We will update you on the federal budget process which includes a detailed spending plan. Each fiscal year (FY) runs from October 1 through September 30 of the following year. As authorized by the Constitution, Congress is in charge of deciding the budget, granting the power to collect taxes, borrow money and approve spending.
July
July 2023– The House Appropriations Committee lowered the boom on the FY 2024 Labor-HHS-Education (L-HHS) Republicans Take Democrats Take and Interior-Environment (Int-Env) Republicans Take Democrats Take appropriations bills this week, introducing measures that cut funding for programs dramatically below their FY 2023 levels. You can watch both subcommittee markups and retrieve additional information here: Subcommittee Markup of Fiscal Year 2024 Labor=-HHS-Education Subcommittee Markup of Fiscal Year 2024 Interior/Environment.
The House Labor-HHS-Education appropriations subcommittee-reported bill recommends:
- A 28% cut below the FY 2023 funding level for the bill overall.
- Cuts funding for the Centers for Disease Control and Prevention by $1.6 billion (18%) below the FY 2023 level.
- Reduces funding for CDC’s National Center for HIV, Viral Hepatitis, STD, and TB Prevention (NCHHSTP) by $200 million. Eliminates funding for the Ending the HIV Epidemic initiative.
- Reduces funding for the CDC’s National Center for Chronic Disease Prevention and Health Promotion (NCCDPHP) by $600 million, eliminates CDC’s Office on Smoking and Health, and likely dramatically reduces or eliminates other NCCDPHP chronic disease programs. More details will be available when the committee report is published.
- Cuts funding for the National Institutes of Health by $3.8 billion.
- Reduces funding for the National Cancer Institute by $2 billion.
- Cuts several specific NIH institutes such as NIAID, NINDS, and others.
- Level funds several institutes/centers such as NHLBI, NIDDK, NIAMS, NIMHD, NCATS.
- Reduces funding for ARPA-H by $1 billion.
- Eliminates the Agency for Healthcare Research and Quality.
- Eliminates HRSA healthcare workforce diversity programs including the Centers of Excellence (COE) and Health Careers Opportunity Program (H-COP).
- Cuts the Department of Education budget by $12 billion (15%) below the FY 2023 level.
- A litany of controversial policy riders.
The House Interior/Environment appropriations subcommittee-reported bill recommends:
- A 14% cut below the FY 2023 funding level for the bill overall.
- Cuts funding for the Environmental Protection Agency (EPA) by $4 billion (40%).
- Reduces funding for EPA environmental programs by $857 million (26%).
- Reduces the Hazardous Substance Superfund program by $927 million (72%).
- A myriad of controversial policy riders.
June
June 2023- Late last week, the Senate Appropriations Committee held a markup of the Fiscal Year (FY) 2024 Military Construction, Veterans Affairs, and Related Agencies (MilCon-VA) Appropriations Bill; the Agriculture, Rural Development, Food and Drug Administration, and Related Agencies (Ag-FDA), Appropriations Bill, and the 302(b) subcommittee allocations.
All measures before the Senate Appropriations Committee were approved during the markup and reported out of committee. The FY24 Senate MilCon-VA and Ag-FDA bills were not considered in subcommittee before the full committee markup. The markup schedule for remaining bills in the House and Senate is unclear.
Additional information on the FY24 Senate MilCon-VA Bill and Report, FY24 Senate Ag-FDA Bill and Report, and FY24 Senate 302(b) allocations can be found here.
Key overarching items from the markup include:
MilCon-VA
- $121.01 billion for the Veterans Health Administration, a proposed increase of $1.35 billion over FY23
- $938 million for VA Medical and Prosthetic Research, a proposed increase of $22 million over FY23.
Ag-FDA
- $6.63 billion for the Food and Drug Administration (including discretionary appropriations and user fees), a proposed increase of $62.24 million over FY23.
- $416.24 million (not including user fees) for the Center for Food Safety and Applied Nutrition at FDA, an increase of $14.38 million over FY23.
- $515.75 million (not including user fees for the Center for Drug Evaluation and Research, a decrease of $35.75 million from FY23.
- $218.89 million (not including user fees) for the Center for Biologics Evaluation and Research, a decrease of $4.58 million from FY23.
- $150.53 million (not including user fees) for the Center for Veterinary Medicine, an increase of $2.4 million over FY23.
- $355.74 million (not including user fees) for the Center for Devices and Radiological Health, a decrease of $324 thousand from FY23.
- $1.34 billion in Prescription Drug User Fees, an increase of $26.21 million over FY23.
- $331.27 million in Medical Device User Fees, an increase of $6.5 million over FY23.
- $594.15 million in Human Generic Drug User Fees, an increase of $11.65 million over FY23.
- $42.43 million in Biosimilar User Fees, an increase of $832,000 over FY23.
- $33.5 million in Animal Drug User Fees, an increase of $1.36 million over FY23.
- $25 million in Generic Animal Drug User Fees, a decrease of $4.3 million from FY23.
- $712 million in Tobacco Product User Fees, level-funded from FY23
January
January 2023- House Republicans are floating a new proposal to buy more time to negotiate spending cuts through needed congressional action to raise the debt ceiling. The general concept prioritizes short-term extensions to align the dates for a comprehensive debt ceiling fix with the enactment of the Fiscal Year (FY) 2024 spending bills. Democrats prefer a “clean” fix to the debt ceiling but have asked Republicans for more details on the plan before any negotiations can take place. “Roll Call” has a timely summary.
Details on the administration’s FY 2024 budget request to Congress remain sparse. Legislators continue to contact the administration to feature certain priorities and programs, but few details have been released at this point. The lack of information is leading many to speculate the budget request will not be released on the first Monday in February and will likely delayed (possibly until March). More information will be known during President Biden’s upcoming State of the Union Address the evening of Tuesday, February 7th.
August
August 2022- During the week of August 1st , Senate Appropriations Committee Chairman Patrick Leahy (D-VT) released “Chairman’s Marks” of the twelve annual Fiscal Year (FY) 2023 appropriations bills. The Senate appropriations bills call for meaningful ongoing investments in medical research, public health, patient care, and education programs. In addition to the annual funding measures, Chairman Leahy and subcommittee chairs introduced a $21 billion emergency supplemental appropriations bill to address the COVID-19 pandemic.
Absent an overarching agreement on topline numbers for FY 2023 appropriations accounts though (defense vs. non-defense), there is tremendous flexibility in final funding for key programs despite the current support in both House and Senate drafts.
Of particular interest to the gastrointestinal community, the FY 2023 Senate appropriations bills include:
National Institutes of Health (NIH)
- $2.43 billion for the National Institute of Diabetes & Digestive & Kidney Diseases (NIDDK), a proposed increase of $79.56 million over FY 2022 and level with the House proposal.
- $174.31 million for the National Center for Complimentary and Integrative Health (NCCIH), a proposed increase of $14.94 million over FY 2022 and $9.91 million more than the House proposal.
- $907.76 million for the National Center for Advancing Translational Sciences (NCATS), a proposed increase of $25.49 million over FY 2022 and $6.08 million more than the House proposal.
- $2.56 billion for the Office of the Director, a proposed decrease of $60.00 million below FY 2022 and $20.00 million more than the House proposal, including $707.40 million for the Common Fund, a proposed increase of $50.00 million over FY 2022 and $29.25 more than the House proposal.
Department of Defense (DoD)
- $370 million for the Peer-Reviewed Medical Research Program, level funded with FY 2022.
- $130 million for the Peer-Reviewed Cancer Research Program, level funded with FY 2022 and level with the House proposal.
Food and Drug Administration (FDA)
- $1.19 billion for the Center for Food Safety and Applied Nutrition and related field activities, a proposed increase of $52.36 million over FY 2022 and $50.00 million less than the House proposal.
Other items of interest include:
Labor-HHS-Education
- $9.67 billion for the Health Resources and Services Administration (HRSA), an increase of $780.42 million over FY 2022 and $97.42 million more than the House.
- $10.5 billion for the Centers for Disease Control and Prevention (CDC), an increase of $2.04 billion over FY 2022 and roughly the same amount proposed by the House.
- $46.96 billion for the National Institutes of Health (NIH), an increase of $2 billion over FY 2022 and $500 million less than the House.
- $2 billion for the Advanced Research Projects Agency for Health (ARPA-H), an increase of $1 billion over FY 2022 and $750 million less than the House. The Senate proposal includes ARPA-H funding within NIH funding while the House proposal has them funded as separate entities and they are separated in this memo for the sake of clarity and comparison.
- $9.15 billion for the Substance Abuse and Mental Health Services Administration (SAMHSA), an increase of $2.6 billion over FY 2022 and roughly the same amount as the House.
- $385.4 million for the Agency for Healthcare Research and Quality (AHRQ), an increase of $35 million over FY 2022 and roughly the same amount as the House.
