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951 records in US in 2017
United States · United States Congress · 2 March 2017
Investing in Testing Act of 2017 This bill requires the Centers for Disease Control and Prevention to study the health implications of contamination of drinking water by perfluoroalkyl and polyfluoroalkyl substances (PFASs). (PFASs can accumulate in the body and are commonly found at low levels in food, water, and the environment.)
United States · United States Congress · 2 March 2017
Freedom to Use Contracted Entities Act This bill allows a state Medicaid program to use a contractor to make eligibility determinations on its behalf, so long as the contract does not provide incentives for the contractor to delay eligibility determinations or to deny eligibility for individuals otherwise eligible for medical assistance.
United States · United States Congress · 2 March 2017
This bill allows the Centers for Medicare & Medicaid Services (CMS) to waive specified requirements for a state Medicaid program to provide certain premium assistance if the CMS determines that such waivers are cost-effective.
United States · United States Congress · 2 March 2017
This bill increases the maximum allowable cost-sharing or similar charge that a state Medicaid program may impose, for outpatient services received at a hospital emergency room, from up to twice the nominal amount (currently $4) to up to $25.
United States · United States Congress · 2 March 2017
Women's Health Protection Act of 2017 This bill prohibits any government from imposing on abortion services: a requirement that a medical professional perform specific tests or medical procedures; a requirement that the same clinician who performs a patient's abortion also perform additional tests, services or procedures; a limitation on an abortion provider's ability to prescribe or dispense drugs or provide services via telemedicine; a requirement or limitation concerning the physical plant, equipment, staffing, or hospital transfer arrangements of facilities where abortions are performed, or the credentials, hospital privileges, or status of personnel at those facilities; a requirement that, prior to obtaining an abortion, a patient make medically unnecessary in-person visits to any individual or entity; a limitation on medical training for abortion procedures; a prohibition prior to fetal viability, including a prohibition on a particular abortion procedure; a prohibition after fetal viability when continuation of the pregnancy would pose a risk to the woman's life or health; a restriction on a woman's ability to obtain an immediate abortion when a delay would pose a risk to the woman's health; or a restriction on obtaining an abortion prior to fetal viability based on a woman's reasons or perceived reasons or that requires her to state her reasons before obtaining an abortion. A measure or action that is similar to a requirement or limitation listed above is prohibited if it singles out abortion services or makes abortion services more difficult to access and does not significantly advance women's health or the safety of abortion services.
United States · United States Congress · 2 March 2017
Local and Municipal Health Care Choice Act of 2017 This bill amends the Public Health Service Act to authorize a local government in a secondary state to provide group health coverage to its officers, employees, or retirees and their dependents through a local government employee health benefits pool or program authorized under the laws of a primary state unless the municipal league, municipal association, or county association in the secondary state objects. Such pools and programs must do business in the primary state. Such pools and programs are subject to the primary state's laws, rules, regulations, agreements, and orders pertaining to: group health coverage issued by such a pool or program; the offer, sale, rating, renewal, and issuance of group health coverage to local government officials, employees, or retirees and their dependents; the management, operations, and investment activities of such a pool or program; loss control and claims administration for such a pool or program; or payment of taxes levied on health insurance issuers, brokers, or policyholders. Such pools and programs are exempt from these policies of the secondary state. These policies do not include policies governing the use of care or cost management techniques. The policies of the primary state must apply to such pools and programs in both the primary state and secondary state. Secondary states may require such a pool or program to: (1) register with the state, (2) comply with certain court injunctions, or (3) comply with state laws regarding fraud and abuse or unfair claims settlement practices.
