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Evidence-based medicine (EBM), previously translational medicine, can be defined as improving care based on empirical research and/or hands-on practice. The EBM’s approach is based on either direct patient care (bottom-up) or an experiment translated into guidelines (top-down).  EBM is used in either in conjunction or as quality assessment tool(s) for continuous quality improvement (CQI). The healthcare leader must utilize the evidence to promote healthcare quality.

· Explain the process of evidence-based analysis.

· Highlight the major players and their roles in EBM policy (i.e., government, providers, patients, etc.).

· Explain the EBM “Levels of Evidence” as defined in your course text.

· Review the case “Constraints of the ACA on Evidence-Based Medicine.”

· Provide a written analysis of the case “Constraints of the ACA on Evidence-Based Medicine”
ATTACHMENT INCLUDED
(Utilize the  “Levels of  Evidence and Grades of  Recommendations” as defined by the National Guideline) Clearinghouse.

· Summarize the policy of EBM in your conclusion.

The paper

· Must be 3 double-spaced pages in length (not including title and reference pages) and formatted according to APA style.

·

Must include a separate title page with the following:

· Title of paper

· Student’s name

· Course name and number

· Instructor’s name

· Date submitted

· Must use at least five scholarly sources in addition to the course text.

REFERENCE FOR THE CASE

McLaughlin, C. P., & McLaughlin, C. D. (2014). Health Policy Analysis: An interdisciplinary approach (2nd ed.). Sudbury, MA: Jones and Bartlett Publishers. Print ISBN: 9781284037777

knowledgeable about its concepts and terms. The trained analyst will
recognize that it follows the logical paradigm adopted by systems analysts,
industrial engineers, and quality and safety improvement managers—that
is, the scientific method. Much of the actual research and analysis will be
carried out by health professionals in the burgeoning cottage industry of
providing meta-analyses, summary reviews, protocols, and guidelines. It is
important to know and understand the hierarchy of evidence and stay
current with the rapidly expanding development of decision aids and with
studies about how to activate and engage patients in clinical decision
making. Although political and economic interests will try to seize the
process of policy analysis and warp it in their favor, the antidote is to
maintain high standards for validity and quality of evidence throughout.
Policy makers in the United States are increasingly demanding such
professionalism behind the scenes, if not in their public discourse.

Case 9 Constraints of the ACA on Evidence-Based Medicine

The ACA expanded the emphasis on developing evidence-based
medicine in the 2009 stimulus act and established the Patient-Centered
Outcomes Research Institute (PCORI) within the Centers for Medicare
& Medicaid Services. However, the same legislation limited the ways
the Institute’s research could be used within the Department of Health
and Human Services. There clearly was a concern among federal
lawmakers that these research findings would find their way directly
into the workings of the even more controversial Medicare Advisory
Payment Commission.

Pearson and Bach (2010) noted:
Under current law and because of years of precedent, Medicare generally covers
any treatment that is deemed “reasonable and necessary,” regardless of the evidence
on the treatment’s comparative effectiveness or its cost in relation to other
treatments. Likewise, with only rare exceptions, Medicare does not use comparative
effectiveness information to set payment rates. Instead it links reimbursement in
one way or another to the underlying cost of providing services. (p. 1796)

This is quite different from the way comparative effectiveness research
is used in other counties at various regulatory stages, such as new drug
approvals and approved protocols.

Congress maintained this status quo, in part, by placing a number of
constraints on the use of comparative effectiveness research. Section
6301 amended Section 1181 of the Social Security Act to establish the

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Institute with the following purpose:
The Institute is to assist patients, clinicians, purchasers, and policy-makers in
making informed health decisions by advancing the quality and relevance of
evidence concerning the manner in which diseases, disorders, and other health
conditions can effectively and appropriately be prevented, diagnosed, treated,
monitored, and managed through research and evidence synthesis that considers
variations in patient subpopulations, and the dissemination of research findings
with respect to the relative health outcomes, clinical effectiveness, and
appropriateness of the medical treatments, services, and items described in
subsection (a)(2)(B).

