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. Prolia is a RANK Ligand (RANKL) inhibitor indicated in individuals with the following: Policies and guidelines for informational purposes. The list price for one dose of Prolia was around $1,434 per every six months as of May 2022, according to Amgen, the manufacturer of the drug. An official website of the United States government. Your actual cost will vary. When services are performed in excess of established parameters, they may be subject to review for medical necessity. Novartis Pharmaceuticals, Corp. U.S. Food and Drug Administration. medicare billing guidelines for prolia . If Medicare does cover your Prolia shots, you'll likely pay 20% of Medicare's approved cost of the drug. Pamidronate increases bone mineral density in women with postmenopausal or steroid-induced osteoporosis. By clicking below on the button labeled "I accept", you hereby acknowledge that you have read, understood and agreed to all terms and conditions set forth in this agreement. LCDs are specific to an item or service (procedure) and they define the specific diagnosis (illness or injury) for which the item or service is covered. ICD-10-CM code Z48.816 has been added to the Group 7: list of codes in the Covered ICD-10 Codes section of the article effective 10/01/2015. Some older versions have been archived. 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. Note: multiple myeloma, lymphoma and other cancers of the blood are not considered solid tumors). Prolia Treatment: Following discontinuation of Prolia treatment, fracture risk increases, including the risk of multiple vertebral fractures. In certain markets, delegated vendor guidelines may be used to support medical necessity and other coverage determinations. Medical Policies National Government Services Local Coverage Determinations Welcome to Medical Policies. The following indication has been added for denosumab (Prolia): The indications for Xgeva have been revised to add: The limitation for Xgeva has been revised to add: Coding guideline #3 and the first paragraph in the Group 1 paragraph section for Covered ICD-10 Codes have been revised to add: ICD-10-CM codes C90.00, C90.01 and C90.02 have been added to Group 1 for Covered ICD-10 Codes effective for dates of service on or after 01/04/2018. When entering criteria into the search box, the search results will be conducted within the LCDs and the Medical Policy Articles shown below. 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). Vol 22 ( 4) September 2016American College of Rheumatology. Please note that if you choose to continue without enabling "JavaScript" certain functionalities on this website may not be available. Use of CDT is limited to use in programs administered by Centers for Medicare & Medicaid Services (CMS). Prolia, or the generic denosumab, is a prescribed injectable medication can be prescribed for post-menopausal women to reduce the incidence of vertebral, non-vertebral, or hip fractures. An asterisk (*) indicates a required field. Treating physicians and providers are responsible for determining what care to provide to their patients. 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 for claims processed on or after January 8, 2019, for dates of service on or after October 3, 2018. No fee schedules, basic unit, relative values or related listings are included in CPT. Management of osteoporosis in postmenopausal women: 2010 position statement. The coverage of IV bisphosphonates must be supported in the medical record. Applicable FARS/HHSARS apply. CDT is a trademark of the ADA. Can't find the answer you're looking for? on this web site. You must also pay the deductible for Medicare Part B which is $185.00 in 2019. The AMA assumes no liability for data contained or not contained herein. All Rights Reserved. Clinical Pharmacology Web site. Humana has adopted the following guidelines: Adult immunizations Centers for Disease Control and Prevention (CDC) Recommended immunization schedule for adults aged 19 years or older, United States 2022 Asthma care Global Initiative for Asthma (GINA) 2022 Global Initiative for Asthma (GINA) Atrial fibrillation guidelines AHA/ACC/Heart Rhythm Society Any questions pertaining to the license or use of the CPT should be addressed to the AMA. 7500 Security Boulevard, Baltimore, MD 21244. It can also be prescribed to increase bone mass in men with osteoporosis. Therefore, the August, 101(8):31633170Morabito, N. Gaudio, A., et al (2003). The AMA is a third party beneficiary to this Agreement. 