Healthcare

Mental Health Services for Students Act of 2023

United States · United States Congress · 8 June 2023

Mental Health Services for Students Act of 2023 This bill provides specific statutory authority for the Project AWARE (Advancing Wellness and Resiliency in Education) State Educational Agency Grant Program that is administered by the Substance Abuse and Mental Health Services Administration. The program supports school-based mental health services, including screening, treatment, and outreach programs.

Promising Pathway Act

United States · United States Congress · 8 June 2023

Promising Pathway Act  This bill provides for expedited, provisional approval of drugs for serious or life-threatening diseases or conditions. Specifically, the bill allows for provisional approval of drugs that are used to treat, prevent, or diagnose a serious or life-threatening disease or condition for which premature death is likely without early medical intervention. The Food and Drug Administration (FDA) must evaluate applications within 90 days of receipt. The FDA may approve applications if there is early evidence, including real-world and real-time evidence, of the drug's efficacy, as well as substantial evidence of the drug's safety. Provisional approval is valid for two years and may be renewed for up to eight years. The FDA may withdraw provisional approval in the event of serious adverse health effects.  Drug sponsors that receive provisional approval must require all patients receiving the drug to participate in an observational registry, through which the drug sponsor may collect and submit data relating to the drug until it is fully approved. Registries may be operated by the drug sponsor or another entity. The FDA must annually review these registries; sponsors of registries that fail to meet the bill's requirements are subject to civil penalties.   

LEGISLATIVE HEARING ON H.R. 630, TO AMEND THE INDIAN HEALTH CARE IMPROVEMENT ACT TO ESTABLISH AN URBAN INDIAN ORGANIZATION CONFER POLICY FOR THE DEPARTMENT OF HEALTH AND HUMAN SERVICES, ``URBAN INDIAN HEALTH CONFER ACT''; H.R. 1240, TO TRANSFER ADMINISTRATIVE JURISDICTION OF CERTAIN FEDERAL LANDS FROM THE ARMY CORPS OF ENGINEERS TO THE BUREAU OF INDIAN AFFAIRS, TO TAKE SUCH LANDS INTO TRUST FOR THE WINNEBAGO TRIBE OF NEBRASKA, AND FOR OTHER PURPOSES, ``WINNEBAGO LAND TRANSFER ACT OF 2023''; H.R. 1722, TO AMEND THE GRAND RONDE RESERVATION ACT, AND FOR OTHER PURPOSES, ``GRAND RONDE RESERVATION ACT AMENDMENT OF 2023''; H.R. 2461, TO RATIFY A TREATY BETWEEN THE SAN JUAN SOUTHERN PAIUTE TRIBE AND THE NAVAJO NATION, TO PROVIDE FOR THE CREATION OF A RESERVATION FOR THE SAN JUAN SOUTHERN PAIUTE TRIBE, AND FOR OTHER PURPOSES, ``SAN JUAN SOUTHERN PAIUTE TRIBAL HOMELANDS ACT OF 2023''; H.R. 2839, TO AMEND THE SILETZ RESERVATION ACT TO ADDRESS THE HUNTING, FISHING, TRAPPING, AND ANIMAL GATHERING RIGHTS OF THE CONFEDERATED TRIBES OF SILETZ INDIANS, AND FOR OTHER PURPOSES; AND H.R. 3371, TO DIRECT THE SECRETARY OF THE INTERIOR TO COMPLETE ALL ACTIONS NECESSARY FOR CERTAIN LAND TO BE HELD IN RESTRICTED FEE STATUS BY THE OGLALA SIOUX TRIBE AND CHEYENNE RIVER SIOUX TRIBE, AND FOR OTHER PURPOSES, ``WOUNDED KNEE MASSACRE MEMORIAL AND SACRED SITE ACT''

United States · United States House of Representatives · 7 June 2023

Children’s Hospital GME Support Reauthorization Act of 2023

United States · United States Congress · 7 June 2023

Children's Hospital GME Support Reauthorization Act of 2023 This bill reauthorizes through FY2028 the Children's Hospital Graduate Medical Education Payment program, which supports education and training for medical residents and fellows in children's hospitals. The bill also bars children's hospitals that provide gender-affirming care to minors from receiving payments through the program. Under the bill, gender-affirming care generally includes procedures (e.g., surgeries or hormone therapies) that change the body of an individual to correspond to a sex that is different than the individual's biological sex. It excludes, however, specified types of procedures, including those for treating (1) individuals who have both ovarian and testicular tissue or abnormal sex chromosome structure or hormones, or (2) infections or other harms that result from a previous gender-transition procedure.