Department of Defense
- $37.62 billion for the Defense Health Program (DHP), an increase of $370 million over FY 2022 and $450 million less than the House.
- $370 million for the Peer-Reviewed Medical Research Program (PRMRP), level-funded from FY 2022. This program is traditionally not included in the House appropriations bill.
Emergency Supplemental Funding
- $16 billion in additional funding to sustain the public health response to COVID-19.
- $9 billion for the Biomedical Advanced Research and Development Agency (BARDA), to procure vaccines, therapeutics, tests, and diagnostics, and medical supplies
- $6.25 billion in flexible funding to allow the Department of Health and Human Services (HHS) to purchase and distribute vaccines, therapeutics, and diagnostics.
- o $750 million for research and clinical trials to continue to identify and respond to emerging COVID-19 strains.
- $5 billion to sustain the global COVID-19 response.
- $82 million in additional funding to establish the HHS Coordination Operations and Response Element (H-CORE) to synchronize and coordinate (annually) the response to COVID-19 and other emerging public health threats.
Relevant Report Language
Dietary Supplements.—The Committee supports FDA’s proposal to require that all products marked as dietary supplements be listed with FDA, including basic information about these products. Further, the Committee believes that the FDA’s authorities over products marketed as dietary supplements should be clarified to facilitate enforcement against unlawfully marketed products. This would allow FDA to know when new products are introduced to the market, quickly identify dangerous or illegal products on the market, and take action to protect consumers.
Medical Foods.—The Committee recognizes the unique role medical foods play in the nutritional management of inborn errors of metabolism and encourages a flexible regulatory process that would enhance access to safe medical foods for individuals with serious or life-threatening inborn errors of metabolism. The Committees encourages the FDA to continue focusing on this issue.
Peer-Reviewed Medical Research Program.—The Committee recommends $370,000,000 for the Peer-Reviewed Medical Research Program. The Committee directs the Secretary of Defense, in conjunction with the Service Surgeons General, to select medical research projects of clear scientific merit and direct relevance to military health. Research areas (relevant to GI) considered under this funding are restricted to: Alzheimer’s; celiac disease; dystonia; eating disorders; Ehlers-Danlos syndrome; food allergies; gulf war illness; inflammatory bowel diseases; interstitial cystitis; lupus; malaria; maternal mental health; non-opioid therapy for pain management; pancreatitis; Parkinson’s; peripheral neuropathy; polycystic kidney disease; pressure ulcers; scleroderma; sleep disorders and restriction; along with many other disease states. The Committee emphasizes that the additional funding provided under the Peer-Reviewed Medical Research Program shall be devoted only to the purposes listed above
Chronic Pain Management Research.—The Committee recommends $15,000,000 for a chronic pain management research program to research opioid-alternative or non-addictive methods to treat and manage chronic pain. Chronic pain is defined as a pain that occurs on at least half the days for 6 months or more and which can be caused by issues, including but not limited to: combat- and training-related physical or mental stress and trauma, migraines and chronic headaches, traumatic brain injury, arthritis, muscular-skeletal conditions, neurological disease, tick and vectorborne disease, other insect-transmitted or tropical disease, and cancer. The funds provided in the chronic pain management research program shall be used to conduct research on the effects of using prescription opioids to manage chronic pain and for researching alternatives, namely non-opioid or non-addictive methods to treat and manage chronic pain, with a focus on issues related to military populations.
Pain Management.—The Committee includes an additional $10,000,000 to support research into non-pharmacological treatments for pain management and urges NCCIH, along with DoD and the VA to continue to support research, including comorbidities such as opioid use disorder in military personnel, veterans, and their families. Committee urges NIH, VA, and DOD to support and expand research on non-pharmacological treatments to ensure the best quality of care for our Nation’s veterans and service members.
Office of Nutrition Research.—The Committee provides $25,000,000 for the Office of Nutrition Research to support the recent efforts at NIH to prioritize nutrition research across Institutes and Centers. These funds will support the resources needed to effectively operate as a trans-NIH entity and fully operationalize the first NIH-wide strategic plan for nutrition research.
Lowering the Cost of Care.—The Committee encourages CMMI to consider creative pilot projects that lower the cost of care among older Americans and enable individuals that retire overseas to retain and utilize their Medicare primary healthcare benefits. The pilot should consider potential cost savings involving international collaborations where the quality of care is comparable and less expensive. CMS shall provide an update on this effort in the fiscal year 2024 CJ.
Pain Management.—The Committee remains deeply concerned about the epidemic of acute and chronic pain, including its interrelationship with the opioid crisis. The COVID–19 pandemic has exacerbated these problems. As recommended in the HHS Pain Management Best Practices Inter-Agency Task Force report [Task Force report], the Committee urges the Department to coordinate with the Departments of Defense [DoD] and Veterans Affairs [VA] to launch a public awareness campaign to educate Americans about the differences between acute and chronic pain and available evidence-based non-opioid treatment options. The Committee again urges the Department to widely disseminate the report’s recommendations, including the importance of individualized, multidisciplinary, patient-centered care in the treatment of pain to healthcare providers and other public health stakeholders, including but not limited to State public health departments, medical licensing boards, medical schools, and VA facilities, and to update relevant pain management policies and educational tools to reflect Task Force recommended best practices across all relevant HHS agencies. The Committee directs the Department to provide the Committees on Appropriations a report on its progress to disseminate the Task Force report’s recommendations as well as resources required to generate a public awareness campaign on the differences between acute and chronic pain and the full range of treatment options in the Task Force report within 180 days of enactment of this act.
May
May 6, 2022- H.R.7667 – Food and Drug Amendments of 2022. The House has introduced bipartisan legislation to reauthorize user fees at FD to amend the Federal Food, Drug, and Cosmetic Act to revise and extend the user-fee programs for prescription drugs, medical devices, generic drugs, and biosimilar biological products, and for other purposes. The bill can be viewed here.
July
July 2021- DEPARTMENTS OF LABOR, HEALTH AND HUMAN SERVICES, AND EDUCATION, AND RELATED AGENCIES APPROPRIATIONS BILL, 2022
The Committee includes an increase of $3,500,000 to expand public health education and awareness activities that help to improve surveillance, diagnosis, and proper treatment for chronic diseases. This competitive grant program expands and advances CDC’s work with stakeholders on education, outreach, and public awareness activities for a variety of chronic diseases for which there is a clear disparity in public and professional awareness that are not already specified under CDC in this report. The line item now calls for $5,000,000 for Chronic Disease Education and Awareness.
June
At the end of May, President Biden released its comprehensive Fiscal Year 2022 (FY22) Budget Request to Congress. Below, please find a summary of key funding items from this Budget Request:
- $107.45 billion in discretionary funding for the U.S. Department of Health and Human Services (HHS), a requested increase of $24.35 billion over FY21 (and $1.5 trillion in total funding for HHS). FY22 HHS Budget Request
- $6.53 billion in total funding for the Food and Drug Administration (FDA), a requested increase of $477 million over FY21. FY22 FDA Budget Request
- $12.55 billion in total funding for the Health Resources and Services Administration (HRSA), a requested increase of $497 million over FY21. FY22 HRSA Budget Request
- $15.41 billion in total funding for the Centers for Disease Control and Prevention (CDC), a requested increase of $1.44 billion over FY21. FY22 CDC Budget Request
- $51.95 billion in total funding for the National Institutes of Health (NIH), a requested increase of $9.03 billion over FY21, which includes $6.5 million for the new Advanced Research Project Agency for Health (ARPA-H) within NIH. FY22 NIH Budget Request
- $489 million for the Agency for Healthcare Research and Quality (AHRQ), a requested increase of $53 million over FY21. FY22 AHRQ Budget Request
It is important to note that the budget request also includes broad legislative proposals related to affordable health care/insurance coverage and access, including:
- Prescription Drug Costs– Allowing Medicare to negotiate payments for certain high-cost drugs and requiring manufacturers to pay rebates when drug prices rise faster than the inflation rate.
- Strengthening Medicare, Medicaid, and ACA Coverage– Making Medicaid more accessible and also lowering deductibles for ACA marketplace plans.
- Creating Additional Public Coverage Options– Creating a public coverage option that would be available through ACA exchanges while lowering the age of Medicare Eligibility to 60. Also, providing Medicaid-like coverage through the exchanges in states that have not expanded Medicaid.
Of specific interest to the digestive health community, the FY22 Budget Request includes:
Centers for Disease Control and Prevention
- $15.41 billion in total funding for CDC, a requested increase of $1.44 billion over FY21.This includes $1.45 billion for Chronic Disease Prevention and Health Promotion, an increase of $176 million over FY21.
- $1.5 million for the CDC Chronic Disease Education and Awareness Program, level funded from FY21.
