Local Coverage Determination (LCD)

Bone Mass Measurement

L36460

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Proposed LCD
Proposed LCDs are works in progress that are available on the Medicare Coverage Database site for public review. Proposed LCDs are not necessarily a reflection of the current policies or practices of the contractor.

Document Note

Note History

Contractor Information

LCD Information

Document Information

Source LCD ID
N/A
LCD ID
L36460
Original ICD-9 LCD ID
Not Applicable
LCD Title
Bone Mass Measurement
Proposed LCD in Comment Period
N/A
Source Proposed LCD
DL36460
Original Effective Date
For services performed on or after 02/01/2016
Revision Effective Date
For services performed on or after 01/04/2024
Revision Ending Date
N/A
Retirement Date
N/A
Notice Period Start Date
12/17/2015
Notice Period End Date
01/31/2016

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Issue

Issue Description

No changes, annual review was completed.

Issue - Explanation of Change Between Proposed LCD and Final LCD

CMS National Coverage Policy

Language quoted from Centers for Medicare and Medicaid Services (CMS). National Coverage Determinations
(NCDs) and coverage provisions in interpretive manuals is italicized throughout the policy. NCDs and
coverage provisions in interpretive manuals are not subject to the Local Coverage Determination (LCD)
Review Process (42 CFR 405.860[b] and 42 CFR 426 [Subpart D]). In addition, an administrative law judge
may not review an NCD. See §1869(f)(1)(A)(i) of the Social Security Act.

Unless otherwise specified, italicized text represents quotation from one or more of the following CMS
sources:

Title XVIII of the Social Security Act (SSA):

Section 1862(a)(1)(A) excludes expenses incurred for items or services which are not reasonable and necessary
for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member.

Section 1833(e) prohibits Medicare payment for any claim which lacks the necessary information to process
the claim.

Section 1861(r) provides the definition of a physician.

Section 1861(s)(2)(V)(15) includes bone mass measurement as a physician service.

Section 1861(rr) provides the definition of bone mass measurement.

Code of Federal Regulations:

Title IV of the Balanced Budget Act of 1997, Section 4106 includes language providing for Medicare coverage
of bone mass measurement procedures, and coverage of FDA-approved bone mass measurement techniques
and equipment for "qualified" individuals. These procedures are only covered when medically necessary.

CMS Publications:

CMS Manual System, Pub. 100-02, Medicare Benefit Policy Manual, Chapter 15:

80.5 Bone Mass Measurements (BMMs)

CMS Manual System, Pub. 100-03, Medicare National Coverage Determinations, Chapter 1:

150.3 Bone (Mineral) Density Studies (Effective January 1, 2007)

CMS Manual System, Pub. 100-04, Medicare Claims Processing Manual, Chapter 13:

140 Bone Mass Measurements (BMMs).

Coverage Guidance

Coverage Indications, Limitations, and/or Medical Necessity

Bone mass measurement (BMM) studies are radiologic, radioisotopic or other procedures that meet all of the
following conditions:


  • quantify bone mineral density, Mdetect bone loss or determine bone quality;
  • are 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) under 21 CFR part 807, or approved for marketing under 21 CFR part
    814.
  • include a physician's interpretation of the results.


The following procedures are used to measure bone mineral density:

  • dual energy x-ray absorptiometry (DXA)
  • radiographic absorptiometry (RA);
  • bone sonometry (ultrasound);
  • single energy x-ray absorptiometry; (SEXA),
  • quantitative computed tomography (QCT).


Indications:

Medicare will cover a bone mass measurement test when it meets all of the following criteria:


1. It is performed with one of the covered tests listed above.

2. It is performed on a qualified individual for the purpose of identifying bone mass, detecting bone loss or
determining bone quality. The term "qualified individual" means an individual who meets the medical
indications for at least one of the five categories listed below:


° A woman who has been determined by the physician or a qualified nonphysician practitioner
treating her to be estrogen-deficient and at clinical risk for osteoporosis, based on her medical
history and other findings;
° An individual with vertebral abnormalities as demonstrated by an x-ray to be indicative of
osteoporosis, osteopenia (low bone mass), or vertebral fracture;
° An individual receiving (or expecting to receive) glucocorticoid (steroid) therapy equivalent to 5
mg of prednisone, or greater, per day, for more than three (3) months;
° An individual with primary hyperparathyroidism;
° An individual being monitored to assess the response to or efficacy of an FDA-approved
osteoporosis drug therapy.

3. It is furnished by a qualified supplier or provider of such services under at least the general level of
supervision of a physician as defined in 42 CFR 410.32(b).

4. The test is ordered by the individual's physician or qualified non-physician practitioner, who is treating
the beneficiary following an evaluation of the need for the measurement, including a determination as
to the medically appropriate measurement to be used for the individual, and who uses the results in the
management of the patient.

5. The test is reasonable and necessary for diagnosing, treating, or monitoring of a "qualified individual"
as defined above in #2. Monitoring is defined as subsequent testing in patients on FDA-approved drug
therapy.

6. Medicare may cover a bone mass measurement for a beneficiary once every 2 years (if at least 23
months have passed since the month the last bone mass measurement was performed).

7. For conditions specified, Medicare will cover a bone mass measurement for a qualified beneficiary
more frequently than every two years, if medically necessary for the diagnosis or treatment of the
patient and if related to the condition listed. In these instances payment may be made for tests
performed after eleven months have elapsed since the previous bone mass measurement test.
Examples include, but are not limited to, the following medical circumstance:

° Monitoring beneficiaries on long-term glucocorticoid ( 5 mg/day) therapy of more than 3
months (patients must be on glucocorticoids for greater than three months duration, but BMM
monitoring is at yearly intervals).


° Confirming baseline BMMs to permit monitoring of beneficiaries in the future.

In addition, bone mass measurement for the following may be reimbursed more frequently than
every two years:


° Follow up bone mineral density testing to assess FDA-approved osteoporosis drug therapy until
a response to such therapy has been documented over time.

8. A confirmatory baseline BMM is only covered when it is performed with a dual-energy x-ray
absorptiometry system (axial skeleton) and 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).

9. For an individual being monitored to assess the response to, or efficacy of, an FDA-approved
osteoporosis drug therapy, the test is only covered if it is performed with a dual-energy x-ray
absorptiometry system (axial skeleton).

10. The test must include a physician's interpretation of the results.

11. Since not every woman who has been prescribed estrogen replacement therapy (ERT) may be receiving
an "adequate" dose of the therapy, the fact that a woman is receiving ERT should not preclude her
treating physician/other qualified nonphysician practitioner from ordering a bone mass measurement
test for her. If a bone mass measurement test is ordered for a woman following a careful evaluation of
her medical need, it is expected that the ordering/treating physician/qualified non-physician practitioner
will document, why he or she believes that the woman is estrogen deficient and at clinical risk for
osteoporosis.

Summary of Evidence

N/A

Analysis of Evidence (Rationale for Determination)

N/A

Proposed Process Information

Synopsis of Changes
Changes Fields Changed
N/A
Associated Information
Sources of Information
Bibliography
Open Meetings
Meeting Date Meeting States Meeting Information
N/A
Contractor Advisory Committee (CAC) Meetings
Meeting Date Meeting States Meeting Information
N/A
MAC Meeting Information URLs
N/A
Proposed LCD Posting Date
Comment Period Start Date
Comment Period End Date
Reason for Proposed LCD
Requestor Information
This request was MAC initiated.
Requestor Name Requestor Letter
View Letter
N/A
Contact for Comments on Proposed LCD

Coding Information

Bill Type Codes

Code Description

Please accept the License to see the codes.

N/A

Revenue Codes

Code Description

Please accept the License to see the codes.

N/A

CPT/HCPCS Codes

Please accept the License to see the codes.

N/A

ICD-10-CM Codes that Support Medical Necessity

Group 1

Group 1 Paragraph:

N/A

Group 1 Codes:

N/A

N/A

ICD-10-CM Codes that DO NOT Support Medical Necessity

Group 1

Group 1 Paragraph:

N/A

Group 1 Codes:

N/A

N/A

Additional ICD-10 Information

General Information

Associated Information
N/A
Sources of Information

This bibliography presents those sources that were obtained during the development of this policy. CGS Administrators is not responsible for the continuing viability of Web site addresses listed below. © 2002
CPT Physicians' Current Procedural Terminology, American Medical Association.

Banks L. Dual energy X-ray absorptiometry (DXA). Grainger & Allison's Diagnostic Radiology: A Textbook
of Medical Imaging, 4th edition, Chapter 8.

Bonnick SL. Osteoporosis in men and women. Clinical Cornerstone. 2006;8(1):28-39.

Cranney A, Jamal S, Tsang J, Joss R, Leslie W. Low bone mineral density and fracture burden in
postmenopausal women. Canadian Medical Association Journal. 2007;177(6).

Greenspan SL, Emkey RD, Bone HG, et al. Significant differential effects of alendronate, estrogen, or
combination therapy on the rate of bone loss after discontinuation of treatment of postmenopausal osteoporosis:
a randomized, double-blind, placebo-controlled trial. Annals of Internal Medicine.2002;137:875-883.

Hillner BE, Ingle JN, Chlebowski RT. 2003 Update on the role of bisphonates and bone health issues in
women with breast cancer - American Society of Clinical Oncology. Journal of Clinical Oncology.
2003;21(21):4042-4052.
Hochberg MD. Recommendations for Measurement of bone mineral density and identifying person to be
treated for osteoporosis. Rheumatic Disease Clinics of North America.2006;32:681-689.

Hodgson SF, Watts NB, Chairmen, AACE Osteoporosis Task Force. American Association of Clinical
Endocrinologists (AACE) Medical Guidelines for Clinical Practice for the Prevention and Management of
Postmenopausal Osteoporosis: 2001 Edition, with selected updates for 2003. Endocrine Practice. 2003;9(6).

Lane MJ, Serota AC, Raphael B. Osteoporosis: differences and similarities in male and female patients.
Orthopedic Clinics of North America. 2006;37:601-609.

Larsen PR, Kromemeberg HM, Melmed S, Polonsky KS. Osteoporosis, diagnosis and prevention and therapy.
Williams Textbook of Endocrinology, 10th edition.

Leslie WD, Tsang JF, Caetano PA, Lix LM, for the Manitoba Bone Density Program. Effectiveness of bone
density measurement for predicting osteoporotic fractures in clinical practice. The Journal of Endocrinology &
Metabolism. 2007;92:77-81.

Lewiecki EM, Watts NB, McClung, et al. Position statement: official positions of the international society for
clinical densitometry. Journal of Clinical Endocrinology and Metabolism. 2004;89(8).

O'Gradaigh D. Debiram I, Love S, Richards HK, Compston JE. A prospective study of discordance in
diagnosis of osteoporosis using spine and proximal femur bone densitometry. Osteoporosis International.
2003;14:13-18.

Shaker JL, Lukert BP. Osteoporosis Associated with excess glucocorticoids. endocrinol metabolism. Clinics of
North America. 2005;34:341-356.

Bibliography

N/A

Revision History Information

Revision History Date Revision History Number Revision History Explanation Reasons for Change
01/04/2024 R19

R19

Revision Effective: 01/04/2024

Revision Explanation: Annual review, no changes.

12-29-2023: At this time 21st Century Cures Act will apply to new and revised LCDs that restrict coverage which requires comment and notice. This revision is not a restriction to the coverage determination; and, therefore not all the fields included on the LCD are applicable as noted in this policy.

  • Other (Annual Review)
01/05/2023 R18

R18

Revision Effective: 01/05/2023

Revision Explanation: Annual review, corrected formatting to Coverage Indications, Limitations and/or Medical Necessity.

12/28/2022: At this time 21st Century Cures Act will apply to new and revised LCDs that restrict coverage which requires comment and notice. This revision is not a restriction to the coverage determination; and, therefore not all the fields included on the LCD are applicable as noted in this policy.

  • Other (Annual Review)
01/06/2022 R17

R17

Revision Effective: 01/06/2022

Revision Explanation: Annual review no changes made

12/28/2021: At this time 21st Century Cures Act will apply to new and revised LCDs that restrict coverage which requires comment and notice. This revision is not a restriction to the coverage determination; and, therefore not all the fields included on the LCD are applicable as noted in this policy.

  • Other (Annual Review)
12/24/2020 R16

R16

Revision Effective: 12/24/2020

Revision Explanation: Annual review no changes made

12/17/2020: At this time 21st Century Cures Act will apply to new and revised LCDs that restrict coverage which requires comment and notice. This revision is not a restriction to the coverage determination; and, therefore not all the fields included on the LCD are applicable as noted in this policy.

  • Other (Annual Review)
12/26/2019 R15

R15

Revision Effective: 12/20/2019

Revision Explanation: Annual review no changes made

12/20/2019:At this time 21st Century Cures Act will apply to new and revised LCDs that restrict coverage which requires comment and notice. This revision is not a restriction to the coverage determination; and, therefore not all the fields included on the LCD are applicable as noted in this policy.

  • Other (Annual Review)
09/26/2019 R14

R14

Revision Effective: 09/26/2019

Revision Explanation: Remove coding details and converted policy into new policy template that no longer includes coding section based on CR 10901.

09/23/2019:At this time 21st Century Cures Act will apply to new and revised LCDs that restrict coverage which requires comment and notice. This revision is not a restriction to the coverage determination; and, therefore not all the fields included on the LCD are applicable as noted in this policy.

  • Revisions Due To Code Removal
07/01/2018 R13

R13

Revision Effective: 07/01/2018

Revision Explanation: Code 0508T was added as covered based on new indications added to NCD 150.3.

 

12/26/2018:At this time 21st Century Cures Act will apply to new and revised LCDs that restrict coverage which requires comment and notice. This revision is not a restriction to the coverage determination; and, therefore not all the fields included on the LCD are applicable as noted in this policy

  • Revisions Due To CPT/HCPCS Code Changes
03/01/2018 R12

R12

Revision Effective: N/A

Revision Explanation: Annual review no changes made to policy at this time.

 

12/26/2018:At this time 21st Century Cures Act will apply to new and revised LCDs that restrict coverage which requires comment and notice. This revision is not a restriction to the coverage determination; and, therefore not all the fields included on the LCD are applicable as noted in this policy

  • Other (Annual review)
03/01/2018 R11

R11
Revision Effective: 03/01/2018
Revision Explanation: Added Z79.811 as a covered ICD-10 in groups 1 and 2.

 

05/07/2018:At this time 21st Century Cures Act will apply to new and revised LCDs that restrict coverage which requires comment and notice. This revision is not a restriction to the coverage determination; and, therefore not all the fields included on the LCD are applicable as noted in this policy

  • Reconsideration Request
01/01/2017 R10

R10
Revision Effective: N/A
Revision Explanation: Annual review no changes made.

 

12/21/2017:At this time 21st Century Cures Act will apply to new and revised LCDs that restrict coverage which requires comment and notice. This revision is not a restriction to the coverage determination; and, therefore not all the fields included on the LCD are applicable as noted in this policy

 

  • Other (annual review)
01/01/2017 R9

R
Revision Effective: 01/01/2017
Revision Explanation: M85.841 was left off in error in the group 1 ICD-10 codes for 77080.

 

12/05/2017:At this time 21st Century Cures Act will apply to new and revised LCDs that restrict coverage which requires comment and notice. This revision is not a restriction to the coverage determination; and, therefore not all the fields included on the LCD are applicable as noted in this policy

  • Typographical Error
02/01/2016 R8

R8
Revision Effective: 02/01/2016
Revision Explanation: Z13.820 was included in error in the group 1 ICD-10 codes for 77080.

 

08/24/2017:At this time 21st Century Cures Act will apply to new and revised LCDs that restrict coverage which requires comment and notice. This revision is not a restriction to the coverage determination; and, therefore not all the fields included on the LCD are applicable as noted in this policy.

  • Typographical Error
02/01/2016 R7 R7
Revision Effective: N/A
Revision Explanation: Annual review no changes.
  • Other (Annual Review)
02/01/2016 R6 R6
Revision Effective: 10/01/2015
Revision Explanation: ICD-10 codes E21.3 and E23.0 left off in error.
  • Typographical Error
02/01/2016 R5 R5
Revision Effective: 02/01/2016
Revision Explanation: CPT code 77085 was left off inadvertently from the list in the CPT/HCPCS section. It was listed above group 2 for ICD-10 codes but not included in CPT section.
  • Typographical Error
02/01/2016 R4 R4
Revision Effective: N/A
Revision Explanation: Corrected typographical error in group 1 paragraph ICd-10 section to show code should be 77080.
  • Typographical Error
02/01/2016 R3 R3
Revision Effective: 02/01/2016
Revision Explanation: Per CR9252 CMS updated NCD for bone mass measurement and removed M85.80 as approved dx for bone mass measurement. This dx has been removed from group 1 and 2 ICD-10 code groups.
  • Revisions Due To ICD-10-CM Code Changes
02/01/2016 R2 R1
Revision Effective: 02/01/2016
Revision Explanation: M48.50XA-M48.58XA was ranged in error and has been undone as the other 7th character for this range are not included.
  • Typographical Error
02/01/2016 R1 R1
Revision Effective: N/A
Revision Explanation: Correcting typographical error in first paragraph that left open italics.
  • Typographical Error
N/A

Associated Documents

Attachments
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Related National Coverage Documents
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Public Versions
Updated On Effective Dates Status
12/29/2023 01/04/2024 - N/A Currently in Effect You are here
12/28/2022 01/05/2023 - 01/03/2024 Superseded View
Some older versions have been archived. Please visit the MCD Archive Site to retrieve them.

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