evekhm/cms_iom_3000 huggingface dataset:
Proposed LCD - Cervical Fusion (DL39770)

Riew KD, Ecker E, Dettori JR. Anterior cervical discectomy and fusion for the management of axial neck pain in the absence of radiculopathy or myelopathy.Evid Based Spine Care J.2010;1(3):45-50.Carragee EJ, Hurwitz EL, Cheng I, et al. Treatment of neck pain: injections and surgical interventions: results of the Bone and Joint Decade 2000-2010 Task Force on Neck Pain and Its Associated Disorders.Spine (Phila Pa 1976).2008;33(4 Suppl):S153-169.Palit M, Schofferman J, Goldthwaite N, et al. Anterior discectomy and fusion for the management of neck pain.Spine (Phila Pa 1976).1999;24(21):2224-2228.Garvey TA, Transfeldt EE, Malcolm JR, Kos P. Outcome of anterior cervical discectomy and fusion as perceived by patients treated for dominant axial-mechanical cervical spine pain.Spine (Phila Pa 1976).2002;27(17):1887-1895; discussion 1895.Whitecloud TS, 3rd, Seago RA. Cervical discogenic syndrome. Results of operative intervention in patients with positive discography.Spine (Phila Pa 1976).1987;12(4):313-316.Simmons EH, Bhalla SK. Anterior cervical discectomy and fusion. A clinical and biomechanical study with eight-year follow-up.J Bone Joint Surg Br.1969;51(2):225-237.Carragee EJ, Hurwitz EL, Cheng I, et al. Treatment of neck pain: injections and surgical interventions: results of the Bone and Joint Decade 2000-2010 Task Force on Neck Pain and Its Associated Disorders.J Manipulative Physiol Ther.2009;32(2 Suppl):S176-193.Nystrom B, Svensson E, Larsson S, Schillberg B, Mork A, Taube A. A small group Whiplash-Associated-Disorders (WAD) patients with central neck pain and movement induced stabbing pain, the painful segment determined by mechanical provocation: Fusion surgery was superior to multimodal rehabilitation in a randomized trial.Scand J Pain.2016;12:33-42.Kreiner DS, Shaffer WO, Baisden JL, et al. An evidence-based clinical guideline for the diagnosis and treatment of degenerative lumbar spinal stenosis (update).Spine J.2013;13(7):734-743.Isaac Z, Atlas SJ, K L. Management of non-radicular neck pain in adults. UpToDate. www.uptodate.com. Published 2023. Updated Oct. 4, 2023. Accessed Oct. 30, 2023.
Proposed LCD - Lower Limb Prostheses (DL33787)

