evekhm/cms_iom_500 huggingface dataset:
Proposed LCD - Magnetic-Resonance-Guided Focused Ultrasound Surgery (MRgFUS) for Essential Tremor and Tremor Dominant Parkinson's Disease (DL37738)
Chang JW, Chang KP, Lipsman N, et al. A prospective trial of magnetic resonance-guided focused ultrasound thalamotomy for essential tremor: results of the 2-year follow-up.ANN NEUROL2018;83:107-114.P.S. Fishman, W.J. Elias, P. Ghanouni, R. Gwinn, N. Lipsman, M. Schwartz, J. W. Chang, T. Taira, V. Krishna, A. Rezai, K. Yamada, K. Igase, R. Cosgrove, H. Kashima, M.G.Kaplitt, T.S. Tierney, and H.M. Eisenberg, "Neurological adverse event profile of magnetic resonance imaging-guided focused ultrasound thalamotomy for essential tremor,"Moy Disord, vol. 33, no. 5, pp. 843-847-, May 2018.Krishna V, Sammartino, F, Cosgrove R, et al.Tremor Outcomes Improve with Experience in Focused Ultrasound Thalamotomy. In press.Moosa S, Martnez-Fernndez R, Elias WJ, Del Alamo M, Eisenberg HM, Fishman PS. The role of high-intensity focused ultrasound as a symptomatic treatment for Parkinsons disease.Mov Disord. 2019;34(9):1243-1251. doi:10.1002/mds.27779Ahmed N, Gandhi D, Melhem ER, Frenkel V. MRI guided focused ultrasound-mediated delivery of therapeutic cells to the brain: A review of the state-of-the-art methodology and future applications.Front Neurol. 2021;12:669449. doi:10.3389/fneur.2021.669449Lin F, Wu D, Yu J, et al. Comparison of efficacy of deep brain stimulation and focused ultrasound in parkinsonian tremor: a systematic review and network meta-analysis.J Neurol Neurosurg Psychiatry. 2021;92(4):434-443. doi:10.1136/jnnp-2020-323656
Proposed LCD - Magnetic-Resonance-Guided Focused Ultrasound Surgery (MRgFUS) for Essential Tremor and Tremor Dominant Parkinson's Disease (DL37738)
Schreglmann SR, Krauss JK, Chang JW, Bhatia KP, Kgi G. Functional lesional neurosurgery for tremor: a systematic review and meta-analysis.J Neurol Neurosurg Psychiatry. 2018;89(7):717-726. doi:10.1136/jnnp-2017-316302Xu Y, He Q, Wang M, et al. Safety and efficacy of magnetic resonance imaging-guided focused ultrasound neurosurgery for Parkinsons disease: a systematic review.Neurosurg Rev. 2021;44(1):115-127. doi:10.1007/s10143-019-01216-yLennon JC, Hassan I. Magnetic resonance-guided focused ultrasound for Parkinsons disease since ExAblate, 2016-2019: a systematic review.Neurol Sci. 2021;42(2):553-563. doi:10.1007/s10072-020-05020-1Ge Y, Wang Z, Gu F, et al. Clinical application of magnetic resonance-guided focused ultrasound in Parkinsons disease: a meta-analysis of randomized clinical trials.Neurol Sci. 2021;42(9):3595-3604. doi:10.1007/s10072-021-05443-4Magara A, Bhler R, Moser D, Kowalski M, Pourtehrani P, Jeanmonod D. First experience with MR-guided focused ultrasound in the treatment of Parkinsons disease.J Ther Ultrasound. 2014;2(1):11. doi:10.1186/2050-5736-2-11Schlesinger I, Eran A, Sinai A, et al. MRI Guided Focused Ultrasound Thalamotomy for Moderate-to-Severe Tremor in Parkinsons Disease. Parkinsons Disease.; 2015.
