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Bill· HRH.R. 2468 (114th)referred
United States · United States Congress · 20 May 2015
Minority Inclusion in Clinical Trials Act of 2015 This bill expresses the sense of Congress that the National Institute on Minority Health and Health Disparities shall include within its strategic plan ways to increase representation of underrepresented communities in clinical trials. The bill directs the Department of Health and Human Services (HHS) to award grants for expanding existing opportunities for scientists and researchers, and for promoting the inclusion of underrepresented minorities in the health professions, to eligible entities that demonstrate a commitment to health workforce development in underrepresented communities. To be eligible to receive a grant, an entity must be an educational institution or entity that historically produces or trains meaningful numbers of underrepresented minority health professionals. Grants shall be used to implement, expand, or evaluate workforce diversity programs that shall enhance diversity by considering minority status as part of an individualized consideration of qualifications. HHS must carry out the following activities to eliminate disparities in maternal health outcomes: conduct research into the determinants and the distribution of disparities in maternal care, health risks, and health outcomes and improve the capacity of the performance measurement infrastructure to measure such disparities; expand access to services that have been demonstrated to improve the quality and outcomes of maternity care for vulnerable populations; and establish a demonstration project in up to eight states to compare the effectiveness of interventions to reduce disparities in maternity services and outcomes and implement and assess effective interventions. HHS must establish and coordinate a health and health care disparities education program to support, develop, and implement educational initiatives and outreach strategies that inform health care professionals and the public about the existence of, and methods to reduce, racial and ethnic disparities in health and health care.
Bill· SS. 1406 (114th)referred
United States · United States Congress · 20 May 2015
Saving Access to Compounded Medications for Special Needs Patients Act This bill amends the Federal Food, Drug, and Cosmetic Act to allow drugs to be compounded (manufactured at a small scale) and distributed to practitioners for treatment of, or administration to, patients of that practitioner. Currently, drugs may be compounded only for identified individual patients. (Compounded drugs do not need to meet certain requirements for drugs regarding manufacturing, labeling, or FDA approval.) Compounded drugs must comply with United States Pharmacopeia standards. A memorandum of understanding (MOU) between the FDA and a state regarding compounded drugs no longer must address interstate distribution of inordinate amounts of compounded drugs. Such an MOU must not create an unfunded mandate on a state. (Compounders in states that do not have an MOU with the FDA may not distribute more than 5% of their orders out of state.)
Bill· SS. 1396 (114th)referred
United States · United States Congress · 20 May 2015
Value Based Insurance Design Seniors Copayment Reduction Act of 2015 Directs the Department of Health and Human Services (HHS) to establish a demonstration program to test Value-Based Insurance Design methodologies in Medicare Advantage plans under part C (Medicare+Choice) of title XVIII (Medicare) of the Social Security Act for beneficiaries with chronic clinical conditions. Defines "value-based insurance design methodology" as one for identifying specific prescription medications and clinical services for which copayments or coinsurance should be reduced or eliminated due to the high-value and effectiveness of such medications and services for specific clinical conditions. Directs HHS to expand the demonstration program, except in certain circumstances, by issuing regulations to implement, on a permanent basis, those components that are beneficial to Medicare beneficiaries and the Medicare program.
Bill· SS. 1391 (114th)referred
United States · United States Congress · 20 May 2015
Cerebral Cavernous Malformations Clinical Awareness, Research, and Education Act of 2015 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: (1) coordinate with clinical centers, investigators, and advocates to support investigational new drug applications in order to hasten clinical trials for CCM, and (2) support appropriate requests for designation of drugs for use in rare subpopulations of CCM patients as orphan drugs. (Orphan drugs are drugs developed to treat rare medical conditions and are eligible for certain incentives.)
Bill· HRH.R. 2460 (114th)referred
United States · United States Congress · 19 May 2015
This bill directs the Department of Veterans Affairs (VA) to enter into an agreement or a contract with each state home to pay for adult day health care for a veteran eligible for, but not receiving, nursing home care. The veteran must need such care either specifically for a service-connected disability, or, if not specifically for one, the veteran must have a service-connected disability rated 70% or more. Payment under each agreement or contract between the VA and a state home must equal 65% of the payment that the VA would otherwise pay to the state home if the veteran were receiving nursing home care.
Bill· HRH.R. 2446 (114th)open
United States · United States Congress · 19 May 2015
Amends title XIX (Medicaid) of the Social Security Act to require states to have in place a system for the electronic verification of visits conducted as part of personal care services or else have their federal medical assistance percentage reduced by specified amounts.