ADDING CONSTRAINTS
However, the ACA went on to specify:

SEC. 1182 o42 U.S.C. 1320e–1. (a) The Secretary may only use evidence and
findings from research conducted under section 1181 to make a determination
regarding coverage under title XVIII (Medicare) if such use is through an iterative
and transparent process which includes public comment and considers the effect on
subpopulations.

(b) Nothing in section 1181 shall be construed as—

(1) superceding or modifying the coverage of items or services under title XVIII
that the Secretary determines are reasonable and necessary under section 1862(l)
(1); or

(2) authorizing the Secretary to deny coverage of items or services under such title
solely on the basis of comparative clinical effectiveness research.

(c)(1) The Secretary shall not use evidence or findings from comparative clinical
effectiveness research conducted under section 1181 in determining coverage,
reimbursement, or incentive programs under title XVIII in a manner that treats
extending the life of an elderly, disabled, or terminally ill individual as of lower
value than extending the life of an individual who is younger, nondisabled, or not
terminally ill.

(2) Paragraph (1) shall not be construed as preventing the Secretary from using
evidence or findings from such comparative clinical effectiveness research in
determining coverage, reimbursement, or incentive programs under title XVIII
based upon a comparison of the difference in the effectiveness of alternative
treatments in extending an individual’s life due to the individual’s age.

The law further restricted use of the findings in other sections:
(d)(1) The Secretary shall not use evidence or findings from comparative clinical
effectiveness research conducted under section 1181 in determining coverage,
reimbursement, or incentive programs under title XVIII in a manner that precludes,
or with the intent to discourage, an individual from choosing a health care treatment
based on how the individual values the tradeoff between extending the length of
their life and the risk of disability.

(2)(A) Paragraph (1) shall not be construed to—
(i) limit the application of differential copayments under title XVIII based on

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factors such as cost or type of service; or

(ii) prevent the Secretary from using evidence or findings from such comparative
clinical effectiveness research in determining coverage, reimbursement, or
incentive programs under such title based upon a comparison of the difference in
the effectiveness of alternative health care treatments in extending an individual’s
life due to that individual’s age, disability, or terminal illness.

(3) Nothing in the provisions of, or amendments made by the Patient Protection and
Affordable Care Act, shall be construed to limit comparative clinical effectiveness
research or any other research, evaluation, or dissemination of information
concerning the likelihood that a health care treatment will result in disability.

(e) The Patient-Centered Outcomes Research Institute established under section
1181(b)(1) shall not develop or employ a dollars-per-quality adjusted life year (or
similar measure that discounts the value of a life because of an individual’s
disability) as a threshold to establish what type of health care is cost effective or
recommended. The Secretary shall not utilize such an adjusted life year (or such a
similar measure) as a threshold to determine coverage, reimbursement, or incentive
programs under title XVIII.

Additional constraints in the law included:

• Section 6301 (d)(8)(iv), which states: “The Institute shall ensure
that the research findings … do not include practice guidelines,
coverage recommendations, payment, or policy
recommendations.”

• Section 6301(j), which addresses the rule of construction, includes
this language concerning coverage: “Nothing in this section shall
be construed … to permit the Institute to mandate coverage,
reimbursement, or other policies for any public or private payer.”

• Section 6301 adds a Section 937 on Dissemination and Building
Capacity for Research to Title IX of the Public Health Service
Act, which states: “Materials, forums, and media used to
disseminate the findings, informational tools, and resource
databases shall … not be construed as mandates, guidelines, or
recommendations for payment, coverage, or treatment.”

Discussion Questions
1. What do you think are the interests that are being protected here?

2. How effective are these constraints likely to be?

3. Why is the United States constraining these analyses while other
countries are using them?

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