Proposed LCD - Magnetic-Resonance-Guided Focused Ultrasound Surgery (MRgFUS) for Essential Tremor and Tremor Dominant Parkinson's Disease (DL37738)
Schlesinger I, Eran A, Sinai A, et al. MRI Guided Focused Ultrasound Thalamotomy for Moderate-to-Severe Tremor in Parkinsons Disease. Parkinsons Disease.; 2015.Zaaroor M, Sinai A, Goldsher D, Eran A, Nassar M, Schlesinger I. Magnetic resonanceguided focused ultrasound thalamotomy for tremor: a report of 30 Parkinsons disease and essential tremor cases.J Neurosurg. 2018;128(1):202-210. doi:10.3171/2016.10.jns16758Fasano A, Llinas M, Munhoz RP, Hlasny E, Kucharczyk W, Lozano AM. MRI-guided focused ultrasound thalamotomy in non-ET tremor syndromes.Neurology. 2017;89(8):771-775. doi:10.1212/WNL.0000000000004268Bond AE, Shah BB, Huss DS, et al. Safety and efficacy of focused ultrasound thalamotomy for patients with medication-refractory, tremor-dominant Parkinson disease: A randomized clinical trial.JAMA Neurol. 2017;74(12):1412-1418. doi:10.1001/jamaneurol.2017.3098Martnez-Fernndez R, Rodrguez-Rojas R, Del lamo M, et al. Focused ultrasound subthalamotomy in patients with asymmetric Parkinsons disease: a pilot study.Lancet Neurol. 2018;17(1):54-63. doi:10.1016/S1474-4422(17)30403-9Ito H, Fukutake S, Yamamoto K, Yamaguchi T, Taira T, Kamei T. Magnetic resonance imaging-guided focused ultrasound thalamotomy for Parkinsons disease.Intern Med. 2018;57(7):1027-1031. doi:10.2169/internalmedicine.9586-17
Proposed LCD - Magnetic-Resonance-Guided Focused Ultrasound Surgery (MRgFUS) for Essential Tremor and Tremor Dominant Parkinson's Disease (DL37738)
Iacopino DG, Gagliardo C, Giugno A. Preliminary experience with a transcranial magnetic resonance- guided focused ultrasound surgery system integrated with a 1.5- T MRI unit in a series of patients with essential tremor and Parkinsons disease.Neurosurg Focus. 2018;44.Fasano A, De Vloo P, Llinas M, et al. Magnetic resonance imaging-guided focused ultrasound thalamotomy in Parkinson tremor: Reoperation after benefit decay.Mov Disord. 2018;33(5):848-849. doi:10.1002/mds.27348Jung NY, Park CK, Kim M. The efficacy and limits of magnetic resonance guided focused ultrasound pallidotomy for Parkinsons disease: a phase I clinical trial.J Neurosurg. 2018:1-9.Sperling SA, Shah BB, Barrett MJ, et al. Focused ultrasound thalamotomy in Parkinson disease: Nonmotor outcomes and quality of life: Nonmotor outcomes and quality of life.Neurology. 2018;91(14):e1275-e1284. doi:10.1212/WNL.0000000000006279Ito H, Fukutake S, Yamamoto K, et al. Magnetic resonance imaging-guided focused ultrasound thalamotomy for Parkinsons disease with cardiac pacemaker: A case report.Mov Disord Clin Pract. 2018;5(3):339-340. doi:10.1002/mdc3.12578Gallay MN, Moser D, Rossi F, et al. MRgFUS pallidothalamic tractotomy for chronic therapy-resistant Parkinsons disease in 51 consecutive patients: Single center experience.Front Surg. 2019;6:76. doi:10.3389/fsurg.2019.00076Martnez-Fernndez R, Mez-Mir JU, Rodrguez-Rojas R, et al. Randomized trial of focused ultrasound subthalamotomy for Parkinsons disease.N Engl J Med. 2020;383(26):2501-2513. doi:10.1056/NEJMoa2016311
Proposed LCD - Magnetic-Resonance-Guided Focused Ultrasound Surgery (MRgFUS) for Essential Tremor and Tremor Dominant Parkinson's Disease (DL37738)
