RETIRED Local Coverage Determination (LCD)

Bisphosphonates (Intravenous [IV]) and Monoclonal Antibodies in the Treatment of Osteoporosis and Their Other Indications

L33270

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Contractor Information

Contractor Name	Contract Type	Contract Number	Jurisdiction	States
First Coast Service Options, Inc.	A and B MAC	09101 - MAC A	J - N	Florida
First Coast Service Options, Inc.	A and B MAC	09102 - MAC B	J - N	Florida
First Coast Service Options, Inc.	A and B MAC	09201 - MAC A	J - N	Puerto Rico Virgin Islands
First Coast Service Options, Inc.	A and B MAC	09202 - MAC B	J - N	Puerto Rico
First Coast Service Options, Inc.	A and B MAC	09302 - MAC B	J - N	Virgin Islands

LCD Information

Document Information

LCD ID
L33270

LCD Title
Bisphosphonates (Intravenous [IV]) and Monoclonal Antibodies in the Treatment of Osteoporosis and Their Other Indications

Proposed LCD in Comment Period
N/A

Source Proposed LCD
N/A

Original Effective Date
For services performed on or after 10/01/2015

Revision Effective Date
For services performed on or after 01/21/2021

Revision Ending Date
12/14/2023

Retirement Date
12/14/2023

Notice Period Start Date
N/A

Notice Period End Date
N/A

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CMS National Coverage Policy

This LCD supplements but does not replace, modify or supersede existing Medicare applicable National Coverage Determinations (NCDs) or payment policy rules and regulations for Bisphosphonates (Intravenous [IV]) and Monoclonal Antibodies in the Treatment of Osteoporosis and Their Other Indications. Federal statute and subsequent Medicare regulations regarding provision and payment for medical services are lengthy. They are not repeated in this LCD. Neither Medicare payment policy rules nor this LCD replace, modify or supersede applicable state statutes regarding medical practice or other health practice professions acts, definitions and/or scopes of practice. All providers who report services for Medicare payment must fully understand and follow all existing laws, regulations and rules for Medicare payment for Bisphosphonates (Intravenous [IV]) and Monoclonal Antibodies in the Treatment of Osteoporosis and Their Other Indications and must properly submit only valid claims for them. Please review and understand them and apply the medical necessity provisions in the policy within the context of the manual rules. Relevant CMS manual instructions and policies may be found in the following Internet-Only Manuals (IOMs) published on the CMS Web site.

Internet Only Manual (IOM) Citations:

CMS IOM Publication 100-02, Medicare Benefit Policy Manual,
- Chapter 15, Section 50 Drugs and Biologicals, Sections 50.1 Definition of Drug or Biological, 50.2 Determining Self-Administration of Drug or Biological, 50.3 Incident To Requirements, 50.4 Reasonableness and Necessity, 50.4.1 Approved Use of Drug, 50.4.2 Unlabeled Use of Drug, and 50.4.3 Examples of Not Reasonable and Necessary
CMS IOM Publication 100-04, Medicare Claims Processing Manual,
- Chapter 17, Section 10 Payment Rules for Drugs and Biologicals
CMS IOM Publication 100-08, Medicare Program Integrity Manual,
- Chapter 13, Section 13.5.4 Reasonable and Necessary Provision in an LCD

Social Security Act (Title XVIII) Standard References:

Title XVIII of the Social Security Act, Section 1862(a)(1)(A) states that no Medicare 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 1862(a)(7). This section excludes routine physical examinations.

Coverage Guidance

Coverage Indications, Limitations, and/or Medical Necessity

This LCD addresses “incident to” drugs that are not self-administered for certain patients with osteoporosis. The other indications for these drugs are also addressed.

