legislative udpate

Insights & Analysis

Last updated on:
July 23, 2021

Overview

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.

Cures 2.0

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

Key Cures 2.0 Components

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:

  • Require pandemic planning and assessment of COVID patients called long haulers, who suffer from symptoms long after being infected
  • Expand Medicare coverage by making innovative new health care technologies such as breakthrough drugs, regenerative medicine and devices accessible to beneficiaries
  • Increase diversity in clinical trials to ensure that new drugs and treatments are useful for all populations
  • Require the FDA to improve upon the collection and use of real-world evidence when developing new patient-focused treatments
  • Expand caregiver training programs to ensure patients receive a higher quality of care
  • Improve accessibility and availability of health information for patients so they better understand their illness and treatment options
  • Make telehealth services more accessible for Medicare, Medicaid and Children’s Health Insurance Program (CHIP) beneficiaries

See full report here: Cures 2.0 Components

Innovation - ARPA-H Initiative for Medical Research

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:

  • Take on work that requires large scale, sustained coordination
  • Expand capacity in fields such as technologies, data resources, and disease models
  • Establish new paradigms by supporting high-risk endeavors
  • Use solutions, such as financial incentives, to overcome market failures
  • Complement research undertaken by the NIH and the private sector.

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

Last updated on:
June 23, 2021

OVERVIEW

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.

FY2022 Budget Proposal

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

ARPA-H

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.

DOD

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.

Entitlements and Deficits in Biden's fy2022 budget

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:

  • Social Security would increase from $1.2 trillion (5.1% of GDP) in FY2022 to nearly $2 trillion (5.9% of GDP)
  • Medicare would increase from $766 billion (3.3% of GDP) to $1.4 trillion (4.2% of GDP)
  • Medicaid would rise from $571 billion (2.4% of GDP) to $837 billion (2.5% of GDP). During the pandemic, Medicaid enrollment increased by 10 million people and now totals 80 million Americans, nearly 1 in 4 — the largest population since the program was first created in 1965.
  • Total discretionary and mandatory spending would be more than $8 trillion and the debt would reach 117% of GDP 
  • Deficit reduction of more than $2 trillion in subsequent decades would be achieved by implementing $3 trillion in proposed tax increases on corporations, capital gains and the top income tax bracket (Americans making less than $400,000 would not pay increased taxes)

BUDGET NUMBERS BY TOPIC

The President’s FY22 plan for the next fiscal year provides:

HEALTH

  • ·$10.1 billion for global health programs, including nearly $1 billion to "fund global health security programs and support to end the COVID-19 pandemic, an increase of over $800 million above the FY 2021 enacted level" – this is part of a $58.5 billion budget request for State Department and US Agency for International Development, a 10% increase from the enacted budget for FY21 with specific investments in addressing global health, climate change, workforce and cybersecurity
  • $10.7 billion in discretionary funding for the Department of Health and Human Services (HHS), an increase of $3.9 billion from 2021 enacted levels that includes funding for NIH and the new ARPA-H
  • $51 billion for the National Institutes of Health (NIH)
  • $6.5 billion to launch the Advanced Research Projects Agency for Health (ARPA-H), a new program aimed at driving innovation in health research that will focus initially on diseases like cancer, diabetes and Alzheimer's (housed within NIH but operating like DoD’s DARPA)
  • $8.7 billion in discretionary funding for the US Centers for Disease Control and Prevention (CDC) – the largest increase in 20 years
  • $1.6 billion for the Community Mental Health Services Block Grant – twice the FY2021 level of funding
  • $10.7 billion to address opioids – $3.9 billion above FY2021
  • Increases funding for the Indian Health Service by $2.2 billion and provides $900 million to fund tribal efforts to expand affordable housing, improve housing conditions and infrastructure, and increase economic opportunities for low-income families

EDUCATION

  • $102.8 billion for the Department of Education – 40% boost from 2021 enacted levels
  • $36.5 billion for Title I schools, in which children from low-income families make up at least 40% of enrollment – a $20 billion increase from 2021 enacted levels, the largest ever annual increase for Title I funding
  • $15 billion for special education funding, 12% increase
  • $8,370 maximum value of the Pell Grant, an increase from the current $6,495 as 7.3 million students will participate in this program in 2022

CLIMATE CRISIS

  • An increase of more than $14 billion compared to 2021 enacted levels across nearly every agency to tackle the climate crisis
  • $46.2 billion for the Department of Energy with the goal of carbon neutrality in 30 years through the renamed Office of Fossil Energy and Carbon Management that would received $890 million, an 18.7% increase from last year
  • An increase of more than $450 million to facilitate climate mitigation, resilience, adaptation, and environmental justice projects in Indian Country

