Description:
Ambulatory blood pressure (BP) monitors (24-hour sphygmomanometers) are portable devices that continually record BP while the patient is involved in daily activities. There are various types of ambulatory monitors; this evidence review addresses fully automated monitors, which inflate and record BP at preprogrammed intervals. Ambulatory blood pressure monitoring (ABPM) has the potential to improve the accuracy of diagnosing hypertension and thus improve the appropriateness of medication treatment.

For individuals with elevated office BP who receive 24-hour automated ABPM, the evidence includes randomized controlled trials, cohort studies, and studies of diagnostic accuracy. Relevant outcomes are test accuracy, other test performance measures, morbid events, and medication use. Data from large prospective cohort studies have established that ABPM correlates more strongly with cardiovascular outcomes than with other methods of BP measurement. Compared directly with other methods, ABPM performed over a 24-hour period has higher sensitivity, specificity, and predictive value for the diagnosis of hypertension than office or home BP measurements. Substantial percentages of patients with elevated office BP have normal BP on ABPM (white coat hypertension). Prospective cohort studies have reported that patients with white coat hypertension have an intermediate risk of cardiovascular outcomes compared with normotensive and hypertensive patients. The benefit of medication treatment in these patients is uncertain, and they are at risk of overdiagnosis and overtreatment based on office BP measurements alone. Use of ABPM in these patients will improve outcomes by eliminating unnecessary pharmacologic treatment and avoiding adverse events in patients not expected to benefit. The evidence is sufficient to determine that the technology results in a meaningful improvement in the net health outcome.

Background 
Typically done over a 24-hour period with a fully automated device, ambulatory blood pressure monitoring (ABPM) provides more detailed blood pressure (BP) information than readings typically obtained during office visits. The greater number of readings with ABPM ameliorates the variability of single BP measurements and is more representative of the circadian rhythm of BP.

ABPM has a number of potential applications. One of the most common is evaluating suspected white coat hypertension, which is defined as an elevated office BP with normal BP readings outside the physician’s office. The etiology of white coat hypertension is poorly understood but may be related to an "alerting" or anxiety reaction associated with visiting the physician's office.

In assessing patients with elevated office BP, ABPM is often intended to identify those with normal ambulatory readings who do not have sustained hypertension. Because this group of patients would otherwise be treated based on office BP readings alone, ABPM could improve outcomes by allowing these patients to avoid unnecessary treatment. However, this assumes patients with white coat hypertension are not at increased risk for cardiovascular events and would not benefit from antihypertensive treatment.

Other uses of ABPM include monitoring patients with established hypertension under treatment; evaluating refractory or resistant BP; evaluating whether symptoms such as lightheadedness correspond with BP changes; evaluating night-time BP; examining diurnal patterns of BP; and other potential uses.

This evidence review does not directly address other uses of ABPM, including its use for the evaluation of "masked" hypertension. Masked hypertension refers to normal BP readings in the office and elevated BP readings outside of the office. This phenomenon has recently received greater attention, with estimates that up to 10% to 20% of individuals may exhibit this pattern. 

Regulatory Status
Many ambulatory blood pressure monitors have been cleared for marketing by the U.S. Food and Drug Administration through the 510(k) process. As an example of a Food and Drug Administration indication, the Welch Allyn Ambulatory Blood Pressure Monitoring 6100 is indicated “as an aid or adjunct to diagnosis and treatment when it is necessary to measure adult or pediatric patients’ systolic and diastolic blood pressures over an extended period of time.”¹

Policy:
Automated ambulatory blood pressure (BP) monitoring over a 24-hour period may be considered MEDICALLY NECESSARY for patients with elevated office BP, when performed one time to differentiate between ‘white coat hypertension’ and true hypertension, and when the following conditions are met (See Policy Guidelines for considerations in pediatric patients):

• Office BP elevation is in the mild to moderate range (< 180/110), not requiring immediate treatment with medications.
• There is an absence of hypertensive end-organ damage on physical examination and laboratory testing.

All other uses of ambulatory BP monitoring for patients with elevated office BP, including but not limited to repeated testing in patients with persistently elevated office BP, and monitoring of treatment effectiveness, is investigational and/or unproven and therefore considered NOT MEDICALLY NECESSARY.

