This month we are focused on innovation! President Biden has set up his team to push forward the new ARPA-H initiative and has begun public and private meetings with stakeholders to gain input and garner support for this $6.5 billion program. Meanwhile Congress has unveiled the Cures 2.0 legislation which tackles some of the biggest challenges to innovation: lack of CMS coverage and appropriate reimbursement, insufficient R&D funding, health inequities, lack of diversity in clinical trial representation and more. See details below.
On June 22, 2021, Congresswoman Diana DeGette (D-CO-01) and Congressman Fred Upton (RMI-06) released draft legislation called Cures 2.0 to build on the success of their previous legislation called the 21st Century Cures Act, which was signed into law in 2016 with overwhelming bipartisan support. The preceding legislation was focused on improving how new drugs and medical innovation are researched and developed in the U.S. and included the Cancer Moonshot Program led by then Vice President Biden. The new Cures 2.0 proposal seeks to improve how those new therapies and innovations are delivered to patients. The proposal will continue to be developed and revised as it moves through Congress.
See full report here: Cures 2.0 Legislation
The Cures 2.0 would Authorize President Biden's Advanced Research Projects Agency for Health (ARPA-H) initiative and address several areas impacting the delivery of medical innovations to patients with the following actions:
See full report here: Cures 2.0 Components
Cures 2.0 establishes President Biden’s ARPA-H initiative with $6.5 billion. Its mission would be to speed transformational innovation in health research and application and advance the implementation of health breakthroughs. The new ARPA-H would be largely modeled after the military’s Defense Advanced Research Projects Agency, or DARPA. ARPA-H would aim to accelerate new medical breakthroughs with the intent to cure cancer, Alzheimer’s and other devastating diseases. Specifically, ARPA-H would:
To support additional research, it would provide $25 billion for universities, research institutions, and public laboratories throughout the country to continue their work on thousands of federally funded research projects.
See full report here: ARPA-H Initiative for Medical Research
As we enter these summer months, the House has picked up the pace on appropriations with markups starting now in the various subcommittees. Meanwhile, the Senate Appropriations Committee's deadlines for each of their subcommittees to receive requests from Senators to submit their requests have either passed or are soon to pass by mid-July. With Chairwoman Rosa DeLauro (D-CT) committed to moving all 12 appropriations bills to the floor before the August recess, it is a frenetic pace in the House that will be followed by Senate markups later in the year, then conference committee negotiations in late fall. All of this work is based on President Biden's FY2022 budget proposal released on May 28.
On May 28, President Biden unveiled his $6 trillion FY2022 budget proposal, following up on his “skinny budget” released on April 15 which G2G summarized previously here. The non-defense discretionary budget is up almost 20% from FY2021, while the defense budget has a 1.7% increase. His proposal also includes the American Jobs Plan and the American Families Plan, the $4 trillion infrastructure, jobs and economic proposal previously announced in the spring and summarized here. See Biden Budget section-by-section analysis
Over the past few months, G2G has been working with the White House Office of Science and Technology Policy (OSTP) and theirBiomedical Science Initiatives leadership. The OSTPis establishing the framework for the Advanced Research Projects Agency-Health (ARPA-H) that was included in President Biden’s FY2022 budget. Modeled after the Defense Advanced Research Projects Agency (DARPA), ARPA-H would tackle bold challenges requiring large-scale, cross-sector coordination, employing a nontraditional and nimble approach to high-risk research. Specifically, under Director Eric Lander, PhD(from the Broad Institute and MIT who was sworn in as the first Cabinet-level Director of OSTP on June 2) ARPA-H will advance translational science and drive transformational health innovations that tackle gaps in the system and implement health breakthroughs. OSTP has shared that they are working toframethe new ARPA-H office throughstakeholder meetings over the next few months. They are eager for input on how best to implement this initiative, so we will continue to share informationto contribute to this process.
G2G recently engaged with the leadership of the Department of Defense's USAMRDC, Defense Health Agency (DHA)and the Office of the Secretary of Defensepolicy division about how best to bring innovations to the DoD under the new DHA organization. The key to program office engagement or to secureR&D funds, procurement orany DoD collaboration for broad adoption of innovations across the defense enterpriseis showingWarfighter application. The focus on prolonged field care remains a priority despite the extensive work on COVID response. Finally, the DoD is full steam ahead in planning for the annual MHSRS this August 23-26 in Kissimmee, Florida.
In the budget proposal, President Biden attempts to address entitlement needs and deficit control. Some highlights on what his budget would achieve by 2031 include:
The President’s FY22 plan for the next fiscal year provides:
STEM education funding resources are spread across several federal departments and agencies. Here is a quick overview for navigating ways to pursue funding based on FY2021 funding levels. The new administration and many in Congress are focused on advancing funding for science and STEM, so we expect increasing funding for FY2022.
The department has a few programs dedicated to STEM education but funds this work through a range of discretionary and formula-based grant programs. It spent $578 million on STEM education through its discretionary grant programs in FY2020 that included level funding for Student Support and Academic Enrichment Grants, Supporting Effective Instruction State Grants, and 21st Century Community Learning Centers and an $800,000 increase to the Minority Science and Engineering Improvement Program. To help improve STEM instruction, the Education Innovation and Research program received a $2 million increase for a total of $67 million.
NSF funds the Education and Human Resources Directorate, which supports pedagogy research, fellowships, and capacity-building activities with an increase from $940 million to $968 million last year. NSF received $5 million for the CyberCorps Scholarship for Service, $2 million for the Louis Stokes Alliances for Minority Participation program, and $1.5 million each for the HBCU Undergraduate, Tribal Colleges and Universities, and Hispanic-Serving Institutions programs.
