Medical Policies - Radiology


Pulse-Echo Ultrasound Bone Density Measurement

Number:RAD601.071

Effective Date:07-01-2018

Coverage:

*CAREFULLY CHECK STATE REGULATIONS AND/OR THE MEMBER CONTRACT*

Bone density measurement using pulse-echo ultrasound is considered experimental, investigational and/or unproven.

NOTE 1: This policy does not address other bone mineral density (BMD) technologies, including ultrasound densitometry, dual x-ray absorptiometry (DXA), or peripheral measurements of BMD to screen for the risk of or the diagnosis of osteoporosis.

Description:

Bone mineral density (BMD) studies can be used to identify individuals with osteoporosis and to monitor response to osteoporosis treatment, with the goal of reducing the risk of fracture. One technology that is available is the pulse-echo ultrasound, which is portable and used to screen and diagnose osteoporosis.

Background

Risk factors for fracture include low bone mass, low bone strength, a personal history of fracture as an adult, or a history of fracture in a first-degree relative. Osteoporosis, defined as low bone mass leading to an increased risk of fragility fractures, is an extremely common disease in the elderly population due to age-related bone loss in both sexes and menopause-related bone loss in women. The World Health Organization (WHO) has diagnostic thresholds for osteoporosis based on bone mineral density (BMD) measurements compared with a T-score, which is the standard deviation difference between an individual’s BMD and that of a young-adult reference population. Conditions that can cause or contribute to osteoporosis include lifestyle factors such as low intake of calcium, high intake of alcohol or cigarette smoking, and thinness. Other risk factors for osteoporosis include certain endocrine, hematologic, gastrointestinal tract and genetic disorders, hypogonadal states, and medications.

BMD can be measured using different techniques in a variety of central (i.e., hip or spine) or peripheral (i.e., wrist, finger, heel) sites. While BMD measurements are predictive of fragility fractures at all sites, central measurements of the hip and spine are the most predictive. Fractures of the hip and spine (i.e., vertebral fractures) are also considered to be the most clinically relevant. BMD is typically expressed as a T-score.

The utility of screening BMD measurements can be established by demonstrating that screening identifies a population at increased risk of fracture and that, by treating those at-risk individuals, the rate of fractures is reduced thereby lowering fracture-related morbidity and mortality. These potential benefits of screening should outweigh the risks of screening (radiation exposure) or false positives (initiation of unnecessary treatment).

Ultrasound densitometry is a technique for measuring BMD at peripheral sites, typically the heel but also the tibia and phalanges. Compared with osteoporotic bone, normal bone demonstrates higher attenuation of the ultrasound wave and is associated with a greater velocity of the wave passing through bone. Ultrasound densitometry has no radiation exposure, and machines may be purchased for use in an office setting.

These techniques dominate BMD testing. Single- and dual-photon absorptiometry and radiographic absorptiometry are now rarely used and may be considered obsolete.

Pulse-Echo Ultrasound for Bone Density Measurement

Bindex® (Bone Index Finland OY) is a pulse-echo ultrasound tool for the screening and diagnosis of osteoporosis. (1) The device measures cortical bone thickness at the upper shaft of the tibia and calculates a density index from this measure alongside other clinical risk factors or patient characteristics.

The portable, pocket-size handheld Bindex® device is a transducer that can be connected to any computer or Windows tablet, through a USB (universal serial bus) cable. (1) A custom ruler is used to measure to a point one-third of the length of the proximal tibia from the knee joint, where the Bindex® ultrasound measurement will be taken. Ultrasound gel is applied to the measurement site and the hardware is calibrated using the Bindex® software. To take a measurement, the transducer is moved over the measurement site for a few minutes. Cortical thickness is estimated by multiplying the speed of sound by the time lag between ultrasound echoes from the front and back surfaces of the cortical bone layer. The transducer collects the sound waves reflected from the bone and transmits the signal to the connected computer, which immediately displays the results using the Bindex® software. The Bindex® measurement typically takes under 15 minutes to do.

