1150 Connecticut Ave., NW | Suite 300 | Washington, DC 20036
P 202-785-7900 | F 202-785-7950 | www.heart.org
330 N. Wabash Ave.| Suite 39300 | Chicago, IL 60611-5885
P 312-464-5000 | F 312-464-4184 | www.ama-assn.org
May 18, 2018
Tamara Syrek-Jensen, J.D.
Director, Evidence and Analysis Group, Center for Clinical Standards and Quality
Centers for Medicare & Medicaid Services
7500 Security Blvd., C1-14-15
Baltimore, MD 21244
Via email: [email protected].gov
Formal National Coverage Determination Request for Reconsideration of an Existing National
Coverage Determination: Ambulatory Blood Pressure Monitoring
Dear Ms. Syrek-Jensen:
On behalf of the American Heart Association and the American Medical Association, we are pleased to
co-submit the attached documents which represent a request for NCD Reconsideration for coverage of
ambulatory blood pressure monitoring (ABPM) to diagnose hypertension in Medicare beneficiaries.
This change would align Medicare coverage policy with the 2016 recommendation of the U.S.
Preventive Services Task Force (USPSTF).
Improving the diagnosis and control of high blood pressure is an organizational priority for both of our
organizations. Launched in 2016, Target: BP™ is a national collaboration between the American Heart
Association and the American Medical Association, to reduce the number of Americans who have heart
attacks and strokes by urging medical practices, health service organizations and patients to prioritize
blood pressure control. Target: BP aims to increase awareness, engagement and action of health care
providers and patients by educating them on steps they can take to help improve blood pressure
control and, in turn, prevent the progression to serious or sometimes deadly co-morbid conditions, with
a shared commitment to increase the national blood pressure control rate to 70 percent or higher.
Together our collective efforts will galvanize more physician practices and health care organizations
across the country to prioritize blood pressure control within the patient populations they serve.
Our organizations have also identified it as a priority to improve coverage of the evidence-based
practices that support better diagnosis and control of high blood pressure. To this end, enclosed is a
formal request for reconsideration, which includes a summary of new evidence in support of ABPM
since CMS last considered an NCD. We have also enclosed a detailed evidence review describing the
USPSTF recommendation, current professional society guidelines, and recent peer-reviewed literature
related to ABPM to serve as a comprehensive evidence base that supports an expansion of the current
NCD.
The American Heart Association and the American Medical Association are grateful for the guidance
CMS has provided in informing this NCD request to date. Please do not hesitate to contact Madeleine
Konig at [email protected] or 202-785-7930 should you require any additional information.
Sincerely,
John Warner, MD, FAHA James L. Madara, MD
President Executive Vice President, CEO
American Heart Association
American Medical Association
Formal Request for Reconsideration of an Existing National Coverage Determination:
Ambulatory Blood Pressure Monitoring (20.19)
May 2018
Request for NCD Reconsideration
Accurate diagnosis of hypertension is crucial. Formal diagnosis of hypertension, as defined by the
American Heart Association (AHA) and American College of Cardiology (ACC), occurs when individuals
have an office systolic blood pressure ≥ 130 mm Hg or diastolic blood pressure ≥ 80 mm Hg (newly
revised from an earlier 140/90 mm Hg standard).
i,ii
Of the more than 55.5 million Medicare beneficiaries
in the United States,
iii
55 percent have hypertension, including nearly 40 percent of disabled Medicare
beneficiaries and over 58 percent of aged Medicare beneficiaries, according to 2015 administrative
claims data from the Centers for Medicare and Medicaid Services (CMS);
iv
rates under the new
definition of hypertension will likely be higher. Further, there are significant racial disparities in
hypertension prevalence: while approximately 55 percent of non-Hispanic white Medicare beneficiaries
have hypertension, the prevalence rate among black Medicare beneficiaries is 62.5 percent.
v
Cardiovascular disease (CVD) has been the leading cause of death in the United States for almost a
century
vi,vii
and, of CVD attributable deaths, more than nine percent are because of high blood
pressure.
viii
Fortunately, blood pressure management, along with not smoking, eating a healthy diet,
engaging in physical activity, maintaining a healthy weight, and controlling diabetes and elevated lipid
levels can prevent approximately 80 percent of CVDs.
ix
CMS itself has called hypertension “the most
important modifiable risk factor for coronary heart disease… stroke… congestive heart failure, and end-
stage renal disease.”