Policy Guidelines
For pediatric patients, the principles of ambulatory blood pressure monitoring used to confirm a diagnosis of hypertension are the same as in adults, with the following special considerations per 2022 American Heart Association guidelines on ambulatory blood pressure monitoring in children and adolescents:

• A device should be selected that is appropriate for use in pediatric patients, including the use of a cuff size appropriate to the child's size.
• Threshold levels for the diagnosis of hypertension should be based on pediatric normative data, which use gender- and height-specific values derived from large pediatric populations.
• Recommendations from the American Heart Association concerning the classification of hypertension in pediatric patients using clinic and ambulatory blood pressure, which are given in Table PG1.
• Additional considerations from the American Heart Association for the pediatric population are detailed in Supplemental Information.

Table PG1. Classification of Ambulatory Blood Pressure Levels in Children and Adolescents

Classification	Clinic Systolic or Diastolic BP		Mean Ambulatory Systolic or Diastolic BP
Category	< 13 y of age	≥ 13 y of age	< 13 y of age	≥ 13 y of age
Normal BP	< 95th percentile	< 130/80 mmHg	< 95th percentile OR adolescent cut pointsa	< 125/75 mmHg over 24-h AND < 130/80 mmHg while awake AND < 110/65 mmHg while asleep
White coat hypertension	< 95th percentile	≥ 130/80
Masked hypertension	< 95th percentile	< 130/80	≥ 95th percentile OR adolescent cut pointsa	≥ 125/75 mmHg over 24-h OR ≥ 130/80 mmHg while awake OR ≥ 110/65 mmHg while asleep
Ambulatory hypertension	< 95th percentile	≥ 130/80

Adapted from Flynn et al. (2022). [Hypertension. 2022 May 23.101161HYP0000000000000215. PMID: 35603599]
BP: blood pressure.
^a Including 24 h, wake, and sleep blood pressure.

Coding
See the Codes table for details.

Benefit Application
BlueCard^®/National Account Issues
State or federal mandates (e.g., FEP) may dictate that all devices approved by the U.S. Food and Drug Administration (FDA) may not be considered investigational and must be considered only on the basis of medical necessity.

Rationale Evidence reviews assess whether a medical test is clinically useful. A useful test provides information to make a clinical management decision that improves the net health outcome. That is, the balance of benefits and harms is better when the test is used to manage the condition than when another test or no test is used to manage the condition.

The first step in assessing a medical test is to formulate the clinical context and purpose of the test. The test must be technically reliable, clinically valid, and clinically useful for that purpose. Evidence reviews assess the evidence on whether a test is clinically valid and clinically useful. Technical reliability is outside the scope of these reviews, and credible information on technical reliability is available from other sources.

24-Hour Automated Ambulatory Blood Pressure Monitoring
The focus of the current review is on the use of ambulatory blood pressure monitoring (ABPM) in previously untreated patients with elevated office blood pressure (BP). In this situation, ABPM is primarily intended to evaluate white coat hypertension (WCH), or "isolated clinic hypertension." This entity is defined as an elevated office BP with normal BP readings outside the physician's office. It is diagnosed by obtaining multiple out-of-office BP measurements and comparing them with office readings.

Clinical Context and Test Purpose
The purpose of 24-hour automated ABPM in patients who have elevated office BP is to confirm a diagnosis of hypertension and to initiate an appropriate treatment regimen.

The question addressed in this evidence review is: Does the use of ABPM monitoring for the diagnosis of hypertension improve the net health outcome in individuals with elevated office BP?

The following PICO was used to select literature to inform this review.

Populations
The relevant population of interest is individuals with elevated office BP determined using guideline-based parameters.

Interventions
The test being considered is 24-hour automated ABPM.

Comparators
The following tests are currently being used: repeated BP measurement in office and/or home settings.

Outcomes
The general outcomes of interest are accurate BP readings to confirm a diagnosis of hypertension and to initiate appropriate treatment for those with elevated BP readings. Ruling out a diagnosis of hypertension avoids inappropriate treatment and adverse events of therapy. Twenty-four hour automated ABPM may be used when there is persistent unexplained variability in serial elevated BP measurements over a 1 to 3 month period.

Study Selection Criteria
For the evaluation of clinical validity of 24-hour automated ABPM, studies that meet the following eligibility criteria were considered:

• Reported on the accuracy of the marketed version of the technology
• Included a suitable reference standard
• Patient/sample clinical characteristics were described
• Patient/sample selection criteria were described

Establishing reference values for ABPM is integral to providing guidelines for "normal" and "abnormal" ABPM readings.^5,6 Studies that have compared ABPM measurements with office measurement have consistently revealed lower ABPM values. Therefore, it is not possible to use reference values for office BP to evaluate the results of ABPM.