Yamamoto K, Ito H, Fukutake S, et al. Focused ultrasound thalamotomy for tremor-dominant Parkinsons disease: A prospective 1-year follow-up study.Neurol Med Chir (Tokyo). 2021;61(7):414-421. doi:10.2176/nmc.oa.2020-0370Food and Drug Administration. Exablate Model 4000 Types 1.0 and 1.1 System Summary of Safety and Effectiveness Data. December 16, 2018. Accessed 11/07/2022. https://www.accessdata.fda.gov/cdrh_docs/pdf15/P150038S006B.pdfNational Government Services, Inc. Magnetic Resonance Image Guided High Intensity Focused Ultrasound (MRgFUS) for Tremor.LCDL37421. Revised effective date 4/01/2018. Accessed 11/07/2022.Pouratian N, Baltuch G, Elias WJ, Gross R. American Society for stereotactic and Functional Neurosurgery position statement on magnetic resonance-guided focused ultrasound for the management of essential tremor.Neurosurgery. 2020;87(2):E126-E129. doi:10.1093/neuros/nyz510Wisconsin Physicians Service Insurance Corp. Category III Codes. LCD L35490. Revised effective date 6/12/2022. Accessed 11/07/2022.Palmetto GBA. Magnetic Resonance Image Guided High Intensity Focused Ultrasound (MRgFUS) for Essential Tremor.LCDL37761.Revised effective date 8/13/2020. Accessed 11/07/2022.CGS Administrators, LLC. Magnetic Resonance Guided Focused Ultrasound Surgery System (MRgFUS) for the treatment of neurologic conditions.LCDL37790. Revised effective date 6/12/2022. Accessed 11/07/2022.Parkinsons Disease. Medical Policy Bulletin 0307. Revised effective date 9/16/2022. Accessed 11/07/2022.MRI Guided High Intensity Focused Ultrasound Ablation for Non-Oncologic Indications. Medical Policy MED.00057. Revised effective date 9/16/2022. Accessed 11/07/2022.
Proposed LCD - Magnetic-Resonance-Guided Focused Ultrasound Surgery (MRgFUS) for Essential Tremor and Tremor Dominant Parkinson's Disease (DL37738)
MRI Guided High Intensity Focused Ultrasound Ablation for Non-Oncologic Indications. Medical Policy MED.00057. Revised effective date 9/16/2022. Accessed 11/07/2022.Blue Cross Blue ShieldLA. Magnetic Resonance-Guided Focused Ultrasound. Policy 00180. Revised effective date 1/10/2022. Accessed 11/07/2022.Blue Cross Blue ShieldNC. MRI-Guided Focused Ultrasound (MRgFUS). Medical Policy. Revised effective date 5/2022. Accessed 11/07/2022.Magnetic ResonanceGuided Focused Ultrasound. Medical Policy 7.01.109. Revised effective date 8/22/2022. Accessed 11/07/2022.Magnetic Resonance (MR) Guided Focused Ultrasound (MRgFUS) and High Intensity Focused Ultrasound (HIFU) Ablation. Surgery Policy 139. Revised effective date 12/01/2021. Accessed 11/07/2022.Tufts Health Plan. Medical Necessity Guidelines: Noncovered Investigational Services. Revised effective date 10/01/2022. Accessed 11/07/2022.Wellmark. MRI-Guided High-Intensity Focused Ultrasound (MRgFUS) Ablation. Medical Policy 04.01.09. Revised effective date 1/2022. Accessed 11/07/2022.Deuschl G, Antonini A, Costa J, et al. European Academy of Neurology/Movement Disorder Society-European section guideline on the treatment of Parkinsons disease: I. invasive therapies.Mov Disord. 2022;37(7):1360-1374. doi:10.1002/mds.29066ECRI. ExAblate Neuro (InSightec, Inc.) for Treating Tremor-dominant Parkinson Disease. Plymouth Meeting (PA):2020 Jul 23. (Clinical Evidence Assessment).