x
CVD is also enormously costly. Direct medical costs for CVD are some of the most expensive in the
healthcare industry, exceeding expenditures for other costly diseases like Alzheimer’s and diabetes.
xi
In
2016, CVD cost the United States $555 billion including $318 billion in direct medical costs and another
$237 million in indirect costs (e.g. lost work productivity).
xii
By 2035, CVD will cost an estimated $1.1
trillion ($749 billion direct, $368 billion indirect).
xiii
High blood pressure accounts for the second largest
expenditure among CVD; in 2016, the United States spent $68 billion for high blood pressure and will
spend an estimated $154 billion in 2035.
xiv
This projected increase in expenditure will be driven by the
aging US population particularly as Baby Boomers become eligible for Medicare.
xv
Estimates suggest
Baby Boomers ages 80 and older will be the largest driver of CVD expenditure increase by 2035.
xvi
A more accurate diagnosis of hypertension can prevent hospitalizations, overtreatment, and other
costly CVD-related outcomes, both direct and indirect, ultimately saving important resources for
Medicare.
New Evidence Supports a Reconsideration
A large body of evidence amassed since CMS last reviewed this benefit supports ambulatory blood
pressure monitoring (ABPM) as an effective diagnostic tool to correctly diagnose
HBP/hypertension.
xvii,xviii,xix,xx,xxi,xxii,xxiii,xxiv
Currently, ABPM is covered only in cases of suspected white coat hypertension (WCH). Suspected
WCH, as currently defined by CMS, occurs when patients have an “office blood pressure >140/90 mm
Hg on at least three clinic/office visits with two separate measurements made at each visit.”
xxv
CMS
further defines WCH to include “at least two blood pressure measurements taken outside the office
which are <140/90 mm Hg…[along with] no evidence of end-organ damage.”
xxvi
CMS’s decision to cover ABPM for cases of suspected white-coat hypertension was made in 2001;
minor modifications specifying that a physician must review the ABPM data were made in 2003.
xxvii
In
the fifteen years since, researchers have devoted considerable research to ascertaining the diagnostic
value of ABPM and found it to be an effective, evidence-based tool in circumstances beyond suspected
WCH (see evidence review included in submission). In the most recent guidelines that AHA released
with the American College of Cardiology (ACC), along with the American Academy of Physician
Assistants (AAPA), Association of Black Cardiologists (ABC), American College of Preventive Medicine
(ACPM), American Geriatrics Society (AGS), American Pharmacists Association (APhA), American
Society of Hypertension (ASH), American Society for Preventive Cardiology (ASPC), National Medical
Association (NMA), and Preventive Cardiovascular Nurses Association (PCNA),
xxviii
we recommend
ABPM for a broader set of indications.
This National Coverage Determination Reconsideration request seeks to expand Medicare coverage
for ABPM. While considerable evidence also supports the use of ABPM in the context of treatment and
blood pressure management, this request focuses on diagnosis.
In support of this request, we have provided information from recent peer reviewed literature that
demonstrates the evidence and the benefits of ABPM as a diagnostic test for a range of patients both
with and without elevated office blood pressure. The evidence in support of such a determination is
summarized below. Further detail on this evidence is available in the accompanying evidence review.
Benefit category
The proposed benefit would fall under the following benefit category:
• Diagnostic Tests (other)
Submitted by
• American Heart Association (AHA)
• American Medical Association (AMA)
Description of Service
There are currently four current procedural terminology (CPT) codes related to ambulatory blood
pressure monitoring:
• 93784: Ambulatory blood pressure monitoring, utilizing a system such as magnetic tape and/or
computer disk, for 24 hours or longer; including recording, scanning analysis, interpretation and
report
• 93786: recording only
• 93788: scanning analysis with report
• 93790: review with interpretation and report
CMS defines ABPM as involving “the use of a non-invasive device, which is used to measure blood
pressure in 24-hour cycles. These 24-hour measurements are stored in the device and are later
interpreted at the physician’s office. ABPM must be performed for at least 24 hours to meet coverage
criteria.”
xxix
Since April 1, 2002, coverage for ABPM has been limited to beneficiaries with suspected “white coat
hypertension.” CMS currently defines suspected “white coat hypertension” as:
• Office blood pressure >140/90 mm Hg on at least three separate clinic/office visits with two
separate measurements made at each visit;
• At least two documented separate blood pressure measurements taken outside the office which
are < 140/90 mm Hg; and
• No evidence of end-organ damage.