Sickle Cell Disease and Other Heritable Blood Disorders Research, Surveillance, Prevention, and Treatment Act of 2023

United States · United States Congress · 7 June 2023

Sickle Cell Disease and Other Heritable Blood Disorders Research, Surveillance, Prevention, and Treatment Act of 2023 This bill reauthorizes through FY2028 the Sickle Cell Disease Treatment Demonstration Program, which supports efforts to improve treatment and prevention of sickle cell disease and complications from that disease. (Sickle cell disease is an inherited blood disorder that can lead to pain, anemia, infections, and stroke.) 

SCREENS for Cancer Act of 2024

United States · United States Congress · 7 June 2023

Screening for Communities to Receive Early and Equitable Needed Services for Cancer Act of 2023 or the SCREENS for Cancer Act of 2023 This bill reauthorizes through FY2028 and makes changes to the National Breast and Cervical Cancer Early Detection Program. This program provides funding to states for breast and cervical cancer screening, diagnostic, and treatment services for individuals who have low incomes, are uninsured, or otherwise lack access to such services. Changes to the program include (1) expanding its scope to include addressing disparities and ensuring equitable access to screening and diagnostic services, and (2) eliminating requirements for states to expend a specified percentage of funding on screening and referral services.

SCREENS for Cancer Act of 2023

United States · United States Congress · 7 June 2023

Screening for Communities to Receive Early and Equitable Needed Services for Cancer Act of 2023 or the SCREENS for Cancer Act of 2023 This bill reauthorizes through FY2028 and makes changes to the National Breast and Cervical Cancer Early Detection Program. This program provides funding to states for breast and cervical cancer screening, diagnostic, and treatment services for individuals who have low incomes, are uninsured, or otherwise lack access to such services.

Sickle Cell Disease and Other Heritable Blood Disorders Research, Surveillance, Prevention, and Treatment Act of 2023

United States · United States Congress · 7 June 2023

Sickle Cell Disease and Other Heritable Blood Disorders Research, Surveillance, Prevention, and Treatment Act of 2023 This bill reauthorizes through FY2028 the Sickle Cell Disease Treatment Demonstration Program, which supports efforts to improve treatment and prevention of sickle cell disease and complications from that disease. (Sickle cell disease is an inherited blood disorder that can lead to pain, anemia, infections, and stroke.)

Special Diabetes Program Reauthorization Act of 2023

United States · United States Congress · 7 June 2023

Special Diabetes Program Reauthorization Act of 2023 This bill reauthorizes and funds through calendar year 2025 the Special Diabetes Program for Type I Diabetes and the Special Diabetes Program for Indians. The Special Diabetes Program for Type I Diabetes supports research on the prevention and cure of Type I diabetes, and the Special Diabetes Program for Indians supports diabetes treatment and prevention for tribal populations.

Animal Drug and Animal Generic Drug User Fee Amendments of 2023

United States · United States Congress · 7 June 2023

Animal Drug and Animal Generic Drug User Fee Amendments of 2023 This bill reauthorizes the Food and Drug Administration (FDA) to collect fees for brand-name and generic animal drug applications through FY2028. It also makes related updates to fee calculations and FDA reporting requirements. The bill also (1) provides for a specific fee for requests to establish generic investigational new animal drug files and requires other application fees to be adjusted accordingly; (2) authorizes the FDA to remove species from the definition of major species (currently horses, dogs, cats, cattle, pigs, chickens, and turkeys); and (3) provides statutory authority for the FDA to report on its progress supporting antimicrobial stewardship in veterinary settings (i.e., supporting responsible use of antimicrobial drugs for animals to slow the development of drug-resistant bacteria). Animal drugs are drugs that are intended for animals other than humans (e.g., pets and livestock). Animal drugs must be approved by the FDA before they may be offered on the commercial market. The FDA is authorized to collect fees for animal drug applications in order to support its regulatory activities; this authority currently expires at the end of FY2023.

