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CMS Transmittals



National Coverage Determination
Procedure Code: 8XXXX
Collagen Crosslinks, Any Method
CMS Policy Number: 190.19
Back to NCD List

Description: Collagen crosslinks, part of the matrix of bone upon which bone mineral is deposited, are biochemical markers the excretion of which provides a quantitative measurement of bone resorption. Elevated levels of urinary collagen crosslinks indicate elevated bone resorption. Elevated bone resorption contributes to age-related and postmenopausal loss of bone leading to osteoporosis and increased risk of fracture. The collagen crosslinks assay can be performed by immunoassay or by high performance liquid chromatography (HPLC). Collagen crosslink immunoassays measure the pyridinoline crosslinks and associated telopeptides in urine.

Bone is constantly undergoing a metabolic process called turnover or remodeling. This includes a degradation process, bone resorption, mediated by the action of osteoclasts, and a building process, bone formation, mediated by the action of osteoblasts. Remodeling is required for the maintenance and overall health of bone and is tightly coupled; that is, resorption and formation must be in balance. In abnormal states of bone remodeling, when resorption exceeds formation, it results in a net loss of bone. The measurement of specific, bone-derived resorption products provides analytical data about the rate of bone resorption.

Osteoporosis is a condition characterized by low bone mass and structural deterioration of bone tissue, leading to bone fragility and an increased susceptibility to fractures of the hip, spine, and wrist. The term primary osteoporosis is applied where the causal factor in the disease is menopause or aging. The term secondary osteoporosis is applied where the causal factor is something other than menopause or aging, such as long-term administration of glucocorticosteroids, endocrine-related disorders (other than loss of estrogen due to menopause), and certain bone diseases such as cancer of the bone.

With respect to quantifying bone resorption, collagen crosslink tests can provide adjunct diagnostic information in concert with bone mass measurements. Bone mass measurements and biochemical markers may have complementary roles to play in assessing effectiveness of osteoporosis treatment. Proper management of osteoporosis patients, who are on long-term therapeutic regimens, may include laboratory testing of biochemical markers of bone turnover, such as collagen crosslinks, that provide a profile of bone turnover responses within weeks of therapy. Changes in collagen crosslinks are determined following commencement of antiresorptive therapy. These can be measured over a shorter time interval when compared to bone mass density. If bone resorption is not elevated, repeat testing is not medically necessary.

Indications:
Generally speaking, collagen crosslink testing is useful mostly in “fast losers” of bone. The age when these bone markers can help direct therapy is often pre-Medicare. By the time a fast loser of bone reaches age 65, she will most likely have been stabilized by appropriate therapy or have lost so much bone mass that further testing is useless. Coverage for bone marker assays may be established, however, for younger Medicare beneficiaries and for those men and women who might become fast losers because of some other therapy such as glucocorticoids. Safeguards should be incorporated to prevent excessive use of tests in patients for whom they have no clinical relevance.

Collagen crosslinks testing is used to:

  • Identify individuals with elevated bone resorption, who have osteoporosis in whom response to treatment is being monitored.
  • Predict response (as assessed by bone mass measurements) to FDA approved antiresorptive therapy in postmenopausal women.
  • Assess response to treatment of patients with osteoporosis, Paget’s disease of the bone, or risk for osteoporosis where treatment may include FDA approved antiresorptive agents, anti- estrogens or selective estrogen receptor moderators.

    Limitations:
    Because of significant specimen to specimen collagen crosslink physiologic variability (15-20%), current recommendations for appropriate utilization include: one or two base-line assays from specified urine collections on separate days; followed by a repeat assay about 3 months after starting anti-resorptive therapy; followed by a repeat assay in 12 months after the 3-month assay; and thereafter not more than annually, unless there is a change in therapy in which circumstance an additional test may be indicated 3 months after the initiation of new therapy.

    Some collagen crosslink assays may not be appropriate for use in some disorders, according to FDA labeling restrictions.

    Frequency Limitations: Current recommendations for appropriate utilization include: one or two base-line assays from specified urine collections on separate days; followed by a repeat assay about three months after starting anti-resorptive therapy; followed by a repeat assay in 12 months after the three-month assay; and thereafter not more than annually, unless there is a change in therapy in which circumstance an additional test may be indicated three months after the initiation of new therapy.



    To review all requirements of this policy, please see: CMS NCD listing by Chapter

    Covered ICD-10 Codes.

    ICD-10Descriptor
    C44.1321 Sebaceous cell carcinoma skin/ r upper eyelid, inc canthus
    C44.1322 Sebaceous cell carcinoma skin/ right low eyelid, inc canthus
    C44.1391 Sebaceous cell carcinoma skin/ left upr eyelid, inc canthus
    C44.1392 Sebaceous cell carcinoma skin/ left low eyelid, inc canthus
    E05.00 Thyrotoxicosis w diffuse goiter w/o thyrotoxic crisis
    E05.01 Thyrotoxicosis w diffuse goiter w thyrotoxic crisis or storm
    E05.10 Thyrotxcosis w toxic sing thyroid nodule w/o thyrotxc crisis
    E05.11 Thyrotxcosis w toxic single thyroid nodule w thyrotxc crisis
    E05.20 Thyrotxcosis w toxic multinod goiter w/o thyrotoxic crisis
    E05.21 Thyrotxcosis w toxic multinodular goiter w thyrotoxic crisis
    E05.30 Thyrotxcosis from ectopic thyroid tissue w/o thyrotxc crisis
    E05.31 Thyrotxcosis from ectopic thyroid tissue w thyrotoxic crisis
    E05.40 Thyrotoxicosis factitia without thyrotoxic crisis or storm
    E05.41 Thyrotoxicosis factitia with thyrotoxic crisis or storm
    E05.80 Other thyrotoxicosis without thyrotoxic crisis or storm
    E05.81 Other thyrotoxicosis with thyrotoxic crisis or storm
    E05.90 Thyrotoxicosis, unsp without thyrotoxic crisis or storm
    E05.91 Thyrotoxicosis, unspecified with thyrotoxic crisis or storm
    E06.3 Autoimmune thyroiditis
    E07.9 Disorder of thyroid, unspecified
    E21.0 Primary hyperparathyroidism
    E21.1 Secondary hyperparathyroidism, not elsewhere classified
    E21.2 Other hyperparathyroidism
    E21.3 Hyperparathyroidism, unspecified
    E28.310 Symptomatic premature menopause
    E28.319 Asymptomatic premature menopause
    E28.39 Other primary ovarian failure
    E28.8 Other ovarian dysfunction
    E28.9 Ovarian dysfunction, unspecified
    E55.9 Vitamin D deficiency, unspecified
    E58 Dietary calcium deficiency
    E59 Dietary selenium deficiency
    E60 Dietary zinc deficiency
    E61.0 Copper deficiency
    E61.1 Iron deficiency
    E61.2 Magnesium deficiency
    E61.3 Manganese deficiency
    E61.4 Chromium deficiency
    E61.5 Molybdenum deficiency
    E61.6 Vanadium deficiency
    E88.02 Plasminogen deficiency
    E89.40 Asymptomatic postprocedural ovarian failure
    E89.41 Symptomatic postprocedural ovarian failure
    M48.50XA Collapsed vertebra, NEC, site unsp, init
    M48.51XA Collapsed vertebra, NEC, occipito-atlanto-axial region, init
    M48.52XA Collapsed vertebra, NEC, cervical region, init
    M48.53XA Collapsed vertebra, NEC, cervicothoracic region, init
    M48.54XA Collapsed vertebra, NEC, thoracic region, init
    M48.55XA Collapsed vertebra, NEC, thoracolumbar region, init
    M48.56XA Collapsed vertebra, NEC, lumbar region, init
    M48.57XA Collapsed vertebra, NEC, lumbosacral region, init
    M48.58XA Collapsed vertebra, NEC, sacr/sacrocygl region, init
    M80.00XA Age-rel osteopor w current path fracture, unsp site, init
    M80.011A Age-rel osteopor w current path fracture, r shoulder, init
    M80.012A Age-rel osteopor w current path fracture, l shoulder, init
    M80.019A Age-rel osteopor w current path fx, unsp shoulder, init
    M80.021A Age-rel osteopor w current path fracture, r humerus, init
    M80.022A Age-rel osteopor w current path fracture, l humerus, init
    M80.029A Age-rel osteopor w current path fracture, unsp humerus, init
    M80.031A Age-rel osteopor w current path fracture, r forearm, init
    M80.032A Age-rel osteopor w current path fracture, l forearm, init
    M80.039A Age-rel osteopor w current path fracture, unsp forearm, init
    M80.041A Age-rel osteopor w current path fracture, right hand, init
    M80.042A Age-rel osteopor w current path fracture, left hand, init
    M80.049A Age-rel osteopor w current path fracture, unsp hand, init
    M80.051A Age-rel osteopor w current path fracture, right femur, init
    M80.052A Age-rel osteopor w current path fracture, left femur, init
    M80.059A Age-rel osteopor w current path fracture, unsp femur, init
    M80.061A Age-rel osteopor w current path fracture, r low leg, init
    M80.062A Age-rel osteopor w current path fracture, l low leg, init
    M80.069A Age-rel osteopor w current path fracture, unsp low leg, init
    M80.071A Age-rel osteopor w current path fracture, right ank/ft, init
    M80.072A Age-rel osteopor w current path fracture, left ank/ft, init
