Lewis-Burke Health Highlights

House Votes to Advance Build Better Act, Includes Sweeping Healthcare Provisions

Congressional Budget Office Releases Cost Estimate for Build Back Better Legislation

Reps. DeGette, Upton Introduce 21st Century Cures 2.0 Act

Senate Republicans Challenge Vaccine Mandate

CDC Releases New Data on Overdose Deaths

AHRQ Holds November 2021 Meeting

PCORI Holds Annual Meeting

House Appropriations Subcommittee Holds Hearing to Address the U.S. Role in Global COVID-19 Vaccine Equity

CDC NIOSH Hosts Discussion on Mental Health of Healthcare Workers During COVID-19

Non-NIH Grants

**House Votes to Advance Build Better Act, Includes Sweeping Healthcare Provisions**

This morning, the House of Representatives voted 220-213 to send the Senate a $2.2 trillion reconciliation package, the Build Back Better Act, after a nearly nine-hour speech by Minority Leader Kevin McCarthy (R-CA) designed to stall the final vote. The Senate is expected to take up the bill after the Thanksgiving break. It is likely that the Senate will further modify the package in its size and scope as Democrats continue to disagree over issues including paid family leave and tax provisions. Democratic leadership in Congress plans to pass the legislation and send it to the President’s desk by the end of the year. More information on provisions included in the package is below.

An additional $1 billion, for a total of $2 billion, to support the construction and renovation of health centers and federally-qualified health center facilities.
$2 billion for the National Health Service Corps, in place of $650 million in the previous draft of the reconciliation package prepared by the House in September.
$500 million for the Nurse Corps, in place of $200 million in the previous draft.
$500 million for Schools of Medicine located in underserved areas, with a preference given to Minority-Serving Institutions, to support a variety of activities including the recruitment, enrollment, and retention of individuals from disadvantaged backgrounds and underserved areas, curriculum development, construction, and infrastructure modernization efforts.
$500 million for Schools of Nursing located in underserved areas to support a variety of activities including recruitment, enrollment, and retention of individuals from disadvantaged background and underserved areas, curriculum development, and infrastructure modernization efforts.
Increases in Graduate Medical Education slots to 4,000 from the 1,000 provided in the Consolidated Appropriations Act of 2021.
Creates a price negotiation program for prescription drugs in Medicare Part B and D. Drugs that would be subject to negotiation would be those representing the highest by gross spending, that are single-source drugs outside of their initial exclusivity periods (i.e., 9 years for small molecule drugs and 12 years for biologics), as well as insulin products. The bill provides the Secretary of Health and Human Services (HHS) the authority to negotiate the prices of up to 10 drugs for 2025, and then in each following year up to 20 drugs for 2028 and beyond. The bill would also limit out-of-pocket cost-sharing to $2,000 and additional cost-sharing assistance for insulin products by capping monthly co-pays at $35.
Modifies the Medicare Part D prescription drug program by limiting out-of-pocket costs for beneficiaries by requiring insurers to pay 65 percent of a brand drugs cost, and 75 percent of a generic drugs cost. When beneficiaries reach the catastrophic coverage gap, plans would be required to pay 60 percent of drug costs.
Improves access to vaccines for Medicare, Medicaid, and CHIP beneficiaries.

Congressional Budget Office Releases Cost Estimate for Build Back Better Legislation

According to a cost estimate by the Congressional Budget Office (CBO), the Build Back Better Act championed by Congressional Democrats and the White House will increase deficits by over $367 billion between 2022 and 2031. However, this figure does not include revenue generated by the tax enforcement provisions in the bill, because by rule, CBO does not estimate the effect of increased appropriations. However, CBO wrote that if Congress were to provide the Internal Revenue Service (IRS) with an additional $80 billion for tax enforcement, “revenues would increase by a total of $207 billion over the 2022-2031 period.”