United States · United States Congress · 2 March 2017
Strengthening Mosquito Abatement for Safety and Health Act or the SMASH Act This bill amends the Public Health Service Act to revise and extend through FY2023 Centers for Disease Control and Prevention (CDC) grants for mosquito control programs. The grant program is expanded so that grants may be used to address emerging, infectious mosquito-borne diseases and to improve existing control programs. The CDC must give preference to applicants that have: (1) a public health emergency due to a mosquito-borne disease, or (2) a control program that is consistent with existing state preparedness plans. The requirement for matching funds may be waived if the area covered by a grant applicant has an extreme need due to the size or density of the human population, the size or density of the mosquito population, or the severity of the mosquito-borne disease. CDC grants to help public health agencies improve surveillance and response activities are extended through FY2023. The Government Accountability Office must report on the surveillance and control of mosquito-borne infectious diseases in the United States and territories.
United States · United States Congress · 2 March 2017
Public Option Deficit Reduction Act This bill amends the Patient Protection and Affordable Care Act to require the Department of Health and Human Services (HHS) to offer a public health insurance option that ensures choice, competition, and stability of affordable, high-quality coverage throughout the United States. The bill declares that HHS's primary responsibility is to create a low-cost plan without compromising quality or access to care. The bill sets forth provisions related to the establishment and governance of the public health insurance option, including that plans under the option must: (1) be offered only through health insurance exchanges; (2) comply with requirements for plans offered through exchanges, including requirements related to benefits, benefit levels, provider networks, notices, consumer protections, and cost sharing; and (3) include plans with bronze, silver, and gold tier benefits. HHS must: (1) establish an office of the ombudsman for the public health insurance option; (2) collect data to establish premiums and payment rates; (3) establish geographically adjusted premiums at a level sufficient to fully finance the costs of the health benefits provided, administrative costs, and a contingency margin; and (4) establish payment rates for health care providers at Medicare rates, with higher rates for the first three years. The bill appropriates funding for the establishment of the public health insurance option. HHS must repay this amount over 10 years. HHS may use innovative payment mechanisms and policies to determine payments for items and services under the public health insurance option.
United States · United States Congress · 2 March 2017
This bill eliminates the requirement for a state Medicaid program to allow an individual to select a managed-care entity from among two or more qualified entities. Instead, a state Medicaid program may, but is not required to, do so.
United States · United States Congress · 2 March 2017
Expresses support for the designation of National Spinal CSF (cerebrospinal fluid) Leak Awareness Week. (CSF is the fluid that surrounds the brain and spinal cord. CSF leaks can cause intense headaches.)
United States · United States Congress · 2 March 2017
Expresses serious concern about the public health threat posed by polio. Implores various entities to act with haste and dedication to eradicate polio by 2018. Calls upon the executive branch to provide the necessary resources to end the scourge of polio, including closely monitoring laboratory stocks of the polio virus.
United States · United States House of Representatives · 1 March 2017
United States · United States Congress · 1 March 2017
Commemorates October 20, 2017, as the 100th anniversary of the Academy of Nutrition and Dietetics. Applauds the academy for its efforts to: (1) promote food and nutrition professionals; and (2) improve health and wellness through research, education, and advocacy.
United States · United States Congress · 1 March 2017
Helping Veterans Exposed to Burn Pits Act This bill directs the Department of Veterans Affairs (VA) to establish a center of excellence in the prevention, diagnosis, mitigation, treatment, and rehabilitation of health conditions relating to exposure to burn pits and other environmental exposures in Afghanistan or Iraq. The VA shall, in selecting the center's site, consider entities that: are equipped with the specialized equipment needed to study, diagnose, and treat health conditions relating to such exposure; have a track record of publishing information on post-deployment health exposures among veterans who served in support of Operation Iraqi Freedom and Operation Enduring Freedom; have access to animal models and in vitro models of dust immunology and lung injury consistent with the injuries of members of the Armed Forces who served in support of such operations; and have expertise in allergy, immunology, and pulmonary diseases. The VA shall ensure that the center collaborates with the Department of Defense (DOD), institutions of higher education, and other appropriate public and private entities to: provide for dissemination within the VA of best practices for the treatment of such conditions and the training of health professionals, provide guidance for the VA and DOD health systems in determining the personnel required to provide quality health care for members of the Armed Forces and veterans with such conditions, establish, and oversee a program to train VA and DOD health professionals in the treatment of such conditions, facilitate advancements in the study of the short-term and long-term effects of such exposure, conduct basic science and translational research on such conditions for the purposes of understanding the etiology of such conditions and developing preventive interventions and new treatments, and provide medical treatment to veterans diagnosed with medical conditions specific to exposure to burn pits and other environmental exposures. The center shall have access to and make use of the data accumulated by the burn pits registry.
