 
| Title of Law: |
Medicare
Prescription Drug, Improvement, and Modernization Act of
2003 |
| Law #: |
Public Law
108-173 |
| Passed by Congress: |
108th Congress
(1st Session) |
The
following are excerpts, highlighted
in red,
from the final legislation and/or conference report which
contain mentions of the National Academies, including studies.
(Pound signs [##] between passages denote the deletion of
unrelated text.)
HR
1 Hastert (R.-Ill.) 11/28/03
Enrolled (finally passed both
houses)
A
bill to amend Title XVIII of the Social Security Act to
provide for a voluntary program for prescription drug coverage
under the Medicare program, to modernize the Medicare program,
and for other purposes.
--- --- --- --- --- --- --- --- ---
--- --- --- --- --- --- --- --- --- --- --- --- --- --- ---
--- --- --- --- --- --- --- --- --- --- --- --- ---
######
SEC.
107. STUDIES AND REPORTS.
######
(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
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.
######
SEC.
109. EXPANDING THE WORK OF MEDICARE QUALITY IMPROVEMENT
ORGANIZATIONS TO INCLUDE PARTS C AND D.
(a)
APPLICATION TO MEDICARE MANAGED CARE AND PRESCRIPTION DRUG
COVERAGE.—Section 1154(a)(1) (42 U.S.C. 1320c-3(a)(1)) is
amended by inserting “, to Medicare Advantage organizations
pursuant to contracts under part C, and to prescription drug
sponsors pursuant to contracts under part D” after “under
section 1876”.
(b)
PRESCRIPTION DRUG THERAPY QUALITY IMPROVEMENT.—Section 1154(a)
(42 U.S.C. 1320c-3(a)) is amended by adding at the end the
following new paragraph:
“(17)
The organization shall execute its responsibilities under
subparagraphs (A) and (B) of paragraph (1) by offering to
providers, practitioners, Medicare Advantage organizations
offering Medicare Advantage plans under part C, and
prescription drug sponsors offering prescription drug plans
under part D quality improvement assistance pertaining to
prescription drug therapy. For purposes of this part and title
XVIII, the functions described in this paragraph shall be
treated as a review function.”.
(c)
EFFECTIVE DATE.—The amendments made by this section shall
apply on and after January 1, 2004.
(d)
IOM STUDY OF QIOS.—
(1)
IN GENERAL.—The Secretary shall request the Institute of
Medicine of the National Academy of Sciences to conduct an
evaluation of the program under part B of title XI of the
Social Security Act. The study shall include a review of the
following:
(A)
An overview of the program under such part.
(B)
The duties of organizations with contracts with the Secretary
under such part.
(C)
The extent to which quality improvement organizations improve
the quality of care for medicare beneficiaries.
(D)
The extent to which other entities could perform such quality
improvement functions as well as, or better than, quality
improvement organizations.
(E)
The effectiveness of reviews and other actions conducted by
such organizations in carrying out those duties.
(F)
The source and amount of funding for such
organizations.
(G)
The conduct of oversight of such organizations.
(2)
REPORT TO CONGRESS.—Not later than June 1, 2006, the Secretary
shall submit to Congress a report on the results of the study
described in paragraph (1), including any recommendations for
legislation.
(3)
INCREASED COMPETITION.—If the Secretary finds based on the
study conducted under paragraph (1) that other entities could
improve quality in the medicare program as well as, or better
than, the current quality improvement organizations, then the
Secretary shall provide for such increased competition through
the addition of new types of entities which may perform
quality improvement functions.
######
SEC.
238. INSTITUTE OF MEDICINE EVALUATION AND REPORT ON HEALTH
CARE PERFORMANCE MEASURES.
(a)
EVALUATION.—
(1)
IN GENERAL.—Not later than the date that is 2 months after the
date of the enactment of this Act, the Secretary shall enter
into an arrangement under which the Institute of Medicine of
the National Academy of Sciences (in this section referred to
as the “Institute”) shall conduct an evaluation of leading
health care performance measures in the public and private
sectors and options to implement policies that align
performance with payment under the medicare program under
title XVIII of the Social Security Act (42 U.S.C. 1395 et
seq.).
(2)
SPECIFIC MATTERS EVALUATED.—In conducting the evaluation under
paragraph (1), the Institute shall—
(A)
catalogue, review, and evaluate the validity of leading health
care performance measures;
(B)
catalogue and evaluate the success and utility of alternative
performance incentive programs in public or private sector
settings; and
(C)
identify and prioritize options to implement policies that
align performance with payment under the medicare program that
indicate—
(i)
the performance measurement set to be used and how that
measurement set will be updated;
(ii)
the payment policy that will reward performance;
and
(iii)
the key implementation issues (such as data and information
technology requirements) that must be addressed.