NASA’s Office of STEM Engagement funding rose by $7 million to $127 million with $3 million for the Space Grant program (with at least $760,000 going to each of the 52 participating jurisdictions), $2 million for the Minority University Research and Education Project, and $2 million for NASA’s Established Program to Stimulate Competitive Research. Also, NASA’s Science Mission Directorate received $45.6 million to support these STEM activities.
DOE’s primary STEM education account, Workforce Development for Teachers and Scientists, increased from $1 million to $29 million. The Science Undergraduate Laboratory Internship Program and the Graduate Student Research Program grew to $14 million and the STEM outreach activities was nearly doubled to $1.5 million.
The National Defense Education Program budget decreased last year from $144 million to $137 million, mostly due to Congressional support waning for the Manufacturing Engineering Education Program. While DOD requested $100 million for NDEP, Congress added $35 million for assorted STEM education and outreach activities and $2 million for civics education. The SMART (Science, Mathematics, And Research for Transformation) scholarship-for-service program received about $77 million.
The $3 million increase to $33 million for NOAA was directed to the José E. Serrano Educational Partnership Program with Minority-Serving Institutions while NOAA’s Office of Oceanic and Atmospheric Research funded the Sea Grant College Program with a $1 million increase to $75 million in FY2021.
While vaccinations are well underway and new CDC guidelines allow the masks to come off in certain settings, President Biden and Democrats in Congress continue to press ahead with big spending packages. New guidance on the American Rescue Plan enacted in March just came out from the Treasury Department, signaling counties, municipalities and nonprofits can be recipients of funds (see details below on eligible uses of funds). With that done, next on the agenda is pushing forward the infrastructure bill in the form of the American Jobs Plans and the American Families Plan and gearing up for the markup of the 12 annual appropriations bills set to start late June/early July. Plus, Appropriations Chair Rosa DeLauro (D-CT) just introduced an Emergency Security Supplemental bill in response to the January 6th incident on Capitol Hill. Read more below.
Highlights of the funding included in the American Rescue Plan, which was enacted March 11, include:
To implement ARP or ARPA, the Administration unveiled details on how funds can be spent and accessed. On May 10, the U.S. Treasury announced the launch of the Coronavirus State and Local Fiscal Recovery Funds, established by the American Rescue Plan Act to provide $350 billion in emergency funding for eligible state, local, territorial, and Tribal governments. The funding is based on the share of the U.S. population and counties that are urban Community Development Block Grant (CDBG) recipients will receive the larger of the population-based share or the share under a modified CDBG allocation formula. Examples include $239,898,257 for Cuyahoga County to $511,721,590 for Cleveland and $255,764,417 for Franklin County and $187,030,138 for Columbus.
Treasury also released details on how these funds can only be used to respond to acute pandemic response needs, fill revenue shortfalls among these governments to fill vital services and help retain jobs, and support the communities and populations hardest-hit by the COVID-19 crisis with immediate economic stabilization. Examples include direct COVID-19 health response, such as containment, testing, vaccination, mitigation, medical care and supplies, quarantine facilities, public health surveillance health communication and enforcement in hospitals, clinics, schools, and clinics. To help small businesses and tourism and travel industries facing financial challenges caused by the pandemic and needing to invest in COVID-19 prevention and mitigation tactics, recipients can execute a broad array of loan, grant, in-kind assistance, and counseling programs to enable faster rebounding from the downturn.
There is a broad range of uses to address the disproportionate public health and economic impacts of the crisis on the hardest-hit communities, populations, and households. This includes community health workers, community violence intervention programs, assistance for those experiencing homelessness and need access to affordable housing, navigation services for health, housing, counseling, and other needs, and educational supports in high-poverty school districts, and childcare.
Other examples of eligible uses in infrastructure include water management and remediation of lead hazards, sewer clean up, and broadband implementation in areas that are currently unserved or underserved—lacking a wireline connection that reliably delivers minimum speeds of 25 Mbps download and 3 Mbps upload. For the latter, recipients should build broadband infrastructure with modern technologies in mind, specifically offering reliable 100 Mbps download and 100 Mbps upload speeds, unless impracticable. These allowances also include projects that address the impacts of climate change. Finally, while recipients can build their internal capacity to successfully implement economic relief programs, with investments in data analysis, targeted outreach, technology infrastructure, and impact evaluations, they cannot use funds for general economic development.
Accessing these funds occurs directly through the Treasury Submission Portal. Local governments should expect to receive funds in two tranches, with 50% provided beginning in May 2021 and the balance delivered 12 months later. However, states that have experienced a net increase in the unemployment rate of more than 2 percentage points from February 2020 to the latest available data as of the date of certification will receive their full allocation of funds in a single payment.
In March, President Biden unveiled his $2.6 trillion proposal in Pittsburgh as an investment to benefit communities of color, rural Americans and all Americans burdened by the need for infrastructure repair and modernization. Then on April 28, President Biden released his American Families Plan in this two-part proposal to help the nation's economy recover from the coronavirus pandemic. The plan is paid for with corporate tax hikes that move the corporate income tax rate to 28%, up from 21% that was cut during the Trump Administration and was previously as high as 35% as well as with an increase in the minimum tax on US corporations to 21% and a 15% minimum tax on income the largest corporations report to investors. Highlights include:
On May 14, Chair Rosa DeLauro (D-CT) introduced a $1.9 billion funding bill, based on the recommendations of the Task Force 1-6 Capitol Security Review led by Lieutenant General (Retired) Russel L. Honoré and comprised of senior retired military leaders and law enforcement experts. It contains funding in the jurisdiction of six Appropriations Subcommittees: Legislative Branch; Commerce, Justice, Science, and Related Agencies; Defense; Financial Services and General Government; Homeland Security; and Interior, Environment, and Related Agencies. Some highlights of the legislation include: