evekhm/cms_iom_500 huggingface dataset:
Proposed LCD - Urine Drug Testing (DL36707)
Jones T, Moore TM, Levy J, Browder JH, Daffron S, Passik SD. A comparison of various risk screening methods for patients receiving opioids for chronic pain management.Clinical Journal of Pain.2012; 28(2):93-100.Jones T, Passik SD. A comparison of methods of administering the opioid risk tool.Journal of Opioid Management.2011; 7(5): 347-352.Mallya A., Purnell AL, Svrakic DM, et al. Witnesses versus unwitnessed random urine tests in the treatment of opioid dependence.Am J Addict.2013; 22(2):175-177.Moore TM, Jones T, Browder JH, Daffron S, Passik SD. A comparison of common screening methods for predicting aberrant drug-related behavior among patients receiving opioids of chronic pain management.Pain Medicine.2009; 10(8):1426-1433.Nafziger AN, Bertino JS. Utility and application of urine drug testing in chronic pain management with opioids.Clin J Pain.2009;25(1)73-79.Nicholson B, Passik S. Management of chronic non-cancer pain in the primary care setting.SMJ. 2007;100(10):1028-1034.Passik S, Jones T. Risk assessment 2.0.PainWeek Journal. 2013; 1(3): 5-9.Reisfield GM, Wasan AD, Jamison RN. The prevalence and significance of cannabis uses in patients prescribed chronic opioid therapy: a review of the extant literature.Pain Med. 2009; 10(8):1434-1441.Schneider J, Miller A. Urine drug tests in a private chronic pain practice.PPM.January/February 2008.
Proposed LCD - External Upper Limb Tremor Stimulator Therapy (DL39591)
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.
Proposed LCD - External Upper Limb Tremor Stimulator Therapy (DL39591)
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.An external upper limb tremor stimulator of the peripheral nerves of the wrist (K1018) and related supplies and accessories (K1019) will be denied as 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.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.General InformationAssociated Information
Proposed LCD - External Upper Limb Tremor Stimulator Therapy (DL39591)
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 REQUIREMENTSRefer to the LCD-related Policy article, located at the bottom of this policy under the Related Local Coverage Documents section for additional information.MiscellaneousAppendicesN/AUtilization GuidelinesRefer to Coverage Indications, Limitations and/or Medical NecessitySources of InformationN/ABibliography
Proposed LCD - External Upper Limb Tremor Stimulator Therapy (DL39591)
Bhatia KP, Bain P, Bajaj N, et al. Consensus Statement on the classification of tremors. from the task force on tremor of the International Parkinson and Movement Disorder Society.Mov Disord.2018;33(1):75-87.Louis ED, Ottman R. How many people in the USA have essential tremor? Deriving a population estimate based on epidemiological data.Tremor Other Hyperkinet Mov (N Y). 2014;4:259.Louis ED. The Roles of Age and Aging in Essential Tremor: An Epidemiological Perspective.Neuroepidemiology. 2019;52(1-2):111-118.Lin PT, Ross EK, Chidester P, et al. Noninvasive neuromodulation in essential tremor demonstrates relief in a sham-controlled pilot trial.Mov Disord. 2018;33(7):1182-1183.Pahwa R, Dhall R, Ostrem J, et al. An Acute Randomized Controlled Trial of Noninvasive Peripheral Nerve Stimulation in Essential Tremor.Neuromodulation. 2019.Yu JY, Rajagopal A, Syrkin-Nikolau J, et al. Transcutaneous Afferent Patterned Stimulation Therapy Reduces Hand Tremor for One Hour in Essential Tremor Patients.Frontiers in neuroscience. 2020;14:530300.Isaacson SH, Peckham E, Tse W, et al. Prospective Home-use Study on Non-invasive Neuromodulation Therapy for Essential Tremor.Tremor Other Hyperkinet Mov (N Y). 2020;10:29.Brillman S, Colletta K, Borucki S, et al. Real-World Evidence of Transcutaneous Afferent Patterned Stimulation for Essential Tremor. 2022;12(1).Zesiewicz T, Elble R, Louis E, et al. Evidence-based guideline update: treatment of essential tremor: report of the Quality Standards subcommittee of the American Academy of Neurology. 2011;77(19):1752-1755.