History/Background and/or General Information

Osteoporosis is characterized by decreased bone mass and increased fracture risk, most commonly at the spine, hip, and wrist. The diagnosis can be confirmed by a finding of low bone mass, evidence of fracture on x-ray, a history of osteoporotic fracture, or height loss or kyphosis indicative of vertebral fracture. While osteoporosis occurs in both men and women, it is most common among women following menopause. In healthy people, bone formation and resorption are closely linked; old bone is resorbed and replaced by newly formed bone. In postmenopausal osteoporosis, bone resorption exceeds bone formation, leading to bone loss and increased risk of fracture. The World Health Organization (WHO) defines osteoporosis in a postmenopausal woman or a man over the age of 50 as a bone mineral density (BMD) T-score less than or equal to -2.5 at the total hip, femoral neck, or lumbar spine (at least two vertebral levels measured in the posterior-anterior projection, not the lateral projection) as noted below.

Normal: T-score above (i.e., better than) or equal to -1.0
Osteopenia: T-score between -1.0 and -2.5
Osteoporosis: T-score below (i.e., worse than) or equal to -2.5

In addition to diagnosis through densitometry, osteoporosis can be diagnosed clinically, regardless of the T-score. The presence of a fragility fracture constitutes a clinical diagnosis of osteoporosis. It is important to distinguish between risk factors for osteoporosis as defined by BMD and risk factors for osteoporotic fracture. The use of BMD T-scores to assess fracture risk can be markedly improved by combining BMD with information about other risk factors, particularly the woman’s age and fracture history. The major risk factors in postmenopausal women are advanced age, genetics, lifestyle factors (e.g., low calcium and vitamin D intake, smoking, and heavy alcohol consumption), thinness, and menopausal status. Because nearly 50% of postmenopausal women in the community over the age of 50 years who suffer an osteoporotic fracture do not have osteoporosis as defined by a BMD test, the WHO developed the fracture risk assessment tool (FRAX) to identify clinical risk factors of patients at high risk for osteoporotic fractures:

Age
Sex
Prior fragility fracture after age 50
History of corticosteroid use (5 mg per day or more for three months or longer)
Parental history of hip fracture
Rheumatoid arthritis
Secondary osteoporosis (e.g., type 1 diabetes, osteogenesis imperfecta in adults, longstanding hyperthyroidism, hypogonadism, premature menopause [before age 40], chronic malabsorption and chronic liver disease)
Current smoker
Alcohol use of greater than 2 medium glasses of wine or beer per day
Body Mass Index (BMI) (less than 21 kg/m2)

Other secondary causes of osteoporosis include the following:

Oral glucocorticosteroid therapy for longer than 3 months
Hypogonadism
Transplant history
Obesity surgery
Malabsorption disease
Aromatase therapy for breast cancer
Excess urinary calcium excretion
Vitamin D deficiency
Hypocalcemia
Multiple myeloma
Endocrine disorders such as hyperthyroidism, Cushing’s syndrome, and disorders of collagen structures
Renal failure (increase bone resorption, or decreased bone formation leading to renal osteodystrophy)
Paget’s disease
Liver/biliary disease
Metastatic cancer involving bone

Medical management focused on lifestyle may be all that is needed for postmenopausal women who are at low risk for osteoporotic fracture. The North American Menopause Society (NAMS) recommends adding osteoporosis drug therapy in the following populations:

All postmenopausal women who have had an osteoporotic vertebral or hip fracture
All postmenopausal women who have had BMD values consistent with osteoporosis (i.e., T-scores equal to or worse than -2.5) at the lumbar spine, femoral neck, or total hip region

Covered Indications

In order to be covered by Medicare, a drug or biological must be safe and effective and otherwise reasonable and medically necessary. Drugs and biologicals approved for marketing by the Food and Drug Administration (FDA) are considered safe and effective when used for indications specified in the FDA labeling. The FDA labeling lists the safe and effective indications, dosage, and frequency of the agents. Please refer to CMS IOM Publication 100-02, Medicare Benefit Policy Manual, Chapter 15, Section 50 Drugs and Biologicals.

In addition to FDA approved indications, Medicare may consider coverage of off-label uses based on guidance provided in the CMS IOM Publication 100-02, Medicare Benefit Policy Manual, Chapter 15, Section 50.4.2 for Unlabeled Use of Drug.

Bisphosphonates

The following bisphosphonate injections (administered intravenously [IV]) will be considered medically reasonable and necessary when administered as outlined in this LCD. The coverage of IV bisphosphonates must be supported in the medical record.

Criteria for the diagnosis of osteoporosis, and
History of treatment as related to progression of disease and ongoing risk factors, and
Description of treatment failure, or contraindication, or adverse side effects, of oral or self administered drugs for osteoporosis as applicable to the patient that supports IV therapy in lieu of standard oral treatment protocol.

The following IV bisphosphonate injections are considered medically reasonable and necessary when administered as outlined in this LCD:

Ibandronate sodium injection (Boniva®)
Pamidronate (Aredia®)
Zoledronic acid injection (Reclast®)
Zoledronic acid injection (Zometa®)

Boniva® is a bisphosphonate that inhibits osteoclast activity and reduces bone resorption and turnover, leading to, on average, a net gain in bone mass.

Boniva® is available in oral and IV forms. The IV form will be considered reasonable and necessary only for patients for whom oral therapy cannot be tolerated.

Given the oral equivalent and the availability of Boniva® tablets, and the Medicare manual language on the reasonable and necessary criteria for route of admission, the IV administration is allowed under the following circumstances:

Patient has a diagnosis of esophageal stricture, achalasia, or other severe esophageal dysmotility disorder; OR
Patient has a history of severe malabsorption making use of oral bisphosphonates ineffective; OR
Patient has an inability to stand or sit upright for 60 minutes; OR
Patient has documented adverse effects following the initiation of treatment of the oral form of the medication that required the withdrawal of the oral form of the medication.

See the FDA drug label for the FDA approved indications and dosages for Boniva®. https://labels.fda.gov

The following Off-label Indications for Boniva® Injection will be considered medically reasonable and necessary:

Corticosteroid-induced osteoporosis
Paget’s disease
Bone metastases in patients with prostate cancer

Aredia® is a bisphosphonate which is administered intravenously, is used to inhibit bone resorption and to decrease serum calcium.

See the FDA drug label for the FDA approved indications and dosages for Aredia®. https://labels.fda.gov

The following Off-label Indications for Aredia® will be considered medically reasonable and necessary:

Treatment of postmenopausal osteoporosis
Treatment of the prevention of glucocorticoid-induced osteoporosis

Zoledronic acid (Reclast® and Zometa®) is a bisphosphonic acid, which is an inhibitor of osteoclastic bone resorption. Zoledronic acid binds to the bone matrix, which decreases osteoclastic activity, prevents bone resorption and skeletal calcium release induced by various stimulatory factors released by tumors.

See the FDA drug label for the FDA approved indications and dosages for Reclast® and Zometa®. https://labels.fda.gov

Reclast® for Glucocorticoid-Induced Osteoporosis in Men and Women is allowed under the following circumstances:

the patient is either initiating or continuing to take system glucocorticoids in a daily dosage of 7.5 mg or greater of prednisone and who are expected to remain on glucocorticoids for at least 12 months
the patient is taking at least 1,200 mg calcium and 800-1,000 IU vitamin D per day

Reclast® for Women or Men with Osteoporosis is allowed under the following circumstances:

the patient is taking at least 1,200 mg calcium and 800-1,000 IU vitamin D per day

Reclast® for Paget’s Disease is allowed under the following circumstances:

the patient has been instructed to take 1,500 mg elemental calcium daily in divided doses (750 mg two times per day, or 500 mg three times per day) and 800 IU vitamin D per day, particularly in the 2 weeks following the administration of Reclast®
the patient has one of the following:
- An elevated serum alkaline phosphatase of two times or higher than the upper limit of the age-specific normal reference range, or
- The patient is symptomatic, or
- The patient is at risk for complications from the disease, to induce remission (normalization of serum alkaline phosphatase) prior to treatment with Reclast®

Reclast® for Re-Treatment of Paget’s Disease is allowed under the following circumstances:

the patient is experiencing a relapse based on serum alkaline phosphatase, or
the patient has failed to achieve normalization of their serum alkaline phosphatase, or
the patient has symptoms as dictated by current standard medical practice.

Zometa® is allowed under the following circumstances:

the patient is not on any other bisphosphonate medication(s)
the renal status of the patient has been monitored
Retreatment with Zometa® 4 mg may be considered if serum calcium does not return to normal or remain normal after treatment.

Zometa® for Hypercalcemia of Malignancy is allowed under the following circumstance:

the patient has an albumin-corrected serum calcium of ≥ 12 mg/dL (3.0 mmol/L)

Zometa® for Multiple Myeloma and Metastatic Bone Lesions of Solid Tumors is allowed under the following circumstances:

the patient was coadministered oral calcium supplements of 500 mg and a multiple vitamin containing 400 IU of vitamin D per day

The following Off-label Indication for Zometa® Injection will be considered medically reasonable and necessary:

Drug-induced osteopenia, secondary to androgen-deprivation therapy in prostate cancer patients (prophylaxis).

Monoclonal Antibodies - RANK ligand (RANKL) Inhibitors:

The following monoclonal antibodies injections (administered subcutaneously [SQ]) will be considered medically reasonable and necessary when administered as outlined in this LCD. The coverage of SQ monoclonal antibodies must be supported in the medical record.

Criteria for the diagnosis of osteoporosis, and
History of treatment as related to progression of disease and ongoing risk factors, and
Description of treatment failure, or contraindication, or adverse side effects of oral or self-administered drugs for osteoporosis as applicable to the patient that supports monoclonal antibodies via SQ injection therapy in lieu of standard oral treatment protocol.

Denosumab (Prolia® and Xgeva®) binds to RANKL, a transmembrane of soluble protein essential for the formation, function, and survival of osteoclasts, the cells responsible for bone resorption. Denosumab prevents RANKL from activating its receptor, RANK, on the surface of osteoclasts and their precursors. Prevention of the RANKL/RANK interaction inhibits osteoclast formation, function, and survival, thereby decreasing bone resorption and increasing bone mass and strength in both cortical and trabecular bone.

Prolia® (denosumab) is a human IgG2 monoclonal antibody with affinity and specificity for human RANKL (receptor activator of nuclear factor kappa – B ligand). It is produced in genetically engineered mammalian (Chinese hamster ovary) cells. See the FDA drug label for the FDA approved indications and dosages for Prolia®. https://labels.fda.gov

Xgeva® (denosumab) is a human IgG2 monoclonal antibody that binds to human RANKL that is produced in genetically engineered mammalian (Chinese hamster ovary) cells. See the FDA drug label for the FDA approved indications and dosages for Xgeva®. https://labels.fda.gov

Prolia® for all patients is allowed under the following circumstances:

the oral health of the patient was discussed
the patient was instructed to take 1,000 mg of calcium and at least 400 IU of vitamin D per day

Prolia® for Men and Postmenopausal Women with Osteoporosis is allowed under the following circumstances:

criteria for the diagnosis of osteoporosis is met, and
there is a history of treatment as related to progression of disease and ongoing risk factors, and
The patient meets the definition of osteoporosis with high risk for fracture, or
The patient has failed or is intolerant of other available osteoporotic therapy

Prolia® for Treatment of Bone Loss in Women Receiving Adjuvant Aromatase Inhibitor Therapy for Breast Cancer is allowed under the following circumstance:

the patient is a woman receiving adjuvant aromatase inhibitor therapy for breast cancer

Prolia® for Treatment of Bone Loss in Men Receiving Androgen Deprivation Therapy for non-metastatic prostate cancer is allowed under the following circumstance:

the patient is a man receiving androgen deprivation therapy for prostate cancer

Xgeva® for all patients is allowed under the following circumstances:

the patient is taking calcium and vitamin D supplements as necessary to treat or prevent hypocalcemia

Limitations:

If the drug use is not indicated on the FDA label, and is not included in one of the compendium approved by CMS (American Hospital formulary Services [AHFS], Clinical Pharmacology, NCCN Drugs and Biologicals Compendium and/or Thomson Micromedex DrugDex®) and the off-label use is not listed above, the drug use would not be considered medically reasonable and necessary, and, therefore is not allowed. Not only does the indication for the use of the drug need to meet medical necessity requirements, but the route of administration is also subject to medical necessity criteria.

