy, most notably the long-term fate of Medicare reimbursement for telehealth services.

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AMIA's Washington Download is your source for health informatics policy news and information from around the Beltway, covering action from the Hill, the Administration and important AMIA collaborators.