United States · United States Congress · 1 March 2017
CT Colonography Screening for Colorectal Cancer Act of 2017 This bill amends title XVIII (Medicare) of the Social Security Act to: (1) provide Medicare coverage for screening computed tomography colonography (CTC) as a colorectal cancer screening test, and (2) exclude screening CTC from a special Medicare payment rule applicable to certain imaging services.
United States · United States Congress · 1 March 2017
Improving Access to Mental Health Act This bill amends title XVIII (Medicare) of the Social Security Act to: (1) increase the Medicare reimbursement rate for clinical social worker services, (2) exclude clinical social worker services from the prospective payment system in which predetermined amounts form the basis for payment under Medicare, and (3) alter the definition of “clinical social worker services” as it relates to Medicare. Under current law, “clinical social worker services”: (1) include services performed for the diagnosis and treatment of mental illnesses, and (2) exclude services furnished to an inpatient of a skilled nursing facility as a condition of the facility's participation in the Medicare program. The bill repeals these provisions and instead specifies that such services include certain types of health behavior assessment and intervention.
United States · United States Congress · 1 March 2017
Medicare Patient Access to Hospice Act of 2017 This bill amends title XVIII (Medicare) of the Social Security Act to allow physician assistants to provide hospice care under Medicare.
United States · United States Congress · 1 March 2017
State Medicaid Waiver Flexibility Act of 2017 This bill indefinitely extends a state's Medicaid managed care waiver if: (1) the waiver was in effect as of January 1, 2017, (2) the waiver's renewal has been approved at least twice, and (3) the waiver's terms or conditions remain unchanged.
United States · United States Congress · 1 March 2017
DXM Abuse Prevention Act of 2017 This bill amends the Federal Food, Drug, and Cosmetic Act to: (1) require a retailer that sells certain drugs containing dextromethorphan (DXM) to have a verification system that is intended to ensure that no one under 18 years of age purchases such drugs from the retailer, (2) establish other restrictions on the sale of over-the-counter drugs containing DXM, and (3) establish restrictions on the distribution of bulk DXM.
United States · United States Congress · 1 March 2017
Living Donor Protection Act of 2017 This bill prohibits discrimination based on an individual's status as a living organ donor in the offering, issuance, cancellation, coverage, price, or any other condition of a life insurance policy, disability insurance policy, or long-term care insurance policy. The bill amends the Family and Medical Leave Act of 1993 to specifically include living organ donation as a serious health condition that entitles a covered employee to leave under that Act. The Department of Health and Human Services must update public service announcements, websites, and other media regarding live organ donation to educate the public on the benefits of live organ donation and on access to insurance for living organ donors.
United States · United States Congress · 1 March 2017
World's Greatest Healthcare Plan Act of 2017 This bill amends the Internal Revenue Code to repeal the requirements for individuals to maintain minimum essential coverage and for large employers to offer affordable coverage to full time employees. Health insurance is no longer required to cover preventive care at no cost or include the essential health benefits. Individuals enrolling in health insurance who have not maintained continuous coverage over the previous 12 months are charged an extra 20% on premiums for each consecutive year without coverage, unless the individual is subject to similar state incentives to maintain coverage. States may enroll uninsured residents in high deductible health plans. Individuals must be permitted to opt-out of this coverage. The Department of Health and Human Services (HHS) must develop a risk adjustment mechanism for health insurance in the individual market. For residents of a state to qualify for premium subsidies or the health insurance tax credit in this bill, the state must permit health insurance with an annual limit on benefits to be sold on its exchange. The bill establishes an advanceable, refundable health insurance tax credit for taxpayers enrolled in coverage that does not cover abortion except in certain circumstances. States may: (1) apply to HHS to use unclaimed health insurance tax credits for indigent health care; and (2) enroll Medicaid-eligible individuals in health insurance that qualifies for the tax credit instead of in Medicaid, at the individual's option. The tax on excess health benefits (commonly called the Cadillac tax) is repealed. The bill establishes Roth HSAs (health savings accounts) for paying certain medical expenses and health insurance premiums. The tax deduction for medical expenses is eliminated. This bill amends title XIX (Medicaid) and title XVIII (Medicare) of the Social Security Act, including to turn federal Medicaid payments into block grants.
