evekhm/cms_iom_500 huggingface dataset:
(Medicare National Coverage Determinations Manual)
240.2.1  Home Use of Oxygen in Approved Clinical Trials (Effective March 20, 2006)  (Rev. 57, Issued:  05- 26-06; Effective:  03 -20-06; Implementation:  10- 03-06)  A.  General   Oxygen is a colorless, odorless gas that comprises 21 percent of the atmospheric gases at sea level.  Historically, long term supplemental oxygen has been administered in higher than atmospheric concentrations to patients with chronic hypoxemia, generally resulting from cardiac and/or pulmonary disease.  The need for supplemental oxygen is assessed by direct or indirect measurement of the partial pressure of oxygen (conventionally expressed in millimeters of mercury, mmHg) and the oxygen saturation of hemoglobin in arterial blood (expressed as a percent).  Chronic oxygen therapy is generally administered via nasal cannulae, face mask, or tracheostomy, from a stationary or portable oxygen tank or an oxygen concentrator.   The medical literature documents health benefits as well as serious adverse events associated with supplemental oxygen use.  In this light, it is clear that the decision to initiate, continue, or discontinue the use of supplemental oxygen should be guided by high quality scientific evidence.   B.  Nationally Covered Indications   Effective for services performed on or after March 20, 2006 t he home use of oxygen is covered for those beneficiaries with arterial oxygen partial pressure measurements from 56 to 65 mmHg or oxygen saturation at or above 89% who are enrolled subjects in clinical trials approved by the Centers for Medicare & Medicaid S ervices and sponsored by the National Heart, Lung & Blood Institute (NHLBI).  C.  Nationally Non -Covered Indications   N/A  D.  Other   This policy does not alter Medicare coverage for items and service that may be covered or non -covered according to the existing national coverage determination for the home use of oxygen provided outside the context of approved clinical trials (National Coverage Determination Manual, section 240.2and 310.1).  (This NCD was last reviewed April 2006)   240.2.2-  Home Oxygen Use to Treat Cluster Headache (CH) (RETIRED)  (Rev. 11892; Issued: 03- 09-23; Effective: 04 -10-23; Implementation:04- 10-23)
(Medicare National Coverage Determinations Manual)
240.2.2-  Home Oxygen Use to Treat Cluster Headache (CH) (RETIRED)  (Rev. 11892; Issued: 03- 09-23; Effective: 04 -10-23; Implementation:04- 10-23)  Effective September 27, 2021, the Centers for Medicare & Medicaid Services removed the national coverage determination (NCD) for home oxygen use to treat cluster headaches. In the absence of an NCD, coverage determinations will be made by the Medicare Administrative Contractors under section 1862(a)(1)(A) of the Social Security Act, as allowed and described i n Chapter 1, Section 240.2 (Home Use of Oxygen), Subsection D, of Publication 100- 03 of the NCD Manual.   240.3 - Heat Treatment, Including the Use of Diathermy and Ultra-Sound for Pulmonary Conditions  (Rev. 1, 10- 03-03) CIM 35 -3  Not Covered   There is no physiological rationale or valid scientific documentation of effectiveness of diathermy or ultrasound heat treatments for asthma, bronchitis, or any other pulmonary condition and for such purpose this treatment cannot be considered reasonable a nd necessary within the meaning of 1862(a)(1)  of the Act.   Cross -reference:  150.5.   240.4 - Continuous Positive Airway Pressure (CPAP) Therapy For Obstructive Sleep Apnea (OSA) (Effective April 4, 2005) (Effective March 13, 2008)  (Rev. 96, Issued: 10- 15-08, Effective: 03 -13-08, Implementation: 08- 04-08)  A. General   Continuous Positive Airway Pressure (CPAP) is a non- invasive technique for providing single levels of air pressure from a flow generator, via a nose mask, through the nares. The purpose is to prevent the collapse of the oropharyngeal walls and the obstruction of airflow during sleep, which occurs in obstructive sleep apnea (OSA).   The apnea hypopnea index (AHI) is equal to the average number of episodes of apnea and hypopnea per hour.  The respiratory disturbance index (RDI) is equal to the average number of respiratory disturbances per hour.
