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The year kicked off with more questions than answers: will Congress agree on a final FY2022 appropriations omnibus package or settle for a year-long Continuing Resolution, how will Build Back Better legislation be rewritten and cut back to pass Congress, what key legislation will be enacted by year’s end, and what will the elections in November 2022 mean for the House, Senate and the White House, among others. While much is up in the air, some significant legislative measures are moving through Congress.
While the America COMPETES Act is set to pass the House in a matter of days and HELP Committee Chair Murray is teaming up with Ranking Senator Burr to move pandemic preparedness legislation, the Cures 2.0 and ARPA-H legislation are moving more slowly. Appropriations seem to be moving the slowest of all measures. Congress is aiming to finish FY2022 appropriations in the end of February, but if they can't come to agreement, they may have to pass a year-long Continuing Resolution (CR) that level funds all departments, agencies and programs. Regardless of whether it is an omnibus enacted in March or short-term CRs or a year-long CR, this delayed resolution of the legislation stalls the release of President Biden's FY2023 budget proposal and further blocks the House and Senate Appropriations Committees from being able to start the annual funding process until April or May.
On January 27, the House announced the America COMPETES Act in response to the landmark innovation policy package called the U.S. Innovation and Competition Act (USICA), which the Senate passed in June last year. The House is aiming to pass the America COMPETES Act the first week of February. Although there are several policy disagreements, both chambers are committed to moving legislation to establish new innovation initiatives and set funding targets that, if met, would add billions of dollars to the current annual budgets of selected research agencies. USICA and the COMPETES Act would both establish a new National Science Foundation directorate and a program to seed regional innovation hubs across the U.S. Both would allocate $52 billion for semiconductor production and R&D initiatives that were authorized last year and would include provisions impacting trade policy and foreign relations. The COMPETES Act includes provisions that have no counterpart in USICA, such as ones that would support climate change mitigation efforts abroad and remove caps on green cards for doctoral graduates in STEM fields. If the bill passes the House, the differences with USICA will be addressed in the House-Senate conference committee.
House vs. Senate
The House Science Committee created the key innovation sections of the COMPETES Act last spring and summer and the Senate developed USICA, focused on channeling funding toward key technology areas in three agencies: NSF, the Department of Energy Office of Science, and the National Institute of Standards and Technology. The House bill focuses more on building up NSF, addresses improving STEM education and broadening participation in STEM fields among underrepresented groups, and prioritizes quantum information science, high-intensity lasers, and fusion energy R&D. The House’s NSF provisions double funding from $8.5 billion to $17.9 billion over five years, cumulatively providing $35.6 billion in additional funding over that period. It also includes $1.4 billion in funding for the newly created Science and Engineering Solutions Directorate that rises to $3.4 billion, totaling almost $13.3 billion over the five years, whereas the Senate USICA provides the newly created Technology and Innovation Directorate with $29 billion over that period. The Senate bill, USICA, addresses some agencies unmentioned in the House bill, incorporating a sweeping policy update for NASA and recommending that Congress immediately double the Defense Advanced Research Projects Agency’s (DARPA) budget, which means an additional $17.5 billion over five years.
The House COMPETES Act and Senate USICA would both establish a grant program within the Commerce Department for funding consortia of state and local governments, universities, businesses, and other entities to develop and implement regional innovation strategies. USICA provides $10 billion funding over five years, whereas the COMPETES Act proposes about $7 billion for regional programs. In addition, both bills would provide $52 billion over five years for implementation of the CHIPS for America Act, which was enacted as part of the National Defense Authorization Act for Fiscal Year 2021. The COMPETES Act supplements the CHIPS Act by directing DOE to establish up to four Microelectronics Science Research Centers, each with a budget of up to $25 million annually. Finally, USCIA proposes a massive expansion of the NSF’s and DOE’s EPSCoR programs, which set aside funds for states and territories that have historically received a low share of total agency R&D funds, with the aim of building up their research capacity. In contrast, the COMPETES Act proposes creating programs to build capacity at institutions outside the top tier, regardless of where they are located. USICA includes about $500 billion for energy and environmental programs and $5 billion for the Department of Energy Office of Science that was proposed by the Senate Energy and Natural Resources Committee that is chaired by Senator Joe Manchin (D-WV), who is critical to final negotiations.
STEM & Immigration
On January 21, the White House announced a series of immigration policy changes that aim to improve the ability of the U.S. to attract and retain international STEM talent. The administration added 22 new STEM fields to the Optional Practical Training (OPT) program, which allows international students to work in the U.S. after graduation for a period of time. The announcement states that the added fields of study are “primarily new multidisciplinary or emerging fields and are critical in attracting talent to support U.S. economic growth and technological competitiveness.” These include bioenergy, climate and Earth system sciences, cloud computing, data science and visualization, and “human-centered technology design,” which encompasses fields such as human-computer interaction and neuroscience. Students in the listed fields will now be eligible for a 24-month extension of their time in the OPT program, beyond the regular 12-month duration for non-STEM students.