ABPM is not presently covered for any other uses. This NCD Reconsideration request seeks to expand
coverage for ABPM in accordance with the indications listed below.
Description of Proposed Use of Service for Identified Medical Conditions in Target Medicare Population
and Medical Conditions for Which It Can Be Used
In 2017, AHA/ACC released a set of guidelines for the prevention, detection, evaluation, and
management of high blood pressure in adults.
xxx
These guidelines included recommended applications
of ABPM. Broadly, AHA/ACC recommends out-of-office BP measurements to confirm the diagnosis of
hypertension. Specific recommendations are:
1. In adults with an untreated systolic blood pressure (SBP) greater than 130 mm Hg but less than
160 mm Hg or diastolic blood pressure (DBP) greater than 80 mm Hg but less than 100 mm Hg,
it is reasonable to screen for the presence of white coat hypertension by using either daytime
ABPM or HBPM before diagnosis of hypertension [moderate recommendation, is reasonable].
2. In adults with white coat hypertension, periodic monitoring with either ABPM or HBPM is
reasonable to detect transition to sustained hypertension [moderate recommendation].
3. In adults being treated for hypertension with office BP readings not at goal and HBPM readings
suggestive of a significant white coat effect, confirmation by ABPM can be useful [moderate
recommendation, is reasonable].
4. In adults with untreated office BPs that are consistently between 120 mm Hg and 129 mm Hg
for SBP or between 75 mm Hg and 79 mm Hg for DBP, screening for masked hypertension with
HBPM (or ABPM) is reasonable [moderate recommendation].
5. In adults on multiple-drug therapies for hypertension and office BPs within 10 mm Hg above
goal, it may be reasonable to screen for white coat effect with HBPM or ABPM [weak
recommendation, may be reasonable].
6. In adults being treated for hypertension with elevated HBPM readings suggestive of masked
uncontrolled hypertension, confirmation of the diagnosis by ABPM might be reasonable before
intensification of antihypertensive drug treatment [weak recommendation may be reasonable].
Indications
Based on the guidelines noted above, we request coverage of ABPM for the diagnosis of hypertension.
Recommendation for a Clinically-Beneficial Application of Ambulatory Blood Pressure Monitoring for the
Target Medicare Population
Compilation of Supporting Medical and Scientific Evidence for Medical Benefit
The United States Preventive Services Task Force commissioned an evidence review by the Kaiser
Permanente Research Affiliates Evidence-based Practice Center and released a recommendation in
2015 in support of screening for adults for high blood pressure and “obtaining measurements outside
the clinical setting for diagnostic confirmation before treatment.”
xxxi
USPSTF made the following
conclusion regarding the evidence on ABPM:
The USPSTF found convincing evidence that ABPM is the best method for diagnosing
hypertension. Although the criteria for establishing hypertension varied across studies, there
was significant discordance between the office diagnosis of hypertension and 12- and 24-hour
average blood pressures using ABPM, with significantly fewer patients requiring treatment
based on ABPM (Figure 1).
30
Elevated ambulatory systolic blood pressure was consistently and
significantly associated with increased risk for fatal and nonfatal stroke and cardiovascular
events, independent of office blood pressure (Figure 2).
30
For these reasons, the USPSTF
recommends ABPM as the reference standard for confirming the diagnosis of
hypertension.
xxxii
(emphasis added)
The AHA evidence review submitted with this NCD request outlines the relevant peer-reviewed
literature on ABPM published since that time. Specifically, this review focuses on the most recent
evidence on ABPM’s efficacy as a diagnostic tool, its ability to prevent overtreatment, its predictive
capabilities, and how ABPM is currently used in the physician office setting. The evidence review
contains detailed descriptions of relevant studies, their results, and full references for CMS’s
consideration. The following section briefly summarizes this evidence.
ABPM as a diagnostic tool
Research demonstrates that ABPM is a superior diagnostic tool compared to office based blood
pressure monitoring (OBPM).
xxxiii,xxxiv,xxxv,xxxvi
ABPM has superior specificity and sensitivity compared to
OBPM, and best practices suggest it is clinically important for confirmation of hypertension
diagnosis.
xxxvii
ABPM measurements are generally lower than those obtained by OBPM in the same
patients
xxxviii
which suggests a white-coat effect CMS has already deemed worthy of Medicare
coverage.