Bill· HRH.R. 2437 (114th)referred
United States · United States Congress · 19 May 2015
Amends title XVIII (Medicare) of the Social Security Act to direct the Secretary of Health and Human Services to begin the process to develop and implement a prior authorization process for certain durable medical equipment, prosthetics, orthotics, and supplies.
Bill· HRH.R. 2459 (114th)referred
United States · United States Congress · 19 May 2015
Delivering Antimicrobial Transparency in Animals Act of 2015 This bill amends the Federal Food, Drug, and Cosmetic Act to revise reporting requirements for new animal drugs containing an antimicrobial. Certain live poultry dealers, swine contractors, and feed lot operators who purchase, contract, or manufacture animal feed containing a new antimicrobial animal drug must annually report to the Food and Drug Administration, by food-producing animal, the amount of drug per kilogram of feed, and the quantity of feed sold or distributed. Additional information must be provided for feed sold or distributed under a veterinary feed directive. The FDA may specify alternative reporting requirements to improve the accuracy of reports, lessen the burden of reporting, facilitate providing public summaries of reports, or improve the FDA's ability to use reports or the public's ability to use summaries. The FDA must publish summaries of these reports and reports from sponsors of new antimicrobial animal drugs, with data reported by antimicrobial drug class. Alternative reporting requirements are specified for antimicrobial drug classes with fewer than three new animal drugs. The FDA must increase collaboration and coordination with the Department of Agriculture to expand the collection of data on the use of antimicrobials on food-producing animals and to provide information for the Animal and Plant Health Inspection Service and Economic Research Service. The Government Accountability Office must evaluate the voluntary approach used by the FDA to eliminate injudicious use of antimicrobial drugs in food-producing animals and the effectiveness of FDA data collection activities regarding antimicrobial resistance.
Bill· HRH.R. 2456 (114th)referred
United States · United States Congress · 19 May 2015
This bill amends the Public Health Service Act to allow the National Institutes of Health (NIH) to require the sharing of scientific data generated from research that is fully funded by the NIH.
Bill· HRH.R. 2455 (114th)referred
United States · United States Congress · 19 May 2015
This bill amends the Federal Food, Drug, and Cosmetic Act to require the Food and Drug Administration (FDA) to define "precision drug or biological product." (Precision medications are commonly understood to be treatments for those patients who are likely to respond to the medication based on a biomarker, which is a biological characteristic such as a genetic factor.) The FDA must issue and periodically update guidance that addresses the development and use of biomarkers to identify the subset of patients that are likely to respond to a medication. The FDA may rely upon data previously submitted for a different approved medication or indication to expedite the clinical development of a precision medication that has been designated for the treatment of a serious or rare condition.
Bill· HRH.R. 2452 (114th)referred
United States · United States Congress · 19 May 2015
This bill amends the Federal Food, Drug, and Cosmetic Act to revise the requirements for health care economic information that is provided to entities selecting drugs for coverage or reimbursement, such as formularies. The information must include a conspicuous and prominent statement describing the differences between the information and the labeling approved for the drug. "Health care economic information" is an analysis that describes the economic consequences of the use of a drug. Such an analysis is no longer required to compare the use of the drug to another intervention or no intervention. An analysis that relates only to an indication for which the drug is not approved is not health care economic information.
Bill· HRH.R. 2448 (114th)referred
United States · United States Congress · 19 May 2015
This bill amends the Public Health Service Act to require each national research institute to conduct or support high-risk, high-reward research that pursues innovative approaches to major biomedical challenges. The National Institutes of Health determines the percentage of funding each national research institute must set aside for this research.
Bill· HRH.R. 2447 (114th)referred
United States · United States Congress · 19 May 2015
This bill amends the Public Health Service Act to require the National Institutes of Health (NIH) to develop and maintain a biomedical research strategic plan. The NIH must use the strategic plan to identify research opportunities and to develop individual strategic plans for each of the national research institutes and national centers. Strategic plans must identify strategic focus areas in a manner that considers the return on investment of biomedical research and contributes to expanding knowledge to improve the public's health. Strategic focus areas must include overarching Mission Priority Focus Areas, which serve the goal of preventing or eliminating the burden of a medical condition. The NIH must: (1) ensure that rare and pediatric diseases and conditions remain a priority under the strategic plan, (2) publish the initial strategic plan within 270 days, (3) conduct progress reviews for each strategic focus area at least annually, and (4) update the strategic plan every five years.
Bill· HRH.R. 2445 (114th)referred
United States · United States Congress · 19 May 2015
This bill expresses the sense of Congress that participation in or sponsorship of scientific conferences and meetings is essential to the mission of the Food and Drug Administration.
