Healthcare

SAFE Act of 2016

United States · United States Congress · 23 March 2016

Strengthening Accreditation For Everyone Act of 2016 or the SAFE Act of 2016 This bill amends title XVIII (Medicare) of the Social Security Act to revise the factors that the Centers for Medicare & Medicaid Services must consider with respect to determining whether certain national accreditation demonstrates a provider's compliance with applicable requirements of the Medicare program.

HIP Act

United States · United States Congress · 23 March 2016

Healthy Inpatient Procedures Act of 2016 or the HIP Act This bill delays and suspends implementation of Medicare's Comprehensive Care for Joint Replacement Model, which tests episode-based payment and quality measurement for care associated with hip and knee replacements. The bill also reduces and rescinds specified FY2017 and FY2018 funding that was appropriated for the Prevention and Public Health Trust Fund.

Better Care, Lower Cost Act

United States · United States Congress · 23 March 2016

Better Care, Lower Cost Act This bill amends titles XVIII (Medicare) and XIX (Medicaid) of the Social Security Act to establish an integrated chronic care delivery program through which qualified "Better Care Programs" (BCPs) shall: (1)  promote accountability and better care management for chronically ill patient populations, (2) coordinate items and services under Medicare, and (3) encourage investment in infrastructure and redesigned care processes. A health plan (including a Medicare Advantage plan) or group of providers may participate as a BCP if certified to do so by the Department of Health and Human Services (HHS). The program shall focus on containing long-term costs and improving the overall health of the Medicare population by implementing, through qualified BCPs, strategies that prevent, delay, or minimize the progression of illness or disability associated with chronic conditions. With respect to a BCP enrollee who is dually eligible for both Medicare and Medicaid, Medicare shall be the primary payor. A Medigap policy (supplemental insurance that covers health care costs not covered by Medicare) may not provide for coverage of cost-sharing for Medicare services furnished to a BCP enrollee by a provider that is not a qualified BCP professional. HHS, acting through the Agency for Healthcare Research and Quality, shall designate and provide core funding for at least three Chronic Care Innovation Centers. To be eligible for such designation and funding, an eligible entity must partner with other specified entities to develop new, evidence-based curricula that addresses the need for chronic care management.

Medicare Prescription Drug Abuse Prevention Act of 2016

United States · United States Congress · 23 March 2016

Medicare Prescription Drug Abuse Prevention Act of 2016 This bill amends title XVIII (Medicare) of the Social Security Act to: (1) authorize a Medicare prescription drug plan (PDP) sponsor to establish a drug management program under which the PDP sponsor may limit an at-risk beneficiary's access to coverage for frequently abused drugs to include only those drugs that are prescribed by selected prescribers and dispensed by selected pharmacies; and (2) require a PDP sponsor to have in place a utilization management tool to prevent drug abuse. With respect to a drug management program, a PDP sponsor must: (1) provide specified notice to a beneficiary who has been identified by the Centers for Medicare & Medicaid (CMS) as "at-risk" and consequently enrolled in the program; and (2) in selecting prescribers and dispensers, ensure that the beneficiary continues to have reasonable access to drugs. These determinations shall be subject to expedited reconsideration and appeal. A PDP sponsor must review and consider an at-risk beneficiary's preferences regarding prescriber and pharmacy selection. Certain individuals, including those receiving hospice care or residing in a long-term care facility, are exempted from enrollment in a drug management program. CMS must, for purposes of quality or performance assessments, review and consider complaints received from at-risk beneficiaries regarding lack of access due to their enrollment in a drug management program. In addition, CMS must establish rules and procedures requiring a PDP sponsor to provide specified program data.

Access to Substance Abuse Treatment Act of 2016

United States · United States Congress · 23 March 2016

Access to Substance Abuse Treatment Act of 2016 This bill amends the Public Health Service Act to require the Center for Substance Abuse Treatment to award grants to federally qualified health centers, substance abuse treatment centers, rehabilitation treatment centers, and residential treatment centers to expand access to evidence-based and cost-effective substance abuse treatment services. Priority for grants must be given to centers and programs: (1) serving communities with a greater incidence of substance abuse; or (2) providing, or proposing to incorporate, medication-assisted treatment. Services must be delivered in a manner reflecting person-centered care.

Expressing support for designation of September as "National Brain Aneurysm Awareness Month".

United States · United States Congress · 23 March 2016

Expresses support for: (1) the designation of National Brain Aneurysm Awareness Month; and (2) research to prevent, detect, and treat brain aneurysms.

Ending Homelessness Act of 2016

United States · United States Congress · 23 March 2016

Ending Homelessness Act of 2016 This bill amends the McKinney-Vento Homeless Assistance Act to make additional FY2017-FY2021 appropriations available for: (1) emergency relief grants to address the unmet needs of homeless populations in jurisdictions with the highest need, (2) rental assistance under the United States Housing Act of 1937 for persons and households who are homeless, and (3) homeless outreach and coordination services. Beginning in FY2017, the bill also provides annual additional funds for: (1) the Housing Trust Fund to provide grants to states for use to increase homeownership and the supply of rental housing for extremely low- and very low-income families, including homeless families; and (2) incremental project-based voucher or rental assistance under the Federal Housing Enterprises Financial Safety and Soundness Act of 1992. When the Department of Housing and Urban Development (HUD) allocates grants to states from the Housing Trust Fund for rental housing, the dwelling units must be subject to legally binding commitments to ensure that the residing family's contribution toward rent does not exceed 30% of the family's adjusted income. The bill provides funding to HUD to expand the Healthcare and Housing (H2) Systems Integration Initiative by assisting states and localities in coordinating policies among Medicaid programs, behavioral health providers, housing providers, and finance support services for homeless persons. The bill also makes permanent: (1) certain housing assistance programs under the Homeless Assistance Act, and (2) the U.S. Interagency Council on Homelessness.