Reference values for ABPM have been derived by several methods: (1) estimates of population-based ABPM results to define the range and distribution of ABPM values; (2) direct comparisons of average ABPM values and office BP to determine the level of ABPM that corresponds to an office BP of 140/90 mmHg; and (3) correlations of ABPM results with cardiovascular outcomes to determine ABPM levels at which the risk for cardiovascular events increases, or is similar to the risk associated with an office BP of 140/90 mmHg.^7,8

Although specific recommendations vary slightly, current thresholds for defining a normal ABPM are a 24-hour average BP of 130/80 mmHg and daytime average BP of 135/85 mmHg. An ABPM (1999) consensus conference task force considered data on the statistical distribution of ABPM, correlation with office BP, and correlation with cardiovascular outcomes in deriving recommendations for reference values for ABPM.⁹ Their recommendations are summarized in Table 1. Subsequent studies have identified racial and ethnic variations in ABPM results,¹⁰ but the impact of these differences on clinical management may be minimal.¹¹

Table 1. Adult Ambulatory Blood Pressure Monitoring Thresholds

ABPM Measure	95th Percentile	Normotension, mmHg	Hypertension, mmHg
24-hour average, mmHg	132/82	≤ 130/80	> 135/85
Daytime average, mmHg	138/87	≤ 135/85	> 140/90
Nighttime average, mmHg	123/74	≤ 120/70	> 125/75

Adapted from Staessen et al. (1999).⁹
ABPM: ambulatory blood pressure monitoring.

Clinically Valid
A test must detect the presence or absence of a condition, the risk of developing a condition in the future, or treatment response (beneficial or adverse).

Review of Evidence
Adults
Many prospective cohort studies have compared ABPM with office BP in predicting cardiovascular events. Although the results of these studies are not entirely consistent, most have reported that ABPM has greater predictive ability for cardiovascular events than office BP measurement.^12,13 A summary of relevant systematic reviews and meta-analyses of these studies follows.

Hansen et al. (2007) conducted a patient-level meta-analysis using data from 4 populations in Belgium, Denmark, Japan, and Sweden (N = 7,030 patients).¹⁴ The predictive values of ABPM and in-clinic BP for fatal and nonfatal cardiovascular events were reported. Both ABPM and office BP were predictors of outcomes in univariate and partially adjusted multivariate models. In the fully adjusted model, ABPM remained a significant predictor of outcomes while office BP did not.

Conen and Bamberg (2008) conducted a meta-analysis of 20 cohort studies that evaluated the correlation between ABPM and outcomes, controlling for office BP in the analysis.¹⁵ Reviewers reported that ABPM was a strong predictor of cardiovascular outcomes and that controlling for office BP had little effect on risk estimates. These results support the hypothesis that risk information obtained from ABPM is independent of that obtained from office BP.

A systematic review by Piper et al. (2015), conducted for the U.S. Preventive Services Task Force, identified 7 studies of diagnostic accuracy.¹⁶ Four were rated high-quality and 3 moderate quality. Four studies directly compared ABPM with automated office BP readings. Using ABPM as the reference standard, the sensitivity of office BP measurement for the diagnosis of hypertension ranged from 51% to 91%, specificity ranged from 97% to 98%, and the positive predictive value ranged from 76% to 84%.

Numerous other studies have directly compared ABPM with office BP and/or home self-measured BP. Hodgkinson et al. (2011) performed a systematic review of studies that compared ABPM with home or office BP and used defined thresholds to determine the accuracy of the diagnosis of hypertension.¹⁷ Of 10 studies identified, 7 compared ABPM with office BP measurements and 3 compared ABPM with home self-measurement. Using a 24-hour ABPM threshold of 135/85 mm Hg, clinic BP measurements had a sensitivity of 75% (95% confidence interval [CI], 61% to 85%) and a specificity of 75% (95% CI, 48% to 90%). Home BP self-measurement had a sensitivity of 86% (95% CI, 78% to 91%) and a specificity of 62% (95% CI, 48% to 75%). The accuracy of office and home BP was considered inadequate for use as a single diagnostic test for hypertension, and it was hypothesized that the use of office and/or home measurements might lead to substantial overdiagnosis and overtreatment.

