Because this coverage depends on your individual medical benefit coverage plan, it is best to discuss the details with your plan and your physician. Prolia (Denosumab) reduces the possibility of fractures of the hip and vertebral and non-vertebral fractures. DISCLOSED HEREIN. While osteoporosis occurs in both men and women, it is most common among women following menopause. The AMA assumes no liability for data contained or not contained herein. You can collapse such groups by clicking on the group header to make navigation easier. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. Xgeva (denosumab). If you're looking for a new Medicare Advantage plan with drug coverage or a new Part D drug plan that may cover Prolia, you can compare plans online for free or request a free plan quote from a licensed insurance agent. Applicable Federal Acquisition Regulation Clauses (FARS)/Department of Defense Federal Acquisition Regulation supplement (DFARS) Restrictions Apply to Government Use. Documentation supporting the diagnosis of osteoporosis. You, your employees and agents are authorized to use CPT only as contained in the following authorized materials of CMS internally within your organization within the United States for the sole use by yourself, employees and agents. The page could not be loaded. Denosumab (Prolia & Xgeva) - Commercial Medical . The American Hospital Association ("the AHA") has not reviewed, and is not responsible for, the completeness or accuracy of any information contained in this material, nor was the AHA or any of its affiliates, involved in the preparation of this material, or the analysis of information provided in the material. This article contains billing and coding guidelines that complement the Local Coverage Determination (LCD) Drugs and Biologicals, Coverage of, for Label and Off-Label Uses. Absence of a Bill Type does not guarantee that the What Is the Medicare Donut Hole for 2022? Prolia for all patients is allowed under the following circumstances: Prolia for Men and Postmenopausal Women with Osteoporosis is allowed under the following circumstances: Prolia for Treatment of Bone Loss in Women Receiving Adjuvant Aromatase Inhibitor Therapy for Breast Cancer is allowed under the following circumstance: Prolia for Treatment of Bone Loss in Men Receiving Androgen Deprivation Therapy for non-metastatic prostate canceris allowed under the following circumstance: Xgeva for all patients is allowed under the following circumstances: 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. (Prolia and Xgeva ); Medicare has determined under Section 1861(t) [of the Social Security Act] that this drug may be paid when it is . I am on Medicare Osteoclasts are the cells that drive the process. Does Medicare Cover Bone Density Testing? For Government Resources Regarding Medicare, Please Visit www.medicare.gov. You can use your browser's Print function (Ctrl-P on a PC or Command-P on a Mac) to view a print preview and then select PDF as the output. The administration of denosumab, when billed, should be billed using the therapeutic administration code 96372 (Therapeutic prophylactic, or diagnostic injection (specify substance or drug); subcutaneous or intramuscular. (2008). Policies, Guidelines & Manuals. Prolia is approved by the U.S. Food and Drug Administration (FDA) to treat bone loss and minimize fracture risk. 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). 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. Neither the United States Government nor its employees represent that use of such information, product, or processes Current Dental Terminology © 2021 American Dental Association. Sign up to get the latest information about your choice of CMS topics in your inbox. endobj CDT is a trademark of the ADA. Prolia Coding and Billing Information Guide; Asia Diagnostic Guide to Aquatic Animal Diseases 402/2; Prevalence and Incidence of Rare Diseases; Development of Algorithms for Diagnosing Forms of Lichen Planus and Predicting of the Disease's Course; No Role for Human Papillomavirus Infection in Oral Cancers in a Region in Southern India 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. been made to provide accurate and complete information, CMS does not guarantee that there are no errors in the information displayed Abstract:Denosumab is a receptor activator of nuclear factor kappa-B ligand (RANKL) inhibitor. This page displays your requested Local Coverage Determination (LCD). There are multiple ways to create a PDF of a document that you are currently viewing. In most instances Revenue Codes are purely advisory. You agree to take all necessary steps to insure that your employees and agents abide by the terms of this agreement. Billing and Coding articles provide guidance for the related Local Coverage Determination (LCD) and assist providers in submitting correct claims for payment. Accessed 06/28/2021. Another option is to use the Download button at the top right of the document view pages (for certain document types). Response to Comment (RTC) articles list issues raised by external stakeholders during the Proposed LCD comment period. Retreatment with Zometa 4 mg may be considered if serum calcium does not return to normal or remain normal after treatment. If you qualify for coverage for Prolia under Medicare Part B, your plan will typically pay 80% of the injection while you pay the remaining 20%. Many Medicare recipients enroll in Part D prescription drug plans to help cover the costs of medications. Therefore, if a drug is self-administered by more than 50 percent of Medicare beneficiaries, the drug is excluded from coverage" and the MAC will make no payment for the drug. Boniva is available in oral and IV forms. hb```b``d`e`Y @16N,|8wTj )d0x*j2CS 6KX4& No fee schedules, basic unit, relative values or related listings are included in CPT. 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 womans age and fracture history. Under Medicare Part D, the amount you'll have to pay out of pocket depends on the terms of your plan, what tier your plan classifies the drug as and what stage of coverage you're in. August, 101(8):31633170Morabito, N. Gaudio, A., et al (2003). Making copies or utilizing the content of the UB-04 Manual, including the codes and/or descriptions, for internal purposes, resale and/or to be used in any You can use the Contents side panel to help navigate the various sections. CPT is provided "as is" without warranty of any kind, either expressed or implied, including but not limited to, the implied warranties of merchantability and fitness for a particular purpose. Blackwell Publishing Ltd.Prolia (denosumab) prescribing information. product or publication; creating any modified or derivative work of the UB-04 Manual and/or codes and descriptions; and/or making any commercial use of UB-04 Please review and accept the agreements in order to view Medicare Coverage documents, which may include licensed information and codes. Please visit the, Menopausal status (for female beneficiaries only). The license granted herein is expressly conditioned upon your acceptance of all terms and conditions contained in this agreement. Medicare has determined under Section 1861(t) that this drug may be paid when it is administered incident to a physicians service and is determined to be reasonable and necessary. To license the electronic data file of UB-04 Data Specifications, contact Tim Carlson at (312) 893-6816. 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. 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. Does Medicare Cover Prostate Cancer Treatment? <>/Filter/FlateDecode/ID[<8C8627A9F9B4B2110A00106DE140FC7F>]/Index[702 89]/Info 701 0 R/Length 148/Prev 166569/Root 703 0 R/Size 791/Type/XRef/W[1 3 1]>>stream The information displayed in the Tracking Sheet is pulled from the accompanying Proposed LCD and its correlating Final LCD and will be updated as new data becomes available. Pamidronate Disodium. Boniva (ibandronate) Injection. Correct coding requires that a bone metastasis diagnosis (ICD-10-CM code C79.51) be present on the claim as the primary diagnosis and the original cancer or history of cancer be included as the secondary diagnosis. HCPCS code J0897 should be used to report denosumab (Prolia, Xgeva) for claims submitted to the Part A and Part B MAC. The ICD-10-CM codes for intolerance to other available osteoporosis therapy have been moved to Group 4. Publication 100-04: Medicare Claims Processing Manual. Your MCD session is currently set to expire in 5 minutes due to inactivity. endobj Organizations who contract with CMS acknowledge that they may have a commercial CDT license with the ADA, and that use of CDT codes as permitted herein for the administration of CMS programs does not extend to any other programs or services the organization may administer and royalties dues for the use of the CDT codes are governed by their commercial license. Unless specified in the article, services reported under other Medicare.Org Is A Non-Government Resource That Provides Information Regarding Medicare, Medicare Advantage, And More. 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. As used herein, "you" and "your" refer to you and any organization on behalf of which you are acting. Prolia is an injectable medication that works by disrupting the activation of osteoclasts to slow down bone loss. In postmenopausal osteoporosis, bone resorption exceeds bone formation, leading to bone loss and increased risk of fracture. CMS DISCLAIMS RESPONSIBILITY FOR ANY LIABILITY ATTRIBUTABLE TO END USER USE OF THE CPT. (N.D.). Lexi-Drugs Web site. Zometa (zoledronic acid). Prior vertebral fracture was a predictor of multiple vertebral fractures after Prolia Amgen, Inc.Prolia (denosumab) prescribing information. medicare billing guidelines for prolia summer camps in sandy springs. UnitedHealthcare Medicare Advantage Policies, Coverage Summaries and Guidelines. The following HCPCS/CPT code(s) are: Code Description J0897 Injection, denosumab, 1 . 