Proposed LCD - Magnetic-Resonance-Guided Focused Ultrasound Surgery (MRgFUS) for Essential Tremor and Tremor Dominant Parkinson's Disease (DL37738)
ECRI. ExAblate Neuro (InSightec, Inc.) for Treating Tremor-dominant Parkinson Disease. Plymouth Meeting (PA):2020 Jul 23. (Clinical Evidence Assessment).Chou KL, Tarsey D. Device-assisted and lesioning procedures for Parkinson disease. UpToDate. Updated 10/13/2022. Accessed 11/07/2022. https://www.uptodate.com/contents/device-assisted-and-lesioning-procedures-for-parkinson-disease?search=deep%20brain%20stimulation%20parkinsons&source=search_result&selectedTitle=1~150&usage_type=default&display_rank=1#H3670506581Ghanouni P, Pauly KB, Elias WJ, et al. Transcranial MRI-Guided Focused Ultrasound: A Review of the Technologic and Neurologic Applications.AJR Am J Roentgenol. 2015;205:150.Na YC, Chang WS, Jung HH, et al. Unilateral magnetic resonance-guided focused ultrasound pallidotomy for Parkinson disease.Neurology. 2015;85:549.
Proposed LCD - Enteral Nutrition (DL38955)
CMS National Coverage PolicyN/ACoverage Indications, Limitations, and/or Medical NecessityFor 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.The purpose of a Local Coverage Determination (LCD) is to provide information regarding reasonable and necessary criteria based on Social Security Act  1862(a)(1)(A) provisions.In addition to the reasonable and necessary criteria contained in this LCD there are other payment rules, which are discussed in the following documents, that must also be met prior to Medicare reimbursement:The LCD-related Standard Documentation Requirements Article, located at the bottom of this policy under the Related Local Coverage Documents section.The LCD-related Policy Article, located at the bottom of this policy under the Related Local Coverage Documents section.Refer to the Supplier Manual for additional information on documentation requirements.Refer to the DME MAC web sites for additional bulletin articles and other publications related to this LCD.For the items addressed in this LCD, the reasonable and necessary criteria, based on Social Security Act  1862(a)(1)(A) provisions, are defined by the following coverage indications, limitations and/or medical necessity.Enteral nutrition is covered for a beneficiary who requires feedings via an enteral access device to provide sufficient nutrients to maintain weight and strength commensurate with the beneficiary's overall health status and has a permanent:full or partial non-function or disease of the structures that normally permit food to reach the small bowel; OR,disease that impairs digestion and/or absorption of an oral diet, directly or indirectly, by the small bowel.
Proposed LCD - Enteral Nutrition (DL38955)
full or partial non-function or disease of the structures that normally permit food to reach the small bowel; OR,disease that impairs digestion and/or absorption of an oral diet, directly or indirectly, by the small bowel.Refer to the LCD-related Policy Article for the definition of test of permanence.Adequate nutrition must not be possible by dietary adjustment and/or oral supplements.Typical examples of conditions associated with non-function or disease of the structures that permit food from reaching the small bowel that qualify for coverage are head and neck cancer with reconstructive surgery and central nervous system disease leading to interference with the neuromuscular mechanisms of ingestion of such severity that the beneficiary cannot be maintained with oral feeding (not all inclusive).Typical examples of conditions associated with impaired digestion and/or absorption of an oral diet by the small bowel that may qualify for coverage include inflammatory bowel disease, surgical resection of small bowel, cystic fibrosis, chronic pancreatitis, and advanced liver disease (not all inclusive).If the coverage requirements for enteral nutrition are met, medically necessary nutrients, administration supplies, and equipment are covered.For coverage of the following scenarios, see the LCD-related Policy Article:Enteral nutrition for temporary impairmentsEnteral nutrition for beneficiaries with a functioning gastrointestinal tract whose need for enteral nutrition is not due to reasons related to the non-function or disease of the structures that normally permit food to reach the small bowelOrally administered enteral nutrition products, related supplies and equipment