In a similar systematic review, Stergiou and Bliziotis (2011) compared the accuracy of ABPM with home BP measurement for the diagnosis of hypertension.¹⁸ Sixteen studies were selected. The sensitivity of home BP measurement, compared with ABPM, ranged from 36% to 100% (median, 74%). The specificity ranged from 44% to 96% (median, 84%). Reviewers also reported the diagnostic agreement between the 2 methods of BP measurement, as assessed using the κ statistic. Kappa could be calculated in 11 studies; the range of scores was 0.37 to 0.73 (median, 0.46). This κ level indicates moderate agreement between ABPM and home monitoring in the diagnosis of hypertension.

Children and Adolescents
Ambulatory blood pressure monitoring has been used in children and adolescents for similar purposes as in adults, including use in children and adolescents with elevated office BP to distinguish true hypertension from WCH. The evidence base for children and adolescents is smaller but generally consistent with the evidence in adults. A representative sample of studies follows.

Normative values for pediatric patients have been established by large population-based studies of children and adolescents.¹⁹ Elevated readings are defined as values greater than the 95th percentile for sex, age, and height. These studies have also established that patterns of ambulatory BP in children differ from those in adults. In children, ambulatory BP is generally higher than the corresponding office BP, in contrast to adult ambulatory BP readings that are on average lower than office BP. This pattern is more pronounced in younger children, and the difference progressively declines with age. Guidelines for classification of hypertension in children and adolescents were published by the American Heart Association (2008).²⁰

In a European study reported by Valent-Moric et al. (2012), 139 children and adolescents between the ages of 4 and 19 years with elevated office BP were evaluated by ABPM.²¹ Thirty-two (23.0%) of 139 participants had WCH, as evidenced by a normal 24-hour ABPM result. Of patients with true hypertension, 21 (19.6%) of 107 had evidence of target organ damage, compared with none of the patients with WCH. In a similar study (2000) from the U.S., Sorof and Portman (2000) reported on 67 otherwise healthy children who underwent ABPM, 51 of whom had an elevated office BP.²² Using 3 definitions of WCH at varying BP cutoffs, WCH was identified in 22% to 53% of children with elevated office BP. In a study from Japan, Matsuoka et al. (2002) assessed 206 children and adolescents between the ages of 6 and 25 years who underwent ABPM, 70 of whom had elevated office BP.²³ Among the 70 patients with elevated office BP, 33 (47%) had WCH, as defined by a normal ABPM result. A "white coat" effect of 10 mm Hg or more was reported in 50% of patients with office hypertension and 25% of patients with normal office BP.

Section Summary: Clinically Valid
For adults, studies comparing home BP monitoring to office monitoring with ABPM as the criterion standard have reported that the sensitivity and specificity of alternative methods of diagnosing hypertension are suboptimal. For children and adolescents, reference values for normal and abnormal ABPM results, derived from epidemiologic research, have been used to differentiate WCH from true hypertension.

Clinically Useful
A test is clinically useful if the use of the results informs management decisions that improve the net health outcome of care. The net health outcome can be improved if patients receive correct therapy, more effective therapy, or avoid unnecessary therapy or testing.

Direct Evidence
Direct evidence of clinical utility is provided by studies that have compared health outcomes for patients managed with and without the test. Because these are intervention studies, the preferred evidence would be from randomized controlled trials (RCTs).

Direct evidence of the efficacy of ABPM for improving outcomes in this the outpatient setting would be obtained from RCTs comparing outcomes for (1) patients diagnosed and treated based on conventional BP measurements alone with (2) patients additionally undergoing ABPM used to guide therapy (e.g., withholding or randomizing treatment among those with WCH). This notion parallels the statement from the U.S. National High Blood Pressure Education Program working group on ABPM in 1992: "Ideally, de novo longitudinal studies should be undertaken to determine which ambulatory profiles are associated with increased cardiovascular risk and what transformations of ambulatory profiles induced by antihypertensive therapy are associated with reductions in risk."²⁴ Randomized controlled trials using ABPM to monitor treatment response, but not to diagnose, hypertension have been conducted. However, a subgroup analysis of the Systolic Hypertension in Europe (Syst-Eur) trial (2000) addressed this question indirectly.²⁵

The Syst-Eur trial (2000), a large, multicenter RCT, enrolled patients 60 years of age or older with isolated systolic hypertension and randomized them to antihypertensive treatment or placebo.²⁵ A subgroup analysis evaluated 695 patients (from the total Syst-Eur sample of 4695 patients) who underwent 24-hour ABPM in addition to the usual study protocol. Conventional BP was defined from the mean of 6 baseline clinic BP readings (2 readings obtained with the patient seated at each of 3 baseline visits at least 1 month apart). Participants were classified into 3 groups based on ABPM readings: nonsustained hypertension (i.e., WCH), mild-sustained hypertension, and moderate-sustained hypertension. Reduction in cardiovascular events was compared between active and placebo groups among patients in each category. For patients with nonsustained hypertension, there was a numerically lower rate of adverse outcomes in the treated group for stroke (0 vs. 2; p = .16) and cardiovascular events (2 vs. 6; p = .17) (i.e., differences were not statistically significant). There was a significant reduction in events with treatment only among patients with moderate-sustained hypertension.