(3)
SCOPE OF HEALTH CARE PERFORMANCE MEASURES.—The health care
performance measures described in paragraph (2)(A) shall
encompass a variety of perspectives, including physicians,
hospitals, other health care providers, health plans,
purchasers, and patients.
(4)
CONSULTATION WITH MEDPAC.—In evaluating the matters described
in paragraph (2)(C), the Institute shall consult with the
Medicare Payment Advisory Commission established under section
1805 of the Social Security Act (42 U.S.C.
1395b-6).
(b)
REPORT.—Not later than the date that is 18 months after the
date of enactment of this Act, the Institute shall submit to
the Secretary and appropriate committees of jurisdiction of
the Senate and House of Representatives a report on the
evaluation conducted under subsection (a)(1) describing the
findings of such evaluation and recommendations for an overall
strategy and approach for aligning payment with performance,
including options for updating performance measures, in the
original medicare fee-for-service program under parts A and B
of title XVIII of the Social Security Act, the Medicare
Advantage program under part C of such title, and any other
programs under such title XVIII.
(c)
AUTHORIZATION OF APPROPRIATIONS.—There are authorized to be
appropriated such sums as may be necessary for purposes of
conducting the evaluation and preparing the report required by
this section.
######
*********************************************************************************
HRpt
108-391 - To accompany H.R. 1 - MEDICARE PRESCRIPTION DRUG,
IMPROVEMENT, AND MODERNIZATION ACT OF 2003
Conference
Committee
(11/21/03)
--- --- --- --- --- --- --- --- ---
--- --- --- --- --- --- --- --- --- --- --- --- --- --- ---
--- --- --- --- --- --- --- --- --- --- --- --- ---
######
“SPECIAL
PROVISIONS RELATING TO MEDICARE PRESCRIPTION DRUG
BENEFIT
######
SEC.
107. STUDIES AND REPORTS.
######
(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
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.
######
SEC.
109. EXPANDING THE WORK OF MEDICARE QUALITY IMPROVEMENT
ORGANIZATIONS TO INCLUDE PARTS C AND D.
(a)
APPLICATION TO MEDICARE MANAGED CARE AND PRESCRIPTION DRUG
COVERAGE.—Section 1154(a)(1) (42 U.S.C. 1320c-3(a)(1)) is
amended by inserting “, to Medicare Advantage organizations
pursuant to contracts under part C, and to prescription drug
sponsors pursuant to contracts under part D” after “under
section 1876”.
(b)
PRESCRIPTION DRUG THERAPY QUALITY IMPROVEMENT.—Section 1154(a)
(42 U.S.C. 1320c-3(a)) is amended by adding at the end the
following new paragraph:
“(17)
The organization shall execute its responsibilities under
subparagraphs (A) and (B) of paragraph (1) by offering to
providers, practitioners, Medicare Advantage organizations
offering Medicare Advantage plans under part C, and
prescription drug sponsors offering prescription drug plans
under part D quality improvement assistance pertaining to
prescription drug therapy. For purposes of this part and title
XVIII, the functions described in this paragraph shall be
treated as a review function.”.
(c)
EFFECTIVE DATE.—The amendments made by this section shall
apply on and after January 1, 2004.
(d)
IOM STUDY OF QIOS.—
(1)
IN GENERAL.—The Secretary shall request the Institute of
Medicine of the National Academy of Sciences to conduct an
evaluation of the program under part B of title XI of the
Social Security Act. The study shall include a review of the
following:
(A)
An overview of the program under such part.
(B)
The duties of organizations with contracts with the Secretary
under such part.
(C)
The extent to which quality improvement organizations improve
the quality of care for medicare beneficiaries.
(D)
The extent to which other entities could perform such quality
improvement functions as well as, or better than, quality
improvement organizations.
(E)
The effectiveness of reviews and other actions conducted by
such organizations in carrying out those duties.
(F)
The source and amount of funding for such
organizations.
(G)
The conduct of oversight of such organizations.
(2)
REPORT TO CONGRESS.—Not later than June 1, 2006, the Secretary
shall submit to Congress a report on the results of the study
described in paragraph (1), including any recommendations for
legislation.
