STUDIES AND REPORTS.

SEC. 107. STUDIES AND REPORTS.(a) Study Regarding Regional Variations in Prescription Drug Spending.—(1) In general.—The Secretary shall conduct a study that examines variations in per capita spending for covered part D drugs under part D of title XVIII of the Social Security Act among PDP regions and, with respect to such spending, the amount of such variation that is attributable to—(A) price variations (described in section 1860D–15(c)(2) of such Act); and(B) differences in per capita utilization that is not taken into account in the health status risk adjustment provided under section 1860D–15(c)(1) of such Act.(2) Report and recommendations.—Not later than January 1, 2009, the Secretary shall submit to Congress a report on the study conducted under paragraph (1). Such report shall include—(A) information regarding the extent of geographic variation described in paragraph (1)(B);(B) an analysis of the impact on direct subsidies under section 1860D–15(a)(1) of the Social Security Act in different PDP regions if such subsidies were adjusted to take into account the variation described in subparagraph (A); and(C) recommendations regarding the appropriateness of applying an additional geographic adjustment factor under section 1860D–15(c)(2) that reflects some or all of the variation described in subparagraph (A).(b) Review and Report on Current Standards of Practice for Pharmacy Services Provided to Patients in Nursing Facilities.—(1) Review.—(A) In general.—Not later than 12 months after the date of the enactment of this Act, the Secretary shall conduct a thorough review of the current standards of practice for pharmacy services provided to patients in nursing facilities.(B) Specific matters reviewed.—In conducting the review under subparagraph (A), the Secretary shall—(i) assess the current standards of practice, clinical services, and other service requirements generally used for pharmacy services in long-term care settings; and(ii) evaluate the impact of those standards with respect to patient safety, reduction of medication errors and quality of care.(2) Report.—117 STAT. 2170(A) In general.—Not later than the date that is 18 months after the date of the enactment of this Act, the Secretary shall submit a report to Congress on the study conducted under paragraph (1)(A).(B) Contents.—The report submitted under subparagraph (A) shall contain—(i) a description of the plans of the Secretary to implement the provisions of this Act in a manner consistent with applicable State and Federal laws designed to protect the safety and quality of care of nursing facility patients; and(ii) recommendations regarding necessary actions and appropriate reimbursement to ensure the provision of prescription drugs to medicare beneficiaries residing in nursing facilities in a manner consistent with existing patient safety and quality of care standards under applicable State and Federal laws.(c) IOM Study on Drug Safety and Quality.—(1) In general.—The Secretary shall enter into a contract with the Institutes of Medicine of the National Academies of Science (such Institutes referred to in this subsection as the “IOM”) to carry out a comprehensive study (in this subsection referred to as the “study”) of drug safety and quality issues in order to provide a blueprint for system-wide change.(2) Objectives.—(A) The study shall develop a full understanding of drug safety and quality issues through an evidence-based review of literature, case studies, and analysis. This review will consider the nature and causes of medication errors, their impact on patients, the differences in causation, impact, and prevention across multiple dimensions of health care delivery-including patient populations, care settings, clinicians, and institutional cultures.(B) The study shall attempt to develop credible estimates of the incidence, severity, costs of medication errors that can be useful in prioritizing resources for national quality improvement efforts and influencing national health care policy.(C) The study shall evaluate alternative approaches to reducing medication errors in terms of their efficacy, cost-effectiveness, appropriateness in different settings and circumstances, feasibility, institutional barriers to implementation, associated risks, and the quality of evidence supporting the approach.(D) The study shall provide guidance to consumers, providers, payers, and other key stakeholders on high-priority strategies to achieve both short-term and long-term drug safety goals, to elucidate the goals and expected results of such initiatives and support the business case for them, and to identify critical success factors and key levers for achieving success.(E) The study shall assess the opportunities and key impediments to broad nationwide implementation of medication error reductions, and to provide guidance to policy-makers and government agencies (including the Food and Drug Administration, the Centers for Medicare & Medicaid 117 STAT. 2171 Services, and the National Institutes of Health) in promoting a national agenda for medication error reduction.(F) The study shall develop an applied research agenda to evaluate the health and cost impacts of alternative interventions, and to assess collaborative public and private strategies for implementing the research agenda through AHRQ and other government agencies.(3) Conduct of study.—(A) Expert committee.—In conducting the study, the IOM shall convene a committee of leading experts and key stakeholders in pharmaceutical management and drug safety, including clinicians, health services researchers, pharmacists, system administrators, payer representatives, and others.(B) Completion.—The study shall be completed within an 18-month period.(4) Report.—A report on the study shall be submitted to Congress upon the completion of the study.(5) Authorization of appropriations.—There are authorized to be appropriated to carry out this section such sums as may be necessary.(d) Study of Multi-year Contracts.—(1) In general.—The Secretary shall provide for a study on the feasibility and advisability of providing for contracting with PDP sponsors and MA organizations under parts C and D of title XVIII on a multi-year basis.(2) Report.—Not later than January 1, 2007, the Secretary shall submit to Congress a report on the study under paragraph (1). The report shall include such recommendations as the Secretary deems appropriate.(e) GAO Study Regarding Impact of Assets Test for Subsidy Eligible Individuals.—(1) Study.—The Comptroller General of the United States shall conduct a study to determine the extent to which drug utilization and access to covered part D drugs under part D of title XVIII of the Social Security Act by subsidy eligible individuals differs from such utilization and access for individuals who would qualify as such subsidy eligible individuals but for the application of section 1860D–14(a)(3)(A)(iii) of such Act.(2) Report.—Not later than September 30, 2007, the Comptroller General shall submit a report to Congress on the study conducted under paragraph (1) that includes such recommendations for legislation as the Comptroller General determines are appropriate.(f) Study on Making Prescription Pharmaceutical Information Accessible for Blind and Visually-Impaired Individuals.—(1) Study.—(A) In general.—The Secretary shall undertake a study of how to make prescription pharmaceutical information, including drug labels and usage instructions, accessible to blind and visually-impaired individuals.(B) Study to include existing and emerging technologies.—The study under subparagraph (A) shall include a review of existing and emerging technologies, including assistive technology, that makes essential 117 STAT. 2172 information on the content and prescribed use of pharmaceutical medicines available in a usable format for blind and visually-impaired individuals.(2) Report.—(A) In general.—Not later than 18 months after the date of the enactment of this Act, the Secretary shall submit a report to Congress on the study required under paragraph (1).(B) Contents of report.—The report required under paragraph (1) shall include recommendations for the implementation of usable formats for making prescription pharmaceutical information available to blind and visually-impaired individuals and an estimate of the costs associated with the implementation of each format.