Staessen et al. (1999) analyzed follow-up data (median follow-up, 4.4 years) from an apparently overlapping subset of 808 older individuals from the Syst-Eur trial who had isolated systolic hypertension measured conventionally (i.e., systolic BP, 160 to 219 mmHg; diastolic BP, < 95 mmHg) and BP by ABPM. Average systolic BP and diastolic BP were higher with conventional measurements (by 21.9 mm and 1.9 mmHg, respectively). Ambulatory blood pressure monitoring was significantly associated with cardiovascular endpoints, even when conventional BP was taken into account.⁹

Chain of Evidence
Indirect evidence on clinical utility rests on clinical validity. If the evidence is insufficient to demonstrate test performance, no inferences can be made about clinical utility.

Well-designed, prospective cohort studies could provide indirect evidence on the potential benefit of treating patients with WCH. Ideally, prospective studies would compare the outcomes of untreated patients with WCH to normotensive and sustained hypertensive patients (the latter being treated). Studies would have to control for important potential confounders such as adequacy of BP control, age, sex, smoking status, lipid levels, and diabetes. Well-designed and -conducted prospective cohort studies finding that untreated WCH patients have a cardiovascular event risk similar to that of normotensive patients would imply that these patients accrue little treatment benefit. In contrast, if the cardiovascular risk for patients with WCH is increased, then there is a potential benefit to treatment.

The systematic review by Piper et al. (2015), performed for the U.S. Preventive Services Task Force, identified 11 cohort studies that compared ABPM with alternative methods for predicting cardiovascular events.¹⁶ Six studies were rated good quality and 5 were rated fair quality. There was a significant correlation between ABPM measures and outcomes in most studies. For each 10-mm increase in the average 24-hour systolic BP, the hazard ratio for fatal and nonfatal cardiovascular events ranged from 1.11 to 1.42, and the hazard ratio for stroke ranged from 1.28 to 1.40.

Section Summary: Clinically Useful
Data from large prospective cohort studies have established that ABPM correlates more strongly with cardiovascular outcomes than other methods of BP measurement and that WCH, as defined by ABPM, is associated with an intermediate risk of cardiovascular outcomes compared with normotensive and hypertensive patients.

Summary of Evidence
For individuals with elevated office BP who receive 24-hour automated ABPM, the evidence includes RCTs, cohort studies, and studies of diagnostic accuracy. Relevant outcomes are test accuracy, other test performance measures, morbid events, and medication use. Data from large prospective cohort studies have established that ABPM correlates more strongly with cardiovascular outcomes than with other methods of BP measurement. Compared directly with other methods, ABPM performed over a 24-hour period has higher sensitivity, specificity, and predictive value for the diagnosis of hypertension than office or home BP measurements. Substantial percentages of patients with elevated office BP have normal BP on ABPM. Prospective cohort studies have reported that patients with WCH have an intermediate risk of cardiovascular outcomes compared with normotensive and hypertensive patients. The benefit of medication treatment in these patients is uncertain, and they are at risk of overdiagnosis and over treatment based on office BP measurements alone. Use of automated ABPM in these patients will improve outcomes by eliminating unnecessary pharmacologic treatment and avoiding adverse events in patients not expected to benefit. The evidence is sufficient to determine that the technology results in an improvement in the net health outcome.

The purpose of the following information is to provide reference material. Inclusion does not imply endorsement or alignment with the evidence review conclusions.

Practice Guidelines and Position Statements
Guidelines or position statements will be considered for inclusion in Supplemental Information if they were issued by, or jointly by, a U.S. professional society, an international society with U.S. representation, or National Institute for Health and Care Excellence (NICE). Priority will be given to guidelines that are informed by a systematic review, include strength of evidence ratings, and include a description of management of conflict of interest.

American Academy of Pediatrics
In 2017, the American Academy of Pediatrics published clinical guidelines for the screening and management of high blood pressure (BP) in children and adolescents.²⁶ Table 2 lists the recommendations made.

