evekhm/cms_iom_500 huggingface dataset:
Article - Billing and Coding: Omalizumab (A52448)
CMS National Coverage PolicyN/AArticle TextThis article contains billing and coding guidelines that complement the Local Coverage Determination (LCD) Drugs and Biologicals, Coverage of, for Label and Off-Label Uses.Abstract:Omalizumab is a recombinant DNA-derived humanized IgG1k monoclonal antibody that selectively binds to human immunoglobulin E (IgE).Definitions:Moderate persistent asthmaModerate persistent asthma is defined by the National Heart, Lung, and Blood Institute (NHLBI) as:Daily symptomsDaily use of inhaled short-acting beta2-agonistSome limitation with normal activityExacerbations requiring oral systemic corticosterioids>2/yearNighttime symptoms greater than 1 time a week but not nightlyFEV1>60% but <80% predictedFEF1/FVC reduced 5%Severe persistent asthmaSevere persistent asthma is defined by the National Heart, Lung, and Blood Institute (NHLBI) as:Symptoms throughout the dayUse of inhaled short-acting beta2-agonist several times per dayExtremely limited normal activityExacerbations requiring oral systemic corticosterioids>2/yearNighttime symptoms often 7x/weekFEV1<60% predictedFEV1/FVC reduced >5%NHLBI normal ranges by age for FEV1/FVC8-19 years of age  85%;20-39 years of age  80%;40-59 years of age  75%;60-80 years of age  70%.The presence of one of these features of severity (moderate or severe) is sufficient to place a patient in that category. These clinical features are based on pre-treatment symptoms and measurements.Because of the chance of anaphylaxis with omalizumab, patients should receive omalizumab treatment in a doctor's office or clinic setting and be observed for an appropriate period of time after each treatment. Omalizumab should only be administered in a healthcare setting by healthcare providers prepared to manage anaphylaxis that can be life-threatening.Omalizumab has not been shown to alleviate asthma exacerbations acutely and should not be used for the treatment of acute bronchospasm or status asthmaticus.Utilization:
Article - Billing and Coding: Omalizumab (A52448)
Omalizumab has not been shown to alleviate asthma exacerbations acutely and should not be used for the treatment of acute bronchospasm or status asthmaticus.Utilization:Dose and frequency should be in accordance with the FDA label or recognized compendia (for off-label uses). When services are performed in excess of established parameters, they may be subject to review for medical necessity.Omalizumab is covered when the drug is administered by a physician or incident to a physicians service in a clinic or office setting.Omalizumab is not covered if self-administered by the patient.FDA and Compendia Review:American Society of Health-System Pharmacists, Inc. AHFS Drug Information. Bethesda, MD: 2007.Clinical Pharmacology Web site. http://www.clinicalpharmacology.com/. Accessed 06/15/2021.Lexi-Drugs Web site. http://online.lexi.com/lco/action/home. Accessed 06/15/2021.National Comprehensive Cancer Network Web site. http://www.nccn.org/index.asp. Accessed 06/15/2021.Micromedex DrugDex Thomson Web site. http://www.thomsonhc.com/home/dispatch. Accessed 06/15/2021.U.S. Food and Drug Administration label approved 06/20/2003. Drugs@FDA Web site. http://www.accessdata.fda.gov/scripts/cder/drugsatfda/. Accessed 02/16/2022.United States Pharmacopoeia (USP), Volume I; Drug Information for the Health Care Professional, 2007.
Article - Billing and Coding: Paclitaxel (e.g., Taxol®/Abraxane ™) (A52450)
CMS National Coverage PolicyN/AArticle TextThis article contains billing and coding guidelines that complement the Local Coverage Determination (LCD) Drugs and Biologicals, Coverage of, for Label and Off-Label Uses.Abstract:Paclitaxel is a natural product with antitumor (antineoplastic) activity obtained via a semi-synthetic process from Taxus baccata. Paclictaxel is administered as an intravenous agent and inhibits the replication of cells by interfering with mitosis (cellular division).Documentation Requirements:For any claims submitted for albumin-bound paclitaxel, documentation should be included in the patient's medical record showing prior therapy included an anthracycline unless clinically contraindicated.When modifier JW is used to report that a portion of the drug is discarded, the medical record must clearly show the amount administered and the amount wasted. Effective July 1, 2023 (CR 13056) JZ Modifier is required on all claims that bill for drugs separately payable under Medicare Part B when there are no discarded amounts from single-dose containers or single-use packages.Utilization:Dose and frequency should be in accordance with the FDA label or recognized compendia (for off-label uses). When services are performed in excess of established parameters, they may be subject to review for medical necessity.Coding Information:When billing for metastatic (secondary) disease, only use the code for the primary malignancy if still present, and only use the related personal history of Z code if not.FDA and Compendia Review:American Society of Health-System Pharmacists, Inc.AHFS Drug Information.Bethesda, MD: 2007.Clinical Pharmacology Web site. http://www.clinicalpharmacology.com/. Accessed 06/06/2023.Lexi-Drugs Web site. http://online.lexi.com. Accessed 06/06/2023.Micromedex DrugDex. http://www.thomsonhc.com/home/dispatch. Accessed 06/06/2023.National Comprehensive Cancer Network Web site. http://www.nccn.org/index.asp. Accessed 06/02/2023.