Bindex® software uses the cortical thickness measurement plus age, weight and height of the person being measured, to calculate the density index. (1) These values are displayed alongside pre-determined density index thresholds that estimate the probability of osteoporosis. Results are displayed using a 'traffic light' color bar; green shows a low probability of osteoporosis and a low need for further investigation, yellow shows that more investigations are needed, and red shows a high risk of osteoporosis and a need for treatment without dual-energy X?ray absorptiometry (DXA). Results are saved in the Bindex® database on the computer and can be exported in a portable document format (PDF).

Regulatory Status

The Bindex® device and software (Bone Index Finland, Ltd., Kuopio, Finland) has been cleared for marketing by the U.S. Food and Drug Administration (FDA) through the 510(k) process on January 9, 2017 as the Bindex® BI-2 device is identical to the predicate device. (2, 3) The FDA-approved label states, “Bindex measures apparent cortical bone thickness at the proximal tibia and can be used in conjunction with other clinical risk factors or patient characteristics as an aid to the physician in the diagnosis of osteoporosis and other medical conditions leading to reduced bone strength and in the determination of fracture risk.” (3) The Bindex® BI-2 system consists of a handheld ultrasound transducer and software. Bindex® is designed to help guide further investigations and treatment in people who may have osteoporosis and may be used in the primary, secondary or home care setting (for example, on a home visit). Bindex® would be used by a trained healthcare professional. FDA product code: MUA.

Rationale:

This medical policy was created in July 2018 and was based on guidelines published in the United Kingdom (U.K.) by the National Institute for Health and Care Excellence (NICE) in 2017. The following is a summary of peer reviewed scientific literature search of the MedLine database through June 6, 2018.

Medical policies assess the clinical evidence to determine whether the use of a technology improves the net health outcome. Broadly defined, health outcomes are length of life, quality of life, and ability to function - including benefits and harms. Every clinical condition has specific outcomes that are important to patients and to managing the course of that condition. Validated outcome measures are necessary to ascertain whether a condition improves or worsens; and whether the magnitude of that change is clinically significant. The net health outcome is balance of benefits and harms.

To assess whether the evidence is sufficient to draw conclusions about the net health outcome of a technology, 2 domains are examined: the relevance and the quality and credibility. To be relevant, studies must represent one or more intended clinical use of the technology in the intended population and compare an effective and appropriate alternative at a comparable intensity. For some conditions the alternative will be supportive care or surveillance. The quality and credibility of the evidence depend on study design and conduct, minimizing bias and confounding that can generate incorrect findings. The randomized controlled trial (RCT) is preferred to assess efficacy; however, in some circumstances, nonrandomized studies may be adequate. RCTs are rarely large enough or long enough to capture less common adverse events and long-term effects. Other types of studies can be used for these purposes and to assess generalizability to broader clinical populations and settings of clinical practice.

Pulse-Echo (PE) Ultrasound for Bone Density Measurement

Ultrasound transmission measurement through the os calcis is an emerging technique and a promising clinical tool for early assessment of osteoporosis. (4) In a Finnish study from Jurvelin et al. (2010), the investigators reported on the frequency measurements of 2.25 and 5.0 megahertz (MHz) to exact the dual frequency ultrasound (DRUS) used in axial pulse-echo (PE) ultrasound in order to minimize the effects on soft tissues overlying the bone and have the correct PE parameters. (5) The result was confirmation that DRUS used in PE ultrasound technique did detect the changes in bone density, despite variable composition of soft tissue. The safety frequency levels to soft tissue were determined by an earlier study from Reikkinen et al. in 2008, from Finland. (6) The prior study from Reikkinen et al. in 2006 studied the range of frequency from 0.3 to 6.7 MHz to determine what frequencies could be utilized. (7) Despite the Reikkinen et al. 2006 assessment having been done on human trabecular bone samples (n=25), the comparative study was necessary to determine the MHz frequencies for several techniques. A comparison was done using acoustic/ultrasound, dual energy x-ray absorptiometry (DXA) and mechanical techniques. The numerical corrections for PE ultrasound frequencies were determined to reduce any uncertainties to the overlying soft tissues and to arrive at the correct bone mineral density (BMD) measurements.