To amend title 38, United States Code, to strengthen benefits for children of Vietnam veterans born with spina bifida, and for other purposes.

United States · United States Congress · 7 June 2023

This bill addresses Department of Veterans Affairs (VA) benefits and care for certain children with spina bifida or other birth defects. The bill requires the VA to provide health care, job training, and monetary benefits for the duration of the child's life. The bills covers a child, regardless of age or marital status, who: (1) has spina bifida and is the natural child of a Vietnam veteran or a veteran of specified service in Korea or Thailand who was conceived after the date on which the veteran entered service in Vietnam, Korea, or Thailand; or (2) has certain birth defects and is the natural child of a woman Vietnam veteran. The bill requires the VA to establish an advisory council on health care and benefits for covered children. Additionally, the VA must establish care and coordination teams for covered children. At least every 180 days, the teams must conduct outreach to ensure the continued care of the children and assist with any necessary changes in care. The VA must report to Congress a list of conditions that will trigger outreach to covered children, and must attempt to contact such children as soon as practicable after the identification of a condition. The Veterans Benefits Administration and the Veterans Health Administration must enter into a memorandum of understanding to better assist covered children.

Dillon’s Law

United States · United States Congress · 7 June 2023

Dillon's Law This bill requires the Department of Health and Human Services to give preference when awarding certain grants for preventive health service programs to states that (1) allow all trained individuals to administer epinephrine, and (2) provide civil liability protections related to that administration.

Improving Mental Health and Drug Treatment Act of 2023

United States · United States Congress · 7 June 2023

Improving Mental Health and Drug Treatment Act of 2023  This bill permanently allows state Medicaid programs to receive federal payment for substance-use disorder services that are provided at institutions for mental diseases (IMDs) for individuals aged 21 to 64. The bill also extends the maximum length of stay over a 12-month period from 30 days to 45 days and requires state Medicaid programs to review IMD compliance with relevant standards of care.

SOS: Sustaining Outpatient Services Act

United States · United States Congress · 7 June 2023

SOS: Sustaining Outpatient Services Act This bill allows for payment under the Medicare prospective payment system for hospital outpatient department services of certain items and services that are furnished at off-campus outpatient departments. Specifically, the bill allows for payment of items and services for which payments to physician specialists (under the Medicare physician fee schedule) did not exceed $2 million during the previous year.

Midwives for MOMS Act of 2023

United States · United States Congress · 7 June 2023

Midwives for Maximizing Optimal Maternity Services Act of 2023 or the Midwives for MOMS Act of 2023 This bill establishes grants within the Health Resources and Services Administration (HRSA) for establishing or expanding midwifery programs at institutions of higher education and nursing schools. In awarding grants, HRSA must give special consideration to institutions that focus on increasing the number of midwife professionals from underrepresented groups and promote practicing in areas with limited access to professional health care.

Expanding Access to Palliative Care Act

United States · United States Congress · 7 June 2023

Expanding Access to Palliative Care Act This bill requires the Center for Medicare and Medicaid Innovation (CMMI) to test a model that provides community-based palliative care and care coordination for high-risk Medicare beneficiaries and that may replace the Medicare Care Choices Model (which ended on December 31, 2021). Under the new model, multi-disciplinary teams must provide coordinated, palliative care that is available 24-7 for Medicare beneficiaries with serious illnesses or injuries, such as cancer. The CMMI must evaluate the model by comparing patients participating in the model with those outside of the model in relation to specified metrics, including the election and duration of hospice care.

A resolution designating May 2023 as "ALS Awareness Month".

United States · United States Congress · 7 June 2023

This resolution designates May 2023 as ALS Awareness Month. Amyotrophic lateral sclerosis (ALS) is a progressive neurodegenerative disease, also known as Lou Gehrig's disease, that affects nerve cells in the brain and spinal cord.