    M80.079A Age-rel osteopor w current path fracture, unsp ank/ft, init
    M80.08XA Age-rel osteopor w current path fracture, vertebra(e), init
    M80.80XA Oth osteopor w current path fracture, unsp site, init
    M80.811A Oth osteopor w current path fracture, r shoulder, init
    M80.812A Oth osteopor w current path fracture, l shoulder, init
    M80.819A Oth osteopor w current path fracture, unsp shoulder, init
    M80.821A Oth osteopor w current path fracture, r humerus, init
    M80.822A Oth osteopor w current path fracture, l humerus, init
    M80.829A Oth osteopor w current path fracture, unsp humerus, init
    M80.831A Oth osteopor w current path fracture, r forearm, init
    M80.832A Oth osteopor w current path fracture, l forearm, init
    M80.839A Oth osteopor w current path fracture, unsp forearm, init
    M80.841A Oth osteopor w current path fracture, right hand, init
    M80.842A Oth osteopor w current path fracture, left hand, init
    M80.849A Oth osteopor w current path fracture, unsp hand, init
    M80.851A Oth osteopor w current path fracture, right femur, init
    M80.852A Oth osteopor w current path fracture, left femur, init
    M80.859A Oth osteopor w current path fracture, unsp femur, init
    M80.861A Oth osteopor w current path fracture, r low leg, init
    M80.862A Oth osteopor w current path fracture, l low leg, init
    M80.869A Oth osteopor w current path fracture, unsp lower leg, init
    M80.871A Oth osteopor w current path fracture, right ank/ft, init
    M80.872A Oth osteopor w current path fracture, left ank/ft, init
    M80.879A Oth osteopor w current path fracture, unsp ank/ft, init
    M80.88XA Oth osteopor w current path fracture, vertebra(e), init
    M81.0 Age-related osteoporosis w/o current pathological fracture
    M81.6 Localized osteoporosis [Lequesne]
    M81.8 Other osteoporosis without current pathological fracture
    M84.40XA Pathological fracture, unsp site, init encntr for fracture
    M84.411A Pathological fracture, right shoulder, init for fx
    M84.412A Pathological fracture, left shoulder, init for fx
    M84.419A Pathological fracture, unsp shoulder, init for fx
    M84.421A Pathological fracture, right humerus, init for fx
    M84.422A Pathological fracture, left humerus, init for fx
    M84.429A Pathological fracture, unsp humerus, init for fx
    M84.431A Pathological fracture, right ulna, init encntr for fracture
    M84.432A Pathological fracture, left ulna, init encntr for fracture
    M84.433A Pathological fracture, right radius, init for fx
    M84.434A Pathological fracture, left radius, init encntr for fracture
    M84.439A Pathological fracture, unsp ulna and radius, init for fx
    M84.441A Pathological fracture, right hand, init encntr for fracture
    M84.442A Pathological fracture, left hand, init encntr for fracture
    M84.443A Pathological fracture, unsp hand, init encntr for fracture
    M84.444A Pathological fracture, right finger(s), init for fx
    M84.445A Pathological fracture, left finger(s), init for fx
    M84.446A Pathological fracture, unsp finger(s), init for fx
    M84.451A Pathological fracture, right femur, init encntr for fracture
    M84.452A Pathological fracture, left femur, init encntr for fracture
    M84.453A Pathological fracture, unsp femur, init encntr for fracture
    M84.454A Pathological fracture, pelvis, init encntr for fracture
    M84.459A Pathological fracture, hip, unsp, init encntr for fracture
    M84.461A Pathological fracture, right tibia, init encntr for fracture
    M84.462A Pathological fracture, left tibia, init encntr for fracture
    M84.463A Pathological fracture, right fibula, init for fx
    M84.464A Pathological fracture, left fibula, init encntr for fracture
    M84.469A Pathological fracture, unsp tibia and fibula, init for fx
    M84.471A Pathological fracture, right ankle, init encntr for fracture
    M84.472A Pathological fracture, left ankle, init encntr for fracture
    M84.473A Pathological fracture, unsp ankle, init encntr for fracture
    M84.474A Pathological fracture, right foot, init encntr for fracture
    M84.475A Pathological fracture, left foot, init encntr for fracture
    M84.476A Pathological fracture, unsp foot, init encntr for fracture
    M84.477A Pathological fracture, right toe(s), init for fx