ABPM is also useful for diagnosing a number of other conditions beyond suspected WCH, including
masked hypertension
xxxix,xl
and elevated BP during sleep.
xli
These conditions are no less significant
public health issue than WCH which is currently covered by Medicare; an estimated 12.3 percent of US
adults ages 21 and older have masked hypertension, including 28 percent of adults over the age of
65.
xlii
Further, elderly individuals, those with type 2 diabetes, chronic kidney disease and treatment
resistant hypertension are at increased risk for elevated nighttime BP.
xliii,xliv
ABPM as a means to prevent overtreatment
Because of its superior effectiveness, ABPM can help prevent overtreatment stemming from
misdiagnosis of hypertension. This is especially important among older adults. In one study, ABPM
revealed around one third of elderly patients receiving hypertension treatment were at risk for
hypotension, and more than half of patients were actually hypotensive.
xlv
Falls due to low blood
pressure among the elderly can restrict mobility, either from physical injury or fear of subsequent
falls,
xlvi
making it especially important that clinicians not subject their elderly patients to antihypertensive
treatment that is unnecessary at best, and potentially harmful at worst.
A systemic review conducted on behalf of the United States Preventive Services Task Force found
between 35 and 95 percent of individuals with hypertension based on OBPM measurements were still
categorized as hypertensive after ABPM,
xlvii
indicating that OBPM has an inconsistent predictive value
and warrants confirmation through ABPM. From the population perspective, reclassifying individuals
from hypertension to normotension (because of WCH) and normotension to hypertension (because of
masked hypertension) may have little net effect on proportions of the two classifications.
xlviii
Nevertheless, from the individual perspective, ABPM can reduce misclassification to facilitate treatment
tailored to an individual patient’s accurate blood pressure patterns and thus can reduce overtreatment
and the associated risks.
xlix
Predictive and preventive capabilities of ABPM
Ambulatory blood pressure is an important predictor of a number of health outcomes and, as such,
ABPM presents an effective preventive tool for clinicians and patients. Target organ damage (TOD) due
to hypertension can affect the heart, kidneys, and brain and increase risk of negative health outcomes
including heart failure and myocardial infarction, renal failure, and stroke.
l,li
ABPM is a better predictor
of TOD than OBPM,
lii
including, but not limited to cardiovascular events.
liii
When analyzed with
biomarkers like amino-terminal pro-B-type natriuretic peptide (NT-proBNP), ABPM has potential to
better predict atherosclerotic cardiovascular disease.
liv
ABPM is well suited to identify hidden forms of hypertension, such as non-dipping or reverse-dipping
(i.e. blood pressure that does not decrease during sleep or actually increases during sleep), that are
prevalent among chronic kidney disease (CKD) patients, along with sustained or masked
hypertension.
lv,lvi
ABPM may also assist in controlling ambulatory blood pressure to prevent cognitive
decline, depression, decreases in physical mobility,
lvii
increases in white matter hyperintensity
volume,
lviii
and enlarged perivascular spaces in the brain.
lix
This is especially important among the aged
Medicare population where cognitive and physical decline may lead to transition from the home and/or
community to long-term care facilities.
ABPM in clinical practice
Assessing the usage and effectiveness of ABPM under typical clinical conditions is an integral step in
understanding the potential benefit expanding coverage of ABPM under Medicare could have.
For the purposes of clinical practice, ABPM provides several distinct advantages
lx
:
• Ambulatory blood pressure monitoring allows multiple blood pressure readings to be taken
across a 24-hour period compared to OBPM which only allows for the measurement of blood
pressure at a clinic visit.
• US and international guidelines strongly recommend the use of ambulatory blood pressure
monitoring in clinical practice.
• Using ambulatory blood pressure monitoring to rule out white-coat hypertension prevents
patients from being prescribed unnecessary antihypertensive medications.
• Using ambulatory blood pressure monitoring to identify masked hypertension identifies patients
who do not have high office blood pressure but are at high cardiovascular disease risk.
• Ambulatory blood pressure monitoring also allows measurement of nocturnal blood pressure, an
increasingly important prognostic parameter for cardiovascular disease risk.
However, in surveys, many clinics and clinicians report a lack of access to ABPM
lxi,lxii
and, perhaps
because of this, many physicians report not having used ABPM to confirm hypertension diagnosis.
lxiii
Providers reported difficulty accessing testing centers and the cost of ABPM as the primary barriers for
implementing ABPM.
lxiv
Reasoning for How Coverage of ABPM Will Help Improve Medical Benefit to the Target Population
The evidence outlined in this document and the supporting evidence review reinforces the case for
ABPM as a diagnostic tool for patients with and without elevated OBPM, yet Medicare only covers for
ABPM for patients with elevated OBPM when WCH is suspected. Medicare beneficiaries would benefit
considerably from an expansion of coverage for ABPM, particularly elderly Medicare beneficiaries.
