Summary:
(This measure has not been amended since it was reported to the Senate on February 14, 2013. The summary of that version is repeated here.)

Pandemic and All-Hazards Preparedness Act Reauthorization of 2013 - Title I: Strengthening National Preparedness and Response for Public Health Emergencies - (Sec. 101) Amends the Public Health Service Act (PHSA) to require the Secretary of Health and Human Services (HHS) to submit the National Health Security Strategy to the relevant congressional committees in 2014. Revises the Strategy's preparedness goals, in part to specify that the drills and exercises included in periodic evaluations of federal, state, local, and tribal preparedness and response capabilities also include drills and exercises to ensure medical surge capacity for events without notice.

Requires the Strategy to include: (1) provisions for increasing the preparedness, response capabilities, and surge capacity of ambulatory care facilities, dental health facilities, and critical care service systems; (2) plans for optimizing a coordinated and flexible approach to the medical surge capacity of hospitals, other health care facilities, critical care, and trauma care and emergency medical systems; (3) provisions taking into account the unique needs of individuals with disabilities in a public health emergency; and (4) strategic initiatives to advance countermeasures to diagnose, mitigate, prevent, or treat harm from any biological agent or toxin or any chemical, radiological, or nuclear agent or agents, whether naturally occurring, unintentional, or deliberate.

Requires the Secretary to: (1) monitor emerging issues and concerns as they relate to medical and public health preparedness and response for at-risk individuals in the event of a public health emergency; (2) disseminate and update novel and best practices of outreach to and care of at-risk individuals before, during, and following public health emergencies in as timely a manner as is practicable, including from the time a public health threat is identified; and (3) ensure that public health and medical information distributed by HHS during a public health emergency is delivered in a manner that takes into account the range of communication needs of the intended recipients, including at-risk individuals.

(Sec. 102) Requires the Assistant Secretary for Preparedness and Response to provide integrated policy coordination and strategic direction with respect to all matters related to federal public health and medical preparedness and execution and deployment of the federal response for public health emergencies and incidents covered by the National Response Plan before, during, and following public health emergencies.

Requires the Assistant Secretary, with respect to overseeing advanced research, development, and procurement of qualified countermeasures, security countermeasures, and qualified pandemic or epidemic products, to: (1) identify and minimize gaps, duplication and other inefficiencies in medical and public health preparedness and response activities and the actions necessary to overcome these obstacles; (2) align and coordinate medical and public health grants and cooperative agreements as applicable to preparedness and response activities authorized under the PHSA; (3) carry out drills and operational exercises to identify, inform, and address gaps in and policies related to all-hazards medical and public health preparedness; and (4) conduct periodic meetings with the Assistant to the President for National Security Affairs to provide an update on, and to discuss, medical and public health preparedness and response activities.

Requires the Assistant Secretary to develop and update annually a five-year budget plan based on medical countermeasures priorities.

Gives the Assistant Secretary for Preparedness: (1) lead responsibility within HHS for emergency preparedness and response policy and coordination, and (2) authority over and responsibility for the Biomedical Advanced Research and Development Authority (BARDA) as well as grants and related authorities related to trauma care. Transfers director authority and responsibility from the Secretary to the Assistant Secretary for the Medical Reserve Corps and the Emergency System for Advance Registration of Volunteer Health Professionals. Authorizes the Assistant Secretary to exercise the responsibilities and authorities of the Secretary with respect to the coordination of the Public Health Emergency Preparedness Cooperative Agreement Program.

Requires the Assistant Secretary to develop the Public Health Emergency Medical Countermeasures Enterprise Strategy and Implementation Plan, a coordinated strategy and accompanying implementation plan for medical countermeasures to address chemical, biological, radiological, and nuclear threats. Requires the Government Accountability Office (GAO) to conduct an independent evaluation of the strategy and implementation plan. Requires the Secretary to ensure that information and items that could compromise national security, contain confidential commercial information, or contain proprietary information are not disclosed. Requires the Secretary to report to the relevant congressional committees regarding coordination with the Department of Defense (DOD) regarding countermeasure activities to address chemical, biological, radiological, and nuclear threats.

(Sec. 103) Requires the Secretary to establish the National Advisory Committee on Children and Disasters. Terminates the Committee on September 30, 2018.

(Sec. 104) Revises and reauthorizes through FY2018 the National Disaster Medical System. Requires the Secretary to take steps to ensure that a range of public health and medical capabilities are represented in the System, which take into account the needs of at-risk individuals, in the event of a public health emergency. Authorizes the Secretary to determine and pay claims for reimbursement for services provided through the System directly or through contracts that provide for payment in advance or by way of reimbursement.

(Sec. 105) Reauthorizes through FY2018 a program for public health emergency readiness of the Department of Veterans Affairs (VA) medical centers.

Title II: Optimizing State and Local All-Hazards Preparedness and Response - (Sec. 201) Allows the Secretary to authorize a state or tribe to temporarily reassign state and local public health department or agency personnel funded through PHSA programs to immediately address a public health emergency in the state or tribe. Requires such reassignments to be voluntary. Requires GAO to evaluate such temporary reassignments. Terminates this temporary reassignment authority on September 30, 2018.

(Sec. 202) Revises and reauthorizes for FY2014-FY2018 a program of cooperative agreements to improve state and local public health security. Revises requirements for the All-Hazards Public Health Emergency Preparedness and Response Plan.

Requires the Secretary to: (1) update periodically criteria for an effective state plan for responding to pandemic influenza, and (2) require the integration of such criteria into the benchmarks and standards that measure levels of preparedness.

Eliminates the authority for pilot demonstration projects to purchase and implement the use of advanced diagnostic medical equipment to analyze real-time clinical specimens for pathogens of public health or bioterrorism significance.

Makes amounts provided to an eligible entity under a cooperative agreement to achieve preparedness goals for a fiscal year that remain unobligated at the end of such year available for the next fiscal year, contingent upon the entity's achieving benchmarks and submitting a pandemic influenza plan. Eliminates limits on the amount of an award that an entity may carry over to the succeeding fiscal year.

Reauthorizes appropriations for FY2014-FY2018 for the influenza vaccine tracking and distribution program in an influenza pandemic.

(Sec. 203) Includes dental entities among those that may carry out education and training activities to improve responses to public health emergencies. Reauthorizes the Emergency System for Advance Registration of Health Professions Volunteers (ESAR-VHP) for FY2014-FY2018, which provides a single national interoperable network of systems to verify the credentials and licenses of health care professionals who volunteer to provide health services during a public health emergency.

Reauthorizes for FY2014-FY2018 the Medical Reserve Corps to provide for an adequate supply of volunteers in the case of a public health emergency. Requires training exercises to incorporate the needs of at-risk individuals in the event of such an emergency.

Revises and reauthorizes appropriations for FY2014-FY2018 for a program of grants and cooperative agreements to improve surge capacity and enhance community and hospital preparedness. Expands the purpose of the program to address the needs of children and other at-risk individuals. Makes community health centers eligible for such a program. Requires the Secretary to implement objective, evidence-based metrics to ensure that entities receiving such grant awards are meeting, to the extent practicable, the applicable goals of the National Health Security Strategy. Makes amounts provided to an eligible entity under the program for a fiscal year that remain unobligated at the end of such year available to the entity for the next fiscal year for the same purposes. Makes continued availability of such funds contingent upon achieving benchmarks and submitting a pandemic influenza plan.

(Sec. 204) Reauthorizes appropriations for FY2014-FY2018 for a program to improve public health alert communications and surveillance and public health situational awareness capability. Includes poison control centers in the integrated system of public health alert communications and surveillance networks.

Requires the Secretary to submit to the appropriate congressional committees a coordinated strategy and an accompanying implementation plan that demonstrates the measurable steps the Secretary will carry out to: (1) develop, implement, and evaluate the public health situation awareness network; (2) modernize and enhance biosurveillance activities; and (3) improve information sharing, coordination, and communication among disparate biosurveillance systems supported by HHS. Requires the network to include data from community health centers and other health centers. Defines "biosurveillance" as the process of gathering near real-time biological data that relates to human and zoonotic disease activity and threats to human or animal health, in order to achieve early warning and identification of such health threats, early detection and prompt ongoing tracking of health events, and overall situational awareness of disease activity.

Requires the National Biodefense Science Board to provide expert advice and guidance regarding the measurable steps the Secretary should take to modernize and enhance biosurveillance activities pursuant to the efforts of HHS to ensure comprehensive, real-time all-hazards biosurveillance capabilities.

(Sec. 205) Repeals the requirement that the Secretary report annually to designated congressional committees on the Secretary's exercise of specified authority, including expedited procurement authority, under the Project Bioshield Act of 2004.

Title III: Enhancing Medical Countermeasure Review - (Sec. 301) Amends the Federal Food, Drug, and Cosmetic Act (FFDCA) to revise requirements for special protocol assessments to include agreements on the design and size of animal and any associated clinical trials which, in combination, are intended to form the primary basis of an effectiveness claim for a countermeasure or epidemic or pandemic product when human efficacy studies are not ethical or feasible.

