Healthcare

NO PBMs Act

United States · United States Congress · 20 July 2023

Neighborhood Options for Patients Buying Medicines Act or the NO PBMs Act This bill specifies that prescription drug plan sponsors and pharmacy benefit managers under the Medicare prescription drug benefit must permit any pharmacy that meets the plan's contractual terms for network participation to participate in that network and that such terms must be reasonable. The Centers for Medicare & Medicaid Services must set standards for reasonable terms.

I CAN Act

United States · United States Congress · 20 July 2023

Improving Care and Access to Nurses Act or the I CAN Act This bill allows other health care providers besides physicians (e.g., nurses) to provide certain services under Medicare and Medicaid. Among other changes, the bill (1) allows a nurse practitioner or physician assistant to fulfill documentation requirements for Medicare coverage of special shoes for diabetic individuals; (2) expedites the ability of physician assistants, nurse practitioners, and clinical nurse specialists to supervise Medicare cardiac, intensive cardiac, and pulmonary rehabilitation programs; and (3) allows nurse practitioners to certify the need for inpatient hospital services under Medicare and Medicaid.

IMPROVE Part D Regulations Act

United States · United States Congress · 20 July 2023

Initiating Meaningful Patient Review Of Various Existing Part D Regulations Act or the IMPROVE Part D Regulations Act This bill requires the Centers for Medicare & Medicaid Services (CMS) to conduct patient-focused listening sessions on how to improve the Medicare prescription drug benefit. Specifically, the CMS must conduct at least one listening session with beneficiaries, health care providers, and other stakeholders about ways to improve the Medicare prescription drug benefit, including with respect to the information, tools, and mechanisms available to beneficiaries for navigating coverage options and requirements. The CMS must consider potential regulatory changes in light of these sessions.

Reproductive Health Patient Navigator Act of 2023

United States · United States Congress · 20 July 2023

Reproductive Health Patient Navigator Act of 2023 This bill provides funding for patient navigator grants to assist individuals in accessing abortion services. The Department of Health and Human Services must award the grants to state, tribal, or local governments; nonprofits; or community organizations that offer unbiased and medically accurate programs, services, or activities to connect individuals with abortion services. Grant-funded activities include, among others, coordinating the scheduling, financing, and other logistics of abortion services. Further, the bill prohibits individuals, entities, and states from preventing or otherwise disadvantaging an entity that is eligible to receive a grant from carrying out activities to assist individuals with accessing abortion services, including in any state in which those services are not lawful. Such activities include providing (or assisting in the provision of) abortion care and other reproductive health services that are either (1) lawful in the state where the services are provided, or (2) provided to an individual who does not reside in the state where the services are provided. The Department of Justice may bring civil actions for violations; the bill also provides for a private right of action.  

PROTECTS Act

United States · United States Congress · 20 July 2023

Promote Responsible Oversight and Targeted Employee background Check Transparency for Seniors Act or the PROTECTS Act This bill allows Medicaid and Medicare providers (e.g., skilled nursing facilities) to access, through the National Practitioner Data Bank, disciplinary information concerning affiliated physicians and other health care practitioners, as reported by state licensing authorities.

LOST Organs Act of 2023

United States · United States Congress · 20 July 2023

Lost Opportunities to Supply Transplantable Organs Act of 2023 or the LOST Organs Act of 2023 This bill requires the Organ Procurement and Transplantation Network to take specified actions related to the transportation of organs, including tracking and publicly reporting the status of organs in the transplant supply chain. (The Organ Procurement and Transplantation Network is a public-private partnership that links the professionals involved in the U.S. donation and transplantation system.)

PBM Oversight Act of 2023

United States · United States Congress · 20 July 2023

PBM Oversight Act of 2023 This bill requires prescription drug plan (PDP) sponsors under the Medicare prescription drug benefit to report certain information about the involvement of affiliated committees in decisions about formularies. Specifically, PDP sponsors that use formularies must report to the Centers for Medicare & Medicaid Services the names and descriptions of committees that are affiliated with the PDP sponsor, or a contracted pharmacy benefit manager, that are authorized to change initial recommendations of the pharmacy and therapeutic committee about formularies. PDP sponsors must also report any formulary changes that were made by an affiliated committee and provide justifications for these decisions. The Government Accountability Office must report on the use of these types of committees with respect to formularies under the Medicare prescription drug benefit, including decision-making trends.