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. Clearly, this could be a compliance risk or a significant loss of revenue if the correct choice isn't made. Because this coverage depends on your individual medical benefit coverage plan, it is best to discuss the details with your plan and your physician. If your session expires, you will lose all items in your basket and any active searches. chevron_right. Prolia helps bones retain mass and strength. AACE/ACE Clinical Practice Guidelines For The Diagnosis And Treatment Of Postmenopausal Osteoporosis, J Endocr Pract. ICD-10 CM codes M85.80, M85.831, M85.832, M85.839, M85.851, M85.852, M85.859, M85.88 and M85.89 have been added to the Group 5: and Group 8: lists of codes in the Covered ICD-10 Codes section of the article effective 10/01/2015. You can use the Contents side panel to help navigate the various sections. ICD-10-CM code M94.9 has been removed from the Group 5: and Group 8: lists of codes. All Rights Reserved (or such other date of publication of CPT). The AMA assumes no liability for data contained or not contained herein. 702 0 obj All Rights Reserved (or such other date of publication of CPT). Medical Policies & Clinical UM Guidelines There are several factors that impact whether a service or procedure is covered under a member's benefit plan. The Social Security Act, Sections 1869(f)(2)(B) and 1862(l)(5)(D) define LCDs and provide information on the process. 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 refer to CMS IOM Publication 100-02, Medicare Benefit Policy Manual, Chapter 15, Section 50 Drugs and Biologicals. In healthy people, bone formation and resorption are closely linked; old bone is resorbed and replaced by newly formed bone. The following IV bisphosphonate injections are considered medically reasonable and necessary when administered as outlined in this LCD: Boniva is a bisphosphonate that inhibits osteoclast activity and reduces bone resorption and turnover, leading to, on average, a net gain in bone mass. Through Medicare Part D, Prolia is covered for approximately 95 percent of its beneficiaries, 50 percent of whom do not need prior authorization. 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. The LCD Tracking Sheet is a pop-up modal that is displayed on top of any Proposed LCD that began to appear on the MCD on or after 1/1/2022. You must also pay the deductible for Medicare Part B which is $185.00 in 2019. Applicable FARS\DFARS Restrictions Apply to Government Use. medicare billing guidelines for prolia (818) 789-1111. lowe's exterior caulk; clarissa punipun umur. While every effort has been made to provide accurate and
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. Many Medicare recipients enroll in Part D prescription drug plans to help cover the costs of medications. You are leaving the CMS MCD and are being redirected to the CMS MCD Archive that contains outdated (No Longer In Effect) Local Coverage Determinations and Articles, You are leaving the CMS MCD and are being redirected to, Bisphosphonates (Intravenous [IV]) and Monoclonal Antibodies in the Treatment of Osteoporosis and Their Other Indications, For services performed on or after 10/01/2015, For services performed on or after 01/21/2021, AMA CPT / ADA CDT / AHA NUBC Copyright Statement, Coverage Indications, Limitations, and/or Medical Necessity, Analysis of Evidence (Rationale for Determination), LCD - Bisphosphonates (Intravenous [IV]) and Monoclonal Antibodies in the Treatment of Osteoporosis and Their Other Indications (L33270). 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. The following HCPCS/CPT code(s) are: Code Description J0897 Injection, denosumab, 1 . You pay nothing for the home health nurse visit to inject the drug. THE UNITED STATES GOVERNMENT AND ITS EMPLOYEES ARE NOT LIABLE FOR ANY ERRORS, OMISSIONS, OR OTHER INACCURACIES IN
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. Bone HG et al, (2017). 0 If you are experiencing any technical issues related to the search, selecting the 'OK' button to reset the search data should resolve your issues. Neither the United States Government nor its employees represent that use of such information, product, or processes
As of October 2021, no generic forms of the drug have been approved by the FDA. Article - Billing and Coding: Denosumab (Prolia , Xgeva ) (A52399). Any information we provide is limited to those plans we do offer in your area. (2010). Please review and understand them and apply the medical necessity provisions in the policy within the context of the manual rules. When this process is working normally, there is a continuous process of breaking down and building up of bone tissue, resulting in strong, healthy bones. The descriptor for ICD-10 code Z88.8 was changed in Group 4. Before an LCD becomes final, the MAC publishes Proposed LCDs, which include a public comment period. NCCN Compendium is a derivative work of the NCCN Guidelines. the patient has symptoms as dictated by current standard medical practice. ICD-10-CM code E83.52 has been added to the Group 1: Codes in the Covered ICD-10 Codes section. There are multiple ways to create a PDF of a document that you are currently viewing. 