Medical necessity is not demonstrated in the cases where a patient has not taken the oral form of a medication before the IV form of the drug, either for patient or provider convenience purposes, or for financial or emotional reasons.

Combination use of a bisphosphonate and a monoclonal antibody for the treatment of osteoporosis during an episode of care is not considered medically reasonable and necessary. Combination use of IV and/or oral forms of bisphosphonate therapy as treatment for osteoporosis during an episode of care is not covered. An episode of care includes the duration and frequency of the IV drugs in accordance with FDA labels.

Hypocalcemia, hypovitaminosis D, and other disturbances of bone and mineral metabolism must be effectively treated before starting therapy. Patients must receive supplemental calcium and vitamin D.

The optimal duration of the use of the drugs listed in this LCD has not been determined. It is expected that treatment with these drugs in a Medicare beneficiary meets the evidence-based peer reviewed literature and standards of care in the medical community.

Boniva® Injection is contraindicated for the following conditions:

Severe renal impairment defined as patients with serum creatinine >200µmol/L [2.3 mg/dL] or creatinine clearance measured or estimated <30 mL/min
Known hypersensitivity to Boniva® injections or to any of its excipients
Uncorrected hypocalcemia

Aredia® is contraindicated for the following:

Aredia is contraindicated in patients with clinically significant hypersensitivity to Aredia or other bisphosphonates.
Pregnancy and lactation
Patients who receive Aredia should have serum creatinine assessed prior to each treatment.
Serum calcium, electrolytes, phosphate, magnesium, and CBC, differential, and hematocrit/hemoglobin must be closely monitored in patients treated with Aredia.
Patients who have preexisting anemia, leukopenia, or thrombocytopenia should be monitored carefully in the first 2 weeks following treatment

Reclast® used for prevention without a confirmed diagnosis of osteoporosis in postmenopausal women will not be covered because it is not considered medically reasonable and necessary in the diagnosis and treatment of a specific illness or injury as defined in the Social Security Act, Section 1862(a)(1)(A) and as stated in CMS IOM Publication 100-02, Medicare Benefit Policy Manual, Chapter 15, Section 50.4.

Reclast® is contraindicated in the following conditions:

Hypocalcemia
Hypersensitivity to the active substance (zoledronic acid) or to any of the excipients
Pregnancy and lactation
Patients receiving Zometa®
Severe renal impairment defined as patients with serum creatinine clearance measured or estimated <35 mL/min

Zometa® is contraindicated for the following conditions:

Hypersensitivity to zoledronic acid or any component of Zometa®
Pregnancy and lactation
Patients receiving Reclast®

Prolia® is contraindicated for the following conditions:

Hypocalcemia
Patients receiving Xgeva

Xgeva® is not indicated for the following indication:

Prevention of skeletal related events in patients with multiple myeloma and other cancers of the blood. Effective for dates of service on or after 01/04/2018, the FDA has approved denosumab (Xgeva®) for the treatment of skeletal-related events in patients with multiple myeloma.

Xgeva® is contraindicated for the following conditions:

Hypocalcemia
Hypersensitivity to Xgeva
Patients receiving Prolia

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

Contractor Advisory Committee (CAC) Meetings

MAC Meeting Information URLs

Proposed LCD Posting Date

Comment Period Start Date

Comment Period End Date

Reason for Proposed LCD

Requestor Name	Requestor Letter
	View Letter

Requestor Information

Contact for Comments on Proposed LCD

Coding Information

Bill Type Codes

Code	Description
Please accept the License to see the codes.

Revenue Codes

Code	Description
Please accept the License to see the codes.

ICD-10-CM Codes that Support Medical Necessity

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

Additional ICD-10 Information

General Information

Associated Information

Documentation Requirements

Please refer to the related Local Coverage Article: Billing and Coding: Bisphosphonates (Intravenous [IV]) and Monoclonal Antibodies in the Treatment of Osteoporosis and Their Other Indications (A57603) for documentation requirements, utilization parameters and all coding information as applicable.