SITE Act

United States · United States Congress · 7 June 2023

Site-based Invoicing and Transparency Enhancement Act or the SITE Act  This bill modifies the payment methodology for services that are furnished at off-campus outpatient departments of hospitals under Medicare. It also establishes a nurse training program through hospitals. Under current law, off-campus outpatient departments of hospitals that began billing prior to November 2, 2015, or that were under construction as of that date, are exempt from certain site-neutral payment requirements under Medicare. The bill ends this exemption. It also (1) reduces payments for services furnished at off-campus outpatient emergency departments that are six or fewer miles from a hospital, and (2) requires off-campus outpatient departments of hospitals to have unique health identifiers. Additionally, the bill provides for funding of regional nurse education hubs. The Centers for Medicare & Medicaid Services may select one hospital in each referral region to operate as a hub for training, in coordination with nursing schools, Medicare and Medicaid providers, and other training partners. The bill provides for up to 20,000 nursing student positions in the program by 2030.

Expanded Telehealth Access Act

United States · United States Congress · 6 June 2023

Expanded Telehealth Access Act This bill expands the types of health care practitioners who may provide telehealth services under Medicare. Specifically, the bill permanently allows audiologists, physical therapists, occupational therapists, speech-language pathologists, and other providers designated by the Centers for Medicare & Medicaid Services to provide telehealth services under Medicare. It also specifically allows occupational therapy assistants and physical therapist assistants to provide such services. 

Access to Breast Cancer Diagnosis Act of 2023

United States · United States Congress · 6 June 2023

Expanding Access to Diabetes Self-Management Training Act of 2023

United States · United States Congress · 6 June 2023

Expanding Access to Diabetes Self-Management Training Act of 2023 This bill expands Medicare coverage of diabetes outpatient self-management training. It also requires the Center for Medicare and Medicaid Innovation to test a model in which such training is provided virtually.

Access to Genetic Counselor Services Act of 2023

United States · United States Congress · 6 June 2023

Access to Genetic Counselor Services Act of 2023 This bill provides for coverage under Medicare of genetic counseling services that are furnished by genetic counselors. Covered services include those services, as well as incidental services and supplies, that would otherwise be covered under Medicare if provided by a physician.

Action for Dental Health Act of 2023

United States · United States Congress · 6 June 2023

Action for Dental Health Act of 2023 This bill reauthorizes through FY2028 grants for states to support dental health workforce activities in areas that face a shortage of dental health providers.

Medicaid Primary Care Improvement Act

United States · United States Congress · 6 June 2023

Medicaid Primary Care Improvement Act This bill specifies that state Medicaid programs are authorized to provide primary care services through direct primary care arrangements (i.e., arrangements in which primary care providers receive a fixed periodic fee for their services). The Centers for Medicare & Medicaid Services must (1) issue guidance on how state Medicaid programs may implement direct primary care arrangements, and (2) report on the extent to which state Medicaid programs contract with independent providers and on the quality and cost of care under direct primary care arrangements that are offered through Medicaid managed care organizations.

Preventing Maternal Deaths Reauthorization Act of 2023

United States · United States Congress · 6 June 2023

Preventing Maternal Deaths Reauthorization Act of 2023 This bill reauthorizes through FY2028 and otherwise modifies federal support for state-based efforts to improve maternal mortality review committees; enhance surveillance of pregnancy-associated and -related deaths; and otherwise improve, and reduce disparities in, maternal health outcomes. The bill also requires the Centers for Disease Control and Prevention to annually disseminate best practices for preventing maternal mortality and morbidity to hospitals, professional societies, and perinatal quality collaboratives (i.e., networks of perinatal care providers and public health professionals that work to improve pregnancy outcomes through continuous quality improvement).

A resolution expressing support for recognizing September 20 as National Service Dog Day.

United States · United States Congress · 6 June 2023

This resolution supports National Service Dog Day to raise awareness of the positive impact service dogs have on individuals with disabilities.

Providing for consideration of the bill (H.R. 12) to protect a person's ability to determine whether to continue or end a pregnancy, and to protect a health care provider's ability to provide abortion services.

United States · United States Congress · 6 June 2023

Sets forth the rule for consideration of the bill (H.R. 12) to protect a person's ability to determine whether to continue or end a pregnancy, and to protect a health care provider's ability to provide abortion services.