Article - Billing and Coding: Paclitaxel (e.g., Taxol®/Abraxane ™) (A52450)
National Comprehensive Cancer Network Web site. http://www.nccn.org/index.asp. Accessed 06/02/2023.U.S. Food and Drug Administration label Drugs@FDA Web site. http://www.accessdata.fda.gov/scripts/cder/drugsatfda/. Accessed 02/01/2008.
Article - Billing and Coding: Ranibizumab and biosimilars, Aflibercept, Aflibercept HD, Brolucizumab-dbll and Faricimab-svoa (A52451)
CMS National Coverage PolicyN/AArticle TextThis article contains billing and coding guidelines that complement the Local Coverage Determination (LCD) Drugs and Biologicals, Coverage of, for Label and Off-Label Uses.Abstract:Ranibizumab, a recombinant humanized immunoglobin G, kappa monoclonal antibody fragment, is a vascular endothelial growth factor A (VEGF-A) antagonist used as an intravitreal injection.Aflibercept is a recombinant fusion protein consisting of portions of human VEGF receptors 1 and 2 extracellular domains fused to the Fc portion of human IgG1 formulated as an iso-osmotic solution for intravitreal administration.Brolucizumab-dbllis a human vascular endothelial growth factor (VEGF) inhibitor used as an intravitreal injection.Faricimab-svoa is a vascular endothelial growth factor (VEGF) inhibitor and angiopoietin-2 (Ang-2) inhibitor.Ranibizumab-eqrn is a vascular endothelial growth factor (VEGF) inhibitor interchangeable to Lucentis (ranibizumab).Aflibercept HD is a vascular endothelial growth factor (VEGF) inhibitor used as an intravitreal injection.Utilization:The dose and frequency of administration should be consistent with the FDA approved package insert. When dose and/or frequency are different from the FDA approved package insert, literature support for the specific schedule chosen should be available.Coding Information:The administration for ranibizumab, ranibizumab-nuna, ranibizumab-eqrn, aflibercept, aflibercept HD,brolucizumab-dbllor faricimab-svoa must be billed on the same claim as the drug, with CPT code 67028 (intravitreal injection of a pharmacologic agent).The appropriate site modifier (RT, LT or 50) must be appended to CPT code 67028 to indicate if the service was performed unilaterally or bilaterally. Claims without a modifier will be returned to the provider unprocessed.If the drug is denied as not reasonable and necessary, the associated injection code will also be denied.For claims submitted to the Part A and Part B MAC:
Article - Billing and Coding: Ranibizumab and biosimilars, Aflibercept, Aflibercept HD, Brolucizumab-dbll and Faricimab-svoa (A52451)
For claims submitted to the Part A and Part B MAC:Ranibizumab should be reported with HCPCS code J2778.Aflibercept should be reported with HCPCS code J0178.Brolucizumab-dbllshould be reported with HCPCS code J0179.Ranibizumab-nuna should be reported with HCPCS code Q5124.Faricimab-svoa should be reported with HCPCS code J2777.Ranibizumab-eqrn should be reported with HCPCS codes Q5128.Aflibercept HD should be reported with HCPCS code J0177.FDA and Compendia Review:American Society of Health-System Pharmacists, Inc.AHFS Drug Information.Bethesda, MD: 2014.Clinical Pharmacology Web site. http://www.clinicalpharmacology.com/. Accessed 03/08/222.FDA Web site. https://www.accessdata.fda.gov/scripts/cder/daf/Lexi-Drugs Web site. http://online.lexi.com/lco/action/home. Accessed 03/08/2022.Micromedex DrugDex Thomson Web site. http://www.thomsonhc.com/home/dispatch. Accessed 03/08/2022.National Comprehensive Cancer Network Web site. http://www.nccn.org/index.asp. Accessed 03/08/2022.