Bill· HRH.R. 2444 (114th)referred
United States · United States Congress · 19 May 2015
This bill authorizes the Commissioner of Food and Drugs to award grants to institutions of higher education and nonprofit organizations to study and recommend improvements to the process of continuous manufacturing of drugs and biological products and similar innovative monitoring and control techniques.
Bill· HRH.R. 2443 (114th)referred
United States · United States Congress · 19 May 2015
This bill requires the Department of Health and Human Services to publish guidance that revises “Recommendations for Clinical Laboratory Improvement Amendments of 1988 (CLIA) Waiver Applications for Manufacturers of In Vitro Diagnostic Devices” and includes guidance on using comparable performance between types of users to demonstrate the accuracy of a medical device.
Bill· HRH.R. 2440 (114th)referred
United States · United States Congress · 19 May 2015
This bill amends the Public Health Service Act to require the Department of Health and Human Services (HHS) to establish a loan repayment program for health professionals engaging in research. The maximum awards of the loan repayment programs for minority health disparities research, AIDS research, research with respect to contraception and infertility, research as an employee of the National Institutes of Health, clinical researchers from disadvantaged backgrounds, clinical researchers, and pediatric research are increased and may be adjusted for inflation by HHS.
Bill· HRH.R. 2439 (114th)referred
United States · United States Congress · 19 May 2015
This bill amends the Public Health Service Act to revise the Silvio O. Conte Senior Biomedical Research Service to: (1) remove the limit on the number of members, (2) expand eligibility for appointment, (3) set a maximum pay rate, and (4) remove the option for members to contribute to the retirement system of an institution of higher education. The Department of Health and Human Services must report on the implementation of these amendments, including whether the amendments improved the ability of the Food and Drug Administration to hire and retain qualified experts to fulfill obligations under user fee agreements.
Bill· HRH.R. 2438 (114th)referred
United States · United States Congress · 19 May 2015
This bill requires the Food and Drug Administration to issue guidance that addresses using alternative statistical methods, including adaptive trial design and Bayesian methods, in clinical trials and in the development and review of drugs and biological products.
Bill· HRH.R. 2436 (114th)referred
United States · United States Congress · 19 May 2015
This bill requires the National Institutes of Health (NIH) to convene a workshop within 180 days of enactment of this Act on appropriate age groupings and age exclusions in human research. Not later than 180 days after the conclusion of the workshop, the NIH must publish guidelines addressing consideration of age in human research. The NIH must publish the number of children included in NIH research disaggregated by age group, race, and gender.
Bill· HRH.R. 2435 (114th)referred
United States · United States Congress · 19 May 2015
This bill amends the Federal Food, Drug, and Cosmetic Act to revise Board of Directors membership, Executive Director compensation, and accounting for the Reagan-Udall Foundation for the Food and Drug Administration.
Bill· HRH.R. 2433 (114th)referred
United States · United States Congress · 19 May 2015
This bill amends the Federal Food, Drug, and Cosmetic Act to require the Food and Drug Administration to describe the responsibilities of each agency center charged with reviewing drugs, medical devices, or biological products when reviewing a product that is a combination of drug, medical device, or biological product.
Bill· HRH.R. 2428 (114th)referred
United States · United States Congress · 19 May 2015
This bill amends the Federal Food, Drug, and Cosmetic Act to expand the humanitarian device exemption to authorize the Food and Drug Administration (FDA) to exempt from effectiveness requirements certain medical devices intended to benefit fewer than 8,000 individuals. Currently, the FDA may exempt devices intended to benefit fewer than 4,000 individuals. Within 18 months of enactment of this Act, the FDA must define “probable benefit” for these devices.
Bill· HRH.R. 2427 (114th)referred
United States · United States Congress · 19 May 2015
This bill amends the Federal Food, Drug, and Cosmetic Act to require the Food and Drug Administration (FDA) to provide an opportunity for a person whose premarket submission for a medical device is subject to review by a classification panel to provide recommendations on the expertise needed among the members of the panel. The FDA must consider these recommendations and ensure that panels include at least two members with expertise clinically relevant to the device and at least one member who is knowledgeable about the technology of the device. The person whose device is under review may designate a representative (who may be accompanied by experts) to participate in panel meetings.
Bill· HRH.R. 2426 (114th)referred
United States · United States Congress · 19 May 2015
This bill amends the Federal Food, Drug, and Cosmetic Act to require the Food and Drug Administration (FDA), not later than 120 days after enactment of the 21st Century Cures Act (H.R. 6, a bill introduced on May 19, 2015), to identify types of class I medical devices (devices that do not need special controls to assure their safety and effectiveness) for which a report is no longer needed prior to marketing to provide reasonable assurance of safety and effectiveness. (Currently, a report is needed for a class I device only if the device is of substantial importance in preventing impairment of human health or if it presents a potential unreasonable risk of illness or injury.) Not later than 180 days after enactment of the 21st Century Cures Act, the FDA must publish a list of types of class II medical devices (devices that need special controls to assure their safety and effectiveness) for which a report is no longer needed prior to marketing to provide reasonable assurance of safety and effectiveness. (Currently, such a list must be published each time the FDA exempts a type of class II device from the reporting requirement.) The public comment period for such an exemption is extended to 60 days.
