USC Subpart 2

USC Subpart 2
in effect

42 U.S.C. § 299b–33 Health care delivery system research

(a) PurposeThe 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 CenterThe 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 generalThe 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 requirementsThe research conducted pursuant to paragraph (1) shall—(A) address the priorities identified by the Secretary in the national strategic plan established under section 280j of this title; (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 1395aaa(a) of this title in the report required under section 280j–2 of this title; (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 1320b–9a of this title 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 availabilityThe 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 technologyThe 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 300jj–32 of this title, as well as any relevant standards, certification criteria, or implementation specifications. (e) PrioritizationThe 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 300jj of this title. (f) CoordinationThe Center shall coordinate its activities with activities conducted by the Center for Medicare and Medicaid Innovation established under section 1315a of this title. (g) FundingThere is authorized to be appropriated to carry out this section $20,000,000 for fiscal years 2010 through 2014.

42 U.S.C. § 299b–34 Quality improvement technical assistance and implementation

(a) In generalThe 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 awardTo 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 280g–12 of this title, a Federal Indian Health Service program or a health program operated by an Indian tribe (as defined in section 1603 of title 25), 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 awardTo 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 11 So in original. Probably should be “of”. 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 awardTo 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 awardTo 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 22 So in original. Probably should be “a 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 fundsThe 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 generalThe 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 299b–33 of this title; (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 evaluationBased 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) CoordinationThe entities that receive a grant or contract under this section shall coordinate with health information technology regional extension centers under section 300jj–32(c) of this title and the primary care extension program established under section 280g–12 of this title regarding the dissemination of quality improvement, system delivery reform, and best practices information.

42 U.S.C. § 299b–35 Grants or contracts to implement medication management services in treatment of chronic diseases

(a) In generalThe Secretary, acting through the Patient Safety Research Center established in section 299b–33 of this title (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 entitiesTo 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 256a–1 of this title or in collaboration with primary care extension programs established in section 280g–12 of this title; (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 individualsThe 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 individualsMTM 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 expertsIn 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 SecretaryAn 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 1395aaa of this title, as determined by the Secretary. (g) Evaluation and reportThe 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 measuresThe Secretary may, through the quality measure development program under section 299b–31 of this title, 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.

42 U.S.C. § 299b–36 Program to facilitate shared decisionmaking

(a) PurposeThe purpose of this section is to facilitate collaborative processes between patients, caregivers or authorized representatives, and clinicians that engages 11 So in original. Probably should be “engage”. the patient, caregiver or authorized representative in decisionmaking, provides 22 So in original. Probably should be “provide”. patients, caregivers or authorized representatives with information about trade-offs among treatment options, and facilitates 33 So in original. Probably should be “facilitate”. the incorporation of patient preferences and values into the medical plan. (b) DefinitionsIn this section:(1) Patient decision aidThe 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 careThe 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 44 So in original. Probably should be “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 generalFor 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 1395aaa of this title. Such contract shall provide that the entity perform the duties described in paragraph (2). (B) Timing for first contractAs soon as practicable after March 23, 2010, the Secretary shall enter into the first contract under subparagraph (A). (C) Period of contractA contract under subparagraph (A) shall be for a period of 18 months (except such contract may be renewed after a subsequent bidding process). (2) DutiesThe following duties are described in this paragraph:(A) Develop and identify standards for patient decision aidsThe 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 aidsThe entity shall review patient decision aids and develop a certification process whether 55 So in original. 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 produce patient decision aids to assist health care providers and patients(1) In generalThe 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 aidsPatient 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) DistributionThe Director shall ensure that patient decision aids produced with grants or contracts under this section are available to the public. (4) Nonduplication of effortsThe 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 generalThe 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 generalThe 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) ObjectivesThe 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 generalThe 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) PreferenceIn 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) LimitationFunds 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) GuidanceThe Secretary may issue guidance to eligible grantees under this subsection on the use of patient decision aids. (f) FundingFor 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.

42 U.S.C. § 299b–37 Dissemination and building capacity for research

(a) In general(1) DisseminationThe Office of Communication and Knowledge Transfer (referred to in this section as the “Office”) at the Agency for Healthcare Research and Quality (or any other relevant office designated by Agency for Healthcare Research and Quality), in consultation with the National Institutes of Health, shall broadly disseminate the research findings that are published by the Patient Centered Outcomes Research Institute established under section 1320e(b) of this title (referred to in this section as the “Institute”) and other government-funded research relevant to comparative clinical effectiveness research. The Office shall create informational tools that organize and disseminate research findings for physicians, health care providers, patients, payers, and policy makers. The Office shall also develop a publicly available resource database that collects and contains government-funded evidence and research from public, private, not-for profit, and academic sources. (2) RequirementsThe Office shall provide for the dissemination of the Institute’s research findings and government-funded research relevant to comparative clinical effectiveness research to physicians, health care providers, patients, vendors of health information technology focused on clinical decision support, appropriate professional associations, and Federal and private health plans. Materials, forums, and media used to disseminate the findings, informational tools, and resource databases shall—(A) include a description of considerations for specific subpopulations, the research methodology, and the limitations of the research, and the names of the entities, agencies, instrumentalities, and individuals who conducted any research which was published by the Institute; and (B) not be construed as mandates, guidelines, or recommendations for payment, coverage, or treatment. (b) Incorporation of research findingsThe Office, in consultation with relevant medical and clinical associations, shall assist users of health information technology focused on clinical decision support to promote the timely incorporation of research findings disseminated under subsection (a) into clinical practices and to promote the ease of use of such incorporation. (c) FeedbackThe Office shall establish a process to receive feedback from physicians, health care providers, patients, and vendors of health information technology focused on clinical decision support, appropriate professional associations, and Federal and private health plans about the value of the information disseminated and the assistance provided under this section. (d) Rule of constructionNothing in this section shall preclude the Institute from making its research findings publicly available as required under section 1320e(d)(8) of this title. (e) Training of researchersThe Agency for Health Care Research and Quality, in consultation with the National Institutes of Health, shall build capacity for comparative clinical effectiveness research by establishing a grant program that provides for the training of researchers in the methods used to conduct such research, including systematic reviews of existing research and primary research such as clinical trials. At a minimum, such training shall be in methods that meet the methodological standards adopted under section 1320e(d)(9) of this title. (f) Building data for researchThe Secretary shall provide for the coordination of relevant Federal health programs to build data capacity for comparative clinical effectiveness research, including the development and use of clinical registries and health outcomes research data networks, in order to develop and maintain a comprehensive, interoperable data network to collect, link, and analyze data on outcomes and effectiveness from multiple sources, including electronic health records. (g) Authority to contract with the InstituteAgencies and instrumentalities of the Federal Government may enter into agreements with the Institute, and accept and retain funds, for the conduct and support of research described in this part, provided that the research to be conducted or supported under such agreements is authorized under the governing statutes of such agencies and instrumentalities.

Starting a business? Corpus forms LLCs in all 50 states and DC.