Protecting Seniors from High Drug Costs Act

United States · United States Congress · 20 July 2023

Protecting Seniors from High Drug Costs Act This bill limits cost-sharing for covered drugs under the Medicare prescription drug benefit to the negotiated price of the drug, net any manufacturer price concessions. Prescription drug plan sponsors are subject to civil penalties for violations.

BURDENSOME RED TAPE: OVERREGULATION IN HEALTH CARE AND THE IMPACT ON SMALL BUSINESSES

United States · United States House of Representatives · 19 July 2023

MORE Act

United States · United States Congress · 19 July 2023

DEMO Act

United States · United States Congress · 19 July 2023

Impacts and Outcomes for Health Career Training Act

United States · United States Congress · 19 July 2023

HOPE Act

United States · United States Congress · 19 July 2023

Promoting Health Careers in Community and Technical Colleges Act

United States · United States Congress · 19 July 2023

Mentoring and Supporting Families Act

United States · United States Congress · 19 July 2023

No Obamacare for Illegal Aliens Act of 2023

United States · United States Congress · 19 July 2023

Access to Infertility Treatment and Care Act

United States · United States Congress · 19 July 2023

Concentrating on High-value Alzheimer's Needs to Get to an End Act of 2023

United States · United States Congress · 19 July 2023

Concentrating on High-value Alzheimer's Needs to Get to an End Act of 2023 or the CHANGE Act of 2023 This bill specifies that Medicare annual wellness visits and initial preventive physical examinations must include the use of an approved tool from the National Institute of Aging to detect cognitive impairment, as well as associated documentation of the tool that was used and the results.

Accelerating Kids’ Access to Care Act

United States · United States Congress · 19 July 2023

Accelerating Kids' Access to Care Act This bill requires state Medicaid programs to establish a process through which qualifying out-of-state providers may enroll as participating providers for five years without undergoing additional screening requirements, unless the state has an agreement with other states that governs coverage of children with medically complex conditions that is in accordance with specified guidance from the Centers for Medicare & Medicaid Services (CMS). Among other requirements, a qualifying provider must (1) serve individuals under the age of 21; (2) have previously been screened for Medicare participation or for participation in the Medicaid program of the state in which the provider is located; and (3) have been determined by the CMS or state Medicaid program to pose a limited risk of fraud, waste, or abuse.

No Obamacare for Illegal Aliens Act

United States · United States Congress · 19 July 2023

Investing in Rural America Act

United States · United States Congress · 19 July 2023

Investing in Rural America Act This bill allows Farm Credit System (FCS) institutions to provide financing and technical assistance for essential community facility projects as part of the Department of Agriculture's Community Facilities Direct Loan & Grant Program. (This program provides funding to develop essential community facilities in rural areas.) The FCS financing and technical assistance may be provided in order to make capital available to develop, build, maintain, improve, or provide other support for essential community facilities in rural communities (e.g., certain facilities that provide healthcare, community support, public safety, educational, or utility services).  Under the bill, the financing provided by an FCS institution may not exceed 15% of the institution’s total assets unless the FCS institution offers at least one non-FCS lending institution an interest in the financing under reasonable terms and conditions acceptable to the borrower. The FCS institution must also report the offer to the Farm Credit Administration (FCA). The FCA must submit an annual report to Congress on the activities undertaken by FCS institutions under this bill, including through the partnerships between FCS institutions and other lending institutions. The FCA must post the report on the agency's website. 

CARGO Act of 2023

United States · United States Congress · 19 July 2023

Cease Animal Research Grants Overseas Act of 2023 or the CARGO Act of 2023 This bill prohibits the National Institutes of Health from awarding support for any research that uses live animals unless the research occurs in the United States (including U.S. territories and possessions).  

Supporting the ideals of Bump Day, a global day of maternal health awareness, action and advocacy, and reaffirming United States leadership to end preventable maternal deaths in the United States and globally.

United States · United States Congress · 19 July 2023

This resolution recognizes Bump Day, an annual social media campaign that celebrates baby bumps and healthy pregnancies while raising awareness of unmet needs for maternal health care.

Securing Gene Synthesis Act

United States · United States Congress · 19 July 2023

Securing Gene Synthesis Act This bill requires the Department of Health and Human Services to issue regulations to prevent the misuse of de novo gene synthesis products (i.e., manufactured gene products), including screening protocols for providers of these products. Federal agencies and entities that receive federal funds may only purchase such products from providers that comply with the screening protocols.

Health Impacts of Nuclear War Act of 2023

United States · United States Congress · 19 July 2023

Health Impacts of Nuclear War Act of 2023 This bill requires the Department of Health and Human Services (HHS) to evaluate the consequences of the environmental impacts of nuclear war on human health and the ability of the United States to address these consequences. Specifically, HHS must conduct a five-year research and preparedness program that addresses the environmental effects of explosions of nuclear weapons (e.g., vast quantities of soot) and the resulting impact on human health (e.g., increased cancer rates). HHS may implement the program directly, as well as through grants, contracts, and cooperative agreements with nonprofits, nonprofit research institutions, or institutions of higher education. Additionally, HHS must, in coordination with other specified agencies and stakeholders, assess the ability of U.S. health systems to respond to these health consequences and identify any critical gaps or uncertainties.

CHANGE Act of 2023

United States · United States Congress · 19 July 2023

Concentrating on High-value Alzheimer's Needs to Get to an End Act of 2023 or the CHANGE Act of 2023 This bill specifies that Medicare annual wellness visits and initial preventive physical examinations must include the use of an approved tool from the National Institute of Aging to detect cognitive impairment, as well as associated documentation of the tool that was used and the results.

Access to Infertility Treatment and Care Act

United States · United States Congress · 19 July 2023

Medicare Audiology Access Improvement Act of 2023

United States · United States Congress · 19 July 2023

Medicare Audiology Access Improvement Act of 2023 This bill provides for Medicare coverage of certain audiology services. Specifically, the bill expands coverage to include diagnostic and treatment services that are furnished by audiologists and that would otherwise be covered if provided by a physician, including incidental services, regardless of whether such services are provided pursuant to a referral from, or under the supervision of, a physician or other health care practitioner.

Accelerating Kids’ Access to Care Act

United States · United States Congress · 19 July 2023

Accelerating Kids' Access to Care Act This bill requires state Medicaid programs to establish a process through which qualifying out-of-state providers may enroll as participating providers for five years without undergoing additional screening requirements, unless the state has an agreement with other states that governs coverage of children with medically complex conditions that is in accordance with specified guidance from the Centers for Medicare & Medicaid Services (CMS). Among other requirements, a qualifying provider must (1) serve individuals under the age of 21; (2) have previously been screened for Medicare participation or for participation in the Medicaid program of the state in which the provider is located; and (3) have been determined by the CMS or state Medicaid program to pose a limited risk of fraud, waste, or abuse.

Artificial Intelligence and Biosecurity Risk Assessment Act

United States · United States Congress · 19 July 2023

Artificial Intelligence and Biosecurity Risk Assessment Act This bill requires the Administration for Strategic Preparedness and Response to assess the risks posed by artificial intelligence in developing novel pathogens, viruses, bioweapons, or chemical weapons and to address these risks through related initiatives and activities, such as by including the risk assessment in the National Health Security Strategy (a coordinated strategy among federal, state, and local entities to address public health emergencies).