CYBERSECURITY

  • $750 million to nine federal agencies significantly impacted by the devastating SolarWinds cybersecurity incident, including the departments of State, Homeland Security, Treasury and Justice
  • $110 million increase for the DHS cybersecurity branch for a total of $2.1 billion

CRIMINAL JUSTICE

  • $1.6 billion budget to counter international and domestic terrorism, including $4 million for the National Institute of Justice research to find root causes for domestic terrorism threats
  • $2.1 billion for the Department of Justice to address gun violence, which is an increase of $232 million above 2021 enacted levels
  • $421 million for state and local grant programs that include efforts by states to craft gun licensing laws
  • $1 billion for Department of Justice Violence Against Women Act programs, which is nearly double 2021 enacted levels
  • $1.3 billion in community policing that includes $13.6 million in funds for Task Force Officer Body Worn Camera Support as a part of the $35.3 billion Department of Justice budget

HOUSING

  • $30.4 billion for Housing Choice Vouchers to expand housing assistance to 200,000 additional families, and a $500 million increase for Homeless Assistance Grants to support more than 100,000 households, including survivors of domestic violence and homeless youth
  • $85 million in grants to state fair housing agencies, a 16% increase from last year

DEFENSE

  • $112 billion for research and development, or a 5% increase from this year’s $106.6 billion request
  • The Pentagon is seeking to boost R&D of new technologies such as AI, microchips, and hypersonic weapons, shifting toward deterring China and Russia and away from decades-long counterterrorism operations in the Middle East
  • Army left out Boeing’s upgraded Chinook CH-47 helicopters from the budget, stating it will be included in a separate wish list sent to Congress later this year, but for the past two years Congress rejected the Army’s plans to curtail this program, key for transporting troops, supplies and artillery to the battlefield

VETERANS

  • $270 billion for the VA, a 10% increase from 2021
  • $621 million specific to the Department’s Opioid Prevention and Treatment programs
  • $81.5 million increase for the Digital GI Bill Modernization Effort, $5 million increase for the Veterans’ Clean Energy Job Training in conjunction with the Department of Labor and $3.6 million increase for the Disabilities Employment Pilot Project
  • $3.3 billion increase for medical care that includes additional $111.3 billion to be provided in advance appropriations for FY2023 (just as Congress did last year in providing $94.2 billion in FY2022 advance appropriations)
  • $4.8 billion for the VA's Office of Information Technology modernization efforts

TRANSPORTATION

  • $88 billion plus $76 billion under the American Jobs Plan – breaks down to $25.7 billion for discretionary funding (14.8% increase) and $62 billion for mandatory programs
  • 40% boost for the Federal Railroad Administration that includes $2.7 billion for Amtrak
  • $2.4 billion over three years for the U.S. Postal Service to electrify its fleet of vehicles

IMMIGRATION

  • $861 million in assistance to the Central America to address the root causes of irregular migration
  • Increases the budget of the Executive Office for Immigration Review by 21% to $891 million to reduce court backlogs and hire 100 new immigration judges and support teams
  • $2 billion more for HHS to care for unaccompanied migrant children following a record number of minors at the US-Mexico border this year – Administration for Children and Families within HHS, which is tasked with caring for migrant children, requested $3.3 billion for the unaccompanied children program, up $2 billion from fiscal year 2021, due to 17,847 children in HHS care, as of May 26
  • $30 million for a new "Separated Families Services Fund" to provide mental health and other services to families separated at the US southern border under the Trump administration.
  • Doubling the number of visas for Afghans who assisted the US during the war from 4,000 to 8,000 as the US pulls its military forces from Afghanistan

STEM EDUCATION FUNDING RESOURCES

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.

Department of Education

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.

National Science Foundation (NSF)

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 

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.

 Department of Energy

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. 

Department of Defense (DOD)

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.

National Oceanic and Atmospheric Administration (NOAA)

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.

Last updated on:
May 17, 2021

OVERVIEW

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.

BUDGET

American Rescue Plan Act Implementation – Coronavirus State and Local Fiscal Recovery Funds

Highlights of the funding included in the American Rescue Plan, which was enacted March 11, include:

  • $362 billion – State and local fiscal recovery, includes $100 million per state with U.S. territories and tribal governments each having their own allotment of $100 million to be split among them, for critical capital projects directly enabling work, education and health monitoring in response to COVID-19
  • $656.18 billion – Direct financial assistance to individuals, households and small businesses
  • $56.27 billion – Assistance to individuals and families
  • $211.57 billion – Education and childcare
  • $86.24 billion – Health
  • $40.16 billion – Transportation
  • $61.32 billion – Other programs, e.g., disaster relief, emergency food and shelter, firefighter assistance, emergency response staffing, emergency management performance grants, economic assistance programs, environmental justice grants, air pollution grants, emergency connectivity fund for schools and libraries, National Endowment for the Arts

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.