Table 2. Guidelines on Screening and Management of High Blood Pressure in Children and Adolescents

Recommendation	LOE	SOR
"ABPM should be performed for confirmation of HTN in children and adolescents with office BP measurements in the elevated BP category for 1 year or more or with stage 1 HTN over 3 clinic visits."	C	Moderate
"Routine performance of ABPM should be strongly considered in children and adolescents with high-risk conditions to assess HTN severity and determine if abnormal circadian BP patterns are present, which may indicate increased risk for target organ damage."	B	Moderate
"ABPM should be performed by using a standardized approach with monitors that have been validated in a pediatric population, and studies should be interpreted by using pediatric normative data."	C	Moderate
"Children and adolescents with suspected WCH should undergo ABPM."	B	Strong

ABPM: ambulatory blood pressure monitoring; BP: blood pressure; HTN: hypertension; LOE: level of evidence; SOR: strength of recommendation; WCH: white coat hypertension.

American College of Cardiology et al.
In 2017, the American College of Cardiology, with 10 other medical specialty societies, published guidelines on the prevention, detection, evaluation, and management of high BP in adults.²⁷ Table 3 lists the recommendations made.

Table 3. Guidelines on Prevention, Detection, Evaluation, and Management of High Blood Pressure in Adults

Recommendations	COR	LOE
"In adults with an untreated SBP greater than 130 mmHg but less than 160 mmHg or DBP greater than 80 mm Hg but less than 100 mmHg, it is reasonable to screen for the presence of white coat hypertension by using either daytime ABPM or HBPM before diagnosis of hypertension."	IIa	B-NR
"In adults with white coat hypertension, periodic monitoring with either ABPM or HBPM is reasonable to detect transition to sustained hypertension."	IIa	C-LD
"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."	IIa	C-LD
"In adults with untreated office BPs that are consistently between 120 mmHg and 129 mmHg for SBP or between 75 mmHg and 79 mmHg for DBP, screening for masked hypertension with HBPM (or ABPM) is reasonable."	IIa	B-NR
"In adults on multiple-drug therapies for hypertension and office BPs within 10 mmHg above goal, it may be reasonable to screen for white coat effect with HBPM (or ABPM)."	IIb	C-LD

ABPM: ambulatory blood pressure monitoring; COR: class of recommendation; DBP: diastolic blood pressure; HBPM: home blood pressure monitoring; LOE: level of evidence; SBP: systolic blood pressure.

American Heart Association
In 2022 , the American Heart Association updated its 2014 recommendations²⁸ on routine ambulatory blood pressure monitoring (ABPM) in children and adolescents, which included the following:²⁹

• "To confirm the diagnosis of hypertension in a patient with hypertension on the basis of clinic BP measurements:
  • Distinguish between ambulatory hypertension and WCH [white coat hypertension].
• To better assess BP in a patient with clinic BP persistently in the elevated but not hypertensive range
• To evaluate for possible masked hypertension when there is a clinical suspicion of hypertension, but clinic BP readings are normal or in the elevated BP range
• To evaluate for possible masked hypertension when there is clinical suspicion of hypertension, but clinic BP readings are normal or in the elevated BP range
• To assess BP patterns in high-risk patients:
  • Assess for abnormal circadian variation in BP, such as abnormal dipping, or isolated nocturnal hypertension in patients with diabetes, CKD [chronic kidney disease], solid-organ transplant, and severe obesity with or without sleep-disordered breathing.
  • Assess the severity and persistence of BP elevation in patients at high risk for hypertensive TOD [target organ damage].
• To optimize drug therapy for hypertension:
  • Confirm BP control in treated patients.
  • Evaluate for pseudo-resistant hypertension.
  • Determine if symptoms suggestive of hypotension can be confirmed as such.
• An ABPM device suitable for use in children should be selected:
  • Only oscillometric or auscultatory ABP devices that have been validated according to American National Standards Institute (ANSI)/Association for the Advancement of Medical Instrumentation (AAMI)/International Organization for Standardization (ISO) should be used. The British Hypertension standard is acceptable for devices marketed before publication of the ANSI/AAMI/ISO standards.
  • Appropriate cuff sizes as recommended in the 2017 CPG [clinical practice guideline] must be available for the device selected."