(Sec. 302) Revises the Secretary's authority to allow the use of unapproved medical products or the unapproved use of an approved product. Authorizes the Secretary to make a declaration that the circumstances exist justifying such an authorization and base the determination on: (1) a (general) threat (rather than a specific threat as under current law), (2) a significant potential for a public health emergency, (3) the health and security of U.S. citizens abroad, and (4) the identification of a material threat sufficient to affect national security. Eliminates the one-year expiration date for such an authorization (thus allowing it to continue).

Requires the Secretary to give a sponsor of a product subject to such an authorization a written explanation of the scientific, regulatory, or other obstacles to approval, licensure, or clearance of such product or use, including specific actions to be taken by the Secretary and the sponsor to overcome such obstacles.

Conditions such an authorization, with respect to the emergency use of an unapproved product, on the collection and analysis of information concerning the safety and effectiveness of the product when the authorization is in effect and for a reasonable time afterward.

Authorizes the Secretary to review and revise such an authorization.

Authorizes the Secretary to determine that a laboratory examination or procedure associated with a medical device subject to an authorization is deemed to be in a particular category of examinations and procedures if such categorization would be beneficial to protecting the public health and the benefits of the categorization outweigh the risks. Authorizes the Secretary to extend the expiration date of eligible medical countermeasures during an emergency if: (1) the extension is intended to support the U.S. ability to protect the public health or military preparedness and effectiveness; and (2) the extension is supported by an appropriate scientific evaluation conducted or accepted by the Secretary.

Authorizes the Secretary to permit deviations from good manufacturing practice requirements when the circumstances of a domestic, military, or public health emergency or material threat so warrant.

Authorizes the Secretary to waive prescription requirements during an emergency and create and issue emergency use instructions to inform health care providers or individuals to whom an eligible product is to be administered concerning the product's approved, licensed, or cleared conditions.

Authorizes the Secretary to waive requirements for a risk evaluation and mitigation strategy in the event of a domestic, military, or public health emergency (currently, such waiver authority applies only to a public health emergency) or the identification of a material threat sufficient to affect national security or the health and security of U.S. citizens abroad.

Permits a government entity to introduce into interstate commerce a product intended for emergency use if that product is intended to be held and not used, and is held and not used, unless and until it is: (1) approved, cleared, or licensed; (2) authorized for investigational use; or (3) authorized for emergency use.

(Sec. 304) Requires the Secretary to: (1) ensure the appropriate involvement of Food and Drug Administration (FDA) personnel in interagency activities related to countermeasure advanced research and development, (2) ensure the appropriate involvement and consultation of FDA personnel in flexible manufacturing activities, (3) promote countermeasure expertise within the FDA, and (4) maintain teams composed of FDA personnel with expertise on countermeasures.

Requires the Secretary to provide final guidance to industry within one year after enactment of this Act regarding the development of animal models to support approval, clearance, or licensure of countermeasures and epidemic and pandemic products when human efficacy studies are not ethical or feasible.

Requires the Secretary to establish a procedure by which a sponsor or applicant developing a countermeasure for which human efficacy studies are not ethical or practicable, and that has an approved investigational new drug application or investigational device exemption, may request and receive: (1) a meeting to discuss proposed animal model development activities, and (2) a meeting before initiating pivotal animal studies. Requires such meetings to include discussion of animal models for pediatric populations, as appropriate.

Requires the Secretary to take into account the material threat posed by the chemical, biological, radiological, or nuclear agent for which the countermeasure under review is intended when evaluating a countermeasure for approval, licensure, or clearance.

Requires that, when practicable and appropriate, teams of FDA personnel reviewing applications or submissions include a reviewer with sufficient training or experience with countermeasures pursuant to established protocols.

(Sec. 305) Requires the Secretary to establish a formal process for obtaining scientific feedback and interactions regarding the development and regulatory review of eligible countermeasures by facilitating the development of written regulatory management plans. Allows a sponsor or applicant of an eligible countermeasure to initiate such process upon submission of a written request to the Secretary which includes a proposed regulatory management plan. Requires the FDA to work with the sponsor or applicant to agree on a regulatory management plan within 90 days. Sets forth the required contents for a regulatory management plan, which includes developmental milestones and performance targets and goals. Requires the Secretary to establish regulatory management plans for all security countermeasures for which a request is submitted. Allows the Director of BARDA to prioritize which other eligible countermeasures may receive regulatory management plans if the Secretary determines that resources are not available to establish regulatory management plans for all other eligible countermeasures.

(Sec. 306) Directs the Secretary to make publicly available on the FDA website, within 180 days and annually thereafter, a report detailing the countermeasure development and FDA review activities.

(Sec. 307) Requires the Secretary to solicit input from the Assistant Secretary for Preparedness and Response and the Director of BARDA regarding pediatric studies for medical countermeasures.

Requires the Secretary to notify the Assistant Secretary and the Director of BARDA of all pediatric studies in the written request for a pediatric study issued by the Commissioner of Food and Drugs.

Requires the Secretary to consider additional information in developing the priority list of needs in pediatric therapeutics that require study, including the availability of countermeasures to address the needs of pediatric populations.

Directs the FDA's Pediatric Advisory Committee to advise and make recommendations to the Secretary on the development of countermeasures for pediatric populations.

Title IV: Accelerating Medical Countermeasure Advanced Research and Development - (Sec. 401) Extends from 8 years to 10 years: (1) the time during which a security countermeasure should qualify for approval or licensing for inclusion in Project Bioshield, and (2) the duration of a procurement contract for a security countermeasure. Requires a contract to procure security countermeasures to include a clear statement of defined government purpose limited to uses related to a security countermeasure.

Authorizes the Secretary to enter into contracts and other agreements that are in the government's best interest in meeting identified security countermeasure needs, including reimbursement of the cost of advanced research and development as a reasonable, allowable, and allocable direct cost of the contract involved.

Reauthorizes appropriations for FY2014-FY2018 for the Special Reserve Fund for procurement of security countermeasures and for countermeasure advanced research and development under BARDA. Prohibits the Secretary from utilizing more than 50% of such amount for research and development. Requires the Secretary to report to the appropriate congressional committees if the amount in the Fund falls below a specified threshold.

(Sec. 402) Revises and reauthorizes for FY2014-FY2018 the Biodefense Medical Countermeasure Development Fund used to support BARDA to accelerate countermeasure and product advanced research and development.

Authorizes the Secretary to support innovation under BARDA by promoting dose sparing technologies, efficacy increasing technologies, and platform technologies.

Requires the Secretary to provide a clear statement of defined government purpose related to BARDA activities for the awarding of contracts, grants, and cooperative agreements for a qualified countermeasure or qualified pandemic or epidemic product. Extends the Freedom of Information Act (FOIA) exemption for specific technical data or scientific information that is created or obtained during countermeasure and product advanced research and development under PHSA that reveals significant and not otherwise known vulnerabilities of existing medical or public health defenses against biological, chemical, nuclear, or radiological threats.

Extends the antitrust exemption to permit meetings and consultations to discuss the development of security countermeasures, qualified countermeasures, or qualified pandemic or epidemic products. Makes such exemption retroactive to December 17, 2012.

Requires GAO to report on activities carried out to facilitate flexible manufacturing capacity.

Includes within the definition of a qualified countermeasure and a qualified pandemic or epidemic product a product or technology intended to enhance the use or effect of a drug, biological product, or device that is a medical countermeasure.

(Sec. 403) Reauthorizes the Strategic National Stockpile for FY2014-FY2018. Requires the Secretary to: (1) submit to the appropriate congressional committees, to the extent that the disclosure of such information does not compromise national security, the annual review of the contents of the Stockpile; and (2) review and revise the contents of the Stockpile to ensure that the potential depletion of countermeasures currently in the Stockpile is identified and appropriately addressed, including through necessary replenishment.