Eligible Uses

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.

Infrastructure – American Jobs Plan and American Families Plan

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:

American Jobs Plan - $2.9 trillion
  • $621 billion – Transportation: roads, bridges, public transit, rail, ports, waterways, airports and electric vehicles in service of improving air quality, reducing congestion and limiting greenhouse gas emissions. This includes $115 billion to modernize 20,000 miles of highways, roads and main streets; $20 billion to improve road safety for all users; and fix the "most economically significant large bridges" and repair the worst 10,000 smaller bridges. Another $80 billion would go to address Amtrak's repair backlog and modernization and $25 billion to airports and $17 billion to inland waterways, ports and ferries. Finally, this proposal funds electric vehicles with a $174 billion investment, giving consumers rebates and tax incentives to buy American-made electric vehicles and establishing grant and incentive programs to build a national network of 500,000 charging stations by 2030, and would also replace 50,000 diesel transit vehicles and electrify at least 20% of yellow school buses.
  • $400 billion – Homecare for aging and disabled Americans and access to long-term care services under Medicaid
  • $300 billion – Manufacturing: $50 billion for semiconductor manufacturing, $30 billion for medical manufacturing, $20 billion for regional innovation hubs that would support community-led projects, and $46 billion for federal purchases of electric cars, charging ports, and electric heat pumps for housing and commercial buildings that would boost the clean energy industry (related, Biden signed an executive order to boost American manufacturing by changing the rules regarding federal spending on American-made goods, equipment, vehicles and materials for infrastructure projects with a 180-day deadline that comes up in July)
  • $213 billion – Housing: building, renovating and retrofitting more than two million homes and housing units, plus build and rehabilitate more than 500,000 homes for low- and middle-income homebuyers
  • $180 billion – R&D to advance US leadership in critical technologies, upgrade our research infrastructure and establish America as a leader in climate science, innovation and research and development
  • $100 billion – Schools: to build new public schools and upgrade existing buildings with better ventilation systems, updated technology labs, and improved school kitchens that can prepare more nutritious meals, plus $12 billion would go to states to use towards infrastructure needs at community colleges
  • $100 billion – Digital infrastructure: to give every American access to affordable, reliable and high-speed broadband
  • $100 billion – Workforce development
  • $18 billion – Veterans’ hospitals modernization
American Families Plan - $1.8 trillion
  • $200 billion – Universal, high quality preschool to all 3- and 4-year olds
  • $109 billion – Two years of free community college to all Americans, including DREAMers
  • $62 billion – Help make college more affordable for low- and middle-income students, including Historically Black Colleges and Universities
  • $2.8 billion – Teachers: for Grow Your Own programs and year-long, paid teacher residency programs and to double scholarships for future teachers from $4,000 to $8,000 per year while earning their degree
  • $25 billion – Nutrition: for Summer Pandemic-EBT to make the successful program permanent, plus $1 billion for healthy foods incentive demonstration to support schools that are further expanding healthy food offerings
  • Paid leave and childcare assistance and unemployment insurance reform
  • Tax cuts for lower- and middle-income workers and families, including Child Tax Credit, the Earned Income Tax Credit, and the Child and Dependent Care Tax Credit, plus expanded health insurance tax credits

Emergency Security Supplemental to Respond to January 6th Appropriations Act

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:

  • $631.6 million – Reimbursing the National Guard, DC and Capitol Police for their response and subsequent presence at the Capitol, including equipment replacement, and wellness and trauma support
  • $39.5 million – Prosecuting the hundreds of perpetrators who attacked law enforcement and defiled the Capitol Complex
  • $529.7 million – Improving security by hardening windows and doors, constructing security screening vestibules, and installing new cameras
  • $200 million – Creating a dedicated Quick Reaction Force to augment the Capitol Police in cases of emergency
  • $130.6 million – Reimbursing Architect of Capitol and House of Representatives for enhanced cleaning, personal protective equipment, telework equipment, emergency supplies and essential overtime pay
  • $21.5 million – Enhancing security and threat assessments for Members of Congress via the House Sergeant-at-Arms that includes centralized coordination of Member Security while traveling and the installation of basic security and camera system in district offices
  • $18 million – Bolstering Capitol Police security with body cameras, specialized training and riot control equipment
  • $5 million – Requiring General Services Administration (GAO) security assessments