National Institutes of Health
- $51.95 billion in total funding for NIH, a requested increase of $9.03 billion over FY21, which includes $6.5 billion for the new Advanced Research Project Agency for Health (ARPA-H) within NIH.
- $2.36 billion for the National Institute of Diabetes and Digestive and Kidney Diseases, an increase of $78.82 million over FY21.
- $878.96 million for the National Center for Advancing Translational Sciences, an increase of $23.54 million over FY21.
- $2.39 billion for the Office of the Director, an increase of $110.99 million over FY21, which includes $658.54 million for the Common Fund, an increase of $10 million over FY21.
Department of Veterans Affairs
- $70.32 billion for VHA Medical Services, an increase of $2.34 billion over FY21.
- $6.73 billion for VA Medical Facilities, an increase of $151.41 million over FY21.
- $882 million for VA Medical and Prosthetic Research Program, an increase of $87 million over FY21.
Department of Defense
- $35.6 billion for the Defense Health Program, an increase of $2.5 billion over FY21.
The DoD request traditionally does not include programs supported by the Congressionally Directed Medical Research Programs.
NIH Significant Items
ARPA-H- The FY 2022 President’s Budget provides $6.5 billion to establish ARPA-H as a new research entity within NIH. ARPA-H will complement the research portfolio of NIH’s existing Institutes and Centers, investing in breakthrough health technologies and strategies to accelerate the development of evidence-based, real-world-driven cures for and transformative advances in a range of biomedical and health research areas and diseases.
Gastroparesis Clinical Research Consortium – In people with gastroparesis, stomach muscles that grind food into pieces for digestion in the adjoining small intestine work poorly, and the stomach takes too long to empty its contents. This “delayed gastric emptying” can cause chronic nausea, vomiting, and abdominal pain, often leading to malnutrition, dehydration, and other serious complications. Diabetes, surgery, and other conditions are known to cause gastroparesis in some people, but often the causes are unknown, which makes the development of treatments more challenging. In 2006, NIDDK established the multi-center Gastroparesis Clinical Research Consortium to accelerate research on the causes and progression of this disorder and to explore new treatment approaches. The Consortium includes a Gastroparesis Registry—the largest clinical and physiologic data repository on adult gastroparesis in the world. Women make up the majority of participants, reflecting the higher incidence of gastroparesis in this group. Over the years, the Consortium has undertaken several trials to characterize gastroparesis and test new approaches to diagnosis and treatment. For example, a recent study of people in the Registry with both diabetes and symptoms of gastroparesis found that those with delayed gastric emptying had a higher number of diabetic complications than those with normal gastric emptying. Consortium researchers found that the balance of parasympathetic (active during rest) and sympathetic (active during stress) nervous system functioning is disrupted in many people with gastroparesis. Using information from the Registry, Consortium researchers studied people who underwent treatment with gastric electrical stimulation and determined that this procedure was effective for treating nausea in people with more severe gastroparesis. The Consortium was recently continued for an additional five years, including support for the first U.S.-based registry of children and adolescents with gastroparesis, ancillary studies, and a repository of samples to allow further studies of disease processes and biomarker identification
Digestive Diseases and Nutrition – The objectives of this program are to enhance understanding of liver and other digestive diseases, nutrition, and obesity, and to develop and test strategies for disease prevention and treatment. This program supports basic, clinical, and translational research, as well as research training, encompassing fundamental studies of the digestive system, disease-targeted research involving the esophagus, stomach, small intestine, large intestine and anorectum, liver and biliary system, and pancreas, studies relevant to nutrition and eating disorders, and research on obesity. In FY 2022, NIDDK will continue to support research aimed at improving the prevention and treatment of diseases associated with the digestive system. For example, recent NIDDK-supported research on therapeutic approaches to inflammatory bowel disease have found a tell-tale combination of cells in people with Crohn’s disease who do not respond to one of its most effective treatments, targeting a component of the inflammatory response called tumor necrosis factor.36 Another study showed that high levels of a common fungus in the gut could signal whether a microbe-based treatment called fecal microbiota transplantation would be successful for people with ulcerative colitis.37 Other NIDDK- supported digestive disease researchers have developed a new mouse model that mimics the immune system features and gluten-dependent intestinal damage seen in people with celiac disease, providing a new research tool for discovering and testing therapies.38 A number of recent advances by investigators in the NIDDK’s International Study Group of Pediatric Pancreatitis: In Search for a Cure study, part of the Consortium for the Study of Chronic Pancreatitis, Diabetes, and Pancreatic Cancer, have enhanced understanding of pancreatitis development and management in children.39 Among advances in research on liver diseases, scientists working on biliary atresia, a severe and potentially deadly childhood liver disease, found that a newborn screening approach could identify those with the disease and enable earlier diagnosis and treatment, and another group identified a unique gene activity signature for this disease that predicts survival and could inform new treatment approaches.40 NIDDK has supported research to discover that consuming high amounts of fructose, such as in foods containing the additive high-fructose corn syrup, may promote nonalcoholic fatty liver disease through damaging the intestinal barrier.41 In research on obesity, scientists have found that people with severe obesity who underwent bariatric surgery had significantly more short- and long-term weight loss compared to those who did not have surgery. 42 Guided by the recently released Strategic Plan for NIH Nutrition Research, NIDDK seeks to accelerate progress in research on nutrition by funding studies on new technologies to sample and monitor nutrients, metabolites, hormones, and the gut, including its resident microbes.43 Advances in these areas will pave the way for improvements in the prevention, diagnosis, and treatment of digestive diseases in FY 2022 and beyond.
NIDDK Director’s Overview – The mission of the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) is to support and conduct research to combat diabetes and other endocrine and metabolic diseases; liver and other digestive diseases; nutritional disorders; obesity; and kidney, urologic, and hematologic diseases. The Institute’s mission includes some of the most chronic, common, and costly diseases and conditions affecting the U.S. population, as well as other conditions that are less widespread but still devastating. Diabetes affects an estimated 34.2 million people in the United States, greatly increasing the risk for many serious complications, such as heart disease and kidney failure. Estimates of chronic kidney disease (CKD) show that about 37 million Americans are affected, and over 783,000 people were treated for irreversible kidney failure in the Nation in 2018. Many urologic diseases, such as urinary incontinence, urinary tract infections, and benign prostatic hyperplasia, are also highly prevalent. Digestive diseases accounted for an estimated 66.4 million ambulatory care visits to doctor’s offices, outpatient hospital clinics, and emergency departments in 2016, as well as 15.9 million hospitalizations with digestive diseases as a primary or secondary diagnosis. Obesity affects more than 40 percent of U.S. adults and over 18 percent of children and adolescents. It is a strong risk factor for type 2 diabetes; fatty liver disease, including nonalcoholic steatohepatitis; and many other diseases. Cystic fibrosis and other genetic diseases within NIDDK’s purview are less common, but still severe in their impacts. Building on emerging opportunities from past research investments, our Institute will continue its vigorous pursuit of research to combat the diseases and disorders within its mission, being guided by the following priorities: maintain a vigorous investigator-initiated research portfolio, support pivotal clinical studies and trials, promote a steady and diverse pool of talented new investigators, foster exceptional research training and mentoring opportunities, and ensure knowledge dissemination through outreach and communications.
April
April 19, 2021- A traditional comprehensive and detailed administration budget request is expected to be released in mid-May. Highlights of President Biden’s FY 2022 topline budget request include:
- $905 million for the Strategic National Stockpile. (Office of the Assistant Secretary for Preparedness and Response (ASPR) and the Food and Drug Administration (FDA). The discretionary request proposes $905 million for ASPR’s Strategic National Stockpile (SNS) to maintain replenishment of critical medical supplies and restructuring efforts initiated during the COVID-19 pandemic. The Administration would ensure SNS investments position the Nation to respond to the most likely chemical, biological, radiological, and nuclear threats as opposed to simply restocking expired material. In addition, the Administration would make investments to enhance FDA’s organizational capacity.)
- $153 million for the Social Determinants of Health Program at CDC, an increase of $150 million over FY 2021. (This program is designed to promote Health Equity by Addressing Racial Disparities. The request builds on the American Rescue Plan Act of 2021 to advance equity and reduce health disparities in all healthcare programs. It also provides additional funding to increase the diversity of the healthcare workforce and expand access to culturally competent care and includes $153 million for CDC’s Social Determinants of Health program, an increase of $150 million over the 2021 enacted level, to support all States and Territories in improving health equity and data collection for racial and ethnic populations)
April 12, 2021– Last week, the White House issued its top-line discretionary spending proposal for FY 2022. The blueprint provides less detail than a typical budget submission. A more detailed proposal is expected in mid-to-late May. Highlights of the blueprint include proposed spending increases on domestic discretionary programs such as public health, research, education, and the environment; with less of an emphasis on security/defense spending.