In 2019, the American Heart Association published a new scientific statement on BP monitoring in humans that provides an overview of BP measurement overall.³⁰ This scientific statement includes a summary of current knowledge about ABPM on topics such as medical staff or provider training; devices, cuffs and equipment; patient preparation and instruction; frequency and number of readings; duration of monitoring, and analysis of readings.

National Institute for Health and Care Excellence
In 2022, the NICE updated its 2019 guidance on the diagnosis and management of hypertension in adults.³¹ For diagnosing hypertension, the NICE made the following recommendations for ABPM:

• "If the clinic blood pressure is between 140/90 mmHg and 180/120 mmHg, offer ambulatory blood pressure monitoring (ABPM) to confirm the diagnosis of hypertension."
• "If ABPM is unsuitable or the person is unable to tolerate it, offer home blood pressure monitoring (HBPM) to confirm the diagnosis of hypertension."
• "When using ABPM to confirm a diagnosis of hypertension, ensure that at least 2 measurements per hour are taken during the person's usual waking hours. Use the average of at least 14 measurements taken during usual waking hours to confirm a diagnosis of hypertension."
• "Confirm diagnosis of hypertension in people with a clinic blood pressure of 140/90 mmHg or higher AND ABPM daytime average or HBPM average of 135/85 mmHg or higher."

U.S. Preventive Services Task Force Recommendations
The U.S. Preventive Services Task Force (USPSTF) (2021) commissioned a systematic review and reaffirmed its prior 2015 recommendations on screening for hypertension in adults.^32,33,34 The following recommendation was given a grade A rating:

• "The USPSTF recommends screening for high blood pressure in adults aged 18 years or older. The USPSTF recommends obtaining measurements outside of the clinical setting for diagnostic confirmation before starting treatment."

The document further elaborated on the choice of office measurements, recommending ABPM as the reference standard for confirming the diagnosis of hypertension.³⁴

In 2021, the USPSTF issued updated recommendations for high BP screening in children and adolescents.³⁵ Based on a systematic review of 42 studies, the USPSTF concluded that the current evidence is insufficient to assess the balance of benefits and harms of screening for high BP in this population.³⁶

Ongoing and Unpublished Clinical Trials
Some currently ongoing and unpublished trials that might influence this review are listed in Table 4.

Table 4. Summary of Key Trials

NCT No.	Trial Name	Planned Enrollment	Completion Date
Ongoing
NCT04826250	The Effect of Timing of Antihypertensive Medication on Diurnal Fluctuations in Blood Pressure Using a Wearable Sensor With Continuous Monitoring (ABPM)	150	June 2022 (recruiting)
NCT03480217	Assessing the Effectiveness of a Multifaceted Implementation Strategy to Increase the Uptake of the USPSTF Hypertension Screening Recommendations in an Ambulatory Care Network: a Cluster Randomized Trial	2000	July 2022 (ongoing)
NCT04726761	Frequent Cuff Inflations May Disrupt the Accuracy of 24-hour Ambulatory Blood Pressure Monitoring	154	Aug. 2022 (recruiting)

NCT: national clinical trial.