    M84.478A Pathological fracture, left toe(s), init encntr for fracture
    M84.479A Pathological fracture, unsp toe(s), init encntr for fracture
    M84.48XA Pathological fracture, other site, init encntr for fracture
    M84.50XA Pathological fracture in neoplastic disease, unsp site, init
    M84.511A Path fracture in neoplastic disease, r shoulder, init
    M84.512A Path fracture in neoplastic disease, l shoulder, init
    M84.519A Path fracture in neoplastic disease, unsp shoulder, init
    M84.521A Pathological fracture in neoplastic disease, r humerus, init
    M84.522A Pathological fracture in neoplastic disease, l humerus, init
    M84.529A Path fracture in neoplastic disease, unsp humerus, init
    M84.531A Path fracture in neoplastic disease, right ulna, init
    M84.532A Pathological fracture in neoplastic disease, left ulna, init
    M84.533A Path fracture in neoplastic disease, right radius, init
    M84.534A Path fracture in neoplastic disease, left radius, init
    M84.539A Path fracture in neopltc disease, unsp ulna and radius, init
    M84.541A Path fracture in neoplastic disease, right hand, init
    M84.542A Pathological fracture in neoplastic disease, left hand, init
    M84.549A Pathological fracture in neoplastic disease, unsp hand, init
    M84.550A Pathological fracture in neoplastic disease, pelvis, init
    M84.551A Path fracture in neoplastic disease, right femur, init
    M84.552A Path fracture in neoplastic disease, left femur, init
    M84.553A Path fracture in neoplastic disease, unsp femur, init
    M84.559A Pathological fracture in neoplastic disease, hip, unsp, init
    M84.561A Path fracture in neoplastic disease, right tibia, init
    M84.562A Path fracture in neoplastic disease, left tibia, init
    M84.563A Path fracture in neoplastic disease, right fibula, init
    M84.564A Path fracture in neoplastic disease, left fibula, init
    M84.569A Path fx in neopltc disease, unsp tibia and fibula, init
    M84.571A Path fracture in neoplastic disease, right ankle, init
    M84.572A Path fracture in neoplastic disease, left ankle, init
    M84.573A Path fracture in neoplastic disease, unsp ankle, init
    M84.574A Path fracture in neoplastic disease, right foot, init
    M84.575A Pathological fracture in neoplastic disease, left foot, init
    M84.576A Pathological fracture in neoplastic disease, unsp foot, init
    M84.58XA Pathological fracture in neoplastic disease, oth site, init
    M84.60XA Pathological fracture in oth disease, unsp site, init for fx
    M84.611A Pathological fracture in oth disease, right shoulder, init
    M84.612A Pathological fracture in oth disease, left shoulder, init
    M84.619A Pathological fracture in oth disease, unsp shoulder, init
    M84.621A Pathological fracture in oth disease, right humerus, init
    M84.622A Pathological fracture in oth disease, left humerus, init
    M84.629A Pathological fracture in oth disease, unsp humerus, init
    M84.631A Pathological fracture in oth disease, right ulna, init
    M84.632A Pathological fracture in oth disease, left ulna, init for fx
    M84.633A Pathological fracture in oth disease, right radius, init
    M84.634A Pathological fracture in oth disease, left radius, init
    M84.639A Path fracture in oth disease, unsp ulna and radius, init
    M84.641A Pathological fracture in oth disease, right hand, init
    M84.642A Pathological fracture in oth disease, left hand, init for fx
    M84.649A Pathological fracture in oth disease, unsp hand, init for fx
    M84.650A Pathological fracture in oth disease, pelvis, init for fx
    M84.651A Pathological fracture in oth disease, right femur, init
    M84.652A Pathological fracture in oth disease, left femur, init
    M84.653A Pathological fracture in oth disease, unsp femur, init
    M84.659A Pathological fracture in oth disease, hip, unsp, init for fx
    M84.661A Pathological fracture in oth disease, right tibia, init
    M84.662A Pathological fracture in oth disease, left tibia, init
    M84.663A Pathological fracture in oth disease, right fibula, init
    M84.664A Pathological fracture in oth disease, left fibula, init
    M84.669A Path fracture in oth disease, unsp tibia and fibula, init
    M84.671A Pathological fracture in oth disease, right ankle, init
    M84.672A Pathological fracture in oth disease, left ankle, init
    M84.673A Pathological fracture in oth disease, unsp ankle, init
    M84.674A Pathological fracture in oth disease, right foot, init
    M84.675A Pathological fracture in oth disease, left foot, init for fx
    M84.676A Pathological fracture in oth disease, unsp foot, init for fx
    M84.68XA Pathological fracture in oth disease, oth site, init for fx
    M84.751A Incomplete atypical femoral fracture, right leg, init
    M85.80 Oth disrd of bone density and structure, unspecified site
    M85.811 Oth disrd of bone density and structure, right shoulder
    M85.812 Oth disrd of bone density and structure, left shoulder
    M85.819 Oth disrd of bone density and structure, unsp shoulder
    M85.821 Oth disrd of bone density and structure, right upper arm
    M85.822 Oth disrd of bone density and structure, left upper arm
    M85.829 Oth disrd of bone density and structure, unsp upper arm
    M85.831 Oth disrd of bone density and structure, right forearm
    M85.832 Oth disrd of bone density and structure, left forearm
    M85.839 Oth disrd of bone density and structure, unspecified forearm
    M85.841 Oth disrd of bone density and structure, right hand
    M85.842 Oth disrd of bone density and structure, left hand
    M85.849 Oth disrd of bone density and structure, unspecified hand
    M85.851 Oth disrd of bone density and structure, right thigh
    M85.852 Oth disrd of bone density and structure, left thigh
    M85.859 Oth disrd of bone density and structure, unspecified thigh
    M85.861 Oth disrd of bone density and structure, right lower leg
    M85.862 Oth disrd of bone density and structure, left lower leg
    M85.869 Oth disrd of bone density and structure, unsp lower leg
    M85.871 Oth disrd of bone density and structure, right ank/ft
    M85.872 Oth disrd of bone density and structure, left ankle and foot
    M85.879 Oth disrd of bone density and structure, unsp ankle and foot
    M85.88 Oth disrd of bone density and structure, other site
    M85.89 Oth disrd of bone density and structure, multiple sites
    M85.9 Disorder of bone density and structure, unspecified
    M88.0 Osteitis deformans of skull
    M88.1 Osteitis deformans of vertebrae
    M88.811 Osteitis deformans of right shoulder
    M88.812 Osteitis deformans of left shoulder
    M88.819 Osteitis deformans of unspecified shoulder
    M88.821 Osteitis deformans of right upper arm
    M88.822 Osteitis deformans of left upper arm
    M88.829 Osteitis deformans of unspecified upper arm
    M88.831 Osteitis deformans of right forearm
    M88.832 Osteitis deformans of left forearm
    M88.839 Osteitis deformans of unspecified forearm
    M88.841 Osteitis deformans of right hand
    M88.842 Osteitis deformans of left hand
    M88.849 Osteitis deformans of unspecified hand
    M88.851 Osteitis deformans of right thigh
    M88.852 Osteitis deformans of left thigh
    M88.859 Osteitis deformans of unspecified thigh
    M88.861 Osteitis deformans of right lower leg
    M88.862 Osteitis deformans of left lower leg
    M88.869 Osteitis deformans of unspecified lower leg
    M88.871 Osteitis deformans of right ankle and foot
    M88.872 Osteitis deformans of left ankle and foot
    M88.879 Osteitis deformans of unspecified ankle and foot
    M88.88 Osteitis deformans of other bones
    M88.89 Osteitis deformans of multiple sites
    M88.9 Osteitis deformans of unspecified bone
    M89.9 Disorder of bone, unspecified
    M94.9 Disorder of cartilage, unspecified
    N92.4 Excessive bleeding in the premenopausal period
    N95.0 Postmenopausal bleeding
    N95.1 Menopausal and female climacteric states
    N95.8 Other specified menopausal and perimenopausal disorders
    N95.9 Unspecified menopausal and perimenopausal disorder
    P78.84 Gestational alloimmune liver disease
    S12.9XXA Fracture of neck, unspecified, initial encounter
    Z79.3 Long term (current) use of hormonal contraceptives
    Z79.51 Long term (current) use of inhaled steroids
    Z79.52 Long term (current) use of systemic steroids
    Z79.84 Long term (current) use of oral hypoglycemic drugs
    Z79.891 Long term (current) use of opiate analgesic
    Z79.899 Other long term (current) drug therapy

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