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. Treating physicians and providers are responsible for determining what care to provide to their patients. http://www.clinicalpharmacology.com/. Facts and Comparisons 4.0. These policies apply to Medicare Advantage plans insured through UnitedHealthcare Insurance Company or one of its affiliated companies. Prolia is often covered by Medicare Part A or Part B, together referred to as "Original Medicare." Clearly, this could be a compliance risk or a significant loss of revenue if the correct choice isn't made. Medicare program. What Is Osteoporosis, and Are You At Risk? AMA disclaims responsibility for any errors in CPT that may arise as a result of CPT being used in conjunction with any software and/or hardware system that is not Year 2000 compliant. 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. All Rights Reserved. ICD-10-CM codes M80.00XA-M80.88XS have been added to the following Group Code lists: Group 2:, Group 3:, Group 5: and Group 8:. The AMA assumes no liability for data contained or not contained herein. J Clin Endocrinol Metab. There are different article types: Articles are often related to an LCD, and the relationship can be seen in the "Associated Documents" section of the Article or the LCD. Throughout your life, your body breaks down existing bone and builds new bone in its place to keep your skeleton strong. (2010). (2012). "JavaScript" disabled. Previous treatment of osteoporosis, agents used, outcomes and adverse reactions if any. You acknowledge that the ADA holds all copyright, trademark and other rights in CDT. Revision Number: 7Publication: July 2018 ConnectionLCR A/B2018-060. In postmenopausal osteoporosis, bone resorption exceeds bone formation, leading to bone loss and increased risk of fracture. Drug-induced osteopenia, secondary to androgen-deprivation therapy in prostate cancer patients (prophylaxis). We do not offer every plan available in your area. 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. Combination use of IV and/or oral forms of bisphosphonate therapy as treatment for osteoporosis during an episode of care is not covered. Prior vertebral fracture was a predictor of multiple vertebral fractures after Prolia Zometa (zoledronic acid). This leads to a loss of bone density. While there is no cure for osteoporosis, there are treatments that can help by slowing bone deterioration. 10/21/2014- Formatting corrected under the "General Information" section of this LCD. For purpose of this exclusion, "the term 'usually' means more than 50 percent of the time for all Medicare beneficiaries who use the drug. The effective date of this revision is based on date of service. For your pharmacy patients: Some Medicare Part D plans have a preferred specialty pharmacy and some commercial plans require a specific specialty pharmacy for filling a patient's Prolia prescription. Osteoporosis puts you at an increased risk for debilitating fractures, but there are treatments available to lower the likelihood of injury due to a fall or other accident. Is the proper administration code 96372 or 96401. endstream CMS DISCLAIMS RESPONSIBILITY FOR ANY LIABILITY ATTRIBUTABLE TO END USER USE OF THE CPT. Updated to include revisions made since April 2014. Amgen, Inc.Reclast (zoledronic acid) Injection prescribing information. 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. fascinator near strasbourg; princess illustration. 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. 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. Applicable FARS\DFARS Restrictions Apply to Government Use. We're committed to supporting you in providing quality care and services to the members in our network. The following statement has been further clarified to add (calcium 1000 mg daily and at least 400 IU vitamin D daily). Also, you can decide how often you want to get updates. The Bill type codes have been removed from this article. Complete absence of all Revenue Codes indicates In healthy people, bone formation and resorption are closely linked; old bone is resorbed and replaced by newly formed bone. You must meet your Medicare Part B deductible ( $233 per year in 2022) before Medicare will pay its share. When services are performed in excess of established parameters, they may be subject to review for medical necessity. ICD-10-CM code E83.52 has been added to the Group 1: Codes in the Covered ICD-10 Codes section. <> The other indications for these drugs are also addressed. Fee schedules, relative value units, conversion factors and/or related components are not assigned by the AMA, are not part of CPT, and the AMA is not 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. Can't find the answer you're looking for? Documentation supporting the diagnosis of breast cancer or nonmetastatic prostate cancer. Many Medicare recipients enroll in Part D prescription drug plans to help cover the costs of medications. 