Article - Billing and Coding: Luteinizing Hormone-Releasing Hormone (LHRH) Analogs (A52453)
CMS National Coverage PolicyN/AArticle TextThis article contains billing and coding guidelines that complement the Local Coverage Determination (LCD) Drugs and Biologicals, Coverage of, for Label and Off-Label Uses.Abstract:Synthetic luteinizing hormone-releasing hormone (LHRH) analogs (also called LHRH agonists) available in the United States include leuprolide acetate (Lupron, Eligard, Viadur, Lutrate), goserelin acetate (Zoladex), triptorelin (Trelstar Depot, TrelstarLA, Triptodur), and histrelin acetate (Vantas). These drugs may be administered by injection or placed as small implants under the skin monthly, or every 3, 4, 6, or 12 months, depending on the preparation. The FDA approved indications and recognized off-label uses (which meet criteria in LCD L33394) vary by product. Leuprolide mesylate (Cancevi) has been added effective for dates of service on or after 05/26/2021.Specific coding guidelines for this drug:Once yearly implants (J9219 and J9225) will not be reimbursed more often than once in a 12-month period and will be denied when submitted with a diagnosis that is not covered. In addition, once yearly implant therapy is not reasonable unless the physician expects the life expectancy of the patient to be longer than one year.Leuprolide AcetateHCPCS code J9218 (leuprolide acetate, per 1 mg.) describes ausuallyself-administered form of leuprolide acetate and is not covered under Medicare Part A/B. Please refer to the Self-Administered Drug Exclusion List  Medical Policy Articles (A53021 for J-K MAC and A53022 for J6 MAC).Claims for leuprolide acetate billed for prostate cancer at dosages (i.e. J1950 for 3.75 mg of leuprolide acetate) which are medically indicated for other diagnoses will be subject to review and possible denial.
Article - Billing and Coding: Luteinizing Hormone-Releasing Hormone (LHRH) Analogs (A52453)
The 10.8 mg implant is not labeled for use in women (AHFS, 2007) and is considered contraindicated in women (Drugdex, 2009).Camcevi (leuprolide mesylate) is a ready-to-use, 6-month depot formulation of the approved gonadotropin releasing hormone (GnRH) agonist leuprolide.Lutrate (leuprolide acetate for depot suspension) a gonadotropin-releasing hormone (GnRH) agonist- 22.5 mg for 3 months administration.Documentation Requirements:The medical record documentation for patients receiving a once-yearly implant should support ongoing follow-up visits at least every three (3) to four (4) months. This documentation must be submitted upon request. Claims submitted without requested supporting evidence in the medical record will be denied as being not medically necessary.Utilization Guidelines:Drugs may be designed to deliver their respective agents at a controlled rate for a specified therapeutic period of time (e.g., those formulated in depot or implant form). Eligard, for example, (packaged as 22.5 mg /vial) is designed to deliver the 22.5 mg of leuprolide acetate at a controlled rate over a 3-month therapeutic period; Vantas (packaged as a 50 mg implant) is formulated to deliver histrelin continuously for 12 months. We would expect, therefore, to see the billing frequency for these drugs to match the particular drug formulation administered. For example, the Vantas 50 mg implant would only be billed once per 12 months.The leuprolide acetate and histrelin implants are designed to deliver their respective agents for 12 months at a controlled rate. Therefore, payment for these agents is usually limited to once in a 12-month period.Surgical implant forms of leuprolide acetate and histrelin acetate hormonal therapy must be removed after twelve months. When a surgical implant is removed, another surgical implant may be inserted to continue therapy.Coverage of leuprolide acetate and histrelin acetate, administered every 12 months in the surgical implant form for treatment of prostate cancer, is considered medically appropriate only for patients having a reasonable expectation of surviving at least 12 months.