Proposed LCD - Enteral Nutrition (DL38955)
NUTRIENTSEnteral formulas consisting of semi-synthetic intact protein/protein isolates (B4150 or B4152) are appropriate for the majority of beneficiaries requiring enteral nutrition.The medical necessity for special enteral formulas (B4149, B4153, B4154, B4155, B4157, B4161, and B4162) must be justified in each beneficiary. If a special enteral nutrition formula is provided and if the medical record does not document why that item is medically necessary, it will be denied as not reasonable and necessary. (Refer to theLCD-related Policy Article for policy specific documentation requirements.)EQUIPMENT AND SUPPLIESEnteral nutrition may be administered by syringe, gravity, or pump. Some enteral beneficiaries may experience complications associated with syringe or gravity method of administration.If a pump (B9002) is ordered, there must be documentation in the beneficiary's medical record to justify its use (e.g., gravity feeding is not satisfactory due to reflux and/or aspiration, severe diarrhea, dumping syndrome, administration rate less than 100 ml/hr, blood glucose fluctuations, circulatory overload, gastrostomy/jejunostomy tube used for feeding). If the medical necessity of the pump is not documented, the pump will be denied as not reasonable and necessary.In-line digestive enzyme cartridges (B4105) are reasonable and necessary for beneficiaries who:meet the coverage criteria for enteral nutrition; AND,have a diagnosis of Exocrine Pancreatic Insufficiency (EPI) (refer to the Group 1 Codes in the LCD-related Policy Article for applicable diagnoses).
Proposed LCD - Enteral Nutrition (DL38955)
More than two in-line digestive enzyme cartridges (B4105) per day will be denied as not reasonable and necessary.The feeding supply allowance (B4034, B4035, and B4036) must correspond with the method of enteral nutrition administration (syringe, pump, gravity). If a feeding supply kit does not correspond with the method in which the enteral nutrition is being administered, then the feeding supply kit will be denied as not reasonable and necessary.For dates of service prior to January 1, 2023, the feeding supply allowance (B4034, B4035, and B4036) must correspond to the method of administration indicated in question 5 of the DME Information Form (DIF). If it does not correspond, it will be denied as not reasonable and necessary.If a pump supply allowance (B4035) is provided and if the medical necessity of the pump is not documented, it will be denied as not reasonable and necessary.The codes for feeding supply allowances (B4034, B4035, and B4036) are specific to the route of administration. Claims for more than one type of kit code delivered on the same date or provided on an ongoing basis will be denied as not reasonable and necessary.Enteral feeding supply kit allowances (B4034, B4035, and B4036), are all-inclusive, with the exception of B4105 in-line digestive enzyme cartridge. Separate billing for any item including an item using a specific HCPCS code, if one exists, or B9998 (ENTERAL SUPPLIES, NOT OTHERWISE CLASSIFIED) will be denied as unbundling.Refer to theLCD-related Policy Article CODING GUIDELINES section for additional information about enteral feeding supply allowances.More than three nasogastric tubes (B4081, B4082, and B4083), or one gastrostomy/jejunostomy tube (B4087 or B4088) every three months is not reasonable and necessary.GENERALA Standard Written Order (SWO) must be communicated to the supplier before a claim is submitted. If the supplier bills for an item addressed in this policy without first receiving a completed SWO, the claim shall be denied as not reasonable and necessary.
