This article defines coding and coverage for denosumab (Prolia™, Xgeva™) including off-label indications. National Government Services Local Coverage Determination (LCD) "Coverage of Drugs and Biologicals for Label and Off-Label Uses" allows coverage for off-label indications only if the United States Pharmacopeia Drug Information (USP-DI), the American Hospital Formulary Services (AHFS) and/or Thomson Healthcare DrugPoints® (as described in the LCD) define such indications or if National Government Services has published an article or LCD expanding such coverage. Effective for dates of service on or after 11/25/2008, American Hospital Formulary Services (AHFS), Clinical Pharmacology, NCCN Drugs and Biologics Compendium and/or Thomson Micromedex DrugDex® compendium has replaced the USP-DI and Thomson Healthcare DrugsPoints®. Providers may request approval for additional off-label indications by submitting this request in writing with supporting medical literature. The aforementioned National Government Services LCD, which describes the requirements for such a request, can be accessed through our contractor Web site at www.NGSMedicare.com or on the Medicare Coverage Database at www.cms.gov/medicare-coverage-database.
Abstract: Denosumab is a receptor activator of nuclear factor kappa-B ligand (RANKL) inhibitor. Binding to the transmembrane or soluble protein RANKL inhibits the formation, function, and survival of osteoclasts resulting in decreased bone resorption and increased bone mass and strength.
Supplemental calcium and vitamin D are required.
Hypocalcemia must be corrected prior to initiation of denosumab therapy.
The FDA has appoved the use of denosumab (Prolia™). Medicare has determined under Section 1861(t) that this drug may be paid when it is administered incident to a physician's service and is determined to be reasonable and necessary. Such determination of reasonable and necessary is currently left to the discretion of the Medicare contractors.
Indications: - For the treatment of postmenopausal women with osteoporosis at high risk for fracture,
- defined as a history of osteoporotic fracture, or multiple risk factors for fractures;
- For the treatment of postmenopausal women with osteoporosis who have failed or are intolerant to other available osteoporosis therapy.
- For patients with significant renal failure where treatment with biphosphonate is not indicated, CrCl less than 35 ml/min.
Effective 11/18/2010, the FDA approved a second indication for denosumab (Xgeva!22). Xgeva!22 is approved for the treatment of patients with bone metastases from solid tumors.
Effective 09/16/2011, the FDA approved denosumab (Prolia®) as a treatment to increase bone mass in men at high risk for fracture receiving androgen deprivation therapy for nonmetastatic prostate cancer. In these patients Prolia® also reduced the incidence of vertebral fractures.
Prolia® is also indicated as a treatment to increase bone mass in women at high risk for fracture receiving adjuvant aromatase inhibitor therapy for breast cancer.
Effective 09/02/2012, the FDA approved denosumab (Prolia®) as a treatment to increase bone mass in men with osteoporosis at high risk for fracture defined as a history of osteoporotic fracture, or multiple risk factors for fracture; or patients who have failed or are intolerant to other available osteoporosis therapy. Limitations: - Denosumab (Prolia™) is contraindicated in patients with hypocalcemia.
- Denosumab (Xgeva!22) is not approved for patients with multiple myeloma or other cancer of the blood.
Documentation Requirements: The patient's medical record should contain documentation that fully supports the medical necessity for the administration of the denosumab(Prolia™). For postmenopausal osteoporosis at high risk for fracture such documentation should include
1 through 5 and for men the documentation should include 2 through 5, but is not limited to:
- Patients age, sex and menopausal status.
- Documentation supporting the diagnosis of osteoporosis.
- Previous treatment of osteoporosis, agents used, outcomes and adverse reactions if any.
- History of previous fractures, including type of fracture, cause and time since occurrence.
- Risk factors for future fracture including preventive measures.
For the treatment of cancer treatment-induced bone loss (CTIBL) due to hormone ablation such documentation should include, but is not limited to:
- Documentation supporting the diagnosis of breast cancer (in women) or nonmetastatic prostate cancer.
- Use of adjuvant aromatase inhibitor (AI) therapy (in women) or androgen deprivation therapy (ADT).
- Additional diagnoses for risk factors, if any.
The patient's medical record should contain documentation that fully supports the medical necessity for the administration of the denosumab (Xgeva™). Such documentation should include, but is not limited to:
- Documentation of bone metastasis from a solid tumor and adequate calcium levels as well as the use of Vitamin D if indicated.
Utilization: The recommended dose for the treatment of osteoporosis is 60 milligrams (mg) subcutaneously once every 6 months, plus calcium 1000 mg orally once daily and at least vitamin D 400 international units orally once daily.
Denosumab (Xgeva™) is administered at a dose of 120 mg every four weeks as a subcutaneous injection.
Coding Guidelines: General Guidelines for claims submitted to intermediaries or Part A or Part B MAC: - Effective for dates of service on or after 01/01/2012, HCPCS code J0897 should be used to report denosumab (Prolia!22, Xgeva!22) for claims submitted to the FI or Part A MAC and Part B MAC.
- For dates of service prior to 01/01/2012, claims submitted to the Part B MAC, denosumab (Prolia™, Xgeva™) should be billed using HCPCS code J3590, Unclassified biologics. Include the name of the product and the dosage administered in item 19 of the CMS-1500 form or the electronic equivalent.
- For claims submitted to the FI or Part A MAC, denosumab (Prolia™, Xgeva™) should be coded using HCPCS code C9399. Effective for dates of service on or after 11/01/2010 through 12/31/2011, HCPCS code C9272 should be used to report denosumab (Prolia™, Xgeva™) for claims submitted to the FI or Part A MAC.
- Administration of Denosumab may be billed using the chemotherapy administration code 96401 (Chemotherapy administration, subcutaneous or intramuscular; non-hormonal anti-neoplastic).
- Correct coding requires that a bone metastasis diagnosis (ICD-9-CM code 198.5) be present on the claim as the primary diagnosis and the original cancer or history of cancer be included as the secondary diagnosis. This article does not limit the primary cancer (as long as it is a solid tumor and not a myeloma or other cancer of the blood).
- Any significant and separately identifiable E&M service billed should accurately reflect the level of the components documented. Observation of the patient by the physician post-injection may be included in the E&M service. Only face-to-face time with the physician may be considered. Observation and treatment time by the office or hospital staff may not be billed separately or counted towards a physician E&M service.
- For claims submitted to the Part B MAC, the denosumab is reimbursable in the following places of service: office (11), home (12), assisted living facility (13), group home (14), temporary lodging (16), urgent care facility (20), custodial care facility (33), independent clinic (49) and state or local public health clinic (71), only when supplied as an "incident to" service by the physician.
Additional Information:
Sources of Information: Clinical Pharmacology Web site. http://www.clinicalpharmacology.com/. Accessed 10/01/2010.
National Comprehensive Cancer Network Web site. http://www.nccn.org/index.asp. Accessed 10/01/2010.
Prolia Web site. http://www.proliahcp.com/. Accessed 10/01/2010.
Thomson Micromedex DrugDex®. Thomson Web site. http://www.thomsonhc.com/home/dispatch. Accessed 10/01/2010.
Based on a reconsideration request the following sources have been added:
Ellis GK, Bone HG, Chlebowski R, et al. Randomized trial of denosumab in patients receiving adjuvant aromatase inhibitors for nonmetastatic breast cancer.
J Clin Oncol. 2008;26(30):4875-4882.
FDA label for Prolia® (denosumab) revised
09/2012. Smith MR, Egerdie B, Toriz NH, et al. Denosumab in men receiving androgen-deprivation therapy for prostate cancer.
N Engl J Med. 2009;361:745-755.
History:
Article published November 2012: The "Indications" section has been revised to add FDA approval for denosumab (Prolia®) as a treatment to increase bone mass in men with osteoporosis at high risk for fracture defined as a history of osteoporotic fracture, or multiple risk factors for fracture; or patients who have failed or are intolerant to other available osteoporosis therapy effective 09/02/2012. The "ICD-9 Codes that are Covered" paragraph section has been revised to include men in the language "for treatment to increase bone mass in postmenopausal women and for men with osteoporosis at high risk for fracture or postmenopausal women and for men with osteoporosis who have failed or are intolerant to other available osteoporosis therapy." The "Documentaion and Utilization" requirements have also been revised to include men with osteoporosis. In the "Sources of Information" section the FDA label date for denosumab (Prolia®) has been revised. Article corrected 09/20/2012: ICD-9-CM code 174.4 has been added as payable diagnosis when reported to increase bone mass in women at high risk for fracture receiving adjuvant aromatase inhibitor therapy for breast cancer effective for dates of service on or after 02/01/2012. This diagnosis was inadvertently omitted with the July 2012 update.
08/20/2012 - In accordance with Section 911 of the Medicare Modernization Act of 2003, carrier number 00630 is removed from this Article. Effective on this date, claims processing for Indiana Part B is performed by Wisconsin Physician Services, the Part A/Part B MAC contractor for this state.
07/23/2012 - In accordance with Section 911 of the Medicare Modernization Act of 2003, fiscal intermediary numbers 00130 and 00452 are removed from this Article. Effective on this date, claims processing for Indiana and Michigan is performed by Wisconsin Physician Services, the Part A/Part B MAC contractor for these states.
Article published July 2012: The "ICD-9 Codes that are Covered" section has been corrected to indicate that ICD-9-CM code 733.01 should be reported for the treatment of postmenopausal women with osteoporosis at high risk for fracture
or ICD-9-CM code 733.01 and a secondary diagnosis should be reported for postmenopausal women with osteoporosis who have failed or are intolerant to other available osteoporosis therapy
ICD-9-CM codes 733.00, 733.01, 733.09 and 185 have been added as payable diagnoses when reported to increase bone mass in men at high risk for fracture receiving androgen deprivation therapy for nonmetastatic prostate cancer effective for dates of service on or after 02/01/2012.
ICD-9-CM codes 733.00, 733.01, 733.09, 174.0, 174.1, 174.2, 174.3, 174.5, 174.6, 174.8 and 174.9 have been added as payable diagnoses when reported to increase bone mass in women at high risk for fracture receiving adjuvant aromatase inhibitor therapy for breast cancer effective for dates of service on or after 02/01/2012.
Article corrected 03/08/2012: The ICD-9 Codes that are Covered" section has been revised to indicate that ICD-9-CM code 733.01 should be reported for the treatment of postmenopausal women with osteoporosis at high risk for fracture. ICD-9-CM code 733.01 and a secondary diagnosis should be reported for postmenopausal women with osteoporosis who have failed or are intolerant to other available osteoporosis therapy effective for dates of service on or after 03/01/2012.
Article published March 2012: Based on a reconsideration request the following ICD-9-CM code changes have been made effective for dates of service on or after 02/01/2012:
ICD-9-CM codes 733.90 and V10.46 must be reported along with either V58.69 or V66.5 for treatment to increase bone mass in men at high risk for fracture receiving androgen deprivation therapy for nonmetastatic prostate cancer.
ICD-9-CM codes 733.90 and V10.3 must be reported along with V07.52, V58.69 or V66.5 for treatment to increase bone mass in women at high risk for fracture receiving adjuvant aromatase inhibitor therapy for breast cancer.
The ICD-9-CM code list for high risk of fracture has been removed. Separate documentation requirements have been added for the treatment of cancer treatment-induced bone loss (CTIBL) due to hormone ablation. The sources of information have been revised to include the FDA label.
Article published 01/01/2012: Based on the 2012 annual HCPCS update, HCPCS code C9272 has been deleted and replaced with HCPCS code J0897. HCPCS code J0897 has been added to the "CPT/HCHCS Code" section of the article. The following statement has been added to the CPT/HCPCS Code paragraph section of the article and as Coding Guideline #1 in the "Coding Guidelines" section of the article:
- Effective for dates of service on or after 01/01/2012, HCPCS code J0897 should be used to report denosumab (Prolia!22, Xgeva!22) for claims submitted to the FI or Part A MAC and carrier or Part B MAC.
Coding Guideline #2 has been revised to add that for dates of service prior to 01/01/2012, claims submitted to the carrier or Part B MAC, denosumab (Prolia!22, Xgeva!22) should be billed using HCPCS code J3590, Unclassified biologics. Include the name of the product and the dosage administered in item 19 of the CMS-1500 form or the electronic equivalent.
Coding Guideline #3 has been revised to add that for dates of service on or after 11/01/2010 through 12/31/2011, HCPCS code C9272 should be used to report denosumab (Prolia!22, Xgeva!22) for claims submitted to the FI or Part A MAC.
Article published 11/01/2011: The following indications have been added to the "Indications" section of the article for Prolia®:
- Effective 09/16/2011, the FDA approved denosumab (Prolia®) as a treatment to increase bone mass in men at high risk for fracture receiving androgen deprivation therapy for nonmetastatic prostate cancer. In these patients Prolia® also reduced the incidence of vertebral fractures.
- Prolia® is also indicated as a treatment to increase bone mass in women at high risk for fracture receiving adjuvant aromatase inhibitor therapy for breast cancer.
ICD-9-CM codes 174.0, 174.1, 174.2, 174.3, 174.5, 174.6, 174.8, 174.9 and 185 have been added to the "Secondary Diagnoses" list for "High Risk of Fracture" in the "ICD-9 Codes that are Covered" section of the article effective for dates of service on or after 09/16/2011.
10/17/2011 - In accordance with Section 911 of the Medicare Modernization Act of 2003, intermediary numbers 00160 and 00332 are removed from this article. Effective on this date, claims processing for Kentucky - Part A and Ohio -Part A is performed by CGS Administrators, LLC, the Part A/Part B MAC contractor for these states.
Article corrected 06/16/2011: Coding guideline number three has been revised to state that denosumab
may be billed using the chemotherapy administration code 96401, (Chemotherapy administration, subcutaneous or intramuscular; non-hormonal anti-neoplastic). CPT/HCPCS code 96401 has been added to the "CPT/HCPCS Codes" section of the article and CPT code 96372 has been removed. The use of CPT code 96401 is retroactive to the original effective date of the article.
Article pulished June 2011: Coding guideline number three has been revised to state that denosumab should be billed using the chemotherapy administration code 96401, (Chemotherapy administration, subcutaneous or intramuscular; non-hormonal anti-neoplastic).
05/16/2011 - In accordance with Section 911 of the Medicare Modernization Act of 2003, fiscal intermediary number 00453 is removed from this Article. Effective on this date, claims processing for Virginia and West Virginia is performed by Palmetto Government Benefits Administration, the Part A/Part B MAC contractor for these states.
04/30/2011 - In accordance with Section 911 of the Medicare Modernization Act of 2003, carrier number 00660 is removed from this Article. Effective on this date, claims processing for Kentucky is performed by Cigna Government Services, the Part A/Part B MAC contractor for this state.
Article corrected 02/10/2011: The article has been corrected to indicate that HCPCS code C9272 became effective for dates of service on or after 10/01/2010 based on CMS transmittal 2061 and has been added back to the effective date of this article 11/01/2010. The revision history for 01/01/2011 has been corrected to indicate that in the "ICD-9 Codes that are Covered" section ICD-9-CM code 198.5 has been added effective for dates of service 11/18/2010 and ICD-9 codes 585.3, 585.4 and 585.5 have been added to the secondary diagnosis list for intolerance to other available osteoporosis therapy effective for dates of service on or after 11/01/2010. The last sentence of Coding Guideline #4 has been corrected to state: "This article does not limit the primary cancer (as long as it is a solid tumor and not a myeloma or other cancer of the blood)." This has also been corrected in the paragraph in the "ICD-9 Codes that are Covered" section of the article.
Article published 02/01/2011: The following coding guideline has been added:
Correct coding requires that a bone metastasis diagnosis (ICD-9-CM code 198.5) be present on the claim as the primary diagnosis and the original cancer or history of cancer be included as the secondary diagnosis. This article does not limit the primary cancer so the primary cancer diagnosis codes are not listed."
The "ICD-9 Codes that are Covered" section of the article has been clarified to indicate that for the treatment of patients with bone metastases from solid tumors correct coding requires that a bone metastasis diagnosis (ICD-9-CM code 198.5) be present on the claim as the primary diagnosis and the original cancer or history of cancer be included as the secondary diagnosis and that this article does not limit the primary cancer so the primary cancer diagnosis codes are not listed. The following statement has also been added to this section: "For the treatment of postmenopausal women with osteoporosis at high risk for fracture and women with osteoporosis who have failed or are intolerant to other available osteoporosis therapy both a primary and secondary diagnosis must be reported."
Article published 01/01/2011: The "Indications" section of the article has been revised to include FDA approved indication for denosumab Xgeva!22 for the treatment of bone metastases from solid tumors effective 11/18/2010. The following indication has also been added to the "Indications" section of the article:
- For patients with significant renal failure where treatment with biphosphonate is not indicated, CrCl less than 35 ml/min.
The "Limitations" section of the article has been revised to include that denosumab (Xgeva!22) is not approved for patients with multiple myeloma or other cancer of the blood. The "Documentation" section of the article has been revised to include that the patients medical record should include documentation of bone metastasis from a solid tumor and adequate calcium levels as well as the use of Vitamin D if indicated for denosumab (Xgeva!22). The "Utilization" section of the article has been revised to include that denosumab (Xgeva!22) is administered at a dose of 120mg every four weeks as a subcutaneous injection. In the "ICD-9 Codes that are Covered" ICD9-CM code 198.5 has been added effective for dates of service 11/18/2010 and ICD-9 codes 585.3, 585.4 and 585.5 have been added to the secondary diagnosis list for intolerance to other available osteoporosis therapy effective for dates of service on or after 11/01/2010. In the "General Guidelines" section Xgeva!22 has been added to Coding Guidelines 1 and 2. The article has been revised to indicate that effective for dates of service on or after 11/01/2010, HCPCS code C9272 should be used to report denosumab (Prolia!22, Xgeva!22) for claims submitted to the FI or Part A MAC.
Article published 11/01/2010: Original version of article.
The original version of the corresponding LCD became effective on 12/01/2007.
11/21/2010 - For the following CPT/HCPCS codes either the short description and/or the long description was changed. Depending on which description is used in this article, there may not be any change in how the code displays in the document:
96372 descriptor was changed in Group 1
11/21/2011 - The following CPT/HCPCS codes were deleted:
C9272 was deleted from Group 1
Bill Codes:
11 - Hospital Inpatient (Including Medicare Part A)
13 - Hospital Outpatient
85 - Critical Access Hospital
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