United States · United States Congress · 1 March 2017
Commemorates the 100th anniversary of the Academy of Nutrition and Dietetics. Expresses hope that the academy will continue to improve the nation's health by advancing the profession of dietetics through research, education, and advocacy.
United States · United States Congress · 1 March 2017
Protecting Beneficiary Access to Complex Rehab Technology Act of 2017 This bill amends title XVIII (Medicare) of the Social Security Act to prohibit the application of Medicare competitive acquisition rates to complex rehabilitative wheelchairs and accessories. (A competitive bidding program has replaced the use of established fee schedule amounts to determine payments under Medicare for certain durable medical equipment such as wheelchairs.)
United States · United States Congress · 1 March 2017
Removing Barriers to Colorectal Cancer Screening Act of 2017 This bill waives Medicare coinsurance requirements with respect to colorectal cancer screening tests, regardless of the code billed for a resulting diagnosis or procedure.
United States · United States Congress · 1 March 2017
Expresses support for the goals and ideals of Multiple Sclerosis Awareness Week. Reaffirms the U.S. commitment to ending multiple sclerosis by promoting awareness about individuals affected by multiple sclerosis and supporting research and education programs. Recognizes people living with multiple sclerosis and salutes the health care professionals and medical researchers who assist those so affected and continue to work to find ways to stop the disease, restore what has been lost, and end multiple sclerosis forever.
United States · United States Congress · 1 March 2017
Expresses support for the goals and ideals of National Colorectal Cancer Awareness Month.
United States · United States Congress · 28 February 2017
Independent Outside Audit of the Indian Health Service Act of 2017 This bill requires the Department of Health and Human Services to contract with private entities to assess the health care delivery systems and financial management of the Indian Health Service (IHS). The assessment must address IHS issues including: the demographics and health care needs of the patient population, health care capabilities and resources, staffing levels at medical facilities and the productivity of each health care provider, information technology strategies related to providing health care, business processes, the competency of leadership regarding specified issues, tracking patients eligible for other federal health care programs, and the number of procurement contracts and awards under the Buy Indian Act.
United States · United States Congress · 28 February 2017
Securing our Agriculture and Food Act This bill amends the Homeland Security Act of 2002 to direct the Assistant Secretary for Health Affairs for the Department of Homeland Security (DHS) to carry out a program to coordinate DHS efforts related to defending the food, agriculture, and veterinary systems of the United States against terrorism and other high-consequence events that pose a high risk to homeland security. Such program shall: provide oversight and management of DHS's responsibilities pursuant to Homeland Security Presidential Directive 9 - Defense of United States Agriculture and Food; provide oversight and integration of DHS activities related to veterinary public health, food defense, and agricultural security; lead DHS policy initiatives related to food, animal, and agricultural incidents and to overall domestic preparedness for, and collective response to, agricultural terrorism; coordinate with other DHS components on activities related to food and agriculture security and screening procedures for domestic and imported products; and coordinate with appropriate federal departments and agencies.
United States · United States Congress · 28 February 2017
Territory Health Insurance Tax Relief Act of 2017 This bill amends the Patient Protection and Affordable Care Act to exclude premiums paid by residents of U.S. territories from a health insurer's net premiums when calculating the annual fee on the health insurer, thereby lowering the fee for health insurers that collect such premiums. These premiums are still included in total health premiums when calculating the annual fee on health insurers, thus the total amount collected annually from health insurers is reduced.
United States · United States Congress · 28 February 2017
Cerebral Cavernous Malformations Clinical Awareness, Research, and Education Act of 2017 or the CCM-CARE Act This bill amends the Public Health Service Act to require the National Institutes of Health (NIH) to strengthen and coordinate its efforts concerning cerebral cavernous malformation (CCM). (CCM is a condition in which blood vessels in the brain and spinal cord become enlarged, which can lead to seizures, paralysis, hearing or vision loss, or bleeding in the brain.) The NIH may award grants and enter into cooperative agreements for CCM research. The NIH must: (1) award grants and contracts to plan and provide support for a network of CCM Clinical Research Centers; (2) identify and support additional centers to facilitate medical research to develop a cure for CCM and enhance medical care for CCM; and (3) convene a Cerebral Cavernous Malformations Research Consortium to develop programs for clinicians, scientists, and patients. The Centers for Disease Control and Prevention may award grants and enter into cooperative agreements for the collection, analysis, and reporting of data on CCM. The Department of Health and Human Services must award grants and enter into cooperative agreements for epidemiological activities related to CCM and must provide for a national CCM surveillance program. The Food and Drug Administration must, in order to hasten clinical trials for CCM, coordinate with clinical centers, investigators, and advocates to support: (1) qualification of biomarkers, (2) qualification of patient reported outcome measures for quality of life, (3) investigational new drug applications, and (4) adaptive trial designs for rare disease research and expedited review of medications.
United States · United States Congress · 28 February 2017
Mental Health and Substance Abuse Treatment Accessibility Act of 2017 This bill amends the Public Health Service Act to permit the Department of Health and Human Services to make loans and loan guarantees: (1) for construction or renovation of psychiatric or substance abuse treatment facilities, and (2) to refinance such loans and loan guarantees. The bill establishes terms and conditions for these loans and loan guarantees. The bill establishes the Mental Health and Substance Use Treatment Trust Fund. Revenues from the loans and loan guarantees that exceed the cost of carrying out the program may be appropriated to the fund. Amounts in the fund are available for block grants for community mental health services.
United States · United States Congress · 28 February 2017
Affordable and Safe Prescription Drug Importation Act This bill amends the Federal Food, Drug, and Cosmetic Act to require the Food and Drug Administration (FDA) to promulgate regulations within 180 days permitting wholesalers, pharmacies, and individuals to import certain prescription drugs from Canada. The FDA, within two years, may permit the importation of prescription drugs from other countries. The bill establishes a process for certifying foreign sellers—a licensed foreign pharmacy or foreign wholesale distributor.
United States · United States Congress · 28 February 2017
Expresses support for: (1) the designation of Rare Disease Day; and (2) a national and global commitment to developing new treatments, diagnostics, and cures for rare diseases and disorders.
United States · United States Congress · 28 February 2017
Congenital Heart Futures Reauthorization Act of 2017 This bill amends the Public Health Service Act to replace the authorization for a National Congenital Heart Disease Surveillance System with a requirement for the Department of Health and Human Services, regarding congenital heart disease, to enhance and expand research and surveillance infrastructure, and to plan and implement a public outreach and education campaign. (Congenital heart disease is a condition caused by a heart defect that is present at birth.) The Centers for Disease Control and Prevention must conduct: (1) a study of congenital heart disease, from birth to adulthood, that considers health care utilization, demographic factors, and outcomes; and (2) an awareness, outreach, and education campaign regarding congenital heart disease. Data from the study must be made available to the public. The National Heart, Lung, and Blood Institute must report on its ongoing research efforts regarding congenital heart disease, future plans for such research, and areas of greatest need for such research.
United States · United States Congress · 28 February 2017
Territory Health Insurance Tax Relief Act of 2017 This bill amends the Patient Protection and Affordable Care Act to exclude premiums paid by residents of U.S. territories from a health insurer's net premiums when calculating the annual fee on the health insurer, thereby lowering the fee for health insurers that collect such premiums. These premiums are still included in total health premiums when calculating the annual fee on health insurers, thus the total amount collected annually from health insurers is reduced.
United States · United States Congress · 28 February 2017
Cerebral Cavernous Malformations Clinical Awareness, Research, and Education Act of 2017 or the CCM-CARE Act This bill amends the Public Health Service Act to require the National Institutes of Health (NIH) to strengthen and coordinate its efforts concerning cerebral cavernous malformation (CCM). (CCM is a condition in which blood vessels in the brain and spinal cord become enlarged, which can lead to seizures, paralysis, hearing or vision loss, or bleeding in the brain.) The NIH may award grants and enter into cooperative agreements for CCM research. The NIH must: (1) award grants and contracts to plan and provide support for a network of CCM Clinical Research Centers; (2) identify and support additional centers to facilitate medical research to develop a cure for CCM and enhance medical care for CCM; and (3) convene a Cerebral Cavernous Malformations Research Consortium to develop programs for clinicians, scientists, and patients. The Centers for Disease Control and Prevention may award grants and enter into cooperative agreements for the collection, analysis, and reporting of data on CCM. The Department of Health and Human Services must award grants and enter into cooperative agreements for epidemiological activities related to CCM and must provide for a national CCM surveillance program. The Food and Drug Administration must, in order to hasten clinical trials for CCM, coordinate with clinical centers, investigators, and advocates to support: (1) qualification of biomarkers, (2) qualification of patient reported outcome measures for quality of life, (3) investigational new drug applications, and (4) adaptive trial designs for rare disease research and expedited review of medications.
United States · United States Congress · 28 February 2017
Affordable and Safe Prescription Drug Importation Act This bill amends the Federal Food, Drug, and Cosmetic Act to require the Food and Drug Administration (FDA) to promulgate regulations within 180 days permitting wholesalers, pharmacies, and individuals to import certain prescription drugs from Canada. The FDA, within two years, may permit the importation of prescription drugs from other countries. The bill establishes a process for certifying foreign sellers—a licensed foreign pharmacy or foreign wholesale distributor.
United States · United States Congress · 28 February 2017
Independence at Home Act of 2017 This bill amends title XVIII (Medicare) of the Social Security Act to establish a permanent Independence at Home Medical Practice Program, under which a primary care practice shall be accountable for: (1) providing comprehensive, coordinated, continuous, and accessible care to applicable Medicare beneficiaries at home; and (2) coordinating health care across all treatment settings. Subject to meeting specified quality performance standards, a participating practice is eligible to receive an incentive payment under the program if actual expenditures for applicable beneficiaries are less than the estimated spending target established by the Centers for Medicare & Medicaid Services (CMS). CMS shall terminate a program agreement with a participating practice if the practice: (1) for the third of three consecutive years under the program, will not receive an incentive payment; or (2) fails to meet a minimum number of quality performance standards established by CMS. The bill extends the existing Independence at Home Medical Practice Demonstration Program pending implementation of the permanent program. In addition, the bill removes the limit on the number of beneficiaries that may participate in the demonstration program.
United States · United States Congress · 28 February 2017
Cancer Care Payment Reform Act of 2017 This bill amends title XVIII (Medicare) of the Social Security Act to establish the Oncology Medical Home Demonstration Project, through which the Centers for Medicare & Medicaid Services (CMS) shall make special payments to participating oncology practices that coordinate patient care and meet other specified requirements. During the first two years of the project, CMS shall pay a care coordination management fee to each such practice. After the third, fourth, and fifth years of the project, CMS shall pay a performance incentive payment to each participating practice that meets or exceeds performance standards developed by CMS. CMS shall assess the performance of each participating oncology practice annually. Performance standards shall address: (1) specified measures related to patient care, resource utilization, survivorship, and end-of-life care; and (2) the patient experience of care, as reflected in surveys submitted by each practice. CMS shall also assess the extent to which a practice has used breakthrough or other best-in-class therapies. To the extent practicable, CMS shall select practices of varying sizes and geographic areas for participation.