The primary evidence used for this medical policy were 3 studies of 2218 women: Karjalainen et al. (2016) (8), Schousboe et al. (2017) (9), and Karjalainen et al. (2018) (10), which are compared and summarized in Table 1. NICE reviewed 2 of the studies and included in their assessment of 2017. (1, 8, 9)

Table 1. Summary of Study Trials (1, 8-10)

Study

N of Pts

Study Design

Method

Outcome

Strength and Limitation

Karjalainen et al. (2016) (8)

Based in Finland

572

Study design unclear if prospective or retrospective.

Age range from 20 to 91 years.

PE compared with DXA.

FRAX questionnaire used to compare to the Bindex® software risk calculation score.

The FRAX followed by Bindex® approach showed 85% sensitivity and 79% specificity for treatment decisions based on the Finnish standard criteria.

The false negative rate of the FRAX followed by Bindex® approach was 14.6%.

Using the FRAX followed by Bindex® approach, 84% (of the total number of women) avoided DXA tests with the Bindex® approach. Reproducibility between Bindex® operators was good.

The study did not take into account the use of DXA for baseline measurements to monitor treatment efficacy.

The same population was used to develop and validate the DI index thresholds, so the results do not validate the performance of Bindex®.

Schousboe et al. (2017) (9)

Based in USA and Finland

555

Post-menopausal women (43% with hip osteoporosis, 57% without hip osteoporosis)

Age range from 50 to 89 years.

PE compared with DXA.

Using single- or multi-site DI measures (taken from the proximal and distal tibia and radius) were shown to have good sensitivity and specificity (80.0%-82.0%). Avoiding DXA could have been done in 73% of pts.

Recruitment by mail has an effect on the participation of frail individuals with hip osteoporosis who could not travel to the clinic. The manufacturer states that measurements should be taken from the upper shaft of the tibia, but measurements were taken from other bones in this study. Authors suggest more prospective studies.

Karjalainen et al. (2018) (10)

Based in Finland

1091

Study design unclear if prospective or retrospective.

Post-menopausal women (888 had 1 or more risk factors, 100 deemed healthy).

Age range from 50 to 89 years.

PE compared with DXA.

Using multi-site DI measures (taken from tibia and radius, with 988 women having measurements of the hip) were shown to have good sensitivity and specificity (93.7%-81.6%). Applications of thresholds for DI showed 32% of subjects would require additional DXA. For single-site for sensitivity and specificity was 84.7%-82.0%).

The study was not a RCT, nor was it clear as to the study design.

Additionally, there was no details regarding recruitment or what was included from physical finding to be considered healthy or no-risk/low-risk for osteoporosis.

Table Key:

N: number.

pts: patients.

PE: pulse-echo ultrasound.

DXA: dual-energy X-ray absorptiometry.

DI: density index.

FRAX: fracture risk assessment tool.

RCT: randomized controlled trial.

Ongoing and Unpublished Clinical Trials

A search of ClinicalTrials.gov in June 2018 yielded the following completed clinical trials.

NCT Number

Trial Name

Planned Enrollment

Completion Date

Completed

NCT01978834a

Age Depended Diagnostic Thresholds for Osteoporosis Bindex Ultrasonometer

560

Oct 2014

(completed, unpublished)

NCT01935232a

Bindex Ultrasonometer for Osteoporosis Diagnostics

135

Dec 2014 (terminated early)

Ongoing

There were no ongoing clinical trials that would likely influence this policy.

Table Key:

NCT: National Clinical Trial.

a: industry-sponsored clinical trial.

There were no clinical trials found using “osteoporosis; osteoporosis screening, osteoporosis risk” when combined with “pulse-echo, Bindex”.

Practice Guidelines and Position Statements

National Institute for Health and Care Excellence (NICE)

In May of 2017, the U.K.’s NICE released a medical technology briefing for the use of Bindex® as a method to investigate suspected osteoporosis. (1). While NICE did not have a specific recommendation, they did provide a summary of the main points of evidence and key uncertainties:

“The main points from the evidence summarized in this briefing are from 2 diagnostic accuracy studies (1 US and 1 Finnish), including a total of 1,127 women in primary care. The studies show reasonable agreement for osteoporosis risk when determined in women with intermediate risk using FRAX and Bindex compared with FRAX and DXA.” (NOTE, this technology review did not include the third study of 1091 women published in January 2018 by Karjalainen et al. [10].