Patient Right to Shop Act

United States · United States Congress · 18 July 2023

Protect Children’s Innocence Act

United States · United States Congress · 18 July 2023

Pandemic and All-Hazards Preparedness and Response Act

United States · United States Congress · 18 July 2023

Pandemic and All-Hazards Preparedness and Response Act This bill reauthorizes through FY2028 and modifies public health preparedness and response programs and activities. The bill also addresses potential shortages of drugs and medical devices. Affected public health programs and activities include the Public Health Emergency Preparedness Program and other programs that support state, territorial, tribal, and local preparedness and response; activities that support the development of medical countermeasures, diagnostic testing capacity, and the administration of the Strategic National Stockpile; requirements concerning biosecurity, including with respect to biological agents and toxins that pose a threat to animal, plant, and human health; and the Volunteer Medical Reserve Corps and other programs to enable volunteer health providers and other health professionals to respond during disasters and emergencies. The bill also (1) establishes specific procedures with respect to certain claims for compensation for deaths or injuries in association with COVID-19 vaccinations or medical countermeasures; (2) establishes programs to address the needs of individuals with disabilities and other at-risk individuals during public health emergencies; and (3) makes various changes to address and mitigate shortages of drugs and devices, including by expanding certain reporting and notification requirements.

Rural Hospital Technical Assistance Program Act

United States · United States Congress · 18 July 2023

Rural Hospital Technical Assistance Program Act This bill provides statutory authority for the Rural Hospital Technical Assistance Program within the Department of Agriculture (USDA). Under the bill, USDA must establish and maintain (directly or by grant, contract, or cooperative agreement) a program to help eligible hospital facilities in rural areas with a population of 50,000 inhabitants or less.  The program must provide tailored technical assistance and training to hospital facilities to identify development needs for maintaining essential health care services and support action plans for financial, operational, and quality improvement projects to meet these needs. Development needs include (1) constructing, expanding, and modernizing health care facilities; (2) increasing telehealth capabilities; and (3) acquiring or upgrading health care information systems (e.g., electronic health records). The program must also provide technical assistance and training to help hospital facilities to better manage their financial and business strategies and identify, and apply for assistance from, USDA loan and grant programs. In selecting eligible hospital facilities to participate in the program, USDA must give priority to borrowers and grantees of certain USDA rural assistance programs.   USDA must also submit an annual report to Congress on the progress and results of the program. 

Securing Gene Synthesis Act

United States · United States Congress · 18 July 2023

Securing Gene Synthesis Act This bill requires the Department of Health and Human Services to issue regulations to prevent the misuse of de novo gene synthesis products (i.e., manufactured gene products), including screening protocols for providers of these products. Federal agencies and entities that receive federal funds may only purchase such products from providers that comply with the screening protocols.

Pediatricians Accelerate Childhood Therapies Act of 2023

United States · United States Congress · 18 July 2023

Pediatricians Accelerate Childhood Therapies Act of 2023 This bill requires the National Institutes of Health (NIH) to make awards to support early-career pediatric researchers. It also provides statutory authority for the NIH Pediatric Research Consortium to coordinate pediatric research across national health research institutions.

Protecting PAHPA Act of 2023

United States · United States Congress · 18 July 2023

Protecting Pandemic and All-Hazards Preparedness Act of 2023 or the Protecting PAHPA Act of 2023 This bill extends through FY2028 and modifies various programs and activities that support public health preparedness and response. The bill also addresses matters concerning shortages of drugs and medical devices and recalls of drugs. For example, the bill modifies activities of the Office of the Assistant Secretary for Preparedness and Response, the Centers for Disease Control and Prevention, and the Biomedical Advanced Research and Development Authority; grants to support preparedness and response activities of health departments, hospitals, and public health laboratories; programs to facilitate the response of volunteer health providers and other professionals during disasters and emergencies; efforts related to the management and operation of the Strategic National Stockpile; federal partnerships and initiatives for collaborating and coordinating during public health and other emergencies and with the development of medical countermeasures and diagnostic testing capacity; and requirements for collecting and reporting public health and health care data and information. Additionally, the bill makes various changes to address and mitigate shortages of drugs and devices, including by (1) setting out a process to safely extend the expiration date of certain medical countermeasures and other life-saving drugs, and (2) expanding requirements for drug manufacturers to notify the Food and Drug Administration concerning potential shortages. Further, the bill expands the authority of the Secretary of the Department of Health and Human Services to order the recall of controlled substances to cover all drugs.