(Medicare National Coverage Determinations Manual)
Apnea is defined as a cessation of airflow for at least 10 seconds.  Hypopnea is defined as an abnormal respiratory event lasting at least 10 seconds with at least a 30% reduction in thoracoabdominal movement or airflow as compared to baseline, and with at  least a 4% oxygen desaturation.   The AHI and/or RDI may be measured by polysomnography (PSG) in a facility- based sleep study laboratory, or by a Type II home sleep test (HST) monitor, a Type III HST monitor, or a Type IV HST monitor measuring at least 3 channels.  B. Nationally Covered Indications   Effective for claims with dates of service on and after March 13, 2008, the Centers for Medicare & Medicaid Services (CMS) determines that CPAP therapy when used in adult patients with OSA is considered reasonable and necessary under the following situations:   1. The use of CPAP is covered under Medicare when used in adult patients with OSA. Coverage of CPAP is initially limited to a 12 -week period to identify beneficiaries diagnosed with OSA as subsequently described who benefit from CPAP.  CPAP is subsequently covered only for those beneficiaries diagnosed with OSA who benefit from CPAP during this 12- week period.  2. The provider of CPAP must conduct education of the beneficiary prior to the use of the CPAP device to ensure that the beneficiary has been educated in the proper use of the device.  A caregiver, for example a family member, may be compensatory, if consiste ntly available in the beneficiary's home and willing and able to safely operate the CPAP device.   3. A positive diagnosis of OSA for the coverage of CPAP must include a clinical evaluation and a positive:   a. attended PSG performed in a sleep laboratory; or   b. unattended HST with a Type II home sleep monitoring device; or   c. unattended HST with a Type III home sleep monitoring device; or   d. unattended HST with a Type IV home sleep monitoring device that  measures at least 3 channels.
(Medicare National Coverage Determinations Manual)
c. unattended HST with a Type III home sleep monitoring device; or   d. unattended HST with a Type IV home sleep monitoring device that  measures at least 3 channels.   4. The sleep test must have been previously ordered by the beneficiarys treating physician and furnished under appropriate physician supervision.  5. An initial 12 -week period of CPAP is covered in adult patients with OSA if either of the following criterion using the AHI or RDI are met:   a. AHI or RDI greater than or equal to 15 events per hour, or   b. AHI or RDI greater than or equal to 5 events and less than or equal to 14 events per hour with documented symptoms of excessive daytime sleepiness, impaired cognition, mood disorders or insomnia, or documented hypertension, ischemic heart disease, or history of stroke.   6. The AHI or RDI is calculated on the average number of events of per hour.  If the AHI or RDI is calculated based on less than 2 hours of continuous recorded sleep, the total number of recorded events to calculate the AHI or RDI during sleep testing must be at a minimum the number of events that would have been required in a 2- hour period.   7. Apnea is defined as a cessation of airflow for at least 10 seconds.  Hypopnea is defined as an abnormal respiratory event lasting at least 10 seconds with at least a 30% reduction in thoracoabdominal movement or airflow as compared to baseline, and with at  least a 4% oxygen desaturation.   8. Coverage with Evidence Development (CED): Medicare provides the following limited coverage for CPAP in adult beneficiaries who do not qualify for CPAP coverage based on criteria 1 -7 above.  A clinical study seeking Medicare payment for CPAP provided to a beneficiary who is an enrolled subject in that study must address one or more of the following questions:   a. In Medicare- aged subjects with clinically identified risk factors for OSA, how does the diagnostic accuracy of a clinical trial of CPAP compare with PSG and Type II, III & IV HST in identifying subjects with OSA who will respond to CPAP?
(Medicare National Coverage Determinations Manual)
b. In Medicare- aged subjects with clinically identified risk factors for OSA who have not undergone confirmatory testing with PSG or Type II, III & IV HST, does CPAP cause clinically meaningful harm?   c. The study must meet the following additional standards:   d. The principal purpose of the research study is to test whether a particular intervention potentially improves the participants health outcomes.  e. The research study is well -supported by available scientific and medical information or it is intended to clarify or establish the health outcomes of interventions already in common clinical use.   f. The research study does not unjustifiably duplicate existing studies.  g. The research study design is appropriate to answer the research question being asked in the study.  h. The research study is sponsored by an organization or individual capable of executing the proposed study successfully.  i. The research study is in compliance with all applicable Federal regulations concerning the protection of human subjects found at 45 CFR Part 46.  If a study is Food and Drug Administration -regulated, it also must be in compliance with 21 CFR Parts 50 and 56.  j. All aspects of the research study are conducted according to the appropriate standards of scientific integrity.   k. The research study has a written protocol that clearly addresses, or incorporates by reference, the Medicare standards.   l. The clinical research study is not designed to exclusively test toxicity or disease pathophysiology in healthy individuals.  Trials of all medical technologies measuring therapeutic outcomes as one of the objectives meet this standard only if the disease or condition being studied is life -threatening as defined in 21 CFR 312.81(a) and the patient has no other viable treatment options.   m. The clinical research study is registered on the ClinicalTrials.gov Web site by the principal sponsor/investigator prior to the enrollment of the first study subject.   n. The research study protocol specifies the method and timing of public release of all pre -specified outcomes to be measured, including release of outcomes if outcomes are negative or study is terminated early.  The results must be made public within 24 mont hs of the end of data collection.  If a report is planned for publication in a peer -reviewed journal, then that initial release may be an abstract that meets the requirements of the International Committee of Medical Journal Editors.  However, a full repor t of the outcomes must be made public no later than 3 years after the end of data collection.
(Medicare National Coverage Determinations Manual)
o. The research study protocol must explicitly discuss subpopulations affected by the treatment under investigation, particularly traditionally underrepresented groups in clinical studies, how the inclusion and exclusion criteria affect enrollment of these populations, and a plan for the retention and reporting of said populations in the trial.  If the inclusion and exclusion criteria are expected to have a negative effect on the recruitment or retention of underrepresented populations, the protocol must discuss why these criteria are necessary.   p. The research study protocol explicitly discusses how the results are or are not expected to be generalizable to the Medicare population to infer whether Medicare patients may benefit from the intervention.  Separate discussions in the protocol may be neces sary for populations eligible for Medicare due to age, disability, or Medicaid eligibility.   C. Nationally Non -covered Indications   Effective for claims with dates of services on and after March 13, 2008, other diagnostic tests for the diagnosis of OSA, other than those noted above for prescribing CPAP, are not sufficient for the coverage of CPAP.   D. Other  N/A  (This NCD last reviewed March 2008.)   240.4.1  Sleep Testing for Obstructive Sleep Apnea (OSA) (Effective  March 3, 2009)  (Rev. 103, Issued: 07- 10-09, Effective: 03 -03-09, Implementation: 08- 10-09)  A. General
(Medicare National Coverage Determinations Manual)
A. General   Obstructive sleep apnea (OSA) is the collapse of the oropharyngeal walls and the obstruction of airflow occurring during sleep.  Diagnostic tests for OSA have historically been classified into four types.  The most comprehensive is designated Type I attended facility based polysomnography (PSG), which is considered the reference standard for diagnosing OSA.  Attended facility based polysomnogram is a comprehensive diagnostic sleep test including at least electroencephalography (EEG), electro -oculography (EO G), electromyography (EMG), heart rate or electrocardiography (ECG), airflow, breathing/respiratory effort, and arterial oxygen saturation (SaO 2) furnished in a sleep laboratory facility in which a technologist supervises the recording during sleep time and has the ability to intervene if needed.  Overnight PSG is the conventional diagnostic test for OSA.  The American Thoracic Society and the American Academy of Sleep Medicine have recommended supervised PSG in the sleep laboratory over 2 nights for the diagnosis of OSA and the initi ation of continuous positive airway pressure (CPAP).   