Establishing the congressional budget for the United States Government for fiscal year 2017 and setting forth the appropriate budgetary levels for fiscal years 2018 through 2026.

United States · United States Congress · 23 March 2016

Establishes the congressional budget for the federal government for FY2017 and sets forth budgetary levels for FY2018-FY2026. Recommends levels and amounts for FY2017-FY2026 for federal revenues, new budget authority, budget outlays, deficits (on-budget), debt subject to limit, debt held by the public, and the major functional categories of spending. Includes reconciliation instructions directing 12 House authorizing committees to submit deficit reduction legislation to the House Budget Committee within 90 days of adoption of the budget resolution. Sets forth budget enforcement procedures addressing: long-term direct spending; allocations for Overseas Contingency Operations/ Global War on Terrorism; changes in mandatory programs; estimates of debt service costs, credit programs, direct spending legislation, macroeconomic effects, land conveyances, and energy saving performance contracts; adjustments of spending levels; advance appropriations; transfers to the Highway Trust Fund; Federal National Mortgage Association (Fannie Mae) and Federal Home Loan Mortgage Corporation (Freddie Mac) guarantee fees; and Federal Reserve System surpluses. Establishes reserve funds for legislation relating to: poverty reduction, repeal of the Patient Protection and Affordable Care Act, health care reform, graduate medical education, trade agreements, tax reform, revenue measures, federal retirement reform, coal miner pension and health care funds, and the commercialization of air traffic control. Provides estimates for the rate of growth in direct spending and proposes changes to specified programs. Includes policy statements on mandatory savings outside of the reconciliation process, mandatory spending controls, budget process reform, and several public policy issues.

Trade Protection Not Troll Protection Act

United States · United States Congress · 22 March 2016

Trade Protection Not Troll Protection Act This bill amends the Tariff Act of 1930, with respect to unfair practices in the import trade, to consider an industry in the United States to exist if there is in the United States substantial investment in licensing activities that leads to the adoption and development of articles that incorporate the patent, copyright, trademark, mask work, or design. If the U.S. International Trade Commission (ITC), at the beginning of an investigation of an alleged unfair practice, identifies a domestic industry as the dispositive issue in question, it shall direct the assigned administrative law judge (ALJ) to: expedite fact finding on the domestic industry requirement, and issue an initial determination on this matter within 100 days after the investigation begins. Any initial determination by the assigned ALJ shall stay the investigation pending ITC action. The ITC may determine during an investigation that exclusion of the articles concerned from entry into the United States would not be in the public interest, and terminate the investigation, in whole or in part, without any further determination, after considering the nature of the articles concerned and the effect of exclusion upon: the public health and welfare, the U.S. economy (including competitive conditions), the production of like or directly competitive articles by the complainant and its licensees, and U.S. consumers. Any person adversely affected by an ITC ruling that identifies a domestic industry as the dispositive issue in question may appeal that ruling, within 60 days after all administrative remedies are exhausted, to the U.S. Court of Appeals for the Federal Circuit. ITC discretion not to exclude any articles concerned, even though an importer has violated the ban on unfair competition, is repealed. If the ITC also determines that exclusion would be in the public interest, it shall direct exclusion of the articles. During an investigation, if the ITC determines there is reason to believe that an unfair import practice has occurred, and exclusion of the articles concerned would be in the public interest, the ITC may direct the exclusion the articles concerned, after considering the factors mentioned above. (Currently the ITC may not direct an exclusion until an investigation concludes and it determines, as a result of the investigation, that an unfair import trade practice has occurred.)

Conscience Protection Act of 2016

United States · United States Congress · 22 March 2016

Conscience Protection Act of 2016 This bill amends the Public Health Service Act to codify the prohibition against the federal government and state and local governments that receive federal financial assistance for health-related activities penalizing or discriminating against a health care provider based on the provider's refusal to be involved in, or provide coverage for, abortion. Health care providers include health care professionals, health care facilities, social services providers, health care professional training programs, and health insurers. The Office for Civil Rights of the Department of Health and Human Services, in coordination with the Department of Justice (DOJ), must investigate complaints alleging discrimination based on an individual's religious belief, moral conviction, or refusal to be involved in an abortion. DOJ or any entity adversely affected by such discrimination may obtain equitable or legal relief in a civil action. Administrative remedies do not need to be sought or exhausted prior to commencing an action or granting relief. Such an action may be brought against a governmental entity.

Coal Ash Landfill Safety Act

United States · United States Congress · 22 March 2016

Coal Ash Landfill Safety Act This bill directs the Environmental Protection Agency (EPA) to review regulations related to the disposal of coal combustion residuals (coal ash) in municipal solid waste landfills to determine if such regulations provide public health and environmental protection that is at least equivalent to the protection provided by the coal combustion residuals rule for certain other landfills and surface impoundments. The review must be completed within six months. To the extent the EPA determines that the regulations fails to provide at least equivalent protection, it must revise the regulations to provide equivalent or greater protection.

Expressing support for the designation of March 30, 2016, as "World Bipolar Day".

United States · United States Congress · 22 March 2016

Expresses support for: (1) the designation of World Bipolar Day, (2) improved sensitivity towards those struggling with bipolar disorder, and (3) comprehensive mental health reform.