Theeven P, Hemmen B, Rings F, et al. Functional added value of microprocessor-controlled knee joints in daily life performance of Medicare Functional Classification Level-2 amputees.Journal of rehabilitation medicine.2011;43(10):906-915.Fard B, Persoon S, Jutte PC, et al. Amputation and prosthetics of the lower extremity: The 2020 Dutch evidence-based multidisciplinary guideline.Prosthetics and orthotics international.2023;47(1):69-80.Webster JB, Crunkhorn A, Sall J, Highsmith MJ, Pruziner A, Randolph BJ. Clinical Practice Guidelines for the Rehabilitation of Lower Limb Amputation: An Update from the Department of Veterans Affairs and Department of Defense.American journal of physical medicine & rehabilitation.2019;98(9):820-829.Sedki I, Fisher K. Developing prescribing guidelines for microprocessor-controlled prosthetic knees in the South East England.Prosthetics and orthotics international.2015;39(3):250-254.Centers for Medicare & Medicaid. Health Technology Assessment: Lower Limb Prosthetic Workgroup Consensus Document. https://www.cms.gov/Medicare/Coverage/DeterminationProcess/downloads/LLP_Consensus_Document.pdf. 2017. Accessed September 6, 2023.Kuhlmann A, Kruger H, Seidinger S, Hahn A. Cost-effectiveness and budget impact of the microprocessor-controlled knee C-Leg in transfemoral amputees with and without diabetes mellitus. Eur J Health Econ. 2020;21(3):437-449.Chen C, Hanson M, Chaturvedi R, Mattke S, Hillestad R, Liu HH. Economic benefits of microprocessor controlled prosthetic knees: a modeling study. Journal of neuroengineering and rehabilitation. 2018;15(Suppl 1):62.Sterne JAC SJ, Page MJ, Elbers RG, Blencowe NS, Boutron I, Cates CJ, Cheng H-Y, Corbett MS, Eldridge SM, Hernn MA, Hopewell S, Hrbjartsson A, Junqueira DR, Jni P, Kirkham JJ, Lasserson T, Li T, McAleenan A, Reeves BC, Shepperd S, Shrier I, Stewart LA, Tilling K, White IR, Whiting PF, Higgins JPT. RoB 2: a revised tool for assessing risk of bias in randomised trials. BMJ. 2019;366:l4898.Higgins J LT, Sterne J. Revised Cochrane Risk of Bias Tool for Randomized Trials (RoB2) Additional Considerations for Crossover Trials. https://www.riskofbias.info/welcome/rob-2-0-tool/rob-2-for-crossover-trials. 2021. Accessed September 6, 2023.Sterne JAC HM, Reeves BC, Savovic J, Berkman ND, Viswanathan M, Henry D, Altman DG, Ansari MT, Boutron I, Carpenter JR, Chan AW, Churchill R, Deeks JJ, Hrbjartsson A, Kirkham J, Jni P, Loke YK, Pigott TD, Ramsay CR, Regidor D, Rothstein HR, Sandhu L, Santaguida PL, Schnemann HJ, Shea B, Shrier I, Tugwell P, Turner L, Valentine JC, Waddington H, Waters E, Wells GA, Whiting PF, Higgins JPT. ROBINS-I: a tool for assessing risk of bias in non-randomized studies of interventions. BMJ 2016; 355; i4919; doi: 10.1136/bmj.i4919.GDT: G. GRADEpro Guideline Development Tool [Software]. McMaster University, 2015 (developed by Evidence Prime, Inc.). gradepro.org. (Accessed February 7, 2023).
Proposed LCD - Cervical Fusion (DL39793)

Carragee EJ, Hurwitz EL, Cheng I, et al. Treatment of neck pain: injections and surgical interventions: results of the Bone and Joint Decade 2000-2010 Task Force on Neck Pain and Its Associated Disorders.Spine (Phila Pa 1976).2008;33(4 Suppl):S153-169.Palit M, Schofferman J, Goldthwaite N, et al. Anterior discectomy and fusion for the management of neck pain.Spine (Phila Pa 1976).1999;24(21):2224-2228.Garvey TA, Transfeldt EE, Malcolm JR, Kos P. Outcome of anterior cervical discectomy and fusion as perceived by patients treated for dominant axial-mechanical cervical spine pain.Spine (Phila Pa 1976).2002;27(17):1887-1895; discussion 1895.Whitecloud TS, 3rd, Seago RA. Cervical discogenic syndrome. Results of operative intervention in patients with positive discography.Spine (Phila Pa 1976).1987;12(4):313-316.Simmons EH, Bhalla SK. Anterior cervical discectomy and fusion. A clinical and biomechanical study with eight-year follow-up.J Bone Joint Surg Br.1969;51(2):225-237.Carragee EJ, Hurwitz EL, Cheng I, et al. Treatment of neck pain: injections and surgical interventions: results of the Bone and Joint Decade 2000-2010 Task Force on Neck Pain and Its Associated Disorders.J Manipulative Physiol Ther.2009;32(2 Suppl):S176-193.Nystrom B, Svensson E, Larsson S, Schillberg B, Mork A, Taube A. A small group Whiplash-Associated-Disorders (WAD) patients with central neck pain and movement induced stabbing pain, the painful segment determined by mechanical provocation: Fusion surgery was superior to multimodal rehabilitation in a randomized trial.Scand J Pain.2016;12:33-42.Kreiner DS, Shaffer WO, Baisden JL, et al. An evidence-based clinical guideline for the diagnosis and treatment of degenerative lumbar spinal stenosis (update).Spine J.2013;13(7):734-743.Isaac Z, Atlas SJ, K L. Management of non-radicular neck pain in adults. UpToDate. www.uptodate.com. Published 2023. Updated October 4, 2023. Accessed October 30, 2023.
Proposed LCD - Cervical Fusion (DL39799)