Artificial Intelligence and Biosecurity Risk Assessment Act

United States · United States Congress · 18 July 2023

Artificial Intelligence and Biosecurity Risk Assessment Act This bill requires the Administration for Strategic Preparedness and Response to assess the risks posed by artificial intelligence in developing novel pathogens, viruses, bioweapons, or chemical weapons and to address these risks through related initiatives and activities, such as by including the risk assessment in the National Health Security Strategy (a coordinated strategy among federal, state, and local entities to address public health emergencies).

POST FAST Act of 2023

United States · United States Congress · 18 July 2023

Publish Overdose and Suicide Tracking For American Safety Today Act of 2023 or the POST FAST Act of 2023 This bill requires the Centers for Disease Control and Prevention to publish data about suicides and drug overdoses in the United States for a given month within 60 days of the end of that month.

Servicemember Mental Health Support Act of 2023

United States · United States Congress · 18 July 2023

Servicemember Mental Health Support Act of 2023 This bill requires the Department of Defense to report on (1) the policies of the Armed Forces for mental health referrals; and (2) the impact of removing requirements for a primary care referral for outpatient mental health care on the readiness of the military, the utilization of outpatient mental health care services by members of the Armed Forces, and suicide prevention.

Pediatricians Accelerate Childhood Therapies Act of 2023

United States · United States Congress · 18 July 2023

Pediatricians Accelerate Childhood Therapies Act of 2023 This bill requires the National Institutes of Health (NIH) to make awards to support early-career pediatric researchers. It also provides statutory authority for the NIH Pediatric Research Consortium to coordinate pediatric research across national health research institutions.

Strategy for Public Health Preparedness and Response to Artificial Intelligence Threats

United States · United States Congress · 18 July 2023

Strategy for Public Health Preparedness and Response to Artificial Intelligence Threats This bill requires the Department of Health and Human Services to develop a strategy for public health preparedness, response, and biodefense that addresses the risks to national health security posed by the misuse of artificial intelligence, such as biological weapons and viruses and bacteria that are resistant to treatment.

MAPS Act

United States · United States Congress · 18 July 2023

Mapping America's Pharmaceutical Supply Act or the MAPS Act This bill requires the Department of Health and Human Services (HHS) to support efforts to map the U.S. pharmaceutical supply chain and identify associated vulnerabilities. As part of these efforts, HHS must support the development of a database of certain essential medicines and the identification of information about their supply chain, including the location of manufacturing facilities. Qualifying essential medicines are those that are likely to be needed in the event of a public health emergency or chemical, biological, radiological, or nuclear threat or for which a shortage would pose a significant threat to the U.S. health care system or at-risk populations. 

Jimmy Deal Trafficking Survivors Assistance Act of 2023

United States · United States Congress · 18 July 2023

Jimmy Deal Trafficking Survivors Assistance Act of 2023 This bill requires the Transportation Security Administration (TSA) to provide air travel assistance for survivors of human trafficking who do not have the identification documents necessary for air travel. Specifically, the TSA must establish the position of Trafficking Survivor Point of Contact (TSPoC) at every TSA screening airport. The TSPoC must liaise and establish relationships with service providers and provide air travel assistance for survivors of human trafficking. The TSPoC must provide information to an eligible service provider and assist the provider or the individual (who does not have the identification documents necessary for air travel) throughout the vetting process, travel, and arrival at the destination airport. The bill directs a TSPoC to follow specific procedures. Under the bill, a service provider is a nonprofit organization that provides services to individuals who are victims of human trafficking, including (1) emergency services, such as shelter, food, clothing, and transportation; (2) case management or wraparound services; (3) mental health care or other medical services; and (4) legal services. 