Bill· HRH.R. 2425 (114th)referred
United States · United States Congress · 19 May 2015
This bill amends the Federal Food, Drug, and Cosmetic Act to allow a person to request that the Food and Drug Administration (FDA) recognize all or part of a performance standard established by a nationally or internationally recognized standard organization as a standard to which a medical device may conform in order to meet an FDA requirement. When a request to recognize a standard is received, the FDA must determine whether to recognize all, part, or none of the standard and publish the rationale for that determination. (Currently, the FDA recognizes certain performance standards, but it is not required to respond to requests or publish rationales for recognizing standards.) The FDA must: (1) publish the rationale for recognizing only part of a standard, (2) periodically train employees who review premarket submissions for medical devices on the concept and use of recognized standards for purposes of meeting requirements, and (3) publish its principles for recognizing standards.
Bill· HRH.R. 2424 (114th)referred
United States · United States Congress · 19 May 2015
This bill amends the Federal Food, Drug, and Cosmetic Act to require Food and Drug Administration (FDA) employees involved in reviewing premarket submissions of medical devices to receive training regarding the "least burdensome appropriate means" concept. (Currently, the FDA must consider evaluating medical devices by the least burdensome appropriate means that would have a reasonable likelihood of resulting in approval.) The ombudsman for the FDA unit responsible for the premarket review of devices must audit this training and include in the audit interviews with persons from industry regarding their experience in the device premarket review process. When the FDA requests additional information about a medical device that is required to have premarket approval, it must consider the least burdensome appropriate means necessary for an applicant to demonstrate the safety and effectiveness of the device.
Bill· HRH.R. 2423 (114th)referred
United States · United States Congress · 19 May 2015
This bill amends the Federal Food, Drug, and Cosmetic Act to define “valid scientific evidence” to include well-documented case histories or studies published in peer-reviewed journals for purposes of the Food and Drug Administration (FDA) determining the effectiveness of a medical device without clinical investigation. Under specified conditions, the FDA may request the data underlying a study that is offered as valid scientific evidence.
Bill· HRH.R. 2422 (114th)referred
United States · United States Congress · 19 May 2015
This bill amends the Federal Food, Drug, and Cosmetic Act to require the Food and Drug Administration (FDA) to establish a third-party quality system assessment program to accredit persons to assess whether a medical device manufacturer's quality system can ensure the safety and effectiveness of an approved medical device after certain changes, including changes in manufacturing or changes to enhance device safety. Device manufacturers are allowed to make changes to a device without submitting to the FDA the 30-day notice required for manufacturing changes or a premarket approval supplement if their quality system has been certified by an accredited person. An accredited person who assesses a device manufacturer's quality system must submit a summary of their assessment and, as appropriate, a certification to the FDA within 30 days of the assessment. An assessment summary and certification is deemed accepted by the FDA 30 days after submission unless the FDA determines that additional information is needed to support certification, the assessment or certification is unwarranted, or an action other than acceptance of the certification is otherwise justified. Periodic reports by device manufacturers must describe any changes made to a device without submission of the 30-day notice or the premarket approval supplement. Certifications accepted by the FDA remain in effect for two years. The FDA must report on this quality system assessment program no later than January 31, 2022. The program is terminated at the end of FY2022.
Bill· HRH.R. 2421 (114th)referred
United States · United States Congress · 19 May 2015
This bill amends the Public Health Service Act to require the Director of the National Institutes of Health (NIH) to appoint the directors of the national research institutes and national centers (excluding the National Cancer Institute) instead of the Secretary of Health and Human Services (HHS). Directors appointed by the Director of NIH have five-year terms. This bill amends the Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 1993 to remove a provision that makes appropriations available for compensation of consultants or individual scientists appointed for limited periods of time to the Public Health Service. Before a national research institute or national center awards a grant for a research project (R-series grant) the director of the institute or center must review and approve the award, taking into consideration the mission and priorities of the institute or center and whether other agencies are funding projects to accomplish the same goal. HHS must enter an arrangement with the National Academy of Medicine (formerly known as the Institute of Medicine) under which a study is completed on the extent to which federally funded biomedical research is duplicative and recommendations are made on preventing such duplication.
