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Bill· HRH.R. 5998 (112th)referred
United States · United States Congress · 21 June 2012
USPSTF Transparency and Accountability Act of 2012 - Amends the Public Health Service Act to expand the scope and responsibilities of the United States Preventive Services Task Force to require it to: (1) publish research plans to guide its systematic review of evidence relating to the effectiveness of preventive services; (2) make available reports on such evidence and recommendations for public comment; (3) establish a system for grading preventive care products and services (Grades A, B, C, and D and a Grade I for insufficient information); and (4) convene a preventive services stakeholders board to advise it on developing, updating, publishing, and disseminating evidence-based recommendations on the use of clinical preventive services. Provides for the disclosure and management of conflicts of interest by members of the Task Force and the preventive services stakeholders board. Directs the Government Accountability Office (GAO) to submit a report that: (1) lists current recommendations of the Task Force; (2) compares Task Force recommendations and recommendations of other federal health agencies, national medical professional societies, and patient and disease advocacy organizations; and (3) analyzes the impact of Task Force recommendations on public and private insurance coverage, access, and outcomes, including the impact of morbidity and mortality. Amends title XVIII (Medicare) of the Social Security Act to eliminate the discretion of the Secretary of Health and Human Services (HHS) to deny payment for a Medicare preventive service that has not received an A, B, C, or I grade by the Task Force.
Bill· HRH.R. 5994 (112th)referred
United States · United States Congress · 21 June 2012
Choice in Healthcare Act - Directs the Secretary of Health and Human Services (HHS) to establish a demonstration program under which Medicare and Medicaid eligible beneficiaries are given: (1) the option of purchasing qualifying health benefits coverage, and (2) access to a debit style card (Medi-Choice card) for purchasing such coverage under the program and for paying certain other out-of-pocket health care expenditures. Directs the Secretary to contract with a major credit card provider or financial institution for issuing Medi-Choice cards under the program. Limits the demonstration program to specified counties in California and to a period of ten years.
Bill· HRH.R. 6006 (112th)referred
United States · United States Congress · 21 June 2012
Early Treatment for HIV Act of 2012 - Amends title XIX (Medicaid) of the Social Security Act (SSA) to: (1) give states the option to provide Medicaid coverage for low-income HIV-infected individuals, and (2) provide an enhanced federal medical assistance percentage (FMAP) to states taking this option. Amends SSA title XI to exempt medical assistance for optional low-income HIV-infected individuals from the funding limitation for territories.
Bill· HRH.R. 5989 (112th)referred
United States · United States Congress · 21 June 2012
Excellence in Mental Health Act - Amends the Public Health Service Act (PHSA) to set forth criteria for the certification of federally-qualified community behavioral health centers. Amends title XIX (Medicaid) of the Social Security Act to make such centers eligible for payments for services under Medicaid. Amends the PHSA to authorize the Secretary of Health and Human Services (HHS) to award matching grants to states or Indian tribes to expend funds for the construction or modernization of facilities used to provide mental health and substance abuse services to individuals. Expands the 340B drug discount program (a program limiting the cost of covered outpatient drugs to certain federal grantees) to allow participation by entities providing community mental health services or providing treatment services for substance abuse.
Resolution· SRESS.Res. 501 (112th)passed
United States · United States Congress · 20 June 2012
Expresses support for the annual National Men's Health Week.
Bill· HRH.R. 5979 (112th)referred
United States · United States Congress · 20 June 2012
Medicaid Accountability and Care Act of 2012 - Amends title XIX (Medicaid) of the Social Security Act (SSA) to revise payments to states under the Medicaid program, including granting an option to receive Medicare payments for full-benefit dual eligible individuals (who are eligible for Medicare benefits under SSA title XVIII as well as Medicaid).
Bill· SS. 3313 (112th)referred
United States · United States Congress · 19 June 2012
Women Veterans and Other Health Care Improvements Act of 2012 - Directs the Secretary of Veterans Affairs (VA) to facilitate collaborative research to meet the long-term reproductive health care needs of veterans who have a service-connected genitourinary disability or a condition that was aggravated in the line of active duty, such as a spinal cord injury, that affects the veterans' ability to reproduce. Includes fertility counseling and treatment within authorized VA medical services. Directs the Secretary to furnish such counseling and treatment, including the use of assisted reproductive technology, to a spouse or surrogate of a severely wounded veteran who has an infertility condition incurred or aggravated in the line of duty and who is enrolled in the VA health care system, as long as the spouse and veteran apply jointly for such counseling and treatment. Requires the Secretary to enhance the capabilities of the VA women veterans call center: (1) to respond to requests for assistance with accessing VA health care and benefits, and (2) for referral to community resources to obtain assistance with services not furnished by the VA. Amends the Caregivers and Veterans Omnibus Health Services Act of 2010 relating to a pilot program of group retreat reintegration and readjustment counseling for women veterans recently separated from service to: (1) increase from at least 3 to at least 14 the number of locations for such counseling, and (2) extend the pilot program for an additional 2 years. Requires a pilot program under such Act relating to the provision of child care assistance for certain veterans receiving VA health care to be extended until two years after the program is established in the third Veterans Integrated Service Network. (Under current law, such program terminates two years after its original commencement.) Directs the Secretary to carry out a pilot program to assess the feasibility and advisability of providing child care assistance to veterans receiving or in need of VA readjustment counseling and related mental health services. Requires the program to continue until two years after it is begun at the last Readjustment Counseling Service Region chosen by the Secretary.
Resolution· SRESS.Res. 499 (112th)passed
United States · United States Congress · 19 June 2012
Commends the National Institute of Biomedical Imaging and Bioengineering for its leadership in research and its role in advancing technologies that improve patient health. Recognizes: (1) the remarkable impact that biomedical research supported by the Institute has had on patients, and (2) the importance of maintaining a strong commitment to pursuing the next generation of life-saving treatments and technologies.
Bill· HRH.R. 5959 (112th)referred
United States · United States Congress · 19 June 2012
Appalachian Communities Health Emergency Act or the ACHE Act - Requires the Director of the National Institute of Environmental Health Sciences to conduct or support comprehensive studies on the health impacts of mountaintop removal coal mining on individuals in the surrounding communities. Directs the Secretary of Health and Human Services (HHS), upon receipt of a report on study results, to publish a determination of whether such mining presents any health risks to individuals in those communities. Defines "mountaintop removal coal mining" as surface coal mining that uses blasting with explosives in the steep slope regions of Kentucky, Tennessee, West Virginia, and Virginia. Prohibits issuance of an authorization for any mountaintop removal coal mining project (or expansion), under the Federal Water Pollution Control Act (commonly known as the Clean Water Act) or the Surface Mining Control and Reclamation Act of 1977, until and unless the Secretary publishes a determination that such mining does not present any health risk to individuals in the surrounding communities. Imposes requirements for continuous monitoring of air, noise, and water pollution and frequent monitoring of soil until a determination by the Secretary is made. Assesses a one-time fee upon persons that conduct such mining projects, sufficient to cover the federal cost of the health studies and pollution monitoring required by this Act.