Health Savings Protection Act

United States · United States Congress · 22 March 2016

Health Savings Protection Act This bill amends the Internal Revenue Code to exempt from the excise tax on excess benefit employer-sponsored health care plans any amounts contributed to an Archer medical savings plan, a tax-exempt health savings account, or a health flexible spending arrangement by an employee or an employer through salary reduction contributions.

HEALTHIER Act of 2016

United States · United States Congress · 21 March 2016

Health for Each American Less fortunate Through Help from medical professionals In Every Rural and impoverished area Act of 2016 or the HEALTHIER Act of 2016 This bill requires the Department of Health and Human Services to award grants to states with a volunteer health care provider law that permits a volunteer to provide health care services without being licensed in the state if the volunteer is licensed in another state. The law must: (1) require the services to be provided in a rural or impoverished area and to be within the scope of practice of the provider in the state, and (2) prohibit the services from being provided for more than seven consecutive days.

Expressing concern regarding the preventable loss of life associated with sports-related sudden death of student athletes in the United States, and emphasizing the importance of rigorous, evidence-based pre-participation physical examinations for student athletes.

United States · United States Congress · 21 March 2016

Encourages local school districts, youth sports associations, and college and university athletic departments to regularly update their pre-participation physical examination policies in accordance with evidence-based best practices and with respect for parental considerations.

Recognizing and supporting the goals of "World Sleep Day", on March 18, 2016.

United States · United States Congress · 21 March 2016

Expresses support for the goals and ideals of World Sleep Day to raise awareness of sleep disorders and to reduce the burden of sleep problems on society. Applauds the goals and approaches of the World Sleep Society to advance sleep health by promoting and encouraging education, research, and patient care, particularly where the practice of sleep medicine is less developed. Encourages members of the international community to promote the advancement of sleep health.

HEALTHCARE.GOV: A REVIEW OF OPERATIONS AND ENROLLMENT

United States · United States Senate · 17 March 2016

Patient Access to Durable Medical Equipment Act of 2016

United States · United States Congress · 17 March 2016

Patient Access to Durable Medical Equipment Act of 2016 This bill amends title XVIII (Medicare) of the Social Security Act to establish a bid ceiling for durable medical equipment (such as wheelchairs) under Medicare's competitive acquisition program, through which rates are set according to a bidding process rather than by an established fee schedule. Specifically, the bid ceiling for such an item shall not be less than the fee schedule amount that would otherwise be determined. Under current law, the Centers for Medicare & Medicaid Services (CMS) must use payment information from competitive acquisition programs to make payment adjustments for areas outside of such programs. The bill requires CMS, in making these adjustments, to account for stakeholder input. In addition, CMS must account for a comparison of competitive acquisition areas and other areas with respect to the following factors: average travel distance and cost associated with furnishing items and services, barriers to access, average delivery time, average volume of items and services furnished by suppliers, and number of suppliers. In addition, CMS shall delay by 15 months the full implementation of new Medicare payment rates for durable medical equipment. On a monthly basis, CMS must publish on its website the results of the monitoring of health outcomes and Medicare beneficiaries' access to durable medical equipment. The bill accelerates the applicability, from January 1, 2019, to October 1, 2018, of provisions of current law that limit federal Medicaid reimbursement to states for durable medical equipment to Medicare payment rates.

Ozone Standards Implementation Act of 2016

United States · United States Congress · 17 March 2016

Ozone Standards Implementation Act of 2016 This bill amends the Clean Air Act by revising the National Ambient Air Quality Standards (NAAQS) program. The bill delays the implementation of the ozone NAAQS that were published in 2015. The bill extends until: (1) October 26, 2024, the deadline for states to submit designations to implement the 2015 ozone NAAQS; and (2) October 26, 2025, the deadline for the Environmental Protection Agency (EPA) to designate state areas as attainment, nonattainment, or unclassifiable areas with respect to the 2015 ozone NAAQS. States must submit a state implementation plan (SIP) by October 26, 2026, to implement, maintain, and enforce the 2015 ozone NAAQS. The bill also changes the review cycle for criteria pollutant NAAQS from a 5-year review cycle to a 10-year review cycle. The EPA may not complete its next review of ozone NAAQS before October 26, 2025. The EPA may consider, as a secondary consideration, likely technological feasibility in establishing and revising NAAQS for a pollutant if a range of air quality levels for such pollutant are requisite to protect public health with an adequate margin of safety. Prior to establishing or revising NAAQS, the EPA must obtain advice from its scientific advisory committee regarding potential adverse public health, welfare, social, economic, or energy effects which may result from attaining and maintaining NAAQS. The EPA must publish regulations and guidance for implementing NAAQS concurrently with the issuance of a new or revised standard. New or revised NAAQS shall not apply to preconstruction permits for constructing or modifying a major emitting facility or major stationary source of air pollutants until those regulations and guidance have been published. The bill provides that in Extreme Ozone Nonattainment Areas, contingency measures are not required to be included in nonattainment plans. Technological achievability and economic feasibility must be taken into consideration in plan revisions for milestones for particulate matter nonattainment areas.