(3)
INCREASED COMPETITION.—If the Secretary finds based on the
study conducted under paragraph (1) that other entities could
improve quality in the medicare program as well as, or better
than, the current quality improvement organizations, then the
Secretary shall provide for such increased competition through
the addition of new types of entities which may perform
quality improvement functions.
######
SUBTITLE
D—ADDITIONAL REFORMS
######
SEC.
238. INSTITUTE OF MEDICINE EVALUATION AND REPORT ON HEALTH
CARE PERFORMANCE MEASURES.
(a)
EVALUATION.—
(1)
IN GENERAL.—Not later than the date that is 2 months after the
date of the enactment of this Act, the Secretary shall enter
into an arrangement under which the Institute of Medicine of
the National Academy of Sciences (in this section referred to
as the “Institute”) shall conduct an evaluation of leading
health care performance measures in the public and private
sectors and options to implement policies that align
performance with payment under the medicare program under
title XVIII of the Social Security Act (42 U.S.C. 1395 et
seq.).
(2)
SPECIFIC MATTERS EVALUATED.—In conducting the evaluation under
paragraph (1), the Institute shall—
(A)
catalogue, review, and evaluate the validity of leading health
care performance measures;
(B)
catalogue and evaluate the success and utility of alternative
performance incentive programs in public or private sector
settings; and
(C)
identify and prioritize options to implement policies that
align performance with payment under the medicare program that
indicate—
(i)
the performance measurement set to be used and how that
measurement set will be updated;
(ii)
the payment policy that will reward performance;
and
(iii)
the key implementation issues (such as data and information
technology requirements) that must be addressed.
(3)
SCOPE OF HEALTH CARE PERFORMANCE MEASURES.—The health care
performance measures described in paragraph (2)(A) shall
encompass a variety of perspectives, including physicians,
hospitals, other health care providers, health plans,
purchasers, and patients.
(4)
CONSULTATION WITH MEDPAC.—In evaluating the matters described
in paragraph (2)(C), the Institute shall consult with the
Medicare Payment Advisory Commission established under section
1805 of the Social Security Act (42 U.S.C.
1395b-6).
(b)
REPORT.—Not later than the date that is 18 months after the
date of enactment of this Act, the Institute shall submit to
the Secretary and appropriate committees of jurisdiction of
the Senate and House of Representatives a report on the
evaluation conducted under subsection (a)(1) describing the
findings of such evaluation and recommendations for an overall
strategy and approach for aligning payment with performance,
including options for updating performance measures, in the
original medicare fee-for-service program under parts A and B
of title XVIII of the Social Security Act, the Medicare
Advantage program under part C of such title, and any other
programs under such title XVIII.
(c)
AUTHORIZATION OF APPROPRIATIONS.—There are authorized to be
appropriated such sums as may be necessary for purposes of
conducting the evaluation and preparing the report required by
this section.
######
SUBPART
3—APPLICATION TO MEDICARE ADVANTAGE PROGRAM AND TREATMENT OF
EMPLOYER-SPONSORED PROGRAMS AND OTHER PRESCRIPTION DRUG
PLANS
######
Studies
and Reports (Section 107 of Conference agreement; New Section
1860D-10 of House bill; Section 102, Section 106 and Section
110 of Senate bill).
######
Conference
Agreement
The
agreement requires the Secretary to study variations in per
capita spending for covered Part D drugs among PDP regions to
determine the amount of such variation that is attributable to
price variations and the differences in per capita utilization
that is not taken into account in the health status risk
adjustment made to PDP bids. The Secretary is required to
submit a report to Congress on the study including information
on the extent of geographic variation in per capita
utilization, an analysis of the impact of direct subsidies and
whether such subsidies should be adjusted to take into account
such variation, and recommendations regarding the
appropriateness of applying an additional geographic
adjustment factor to bids.
The
conference agreement requires the Secretary, within six months
of enactment, to review the current standards of practice for
pharmacy services provided to patients in nursing facilities.
Specifically, the Secretary is to assess: (1) the current
standards of practice, clinical services, and other service
requirements generally utilized for such pharmacy services;
and (2) evaluate the impact of those standards with respect to
patient safety, reduction of medication errors, and quality of
care. The report is to contain a description of the
Secretary’s plans to implement 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. The
report must also include recommendations regarding necessary
actions.