Bill· HRH.R. 2420 (114th)referred
United States · United States Congress · 19 May 2015
This bill directs the National Institutes of Health (NIH) to reduce the administrative burdens of researchers funded by the NIH.
Bill· HRH.R. 2419 (114th)referred
United States · United States Congress · 19 May 2015
This bill amends the Public Health Service Act to reauthorize the National Institutes of Health through FY2018.
Bill· HRH.R. 2416 (114th)referred
United States · United States Congress · 19 May 2015
This bill amends the Federal Food, Drug, and Cosmetic Act to require the Food and Drug Administration (FDA) to establish a program to evaluate the potential use of evidence from clinical experience to support the approval of a new indication for an approved drug and to support post-approval study requirements. "Evidence from clinical experience" means data from sources other than randomized clinical trials, including from observational studies, registries, and therapeutic use. Before implementing the program, the FDA must establish a draft framework for the program that describes current sources of data from clinical experience, gaps in current data collection activities, standards and methodologies for collection and analysis of data from clinical experience, and priority areas, remaining challenges, and potential pilot opportunities that the program will address. The FDA must use the program to inform guidance to industry on the collection and use of evidence from clinical experience.
Bill· HRH.R. 2415 (114th)referred
United States · United States Congress · 19 May 2015
This bill amends the Federal Food, Drug, and Cosmetic Act to require the Food and Drug Administration (FDA) to establish a streamlined data review program under which the holder of an approved application for a drug or biological product may submit a summary of clinical data to support approval of the drug for the treatment of cancer or another indication subject to the program. For a drug to be eligible for the streamlined data review program there must be a database regarding the safety of the drug and the full data sets used to develop the data summaries must be submitted, unless the FDA determines that the full data sets are not required. The FDA must annually publish: (1) the number of applications reviewed under the streamlined data review program, (2) the average time for completion of review under the streamlined data review program compared to review of other applications for new indications, and (3) the number of applications reviewed under the streamlined data review program for which the FDA made use of full data sets.
Bill· HRH.R. 2414 (114th)referred
United States · United States Congress · 19 May 2015
This bill requires the Department of Health and Human Services to issue draft guidance on the dissemination of scientific and medical information that is not included in the approved labeling of drugs and medical devices.
Resolution· HRESH.Res. 275 (114th)referred
United States · United States Congress · 19 May 2015
Expresses support for the observance of National Asian American and Pacific Islander HIV/AIDS Awareness Day. Recognizes the importance of: (1) culturally and linguistically competent services as a core element in reducing HIV/AIDS rates in Asian American, Native Hawaiian, and Pacific Islander communities; and (2) addressing the gaps in research and data in order to fully understand the HIV/AIDS epidemic in such communities. Recognizes the people across the United States infected and affected by HIV/AIDS who are commemorating this day and who work to reduce the impact of HIV/AIDS on Asian American, Native Hawaiian, and Pacific Islander communities.
Bill· SS. 1376 (114th)open
United States · United States Congress · 19 May 2015
National Defense Authorization Act for Fiscal Year 2016 This bill authorizes FY2016 appropriations and sets forth policies regarding the military activities of the Department of Defense (DOD), military construction, and the defense activities of the Department of Energy (DOE). The bill authorizes appropriations, but does not provide appropriations, which are considered in subsequent appropriations legislation. The bill authorizes appropriations to DOD for: Procurement; Research, Development, Test, and Evaluation; Operation and Maintenance; the Revolving and Working Capital Funds; and Overseas Contingency Operations. The bill also authorizes the FY2016 personnel strengths for active duty and reserve forces and sets forth policies regarding: military personnel; compensation and other personnel benefits; health care; acquisition policy and management; DOD organization and management; civilian personnel matters; matters relating to foreign nations; cooperative threat reduction; and strategic programs, cyber, and intelligence matters. The bill authorizes appropriations and sets forth policies for DOE national security programs, including the National Nuclear Security Administration. Military Construction Authorization Act for Fiscal Year 2016 The bill authorizes appropriations and sets forth policies regarding military construction for the Army, Navy, Air Force, defense agencies, the North Atlantic Treaty Organization Security Investment Program, and Guard and Reserve Forces facilities. The bill also authorizes appropriations for base realignment and closure activities.
