Carol A. Kelly

Executive Vice President

Health Care Systems and Federal Legislative Policy

Direct: 202 434 7203

<ckelly@AdvaMed.org>

June 25, 2004

Carolyn Clancy, MD

Director

Agency for Healthcare Research and Quality

U.S. Department of Health and Human Services

FDA Docket ID \# 2004S-0170

> Re: Medicare Prescription Drug, Improvement, and Modernization Act of
> 2003, Section 1013: Suggested Priority Topics for Research

Dear Dr. Clancy:

On behalf of the Advanced Medical Technology Association's (AdvaMed's)
more than 1,100 members, I am pleased to submit these comments and
recommendations on the research priorities for the Agency for Healthcare
Quality and Research (AHRQ) pursuant to section 1013 of the Medicare
Prescription Drug, Improvement and Modernization Act of 2003 (MMA).

AdvaMed is the largest medical technology trade association in the
world, representing more than 1,100 innovators and manufacturers of
medical devices, diagnostic products and medical information systems.
Our members produce nearly 90 percent of the \$71 billion in health care
technology products consumed annually in the United States, and nearly
50 percent of \$169 billion purchased around the world annually.

As you know, section 1013 of MMA directs the Secretary of the U.S.
Department of Health and Human Services (HHS) to act through AHRQ to:

> conduct and support research to meet the priorities and requests for
> scientific evidence and information identified by such programs with
> respect to --

(i) the outcomes, comparative clinical effectiveness, and
    appropriateness of health care items and services (including
    prescription drugs); and

(ii) strategies for improving the efficiency and effectiveness of such
     programs, including the ways in which such items and services are
     organized, managed, and delivered under such programs.

MMA Sec. 1013(a)(1)(A). Further, section 1013 requires the Secretary to
establish priorities for this research. On April 23, 2004, AHRQ
published a notice in the [Federal Register]{.underline} that requested
comments on recommendations for research performed under section 1013.
Notice to Suggest Priority Topics for Research under MMA Section 1013,
69 Fed. Reg. 22,045 (2004). The notice specified that:

> While the statute does not limit the scope of the initial priority
> list, recent congressional activity suggests that the initial priority
> list should be directed toward evaluating existing evidence regarding
> the comparative clinical effectiveness of prescription drugs in
> anticipation of the Medicare prescription drug benefit. Therefore, the
> Department requests that recommendations for the initial priority list
> focus on prescription drugs . . . .

69 Fed. Reg. at 22,046. Consequently, our comments do not address AHRQ's
initial priority list for research, but rather address the priority
topics for research for FY 2006 (and beyond) and the overall approach
that HHS and AHRQ should take in implementing section 1013. Moreover, we
will focus our comments on AHRQ's research on "outcomes, comparative
clinical effectiveness, and appropriateness of health care items and
services", rather than its research to address "strategies for improving
the efficiency and effectiveness" of federal health care programs.

Our comments will discuss two issue areas: (i) the topics of AHRQ's
research; and (ii) AHRQ's approach to performing research.

[Topics of AHRQ Research]{.underline}

Section 1013 states that the Secretary "may include health care items
and services which impose a high cost on such programs, as well as those
which may be underutilized or overutilized and which may significantly
improve the prevention, treatment, or cure of diseases and conditions
(including chronic conditions) which impose high direct or indirect
costs on patients or society." MMA Sec. 1013 (a)(2)(C)(ii).

In keeping with this directive from Congress, we recommend that the
topics for AHRQ research follow the recommendations set forth by the
Institute of Medicine (IOM) in its 2003 report "Priority Areas for
National Action: Transforming Health Care Quality" (Priority Areas
Report). The Priority Areas Report provides a crucial starting point for
AHRQ research because it was developed under contract with HHS to carry
out the recommendations of another IOM report issued in 2001 entitled
"Crossing the Quality Chasm: A New Health System for the 21^st^
Century", in which the IOM calls for substantial change in the U.S.
healthcare system that aims to promote health care that is safe,
effective, patient-centered, timely, efficient, and equitable. Thus, the
Priority Areas Report is part of a larger, HHS-wide effort to identify
priorities, goals, and action plans for improving the U.S. healthcare
system and the quality of healthcare delivered in the United States.
This effort is consistent with the congressional intent underlying MMA
section 1013. Moreover, the "Priority Areas" report takes a broad-based
approach that is not purely disease-based, but rather includes
preventive care and behavioral health as means to improve the quality of
care. We agree with this approach to priority-setting and believe that
it should be applied by HHS as it sets priorities for section 1013
research.

Moreover, we recommend that as HHS considers items and services that
"may be underutilized or overutilized," it use as a reference the
article (and technical appendix) written by Elizabeth McGlynn et al
entitled "The Quality of Health Care Delivered to Adults in the United
States," 348 [New England Journal of Medicine]{.underline} 2635 (June
26, 2003). McGlynn et al have conducted quality of care research
encompassing a broad range of conditions that show that less than 55% of
patients in the United States receive recommended care. The research
performed by McGlynn et al highlights that underutilization of effective
items and services remains a serious threat that exists in relation to
quality of care and underscores the importance of efforts by HHS to
research and publicize the importance of following recommended care.
Thus, we strongly recommend that HHS not only focus on determining which
items and services are the optimal or most effective treatment
modalities for given conditions, but also recognize and take steps to
address the almost 50% of patients who simply do not receive baseline,
standard care.