Proposed LCD - Enteral Nutrition (DL38955)
A Standard Written Order (SWO) must be communicated to the supplier before a claim is submitted. If the supplier bills for an item addressed in this policy without first receiving a completed SWO, the claim shall be denied as not reasonable and necessary.For Durable Medical Equipment, Prosthetics, Orthotics and Supplies (DMEPOS) base items that require a Written Order Prior to Delivery (WOPD), the supplier must have received a signed SWO before the DMEPOS item is delivered to a beneficiary. If a supplier delivers a DMEPOS item without first receiving a WOPD, the claim shall be denied as not reasonable and necessary. Refer to the LCD-related Policy Article, located at the bottom of this policy under the Related Local Coverage Documents section.For DMEPOS base items that require a WOPD, and also require separately billed associated options, accessories, and/or supplies, the supplier must have received a WOPD which lists the base item and which may list all the associated options, accessories, and/or supplies that are separately billed prior to the delivery of the items. In this scenario, if the supplier separately bills for associated options, accessories, and/or supplies without first receiving a completed and signed WOPD of the base item prior to delivery, the claim(s) shall be denied as not reasonable and necessary.An item/service is correctly coded when it meets all the coding guidelines listed in CMS HCPCS guidelines, LCDs, LCD-related Policy Articles, or DME MAC articles. Claims that do not meet coding guidelines shall be denied as not reasonable and necessary/incorrectly coded.Proof of delivery (POD) is a Supplier Standard and DMEPOS suppliers are required to maintain POD documentation in their files. Proof of delivery documentation must be made available to the Medicare contractor upon request. All services that do not have appropriate proof of delivery from the supplier shall be denied as not reasonable and necessary.REFILL REQUIREMENTS
Proposed LCD - Enteral Nutrition (DL38955)
REFILL REQUIREMENTSFor DMEPOS items and supplies provided on a recurring basis, billing must be based on prospective, not retrospective use. For DMEPOS products that are supplied as refills to the original order, suppliers must contact the beneficiary prior to dispensing the refill and not automatically ship on a pre-determined basis, even if authorized by the beneficiary. This shall be done to ensure that the refilled item remains reasonable and necessary, existing supplies are approaching exhaustion, and to confirm any changes or modifications to the order. Contact with the beneficiary or designee regarding refills must take place no sooner than 14 calendar days prior to the delivery/shipping date. For delivery of refills, the supplier must deliver the DMEPOS product no sooner than 10 calendar days prior to the end of usage for the current product. This is regardless of which delivery method is utilized.For all DMEPOS items that are provided on a recurring basis, suppliers are required to have contact with the beneficiary or caregiver/designee prior to dispensing a new supply of items. Suppliers must not deliver refills without a refill request from a beneficiary. Items delivered without a valid, documented refill request will be denied as not reasonable and necessary.Suppliers must not dispense a quantity of supplies exceeding a beneficiary's expected utilization. Suppliers must stay attuned to changed or atypical utilization patterns on the part of their clients. Suppliers must verify with the treating practitioner that any changed or atypical utilization is warranted.Regardless of utilization, a supplier must not dispense more than a 1-month quantity at a time.Supply allowance HCPCS codes (B4034, B4035, and B4036) are daily allowances which are considered all-inclusive and therefore refill requirements are not applicable to these HCPCS codes. Refer to the Coding Guidelines section in theLCD-related Policy Articlefor further clarification.
Proposed LCD - Enteral Nutrition (DL38955)
General InformationAssociated InformationDOCUMENTATION REQUIREMENTSSection 1833(e) of the Social Security Act precludes payment to any provider of services unless "there has been furnished such information as may be necessary in order to determine the amounts due such provider. It is expected that the beneficiary's medical records will reflect the need for the care provided. The beneficiary's medical records include the treating practitioner's office records, hospital records, nursing home records, home health agency records, records from other healthcare professionals and test reports. This documentation must be available upon request.GENERAL DOCUMENTATION REQUIREMENTSIn order to justify payment for DMEPOS items, suppliers must meet the following requirements:SWOMedical Record Information (including continued need/use if applicable)Correct CodingProof of DeliveryRefer to the LCD-related Standard Documentation Requirements article, located at the bottom of this policy under the Related Local Coverage Documents section for additional information regarding these requirements.Refer to the Supplier Manual for additional information on documentation requirements.Refer to the DME MAC web sites for additional bulletin articles and other publications related to this LCD.POLICY SPECIFIC DOCUMENTATION REQUIREMENTSItems covered in this LCD have additional policy-specific requirements that must be met prior to Medicare reimbursement.Refer to the LCD-related Policy article, located at the bottom of this policy under the Related Local Coverage Documents section for additional information.MiscellaneousAppendicesUtilization GuidelinesRefer to Coverage Indications, Limitations and/or Medical NecessitySources of InformationReserved for future use.BibliographyN/A