Carragee EJ, Hurwitz EL, Cheng I, et al. Treatment of neck pain: injections and surgical interventions: results of the Bone and Joint Decade 2000-2010 Task Force on Neck Pain and Its Associated Disorders.Spine (Phila Pa 1976).2008;33(4 Suppl):S153-169.Palit M, Schofferman J, Goldthwaite N, et al. Anterior discectomy and fusion for the management of neck pain.Spine (Phila Pa 1976).1999;24(21):2224-2228.Garvey TA, Transfeldt EE, Malcolm JR, Kos P. Outcome of anterior cervical discectomy and fusion as perceived by patients treated for dominant axial-mechanical cervical spine pain.Spine (Phila Pa 1976).2002;27(17):1887-1895; discussion 1895.Whitecloud TS, 3rd, Seago RA. Cervical discogenic syndrome. Results of operative intervention in patients with positive discography.Spine (Phila Pa 1976).1987;12(4):313-316.Simmons EH, Bhalla SK. Anterior cervical discectomy and fusion. A clinical and biomechanical study with eight-year follow-up.J Bone Joint Surg Br.1969;51(2):225-237.Carragee EJ, Hurwitz EL, Cheng I, et al. Treatment of neck pain: injections and surgical interventions: results of the Bone and Joint Decade 2000-2010 Task Force on Neck Pain and Its Associated Disorders.J Manipulative Physiol Ther.2009;32(2 Suppl):S176-193.Nystrom B, Svensson E, Larsson S, Schillberg B, Mork A, Taube A. A small group Whiplash-Associated-Disorders (WAD) patients with central neck pain and movement induced stabbing pain, the painful segment determined by mechanical provocation: Fusion surgery was superior to multimodal rehabilitation in a randomized trial.Scand J Pain.2016;12:33-42.Kreiner DS, Shaffer WO, Baisden JL, et al. An evidence-based clinical guideline for the diagnosis and treatment of degenerative lumbar spinal stenosis (update).Spine J.2013;13(7):734-743.Isaac Z, Atlas SJ, K L. Management of non-radicular neck pain in adults. UpToDate. www.uptodate.com. Published 2023. Updated October 4, 2023. Accessed October 30, 2023.
Article - Billing and Coding: Bortezomib (A52371)

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:Bortezomibis an antineoplastic agent which inhibits the activity of the 26S proteasome. It exhibits cytotoxicity to various malignant cells, including myeloma and lymphoma cells.Documentation Requirements: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.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.FDA label for Velcade (bortezomib) approval 01/23/2012.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.U.S. Food and Drug Administration approval letter for VELCADE (bortezomib), dated May 13, 2003.U.S. Food and Drug Administration label for bortezomib approved 10/08/2014 accessed on line at http://www.accessdata.fda.gov/scripts/cder/drugsatfda/ on 10/23/2014.United States Pharmacopoeia (USP), Volume I; Drug Information for the Health Care Professional, 2007.
Article - Billing and Coding: Ibandronate Sodium (A52421)

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.The intravenous form of ibandronate was approved by the Food and Drug Administration (FDA) for use every three (3) months.Specific coding guidelines for this drug:Ibandronate sodium is available in oral and intravenous forms. National Government Services will consider the intravenous form to be reasonable and necessary only for patients for whom biphosphonate therapy including oral ibandronate sodium is medically necessary and who cannot tolerate oral therapy. Documentation must show that the patient cannot tolerate oral biphosphonates or that they are otherwise medically contraindicated.Coding Information:When submitting claims for senile osteoporosis or other osteoporosis, ICD-10-CM code K20.80, K20.81, K20.90, K20.91 or Z87.19 shouldonlybe added to claims to indicate that the patient has severe esophagitis and cannot take the oral drugs.When submitting claims for senile osteoporosis or other osteoporosis, ICD-10-CM code T50.995A-T50.995S, Y63.8, Z91.89 or Z92.89 shouldonlybe added to claims to indicate that the patient cannot tolerate oral ibandronate sodium.For management of hypercalcemia of malignancy (E83.52), the rationale for the use of the drug and the related malignancy must be documented in the patients medical record.When submitting claims for patients with osteoporosis as a complication of transplant, the related complication of transplant code as well as T50.995A-T50.995S or Z87.19 is required.When ibandronate is used to prevent osteoporosis in a postmenopausal woman who is not being treated for osteopenia, the claim should include the -GY modifier which will result in denial of Medicare payment.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.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 08/21/2023.Lexi-Drugs Web site. http://online.lexi.com. Accessed 08/21/2023.Micromedex DrugDex. http://www.micromedexsolutions.com/home/dispatch. Accessed 08/21/2023.National Comprehensive Cancer Network Web site. http://www.nccn.org/index.asp. Accessed 08/21/2023.U.S. Food and Drug Administration label approved 01/06/2006 accessed on line athttp://www.accessdata.fda.gov/scripts/cder/drugsatfda/on 11/19/2007.United States Pharmacopoeia (USP), Volume I; Drug Information for the Health Care Professional, 2007.
Article - Clinical Trials – Medical Policy Article (A52430)