Improving Public Health Preparedness Act

United States · United States Congress · 6 June 2023

Improving Public Health Preparedness Act This bill expressly transfers to the Office of the Assistant Secretary for Preparedness and Response (ASPR) the responsibility for administering the Strategic National Stockpile and related activities. (The Strategic National Stockpile consists of drugs, vaccines, medical products, and other supplies that may be deployed to respond to public health emergencies.) Current law requires the Department of Health and Human Services to administer the stockpile in collaboration with ASPR and the Centers for Disease Control and Prevention. However, ASPR assumed general responsibility for overseeing the stockpile in 2018.

To amend title III of the Public Health Service Act to reauthorize the program of payments to children's hospitals that operate graduate medical education programs.

United States · United States Congress · 6 June 2023

This bill reauthorizes through FY2028 the Children's Hospital Graduate Medical Education Payment program, which supports education and training for medical residents and fellows in children's hospitals.

To amend the Federal Food, Drug, and Cosmetic Act to increase transparency in generic drug applications.

United States · United States Congress · 6 June 2023

This bill requires the Food and Drug Administration (FDA) to inform generic drug applicants, upon request or during review, whether the drug is qualitatively and quantitatively the same as the listed brand-name drug (and if not, the reasons why). The FDA must also update or publish guidance on how it makes such determinations.

Pride In Mental Health Act of 2023

United States · United States Congress · 6 June 2023

Pride in Mental Health Act of 2023 This bill establishes grants and reporting requirements concerning the mental and behavioral health of youth who are lesbian, gay, bisexual, queer or questioning, nonbinary, intersex, or Two Spirit (gender-variant members of indigenous communities). Specifically, the Substance Abuse and Mental Health Services Administration (SAMHSA) must award grants to assess and improve mental health and substance abuse outcomes for those youth. Recipients may use grants for providing mental and behavioral health resources for such youth (including training for caregivers and school-based interventions) and collecting data. Recipients may not use grants for any practice or treatment that seeks to change another individual's sexual orientation or gender (i.e., conversion therapy). Additionally, the Department of Health and Human Services (HHS) must (1) conduct a survey to measure issues related to mental health and health care among such youth; and (2) report about the mental health and related care of such youth who are in foster care and otherwise participate in federal social services programs. HHS must also review existing publications on SAMHSA's website that focus on lesbian, gay, bisexual, transgender, queer or questioning, nonbinary, intersex, and Two Spirit individuals and update or commission new publications to fill information gaps related to the mental and behavioral health of those individuals.

Supporting Families through Addiction Act of 2023

United States · United States Congress · 6 June 2023

Supporting Families through Addiction Act of 2023 This bill directs the Substance Abuse and Mental Health Services Administration to award grants to certain nonprofits to develop or expand services for individuals with substance use disorders and their families. 

Supporting the designation of June 6, 2023, as National Naloxone Awareness Day.

United States · United States Congress · 6 June 2023

This resolution supports the designation of National Naloxone Awareness Day. Naloxone is a medication that temporarily reverses opioid overdoses.

Ensuring Sufficient Supply of Testing Act

United States · United States Congress · 6 June 2023

Ensuring Sufficient Supply of Testing Act This bill expressly authorizes the Department of Health and Human Services (HHS) to enter into certain contracts and cooperative agreements with clinical laboratories as part of maintaining the Strategic National Stockpile. The Strategic National Stockpile consists of drugs, vaccines, medical products, and other supplies that may be deployed to respond to bioterrorist attacks or other public health emergencies. Current law permits HHS to enter into specified types of contracts and cooperative agreements with vendors (e.g., manufacturers and distributors of medical products) for managing inventory of and ensuring production capacity for supplies needed for the stockpile. The bill specifies that clinical laboratories may participate as vendors in those types of contracts and agreements.

Humane Correctional Health Care Act

United States · United States Congress · 6 June 2023

Humane Correctional Health Care Act This bill allows states to cover inmates of public institutions under Medicaid and the Children's Health Insurance Program (CHIP). The Government Accountability Office must report on specified information relating to the health of inmates and the effects of Medicaid and CHIP coverage.

