611300Patient Protection and Affordable Care Act — Title III - Improving the Quality and Efficiency of Health Care. Subtitle F - Health Care Quality ImprovementsUnited States Congress
SEC. 3501. HEALTH CARE DELIVERY SYSTEM RESEARCH; QUALITY IMPROVEMENT TECHNICAL ASSISTANCE.edit
Part D of title IX of the Public Health Service Act, as amended by section 3013, is further amended by adding at the end the following:
Subpart II--Health Care Quality Improvement Programsedit
SEC. 933. HEALTH CARE DELIVERY SYSTEM RESEARCH.edit
(a) Purpose- The purposes of this section are to--
(1) enable the Director to identify, develop, evaluate, disseminate, and provide training in innovative methodologies and strategies for quality improvement practices in the delivery of health care services that represent best practices (referred to as `best practices') in health care quality, safety, and value; and
(2) ensure that the Director is accountable for implementing a model to pursue such research in a collaborative manner with other related Federal agencies.
(b) General Functions of the Center- The Center for Quality Improvement and Patient Safety of the Agency for Healthcare Research and Quality (referred to in this section as the `Center'), or any other relevant agency or department designated by the Director, shall--
(1) carry out its functions using research from a variety of disciplines, which may include epidemiology, health services, sociology, psychology, human factors engineering, biostatistics, health economics, clinical research, and health informatics;
(2) conduct or support activities consistent with the purposes described in subsection (a), and for--
(A) best practices for quality improvement practices in the delivery of health care services; and
(B) that include changes in processes of care and the redesign of systems used by providers that will reliably result in intended health outcomes, improve patient safety, and reduce medical errors (such as skill development for health care providers in team-based health care delivery and rapid cycle process improvement) and facilitate adoption of improved workflow;
(3) identify health care providers, including health care systems, single institutions, and individual providers, that--
(A) deliver consistently high-quality, efficient health care services (as determined by the Secretary); and
(B) employ best practices that are adaptable and scalable to diverse health care settings or effective in improving care across diverse settings;
(4) assess research, evidence, and knowledge about what strategies and methodologies are most effective in improving health care delivery;
(5) find ways to translate such information rapidly and effectively into practice, and document the sustainability of those improvements;
(6) create strategies for quality improvement through the development of tools, methodologies, and interventions that can successfully reduce variations in the delivery of health care;
(7) identify, measure, and improve organizational, human, or other causative factors, including those related to the culture and system design of a health care organization, that contribute to the success and sustainability of specific quality improvement and patient safety strategies;
(8) provide for the development of best practices in the delivery of health care services that--
(A) have a high likelihood of success, based on structured review of empirical evidence;
(B) are specified with sufficient detail of the individual processes, steps, training, skills, and knowledge required for implementation and incorporation into workflow of health care practitioners in a variety of settings;
(C) are designed to be readily adapted by health care providers in a variety of settings; and
(D) where applicable, assist health care providers in working with other health care providers across the continuum of care and in engaging patients and their families in improving the care and patient health outcomes;
(9) provide for the funding of the activities of organizations with recognized expertise and excellence in improving the delivery of health care services, including children's health care, by involving multiple disciplines, managers of health care entities, broad development and training, patients, caregivers and families, and frontline health care workers, including activities for the examination of strategies to share best quality improvement practices and to promote excellence in the delivery of health care services; and
(10) build capacity at the State and community level to lead quality and safety efforts through education, training, and mentoring programs to carry out the activities under paragraphs (1) through (9).
(c) Research Functions of Center-
(1) IN GENERAL- The Center shall support, such as through a contract or other mechanism, research on health care delivery system improvement and the development of tools to facilitate adoption of best practices that improve the quality, safety, and efficiency of health care delivery services. Such support may include establishing a Quality Improvement Network Research Program for the purpose of testing, scaling, and disseminating of interventions to improve quality and efficiency in health care. Recipients of funding under the Program may include national, State, multi-State, or multi-site quality improvement networks.
(2) RESEARCH REQUIREMENTS- The research conducted pursuant to paragraph (1) shall--
(A) address the priorities identified by the Secretary in the national strategic plan established under section 399HH;
(B) identify areas in which evidence is insufficient to identify strategies and methodologies, taking into consideration areas of insufficient evidence identified by the entity with a contract under section 1890(a) of the Social Security Act in the report required under section 399JJ;
(C) address concerns identified by health care institutions and providers and communicated through the Center pursuant to subsection (d);
(D) reduce preventable morbidity, mortality, and associated costs of morbidity and mortality by building capacity for patient safety research;
(E) support the discovery of processes for the reliable, safe, efficient, and responsive delivery of health care, taking into account discoveries from clinical research and comparative effectiveness research;
(F) allow communication of research findings and translate evidence into practice recommendations that are adaptable to a variety of settings, and which, as soon as practicable after the establishment of the Center, shall include--
(i) the implementation of a national application of Intensive Care Unit improvement projects relating to the adult (including geriatric), pediatric, and neonatal patient populations;
(ii) practical methods for addressing health care associated infections, including Methicillin-Resistant Staphylococcus Aureus and Vancomycin-Resistant Entercoccus infections and other emerging infections; and
(iii) practical methods for reducing preventable hospital admissions and readmissions;
(G) expand demonstration projects for improving the quality of children's health care and the use of health information technology, such as through Pediatric Quality Improvement Collaboratives and Learning Networks, consistent with provisions of section 1139A of the Social Security Act for assessing and improving quality, where applicable;
(H) identify and mitigate hazards by--
(i) analyzing events reported to patient safety reporting systems and patient safety organizations; and
(ii) using the results of such analyses to develop scientific methods of response to such events;
(I) include the conduct of systematic reviews of existing practices that improve the quality, safety, and efficiency of health care delivery, as well as new research on improving such practices; and
(J) include the examination of how to measure and evaluate the progress of quality and patient safety activities.
(d) Dissemination of Research Findings-
(1) PUBLIC AVAILABILITY- The Director shall make the research findings of the Center available to the public through multiple media and appropriate formats to reflect the varying needs of health care providers and consumers and diverse levels of health literacy.
(2) LINKAGE TO HEALTH INFORMATION TECHNOLOGY- The Secretary shall ensure that research findings and results generated by the Center are shared with the Office of the National Coordinator of Health Information Technology and used to inform the activities of the health information technology extension program under section 3012, as well as any relevant standards, certification criteria, or implementation specifications.
(e) Prioritization- The Director shall identify and regularly update a list of processes or systems on which to focus research and dissemination activities of the Center, taking into account--
(1) the cost to Federal health programs;
(2) consumer assessment of health care experience;
(3) provider assessment of such processes or systems and opportunities to minimize distress and injury to the health care workforce;
(4) the potential impact of such processes or systems on health status and function of patients, including vulnerable populations including children;
(5) the areas of insufficient evidence identified under subsection (c)(2)(B); and
(6) the evolution of meaningful use of health information technology, as defined in section 3000.
(f) Coordination- The Center shall coordinate its activities with activities conducted by the Center for Medicare and Medicaid Innovation established under section 1115A of the Social Security Act.
(g) Funding- There is authorized to be appropriated to carry out this section $20,000,000 for fiscal years 2010 through 2014.
SEC. 934. QUALITY IMPROVEMENT TECHNICAL ASSISTANCE AND IMPLEMENTATION.edit
(a) In General- The Director, through the Center for Quality Improvement and Patient Safety of the Agency for Healthcare Research and Quality (referred to in this section as the `Center'), shall award--
(1) technical assistance grants or contracts to eligible entities to provide technical support to institutions that deliver health care and health care providers (including rural and urban providers of services and suppliers with limited infrastructure and financial resources to implement and support quality improvement activities, providers of services and suppliers with poor performance scores, and providers of services and suppliers for which there are disparities in care among subgroups of patients) so that such institutions and providers understand, adapt, and implement the models and practices identified in the research conducted by the Center, including the Quality Improvement Networks Research Program; and
(2) implementation grants or contracts to eligible entities to implement the models and practices described under paragraph (1).
(b) Eligible Entities-
(1) TECHNICAL ASSISTANCE AWARD- To be eligible to receive a technical assistance grant or contract under subsection (a)(1), an entity--
(A) may be a health care provider, health care provider association, professional society, health care worker organization, Indian health organization, quality improvement organization, patient safety organization, local quality improvement collaborative, the Joint Commission, academic health center, university, physician-based research network, primary care extension program established under section 399W, a Federal Indian Health Service program or a health program operated by an Indian tribe (as defined in section 4 of the Indian Health Care Improvement Act), or any other entity identified by the Secretary; and
(B) shall have demonstrated expertise in providing information and technical support and assistance to health care providers regarding quality improvement.
(2) IMPLEMENTATION AWARD- To be eligible to receive an implementation grant or contract under subsection (a)(2), an entity--
(A) may be a hospital or other health care provider or consortium or providers, as determined by the Secretary; and
(B) shall have demonstrated expertise in providing information and technical support and assistance to health care providers regarding quality improvement.
(c) Application-
(1) TECHNICAL ASSISTANCE AWARD- To receive a technical assistance grant or contract under subsection (a)(1), an eligible entity shall submit an application to the Secretary at such time, in such manner, and containing--
(A) a plan for a sustainable business model that may include a system of--
(i) charging fees to institutions and providers that receive technical support from the entity; and
(ii) reducing or eliminating such fees for such institutions and providers that serve low-income populations; and
(B) such other information as the Director may require.
(2) IMPLEMENTATION AWARD- To receive a grant or contract under subsection (a)(2), an eligible entity shall submit an application to the Secretary at such time, in such manner, and containing--
(A) a plan for implementation of a model or practice identified in the research conducted by the Center including--
(i) financial cost, staffing requirements, and timeline for implementation; and
(ii) pre- and projected post-implementation quality measure performance data in targeted improvement areas identified by the Secretary; and
(B) such other information as the Director may require.
(d) Matching Funds- The Director may not award a grant or contract under this section to an entity unless the entity agrees that it will make available (directly or through contributions from other public or private entities) non-Federal contributions toward the activities to be carried out under the grant or contract in an amount equal to $1 for each $5 of Federal funds provided under the grant or contract. Such non-Federal matching funds may be provided directly or through donations from public or private entities and may be in cash or in-kind, fairly evaluated, including plant, equipment, or services.
(e) Evaluation-
(1) IN GENERAL- The Director shall evaluate the performance of each entity that receives a grant or contract under this section. The evaluation of an entity shall include a study of--
(A) the success of such entity in achieving the implementation, by the health care institutions and providers assisted by such entity, of the models and practices identified in the research conducted by the Center under section 933;
(B) the perception of the health care institutions and providers assisted by such entity regarding the value of the entity; and
(C) where practicable, better patient health outcomes and lower cost resulting from the assistance provided by such entity.
(2) EFFECT OF EVALUATION- Based on the outcome of the evaluation of the entity under paragraph (1), the Director shall determine whether to renew a grant or contract with such entity under this section.
(f) Coordination- The entities that receive a grant or contract under this section shall coordinate with health information technology regional extension centers under section 3012(c) and the primary care extension program established under section 399W regarding the dissemination of quality improvement, system delivery reform, and best practices information.'.
SEC. 3502. ESTABLISHING COMMUNITY HEALTH TEAMS TO SUPPORT THE PATIENT-CENTERED MEDICAL HOME.edit
(a) In General- The Secretary of Health and Human Services (referred to in this section as the `Secretary') shall establish a program to provide grants to or enter into contracts with eligible entities to establish community-based interdisciplinary, interprofessional teams (referred to in this section as `health teams') to support primary care practices, including obstetrics and gynecology practices, within the hospital service areas served by the eligible entities. Grants or contracts shall be used to--
(1) establish health teams to provide support services to primary care providers; and
(2) provide capitated payments to primary care providers as determined by the Secretary.
(b) Eligible Entities- To be eligible to receive a grant or contract under subsection (a), an entity shall--
(1)(A) be a State or State-designated entity; or
(B) be an Indian tribe or tribal organization, as defined in section 4 of the Indian Health Care Improvement Act;
(2) submit a plan for achieving long-term financial sustainability within 3 years;
(3) submit a plan for incorporating prevention initiatives and patient education and care management resources into the delivery of health care that is integrated with community-based prevention and treatment resources, where available;
(4) ensure that the health team established by the entity includes an interdisciplinary, interprofessional team of health care providers, as determined by the Secretary; such team may include medical specialists, nurses, pharmacists, nutritionists, dieticians, social workers, behavioral and mental health providers (including substance use disorder prevention and treatment providers), doctors of chiropractic, licensed complementary and alternative medicine practitioners, and physicians' assistants;
(5) agree to provide services to eligible individuals with chronic conditions, as described in section 1945 of the Social Security Act (as added by section 2703), in accordance with the payment methodology established under subsection (c) of such section; and
(6) submit to the Secretary an application at such time, in such manner, and containing such information as the Secretary may require.
(c) Requirements for Health Teams- A health team established pursuant to a grant or contract under subsection (a) shall--
(1) establish contractual agreements with primary care providers to provide support services;
(2) support patient-centered medical homes, defined as a mode of care that includes--
(A) personal physicians;
(B) whole person orientation;
(C) coordinated and integrated care;
(D) safe and high-quality care through evidence-informed medicine, appropriate use of health information technology, and continuous quality improvements;
(E) expanded access to care; and
(F) payment that recognizes added value from additional components of patient-centered care;
(3) collaborate with local primary care providers and existing State and community based resources to coordinate disease prevention, chronic disease management, transitioning between health care providers and settings and case management for patients, including children, with priority given to those amenable to prevention and with chronic diseases or conditions identified by the Secretary;
(4) in collaboration with local health care providers, develop and implement interdisciplinary, interprofessional care plans that integrate clinical and community preventive and health promotion services for patients, including children, with a priority given to those amenable to prevention and with chronic diseases or conditions identified by the Secretary;
(5) incorporate health care providers, patients, caregivers, and authorized representatives in program design and oversight;
(6) provide support necessary for local primary care providers to--
(A) coordinate and provide access to high-quality health care services;
(B) coordinate and provide access to preventive and health promotion services;
(C) provide access to appropriate specialty care and inpatient services;
(D) provide quality-driven, cost-effective, culturally appropriate, and patient- and family-centered health care;
(E) provide access to pharmacist-delivered medication management services, including medication reconciliation;
(F) provide coordination of the appropriate use of complementary and alternative (CAM) services to those who request such services;
(G) promote effective strategies for treatment planning, monitoring health outcomes and resource use, sharing information, treatment decision support, and organizing care to avoid duplication of service and other medical management approaches intended to improve quality and value of health care services;
(H) provide local access to the continuum of health care services in the most appropriate setting, including access to individuals that implement the care plans of patients and coordinate care, such as integrative health care practitioners;
(I) collect and report data that permits evaluation of the success of the collaborative effort on patient outcomes, including collection of data on patient experience of care, and identification of areas for improvement; and
(J) establish a coordinated system of early identification and referral for children at risk for developmental or behavioral problems such as through the use of infolines, health information technology, or other means as determined by the Secretary;
(7) provide 24-hour care management and support during transitions in care settings including--
(A) a transitional care program that provides onsite visits from the care coordinator, assists with the development of discharge plans and medication reconciliation upon admission to and discharge from the hospitals, nursing home, or other institution setting;
(B) discharge planning and counseling support to providers, patients, caregivers, and authorized representatives;
(C) assuring that post-discharge care plans include medication management, as appropriate;
(D) referrals for mental and behavioral health services, which may include the use of infolines; and
(E) transitional health care needs from adolescence to adulthood;
(8) serve as a liaison to community prevention and treatment programs;
(9) demonstrate a capacity to implement and maintain health information technology that meets the requirements of certified EHR technology (as defined in section 3000 of the Public Health Service Act (42 U.S.C. 300jj)) to facilitate coordination among members of the applicable care team and affiliated primary care practices; and
(10) where applicable, report to the Secretary information on quality measures used under section 399JJ of the Public Health Service Act.
(d) Requirement for Primary Care Providers- A provider who contracts with a care team shall--
(1) provide a care plan to the care team for each patient participant;
(2) provide access to participant health records; and
(3) meet regularly with the care team to ensure integration of care.
(e) Reporting to Secretary- An entity that receives a grant or contract under subsection (a) shall submit to the Secretary a report that describes and evaluates, as requested by the Secretary, the activities carried out by the entity under subsection (c).
(f) Definition of Primary Care- In this section, the term `primary care' means the provision of integrated, accessible health care services by clinicians who are accountable for addressing a large majority of personal health care needs, developing a sustained partnership with patients, and practicing in the context of family and community.
SEC. 3503. MEDICATION MANAGEMENT SERVICES IN TREATMENT OF CHRONIC DISEASE.edit
Title IX of the Public Health Service Act (42 U.S.C. 299 et seq.), as amended by section 3501, is further amended by inserting after section 934 the following:
SEC. 935. GRANTS OR CONTRACTS TO IMPLEMENT MEDICATION MANAGEMENT SERVICES IN TREATMENT OF CHRONIC DISEASES.edit
(a) In General- The Secretary, acting through the Patient Safety Research Center established in section 933 (referred to in this section as the `Center'), shall establish a program to provide grants or contracts to eligible entities to implement medication management (referred to in this section as `MTM') services provided by licensed pharmacists, as a collaborative, multidisciplinary, inter-professional approach to the treatment of chronic diseases for targeted individuals, to improve the quality of care and reduce overall cost in the treatment of such diseases. The Secretary shall commence the program under this section not later than May 1, 2010.
(b) Eligible Entities- To be eligible to receive a grant or contract under subsection (a), an entity shall--
(1) provide a setting appropriate for MTM services, as recommended by the experts described in subsection (e);
(2) submit to the Secretary a plan for achieving long-term financial sustainability;
(3) where applicable, submit a plan for coordinating MTM services through local community health teams established in section 3502 of the Patient Protection and Affordable Care Act or in collaboration with primary care extension programs established in section 399W;
(4) submit a plan for meeting the requirements under subsection (c); and
(5) submit to the Secretary such other information as the Secretary may require.
(c) MTM Services to Targeted Individuals- The MTM services provided with the assistance of a grant or contract awarded under subsection (a) shall, as allowed by State law including applicable collaborative pharmacy practice agreements, include--
(1) performing or obtaining necessary assessments of the health and functional status of each patient receiving such MTM services;
(2) formulating a medication treatment plan according to therapeutic goals agreed upon by the prescriber and the patient or caregiver or authorized representative of the patient;
(3) selecting, initiating, modifying, recommending changes to, or administering medication therapy;
(4) monitoring, which may include access to, ordering, or performing laboratory assessments, and evaluating the response of the patient to therapy, including safety and effectiveness;
(5) performing an initial comprehensive medication review to identify, resolve, and prevent medication-related problems, including adverse drug events, quarterly targeted medication reviews for ongoing monitoring, and additional followup interventions on a schedule developed collaboratively with the prescriber;
(6) documenting the care delivered and communicating essential information about such care, including a summary of the medication review, and the recommendations of the pharmacist to other appropriate health care providers of the patient in a timely fashion;
(7) providing education and training designed to enhance the understanding and appropriate use of the medications by the patient, caregiver, and other authorized representative;
(8) providing information, support services, and resources and strategies designed to enhance patient adherence with therapeutic regimens;
(9) coordinating and integrating MTM services within the broader health care management services provided to the patient; and
(10) such other patient care services allowed under pharmacist scopes of practice in use in other Federal programs that have implemented MTM services.
(d) Targeted Individuals- MTM services provided by licensed pharmacists under a grant or contract awarded under subsection (a) shall be offered to targeted individuals who--
(1) take 4 or more prescribed medications (including over-the-counter medications and dietary supplements);
(2) take any `high risk' medications;
(3) have 2 or more chronic diseases, as identified by the Secretary; or
(4) have undergone a transition of care, or other factors, as determined by the Secretary, that are likely to create a high risk of medication-related problems.
(e) Consultation With Experts- In designing and implementing MTM services provided under grants or contracts awarded under subsection (a), the Secretary shall consult with Federal, State, private, public-private, and academic entities, pharmacy and pharmacist organizations, health care organizations, consumer advocates, chronic disease groups, and other stakeholders involved with the research, dissemination, and implementation of pharmacist-delivered MTM services, as the Secretary determines appropriate. The Secretary, in collaboration with this group, shall determine whether it is possible to incorporate rapid cycle process improvement concepts in use in other Federal programs that have implemented MTM services.
(f) Reporting to the Secretary- An entity that receives a grant or contract under subsection (a) shall submit to the Secretary a report that describes and evaluates, as requested by the Secretary, the activities carried out under subsection (c), including quality measures endorsed by the entity with a contract under section 1890 of the Social Security Act, as determined by the Secretary.
(g) Evaluation and Report- The Secretary shall submit to the relevant committees of Congress a report which shall--
(1) assess the clinical effectiveness of pharmacist-provided services under the MTM services program, as compared to usual care, including an evaluation of whether enrollees maintained better health with fewer hospitalizations and emergency room visits than similar patients not enrolled in the program;
(2) assess changes in overall health care resource use by targeted individuals;
(3) assess patient and prescriber satisfaction with MTM services;
(4) assess the impact of patient-cost sharing requirements on medication adherence and recommendations for modifications;
(5) identify and evaluate other factors that may impact clinical and economic outcomes, including demographic characteristics, clinical characteristics, and health services use of the patient, as well as characteristics of the regimen, pharmacy benefit, and MTM services provided; and
(6) evaluate the extent to which participating pharmacists who maintain a dispensing role have a conflict of interest in the provision of MTM services, and if such conflict is found, provide recommendations on how such a conflict might be appropriately addressed.
(h) Grants or Contracts To Fund Development of Performance Measures- The Secretary may, through the quality measure development program under section 931 of the Public Health Service Act, award grants or contracts to eligible entities for the purpose of funding the development of performance measures that assess the use and effectiveness of medication therapy management services.'.
SEC. 3504. DESIGN AND IMPLEMENTATION OF REGIONALIZED SYSTEMS FOR EMERGENCY CARE.edit
(a) In General- Title XII of the Public Health Service Act (42 U.S.C. 300d et seq.) is amended--
(1) in section 1203--
(A) in the section heading, by inserting `for trauma systems' after `grants'; and
(B) in subsection (a), by striking `Administrator of the Health Resources and Services Administration' and inserting `Assistant Secretary for Preparedness and Response';
(2) by inserting after section 1203 the following:
SEC. 1204. COMPETITIVE GRANTS FOR REGIONALIZED SYSTEMS FOR EMERGENCY CARE RESPONSE.edit
(a) In General- The Secretary, acting through the Assistant Secretary for Preparedness and Response, shall award not fewer than 4 multiyear contracts or competitive grants to eligible entities to support pilot projects that design, implement, and evaluate innovative models of regionalized, comprehensive, and accountable emergency care and trauma systems.
(b) Eligible Entity; Region- In this section:
(1) ELIGIBLE ENTITY- The term `eligible entity' means--
(A) a State or a partnership of 1 or more States and 1 or more local governments; or
(B) an Indian tribe (as defined in section 4 of the Indian Health Care Improvement Act) or a partnership of 1 or more Indian tribes.
(2) REGION- The term `region' means an area within a State, an area that lies within multiple States, or a similar area (such as a multicounty area), as determined by the Secretary.
(3) EMERGENCY SERVICES- The term `emergency services' includes acute, prehospital, and trauma care.
(c) Pilot Projects- The Secretary shall award a contract or grant under subsection (a) to an eligible entity that proposes a pilot project to design, implement, and evaluate an emergency medical and trauma system that--
(1) coordinates with public health and safety services, emergency medical services, medical facilities, trauma centers, and other entities in a region to develop an approach to emergency medical and trauma system access throughout the region, including 9-1-1 Public Safety Answering Points and emergency medical dispatch;
(2) includes a mechanism, such as a regional medical direction or transport communications system, that operates throughout the region to ensure that the patient is taken to the medically appropriate facility (whether an initial facility or a higher-level facility) in a timely fashion;
(3) allows for the tracking of prehospital and hospital resources, including inpatient bed capacity, emergency department capacity, trauma center capacity, on-call specialist coverage, ambulance diversion status, and the coordination of such tracking with regional communications and hospital destination decisions; and
(4) includes a consistent region-wide prehospital, hospital, and interfacility data management system that--
(A) submits data to the National EMS Information System, the National Trauma Data Bank, and others;
(B) reports data to appropriate Federal and State databanks and registries; and
(C) contains information sufficient to evaluate key elements of prehospital care, hospital destination decisions, including initial hospital and interfacility decisions, and relevant health outcomes of hospital care.
(d) Application-
(1) IN GENERAL- An eligible entity that seeks a contract or grant described in subsection (a) shall submit to the Secretary an application at such time and in such manner as the Secretary may require.
(2) APPLICATION INFORMATION- Each application shall include--
(A) an assurance from the eligible entity that the proposed system--
(i) has been coordinated with the applicable State Office of Emergency Medical Services (or equivalent State office);
(ii) includes consistent indirect and direct medical oversight of prehospital, hospital, and interfacility transport throughout the region;
(iii) coordinates prehospital treatment and triage, hospital destination, and interfacility transport throughout the region;
(iv) includes a categorization or designation system for special medical facilities throughout the region that is integrated with transport and destination protocols;
(v) includes a regional medical direction, patient tracking, and resource allocation system that supports day-to-day emergency care and surge capacity and is integrated with other components of the national and State emergency preparedness system; and
(vi) addresses pediatric concerns related to integration, planning, preparedness, and coordination of emergency medical services for infants, children and adolescents; and
(B) such other information as the Secretary may require.
(e) Requirement of Matching Funds-
(1) IN GENERAL- The Secretary may not make a grant under this section unless the State (or consortia of States) involved agrees, with respect to the costs to be incurred by the State (or consortia) in carrying out the purpose for which such grant was made, to make available non-Federal contributions (in cash or in kind under paragraph (2)) toward such costs in an amount equal to not less than $1 for each $3 of Federal funds provided in the grant. Such contributions may be made directly or through donations from public or private entities.
(2) NON-FEDERAL CONTRIBUTIONS- Non-Federal contributions required in paragraph (1) may be in cash or in kind, fairly evaluated, including equipment or services (and excluding indirect or overhead costs). Amounts provided by the Federal Government, or services assisted or subsidized to any significant extent by the Federal Government, may not be included in determining the amount of such non-Federal contributions.
(f) Priority- The Secretary shall give priority for the award of the contracts or grants described in subsection (a) to any eligible entity that serves a population in a medically underserved area (as defined in section 330(b)(3)).
(g) Report- Not later than 90 days after the completion of a pilot project under subsection (a), the recipient of such contract or grant described in shall submit to the Secretary a report containing the results of an evaluation of the program, including an identification of--
(1) the impact of the regional, accountable emergency care and trauma system on patient health outcomes for various critical care categories, such as trauma, stroke, cardiac emergencies, neurological emergencies, and pediatric emergencies;
(2) the system characteristics that contribute to the effectiveness and efficiency of the program (or lack thereof);
(3) methods of assuring the long-term financial sustainability of the emergency care and trauma system;
(4) the State and local legislation necessary to implement and to maintain the system;
(5) the barriers to developing regionalized, accountable emergency care and trauma systems, as well as the methods to overcome such barriers; and
(6) recommendations on the utilization of available funding for future regionalization efforts.
(h) Dissemination of Findings- The Secretary shall, as appropriate, disseminate to the public and to the appropriate Committees of the Congress, the information contained in a report made under subsection (g).'; and
(3) in section 1232--
(A) in subsection (a), by striking `appropriated' and all that follows through the period at the end and inserting `appropriated $24,000,000 for each of fiscal years 2010 through 2014.'; and
(B) by inserting after subsection (c) the following:
(d) Authority- For the purpose of carrying out parts A through C, beginning on the date of enactment of the Patient Protection and Affordable Care Act, the Secretary shall transfer authority in administering grants and related authorities under such parts from the Administrator of the Health Resources and Services Administration to the Assistant Secretary for Preparedness and Response.'.
(b) Support for Emergency Medicine Research- Part H of title IV of the Public Health Service Act (42 U.S.C. 289 et seq.) is amended by inserting after the section 498C the following:
SEC. 498D. SUPPORT FOR EMERGENCY MEDICINE RESEARCH.edit
(a) Emergency Medical Research- The Secretary shall support Federal programs administered by the National Institutes of Health, the Agency for Healthcare Research and Quality, the Health Resources and Services Administration, the Centers for Disease Control and Prevention, and other agencies involved in improving the emergency care system to expand and accelerate research in emergency medical care systems and emergency medicine, including--
(1) the basic science of emergency medicine;
(2) the model of service delivery and the components of such models that contribute to enhanced patient health outcomes;
(3) the translation of basic scientific research into improved practice; and
(4) the development of timely and efficient delivery of health services.
(b) Pediatric Emergency Medical Research- The Secretary shall support Federal programs administered by the National Institutes of Health, the Agency for Healthcare Research and Quality, the Health Resources and Services Administration, the Centers for Disease Control and Prevention, and other agencies to coordinate and expand research in pediatric emergency medical care systems and pediatric emergency medicine, including--
(1) an examination of the gaps and opportunities in pediatric emergency care research and a strategy for the optimal organization and funding of such research;
(2) the role of pediatric emergency services as an integrated component of the overall health system;
(3) system-wide pediatric emergency care planning, preparedness, coordination, and funding;
(4) pediatric training in professional education; and
(5) research in pediatric emergency care, specifically on the efficacy, safety, and health outcomes of medications used for infants, children, and adolescents in emergency care settings in order to improve patient safety.
(c) Impact Research- The Secretary shall support research to determine the estimated economic impact of, and savings that result from, the implementation of coordinated emergency care systems.
(d) Authorization of Appropriations- There are authorized to be appropriated to carry out this section such sums as may be necessary for each of fiscal years 2010 through 2014.'.
SEC. 3505. TRAUMA CARE CENTERS AND SERVICE AVAILABILITY.edit
(a) Trauma Care Centers-
(1) GRANTS FOR TRAUMA CARE CENTERS- Section 1241 of the Public Health Service Act (42 U.S.C. 300d-41) is amended by striking subsections (a) and (b) and inserting the following:
(a) In General- The Secretary shall establish 3 programs to award grants to qualified public, nonprofit Indian Health Service, Indian tribal, and urban Indian trauma centers--
(1) to assist in defraying substantial uncompensated care costs;
(2) to further the core missions of such trauma centers, including by addressing costs associated with patient stabilization and transfer, trauma education and outreach, coordination with local and regional trauma systems, essential personnel and other fixed costs, and expenses associated with employee and non-employee physician services; and
(3) to provide emergency relief to ensure the continued and future availability of trauma services.
(b) Minimum Qualifications of Trauma Centers-
(1) PARTICIPATION IN TRAUMA CARE SYSTEM OPERATING UNDER CERTAIN PROFESSIONAL GUIDELINES- Except as provided in paragraph (2), the Secretary may not award a grant to a trauma center under subsection (a) unless the trauma center is a participant in a trauma system that substantially complies with section 1213.
(2) EXEMPTION- Paragraph (1) shall not apply to trauma centers that are located in States with no existing trauma care system.
(3) QUALIFICATION FOR SUBSTANTIAL UNCOMPENSATED CARE COSTS- The Secretary shall award substantial uncompensated care grants under subsection (a)(1) only to trauma centers meeting at least 1 of the criteria in 1 of the following 3 categories:
(A) CATEGORY A- The criteria for category A are as follows:
(i) At least 40 percent of the visits in the emergency department of the hospital in which the trauma center is located were charity or self-pay patients.
(ii) At least 50 percent of the visits in such emergency department were Medicaid (under title XIX of the Social Security Act (42 U.S.C. 1396 et seq.)) and charity and self-pay patients combined.
(B) CATEGORY B- The criteria for category B are as follows:
(i) At least 35 percent of the visits in the emergency department were charity or self-pay patients.
(ii) At least 50 percent of the visits in the emergency department were Medicaid and charity and self-pay patients combined.
(C) CATEGORY C- The criteria for category C are as follows:
(i) At least 20 percent of the visits in the emergency department were charity or self-pay patients.
(ii) At least 30 percent of the visits in the emergency department were Medicaid and charity and self-pay patients combined.
(4) TRAUMA CENTERS IN 1115 WAIVER STATES- Notwithstanding paragraph (3), the Secretary may award a substantial uncompensated care grant to a trauma center under subsection (a)(1) if the trauma center qualifies for funds under a Low Income Pool or Safety Net Care Pool established through a waiver approved under section 1115 of the Social Security Act (42 U.S.C. 1315).
(5) DESIGNATION- The Secretary may not award a grant to a trauma center unless such trauma center is verified by the American College of Surgeons or designated by an equivalent State or local agency.
(c) Additional Requirements- The Secretary may not award a grant to a trauma center under subsection (a)(1) unless such trauma center--
(1) submits to the Secretary a plan satisfactory to the Secretary that demonstrates a continued commitment to serving trauma patients regardless of their ability to pay; and
(2) has policies in place to assist patients who cannot pay for part or all of the care they receive, including a sliding fee scale, and to ensure fair billing and collection practices.'.
(2) CONSIDERATIONS IN MAKING GRANTS- Section 1242 of the Public Health Service Act (42 U.S.C. 300d-42) is amended by striking subsections (a) and (b) and inserting the following:
(a) Substantial Uncompensated Care Awards-
(1) IN GENERAL- The Secretary shall establish an award basis for each eligible trauma center for grants under section 1241(a)(1) according to the percentage described in paragraph (2), subject to the requirements of section 1241(b)(3).
(2) PERCENTAGES- The applicable percentages are as follows:
(A) With respect to a category A trauma center, 100 percent of the uncompensated care costs.
(B) With respect to a category B trauma center, not more than 75 percent of the uncompensated care costs.
(C) With respect to a category C trauma center, not more than 50 percent of the uncompensated care costs.
(b) Core Mission Awards-
(1) IN GENERAL- In awarding grants under section 1241(a)(2), the Secretary shall--
(A) reserve 25 percent of the amount allocated for core mission awards for Level III and Level IV trauma centers; and
(B) reserve 25 percent of the amount allocated for core mission awards for large urban Level I and II trauma centers--
(i) that have at least 1 graduate medical education fellowship in trauma or trauma related specialties for which demand is exceeding supply;
(ii) for which--
(I) annual uncompensated care costs exceed $10,000,000; or
(II) at least 20 percent of emergency department visits are charity or self-pay or Medicaid patients; and
(iii) that are not eligible for substantial uncompensated care awards under section 1241(a)(1).
(c) Emergency Awards- In awarding grants under section 1241(a)(3), the Secretary shall--
(1) give preference to any application submitted by a trauma center that provides trauma care in a geographic area in which the availability of trauma care has significantly decreased or will significantly decrease if the center is forced to close or downgrade service or growth in demand for trauma services exceeds capacity; and
(2) reallocate any emergency awards funds not obligated due to insufficient, or a lack of qualified, applications to the significant uncompensated care award program.'.
(3) CERTAIN AGREEMENTS- Section 1243 of the Public Health Service Act (42 U.S.C. 300d-43) is amended by striking subsections (a), (b), and (c) and inserting the following:
(a) Maintenance of Financial Support- The Secretary may require a trauma center receiving a grant under section 1241(a) to maintain access to trauma services at comparable levels to the prior year during the grant period.
(b) Trauma Care Registry- The Secretary may require the trauma center receiving a grant under section 1241(a) to provide data to a national and centralized registry of trauma cases, in accordance with guidelines developed by the American College of Surgeons, and as the Secretary may otherwise require.'.
(4) GENERAL PROVISIONS- Section 1244 of the Public Health Service Act (42 U.S.C. 300d-44) is amended by striking subsections (a), (b), and (c) and inserting the following:
(a) Application- The Secretary may not award a grant to a trauma center under section 1241(a) unless such center submits an application for the grant to the Secretary and the application is in such form, is made in such manner, and contains such agreements, assurances, and information as the Secretary determines to be necessary to carry out this part.
(b) Limitation on Duration of Support- The period during which a trauma center receives payments under a grant under section 1241(a)(3) shall be for 3 fiscal years, except that the Secretary may waive such requirement for a center and authorize such center to receive such payments for 1 additional fiscal year.
(c) Limitation on Amount of Grant- Notwithstanding section 1242(a), a grant under section 1241 may not be made in an amount exceeding $2,000,000 for each fiscal year.
(d) Eligibility- Except as provided in section 1242(b)(1)(B)(iii), acquisition of, or eligibility for, a grant under section 1241(a) shall not preclude a trauma center from being eligible for other grants described in such section.
(e) Funding Distribution- Of the total amount appropriated for a fiscal year under section 1245, 70 percent shall be used for substantial uncompensated care awards under section 1241(a)(1), 20 percent shall be used for core mission awards under section 1241(a)(2), and 10 percent shall be used for emergency awards under section 1241(a)(3).
(f) Minimum Allowance- Notwithstanding subsection (e), if the amount appropriated for a fiscal year under section 1245 is less than $25,000,000, all available funding for such fiscal year shall be used for substantial uncompensated care awards under section 1241(a)(1).
(g) Substantial Uncompensated Care Award Distribution and Proportional Share- Notwithstanding section 1242(a), of the amount appropriated for substantial uncompensated care grants for a fiscal year, the Secretary shall--
(1) make available--
(A) 50 percent of such funds for category A trauma center grantees;
(B) 35 percent of such funds for category B trauma center grantees; and
(C) 15 percent of such funds for category C trauma center grantees; and
(2) provide available funds within each category in a manner proportional to the award basis specified in section 1242(a)(2) to each eligible trauma center.
(h) Report- Beginning 2 years after the date of enactment of the Patient Protection and Affordable Care Act, and every 2 years thereafter, the Secretary shall biennially report to Congress regarding the status of the grants made under section 1241 and on the overall financial stability of trauma centers.'.
(5) AUTHORIZATION OF APPROPRIATIONS- Section 1245 of the Public Health Service Act (42 U.S.C. 300d-45) is amended to read as follows:
For the purpose of carrying out this part, there are authorized to be appropriated $100,000,000 for fiscal year 2009, and such sums as may be necessary for each of fiscal years 2010 through 2015. Such authorization of appropriations is in addition to any other authorization of appropriations or amounts that are available for such purpose.'.
(6) DEFINITION- Part D of title XII of the Public Health Service Act (42 U.S.C. 300d-41 et seq.) is amended by adding at the end the following:
In this part, the term `uncompensated care costs' means unreimbursed costs from serving self-pay, charity, or Medicaid patients, without regard to payment under section 1923 of the Social Security Act, all of which are attributable to emergency care and trauma care, including costs related to subsequent inpatient admissions to the hospital.'.
(b) Trauma Service Availability- Title XII of the Public Health Service Act (42 U.S.C. 300d et seq.) is amended by adding at the end the following:
(a) Establishment- To promote universal access to trauma care services provided by trauma centers and trauma-related physician specialties, the Secretary shall provide funding to States to enable such States to award grants to eligible entities for the purposes described in this section.
(b) Awarding of Grants by States- Each State may award grants to eligible entities within the State for the purposes described in subparagraph (d).
(c) Eligibility-
(1) IN GENERAL- To be eligible to receive a grant under subsection (b) an entity shall--
(A) be--
(i) a public or nonprofit trauma center or consortium thereof that meets that requirements of paragraphs (1), (2), and (5) of section 1241(b);
(ii) a safety net public or nonprofit trauma center that meets the requirements of paragraphs (1) through (5) of section 1241(b); or
(iii) a hospital in an underserved area (as defined by the State) that seeks to establish new trauma services; and
(B) submit to the State an application at such time, in such manner, and containing such information as the State may require.
(2) LIMITATION- A State shall use at least 40 percent of the amount available to the State under this part for a fiscal year to award grants to safety net trauma centers described in paragraph (1)(A)(ii).
(d) Use of Funds- The recipient of a grant under subsection (b) shall carry out 1 or more of the following activities consistent with subsection (b):
(1) Providing trauma centers with funding to support physician compensation in trauma-related physician specialties where shortages exist in the region involved, with priority provided to safety net trauma centers described in subsection (c)(1)(A)(ii).
(2) Providing for individual safety net trauma center fiscal stability and costs related to having service that is available 24 hours a day, 7 days a week, with priority provided to safety net trauma centers described in subsection (c)(1)(A)(ii) located in urban, border, and rural areas.
(3) Reducing trauma center overcrowding at specific trauma centers related to throughput of trauma patients.
(4) Establishing new trauma services in underserved areas as defined by the State.
(5) Enhancing collaboration between trauma centers and other hospitals and emergency medical services personnel related to trauma service availability.
(6) Making capital improvements to enhance access and expedite trauma care, including providing helipads and associated safety infrastructure.
(7) Enhancing trauma surge capacity at specific trauma centers.
(8) Ensuring expedient receipt of trauma patients transported by ground or air to the appropriate trauma center.
(9) Enhancing interstate trauma center collaboration.
(e) Limitation-
(1) IN GENERAL- A State may use not more than 20 percent of the amount available to the State under this part for a fiscal year for administrative costs associated with awarding grants and related costs.
(2) MAINTENANCE OF EFFORT- The Secretary may not provide funding to a State under this part unless the State agrees that such funds will be used to supplement and not supplant State funding otherwise available for the activities and costs described in this part.
(f) Distribution of Funds- The following shall apply with respect to grants provided in this part:
(1) LESS THAN $10,000,000- If the amount of appropriations for this part in a fiscal year is less than $10,000,000, the Secretary shall divide such funding evenly among only those States that have 1 or more trauma centers eligible for funding under section 1241(b)(3)(A).
(2) LESS THAN $20,000,000- If the amount of appropriations in a fiscal year is less than $20,000,000, the Secretary shall divide such funding evenly among only those States that have 1 or more trauma centers eligible for funding under subparagraphs (A) and (B) of section 1241(b)(3).
(3) LESS THAN $30,000,000- If the amount of appropriations for this part in a fiscal year is less than $30,000,000, the Secretary shall divide such funding evenly among only those States that have 1 or more trauma centers eligible for funding under section 1241(b)(3).
(4) $30,000,000 OR MORE- If the amount of appropriations for this part in a fiscal year is $30,000,000 or more, the Secretary shall divide such funding evenly among all States.
For the purpose of carrying out this part, there is authorized to be appropriated $100,000,000 for each of fiscal years 2010 through 2015.'.
SEC. 3506. PROGRAM TO FACILITATE SHARED DECISIONMAKING.edit
Part D of title IX of the Public Health Service Act, as amended by section 3503, is further amended by adding at the end the following:
SEC. 936. PROGRAM TO FACILITATE SHARED DECISIONMAKING.edit
(a) Purpose- The purpose of this section is to facilitate collaborative processes between patients, caregivers or authorized representatives, and clinicians that engages the patient, caregiver or authorized representative in decisionmaking, provides patients, caregivers or authorized representatives with information about trade-offs among treatment options, and facilitates the incorporation of patient preferences and values into the medical plan.
(b) Definitions- In this section:
(1) PATIENT DECISION AID- The term `patient decision aid' means an educational tool that helps patients, caregivers or authorized representatives understand and communicate their beliefs and preferences related to their treatment options, and to decide with their health care provider what treatments are best for them based on their treatment options, scientific evidence, circumstances, beliefs, and preferences.
(2) PREFERENCE SENSITIVE CARE- The term `preference sensitive care' means medical care for which the clinical evidence does not clearly support one treatment option such that the appropriate course of treatment depends on the values of the patient or the preferences of the patient, caregivers or authorized representatives regarding the benefits, harms and scientific evidence for each treatment option, the use of such care should depend on the informed patient choice among clinically appropriate treatment options.
(c) Establishment of Independent Standards for Patient Decision Aids for Preference Sensitive Care-
(1) CONTRACT WITH ENTITY TO ESTABLISH STANDARDS AND CERTIFY PATIENT DECISION AIDS-
(A) IN GENERAL- For purposes of supporting consensus-based standards for patient decision aids for preference sensitive care and a certification process for patient decision aids for use in the Federal health programs and by other interested parties, the Secretary shall have in effect a contract with the entity with a contract under section 1890 of the Social Security Act. Such contract shall provide that the entity perform the duties described in paragraph (2).
(B) TIMING FOR FIRST CONTRACT- As soon as practicable after the date of the enactment of this section, the Secretary shall enter into the first contract under subparagraph (A).
(C) PERIOD OF CONTRACT- A contract under subparagraph (A) shall be for a period of 18 months (except such contract may be renewed after a subsequent bidding process).
(2) DUTIES- The following duties are described in this paragraph:
(A) DEVELOP AND IDENTIFY STANDARDS FOR PATIENT DECISION AIDS- The entity shall synthesize evidence and convene a broad range of experts and key stakeholders to develop and identify consensus-based standards to evaluate patient decision aids for preference sensitive care.
(B) ENDORSE PATIENT DECISION AIDS- The entity shall review patient decision aids and develop a certification process whether patient decision aids meet the standards developed and identified under subparagraph (A). The entity shall give priority to the review and certification of patient decision aids for preference sensitive care.
(d) Program To Develop, Update and Patient Decision Aids To Assist Health Care Providers and Patients-
(1) IN GENERAL- The Secretary, acting through the Director, and in coordination with heads of other relevant agencies, such as the Director of the Centers for Disease Control and Prevention and the Director of the National Institutes of Health, shall establish a program to award grants or contracts--
(A) to develop, update, and produce patient decision aids for preference sensitive care to assist health care providers in educating patients, caregivers, and authorized representatives concerning the relative safety, relative effectiveness (including possible health outcomes and impact on functional status), and relative cost of treatment or, where appropriate, palliative care options;
(B) to test such materials to ensure such materials are balanced and evidence based in aiding health care providers and patients, caregivers, and authorized representatives to make informed decisions about patient care and can be easily incorporated into a broad array of practice settings; and
(C) to educate providers on the use of such materials, including through academic curricula.
(2) REQUIREMENTS FOR PATIENT DECISION AIDS- Patient decision aids developed and produced pursuant to a grant or contract under paragraph (1)--
(A) shall be designed to engage patients, caregivers, and authorized representatives in informed decisionmaking with health care providers;
(B) shall present up-to-date clinical evidence about the risks and benefits of treatment options in a form and manner that is age-appropriate and can be adapted for patients, caregivers, and authorized representatives from a variety of cultural and educational backgrounds to reflect the varying needs of consumers and diverse levels of health literacy;
(C) shall, where appropriate, explain why there is a lack of evidence to support one treatment option over another; and
(D) shall address health care decisions across the age span, including those affecting vulnerable populations including children.
(3) DISTRIBUTION- The Director shall ensure that patient decision aids produced with grants or contracts under this section are available to the public.
(4) NONDUPLICATION OF EFFORTS- The Director shall ensure that the activities under this section of the Agency and other agencies, including the Centers for Disease Control and Prevention and the National Institutes of Health, are free of unnecessary duplication of effort.
(e) Grants To Support Shared Decisionmaking Implementation-
(1) IN GENERAL- The Secretary shall establish a program to provide for the phased-in development, implementation, and evaluation of shared decisionmaking using patient decision aids to meet the objective of improving the understanding of patients of their medical treatment options.
(2) SHARED DECISIONMAKING RESOURCE CENTERS-
(A) IN GENERAL- The Secretary shall provide grants for the establishment and support of Shared Decisionmaking Resource Centers (referred to in this subsection as `Centers') to provide technical assistance to providers and to develop and disseminate best practices and other information to support and accelerate adoption, implementation, and effective use of patient decision aids and shared decisionmaking by providers.
(B) OBJECTIVES- The objective of a Center is to enhance and promote the adoption of patient decision aids and shared decisionmaking through--
(i) providing assistance to eligible providers with the implementation and effective use of, and training on, patient decision aids; and
(ii) the dissemination of best practices and research on the implementation and effective use of patient decision aids.
(3) SHARED DECISIONMAKING PARTICIPATION GRANTS-
(A) IN GENERAL- The Secretary shall provide grants to health care providers for the development and implementation of shared decisionmaking techniques and to assess the use of such techniques.
(B) PREFERENCE- In order to facilitate the use of best practices, the Secretary shall provide a preference in making grants under this subsection to health care providers who participate in training by Shared Decisionmaking Resource Centers or comparable training.
(C) LIMITATION- Funds under this paragraph shall not be used to purchase or implement use of patient decision aids other than those certified under the process identified in subsection (c).
(4) GUIDANCE- The Secretary may issue guidance to eligible grantees under this subsection on the use of patient decision aids.
(f) Funding- For purposes of carrying out this section there are authorized to be appropriated such sums as may be necessary for fiscal year 2010 and each subsequent fiscal year.'.
SEC. 3507. PRESENTATION OF PRESCRIPTION DRUG BENEFIT AND RISK INFORMATION.edit
(a) In General- The Secretary of Health and Human Services (referred to in this section as the `Secretary'), acting through the Commissioner of Food and Drugs, shall determine whether the addition of quantitative summaries of the benefits and risks of prescription drugs in a standardized format (such as a table or drug facts box) to the promotional labeling or print advertising of such drugs would improve health care decisionmaking by clinicians and patients and consumers.
(b) Review and Consultation- In making the determination under subsection (a), the Secretary shall review all available scientific evidence and research on decisionmaking and social and cognitive psychology and consult with drug manufacturers, clinicians, patients and consumers, experts in health literacy, representatives of racial and ethnic minorities, and experts in women's and pediatric health.
(c) Report- Not later than 1 year after the date of enactment of this Act, the Secretary shall submit to Congress a report that provides--
(1) the determination by the Secretary under subsection (a); and
(2) the reasoning and analysis underlying that determination.
(d) Authority- If the Secretary determines under subsection (a) that the addition of quantitative summaries of the benefits and risks of prescription drugs in a standardized format (such as a table or drug facts box) to the promotional labeling or print advertising of such drugs would improve health care decisionmaking by clinicians and patients and consumers, then the Secretary, not later than 3 years after the date of submission of the report under subsection (c), shall promulgate proposed regulations as necessary to implement such format.
(e) Clarification- Nothing in this section shall be construed to restrict the existing authorities of the Secretary with respect to benefit and risk information.
SEC. 3508. DEMONSTRATION PROGRAM TO INTEGRATE QUALITY IMPROVEMENT AND PATIENT SAFETY TRAINING INTO CLINICAL EDUCATION OF HEALTH PROFESSIONALS.edit
(a) In General- The Secretary may award grants to eligible entities or consortia under this section to carry out demonstration projects to develop and implement academic curricula that integrates quality improvement and patient safety in the clinical education of health professionals. Such awards shall be made on a competitive basis and pursuant to peer review.
(b) Eligibility- To be eligible to receive a grant under subsection (a), an entity or consortium shall--
(1) submit to the Secretary an application at such time, in such manner, and containing such information as the Secretary may require;
(2) be or include--
(A) a health professions school;
(B) a school of public health;
(C) a school of social work;
(D) a school of nursing;
(E) a school of pharmacy;
(F) an institution with a graduate medical education program; or
(G) a school of health care administration;
(3) collaborate in the development of curricula described in subsection (a) with an organization that accredits such school or institution;
(4) provide for the collection of data regarding the effectiveness of the demonstration project; and
(5) provide matching funds in accordance with subsection (c).
(c) Matching Funds-
(1) IN GENERAL- The Secretary may award a grant to an entity or consortium under this section only if the entity or consortium agrees to make available non-Federal contributions toward the costs of the program to be funded under the grant in an amount that is not less than $1 for each $5 of Federal funds provided under the grant.
(2) DETERMINATION OF AMOUNT CONTRIBUTED- Non-Federal contributions under paragraph (1) may be in cash or in-kind, fairly evaluated, including equipment or services. Amounts provided by the Federal Government, or services assisted or subsidized to any significant extent by the Federal Government, may not be included in determining the amount of such contributions.
(d) Evaluation- The Secretary shall take such action as may be necessary to evaluate the projects funded under this section and publish, make publicly available, and disseminate the results of such evaluations on as wide a basis as is practicable.
(e) Reports- Not later than 2 years after the date of enactment of this section, and annually thereafter, the Secretary shall submit to the Committee on Health, Education, Labor, and Pensions and the Committee on Finance of the Senate and the Committee on Energy and Commerce and the Committee on Ways and Means of the House of Representatives a report that--
(1) describes the specific projects supported under this section; and
(2) contains recommendations for Congress based on the evaluation conducted under subsection (d).
(a) Health and Human Services Office on Women's Health-
(1) ESTABLISHMENT- Part A of title II of the Public Health Service Act (42 U.S.C. 202 et seq.) is amended by adding at the end the following:
SEC. 229. HEALTH AND HUMAN SERVICES OFFICE ON WOMEN'S HEALTH.edit
(a) Establishment of Office- There is established within the Office of the Secretary, an Office on Women's Health (referred to in this section as the `Office'). The Office shall be headed by a Deputy Assistant Secretary for Women's Health who may report to the Secretary.
(b) Duties- The Secretary, acting through the Office, with respect to the health concerns of women, shall--
(1) establish short-range and long-range goals and objectives within the Department of Health and Human Services and, as relevant and appropriate, coordinate with other appropriate offices on activities within the Department that relate to disease prevention, health promotion, service delivery, research, and public and health care professional education, for issues of particular concern to women throughout their lifespan;
(2) provide expert advice and consultation to the Secretary concerning scientific, legal, ethical, and policy issues relating to women's health;
(3) monitor the Department of Health and Human Services' offices, agencies, and regional activities regarding women's health and identify needs regarding the coordination of activities, including intramural and extramural multidisciplinary activities;
(4) establish a Department of Health and Human Services Coordinating Committee on Women's Health, which shall be chaired by the Deputy Assistant Secretary for Women's Health and composed of senior level representatives from each of the agencies and offices of the Department of Health and Human Services;
(5) establish a National Women's Health Information Center to--
(A) facilitate the exchange of information regarding matters relating to health information, health promotion, preventive health services, research advances, and education in the appropriate use of health care;
(B) facilitate access to such information;
(C) assist in the analysis of issues and problems relating to the matters described in this paragraph; and
(D) provide technical assistance with respect to the exchange of information (including facilitating the development of materials for such technical assistance);
(6) coordinate efforts to promote women's health programs and policies with the private sector; and
(7) through publications and any other means appropriate, provide for the exchange of information between the Office and recipients of grants, contracts, and agreements under subsection (c), and between the Office and health professionals and the general public.
(c) Grants and Contracts Regarding Duties-
(1) AUTHORITY- In carrying out subsection (b), the Secretary may make grants to, and enter into cooperative agreements, contracts, and interagency agreements with, public and private entities, agencies, and organizations.
(2) EVALUATION AND DISSEMINATION- The Secretary shall directly or through contracts with public and private entities, agencies, and organizations, provide for evaluations of projects carried out with financial assistance provided under paragraph (1) and for the dissemination of information developed as a result of such projects.
(d) Reports- Not later than 1 year after the date of enactment of this section, and every second year thereafter, the Secretary shall prepare and submit to the appropriate committees of Congress a report describing the activities carried out under this section during the period for which the report is being prepared.
(e) Authorization of Appropriations- For the purpose of carrying out this section, there are authorized to be appropriated such sums as may be necessary for each of the fiscal years 2010 through 2014.'.
(2) TRANSFER OF FUNCTIONS- There are transferred to the Office on Women's Health (established under section 229 of the Public Health Service Act, as added by this section), all functions exercised by the Office on Women's Health of the Public Health Service prior to the date of enactment of this section, including all personnel and compensation authority, all delegation and assignment authority, and all remaining appropriations. All orders, determinations, rules, regulations, permits, agreements, grants, contracts, certificates, licenses, registrations, privileges, and other administrative actions that--
(A) have been issued, made, granted, or allowed to become effective by the President, any Federal agency or official thereof, or by a court of competent jurisdiction, in the performance of functions transferred under this paragraph; and
(B) are in effect at the time this section takes effect, or were final before the date of enactment of this section and are to become effective on or after such date,
shall continue in effect according to their terms until modified, terminated, superseded, set aside, or revoked in accordance with law by the President, the Secretary, or other authorized official, a court of competent jurisdiction, or by operation of law.
(b) Centers for Disease Control and Prevention Office of Women's Health- Part A of title III of the Public Health Service Act (42 U.S.C. 241 et seq.) is amended by adding at the end the following:
SEC. 310A. CENTERS FOR DISEASE CONTROL AND PREVENTION OFFICE OF WOMEN'S HEALTH.edit
(a) Establishment- There is established within the Office of the Director of the Centers for Disease Control and Prevention, an office to be known as the Office of Women's Health (referred to in this section as the `Office'). The Office shall be headed by a director who shall be appointed by the Director of such Centers.
(b) Purpose- The Director of the Office shall--
(1) report to the Director of the Centers for Disease Control and Prevention on the current level of the Centers' activity regarding women's health conditions across, where appropriate, age, biological, and sociocultural contexts, in all aspects of the Centers' work, including prevention programs, public and professional education, services, and treatment;
(2) establish short-range and long-range goals and objectives within the Centers for women's health and, as relevant and appropriate, coordinate with other appropriate offices on activities within the Centers that relate to prevention, research, education and training, service delivery, and policy development, for issues of particular concern to women;
(3) identify projects in women's health that should be conducted or supported by the Centers;
(4) consult with health professionals, nongovernmental organizations, consumer organizations, women's health professionals, and other individuals and groups, as appropriate, on the policy of the Centers with regard to women; and
(5) serve as a member of the Department of Health and Human Services Coordinating Committee on Women's Health (established under section 229(b)(4)).
(c) Definition- As used in this section, the term `women's health conditions', with respect to women of all age, ethnic, and racial groups, means diseases, disorders, and conditions--
(1) unique to, significantly more serious for, or significantly more prevalent in women; and
(2) for which the factors of medical risk or type of medical intervention are different for women, or for which there is reasonable evidence that indicates that such factors or types may be different for women.
(d) Authorization of Appropriations- For the purpose of carrying out this section, there are authorized to be appropriated such sums as may be necessary for each of the fiscal years 2010 through 2014.'.
(c) Office of Women's Health Research- Section 486(a) of the Public Health Service Act (42 U.S.C. 287d(a)) is amended by inserting `and who shall report directly to the Director' before the period at the end thereof.
(d) Substance Abuse and Mental Health Services Administration- Section 501(f) of the Public Health Service Act (42 U.S.C. 290aa(f)) is amended--
(1) in paragraph (1), by inserting `who shall report directly to the Administrator' before the period;
(2) by redesignating paragraph (4) as paragraph (5); and
(3) by inserting after paragraph (3), the following:
(4) OFFICE- Nothing in this subsection shall be construed to preclude the Secretary from establishing within the Substance Abuse and Mental Health Administration an Office of Women's Health.'.
(e) Agency for Healthcare Research and Quality Activities Regarding Women's Health- Part C of title IX of the Public Health Service Act (42 U.S.C. 299c et seq.) is amended--
(1) by redesignating sections 925 and 926 as sections 926 and 927, respectively; and
(2) by inserting after section 924 the following:
SEC. 925. ACTIVITIES REGARDING WOMEN'S HEALTH.edit
(a) Establishment- There is established within the Office of the Director, an Office of Women's Health and Gender-Based Research (referred to in this section as the `Office'). The Office shall be headed by a director who shall be appointed by the Director of Healthcare and Research Quality.
(b) Purpose- The official designated under subsection (a) shall--
(1) report to the Director on the current Agency level of activity regarding women's health, across, where appropriate, age, biological, and sociocultural contexts, in all aspects of Agency work, including the development of evidence reports and clinical practice protocols and the conduct of research into patient outcomes, delivery of health care services, quality of care, and access to health care;
(2) establish short-range and long-range goals and objectives within the Agency for research important to women's health and, as relevant and appropriate, coordinate with other appropriate offices on activities within the Agency that relate to health services and medical effectiveness research, for issues of particular concern to women;
(3) identify projects in women's health that should be conducted or supported by the Agency;
(4) consult with health professionals, nongovernmental organizations, consumer organizations, women's health professionals, and other individuals and groups, as appropriate, on Agency policy with regard to women; and
(5) serve as a member of the Department of Health and Human Services Coordinating Committee on Women's Health (established under section 229(b)(4)).'.
(c) Authorization of Appropriations- For the purpose of carrying out this section, there are authorized to be appropriated such sums as may be necessary for each of the fiscal years 2010 through 2014.'.
(f) Health Resources and Services Administration Office of Women's Health- Title VII of the Social Security Act (42 U.S.C. 901 et seq.) is amended by adding at the end the following:
(a) Establishment- The Secretary shall establish within the Office of the Administrator of the Health Resources and Services Administration, an office to be known as the Office of Women's Health. The Office shall be headed by a director who shall be appointed by the Administrator.
(b) Purpose- The Director of the Office shall--
(1) report to the Administrator on the current Administration level of activity regarding women's health across, where appropriate, age, biological, and sociocultural contexts;
(2) establish short-range and long-range goals and objectives within the Health Resources and Services Administration for women's health and, as relevant and appropriate, coordinate with other appropriate offices on activities within the Administration that relate to health care provider training, health service delivery, research, and demonstration projects, for issues of particular concern to women;
(3) identify projects in women's health that should be conducted or supported by the bureaus of the Administration;
(4) consult with health professionals, nongovernmental organizations, consumer organizations, women's health professionals, and other individuals and groups, as appropriate, on Administration policy with regard to women; and
(5) serve as a member of the Department of Health and Human Services Coordinating Committee on Women's Health (established under section 229(b)(4) of the Public Health Service Act).
(c) Continued Administration of Existing Programs- The Director of the Office shall assume the authority for the development, implementation, administration, and evaluation of any projects carried out through the Health Resources and Services Administration relating to women's health on the date of enactment of this section.
(d) Definitions- For purposes of this section:
(1) ADMINISTRATION- The term `Administration' means the Health Resources and Services Administration.
(2) ADMINISTRATOR- The term `Administrator' means the Administrator of the Health Resources and Services Administration.
(3) OFFICE- The term `Office' means the Office of Women's Health established under this section in the Administration.
(e) Authorization of Appropriations- For the purpose of carrying out this section, there are authorized to be appropriated such sums as may be necessary for each of the fiscal years 2010 through 2014.'.
(g) Food and Drug Administration Office of Women's Health- Chapter X of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 391 et seq.) is amended by adding at the end the following:
(a) Establishment- There is established within the Office of the Commissioner, an office to be known as the Office of Women's Health (referred to in this section as the `Office'). The Office shall be headed by a director who shall be appointed by the Commissioner of Food and Drugs.
(b) Purpose- The Director of the Office shall--
(1) report to the Commissioner of Food and Drugs on current Food and Drug Administration (referred to in this section as the `Administration') levels of activity regarding women's participation in clinical trials and the analysis of data by sex in the testing of drugs, medical devices, and biological products across, where appropriate, age, biological, and sociocultural contexts;
(2) establish short-range and long-range goals and objectives within the Administration for issues of particular concern to women's health within the jurisdiction of the Administration, including, where relevant and appropriate, adequate inclusion of women and analysis of data by sex in Administration protocols and policies;
(3) provide information to women and health care providers on those areas in which differences between men and women exist;
(4) consult with pharmaceutical, biologics, and device manufacturers, health professionals with expertise in women's issues, consumer organizations, and women's health professionals on Administration policy with regard to women;
(5) make annual estimates of funds needed to monitor clinical trials and analysis of data by sex in accordance with needs that are identified; and
(6) serve as a member of the Department of Health and Human Services Coordinating Committee on Women's Health (established under section 229(b)(4) of the Public Health Service Act).
(c) Authorization of Appropriations- For the purpose of carrying out this section, there are authorized to be appropriated such sums as may be necessary for each of the fiscal years 2010 through 2014.'.
(h) No New Regulatory Authority- Nothing in this section and the amendments made by this section may be construed as establishing regulatory authority or modifying any existing regulatory authority.
(i) Limitation on Termination- Notwithstanding any other provision of law, a Federal office of women's health (including the Office of Research on Women's Health of the National Institutes of Health) or Federal appointive position with primary responsibility over women's health issues (including the Associate Administrator for Women's Services under the Substance Abuse and Mental Health Services Administration) that is in existence on the date of enactment of this section shall not be terminated, reorganized, or have any of it's powers or duties transferred unless such termination, reorganization, or transfer is approved by Congress through the adoption of a concurrent resolution of approval.
(j) Rule of Construction- Nothing in this section (or the amendments made by this section) shall be construed to limit the authority of the Secretary of Health and Human Services with respect to women's health, or with respect to activities carried out through the Department of Health and Human Services on the date of enactment of this section.
Section 340A of the Public Health Service Act (42 U.S.C. 256a) is amended--
(1) by striking subsection (d)(3) and inserting the following:
(3) LIMITATIONS ON GRANT PERIOD- In carrying out this section, the Secretary shall ensure that the total period of a grant does not exceed 4 years.';
(2) in subsection (e), by adding at the end the following:
(3) MINIMUM CORE PROFICIENCIES- The Secretary shall not award a grant to an entity under this section unless such entity provides assurances that patient navigators recruited, assigned, trained, or employed using grant funds meet minimum core proficiencies, as defined by the entity that submits the application, that are tailored for the main focus or intervention of the navigator involved.'; and
(3) in subsection (m)--
(A) in paragraph (1), by striking `and $3,500,000 for fiscal year 2010.' and inserting `$3,500,000 for fiscal year 2010, and such sums as may be necessary for each of fiscal years 2011 through 2015.'; and
(B) in paragraph (2), by striking `2010' and inserting `2015'.
Except where otherwise provided in this subtitle (or an amendment made by this subtitle), there is authorized to be appropriated such sums as may be necessary to carry out this subtitle (and such amendments made by this subtitle).
