(Medicare National Coverage Determinations Manual)

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.  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   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   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   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.   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.   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).