Expressing support for the designation of the first Tuesday in June as "National Cancer Survivor Beauty and Support Day".

United States · United States Congress · 6 June 2023

This resolution expresses support for the designation of National Cancer Survivor Beauty and Support Day.

Humane Correctional Health Care Act

United States · United States Congress · 6 June 2023

Humane Correctional Health Care Act This bill allows states to cover inmates of public institutions under Medicaid and the Children's Health Insurance Program (CHIP). The Government Accountability Office must report on specified information relating to the health of inmates and the effects of Medicaid and CHIP coverage.

Expanding Access to Diabetes Self-Management Training Act of 2023

United States · United States Congress · 6 June 2023

Expanding Access to Diabetes Self-Management Training Act of 2023 This bill expands Medicare coverage of diabetes outpatient self-management training. It also requires the Center for Medicare and Medicaid Innovation to test a model in which such training is provided virtually.

Veterans Homecare Choice Act of 2023

United States · United States Congress · 6 June 2023

Veterans Homecare Choice Act of 2023 This bill includes any nurse registry as an eligible health care provider under the Veterans Community Care Program of the Department of Veterans Affairs. Under the bill, a nurse registry is a person who satisfies applicable state licensure requirements and procures, or attempts to procure, contracts or agreements on behalf of registered nurses, licensed practical nurses, certified nursing assistants, home health aides, companions, or homemakers under which such individuals may furnish health care-related or assistive services and receive compensation.

Supporting Families through Addiction Act of 2023

United States · United States Congress · 6 June 2023

Supporting Families through Addiction Act of 2023 This bill directs the Substance Abuse and Mental Health Services Administration to award grants to certain nonprofits to develop or expand services for individuals with substance use disorders and their families.

Firefighter Cancer Registry Reauthorization Act of 2023

United States · United States Congress · 5 June 2023

Firefighter Cancer Registry Reauthorization Act of 2023 This bill reauthorizes through FY2028 the National Firefighter Registry for Cancer. This is a voluntary registry maintained by the National Institute of Occupational Safety & Health that collects relevant health and occupational information to better understand and reduce cancers among firefighters.

Veterans Mental and Behavioral Health Quality of Care Act

United States · United States Congress · 5 June 2023

Veterans Mental and Behavioral Health Quality of Care Act This bill requires the Department of Veterans Affairs (VA) to use an independent and objective outside organization to study the difference in the quality of care between behavioral and mental health care provided by VA providers and care provided by non-VA providers.

FLASH Act of 2023

United States · United States Congress · 5 June 2023

Fast-track Logistics for Acquiring Supplies in a Hurry Act of 2023 or the FLASH Act of 2023 This bill expands federal contracting and other authorities to support the development and acquisition of products and supplies that are necessary for national public health and health security. Specifically, the Department of Health and Human Services (HHS) may use noncompetitive procedures to procure medical countermeasures (e.g., vaccines), chemical materials and reagents, manufacturing supplies, and similar items that are needed to develop products for national public health and health security. Additionally, HHS may acquire, subject to dollar limits and other conditions, innovative commercial products and services by soliciting proposals and selecting proposals through peer review. Further, the bill expands the activities of the Biomedical Advanced Research and Development Authority (BARDA) to include supporting the design and development of prototypes for products to diagnose, mitigate, prevent, treat, or otherwise respond to biological, chemical, radiological, or nuclear threats, including pandemics or epidemics. If BARDA enters an initial transaction to design or develop such a test or prototype using competitive procedures, BARDA may use noncompetitive procedures for a follow-on transaction to produce the test or prototype.

Small Business Flexibility Act

United States · United States Congress · 5 June 2023

Small Business Flexibility Act  This bill requires the Internal Revenue Service to notify employers, particularly small businesses, about the availability of individual coverage health reimbursement arrangements (ICHRAs), qualified small employer health reimbursement arrangements (QSEHRAs), and the small business health care tax credit. Under ICHRAs, employers agree to reimburse employees for incurred medical expenses up to a limit for a specified period (e.g., a calendar year), and employees obtain their own individual coverage that meets certain requirements of the Patient Protection and Affordable Care Act (coverage of preventive services and no annual or lifetime limits). QSEHRAs are available to employers with fewer than 50 full-time employees. The small business health care tax credit is available to employers with fewer than 25 full-time employees.