The legislation would provide universal pre-K, subsidies for childcare and four weeks of subsidized paid family leave, increase premium assistance for the Affordable Care Act marketplaces, assist low-income families in states that refused to expand their Medicaid program, add a hearing benefit to Medicare, and allow Medicare to negotiate prescription drug prices. In total, the changes to the prescription drug benefit in Medicare Parts B and D in the bill would save nearly $300 billion over a ten-year period.

Reps. DeGette, Upton Introduce 21st Century Cures 2.0 Act
On November 16, Representatives Diana DeGette (D-CO) and Fred Upton (R-MI) introduced the long-awaited bipartisan 21st Century Cures 2.0 Act (Cures 2.0). Reps. DeGette and Upton have been working on Cures 2.0, a follow up to the landmark 2016 21st Century Cures Act, since at least December 2019, and the introduction of this bill follows the June release of a discussion draft and accompanying request for information (RFI). The legislation would authorize the creation of and $6.5 billion in funding for the Advanced Research Projects Agency for Health (ARPA-H), authorize funding for research relief through the Research Investment to Spark the Economy (RISE) Act, and include other provisions related to research, public health, and healthcare delivery. Given that Congress has many competing priorities in the coming months including completing the fiscal year (FY) 2022 appropriations process, it is unlikely that the legislation will become law before the end of the calendar year. Lewis-Burke’s full analysis of the bill is available here.

Senate Republicans Challenge Vaccine Mandate
Senators Chuck Grassley (R-IA) and Mike Braun (R-IN) filed a resolution under the Congressional Review Act (CRA) on behalf of Senate Republicans challenging the Biden Administration’s vaccination mandate for private businesses. On November 5, The Occupational Safety and Health Administration (OSHA) issued an Emergency Temporary Standard (ETS) requiring large employers to have their employees get vaccinated against the COVID-19 virus, or subject themselves to weekly COVID-19 testing. 

The CRA provides a process that allows Congress to challenge a rule issued by the administration. Under the CRA, members of Congress file a joint resolution of disapproval which is considered under expedited procedures. Congress would need to pass the resolution and the President would have to sign it into law to nullify the rule, which is unlikely in this case given the political circumstances.

Several legal challenges were filed against the mandate across the country. The Fifth Circuit Court of Appeals initially granted a temporary restraining order on the ETS. The cases will be consolidated, and arguments will be heard by the Sixth Circuit Court of Appeals.

CDC Releases New Data on Overdose Deaths
According to preliminary data from the Centers for Disease Control and Prevention (CDC), the United States has reached 100,000 deaths due to drug overdoses over a 12-month period for the first time. This data shows that Vermont saw the highest percent increase in this time period; the state saw an increase of nearly 70 percent, from 123 deaths in the twelve months leading up to April 2020 to 209 deaths the next year. In a statement, President Biden said, “my Administration is committed to doing everything in our power to address addiction and end the overdose epidemic. Through the American Rescue Plan, we’ve delivered nearly $4 billion to strengthen and expand services for substance use disorder and mental health.”

AHRQ Holds November 2021 Meeting
The Agency for Healthcare Research and Quality (AHRQ) held its quarterly meeting on November 17. The meeting focused on healthcare quality measurements and included an update on primary care research. The AHRQ Digital Healthcare Research Program announced their new research overview report, “Improving Healthcare Through AHRQ’s Digital Healthcare Research Program”, which summarizes the research activities and outcomes funded by this program in 2020. In 2020, the program supported 103 research grants and eight contracts for a total investment of $144.5 million, which included $37.4 million to strengthen patient engagement and shared decision-making, $65.3 million to support clinicians’ decision-making, and $41.8 million to improve the delivery of health services at the health systems level. In addition, the Digital Healthcare Research Program discussed its current and future initiatives focusing on how digital healthcare works best for key stakeholders, including patients, clinicians, and health systems. This program provides funding for digital healthcare research in primary care, including $68 million to improve primary care delivery on chronic conditions. Over the past five years, the program has funded 62 primary care grants focusing on topics such as artificial intelligence, clinical decision support, health information exchange, electronic health records, mHealth, and telemedicine in the primary care setting.