Three categories of portable monitors (used both in attended and unattended settings) have been developed for the diagnosis of OSA.  Type II monitors have a minimum of 7 channels (e.g., EEG, EOG, EMG, ECG -heart rate, airflow, breathing/respiratory effort, SaO2)-this type of device monitors sleep staging, so AHI can be calculated).  Type III monitors have a minimum of 4 monitored channels including ventilation or airflow (at least two channels of respiratory movement or respiratory movement and airflow), hea rt rate or ECG, and oxygen saturation.  Type IV devices may measure one, two, three or more parameters but do not meet all the criteria of a higher category device. Some monitors use an actigraphy algorithm to identify periods of sleep and wakefulness.   B. Nationally Covered Indications
(Medicare National Coverage Determinations Manual)
B. Nationally Covered Indications   Effective for claims with dates of service on and after March 3, 2009, the Centers for Medicare & Medicaid  Services finds that the evidence is sufficient to determine that the results of the sleep tests identified below can be used by a beneficiarys treating physician to diagnose OSA, that the use of such sleep testing technologies demonstrates improved health outcomes in Medicare beneficiaries who have OSA and receive the appropriate treatment, and that these tests are thus reasonable and necessary under  section 1862(a)(1)(A) of the Social Security Act.  1. Type I PSG is covered when used to aid the diagnosis of OSA in beneficiaries who have clinical signs and symptoms indicative of OSA if performed attended in a sleep lab facility.   2. Type II or Type III sleep testing devices are covered when used to aid the diagnosis of OSA in beneficiaries who have clinical signs and symptoms indicative of OSA if performed unattended in or out of a sleep lab facility or attended in a sleep lab faci lity.  3. Type IV sleep testing devices measuring three or more channels, one of which is airflow, are covered when used to aid the diagnosis of OSA in beneficiaries who have signs and symptoms indicative of OSA if performed unattended in or out of a sleep lab fa cility or attended in a sleep lab facility.   4. Sleep testing devices measuring three or more channels that include actigraphy, oximetry, and peripheral arterial tone, are covered when used to aid the diagnosis of OSA in beneficiaries who have signs and symptoms indicative of OSA if performed unattended in or out of a sleep lab facility or attended in a sleep lab facility.   C. Nationally Non -Covered Indications   Effective for claims with dates of services on and after March 3, 2009, other diagnostic sleep tests for the diagnosis of OSA, other than those noted above for prescribing CPAP, are not sufficient for the coverage of CPAP and are not covered.   D. Other  N/A  (This NCD last reviewed March 2009.)   240.5 - Intrapulmonary Percussive Ventilator (IPV)  (Rev. 1, 10- 03-03) CIM 60 -21  Not Covered
(Medicare National Coverage Determinations Manual)
N/A  (This NCD last reviewed March 2009.)   240.5 - Intrapulmonary Percussive Ventilator (IPV)  (Rev. 1, 10- 03-03) CIM 60 -21  Not Covered   IPV is a mechanized form of chest physical therapy.  Instead of a therapist clapping or slapping the patients chest wall, the IPV delivers mini- bursts (more than 200 per minute) of respiratory gasses to the lungs via a mouthpiece.  Its intended purpose is  to mobilize endobronchial secretions and diffuse patchy atelectasis. The patient controls variables such as inspiratory time, peak pressure and delivery rates.   Studies do not demonstrate any advantage of IPV over that achieved with good pulmonary care in the hospital environment and there are no studies in the home setting.  There are no data to support the effectiveness of the device.  Therefore, IPV in the home  setting is not covered.   240.6-  Transverse (Catheter) Pulmonary Embolectomy (RETIRED)  (Rev. 11892; Issued: 03- 09-23; Effective: 04 -10-23; Implementation:04- 10-23)    Effective October 28, 2021, the Centers for Medicare & Medicaid Services removed the national coverage determination (NCD) for Transvenous (Catheter) Pulmonary Embolectomy  (TPE).  In the absence  of an NCD,  coverage  determinations  will be made by the Medicare Administrative Contractors under section 1862(a)(1)(A) of the Social Security Act.   240.7 - Postural Drainage Procedures and Pulmonary Exercises  (Rev. 1, 10- 03-03) CIM 35 -15  In most cases, postural drainage procedures and pulmonary exercises can be carried out safely and effectively by nursing personnel.  However, in some cases patients may have acute or severe pulmonary conditions involving complex situations in which these procedures or exercises require the knowledge and skills of a physical therapist or a respiratory therapist.  Therefore, if the attending physician determines as part of his/her plan of treatment that for the safe and effective administration of such servic es the procedures or exercises in question need to be performed by a physical therapist, the services of such a therapist constitute covered physical therapy when provided as an inpatient hospital service, extended care service, home health service, or outpatient physical therapy service.