Bill· SS. 1368 (114th)referred
United States · United States Congress · 19 May 2015
Special Inspector General for Monitoring the ACA Act of 2015 or the SIGMA Act of 2015 Establishes the Office of the Special Inspector General for Monitoring the Affordable Care Act to conduct, supervise, and coordinate audits and investigations of the implementation and administration of programs and activities established under, and payment system changes made by, the Affordable Care Act (the Patient Protection and Affordable Care Act and the health care provisions of the Health Care and Education Reconciliation Act of 2010). Requires the Special Inspector General to be appointed by the President, with the advice and consent of the Senate. Requires the Special Inspector General to appoint an Assistant Inspector General for Auditing and an Assistant Inspector General for Investigations. Places the Special Inspector General under the supervision of the Department of Health and Human Services, but prohibits federal agencies involved in implementing or administering the Affordable Care Act from preventing or prohibiting the Special Inspector General from initiating, carrying out, or completing any audit or investigation.
Resolution· SRESS.Res. 181 (114th)passed
United States · United States Congress · 19 May 2015
Designates May 19, 2015, as National Schizencephaly Awareness Day. (Schizencephaly is a rare brain birth defect that can cause severe mental and physical health problems.)
Bill· HRH.R. 6 (114th)referred
United States · United States Congress · 19 May 2015
21st Century Cures Act This bill amends the Public Health Service Act to reauthorize the National Institutes of Health (NIH) through FY2018. The NIH Innovation Fund is established to fund a strategic plan, early stage investigators, and high-risk, high-reward research. The NIH may require scientific data to be shared if the research is fully funded by the NIH. The NIH and the Food and Drug Administration (FDA) must implement a system that allows further research on clinical trial data. The Centers for Disease Control and Prevention must expand surveillance of neurological diseases. The Council for 21st Century Cures is established to accelerate the discovery, development, and delivery of innovative cures, treatments, and preventive measures. The Department of Health and Human Services must monitor the use of antibacterial and antifungal drugs and resistance to these drugs. Requirements are established for interoperability and certification of health information technology. Practices that discourage the exchange of electronic health information are prohibited. This bill amends the Federal Food, Drug, and Cosmetic Act to revise the drug approval process, including by: (1) allowing patient experience data to be considered in the risk-benefit assessment of a new drug, (2) requiring the FDA to qualify drug development tools, (3) allowing the FDA to rely upon data previously submitted for a different purpose to expedite the development of certain drugs, and (4) establishing a streamlined data review program for approval of a drug for an additional indication. Manufacturers and distributors of investigational drugs for serious conditions must publish their policies on compassionate use requests. The marketing exclusivity period is extended by six months for a drug approved for a new indication that is a rare disease or condition. The priority review voucher program for rare pediatric diseases is revised and extended. The FDA must: (1) establish a program for priority review of breakthrough medical devices, (2) identify types of devices that do not require a report preceding introduction, and (3) rely on a third-party to determine the safety and effectiveness of changes to medical devices. Regarding medical devices, this bill defines “valid scientific evidence” and makes changes to classification panels and the humanitarian device exemption. “Health software” is defined and, with certain exceptions, exempted from FDA regulations. This bill amends title XVIII (Medicare) of the Social Security Act to require the Centers for Medicare & Medicaid Services (CMS) to: (1) increase certain payments for new antimicrobial drugs, (2) establish a payment methodology for certain medical devices, and (3) publish online estimated payments for certain outpatient items and services. A pharmaceutical and technology ombudsman within the CMS must respond to complaints from manufacturers of medical products. Medicare prescription drug plan sponsors may limit the access of certain beneficiaries to frequently abused drugs. This bill amends the Controlled Substances Import and Export Act to allow exported controlled substances to be re-exported within the European Economic Area.
Bill· HRH.R. 2400 (114th)referred
United States · United States Congress · 18 May 2015
Special Inspector General for Monitoring the ACA Act of 2015 or the SIGMA Act of 2015 Establishes the Office of the Special Inspector General for Monitoring the Affordable Care Act to conduct, supervise, and coordinate audits and investigations of the implementation and administration of programs and activities established under, and payment system changes made by, the Affordable Care Act (the Patient Protection and Affordable Care Act and the health care provisions of the Health Care and Education Reconciliation Act of 2010). Requires the Special Inspector General to be appointed by the President, with the advice and consent of the Senate. Requires the Special Inspector General to appoint an Assistant Inspector General for Auditing and an Assistant Inspector General for Investigations. Places the Special Inspector General under the supervision of the Department of Health and Human Services, but prohibits federal agencies involved in implementing or administering the Affordable Care Act from preventing or prohibiting the Special Inspector General from initiating, carrying out, or completing any audit or investigation.