(Sec. 404) Revises membership requirements for the National Biodefense Science Board. Requires the Board to give any recommendation, finding, or report provided to the Secretary also to the appropriate congressional committees.

measure amended reported senate february summary version repeated pandemic hazards preparedness act reauthorization title strengthening national preparedness response public health emergencies sec amends public_health_service_act phsa require secretary health_and_human_services hhs submit national health security strategy relevant congressional committees revises strategy preparedness goals specify drills exercises included periodic evaluations federal state local tribal preparedness response capabilities include drills exercises ensure medical surge capacity events notice requires strategy include provisions increasing preparedness response capabilities surge capacity ambulatory care facilities dental health facilities critical care service systems plans optimizing coordinated flexible approach medical surge capacity hospitals health_care facilities critical care trauma care emergency medical systems provisions taking account unique needs individuals disabilities public health emergency strategic initiatives advance countermeasures diagnose mitigate prevent treat harm biological agent toxin chemical radiological nuclear agent agents naturally occurring unintentional deliberate requires secretary monitor emerging issues concerns relate medical public health preparedness response risk individuals event public health emergency disseminate update novel best practices outreach care risk individuals following public health emergencies timely manner practicable including time public health threat identified ensure public health medical information distributed hhs public health emergency delivered manner takes account range communication needs intended recipients including risk individuals sec requires assistant secretary preparedness response provide integrated policy coordination strategic direction respect matters related federal public health medical preparedness execution deployment federal response public health emergencies incidents covered national response plan following public health emergencies requires assistant secretary respect overseeing advanced research development procurement qualified countermeasures security countermeasures qualified pandemic epidemic products identify minimize gaps duplication inefficiencies medical public health preparedness response activities actions necessary overcome obstacles align coordinate medical public health grants cooperative agreements applicable preparedness response activities authorized phsa carry drills operational exercises identify inform address gaps policies related hazards medical public health preparedness conduct periodic meetings assistant president national security affairs provide update discuss medical public health preparedness response activities requires assistant secretary develop update annually year budget plan based medical countermeasures priorities gives assistant secretary preparedness lead responsibility hhs emergency preparedness response policy coordination authority responsibility biomedical advanced research development authority grants related authorities related trauma care transfers director authority responsibility secretary assistant secretary medical_reserve_corps emergency system advance registration volunteer health professionals authorizes assistant secretary exercise responsibilities authorities secretary respect coordination public health emergency preparedness cooperative agreement program requires assistant secretary develop public health emergency medical countermeasures enterprise strategy implementation plan coordinated strategy accompanying implementation plan medical countermeasures address chemical biological radiological nuclear threats requires government_accountability_office gao conduct independent evaluation strategy implementation plan requires secretary ensure information items compromise national security contain confidential commercial information contain proprietary information disclosed requires secretary report relevant congressional committees coordination department_of_defense dod countermeasure activities address chemical biological radiological nuclear threats sec requires secretary establish national advisory_committee children disasters terminates committee september sec revises reauthorizes fy2018 national disaster medical system requires secretary steps ensure range public health medical capabilities represented system account needs risk individuals event public health emergency authorizes secretary determine pay claims reimbursement services provided system directly contracts provide payment advance way reimbursement sec reauthorizes fy2018 program public health emergency readiness department_of_veterans_affairs medical centers title optimizing state local hazards preparedness response sec allows secretary authorize state tribe temporarily reassign state local public health department agency personnel funded phsa programs immediately address public health emergency state tribe requires voluntary requires gao evaluate temporary terminates temporary reassignment authority september sec revises reauthorizes fy2014-fy2018 program cooperative agreements improve state local public health security revises requirements hazards public health emergency preparedness response plan requires secretary update periodically criteria effective state plan responding pandemic influenza require integration criteria benchmarks standards measure levels preparedness eliminates authority pilot demonstration projects purchase implement use advanced diagnostic medical equipment analyze real time clinical specimens pathogens public health bioterrorism significance makes amounts provided eligible entity cooperative agreement achieve preparedness goals fiscal year remain unobligated end year available fiscal year contingent entity achieving benchmarks submitting pandemic influenza plan eliminates limits award entity carry succeeding fiscal year reauthorizes appropriations fy2014-fy2018 influenza vaccine tracking distribution program influenza pandemic sec includes dental entities carry education training activities improve responses public health emergencies reauthorizes emergency system advance registration health professions volunteers fy2014-fy2018 provides single national interoperable network systems verify credentials licenses health_care professionals volunteer provide health services public health emergency reauthorizes fy2014-fy2018 medical_reserve_corps provide adequate supply volunteers case public health emergency requires training exercises incorporate needs risk individuals event emergency revises reauthorizes appropriations fy2014-fy2018 program grants cooperative agreements improve surge capacity enhance community hospital preparedness expands purpose program address needs children risk individuals makes community health centers eligible program requires secretary implement objective evidence based metrics ensure entities receiving grant awards meeting extent practicable applicable goals national health security strategy makes amounts provided eligible entity program fiscal year remain unobligated end year available entity fiscal year purposes makes continued availability funds contingent achieving benchmarks submitting pandemic influenza plan sec reauthorizes appropriations fy2014-fy2018 program improve public health alert communications surveillance public health situational awareness capability includes poison control centers integrated system public health alert communications surveillance networks requires secretary submit appropriate congressional committees coordinated strategy accompanying implementation plan demonstrates measurable steps secretary carry develop implement evaluate public health situation awareness network modernize enhance activities improve information sharing coordination communication disparate systems supported hhs requires network include data community health centers health centers defines process gathering near real time biological data relates human zoonotic disease activity threats human animal health order achieve early warning identification health threats early detection prompt ongoing tracking health events overall situational awareness disease activity requires national biodefense science board provide expert advice guidance measurable steps secretary modernize enhance activities pursuant efforts hhs ensure comprehensive real time hazards capabilities sec repeals requirement secretary report annually designated congressional committees secretary exercise specified authority including expedited procurement authority project act title iii enhancing medical countermeasure review sec amends federal food drug cosmetic act ffdca revise requirements special protocol assessments include agreements design size animal associated clinical trials combination intended form primary basis effectiveness claim countermeasure epidemic pandemic product human efficacy studies ethical feasible sec revises secretary authority allow use unapproved medical products unapproved use approved product authorizes secretary declaration circumstances exist justifying authorization base determination general threat specific threat current law significant potential public health emergency health security citizens abroad identification material threat sufficient affect national security eliminates year expiration date authorization allowing continue requires secretary sponsor product subject authorization written explanation scientific regulatory obstacles approval licensure clearance product use including specific actions taken secretary sponsor overcome obstacles conditions authorization respect emergency use unapproved product collection analysis information concerning safety effectiveness product authorization effect reasonable time authorizes secretary review revise authorization authorizes secretary determine laboratory examination procedure associated medical device subject authorization deemed particular category examinations procedures categorization beneficial protecting public health benefits categorization outweigh risks authorizes secretary extend expiration date eligible medical countermeasures emergency extension intended support ability protect public health military preparedness effectiveness extension supported appropriate scientific evaluation conducted accepted secretary authorizes secretary permit deviations good manufacturing practice requirements circumstances domestic military public health emergency material threat warrant authorizes secretary waive prescription requirements emergency create issue emergency use instructions inform health_care providers individuals eligible product administered concerning product approved licensed cleared conditions authorizes secretary waive requirements risk evaluation mitigation strategy event domestic military public health emergency currently waiver authority applies public health emergency identification material threat sufficient affect national security health security citizens abroad permits government entity introduce interstate commerce product intended emergency use product intended held held approved cleared licensed authorized investigational use authorized emergency use sec requires secretary ensure appropriate involvement food_and_drug_administration fda personnel interagency activities related countermeasure advanced research development ensure appropriate involvement consultation fda personnel flexible manufacturing activities promote countermeasure expertise fda maintain teams composed fda personnel expertise countermeasures requires secretary provide final guidance industry year enactment act development animal models support approval clearance licensure countermeasures epidemic pandemic products human efficacy studies ethical feasible requires secretary establish procedure sponsor applicant developing countermeasure human efficacy studies ethical practicable approved investigational new drug application investigational device exemption request receive meeting discuss proposed animal model development activities meeting initiating animal studies requires meetings include discussion animal models pediatric populations appropriate requires secretary account material threat posed chemical biological radiological nuclear agent countermeasure review intended evaluating countermeasure approval licensure clearance requires practicable appropriate teams fda personnel reviewing applications submissions include reviewer sufficient training experience countermeasures pursuant established protocols sec requires secretary establish formal process obtaining scientific feedback interactions development regulatory review eligible countermeasures facilitating development written regulatory management plans allows sponsor applicant eligible countermeasure initiate process submission written request secretary includes proposed regulatory management plan requires fda work sponsor applicant agree regulatory management plan days sets forth required contents regulatory management plan includes developmental milestones performance targets goals requires secretary establish regulatory management plans security countermeasures request submitted allows director prioritize eligible countermeasures receive regulatory management plans secretary determines resources available establish regulatory management plans eligible countermeasures sec directs secretary publicly available fda website days annually report detailing countermeasure development fda review activities sec requires secretary solicit input assistant secretary preparedness response director pediatric studies medical countermeasures requires secretary notify assistant secretary director pediatric studies written request pediatric study issued commissioner food_and_drugs requires secretary consider additional information developing priority list needs pediatric require study including availability countermeasures address needs pediatric populations directs fda pediatric_advisory_committee advise recommendations secretary development countermeasures pediatric populations title accelerating medical countermeasure advanced research development sec extends years years time security countermeasure qualify approval licensing inclusion project duration procurement contract security countermeasure requires contract procure security countermeasures include clear statement defined government purpose limited uses related security countermeasure authorizes secretary enter contracts agreements government best interest meeting identified security countermeasure needs including reimbursement cost advanced research development reasonable allowable allocable direct cost contract involved reauthorizes appropriations fy2014-fy2018 special reserve fund procurement security countermeasures countermeasure advanced research development prohibits secretary utilizing research development requires secretary report appropriate congressional committees fund falls specified threshold sec revises reauthorizes fy2014-fy2018 biodefense medical countermeasure development fund support accelerate countermeasure product advanced research development authorizes secretary support innovation promoting dose technologies efficacy increasing technologies platform technologies requires secretary provide clear statement defined government purpose related activities awarding contracts grants cooperative agreements qualified countermeasure qualified pandemic epidemic product extends freedom information act foia exemption specific technical data scientific information created obtained countermeasure product advanced research development phsa reveals significant known vulnerabilities existing medical public health defenses biological chemical nuclear radiological threats extends antitrust exemption permit meetings consultations discuss development security countermeasures qualified countermeasures qualified pandemic epidemic products makes exemption retroactive december requires gao report activities carried facilitate flexible manufacturing capacity includes definition qualified countermeasure qualified pandemic epidemic product product technology intended enhance use effect drug biological product device medical countermeasure sec reauthorizes strategic national stockpile fy2014-fy2018 requires secretary submit appropriate congressional committees extent disclosure information compromise national security annual review contents stockpile review revise contents stockpile ensure potential depletion countermeasures currently stockpile identified appropriately addressed including necessary replenishment sec revises membership requirements national biodefense science board requires board recommendation finding report provided secretary appropriate congressional committees


Summary: Health and Human Services Hiree Clarification Act of 2013 - Amends the Public Health Service Act to state that provisions authorizing the appointment of special consultants or authorizing individual scientists to receive fellowships do not authorize the designation, appointment, or employment of any special consultant, fellow, or other employee by an agency outside of the Department of Health and Human Services (HHS).

health_and_human_services clarification act amends public_health_service_act state provisions authorizing appointment special consultants authorizing individual scientists receive fellowships authorize designation appointment employment special consultant fellow employee agency outside department_of_health_and_human_services hhs


Summary:
Defund Obamacare Act - Deauthorizes appropriations to carry out the Patient Protection and Affordable Care Act or the Health Care and Education Reconciliation Act of 2010, or any amendments made by them.

Rescinds the unobligated balance of funds made available under such Acts.

defund obamacare act deauthorizes appropriations carry patient_protection affordable care act health_care_and_education reconciliation act amendments rescinds unobligated balance funds available acts


Summary:
(This measure has not been amended since it was passed by the Senate on December 8, 2014. The summary of that version is repeated here.)

Newborn Screening Saves Lives Reauthorization Act of 2014 - (Sec. 2) Amends the Public Health Service Act to revise and extend through FY2019 a grant program for screening, counseling, and other services related to heritable disorders that can be detected in newborns. Allows grants to be used to improve timeliness of newborn screening and provide training to health care professionals on the importance of timely screening and on the sharing of medical and diagnostic information with providers and families.

(Sec. 3) Extends through FY2019 a grant program to evaluate the effectiveness of screening, counseling, or health care services in reducing the morbidity and mortality caused by heritable disorders in newborns and children. Expands the program to include evaluation of health outcomes through adolescence and best practices for timely screening of newborns.

(Sec. 4) Extends for five years the operation of the Advisory Committee on Heritable Disorders in Newborns and Children. Authorizes the Secretary of Health and Human Services (HHS) to continue the Advisory Committee after such time.

(Sec. 5) Extends through FY2019 the clearinghouse for newborn screening information. Expands the duties of the clearinghouse to include: (1) maintaining current information on the number of conditions for which screening is conducted in each state; and (2) disseminating guidelines for diagnosis, counseling, and treatment of conditions detected by newborn screening.

(Sec. 6) Extends through FY2019 requirements for the Director of the Centers for Disease Control and Prevention (CDC) to provide for quality assurance of laboratories involved in screening newborns and children for heritable disorders. Authorizes the Director to coordinate surveillance activities, including through standardized data collection and reporting and electronic health records.

(Sec. 7) Makes permanent the Interagency Coordinating Committee on Newborn and Child Screening. Adds the Administrator of the Health Resources and Services Administration and the Commissioner of Food and Drugs (FDA) to this committee.

(Sec. 8) Requires the Director to update the national contingency plan for newborn screening at least every five years.

(Sec. 9) Authorizes the Secretary to expand the Hunter Kelly Newborn Screening Research Program to: (1) provide research and data for newborn conditions under review by the Advisory Committee to be added to the Recommended Uniform Screening Panel, and (2) conduct pilot studies on conditions recommended by the Advisory Committee to ensure that screenings are ready for nationwide implementation.

(Sec. 11) Requires the Comptroller General (GAO) to report on the timeliness of newborn screening. Requires the Secretary to report on newborn screening activities and expenditures.

(Sec. 12) Directs HHS to update the Federal Policy for the Protection of Human Subjects, also known as the Common Rule, not later than two years after enactment of this Act. Applies the following provisions until HHS updates the Common Rule:

 requires federally funded research on newborn dried blood spots to be considered research on human subjects (which requires the informed consent of the subject), and eliminates the ability of an institutional review board to waive informed consent requirements for research on newborn dried blood spots.

measure amended passed senate december summary version repeated newborn screening lives reauthorization act sec amends public_health_service_act revise extend fy2019 grant program screening counseling services related disorders detected newborns allows grants improve timeliness newborn screening provide training health_care professionals importance timely screening sharing medical diagnostic information providers families sec extends fy2019 grant program evaluate effectiveness screening counseling health_care services reducing morbidity mortality caused disorders newborns children expands program include evaluation health outcomes best practices timely screening newborns sec extends years operation advisory_committee disorders newborns children authorizes secretary health_and_human_services hhs continue advisory_committee time sec extends fy2019 clearinghouse newborn screening information expands duties clearinghouse include maintaining current information number conditions screening conducted state disseminating guidelines diagnosis counseling treatment conditions detected newborn screening sec extends fy2019 requirements director centers_for_disease_control_and_prevention cdc provide quality assurance laboratories involved screening newborns children disorders authorizes director coordinate surveillance activities including standardized data collection reporting electronic health records sec makes permanent interagency_coordinating_committee newborn child screening adds administrator health_resources_and_services_administration commissioner food_and_drugs fda committee sec requires director update national contingency plan newborn screening years sec authorizes secretary expand hunter newborn screening research program provide research data newborn conditions review advisory_committee added recommended uniform screening panel conduct pilot studies conditions recommended advisory_committee ensure screenings ready nationwide implementation sec requires comptroller_general gao report timeliness newborn screening requires secretary report newborn screening activities expenditures sec directs hhs update federal policy protection human subjects known common rule later years enactment act applies following provisions hhs updates common rule requires federally funded research newborn dried blood considered research human subjects requires informed consent subject eliminates ability institutional review board waive informed consent requirements research newborn dried blood


Summary:
Inspiring Scientific Research and Innovation Supplemental Appropriations Act, 2013 - Appropriates, for FY2013, an additional $3 billion to the National Institutes of Health (NIH), to remain available until expended.

Amends the Internal Revenue Code to increase the recovery period for the depreciation of an airplane: (1) used in directly carrying out activities essential to the function of a trade or business other than the commercial or contract carrying of freight or passengers; and (2) whose primary use is not for the transportation of freight or passengers, other than medical or emergency transportation. Provides a special effective date rule for property for which there is a qualified written binding contract in effect before the date of enactment of this Act.

scientific research innovation supplemental appropriations act appropriates fy2013 additional billion national_institutes_of_health nih remain available expended amends_the_internal_revenue_code increase recovery period depreciation airplane directly carrying activities essential function trade business commercial contract carrying freight passengers primary use transportation freight passengers medical emergency transportation provides special effective date rule property qualified written binding contract effect date enactment act


Summary:
Cutting Costly Codes Act of 2013 - Prohibits the Secretary of Health and Human Services (HHS) from implementing, administering, or enforcing specified regulations insofar as they would replace International Classification of Diseases (ICD)-9 with ICD-10 as a standard for code sets for appropriate data elements for financial and administrative transactions involving the electronic exchange of health information.

(The ICD is a health care classification system of diagnostic codes for classifying diseases.)

cutting costly codes act prohibits secretary health_and_human_services hhs implementing administering enforcing specified regulations insofar replace international classification diseases icd-10 standard code sets appropriate data elements financial administrative transactions involving electronic exchange health information health_care classification system diagnostic codes classifying diseases


Summary:
Research First Act of 2013 - Appropriates, for FY2013, an additional $1.55 billion to the National Institutes of Health (NIH).

Rescinds: (1) $400 million from the Department of Defense--Overseas Contingency Operations--Operation and Maintenance--Afghanistan Infrastructure Fund account, and (2) $1.15 billion from the Department of Defense (DOD) account.

research act appropriates fy2013 additional billion national_institutes_of_health nih rescinds million department_of_defense overseas contingency operations operation maintenance afghanistan infrastructure fund account billion department_of_defense dod account


Summary: Prohibits the award by states of American Health Benefit Exchange grant funds under the Patient Protection and Affordable Care Act to an entity for the operation of a Navigator program (to raise awareness of the availability of qualified health plans) or for facilitation or advocacy for enrollment in a qualified health plan, until the Secretary of Health and Human Services (HHS) certifies to Congress that the entity has certified that it will not use such funds to: (1) provide advice concerning benefits, terms, and features of a particular qualified health plan or offer advice about which such plan is better or worse or suitable for a particular individual or employer; (2) recommend or endorse a particular qualified health plan or advise consumers about which plan to choose; (3) accept any compensation or consideration dependent, in whole or in part, on whether an individual enrolls in or purchases such a plan; or (4) violate any applicable insurance law or regulation of the applicable state or any subpoena or order of the state's insurance commissioner.

prohibits award states american_health_benefit_exchange grant funds patient_protection affordable care act entity operation navigator program raise awareness availability qualified health plans facilitation advocacy enrollment qualified health plan secretary health_and_human_services hhs certifies congress entity certified use funds provide advice concerning benefits terms features particular qualified health plan offer advice plan better suitable particular individual employer recommend endorse particular qualified health plan advise consumers plan choose accept compensation consideration dependent individual enrolls purchases plan violate applicable insurance law regulation applicable state subpoena order state insurance commissioner


Summary:
Inspiring Scientific Research and Innovation Supplemental Appropriations Act, 2014 - Appropriates, for FY2014, an additional $3 billion to the National Institutes of Health (NIH), to remain available until expended.

Amends the Internal Revenue Code to increase the recovery period for the depreciation of an airplane: (1) used in directly carrying out activities essential to the function of a trade or business other than the commercial or contract carrying of freight or passengers; and (2) whose primary use is not for the transportation of freight or passengers, other than medical or emergency transportation. Provides a special effective date rule for property for which there is a qualified written binding contract in effect before the date of enactment of this Act.

scientific research innovation supplemental appropriations act appropriates fy2014 additional billion national_institutes_of_health nih remain available expended amends_the_internal_revenue_code increase recovery period depreciation airplane directly carrying activities essential function trade business commercial contract carrying freight passengers primary use transportation freight passengers medical emergency transportation provides special effective date rule property qualified written binding contract effect date enactment act


Summary:
Special Inspector General for Monitoring the ACA Act of 2014 or the SIGMA Act of 2014 - Establishes the Office of the Special Inspector General for Monitoring the Affordable Care Act to conduct, supervise, and coordinate audits and investigations of the implementation and administration of programs and activities established under, and payment system changes made by, the Affordable Care Act (the Patient Protection and Affordable Care Act and the health care provisions of the Health Care and Education Reconciliation Act of 2010). Requires the Special Inspector General to be appointed by the President, with the advice and consent of the Senate.

Requires the Special Inspector General to appoint an Assistant Inspector General for Auditing and an Assistant Inspector General for Investigations.

Places the Special Inspector General under the supervision of the Secretary of Health and Human Services (HHS), but prohibits federal agencies involved in implementing or administering the Affordable Care Act from preventing or prohibiting the Special Inspector General from initiating, carrying out, or completing any audit or investigation.

special inspector_general monitoring act act establishes office special inspector_general monitoring affordable care act conduct supervise coordinate audits investigations implementation administration programs activities established payment system changes affordable care act patient_protection affordable care act health_care provisions health_care_and_education reconciliation act requires special inspector_general appointed president advice consent senate requires special inspector_general appoint assistant inspector_general auditing assistant inspector_general investigations places special inspector_general supervision secretary health_and_human_services hhs prohibits federal agencies involved implementing administering affordable care act preventing prohibiting special inspector_general initiating carrying completing audit investigation


Summary:
Better Efficiency and Administrative Simplification Act of 2014 - Amends title XVIII (Medicare) of the Social Security Act to allow individuals the option to receive the Medicare Summary Notice (explanation of benefits) electronically.

Requires the Secretary of Health and Human Services (HHS) to: (1) apply a similar option to other Medicare statements and notifications, and (2) provide such Medicare Summary Notice and any other such statements and notifications on a more frequent basis than is otherwise required under Medicare.

Extends from at least once every 5 years to at least once every 10 years the application of competitive procedures when the contract of a Medicare administrative contractor comes up for renewal.

better efficiency administrative simplification act amends title xviii medicare social_security_act allow individuals option receive medicare summary notice explanation benefits electronically requires secretary health_and_human_services hhs apply similar option medicare statements notifications provide medicare summary notice statements notifications frequent basis required medicare extends years years application competitive procedures contract medicare administrative contractor comes renewal


Summary:
Commission for Our Veterans' Care Act - Establishes the Commission on Access to Care to undertake a comprehensive evaluation and assessment of access to health care at the Department of Veterans Affairs (VA).

Includes among the matters to be evaluated and assessed by the Commission:

 the appropriateness of the VA's current standards concerning access to health care, the measurement of such standards, the appropriateness of performance standards and incentives in relation to the VA's current standards for access to health care, staffing levels throughout the Veterans Health Administration (VHA) and whether they are sufficient to meet current demand. Directs the President to require the VA Secretary and the heads of other relevant federal agencies to implement each recommendation that the President considers feasible and advisable and determines can be implemented without further legislative action.

commission veterans care act establishes_the_commission access care undertake comprehensive evaluation assessment access health_care department_of_veterans_affairs includes matters evaluated assessed commission appropriateness current standards concerning access health_care measurement standards appropriateness performance standards incentives relation current standards access health_care staffing levels veterans_health_administration vha sufficient meet current demand directs president require secretary heads relevant federal agencies implement recommendation president considers feasible advisable determines implemented legislative action


Summary:
Equalizing Transparency for Veterans Act - Directs the Secretary of Veterans Affairs (VA) to biennially publish information on the VA's provision of health care on a VA Internet database that is publicly available.

Includes among that information for each VA medical facility:

 quality measures regarding inpatient and outpatient care that the Secretary of Health and Human Services (HHS) is required to make publicly available under the Medicare program; the average length of stay, opioid prescription rate, and suicide rate for patients discharged from the facility; and the average number of days a patient waited for an appointment or procedure at such facility. Includes in such information for each VA nursing home any quality measures the Secretary of HHS makes publicly available regarding Medicare nursing homes.

Directs the Secretary to establish a process to validate the published information.

Requires the Secretary to annually submit a plan to Congress to improve each VA medical facility that ranks within the bottom quartile on each quality measure used by the Secretary to rank such facilities.

Directs the Secretary to establish a toll-free telephone number for individuals to use to notify the Secretary of low-quality care being provided at a VA medical facility.

equalizing transparency veterans act_-_directs secretary veterans_affairs biennially publish information provision health_care internet database publicly available includes information medical facility quality measures inpatient outpatient care secretary health_and_human_services hhs required publicly available medicare program average length stay opioid prescription rate suicide rate patients discharged facility average number days patient appointment procedure facility includes information nursing home quality measures secretary hhs makes publicly available medicare nursing homes directs secretary establish process validate published information requires secretary annually submit plan congress improve medical facility ranks quartile quality measure secretary rank facilities directs secretary establish toll free telephone number individuals use notify secretary low quality care provided medical facility


Summary:
Serving America's Veterans Effectively Act of 2014 or the SAVE Act of 2014 - Directs the Secretary of Health and Human Services (HHS) to:

 require the inclusion of a patient's status as a veteran in the patient information that the Secretary requires for meaningful use of electronic health records under the Medicare and Medicaid programs, include an inquiry into whether a patient is a veteran and any relevant circumstances relating to a veteran's service in the Armed Forces as part of the initial preventive examination of Medicare beneficiaries, and take such additional actions as may be appropriate to promote awareness among nongovernmental physicians of the special circumstances and health care needs of veterans. Authorizes the Secretary to make grants to organizations to educate health care providers on appropriate health care for veterans.

serving america veterans effectively act save act directs secretary health_and_human_services hhs require inclusion patient status veteran patient information secretary requires meaningful use electronic health records medicare medicaid programs include inquiry patient veteran relevant circumstances relating veteran service armed_forces initial preventive examination medicare beneficiaries additional actions appropriate promote awareness nongovernmental physicians special circumstances health_care needs veterans authorizes secretary grants organizations educate health_care providers appropriate health_care veterans


Summary:
Streamlining Verification for Americans Act - Requires the Secretary of the Treasury to allow large employers to prospectively report information regarding health care coverage available to employees eligible for premium subsidies on a health care exchange.

Amends the Patient Protection and Affordable Care Act to require the Secretary of Health and Human Services (HHS), upon an individual's request, to make an advance determination of the individual's eligibility for premium subsidies based on information other than the individual's most recent taxable year income.

Requires the Government Accountability Office (GAO) to evaluate the notification of employers by health care exchanges regarding employees determined to be eligible for premium subsidies and the appeals process for eligibility determinations.

Amends the Internal Revenue Code of 1986 to allow a person reporting an individual's health coverage to the Treasury to identify the individual using their birth date in place of their taxpayer identification number (TIN) in certain circumstances.

Allows large employers or persons reporting an employee's or individual's health coverage to the Treasury to provide the required statement to the employee or individual electronically.

Prohibits provision of premium subsidies and assessment of the penalty for not maintaining minimum essential coverage between December 31, 2014, and the date a process is established to verify eligibility for premium subsidies.

streamlining verification americans act_-_requires secretary treasury allow large employers report information health_care coverage available employees eligible premium subsidies health_care exchange amends patient_protection affordable care act require secretary health_and_human_services hhs individual request advance determination individual eligibility premium subsidies based information individual recent taxable year income requires government_accountability_office gao evaluate notification employers health_care exchanges employees determined eligible premium subsidies appeals process eligibility determinations amends_the_internal_revenue_code allow person reporting individual health coverage treasury identify individual birth date place taxpayer identification number tin certain circumstances allows large employers persons reporting employee individual health coverage treasury provide required statement employee individual electronically prohibits provision premium subsidies assessment penalty maintaining minimum essential coverage december date process established verify eligibility premium subsidies


Summary:
Public Health Emergency Preparedness Act - Makes a $5 billion supplemental appropriation to the Department of Health and Human Service (HHS) Public Health Emergency Fund.

Designates the funding as an emergency requirement exempt from budget enforcement limits. Makes the funding available, however, only if the President subsequently designates the amount as an emergency requirement.

Permits the activities funded under this Act to include acquisition of products such as drugs, vaccines and other biological products, and medical devices for deposit into the Strategic National Stockpile.

Amends the Balanced Budget and Emergency Deficit Control Act of 1985 (Gramm-Rudman-Hollings Act) to add the Public Health Emergency Fund to the list of programs and activities exempt from a sequestration. (A sequestration is a process of automatic, usually across-the-board spending reductions under which budgetary resources are permanently cancelled to enforce specific budget policy goals.)

public health emergency preparedness act makes billion supplemental appropriation department_of_health_and_human_service hhs public health emergency fund designates funding emergency requirement exempt budget enforcement limits makes funding available president subsequently designates emergency requirement permits activities funded act include acquisition products drugs vaccines biological products medical devices deposit strategic national stockpile amends balanced_budget emergency deficit control act gramm rudman hollings act add public health emergency fund list programs activities exempt sequestration sequestration process automatic usually board spending reductions budgetary resources permanently cancelled enforce specific budget policy goals


Summary:
Incentivizing Healthcare Quality Outcomes Act of 2014 - Amends title XVIII (Medicare) of the Social Security Act. in order to incentivize healthcare quality outcomes, to prescribe specific adjustment factors for incentive payments to: (1) healthcare delivery organizations, and (2) healthcare professionals (who are not part of an applicable healthcare delivery organization) in a geographic region to coordinate care and reduce potentially preventable outcomes.

Directs the Secretary of Health and Human Services (HHS) to establish geographic regions to which health professionals shall be assigned.

Requires the Secretary to select a methodology of identifying potentially preventable: (1) inpatient hospital complications, (2) admissions and readmissions, (3) emergency room visits, (4) outpatient procedures and tests, as well as (5) outcomes. Requires selection of a methodology also for risk adjusting the rate of each potentially preventable outcome.

Directs the Secretary to: (1) give confidential reports to healthcare delivery organizations with respect to potentially preventable outcomes, (2) make information available to the public regarding potentially preventable outcomes of each applicable healthcare delivery organization, (3) apply to state plans (or waivers) under SSA title XIX (Medicaid) regulations that will relate to payment adjustments for potentially preventable outcomes, and (4) award quality improvement grants to eligible healthcare delivery organizations with an organization-specific adjustment factor lower than the factor for 75% of all other such organizations.

Directs the Comptroller General (GAO) to study the impact of this Act on Medicare beneficiaries' care, Medicare expenditures, and Medicare providers.

incentivizing healthcare quality outcomes act amends title xviii medicare social_security_act order incentivize healthcare quality outcomes prescribe specific adjustment factors incentive payments healthcare delivery organizations healthcare professionals applicable healthcare delivery organization geographic region coordinate care reduce potentially preventable outcomes directs secretary health_and_human_services hhs establish geographic regions health professionals shall assigned requires secretary select methodology identifying potentially preventable inpatient hospital complications admissions emergency room visits outpatient procedures tests outcomes requires selection methodology risk adjusting rate potentially preventable outcome directs secretary confidential reports healthcare delivery organizations respect potentially preventable outcomes information available public potentially preventable outcomes applicable healthcare delivery organization apply state plans waivers ssa title xix medicaid regulations relate payment adjustments potentially preventable outcomes award quality improvement grants eligible healthcare delivery organizations organization specific adjustment factor lower factor organizations directs comptroller_general gao study impact act medicare beneficiaries care medicare expenditures medicare providers


Summary:
Fit to Serve Act - Authorizes the Secretary of Defense (DOD) to provide for the dissemination to potential military recruits of information on healthy body weight. Includes in the information that may be provided healthy weight according to age, height, and gender, the risks of obesity, and achieving and maintaining a healthy weight. Authorizes the dissemination of such information both electronically and in writing.

Authorizes each military department Secretary to enter into joint use agreements with local governments in the vicinity of military installations in order to permit the use of athletic facilities at such installations by local civilians.

fit serve act_-_authorizes secretary defense dod provide dissemination potential military recruits information healthy body weight includes information provided healthy weight according age height gender risks obesity achieving maintaining healthy weight authorizes dissemination information electronically writing authorizes military department secretary enter joint use agreements local governments vicinity military installations order permit use athletic facilities installations local civilians


Summary:
Servicemember's Electronic Health Records Act of 2013 - Amends the Wounded Warrior Act to require the Secretaries of Defense and Veterans Affairs, in implementing electronic health record systems that provide for the full interoperability of personal health care information between the Department of Defense (DOD) and Department of Veterans Affairs (VA), to ensure that: (1) a health data authoritative source that can be accessed by multiple providers and that standardizes the input of new medical information is created by the Departments within 180 days, (2) the ability of patients of both Departments to download their medical records is achieved within 180 days, (3) full interoperability of personal health care information between the Departments is achieved within one year, (4) acceleration of the exchange of real-time data between the Departments is achieved within one year, (5) the upgrade of the graphical user interface to display a joint common graphical user interface is achieved within one year, and (6) current members of the Armed Forces and their dependents may elect to receive an electronic copy of their health care records beginning not later than June 30, 2015.

Requires the Secretaries to assess the feasibility and advisability of establishing a secure, remote, network-accessible computer storage system (commonly referred to as cloud storage) to: (1) provide members of the Armed Forces and veterans the ability to upload their health care records, and (2) allow DOD and VA medical providers of the Departments to access such records.

servicemember electronic health records act amends wounded warrior act require secretaries_of_defense veterans_affairs implementing electronic health record systems provide interoperability personal health_care information department_of_defense dod department_of_veterans_affairs ensure health data authoritative source accessed multiple providers input new medical information created departments days ability patients departments download medical records achieved days interoperability personal health_care information departments achieved year acceleration exchange real time data departments achieved year upgrade user interface display joint common user interface achieved year current members armed_forces dependents elect receive electronic copy health_care records beginning later june requires secretaries assess feasibility advisability establishing secure remote network accessible computer storage system commonly referred cloud storage provide members armed_forces veterans ability health_care records allow dod medical providers departments access records


Summary:
(This measure has not been amended since it was reported to the Senate on December 19, 2013. The summary of that version is repeated here.)

Newborn Screening Saves Lives Reauthorization Act of 2013 - (Sec. 2) Amends the Public Health Service Act to extend through FY2018 a grant program for newborn and child screening programs for heritable disorders. Includes the improvement of the timely collection, delivery, and receipts, and screening of specimens, and the timely diagnosis of heritable disorders in newborns as a permissible use of grant funds.

(Sec. 3) Extends through FY2018 a demonstration program to evaluate the effectiveness of screening, follow-up, counseling or health care services in reducing the morbidity and mortality caused by heritable disorders in newborn and children. Permits the program to also evaluate and assess: (1) methods to improve quality in the diagnosis, treatment, and disease management of heritable disorders based on gaps in services or care; and (2) methods or best practices by which states or political subdivisions of a state, territories, Indian health care facilities or programs, or any entity with appropriate expertise in newborn screening can achieve the timely collection, delivery, receipt, and screening of newborn screening specimens, and the timely diagnosis of heritable disorders in newborns.

(Sec. 4) Reauthorizes through FY2018 and extends for five years the operation of the Advisory Committee on Heritable Disorders in Newborns and Children. Expands the duties of the Advisory Committee to include providing technical assistance to individuals and organizations regarding the submission of nominations to the uniform screening panel. Requires the Advisory Committee to give recommendations, advice, or information to the Secretary of Health and Human Services (HHS) on the timely collection, delivery, receipt, and screening of specimens to be tested for heritable disorders in newborns.

Revises the process for the Secretary to consider the Advisory Committee's recommendations.

Requires the Advisory Committee to meet at least four times per year.

(Sec. 5) Extends through FY2018 the Newborn Screening Clearinghouse of current education and family support and services information, materials, resources, research, and data on newborn screening.

(Sec. 6) Extends through FY2018 a quality assurance program requiring the Secretary, acting through the Director of the Centers for Disease Control and Prevention (CDC), to provide for quality assurance of laboratories involved in screening for heritable disorders. Authorizes the Secretary, acting through the Director, to also provide for the coordination of surveillance activities.

(Sec. 7) Makes the Interagency Coordinating Committee on Newborn and Child Screening permanent. Includes the Commissioner of Food and Drugs (FDA) as a member of the Interagency Committee.

(Sec. 8) Requires the national contingency plan for newborn screening to be updated at least every five years.

(Sec. 9) Allows the expansion of the Hunter Kelly Newborn Screening Research Program to include: (1) providing research findings and data for newborn conditions under review by the Advisory Committee to be added to the recommended uniform screening panel, and (2) conducting pilot studies on conditions recommended by the Advisory Committee to ensure that the screenings are ready for nationwide implementation.

(Sec. 11) Requires the Comptroller General to report to the relevant congressional committees on the timeliness of screening for heritable disorders in newborns.

Requires the Secretary to report to the relevant congressional committees biennially on activities related to newborn screening and screening children who have or are at risk for heritable disorders.

measure amended reported senate december summary version repeated newborn screening lives reauthorization act sec amends public_health_service_act extend fy2018 grant program newborn child screening programs disorders includes improvement timely collection delivery receipts screening specimens timely diagnosis disorders newborns permissible use grant funds sec extends fy2018 demonstration program evaluate effectiveness screening follow counseling health_care services reducing morbidity mortality caused disorders newborn children permits program evaluate assess methods improve quality diagnosis treatment disease management disorders based gaps services care methods best practices states political subdivisions state territories indian health_care facilities programs entity appropriate expertise newborn screening achieve timely collection delivery receipt screening newborn screening specimens timely diagnosis disorders newborns sec reauthorizes fy2018 extends years operation advisory_committee disorders newborns children expands duties advisory_committee include providing technical assistance individuals organizations submission nominations uniform screening panel requires advisory_committee recommendations advice information secretary health_and_human_services hhs timely collection delivery receipt screening specimens tested disorders newborns revises process secretary consider advisory_committee recommendations requires advisory_committee meet times year sec extends fy2018 newborn screening clearinghouse current education family support services information materials resources research data newborn screening sec extends fy2018 quality assurance program requiring secretary acting director centers_for_disease_control_and_prevention cdc provide quality assurance laboratories involved screening disorders authorizes secretary acting director provide coordination surveillance activities sec makes interagency_coordinating_committee newborn child screening permanent includes commissioner food_and_drugs fda member interagency_committee sec requires national contingency plan newborn screening updated years sec allows expansion hunter newborn screening research program include providing research findings data newborn conditions review advisory_committee added recommended uniform screening panel conducting pilot studies conditions recommended advisory_committee ensure screenings ready nationwide implementation sec requires comptroller_general report relevant congressional committees timeliness screening disorders newborns requires secretary report relevant congressional committees biennially activities related newborn screening screening children risk disorders


Summary:
Improving Quality of Care Within the Department of Veterans Affairs Act of 2013 - Requires the Secretary of Veterans Affairs to: (1) ensure that the Department of Veterans Affairs (VA) has in effect an up-to-date policy on reporting a notifiable infectious disease diagnosed at a VA facility in accordance with applicable state and local law, and (2) develop performance measures to assess whether and to what degree the directors of Veterans Integrated Service Networks (VISN) and VA medical centers are complying with such policy.

Requires the Secretary to enter into a contract with an independent third-party to: (1) assess the organizational structures of VA medical centers, and (2) improve succession planning among key leadership roles at VISN and VA medical centers.

improving quality care department_of_veterans_affairs act requires secretary veterans_affairs ensure department_of_veterans_affairs effect date policy reporting infectious disease diagnosed facility accordance applicable state local law develop performance measures assess degree directors veterans_integrated_service_networks visn medical centers complying policy requires secretary enter contract independent party assess organizational structures medical centers improve succession planning key leadership roles visn medical centers


Summary:
Rural Veterans Improvement Act of 2014 - Directs the Secretary of Veterans Affairs to provide mental health care to veterans who have a mental health issue resulting from a health condition incurred or aggravated in the line of duty and who live in a rural area or highly rural area through shared health facilities or by contracting with or providing payments to mental health care providers that are not otherwise affiliated with the Department of Veterans Affairs (VA) if the Secretary makes specified determinations related to the lack of accessibility to or availability of recommended or requested care from the VA.

Requires the Secretary to report on the effectiveness of complementary and alternative medicine used by the VA in treating veterans with mental health conditions resulting from a health condition that was incurred or aggravated in the line of duty.

Authorizes the Secretary to: (1) award grants of up to $100,000 to state veterans agencies, veterans service organizations, and/or tribal organizations to provide transportation to and from medical centers to veterans in rural and highly rural areas who would otherwise be eligible for reimbursement for or payment of travel expenses by the VA; and (2) carry out a pilot program to assess the feasibility and advisability of providing a housing allowance to health care providers of the VA who accept assignment at rural or highly rural community-based outpatient clinics.

Directs the Secretary to establish a program to train health care professionals for assignment at community-based outpatient clinics that predominantly serve veterans who live in rural and highly rural areas.

Requires the VA Secretary and the Secretary of Defense (DOD) to jointly establish a program to encourage an individual who serves in the Armed Forces with a military occupational specialty relating to the provision of health care to seek employment with the Veterans Health Administration when the individual is discharged or released from service or is contemplating separating from such service.

Directs the Secretary to: (1) conduct a periodic assessment of community-based outpatient clinics in rural and highly rural areas to determine whether expansion and improvement of such clinics is feasible or advisable, and (2) report on the feasibility and advisability of establishing a Polytrauma Rehabilitation Center or Polytrauma Network Site in each area in which the nearest such center or site is more than 300 miles away.

rural veterans improvement act directs secretary veterans_affairs provide mental health_care veterans mental health issue resulting health condition incurred aggravated line duty live rural area highly rural area shared health facilities contracting providing payments mental health_care providers affiliated department_of_veterans_affairs secretary makes specified determinations related lack accessibility availability recommended requested care requires secretary report effectiveness complementary alternative medicine treating veterans mental health conditions resulting health condition incurred aggravated line duty authorizes secretary award grants state veterans agencies veterans service organizations tribal organizations provide transportation medical centers veterans rural highly rural areas eligible reimbursement payment travel expenses carry pilot program assess feasibility advisability providing housing allowance health_care providers accept assignment rural highly rural community based outpatient clinics directs secretary establish program train health_care professionals assignment community based outpatient clinics predominantly serve veterans live rural highly rural areas requires secretary secretary defense dod jointly establish program encourage individual serves armed_forces military occupational specialty relating provision health_care seek employment veterans_health_administration individual discharged released service separating service directs secretary conduct periodic assessment community based outpatient clinics rural highly rural areas determine expansion improvement clinics feasible advisable report feasibility advisability establishing polytrauma rehabilitation center polytrauma network site area nearest center site miles away


Summary:
SGR Repeal and Medicare Beneficiary Access Act of 2013 - Amends title XVIII (Medicare) of the Social Security Act (SSA) to: (1) end and remove sustainable growth rate (SGR) methodology from the determination of annual conversion factors in the formula for payment for physicians' services; (2) freeze the update to the single conversion factor at 0.5% for 2014 through 2018 and at 0.00% for 2019 through 2023, and (3) establish an update of 1% for health professionals participating in alternative payment models (APMs) and an update of 0.5% for all other health professionals after 2023.

Directs the Medicare Payment Advisory Commission (MEDPAC) to report to Congress on the relationship between: (1) physician and other health professional utilization and expenditures (and their rate of increase) of items and services for which Medicare payment is made, and (2) total utilization and expenditures (and their rate of increase) under Medicare parts A (Hospital Insurance), B (Supplementary Medical Insurance), and D (Voluntary Prescription Drug Benefit Program). Requires a separate report on the 2014-2018 update to physicians' services under Medicare

Revises and consolidates components of the three specified existing performance incentive programs into a merit-based incentive payment (MIP) system the Secretary of Health and Human Services (HHS) is directed to establish, under which MIP-eligible professionals (excluding most APM participants) receive annual payment increases or decreases based on their performance.

Requires specified incentive payments to eligible APM participants.

Directs the Secretary to make available on the Physician Compare website certain information, including information regarding the performance of MIP-eligible professionals.

Requires the Comptroller General (GAO) to evaluate the VBP program.

Requires the Secretary to study the application of federal fraud prevention laws related to APMs.

Directs the Secretary to draft a plan for development of quality measures to assess professionals, including non-patient-facing professionals.

Requires the Secretary to establish new Healthcare Common Procedure Coding System (HCPCS) codes for chronic care management services.

Directs the Secretary to conduct an education and outreach campaign to inform professionals who furnish items and services under Medicare part B and part B enrollees of the benefits of chronic care management services.

Authorizes the Secretary to: (1) collect and use information on the resources directly or indirectly related to physicians' services in the determination of relative values under the fee schedule; and (2) establish or adjust practice expense relative values using cost, charge, or other data from suppliers or service providers.

Revises and expands factors for identification of potentially misvalued codes. Sets an annual target for relative value adjustments for misvalued services. Phases-in significant relative value unit (RVU) reductions.

Directs the Secretary to establish a program to promote the use of appropriate use evidence-based criteria for applicable imaging services furnished in an applicable setting by ordering professionals and furnishing professionals.

Expands the kinds of uses of Medicare data available to qualified entities for quality improvement activities.

Directs the Secretary to provide Medicare data to qualified clinical data registries to facilitate quality improvement or patient safety.

Allows continuing renewals of any two-year period for which a physician or practitioner opts out of the Medicare claims process under a private contract with a beneficiary.

Declares it a national objective to achieve widespread exchange of health information through interoperable certified electronic health records (EHR) technology nationwide by December 31, 2017. Directs the Secretary to establish related metrics.

Requires meaningful EHR professionals and hospitals to demonstrate that they have not knowingly and willfully taken any action to limit or restrict the compatibility or interoperability of the certified EHR technology.

Directs GAO to study specified telehealth and remote patient monitoring services.

Modifies extensions and other requirements pertaining to the work geographic adjustment as well as Medicare payment for therapy services and ambulance services.

Revises requirements for: (1) the Medicare-dependent hospital (MDH) program, (2) the Medicare inpatient hospital payment adjustment for low-volume hospitals, as well as (3) specialized Medicare Advantage (MA) plans for special needs individuals.

Amends SSA title XIX (Medicaid) to extend the qualifying individual (QI) program, the transitional medical assistance (TMA) program, and express lane program eligibility.

Amends SSA title XI with respect to continue funding for pediatric quality measures.

Amends the Public Health Service Act to extend certain special diabetes programs.

Extends the abstinence education grant program, the personal responsibility education program, and family-to-family health information centers.

Extends the health workforce demonstration project for low-income individuals under SSA title XX.

Requires each Medicare administrative contractor to establish an improper payment outreach and education program to give service providers and suppliers information on payment errors with a view to reducing improper Medicare payments.

Revises requirements for a Medicaid fraud control unit's authority to investigate and prosecute complaints of abuse and neglect of patients in home and community-based settings.

Authorizes the HHS Inspector General to receive and retain 3% of all amounts collected pursuant to civil debt collection and administrative enforcement actions related to false claims or frauds involving the Medicare or Medicaid program.

Requires valid prescriber National Provider Identifiers on pharmacy claims against prescription drug plans (PDPs).

Directs the Secretary to establish a Commission on Improving Patient Directed Health Care.

Expands the definition of inpatient hospital services for certain cancer hospitals.

Directs the Secretary to provide for the development of one or more quality measures under Medicare to accurately communicate the existence and provide for the transfer of patient health information and patient care preferences when an individual transitions from a hospital to return home or move to other post-acute care settings.

Specifies that the minimum level of supervision with respect to outpatient therapeutic critical access hospital services shall be general supervision.

Requires state licensure of bidding entities under the competitive acquisition program for certain durable medical equipment, prosthetics, orthotics, and supplies (DMEPOS).

Recognizes attending physician assistants as attending physicians to serve hospice patients under Medicare.

Directs the Secretary to conduct remote patient monitoring pilot projects.

Requires the Secretary to establish a Community-Based Institutional Special Needs Plan demonstration project to prevent and delay institutionalization under Medicaid among targeted low-income Medicare beneficiaries.

Directs the Secretary to implement a strategic plan to increase the usefulness of data about Medicaid programs reported by states to the Centers for Medicare and Medicaid Services.

Includes podiatrists as physicians under the Medicaid program.

Modifies Medicare requirements for inclusion of diabetic shoes under medical and other health services.

Directs the Secretary to: (1) publish criteria for a clinic to be certified by a state as a certified community behavioral health clinic, (2) award states planning grants to develop proposals to participate in time-limited related demonstration programs, and (3) select states to participate in such programs.

Requires the Secretary to report annually to Congress on payment adjustments to disproportionate share hospitals (DSHs) in order to provide Congress with information relevant to determining an appropriate level of overall funding for such adjustments during and after a certain period in which aggregate reductions in DSH allotments to states are required.

sgr_repeal medicare beneficiary access act amends title xviii medicare social_security_act ssa end remove sustainable growth rate sgr methodology determination annual conversion factors formula payment physicians services freeze update single conversion factor establish update health professionals participating alternative payment models apms update health professionals directs medicare_payment_advisory_commission medpac report congress relationship physician health professional utilization expenditures rate increase items services medicare payment total utilization expenditures rate increase medicare parts hospital insurance supplementary_medical_insurance voluntary prescription drug benefit program requires separate report update physicians services medicare revises consolidates components specified existing performance incentive programs merit based incentive payment mip system secretary health_and_human_services hhs directed establish mip eligible professionals excluding apm participants receive annual payment increases decreases based performance requires specified incentive payments eligible apm participants directs secretary available physician compare website certain information including information performance mip eligible professionals requires comptroller_general gao evaluate program requires secretary study application federal fraud prevention laws related apms directs secretary draft plan development quality measures assess professionals including non patient facing professionals requires secretary establish new healthcare common procedure coding system hcpcs codes chronic care management services directs secretary conduct education outreach campaign inform professionals furnish items services medicare enrollees benefits chronic care management services authorizes secretary collect use information resources directly indirectly related physicians services determination relative values fee schedule establish adjust practice expense relative values cost charge data suppliers service providers revises expands factors identification potentially misvalued codes sets annual target relative value adjustments misvalued services phases significant relative value unit reductions directs secretary establish program promote use appropriate use evidence based criteria applicable imaging services furnished applicable setting ordering professionals furnishing professionals expands kinds uses medicare data available qualified entities quality improvement activities directs secretary provide medicare data qualified clinical data registries facilitate quality improvement patient safety allows continuing renewals year period physician practitioner medicare claims process private contract beneficiary declares national objective achieve widespread exchange health information interoperable certified electronic health records ehr technology nationwide december directs secretary establish related metrics requires meaningful ehr professionals hospitals demonstrate knowingly willfully taken action limit restrict compatibility interoperability certified ehr technology directs gao study specified telehealth remote patient monitoring services modifies extensions requirements pertaining work geographic adjustment medicare payment therapy services ambulance services revises requirements medicare dependent hospital program medicare inpatient hospital payment adjustment low volume hospitals specialized medicare_advantage plans special needs individuals amends ssa title xix medicaid extend qualifying individual program transitional medical assistance tma program express lane program eligibility amends ssa title respect continue funding pediatric quality measures amends public_health_service_act extend certain special diabetes programs extends abstinence education grant program personal responsibility education program family family health information centers extends health workforce demonstration project low income individuals ssa title requires medicare administrative contractor establish improper payment outreach education program service providers suppliers information payment errors view reducing improper medicare payments revises requirements medicaid fraud control unit authority investigate prosecute complaints abuse neglect patients home community based settings authorizes hhs_inspector general receive retain amounts collected pursuant civil debt collection administrative enforcement actions related false claims involving medicare medicaid program requires valid prescriber national provider identifiers pharmacy claims prescription drug plans pdps directs secretary establish commission improving patient directed health_care expands definition inpatient hospital services certain cancer hospitals directs secretary provide development quality measures medicare accurately communicate existence provide transfer patient health information patient care preferences individual transitions hospital return home post acute care settings specifies minimum level supervision respect outpatient therapeutic critical access hospital services shall general supervision requires state licensure bidding entities competitive acquisition program certain durable medical equipment prosthetics orthotics supplies dmepos recognizes attending physician assistants attending physicians serve hospice patients medicare directs secretary conduct remote patient monitoring pilot projects requires secretary establish community based institutional special needs plan demonstration project prevent delay institutionalization medicaid targeted low income medicare beneficiaries directs secretary implement strategic plan increase usefulness data medicaid programs reported states centers medicare medicaid_services includes podiatrists physicians medicaid program modifies medicare requirements inclusion diabetic shoes medical health services directs secretary publish criteria clinic certified state certified community behavioral health clinic award states planning grants develop proposals participate time limited related demonstration programs select states participate programs requires secretary report annually congress payment adjustments disproportionate share hospitals order provide congress information relevant determining appropriate level overall funding adjustments certain period aggregate reductions dsh allotments states required