Sources of Information

First Coast Service Options, Inc., reference LCD number(s) – L32100

AACE/ACE Clinical Practice Guidelines For The Diagnosis And Treatment Of Postmenopausal Osteoporosis, J Endocr Pract. Vol 22 ( 4) September 2016

American College of Rheumatology. (2008). New NOF guidelines and the WHO fracture assessment tool or FRAX.

American College of Rheumatology. (N.D.). Glucocorticoid-induced osteoporosis.

Bone HG et al, (2017). 10 years of denosumab treatment in postmenopausal women with osteoporosis: results from the phase 3 randomised FREEDOM trial and open-label extension, The Lancet Diabetes and Endocrinology, 5 (7), pp. 513-523. Published online May 22, 2017

Boniva® (ibandronate sodium) prescribing information. (2010). Genentech, U.S.A., Inc.

Cauza, E., Etemad, M., et al (2004). Pamidronate increases bone mineral density in women with postmenopausal or steroid-induced osteoporosis. Journal of Clinical Pharm Ther Oct; 29(5):431-6

Clinical Pharmacology Web site. (2011). Denosumab.

Clinical Pharmacology Web site. (2011). Ibandronate sodium.

Clinical Pharmacology Web site. (2011). Zoledronic acid.

Compendia-Based Drug Bulletin (February 2006). Association of Community Cancer Centers.

Epstein, S. (2006). Update of Current Therapeutic Options for the Treatment of Postmenopausal Osteoporosis. Clinical Therapeutics, 2(28) 151-173.

Facts and Comparisons 4.0. Pamidronate Disodium.

Miller, P. (2005). Optimizing the management of Postmenopausal Osteoporosis with Bisphosphonates: The emerging role of intermittent therapy. Clinical Therapeutics, 27 (4), 361-376.

Miller PD et al, (2016) Denosumab or Zoledronic Acid in Postmenopausal Women With Osteoporosis Previously Treated With Oral Bisphosphonates. J Clin Endocrinol Metab. August, 101(8):3163–3170

Morabito, N. Gaudio, A., et al (2003). Three-year effectiveness of intravenous pamidronate versus pamidronate plus slow-release sodium fluoride for postmenopausal osteoporosis. Osteoporosis International 14:500-506

North American Menopause Society, (2010). Management of osteoporosis in postmenopausal women: 2010 position statement.

Pharmacy and Therapeutics, 29, 431-436. Blackwell Publishing Ltd.

Prolia™ (denosumab) prescribing information. (2010). Amgen, Inc.

Prolia® (denosumab) prescribing information. (2011). Amgen, Inc.

Prolia® (denosumab) prescribing information. (2012). Amgen, Inc.

Prolia® (denosumab) prescribing information. (2018). Amgen, Inc.

Reclast® (zoledronic acid) Injection prescribing information. (2011). Novartis Pharmaceuticals, Corp.

U.S. Food and Drug Administration. Aredia® (pamidronate disodium).

U.S. Food and Drug Administration. Boniva® (ibandronate) Injection. Accessed September 9, 2019.

U.S. Food and Drug Administration. Prolia® (denosumab). Accessed September 9, 2019.

U.S. Food and Drug Administration. Reclast® (zoledronic acid) Injection. Accessed September 9, 2019.

U.S. Food and Drug Administration. Xgeva® (denosumab). Accessed September 9, 2019.

U.S. Food and Drug Administration. Zometa® (zoledronic acid). Accessed September 9, 2019.

United States Pharmacopeia Drug Information (USP DI) (February 2006). Oncology Online for Health Care Professionals. Micromedex, Inc.

World Health Organization (2007). WHO Scientific Group on the Assessment of Osteoporosis at Primary Health Care Level. Summary meeting report, Brussels, Belgium, May 5-7, 2004.

Xgeva™ (densoumab) prescribing information. (2010). Amgen, Inc.

Xgeva® (densoumab) FDA label. (2013).

Xgeva® (densoumab) FDA label. (2018).

Zometa® (zoledronic acid) Injection prescribing information. (2011). Novartis Pharmaceuticals, Corp.