In addition, we support the more specific recommendations for research
priorities as captured in comments submitted by our member companies.
For example, the Guidant Corporation submitted comments to you that
recommended that AHRQ include in its list of research priorities the
following topics: (i) access to cardiovascular care for women in the
Medicare program; and (ii) screening for carotid artery stenosis for
prevention of stroke. In addition, Medtronic, Inc. submitted comments
recommending that AHRQ include in its list of research priorities an
assessment of the current level of adherence to established intensive
insulin management guidelines for the treatment of Type I diabetes and
an examination of what patient-level, provider-level, and organizational
and financial barriers exist that may minimize use of established
guidelines in the treatment of Type I diabetes.

All of these topics reflect the intent of Section 1013 to analyze health
care items and services that may be underutilized and which may
significantly improve the prevention, treatment, or cure of diseases and
conditions, which impose high direct or indirect costs on patients or
society. Consequently, we recommend that HHS include these topics on the
AHRQ priority list for research.

Finally, we believe that health information technology and monitoring
technologies can play an important role in enabling access to
appropriate care, and that HHS should consider research topics that
explore the optimal use of these technologies to address barriers to
care, particularly for underserved populations and geographical areas.
First, AHRQ could examine the effectiveness of ongoing Medicaid disease
management programs in improving the quality of care for Medicaid
beneficiaries, including dual eligibles. AHRQ could study the types of
technologies employed in these disease management programs and analyze
changes in health care quality that have resulted from the use of health
information technology or monitoring technologies. Such a study would
dovetail with CMS's effort to evaluate the progress of the new Medicare
Chronic Care Improvement Program, which will be launched in 2005.
Second, AHRQ could investigate the feasibility of the rapid diffusion of
home monitoring technologies and health information technology in
disproportionately poor or rural communities, and the potential for
significantly improved health care outcomes within these populations
from the use of these technologies. People living in these communities
often have difficulty accessing health care services due to
transportation-related barriers, such as the need to travel large
distances or the lack of resources for the transportation necessary to
get to a doctor's office. Those with chronic conditions could possibly
reap tremendous improvements in their health if their progress could be
monitored regularly from their homes.

 

Of course, it is hard to imagine the successful deployment of
technologies to help manage patients' chronic conditions without the
active engagement of physicians. Therefore, we additionally recommend
that AHRQ explore the full range of barriers to physicians' adoption of
monitoring technologies and health information technology, including
financial challenges in purchasing the technologies.

[AHRQ's Approach to Performing Research]{.underline}

As AHRQ sponsors "systematic reviews" of clinical evidence to guide
patient care, we recommend that the agency ensure a broad-based approach
is taken toward evidence collection and evidence review. As you know,
systematic review processes have become increasingly incorporated into
health care policy decision-making with population-wide impact. Due to
the large-scale application of these systematic reviews, the methods
used are crucial. In particular, systematic review processes typically
adopt an explicit approach with defined inclusion and exclusion criteria
for evidence collection and review. It is critical that these reviews
include analysis of all relevant evidence of effectiveness including
studies that capture the experience of patients and practitioners in
real-world clinical practice. By remaining open to relevant studies that
reflect practical issues for patients, clinicians, and providers, AHRQ's
research ultimately will have a greater impact on patient care.

While it is universally acknowledged that well-designed randomized
controlled trials can provide highly valuable evidence regarding
efficacy of healthcare services, they often study only a very narrow
range of endpoints among those that are important to patients,
physicians and the country as a whole. Other clinical research studies
typically provide complementary evidence that is critical to capture in
evidence reviews. Thus, we recommend that AHRQ include in its analysis
of evidence the influence of the following on patients, physicians, and
providers:

-   Health-related quality of life (including disability reduction,
    functional status, and overall patient satisfaction);

-   Work loss (absenteeism) and productivity loss (presenteeism);

-   Patient adherence;

-   Patient preferences;

-   Symptom control;

-   Geographic variation in practice; and

-   Estimated long-term outcomes (which may result long after a clinical
    trial has ended).

The research that AHRQ will perform under section 1013 ultimately will
have broad implications that reach beyond the Medicare population. All
patients, including those covered by other federal health care programs
and private payors, inevitably will be affected by AHRQ's research.
Thus, as research priorities are developed and studies are designed, we
recommend that AHRQ take this broad impact into account.

Moreover, we believe that when an evidence-based medicine analysis is
used on a population-wide basis, it often loses focus on health
consequences for individual patients. We agree that AHRQ's research
should be disseminated widely. The Department as a whole, however,
should bear in mind the goal of protecting independent, fully informed
medical decision-making as a means to improving overall patient care.

Thank you for the opportunity to comment on the implementation of the
Section 1013 research provision. Should you or your staff have any
questions regarding the foregoing, please contact me.

Sincerely,

/s/

Carol A. Kelly