TITLE I--MEDICARE PRESCRIPTION DRUG BENEFIT
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-
(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.
(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.
(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 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.
(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-
(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 information on the content and prescribed use of pharmaceutical
medicines available in a usable format for blind and visually-impaired individuals.
(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.
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