Resolution· SRESS.Res. 495 (112th)passed
United States · United States Congress · 18 June 2012
Designates June 17-June 23, 2012, as Polycystic Kidney Disease Awareness Week. Recognizes the need for additional research to find treatments and a cure for such disease.
Bill· SS. 3295 (112th)open
United States · United States Congress · 14 June 2012
Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2013 - Department of Labor Appropriations Act, 2013 - Makes appropriations for FY2013 to the Department of Labor (DOL). Department of Health and Human Services Appropriations Act, 2013 - Makes appropriations for FY2013 to the Department of Health and Human Services (HHS). Department of Education Appropriations Act, 2013 - Makes appropriations for FY2013 to the Department Education. Makes appropriations for FY2013 to: (1) the Committee for Purchase From People Who Are Blind or Severely Disabled, (2) the Corporation for National and Community Service, (3) the Corporation for Public Broadcasting, (4) the Federal Mediation and Conciliation Service (FMCS), (5) the Federal Mine Safety and Health Review Commission, (6) the Institute of Museum and Library Services, (7) Medicaid and SCHIP Payment and Access Commission, (8) the Medicare Payment Advisory Commission; (9) the National Council on Disability, (10) the National Health Care Workforce Commission, (11) the National Labor Relations Board (NLRB), (12) the National Mediation Board, (13) the Occupational Safety and Health Review Commission, (14) the Railroad Retirement Board, and (15) the Social Security Administration (SSA). Specifies certain uses and limits on or prohibitions against the use of funds appropriated by this Act.
Resolution· SRESS.Res. 493 (112th)referred
United States · United States Congress · 14 June 2012
Recognizes: (1) that prostate cancer has created a health crisis for African American men; and (2) the importance of health coverage and access to care, as well as promoting informed decision-making between men and their doctors, in screening and treatment options for prostate cancer. Urges federal agencies to support: (1) prostate cancer research and education, awareness, and early detection efforts at the grass roots levels to end such crisis; and (2) the Office of Minority Health of the Department of Health and Human Services (HHS) in improving health and health care outcomes for African Americans at an elevated risk of prostate cancer. Urges investment by the National Cancer Institute and National Institute of Biomedical Imaging and Bioengineering, other elements of the National Institutes of Health (NIH), and the Department of Defense (DOD) in research focusing on the improvement of early detection and treatment of prostate cancer.
Bill· SS. 3290 (112th)referred
United States · United States Congress · 13 June 2012
Prenatal Nondiscrimination Act (PRENDA) of 2012 - Imposes criminal penalties on anyone who knowingly or knowingly attempts to: (1) perform an abortion knowing that the abortion is sought based on the sex or gender of the child, (2) use force or the threat of force to intentionally injure or intimidate any person for the purpose of coercing a sex-selection abortion, (3) solicit or accept funds for the performance of such an abortion, or (4) transport a woman into the United States or across a state line for the purpose of obtaining such an abortion. Defines "sex-selection abortion" as an abortion undertaken to eliminate an unborn child based on the sex or gender of the child. Excludes from the definition of "abortion" actions taken to terminate a pregnancy if the intent is to save the life or preserve the health of the unborn child, remove a dead unborn child caused by spontaneous abortion, or remove an ectopic pregnancy. Authorizes civil actions, for verifiable money damages for injuries and punitive damages, by: (1) fathers, or maternal grandparents if the mother is an unemancipated minor, of unborn children who are the subject of an abortion performed or attempted through any of the above violations; and (2) women upon whom an abortion has been performed with a knowing or attempted use of force or threat of force to intentionally injure or intimidate any person for the purpose of coercing a sex-selection abortion. Authorizes, to prevent an abortion provider from performing or attempting further abortions in violation of this Act, injunctive relief to be obtained by the women upon whom such an abortion is performed or attempted, spouses or parents of a woman upon whom such an abortion is performed, or the Attorney General (DOJ). Deems a violation of this Act to be prohibited discrimination under title VI (Federally Assisted Programs) of the Civil Rights Act of 1964. (Violators of title VI lose federal funding.) Requires a medical or mental health professional to report known or suspected violations to law enforcement authorities. Imposes criminal penalties for a failure to so report. Prohibits a woman having such an abortion from being prosecuted or held civilly liable. Prohibits this Act from being construed to require that a healthcare provider has an affirmative duty to inquire as to the motivation for the abortion, absent the healthcare provider having knowledge or information that the abortion is sought based on the sex or gender of the child.
Bill· SS. 3289 (112th)referred
United States · United States Congress · 13 June 2012
Children's Mental Health Accessibility Act of 2012 - Amends title XIX (Medicaid) of the Social Security Act to: (1) expand the Medicaid home and community-based services waiver to include youth in need of services provided in a psychiatric residential treatment facility; (2) limit, under the waiver, the total number of Medicaid inpatient bed days at psychiatric residential treatment facilities during each fiscal year to the total number for the previous fiscal year as increased by the estimated percentage increase (if any) in the population of individuals under 21 residing in the state over the preceding 12-month period; and (3) change references to mental retardation to references to an intellectual disability.
Resolution· SRESS.Res. 490 (112th)passed
United States · United States Congress · 12 June 2012
Designates the week of September 16, 2012, as Mitochondrial Disease Awareness Week. Reaffirms the importance of an enhanced and coordinated research effort aimed at improving the understanding of primary mitochondrial diseases and the development of treatments and cures. Commends the National Institutes of Health (NIH) for its efforts to organize a symposium to improve the understanding of mitochondrial diseases and to enhance collaboration and chart a course for future mitochondrial disease research. Encourages NIH to place a greater priority on research into primary mitochondrial diseases, to continue to explore the connections between mitochondrial dysfunction and other systemic diseases, to promote collaboration and coordination among the Institutes of NIH and with other organizations, and to consider the recommendations and address research directions identified in the white paper developed from the symposium.
Bill· HRH.R. 5943 (112th)referred
United States · United States Congress · 8 June 2012
Rural Hospital Access Act of 2012 - Amends title XVIII (Medicare) of the Social Security Act to extend through FY2013: (1) the current methodology for payment to subsection (d) hospitals for inpatient hospital services furnished to individuals under the Medicare-dependent, small rural hospital (MDH) program, and (2) increased payments under the Medicare program for low-volume hospitals (with under 1,600 annual discharges). (Generally, a subsection [d] hospital is an acute hospital, particularly one that receives payments under Medicare's inpatient prospective payment system [IPPS] when providing covered inpatient services to eligible beneficiaries.) Directs the Comptroller General to study such programs.
Bill· HRH.R. 5942 (112th)referred
United States · United States Congress · 8 June 2012
Quality Improvement Organization Program Restoration Act - Amends the Trade Adjustment Assistance Extension Act of 2011 to repeal its revisions to requirements for contracts with Medicare Quality Improvement Organizations (QIOs). Amends title XI of the Social Security Act to specify expenditures or funding for: (1) 3-year QIO contracts for contract periods beginning on or after August 1, 2014, and ending on or before July 31, 2021, but with a certain reduction in aggregate funds payable after October 1, 2014; and (2) contracts with utilization and quality control peer review organizations for any contract period beginning on or after August 1, 2014.
Bill· HRH.R. 5937 (112th)referred
United States · United States Congress · 8 June 2012
Breast Cancer Patient Education Act of 2012 - Amends the Public Health Service Act to direct the Secretary of Health and Human Services (HHS) to provide for the planning and implementation of an education campaign to inform breast cancer patients anticipating surgery regarding the availability and coverage of breast reconstruction, prostheses, and other options. Requires such campaign to include dissemination of the following information: (1) breast reconstruction is possible at the time of breast cancer surgery or in a delayed fashion; (2) prostheses or breast forms may be available; (3) federal law mandates that both public and private health plans include coverage of breast reconstruction and prostheses; (4) the patient has a right to choose the provider of reconstructive care, including the potential transfer of care to a surgeon that provides breast reconstructive care; and (5) the patient may opt to undergo breast reconstruction in a delayed fashion for personal reasons or after completion of all other breast cancer treatments. Prohibits such campaign from specifying, or being designed to serve as a tool to limit, the health care providers available to patients.
Bill· SS. 3272 (112th)referred
United States · United States Congress · 7 June 2012
Comprehensive Dental Reform Act of 2012 - Title I: Medicare and Medicaid - Amends titles XVIII (Medicare) and XIX (Medicaid) of the Social Security Act to cover dental services. Increases the federal medical assistance percentage (FMAP) for funding under Medicaid for dental services. Directs the Secretary of Health and Human Services (HHS) to award grants to states and eligibility entities to develop certain case management programs that: (1) identify eligible individuals in need of dental services, with a particular focus on pregnant women, individuals with disabilities, and older adults, and provide them with information regarding dental providers in proximity to their residence; (2) recruit licensed dental providers and coordinate their voluntary provision of medically recommended dental services at no charge; (3) provide community-level oral health education; and (4) identify and coordinate transportation necessary to overcome mobility impairments and transportation barriers. Title II: Public Health Programs - Amends the Public Health Service Act to establish, revise, and extend funding for grant programs for: (1) educating nondental medical and other professionals about oral health care; (2) providing dental services in hospital emergency rooms or in community settings; (3) providing scholarships and education loans for dental therapists and oral health professional students; (4) providing comprehensive oral health services to low-income individuals and individuals in underserved areas; (5) building, operating, or expanding dental clinics in schools; (6) funding research by the Centers for Disease Control and Prevention (CDC) to prevent and manage oral health diseases; and (7) providing rural health clinics with mobile and portable, comprehensive dental services and outreach for senior-care facilities and facilities that provide federal health care and nutrition benefits for women and children. Title III: Department of Veterans Affairs and Department of Defense Matters - Removes restrictions on the authority of the Secretary of Veterans Affairs (VA) to provide dental care to veterans (thereby requiring such care on the same basis as other VA-provided medical care and services). Authorizes such Secretary to carry out a demonstration program to train and employ alternative dental health care providers (providers) in order to increase access to dental health care services (dental services) for veterans in rural and other underserved communities. Authorizes the Secretary of Defense (DOD) to carry out a similar demonstration program to train and employ such providers in order to increase access to dental services for members of the Armed Forces and their dependents who lack ready access to such services. Title IV: Federal Bureau of Prisons - Authorizes the Director of the Bureau of Prisons to carry out a demonstration program to establish programs to train and employ alternative dental health care providers to increase access to dental health services for prisoners within the custody of the Bureau of Prisons. Allows dental services provided under the demonstration program to be administered by alternative dental health care providers and any other dental care providers who are licensed to provided clinical care, through telehealth-enabled collaboration and supervision. Title V: Indian Health Service - Authorizes the Secretary of HHS, through the Indian Health Service, to carry out a demonstration program to establish programs to train and employ alternative dental health care providers to help eliminate oral health disparities and increase access to dental services through health programs operated by the Indian Health Service, Indian tribes, tribal organizations, and Urban Indian organizations. Allows dental services provided under the demonstration program to be administered by alternative dental health care providers and any other dental care providers who are licensed to provided clinical care, through telehealth-enabled collaboration and supervision. Title VI: Reports to Congress - Directs the Secretary of HHS, by October 1, 2016, to submit a report that provides a comprehensive cost-benefit analysis regarding the expansion of coverage for dental services pursuant to this Act, including whether the provision of such services resulted in a reduction in total health care costs for individuals under the Medicare and Medicaid programs. Directs the Comptroller General (GAO): (1) by October 1, 2015, to submit a report that provides a comprehensive analysis and evaluation of the implementation and utilization of the expanded coverage for dental services under this Act for individuals enrolled in Medicare and Medicaid, and (2) by October 1, 2016, to submit a report that provides a comprehensive analysis and evaluation of the demonstration programs authorized by this Act for the training and employment of alternative dental health care providers. Title VII: Funding - Amends the Internal Revenue Code to impose an 0.025% excise tax on the purchase of a security: (1) if such purchase occurs on a trading facility located in the United States, or (2) the purchaser or seller is a U.S. person. Defines "security" to include: (1) stocks, partnership interests, notes, bonds, debentures, or other evidences of indebtedness; and (2) interests in a derivative financial instrument (i.e., any option, forward contract, futures contract, notional principal contract, or any similar financial instrument). Exempts from such tax: (1) initial issues of securities; (2) any note, bond, debenture, or other evidence of indebtedness which has a fixed maturity of not more than 100 days; and (3) securities traded pursuant to certain lending arrangements.
Bill· SS. 3271 (112th)referred
United States · United States Congress · 7 June 2012
Equal Access to Medicare Options Act of 2012 - Amends title XVIII (Medicare) of the Social Security Act to provide all Medicare beneficiaries, regardless of whether they have enrolled in Medicare part B, as well as Medicare Advantage and Medicaid enrollees with the right to guaranteed issue of a supplemental insurance (Medigap) policy. Amends part C (Medicare+Choice) of SSA title XVIII to permit enrollment of individuals with end stage renal disease (ESRD) in Medicare Advantage.
Bill· HRH.R. 5909 (112th)referred
United States · United States Congress · 7 June 2012
Comprehensive Dental Reform Act of 2012 - Title I: Medicare and Medicaid - Amends titles XVIII (Medicare) and XIX (Medicaid) of the Social Security Act to cover dental services. Increases the federal medical assistance percentage (FMAP) for funding under Medicaid for dental services. Directs the Secretary of Health and Human Services (HHS) to award grants to states and eligible entities to develop certain case management programs that: (1) identify eligible individuals in need of dental services, with a particular focus on pregnant women, individuals with disabilities, and older adults, and provide them with information regarding dental providers in proximity to their residence; (2) recruit licensed dental providers and coordinate their voluntary provision of medically recommended dental services at no charge; (3) provide community-level oral health education; and (4) identify and coordinate transportation necessary to overcome mobility impairments and transportation barriers. Title II: Public Health Programs - Amends the Public Health Service Act to establish, revise, and extend funding for grant programs for: (1) educating nondental medical and other professionals about oral health care; (2) providing dental services in hospital emergency rooms or in community settings; (3) providing scholarships and education loans for dental therapists and oral health professional students; (4) providing comprehensive oral health services to low-income individuals and individuals in underserved areas; (5) building, operating, or expanding dental clinics in schools; (6) funding research by the Centers for Disease Control and Prevention (CDC) to prevent and manage oral health diseases; and (7) providing rural health clinics with mobile and portable, comprehensive dental services and outreach for senior-care facilities and facilities that provide federal health care and nutrition benefits for women and children. Title III: Department of Veterans Affairs and Department of Defense Matters - Removes restrictions on the authority of the Secretary of Veterans Affairs (VA) to provide dental care to veterans (thereby requiring such care on the same basis as other VA-provided medical care and services). Authorizes such Secretary to carry out a demonstration program to train and employ alternative dental health care providers (providers) in order to increase access to dental health care services (dental services) for veterans in rural and other underserved communities. Authorizes the Secretary of Defense (DOD) to carry out a similar demonstration program to train and employ such providers in order to increase access to dental services for members of the Armed Forces and their dependents who lack ready access to such services. Title IV: Federal Bureau of Prisons - Authorizes the Director of the Bureau of Prisons to carry out a demonstration program to establish programs to train and employ alternative dental health care providers to increase access to dental health services for prisoners within the custody of the Bureau of Prisons. Allows dental services provided under the demonstration program to be administered by alternative dental health care providers and any other dental care providers who are licensed to provide clinical care, through telehealth-enabled collaboration and supervision. Title V: Indian Health Service - Authorizes the Secretary of HHS, through the Indian Health Service, to carry out a demonstration program to establish programs to train and employ alternative dental health care providers to help eliminate oral health disparities and increase access to dental services through health programs operated by the Indian Health Service, Indian tribes, tribal organizations, and urban Indian organizations. Allows dental services provided under the demonstration program to be administered by alternative dental health care providers and any other dental care providers who are licensed to provide clinical care, through telehealth-enabled collaboration and supervision. Title VI: Reports to Congress - Directs the Secretary of HHS, by October 1, 2016, to submit a report that provides a comprehensive cost-benefit analysis regarding the expansion of coverage for dental services pursuant to this Act, including whether the provision of such services resulted in a reduction in total health care costs for individuals under the Medicare and Medicaid programs. Directs the Comptroller General (GAO): (1) by October 1, 2015, to submit a report that provides a comprehensive analysis and evaluation of the implementation and utilization of the expanded coverage for dental services under this Act for individuals enrolled in Medicare and Medicaid, and (2) by October 1, 2016, to submit a report that provides a comprehensive analysis and evaluation of the demonstration programs authorized by this Act for the training and employment of alternative dental health care providers. Title VII: Funding - Amends the Internal Revenue Code to impose an 0.025% excise tax on the purchase of a security: (1) if such purchase occurs on a trading facility located in the United States, or (2) the purchaser or seller is a U.S. person. Defines "security" to include: (1) stocks, partnership interests, notes, bonds, debentures, or other evidences of indebtedness; and (2) interests in a derivative financial instrument (i.e., any option, forward contract, futures contract, notional principal contract, or any similar financial instrument). Exempts from such tax: (1) initial issues of securities; (2) any note, bond, debenture, or other evidence of indebtedness which has a fixed maturity of not more than 100 days; and (3) securities traded pursuant to certain lending arrangements.
Bill· HRH.R. 5911 (112th)referred
United States · United States Congress · 7 June 2012
Lead Exposure Reduction Amendments Act of 2012 - Amends the Toxic Substances Control Act (TSCA) to exclude from the definition of "abatement" any renovation, remodeling, or other activity: (1) the primary purpose of which is to repair, restore, or remodel target housing, public buildings constructed before 1978, or commercial buildings; and (2) that incidentally results in a reduction or elimination of lead-based paint hazards. Requires the Administrator of the Environmental Protection Agency (EPA), no later than one year prior to proposing any renovation and remodeling regulation, to study the extent to which persons engaged in such activities: (1) are exposed to lead, and (2) disturb lead and create a lead-based paint hazard. Exempts from any such regulation an emergency renovation that is carried out in response to an event that is an act of God as defined by the Comprehensive Environmental Response, Compensation, and Liability Act of 1980 (CERCLA), that presents a risk to the public health or safety, or that threatens to cause significant damage to equipment or property if not attended to immediately. Prohibits such a regulation from requiring post-abatement clearance testing. Requires the Administrator to promulgate regulations to permit an owner of a residential dwelling that is target housing, who resides in such dwelling, to authorize a contractor to forego compliance with such a regulation if the owner submits a certification stating that: (1) the renovation or remodeling project is to be carried out at such dwelling, (2) no pregnant woman or child under the age of six resides or will reside in such housing, and (3) the owner acknowledges that such contractor will be exempt from the requirements of such regulation. Prohibits the Administrator from holding a contractor responsible for a misrepresentation made by the owner of such dwelling unless the contractor has actual knowledge of such a misrepresentation. Requires the Administrator to: (1) recognize a qualifying test kit for use under such Act, and (2) suspend enforcement of any regulation relating to renovation and remodeling of target housing and commercial buildings constructed after January 1, 1960, and public buildings constructed between January 1, 1960, and January 1, 1978, until a specified period after the Administrator recognizes such a test kit.
Resolution· HRESH.Res. 680 (112th)referred
United States · United States Congress · 7 June 2012
Affirms the deep obligation of the House of Representatives to fulfill the promises made to U.S. senior citizens regarding access to Medicare upon retirement. Expresses its firm commitment that no changes in Medicare, including coverage and age of eligibility, be made for U.S. citizens over the age of 55 on the date of enactment of this resolution. Expresses its firm commitment that any Medicare reform package should provide a detailed plan to reduce waste, fraud, and abuse in the Medicare program.