Proposed LCD - External Upper Limb Tremor Stimulator Therapy (DL39591)
Lyons KE, Ott K. R., Shill, H. Essential Tremor in Adult Patients. http://eguideline.guidelinecentral.com/i/1380755-essential-tremor-advisory-ietf/0? 2021. Accessed January 12, 2023Sterne 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.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.GRADEpro GDT: GRADEpro Guideline Development Tool [Software]. McMaster University, 2015 (developed by Evidence Prime, Inc.). gradepro.org. (Accessed May 1, 2020).
Proposed LCD - Respiratory Care (DL34149)
CMS National Coverage PolicyLanguage quoted from the Centers for Medicare & Medicaid Services (CMS) National Coverage Determinations (NCDs) and coverage provisions in interpretive manuals is italicized throughout the policy. NCDs and coverage provisions in interpretive manuals are not subject to the Local Coverage Determination (LCD) Review Process (42 CFR 405.860[b] and 42 CFR 426 [Subpart D]). In addition, an administrative law judge may not review an NCD. See 1869(f)(1)(A)(i) of the Social Security Act.Unless otherwise specified, italicized text represents quotation from one or more of the following CMS sources:Title XVIII of the Social Security Act, 1833(e) prohibits Medicare payment for any claim which lacks the necessary information to process the claim.Title XVIII of the Social Security Act, 1861(cc)(1) discusses CORF facility services.Title XVIII of the Social Security Act, 1861(s)(2)(B) provides coverage of services incident to physicians services furnished to hospital patients.Title XVIII of the Social Security Act, 1862(a)(1)(A) allows coverage and payment for only those services that are considered to be reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member.42 CFR 485.70-CORF personnel qualifications- lists qualifications for respiratory therapists.Federal Register: December 31, 2002 (Volume 67, Number 251) p 79999-80000 Final rule revisions to payment policies specific to G0237-G0239CMS Manual System, Pub 100-02,Medicare Benefit Policy Manual, Chapter 6, 20.4-20.4.1CMS Manual System, Pub 100-02,Medicare Benefit Policy Manual, Chapter 8, 50.8.2CMS Manual System, Pub 100-02,Medicare Benefit Policy Manual, Chapter 12, 10, 20, 20.1, 20.2, 30, 30.1, and 40.5CMS Manual System, Pub 100-03,Medicare National Coverage Determinations Manual, Chapter 1, Part 4, 240.7 and 240.8
Proposed LCD - Respiratory Care (DL34149)
CMS Manual System, Pub 100-03,Medicare National Coverage Determinations Manual, Chapter 1, Part 4, 240.7 and 240.8CMS Manual System, Pub 100-20, One Time Notification, Transmittal 477, dated April 24, 2009, Change Request 6338Coverage Indications, Limitations, and/or Medical NecessityRespiratory care (respiratory therapy) is defined as those services prescribed by a physician or a non-physician practitioner for the assessment and diagnostic evaluation, treatment, management, and monitoring of patients with deficiencies and abnormalities of cardiopulmonary function.Monitoring is defined as the periodic checking of the equipment in actual use to ascertain proper functioning; real time tracking the individuals condition to assure that he/she is receiving effective respiratory therapy services; and periodic evaluation of the patients progress in improvement of respiratory function.Respiratory care (respiratory therapy) services may include but are not limited to the following:application techniques to support oxygenation and ventilation in an acute illness (e.g., establish/maintain artificial airway, ventilatory therapy, precise delivery of oxygen concentrations, aid in removal of secretions from pulmonary tree)therapeutic use/monitoring of medicinal gases, pharmacologically active mists and aerosols, and equipment (e.g., resuscitators, ventilators)bronchial hygiene therapy (e.g., deep breathing, coughing exercises, IPPB, postural drainage, chest percussion/vibration, and nasotracheal/endotracheal suctioning)diagnostic tests ordered by and for the evaluation by a physician or NPP (e.g., pulmonary function test, spirometry, and blood gas analyses etc.)pulmonary rehabilitation techniques (e.g., exercise conditioning, breathing retraining, and patient education regarding management of patients respiratory problems) andperiodic assessment of the patient for the effectiveness of respiratory therapy services.For Pulmonary Rehabilitation services, please refer to Noridian's Billing and Coding: Pulmonary Rehabilitation Services Local Coverage Article under Related Documents at the end of this policy.The above services may be performed by respiratory therapists, physical therapists, nurses, and other qualified personnel as described by relevant state practice acts. Documentation in the medical record must clearly support the need for respiratory therapy services to be separately reimbursed.