Law· SS. 1362 (114th)enacted
United States · United States Congress · 18 May 2015
Amends part A (General Provisions) of title XI of the Social Security Act to authorize the Department of Health and Human Services (HHS) to waive applicable general and Medicaid requirements of the Program of All-Inclusive Care for the Elderly (PACE) in order to conduct demonstration projects through the Center for Medicare and Medicaid Innovation (CMS Innovation Center) that involve PACE. Prohibits HHS, however, as part of a CMS Innovation Center demonstration, from waiving: (1) the requirement to offer items and services under Medicare without limitations, and (2) certain requirements regarding enrollment in and disenrollment from PACE programs. Expresses the sense of the Senate that HHS should use waiver authority to provide, in a budget neutral and expeditious manner, PACE programs with increased operational flexibility to support their ability to improve and innovate and to reduce technical and administrative barriers that have hindered enrollment in them.
Bill· HRH.R. 2403 (114th)referred
United States · United States Congress · 18 May 2015
Coal Healthcare and Pensions Protection Act of 2015 Amends the Surface Mining Control and Reclamation Act of 1977 to address potential shortages in the Multiemployer Health Benefit Plan for payment of health care benefits to retired coal miners by expanding the eligible uses of interest transferable to the plan from the Abandoned Mine Reclamation Fund, and supplemental payments from the General Fund of the Treasury. Requires calculation of such amount by taking into account only those beneficiaries who are actually enrolled in the plan as of the enactment of this Act, as well as those retirees whose health benefits, payable directly by an employer in the bituminous coal industry under a coal wage agreement as a result of a bankruptcy proceeding commenced in 2012, would be denied or reduced. Requires the Department of the Treasury to transfer to the trustees of the 1974 United Mine Workers of America (UMWA) Pension Plan a certain additional amount of funds, to pay pension benefits required under that plan, if the $490 million limitation on certain transfers to the UMWA Combined Benefit Fund and distributions to states and Indian tribes exceeds the aggregate amount required to be transferred to them. Amends the Internal Revenue Code to prescribe a special rule that employer contributions to an employees' trust or annuity benefit plan providing supplemental benefits solely to participants in a pension plan are neither deductible nor nondeductible as such from the employer's gross income. Subjects such contributions, on the other hand, to deduction as an allowable trade or business expense. Treats a trust holding the assets of such a pension benefit plan as a tax-exempt organization. Excludes from taxable wages any payments made to, or on behalf of, an employee or his or her beneficiary under such a plan.
Bill· HRH.R. 2404 (114th)referred
United States · United States Congress · 18 May 2015
Treat and Reduce Obesity Act of 2015 Amends title XVIII (Medicare) of the Social Security Act to authorize the Department of Health and Human Services (HHS), in addition to qualified primary care physicians and other primary care practitioners, to cover intensive behavioral therapy for obesity furnished by: (1) a physician who is not a qualified primary care physician; (2) an evidence-based, community-based HHS-approved lifestyle counseling program; or (3) any other appropriate health care provider (including a physician assistant, nurse practitioner, clinical nurse specialist, a clinical psychologist, and a registered dietitian or nutrition professional). Allows coverage of intensive behavioral therapy for obesity furnished by another appropriate health care provider or program only if it is furnished: (1) upon referral from, and in coordination with, a physician or primary care practitioner in a primary care or other HHS-specified setting; and (2) in an office setting, a hospital outpatient department, a community-based site that complies with the federal regulations concerning the privacy of individually identifiable health information, or another HHS-specified setting. Authorizes HHS to cover under Medicare part D (Voluntary Prescription Drug Benefit Program) medication for treatment of obesity or for weight loss management for an overweight individual with one or more related comorbidities.
Bill· HRH.R. 2396 (114th)referred
United States · United States Congress · 18 May 2015
Sensible Oversight for Technology which Advances Regulatory Efficiency Act or the SOFTWARE Act This bill amends the Federal Food, Drug, and Cosmetic Act to define health software as software that does not acquire, process, or analyze data from an in vitro diagnostic device or signal acquisition system, is not an accessory or part of a medical device, is not used to prevent disease in the transfusion of blood and blood components, and is for: administrative or operational support or the processing and maintenance of financial records; use in clinical, laboratory, or administrative workflow and recordkeeping; managing data but not for active patient monitoring or controlling the functions of a connected medical device; organizing and presenting information for health or wellness education or maintaining a healthy lifestyle; or analyzing information to provide general health information or patient-specific recommendations. The FDA must classify an accessory of a medical device independently from the medical device with which it is used. Health software is exempted from regulation by the FDA (including as a medical device), except for software that provides patient-specific recommendations and poses a significant risk to patient safety. The FDA must review existing regulations and guidance regarding the regulation of health software.
Bill· HRH.R. 2391 (114th)referred
United States · United States Congress · 18 May 2015
Medicaid Generic Drug Price Fairness Act of 2015 This bill amends title XIX (Medicaid) of the Social Security Act to increase the amount of rebate with respect to each generic drug in the manner that the rebate for a dosage form and strength of a single source drug or an innovator multiple source drug is increased, except as provided in special application rules, including a special rule for certain noninnovator multiple source drugs.