Bibliography

N/A

Revision History Information

Revision History Date	Revision History Number	Revision History Explanation	Reasons for Change
12/14/2023	R15	Based on review of the LCD, it was determined that the LCD is no longer required and, therefore, is being retired effective for dates of service on and after 12/14/2023. The U.S. Food and Drug Administration (FDA) labels provide guidelines for utilization of the drugs.	LCD Being Retired
01/21/2021	R14	LCD revised and published on 01/21/2021 to remove the erroneous statement “treatment failure of oral or self-administered drugs for osteoporosis as applicable to the patient that supports IV therapy in lieu of standard oral treatment protocol” listed under Prolia® for Men and Postmenopausal Women with Osteoporosis is allowed under the following circunstances:	Other (Incorrect statement regarding Prolia route of administration)
10/15/2019	R13	Revision Number: 8 Publication: October 2019 Connection LCR A/B 2019-073 Explanation of Revision: Based on CR 10901, the LCD was revised to remove all billing and coding and all language not related to reasonable and necessary provisions (“Bill Type Codes,” “Revenue Codes,” “CPT/HCPCS Codes,” “ICD-10 Codes that Support Medical Necessity,” “Documentation Requirements” and “Utilization Guidelines” sections of the LCD) and place them into a newly created billing and coding article. During the process of moving the ICD-10-CM diagnosis codes to the billing and coding article, the ICD-10-CM diagnosis code ranges were broken out and listed individually. Also, the CMS IOM language has been removed from the LCD and instead, the IOM citation related to this language is referenced in the “CMS National Coverage Policy”, “Covered Indications”, and “Limitations” sections of the LCD. In addition, the Social Security Act and IOM reference sections were updated. The effective date of this revision is for claims processed on or after January 8, 2019, for dates of service on or after October 3, 2018. Also, after review of the information that was moved from the LCD to the billing and coding article the language/”Z” ICD-10-CM diagnosis codes in the “ICD-10-CM Codes that Support Medical Necessity” section of the billing and coding article related to the triple diagnosis requirement for treatment of bone loss in women/men at high risk for fracture has been removed. The effective date of this revision is for dates of service on or after 10/15/2019. 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 LCD.	Other (Revision based on CR 10901)
07/19/2018	R12	Revision Number: 7 Publication: July 2018 Connection LCR A/B2018-060 Explanation of Revision: Based on an LCD reconsideration request, the “FDA indications for Prolia®” section of the LCD was updated to add the FDA approved indication for treatment of glucocorticoid-induced osteoporosis in men and women at high risk of fracture who are either initiating or continuing systemic glucocorticoids in a daily dosage equivalent to 7.5 mg or greater of prednisone and expected to remain on glucocorticoids for at least 6 months. In addition, ICD-10-CM diagnosis code range T38.0X5A - T38.0X5S was added to the “ICD-10 Codes that Support Medical Necessity” section of the LCD under “Group 1 Codes:” for HCPCS code J0897 (Prolia®). Also, the “Sources of Information” section of the LCD was updated. The effective date of these revisions is for claims processed on or after July 19, 2018, for dates of service on or after May 21, 2018. 07/19/2018: 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
06/21/2018	R11	Correction to url for XGEVA 2013 FDA Label.	Typographical Error
06/21/2018	R10	Revision Number: 6 Publication: June 2018 Connection LCR A/B2018-049 Explanation of Revision: Based on an external correspondence and LCD reconsideration, this LCD was revised to add ICD-10-CM codes C90.00, C90.01, C90.02 and M84.50XA – M84.58XS to the “ICD-10 Codes that Support Medical Necessity” section of the LCD under “Group 4 Codes:” for HCPCS code J0897 (Xgeva®). Also, the indication “prevention of skeletal-related events in patients with multiple myeloma” was added to the “FDA indication for Xgeva®” and “Documentation Requirements” sections of the LCD. In addition, the “Limitations” section of the LCD was updated to include a statement that “Effective for dates of service on or after 01/04/2018, the FDA has approved denosumab (Xgeva®) for the treatment of skeletal-related events in patients with multiple myeloma.” Finally, the “Sources of Information” section of the LCD was updated. The effective date of these revisions is for claims processed on or after June 21, 2018, for dates of service on or after January 4, 2018. Furthermore, this LCD was revised based on a LCD reconsideration request to remove the statement indicating the requirement of documentation of serum creatinine level prior to the administration of Prolia® under the subtitle “Prolia All Patients” in the “Documentation Requirements” section of the LCD. Also, the “Sources of Information” section of the LCD was updated. The effective date of this revision is based on date of service. 06/21/2018: 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
02/08/2018	R9	Revision Number: 5 Publication: February 2018 Connection LCR A/B2018-012 Explanation of Revision: This LCD was revised in the “ICD-10 Codes that Support Medical Necessity” section of the LCD under “Group 6 Medical Necessity ICD-10 Codes Asterisk Explanation:” to include an explanation that all the codes within the asterisked range from the first code to the last code apply. The effective date of this revision is based on process date. 02/08/2018: 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.	Provider Education/Guidance Public Education/Guidance
12/07/2017	R8	Revision Number: 4 Publication: December 2017 Connection LCR A/B2017-051 Explanation of Revision: Based on an annual review of the LCD, it was determined that some of the italicized language in the “Indications and Limitations of Coverage and/or Medical Necessity” section of the LCD does not represent direct quotation from the CMS sources listed in the LCD; therefore, this LCD is being revised to assure consistency with the CMS sources. The effective date of this revision is based on date of service. 12/07/2017: 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 (Revisions to the LCD were based on an annual review conducted on August 31, 2017.)
10/14/2016	R7	Revision Number: 3 Publication: October 2016 Connection LCR A/B2016-102 Explanation of Revision: The LCD was revised to remove ICD-10 diagnosis codes M89.9 and M94.9 and replace with the diagnosis code range M85.80-M85.9 in the “ICD-10 Codes that Support Medical Necessity” section of the LCD for HCPCS code J0897 (Prolia®). The effective date of this revision is based on date of service.	Revisions Due To ICD-10-CM Code Changes
03/10/2016	R6	Revision Number: 2 Publication: March 2016 Connection LCR A/B2016-050 Explanation of Revision: The LCD was revised to change ICD-10 diagnosis code range M88.1-M88.9 to ICD-10 diagnosis code range M88.0-M88.9 in the “ICD-10 Codes that Support Medical Necessity” section of the LCD for HCPCS code J3489 (Reclast®). The effective date of this revision is for claims processed on or after 03/10/2016, for dates of service on or after 10/01/15.	Provider Education/Guidance Public Education/Guidance
10/01/2015	R5	Revision Number: 1 Publication: February 2016 Connection LCR A/B2016-039 Explanation of Revision: The LCD was revised to add ICD-10-CM diagnosis code range M80.00XA-M80.88XS to the “ICD-10 Codes that Support Medical Necessity” section of the LCD for HCPCS code J0897 (Prolia®). In addition, the asterisked statement under the “ICD-10 Codes that Support Medical Necessity” section of the LCD was removed for HCPCS codes J1740 (Boniva®) and J3489 (Reclast®), as this information pertains to coding and can be found the ICD-10-CM codebook. The effective date of this revision is for claims processed on or after 02/08/16, for dates of service on or after 10/01/15.	Revisions Due To ICD-10-CM Code Changes
10/01/2015	R4	The language and/or ICD-10-CM diagnoses were updated to be consistent with the current ICD-9-CM LCD’s language and coding.	Aberrant Local Utilization
10/01/2015	R3	05/29/15-revised based on changes to the ICD-9 version of this LCD.	Provider Education/Guidance
10/01/2015	R2	correction to html coding for this LCD.	Other
10/01/2015	R1	10/21/2014- Formatting corrected under the "General Information" section of this LCD.	Other

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Updated On	Effective Dates	Status
12/14/2023	01/21/2021 - 12/14/2023	Retired	You are here
01/15/2021	01/21/2021 - N/A	Superseded	View
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Bisphosphonates (Intravenous [IV]) and Monoclonal Antibodies in the Treatment of Osteoporosis and Their Other Indications

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