The
conference agreement requires the Secretary to enter into a
contract with the Institute of Medicine to carry out a
comprehensive study of drug safety and quality issues in order
to provide a blueprint for system-wide change. The objectives
of the study are to: (1) develop a full understanding of drug
safety and quality issues through an evidence-based review of
the literature, case studies, and analysis; (2) attempt to
develop credible estimates of the incidence, severity and
costs of medication errors; (3) evaluate alterative approaches
to reducing medication errors; (4) provide guidance on
high-priority strategies to achieve drug safety goals; (5)
assess opportunities and key impediments to broad nationwide
implementation of medication error reductions; and (6) develop
an applied research agenda to evaluate the health and cost
impacts of alternative interventions. The study is to be
completed within an 18-month period. Such sums as may be
necessary are authorized.
######
SUBTITLE
D—ADDITIONAL REFORMS
######
Section
238. Study of performance-based payment systems
Present
Law
No
provision.
House
Bill
Section
237. The
Secretary would request that the IOM conduct a study to review
and evaluate public and private sector experiences in: (1)
establishing performance measures and payment incentives under
the Medicare program, and (2) linking performance to
payment.
The Secretary would also request that no later than 18 months
after enactment, the Institute submit a report to the
Secretary and the Congress that included a review and
evaluation of incentives to encourage quality performance, as
specified in the statute. The study would also examine how
these measures and incentives might be applied in the Medicare
MA, EFFS, and FFS programs. The report would include
recommendations regarding appropriate performance measures for
use in assessing and paying for quality and would identify
options for updating performance measures.
Senate
Bill
Section
224. Within 2 months of enactment, the
Secretary would be required to enter into an arrangement with
IOM to evaluate leading health care performance measures and
options to implement policies that align performance with
payment under the Medicare program.
The information that would be catalogued, reviewed and
evaluated by IOM would be specified in statute. A report would
be due to the Secretary and the congressional committees of
jurisdiction within 18 months of enactment. There would be $1
million authorized to be appropriated to conduct the
evaluation and prepare the report.
Conference
Agreement
Section
238. The conference agreement requires that within 2 months of
enactment, the Secretary shall enter into an arrangement with
IOM to evaluate leading health care performance measures in
the public and private sectors and options to implement
policies that align performance with payment under the
Medicare program. The information examined by IOM includes the
validity of leading health care performance measures, the
success and utility of alternative performance incentive
programs, and options to implement policy that aligns
performance with payments. The Institute shall consult with
MedPAC. A report is to be due to the Secretary and the
congressional committees of jurisdiction within 18 months of
enactment. There will be authorized to be appropriated such
sums as may be necessary to conduct the evaluation and prepare
the report.
######
SUBTITLE
B—MISCELLANEOUS PROVISIONS
######
Pediatric
Palliative Care Demonstration
Medicare
is designed for aged and disabled individuals (typically
people over 65 years of age). It was not designed with
children in mind.
The
conferees are aware of potential barriers in the current
system for children with life-threatening illnesses. First, in
order to qualify for hospice, a doctor must certify that a
child has 6 months to live. Determining how long a child has
to live is often difficult. Second, the current system does
not allow a patient to receive curative and palliative care
simultaneously. This means that children can either receive
treatment for their disease or they can receive palliative
care.
HHS
should conduct a demonstration project in up to 6
geographically diverse sites to determine whether palliative
care for children may be improved under circumstances where
such barriers are reduced or eliminated. Such demonstration
shall take place over at least a three-year period.
The
Secretary, in conducting such demonstration project, should
take into account the recommendations of the Institute of
Medicine in its report: “When Children Die: Improving
Palliative and End-of-Life Care for Children and Their
Families.”
In
particular, the Secretary should consider including as part of
the demonstration:
1.
Waivers To Elect Hospice Care and Receive Curative
Treatment.
2.
Care coordination from diagnosis to end of life.
3.
Features to ensure that parents have information about
existing pediatric hospice and palliative care programs to
make decisions about the care of their child.
4.
Bereavement counseling for the family and reimbursement to
provider.
The
conferees believe that it is important that the Secretary have
flexibility when conducting such demonstration to provide
additional benefits so long as they are consistent with the
recommendations contained in the IOM Report and they are
provided in budget neutral manner.
The conferees also believe that the Secretary should provide
reports to Congress, as appropriate, that include an
evaluation of the short- and long-term costs and benefits of
palliative care under traditional Medicare and the
demonstration projects, determine the quality and duration of
palliative care under the demonstration project, and evaluate
whether there is an offset of savings by providing pediatric
palliative care, and the projected cost of implementing the
demonstrations on a national basis.
######
| 
| Subscribe to
e-newsletters | Feedback
| Back
to Top