“Key uncertainties around the evidence are that there are no prospective studies showing the effect of Bindex on the need for DXA scans, and limited data on the correlation between tibial bone thickness and femoral bone mineral density. Also, the Bindex density index threshold values are only validated in women of white European family origin, which may limit the generalizability of the results.”

National Osteoporosis Society (NOS)

The U.K.’s NOS position statement released in 2001, laid out a “code of practice” for providers in Europe regarding utilization of quantitative ultrasound services to identify those at risk for osteoporosis among women going through or following menopause. (11) The NOS made the following key recommendations:

1. “As quantitative ultrasound (QUS) does not measure bone mineral content or density directly, it cannot be used to diagnose osteoporosis as currently defined by bone mineral content (BMC) or bone mineral density (BMD) assessment.

2. Low QUS is an independent risk factor for future osteoporotic fracture in post-menopausal women.

3. Low QUS parameters are stronger predictors of low bone mass than clinical risk factors; individuals found to have low QUS parameters (as defined by machine-specific normative data) may either be referred for confirmation of the diagnosis by axial (preferably hip) BMD measurement or be advised to receive preventative therapy if other strong clinical risk factors are present.

4. In most cases QUS measurements cannot be used to monitor bone loss or assess response to therapy in an individual patient.

5. At present the use of QUS for assessment of bone mass in children, pre-menopausal women and men for clinical care purposes is not recommended.

6. Trained staff must operate all QUS devices and they should be able to demonstrate precision of measurement within the manufacturer’s specification. An experienced physician with specific knowledge of osteoporosis and its management must interpret results.”

However, the NOS position statement does not address the use of PE ultrasound to determine osteoporosis risk or for screening.

American College of Obstetricians and Gynecologists (ACOG)

In 2012 (reaffirmed 2014), the ACOG updated its guidelines on managing osteoporosis in women. (12) The guidelines recommended that bone mineral density (BMD) screening should begin for all women at age 65 years. In addition, ACOG recommended screening for women younger than 65 years in whom the FRAX indicates a 10-year risk of osteoporotic fracture of at least 9.3%. Alternatively, ACOG recommended BMD screening women in younger than 65 or with any of the following risk factors (they are similar, but not identical to risk factors in FRAX):

Personal medical history of a fragility fracture;

Parental medical history of hip fracture;

Weight less than 127 pounds;

Medical causes of bone loss (i.e., medications or disease);

Current smoker;

Alcoholism;

Rheumatoid arthritis;

For women who begin medication treatment for osteoporosis, a repeat BMD is recommended 1 to 2 years later to assess effectiveness. If BMD is improved or stable, additional BMD testing (in the absence of new risk factors) is not recommended. The guideline notes that it generally takes 18 to 24 months to document a clinically meaningful change in BMD and thus a 2-year interval after treatment initiation is preferred to 1 year;

The guidelines do not specifically discuss repeat BMD screening for women who have a normal finding on the initial test;

Routine BMD screening is not recommended for newly menopausal women as a “baseline” screen.

However, the ACOG guidelines do not address the use of PE ultrasound to determine osteoporosis risk or for screening.

National Osteoporosis Foundation (NOF)

The NOF updated its practice guidelines in 2014. (13) NOF guidelines recommended that all postmenopausal women and men ages 50 and older be evaluated clinically for osteoporosis risk to determine the need for BMD testing. Indications for BMD testing included:

“[W]omen age 65 and older and men age 70 and older” regardless of clinical risk factors

“[P]ostmenopausal women and men above age 50-69, based on risk factors profile”

“[P]ostmenopausal women and men age 50 and older who have had an adult age fracture…”

“Adults with a condition … or taking a medication … associated with low bone mass or bone loss”

NOF stated that measurements for monitoring patients should be performed in accordance with medical necessity, expected response, and in consideration of local regulatory requirements.