ABPM has been shown to be effective at diagnosing a number of blood pressure patterns and
comorbid conditions prevalent in the Medicare population which can help ensure Medicare beneficiaries
receive appropriate treatment tailored to their individual health needs.
ABPM is also an effective diagnostic tool to preventing overtreatment, a particularly problematic
phenomenon among aged Medicare beneficiaries who may experience physical and psychological
harm from overly-aggressive antihypertensive treatment that could lead to dangerous drops in blood
pressure and subsequent falls. ABPM is well suited to predict and prevent disease, as ambulatory
blood pressure is associated with a number of negative health outcomes and blood pressure control is
associated with reduced risk of these outcomes.
i
Benjamin, E. J., Blaha, M. J., Chiuve, S. E., Cushman, M., Das, S. R., Deo, R., ... & Jiménez, M. C. (2017). Heart
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ii
Whelton, P. K., Carey, R. M., Aronow, W. S., Casey, D. E., Collins, K. J., Himmelfarb, C. D., ... & MacLaughlin,
E. J. (2017). 2017 ACC/AHA/AAPA/ABC/ACPM/AGS/APhA/ASH/ASPC/NMA/PCNA guideline for the prevention,
detection, evaluation, and management of high blood pressure in adults: a report of the American College of
Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. Journal of the American
College of Cardiology, 24430.
iii
Centers for Medicare and Medicaid Services. Medicare Enrollment Dashboard. https://www.cms.gov/Research-
Statistics-Data-and-Systems/Statistics-Trends-and-Reports/CMSProgramStatistics/Dashboard.html
iv
Centers for Medicare and Medicaid Services. Chronic Conditions. https://www.cms.gov/Research-Statistics-
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v
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vi
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documentation: NHLBI tabulations. http://www.cdc.gov/nchs/data_access/Vitalstatsonline.htm#Mortality_Multiple.
vii
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viii
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ix
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x
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xi
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xii
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xvii
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xviii
Hao, Zirui, et al. Relationship and associated mechanisms between ambulatory blood pressure and clinic
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xix
Wang, Y Claire, et al. Prevalence of Masked Hypertension Among US Adults With Nonelevated Clinic Blood
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xx
Gijón-Conde, T., Graciani, A., López-García, E., Guallar-Castillón, P., García-Esquinas, E., Rodríguez-Artalejo,
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normotension, white-coat hypertension, masked hypertension and sustained hypertension: a population-based
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xxi
O'Brien E, Parati G, Stergiou G, et al. European Society of Hypertension position paper on ambulatory blood
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xxii
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xxiii
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xxiv
Vichayanrat, E., et al. Twenty-four-hour ambulatory blood pressure and heart rate profiles in diagnosing
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xxv
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xxvi
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xxvii
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xxviii
Whelton, P. K., Carey, R. M., Aronow, W. S., Casey, D. E., Collins, K. J., Himmelfarb, C. D., ... &
MacLaughlin, E. J. (2017). 2017 ACC/AHA/AAPA/ABC/ACPM/AGS/APhA/ASH/ASPC/NMA/PCNA guideline for
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xxix
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xxx
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xxxi
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xxxii
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xxxiii
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xxxiv
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xxxv
Grezzana, Giulherme, et al. Impact of Different Normality Thresholds for 24-hour ABPM at the Primary Health
Care Level. Sociedad Brasileira De Cardiologica. 2016. Available Online. DOI: 10.5935/abc.20160204
xxxvi
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xxxvii
Reino-González, Sergio, et al. Validity of clinic blood pressure compared to ambulatory monitoring in
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xxxviii
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xxxix
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xl
Wang, Y Claire, et al. Prevalence of Masked Hypertension Among US Adults With Nonelevated Clinic Blood
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xli
Hermida, Ramón C., et al. Sleep-time blood pressure: Unique sensitive prognostic marker of vascular risk and
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xlii
Wang, Y Claire, et al. Prevalence of Masked Hypertension Among US Adults With Nonelevated Clinic Blood
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xliii
Hermida RC, Moya A, Ayala DE. Ambulatory blood pressure monitoring in diabetes for the assessment and
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xliv
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xlv
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xlvii
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xlviii
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xlix
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li
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lii
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liii
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liv
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lv
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