BUDGET & APPROPRIATIONS
While the fiscal year began on October 1, 2021, Congress and the White House could not pass and enact the 12 appropriations bills on time. Instead Congress passed repeated Continuing Resolutions, with the most recent one in effect until February 18, 2022. Many are skeptical about wrapping up the FY22 process with a bipartisan omnibus package by the end of February. However, the FY2023 appropriations process needs to get underway before the year passes by. The main hangup is not just funding levels and policy riders, but the Build Back Better proposal that hinges on securing a deal with Senator Joe Manchin (D-WV).
Cancer Moonshot Returns
Today President Biden will announce the relaunch of the Cancer Moonshot to expedite progress on cancer screening, prevention and treatments, bringing back a signature program he led in his final year as vice president. The mission remains the same as in 2016 when first launched: “To end cancer as we know it.” Biden’s team previously focused on advancing scientific discovery, improving collaboration and data sharing, and establishing public-private partnerships. The new moonshot will focus on reducing the disease’s death rate by at least 50% in 25 years and will have First Lady Jill Biden, PhD and OSTP actively involved. In 2016, Congress provided $1.8 billion over seven years for the moonshot. With two years of funding totaling $400 million remaining, many cancer advocates worry that a substantial infusion of money is needed to execute Biden’s vision.
On January 25, the bipartisan leaders of the Senate Health Education Labor and Pensions (HELP) Committee unveiled the Prepare for and Respond to Existing Viruses, Emerging New Threats, and Pandemics Act (PREVENT Pandemics Act legislative text and discussion draft), which aims to improve the U.S. preparedness for pandemics after the many shortcomings in the response to COVID-19. The draft includes proposals on topics from improving data collection to speeding the development of vaccines and treatments to improving public health communication. It would not directly provide new funding for pandemic preparedness, but would authorize some programs that could be funded as part of the annual appropriations process.
- Modernizing biosurveillance capabilities and infectious disease data coalition
- Clarifying the Secretary’s public health situational awareness authority to include modernizing applicable existing public health data systems and networks of the Department of Health and Human Services to reflect technological advancements.
- Adding topics for discussion at the public meeting required under current law to improve situational awareness, such as integration of laboratory and other relevant data systems and improving electronic exchange of health information.
- Updating the strategy and implementation plan to improve collaboration among federal departments, implement lessons learned from previous public health emergencies, and identify steps the Secretary will take to prepared and respond to new threats.
- Advancing further development and integration of infectious disease detection, support rapid and accurate reporting of laboratory test results during a public health emergency, and improve coordination with public health officials, clinical laboratories, and other entities with expertise in public health surveillance.
- Allowing the CDC to award grants to states to establish or operate state or regional situational awareness systems.
On October 15, Energy and Commerce Health Subcommittee Chair Anna Eshoo (D-CA) introduced H.R. 5585, the Advanced Research Project Agency-Health (ARPA-H) Act to authorize $3 billion in funding in FY2022 and require a budget request from the president in future years that is separate from the rest of the Department of Health and Human Services (HHS) budget. It would establish this new entity within HHS, but not specifically within the NIH, as the White House has proposed. Emphasizing ARPA-H should prioritize funding for proposals that address a disproportionate disease burden and promote health equity, it would create a presidentially appointed director position for a five-year term and advisory committee of federal officials.
On November 15, Reps. Diana DeGette (D-CO) and Fred Upton (R-MI) who co-wrote the 21st Century Cures Act enacted by President Obama in December 2016 teamed up again to introduce H.R. 6000, the Cures 2.0 Act. It would establish ARPA-H within the NIH, as proposed by President Biden and both the House-passed and Senate draft appropriations bills for FY2022 although the Senate bill’s explanatory statement notes the committee “remains open” to establishing ARPA-H as a free-standing agency outside of the NIH. The DeGette-Upton bill would provide more funding for ARPA-H than the Eshoo bill, totaling $6.5 billion for ARPA-H in FY 2022 and would address other ways to deliver new cures and treatments to patients sooner and improve the overall level of care Americans are provided. See section by section summary and highlights below:
- Transform how Medicare covers innovative new treatments and technologies to make those new discoveries available to patients sooner.
- Increase access to telehealth services for Medicare and Medicaid patients, including those covered under the Children’s Health Insurance Program, known as CHIP, to ensure more Americans are getting the help they need, when they need it.
- Provide training and educational programs for at-home caregivers – including family members with no prior health care experience to help them better care for loved ones when they are home.
- Require more diversity in clinical trials to ensure any new drugs and treatments approved for use in the U.S. are both safe and effective for a greater – and more representative – portion of the population.
- Provide patients more information about the illness they face and the treatment options available to them to make them a more integral part of the decision-making process.
- Address the ongoing COVID-19 pandemic by requiring the Department of Health and Human Services to conduct a nationwide study on the implications of long COVID and develop a nationwide testing and vaccine distribution strategy to be used in future pandemics.