Proposed LCD - Respiratory Care (DL34149)
Respiratory care (respiratory therapy) services can be considered reasonable and necessary for the diagnosis and treatment of a specific illness or injury. The service provided must be consistent with the severity of the patients documented illness and must be reasonable in terms of modality, amount, frequency, and duration of treatment. The treatment must be generally accepted by the professional community as safe and effective for the purpose used, and recognized standards of care should not be violated.Medicare coverage of respiratory care (respiratory therapy) provided as outpatient hospital or extended care services depends on the determination by the attending physician (as part of his/her plan of treatment) that for the safe and effective administration of such services the procedures or exercises in question need to be performed by a respiratory therapist, physical therapists, nurses, and other qualified personnel as described by relevant state practice acts as listed above. In addition, Medicare may cover postural drainage and pulmonary exercises furnished by a respiratory therapist as incident to a physician's professional service.Instructing a patient in the use of equipment, breathing exercises, etc. may be considered reasonable and necessary for the treatment of the patients condition and can usually be given to a patient during the course of treatment by any of the health personnel involved, (e.g., physician, nurse, respiratory care practitioner or other qualified personnel).These educational instructions are bundled into the covered service and separate payment is not made.Separate billing for one-on-one education is rarely necessary and is usually only reasonable at the start of the treatment plan. Initially, for outpatient care where a series of visits provides  an individualized physical conditioning and exercise program using proper breathing techniques separate billing for one-on-one intervention is both reasonable and necessary. Provision of more information than is ordinarily provided during the course of a treatment (e.g., extensive theoretical background in the pathology, etiology, and physiological effects of the disease) is not considered reasonable and necessary. Group sessions that only offer generalized (i.e., non-individualized) education and training are not covered.
Proposed LCD - Respiratory Care (DL34149)
Therapeutic procedures with an individualized physical conditioning and exercise program using proper breathing techniques can be considered for a patient with activity limitations. Breathing retraining, energy conservation, and relaxation techniques are often used. Ventilatory muscle training (VMT) may be considered reasonable and necessary in a very select population of pulmonary patients who demonstrate significantly decreased respiratory muscle strength and who remain symptomatic despite optimal therapy. Routine exercise, or any exercise, without a documented need for skilled care, is not covered.Pulmonary Function TestsPulmonary Function Tests (PFTs) are a broad range of diagnostic procedures that measure two components of the respiratory system's functional status: 1) the mechanical ability to move air in and out of the lungs, and 2) the effectiveness of providing oxygen to the body and removing carbon dioxide.Pulmonary function tests are divided into five general areas:Spirometry,Lung Volume,Diffusion Capacity,Lung compliance, andPulmonary Studies during Exercise Testing.General indications for any of the pulmonary function tests include:To determine the presence of lung disease or abnormality of lung function;To determine the type of abnormality;To determine the extent of abnormality;To determine the extent of disability due to abnormal lung function, andTo determine and evaluate one or more courses of therapy in the treatment of the particular condition.General limitations for any of the pulmonary function tests include:All diagnostic tests payable by Medicare must be ordered by a treating physician and used in patient care. Community standards always apply.The various modalities to assess pulmonary function must be used in a purposeful and logical sequence.Tests performed as components rather than a single test will be denied.Medicare does not cover screening tests.Medicare coverage excludes routine (screening) tests for asymptomatic patients with or without high risk of lung disease (e.g., prolonged smoking history). It also excludes studies as part of a routine exam, and studies as part of an epidemiological survey.