Advancing Precision Medicine Act of 2016

United States · United States Congress · 17 March 2016

Advancing Precision Medicine Act of 2016 This bill permits the Department of Health and Human Services (HHS) to carry out an initiative to address disease prevention, diagnosis, and treatment that may include collecting from a diverse cohort of individuals information that can be used to better understand health and disease. HHS may carry out specified activities relating to the initiative, including coordinating with the Department of Energy to address supercomputing needs. In implementing the initiative, HHS must: (1) collaborate with the National Institutes of Health, the Food and Drug Administration, and the Office of the National Coordinator for Health Information Technology; (2) implement secure data sharing; and (3) ensure inclusion of a broad range of participants, considering factors that contribute to health disparities.

FDA and NIH Workforce Authorities Modernization Act

United States · United States Congress · 17 March 2016

FDA and NIH Workforce Authorities Modernization Act This bill amends the Public Health Service Act to revise the Silvio O. Conte Senior Biomedical Research Service to: (1) increase 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 Government Accountability Office (GAO) must report on these amendments. This bill amends the Federal Food, Drug, and Cosmetic Act to grant the Food and Drug Administration (FDA) additional hiring authority for scientific, technical, or professional positions that support the development, review, and regulation of medical products. The FDA must report on its need for qualified individuals for such positions and must include a recruitment and retention plan. The GAO must report on the FDA's ability to hire, train, and retain qualified staff. The FDA must establish one or more Intercenter Institutes. Each institute must coordinate activities applicable to a major disease area among the FDA centers that review products. Activities may include coordinating staff with relevant expertise, streamlining product review, and enhancing interactions with patients, sponsors, and the biomedical community. Scientific meetings directly related to the duties of a Department of Health and Human Services professional must not be considered conferences for certain purposes. The bill revises Board of Directors membership, Executive Director compensation, and accounting for the Reagan-Udall Foundation for the FDA. The Paperwork Reduction Act does not apply to National Institutes of Health research.

Medical Loss Ratio Accountability Act of 2016

United States · United States Congress · 17 March 2016

Medical Loss Ratio Accountability Act of 2016 This bill amends the Public Health Service Act to require the Department of Health and Human Services (HHS) to audit a statistically significant and representative selection of health insurers to verify that insurer reports on medical loss ratio are accurate. This bill amends the Social Security Act to base determinations of the medical loss ratio of a Medicare Advantage plan on information from the HHS audit of the plan, if the plan was audited.

Ensuring Patient Access to Healthcare Records Act of 2016

United States · United States Congress · 17 March 2016

Ensuring Patient Access to Healthcare Records Act of 2016 This bill amends the Health Information Technology for Economic and Clinical Health Act to allow a health care clearinghouse to use and disclose protected health information under the Health Insurance Portability and Accountability Act (HIPAA). The uses and disclosures include for: (1) research purposes, (2) public health purposes, and (3) releasing protected health information to individuals that request their information. Additionally, a clearinghouse may use and disclose protected health information to prepare and distribute reports that are designed to improve healthcare, subject to certain privacy protections.

Help Efficient, Accessible, Low-cost, Timely Healthcare (HEALTH) Act of 2016

United States · United States Congress · 17 March 2016

Help Efficient, Accessible, Low-cost, Timely Healthcare (HEALTH) Act of 2016 This bill sets conditions for lawsuits arising from health care liability claims regarding health care goods or services or any medical product affecting interstate commerce. Additionally, the bill sets a statute of limitations of three years after the date of manifestation of injury or one-year after the claimant discovers the injury, with certain exceptions. The bill revises other provisions related to health care lawsuits including: (1) limiting noneconomic damages, (2) mandating joint and several liability, (3) limiting attorney contingency fees, (4) limiting punitive damages, and (5) denying punitive damages in the case of products approved by the Food and Drug Administration.

Training Tomorrow's Doctors Today Act

United States · United States Congress · 17 March 2016

Training Tomorrow's Doctors Today Act This bill amends title XVIII (Medicare) of the Social Security Act to require the Centers for Medicare & Medicaid Services (CMS) to increase, for purposes of Medicare payment, the otherwise applicable resident limit for qualifying hospitals. The bill establishes a process for distributing the new residency positions. The bill eliminates the use of three-year rolling averages with respect to calculating, for purposes of Medicare payment, specified limits on certain new or redistributed residency positions. With respect to specified hospitals, all of the time spent by an intern or resident in an approved medical residency training program, regardless of setting, shall be counted for purposes of determining a hospital's number of residents. The bill revises payment rules for graduate medical education (GME) costs with respect to a hospital that establishes a new medical residency training program. With respect to a hospital that has not entered into a GME affiliation agreement, CMS shall establish the hospital's resident amount only after determining that the hospital trains more a specified number of residents. Similarly, CMS shall adjust a hospital's limitation on allopathic and osteopathic residents only after determining that the hospital trains more than a specified number of residents. In specified cases, CMS shall provide a hospital an opportunity to have its resident amount reestablished and its limitation adjustment re-determined. The bill also revises provisions regarding: (1) aggregation rules relating to resident limits, and (2) the period of board eligibility for residents who change specialties. CMS shall establish and implement procedures for adjusting a hospital's indirect medical education payments based on specified performance measures.

To amend title XIX of the Social Security Act to provide the same level of Federal matching assistance, regardless of date of such expansion, for every State that chooses to expand Medicaid coverage to newly eligible individuals.

United States · United States Congress · 17 March 2016

This bill amends title XIX (Medicaid) of the Social Security Act to provide the enhanced federal medical assistance percentage (FMAP) to every state that expands Medicaid coverage for individuals who are newly eligible under the Patient Protection and Affordable Care Act, regardless of when such expansion takes place. Under current law, the enhanced FMAP is equivalent to 100% in 2014 through 2016, 95% in 2017, 94% in 2018, 93% in 2019, and 90% thereafter. The bill retains this enhanced FMAP, but bases it on a term of years rather than on specific dates. The bill applies retroactively.

CLEAR Act of 2016

United States · United States Congress · 17 March 2016

Copper and Lead Evaluation and Reporting Act of 2016 or the CLEAR Act This bill amends the Safe Drinking Water Act to require the Environmental Protection Agency to promulgate new lead and copper regulations that would set a health-based, household action level for lead and copper that triggers: (1) a consumer notification of drinking water contamination; (2) a report to the appropriate public health agency; and (3) an examination by the public water system of service line material and, if applicable, the removal of lead portions of the service line. That action level must be based on the amount of lead that would result in a blood lead level greater than five micrograms per deciliter in an average, healthy infant who consumes infant formula made with water. The regulations must also: provide outreach about the health risk and protection available to consumers with known or suspected lead service lines, institutions and facilities that serve other vulnerable populations, and the caregivers and health care providers of those consumers or populations; require reporting by public water systems for each monitoring period to the populations they serve on information concerning lead and copper levels; require public water systems to provide a public statement of lead service line ownership where a community has such lines; modify monitoring requirements to provide for voluntary, consumer-requested tap samples for lead; and provide for utilizing the results of those samples.

Medicaid Program Integrity Enhancement Act of 2016

United States · United States Congress · 17 March 2016

Medicaid Program Integrity Enhancement Act of 2016 This bill amends title XIX (Medicaid) of the Social Security Act to require a state Medicaid agency to establish a process by which a provider may appeal a decision by the agency to suspend payment to the provider on the basis of credible fraud allegations. The Centers for Medicare & Medicaid Services (CMS) must revise specified regulations related to such suspensions in order to comply with due process requirements established by the bill. Specifically, a state Medicaid agency may not suspend payment until the agency: (1) consults with the state's Medicaid fraud control unit or, if the state has no such unit, with the state's attorney general; (2) certifies that it has considered whether the suspension will jeopardize beneficiary access and whether there is good cause not to suspend payment; and (3) furnishes the provider with the agency's reasons for finding no such good cause. Furthermore, the agency must periodically evaluate whether there is good cause to discontinue a suspension for which an investigation is pending. With specified exceptions, such good cause shall be deemed to exist if the investigation remains unresolved after a suspension has been in effect for 18 months. CMS must also revise specified regulations to provide that an allegation of fraud shall be considered credible only if the allegation has indications of reliability and the state Medicaid agency: (1) has reviewed all allegations, facts, and evidence carefully; (2) acts judiciously on a case-by-case basis; and (3) has considered the potential impact a payment suspension may have on beneficiary access to care.

Lower Drug Costs through Competition Act

United States · United States Congress · 17 March 2016

Lower Drug Costs through Competition Act This bill amends the Federal Food, Drug, and Cosmetic Act to revise provisions regarding review and approval of generic drug applications or supplements to generic drug applications for drugs: (1) for which there is a shortage, or (2) that have not been recently introduced to the market by more than one manufacturer and for which tentative approval has not been granted to more than two applications. The Food and Drug Administration (FDA) must prioritize the review of such submissions and act on them within 180 days. The FDA may expedite the inspection of a facility proposed to manufacture such a drug. Beginning FY2018, the FDA must award a transferrable generic drug priority review voucher to the sponsor of such an application once the drug has a sustained market presence. A voucher may be used to have the FDA review and take action upon a generic drug application within 180 days of submission. The FDA must establish an additional user fee for applications subject to a voucher. This voucher program is terminated at the end of FY2021. The FDA must periodically report on generic drug applications filed before FY2017 that are still pending. For a new drug application to be eligible for a priority review voucher as a tropical disease product application, the application must include new, essential clinical investigations. The Government Accountability Office must study the FDA's program for drug risk evaluation and mitigation strategies.

Title X Transparency Act

United States · United States Congress · 17 March 2016

Title X Transparency Act This bill requires the Government Accountability Office to evaluate the medical items and services offered by recipients of federal family planning assistance or their affiliates, subsidiaries, successors, or clinics.

Improving Medical Device Innovation Act

United States · United States Congress · 17 March 2016

Improving Medical Device Innovation Act This bill amends the Federal Food, Drug, and Cosmetic Act to revise provisions related to medical device performance standards, reporting requirements, and classification panels. A person may request that the Food and Drug Administration (FDA) recognize a performance standard established by a recognized standards 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.) The FDA must: train employees who review premarket submissions for medical devices on recognized standards; review its published principles for recognizing standards; identify types of medical devices for which a premarket report is no longer needed to provide reasonable assurance of safety and effectiveness; ensure that adequate expertise is represented on medical device classification panels; provide an opportunity for a person whose premarket submission is subject to review by a classification panel to recommend expertise needed on the panel; and provide opportunities for patients, patient representatives, and medical device sponsors to recommend individuals for positions on classification panels. The FDA, in coordination with medical device manufacturers, must establish pilot projects to evaluate alternative methods of compliance with reporting requirements for certain medical devices. The Government Accountability Office must report on these pilot projects.

Medicaid Program Integrity Enhancement Act of 2016

United States · United States Congress · 17 March 2016

Medicaid Program Integrity Enhancement Act of 2016 This bill amends title XIX (Medicaid) of the Social Security Act to require a state Medicaid agency to establish a process by which a provider may appeal a decision by the agency to suspend payment to the provider on the basis of credible fraud allegations. The Centers for Medicare & Medicaid Services (CMS) must revise specified regulations related to such suspensions in order to comply with due process requirements established by the bill. Specifically, a state Medicaid agency may not suspend payment until the agency: (1) consults with the state's Medicaid fraud control unit or, if the state has no such unit, with the state's attorney general; (2) certifies that it has considered whether the suspension will jeopardize beneficiary access and whether there is good cause not to suspend payment; and (3) furnishes the provider with the agency's reasons for finding no such good cause. Furthermore, the agency must periodically evaluate whether there is good cause to discontinue a suspension for which an investigation is pending. With specified exceptions, such good cause shall be deemed to exist if the investigation remains unresolved after a suspension has been in effect for 18 months. CMS must also revise specified regulations to provide that an allegation of fraud shall be considered credible only if the allegation has indications of reliability and the state Medicaid agency: (1) has reviewed all allegations, facts, and evidence carefully; (2) acts judiciously on a case-by-case basis; and (3) has considered the potential impact a payment suspension may have on beneficiary access to care.

A resolution designating April 2016 as "National Congenital Diaphragmatic Hernia Awareness Month".

United States · United States Congress · 17 March 2016

Designates April 2016 as National Congenital Diaphragmatic Hernia Awareness Month. (Congenital diaphragmatic hernia is a birth defect that occurs when the diaphragm fails to fully form, allowing abdominal organs to migrate into the chest cavity and preventing lung growth.) Encourages that steps should be taken to: raise awareness of and increase public knowledge about congenital diaphragmatic hernia (CDH); inform all Americans about the dangers of CDH; disseminate information on the importance of quality neonatal care for CDH patients; promote quality prenatal care and the use of ultrasounds to detect CDH in utero; and support research funding of CDH to improve screening and treatment, discover its causes, and develop a cure.

Promoting Access to Diabetic Shoes Act

United States · United States Congress · 16 March 2016

This bill amends title XVIII (Medicare) of the Social Security Act to allow a nurse practitioner to fulfill documentation requirements for coverage, under Medicare, of special shoes for diabetic individuals. Under current law, such requirements may be satisfied only by a physician.

REGROW Act

United States · United States Congress · 16 March 2016

Reliable and Effective Growth for Regenerative Health Options that Improve Wellness or the REGROW Act This bill amends the Public Health Service Act to require the Food and Drug Administration (FDA) to conditionally approve certain cellular therapeutic products without initiation of large-scale clinical trials. A conditionally approved cellular therapy may be marketed if certain conditions are met, including conditions on the source, processing, and function of the cells in the product. The sponsor of a conditionally approved cellular therapy must apply for approval of the product as a biological product within five years. Unless the FDA has decided not to approve the product, the product may be marketed during this five-year period and the FDA may permit continued marketing while the application is being reviewed. An individual administering a conditionally approved cellular therapy must inform the recipient regarding conditional approval. The premarket report for a medical device used for cellular therapy must include specified information regarding the preparation or delivery of the cellular therapy. The approval of a medical device that is a cellular therapy must be based on laboratory performance testing and not clinical trials. A medical device used for cellular therapy is subject to medical device classification. The FDA must not limit the use of these devices to only specific cell types unless unique to the use of the device. The Center for Biologics Evaluation and Research has primary jurisdiction for premarket review of combination products that act primarily through cellular components. The Department of Health and Human Services must work with stakeholders to promote the development of standards for regenerative medicine products.

Preserving Consumer Health Accounts Act of 2016

United States · United States Congress · 16 March 2016

Preserving Consumer Health Accounts Act of 2016 This bill amends the Internal Revenue Code to exempt from the excise tax on excess benefit employer-sponsored health care plans any amounts contributed to an Archer medical savings plan, a tax-exempt health savings account, or a health flexible spending arrangement by an employee or an employer through salary reduction contributions.

Integrating Behavioral Health Through Technology Act of 2016

United States · United States Congress · 16 March 2016

Integrating Behavioral Health Through Technology Act of 2016 This bill requires the Substance Abuse and Mental Health Services Administration (SAMHSA) to establish a pilot program in up to five states under which incentive payments may be provided to clinical psychologists, clinical social workers, and behavioral health facilities for the adoption and use of certified electronic health records technology. SAMHSA must give priority to states that have implemented a health information exchange that includes behavioral health data.

REGROW Act

United States · United States Congress · 16 March 2016

Reliable and Effective Growth for Regenerative Health Options that Improve Wellness or the REGROW Act This bill amends the Public Health Service Act to require the Food and Drug Administration (FDA) to conditionally approve certain cellular therapeutic products without initiation of large-scale clinical trials. A conditionally approved cellular therapy may be marketed if certain conditions are met, including conditions on the source, processing, and function of the cells in the product. The sponsor of a conditionally approved cellular therapy must apply for approval of the product as a biological product within five years. Unless the FDA has decided not to approve the product, the product may be marketed during this five-year period and the FDA may permit continued marketing while the application is being reviewed. An individual administering a conditionally approved cellular therapy must inform the recipient regarding conditional approval. The premarket report for a medical device used for cellular therapy must include specified information regarding the preparation or delivery of the cellular therapy. The approval of a medical device that is a cellular therapy must be based on laboratory performance testing and not clinical trials. A medical device used for cellular therapy is subject to medical device classification. The FDA must not limit the use of these devices to only specific cell types unless unique to the use of the device. The Center for Biologics Evaluation and Research has primary jurisdiction for premarket review of combination products that act primarily through cellular components. The Department of Health and Human Services must work with stakeholders to promote the development of standards for regenerative medicine products.

