For services on or after August 8, 2011, see policy N-196.

Bone mass measurement (BMM) studies use noninvasive imaging techniques to calculate bone mass. BMM studies are performed to detect osteoporosis and to assist in predicting the risk of fractures.

The World Health Organization (WHO) defines osteoporosis as a bone density or bone mass that is at least 2.5 standard deviation (SD) below peak normal mass achieved by healthy adults aged 18-30 years. SD from the mean peak bone mass is termed the “T” score. Thus, a T score of the lumbar spine or hip at least 2.5 SD below the norm defines the condition of osteoporosis.

WHO defines osteopenia as a bone density between minus 1 - 2.5 SD below the bone density of a normal young adult. Osteopenia results when the formation of bone (osteoid synthesis) is not enough to offset normal bone loss (bone lysis).

Osteomalacia, which may mimic osteoporosis radiographically, involves softening of the bones caused by a deficiency of vitamin D; problems with the metabolism of this vitamin; kidney failure and acidosis; phosphate depletion due to low phosphate dietary intake; and/or a side effect of medication used to treat seizures.

The loss of bone density is a major health problem in the United States. Osteoporosis is associated with 70% of fractures in females older than 45 years of age. Up to 20% of patients with osteopenia may have a vertebral fracture. Vertebral fractures are recognized as a major risk factor for future fragility fractures independent of BMM, age and other clinical risk factors for osteoporotic fracture. Measurement of bone mineral density is considered an essential test to determine appropriateness of pharmacologic treatment of osteoporosis.

Bone density can be measured by a variety of techniques in a variety of sites. Sites are generally subdivided into central or axial sites (e.g., hip or spine) and peripheral or appendicular sites (e.g., wrist, heel, ankle). The site chosen for measurement depends upon the reason for the study and the age of the patient. Osteoporosis at one site is not invariably associated with osteoporosis at other sites even though osteoporosis is a systemic disease affecting generalized loss of bone. The clinically significant fracture sites in terms of morbidity and mortality are the hip and spine. Measurement at these sites makes prediction of future fractures more accurate than measuring peripheral sites. Monitoring response to therapy is only covered when performed on axial sites (hips, pelvis, spine).

BMM means a radiologic, radioisotopic, or other procedure that meets all of the following conditions:

• Is performed to identify bone mass, detect bone loss, or determine bone quality;
  
  
• Is performed with either a bone densitometer (other than single-photon or dual-photon absorptiometry) or a bone sonometer system that has been cleared for marketing for BMM by the Food and Drug Administration (FDA) or approved for marketing;
  
  
• Includes a physician's interpretation of the results.

The following techniques are most frequently used to determine bone density and are covered:

• Dual energy x-ray absorption (DEXA): This technique uses low level ionizing radiation to provide direct measurements of bone density. The precision error is low compared to other techniques and is useful in evaluating trabecular bone in locations beneath large amounts of soft tissue (e.g., lumbar vertebrae and proximal femur). It can also be used to measure peripheral sites.
  
  
• Quantitated computerized tomography (QCT): This technique uses ionizing radiation, but at a much higher exposure level than DEXA, without any superiority in precision or accuracy. QCT is used for axial measurements only.
  
  
• Ultrasound bone densitometry:This technique uses speed of sound through bone. Osteoporotic bone demonstrates higher attenuation of the ultrasound signals compared to normal bone. Ultrasound densitometry has no radiation exposure and is used for peripheral sites only.

For a bone mass study to be covered, a patient must meet at least one of the conditions listed below:

• Men 70 years of age and older at risk for osteoporosis.
  
  
• Women 65 years of age and older at risk for osteoporosis.
  
  
• A woman who has been determined by the physician or qualified nonphysician practitioner to be estrogen-deficient and at clinical risk for osteoporosis, based on her medical history or other findings (e.g. who has received aromatase inhibitor).
  
  
• An individual with vertebral abnormalities as demonstrated by x-ray to be indicative of osteoporosis, osteopenia, or vertebral fracture.
  
  
• An individual receiving (or expecting to receive) glucocorticoid (steroid) therapy equivalent to 5.0 mg of prednisone or greater per day for more than three months.
  
  
• An individual with primary hyperparathyroidism.
  
  
• An individual being monitored to assess the response to, or efficacy of an FDA-approved osteoporosis drug therapy.

Bone Mass Measurement studies are covered under the following conditions when:

1. Ordered by the physician or qualified nonphysician practitioner who is treating the patient following an evaluation of the need for a BMM and determination of the appropriate BMM to be used.
   
   A physician or qualified nonphysician practitioner treating the patient for purposes of this provision is one who furnishes a consultation or treats a patient for a specific medical problem, and who uses the results in the management of the patient. For the purposes of the BMM benefit, qualified nonphysician practitioners include physician assistants, nurse practitioners, clinical nurse specialists, and certified nurse midwives. Tests ordered by a physician or qualified nonphysician practitioner who is not treating the patient are not considered reasonable and necessary, and are not covered.
   
   
2. Performed under the appropriate level of physician supervision.
   
   
3. Is reasonable and necessary for diagnosing and treating the condition of a patient who meets the conditions as described above.
   
   
4. Performed with DEXA (axial skeleton) for monitoring the response to or efficacy of an FDA-approved osteoporosis drug therapy.
   