Proposed LCD - Respiratory Care (DL34149)
Medical necessity is an overriding requirement for Medicare coverage of diagnostic testing.When a diagnosis or evaluation can be made clinically or when test results are not necessary to manage the patient's disease, then Pulmonary Function Testing is not reasonable and necessary. In addition, on routine visits for other medical conditions, when a patient claims to be stable or does not report clinically meaningful changes in pulmonary status, a physical exam and interview confirm this, repeat testing is unlikely to be necessary. Noridian has found that in many patients routine use of PFTs at each office visit is not a necessary and reasonable clinical practice and as such, cannot be reimbursed.Providers should pay particular attention to guidelines for the usage of the CPT codes relative to Medicare's standards of reasonable and necessary care found in the Billing and Coding article attached under Related Local Coverage Documents below.1. Spirometry:Spirometryis performed by having the patient breathe into a mouthpiece that is connected to an instrument called a spirometer. The spirometer records the amount of air and the rate that it is breathed in and out over a specified amount of time (approximately 10 seconds). Some of the test measurements are obtained by normal breathing and other measurements require forced inhalation and exhalation.Spirometry is most useful for assessing obstructive lung diseases such as asthma and chronic obstructive pulmonary disease (COPD).Refer to the Billing and Coding article attached under Related Local Coverage Documents below for the CPT codes for Spirometry. Routine and/or repetitive billing for unnecessary batteries of tests is not clinically reasonable.Specific indications for spirometry include:Diagnostic indications:Detect the presence or absence of lung dysfunction suggested by history or clinically significant physical signs and symptoms,Detect the presence or absence of lung dysfunction suggested by other abnormal diagnostic tests (e.g., radiography, arterial blood gas analysis).Monitoring indications:Quantify the severity of known lung disease,Assess the change in lung function over time,Assess the change in lung function following administration of or a change in therapy,Assess the risk for surgical procedures known to affect lung function.Limitations to performing spirometry are:
Proposed LCD - Respiratory Care (DL34149)
Limitations to performing spirometry are:Routine or repetitive batteries of tests are not clinically reasonable.In many scenarios, simple spirometry is a mainstay of pulmonary function testing and is usually sufficient to differentiate between obstructive and restrictive disorders and evaluate their severity. Extensive testing may often not be necessary for adequate clinical assessment.Post-bronchodilator spirometry is used to evaluate the reversible component of bronchospasm and to determine if the patient is a bronchodilator therapy candidate. Claims for spirometry will be subject to medical review as follows: there are clinical signs and symptoms consistent with bronchospasm; or spirometry without bronchodilator is abnormal; or reversibility or nonreversibility of bronchospasm has not been demonstrated. Repeat studies are covered only with clinically significant change, necessitating adjustment/augmentation of therapy, appropriately documented.General clinical contraindications to spirometry include: hemoptysis of unknown origin, pneumothorax, unstable cardiovascular status, thoracic/abdominal or cerebral aneurysms, recent eye surgery, recent thoracic or abdominal surgery, and presence of acute disease processes that interfere with test performance.2. Lung volumeThe entire lung volume is not measured by simple spirometry because it is larger than the air quantity exhaled/inhaled. Lung volume is measured when a person breathes nitrogen or helium gas through a tube for a specified period of time. The change in concentration of the gas in a chamber attached to the tube is measured before and after test breathing, allowing estimation of the lung volume. Measures include total lung capacity, residual volume, and functional residual capacity.Lung volume tests are most useful for assessing restrictive lung diseases such as those caused by scarring inside the lungs or by abnormalities in the ribcage or muscles of the chest wall.CPT codes for lung volume determination may be added when clinically relevant (see Section 4).Indications for a lung volume test are as follows, when consistent with community standards of reasonable clinical practice: