At a Glance…

  • Congress is negotiating FY22 legacy policies and top-line funding levels
  • ONC publishes the long awaited TEFCA
  • Negotiators continue to finalize language for authorizing ARPA-H
  • And more…

As we pass the one-year anniversary of President Joe Biden being sworn in, Congress continues to be in gridlock as congressional and White House negotiators continue to search for a way forward on the Build Back Agenda, debate the future of the filibuster, and agreements on top-line appropriations legislation for the current fiscal year. The fierceness of the Omicron COVID-19 wave has upended agendas as the Biden Administration rushes tests and masks into communities, the Supreme Court striking down executive authorities in mandating vaccines, Congress contemplates new supplementals, and the approval of vaccinations for children under 5 continues to get delayed.

Clock is running out on latest continuing resolution

The current fiscal year, FY22 began on October 1, 2021, but has been funded by a series of continuing resolutions (CRs) that have kept funding at FY21 levels as Congress negotiates funding bills.  The current CR lasts until February 18, which was a compromise between Democrats wanting it to end in January and Republicans preferring a later date to allow for negotiations on legacy policies in the bills as well as agreeing to a topline number. At this stage, there is no public information indicating that the parties have had successful negotiations on this point. If February 18 comes without an agreement, Congress will have to pass a new CR with the question being how long it would be. CRs are deeply detrimental to research agencies as they lack the legal authority to start new programs while their funding is frozen at lower FY21 levels.

House Majority Leader Steny Hoyer (D-MD) has predicted that additional supplemental appropriations may be necessary to respond to the Omicron strain. There is little indication that congressional Republicans would support a supplemental, likely requiring it to go through budget reconciliation to avoid a Senate filibuster.

Congress continues to develop ARPA-H

House negotiators are continuing to develop finalized language to authorize the Advanced Research Projects Agency for Health (ARPA-H). Current debates include whether authorizing it should be a standalone measure or part of a larger bill like Cures 2.0, if it should be under HHS or NIH, as well details in how the agency should be structured and the types of research they would be authorized to support.

Last month, AcademyHealth’s CEO was joined by members Eve Kerr and Rita Mangione-Smith for separate meetings with members of Congress about the critical role that ARPA-H could play to improve healthcare for all and advance equity. Additionally, Simpson and Omada Health’s Lucia Savage wrote an open letter in Health Affairs to ARPA-H’s designers about how health services research can guide and optimize the work of the research agency. They suggest the following five principles in designing the new agency:

  1. Prioritize Health Care Quality And Equity Domains That Have Stagnated
  2. Each High-Priority Challenge Should Address Known Disparities, In Order To Achieve Innovative And Effective Health Care Treatments
  3. Support Research That Includes Equitable Adoption, Adaptation, And Scale
  4. Conduct Regular And Independent Transparent Assessments Of Progress To Build Trust In ARPA-H
  5. Fund Differently To Drive Innovation

Key Senate panel advances Califf for FDA Commissioner

Dr. Robert Califf’s nomination for FDA Commissioner was advanced from a divided Senate Health, Education, Labor, and Pensions Committee with a bipartisan vote in favor – and a bipartisan vote against. The timing for the full Senate confirmation is still to be determined. Dr. Califf would be taking charge of an agency that has been under intense scrutiny as a result of the pandemic, as it has been criticized for the pace of approval for vaccines, treatments, masks, and tests.

ONC published TEFCA to set principles for health information exchange

The Office of the National Coordinator for Health IT (ONC) and its Recognized Coordinating Entity (RCE), The Sequoia Project, published the Trusted Exchange Framework and Common Agreement (TEFCA), creating the baseline legal and technical requirements that will enable secure, nationwide information sharing across different health care entities, completing a critical 21st Century Cures Act requirement. TEFCA is a set of non-binding principles for health information exchange.

OSTP published a report on protecting the integrity of government science

The White House Office of Science and Technology Policy (OSTP) released the report of its Scientific Integrity Task Force. This report is a comprehensive assessment of scientific integrity policies and practices in the US government and is part of the federal work to promote evidence-based policymaking.