Bill· HRH.R. 5894 (112th)referred
United States · United States Congress · 5 June 2012
Patient Protection and Affordable Care Act Education and Outreach Campaign Repeal Act of 2012 - Amends the Patient Protection and Affordable Care Act to repeal the education and outreach campaign regarding preventive benefits. Rescinds the unobligated balance of any funds made available for carrying out such campaign, as in effect on the day before the enactment of this Act.
Resolution· HRESH.Res. 675 (112th)referred
United States · United States Congress · 5 June 2012
Affirms the deep obligation of the House of Representatives to fulfill the promises made to U.S. senior citizens regarding access to Medicare upon retirement. Expresses its firm commitment that no changes in Medicare, including coverage and age of eligibility, be made for U.S. citizens over the age of 55 on the date of enactment of this resolution. Expresses its firm commitment that any Medicare reform package should provide a detailed plan to end waste, fraud, and abuse in the Medicare program.
Resolution· HRESH.Res. 674 (112th)referred
United States · United States Congress · 5 June 2012
Expresses support for: (1) the designation of National Aphasia Awareness Month, and (2) efforts to increase awareness of aphasia and to make the voices of people with aphasia heard.
Bill· SS. 3254 (112th)open
United States · United States Congress · 4 June 2012
National Defense Authorization Act for Fiscal Year 2013 - Authorizes appropriations for the Department of Defense (DOD) for FY2013. Authorizes appropriations to DOD for: (1) procurement, including aircraft, missiles, weapons and tracked combat vehicles, ammunition, shipbuilding and conversion, and other procurement; (2) research, development, test, and evaluation, including missile defense; (3) operation and maintenance; (4) active and reserve military personnel; (5) Working Capital Funds; (6) the National Defense Sealift Fund; (7) the Defense Health Program; (8) chemical agents and munitions destruction; (9) drug interdiction and counter-drug activities; (10) the Defense Inspector General; (11) the National Defense Stockpile; (12) chemical demilitarization; (13) the Armed Forces Retirement Home; (14) overseas contingency operations; (15) the North Atlantic Treaty Organization (NATO) Security Investment Program; (16) Guard and reserve forces facilities; (17) base closure and realignment activities; and (18) the Defense Nuclear Facilities Safety Board. Sets forth provisions or requirements concerning: (1) military personnel policy, including sexual assault, hazing, and related matters, education, and military family readiness; (2) military pay and allowances; (3) military health care; (4) acquisition policy and management, including major defense acquisition programs and wartime contracting; (5) DOD organization and management, including space, intelligence, and cybersecurity matters; (6) financial matters, including counter-drug activities and nuclear matters; (7) civilian personnel matters; (8) matters relating to foreign nations, including assistance and training; (9) cooperative threat reduction; and (10) matters relating to military construction and military family housing. Impact Aid Improvement Act of 2012 - Amends the Elementary and Secondary Education Act of 1965 concerning the federal impact aid program and the determination of taxable value for eligible federal property, foundation payments for local educational agencies, and timely payments. Military Compensation and Retirement Modernization Commission Act of 2012 - Establishes the Military Compensation and Retirement Modernization Commission. National Commission on the Structure of the Air Force Act of 2012 - Establishes the National Commission on the Structure of the Air Force. Military Construction Authorization Act for Fiscal Year 2013 - Authorizes appropriations for FY2013 for military construction for the Armed Forces and defense agencies. Authorizes appropriations to the Department of Energy (DOE) for DOE national security programs. Authorizes the obligation and expenditure of amounts specified in funding tables for a DOD project, program, or activity authorized under this Act.
Bill· HRH.R. 5888 (112th)referred
United States · United States Congress · 1 June 2012
Physician Reentry Demonstration Program Act - Directs the Secretary of Health and Human Services to: (1) establish a demonstration program to assist the development of innovative programs that facilitate physician reentry into clinical practice to provide required primary health services; and (2) award one grant, on a competitive basis, to an eligible entity in each of the 10 regions served by a Department of Health and Human Services (HHS) regional office. Includes as eligible entities: (1) a state, hospital, academic medical center, medical school, or health center; or (2) a nonprofit organization with a demonstrated history or expertise in providing physician education and with the ability to offer programs specifically targeted at reentering physicians. Requires the Secretary to use not more than 15% of funds appropriated for this Act to work with key stakeholders to: (1) conduct a national needs assessment with regard to the supply of physicians who provide primary health services, (2) develop a database that contains a directory of programs that help physicians reenter clinical practice, (3) disseminate evidence-based assessments and evaluation tools to measure the basic core competencies of physicians reentering clinical practice, and (4) assist state regulatory authorities and hospital credentialing committees to structure requirements for reentering physicians r that ensure patient safety while addressing the burdens on such physicians. Directs an entity that receives funds under this Act to use such funds to assist qualifying physicians through: (1) training to reenter clinical practice, (2) paying credentialing and other necessary fees, (3) paying salaries, or (4) providing loan repayment and other financial assistance. Requires a reentering physician who participates in a demonstration program, to be eligible to receive benefits, to provide required primary health services for at least two years at a health center, a Veterans Administration Medical Center if the Secretary of Veterans Affairs (VA) certifies that there is a shortage of physicians at such center, or a school-based health center. Sets forth provisions regarding liability protection for reentering physicians participating in a demonstration program.
Resolution· HRESH.Res. 673 (112th)referred
United States · United States Congress · 1 June 2012
Expresses support for the designation of National Mobility Awareness Month.