A resolution designating March 22, 2016, as "National Rehabilitation Counselors Appreciation Day".

United States · United States Congress · 16 March 2016

(This measure has not been amended since it was introduced. The summary of that version is repeated here.) Designates March 22, 2016, as National Rehabilitation Counselors Appreciation Day. Commends rehabilitation counselors and professional organizations assisting individuals who require rehabilitation.

EXECUTIVE OVERREACH IN DOMESTIC AFFAIRS (PART I)_HEALTH CARE AND IMMIGRATION

United States · United States House of Representatives · 15 March 2016

Federal Aviation Administration Veteran Transition Improvement Act of 2016

United States · United States Congress · 15 March 2016

Federal Aviation Administration Veteran Transition Improvement Act of 2016 This bill applies federal civil service requirements to leave used by disabled armed forces veterans in the personnel management system of the Federal Aviation Administration (FAA). To verify that leave credited to such an employee is used for treating a service-connected disability, the employee shall certify to FAA Human Resource Management that the employee used that leave for purposes of being furnished treatment for that disability by a health care provider.

Helping Veterans Exposed to Burn Pits Act

United States · United States Congress · 15 March 2016

Helping Veterans Exposed to Burn Pits Act This bill directs the Department of Veterans Affairs (VA) to establish a center of excellence in the prevention, diagnosis, mitigation, treatment, and rehabilitation of health conditions relating to exposure to open burn pits and other environmental exposures in Afghanistan or Iraq. The VA shall, in selecting the center's site, consider entities that: are equipped with the specialized equipment needed to study, diagnose, and treat health conditions relating to such exposure; have a publication track record of post-deployment health exposures among veterans who served in support of Operation Iraqi Freedom and Operation Enduring Freedom; have collaborated with a geosciences department that has a medical geology division; have developed animal models and in vitro models of dust immunology and lung injury consistent with the injuries of members of the Armed Forces who served in support of such operations; and have expertise in allergy and immunology, pulmonary diseases, and industrial and management engineering. The VA shall ensure that the center collaborates with the Department of Defense (DOD), institutions of higher education, and other appropriate public and private entities to: provide for dissemination within the VA of best practices for the treatment of such conditions and the training of health professionals; provide guidance for the VA and DOD health systems in determining the personnel required to provide quality health care for members of the Armed Forces and veterans with such conditions; establish, implement, and oversee a comprehensive program to train VA and DOD health professionals in the treatment of such conditions; facilitate advancements in the study of the short-term and long-term effects of such exposure; conduct basic science and translational research on such conditions for the purposes of understanding the etiology of such conditions and developing preventive interventions and new treatments; and provide medical treatment to all veterans identified as part of the burn pits registry established under the Dignified Burial and Other Veterans' Benefits Improvement Act of 2012. The center shall have access to and make use of the data accumulated by such registry.

Mental Health Reform Act of 2016

United States · United States Congress · 15 March 2016

Mental Health Reform Act of 2016 This bill amends the Public Health Service Act to revise Substance Abuse and Mental Health Services Administration (SAMHSA) authorities, duties, centers, reports, and strategic planning. The bill creates the position of Chief Medical Officer within SAMHSA. The Department of Health and Human Services (HHS) must establish the Interdepartmental Serious Mental Illness Coordinating Committee. SAMHSA's Office of Policy, Planning, and Innovation is replaced by the National Mental Health and Substance Use Policy Laboratory. SAMHSA may provide support for: (1) the development of interventions for mental illness, serious emotional disturbances, and substance use disorders; and (2) integration of primary care and behavioral health care. The bill revises and extends through FY2021 SAMHSA support for various services and programs, including: (1) mental health and substance abuse services for homeless individuals, (2) mental and behavioral health education and training grants, and (3) substance use disorder treatment services for children and pregnant and postpartum women. The bill revises and extends block grants for community mental health services and transition from homelessness. SAMHSA must maintain the National Suicide Prevention Lifeline program and National Treatment Referral Routing Service. HHS must ensure health care providers, patients, and others have access to resources regarding the protected health information of patients seeking or undergoing mental or substance use disorder treatment. HHS, the Department of Labor, and the Department of the Treasury must take specified actions regarding requirements for health insurance to provide parity between mental health and substance use disorder benefits and medical and surgical benefits.

Mental Health on Campus Improvement Act

United States · United States Congress · 15 March 2016

Mental Health on Campus Improvement Act This bill amends the Public Health Service Act to require the Substance Abuse and Mental Health Services Administration (SAMHSA) to award grants to institutions of higher education to provide and improve mental and behavioral health services, conduct research regarding improving the mental health of students, and expand outreach and training at institutions of higher education. SAMHSA must give special consideration to programs that: (1) demonstrate the greatest need, (2) propose effective approaches for initiating or expanding campus services, (3) target underserved and at-risk populations, (4) coordinate with a community mental health center or other community mental health resources, (5) identify how the institution of higher education will address psychiatric emergencies, (6) propose innovative practices to improve care or prevention programs, and (7) demonstrate the greatest potential for replication and dissemination. SAMHSA must convene an interagency, public-private sector working group to plan, establish, and begin coordinating and evaluating a targeted public education campaign that is designed to focus on mental and behavioral health at institutions of higher education. The Department of Health and Human Services must establish the College Campus Task Force to discuss mental and behavioral health concerns at institutions of higher education.