Ensuring Access to Lifesaving Drugs Act of 2023

United States · United States Congress · 5 June 2023

Ensuring Access to Lifesaving Drugs Act of 2023 This bill allows the Food and Drug Administration (FDA) to obtain additional information from manufacturers of life-saving drugs in order to assess and potentially modify the drug's expiration date. (The bill defines life-saving drug as a medical countermeasure or a drug that is in short supply and that is life-supporting, life-sustaining, or intended to be used to prevent or treat a debilitating disease or condition in humans or animals.) Specifically, the FDA may order a manufacturer of a life-saving drug to submit data and other information from any stage of the drug's development in order to assess the drug's stability and the longest supported expiration date. If such information is not readily available, the FDA may order the manufacturer to conduct additional studies. The FDA may require changes to the drug's label accordingly. Manufacturers that fail to comply are subject to civil penalties.   

To amend the Public Health Service Act to strike the requirement that the Director of the Centers for Disease Control and Prevention be appointed by and with the advice and consent of the Senate.

United States · United States Congress · 5 June 2023

This bill eliminates the requirement for the Senate to confirm the director of the Centers for Disease Control and Prevention. (The requirement was enacted in 2022 and is currently scheduled to become effective on January 20, 2025.)

Medical Device Shortage Reduction Act of 2023

United States · United States Congress · 5 June 2023

Medical Device Shortage Reduction Act of 2023 This bill expands the scope of required notifications about medical device shortages beyond public health emergencies. Currently, manufacturers of medical devices that are critical during a public health emergency (e.g., devices that are life-supporting, life-sustaining, or intended for use in emergency medical care or during surgery), or for which the Department of Health and Human Services (HHS) determines information about the supply chain is necessary during a public health emergency, must notify HHS of expected shortages of such devices. Manufacturers may voluntarily provide information on expected shortages of other critical medical devices, whether or not there is a public health emergency. The bill expands these provisions so as to generally require manufacturers to notify HHS of expected shortages of critical medical devices, whether or not there is a public health emergency. It also requires manufacturers to develop risk management plans that identify potential risks to the supply chain of such devices. 

Drug Origin Transparency Act of 2023

United States · United States Congress · 5 June 2023

Drug Origin Transparency Act of 2023  This bill requires drug manufacturers to report on the suppliers of ingredients used in their products. Specifically, drug manufacturers must report information relating to the supply chain of their products, including the suppliers of active ingredients and the amount of drugs that are manufactured using those ingredients. Drug manufacturers must also include information about the manufacturers of ingredients on the labels of their products.

Disease X Act of 2023

United States · United States Congress · 5 June 2023

Disease X Act of 2023 This bill expands the priorities of the Biomedical Advanced Research and Development Authority (BARDA) to specifically include viral threats that have the potential to cause a pandemic. In particular, the bill expands the scope of innovation grants and contracts that may be awarded by BARDA to specifically include those that support research and development of certain manufacturing technology for medical countermeasures against viruses, including respiratory viruses, with pandemic potential. It also expands BARDA's authorized strategic initiatives to include advanced research, development, and procurement of countermeasures and products to address viruses with pandemic potential.

KIDS Health Act of 2023

United States · United States Congress · 5 June 2023

Kickstarting Innovative Demonstrations Supporting Kids Health Act of 2023 or the KIDS Health Act of 2023 This bill requires the Centers for Medicare & Medicaid Services (CMS) to implement a demonstration program that supports a whole child health model for children under Medicaid and the Children's Health Insurance Program (CHIP). Specifically, the CMS must award grants to up to 15 states to plan and implement a health care model that supports the physical, behavioral, social, and other needs of children who qualify for Medicaid or CHIP through care coordination and integrated supportive services. States must implement models for 4-6 years. The CMS must provide technical assistance and guidance to states for the demonstration program. The bill also provides for an 80% federal matching rate for program costs. The Government Accountability Office must report on program outcomes.