Report· HearingH.Hrg.112published
United States · United States House of Representatives · 31 May 2012
Bill· HRH.R. 5869 (112th)referred
United States · United States Congress · 30 May 2012
Studying Towards Adjusted Residency Status Act or the STARS Act - Authorizes the Secretary of Homeland Security (DHS) to cancel the removal of, and adjust to conditional nonimmigrant status, an alien who: (1) entered the United States before his or her 16th birthday and has been present in the United States for at least five years immediately preceding this Act's enactment; (2) has earned a high school diploma or general education development certificate in the United States; (3) has been admitted to an accredited four-year institution of higher education in the United States; (4) is a person of good moral character; (5) is not inadmissible or deportable under specified grounds of the Immigration and Nationality Act; (6) has never been under a final order of exclusion, deportation, or removal unless the alien has remained in the United States under color of law after such order's issuance, or received the order before attaining the age of 19; (7) was younger than 19 years old on the date of the submission of the application, except that the alien may submit an application under this section before attaining the age of 21 in the case of an alien who, before attaining the age of 19 years, was granted voluntary departure; (8) has not participated in the persecution of any person on account of race, religion, nationality, membership in a particular social group, or political opinion; (9) has not been convicted of certain offenses under federal or state law; and (10) is not inadmissible or deportable under specified grounds. Authorizes the Secretary to waive specified grounds of inadmissibility or deportability for humanitarian, family unity, or public interest purposes. Provides for a $525 application surcharge (in addition to other applicable application fees). Requires prior to cancellation of removal or granting of conditional nonimmigrant status: (1) an alien to submit biometric and biographic data, and (2) completion of security and law enforcement background checks. Requires an alien applying for relief to: (1) register under the Military Selective Service Act if so required, and (2) undergo a medical examination. Prohibits the Secretary from removing an alien with a pending application who establishes prima facie eligibility for cancellation of removal and conditional nonimmigrant status. Establishes an initial five-year period of conditional nonimmigrant status which shall include employment and limited travel authorization. Terminates such status if the alien: (1) does not enroll in an accredited four-year institution of higher education in the United States within one year after the date on which the alien was granted conditional nonimmigrant status, or does not remain enrolled; (2) becomes a public charge; or (3) ceases to be a person of good moral character. Extends such conditional status for an additional five-year period if the alien: (1) has demonstrated good moral character; (2) is not inadmissible or deportable under specified grounds, has not participated in racial, religious, social, or political persecution, and has not been convicted of certain federal or state offenses; (3) has not abandoned U.S. residency; and (4) has graduated from an accredited four-year institution of higher education in the United States. Provides for a $2,000 extension application surcharge (in addition to other applicable application fees). Authorizes a conditional nonimmigrant to file an application to adjust his or her status to that of an alien lawfully admitted for permanent residence. Requires such application to be filed during the period beginning 3 years after the date of extension and ending on either the date that is 10 years after the date of the granting of initial conditional nonimmigrant status or any other expiration date as extended by the Secretary. Requires such application to show that the alien: (1) has demonstrated good moral character; (2) is not inadmissible or deportable under specified grounds, has not participated in racial, religious, social, or political persecution, and has not been convicted of certain federal or state offenses; and (3) has not abandoned U.S. residency. Requires an alien, prior to adjusting from conditional to permanent resident status, to: (1) satisfy citizenship and federal tax requirements, (2) submit biometric and biographic data, and (3) have had security and law enforcement background checks completed. Authorizes an alien who adjusts to permanent resident status (and meets other specified requirements) to apply after five years in such status for naturalization. Authorizes: (1) the Secretary to cancel removal and grant conditional nonimmigrant status to an alien who has satisfied the conditional status requirements prior to enactment of this Act, and (2) an alien who has met the appropriate requirements during the entire period of conditional nonimmigrant status to apply for permanent resident status. Sets forth provisions regarding: (1) jurisdiction of the Secretary and the Attorney General (DOJ), (2) penalties for false application statements, (3) confidentiality of information, (4) certain tax credits and reduced health care plan cost-sharing, and (5) a Government Accountability Office (GAO) report respecting the number of aliens adjusted under this Act.
Bill· HRH.R. 5866 (112th)referred
United States · United States Congress · 30 May 2012
Medical Device Patient Safety Act - Directs the Secretary of Health and Human Services (HHS), acting through the Commissioner of Food and Drugs, to establish a program to enhance the oversight by the Food and Drug Administration (FDA) of medical device recalls. Requires the program to routinely and systematically assess: (1) information submitted to the Secretary pursuant to a device recall order issued under the Federal Food, Drug, and Cosmetic Act (FDCA); and (2) information required to be reported by a device manufacturer to the Secretary regarding the manufacturer's correction or removal of a device. Requires the Secretary to use such information to proactively identify strategies for mitigating health risks presented by defective or unsafe devices. Requires such program to be designed to identify such things as recall trends, the causes of recalls, and the time to complete a recall. Requires the Secretary to develop explicit criteria for assessing whether a person subject to a recall order or the manufacturer's reporting requirement has performed an effective correction or removal action. Requires the Secretary to document and publish specified information concerning termination of a recall. Permits the Secretary to conditionally clear for introduction into interstate commerce for commercial distribution a medical device intended for human use if such medical device is cleared pursuant to specified FDCA reporting requirements concerning the introduction of devices into interstate commerce. Permits the Secretary, as part of such conditional clearance, to: (1) impose specified restrictions on the sale, distribution, or use of the device; (2) require specified labeling for the device; and (3) require the maintenance of specified records that enable the FDA to track the device and determine the safety and effectiveness of the device.
Bill· SS. 3242 (112th)referred
United States · United States Congress · 24 May 2012
Medicare Hearing Health Care Enhancement Act of 2012 - Amends title XVIII (Medicare) of the Social Security Act to revise the definition of Medicare-covered audiology (hearing and balance assessment) services provided by a qualified and legally authorized audiologist to declare that such services are covered without regard to any requirement that: (1) the individual receiving them be under the care of (or referred by) a physician or other health care practitioner, or (2) such services are provided under the supervision of a physician or other health practitioner. Includes audiology services as medical services, as so redefined, under Medicare part B.
Bill· SS. 3237 (112th)referred
United States · United States Congress · 24 May 2012
Accelerating the End of Breast Cancer Act of 2012 - Establishes the Commission to Accelerate the End of Breast Cancer to help end breast cancer by January 1, 2020. Directs the Commission to: (1) identify opportunities and ideas within the public and private sectors, basic and applied sciences, and epidemiology that can be turned into real world strategies to prevent breast cancer and breast cancer metastasis; (2) recommend projects to leverage such opportunities and ideas in the areas of the primary prevention of breast cancer and the causes and prevention of breast cancer metastasis; (3) promote ideas that are intellectually compelling and innovative; (4) accelerate potentially transformational scientific advances that are not being prioritized within the federal government and that are unlikely to be achieved by the private sector; (5) identify promising but underdeveloped areas of research that would benefit from a cluster of support from government, industry, and academia to rapidly advance knowledge into practices; (6) create opportunities for transdisciplinary, cross-cutting collaborations; (7) submit its strategic vision within six months after its initial members are appointed; and (8) ensure that its activities are coordinated with, and do not duplicate the efforts of, programs and laboratories of other government agencies. Directs the President to enter into an agreement with the Institute of Medicine for an evaluation of the Commission's progress. Establishes the Accelerating the End of Breast Cancer Fund to carry out this Act. Terminates the Commission on June 1, 2020.
Resolution· SRESS.Res. 473 (112th)passed
United States · United States Congress · 24 May 2012
Commends Rotary International and others for their efforts in vaccinating children around the world against polio and for the tremendous strides made toward eradicating the disease. Encourages the United States and the international community to remain committed to the elimination of polio.