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14. Hansen TW, Kikuya M, Thijs L, et al. Prognostic superiority of daytime ambulatory over conventional blood pressure in four populations: a meta-analysis of 7,030 individuals. J Hypertens. Aug 2007; 25(8): 1554-64. PMID 17620947
15. Conen D, Bamberg F. Noninvasive 24-h ambulatory blood pressure and cardiovascular disease: a systematic review and meta-analysis. J Hypertens. Jul 2008; 26(7): 1290-9. PMID 18550999
16. Piper MA, Evans CV, Burda BU, et al. Diagnostic and predictive accuracy of blood pressure screening methods with consideration of rescreening intervals: a systematic review for the U.S. Preventive Services Task Force. Ann Intern Med. Feb 03 2015; 162(3): 192-204. PMID 25531400
17. Hodgkinson J, Mant J, Martin U, et al. Relative effectiveness of clinic and home blood pressure monitoring compared with ambulatory blood pressure monitoring in diagnosis of hypertension: systematic review. BMJ. Jun 24 2011; 342: d3621. PMID 21705406
18. Stergiou GS, Bliziotis IA. Home blood pressure monitoring in the diagnosis and treatment of hypertension: a systematic review. Am J Hypertens. Feb 2011; 24(2): 123-34. PMID 20940712
19. Stergiou GS, Karpettas N, Panagiotakos DB, et al. Comparison of office, ambulatory and home blood pressure in children and adolescents on the basis of normalcy tables. J Hum Hypertens. Apr 2011; 25(4): 218-23. PMID 20520632
20. Urbina E, Alpert B, Flynn J, et al. Ambulatory blood pressure monitoring in children and adolescents: recommendations for standard assessment: a scientific statement from the American Heart Association Atherosclerosis, Hypertension, and Obesity in Youth Committee of the council on cardiovascular disease in the young and the council for high blood pressure research. Hypertension. Sep 2008; 52(3): 433-51. PMID 18678786
21. Valent-Moric B, Zigman T, Zaja-Franulovic O, et al. The importance of ambulatory blood pressure monitoring in children and adolescents. Acta Clin Croat. Mar 2012; 51(1): 59-64. PMID 22920003
22. Sorof JM, Portman RJ. White coat hypertension in children with elevated casual blood pressure. J Pediatr. Oct 2000; 137(4): 493-7. PMID 11035827
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25. Fagard RH, Staessen JA, Thijs L, et al. Response to antihypertensive therapy in older patients with sustained and nonsustained systolic hypertension. Systolic Hypertension in Europe (Syst-Eur) Trial Investigators. Circulation. Sep 05 2000; 102(10): 1139-44. PMID 10973843
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27. Whelton PK, Carey RM, Aronow WS, et al. 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: Executive Summary: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. J Am Coll Cardiol. May 15 2018; 71(19): 2199-2269. PMID 29146533
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31. National Institute for Health and Care Excellence. Hypertension in adults: diagnosis and management [NG136]. 2022; https://www.nice.org.uk/guidance/ng136. Accessed June 2, 2022.
32. U.S. Preventive Services Task Force. Screening for Hypertension in Adults. 2021; https://www.uspreventiveservicestaskforce.org/uspstf/recommendation/hypertension-in-adults-screening. Accessed June 1, 2022.
33. Siu AL. Screening for high blood pressure in adults: U.S. Preventive Services Task Force recommendation statement. Ann Intern Med. Nov 17 2015; 163(10): 778-86. PMID 26458123
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35. U.S. Preventive Services Task Force. High Blood Pressure in Children and Adolescents: Screening. 2020; https://www.uspreventiveservicestaskforce.org/uspstf/recommendation/blood-pressure-in-children-and-adolescents-hypertension-screening. Accessed June 2, 2022.
36. Gartlehner G, Vander Schaaf EB, Orr C, et al. Screening for Hypertension in Children and Adolescents: Updated Evidence Report and Systematic Review for the US Preventive Services Task Force. JAMA. Nov 10 2020; 324(18): 1884-1895. PMID 33170247
37. Centers for Medicare & Medicaid Services. National Coverage Determination (NCD) for Ambulatory Blood Pressure Monitoring [20.19]. 2019; https://www.cms.gov/medicare-coverage-database/details/ncd-details.aspx?ncdid=254. 

Coding Section

Codes	Number	Description
CPT	93784	Ambulatory blood pressure monitoring, including recording, scanning analysis, interpretation and report
	93786	Recording only
	93788	Scanning analysis with report
	93790	Physician review with interpretation and report
ICD-9 Procedure	No Code
ICD-9 Diagnosis	401.0-401.9	Essential hypertension code range
	796.2	Elevated blood pressure reading without diagnosis of hypertension
HCPCS	A4670	Automatic blood pressure monitor
ICD-10-CM (effective 10/01/15)	I10	Essential (primary) hypertension
	I11.0-I11.9	Hypertensive heart disease code range
	R03.0-R03.1	Abnormal blood-pressure reading, without diagnosis code range
	Z01.30-Z01.31	Encounter for examination of blood pressure code range
ICD-10-PCS (effective 10/01/15)		Not applicable. ICD-10-PCS codes are only used for inpatient services. Guideline is only for outpatient services.
Type of Service	DME
Place of Service	Inpatient/Outpatient/Physician's Office/ Home

Procedure and diagnosis codes on Medical Policy documents are included only as a general reference tool for each policy. They may not be all-inclusive.

This medical policy was developed through consideration of peer-reviewed medical literature generally recognized by the relevant medical community, U.S. FDA approval status, nationally accepted standards of medical practice and accepted standards of medical practice in this community, Blue Cross Blue Shield Association technology assessment program (TEC) and other nonaffiliated technology evaluation centers, reference to federal regulations, other plan medical policies, and accredited national guidelines.

"Current Procedural Terminology © American Medical Association. All Rights Reserved" 

History From 2024 Forward     

07/10/2024 Annual review, no change to policy intent 

01012024  NEW POLICY