Similar to other health agencies like the National Institutes of Health (NIH) and the Centers for Disease Control and Prevention (CDC), AHRQ is interested in advancing its efforts in climate change and environmental justice and is seeking input from the public on how the agency could address climate change through health systems research, practice improvement, and data and analytics. A Request for Information (RFI) is currently open until December 13 to collect feedback on how AHRQ can help build the healthcare system’s resilience to climate threats, reduce the healthcare industry's contribution to climate change while increasing sustainability, and address environmental justice issues in healthcare.

PCORI Holds Annual Meeting
The Patient-Centered Outcomes Research Institute (PCORI) held its annual meeting to bring together researchers, patient advocates, clinicians, insurers, and health system executives to discuss the organization’s proposed principles in their National Priorities for Health platform. These priorities were released for comment in June and adopted by PCORI’s Board of Governors in October. The five principles are increasing evidence for interventions and emerging innovations in health, enhancing the infrastructure for accelerating patient-centered outcomes research, advancing health communication, achieving health equity, and accelerating progress toward an integrated learning health system. PCORI indicated that the five National Priorities for Health will serve as the foundation for developing their research agenda, including potential new funding opportunities, moving forward.

House Appropriations Subcommittee Holds Hearing to Address the U.S. Role in Global COVID-19 Vaccine Equity
Pandemic response leaders from the Biden Administration addressed the House Appropriations Subcommittee on Labor, Health and Human Services, Education, and Related Agencies (L-HHS-Ed) to testify at a hearing on the United States’ role in global COVID-19 vaccine equity. Subcommittee Chair Rosa DeLauro (D-CT) expressed concern about the lack of equity in distribution of COVID-19 vaccines around the world. In her opening remarks, she indicated that less than 5% of people in low-income countries have received their first dose, and some predictions indicate that low-income countries will not be fully vaccinated until 2023 unless production increases. Ranking Member Tom Cole (R-OK) shared the concern of Chair DeLauro, but argued that the U.S. should not have full responsibility for supplying vaccines to the world, and that the Department of Health and Human Services (HHS) should only serve in a supporting role to the Department of State and the United States Agency for International Development (USAID) in the deployment of vaccines. Both the Chair and the Ranking Member agreed that investment in biomedical research, biodefense infrastructure, and public health must continue in order to address the COVID-19 pandemic and future threats.

Witnesses at the hearing included Dr. Gary Disbrow, Director of the Biomedical Advanced Research and Development Authority (BARDA); Dr. David Kessler, Chief Science Officer of the COVID-19 Response; and Dr. Loyce Pace, Director of the Office of Public Affairs at HHS. All of the witnesses stressed that the U.S. has been pivotal in deploying vaccines globally. The U.S. has delivered over 250 million vaccines to 100 different countries, both directly and through the COVAX program with the World Health Organization (WHO). The goal now is to increase production and distribution of the two-step mRNA vaccines, and to urge other countries within the Group of 7 (G7) – Canada, France, Germany, Italy, Japan, and the United Kingdom – to also deliver a significant amount of COVID-19 vaccines around the world. The Biden Administration is currently working with Pfizer and Moderna on this effort. The witnesses also shared that they are working on a deal to deliver the Johnson & Johnson vaccine to areas of conflict where access is difficult. In addition to increasing vaccine production and encouraging other countries to support the effort to achieve vaccine global equity, Dr. Pace indicated that HHS is working to ensure that there is vaccine readiness in these other countries, including community engagement plans to encourage vaccine uptake, healthcare workforce training to get shots into arms, and addressing supply chain concerns.

