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Ambulatory blood pressure monitors (24-hour sphygmomanometers) are portable devices that continually record blood pressure while the patient is involved in daily activities. There are various types of ambulatory monitors; this policy addresses fully automated monitors, which inflate and record blood pressure at pre-programmed intervals. Ambulatory blood pressure monitoring (ABPM) has the potential to improve the accuracy of diagnosing hypertension and thus improve the appropriateness of medication treatment.
Ambulatory blood pressure monitoring (ABPM), typically done over a 24-hour period with a fully automated device, provides more detailed blood pressure information than readings typically obtained during office visits. The greater number of readings with ABPM ameliorates the variability of single blood pressure measurements and is more representative of the circadian rhythm of blood pressure, compared with the limited number obtained during office measurement.
There are a number of potential applications of ABPM. One of the most common is evaluating suspected white coat hypertension (WCH), which is defined as an elevated office blood pressure with normal blood pressure 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 blood pressure, ABPM is often intended to identify those with normal ambulatory readings who do not have sustained hypertension. Since this group of patients would otherwise be treated based on office blood pressure readings alone, ABPM could improve outcomes by allowing these patients to avoid unnecessary treatment. However, this assumes patients with WCH are not at increased risk for cardiovascular events and would not benefit from antihypertensive treatment.
This policy does not directly address other uses of ABPM, including its use for the evaluation of ‘masked’ hypertension. Masked hypertension refers to normal blood pressure (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 10-20% of individuals may exhibit this pattern. Other potential uses of ABPM include monitoring patients with established hypertension under treatment; evaluating refractory or resistant blood pressure; evaluating whether symptoms such as lightheadedness correspond with blood pressure changes; evaluating nighttime blood pressure; examining diurnal patterns of blood pressure; and/or other potential uses.
Many ambulatory blood pressure monitors have been cleared for marketing by the U.S. Food and Drug Administration (FDA) through the 510(k) marketing process. As an example of an FDA indication, the Welch Allyn ABPM 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. The system is only for measurement, recording, and display. It makes no diagnosis."
POLICYAutomated ambulatory blood pressure 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:
All other uses of ambulatory blood pressure 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 considered investigational.
POLICY EXCEPTIONSFederal Employee Program (FEP) may dictate that all FDA-approved devices, drugs or biologics may not be considered investigational and thus these devices may be assessed only on the basis of their medical necessity.
The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.
For pediatric patients, the principles of ABPM use to confirm a diagnosis of hypertension are the same as in adults, but there are special considerations as follows:
American Heart Association Classification of Ambulatory BP Levels in Children
Classification Clinic BP Mean Ambulatory BP SBP Loadª <95th percentile <95th percentile <25% >95th percentile <95th percentile <25% <95th percentile >95th percentile >25 >95th percentile <95th percentile 25%-50% >95th percentile >95th percentile 25%-50% >95th percentile >95th percentile >50%
Mean Ambulatory BP
Medically Necessary is defined as those services, treatments, procedures, equipment, drugs, devices, items or supplies furnished by a covered Provider that are required to identify or treat a Member's illness, injury or Nervous/Mental Conditions, and which Company determines are covered under this Benefit Plan based on the criteria as follows in A through D:
A. consistent with the symptoms or diagnosis and treatment of the Member's condition, illness, or injury; and
B. appropriate with regard to standards of good medical practice; and
C. not solely for the convenience of the Member, his or her Provider; and
D. the most appropriate supply or level of care which can safely be provided to Member. When applied to the care of an Inpatient, it further means that services for the Member's medical symptoms or conditions require that the services cannot be safely provided to the Member as an Outpatient.
For the definition of Medically Necessary, “standards of good medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. BCBSMS makes no payment for services, treatments, procedures, equipment, drugs, devices, items or supplies which are not documented to be Medically Necessary. The fact that a Physician or other Provider has prescribed, ordered, recommended, or approved a service or supply does not in itself, make it Medically Necessary.
Investigative is defined as the use of any treatment procedure, facility, equipment, drug, device, or supply not yet recognized as a generally accepted standard of good medical practice for the treatment of the condition being treated and; therefore, is not considered medically necessary. For the definition of Investigative, “generally accepted standards of medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. In order for equipment, devices, drugs or supplies [i.e, technologies], to be considered not investigative, the technology must have final approval from the appropriate governmental bodies, and scientific evidence must permit conclusions concerning the effect of the technology on health outcomes, and the technology must improve the net health outcome, and the technology must be as beneficial as any established alternative and the improvement must be attainable outside the testing/investigational setting.
POLICY HISTORY9/1992: Approved by Medical Policy Advisory Committee (MPAC)
8/1999: Reviewed by MPAC; maintained investigational status
2/8/2002: Investigational definition added, Type of Service and Place of Service added
3/12/2002: New 2002 codes added
4/18/2002: Type of Service and Place of Service deleted
5/22/2002: Sources updated
6/4/2002: Code Reference section updated
7/29/2002: Code Reference section revised
11/2002: Reviewed by MPAC; maintained investigational status, Sources updated, ICD-9 procedure code 89.59 added
11/5/2003: Coding reviewed; no changes
11/18/2004: Reviewed by MPAC, remains investigational, Description revised to be consistent with BCBSA policy # 1.01.02
7/19/2005: Code Reference section reviewed, no changes
7/10/2008: Policy reviewed, no changes
03/02/2012: Policy description updated. Policy statement revised to indicate that automated ambulatory blood pressure 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: Office blood pressure elevation is in the mild to moderate range (<180/110), not requiring immediate treatment with medications; and there is an absence of hypertensive end-organ damage on physical examination and laboratory testing. All other uses of ambulatory blood pressure monitoring for patients with elevated office BP remain investigational. FEP verbiage added to the Policy Exceptions section. Code Reference section changed from Non-Covered to Covered. Added 401.0-401.9 and 796.2 to the Covered Codes table. Deleted outdated references from the Sources section.
04/01/2013: Policy reviewed; no changes to policy statement. Removed ICD-9 procedure code 89.59 from the Code Reference section.
03/12/2014: Added "and monitoring of treatment effectiveness" to the investigational policy statement.
02/11/2015: Policy reviewed; description updated. Policy statement unchanged. Policy guidelines updated regarding ABPM use for pediatric patients.
08/21/2015: Code Reference section updated for ICD-10.
04/26/2016: Policy Guidelines updated to add medically necessary and investigative definitions.
05/26/2016: Policy number added.
08/18/2016: Policy description updated. Policy statements unchanged.
09/30/2016: Code Reference section updated to add new ICD-10 diagnosis codes I16.0, I16.1, and I16.9
SOURCE(S)Blue Cross & Blue Shield Association policy #1.01.02
CODE REFERENCEThis may not be a comprehensive list of procedure codes applicable to this policy.
The code(s) listed below are ONLY medically necessary if the procedure is performed according to the "Policy" section of this document.