United States · United States Congress · 28 February 2017
Designates February 28, 2017, as Rare Disease Day. Expresses support for a national and global commitment to developing new treatments, diagnostics, and cures for rare diseases and disorders.
United States · United States Congress · 27 February 2017
Congenital Heart Futures Reauthorization Act of 2017 This bill amends the Public Health Service Act to replace the authorization for a National Congenital Heart Disease Surveillance System with a requirement for the Department of Health and Human Services, regarding congenital heart disease, to enhance and expand research and surveillance infrastructure, and plan and implement a public outreach and education campaign. (Congenital heart disease is a condition caused by a heart defect that is present at birth.) The Centers for Disease Control and Prevention must award grants to nonprofit entities to conduct: (1) a study of congenital heart disease, from birth to adulthood, that considers health care utilization, demographic factors, and outcomes; and (2) an awareness, outreach, and education campaign regarding congenital heart disease. Data from the study must be made available to the public. The National Heart, Lung, and Blood Institute must report on its ongoing research efforts regarding congenital heart disease, future plans for such research, and areas of greatest need for such research.
United States · United States Congress · 27 February 2017
Requests that the President transmit to the House of Representatives, and directs the Department of Health and Human Services to transmit to the House of Representatives, all documents, memoranda, and advisory legal opinions relating to plans to repeal or replace the Patient Protection and Affordable Care Act and the health care provisions of the Health Care and Education Reconciliation Act of 2010.
United States · United States Congress · 27 February 2017
Research to Accelerate Cures and Equity for Children Act or the RACE for Children Act This bill amends the Federal Food, Drug, and Cosmetic Act to expand Food and Drug Administration (FDA) requirements for sponsors of certain drugs and biological products for adult cancer to assess the use of their medications in pediatric populations. (Currently, applications for FDA approval of new medications or new uses of medications must include pediatric assessments of safety and effectiveness for claimed indications, with exceptions.) The pediatric assessment for medications, including orphan drugs, that are used to treat cancer in adults and target a molecule germane to pediatric cancer must assess the safety and effectiveness of the medication for pediatric cancer. The bill limits waivers of pediatric assessments for medications that target a molecule germane to a pediatric cancer for which there is a need for additional treatment options. The FDA may require the sponsor of an approved medication that targets a molecule germane to pediatric cancer to complete a pediatric assessment if: (1) the medication is used for a substantial number of pediatric cancer patients, or (2) there is reason to believe the medication would have a meaningful therapeutic benefit over existing therapies for pediatric cancer patients. The FDA committee that reviews requests for pediatric studies must implement a plan to achieve earlier submission of pediatric studies. (Currently, completion of pediatric clinical studies requested by the FDA extends the patents or marketing exclusivity period for a medication by six months, with exceptions.) The FDA must act within 120 days on proposed pediatric study requests and proposed amendments to requests.
United States · United States Congress · 27 February 2017
Orphan Products Extension Now Accelerating Cures and Treatments Act of 2017 or the OPEN Act This bill amends the Federal Food, Drug, and Cosmetic Act to require the Department of Health and Human Services (HHS) to extend by six months the exclusivity period for a drug or biological product approved by the Food and Drug Administration (FDA) when the product is additionally approved to prevent, diagnose, or treat a new indication that is a rare disease or condition (also known as an orphan disease). HHS may revoke an extension if the application submitted to the FDA for the new indication contained an untrue material statement. HHS must notify the public of products that receive this extension and patents related to those products. Products may receive only one extension under this bill. Extensions under this bill are in addition to other extensions. The bill applies only to products approved after enactment of this bill for a new indication that is a rare disease or condition.