- $8.7 billion in budget authority for the Centers for Disease Control and Prevention (CDC), an increase of $1.6 billion over FY 2021. Combined with annual funding from HHS’s Prevention and Public Health Fund, this would push CDC’s annual program level toward the $10 billion mark.
- $51 billion for the National Institutes of Health (NIH), an increase of $9 billion. The NIH budget proposal includes creation of a new Advanced Research Projects Agency for Health (ARPA-H) housed with NIH and supported by a requested $6.5 billion budget.
- $670 million for the Ending the HIV Epidemic initiative, an increase of $267 million above FY 2021.
- $10.7 billion to address the national opioid crisis, an increase of $3.9 billion above FY 2021.
- An additional $600 million annually to support Historically Black Colleges and Universities and other Minority-Serving Institutions through the Department of Education, and additional investments in HBCU/MSIs at other agencies.
- $882 million for the VA Medical and Prosthetic Research Program, an increase of $67 million over FY 2021.
Learn more at FY2022-Discretionary-Request.pdf (whitehouse.gov) summary, and also the White House Press Release.
March
March 26, 2021 – The administration announced this week that it will issue a top-line Fiscal Year 2022 discretionary spending budget proposal the week of March 29th. It is not fully clear how much detail the proposal will contain, but it will provide enough guidance to enable Congress to get to work on the FY 22 spending bills when it returns.
March 25, 2021 – House Representatives André Carson (D-IN), David McKinley (R-WV), Suzan DelBene (D-WA), and Brian Fitzpatrick (R-PA) are circulating a “Dear Colleague” letter encouraging House appropriators to provide “at least $46.1 billion” for the National Institutes of Health for FY 2022. The letter is consistent with the FY 2022 funding recommendation being made by the scientific and patient community.
March 19, 2021 -The House Appropriations Committee announced subcommittee deadlines for House member appropriations for April 29th. The committee also announced the general framework for requesting community project funding or “earmarks” for FY 2022. The requesting entity must be a non-profit organization and funds are limited to a few specific health and education accounts in the Labor-HHS-Education appropriations bill. Additional information can be found here: House Appropriations Requests
March 4, 2021 -The president and Congress continue to focus on the administration’s American Rescue Plan, which includes COVID-19 economic relief and related spending. View the Senate Committee on the Budget American Rescue Plan Act Summary for more information.
February
February 24, 2021 – The House Labor, Health & Human Services, Education and Related Agencies Appropriations Subcommittee will hold a hearing Wednesday, Feb. 24th at 10 AM EST to examine our nation’s public health infrastructure. Witnesses include state health officials who will relay the challenges presented by the current pandemic and offer recommendations to prepare the country for ongoing public health challenges. View the hearing and related information here.
February 12, 2021 – The CDC Coalition led by the American Public Health Association recommends a FY 2022 funding level of $10 billion for the Centers for Disease Control & Prevention—representing a $2.2 billion increase over FY 2021.
February 11, 2021 – House authorizing committees marked up reconciliation bills this week to correspond with the recently passed budget resolution responding to the Biden COVID-19 American Rescue Plan. Committees have released information regarding their hearings on the legislation. Click on the committee links below to be directed to the corresponding information. Floor considerations of the legislation may begin the week of Februrary 22nd.
House Energy & Commerce
House Ways & Means Committee
House Education & Labor Committee
House Small Business Committee
February 5, 2021 – Congressional committees of jurisdiction will work during the next several weeks to craft corresponding legislative provisions in hopes of advancing the Biden American Rescue Plan COVID-19 relief package to floor consideration starting in late February.
January
January 22, 2021 – An official budget proposal from the Biden Administration for Fiscal Year 2022 may be released in March 2021.
January 20, 2021 – The Biden administration and Democrats in the House and Senate are focused on pushing forward the Biden Emergency COVID Relief Package Proposal, titled the American Rescue Plan. It is possible the legislation could be passed in several pieces.
January 14, 2021 – President-elect Biden issued step one of a two-part emergency legislative proposal for COVID-19 relief targeting working families, vaccine distribution, COVID-19 testing, small business support, educational relief, and racial health inequities. Leaders in the House and Senate have vowed swift action on the proposal. Key measures include:
- $1,400 stimulus checks for most Americans
- Ongoing support for the Paycheck Protection Program (PPP) and small business relief
- $20 billion for COVID-19 vaccine distribution and $50 billion to ramp up COVID-19 testing
- $350 billion for cities, states, and local governments
- Funding to provide healthcare services in medically underserved communities and respond to ethnic health disparities
- $35 billion to expand the Higher Education Emergency Relief Fund
December
December 30, 2020 – President Trump signed the omnibus spending measure which contains all 12 annual Fiscal Year (FY) 2021 appropriations bills, the $900 billion COVID-19 economic stimulus package, and other legislative provisions.
December 29, 2020 – The House passed legislation to increase economic stimulus payments for many Americans to $2,000, enhancing the $600 checks contained in the above-mentioned stimulus package, but the Senate has not taken up that legislation and it is unclear when or if it will.
December 18, 2020 – The $1.4 trillion omnibus appropriations bill incorporating all 12 annual FY 2021 spending measures is close to completion. Work continues on the COVID-19 economic stimulus and spending legislation that is intended to ride along with this omnibus package.
December 11, 2020 – Congress passed a short-term CR to keep federal agencies in business through next week while details on the COVID-19 package and FY 2021 appropriations bills are being solidified. The CR includes a handful of one-week healthcare extenders including the National Health Service Corps, Teaching Health Centers, and support for Disproportionate Share Hospitals.
December 3, 2020 – A bipartisan group of House and Senate members issued a $900 billion COVID-19 economic stimulus and spending proposal this week, primarily as an effort to break the log jam between the more generous House-passed $2.2 trillion HEROES legislation and the $500 billion “skinny” proposal favored by Senate Majority Leader McConnell (R-KY). The hope is that this package can ride along with the federal spending legislation referenced above and provide interim relief while a larger, more comprehensive package is worked out in the new year. Here are some details on the proposal:
- $160 billion for state, local, and tribal governments
- $180 billion for additional unemployment insurance ($300 per week)
- $288 billion for small business support through the Paycheck Protection Program (PPP)
- $12 billion in community lender support
- $45 billion for transportation (airlines, airports, buses, transit and Amtrak)
- $16 billion for vaccine development and distribution, testing and contact tracing
- $35 billion for the Health Care Provider Relief Fund
- $82 billion for education
- $4 billion for student loans
- $25 billion for housing/rental assistance
- $26 billion for nutrition and agriculture, including support for fisheries
- $10 billion for the U.S. Postal Service
- $10 billion for childcare
- $10 billion for rural broadband Internet
- $5 billion for opioid treatment
November
November 10, 2020 – The Senate Appropriations Committee issued its 12 annual appropriations bills as a series of “Chairman’s Marks.” The bills represent the Senate’s negotiating position going into conference with the bills passed by the House earlier this summer. The existing stop gap continuing resolution is keeping government agencies operating through December 11th, and appropriators hope to reach agreement on the bills before then, roll all of them into an omnibus measure, and pass it before the December 11th deadline.
Highlights of the FY 2021 Senate bills include:
Labor-Health and Human Services-Education (L-HHS)
- $96.4 billion for the Department of Health and Human Services (HHS), an increase of $1.5 billion above the FY 2020 enacted level.
- $7.1 billion in programmatic funding for the Health Resources and Services Administration (HRSA), a proposed increase of $67.28 million over FY 2020 and $90 million less than the House proposal.
- $7.82 billion in programmatic funding for the Centers for Disease Control and Prevention (CDC), a proposed increase of $130 million over FY 2020 and $100 million less than the House proposal.
- $43.46 billion for the National Institutes of Health (NIH), a proposed increase of $2 billion over FY 2020 and $3.5 billion less than the House proposal.
- $6 billion for the Substance Abuse and Mental Health Services Administration (SAMHSA), a proposed increase of $117 million over the FY 2020 enacted level and the same allocation that was proposed by the House.
- $256.7 million for the Agency for Healthcare Research and Quality (AHRQ), a proposed decrease of $81.24 million from FY 2020 and $86.24 million less than the House proposal.
- $76.86 billion for the Department of Education, a proposed increase of $490.63 million over FY 2020 and $283 million less than the House proposal.
Department of Defense (DoD)
- $33.2 billion for the Defense Health Program, basically a proposal of level-funding from FY 2020 and essentially the same level as the House proposal.
Military Construction, Veterans Affairs, and Related Agencies (MilCon-VA)
- $800 million for the VA Medical and Prosthetic Research Program, a proposal of level-funding from FY 2020 and $40 million less than the House proposal.