The hospital should report the patient's principal diagnosis in Form Locator (FL) 67 of the UB-04.The principal diagnosis is the condition established after study to be chiefly responsible for this admission.For routine costs associated with clinical trials, this diagnosis will be Z00.6.The hospital enters ICD-10-CM codes for up to eight additional conditions in FLs 67A-67Q if they co-existed at the time of admission or developed subsequently, and which had an effect upon the treatment or the length of stay. It may not duplicate the principal diagnosis listed in FL 67.For inpatient hospital claims, the admitting diagnosis is required and should be recorded in FL 69. (See CMS Publication 100-04,Medicare Claims Processing Manual, Chapter 25, Section 75 for additional instructions.)</ul type=disc>Hospital Outpatient Claims:The hospital should report the full ICD-10-CM code for the diagnosis shown to be chiefly responsible for the outpatient services in FL 67.If no definitive diagnosis is made during the outpatient evaluation, the patient's symptom is reported. If the patient arrives without a referring diagnosis, symptom or complaint, the providershould report an ICD-10-CM code for Persons Without Reported Diagnosis Encountered During Examination and Investigation of Individuals and Populations (Z00.00-Z13.9). For routine costs associated with clinical trials, this diagnosis will be Z00.6.The hospital enters the full ICD-10-CM codes in FLs 67A-67Q for up to eight other diagnoses that co-existed in addition to the diagnosis reported in FL 67.</ul type=disc>For dates of service prior to April 1, 2010, FQHC services should be reported with bill type 73X. For dates of service on or after April 1, 2010, bill type 77X should be used to report FQHC services.
Article - Billing and Coding: Osteopathic Manipulative Treatment (A52435)

CMS National Coverage PolicyN/AArticle TextOsteopathic manipulative treatment (OMT) is a treatment employed, primarily by osteopathic physicians, to facilitate a patients recovery from somatic dysfunction, defined under the American Osteopathic Associations Glossary of Terminology as: impaired or altered function of related components of the somatic (body framework) system: skeletal, arthroidal and myofascial structures and related vascular, lymphatic and neuroelements. The positional and motion aspects of somatic dysfunction are best described using at least one of three parameters: 1. The position of a body part as determined by palpation and reference to its adjacent defined structure, 2. The direction in which motion is freer, and 3. The direction in which motion is restricted.Osteopathic manipulative treatment includes muscle energy, high velocity-low amplitude, counterstrain, myofascial release, visceral, and craniosacral. The chosen treatment will vary depending on patients age and clinical condition.Indications of CoverageOsteopathic Manipulative Treatment is covered when medically necessary and performed by a qualified physician, in patients whose history and physical examination indicate the presence of somatic dysfunction of one or more regions.Note:Osteopathic Manipulative Treatment(OMT) specifically encompasses only the procedure itself.Evaluation and management(E&M)services may be reported seperately using modifier -25 if the patient's condition requires a significant and identifiable E&M service which is above and beyond the usual pre and post service work associated with the OMT procedure; and it is appropriately documented.While the E&M service may be caused or prompted by the same symptoms or condition for which the OMT service was provided; documentation for the E&M must support this was a distinct and seperate purpose from the OMT evaluation and treatment.Different diagnoses are not required for the reporting of the OMT and E&M on the same date.Limitations of CoverageOsteopathic Manipulative Treatment is not covered when the indication of Coverage is not met, and conventional documentation of somatic dysfunction is not present in the patient's medical recordNote: No E&M service is warranted for planned follow-up OMT treatments unless a new condition occurs or the patients condition has changed substantially, necessitating an overall reassessment.
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.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: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.