CBO released a report on the prices that commercial health insurers and Medicare pay

The Congressional Budget Office (CBO) released new analysis on the drivers of per-person spending by different insurance programs. In recent years, commercial health insurers’ per-person spending on hospitals’ and physicians’ services has grown more quickly than analogous spending by the Medicare fee-for-service (FFS) program, according to analysis by the Congressional Budget Office. The main reason for the growth of per-person spending by commercial insurers—and for the difference from the growth of per-person spending by Medicare FFS—has been rapid increases in the prices that commercial insurers pay for hospitals’ and physicians’ services. Prices paid by commercial insurers and Medicare FFS differ, and rise at different rates over time, in part because of differences in how the two sets of prices are determined.

OPM calls for the establishment of Chief Diversity Officers in every agency

The Office of Personnel Management (OPM) has called on all federal agencies to name a Chief Diversity Officer (CDO) who reports directly to senior leadership if they have not already created such a position. As part of this effort, OPM has created a Chief Diversity Officer Council and is investigating ways in which to create new job classifications for federal employees who work as diversity experts. This is a continuation of the Biden Administration’s executive orders on making Diversity, Equity, Inclusion, and Accessibility within the federal workforce a government priority.

GAO announced new appointments to the Health Information Technology Advisory Committee (HITAC)

The Government Accountability Office (GAO) announced the appointment of seven members to the Health Information Technology Advisory Committee (HITAC). The newly appointed members are Hans Buitendijk, Steven Eichner, Rajesh Godavarthi, Hung Luu, Aaron Neinstein, Eliel Oliveira, and Fillipe Southerland. Each are appointed for three-year terms, and may be reappointed for subsequent three-year terms. The 21st Century Cures Act, enacted in December 2016, established the HITAC, which provides recommendations to the National Coordinator for Health Information Technology on policies, standards, implementation specifications, and certification criteria relating to the implementation of a health information technology infrastructure that advances the electronic access, exchange, and use of health information.

What I’m reading…

Eric Topol wrote a commentary in Science arguing that recent federal policy decisions, including a lack of a coordinated data collecting and sharing strategy, has weakened the COVID-19 response efforts. He called for corrective action from public health agencies, including improving the gathering and sharing of data as well as providing consistent and unified communication.

As NIH Director Francis Collins finishes his tenure, he has spoken not only of the successes of NIH, but also of the challenges that face research communities and the implementation of biomedical innovations. In an interview with Nature he noted that he is disappointed that NIH is still deeply under-represented for people of color. We have provided NIH with suggestions on how to advance and strengthen diversity, equity, and inclusion in the biomedical research workforce and advance disparities research projects. Collins has also talked about the importance of learning the lessons from behavioral social sciences to gain insights into combating misinformation and reducing health disparities.

A new study by Wehby in Health Affairs investigates the relationship between a family having access to health insurance and academic achievement in low-income households. The study found that for children whose mothers had a high school education or less when the child was born saw a statistically significant increase in reading scores following the implementation of the 2014 Affordable Care Act (ACA) expansion. Accessing health care has implications beyond quantifiable health outcomes.

Meharry Medical College decided to use part of the funding they received from the CARES Act to give 956 of their students a one-time payment of $10,000. Meharry administrators consider the payment to be an investment in the future career of Black students as an assistance in overcoming financial hurdles they disproportionately face to become medical professionals. Across the board, students at HBCUs are more likely to rely on student loans than students at comparable historically white institutions.

A key group that has not been able to receive vaccines is children under 5 as trials for both Pfizer and Moderna have needed extensions in determining efficacy. Genevieve Wojcik, an epidemiologist and parent of young children talked about the challenges faced by this demographic, from delayed vaccines to inconsistent childcare, all navigated by burnt out parents. Vaccinating everyone who is eligible is critical to protect those who are not able to be vaccinated.  

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