United States · United States Congress · 27 February 2017
Research to Accelerate Cures and Equity for Children Act or the RACE for Children Act This bill amends the Federal Food, Drug, and Cosmetic Act to expand Food and Drug Administration (FDA) requirements for sponsors of certain drugs and biological products for adult cancer to assess the use of their medications in pediatric populations. (Currently, applications for FDA approval of new medications or new uses of medications must include pediatric assessments of safety and effectiveness for claimed indications, with exceptions.) The pediatric assessment for medications, including orphan drugs, that are used to treat cancer in adults and target a molecule germane to pediatric cancer must assess the safety and effectiveness of the medication for pediatric cancer. The bill limits waivers of pediatric assessments for medications that target a molecule germane to a pediatric cancer for which there is a need for additional treatment options. The FDA may require the sponsor of an approved medication that targets a molecule germane to pediatric cancer to complete a pediatric assessment if: (1) the medication is used for a substantial number of pediatric cancer patients, or (2) there is reason to believe the medication would have a meaningful therapeutic benefit over existing therapies for pediatric cancer patients. The FDA committee that reviews requests for pediatric studies must implement a plan to achieve earlier submission of pediatric studies. (Currently, completion of pediatric clinical studies requested by the FDA extends the patents or marketing exclusivity period for a medication by six months, with exceptions.) The FDA must act within 120 days on proposed pediatric study requests and proposed amendments to requests.
United States · United States Congress · 27 February 2017
Restoring Rural Residencies Act of 2017 This bill amends title XVIII (Medicare) of the Social Security Act to require the Centers for Medicare & Medicaid Services to reimburse medical residency training programs under Medicare for certain graduate medical education costs associated with resident time spent in rural community hospitals known as "critical access hospitals."
United States · United States Congress · 27 February 2017
Medicare Mental Health Access Act This bill amends title XVIII (Medicare) of the Social Security Act to expand the definition of "physician," for purposes of the Medicare program, to include a clinical psychologist with respect to the furnishing of qualified psychologist services.
United States · United States Congress · 27 February 2017
Home Health Care Planning Improvement Act of 2017 This bill allows Medicare payment for home health services ordered by a nurse practitioner, a clinical nurse specialist, a certified nurse-midwife, or a physician assistant.
United States · United States Congress · 24 February 2017
Protecting Access to Care Act of 2017 This bill establishes provisions governing health care lawsuits where coverage for the care was provided or subsidized by the federal government, including through a subsidy or tax benefit. The bill does not preempt certain state laws and federal vaccine injury laws and rules. The statute of limitations is three years after the injury or one year after the claimant discovers the injury, whichever occurs first. For a minor, the statute of limitations is three years after the injury, except for a minor under six years old, for whom it is three years after the injury, one year after discovery of the injury, or the minor's eighth birthday, whichever occurs later. These limitations are tolled under certain circumstances. Noneconomic damages are limited to $250,000. Juries may not be informed of this limitation. Parties are liable for the amount of damages directly proportional to their responsibility. These provisions do not preempt state laws that specify a particular monetary amount of damages. Courts must supervise the payment of damages and may restrict attorney contingency fees. The bill sets limits on contingency fees. Certain evidence regarding collateral source benefits (e.g., insurance payments) may be introduced in lawsuits involving injury or wrongful death. Providers of collateral source benefits may not recover any amount from the claimant in such a lawsuit. These provisions do not apply if Medicare is a secondary payer or there is third party liability for Medicaid services. The bill provides for periodic payment of future damage awards. A health care provider who prescribes, or dispenses pursuant to a prescription, a medical product approved by the Food and Drug Administration may not be a party to a product liability lawsuit or a class action lawsuit regarding the medical product.
United States · United States Congress · 17 February 2017
Equitable Access to Care and Health Act or the EACH Act This bill amends the Internal Revenue Code to expand the religious conscience exemption under the Patient Protection and Affordable Care Act to exempt individuals who rely solely on a religious method of healing and for whom the acceptance of medical health services would be inconsistent with their religious beliefs from the requirement to purchase and maintain minimum essential health care coverage.