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. AMA disclaims responsibility for any errors in CPT that may arise as a result of CPT being used in conjunction with any software and/or hardware system that is not Year 2000 compliant. BisphosphonatesThe following bisphosphonate injections (administered intravenously [IV]) will be considered medically reasonable and necessary when administered as outlined in this LCD. This Agreement will terminate upon notice if you violate its terms. For Government Resources Regarding Medicare, Please Visit www.medicare.gov. You acknowledge that the ADA holds all copyright, trademark and other rights in CDT. Use is limited to use in Medicare, Medicaid or other programs administered by the Centers for Medicare and Medicaid Services (CMS). 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. Please refer to CMS IOM Publication 100-02, Medicare Benefit Policy Manual, Chapter 15, Section 50 Drugs and Biologicals. <. AACE/ACE Clinical Practice Guidelines For The Diagnosis And Treatment Of Postmenopausal Osteoporosis, J Endocr Pract. Please review and accept the agreements in order to view Medicare Coverage documents, which may include licensed information and codes. What Is the Medicare Donut Hole for 2022? Please note that codes (CPT/HCPCS and ICD-10) have moved from LCDs to Billing & Coding Articles. All rights reserved. Social Security Act (Title XVIII) Standard References: This LCD addresses incident to drugs that are not self-administered for certain patients with osteoporosis. The guidelines for LCD development are provided in Chapter 13 of the Medicare Program Integrity Manual. Your MCD session is currently set to expire in 5 minutes due to inactivity. New NOF guidelines and the WHO fracture assessment tool or FRAX. Chapter 17: drugs and biologicals. Through Medicare Part D, Prolia is covered for approximately 95 percent of its beneficiaries, 50 percent of whom do not need prior authorization. Please note that if you choose to continue without enabling "JavaScript" certain functionalities on this website may not be available. Proposed LCD document IDs begin with the letters "DL" (e.g., DL12345). The ICD-10-CM codes for intolerance to other available osteoporosis therapy have been moved to Group 4. The following Off-label Indications for Aredia will be considered medically reasonable and necessary: Zoledronic acid (Reclast and Zometa) is a bisphosphonic acid, which is an inhibitor of osteoclastic bone resorption. Most Part D plans will include Prolia on its formulary, or list of covered drugs. note: To find out how much your test, item, or service will cost, talk to your doctor or health care provider. The generic name for Prolia is denosumab. Aredia (pamidronate disodium). Lower levels of estrogen are responsible for a higher rate of bone loss. If you are experiencing any technical issues related to the search, selecting the 'OK' button to reset the search data should resolve your issues. 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. Based on the list price of the drug, the 20% coinsurance would amount to roughly $250. You must also meet the following requirements to be eligible: If you are eligible, Medicare covers 80 percent of the Medicare approved cost. UnitedHealthcare may modify these Policy Guidelines at any time by publishing a new version of the policy on this website. Other (Incorrect statement regarding Prolia route of administration), Other (Revisions to the LCD were based on an annual review conducted on August 31, 2017.). Please visit the, 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, Chapter 17, Section 10 Payment Rules for Drugs and Biologicals, Chapter 13, Section 13.5.4 Reasonable and Necessary Provision in an LCD. Revision Number: 6 Publication: June 2018 Connection LCR A/B2018-049. Some other conditions that increase the chances of osteoporosis are: If you are a post-menopausal woman who has osteoporosis, your physician may suggest taking Prolia. In certain markets, delegated vendor guidelines may be used to support medical necessity and other coverage determinations. Boniva (ibandronate) Injection. Bone HG et al, (2017). 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. 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. 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 license granted herein is expressly conditioned upon your acceptance of all terms and conditions contained in this agreement. http://www.thomsonhc.com/home/dispatch. The FDA labeling lists the safe and effective indications, dosage, and frequency of the agents. A federal government website managed and paid for by the U.S. Centers for Medicare & Medicaid Services. CMS National Coverage Determinations and Medicare Benefit Policy Manual InterQual Criteria/Guidelines NCCN Guidelines Find Your Doctor Find Your Drug Find Your Pharmacy Find a Document Questions? End User Point and Click Amendment: An episode of care includes the duration and frequency of the IV drugs in accordance with FDA labels. Lexi-Drugs Web site. 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. 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