   
5. A BMM is performed by DEXA (axial skeleton) as a confirmatory determination if a patient's screening initial BMM was not performed by DEXA (axial skeleton).

Bone mass measurements reported for conditions or with diagnosis codes other than those listed as eligible are denied as not medically necessary. 

Frequency of BMM studies:

A screening BMM is covered once every two years (at least 23 months have passed since the month the last BMM was performed). When it is determined that the member is not a candidate for drug monitoring and/or therapy, only one study per eligible period will be allowed. However, if medically necessary, a BMM may be covered for a patient more frequently than every two years. Examples include, but are not limited to, the following medical circumstances:

• Monitoring patients on long-term glucocorticoid (steroid) therapy equivalent to 5.0 mg prednisone daily of more than three months duration.
  
  
• Confirmatory baseline BMM to permit monitoring of the patient in the future.

Services performed more frequently than once every two years will be denied as not medically necessary. 

Vertebral fracture assessment (VFA)(procedure code 77082) - VFA can be performed at the same time as a BMM measurement by DXA, and provides a densitometric image of the lateral spine for assessment of vertebral fractures. VFA is only covered for evaluation of one of the following clinical criteria:

• Documented height loss > 2 cm (0.75 in.) or historical height loss > 4 cm (1.5 in.) since young adult;
  
  
• History of fracture after age 50;
  
  
• Commitment to long-term oral or parenteral glucocorticoid therapy;
  
  
• History and/or finding suggestive of vertebral fracture not documented by prior radiologic study.

VFA is not included in the statutory BMM benefit.

Reasons for Noncoverage

• Radiographic absorptiometry and photodensitometry is now rarely used. Single and dual photon absorptionmetry (78350, 78351) are considered not reasonable and necessary, and are therefore not covered.
  
  
• A confirmatory baseline BMM is not covered if the initial BMM was performed by DEXA (axial skeleton).
  
  
• Routine BMM performed on dialysis patients is not covered. The record must establish the medical necessity of testing.
  
  
• Bone mass measurement performed to monitor osteoporosis drug therapy is covered only when performed with dual-energy x-ray absorptiometry. Therefore, codes 76977, 77078, 77079, 77081, 77083, and G0130 will be denied as not medically necessary when reported with diagnosis codes 255.0, 733.00, 733.01-733.03, 733.09, or 733.90.

Services that do not meet the medical necessity criteria will be considered not medically necessary.  Effective January 26, 2009, a provider cannot bill the member for the denied service unless the provider has given advance written notice, informing the member that the service may be deemed not medically necessary and providing an estimate of the cost.  The member must agree in writing to assume financial responsibility, in advance of receiving the service.  The signed agreement, in the form of a Pre-Service Denial Notice, should be maintained in the provider's records.

Documentation Requirements

The patient's medical record must document the medical necessity of services performed for each date of service submitted on a claim, and documentation must be available on request.

The patient’s medical record from the attending physician must indicate the signs/symptoms and risk factors exhibited by the patient that required the ordering of the diagnostic test as defined under “Indications and Limitations of Coverage.” 

NOTE:

This policy is designed to address medical guidelines that are appropriate for the majority of individuals with a particular disease, illness, or condition. Each person's unique clinical circumstances may warrant individual consideration, based on review of applicable medical records.

Each study as (as represented by one procedure code) must be submitted as a unit of  “one.” Quantities greater than one may be denied.

If the provider is performing the study on a referral from the treatment physician or qualified non-physician practitioner, an Evaluation & Management (E/M) code must not be submitted for recording the risk factors and medications. This information is considered part of the study. If the treatment physician is the same provider who performs the study, an E/M code may be submitted if it represents a separate and distinct evaluation of the patient. 

Modifier 25 may be reported with medical care to identify it as a significant, separately identifiable service from the bone mass measurement study. When the 25 modifier is reported, the patient’s records must clearly document that separately identifiable medical care has been rendered.

Title XVIII of the Social Security Act, Section 1862(a)(7). This section excludes routine physical examinations.

Title XVIII of the Social Security Act, Section 1862(a)(1)(A) states that no payment shall be made for items or services which are not reasonable and necessary for the diagnosis or treatment of illness or injury.

Title XVIII of the Social Security Act, Section 1833(e) states that no payment shall be made to any provider for any claim that lacks the necessary information to process the claim.

42 CFR 410.32(b)

CMS Online Manual Pub. 100-2, Chapter 15, Section 80.5

CMS Online Manual Pub. 100-03, Chapter 1, Section 150.3

CMS Online Manual Pub. 100-4, Chapter 13, Section 140

Qaseem A, Snow A, Shekelle P, Hopkins, Jr R, Forciea MA, Owens DK. Screening for Osteoporosis in Men: A Clinical Practice Guideline from the American College of Physicians. Ann Intern Med. 2008;148:680-684.

Liu H, Paige NM, Goldzweig CL, Wong E, Zhou A, Suttorp MJ, Munjas B, Orwoll E, Shekelle P. Screening for Osteoporosis in Men: A Systematic Review for an American College of Physicians Guideline. Ann Intern Med. 2008;148:685-701.

Codes 76977, 77078, 77079, 77081, 77083, and G0130

Code 77080

Code 77082