CDC NIOSH Hosts Discussion on Mental Health of Healthcare Workers During COVID-19
The Centers for Disease Control and Prevention (CDC) National Institute for Occupational Safety and Health (NIOSH) hosted a webinar to discuss the mental health crisis facing healthcare workers and ways to provide support. NIOSH Director John Howard and Surgeon General Vivek Murthy joined the event to share challenges facing care providers and support staff amid to the COVID-19 public health emergency. Dr. Howard highlighted the CDC’s new Mental Health Initiative for Healthcare Workers focused on education and awareness to improve screening and support for mental health and substance use disorders. The panelists also discussed how mental health impacts are particularly severe among nurses, who had already experienced high burnout rates prior to the COVID-19 pandemic, and home health aides, the majority of whom are women and people of color. The CDC is accepting comments via a Request for Information until November 26 on evidence-based interventions to prevent or reduce work-based stress among health workers. NIOSH is expected to continue this focus on supporting healthcare workers as the impacts of the COVID-19 pandemic on the workforce progress.

Non-NIH Grants

OPPORTUNITY NUMBER	OPPORTUNITY TITLE	AGENCY NAME	CLOSE DATE
RFA-FD-22-003	Innovation Award: COVID-19 and Health Equity (U01) Clinical Trials Optional	Food and Drug Administration	11/29/2021
RFA-OH-22-004	World Trade Center Health Research related to WTC Survivors (U01-No Applications with Responders Accepted)	Centers for Disease Control and Prevention - ERA	12/7/2021
RFA-OH-22-003	Occupational Safety and Health Training Project Grants	Centers for Disease Control and Prevention - ERA	12/17/2021
RFA-CE-22-002	Grants to Support New Investigators in Conducting Research Related to Preventing Interpersonal Violence Impacting Children and Youth	Centers for Disease Control and Prevention - ERA	1/4/2022
RFA-CE-22-001	Grants to Support New Investigators in Conducting Research Related to Understanding Polydrug Use Risk and Protective Factors	Centers for Disease Control and Prevention - ERA	1/7/2022
CDC-RFA-DP22-2203	National Initiative to Advance Health Equity in K-12 Education by Preventing Chronic Disease and Promoting Healthy Behaviors	Centers for Disease Control - NCCDPHP	1/10/2022
RFA-PS-22-004	Understanding HIV/STD Risk and Enhancing PrEP Implementation Messaging in a Diverse Community-Based Sample of Gay, Bisexual, and Other Men Who Have Sex with Men in a Transformational Era	Centers for Disease Control and Prevention - ERA	1/18/2022
RFA-PS-22-001	Implementing Pre-exposure Prophylaxis for HIV Prevention in Syringe Service Programs	Centers for Disease Control and Prevention - ERA	1/18/2022
RFA-PS-22-002	Implementation Research on Telehealth Strategies to Support Retention in Care and Treatment among Antiretroviral Therapy (ART) Patients and Pre-exposure Prophylaxis (PrEP) Clients	Centers for Disease Control and Prevention - ERA	1/18/2022
RFA-CK-22-005	Vector-Borne Disease Regional Centers of Excellence	Centers for Disease Control and Prevention - ERA	1/18/2022
RFA-DP-22-002	Epidemiology of Lupus: Longitudinal Studies in Population-Based Cohorts	Centers for Disease Control and Prevention - ERA	1/19/2022
HRSA-22-024	Ryan White HIV/AIDS Program (RWHAP) Access, Care, and Engagement Technical Assistance Center (ACE TA Center)	Health Resources and Services Administration	1/21/2022
PA-20-074	Disseminating and Implementing Patient-Centered Outcomes Research (PCOR) Evidence into Practice through Interoperable Clinical Decision Support	Agency for Health Care Research and Quality	1/25/2022
RFA-DP-22-001	Real-world effectiveness of structured lifestyle interventions in preventing type 2 diabetes	Centers for Disease Control and Prevention - ERA	1/27/2022
RFA-CE-22-004	Research Grants to Prevent Firearm-Related Violence and Injuries (R01)	Centers for Disease Control and Prevention - ERA	2/4/2022