Agriculture, Rural Development, Food and Drug Administration, and Related Agencies (Ag-FDA)
- $3.21 billion for the Food and Drug Administration (FDA), excluding user fees, a proposed increase of $40 million over FY 2020 and essentially the same allocation that was proposed by the House.
Interior, Environment, and Related Agencies (Int-Env)
- $9.1 billion for the Environmental Protection Agency (EPA), a proposed increase of $28 million over FY 2020 and roughly $290 million less than the House proposal.
Health Resources and Services Administration (HRSA)
- $5.71 billion for Community Health Centers, a proposed increase of $87 million over FY 2020.
- $137 million for Ending the HIV Epidemic initiative, a proposed increase of $87 million over FY 2020.
- $2.44 billion for the HIV/AIDS Bureau at HRSA, an increase of $60 million over FY 2020
- $28.55 million for Organ Transplantation, a proposed increase of $1 million over FY 2020
- $5.5 million for the National Living Donor Assistance Center, a proposed increase of $1 million over FY 2020
Centers for Disease Control and Prevention (CDC)
- $1.28 billion for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention, an increase of $5 million over FY 2020
- $39 million for Viral Hepatitis, level funded with FY 2020
- $994.71 billion for Chronic Disease Prevention and Health Promotion at CDC, a proposed increase of $9.8 million over FY 2020
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- $1 million for Inflammatory Bowel Diseases, level funded with FY 2020
- $382 million for Cancer Prevention and Control, a proposed increase of $1 million over FY 2020
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- $43.29 million for Colorectal Cancer, level funded with FY 2020
National Institutes of Health (NIH)
- $6.54 billion for the National Cancer Institute, a proposed increase of $282.22 million over FY 2020
- $2.17 billion for the National Institute of Diabetes and Digestive and Kidney Diseases, a proposed increase of $53.9 million over FY 2020
- $6.14 billion for the National Institute of Allergy and Infectious Diseases, a proposed increase of $266.35 million over FY 2020
- $890 million for the National Center for Advancing Translational Sciences, a proposed increase of $57.12 million over FY 2020
- $2.38 billion for the Office of the Director, a proposed increase of $138.27 million
- $646.3 million for the Common Fund, a proposed increase of $19.79 million
Department of Defense (DoD)
- $115 million for the Peer-Reviewed Cancer Program, a proposed increase of $5 million over FY 2020
November 4, 2020 – Federal agencies are operating under a continuing resolution through December 11, 2020. It is expected that the Senate will begin providing details on their 12 FY 2021 spending measures in the next few weeks. The time crunch between now and December 11th favors an effort to lump all or many of the bills into an omnibus measure, which is a group of several bills.
November 4, 2020 – Senate Majority Leader Mitch McConnell (R-KY) said that Congress should approve a coronavirus relief package before the end of the year. He stated that a coronavirus relief package and government funding past the December 11, 2020 deadline will be top priorities for the Senate.
October
October 1, 2020 – Legislators passed, and President Trump signed into law a stopgap spending measure to continue government funding. The short-term continuing resolution, H.R. 8337, keeps federal agencies operating through Dec. 11th. Work on the 12 regular appropriations bills will remain stalled until after the election. This bill includes a provision which would extend the availability of funding for certain multiyear NIH research grants that were interrupted by COVID-19. The bill also includes several temporary “health extenders” such as ongoing authorization for health centers, the National Health Service Corps, and teaching health centers, and support for disproportionate share health care providers. Here is a summary of H.R. 8337.
October 1, 2020 – The House passed its updated $2.4 trillion HEROES legislation along party lines. The House is scheduled to leave for recess and not return until after the election, but odds are that if a bipartisan deal is reached before the election, then legislators would return to Washington, pass a bill, and send it to the president. The revised House HEROES (H.R. 8406) legislation is very similar to the previous HEROES bill but reduces the overall price by shortening the length of time for certain benefits and initiatives. The new HEROES legislation does contain improved provisions for non-profit relief by expanding the eligibility for benefits to more non-profits regardless of their size, and other improvements. More information on H.R 8406 is available here, and a summary by the House Committee on Appropriations is available here.
September
September 22, 2020 –After negotiations with the White House, the House of Representatives passed H.R. 8337. This stopgap measure has bipartisan support, and will keep federal agencies funded through December 11th. The Senate is expected to follow suit and pass the bill before the September 30th end of the current fiscal year. While the bill keeps agencies level-funded, the relatively “clean” CR does include a provision which would extend the availability of funding for certain multiyear NIH research grants that were interrupted by COVID-19 and set to expire on September 30th. Here is a summary of the continuing resoltion, and more information on the bill.
September 11, 2020 – The White House and legislators have agreed to work to advance a stopgap continuing resolution (CR) to fund federal agencies from Oct. 1 until after the November election. Political considerations are being weighed by both Democrats and Republicans. Republicans want the CR to last until sometime after the election, but expire before the end of the calendar year so they can work with the existing set of congressional and administration players to finish off the process. Democrats, are pressing for a CR that lasts into calendar year 2021.
August
August 14, 2020 – As September 30 marks the end of FY 2020, a continuing appropriations resolution (CR) is expected. This will provide funding for government agencies through the fall, until regular appropriations measures can be enacted.
The House and Senate are both expected to halt negotiations on the HEROS Act and HEALS Act COVID-19 legislation until after the August recess has concluded.
August 7, 2020 – House and Senate appropriators are poised to begin negotiations on the spending details of the COVID-19 stimulus bill. Scientific, patient, provider, and academic groups are encouraging the House and Senate leadership to adopt a funding level of $15.5 billion for National Institutes of Health in the upcoming COVID-19 spending package. This funding would support coronavirus research and support research that was halted or otherwise negatively impacted by the pandemic situation.
July
July 31, 2020 – Senate Republicans issued the HEALS Act—their $1 trillion alternative to the House-passed $3 trillion HEROES legislation addressing COVID-19. The HEALS Act takes a more limited approach, but does contain important economic stimulus, spending, and healthcare access provisions. Notably absent in the Senate package is a COVID-19 National Testing Plan mandate, and meaningful relief for large and mid-sized not-profits. Senators will continue working towards a complete COVID-19 package, which will require bipartisan cooperation.
Fiscal Year (FY) 2021 Appropriations
July 27, 2020 – House Appropriations Committee Chairwoman Nita Lowey (D-NY) worked another major spending bill through the full House of Representatives the week of July 27th, rolling six annual FY 2021 appropriations measures into one package that cleared the House on July 31st. The minibus includes the annual funding bills for 1) Labor-HHS-Education; 2) Defense; 3) Energy and Water; 4) Commerce, Justice and Science; 5) Financial Services; and 6) Transportation, Housing, and Urban Development. See the House Appropriations Committee Press Release here. The full bill text is available here.
July 10, 2020 – Beginning in July, the House Appropriations Committee considered and passed its Fiscal Year (FY) 2021 appropriations bills for the departments of Labor, Health and Human Services, Education, and Related Agencies (L-HHS), Defense, Military Construction, Veterans Affairs, and Related Agencies, Agriculture, Rural Development, Food and Drug Administration, and Related Agencies, Interior, Environment, and Related Agencies, and State, Foreign Operations, and Related Programs. These bills are the first significant movement of the FY 2021 appropriations process and may be voted on in the full House of Representatives in the coming weeks.
Labor-HHS bill key provisions:
$96.4 billion for the Department of Health and Human Services, an increase of $1.5
billion above the FY 2020 enacted level.
- $7.2 billion for Health Resources Services Administration (HRSA), an increase of $157 million above the 2020 enacted level.
- $8 billion for Centers for Disease Control and Prevention (CDC), an increase of $232 million above the FY 2020 enacted level.
- $9 billion in emergency supplemental funding for public health and emergency response activities.
- $1.31 billion for Chronic Disease Prevention and Health Promotion, a proposed increase of $66.5 million over FY 2020.
- $3 million for a new Chronic Disease Education and Awareness Program, a
proposed increase of $3 million over FY 2020.
- $3 million for a new Chronic Disease Education and Awareness Program, a
- $ 47 billion for the National Institutes of Health (NIH), $5.5 billion above the FY 2020 enacted level.
- Within the total, the bill provides $42 billion in annual appropriations (including the full $404 million provided in FY 2021 through the Innovation Account established in the 21st Century Cures Act for specific initiatives), an increase of $500 million above the 2020 enacted level (1.2%), as well as $5 billion in emergency appropriations available through FY 2025. The $5 billion in emergency funding may be used “to offset costs related to reductions in laboratory productivity resulting from interruptions or shutdowns of research activity” in FY 2020, and would be provided to the Office of the Director, with the requirement that at least $2.5 billion be distributed across NIH proportionate to each institute and center’s FY 2020 funding level.
- $2.27 billion for the National Institute of Diabetes and Digestive and Kidney Diseases, a proposed increase of $154.24 million over FY 2020.
- $893.65 million for the National Center for Advancing Translational Sciences, a proposed increase of $60.76 million over FY 2020.
- $4.61 billion for the Office of the Director, a proposed increase of $2.4 billion over FY 2020.
- $631.9 million for the Common Fund, a proposed increase of $5.4 million over FY 2020.
- $6 billion for Substance Abuse and Mental Health Services Administration (SAMHSA) an increase of $96 million above the FY 2020 enacted level.
- $343 million for the Agency for Healthcare Research and Quality (AHRQ), an increase of $5 million above the FY 2020 enacted level.
- $4 billion for Centers for Medicare and Medicaid Services (CMS) administrative expenses, an increase of $315 million above the FY 2020 enacted level.
$73.5 billion in discretionary appropriations for the Department of Education, an increase of $716 million above the FY 2020 enacted level.
Defense Bill key provisions:
$33.3 billion for the Defense Heath Program (basically level-funding from FY2020), including $1.02 billion for congressionally directed medical research activities.
Military Construction/VA Bill key provisions:
$840 million is proposed for the VA Medical and Prosthetic Research Program, an increase of $40 million above the FY 2020 enacted level.
Agriculture-FDA Bill key provisions:
$3.212 billion in discretionary funding for the Food and Drug Administration (FDA), an increase of $40.8 million above the FY 2020 enacted level.
June
June 5, 2020 – House Appropriations Committee Chairwoman Nita Lowey (D-NY) issued a “Dear Colleague” letter to House members announcing the committee’s plans to hold all subcommittee and full committee markups of FY 2021 bills during the weeks of July 6 and 13th. The bills are then expected to be on the House floor the weeks of July 20th and 27th.
May
House Resolution 965 – Authorizing remote voting by proxy in the House of Representatives and providing for official remote committee proceedings during a public health emergency due to a novel coronavirus, and for other purposes, was passed on May 15th. Remote voting is allowed for 45 days with the possibility of extending this period by another 45 days or shortening it, depending on the status of the public health emergency. The new remote voting rules require committees to hold a few hearings and practice deliberations before advancing legislation.
A House Appropriations Committee spokesperson advised the media that the committee would be holding off on FY 2021 markups until after the COVID-19 (HEROES) legislation is finalized. The committee staff is working hard to be prepared to move forward with markups when they do occur.
March 2020
House and Senate Labor-HHS appropriations subcommittees held hearings on February 27th with Health and Human Services Secretary Azar. Congress is prepared to spend emergency funding to respond to needs identified by health officials. On March 5th, President Trump signed the Coronavirus Preparedness and Response Supplemental Appropriations Act (H.R. 6074) allotting $8.3 billion in emergency spending to respond to the outbreak.
February 2020
The House and Senate are both holding subcommittee hearings in the beginning of March to examine the proposed budget of the National Institutes of Health for FY 2021. These links will provide upcoming hearing information for the House and Senate appropriations subcommittees.
House and Senate Labor-HHS appropriations subcommittees held hearings on February 27th with Health and Human Services Secretary Azar. Much of the time at the hearing was dedicated to discussing questions about the coronavirus and the adequacy of the administration’s request for supplemental funding to respond to the public health threat. Congress is preparing to spend emergency funding to respond to needs identified by health officials. Read Secretary Azar’s oral testimony to the House Committee on Ways and Means here.
FY 2021 Appropriations
The President’s administration budget proposal for FY 2021 was issued to Congress on February 10. These funding recommendations do not conform to the two-year budget deal released last year. Congress will now examine this budget proposal and develop the twelve annual appropriations bulls based on funding levels provided by the two-year budget deal. Find the entire budget document here.
- $6.21 billion for FDA, a proposed increase of $265 million above FY 2020.
- $2.02 billion for Human Drugs at FDA, a proposed increase of $49 million over FY 2020.
- $1.12 billion in Prescription Drug User Fees at FDA, a proposed increase of $52 million over FY 2020.
- $526 million in Generic Drug User Fees at FDA, a proposed increase of $10 million over FY 2020.
- $425 million for Biologics at FDA, a proposed increase of $6 million over FY 2020.
- $43 million in Biosimilar User Fees at FDA, a proposed increase of $1 million over FY 2020.
- $7 billion for CDC, a proposed decrease of $693.29 million below FY 2020.
- $813 million for Chronic Disease Prevention and Health Promotion at CDC, a proposed decrease of $427 million from FY 2020.
- Individual chronic disease programs are consolidated into a new proposed block grant program.
- $38.69 billion for NIH, a proposed decrease of $2.99 billion below FY 2020.
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- $2.01 billion for the National Institute of Diabetes and Digestive and Kidney Diseases at NIH, a proposed decrease of $191 million from FY 2020.
- $788 million for the National Center for Advancing Translational Sciences at NIH, a proposed decrease of $45 million from FY 2020.$2.1 billion for the Office of the Director at NIH, a proposed decrease of $148 million from FY 2020.
- $788 million for the National Center for Advancing Translational Sciences at NIH, a proposed decrease of $45 million from FY 2020.
$2.1 billion for the Office of the Director at NIH, a proposed decrease of $148 million from FY 2020.
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FY 2020 Appropriations
Congressional leaders and administration officials have agreed on a comprehensive package for Fiscal Year (FY) 2020 spending which includes all 12 annual appropriations bills that are lumped into two minibus spending measures. Find a press release from the House Committee on Appropriations containing a full summary and the minibus text here.
Key spending highlights of the bills include:
- $95 billion in discretionary spending for the Department of Health & Human Services, an increase of $4.4 billion above FY 2019.
- $7.3 billion for the Health Resources and Services Administration, an increase of $177 million above FY 2019.
- $8 billion for the Centers for Disease Control and Prevention, an increase of $636 million above FY 2019.
- $41.7 billion for the National Institutes of Health, an increase of $2.6 billion above FY 2019.
- $5.9 billion for the Substance Abuse and Mental Health Services Administration, an increase of $140 million above FY 2019.
- $338 million for the Agency for Healthcare Research and Quality, level-funded with FY 2019.
- $73 billion in discretionary spending for the Department of Education, an increase of $1.3 billion above FY 2019.
- $800 million for the VA Medical and Prosthetic Research Program, an increase of $20 million above FY 2019.
- $34 billion for the Defense Health Program, level-funded with FY 2019.
- $5.77 billion including user fees and $3.16 billion in discretionary funding for the Food and Drug Administration, an increase of $91 million above FY 2019.
January 2020
Retiring House Appropriations Committee Chairperson Nita Lowey (D-NY) is expected to push the FY 2021 bills out of committee during her last year in office, and there is similar optimism in the Senate for swift committee action.
For FY 2021, the expectation is that appropriators will hit the ground running in February once the administration’s budget proposal is issued (on the 10th). The recent overarching budget deal covers both FY 2020 and FY 2021, so there is relatively little holding back the FY 2021 process. Retiring House Appropriations Committee Chairperson Nita Lowey (D-NY) is expected to push the FY 2021 bills out of committee as expeditiously as possible during her last year in office, and there is similar optimism in the Senate for swift committee action.
Senate Republicans issued the HEALS Act—their $1 trillion alternative to the House-passed $3 trillion HEROES legislation addressing COVID-19. The HEALS Act takes a more limited approach, but does contain important economic stimulus, spending, and healthcare access provisions. Notably absent in the Senate package is a COVID-19 National Testing Plan mandate, and meaningful relief for large and mid-sized not-profits. See the attached DDNC memo for a more detailed look. Senators will try again next week to find a path forward on the COVID-19 package, which will require bipartisan cooperation.
Earlier this week, the Senate released draft versions of its Fiscal Year (FY) 2021 appropriations bills and corresponding committee reports. The measures, known as “Chairman’s Marks,” because they were not advanced through the official committee markup process, are intended to facilitate negotiations with the House in an effort to craft final, compromise FY 2021 funding bills. At this time, both the House and Senate have expressed an interest in completing the FY 2021 appropriations process before the current continuing resolution expires on December 11th (or at least by the end of the year). Highlights of the FY 2021 Senate bills and their corresponding committee reports include: Labor-Health and Human Services-Education (L-HHS)
- $96.4 billion for the Department of Health and Human Services (HHS), an increase of $1.5 billion above the FY 2020 enacted level.
- $7.1 billion in programmatic funding for the Health Resources and Services Administration (HRSA), a proposed increase of $67.28 million over FY 2020 and $90 million less than the House proposal.
- $7.82 billion in programmatic funding for the Centers for Disease Control and Prevention (CDC), a proposed increase of $130 million over FY 2020 and $100 million less than the House proposal.
- $43.46 billion for the National Institutes of Health (NIH), a proposed increase of $2 billion over FY 2020 and $3.5 billion less than the House proposal.
- $6 billion for the Substance Abuse and Mental Health Services Administration (SAMHSA), a proposed increase of $117 million over the FY 2020 enacted level and the same allocation that was proposed by the House.
- $256.7 million for the Agency for Healthcare Research and Quality (AHRQ), a proposed decrease of $81.24 million from FY 2020 and $86.24 million less than the House proposal.
- $76.86 billion for the Department of Education, a proposed increase of $490.63 million over FY 2020 and $283 million less than the House proposal. Department of Defense (DoD)
- $33.2 billion for the Defense Health Program, basically a proposal of level-funding from FY 2020 and essentially the same level as the House proposal. Military Construction, Veterans Affairs, and Related Agencies (MilCon-VA)
- $800 million for the VA Medical and Prosthetic Research Program, a proposal of level-funding from FY 2020 and $40 million less than the House proposal. Agriculture, Rural Development, Food and Drug Administration, and Related Agencies (Ag-FDA)
- $3.21 billion for the Food and Drug Administration (FDA), excluding user fees, a proposed increase of $40 million over FY 2020 and essentially the same allocation that was proposed by the House. Interior, Environment, and Related Agencies (Int-Env)
- $9.1 billion for the Environmental Protection Agency (EPA), a proposed increase of $28 million over FY 2020 and roughly $290 million less than the House proposal. Of specific interest to the DDNC, the bills include: Health Resources and Services Administration (HRSA)
- $5.71 billion for Community Health Centers, a proposed increase of $87 million over FY 2020.
- $137 million for Ending the HIV Epidemic initiative, a proposed increase of $87 million over FY 2020.
- $2.44 billion for the HIV/AIDS Bureau at HRSA, an increase of $60 million over FY 2020
- $28.55 million for Organ Transplantation, a proposed increase of $1 million over FY 2020
- $5.5 million for the National Living Donor Assistance Center, a proposed increase of $1 million over FY 2020 Centers for Disease Control and Prevention (CDC)
- $1.28 billion for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention, an increase of $5 million over FY 2020
- $39 million for Viral Hepatitis, level funded with FY 2020
- $994.71 billion for Chronic Disease Prevention and Health Promotion at CDC, a proposed increase of $9.8 million over FY 2020
- $1 million for Inflammatory Bowel Diseases, level funded with FY 2020
- $382 million for Cancer Prevention and Control, a proposed increase of $1 million over FY 2020
- $43.29 million for Colorectal Cancer, level funded with FY 2020 National Institutes of Health (NIH)
- $6.54 billion for the National Cancer Institute, a proposed increase of $282.22 million over FY 2020
- $2.17 billion for the National Institute of Diabetes and Digestive and Kidney Diseases, a proposed increase of $53.9 million over FY 2020
- $6.14 billion for the National Institute of Allergy and Infectious Diseases, a proposed increase of $266.35 million over FY 2020
- $890 million for the National Center for Advancing Translational Sciences, a proposed increase of $57.12 million over FY 2020
- $2.38 billion for the Office of the Director, a proposed increase of $138.27 million
- $646.3 million for the Common Fund, a proposed increase of $19.79 million Department of Defense (DoD)
- $115 million for the Peer-Reviewed Cancer Program, a proposed increase of $5 million over FY 2020
Committee Recommendations Centers for Disease Control and Prevention Hepatitis B Vaccination.—The Committee is concerned that despite the availability of an effective hepatitis B virus [HBV] vaccine, only approximately one quarter of adults age 19 and older were vaccinated. Therefore, the Committee is pleased that CDC is evaluating new universal HBV vaccination recommendations including a comprehensive plan to increase adult HBV vaccinations. The Committee urges CDC to promote awareness about the importance of hepatitis B vaccination among medical and health professionals, communities at high risk, and the general public. The Committee directs CDC to submit a report to the Committees on Appropriations of the House of Representatives and the Senate within 180 days of enactment detailing how CDC can increase the rate of HBV adult vaccination to the levels necessary to eliminate new infections of hepatitis B in the United States, and to improve collaboration and coordination across CDC to achieve this goal. Infectious Diseases and the Opioid Epidemic.—The Committee provides $15,000,000, an increase of $5,000,000, to CDC to strengthen efforts to conduct surveillance to improve knowledge of the full scope of the burden of infectious diseases (including viral, bacterial, and fungal pathogens) associated with substance use disorders. CDC is encouraged to take into account risk factors for hepatitis B and C, HIV, and morbidity and mortality related to substance use disorder among other factors when distributing funding. Interventions may include increasing capacity for State and local health departments; expanding access for syringe exchange programs; fully implementing national HIV, hepatitis B, and hepatitis C screening guidelines; and expanding surveillance and data collection on infectious diseases related to opioid use. Inflammatory Bowel Diseases [IBD].—The Committee commends CDC for investing in research on the epidemiology of IBD, as well as on disparities in treatment patterns and overall health outcomes within minority populations and underserved communities. The Committee encourages CDC to continue supporting this research and to develop a plan to reduce the time for persons from underserved communities to receive a diagnosis, including by increasing understanding and awareness of IBD among these populations and the healthcare providers who serve them. Nutrition, Physical Activity, and Obesity.—Evidence shows that physical activity and nutrition help control weight; reduce risk of cardiovascular disease, diabetes, and some cancers; and improve other quality of life factors. The Committee recognizes CDC’s efforts through Active People, Healthy Nation, which aims to help 27,000,000 million Americans become more physically active by 2027, and encourages CDC to continue evidence-based strategies that promote physical activity. National Institutes of Health Deadliest Cancers.—For fiscal year 2020, Congress directed NCI to develop a scientific framework using the process outlined in the Recalcitrant Cancer Research Act of 2012 (Public Law 112–239) for stomach and esophageal cancers. The Committee expects that outlining the state of the science and foremost research questions for both of these diseases will provide a roadmap for future research. The Act defined ‘‘recalcitrant cancers’’ as those for which the 5 year survival rate is below 50 percent. According to NCI, the 5 year survival rates for stomach and esophageal cancers are 32 and 20 per cent, respectively. The Committee expects to be kept informed of NCI’s efforts, alongside the research and advocacy communities, to convene working groups of experts to develop scientific frameworks for both cancers; and to be kept informed of ways in which NCI is supporting research into all recalcitrant cancers. The deadliest cancers, which also include cancers of the brain, liver, lung, ovary, pancreas, and mesothelioma, among others, account for nearly half of all U.S. cancer deaths. While steady advances have made it possible to reduce the overall rate of cancer deaths for more than 2 decades, there has been little progress reducing mortality for these diseases. The Committee recognizes that advances in treating what were once thought of as incurable diseases has previously occurred in unexpected ways, and is encouraged by NCI’s continued support for research related to the deadliest cancers. In particular, the Committee notes the promising focus on diagnostics to make earlier identification possible when successful treatment might still be possible. Given the toll all recalcitrant cancers exact on society and the lack of diagnostic and treatment resources currently available to help patients, the Committee directs NCI to provide an update on its work over the past year for each of the seven deadliest cancers in the fiscal year and to identify future goals for each in the fiscal year 2022 CJ. Liver Cancer.—The Committee notes that liver cancer is a devastating cancer with a 5 year survival rate of only 20 percent. The Committee commends NCI for the creation of a Specialized Center of Research Excellence focused on liver cancer and encourages NCI to continue to support research opportunities for investigators that focus on a better understanding of the biology of liver cancer and new therapeutic targets. Additionally, the Committee commends NCI for its support of the inter-Institute effort to develop the NIH Strategic Plan to Cure Hepatitis B. In view of the well-established fact that up to 60 percent of global liver cancer cases are caused by the hepatitis B virus, NCI is encouraged to continue close collaboration with NIAID and NIDDK and as active participants in the Director’s Trans-NIH Hepatitis B Working Group. The Committee requests an update on NCI’s activities in these areas in the fiscal year 2022 CJ. Pancreatic Cancer.—The Committee appreciates NCI’s recent submissions of the 5 year Review and Update report required by the Recalcitrant Cancer Research Act of 2012 (Public Law 112– 239). This year, the Committee looks forward to the report on the effectiveness of the scientific framework, including research efforts on improvements in pancreatic cancer prevention, detection, diagnosis and treatment. While progress has been made, the Committee encourages NCI to continue to support research efforts to advance discoveries and improve treatment options for patients diagnosed with pancreatic cancer Inflammatory Bowel Diseases [IBD].—The Committee recognizes NIDDK’s leadership in supporting research into Crohn’s disease and ulcerative colitis. The Committee also recognizes the importance of patient-centered, bedside-to-bench approaches to understand complex, chronic diseases such as IBD, and the need to better understand the impact of diet on IBD. The Committee directs NIDDK to pursue research on the interactions among food, the gut, and the brain/nervous system in people with IBD and other chronic gastrointestinal diseases. The Committee notes that this bedside-to-bench approach has been successful in other disease areas, including type 2 diabetes and oncology, and encourages NIDDK to use a similar approach focused on IBD. Celiac Disease.