(Medicare National Coverage Determinations Manual)
NOTE:  Physical therapy furnished in the outpatient department of a hospital is covered under the outpatient physical therapy benefit.   If the attending physician determines that the services should be performed by a respiratory therapist, the services of such a therapist constitute covered respiratory therapy when provided as an inpatient hospital service, outpatient hospital service, or extended care service, assuming that such services are furnished to the skilled nursing facility by a hospital with which the facility has a transfer agreement.  Since the services of a respiratory therapist are not covered under the home health benefit, payment may not be made under the home health benefit for visits by a respiratory therapist to a patients home to provide such services.  Postural drainage procedures and pulmonary exercises are also covered when furnished by a physical therapist or a respiratory therapist as incident to a physicians professional service.   Cross references:   The Medicare Benefit Policy Manual, Chapter 6, Hospital Services Covered Under Part B, 20.  The Medicare Benefit Policy Manual, Chapter 7, Home Health Services, 20.  The Medicare Benefit Policy Manual, Chapter 8, Coverage of Extended Care (SNF) Services Under Health Insurance, 50.  The Medicare Benefit Policy Manual, Chapter 15, Covered Medical and Other Health Services, 60.2.   240.8 - Pulmonary Rehabilitation Services - (Effective September 25, 2007)  (Rev. 173, Issued: 09- 04-14, Effective: Upon Implementation: of ICD -10, Implementation: Upon Implementation of ICD -10)  A. General   Pulmonary rehabilitation was defined in a 1999 joint statement of the American Thoracic Society and the European Respiratory Society as a multi -disciplinary program of care for patients with chronic respiratory impairment that is individually tailored and designed to optimize physical and social performance and autonomy and an evidence- based, multidisciplinary, and comprehensive intervention for patients with chronic respiratory diseases who are symptomatic and often have decreased daily life activities.  Integrated into the individualized treatment of the patient, pulmonary rehabilitation is designed to reduce symptoms, optimize functional status, increase participation, and reduce health care costs through stabilizing or reversing systematic manifestations of the disease.
(Medicare National Coverage Determinations Manual)
Although services that make up pulmonary rehabilitation individually may be covered under Medicare and fall into various applicable benefit categories, the Centers for Medicare & Medicaid Services (CMS) has determined that the Social Security Act (the Act)  does not expressly define a comprehensive Pulmonary Rehabilitation Program as a Part B benefit.  In addition, respiratory therapy services are identified as covered services under the Comprehensive Outpatient Rehabilitation Facility benefit and defined in  42 CFR 410.100(e)(1) to (2)(vi).   B. Nationally Covered Indications   N/A  C. Nationally Non -Covered Indications   N/A  D. Other  The CMS has determined that a national coverage determination (NCD) for pulmonary rehabilitation is not appropriate at this time.  A/B MACs (A) and (B) should continue to make decisions under 1862(a)(1)(A) of the Act through their local coverage determina tion (LCD) process or by case -by-case adjudication.  See Heckler v. Ringer , 466 U.S. 602, 617 (1984) (Recognizing that the Secretary has discretion to either establish a generally applicable rule or to allow individual adjudication.).  See also, 68 Fed. Re g. 63692, 63693 (November 7, 2003).  LCDs can be accessed from the CMS search engine located at:  http://www.cms.hhs.gov/mcd/search.asp.   250 - Skin (Rev. 1, 10- 03-03)  250.1 - Treatment of Psoriasis (Rev. 173, Issued: 09- 04-14, Effective: Upon Implementation: of ICD -10, Implementation: Upon Implementation of ICD -10)  Psoriasis is a chronic skin disease, for which several conventional methods of treatment have been recognized as covered.  These include topical application of steroids or other drugs; ultraviolet light (actinotherapy); and coal tar alone or in combination with ultraviol et B light (Goeckerman treatment).