CMS Approves Ambulatory Blood Pressure Monitors

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TODAY…. I’m discussing NEW information released from CMS.

 

CMS Decision Summary Ambulatory Blood Pressure Monitoring  Devices

July 2, 2019…..The Centers for Medicare & Medicaid Services (CMS) has determined that the evidence is sufficient to cover Ambulatory blood pressure monitoring (ABPM) for the diagnosis of hypertension in Medicare beneficiaries.

What is hypertension (high blood pressure)?

The American Heart Association (AHA) defines blood pressure as…. a force that pushes blood through a network of arteries, veins and capillaries.

The blood pressure reading is the result of two forces:

  1. the systolic pressure occurs as blood pumps out of the heart and into the arteries;
  2. diastolic pressure is created as the heart rests between heart beats (American Heart Association, 2018).

Elevated blood pressure, or hypertension, leads to harm by causing tiny tears in the interior lining of the arteries and coronary vessels…..stimulating a local immune response in the endothelial cells within the atrial walls.

In these regions, the arterial intima retains apolipoprotein B, which attracts lipid-rich macrophages (foam cells).

These preatherotic lesions develop into atherosclerotic plaques which become increasingly fibrotic and can form fissures, hematomas, thrombi, and calcifications (Swirski and Nahrendorf, 2013). The end result is stiff, thickened arteries that narrow the flow of blood to organs and limbs….which both increases pressure on target organs and limits oxygenation of them.

There is also the risk of atherosclerotic plaque rupture, resulting in distal vascular obstruction and ischemia and infarction of end organs, such as stroke in the brain (U.S. Department of Health & Human Services, 2018).

CMS is lowering the blood pressure threshold for hypertension… from the current policy of 140/90 down to 130/80 to align with the latest society recommendations regarding the diagnostic criteria.

This will allow more patients to use ABPM and receive appropriate treatment if needed.

  1. General

Ambulatory blood pressure monitoring (ABPM) is a diagnostic test… that allows for the identification of various types of high blood pressure.

ABPM devises are small… portable machines that are connected to a blood pressure cuff worn by patients…. that record blood pressure at regular periods over 24 to 48 hours while the patient goes about their normal activities..including sleep.

The recording is interpreted by a physician or non-physician practitioner….and appropriate action is taken based on the findings.

Diagnosis and treatment of high blood pressure is important for the management of various conditions…. including cardiovascular disease and kidney disease.

Ambulatory blood pressure monitoring (ABPM) for the diagnosis of hypertension in Medicare beneficiaries is covered under the following circumstances:

  1. For beneficiaries with suspected “white coat hypertension,” which is defined as an average office blood pressure of systolic blood pressure greater than 130 mm … but less than 160 mm … or diastolic blood pressure greater than 80… but less than 100… on two separate clinic/office visits …..with at least two separate measurements made at each visit and with at least two blood pressure measurements taken outside the office which are <130/80 mm Hg.
  2. For beneficiaries with suspected “masked hypertension,” which is defined as average office blood pressure between 120 and 129 for systolic blood pressure or between 75 and 79 for diastolic blood pressure on two separate clinic/office visits…. with at least two separate measurements made at each visit and with at least two blood pressure measurements taken outside the office which are ≥ 130/80

ABPM devices must be:

  • capable of producing standardized plots of blood pressure measurements for 24 hours with daytime and night-time windows and normal blood pressure bands demarcated;
  • provided to patients with oral and written instructions and a test run in the physician’s office must be performed; and
  • interpreted by the treating physician or treating non-physician practitioner.
  • For eligible patients, ABPM is covered once per year.

CMS has covered ABPM since 2001 only for those patients with documented suspected white coat hypertension. On January 16, 2003, a technical correction for this National Coverage Determination was issued…. to clarify that a physician is required to perform the interpretation of the data obtained through ABPM…. but that there are no requirements regarding the setting in which the interpretation is performed.

CMS received a complete, formal request for a reconsideration of the national coverage determination from the American Heart Association and American Medical Association.

You can view the formal request letter on the tracking sheet on the CMS website.

Benefit Category

Medicare is a defined benefit program. For an item or service to be covered by the Medicare program, it must fall within one of the statutorily defined benefit categories outlined in the Social Security Act.

ABPM may be considered to be within the benefits described under sections:

other diagnostic tests  (§1861(s)(3).

Medicare regulations state in part, that “…diagnostic tests must be ordered by the physician who is treating the beneficiary, that is, the physician who furnishes a consultation or treats a beneficiary for a specific medical problem and who uses the results in the management of the beneficiary’s specific medical problem.” (42 CFR 410.32(a))

 

UNDER APPENDIX C

(Current Section 20.19 of the National Coverage Determination Manual)

Item/Service Description

Ambulatory blood pressure monitoring (ABPM) involves 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 by the physician.

Indications and Limitations of Coverage

ABPM must be performed for at least 24 hours to meet coverage criteria.

ABPM is only covered for those patients with suspected white coat hypertension.

Suspected white coat hypertension is defined as:

Office blood pressure >140/90 on at least three separate clinic/office visits with two separate measurements made at each visit;

  1. At least two documented blood pressure measurements taken outside the office which are <140/90 and
  2. No evidence of end-organ damage.
  3. The information obtained by ABPM is necessary in order to determine the appropriate management of the patient. ABPM is not covered for any other uses.

In the rare circumstance that ABPM needs to be performed more than once

in a patient, the qualifying criteria described above must be met for each subsequent ABPM test.

For those patients that undergo ABPM and have an ambulatory blood pressure of <135/85 with no evidence of end-organ damage, it is likely that their cardiovascular risk is similar to that of normotensives. Patients should be followed over time.

Patients for which ABPM demonstrates a blood pressure of >135/85 may be at increased cardiovascular risk, and a physician may wish to consider antihypertensive therapy

Resources:    Medicare.gov Website

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