—The Committee includes sufficient funding for NIH to devote focused research to the study of Celiac disease, including the autoimmune causation underpinning the affliction. Today, the only known treatment for this disease is a gluten-free diet; however, recent public and private sector research has revealed that such a ‘‘treatment’’ is insufficient for many who suffer from Celiac disease. Therefore, the Committee urges NIAID to support new research on celiac disease to better coordinate existing research and focus new research efforts toward causation, and ultimately, a cure of this disease. The Committee encourages NIAID to coordinate with other Institutes and Centers including NIDDK as appropriate and to submit its plan for coordination and execution of this research to the Committees on Appropriations of the House of Representatives and the Senate no later than 90 days after enactment of this act. Food Allergies.—The Committee recognizes the serious issue of food allergies which affect approximately 8 percent of children and 10 percent of adults in the United States. The Committee commends the ongoing work of NIAID in supporting a total of 17 clinical sites for this critical research, including seven sites as part of the Consortium of Food Allergy Research. The Committee encourages NIAID to expand its clinical research network to add new centers of excellence in food allergy clinical care and to select such centers from those with a proven expertise in food allergy research. Hepatitis B.—The Committee applauds NIAID for its leadership of the inter-Institute initiative to develop a NIH Strategic Plan for Trans-NIH Research to Cure Hepatitis B released in December 2019. It is noted that infection with the hepatitis B virus [HBV] is a serious public health threat and that 1 in 20 Americans has been infected while more than 2,000,000 Americans are chronically infected, increasing by 70,000 a year. This serious public health threat results in over 780,000 worldwide deaths each year. The Committee appreciates the Institute’s use of contracts, program announcements, and research resources initiatives to stimulate new research applications and facilitate ongoing work. The Committee urges NIAID to issue new targeted calls for research through Program Project, R01, and U01 Cooperative Research Agreements, such as those successfully used to discover cures for hepatitis C. The Committee also urges NIAID to consider cooperative research to implement the Strategic Plan and the ‘‘Roadmap for a Cure,’’ reported from the Hepatitis B Foundation, to close the gap in our understanding of HBV and hepatitis delta virus molecular biology and develop effective therapeutics. The Committee notes that the Trans-NIH Strategic Plan was specific enough to provide guidance for program announcements without stifling innovation. The Committee requests that NIAID submit, within 90 days of enactment of this act, a specific plan to pursue a cure for hepatitis B in coordination with the Trans-NIH Hepatitis B Working Group. Centers for Medicare and Medicaid Services CT Colonography.—Due to the proven life and cost savings of preventive screening for colorectal cancer, the Committee encourages CMS to consider covering CT Colonography as a Medicare-covered colorectal cancer screening test under section 1861(pp)(1) of the Social Security Act. Sepsis.—The Committee is pleased that CMS and the National Quality Forum plan to update the SEP–1 measure. A CMS study published in February reported an alarming 40 percent increase in the number of Medicare patients hospitalized with sepsis over the past 7 years. The Committee encourages CMS to issue a Request for Information as part of the update to the SEP–1 measure review to collect broad stakeholder input to help ensure the new SEP–1 measure improves health outcomes. The Committee requests an update on these activities in the fiscal year 2022 CJ. Total Parenteral Nutrition Cancer Access.—The Committee requests that CMS provide the Committees on Appropriations of the House of Representatives and the Senate an update 180 days after enactment on its plans to revise the Durable Medical Equipment local policies to allow for parenteral nutrition as first line therapy for patients with head, neck, and gastrointestinal cancers. Department of Defense Peer-Reviewed Medical Research Program.—The Committee recommends $370,000,000 for the Peer-Reviewed Medical Research Program. The Committee directs the Secretary of Defense, in conjunction with the Service Surgeons General, to select medical research projects of clear scientific merit and direct relevance to military health. Research areas considered under this funding are restricted to: Alzheimer’s arthritis, autism, burn pit exposure, cardiomyopathy, congenital heart disease, diabetes, Duchenne muscular dystrophy, eating disorders, emerging viral diseases, epidermolysis bullosa, familial hypercholesterolemia, fibrous dysplasia, focal segmental glomerulosclerosis, food allergies, Fragile X, frontotemporal degeneration, gulf war illness, hemorrhage control, hepatitis B, hydrocephalus, hypertension, inflammatory bowel diseases, lupus, malaria, metals toxicology, mitochondrial disease, multiple sclerosis, myalgic encephalomyelitis/chronic fatigue syndrome, myotonic dystrophy, neurofibromatosis, non-opioid therapy for pain management, nutrition optimization, Parkinson’s, pathogen-inactivated blood products, peripheral neuropathy, plant-based vaccines, platelet like cell production, polycystic kidney disease, pressure ulcers, reconstructive transplantation, respiratory health, rheumatoid arthritis, sleep disorders and restriction, suicide prevention, sustained release drug delivery, tick-borne diseases, trauma, tuberous sclerosis complex, vision, and women’s heart disease. The Committee emphasizes that the additional funding provided under the Peer-Reviewed Medical Research Program shall be devoted only to the purposes listed above. Peer-Reviewed Cancer Research Programs.—The Committee recommends $130,000,000 for the peer-reviewed breast cancer research program, $70,000,000 for the peer-reviewed prostate cancer research program, $30,000,000 for a peer-reviewed melanoma research program, $10,000,000 for the peer-reviewed ovarian cancer research program, $17,500,000 for a peer-reviewed rare cancers research program, and $115,000,000 for the peer-reviewed cancer research program that would research cancers not addressed in the aforementioned programs currently executed by the Department of Defense. The funds provided in the peer-reviewed cancer research program are directed to be used to conduct research in the following areas: bladder cancer; blood cancers; brain cancer; esophageal cancer; kidney cancer; liver cancer; lung cancer; neuroblastoma; pancreatic cancer; pediatric brain tumors; pediatric, adolescent, and young adult cancers; and stomach cancer. The funds provided under the peer-reviewed cancer research program shall be used only for the purposes listed above. The Committee directs the Assistant Secretary of Defense (Health Affairs) to provide a report not later than 18 months after the enactment of this act to the congressional defense committees on the status of the peer-reviewed cancer research program. For each research area, the report should include the funding amount awarded, the progress of the research, and the relevance of the research to servicemembers. Veterans Affairs VA Cancer Moonshot Contribution.—The Committee supports the Department’s contribution utilizing advances in genomic science to provide targeted treatment to veterans. The Department has identified prostate cancer, triple-negative breast cancer, and colorectal cancer as areas of priority. Due to the prevalence of various skin cancers among servicemembers, the Committee directs that skin cancer be included as well. Gulf War Illness Studies.—The Committee urges the Department to consistently utilize the term, ‘‘Gulf War illness.’’ The Committee recommends that the Department continue to conduct epidemiological studies regarding the prevalence of Gulf War illness, morbidity, and mortality in Persian Gulf War veterans, and directs the Department to publish disease-specific morbidity and mortality data related specifically to Persian Gulf War veterans. The Committee urges the Department to focus on recent Gulf War illness treatment research findings and ongoing Gulf War illness treatment research direction to expedite development and clinical implementation of effective treatments, preventions, and cures for Gulf War illness. Furthermore, the Committee encourages VA to strengthen the training of primary, specialty, and mental healthcare providers on Gulf War illness, its clinical manifestations, and promising potential treatments. The Committee directs the Department to submit a report to the Committees on Appropriations of both Houses of Congress no later than 180 days after enactment of this act on the progress of research related to the incidence and prevalence of brain cancer in Gulf War veterans. Food and Drug Administration Gluten Free Labeling.—The Committee urges the FDA to prioritize publication of the final rule entitled ‘‘Food Labeling: Gluten-Free Labeling of Fermented or Hydrolyzed Foods’’ to provide certainty for food manufacturers and ensure people with celiac disease or other forms of gluten intolerance receive accurate information from hydrolyzed or fermented food products labeled as gluten-free. Hepatitis B Drug Development.—The Committee appreciates the FDA’s commitment to patient-focused drug development and its interest in an Externally-Led Patient-Focused Drug Development meeting focusing on the treatment-related needs and challenges of individuals infected with the Hepatitis virus to help inform the focus of new drug development and future clinical trials. The Committee urges the FDA to continue focusing on this issue Medical Foods.—The Committee recognizes the unique role medical foods play in the nutritional management of inborn errors of metabolism and encourages a flexible regulatory process that would enhance access to safe medical foods for individuals with serious or life-threatening inborn errors of metabolism. The Committees encourages the FDA to continue focusing on this issue.