PAR-20-083	Enhancing Regulatory Science for Advancing Pharmaceutical Quality and Manufacturing (U01) Clinical Trials Optional	Food and Drug Administration	4/4/2022
PAR-20-105	Laboratory Flexible Funding Model (LFFM) (U19) Clinical Trials Not Allowed	Food and Drug Administration	4/6/2022
PA-18-794	AHRQ Small Research Grant Program (R03)	Agency for Health Care Research and Quality	7/6/2022
PA-18-795	AHRQ Health Services Research Projects (R01)	Agency for Health Care Research and Quality	7/6/2022
PA-17-232	AHRQ Mentored Clinical Scientist Research Career Development Award (K08)	Agency for Health Care Research and Quality	7/12/2022
PA-17-481	Agency for Healthcare Research and Quality (AHRQ)-sponsored National Research Service Award (NRSA)Individual Postdoctoral Fellowship (F32)	Agency for Health Care Research and Quality	8/8/2022
PA-20-028	Medication Safety: Advancing the Development of Improvement Strategies and Tools (R18)	Agency for Health Care Research and Quality	9/25/2022
PA-18-793	AHRQ Health Services Research Demonstration and Dissemination Grants (R18)	Agency for Health Care Research and Quality	9/29/2022
PAR-19-306	FDA Support for Conferences and Scientific Meetings (R13 Clinical Trial Not Allowed)	Food and Drug Administration	10/11/2022
PA-20-067	AHRQ Mentored Research Scientist Career Development Award (K01)	Agency for Health Care Research and Quality	11/13/2022
PA-20-068	Improving Quality of Care and Patient Outcomes During Care Transitions (R01)	Agency for Health Care Research and Quality	12/6/2022
PA-21-266	Patient Safety Learning Laboratories: Advancing Patient Safety through Design, Systems Engineering, and Health Services Research (R18 Clinical Trial Optional)	Agency for Health Care Research and Quality	1/26/2023
PA-18-765	AHRQ Health Services Research Dissertation Program (R36)	Agency for Health Care Research and Quality	5/1/2023
PAR-21-178	Drug Development Tools Research Grants (U01) Clinical Trial Optional	Food and Drug Administration	5/3/2023
PA-21-202	AHRQ/PCORI Learning Health System Small Grant Pilot Program	Agency for Health Care Research and Quality	6/19/2023
PAR-18-604	Vet-LIRN Network Capacity-Building Projects	Food and Drug Administration	9/2/2023
PAR-18-799	K01 Mentored Research Scientist Development Award	Centers for Disease Control and Prevention - ERA	11/17/2023
PAR-18-798	NIOSH Exploratory/Developmental Grant Program (R21)	Centers for Disease Control and Prevention - ERA	11/17/2023
PAR-18-797	NIOSH Small Research Grant Program	Centers for Disease Control and Prevention - ERA	11/17/2023
PAR-18-812	Occupational Safety and Health Research (R01)	Centers for Disease Control and Prevention - ERA	11/17/2023
PAR-21-179	Minor Use Minor Species Development of Drugs (R01)	Food and Drug Administration	2/2/2024
RFA-FD-22-001	Efficient and Innovative Natural History Studies Addressing Unmet Needs in Rare Diseases (R01) Clinical Trials Not Required	Food and Drug Administration	2/13/2024
PA-21-267	Making Health Care Safer in Ambulatory Care Settings and Long-term Care Facilities (R18)	Agency for Health Care Research and Quality	5/26/2024
PA-21-164	Using Innovative Digital Healthcare Solutions to Improve Quality at the Point of Care (R21/R33 - Clinical Trial Optional)	Agency for Health Care Research and Quality	7/17/2024
PA-21-264	Large Health Services Research Demonstration and Dissemination Projects for Prevention of Healthcare-Associated Infections (R18)	Agency for Health Care Research and Quality	5/26/2025
PA-21-265	Large Research Projects for Prevention of Healthcare-Associated Infections (R01)	Agency for Health Care Research and Quality	5/26/2025
PA-22-048	Large Health Services Research Demonstration and Dissemination Projects for Combating Antibiotic-Resistant Bacteria (CARB)(R18)	Agency for Health Care Research and Quality	10/30/2026
PA-22-047	Large Research Projects for Combating Antibiotic-Resistant Bacteria (CARB) (R01)	Agency for Health Care Research and Quality	10/30/2026