NOF recommended that repeat BMD assessments generally agree with Medicare guidelines of every 2 years, but recognized that testing more frequently may be warranted in certain clinical situations.

NOF also indicated that:

“Central DXA [dual x-ray absorptiometry] assessment of the hip or lumbar spine is the ‘gold standard’ for serial assessment of BMD. Biological changes in bone density are small compared to the inherent error in the test itself, and interpretation of serial bone density studies depends on appreciation of the smallest change in BMD that is beyond the range of error of the test. This least significant change (LSC) varies with the specific instrument used, patient population being assessed, measurement site, technologist’s skill with patient positioning and test analysis, and the confidence intervals used. Changes in the BMD of less than 3-6 % at the hip and 2-4 % at the spine from test to test may be due to the precision error of the testing itself.”

However, the NOF practice guidelines do not address the use of PE ultrasound to determine osteoporosis risk or for screening.

American College of Physicians (ACP)

The 2008 guidelines from the ACP recommended that clinicians periodically perform individualized assessment of risk factors for osteoporosis in men older than 50 years (grade: strong recommendation; moderate-quality evidence). (14) Factors that increase the risk for osteoporosis in men included age (>70 years), low body mass index, weight loss, physical inactivity, corticosteroid use, androgen deprivation therapy, and previous fragility fracture. ACP recommended that clinicians obtain DXA for men who are at increased risk for osteoporosis and are candidates for drug therapy (grade: strong recommendation; moderate-quality evidence). The guidelines indicated that bone density measurement with DXA is the accepted reference standard for diagnosing osteoporosis in men; because treatment trials have not measured the effectiveness of therapy for osteoporosis diagnosed by ultrasound densitometry rather than DXA, the role of ultrasound in diagnosis remains uncertain. This evidence review found no studies that evaluated the optimal intervals for repeated screening by using BMD measurement with DXA in men.

However, the ACP guidelines do not address the use of PE ultrasound to determine osteoporosis risk or for screening.

American College of Radiology (ACR)

Practice guidelines from the ACR, last amended in 2016, state that BMD measurement is indicated whenever a clinical decision is likely to be directly influenced by the result of the test. (15) Indications for DXA included but were not limited to the following patient populations:

1. All women age 65 years and older and men age 70 years and older (asymptomatic screening);

2. Women younger than age 65 years who have additional risk for osteoporosis, based on medical history and other findings. Additional risk factors for osteoporosis include:

a. Estrogen deficiency,

b. A history of maternal hip fracture that occurred after the age of 50 years,

c. Low body mass (less than 127 lb [pounds] or 57.6 kg [kilograms]),

d. History of amenorrhea (more than 1 year before age 42 years);

3. Women younger than age 65 years or men younger than age 70 years who have additional risk factors, including:

a. Current use of cigarettes,

b. Loss of height, thoracic kyphosis;

4. Individuals of any age with bone mass osteopenia, or fragility fractures on imaging studies such as radiographs, CT [computed tomography], or MRI [magnetic resonance imaging];

5. Individuals age 50 years and older who develop a wrist, hip, spine, or proximal humerus fracture with minimal or no trauma, excluding pathologic fractures;

6. Individuals of any age who develop 1 or more insufficiency fractures;

7. Individuals being considered for pharmacologic therapy for osteoporosis;

8. Individuals being monitored to:

a. Assess the effectiveness of osteoporosis drug therapy,

b. Follow-up medical conditions associated with abnormal BMD.

However, the ACR practice guidelines do not address the use of PE ultrasound to determine osteoporosis risk or for screening.

International Society for Clinical Densitometry (ISCD)

The 2013 update of the ISCD guidelines recommended bone density testing in the following patients (16):

“Women age 65 and older;

For post-menopausal women younger than age 65 a bone density test is indicated if they have a risk factor for low bone mass fracture such as:

o Low body weight,

o Prior fracture,

o High risk medication use,

o Disease or condition associated with bone loss;

Women during the menopausal transition with clinical risk factors for fracture, such as low bone weight, prior fracture or high-risk medication use;

Men aged 70 and older;

Men under < 70 years … if they have a risk factors for low bone mass such as:

o Low body weight,

o Prior fracture,

o High risk medication use,

o Disease or condition associated with bone loss;

Adults with a fragility fracture;

Adults with a disease or condition associated with low bone mass or bone loss….;

Anyone being considered for pharmacologic therapy;

Anyone being treated, to monitor treatment effect;

Anyone not receiving therapy in whom evidence of bone loss would lead to treatment.”