STOP Pain Act

United States · United States Congress · 15 March 2016

Safe Treatments and Opportunities to Prevent Pain Act or the STOP Pain Act This bill authorizes the National Institutes of Health (NIH) to intensify and coordinate NIH research into the understanding of pain, therapies for chronic pain, and alternatives to opioids (drugs with effects similar to opium) for pain treatments. The prioritization and direction of federally funded pain research must consider recommendations made by the Interagency Pain Research Coordinating Committee.

A resolution designating March 25, 2016, as "National Cerebral Palsy Awareness Day".

United States · United States Congress · 15 March 2016

Designates March 25, 2016, as National Cerebral Palsy Awareness Day.

Advancing Medical Resident Training in Community Hospitals Act of 2016

United States · United States Congress · 14 March 2016

Advancing Medical Resident Training in Community Hospitals Act of 2016 This bill amends title XVIII (Medicare) of the Social Security Act to revise payment rules for graduate medical education (GME) costs with respect to a hospital that establishes a new medical residency training program. With respect to a hospital that has not entered into a GME affiliation agreement, the Centers for Medicare & Medicaid Services (CMS) shall establish the hospital's full-time equivalent (FTE) resident amount only after determining that the hospital's medical residency training program trains more than 1.0 FTE resident in a cost reporting period. In the case of a hospital with an approved FTE resident amount based on the training of no more than 1.0 FTE resident in a cost reporting period before October 1, 1997, or 3.0 FTE residents in a cost reporting period after that date, CMS shall provide the hospital an opportunity to have its FTE resident amount reestablished when the hospital begins training FTE residents in excess of the applicable threshold. Current law limits the number, subject to the application of certain adjustments, of FTE residents a hospital may have in allopathic and osteopathic medicine for purposes of Medicare payment. The bill specifies that CMS shall determine a hospital's limitation adjustment only after determining that the hospital's medical residency training program trains more than 1.0 FTE residents in a cost reporting period. In the case of a hospital with a limitation adjustment based on the training of no more than 1.0 FTE resident in a cost reporting period before October 1, 1997, or 3.0 FTE residents in a cost reporting period after that date, CMS shall provide the hospital an opportunity to have its adjustment re-determined when the hospital begins training FTE residents in excess of the applicable threshold.

Recognizing the life and legacy of Henrietta Lacks in honor of Women's History Month.

United States · United States Congress · 14 March 2016

Celebrates, during Women's History Month, the life and legacy of Henrietta Lacks. Honors Lacks as a hero of modern medicine for contributions to the medical discoveries resulting from her HeLa cells, which helped make possible some of the most important medical advances of the last century. Recognizes her legacy, which has contributed to developments in bioethics and patient rights.

Puerto Rico Recovery Act of 2016

United States · United States Congress · 14 March 2016

Puerto Rico Recovery Act of 2016 This bill amends the Internal Revenue Code to make citizens of Puerto Rico eligible for the federal earned income tax credit and allow them to claim the refundable portion of the child tax credit on the same basis as U.S. taxpayers. Title XIX (Medicaid) of the Social Security Act (SSAct) is amended to terminate the limitations on general Medicaid funding, as well as the specific federal medical assistance percentage (FMAP, or matching rate), beginning FY2017 for Puerto Rico, the Virgin Islands of the United States, Guam, the Northern Mariana Islands, and American Samoa (territories). The authority to waive or modify certain Medicaid requirements in American Samoa and the Northern Mariana Islands shall now extend as well to Puerto Rico, the U.S. Virgin Islands, and Guam. Federal financial participation shall not be available to a territory, however, for medical assistance (with certain exceptions) for an individual whose family income exceeds 100% percent of the official poverty line. The bill prescribes a formula for Medicaid disproportionate share hospital (DSH) payments to the territories beginning FY2017, and revises a formula element for calculating Medicare DSH payments under the inpatient prospective payment system (IPPS) for subsection (d) hospitals in Puerto Rico. (Generally, a subsection [d] hospital is an acute care hospital, particularly one that receives payments under Medicare's IPPS when providing covered inpatient services to eligible beneficiaries.) The bill repeals the exclusion of Puerto Rico residents from deemed enrollment under part B (Supplementary Medical Insurance Benefits), permitting them now to be deemed enrolled. The Department of Health and Human Services (HHS) shall extend such residents a special seven-month enrollment period. The late enrollment penalty shall be recalculated to 15% of the usual penalty for residents of Puerto Rico who are current enrollees or who enroll during a specified transition period. HHS shall increase the geographic adjustment practice expense index for Puerto Rico. The blended benchmark component of payments to Medicare+Choice organizations for an area in a territory under SSAct title XVIII part C (Medicare+Choice) shall be at least 80% of the national average of specified base payment amounts for the year (but never more than the lowest blended benchmark amount). The bill also eliminates the exclusion from eligibility for premium and cost-sharing subsidies of territory residents otherwise eligible for Medicare part D (Voluntary Prescription Drug Benefit Program) benefits. HHS shall report to Congress on: the treatment of territories under Medicare part D, and the adverse impacts in each territory from practical exclusion from the establishment of American Health Benefit Exchanges or the administration of a federally facilitated exchange.

A bill to reauthorize the program of the Department of Veterans Affairs under which the Secretary of Veterans Affairs provides health services to veterans through qualifying non-Department health care providers.

United States · United States Congress · 14 March 2016

This bill amends the Veterans' Mental Health and Other Care Improvements Act of 2008 to extend through August 7, 2021, the pilot program under which the Department of Veterans Affairs (VA) provides covered health services in highly rural areas to covered veterans through qualifying non-VA health care providers.