Report· HearingS.Hrg.112-773published
United States · United States Senate · 23 May 2012
Bill· SS. 3230 (112th)referred
United States · United States Congress · 23 May 2012
Long Term Care Insurance Integrity Act of 2012 - Requires an insurance issuer that offers a long-term care insurance plan to implement claims dispute resolution procedures that: (1) are designed to expeditiously resolve disputes; (2) provide for alternative means of dispute resolution involving independent third-party review by entities that are mutually acceptable to the issuer and the enrollee, with the reviewer's decision being binding on the issuer; and (3) ensure that an enrollee is eligible to obtain claims review only to the extent and in the manner provided for in the applicable insurance contract. Allows an enrollee to appeal the decision of an independent reviewer to an appropriate state court as provided for under state law.
Bill· SS. 3229 (112th)referred
United States · United States Congress · 23 May 2012
Long-Term Care Insurance Consumer Right-to-Know Act of 2012 - Directs the Secretary of Health and Human Services (HHS) to request the National Association of Insurance Commissioners (NAIC) to issue a white paper with its results from the following activities: (1) review and describe disclosure requirements for long-term care insurance policies under the long-term care insurance model regulation and model act promulgated by NAIC (as adopted as of October 2000 and December 2006), (2) review and describe disclosure requirements for long-term care insurance policies under state laws, (3) review and describe differences in long-term care services among states and develop a standardized definition of long-term care services, and (4) identify and describe key issues to consider in the development of a proposed model form for marketing long-term care insurance policies. Directs the Secretary to request NAIC to: (1) establish a Working Group to develop and issue a model disclosure form for marketing long-term care insurance policies, and (2) amend the model regulation and model act to require the use of such form. Requires the Secretaries of the Treasury and HHS to promulgate regulations requiring issuers of a qualified long-term care insurance contract under certain tax-qualified or Medicaid Partnership policies to use the model form for marketing such contracts. Directs each state to require any issuer of a long-term care insurance policy to use the model form for marketing a policy.
Bill· SS. 3212 (112th)referred
United States · United States Congress · 22 May 2012
Cody Miller Initiative for Safer Prescriptions Act - Amends the Federal Food, Drug, and Cosmetic Act to direct the Secretary of Health and Human Services (HHS) to promulgate regulations regarding the authorship, content, format, and dissemination requirements for patient medication information (PMI) for prescription drugs. Requires such regulations to require the PMI for such a drug: (1) to be scientifically accurate and to be based on the approved professional labeling and authoritative, peer-reviewed literature; and (2) to include plain language that is not promotional in tone or content. Requires that such language include: (1) the established name of the drug; (2) drug uses and clinical benefits; (3) general directions for proper use; (4) contraindications, common side effects, and the most serious risks of the drug; (5) measures patients may take to reduce the side effects and risks; (6) when a patient should contact his or her health care professional; (7) instructions not to share medications; (8) any key storage requirements; (9) recommendations relating to proper disposal of any unused portion of the drug; and (10) known clinically important interactions with other drugs and substances. Requires such regulations to: (1) include standards related to performing timely updates of drug information, ensuring that common information is applied consistently and simultaneously across similar drug products and for drugs within classes of medications, and developing a process to assess the quality and effectiveness of PMI in promoting patient understanding and safe and effective use; and (2) provide for the development of a publicly accessible electronic repository for all PMI. Requires the Secretary to publish on the Food and Drug Administration (FDA) website a link to the Daily Med website.
Bill· HRH.R. 5853 (112th)referred
United States · United States Congress · 22 May 2012
Gray Market Drug Reform and Transparency Act of 2012 - Amends the Federal Food, Drug, and Cosmetic Act to: (1) make it a prohibited act and a misbranding for a wholesale distributor of prescription drugs to purchase or receive a prescription drug from a pharmacy or a pharmacist, (2) require annual reporting by wholesale distributors of prescription drugs, (3) require the Secretary of Health and Human Services (HHS) to establish and maintain a national database of information reported by wholesale distributors of prescription drugs and to require such database to include information on actions taken by states against wholesale distributors (e.g., disciplinary actions and license revocations), (4) require the Secretary to assess and collect fees from wholesale distributors of prescription drugs, and (5) require wholesale distributors of prescription drugs to provide to recipients of a prescription drug in shortage the sales price for such drug at the time of its sale and at the time of any prior sale of such drug when it was in shortage.
Resolution· SRESS.Res. 468 (112th)passed
United States · United States Congress · 21 May 2012
Acknowledges May as National Pediatric Stroke Awareness Month. Urges: (1) support for the efforts, programs, services, and advocacy of organizations that work to enhance public awareness of childhood stroke; and (2) continued coordination and cooperation between government, researchers, families, and the public to improve treatments and prognoses for children who suffer strokes. Expresses support for the work of the National Institutes of Health (NIH) in pursuit of medical progress regarding pediatric stroke.
Report· HearingH.Hrg.112published
United States · United States House of Representatives · 18 May 2012
Bill· HRH.R. 5838 (112th)referred
United States · United States Congress · 18 May 2012
Health Insurance Industry Antitrust Enforcement Act of 2012 - Prohibits the McCarran-Ferguson Act from being construed to permit issuers of health or medical malpractice insurance to engage in any form of price fixing, bid rigging, or market allocations in connection with the conduct of the business of providing health insurance coverage or coverage of medical malpractice claims or actions. Amends such Act to provide that nothing in it shall modify, impair, or supersede the operation of any of the antitrust laws with respect to the business of health insurance. Applies prohibitions against using unfair methods of competition to the business of health insurance without regard to whether such business is carried on for profit.
Bill· HRH.R. 5841 (112th)referred
United States · United States Congress · 18 May 2012
Supporting Child Maltreatment Prevention Efforts in Community Health Centers Act of 2012 - Requires the Secretary of Health and Human Services (HHS), acting through the Director of the National Center for Injury Prevention and Control of the Centers for Disease Control and Prevention (CDC), to award grants to eligible federally qualified health centers to fund a minimum of 10 demonstration projects to promote: (1) universal access to family centered, evidence-based interventions that prevent child maltreatment by addressing parenting practices and skills; and (2) behavioral health and family well-being for families from diverse socioeconomic, cultural, racial, and ethnic backgrounds, including by addressing issues related to sexual orientation and individuals with disabilities. Sets forth permitted uses of grant funds, including to: (1) adapt and implement evidence-based parenting skills training programs for caregivers from all backgrounds who use the health center for health care and child well-visits; (2) adapt instruments and screen caregivers for child maltreatment risk factors such as depression, substance abuse, and intimate partner violence; and (3) provide access to mental health services to caregivers screened positive for child maltreatment risk factors. Requires the Secretary to award a contract for the provision of technical assistance, project coordination, and training for health care professionals for grantees under this Act.