Article - Billing and Coding: Luteinizing Hormone-Releasing Hormone (LHRH) Analogs (A52453)
Coverage of leuprolide acetate and histrelin acetate, administered every 12 months in the surgical implant form for treatment of prostate cancer, is considered medically appropriate only for patients having a reasonable expectation of surviving at least 12 months.GnRH analogs are covered for the indicated diagnosis, with frequency of administration governed by the duration of action of the previously administered GnRH analog. Drugs administered at intervals exceeding these frequencies, and the associated administration services will be denied.FDA and Compendia Review:AHFS Drug Information 2009. Available at http://www.ahfsdruginformation.com/. Accessed 01/28/2009.Clinical Pharmacology Web site. http://www.clinicalpharmacology.com/. Accessed 11/30/2022.FDA Web site:https://www.accessdata.fda.gov/scripts/cder/daf/Lexi-Drugs Web site. http://online.lexi.com. Accessed 11/30/2022Manufacturers drug inserts.Micromedex DrugDex. Thomson Web site. http://www.thomsonhc.com/home/dispatch. Accessed 11/30/2022National Comprehensive Cancer Network (NCCN) Drugs & Biologics Compendium. Available at http://www.nccn.org/professionals/drug_compendium/content/contents.asp Accessed 11/30/2022
Article - Ankle-Foot/Knee-Ankle-Foot Orthoses - Policy Article (A52457)
CMS National Coverage PolicyN/AArticle TextNON-MEDICAL NECESSITY COVERAGE AND PAYMENT RULESFor any item to be covered by Medicare, it must 1) be eligible for a defined Medicare benefit category, 2) be reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member, and 3) meet all other applicable Medicare statutory and regulatory requirements. Information provided in this policy article relates to determinations other than those based on Social Security Act 1862(a)(1)(A) provisions (i.e. reasonable and necessary).For a beneficiarys orthosis to be eligible for reimbursement the reasonable and necessary (R&N) requirements set out in the related Local Coverage Determination must be met. In addition, there are specific statutory payment policy requirements, discussed below, that also must be met.Ankle-foot orthoses (AFO) and knee-ankle-foot orthoses (KAFO) are covered under the Medicare braces benefit (Social Security Act 1861(s)(9)). For coverage under this benefit, the orthosis must be a rigid or semi-rigid device, which is used for the purpose of supporting a weak or deformed body member or restricting or eliminating motion in a diseased or injured part of the body. Items that are not sufficiently rigid to be capable of providing the necessary immobilization or support to the body part for which it is designed do not meet the statutory definition of the braces benefit. Items that do not meet the definition of a brace are statutorily noncovered, no benefit.
Article - Ankle-Foot/Knee-Ankle-Foot Orthoses - Policy Article (A52457)
Both off-the-shelf (OTS) and custom-fit items are considered prefabricated braces for Medicare coding purposes. 42 CFR 414.402 establishes that correct coding of AFO and KAFO items is dependent upon whether there is a need for minimal self-adjustment during the final fitting at the time of delivery. (See definitions below in CODING GUIDELINES.) If a custom fit code is billed when minimal self-adjustment was provided at the final delivery, or if an OTS code is billed when more than minimal self-adjustments were made at the final delivery, the claims will be denied as incorrect coding.A static/dynamic ankle-foot orthosis (AFO) (L4396, L4397) and replacement interface (L4392) are denied as noncovered (no Medicare benefit) when they are used solely for the prevention or treatment of a heel pressure ulcer because for these indications they are not used to support a weak or deformed body member or to restrict or eliminate motion in a diseased or injured part of the body (i.e., it does not meet the definition of a brace).A foot drop splint/recumbent positioning device (L4398) and replacement interface (L4394) are denied as noncovered (no Medicare benefit) when they are used solely for the prevention or treatment of a pressure ulcer because for these indications they are not used to support a weak or deformed body member or to restrict or eliminate motion in a diseased or injured part of the body (i.e., it does not meet the definition of a brace).Elastic or other fabric support garments (A4467 (BELT, STRAP, SLEEVE, GARMENT, OR COVERING, ANY TYPE)) with or without stays or panels do not meet the statutory definition of a brace because they are not rigid or semi-rigid devices. Code A4467 is denied as noncovered (no Medicare benefit). Refer to the CODING GUIDELINES section below for additional information.A foot pressure off-loading/supportive device (A9283) is denied as noncovered (no Medicare benefit), because it does not support a weak or deformed body member or restrict or eliminate motion in a diseased or injured part of the body.