However, the ISCD guidelines do not address the use of PE ultrasound to determine osteoporosis risk or for screening.

American Association of Clinical Endocrinologists (AACE) et al.

In 2016, the AACE and American College of Endocrinology (ACE) issued updated joint guidelines on the diagnosis and treatment of postmenopausal osteoporosis. (17) The guidelines listed the potential uses for BMD measurements in postmenopausal women as:

“Screening for osteoporosis;

Establishing the severity of osteoporosis or bone loss…;

Determining fracture risk…;

Identifying candidates for pharmacologic intervention;

Assessing changes in bone density over time…;

Enhancing acceptance of, and perhaps adherence with, treatment;

Assessing skeletal consequences of diseases, conditions, or medications known to cause bone loss”

However, the AACE et al., joint guidelines do not address the use of PE ultrasound to determine osteoporosis risk or for screening.

North American Menopause Society

The North American Menopause Society issued a 2010 position statement, which indicated that fracture is the most significant risk of low bone density. (18) The statement also concluded that BMD is an important determinant of fracture risk, especially in women 65 years and older.

However, the North American Menopause Society position statement does not address the use of PE ultrasound to determine osteoporosis risk or for screening.

U.S. Preventive Services Task Force (USPSTF)

The USPSTF updated its recommendations on screening for osteoporosis with bone density measurements in January 2011. (19) USPSTF recommended “screening for osteoporosis in women aged 65 years or older and in younger women whose risk of fracture is equal to or greater than that of a 65-year-old white woman who has no additional risk factors.” This represents a change from the previous (2002) version, in which there was no specific recommendation on screening in women younger than 65 years old. The supporting document notes that there are multiple instruments to predict risk for low BMD and that the USPSTF used FRAX.2 The updated USPSTF recommendations stated that the scientific evidence is “insufficient” to recommend for or against routine osteoporosis screening in men. The Task Force did not recommend specific screening tests but said that the most commonly used tests are DXA of the hip and lumbar spine and quantitative ultrasound of the calcaneus. Additionally they did not address the use of PE ultrasound to determine osteoporosis risk through screening.

USPSTF recommended the following on BMD screening intervals: “A lack of evidence exists about the optimal intervals for repeat screening and whether repeated screening is necessary in a woman with normal BMD. Because of limitations in the precision of testing, a minimum of 2 years may be needed to reliably measure a change in BMD; however, longer intervals may be necessary to improve fracture risk prediction.”

USPSTF recommendations for osteoporosis screening are in the process of being updated as of June 2018.

Medicare National Coverage

The Centers for Medicare and Medicaid (CMS) pays for a screening bone mass measurement (BMM) once every 2 years (at least 23 months have passed since the month the last covered BMM was performed). (20) When medically necessary, Medicare may pay for more frequent BMMs. Examples include, but are not limited to, monitoring beneficiaries on long-term glucocorticoid (steroid) therapy of more than 3 months, and confirming baseline BMMs to permit monitoring of beneficiaries in the future.

Conditions for coverage of BMM can be found in chapter 15, section 80.5 of Pub. 100-02, Medicare Benefit Policy Manual. Medicare covers BMM under the following conditions:

“Is ordered by the physician or qualified non-physician practitioner who is treating the beneficiary following an evaluation of the need for a BMM and determination of the appropriate BMM to be used….

Is performed under the appropriate level of physician supervision as defined in 42 CFR 410.32(b).

Is reasonable and necessary for diagnosing and treating the condition of a beneficiary who meets the conditions described in §80.5.6.

In the case of an individual being monitored to assess the response to or efficacy of an FDA [U.S. Food and Drug Administration]-approved osteoporosis drug therapy, is performed with a dual-energy x-ray absorptiometry system (axial skeleton).

In the case of any individual who meets the conditions of 80.5.6 and who has a confirmatory BMM, is performed by a dual-energy x-ray absorptiometry system (axial skeleton) if the initial BMM was not performed by a dual-energy x-ray absorptiometry system (axial skeleton). A confirmatory baseline BMM is not covered if the initial BMM was performed by a dual-energy x-ray absorptiometry system (axial skeleton).”

However, CMS conditions for coverage does not address the use of PE ultrasound to determine osteoporosis risk or for screening.

Summary of Evidence

For individuals who are eligible for screening of bone mineral density (BMD) based on risk factor assessment who receive pulse-echo ultrasound analysis of peripheral sites, the evidence includes observational studies only. Relevant outcomes are disease-specific survival, morbid events, functional outcomes, health status measures, quality of life, and resource utilization. This technology is not commonly used for BMD measurements outside of the investigational setting; few studies have shown that they can select patients who benefit from treatment for osteoporosis. There is little to no evidence on the usefulness of repeat measurement of BMD using these techniques. There is a lack of support or endorsement from nationally recognized or U.S. governmental position statements or practice guidelines. The evidence is insufficient to determine the effects of the technology on health outcomes.

Contract:

Each benefit plan, summary plan description or contract defines which services are covered, which services are excluded, and which services are subject to dollar caps or other limitations, conditions or exclusions. Members and their providers have the responsibility for consulting the member's benefit plan, summary plan description or contract to determine if there are any exclusions or other benefit limitations applicable to this service or supply. If there is a discrepancy between a Medical Policy and a member's benefit plan, summary plan description or contract, the benefit plan, summary plan description or contract will govern.

Coding:

CODING:

Disclaimer for coding information on Medical Policies

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.

The presence or absence of procedure, service, supply, device or diagnosis codes in a Medical Policy document has no relevance for determination of benefit coverage for members or reimbursement for providers. Only the written coverage position in a medical policy should be used for such determinations.

Benefit coverage determinations based on written Medical Policy coverage positions must include review of the member’s benefit contract or Summary Plan Description (SPD) for defined coverage vs. non-coverage, benefit exclusions, and benefit limitations such as dollar or duration caps.

CPT/HCPCS/ICD-9/ICD-10 Codes

The following codes may be applicable to this Medical policy and may not be all inclusive.

CPT Codes

76977, 0508T

HCPCS Codes

None

ICD-9 Diagnosis Codes

Refer to the ICD-9-CM manual

ICD-9 Procedure Codes

Refer to the ICD-9-CM manual

ICD-10 Diagnosis Codes

Refer to the ICD-10-CM manual

ICD-10 Procedure Codes

Refer to the ICD-10-CM manual


Medicare Coverage:

The information contained in this section is for informational purposes only. HCSC makes no representation as to the accuracy of this information. It is not to be used for claims adjudication for HCSC Plans.

The Centers for Medicare and Medicaid Services (CMS) does have a national Medicare coverage position.

A national coverage position for Medicare may have been changed since this medical policy document was written. See Medicare's National Coverage at <http://www.cms.hhs.gov>.

References:

1. NICE – Bindex for investigating suspected osteoporosis (MIB106) (May 2017). Prepared by the National Institute of Health and Care Excellence. Available at <https://www.nice.org.uk> (accessed June 7, 2018).

2. Finland Health – Bone Index has obtained exclusive rights in US for Bindex® - World’s first pocket size diagnostic device for osteoporosis (November 21, 2016). Product Information (Press Release). Prepared by Bone Index LTD., Kuopio, Finland. Available at <http://www.finlandhealth.fi> (accessed June 5, 2018).

3. FDA – Approval Letter 501(k) Premarket Notification - Bindex® BI-2 (January 9, 2017) and Product Label. Prepared by the U.S. Food and Drug Administration, – Center for Devices and Radiologic Health. Available at <http://www.fda.gov> (accessed June 5, 2018).