Resolution· HRESH.Res. 666 (112th)referred
United States · United States Congress · 18 May 2012
Affirms the deep obligation of the House of Representatives to fulfill the promises made to U.S. senior citizens regarding access to Medicare upon retirement. Expresses its firm commitment that no changes in Medicare, including coverage and age of eligibility, be made for U.S. citizens over the age of 55 on the date of enactment of this resolution. Expresses its firm commitment that any Medicare reform package should provide a detailed plan to end waste, fraud, and abuse in the Medicare program.
Bill· SS. 3203 (112th)referred
United States · United States Congress · 17 May 2012
Military Health Care Protection Act of 2012 - Expresses the sense of Congress that: (1) career military personnel and their families endure unique and extraordinary demands and make extraordinary sacrifices over the course of a 20-30 year career, and (2) those decades of sacrifice constitute a significant pre-paid premium for health care during a career member's retirement that is over and above what the member pays with money. Prohibits any cost-sharing requirement under the Department of Defense (DOD) pharmacy benefits program, as well as deductibles under the Civilian Health and Medical Program of the Uniformed Services (CHAMPUS), from being increased by a percentage greater than that year's percentage increase in retired pay. Prohibits CHAMPUS inpatient charges from exceeding 25% of their total cost or $708 per day. Prohibits, beginning with FY2013, the maximum annual limit on charges under CHAMPUS from being increased by a percentage greater than that year's percentage increase in retired pay. Prohibits former members of the Armed Forces who are entitled to retired pay, as well as dependents of members who died while on active duty or from an injury, illness, or disease incurred while on active duty, from being charged an enrollment fee for CHAMPUS coverage or from being subject to denial of claims for coverage based on failure to enroll.
Bill· SS. 3201 (112th)referred
United States · United States Congress · 17 May 2012
Graduate Medical Education Reform Act of 2012 - Amends title XVIII (Medicare) of the Social Security Act to direct the Secretary of Health and Human Services (HHS) to establish and implement procedures under which, beginning in FY2017, the amount of payments that a hospital would otherwise receive for indirect graduate medical education (GME) costs for discharges during a fiscal year is adjusted based on the hospital's performance on measures of patient care priorities. Requires the Secretary to specify measures of patient care priorities, including the extent of training provided in: (1) the delivery of services categorized as evaluation and management codes by the Centers for Medicare and Medicaid Services, (2) a variety of settings and systems, (3) the coordination of patient care across settings, (4) the relevant cost and value of various diagnostic and treatment options, (5) interprofessionality and multidisciplinary care teams, (6) methods for identifying system errors and implementing system solutions, and (7) the use of health information technology. Requires such measures of patient care to be: (1) adopted or endorsed by an accrediting organization, and (2) consensus-based. Allows such measures to include any submitted by teaching hospitals, medical schools, and other stakeholders. Directs the Secretary to report to Congress and the National Health Care Workforce Commission on the GME payments hospitals receive under Medicare.
Bill· HRH.R. 5800 (112th)referred
United States · United States Congress · 17 May 2012
Health Care Price Transparency Promotion Act of 2012 - Amends title XIX (Medicaid) of the Social Security Act to require state Medicaid plans to provide that the state will establish and maintain laws to require disclosure of information on hospital charges, to make such information available to the public, and to provide individuals with information about estimated out-of-pocket costs for health care services. Directs the Director of the Agency for Healthcare Research and Quality to research and report to Congress on: (1) the types of information on the charges and out-of-pocket costs for health care services that individuals find useful in making decisions about where, when, and from whom to receive care; (2) how such types of information vary by whether they have health benefits coverage, and what kinds; and (3) ways in which such information may be available on a timely basis and in easy-to-understand form to individuals facing such decisions.
Report· HearingS.Hrg.112-910published
United States · United States Senate · 16 May 2012
Law· SS. 3187 (112th)enacted
United States · United States Congress · 15 May 2012
Food and Drug Administration Safety and Innovation Act - Amends the Federal Food, Drug, and Cosmetic Act to reauthorize and establish new Food and Drug Administration (FDA) prescription drug user-fee programs and revises requirements relating to: (1) prescription, pediatric, and generic drugs; (2) medical devices; (3) biosimilar biological products; (4) new infectious disease drugs; and (5) drug manufacturer reporting. Prescription Drug User Fee Amendments of 2012 - Extends through FY2017 the authority of the Secretary of Health and Human Services (HHS) to assess and collect prescription drug fees to support the FDA drug development and human drug application review process. Medical Device User Fee Amendments of 2012 - Extends through FY2017 the authority of the Secretary to assess and use fees for expediting the review process for medical device applications and for assuring the safety and effectiveness of such devices. Generic Drug User Fee Amendments of 2012 - Directs the Secretary to assess and collect human generic drug user fees through FY2017, including a fee for drug applications pending on October 1, 2012, a drug master file fee, a generic drug facility fee, and an active pharmaceutical ingredient facility fee. Biosimilar User Fee Act of 2012 - Establishes a new program to assess and use fees to expedite the review process for biosimilar biological product applications. Makes permanent programs to study and provide extended exclusivity periods for new drugs for use in pediatric populations. Permits the FDA to change a classification of a medical device through an administrative order rather than by regulation. Expands reporting requirements for manufacturers of prescription drugs. Provides incentives for the development of new qualified infectious disease products, including: (1) an additional five-year market exclusivity period, and (2) eligibility for priority and fast track review. Requires the Secretary to: (1) expedite the development and review of new drugs designed to treat a serious or life-threatening disease, and (2) include a risk-benefit analysis in the regulatory decision-making process for prescription drugs. Amends the Orphan Drug Act to extend through FY2017 the authorization of appropriations for grants and contracts for development of drugs for rare diseases and conditions. Revises requirements for the reporting by drug manufacturers to HHS of a discontinuance or interruption in the production of life saving drugs. Requires the Secretary to establish a task force to develop and implement a strategic plan for enhancing the Secretary's response to preventing and mitigating drug shortages. Extends until October 1, 2017, the deadline for applications for elections relating to marketing exclusivity for certain drugs containing single enantiomers. Extends through FY2017 the authorization of appropriations for Critical Path Public-Private Partnerships to implement the FDA's Critical Path Initiative. Provides for the regulation of medical gas products. Directs the Secretary to: (1) issue guidance explaining FDA policy for promoting FDA-regulated medical products using the Internet and social media; (2) report to Congress on initiatives to combat prescription drug abuse; (3) reconsider tanning bed labeling requirements; (4) submit an integrated management strategy identifying goals for the FDA Center for Drug Evaluation and Research, the Center for Biologics Evaluation and Research, and the Center for Devices and Radiological Health; and (5) develop and implement strategies to solicit patient participation in the medical product development process.