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. Please enable "JavaScript" and revisit this page or proceed with browsing CMS.gov with Medical Policies & Clinical UM Guidelines There are several factors that impact whether a service or procedure is covered under a member's benefit plan. Accessed September 9, 2019.United States Pharmacopeia Drug Information (USP DI) (February 2006). The AMA disclaims responsibility for any consequences or liability attributable to or related to any use, non-use, or interpretation of information contained or not contained in this file/product. . The Bill type codes have been removed from this article. Title XVIII of the Social Security Act, Section 1862 (a) (7). This section excludes routine physical examinations. If it does, your out-of-pocket price for Xgeva injections may cost more or less than Prolia, depending on where the drugs are classified on the formulary. If you do not agree with all terms and conditions set forth herein, click below on the button labeled "I do not accept" and exit from this computer screen. LCD document IDs begin with the letter "L" (e.g., L12345). If you do not agree with all terms and conditions set forth herein, click below on the button labeled "I do not accept" and exit from this computer screen. ICD-10-CM code M81.8 has been added to the Group 2 list of codes in the Covered ICD-10 Codes section of the article effective 10/01/2015. For the treatment of patients with bone metastases from solid tumors. The AMA does not directly or indirectly practice medicine or dispense medical services. (2010). Amgen, Inc.Prolia (denosumab) prescribing information. 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. First Coast Service Options, Inc.,reference LCD number(s) L32100. Compendia-Based Drug Bulletin (February 2006). MACs are Medicare contractors that develop LCDs and Articles along with processing of Medicare claims. Organizations who contract with CMS acknowledge that they may have a commercial CDT license with the ADA, and that use of CDT codes as permitted herein for the administration of CMS programs does not extend to any other programs or services the organization may administer and royalties dues for the use of the CDT codes are governed by their commercial license. An official website of the United States government. Any use not authorized herein is prohibited, including by way of illustration and not by way of limitation, making copies of CDT for resale and/or license, transferring copies of CDT to any party not bound by this agreement, creating any modified or derivative work of CDT, or making any commercial use of CDT. Please note that if you choose to continue without enabling "JavaScript" certain functionalities on this website may not be available. Speak with a Licensed Medicare Sales Agent 877-388-0596 - TTY 711. You shall not remove, alter, or obscure any ADA copyright notices or other proprietary rights notices included in the materials. used to report this service. It can also be used to help treat bone loss in cancer patients who are receiving treatment for prostate cancer (men) or breast cancer (women). In the formulary, drugs are divided into the following tiers: Because Prolia is a brand name drug with no generic equivalent, it typically falls under Tier 3 or 4. End User Point and Click Amendment: Applications are available at the American Dental Association web site. Amgen, Inc.Reclast (zoledronic acid) Injection prescribing information. The National Osteoporosis Foundation reports that roughly 10 million Americans have osteoporosis and that an additional 44 million people suffer from decreased bone density and may develop the disease in the future. Reproduced by CMS with permission. With Medicare Part D coverage, youre likely to pay coinsurance or a copay. 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. History/Background and/or General Information. Reclast for Glucocorticoid-Induced Osteoporosis in Men and Women is allowed under the following circumstances: Reclast for Women or Men with Osteoporosis is allowed under the following circumstances: Reclast for Pagets Disease is allowed under the following circumstances: Reclast for Re-Treatment of Pagets Disease is allowed under the following circumstances: Zometa is allowed under the following circumstances: Zometa for Hypercalcemia of Malignancy is allowed under the following circumstance: Zometa for Multiple Myeloma and Metastatic Bone Lesions of Solid Tumors is allowed under the following circumstances: The following Off-label Indication for Zometa Injection will be considered medically reasonable and necessary: 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. 