Bill· SS. 1364 (114th)referred
United States · United States Congress · 18 May 2015
Medicaid Generic Drug Price Fairness Act of 2015 This bill amends title XIX (Medicaid) of the Social Security Act to increase the amount of rebate with respect to each generic drug in the manner that the rebate for a dosage form and strength of a single source drug or an innovator multiple source drug is increased, except as provided in special application rules, including a special rule for certain noninnovator multiple source drugs.
Bill· HRH.R. 2366 (114th)referred
United States · United States Congress · 15 May 2015
Field EMS Modernization and Innovation Act This bill amends part A (General Provisions) of title XI of the Social Security Act (SSAct) to require the Center for Medicare and Medicaid Innovation to evaluate the implementation and reimbursement under Medicare of field EMS (emergency medical response and medical care provided outside of a medical facility) other than transportation to the nearest appropriate medical facility. The Social Security Administration (SSA) must: (1) promote innovative payment models for field EMS, (2) develop and evaluate innovative models of field EMS delivery and reimbursement, and (3) pay providers and suppliers of ground ambulance services for reporting certain quality measures. The SSA may establish for field EMS an innovative payment model that has been sufficiently demonstrated. The Public Health Service Act (PHSA) is amended to require the Office of the Assistant Secretary for Preparedness and Response to: (1) award grants to improve field EMS agency readiness and for field EMS education programs, (2) promote medical oversight of field EMS, (3) make recommendations for improving collection and use of field EMS data that the Office of the National Coordinator for Health Information Technology (ONC) must implement, and (4) develop and implement a national emergency medical services strategy to improve patient outcomes in the field and support value-based emergency medical care. Patient safety improvement activities are expanded to include field EMS agencies, medical directors, and emergency medical technicians. Responsibility for the National EMS Information System is transferred from the National Highway Traffic Safety Administration to the ONC. Emergency medical service providers are health care providers for purposes of title XXX (Health Information Technology and Quality) of the PHSA. HHS is responsible for improving the emergency medical care system and field EMS. The Agency for Healthcare Research and Quality must conduct or support field EMS research. Federal field EMS research may be used to determine Medicare coverage. This bill amends the Internal Revenue Code to establish the Emergency Medical Services Trust Fund and allow individuals to contribute to the fund when filing a tax return.
Bill· HRH.R. 2373 (114th)referred
United States · United States Congress · 15 May 2015
Legitimate Use of Medical Marijuana Act or the LUMMA Transfers marijuana from schedule I to schedule II of the Controlled Substances Act (CSA). Provides that in a state in which marijuana may be prescribed for medical use under state law, no provision of the CSA or of the Federal Food, Drug, and Cosmetic Act shall prohibit or otherwise restrict: (1) the prescription of marijuana for medical use; (2) an authorized patient from obtaining, possessing, transporting, or using marijuana for that individual's medical use; (3) an individual from obtaining, possessing, transporting, or manufacturing marijuana pursuant to an authorization under state law; (4) a pharmacy or other entity authorized under state law to distribute medical marijuana to an authorized patient for medical use from obtaining, possessing, or distributing marijuana for that purpose; or (5) an entity authorized by such state from producing, processing, or distributing marijuana for prescribed medical use.
Bill· HRH.R. 2355 (114th)referred
United States · United States Congress · 15 May 2015
Women's Preventive Health Awareness Campaign This bill amends the Public Health Service Act to require the Department of Health and Human Services (HHS) to provide for a national public outreach and educational campaign, including a website, to raise awareness of women's preventive health. The campaign must describe guidelines for women's preventive services, promote well-woman visits, explain the women's preventive services that are covered by health insurance without patient cost sharing, and address health disparities. Well-woman visits that a health care provider determines a woman needs in order to obtain all necessary preventive services must be covered by health insurance without patient cost sharing. Health insurers may limit coverage of women's preventive services where guidelines do not specify the frequency, method, treatment, or setting for the services. Cost sharing for a preventive health service provided by an out-of-network provider shall not be imposed if a woman does not have an in-network provider with the capacity to provide the service. For a preventive health service that varies based on the patient's risk of disease, a woman must be treated as being at high risk for a disease if she has a family history of the disease or if a health care provider determines she is at high risk. Requirements are described for women's preventive services coverage of breast cancer susceptibility screening, HIV testing, breastfeeding support, and contraception. HHS must enter into an agreement with the Institute of Medicine (or another entity) to study and recommend the appropriate billing codes for a well-woman visit.
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