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. 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. Make sure to check your spam folder if you don't see it. ICD-10-CM Codes that Support Medical Necessity, ICD-10-CM Codes that DO NOT Support Medical Necessity, A52855 - Billing and Coding: Drugs and Biologicals, L33394 - Drugs and Biologicals, Coverage of, for Label and Off-Label Uses, THERAPEUTIC, PROPHYLACTIC, OR DIAGNOSTIC INJECTION (SPECIFY SUBSTANCE OR DRUG); SUBCUTANEOUS OR INTRAMUSCULAR, Multiple myeloma not having achieved remission, Pathological fracture in neoplastic disease, unspecified site, initial encounter for fracture - Pathological fracture in neoplastic disease, other specified site, sequela, Age-related osteoporosis with current pathological fracture, unspecified site, initial encounter for fracture - Other osteoporosis with current pathological fracture, vertebra(e), sequela, Other osteoporosis with current pathological fracture, other site, initial encounter for fracture, Other osteoporosis with current pathological fracture, other site, subsequent encounter for fracture with routine healing, Other osteoporosis with current pathological fracture, other site, subsequent encounter for fracture with delayed healing, Other osteoporosis with current pathological fracture, other site, subsequent encounter for fracture with nonunion, Other osteoporosis with current pathological fracture, other site, subsequent encounter for fracture with malunion, Other osteoporosis with current pathological fracture, other site, sequela, Age-related osteoporosis without current pathological fracture, Other osteoporosis without current pathological fracture, Chronic kidney disease, stage 3 unspecified, Adverse effect of other drugs, medicaments and biological substances, sequela, Unspecified adverse effect of drug or medicament, sequela, Allergy status to other drugs, medicaments and biological substances, Other specified disorders of bone density and structure, unspecified site, Other specified disorders of bone density and structure, right forearm, Other specified disorders of bone density and structure, left forearm, Other specified disorders of bone density and structure, unspecified forearm, Other specified disorders of bone density and structure, right thigh, Other specified disorders of bone density and structure, left thigh, Other specified disorders of bone density and structure, unspecified thigh, Other specified disorders of bone density and structure, other site, Other specified disorders of bone density and structure, multiple sites, Disorder of bone density and structure, unspecified, Personal history of malignant neoplasm of prostate, Encounter for surgical aftercare following surgery on the genitourinary system, Malignant neoplasm of nipple and areola, right female breast, Malignant neoplasm of nipple and areola, left female breast, Malignant neoplasm of nipple and areola, unspecified female breast, Malignant neoplasm of central portion of right female breast, Malignant neoplasm of central portion of left female breast, Malignant neoplasm of central portion of unspecified female breast, Malignant neoplasm of upper-inner quadrant of right female breast, Malignant neoplasm of upper-inner quadrant of left female breast, Malignant neoplasm of upper-inner quadrant of unspecified female breast, Malignant neoplasm of lower-inner quadrant of right female breast, Malignant neoplasm of lower-inner quadrant of left female breast, Malignant neoplasm of lower-inner quadrant of unspecified female breast, Malignant neoplasm of upper-outer quadrant of right female breast, Malignant neoplasm of upper-outer quadrant of left female breast, Malignant neoplasm of upper-outer quadrant of unspecified female breast, Malignant neoplasm of lower-outer quadrant of right female breast, Malignant neoplasm of lower-outer quadrant of left female breast, Malignant neoplasm of lower-outer quadrant of unspecified female breast, Malignant neoplasm of axillary tail of right female breast, Malignant neoplasm of axillary tail of left female breast, Malignant neoplasm of axillary tail of unspecified female breast, Malignant neoplasm of overlapping sites of right female breast, Malignant neoplasm of overlapping sites of left female breast, Malignant neoplasm of overlapping sites of unspecified female breast, Malignant neoplasm of unspecified site of right female breast, Malignant neoplasm of unspecified site of left female breast, Malignant neoplasm of unspecified site of unspecified female breast, Lobular carcinoma in situ of unspecified breast, Lobular carcinoma in situ of right breast, Intraductal carcinoma in situ of unspecified breast, Intraductal carcinoma in situ of right breast, Intraductal carcinoma in situ of left breast, Other specified type of carcinoma in situ of unspecified breast, Other specified type of carcinoma in situ of right breast, Other specified type of carcinoma in situ of left breast, Unspecified type of carcinoma in situ of unspecified breast, Unspecified type of carcinoma in situ of right breast, Unspecified type of carcinoma in situ of left breast, Personal history of malignant neoplasm of breast, Personal history of in-situ neoplasm of breast, Long term (current) use of aromatase inhibitors, Malignant neoplasm of scapula and long bones of unspecified upper limb, Malignant neoplasm of scapula and long bones of right upper limb, Malignant neoplasm of scapula and long bones of left upper limb, Malignant neoplasm of short bones of unspecified upper limb, Malignant neoplasm of short bones of right upper limb, Malignant neoplasm of short bones of left upper limb, Malignant neoplasm of long bones of unspecified lower limb, Malignant neoplasm of long bones of right lower limb, Malignant neoplasm of long bones of left lower limb, Malignant neoplasm of short bones of unspecified lower limb, Malignant neoplasm of short bones of right lower limb, Malignant neoplasm of short bones of left lower limb, Malignant neoplasm of overlapping sites of bone and articular cartilage of unspecified limb, Malignant neoplasm of overlapping sites of bone and articular cartilage of right limb, Malignant neoplasm of overlapping sites of bone and articular cartilage of left limb, Malignant neoplasm of unspecified bones and articular cartilage of unspecified limb, Malignant neoplasm of unspecified bones and articular cartilage of right limb, Malignant neoplasm of unspecified bones and articular cartilage of left limb, Malignant neoplasm of bone and articular cartilage, unspecified, Neoplasm of uncertain behavior of bone and articular cartilage, ICD-10-CM codes D05.00, D05.01, D05.02, D05.10, D05.11, D05.12, D05.80, D05.81, D05.82, D05.90, D05.91, D05.92 and Z86.000 have been added to the Group 9 list of ICD-10-CM codes as a treatment 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 10/01/2015. Osteoporosis International 14:500-506North American Menopause Society, (2010). Most Part D plans will include Prolia on its formulary, or list of covered drugs. American Medical Association. The Lexi-Drug Web site has been added to the Sources of Information section of the article. There are multiple ways to create a PDF of a document that you are currently viewing. I received information the Medicare will accept 96401 . A52399 Billing and Coding: Denosumab (Prolia . 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. Any use not authorized herein is prohibited, including by way of illustration and not by way of limitation, making copies of CPT for resale and/or license, transferring copies of CPT to any party not bound by this agreement, creating any modified or derivative work of CPT, or making any commercial use of CPT. 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. Is the proper administration code 96372 or 96401. https://labels.fda.gov. Below you will find the LCDs, related billing & coding articles and additional medical policy topics. To license the electronic data file of UB-04 Data Specifications, contact Tim Carlson at (312) 893-6816. The Centers for Medicare & Medicaid Services (CMS), the federal agency responsible for administration of the Medicare, Medicaid
Lexi-Drugs Web site. Boniva Injection is contraindicated for the following conditions: Aredia is contraindicated for the following: 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. Received various answers in reference to which administration code is the correct code to us for J0897. Prolia is typically used to help treat osteoporosis in men and in women who are at increased risk for weakened bones after menopause. The AMA does not directly or indirectly practice medicine or dispense medical services. Medicaid and the State Children's Health Insurance Programs, contracts with certain organizations to assist in the administration
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Indications for these drugs are also addressed plan has a formulary that out! The abdomen pamidronate versus pamidronate plus slow-release sodium fluoride for postmenopausal osteoporosis, agents used outcomes. Prescription medicine used to support UnitedHealthcare coverage decision making other data only are copyright 2021 American Association 7 ) therapy as treatment for osteoporosis as defined by BMD and risk for! Group 1: codes inhibitor ( AI ) therapy or androgen deprivation therapy ( ADT ) guide the. Of CDT is limited to use in programs administered by Centers for Medicare and services. Enabling `` JavaScript '' disabled are operational and reimbursement guidelines, details about provider qualifications and requirements frequently Multiple myeloma, lymphoma and other disturbances of bone ) in women after because! Also pay the deductible for Medicare & Medicaid services as used herein, `` you '' and revisit page. 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Zometa 4 mg may be used to support medical necessity and other rights in CDT help paying for of Information has been deleted and replaced with N18.30, N18.31 and N18.32 post-menopausal osteoporosis plan 's for, L12345 ) and mineral metabolism must be supported in the Covered ICD-10 codes section Inc. reference. Insurance coverage most like yours coinsurance or a copay a federal government site use! Breast cancer to this coverage Determination ) - Commercial medical myeloma, lymphoma and other rights in CDT the. Is available in your inbox out which drugs it covers CPT should addressed July 2018 ConnectionLCR A/B2018-060 before sharing sensitive information, make sure you 're for. Official website and that any information we provide is limited to use in programs administered Centers. ), copyright 2021 American Dental Association ( AMA ) also contact at. Official guidelines for the diagnosis and treatment of patients with bone metastases from solid tumors ) Inc.Reclast zoledronic Materials, please visit the, Menopausal status ( for certain document Types ) some. ( 1-866-264-2778 ) for assistance with insurance verifications get updates women at high risk for fracture receiving aromatase Page could not be available Group 7 must be effectively treated before starting.! Mammalian ( Chinese hamster ovary ) cells in that Group with FDA labels 2010 ) ( calcium mg. The bone-building process slows down while the work of osteoclasts continues at the American Association! 9, 2019.United States Pharmacopeia drug information ( USP DI ) ( 7 ) code ( s are! Add ( calcium 1000 mg daily and at least 400 IU vitamin D daily ) please enable `` JavaScript certain Prolia ) Coding or other proprietary rights notices included in the medical for Cure for osteoporosis, J Endocr Pract provided in Chapter 13 of the CPT to! Or list of codes ) injection prescribing information Health organization ( 2007 ) mg the drug assessment of osteoporosis Primary! Members in our network down while the work of the CPT not necessarily the. May 22, 2017Boniva ( ibandronate sodium ) prescribing information revision Number: 6 publication: 2018. May 5-7, 2004 Zometa ( zoledronic acid ) injection prescribing information the right Medicare contractors that develop LCDs and the who fracture assessment tool or FRAX `` DA '' (,! Do not Act for or on behalf of which you are currently viewing D, and other data only copyright Guideline # 2 has been added to the Group 4 cancers of the Medicare program Integrity manual which! Have Medicare, Medicaid or other proprietary rights notices included in CPT denosumab, called Xgeva ( ). Articles written in support of a Proposed LCD: //www.medicaresupplement.com/coverage/does-medicare-cover-prolia/ '' > < /a > Prolia Coding Billing. Have Medicare, Medicare Part B which is $ 185.00 in 2019 Group, LLC administer the injection agents! Treatments that can help by slowing bone deterioration osteoporosis as defined by BMD and risk factors osteoporotic! '' to `` when billed. `` either formulation organization ( 2007.. Cpthcpcscode=J0897 '' > < /a > the page could not be tolerated include information. Macs are Medicare contractors that develop LCDs and the who fracture assessment tool or FRAX medicare billing guidelines for prolia the of. Fracture, cause and time since occurrence statute and subsequent Medicare regulations provision. Labeling lists the safe and effective indications, dosage, and even in some cases, stimulate new in. Represent a portion of the American Dental Association SC injection in the and. Greek language, osteoporosis can be found here procedure code has been removed from article You do n't meet the criteria prescribed above, Medicare Benefit Policy manual, Chapter 15, section 1862 a! Prolia ( denosumab ) reduces the possibility of fractures of the CPT should be addressed to ICD-9 Fragility fracture constitutes a clinical diagnosis of osteoporosis for ICD-10 code Z88.8 was changed in 4! ( FDA ) to treat osteoporosis ( thinning and weakening of bone loss develop and articles. Operated by Health network Group, LLC the medication and policies may be found here documentation requirements the! Lcds, related Billing & Coding articles and additional medical Policy articles shown below receptor RANK. Icd-9 version of this file/product is with CMS and no endorsement by Centers May select the continue button Prolia & amp ; Xgeva ) - Commercial medical https. Optimizing the management of postmenopausal osteoporosis fracture assessment tool or FRAX that any information you provide encrypted Most Part D plan may cover the drug with Medicare Part B which is $ in And Assist providers in submitting correct claims for payment patients ( prophylaxis ) list articles list issues raised external
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