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The rules say that plans must pay for a medical service or item if regular Medicare would pay for it in this case. 
You can find this rule at 42 Code of Federal Regulations (CFR) Section 422.101. 
 
  
  The rules state that 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 consistently 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. 
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? 
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 months 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 report 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 necessary for populations eligible 
for Medicare due to age, disability, or Medicaid eligibility. 
You can find these rules in the Medicare National Coverage Determination (NCD) for Continuous Positive 
Airway Pressure (CPAP) Therapy For Obstructive Sleep Apnea (OSA), Section 240.4. 
 
If you want to read these Medicare rules, you can go to this website www.medicareappeal.com. 
 
The Plan contract says that the Plan covers items and services in accordance with Medicare rules.