Drug Shortage Prevention Act of 2023

United States · United States Congress · 18 July 2023

Drug Shortage Prevention Act of 2023 This bill requires drug manufacturers to notify the Food and Drug Administration (FDA) if there is an increased demand, export restriction, or other circumstance that may result in a shortage of certain critical drugs. Currently, drug manufacturers are required to notify the FDA in the event of a discontinuation or interruption in the supply of prescription drugs that are life-supporting, life-sustaining, or used for a debilitating disease or condition, including those used in medical emergencies, surgeries, or public health emergencies. The bill requires drug manufacturers to also notify the FDA if there is an increased demand, export restriction, or other circumstance that may result in a meaningful shortfall or delay in meeting the demand for such drugs. Manufacturers must notify the FDA as soon as possible but no later than 10 days after the onset of the relevant circumstance. The notice must include the reasons for the increased demand, the expected duration, and any other information the FDA requires. The bill's requirements apply to both prescription and nonprescription drugs. Drug manufacturers must also report twice a year (rather than annually) information on the quantities of drugs produced; manufacturers must also provide the names of the suppliers of corresponding active ingredients.

Gene Synthesis Safety and Security Act

United States · United States Congress · 18 July 2023

Gene Synthesis Safety and Security Act This bill requires the Department of Health and Human Services (HHS) to update guidance to address the potential misuse of gene synthesis products (i.e., manufactured genetic products) to obtain biological agents or toxins of concern. The guidance must include recommendations relating to screening protocols, recordkeeping, technological safeguards, and other specified information. HHS must evaluate the current landscape of gene synthesis manufacturers and related technology to inform the guidance. HHS must also solicit public input to develop a list of genetic sequences of concern.

Protecting Taxpayers from Student Loan Bailouts Act

United States · United States Congress · 18 July 2023

Protecting Taxpayers from Student Loan Bailouts Act This bill limits the authority of the Department of Education (ED) to propose or issue regulations and executive actions related to federal student aid programs. The bill prohibits ED from issuing such a proposed rule, final regulation, or executive action if ED determines that the rule, regulation, or action (1) is economically significant, and (2) would result in an increase in a subsidy cost. Economically significant refers to a regulation or executive action that is likely to (1) have an annual effect on the economy of $100 million or more; or (2) adversely affect in a material way the economy, a sector of the economy, productivity, competition, jobs, the environment, public health or safety, or state, local, or tribal governments or communities.

Health Impacts of Nuclear War Act of 2023

United States · United States Congress · 18 July 2023

Health Impacts of Nuclear War Act of 2023 This bill requires the Department of Health and Human Services (HHS) to evaluate the consequences of the environmental impacts of nuclear war on human health and the ability of the United States to address these consequences. Specifically, HHS must conduct a five-year research and preparedness program that addresses the environmental effects of explosions of nuclear weapons (e.g., vast quantities of soot) and the resulting impact on human health (e.g., increased cancer rates). HHS may implement the program directly, as well as through grants, contracts, and cooperative agreements with nonprofits, nonprofit research institutions, or institutions of higher education. Additionally, HHS must, in coordination with other specified agencies and stakeholders, assess the ability of U.S. health systems to respond to these health consequences and identify any critical gaps or uncertainties.

Train More Doctors Act of 2023

United States · United States Congress · 17 July 2023

Train More Doctors Act of 2023 This bill extends the resident cap building period for purposes of Medicare graduate medical education payments for hospitals that began training residents in a new program between July 1, 2018, and July 1, 2021, to take into account the impact of the COVID-19 public health emergency on these hospitals.

Increasing Prescription Drug Competition Act

United States · United States Congress · 17 July 2023

Increasing Prescription Drug Competition Act This bill provides that certifications in generic drug applications of certain patents involved in Risk Evaluation and Mitigation Strategy (REMS) programs have no effect upon the drug's approval. (The Food and Drug Administration sometimes requires a REMS program for certain drugs with safety risks, which may include restrictions on a drug's distribution through elements to ensure safe use (ETASU), such as special requirements for pharmacies that dispense the drug.) Specifically, certifications in generic drug applications with respect to patents that involve an ETASU for REMS requirements have no effect on the effective date of the drug's approval, notwithstanding any other provisions that allow for a stay of approval pending litigation outcomes (i.e., 30-month stay). The bill also specifies that in a civil action alleging patent infringement with respect to REMS requirements, the sponsor of the approved brand-name drug may only seek damages from (rather than an injunction against) the generic drug applicant.