4. Laugier P, Giat P, Berger G. Bone characterization with ultrasound: state of the art and new proposal. Clin Rheumato. Dec 1994; 13 Suppl 1:22-32. PMID 7750239

5. Jurvelin JS, Karjalainen J, Riekkinen O, et al. Bone diagnostics using dual frequency ultrasound measurements. J Acoust Soc Am. Mar 2010; 127(3):2006.

6. Riekkinen O, Hakulinen M, Toyras J, et al. Dual frequency ultrasound measurement of bone - a technique for elimination of soft tissue effects on pulse-echo measurements. J Acoust Soc Am. May 2008; 123(5):3631.

7. Riekkinen O, Hakulinen MA, Timonen M, et al. Influence of overlying soft tissues on trabecular bone acoustic measurement at various ultrasound frequencies. Ultrasound Med Biol. Jul 2006; 32(7):1073-83. PMID 16929321

8. Karjalainen JP, Riekkinen O, Toyras J, et al. New method for point-of-care osteoporosis screening and diagnostics. Osteoporos Int. Mar 2016; 27(3):971-7. PMID 26556741

9. Schousboe JT, Riekkinen O, Karjalainen J. Prediction of hip osteoporosis by DXA using a novel pulse-echo ultrasound device. Osteoporos Int. Jan 2017; 28(1):85-93. PMID 27492435

10. Karjalainen JP, Riekkinen O, Kroger H. Pulse-echo ultrasound method for detection of post-menopausal women with osteoporotic BMD. Osteoporos Int. May 2018; 29(5):1193-9. PMID 29460101

11. NOS – Position statement of the use of quantitative ultrasound in the management of osteoporosis (December 2001). Prepared by the National Osteoporosis Society. Available at www.nos.org.uk (accessed June 7, 2018).

12. American College of Obstetricians and Gynecologists (ACOG) Committee on Practice Bulletins. Osteoporosis (Practice Bulletin N. 129). Obstet Gynecol. Sep 2012, reaffirmed 2014; 120(3):718-734. PMID 22914492

13. NOF – Clinician’s guide to prevention and treatment of osteoporosis (2014). Prepared by the National Osteoporosis Foundation. Available at <https://my.nof.org> (accessed June 7, 2018).

14. Qaseem A, Snow V, Shekelle P, et al. Screening for osteoporosis in men: a clinical practice guideline from the American College of Physicians. Ann Intern Med. May 06 2008; 148(9):680-684. PMID 18458281

15. ACR – ACR Appropriateness Criteria™ - Osteoporosis and bone mineral density (2016). Prepared by the American College of Radiology. Available at <https://acsearch.acr.org> (accessed June 7, 2018).

16. ISCD – 2013 ISCD Official Positions – Adult. Prepared by the International Society for Clinical Densitometry. Available at <http://www.iscd.org> (accessed June 7, 2018).

17. Camacho PM, Petak SM, Binkley N, et al. American Association of Clinical Endocrinologists and American College of Endocrinology Clinical Practice Guidelines for the diagnosis and treatment of postmenopausal osteoporosis - 2016. Endocr Pract. Sep 2 2016; 22(Suppl 4):1-42. PMID 27662240

18. North American Menopause Society. Management of osteoporosis in postmenopausal women: 2010 position statement of The North American Menopause Society. Menopause. Jan-Feb 2010; 17(1):25-54; quiz 55-26. PMID 20061894

19. USPSTF – Osteoporosis: Screening (2011). Prepared by the U.S. Preventive Services Task Force. Available at <http://www.uspreventiveservicestaskforce.org> (accessed June 7, 2018).

20. CMS – Bone Mineral Density Studies (150.3) (2007). Prepared by the Centers for Medicare & Medicaid Services; National Coverage Determination. Available at <http://www.cms.gov> (accessed July 16, 2015).

21. Bone Mineral Density Studies. Chicago, Illinois: Blue Cross Blue Shield Association Medical Policy Reference Manual (2017 March) Radiology 6.01.01.

Policy History:

Date Reason
7/1/2018 New medical document. Bone density measurement using pulse-echo ultrasound is considered experimental, investigational and/or unproven.

Archived Document(s):

Title:Effective Date:End Date:
Pulse-Echo Ultrasound Bone Density Measurement07-01-201804-14-2019
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