Article - Ankle-Foot/Knee-Ankle-Foot Orthoses - Policy Article (A52457)
An inversion/eversion correction device (A9285) is denied as noncovered (no Medicare benefit), because it does not act as a brace; that is, it does not support a weak or deformed body member or restrict or eliminate motion in a diseased or injured part of the body.Socks (L2840, L2850) used in conjunction with orthoses are denied as noncovered (no Medicare benefit).Refer to the Orthopedic Footwear policy for information on coverage of shoes and related items which are an integral part of a brace.There is no separate payment for computer-aided design/computer-aided manufacturing (CAD/CAM) technology when it is used to fabricate an orthosis. Reimbursement, of the CAD/CAM technology utilized in the fabrication of an orthosis, is included in the allowance of the orthosis HCPCS code.Evaluation of the beneficiary, measurement and/or casting, and fitting/adjustments of the orthosis are included in the allowance for the orthosis. There is no separate payment for these services.Payment for ankle-foot orthoses or knee-ankle foot orthoses are included in the payment to a hospital or skilled nursing facility (SNF) if:The orthosis is provided to a beneficiary prior to an inpatient hospital admission or Part A covered SNF stay; and,The medical necessity for the orthosis begins during the hospital or SNF stay (e.g., after ankle, foot, or knee surgery).A claim should not be submitted to the DME MAC in this situation.Payment for ankle-foot orthoses or knee-ankle foot orthoses are also included in the payment to a hospital or a Part A covered SNF stay if:The orthosis is provided to a beneficiary during an inpatient hospital or Part A covered SNF stay prior to the day of discharge; and,The beneficiary uses the item for medically necessary inpatient treatment or rehabilitation.A claim must not be submitted to the DME MAC in this situation.Payment for ankle-foot orthoses or knee-ankle foot orthoses delivered to a beneficiary in a hospital or a Part A covered SNF stay is eligible for coverage by the DME MAC if:
Article - Ankle-Foot/Knee-Ankle-Foot Orthoses - Policy Article (A52457)
Payment for ankle-foot orthoses or knee-ankle foot orthoses delivered to a beneficiary in a hospital or a Part A covered SNF stay is eligible for coverage by the DME MAC if:The orthosis is medically necessary for a beneficiary after discharge from a hospital or Part A covered SNF stay; and,The orthosis is provided to the beneficiary within two days prior to discharge to home; and,The orthosis is not needed for inpatient treatment or rehabilitation but is left in the room for the beneficiary to take home.REQUIREMENTS FOR SPECIFIC DMEPOS ITEMS PURSUANT TO Final Rule 1713 (84 Fed. Reg Vol 217)Final Rule 1713 (84 Fed. Reg Vol 217) requires a face-to-face encounter and a Written Order Prior to Delivery (WOPD) for specified HCPCS codes. CMS and the DME MACs provide a list of the specified codes, which is periodically updated.The required Face-to-Face Encounter and Written Order Prior to Delivery List is availablehere.Claims for the specified items subject to Final Rule 1713 (84 Fed. Reg Vol 217) that do not meet the face-to-face encounter and WOPD requirements specified in the LCD-related Standard Documentation Requirements Article (A55426) will be denied as not reasonable and necessary.If a supplier delivers an item prior to receipt of a WOPD, it will be denied as not reasonable and necessary. If the WOPD is not obtained prior to delivery, payment will not be made for that item even if a WOPD is subsequently obtained by the supplier. If a similar item is subsequently provided by an unrelated supplier who has obtained a WOPD, it will be eligible for coverage.POLICY SPECIFIC DOCUMENTATION REQUIREMENTSIn addition to policy specific documentation requirements, there are general documentation requirements that are applicable to all DMEPOS policies. These general requirements are located in the DOCUMENTATION REQUIREMENTS section of the LCD.Refer to the LCD-related Standard Documentation Requirements article, located at the bottom of this Policy Article under the Related Local Coverage Documents section for additional information regarding GENERAL DOCUMENTATION REQUIREMENTS and the POLICY SPECIFIC DOCUMENTATION REQUIREMENTS discussed below.General RequirementsThe supplier must include on the claim line the diagnosis code(s) for HCPCS codes L4396, L4397, L4392 and L4631.
Article - Ankle-Foot/Knee-Ankle-Foot Orthoses - Policy Article (A52457)
General RequirementsThe supplier must include on the claim line the diagnosis code(s) for HCPCS codes L4396, L4397, L4392 and L4631.For a custom-fabricated orthosis, there must be documentation in the supplier's records to support the medical necessity of that type of device rather than a prefabricated orthosis. This information must be available upon request.When providing orthoses suppliers must:Provide the product that is specified by the treating practitionerBe sure that the treating practitioner's medical record justifies the need for the type of product (i.e., prefabricated versus custom fabricated)Only bill for the HCPCS code that accurately reflects both the type of orthosis and the appropriate level of fittingHave detailed documentation in the supplier's record that justifies the code selectedFor prefabricated orthoses (L1902, L1906, L1910, L1930, L1932, L1951, L1971, L2035, L2112, L2114, L2116, L2132, L2134, L2136, L4350, L4360, L4361, L4370, L4386, L4387, L4396, L4397, L4398), there is no physical difference between orthoses coded as custom fitted versus those coded as OTS. The differentiating factor for proper coding (see definitions in CODING GUIDELINES section below) is the need for minimal self-adjustment at the time of fitting by the beneficiary, caretaker for the beneficiary, or supplier. This minimal self-adjustment does not require the services of a certified orthotist or an individual who has specialized training (as defined in the CODING GUIDELINES section). Items requiring minimal self-adjustment are coded as OTS orthoses. For example, adjustment of straps and closures, bending or trimming for final fit or comfort (not all-inclusive) fall into this category.