12. New vertebral fractures occurred as early as 7 months (on average 19 months) after the last dose of Prolia. You acknowledge that the ADA holds all copyright, trademark and other rights in CDT. Prevention of skeletal related events in patients with multiple myeloma and other cancers of the blood. on this web site. Accessed September 9, 2019. ICD-10-CM code M94.9 has been removed from the Group 5: and Group 8: lists of codes. covers osteoporosis injectable drugs like Prolia, looking for a new Medicare Advantage plan with drug coverage, new Part D drug plan that may cover Prolia, 98% of surveyed Medicare prescription plans cover Prolia. AMA warrants that due to the nature of CPT, it does not manipulate or process dates, therefore there is no Year 2000 issue with CPT. The effective date of this revision is based on date of service. http://www.clinicalpharmacology.com/. The AMA disclaims responsibility for any consequences or liability attributable to or related to any use, non-use, or interpretation of information contained or not contained in this file/product. Your Medicare Part D plan has a formulary that spells out which drugs it covers. CPT codes, descriptions and other data only are copyright 2021 American Medical Association. I received information the Medicare will accept 96401 . For those who meet the criteria prescribed above, Medicare Part B covers Prolia. Included are operational and reimbursement guidelines, details about provider qualifications and requirements, frequently asked questions and other information. ICD-10-CM codes C40.00, C40.10, C403.20, C40.30, C40.80 and C40.90 have been added to the Group 11: Codes. If you have Medicare, you may be responsible for copay or coinsurance costs, depending on your Medicare coverage. We review some of the How do Medigap plans and Medicare Advantage plans differ? "JavaScript" disabled. Taken from the Greek language, osteoporosis means porous bones. special, incidental, or consequential damages arising out of the use of such information, product, or process. I\&B! You'll usually need to satisfy your Medicare Part B deductible before your plan will cover the drug. Accessed 06/28/2021.Prolia Web site. A Local Coverage Determination (LCD) is a decision made by a Medicare Administrative Contractor (MAC) on whether a particular service or item is reasonable and necessary, and therefore covered by Medicare within the specific jurisdiction that the MAC oversees. GOVERNMENT AND ITS EMPLOYEES ARE NOT LIABLE FOR ANY ERRORS, OMISSIONS, OR OTHER INACCURACIES IN THE INFORMATION, PRODUCT, OR PROCESSES Denosumab is administered by subcutaneous injection. endstream Osteoporosis is called a silent disease because there are typically no symptoms until you get a broken bone. An official website of the United States government. Subject to the terms and conditions contained in this Agreement, you, your employees and agents are authorized to use CDT only as contained in the following authorized materials and solely for internal use by yourself, employees and agents within your organization within the United States and its territories. An ICD-10-CM code from Group 5, Group 6 and Group 7 must be reported. ICD-10-CM codes C50.019, C50.119, C50.219, C50.319, C50.419, C50.519, C50.619, C50.819 and C50.919 have been added to the Group 9: Codes. The Tracking Sheet modal can be closed and re-opened when viewing a Proposed LCD. Applicable Federal Acquisition Regulation Clauses (FARS)/Department of Defense Federal Acquisition Regulation supplement (DFARS) Restrictions Apply to Government Use. The AMA does not directly or indirectly practice medicine or dispense medical services. Some older versions have been archived. @D*::::4#b36~&C `CK4"x$3,fa[Q1@Ln1nxoS_wXb{!&7 O1f`r;y1BC HK30C fA ICD-10-CM code E83.52 should be used to report management of hypercalcemia of malignancy. Medicare Part D Coverage for Prolia Many Medicare recipients enroll in Part D prescription drug plans to help cover the costs of medications. Amgen, Inc. Prolia (denosumab) prescribing information. If you are acting on behalf of an organization, you represent that you are authorized to act on behalf of such organization and that your acceptance of the terms of this agreement creates a legally enforceable obligation of the organization. License to use CPT for any use not authorized herein must be obtained through the AMA, CPT Intellectual Property Services, AMA Plaza, 330 Wabash Ave., Suite 39300, Chicago, IL 60611-5885. The Article Text section has been revised to remove the indications and limitations which can be found on the FDA Web site and in the approved compendia. Vol 22 ( 4) September 2016American College of Rheumatology. The first paragraph in the "Indications" section of the article has been revised to include Lexi-Drug compendium. Such determination of reasonable and necessary is currently left to the discretion of the Medicare contractors. As of October 2021, no generic forms of the drug have been approved by the FDA. The code lists in the article help explain which services (procedures) the related LCD applies to, the diagnosis codes for which the service is covered, or for which the service is not considered reasonable and necessary and therefore not covered. See the FDA drug label for the FDA approved indications and dosages for Prolia. Federal government websites often end in .gov or .mil. We follow the guidelines outlined in the CMS IOM Pub. They can help protect and strengthen bones, and even in some cases, stimulate new bone growth. Billing and Coding articles typically include CPT/HCPCS procedure codes, ICD-10-CM diagnosis codes, as well as Bill Type, Revenue, and CPT/HCPCS Modifier codes. Please review and accept the agreements in order to view Medicare Coverage documents, which may include licensed information and codes. American Medical Association. Medicare Part B (Medical Insurance) covers this test once every 24 months (or more often if medically necessary) if you meet one of more of these conditions: You're a woman whose doctor determines you're estrogen-deficient and at risk for osteoporosis, based on your medical history and other findings. Note: multiple myeloma, lymphoma and other cancers of the blood are not considered solid tumors). This Agreement will terminate upon notice if you violate its terms. Talk to your insurance provider. Another option is to use the Download button at the top right of the document view pages (for certain document types). of the Medicare program. Accessed 06/28/2021.National Comprehensive Cancer Network Web site. %%EOF Most Part D plans will include Prolia on its formulary, or list of covered drugs. The views and/or positions presented in the material do not necessarily represent the views of the AHA. J Clin Endocrinol Metab. No portion of the American Hospital Association (AHA) copyrighted materials contained within this publication may be copied without the express written consent of the AHA. AACE/ACE Clinical Practice Guidelines For The Diagnosis And Treatment Of Postmenopausal Osteoporosis, J Endocr Pract. damages arising out of the use of such information, product, or process. You have a bone fracture due to post-menopausal osteoporosis. medicare billing guidelines for prolia . The Medicare program provides limited benefits for outpatient prescription drugs. CDT is a trademark of the ADA. Your actual cost will vary. (2011). Facts and Comparisons 4.0. The views and/or positions presented in the material do not necessarily represent the views of the AHA. 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. 1 All Pharmacy and Medical Lives associated with Medicare FFS, Medicare Advantage, Medicare Part D, and Commercial Coverage Restriction for Prolia in DRG Coverage data snapshot as of June 2021 are included in this analysis. 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. ICD-10-CM official guidelines for coding and reporting, FY 2017. . A57603 - Billing and Coding: Bisphosphonates (Intravenous [IV]) and Monoclonal Antibodies in the Treatment of Osteoporosis and Their Other Indications. FDA label for Prolia https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/125320s202lbl.pdf, FDA label for XGEVA https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/125320s196s199lbl.pdf. U.S. Food and Drug Administration. Accessed 06/28/2021. The following Off-label Indications for Boniva Injection will be considered medically reasonable and necessary: Aredia is a bisphosphonate which is administered intravenously, is used to inhibit bone resorption and to decrease serum calcium. 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. 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. In certain markets, delegated vendor guidelines may be used to support medical necessity and other coverage determinations. 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. American Medical Association. History of previous fractures, including type of fracture, cause and time since occurrence. The Sources of Information has been revised to FDA and Compendia Review. Sources of information other than the FDA and compendia have been moved to a PDF file attached to LCD L33394. New NOF guidelines and the WHO fracture assessment tool or FRAX. The descriptor for ICD-10 code Z88.8 was changed in Group 4. Reclast is contraindicated in the following conditions: Zometa is contraindicated for the following conditions: Prolia is contraindicated for the following conditions: Xgeva is not indicated for the following indication: Xgeva is contraindicated for the following conditions: 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. You must also meet the following requirements to be eligible: If you are eligible, Medicare covers 80 percent of the Medicare approved cost.
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